ML20196K412

Forwards Copy of Agreement State Application,3rd Draft, 980914, Submitted by Pennsylvania Dept of Environ Protection on 990224

ML20196K412
Person / Time
Issue date:	03/17/1999
From:	Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP)
To:	Cameron F, Congel F, Paperiello C NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD), NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS), NRC OFFICE OF THE GENERAL COUNSEL (OGC)
References
NUDOCS 9903240194
Download: ML20196K412 (600)

Text

~ ~

,f

~

.p \ UNrF.D STATES g, jt NUCLEAR REEULATORY COMMISSION WASHINGTON, D.C. sogeH001 t.

g, March 17, 1999 MEMORANDUM TO: Carl Parserello, Director Office of Nuclear Material Safety and Safeguards Francis X. Cameron l Deputy Assistant General Counsel and Special Counsel  !

For Public Liaison and Agreement State Programs

.. Office of General Counsel l F ank Congel, Director incidence Response Openations b'

Hubert J. Miller, Regional Administrator Region i q FROM: Paul H. Lohaus, Director Office of State Programs a [AA t iig *h SUBJECT; NRC COMPLETENESS REVIEW OF DRAFT PENNSYLVANIA AGREEMENT STATE APPLICATION The Bureau of Radiation Protection, Pennsylvania Department of Environmental Protection, submitted on February 24,1999, a draft Agreement State application. A copy marked,

• Agreement State Application,3* Draft, September 14,1998' is attached.

As I have discussed either with you, or with your staff, we plan to follow a revised and streamlined process for reviewing the Pennsylvania request. The first step will be a -

completeness review performed witNn about 60 days of receipt to determine whether the Pennsylvania request contains all essential parts and does not cantain any obvious fatal flaws that would prevent staff from completing a detailed review against the criteria for new agreements. The completeness review would be performed by a team and I am asking that you identify a representative from your Office who could serve on this review team. I would appreciate a response by April 2,1999.

To perform the completenen review, the team would need to rr.eet for one week at a single location. (Based on the Ohio application, I believe that the team should be able to complete a i I

review within one week). We are exploring with the Division of Industrial and Medical Nuclear i Safety, NMSS, the ability to use the Business Process R4-engineering Center as a dedicated place for the team to canduct work and deliberations. The team's product would be a response to Pennsylvania either indicating the application is complete and ready for formal submittal by \ ,

the Governor, or identifying areas in the appication where additional information is needed. g (The response letter to Pennsylvania would be cir::ulated for Office concurrence). The basis for \

the completeness review is the Commission Statement of Policy: " Criteria for Guidance of States and NRC in Discontinuance of NRC Regulatory Authority and Assumption by States .o c 9903240194 990317 Y PDR STPRC ESOPA PDR me hf .,' f&p l

I O

l Agreement State Application 3'd Draft September 14,1998 i

I O

O

l y-

{'v'; THE COMMONWEALTH OF PENNSYLVANIA DRAFT j Harrisburg, PA 17105+NNNNN DATE MODELED ON MASS. LETTER FROM GOV. WELD XXXXXXXXXXXXT 17-NNNNNNN Fax: 717-NNNNI.NNNN DRAFT DRAFT DRAFT DRAFT The Honorable Stuart R. Levin Chairman United States Nuclear Regulatory Commission Washington, D.C. 20555

Dear Mr. Chairman:

I am writing to :.equest formally an agreement between the United States Nuclear Regulatory Commission (NRC) and the Commonwealth of Pennsylvania, as authorized under Section 274b of the Atomic Energy Act of 1954, as amended, and the Pennsylvania Radiation Protection Act of 1984, Section 201, under which the c., commission will discontinue and the Commonwealth will assume certain regulatory

( \j authority for radioactive materials now under federal jurisdiction. The specific

(/ authority requested at this time is for:

A. Byproduct material as defined in Section 11e(1) of the Act l

B. Source materials I C. Special nuclear materials in quantities not sufficient to form a critical mass D. Licensing of Low-Level Radioactive Waste Facilities l I certify that the Commonwealth of Pennsylvania wants to assume regulatory responsibility fer such materials, and that the Commonwealth has a program for the control of radiation hazards adequate to pre :t the public health and safety with respect to materials within Pennsylvania covered by this proposed agreement.

Enclosed is information describing the Commonwealth's radiation control program and regulatory capabilities as well as a copy of our radiation control regulations. At this time, the Commonwealth does not wish to assume authority over uranium milling activities, However, Pennsylvania reserves the right to apply to the NRC at a future date for an amended agreement to assume authority in this area.

Our Administration is hopeful that the proposed agreement may become effective by INSERT DATE.

Sincerely

(

Mv f XXXXXXXXXX Enclosures l

I J

r i

DRAFT I nev2/25/99 AN AGREEMENT O)

(

BETWEEN THE UNITED STATES NUCLEAR REGULATORY COMMISSION AND THE COMMONWEALTH OF PENNSYLVANIA FOR THE DISCONTINUANCE OF CERTAIN COMMISSION REGULATORY AUTHORITY AND RESPONSIBILITY WITHIN THE COMMONWEALTH PURSUANT TO SECTION 274 OF THE ATOMIC ENERGY ACT OF 1954 AS AMENDED

{

O)

(

WHEREAS, The United States Nuclear Regulatory Commission (hereinafter referred to as the Commission) is authorized under Section 274 of the Atomic Energy Act of 1954, as amended (hereinafter referred to as the Act), to enta into agreements with the Governor of any State /Commonw Ith providing for discontinuance of the regulatory authority of the Commission within the State / Commonwealth under Chapters 6,7. and 8, and Section 161 of the Act with respect to byproduct materials as defined in Sections I le. (1) and (2) of the Act, source materials, and special nuclear materials in quantities not sufficient to form a critical mass; and, WHEREAS, The Governor of the Commonwealth of Pennsylvania is authorized under The Radiation Protection Act to enter into this Agreement with the Commission; and, WHEREAS, The Governor of the Commonwealth of Pennsylvania certified on [datel, that the Commonwealth of Pennsylvania (hereinafter referred to as the Commonwealth) has a program for the control of radiation hazards adequate to protect public health and safety with respect to the materials within the Commonwealth covered by this Agreement, and that the Commonw ealth I desires to assume regulatory responsibility for such materials; and, i

, WHEREAS, The Commission found on [date] that the program of the Commonwealth for the

[V ) regulation of the materials covered by this Agreement is compatible with the Commission's program for the regulation of such materials and is adequate to protect public health and safety; and, 1

DRAFT 4

WilEIEAS, The Commonwealth and the Commission recognize the desirability and importance h of cooperation between the Commission and the Commonwealth in the formulation of standards for protection against hazards of radiation and in assuring that Commonwealth and Commission programs for protection against hazards of radiation will be coordinated and compatible; and, WIiEREAS, The Com nission and the Commonwealth recognize the desirability of the reciprocal recognition aflicenses, and of the granting oflimited exemptions from licensing of those materials subject to this Agreement; and, WHEREAS, This Agnement is entered into pursuant to the provisions of the Atomic Energy Act of 1954, as amended; NOW, THEREFORE, It is hereby agreed between the Commission and the Governor of the Commonwealth acting in behalf of the Commonwealth as follows:

ARTICLE 1

[3 Subject to the exceptions provided in Articles II, IV, and V, the Commission shall discontinue, as of the effective date of this Agreement, the regulatory authority of the Commissicn in the Commonwealth under Chapters 6,7, and 8, and Section 161 of the Act with respect to the following materials:

A. Byproduct materials as defined in Section 11 e.(l) of the Act; B. Source materials; C. Special nuclear materials in quantities not sufficient to fonn a critical mass.

D. The regulation of the land disposal of byproduct, source, or special nuclear waste materials received from other persons; ARTICLE II A. This Agreement does not provide for discontinuance of any authority and the Commission shall retain authority and responsibility with respect to:

1. The regulation of the construction and operation of any production or utilization facility or any uranium enrichment facility; o

2

DRAFT

2. The regulation of the export from or import into the United States of byproduct, source, or special nuclear material, or of any production or utilization facility:

3. The regulation of the disposal into the ocean or sea of byproduct, source, or special nuclear materials waste as defined in the regulat;ons or orders of the Commission;

4. The regulation of the disposal of such other byproduct, source, or special - nuclear material as the Commission from time to time determines by regulation or order should, because of the hazards or potential hazards thereof, not be so disposed without a license from the Commission;

5. The evaluation of radiation safety infonnation on sealed sources or devices containing byproduct, source, or special nuclear materials and the registration of the sealed sources or devices for distribution, as provided for in regulations or orders of the Commission.

ARTICLE JJII With the exception of those activities identified in Article II.A.1 through 4, this , freement may be amended, upon application by the Commonwealth and approval by the Comrmssion, to include one or more of the additiona' activities specified in Article 11, paragraphs [those h

(/

activities not included in the agreement], whereby the Commonwealth may then exert regulatory authority and responsibility with respect to those activities.

l

)

l ARTICLE IV i Notwithstanding this Agreement, the Commission may from time to time by rule, regulation, or order, require that the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing source, byproduct, or special nuclear material shall not transfer possession er control of such product except pursuant to a license or an exemption from licensing issued by the Commission.

ARTICLE V This Agreement shall not affect the authority of the Commission under Subsection 161b or 161i of the Act to issue rules, regulations, or orders to protect the common defense and security, to protect restricted data, or to guard against the loss or diversion of special nuclear material.

ARTICLE VI y The Commission will cooperate with the Commonwealth and other Agreement States in the formulation of standards and regulatory programs of the State and the Commission for protection 3

DRAFT against hazards of radiation and to assure that Commission and the Commonwealth programs for protection against hazards of radiation will be coordinated and compatible. The Commonwe{th agrees to cooperate with the Commission and other Agreement States in the formulation of standards and regulatory programs of the Commonwea'h and the Commission for protection against hazards of radiation and to assure that the Commonwealth's program will continue to be compatible with the program of the Commission for the regulation of materials covered by this Agreement.

The Commonwealth and the Commission agree to keep each other informed of proposed changes in their respective rules and regulations, and to provide each other the opportunity for early and substantive contribution to the proposed changes.

The Commonwealth and the Commission agree to keep each other informed of events, accidents, and licensee performance that may have generic implication or otherwise be of regulatory interest.

ARTICLE VII The Commission and the Commonwealth agree that it is desirable to provide reciprocal recognition oflicenses for the materials listed in Anicle I licensed by the other party or by any other Agreement State. Accordingly, the Commission and the Commonwealth agree to develop appropriate rules, regulations, and procedures by which such reciprocity will be accorded.

ARTICLE VIII The Commission, upon its own initiative after reasonable notice and opportunity for hearing to the Commonwealth, or upon request of the Govemor of the Commonwealth, may terminate or suspend all or part of this agreement and reassert the licensing and regulatory authority vested in it under the Act if the Commission fmds that (1) such termination or suspension is required to protect public health and safety, or (2) the Commonwealth has not complied with one or more of the requirements of Section 274 of the Act. The Commission may also, pursuant to Section 274j of the Act, temporarily suspend all or part of this agreement if, in the judgment of the Commission, an emergency situation exists requiring immediate action to protect public health and safety and the Commonwealth has failed to take necessary steps. The Commission shall periodically review actions taken by the Commonwealth under this Agreement to ensure compliance with Section 274 of the Act which requires the Commonwealth program to be adequate to protect public health and safety with respect to the materials covered by this Agreement and to be compatible with the Commission's program.

ARTICLE IX This Agreement shall become etTective on [date], and shall remain in effect unless and until 4

t DRAFT

~

such time as it is terminated pursuant to Article VIII.

Done at [ City, State] this [date) day of[ month], [ year].

FOR TIIE UNITED STATES NUCLEAR REGULATORY COMMISSION

, Chairman FOR THE COMMONWEALTH OF

, Governor T

5

~

rcontents Or die 1 .g,e.me.t etat.

11.atio.

2 L censing the Low-Level Radioactive Waste Disposal Facility

$ Statutory Authority 4 History Organization 6 soo,et

, 7 Resumes f) 8 positio nescription b Training 10 Equipment 11 inspection Forms '

32 Ethics 13 .

Executive Summaries 14 Regulations C '

15 compliance and Enforcement Poli y kAVggrye READY IMfWX"' INDEXING SYSTEM

\

O .

Agreement State Application for the Commonwealth of Pennsylvania O

1 I

O l

c y

\

1.0 INTRO D UCTION p\

i

(

.. .... . .. .. ... . ..... . . ... 2 f 1.1 PROGRAM OBJECTIVES AND NEEDS:-

U .. 3 l .2 STATUTORY ~ A UTHORITY.....*:"."

=....................1...?............-.- _4 1.3 REGbLAiORYkif[HbdlTY...#....;.$..O O I....l...fO #.D..$.3..".k...IS Y 1 b.D

^ ^

.5 1.3.1 Rulemaking Auhhoiity. " * *# *AE"'* M W 'I A .6 1.3.2 EQB Authority and Relationship to the Department-- .6 1.3.3 EQB Legislative Authority..

..7 1.4

SUMMARY

-. 7 2.0 ORGANIZATION AND DUTIES OF TIIE BUREAU OF RADIATION PROTECTION.. .. 7 2.1 DIVISION OF NUCLEAR SAFETY

__8 2.1.1 Nuclear Reactor Oversight Program (Nuclear Safey Section).. .8 2.1.2 Appalachian States LLRWDisposalProgram .8 (Low-LevelRadioactive Waste Section)...

2.1.3 Emergency Response Program (Emergency Response Section)... .9 2.2 DIVISION OF RADIATION CONTROL - .9 l 2.2.1 Licensing ofRahactive Materials.. ..

.10 l 2.2.2 foni:ing Radiation Sourtes...

. .. ] 1 2.2.3 Inspection and Compliance.; 11 2.2.4 SpecialProjects .

.. I2 2.2.3 Emergency Respome 12 2.3 RADON DIVISION -

-12 3.0151PLEh!ENTATION OF TIIE AGREEh!ENT STATE PROGRAh! FOR 51ATERIALS L1CENSEES. . . . . ._. .

.. . . . .. .. 12 3.1 OVERVIEW.- .

12

,A 3.2 LICENSINC. .. .

-13 i

)

k 3.3 ACCOMPLIMIMENTS TOWARDS AGREEMENTSTATE.: .15  !

I 4.0 LICENSING OF LOW-LEVEL RADIOACTIVE WASTE DISPOSAL FACILITY . . 16 l

4.1 APPALACHIAN STATE LOW-LEVEL RADIOACTIVE WASTE COMMISSION - _17 5.0 LAEORATORY SUPPORT .. . . .

.17 '

6.0 REGIONAL EQUIPSIENT ... . 2. . .I9 7.0 TECIINICAL ASSISTANCE . .. b . . . 19 7.1 INTRAAGENCY TECHNICAL ASSISTANCE - . _19 7.2 INTERAGENCY TECHNICAL ASSISTANCE ;

19 7.3 TECHNICAL ASSISTANCE FROM OUTSIDE AGENCY . . -20 7.4 ACQUISITION OF CONTRACTOR SERVICES - =20 8.0 LEGAL ASSISTANCE & SUPPORT.. .. . _. .. . ... 20 9.0 DEP ADVISORY COhih11TTEES ._.... . . . . . 21 9.1 RADlhTION PROTECTION ADVISORY COMMITTEE._ . _21 9.2 IAW. LEVEL WASTE ADVISORY COMMITTEE . 21 9.3 CITIZENS ADVISORY COUNCIL . '

. . .' . . . . _ .22

 ! J J .i .~ , I . - _ _ _l ',, O ' i (. ' ( j 10.0 EAIERGENCY RESPONSE h1ANAGEh1ENT . 22 10.1 PRIMARY RESPONSIBILITY ...... .. . 22 10.2 EMERGENCY PLANNING RESPONSIBILITIES .. .. 22 (O 4 I 1.0 SUnih1ARY. .. .. . . . ... . ... .- . 23 v}

\ l Application 1

1.0 INTRODUCTION

Section 274 of the Atomic~~ Energy Act (42 U.S.C 2021) authorizes states to assume certain regulatory' fun'etions.whiefwould oth'erwise be the responsibilityfof the U.S'. Nuclear Regulatory.

Commission NC).IIhim{chanism'by which a sbite assunie[s h suc' resforisibilitiis,is"an n A'grher' ent between the NRC and the Govemor of the state. Before a state can become an " Agreement State," the Govemor must certify that the state has a program for the control of radiation hazards adequate to protect the public health and safety. In addition, the NRC must determine that the state's program is in accord with the requirements of Subsection (o) of Section 274; and is in all other respects compatible with 'the NRC's program for the regulation of the materials covered by the proposed agreement, and is adequate to protect the public health and safety with respect to such materials. There must also be state legislation authorizing the Govemor to enter into such an agreement.

The Commonwealth of Pennsylvania has established itself as a leader in the area of radiation protection. Numerous significant events have contributed to Pennsylvania attaining this leadership role.

Major events are listed in the Historical Summary which is enclosed with this Application (See Tab 4).

The Commonwealth ofPennsylvania wishes to assume responsibility for regulating byproduct material, source material, special nuclear material in quantities not sufficient to form a critical mass, and the low-level radioactive waste (LLRW) disposal facility.

The Governor of Pennsylvania has included a program description and other information needed to demonstrate that the Commonwealth of Pennsylvania satisfies all federal requirements for becoming an Agreement State and is prepared and qualified to assume regulatory authority for byproduct material as defined in 42 U.S.C. 2014 (e)(1), source material, special nuclear material in quantities not sufficient to form a critical mass, and permanent disposal of LLRW containing any of these materials. This application consists of the Governor's certification, and copies of all statutes and regulations under which the Commonwealth will administer its regulatory program, and a narrative which presents a description of the history, current practices, capabilities, and proposed activities of the Commonwealth of Pennsylvania G relative to a complete radiation safety program.

4 i - -

', [ ,

s

\

Application 2

(N

(  :

1.1 Program Objectives And Needs V - , , . m 4 4 ,

As'th'e Agreement State program is developed and established, theprimary objective of the program w'ill eb' to priit'e ct'the public h'ea'lth)sifety and felfary 5f tlie*citizensjfPenniylvania' T'o accomplish this objective, certain essential features must be built into the regulatory program. The Bureau of Radiation Protection (BRP) has been designated within the Department of Environmental Protection (DEP), to implement a regulatory program so that radioactive materials are used in a safe and acceptable manner in order to protect the health and safety of the citizens of Pennsylvania from excessive or harmful radiation exposure. In the development of the Agreement State program, BRP considers the following features to be essential:

1.

Necessary Statutory Authority: BRP must have the statutory authority necessary to fulfill its responsibilities to protect citizens and the environment.

2. Compatible Regulations: Regulations must be developed which describe the requirements necessary to protect public health and safety.

3. Technically Capable Staff: The quality of any technical prograrn is determined by the capabilities ofits staff. The Agreement State program, therefore, must have a well qualified staff of technica!

and scientific people in sufficient number to implement the program effectively.

4. Technical Resources: The Agreement State program must be able to utilize technical resources available within the DEP, and outside agencies. Advisory committees will also be used to provide guidance to the BRP. -

5. Procedures: Technically correct and compatible precedures for Licensing, Inspection, and Enforcement must be developed in order to administer an effective program.

6. Adequate Emergency Response Capabilities: BRP must be capable of effectively responding to and mitigating any radiological emergencies which may arise.

p 7. The program snust have the necessary Radiation Measuring Instrumentation.

(% 8. Adequate Funding: The Agreement State program must be adequately funded in order to recrd and retain quality staff, purchase instrumentation and equipment, and administer the program effectively.

9. Administrative Support: The Agreement State program must have the necessary administrative support to function effectively and efficiently. In addition, the'necessary procedures and equipment to communicate and analyze data must be available, e.g., data processing, word processing capabilities.

10. Consistency and Quality Control: Personnelin the Agreement State program must be adequately trained in Pennsylvania and NRC regulations, standards, and procedures for uniform f

administration of the licensing and inspection program. .

11. Cooperative Attitude: Although strict enforcement action must be taken when necessary, BRP l

must portray a positive and cooperative service attitude to licensees and the general public and 1 take the necessary steps to assure that the needs of Pennsylvania citizens are met. BRP must also cooperate with other agencies involved with the regulation of radioactive material to assure i effective use of resources and to share information and knowledge.

% e  %

kj.,j j .i I '., ;

i '

- ! l ',  !!

% i 1

1 1

Application 3

1 )

I 1

i l

) 1.2 Statutory Authority )

1 j

ThTPennsylvania G'enerIa 'ssembly has enacted a number oflaws .with adequate authority to j

enable the',' C ornnjonpe'alth tofulfillits'resplmkibilities'as'ah A'gder'n/nt state.Ne[Cinka[A's'sembly

• has designated the Pennsylvania DEP as the agency responsible for administering the Commonwealth's radiation safety and enforcement programs. The BRP has been designated as the Bureau to carry out the duties and responsibilities under the Department's Agreement State program.

A brief description of the significant statutes goveming radiation protection and LLRW disposal programs is provided below:

The Radiation Protection Act, Act 1984-147, ernpowered the Department to establish, implement and maintain a comprehensive statewide radiation protection program. Some of the powers and duties given to the Department under this Act are as follows:

1. Provide for the licensing and regulation, in cooperation with the Federal Government, other state agencies and appropriate private entities of radiologic equipment and procedures.

2. Assuine licensing and regulatory responsibility from the Federal Government for certain radioactive materials.

3. Maintain a comprehensive environmental radiation monitoring program around nuclear power plants and at other locations in the Commonwealth.

4. Establish a nuclear reactor oversight program to evaluate all nuclear power plants in the Commonwealth.

5. Establish and maintain a comprehensive emergency radiation response capability in conjunction with the Pennsylvania Emergency Management Agency.

6. Establish plans and procedures for notification of spent nuclear fuel shiprients.

Subsequent to the enactment of Act 1984-147, additional legislation affecting some of the BRP programs has been enacted by the Pennsylvania General Assembly and approved by the Governor.

in 1985, the Pennsylvania General Assembly and the Governor approved the Appalachian States Low-Level Radioactive Waste Compact.

This Act established the Appalachian States Low-Level Radioactive Waste Commission, and provided for Pennsylvania to enter into a compact with the states of Maryland, Delaware and West Virginia.

In 1988, the Pennsylvania Low-Level Radioactive Waste Disposal Act, Act 1988-12, was enacted and approved.

7 Act 1988-12 provides for the management and disposal oflow-level radioactive waste (LLRW),

siting of LLRW disposal facility, and for the licensing ofits operator. The Act further provides for powers and duties of the Department and the Environmental Quality Board (EQB).

Some of the powers and duties given to the Department under this Act are as fo!!ows:

1. Develop and implement a comprehensive program for the regulation of the generation, storage, handling, transportation, processing, minimization, separation, management and disposal oflow- i level radioactive waste to the extent allowable under Federal law or State law, whichever is more stringent.

2. Implement a regulatory, inspection, enforcement and monitoring program consistent with the terms of an agreement between the United States Nuclear Regulatory Commission (NRC) and the Commonwealth, as prov:ded for in Section 201 of the Radiation Protection Act, and this Act.

3. Enter into a contract with an operator-licensee designate to sert:en the State to locate potentially suitable sites, to study the sites in detail, and to submit a lic'ense application to'operatelthe regional LLRW disposal facility. " " ' ' ' ' """'"'d I

4. License a regional facility operator in accordance with Section 308 and regulations promulgated thereunder.

b U

Application 4 1

5. Issue permits to generators, brokers and carriers orlow-level radioactive waste for access to the (Q .

regional facility in accordance with provisions of this Act and with the specific regulations promulgated under this Act.

6.

g.s . . . . - the Ap alachian St Im,plem, k!7**f d d b,en,t Pennsyl.va.nia's 3  ;

k), e ,, i .., E,I, ] d duties.,a,nd  ; h i,atesr.e,spons.ib,(i

9) LLRW In 1990, the Low-Level Radioacti'- Waste Regional Facility Act, Act 1990-107, was enacted to create a fee system to cover the costs rela

o the establishment of an LLRW Disposal Facility in Pennsylvania. A copy of Acts 1984-147,1988-12,1985-120 and 1990-107 is included in Tab 3 of this document.

1.3 Regulatory Authority The BRP has been authorized to promulgate comprehensive regulations governing its radiation protection pregrams. These regulations are comprehensive enough to allow Pennsylvania to implement the Agreement State programs. The Pennsylvania Act 1984147, section 201; and Act 1988-12, section 301

[2]; authorize the governor of Pennsylvania, on behalf of the Co . monwealth, to enter into agreements with the NRC to assume authority to regulate the use and the dispcsai af certain radioactive materials. In his December 1995 letter to the NRC, Governor Ridge stated Pennsyivania's intent to assume Full Agreement State authorization from NRC, including the authority to regulate the disposal oflow-level radioactive waste. A list ofchapters of the Pennsylvania regulations is as follows:

h V

Il  ; I I - { i ( l., f, j ( i j '

v

)

Application 5

7 .- 2 i

l Commonwealth ofPennsylvania S Pennsylvania Code )

Title 25JnvironmergtalProtection a 4

Department oi' Environmental Protection

/1 LA 4 % & %s %r M u 1.r.'qs v

+

,l a

Article V. Radiological Health Chapter Title 215. General Provisions 216. Registration of Radiation-Producing Machines 217. Licensing of Radioactive Material 218. Fees 219. Standards for Protection Against Radiation 220. Notices, Instructions and Reports to Workers; Inspections 221. X-rays in the Healing Arts 222. [ Reserved]

223. Veterinary Medicine 224 Medical Use ofRadioactive Material 225.

Radiation Safety Requirements for Industrial Radiographic Operations 226. Radiation Safety Requirements for Wireline Service Operations and Subsurface Tracer Studies 227.

Radiation Safety Requirements for Analytical X-ray Equipment, X-ray

~ Gauging Equipment and Electron Microscopes 228. Radiation Safety Requirements for Particle Accelerators 229. [ Reserved) 230. Packaging and Transportation of Radioactive Material b 231. [ Reserved]

.h 232 233.

Licenses And Radiation Safety Requirements ForIrradiators

[ Reserved]

235. [ Reserved]

236. Low Level Radioactive Waste Management and Disposal 237. Rebuttable Presumption of Liability of the Operator of the Regional Low-Level Waste Facility '

240. Radon Certification 4

1.3.1 Rulemaking Authority The Department alone does not have the authority to promulgate regulations. 'This power is reserved for the Environmental Quality Board (EQB). The EQB is comprised of cat inet-level officials, members of the Citizen's Advisory Council, and members of the General Assembly. It is chaired by the Secretary of the Department.

1.3.2 EQB Authority and Relationship to the Department .

> i, - ) i. . } d. .[fj# i<fJ l(",)

The EQB, established pursuant to the Administrative e

(

Code of 1929, formulate, adopt and promulgate rules and regulations under the various acts implemented by the Department. This includes those rules and regulations developed by the Department to cany out the provisions of the Radiation Protection Act and the Low-Level Radioactive Waste Disposal Act.

Application 6

i 1.3.3 EQB Legislative Authority O

(A ,

Under Section 302 of the Radiation Protection Act, the EQB has the power and duty to adopt the rules and regulations of the D.epartment to carry,ou,t the provis, ions of the Radiati,on Protection Act.

Section 302 of the lew,-Level Radioactive Waste Disposal Act specifies the powers and duties,of with regard to low-le' vel radioactive waste! It directs the EQB to adopt regulations develop'ed by the Department for the implementation of the act and any other regulatory requirements the Department finds necessary or appropriate for the protection ofpublic health and the environment from low-level radioactive waste.

J l

1.4 Summary The legislation summarized above and included with the State's application provides Pennsylvania with ample authority to regulate and enforce a complete radiation protection program. Provisions of two separate laws ( Radiation Protection Act, and the Low Level Radioactive Waste Disposal Act) explicitly authorize the Governor to execute necessary agreements with the NRC.

2.0 ORGANIZATION AND DUTIES OF THE BUREAU OF RADIATION PROTECTION The Bureau of Radiation l>rotection is placed within the Department's Deputate for Air, Recycling and Radiation Protection under the direction of a Deputy Secretary. The BRP is headed by a Bureau Director. The BRP Bureau Director reports directly to the Deputy Secretary for Air, Recycling and O Radiation Protection as shown in the organization charts in Tab 5. The Deputy Secretary reports to the Secretary of the Department through the Executive Deputy Secretary for Policy and Communications. The BRP personnel carry out the Department's radiation protection duties and responsibilities as required by the laws of the Commonwealth.

The Department is comprised of six Deputates: Air, Recycling and Radiation Protection; Management and Technical Services; Water Management: Mineral hesources Management; Policy and Communications; and Pollution Prevention and Compliance Assistance. The Department is the sole state agency responsible for the regulation and implementation of radiation protection programs in the Commonwealth.

The BRP has been organized into three divisions which carry out the various radiation protection programs it has been empowered or authorized to perfonn under various Pennsylvania statutes and regulations. The three divisions are - Radiation Control, Nuclear Safety, and Radon. Each division is managed by a Division Chief, who reports directly to the Bureau Director. The BRP organization chart is also included in Tab 5.

The BRP is responsible for implementing the following programs:

1.

Licensing and inspection of radioactive materials not regulated by the federal government.

2. Registration and inspection of medical and industrial x-ray equipment.

3. Nuclear reactor oversight.

4. Siting and licensing of a regional LLRW disposal facility.

5. Nuclear emergency response. - . ' '

6. Radon monitoring and certification.

A description of the duties performed by each Division of the BRP is provided below.

O Application 7 l

2.1 Division of Nuclear Safety O

(' -

The Division of Nuclear Safety (DNS) is comprised of Nuclear Safety, Low-Level Radioactive waste, and Emergency, Response sections as shown in the organization chart. .The DNS has been assigned the following three major responsibilities: I '! r d 5 l j 120 ] ~ b, I ! I. l l ) l !

3 1.

Provide comprehensive Nuclear Reactor Oversight and professional nuclear expertise to the Commonwealth.

2.

Site, license and regula': the Appalachian States Low-Level Radioactive Waste (LLRW) disposal facility.

3.

Develop and maintain an efrective emergency response program, and provide assistance to the Pennsylvania Emergency Management Agency (PEMA) during a nuclear event or emergency.

2.1.1 Nuclear Reactor Oversight Program (Nuclear Safety Section)

The DNS has developed and implemented a comprehensive statewide nuclear reactor oversight review and inspection program as mandated by the Pennsylvania Radiation Protection Act, 1984-147.

The Nuclear Reactor Oversight Program employs several experienced nuclear engineers who are assigned to various nuclear power plant sites in the Commonwealth. The BRP nuclear engineers conduct nuclear plant evaluations and participate in inspections with the U.S. Nuclear Regulatory Commission (NRC) inspectors at these facilities. The nuclear engineers also review and evaluate all licensee-proposed license amendments and provide input into the NRC review process to determine whether the proposed license amendments constitute a significant safety hazard.

The nuclear engineers are also responsible for conducting periodic inspections oflow-level radioactive waste (LLRW) packaging and transportation activities at nuclear power plants. The O

\ /

Department has negotiated a Memorandum of Understanding (MOU) with the NRC to conduct such inspections. The purpose of these inspections is to ensure compliance with the applicable federal regulations. Although the NRC retains the ultimate enforcement power under this MOU, the BRP nuclear engineers provide support to the NRC during any hearings or meetings pertaining to these inspections.

The Act 1984 147, also established a fee system which requires the nuclear utilities in Pennsylvania to pay for the costs associated with the implementation of this program. Each nuclear utility pays to the Department an annual amount of $400,000 per reactor site. There are currently nine operating nuclear power plants at five sites in Pennsylvania.

2.1.2 Appalachian States LLRW Disposal Program (Low-Level Radioactive Waste Section)

The DNS has also established a comprehensive Low-Level Radioactive Waste Disposal Pro;; ram.

This program is mandated by the Pennsylvania Low-Level Radioactive Waste Disposal Act,1988-12. This program is also responsible for the licensing of the regional LLRW Disposal l'acility ia Pennsylvania.

In 1980, Congress enacted the Low-Level Radioactive Waste Policy Act which made each state responsible for the disposal of LLRW generated within its borders and encouraged the states to enter into compacts. States that belong to compacts must provide for regional management of LLRW and can legally exclude waste from outside their compacts. In 1985, Congress amended the Low-Level Radioactive Waste Policy Act to reaffirm the regional compact concept and set deadlines, along with a series of financial incentives and penalties, to encourage states to meet the deadlines for disposal facility development.

The Pennsylvania General Assembly responded to the federal laws by erbicting the Ap'palachian States Low-Level Waste Compact Act of 1985. This Act committed Pennsylvania to find a regional LLRW disposal site for the Appalachian States Compact. The member states of this compact are Delaware, Maryland, West Virginia and Pennsylvania. Pennsylvania was selected as the initial host state because, it generated the largest amount of the waste within the compaat. In 1988, the General Assembly g

V) enacted the Low-Level Radioactive Waste Disposal Act. The Act designated and authorized the Application 8

l l

p 0 partment to select a site operator and to develop a comprehensive program to license and regulate the siang, operation, decommissioning and long-term care of the regional disposal facility. The Act also (w authorized the Department to pennit all generators, brokers and carriers that would use the regional facility DEP selec,ted Chem-Nuclear Systems, LLC (CNS) tl[ rough an open public process to, site, develo and operate the regional faci %ty. The General Assembly, enacted the Low-Level Radioacti0e Waste Regional Facility Act in 1996 to establish a fee system to co've'r the' costs'related to the'dekelop' ment of the Appalachian States LLRW c'Voni facility in Pennsylvania. The nuclear utilities in Pennsylvania and one utility in Maryland have contributed approximately $33 million. The Department has been paying the CNS contract costs from this Fund.

Activities related to the licensing of the LLRW Disposal Facility are presented in Tab 2 of this  !

document.

2 1.3 Emergency Response Program (Emergency Response Section)

The DNS has developed and implemented an effective nuclear emergency response program.

This program is mandated by the Pennsylvania Acts, 1984-147 and 1988-12. A fee system has been established which requires the nuclear utilities in Pennsylvania to pay for the costs associated with the implementation of this program.

Over one half-million individuals live within the Emergency Planning Zone of the five nuclear power plants sites in Pennsylvania. In the event of a nuclear power plant accident, it is essential that effective, timely protective action decisions are made to protect the public. These decisions depend on the continued viability of a comprehensive radiation emergency plan; up-to-date monitoring techniques; radiation detection equipment; ongoing staff training; coordination with nuclear utilities, federal agencies and other state agencies; and participation in drills and exercises.

The Division of Nuclear Safety has a major responsibility in providing technical support and assistance to the Pennsylvania Emergency Management Agency (PEMA) during a nuclear event or emergency. Its nuclear engineers act as on-site representatives for the Commonwealth during nuclear emergencies. A major lesson learned from the 1979 accident at Three Mile Island ( TMI) Nuclear Unit 2, and 1993 security event at TMI Nuclear Unit I was that independently obtained information by the nuclear engineers and their independent assessment were vital to the Commonwealth's decision making process.

Besides the three major activities described above, the Division of Nuclear Safety is also involved in the decommissioning of nuclear facilities, and for establishing plans, and procedures for notification of spent nuclear fuel shipments through the Commonwealth.

2,2 Division of Radiation Control The Division of Radiation Control is comprised of the lice sing, section environmen al surveillance section and the x-ray equipment registration prog: . The licensing section is rr.sponsible for licensing users of naturally occurring and accelerator produced radioactive rnaterial in the Commonwealth.

The registration program consists of registering equipment which produce ionizing radiation. There are three Radiation Protection Field Offices to cany out Pennsylvania's comprehensive radiation protection program which also includes inspection and compliance. These field offices are located in Pittsburgh, Conshohocken, and Harrisburg. Policies and issues relative to the radiation protection program in regional offices fall within the purview of the director ofBRP. Administrative policies and functions in the regional offices are the responsibility of the Regional Director, who reports to the Deputy Secretary for Field Operations who in turn reports directly to the Secretary of the Department. ;  :

i The Environmental Surveillance section is responsible for carrying out a cornprehensive environmental radiation monitoring program throughout the Commonwealth including five nuclear power stations and certain other nuclear facilities.

s Application 9

This section also performs routine monitoring, sampling, and analysis of environmental p parameters to determine levels of radiation and radioactivity in the general environment and around nuclear power reactors and other facilities that utilize radioactive material.

The section develops, plans and procedures,to, respond to accidents occu,rring at r plants, daring radioactive material transportation; and at radionuclide  ;; t useg facilitiesa, I The Environmental Surveillance section will be responsible for evaluating environmental monitoring around the low-level radioactive waste disposal facility and preparation of emergency response plans for the facility.

2.2.1 Licensing of Radioactive Materials In 1971, the State of Pennsylvania began licensing persons to use radioactive materials which were not under thejurisdiction of the federal govemment. Licensing procedures were designed to coincide as closely as possible with the licensing po:icies and procedures used by the NRC and Agreement States.

Licensing guides and forms, DEP policies, application forms, and other administrative tools were developed with the assistance of other Agreement States and the NRC (See Tab 11). Present policies and procedures used in licensing naturally occurring and accelerator produced radioactive materials (NARM) are nearly identical to those used by the NRC in licensing byproduct materials. Applications are reviewed and, when applicable, these reviews are coordinated with Agreement States and appropriate federal agencies. Pre-licensing visits are conducted as necessary. Licenses are generally issued and renewed for five year periods. Prior to termination of a license, BRP requires documentation that all radioactive material has been transferred to an authorized recipient. Fmal close-out surveys are performed by either BRP or the licensees upon approval by BRP.

As of March 5,1998, a total of 453 licenses for naturally occurring and accelerator-produced radioactive materiah (NARM) were in force.

Inspection and Compliance of Licensees: There is an inspection and compliance program which falls under

) the region's comprehensive radiation protection plan. During inspections DEP will assist the licensee with d

compliance problems and recommend actions which can be perfarmed for a better radiation safety program. The inspection of NARM radionuclides has been perf ormed since the program began in 1960.

Inspections of State NARM licensees have been conducted since 1971.

The NARM inspection program is similar to the NRC's materials inspection program.

At the completion of each inspection, the inspector confers with licensee representatives and reviews the results of the inspection. The inspector submits a comprehensive written report to supervisory staff. The report describes inspection findings and lists all items of noncompliance found during the inspection.

Following review by supervisory personnel, a letter is prepared and sent to the lice' n see's management outlining the facility's compliance status. The licensee is required to notify BRP within 20 days concerning actions proposed to correct deficiencies. Should the licensee not bring the radiation prograrn into compliance with license requirements and regulations, BRP may initiate enforcement procedures and impose a civil penalty and/or issue an order to abate the violation.

Licensees have a right to a hearing before the Environmental Hearing Board unless a situation constitutes an imminent threat to public health, in which case BRP may issue an emergency order summarily requiring the owner or operator administrative sanctions. BRP may also direct the Attorney General to obtain an injunction against the violator. Also, a person who is found in violation of any of the provisions of the Radiation Protection Act may be found guilty of a misdemeanor by action of the Pennsylvania Attomey General. A press release may also be issued by BRP if deemed appro% ate.

Follow-up inspections are conducted routinely in cases involving willful or flagrant v%aons, repeated poor performance in an area of concern, or serious breakdown in management controls. Follow-up inspections are usually conducted if more than four serious violations were found during the most recent routine inspection of a licensee. The Supervisory personnel review each enforcement action on a case-by-case basis to decide if a follow-up inspection is indicated. Allitems of non-compliance are given special attention by the inspector during the next inspection of the facihty.

Application 10

)

1

P BRP also conducts special investigations as needed to investigate such items as allegations, O overexposures to personnel, and incidents involving radioactive material. Senior staff supervise such investigations to assure they are conducted promptly, professionally, and thoroughly.

~% . , '

2.2.2 Ionizing Radiation Sources l

As of March 5,1998, BRP had registered 10,929 radiation facilities which included 30,075 radiation producing systems. The following is a listing of facilities by type: f j

RADIATION RADIATION PRODUCING FACILITY "IYPE FACILITIES REGISTERED SYSTEMS REGISTERED Dentists 5997 17,215 Medical Doctors 962 1467 Osteopathic Physicians l 89 112 Chiropractors 1305 1313

{

l Veterinarians 661 775 Podiatrists 734 {

779 Hospitals '251 5481 Medical Clinics 311 612 Homes 18 38 Prisons 20 49 Universities / Schools 53 438 Industries 456 1490 Other Medical 53 276 Other Non-Medical 19 30 Totals 10,929 30,075 2.2.3 Inspection and Compliance , ,

There is an inspection and compliance function within the program for regulating radiation producing equipment. During the period Jan 1,1997, through Oct 1,1997, a total pf 3773 radiation producing systems were inspected. These inspections were conducted by the three regional offices. BRP conducts inspections according to the schedule prescribed in the Radiation Protection Act. Inspection frequencies range from two to four year intervals. During inspections DEP will assist the registrant with compliance problems and recommend actions which can be performed for a better radiation safety

)

program. Similar to the radioactive materials program, letters are prepared and sent to operators of radiation producing systems outlining the facility's compliance status. Should the operator not b-ing the radiation program into compliance with the regulations, BRP may initiate enforcement actions as described {

previously in the case of materials license violations.

I The entire inspection and compliance program is designed to use electronic data processing equipment. This use of data processing assures administrative efficiency and provides BRP a strong compliance data base for determining program effectiveness and future program direction.

i ii$ . ! j I, .;.'l ', l ( ' j l

Application 11 1

l

2.2.4 Special Projects

( '

Regional staff, members have pursued various.special projeca. hiost of these;can be characterized as surveys to better assess'and understand newer modalitiesy in use b' licensees and registrants.! Some of these projects have been published in the proceedings of the' National Confer'enceaon R' diatiori Control Program Directors.

DEP management has supported surveys for the advancement of the public perception of radiation protection and the over ii protection of the citizens within the Commonwealth. In some instances DEP management has eve n taken the lead. For example, James Yusko, the Western Area Radiation Protection Manager, has published many articles on the incidence of radioactive materials in the scrap metal recycling stream.  ;

2.2.5 Emergency Response The regional staff are available for response to radioactive incidents such as lost or damaged sources, contamination of facilities, or transportation mishaps. Personnel respond to an average of approximately 40 incidents per year. The communication structure is such that it includes for personnel paging, two-way radio communication, back-up survey instrumentation, supplementary vehicles, and administrative coordination.

2.3 Radon Division The Radon Division, comprised of the Certification Section and the Radon Monitoring Section, is responsible for providing awareness and education to the public and to certify radon testing, mitigation and laboratory facilities in Pennsylvania.

The Cenification Section employs health physicists who administer the certification program including policy development, application review, fee collection, enforcement of certification regulations, maintenance of certification lists and associated administrative functions.

The Radon Monitoring Section employs health physicists who carry out a comprehensive inspection program of certified testers, mitigators, and laboratories.

In addition, all Radon Division staff participate in public speaking engagements and in implementing various projects funded by the management of EPA State Indoor Radon Grant moneys.

3.0 IMPLEMENTATION OF TIIE AGREEMENT STATE l

PROGRAM FOR MATERIALS LICENSEES I

3.1 Overview. '

l Under Pennsylvania' proposed Agreement State program, the Division of Radiation Control will be the Division responsible for licensing byproduct material, source material, and special nuclear material in quantities not sufficient to form a critical mass.' '

l The Division of Nuclear Safety will be responsible for the licensing ofLLRW disposal site.

O O

Application 12

3.2 Licensing.

As of October,1997,, the NRC had approximately 850 active specific licenses, issued to persons within Pennlylvania. -Therefore a total workload of about 1000 specific licenses,(including some of the

~

existing 453 St' ate NARM' specific' e lice'ns's)'is' anticipated. To haiidje this additional re'gulatory lo'ad, BRP will expand and enhance the basic licensing procedures that it has developed during the past 27 years issuing NARM licenses. The Department's policies and procedures will continue to be consistent with NRC guidelines. New BRP regulatory guides presently under development are patterned after those of the NRC. Standards and procedures for license application review, and approval will continue to be compatible with NRC practice.

Inspection and Enforcement.

The DEP regional offices will conduct routine inspections of activities authorized by Agreement State licenses. Inspection schedules will, as a minimum, be modeled after the NRC's inspection priority system.

Inspections will be conducted from the three regional offices Pittsburgh, Harrisburg and Conshohocken.

Conshohocken is located near the NRC's Region 1 office. The purpose of the PRP Agreement State program will be to promote and protect the radiological health and safety of.'ne public, employees' health and safety, and the environment by:

ensuring compliance with Departmental regulatiort and license conditions; obtaining prompt correction of violations and adverse quality conditions which may affect safety; deterring future violations and occurrences of conditions adverse to quality; and encouraging improvement oflicensee performance, including the prompt identification and reporting ofpotential safety problems.

C

('

Consistent with the purpose of this program, prompt and vigorous enforcement action will be taken when dealing with licensees who do not achieve the necessary attention to detail and the high standard of compliance which BRP expects. The specific enforcement action taken will depend on the circumstances of each case. In no case, however, willlicensees who cannot achieve and maintain adequate levels of protection be permitted to conduct licensed activities.

Following each inspection, the inspector will confer with licensee representatives to inform them of inspection results. The inspector will send a comprehensive written report describing Inspection findings and detailing any apparent violations. Each report will be reviewed by the Regional Manager.

In the event that BRP discovers any deficiency (ies) during an inspection, the Department will send the licensee a written notice itemizing the area (s) ofdeficiency(ieg and will require the licensee to submit within 20 days of the date of the notice a written response including:

corrective steps which have been taken liy the licensee and the results achieved; corrective steps which will be taken; 2nd the date when full compliance will be achieved.

If the licensee fails to provide an adequate response to the written notice, the Department will normally hold a management conference with the licensee prior to taking enforcement action. The Department may also elect to hold a conference for other violations. The purpose of these conferences will be to:

discuss items of deficiency or nonconformance, their significance and causes, and the licensee's '

corrective actions; determine whether there are any aggravating or mitigat'ing'circumsta'nces; nrid obtain other information which will help determine the appropriate enforcement action.

If compliance cannot be achieved through these informal conferences. BRP will take more formal enforcement action. However, for conditions which create an imminent threat to public health and safety, BRP will take immediate action in accordance with Pennsylvania law. Pennsylvania law provides that if k

l Application 13 i

- the Department finds that a condition exists which constitutes an immediate threat to health due to the violation of any provisions of the Radiation Protection Act or any code, rule, regulation or order

~ promulgated under the Act and requiring immediate action to protect the public health or welfare, it may issue an order reciting the existene,e of,such an imngedjateJheat an,d t,he find,ings of the D,epartr pertaining thereto. The Department may summanly caus,e the abatement of such violation or may direct the Attorney General to obtain akinjunction'again'st iuchliolaior7 n~ab' a teme'nt'oriler"will beIffective immediately but willinclude notice of the time and place of a public hearing before the Department to be held within 20 days of the date of such order to assure thejustification of such order.

Potential remedial actions which can be ordered by BRP include civil penalties, orders to modify, suspend, or revoke a license, or impound a radiation' source. A license may be modified, suspended or revoked in the following instances: to remove a threat to the public health and safety or environment; to stop facility construction when funher work could preclude or significantly hinder the lentification or correction of an improperly constructed safety related system or component, or when implementation of the licensee's quality assurance program is not adequate to provide confidence that construction activities are being properly carried out. )

I when the licensee has not responded adequately to other enforcement action; when the licensee interferes with the conduct of an inspection or investigation; or for any reason not mentioned above for which license revocation is legally authorized.

when a licensee is unable or unwilling to comply with BRP's requirements; when a licensee refuses to correct a violation Follow <

spections will be conducted as necessary by BRP staff to verify compliance with Department rules aao enforcement orders and to determine willful or flagrant violations, repeated poor performance in an area of concern, or serious breakdown in management controls. The Regional Manager's will review each case individually to decide if a follow-up inspection is necessary. All previous areas of deficiency will also be given special attention by the inspector during the next routine inspection of the facility.

Anticipated Licenses.

3 The Division of Radiation Control will be responsible for all NRC licenses transferred to DEP

\

with the exception of the LLRW disposal site. Thus, responsibility for the possession of byproduct, source or special nuclear materials in quantities not sufficient to form a critical mass will be assi ned by the Division of Radiation Control within the Bureau of Radiation Protection.

StaffRequirements.

Many different skills will be needed by BRP to adequately administer a regulatory program.

Training and experience in health physics, industrial hygiene, nuclear medicine technology, engineering, physics, pharmacy, chemistry, and biology are all necessary. In addition, expertise in various types of facilities (e.g., hospitals, universities. industries, research institutions, laboratories) is also desirable.

BRP, recognizing these needs, evaluated the training and experience ofits current staff and recruited individuals who would supplement and complement the skills already available within BRP. Resumes of current staff positions are included in Tab 7. The job specifications for these individuals are contained in Tab 8.

Staff members of the Division of Radiation Control, Division of Nuclear Safety, and field offices have the technical background needed to administer and support an Agreement State program. ,

' An indication of the Bureau's practical experience is that during the past twelve months the Bureau has  !

conducted approximately 60 inspections of NARM licensees. To gain even greater experience in inspection procedures, field office staff have accompanied NRC inspectors on approximately 35 inspections in the past year. Field office staff will continue to accompany NRC inspectors to gain additional experience.

The NRC has recommended a staffing level of 1.0 to 1.5 per 100 licenses. The authorized BRP staffing level is approximately 1.4 per 100 licenses The staffing of the Division of Radiation Control for the Agreement State program is adequate in scope and appropriate in' depth. I % '

. '. J O '

Application 14

3.3 Accomplishments Mwards Agreement S't ate.

n

(' '

BRP,has progresse,d steadily described below. The followmg discu,toward accomplishing the Agreement, State program c5je ssion describes specific steps that have been taken. m -n.

\ I ,I l h M k.)D M 3 3 l D $ $ d kl bI I l a) Technically Capable Etaff: Beginning in early 1994, the Department has continued to hire additional technical personnel to meet its staffing requirements. The excellent professional credentials of these personnel are described in Tab 7. Additional training has been provided for appropriate BRP technical staff as detailed in Tab 9. Steps have been initiated to enter all appropriate BRP staff training records into a single computer data base. When a individual has demonstrated competency in a particular area to management, the training chan will be completed and the database updated by management. The routinely updated database will be used to assure that technical staff maintain the appropriate depth and breadth of training. Competency will be demonstrated to management before an inspector or license reviewer is allowed to perform an inspection at a licensed facility.

Necessary Statutory Authority: BRP has adequate statutory authority to administer an effective Agreement State program.

b) Adequate Emergency Response Capabilities: BRP has 25 years experience with response to incidents involving loss, theft, fire and/or damage involving radioactive material. The Division of Radia' tion Control responds to approximately 40 incidents per year. The command structure is also available for personnel paging, two-way radio communication, supplementary vehicles and survey instruments and administrative coordination. BRP has worked closely with the NRC in responding to emergencies. The combination of the Department's regional offices located in Pittsburgh, Harrisburg and the Conshohocken will enable the Department to provide prompt on-site emergency response services throughout the State.

c) Necessary Radiation Measuring Instrumentatidn/ Laboratory Support: As described in Tab 10, BRP has acquired adequate instmmentation and laboratory suppon for the Agreement State program. The Division of Radiation Control has developed an administrative system to ensure that equipment is properly maintained. calibrated, inspected, controlled and replaced as necessa,ry.

d) Adequate Funding: BRP has provided an adequate financial base for its programs and a realistic ,

license fee structure to support Agreement State operations. Tab 6 contains details of these fiscal '

provisions. "

9 1

e) The Bureau of Office Systems and Services manages the Department's procurement, central office advancement account, contract compliance, warehousing, general fixed asset accountability, surplus property management, fleet management, commercial real estate leasing, commercial property management, Commonwealth-owned land and building inventory, Commonwealth-owned surplus land and building report, voice communications systems, radiocommunications systems, new Department headquarters building, records management, publications rnanagement, forms management, word processing, DEP Central Office Duplicating, ofTice systems, DEP mail and messenger services, Commonwealth copier program, state insurance fund, Pennsylvania Bulletin control and submission, and DEP Administrative Manual. These services are provided to the BRP on a routine basis by written and verbal request.

f) Clerical Support - DEP provides one clerical support person to each of the three regions. The Division of Nuclear Safety employs one full time program sfpp, ort s,taff. Additional clerical staff will be assigned as necessary to support program work load.

g) Data Processing - All of the personnel in the Bureau of Radiation Protection have personal computers that contain adequate software capabilities including: word processing, spreadshee; data base management and telecommunications.

Application 15

h) Public Information- The Department has dedicated a considerable amount of time and effort to infc,rming the citizens of Pennsylvania about the Commonwealth's low-level radioactive waste and radiation protection programs, and opportunities for the public to participate at key decision points. DEP also has a web site for public information and the Update. - 4 '

! ) [ 5-l -[ [ j Mi Cil} hh i) Confidential Infortnation - The re] lease ofTl O)) or propnetary inf medica]l personnel is afforded maximum protection consistent with the requirements of 25 Pa. Code i 215.14 (relating to availability ofrecords for public inspection). Unless the Department determines that disclosure is in the public interest, or is necessary for the Department to carry out its duties under the Radiation '

Protection Act, the following records are not available for public inspection:

(1) Trade secrets or secret industrial processes customarily held in confidence; I (2) A report ofinvestigation or inspection, not pertaining to safety and health in industrial plants, which would disclose the institution, progress or results of an investigation undertaken by the Department;

( 3) Personnel, medical and similar files, the disclosure of which would operate to the prejudice or impairment of a person's reputation or personal safety.

4.0 LICENSING OF LOW-LEVEL RADIOACTIVE WASTE DISPOSAL FACILITY The authority for licensing and regulation of the use and disposal of radioactive materials at the federal level is vested in the NRC. However, under the terms of Section 2746 of the Atomic Energy Act of 1954, as amended, a state that can demonstrate a regulatory program that is compatible with the federal program may receive NRC authorization to regulate the use and disposal of radioactive materials within that state.

The Pennsylvania Act 1984-147, Section 201; and Act 1988-12. Section 301(2); authorize the Governor of Pennsylvania, on behalf of the Commonwealth, to enter into agreements with the NRC to assume authority to regulate the use and disposal of certain radioactive materials. In his December 1995 letter to the NRC, Governor Ridge formally announced Pennsylvania's intent to assume Full Agreement State authorization from NRC, including the authority to regulate the disposal oflow-level radioactive waste.

• Since Pennsylvania has been sc.Jed as the host state for the LLRW Disposal Facility for the Appalachian States LLRW Compact, it has enacted laws, described earlier under Statutory Authority, that authorize it to promulgate and implement a comprehensive program to regulate the LLRW disposal facility. Act 1988-12 in Section 30)(2) empowers the Department to implement a regulatory, inspection, enforcement and monitoring program consistent with the terms of an agreement between the United States l Nuclear Regulatory Commission and the Commonwealth, as provided for in Section 201 of Act 1984-147, and this Act(1988-12). Section 301(4) of Act 1988-12, authorizes the Department to license the regional LLRW facility operatorin accordance with Section 308 of that Act. Act 198812 also authorizes promulgation of appropriate and relevant regulations for licensing the regional facility and its operator.  !

The required regulations for licensing the LLRW disposal facility are established in Title 25 of the Pennsylvania Code, Chapter 236, Low-Level Radioactive Waste Management and Disposal. The requirements for licensing the regional facility operator and the license review procedures and standards are described in Subchapter C of Chapter 236. Requirements for the content of the license application are specified in Section 236.204 through 236.211. Review procedures and standards are presented in Sections 236.221 through 236.227, and amendments / change's to the license are contained in Sectioris 230.241 through 236.247. In its February 4,1993 letter to the Department, NRC found that the Chapter 236 regulations were compatible with the applicable federal regulations.

A complete Agreement State Application regarding the LLRW Disposal Facility Licensing is inclujed in Tab 2.

Application 16

l

/ \

4.1 - Appalachian State Low-Level Radioactive Waste Commission 5 ,m h D n. 3 q vv3 The) Appalachian States o rni Low-Level Radioactlye, Waste Co Commission)was created by the Pennsylvania General Assembly in 1985, under a compact entered into by the states of Pennsylvania, Delaware, Maryland and West Virginia. The Congress of the United States consented to the Compact in May 1988. The main purpose for the establishment of the Compact was to provide for the regional management and disposal of LLRW in response to the Federal laws. Pennsylvania has been designated as the initial host state for the regional LLRW disposal facility because it generates much more LLRW than the other three party states. The Commission provides for representation of various states of the Compact,  !

in addition to other duties and powers assigned to it by the Pennsylvania Act 1985-120. A copy of this Act is included in Tab 3. )

The Commission consists of two voting members from each party state, appointed according to the laws of each party state. The host state is entitled to appoint two additional voting members to the Commission, and thus Pennsylvania has four voting members out of ten. An additional voting member shall be appointed to the Commission who shall be a resident of the host county or municipality where the disposal facility is to be located. Alternate members are designated by each party state to vote and act in the member's absence.

The powers and duties of the Commission are listed under Article 2(B) of Act 1985-120. Most of l

its powers are administrative in nature and forbid it to license, regulate or otherwise develop the regional LLRW disposal facility. Salient features ofsome ofits powers and duties are as follows:

1.

Conduct research and establish regulations to promote a reasonable reduction of volume and curie content of LLRW generated in the region. However, the Commission has not established any regulations so far.

g) 2.

3.

Assemble and make available, to the party states and to the public, infonnation concerning LLRW management and disposal needs, technologies and problems.

Keep current and annual inventories of all generators within the region, based on information provided by the party states.

4. Keep an inventory of all regional facilities and specialized facilities.

5. Shall publish an annual report to the governors of the signatory party states.

5.0 LABORATORY SUPPORT s When the BRP is required to independently establish engineering properties of waste and to perform independent environmental monitoring, such studies will be performed by the DEP Bureau of Laboratories (BOL). In the event that the BOL lacks the capability to perform the requisite analyses, DEP is authorized pursuant to Section 501 (relating to coordination of work) and Section 502 (relating to cooperative duties) of the Administrative Code of 1929, as amended, to request such services from other agencies within the Commonwealth.

When necessary, the Department will enter into a memorandum of understanding or cooperative agreement with Pennsylvania's Depanment of Transpor'ation (PennDO ?) Materials and Testing Laboratory. Tests performed by PennDOT's Materials and Testing Laboratory include classification tests using gradation, liquid limit, and plastic limit; moisture density; and foundation testing through shear and consolidation testing. , ,  ; ,; ,; ; j; The BOL consisting of Analytical and Stipport Divisions "A" and "B" is a compo,nent of the Management & Technical Services Deputate. These laboratories conduct bacteriological, biological, chemical, microbiological, physical and radiological testing. The BOL provides analytical services to environmental, regulatory, planning and advisory programs including, but not limited to, testing of water,

[7 wastewater, milk, air contaminants, fuel, toxic materials and chemicals, soils, aquatic life and insects.

\-)

Application 17

Analytical and Support Division "A" consists of the following four sections: Sample Receiving and Computer Operations Section; Air Chemistry and Gravimetric Chemistry Section, Trace Metals Analyses Section and Automated Analyses Section.

The Sample Receiving an,d Computer Operator section is responsibl,e for the receipt of, samples, computer log-rin, preparation and tracking of samples,! A,dd,itional responsibilities of this.section include receipt, storage, and inventory' control of chemicals, gases and supplies utilized by the BOL*. '

Physical, wet chemistry and gravimetric analyses on high volume air filters, source emission tests and freezing point depression measurements, are representative of the type of analyses performed in the Air Chemistry and Gravimetric Analysis Section of the BOL.

The Sections of Trace Metals Analyses and Automated Analyses are responsible for measurement of metals using various automated instrumentation (i.e., atomic absorption and ICP spectrophotometers) and the measurement ofions and other compounds utilizing automated wet chemistry systems and ion chromatographs, respectively.

The Analytical and Support Division "B" of the BOL consists of the following sections:

Radiation Measurements; Organic Chemistry; Mobile Analytical Services; Biological Services; and Laboratory Accreditation and Quality Assurance.

The Radiation Measurements Section (RMS) is responsible for the measurement ofionizing radiation and the identification of radioactive species in such environmental media as water, sediments, wastes, air, milk and vegetation. Methodologies utilized in the RMS include very low level gamma spectroscopy using intrinsic germanium detectors on an ND 6700 system, soft beta by liquid scintillation, alpha and beta by thin window proportional counting, Strontium 89-90 by ion exchange with beta counting, and Radium-226 by radon emanation. With the exception oflodine-131 in milk, the analytical sensitivities used equal or exceed the criteria of the NRC Cooperative Agreement between the Department and the Commission. This agreement is more fully explained below.

BRP and the RMS interact on a day to day basis, with RMS analyzing several thousand samples annually for the BRP. Most of these samples are generated in response to the BRP's program to cany out independent multimedia environmental radiation monitoring and ambient gamma radiation monitoring with thermoluminescent dosimeters (TLDs) at the following NRC licensed sites: Beaver Valley, Peach Bottom, Three Mile Island, Susquehanna and Limerick Nuclear Power Reactor, and Babcock & Wilcox.

The Deparment's BOL conducts a quality assurance program which will include BOUs participation in the United Ste es Environmental Protection Agency's Environmental Radioactivity Laboratory Intercomparison Studies or an equivalent program.

During aberrations in the demand for laboratory analyses, the BRP, following consultation with RMS staff, establishes priority for radioanalytic activities. When necessary, the BRP and the RMS jointly establish scheduling, detection limits and analytical priorities.

The Organic Chemistry Section of the BOL is responsible for the analysis of water, sedimems, fuels, wastes, air and fish flesh for organic contaminants.

The Mobile Analytical Services Section provides on-site analyses oforganic and inorganic parameters for specified projects such as emergency analytical responses to environmental incidents.

The Biological Services Section of the BOL is responsible for identification of microbiological indicators of pollution and the conduct of bioassays and chlorophyll analysis.

Implementation and monitoring of the BOUs quality assurance program and maintaining laboratory procedures is carried out in the Laboratory Accreditation and Quality Assurance Section of the Department's Bureau of Laboratories.

f Application 18

l l

1 l

O(,j 6.0 - liEGIONAL EQUIPMENT DrpM DnP11monipt Each of the three regional offices maintains an inventory ofradiatio testing, and analysis equipment. With few exceptions, the equipment is battery operated and portable. Each office has equipment capable ofdetecting alpha, beta and gamma radiation. Some of the equipment is committed to emergency response kits to be used in response to incider.ts at nuclear power plants.

Each region is responsibic for the maintenance and calibration of the equipment. Actual equipment varics by region. A detailed lirt of the exact equipment maintained by each region is available under Tab 10 7.0 TECHNICAL ASSISTANCE Technical assistance is available to BRP from the following sources:

7.1 Intrangency Technical Assistance Technical assistance in the review of a license application for the low-level radioactive waste disposal facility is available within DEP. The organizational structure of the Department is such that the Director of the Bureau of Radiation Protection can request technical assissnee from any other bureau within DEP. The following areas of expertise are available to the LLRW disposal program for the licensing and regulation of the regional LLRW disposal facility:

Depuwe .or Air and Waste Management Biological, chemical, radiological, environmental sampling and testing Department of Conservation and Natural Resources Geology, seismology, geochemistry, geography i Deputate for Water Management ,

Water resources evaluation, flood control, biotic evaluation,' erosion Deputate for Management and Technical Services Civil engineering, construction management ,

Deputate for Mine-al Resources Management >

Mineal resources evaluaton 1 i

7.2 Interagency Technical Assistance The Depsrtment is authorized under Section 501 (relating to. coordination of work) and Section 502 (relating a cooperative d 4 ties) of the Administrative Code of 1929, as amended, to request such services from other agencies within the Commonwealth. For example, the Department of Transportation can provide te:hnical assistance in areas of rnsteJals engineering, soils engineering and construction materiah tuting. -

t ,

• \,! 7 l ir b ..

l 1

N./

Application 19 l

1

l p) 7.3 Technical Assistance Fntm Outside Agency The Pennsylvania LLRW Disposal Program has received considerable technical assistance in development and licensing of LLRW disposal facility from the National Low-Level Waste Management Program at Idaho National Engineering and Environmental Laboratory (INEEL). The National program is funded by the Department of Energy (DOE), and its objective is to provide technicci expertise, I

t information, and other resources to states and compacts in developing LLRW facilities. This is a valuable resource that has provided very significant help and information to the Pennsylvania program and will continue to do so in the future.

7.4 Acquisition of ContractorSen' ices Procedures and mechanisms for the timely procurement ofcontractual assistance are set forth in the Commonwealth's Contracting for Services Mamal(M215.1, Amended), published by the Govemor's Office of the Budget, Bureau of Financial Management pursuant to 4 PA. Code sec.1.331. This manual approved by the Office of General Counsel and the Office of Attorney General and utilized by all agencies under the Governor's jurisdiction, provides a s'andard approach to the procurement of contractual services and serves as a comprehensive guide for inditiduals involved in the contracting process.

Section 3.3 of the Contracting for Services Manual authorizes the procurement of services for emergency situations. The emergency purchase ofservice provision is intended to allow agencies to immediately obtain the required services without following the standard contracting procedures.

a 8.0 LEGAL ASSISTANCE & SUPPORT Section 204 of the Commonwealth Attorney's Act, Act ofOctober 15, L ,P.L. 950, No.164)(71 P S.

1732-204), provides that the Attorney General, upon the request of the Gmmor or head of any Commonwealth Agency, shall furnish legal advice concerning any matter or issue arising in connection with the exercise of powers or the performance ofduties of the Govemor or agency of the Commonwealth.

As set fonh in Section 301 of the Commonwealth Attorney's Act, General Counsel who serves at the pleasure of the Governor, appoints to Executive agencies including the Department of Environmental Protection a chief counsel and the necessary assistant counsel. In addition, the Office of General Counsel which provides legal services to the Govemor, supervises, coordinates and administers legal services provided by the Department's enicfcouasel.

The Office of Attorney General has delegated to the Office of General Counsel all administrative and civil matters related to the enforcement of the Commonwealth's environmental statutes and regulations.

However, criminal matters are referred to the Office ofAttorney General's Environmental Crimes Unit.

The Office of Chief Counsel provides legal advice and litigation support to every program in the Department on any matter or issue related to the exercise of the official duties and responsibilities of the Department. Under Section 401 of the Commonwealth's Attorney's Act, the Department's Chief Counsel may request the assistance of the General Counsel, the Attomey General or both in any legal action involving the DepartmerL The Department's Office of Chief Counsel employs eighty (80) attorneys in l offices located in Cons'aohocken, Harrisburg, Meadville, Pittsburgh and Wilkes-Barre, PA. The Office of Chief Counsel consists of the following bureaus: Legal Services, Litigation (five offices), Superfund and Regulatory Counsel.

The Bureau of Regulatory Counsel located in Harrisburg serves as counsel to the Department and assigns an attomey to serve c.s counsel to each principal regulatory program. Within this Bureau, an

} p attomey is assigned to advise the BRP on all matters citing on the Commonwealth's radiation protection I program. In addition, counsel assigned to the BRP is required to:

Application 20 l

T

- Review and comment on proposed legislation;

- Review and comment on proposed regulations, policies and procedures.

- Initiate on behalf of the Department or defend against legal actions which involve De t t officiils",or

- issist the%uyil' t

questions Bureau ofl i igation o[l[a,w[a(djol]cs M 9 0 m T i O O" par men m the' development and implementation of the department's overall enforcement strategy.

The Bureau of Litigation has the primary responsiblity for initiation of all enforcement action, and supervising Department personnel when conducting investigations pertinent to enforcement actions. In addition, the Bureau of Litigation has primary responsibility for providing counsel to the Regional Offices of the Department on enforcement, inspection, and legal interpretation questions to assure statewide uniformity of action.

9.0 DEP ADVISORY COMMITTEES DEP encourages public participation in implementing its many programs, To that end, DEP under the Radiation Protection Act may establish special advisory committees as may be necessary to assist the department in drafting rules and regulations and to advise the department regarding implementation of specific portions of the regulations or specific programs of the department . The Secretary appoints advisory committees whose members represent various professional, governmental, academic, business, and other citizen groups that can provide usefui advice to the programs. At present, the following advisory committees are actively involved in assisting the BRP programs.

h O 9.1 Radiation Protection Advisory Committee The Radiation Protection Advisory Committee (RPAC) reviews draft and proposed regulations ,

and provides advice to the Department. The Committee consists of at least 11 members selected by the Secretary of the Department. -

{'

L,:' g ,

9.2 Low-Level Waste Advisory dommittee  %

k .)- 3 4 As required under Section 317 of the Low-Level Radioactive Waste Disposal Act, the Secretary of the Department has appointed a low Level Waste Advisory Committee (LLWAC) that consists of 23 members,19 of which represent local government, environmental, health, engineering, business, acade nic, and other public interest groups. The other four members of the Committee represent the Pennsylvania General Assembly. In addition, the committee also has a representative of the Department who is a nonvoting member. Following receipt of the license application for the regional low-level radioactive waste disposal facility, the potential host municipality and host county will each nominate one additional member to the LLWAC.

The LLWAC reviews and comments on draft regulations necessary for the implementation of the Low Level Radioactive Wa:,te Disposal Act. The LLWAC may also advise the Department regarding policies and issues related to the implementation of the Act when requested to do so bf the Department.

i

. { j i, u.1 1, 4 (u., ! 4I ,i ,! ,l d,,i1 j'.1! ,I,e 4' .1 31 ( m ) i, j r

i

/

U, I

Application 21

~

i i

1 l

l J 9.3 . Citizens Advisory Council

?M hAdyisory The Citizens ,

t"\ OCouncil Q R ??Yhf'.

(CAC) reviews all envjronm\ W% h O N f%

makes appropriate recommendations for revision, modification and codification. The CAC considers, studies and reviews the work of the Department and, upon request makes recommendations for improvement to the Department. The CAC reports annually and on an interim basis (when necessary) to both the Governor and the General Assembly.

The CAC includes persons knowledgeable in ecology, toxicciogy, pi.armacology, and industrial technology. The Council is comprised of 19 members, the Secretary of the Department of Environmental Resources, six members appointed by the Govemor,6 appointments by the President Pro Tempore of the Senate, and 6 members appointed by the Speaker of the Hause of Representatives.

10.0 EMERGENCY RESPONSE MANAGEMENT s .

10.1 Prirnary Responsibihty The Pennsyha a Nergency Management Agency (PEMA) is primarily responsible for the overall policy and direction or the Statewide civil defense and disaster program in this Commonwealth. In j

accordance with 35 P.S. f 7313, PEMA prepares and maintains a current Pennsylvania Emergency i Management Plan for the prevention and minimization ofinjury and damage caused by disaster, prompt 7 and effective response to disaster and disaster emergency relief and recovery. PEMA is empowered to

/ coordinate Federal, Commonwealth and local disaster emergency management activities and to provide

\' technical advice and assistance to Commonwealth agencies and political subdivisions in the preparation of disaster emergency management plans. PEMA is required to respond to disaster relating to atomic energy operations or ri, active materials or objects or materials possessing a radiation-producing capacity.

A Radiological Emergency Response Preparedness, Planning and Recovery Program (RERPPRP) is maintained in PEMA consistent with the Commonwealth's Emergency Management Plan, and applicable Federal and State laws. Specific functions ofPEMA under the RERPPRP include, but are not limited to:

(a) serving as the point of contact for interface between affected facilities and other Commonwealth agencies, departments, counties, municipalities and school districts; (b) anneal review and revision, as necessary, ofAnnex E, " Radiological Emergency Response to Nuclear Power Plants," of the Commonwealth's Emergency Management plan and annual review of the onsite emergency response plan of each utility to ensure consistency with the annex; and (c) developing planning and preparedness procedures for emergency response within the ingestion exposure pathway zone. The statewide plan for radiological emergency response to nuclear power plant incidents is found in Annex E of the Commonwealth Emergency Operations Plan.

10.2 Planning Responsibilities . t,3 ', : m .,_

Emergency!, .1 %

Y l *s. i.3%)L,,..i..li1bC),{QRfQjh Under the Commonwealth's Emergency Operations Plan, the Department's Bureau of Radiation Protection is responsible for technical assessment of accident situations and making protective action l recommendations, as necessary, to PEMA. PEMA implements the recommendations through county and local govemment emergency management agencies. l l I i Application 22 l l

1 BRP regional staff respond to radioactive materials transponation incidents anywhere in the p/ t V Commonwealth. Additional assistance is also available from regional DER emergency response staff. BRP. participates in biannual exercises scored by NRC and/or the Federal Emergency Management Agency at each of the five nuclear drills throughoht peye}r.[ [ ] power ]O {jstations in the Commonwealth. BRP also participates Staff training for response to incidentsQand Q]Q T] f)incl { @udes several cu

                                                                  ]

accidents Emergency Management Agency (FEMA) at the Emmitsburg facility, and at Las Vegas. In-house refresher training is provided prior to exercises. The BRP technical staff also participate in dose assessment training offered by nuclear utilities. l 11.0

SUMMARY

The Commonwealth of Pennsylvania and DEP are committed to administering a high quality Agreement State program that will be effective L protecting the public healti, cafety, welfare and the enviconment. The commitment to this goal is evidenced by the achievements described in this document. BRP has the authority and has assumed the initiatives necessary for Agreement State status, including: The Depanment has the necessary statutory authority to assume the responsibilities required of an , Agreement State copies of the applicable statutes are included under Tab 3.  ! Regulations compatible with those of the NRC have been developed and adopted A set of applicable regulations are included under Tab 14. BRP has gained extensive experience in licensing radioactive material. The Licensing and Inspection and Enforcement Programs for NARM have been in place for the past 21 years. Emergency response capabilities have been frequently demonstrated in the past. NRC Region I and BRP have cooperated in responses to materials incidents for many years. Required fiscal support has [ ()]

• been provided to fund the Agreement State program. Assuring availability of resources to administer an effective regulatory program.

Additional professional staff have been hired to both supplement and complement the BRP technical staff who have managed a major NARM regulatory program for 21 years. The staffing level for the Agreement State program is approximately 1.4 FTE per 100 licenses, compared to the 1.0 - 1.5 staff years per 100 licenses recommended in current NRC guidelines for Agreement State programs. Staff members have attended numerous training courses on a variety of topics related to the regulation of radioactive material. A record of training attended by the staff members is included under Tab 9. BRP has sufficient instrumentation to detect and mearure radiation, including sophisticated fixed and mobile radiochemistry laboratories. A list of various instruments is provided under Tab 10. The Commonwealth of Pennsylvania and the Pennsylvania Depanment of Environmental Protection have committed full administrative suppon to the Agreement State program. Pennsylvania has demonstrated its competence in the control ofradiation hazards and, during the past two years. has aggressively prepared for Agreement State responsibilities. The Commonwealth of Pennsylvania is prepared and qualified to assume regulatory responsibility for byproduct material, source material, special nuclear material in quantities not sufficient to form a critical mass, and the licensing of a low-level radioactive waste disposal facility. The State Public Official and Employee Ethics Laws were passed to strengthen the faith and confidence of the people of the Commonwealth in their government. The applicable statues are available under Tab 12. t j , j ., d( i I j L) Application 23

[ Agreement State Application for Licensing the Low-Level Radioactive Waste Disposal Facility i Commonwealth ofPennsylvania l l Department of Environmental Protection I Bureau ofRadiation Protection

F l

 /
 ),               ,

TABLE OF CONTENTS v Section Page

1. I NTRO D U CTIO N .. .. .. . . . .... ..... ... ... ... . . . . .. . . . . . . .. . . . . .. . . .. . .. . . . .. . . . . . . . . . . . . . . . . .. . ..

1.1 STATUTORY AUTH ORITY...... . .... . ....... .......... ...... .... ....... .. .. ........ .... . ... . ....... ... . .... . .. .. . . 1 1.2 CONTENTS................................................................................................................2 1 l

2. STATUTORY AND REGULATORY FRAMEWORK .................... . .. . ........ .. .. . ...... .... .. I 2.1 STATUTORY AND REGULATORY REQUIREMENTS FOR APPLICATION i REVIEW............................................................ ......................................................1 2.2 LIC EN S ING GUIDANCE .. ... . . ...... .... ....... ........ . .. .. ..... .......... ............ ....... ..... .. . . .. .. . ... 1 r

1 I

3. LLRW LICENSING ORGANIZATION AND RESOURCES ........... .......... .... ... .. .......... .. 1 i

i T 3.1 DEPARTMENT ORGANIZATION ..... ......... ......... .......... ........... . ....... ........ . ...... ... ... I 3.2 LLRW LICEN SING ORGANIZATION ... ... ............. ............ ...... ...... ...... .. .. ........... . .. I 3.3 ROLES AND RESPONSIBILITIES .................. ....... ................ .... ................. .. ............... I 3.3.1 Director, Bureau of Radiation Protection ................. ..................................... .... ...... I 3.3.2 Lic ensing Over sight .... .. ......................... ........ .. ........ . . ... .. ... ........ ....... .. . ... .. ... ..... . .. 5 3.3.3 Chief, Nuclear Safety Division ............................... .. ........... .......... .... ............. ..... 5 3.3.4 Chief, Low-Level Radioactive Waste Section.................... ............ .................. ...... 6 3.3.5 Int egratio n Team .................... ............ ....... .... .............. .... .... .. .......... ... .. . .. .. .. .. ...... .. 6 i 3 .3.6 Le ad Wo rkers . .. . ... . .. . . . . ... . . . . . . . . . . ... . . ... .. . .... .... . .. . .. .. . . . . . . . . . . . . . . . . . . . . . . . . .. .. . . . . . .. 1 3.3.7 Reviewers..............................................................................................................7 3.3.8 Administrative Assistant, Procedares and Records....... .. ......... .......... ... ...... . . .... 7 3.3.9 Lead Worker, Public Information Liaison........ ................. ............ ... ..... ............. 8 3.4 RESOURCES..................................................................................................................8 3.4.1 Legal Ass istance ....... .. .... ........... ...................... ...... . ...... ........ ... ...... . .. . ... .. . . . .. . .. 8 s 3.4.2 Other DEP Bureaus and Deputates .............................. ......... ...............................8

TABLE OF CONTENTS Section. Page 3.4.3 Contractor Technical Assistance....... .. . ........... ................. ....... ....... ......... .. ....... 8 3.4.4 Other Commonwealth Agencies ........................................ ............................... ...... 9 3.4.5 Low-Level Waste Advisory Committee..... ....................... ................... ......... . ..... 9

4. MANAGEMENT CONTROL S YSTEM .. .................. ............ .... ................ ........... ..........I 4.1 LICENSING MANAGEMENT PLAN ....... . .. ....... . ............... ...... ..... .. .. .... .. . . .1....

4.2 FUNCTIONAL AREA S AND TOPICS ... .. .... ......... .. ..................... .. ..... ............. .. 1 O b i l l O 1V

m

  \                                               TABLE OF CONTENTS Section.                                                 Page

5. LICENSE APPLICA IlON REVIEW PROCESS ... ........... ............ ....... ......... . ... ........

5.1 APPLICATION SUBMITTAL AND PUBLIC NOTIFICATION................................... ..! 5.1.1 App licatio n S ubmittal ...... ..... . ................ ......... ....... .... . ... . ... . . . . .. . .. ....... .. .... . .. . . ... . I 5.1.2 P ublic No ti fication . ....... . .. .............. . . .... . ......... ... ... .. .. . . .... ... . . ... ... .... ... 5.2 COMPL ETENES S REVIEW ... ................. .... ... .... ... ... ... ... . ....... .... . .. . ........ .... . . 5.3 P UB LIC B E VIEW AND COMMENT.......... ........... ........... ............ .. .... ....... .. .... . ... 4{ 1 l 5.4 D ETAI L ED RE VI EW .. . .. . ... .......... .. .. . . ..... .. ... ... .... .. ..... . .. . ... ...... . .. ... .. . . 5 ' 5.4.1 D e t ailed Review Proc ess..... ... ............... .. .... . . .......... ... . .. . . . . . . .. ... .... . .... . . 5.4.2 Interrogatory Preparation and Review............... .... ...... . .................... ........ ... ....... 6 5.4.3 In terrogatory Transmittal . ........... . ........ .......... . ....... ............ . . . . . . . . . . . . . . ..6 5.5 REVIEW OF APPLICANT RESPONSES AND FURTHER INTERROGATORY b' ROUNDS...........................................................................................................7

6. PREPARATION OF LICENSING DOCUMENTS .............. .................... ............. . .. .... ...... I 6.1 P REPARATION OF S ER ......... ....... ... .... .. . ... .... . ... ............. ........ ..... ....... ....... ... .... ... . ..

6.2 PREPARATION OF LICENSE AND LICENSE CONDITIONS OR NOTICE OF DEN 1AL..........................................................................................................................2 6.3 PREPARATION OF COMMENT AND RESPONSE DOCUMENT ............ ...... ............ 3 6.4 LICENSING DECISION AND PUBLIC NOTIFICATION / DISTRIBUTION..... . ..... .... 4 l l 6.5 APPEALING THE LICENSING DECISION .. ........ ..... ....... .... . ............ .... ........... .... . 4 i 1 V

I ev (v) 1. INTRODUCTION l The preparation, implementation, and completion of the low-level radioactive waste (LLRW) disposal facility licensing action is a complex and challenging task. It is imperative that i appropriately trained personnel conduct a thorough, integrated review of the LLRW disposal facility license application, that the review process is controlled and documented, and that the results and conclusions of the review are clearly stated and defensible. The purpose of this document is to describe the program that the department will follow when l conducting the initial LLRW disposal facility license application review. 1.1 STATUTORY AUTHOPJTY Responsibility for licensing and regulating the use and disposal of radioactive materials rests at the federal level with the U.S. Nuclear Regulatory Commission (NRC). However, under the terms of Section 274b of the Atomic Energy Act of 1954, as amended, a state that can v) 1 demonstrate a regulatory program that is compatible with the federal regulatory program may receive NRC authorization to regulate the use and disposal of radioactive materials within that r! ate. Section 201 of the Pennsylvania Radiation Protection Act (P.L. 688, No.147), authorizes the Govemor, on behalf of the Commonwealth, to enter into agreements with federal agencies for the purpose of assuming authority to regulate the use and disposal of certain radioactive materials. In his December 1995 letter to NRC, Govemor Ridge formally announced Pennsylvania's intent to assume Full Agreement State authorization from NRC, including the authority to regulate'the disposal ofLLRW. Pennsylvania is serving as the first host ute for a LLRW disposal facility for a four-state compact comprising Maryland, West Virginia, Delaware, and Pennsylvania under the Appalachian States Low-Level Radioactive Waste Compact Act (P.L. 539, No.120). Section 301 of the Pennsylvania Low-Level Radioactive Waste Disposal Act of1988 (35 P.S. 7130, the Act) designates the Department of Environmental Resources, now Environmental Protection (the n (v) department), as the agency responsible for promulgating and implementing a compre 1 l

both ese guidance doc nts in ,)aring the licer.se application and the applicant will

                                          ,th docum-ts it.       . ewing ti     nplication.

\s that the departr . vill - vill be . / the >artment is inaging the license application A third licen docur nsing ientI establish.. requirements and controls review. The .: men' e departa etivities .ociated wit oc licensing process are necessary to caure t! carriec 'emente i of this doc, nt will enable the adequately and effec: d pe nel will condu i thorough, integrated , department to ensurc appropriate iication, thai ;w p. s is document ., and that the results and review of the license v are clearly stated . ' .ble. conclusions of the U 1 l l 1

%d 2

  -3.

IyLRW LICENSING ORGANIZATION AND RESOURCES 3.1 DEPARTMENT ORGANIZATION The Act designates the Secretary of the department as the individual responsible for making the final licensing decision. The Secretary designated the Bureau of Radiation Protection as the lead for conducting the LLRW disposal facility license application review. Figure 3-1 shows the organizational structure of the department and the Bureau ofRadiation Protection's position within the agency. The internal organizational stmeture of the Bureau ofRadiation Protection is shown in Figure 3-2. A description of the LLRW licensing organization and a description of the resources available to augment the LLRW Licensing Organization are presented in the sections that follow. 3.2 LLRW LICENSING ORGANIZATION The Director of the Bureau of Radiation Protection created the LLRW licensing organization shown in Figure 3-3 for the sole purpose of recommending a licensing decision for LLRW disposal activities. The LLRW licensing organization is made up ofpersonnel from the department. The key management positions of Director, Bureau of Radiation Protection; Chief, Nuclear Safety Division; and Chief, Low-Level Radioactive Waste Section, are staffed from within the Bureau of Radiation Protection. Outside resources of technical support contractors and other state agencies are available to augment the management and technical capabilities of the organization. 3.3 ROLES AND RESPONSIBILITIES 3.3.1 Director, Bureau of Radiation Protection The Director, Bureau of Radiation Protection, is responsible for recommending the approval or disapproval of the license application to the Secretary. The Director, Bureau ofRadiation Protection provides policy direction to the LLRW licensing organization and has the ultimate 1

 .u        -

I l 1

                                           -    i b
                                                  * "~
                             -           _~~l                 l L                                                            I        }I n

o - . i t t c e  ; M~'~ 7! iif!

                                                                                                 ].
                                                                                                     =

o r P j . r t .. a l l t a =~ . n ~ -.- - I e - t r m b a h C n r n o D_ l, n i il i o v l t a n - = n z E ~ o eF i P i n f 7I. t a a - g r O = - i z ( t O P t n e E - Ji

                                              -   T_. l 4

3.lj!l i .- g r n a 2 E - D m I _E --

                                                                               ~                               O t       ]

t=6*"4 _ T_ 1 r gl 0 a - a p e r u e A" - mf"{= d{ g D - g a C'ji1J i F a ' i n [ -

                                                             =

m g 2O .. a l

                                                                       - =i.
                                                                              ~:~ pa                 '

l v - ' _ y =. 3 i{, t d - s n g n e O il

                                                                      -- " ~

l P

                                                                     - r~              7=

c_

                                                                     - f {;=

4 [ j iI l j iI l _, :1- -w s . ' -. 8 - i 9 -

                                                                             - =c - -
                                                                                                           . /

6 3i{Ii4 2

                                                                                                             /

j 6

J. 2 l l i II

                                                                          =                    =_==_

i-

                                           ==q d-               =         E   ==.

q 4 J q N I

                                                    =      I            l         l O

1 I =  :

                                                                         =             =

T i E

                                                                        =              =

t r C a E . j l 4 h C T 11 l l n Ot r z i o Ra Ph s3 == ' t c l

                               ]

NC z . i n - - 1 j ll a Ol a I I 1 i g I n ~- .. r To -

                                                         =                                              ._.

O - = A-- nH =- t P Ai a I t

                                        -                                                   =.         ._
                                                                                                        .      3 R      Diz                     .
                                 . l
                                                =.                   l          l    ;

1I = l  ; ll B I An a = = =. = 0 2- Rg F r - = . l

                                                        =

E

                                                                         .           =
                                                                                     .            s
                                                                                                    =.

l l E = e r O O ~

                  ~                                           -      q I 4                             .

u - I l i g U 11 i F A - .. E R  :

                                                          =s.=.        -

U I j j] B I  ; i l it

                                                  -      =_ ,...

n.

                                    ,- -=-- =.
                                                                .     .=

J ,} I [ l il l [ E

                                                        ===-                    E

. - ~=

                                                                      =

J ;1 j l

   ^           .
                                                                                                           .',             e
                                                                                                          ._             i n

_ rd p e s I! k b D r . I. Mty

                                                                                                          .dd   a e
                                                                                                          . L n ez i

a g r _ O ._

                                                                                                                   .!L n                                                                                             i!

i o e t a in lp z i n _krie sc a r D O g r n o- I. _dd b Mt fu  :-i - g is a _ ae ez  % n rU . L i i s k e n _ y n r io e c n k i r bt a _ G i L a t c e Mm r

                                                                                                       !f id e

n S daf o.  !} e t o o e en. e n t s r is t s L I _. i a P i v lic _ lp - h W r n oo D  % t _k wd s i} f y t i f e _ D e ct a et ev _Pi ie 9 v . %by ei f l . r d - ha ih J> , ~ i t c DaR C S C + _ _ dd 4 r E t ae a6_ 6* i a f o a e -. _ ez o R m t s m _. L = i i u d _ y d a a e t u l e a e is n_i r h N v T sR G R u g e A d n .

                                                                            . iten i                       4 B             s                      w I            l l

e e r o io va v ll l-v lL t a a e r s e e O i r r g t = n L- g e s ii i lp n t na r w is In imr e ds  ! AP__. o n e d rr k xD L c iL 1 Wby 3-

                                                                                                                               ..wi

_ ae dd 0 .

                                                                                                  . ez            i e                                                                                               L             s r                                                                                         _.                  y u                          [                                                              _

_ G g i F e i n _ p _ rd e _ k s _b r Oy I. _ dd _La Mb ae ez

                                                                                                                               ,wi   L r

r r s o _ y n G o_

                                                                                             ..                                            w n

u m a n 9 e n O w o Ill

[] z V responsibility for making the licensing recommendation. The Director, Bureau of Radiation Protection is the primary contact between the department and the applicant on all matters regarding the license application. The Director, Bureau of Radiation Protection receives formal communication from the applicant including the license application itself. The Director, Bureau of Radiation Protection is responsible for ensuring that the public is provided with the opportunity to review and comment on the license application and ensuring that all comments are considered prior to issuance of the licensing decision. The Director, Bureau of Radiation Protection is also responsible for ensuring that the Chief, Nuclear %fety Division, has sufficient resources for conducting a comprehensive and timely evaluation of the license application. 3.3.2 Licensing Oversight The Licensing Oversight function is responsible for performing periodic assessments of the project to verify that all license application review activities are being conducted according to the requirements of the Licensing Management Plan and related procedures. The Licensing V Oversight function is equivalent to the Division Chieflevel within the Bureau of Radiation Protection. Appointment to this position is made at the discretion of the Director, Bureau of Radiation Protection. 3.3.3 Chief, Nuclear Safety Division The Chief, Nuclear Safety Division, has overall responsibility for ensuring that a comprehensive and technically adequate review is conducted on the license application in a timely manner. The Chief, Nuclear Safety Division, has the authority to plan, organize, staff, lead, a' nd control project functions and activities. Q Chief, Nuclear Safety Division, sets forth management requirements of the project with the assistance of the Chief, LLRW Section. The Chief, Nuclear Safety Division, cpproves the selection ofIntegration Team members, Lead Workers, and Reviewers. /3 5

[] V 3.3.4 Chief, Low-Level Radioactive Waste Section I The Chief, LLRW Section, is responsible for managing the day-to-day activities of the project and the activities of the Integration Team. The Chief, LLRW Section, is responsible for ensur that the license application review is fully integrated between disciplines, evaluating review l results, making conclusions regarding performance objectives and requirements for issuing the license, and preparing licensing documents. The Chief, LLRW Section, recommends the selection ofIntegration Team members, Lead l Workers, and Reviewers to the Chief, Nuclear Safety Division. The Chief, LLRW Section, is also responsible for progress reporting, schedule, issue resolution, and other technical and management-related activities. 3.3.5 Integration Team The Integra' ion Team is made up ofsenior personnel representing several disciplines, legal g counsel, and management with regulatory experience. The Integration Team is responsible for providing technical, legal, and management advice to the Chief, LLRW Section, ensuring proper I integration during the review process, evaluating review results, and forming conclusions regarding performance objectives and requirements for issuing the license. The Integration Team is also responsible for preparing the Safety Evaluation Report and other licensing documents. 3.3.6 Lead Workers Lead Workers perform a technical and/or management role on the project depending on the qualifications and experience of the individual. Lead Workers are responsible for managing the day-to-day activities of assigned reviewers and conducting reviews of the license application within their area of expertise. The span of control for each Lead Worker corresponds to one or more sections of the license application as assigned by the Chief, LLRW Section (e.g., General Information, Description of Applicant, Quality Assurance / Quality Control, Site Characteristics, O Waste Characteristics, Facility Design and Construction Plan, Facility Operations Plan, Health [V t 6

C'T and Safety Plan, Facility Closure and Decommissioning Plan, Monitoring and Surveillance \

'"j             -

Plans, Performance Assessment, Impact Analysis Report, etc.). Key responsibilities of Lead Workers include: A. Conducting completeness reviews of assigned sections of the license application, B. Managing and/or performing the detailed review of assigned sections of the license application and preparing interrogatories, C. Reviewing draft interrogatories prepared by the reviewers and comment resolution, D. Submitting draft interrogatories to the Integration Team for review, N E. Developing regulatory findings for assigned sections of the license application, and F. Supporting the Integration Team in the development of the Safety Evaluation Report , and other licensing documents.  ! ('N 't) 3.3.7 Reviewers Reviewers are responsible for reviewing assigned portions of the license application, providing comments and draft interrogatories to Lead Workers, and preparing input on assigned sections of the licensing documents. 3.3.8 Administrative Assistant, Procedures and Records The Administrative Assistant, Procedures and Records, has overall responsibility for managing project-related documents and maintaining the procedures and records management system. Specific responsibilities include maintaining the Licensing Management Plan and related procedures, distributing and tracking controlled documents, tracking license application review documents, and collecting filing, storing, and retrieving records. V(h 7

/^\\ 3.3.9 Lead Worker, Public Information Liaison \ G The Lead Worker; Public Infom1ation Liaison, is responsible for accepting, sorting, and distributing input received from the public, the Low-Level Waste Advisory Committee, and host municipality or county; ensuring that responses are prepared for public comments; and responding to public inquiries regarding licensing activities. The Lead Worker, Public Information Liaison, is also responsible for preparing the Comment and Response document. 3.4 RESOURCES Primary personnel resources for conducting the license application review resides within the Bureau of Radiation Protection. However, other sources ofpersonnel resources may be accessed by the Director, Bureau of Radiation Protection for purposes of filling or augmenting LLRW licensing organization responsibilities. A description of additional personnel resources follows. 3.4.1 Legal Assistance O

\

Legal services are provided through the Bureau of Regulatory Counsel. Counsel is available to provide advice on legal and policy matters impacting the Commonwealth's radiation protection program. 3.4.2 Other DEP Bureaus and Deputates The Director, Bureau of Radiation Protection may, through coordination with executive management and according to department policies and procedures, obtain additional personnel support throughout the department. Department personnel are organized by Deputates and Bureaus (Figure 3-1). Department Deputates include: Air, Recycling, and Radiation Protection; Water Management; Management and Technical Services; Mineral Resources Management; Field Operations; and Pollution Prevention and Compliance Assistance. 3.4.3 Contractor Technical Assistance l l

  /G
  \v]

The Director, Bureau of Radiation Protection may, in accordance with policies and procedures 1 l contained in the Commonwealth's Contracting for Services Manual, contract the services of an l 8

f j independent contractor for public involvement, technical, administrative, and other support in i l evaluating the license application. Access and availability of contractor personnel are assured through the terms and conditions established in the agreement with the contractor. 3.4.4 Other Commonwealth Agencies The Director, Bureau of Radiation Protection may obtain personnel resources from other i Commonwealth Agencies. Access and availability of other agency personnel will be acquired and assured through Memoranda of Understanding negotiated between the department and its sister agencies. 3.4.5 Low-Level Waste Advisory Committee l 1 The Low-Level Waste Advisory Committee (LLWAC) consists of 27 members,19 of whom represent local government, environmental, health, engineering, bus ness, academic, and public interest groups, and four who are members of the General Assembly. Representatives of the host municipality and host county will be added as voting members. At the request of the Department, LLWAC provides advice on policies and issues related to the implementation of the Act. LLWAC will be invited to participate in the license application review process, i i j i

                                                                                 =

9

4. V MANAGEMENT CONTROL SYSTEM This section describes the management control system that will be implemented to ensure that the department's responsibilities and activities associated with the license application review process are adequately and effectively carried out. 4.1 LICENSING MANAGEMENT PLAN The management control system consists of the Licensing Management Plan and its implementing administrative procedures. The Licensing Management Plan describes the department's organizational structure and responsibilities for reviewing the license application. The plan also addresses the functional areas and topics that govem the entire license application review process. Members of the LLRW licensing organization are assigned the responsibility for implementing the various requirements. The Chief, Nuclear Safety Division approves the Licensing Management Plan. 4.2 FUNCTIONAL AREAS AND TOPICS Functional areas and topics addressed in the Licensing Management Plan include:

             =

Project Organization: This section describes the function of the LLRW licensing organization and it defines the key res* .ibilities ofproject personnel.

             =

Document Hierarchy and Docm. .nt Preparation: This section describes the document hierarchy that was created to control activities related to licensing activities. This section also establishes the requirements and assigns the responsibilities for l preparing, reviewing, and approving the documents that make up the hierarchy. {

            =

Resource Acquisition: This section establishes the requirements and assigns responsibilities for promptly acquiring the human resources needed to effectively and efliciently review the license application. O 1 I

(

 \
       ')      =

Personnel Qualifications and Training: This section establishes the requirements and assigns the responsibilities for selecting qualified personnel, verifying the education and experience of selected personnel, and conducting general orientation and training. t

              =

Applicant Interface Protocol: This section establishes the requirements and assigns responsibilities for documenting oral and electronic communications, developing and transmitting written correspondence, scheduling technical and management meetings, and arranging site visits.

             =

Public Interface: This section establishes the requirements and assigns responsibilities I for interfacing with the potential host municipality, county, the public, and interested parties from license application receipt through issuance of the licensing decision. l

             =

License Application Receipt and Review: This section establishes the requirements I and assigns the responsibilities for receiving, distributing, reviewing, and tracking the I l

     ]             license application and related documents.                                                 I

[U = Preparing Licensing Documents: This section establishes the requirements and assigns responsibilities for preparing and issuing the Safety Evaluation Report, the Comment and Response document, and the license and license conditions or license denial.

           =

Records Management: This section establishes the requirements and assigns the responsibilities for generating, transmitting, collecting, storing, preserving, and retrieving records.

          =

Evaluations: This section establishes the requirements and assigns the responsibilities for independently evaluating compliance with and effectiveness of the administrative controls for the license application review process.

          =

Regulatory Interpretations: This section establishes the requirements and assigns the

 /mT             responsibilities for preparing and documenting regulatory interpretations.

V 2

Administrative procedures supplement the Plan where it is necessary to have written instructions to implement complex requirements. Administrative procedures are controlled and issued to l

LLRW licensing organization persons involved in implementing the requirements. The Licensing Oversight Function is responsible for assessing compliance with the Licensing Management Plan and the applicable administrative procedures.

                                                                                                  )

I i 3 l

5.

'G')                 I.ICENSE APPLICATION REVIEW PROCESS Section 5 provides a description of the steps in the license application review process, from application receipt through issuance of the licensing decision. The license application review process is illustrated in Figure 5-1.

5.1 APPLICATION SUBMITTAL AND PUBLIC NOTIFICATION 5.1.1 Application Submittal , The applicant is required to submit one signed original and 35 copies of the license application package to the Secretary. Sections 236.204 and 212(c) ofChapter 236 state that the application package will consist of the license application (i.e., general information, program plans, a quality assurance / quality control program, specific technical information and technical analyses, rg\ institutional control information, and financial information), r.n impact analysis report, and the (/ department license and permit applications necessary for construction and operation of the disposal facility. 5.1.2 Public Notification Upon receipt of the license application, the department will notify the applicant, the potential host municipality and county, the LLWAC, other interested parties, and the public that the license application was received. Public notification will be provided through media notifications, mailings, and notices in the Pennsylvania Bulletin, newspapers of wide general circulation, and newspapers in the area where the facility is proposed to be located. The notification will inform the public that the application was received by the department and that the department is reviewing the application to determine ifit is complete. A second public notification will be issued when the license application is determined to be complete. The notification will announce the availability of the application for public review and j O the duration of the comment period, identify the locations where the application can be reviewed, and provide preliminary information about a public information meeting and a public hearing. I l I i

b - s s e t

n. s c e v o ,

                                                              .5u         -     ;a r                                             m ._                                ,eeeatt *it P                                               m_h               e w                                           Co      A t,      H                                        -

i e c ic l v i l b u se - e b u P - - R Ps - - n - - i o - - t - - a - i c - l ia , p -

                                                                                   '8 p                                                -                                                    -

A - - e 4 q s , n e s en vo d e tyeww e s iet g c i v hiivi v r - i- g n i iet ca eei rs be e oQ n L cc fo s S laRR t a osie is Rp eic l e t n e s nne E iar g% op S is nt s n e en OV t s a t p nA e itoR N n & lc io tmetwo el ri avaA. i Y vfo An eo rA r eo 3 sr hteto sa Rong E Y en ce Um + Leic c io is mse peic t t i , nt o e u 2 W t r n ae bt a u Plic D eRlp-p o ci e naD uc t I i em gWsr pr et e r c ao c nD u e e AC oie rs Rn pD v pc p p npt a an pa I e o i DeU A npi t er r P n n t c A Ai f PrT A a o In i o d a R l e v O O e N N L-w o s L s ei e ei e 1 v nc v cn 0

      -                       lo si e     i                                    loe eic                                            si          1 e                                                                       eic r                        Rfe                                            Rf e u                            D                                               D g

i F T P P t J W P L L r 0 0 - 2 5 0 9 3 T O W ') O .

1 5.2 COMPLETENESS REVIEW A completeness review will be performed upon receipt of the application to ensure that the necessary information, data, and analyses are included to effectively perform the detailed review. Each Lead Worker will review his/her assigned section of the license application and determine if the following criteria have been satisfied:

              =                                                                                          I Is the section organized under the headings and sections corresponding to the          '

Department's Format and Content of the Low-Level Radioactive Waste Disposal 1 Facility License Application, and does the section address each area in sufficient detail to pennit an in-depth review? l

             =

Has the department received, or does the application include, all final project data upon which the application relies to reach its conclusions, or which are required in accordance with the requirements of Chapter 2367 The application may incorporate by reference separate documents previously submitted to the department. l

            =                                                                                            .

Does the section and supporting data /infonnation have adequate legibility and i formatting for the detailed review? i Completeness review results will be documented in writing and reviewed and approved with comment resolution documented. The Chief, Nuclear Safety Division, will make the final decision as to whether the license application is complete enough to begin the detailed review. If the Chief, Nuclear Safety Division, determines that the application is incomplete and requires supplemental information, l he/she will prepare a written request to the applican for supplemental infonnation. The request will instruct the applicant to submit to the department any insert pages, replacement pages, and/or addenda needed as a result of the completeness review. Upon receipt of the supplemental information from the applicant, the supplemental materials will be reviewed for completeness i following the same process described above. 3  ! l

When the license application is determined to ba complete, the department will distribute the application for public review. The department w . ! commence with a detailed application review at the same time. 5.3 PUBLIC REVIEW AND COMMENT Upon making the license application available to the public, the department will provide funds, not to exceed S150,000, to the potential host municipality to carry out an independent evaluation of the application. At the request of the potential host county, the department also will provide a reasonable amount of funds, not to exceed $150,000, to the county to carry out an independent evaluation of the application. Within 180 days after distribution of the funding, the potential host municipality and county must present their comments to the department for inclusion in the licensing proceedings. During the license application review process, the department will hold one public information meeting and one public hearing in the area in which the facility is proposed to be located. The department will issue 30-day public notices to announce the meeting and hearing dates and locations. The notices will be placed in the Pennsylvania Bulletin and in newspapers of general circulation in the area of the proposed host municipality. There will be a minimum of 30 days time between the public information meeting and public hearing. The public hearing will provide a formal opportunity for the public to submit comments on the license application. A person that wishes to examine witnesses at the hearing must submit to the department a numbered list of contentions. In accordance with Section 236.222(b), these contentions must be limited to failure of the license application and its contents to conform with the Act and Chapter 236. The applicant is required to submit two copies ofits testimony two weeks before the hearing date and make its staff available to answer questions. The department may establish the duration for oral testimony and may limit the scope of questioning during the hearing. The department will accept written comments regarding the application that are submitted within 180 days after the license application was made available to the public. The written comments and transcripts of the hearing will be considered in the Secretary's decision on the application O 4

[ and become part of the public record. The department will provide written responses to comments and the hearing testimony at the time a licensing decision is made. 5.4 DETAILED REVIEW The detailed review of the license application will begin when the application is deemed complete. Copies of appropriate sections of the license application will be distributed to the Lead Workers according to the applicable requirements and procedures established in the Licensing Management Plan. 5.4.1 n etailed Review Process The objective of the detailed review is to reach a licensing decision by evaluating the information and analyses presented in the application to determine compliance or noncompliance with Chapter 236 regulatory requirements. ' In performing the detailed review, Reviewers will follow the procedures presented in the

 )   Licensing Management Plan and guidance presented in, Guidance for Review of the Low-Level Radioactive Waste Disposal Facility License Application to make findings of compliance or noncompliance with regulatory requirements and to describe the basis / rationale for each of these findings. The detailed review will evaluate the adequacy and validity of the data, calculations, analyses, and conclusions of the application through a review of data, models, assumptions, and the applicant's quality assurance records.

LLRW licensing organization personnel may participate in site visits and in periodic technical meetings with the applicant to discuss issues or concerns. Coordination, conduct, and results of meetings and site visits will be documented by a designated member of the LLRW licensing organization in accordance with the procedures presented in the Licensing Management Plan. If the Reviewer fmds the information in his/her assigned section to be acceptable and sufficient j to develop regulatory findings and bases, he/she will document "no comments"in writing and submit the documentation to the responsible Lead Worker. The Reviewer will then proceed to prepare regulatory findings. 5 )

1 l I n * (b If the Reviewer finds that additienal information, clarification, analysis, or revision is needed to justify a regulatory finding, an interrogatory (i.e., a question or request for supplemental infonnation or revision) will be prepared for submittal to the applicant.  ! 5.4.2 Interrogatory Preparation and Review i The purpose of an interrogatory is to obtain from the applicant additional information to enable the Reviewer to make a determination (i.e., finding) of compliance or noncompliance with applicable regulations and to prepare a description of the bases for these findings. Reviewers will record their draft interrogatories in a standardized format. The interrogatory will i reference the appropriate regulatory requirement and include a justification for requesting the information. The interrogatory will include enough detail to dow the applicant to understand the nature of the information, clarification, justification, or revision requested. Where the interrogatory is based on a disagreement with analyses or conclusions in the application, the interrogatory will include a description of the reason for the disagreement and why the applicant b needs to provide furtherjustification for the conclusions or revise them. To keep the number ofintevogatory rounds to a minimum, an internal review and approval process will be carried out prior to submittal of the intenogatories to the applicant. The Chief LLRW Section, in conjunction with the Integration Team, will review the recommended interrogatories to identify and resolve any inconsistencies or errors and ensure that the intenogatories are directed toward making regulatory findings. The Integration Team will prepare the interrogatories for those sections of the application in which the applicant summarizes compliance with the perfonnance objectives and technical requirements of Chapter 236. The Integration Team also will consider public comments for inclusion in the interrogatory process. An interrogatory tracking system will be used to ensure that all interrogatories are tracked and addressed. 5.4.3 Interrogatory Transmittal All approved interrogatories will be submitted to the Director, Bureau of Radiation Protection for formal submittal to the applicant. The submittal will include a request for responses and instructions for submitting additional information (e.g., insert pages, replacement pages, and 6

addenda). The applicant will be requested to providc enough copies ofresponses and supporting materials for distribution to all persons on the license application distribution list. 5.5 REVIEW OF APPLICANT RESPONSES AND FURTHER INTERROGATORY ROUNDS Upon receipt of the interrogatory responses and supponing materials from the applicant, each < interrogatory response will be entered into the interrogatoy tracking system and copies of the interrogatory responses will be distributed to LLRW licensing organization personnel and to all persons on the license application distribution list. The Reviewers will determine if the applicant's response adequately resolves the concern, and if there is sufficient information to make regulatory findings. The process for reviewing interrogatog responses will be the same as the process described in Section 5.4 (Detailed Review). If the Reviewer finds the response to the interrogatory to be unacceptable, he/she will prepare a follow-up interrogatory that will undergo the same pc eess as outlined in Section 5.4.2. The new,

 \'

follow-up interrogatory developed for an inadequate response will be identified as a " derivative" interrogatory (i.e., one derived from a previous interrogatory that is still open). Preparation of findings and bases will begin when sufficient information is presented in the application to make a regulatory finding. A finding is a determination ofcompliance or noncompliance with each regulatory requirement. A basis for a finding is ajustification that summarizes pertinent supporting data and analyses for the finding. Findings and bases will be documented in a Safety Evaluation Report (SER). N 7

i O

     )      6.

PREPARATION OF LICENSING DOCUMENTS This s-ction describ.:s the preparation, review, and approval oflicensing documents including the Safety Evaluation Report (SER), the license and license conditions or the license denial, as applicable, and the Comment and Response document. This section also discusses public notification of the final licensing decision, and distribution of the licensing documents. 6.1 PREPARATION OF SER The SER will be based on the findings / bases prepared as a result of the detailed review and on evidence presented during the public comment period. The Integration Team, in consultation with the Lead Workers, will develop a detailed outline for the SER. The SER outline will be reviewed and approved by the Chief, LLRW Section. The outline will provide for two SER volumes, as follows:

                   =
  ,s
 /                      Volume I will present an introduction that provides an overview of the proposed

( ,) s facility, the licensee, and the license review process. Volume I also will present integrated findings and bases for compliance with the performance objectives of l Sections 236.13 - 236.16, requirements for issuance of a license under Section > 236.225, and the integrated technical requirements of Chapter 236, based on the findings in Volume II. Volume I will also include the license and license conditions or notice of denial.

                  =                                                                                          l Each section in Volume 11 will present fimdings stating that the pertinent technical requirements in Subchapters B and D through F and the financial arrangements of Subchapter G of Chapter 236 are satisfied, in whole or in part, by the project element

{ reviewed by the Reviewers. Each finding will be supponed by a discussion of the basis for compliance with the regulatory requirement. The SER will be prepared by the Integration Team, and approved for release by the Chief, Nuclear Safety Division and forwarded to the Director, Bureau of Radiation Protection for 1 ( ') l L ,' I

1

                                                                                                        \

I l (g) v recommendation of approval or disapproval. Comment resolution will be documented and the l necessary revisions will be made by the Integration Team. I 6.2 PREPARATION OF LICENSE AND LICENSE CONDITIONS OR NOTICE OF ' DENIAL A license will not be issued unless the department has determined that the requirements for issuance of a license under Section 236.225 have been met. If a decision is made to license, it will be prepared by the Integration Team. The license may include the following information:

                =

Licensee and its address. t

                =

License number.

               =

Expiration date.

               =

Issuing agency. LJ

              =

Limitations on source material, special nuclear material, calibration and check  ! sources, and any other radioactive material that may be received.

              =

Authorized use of the materials. Designation of host and affected municipalities, as required by Section 318(e) of the Act. The Integration Team also will compile a set oflicense conditions. At a minimum, the license conditions will include the conditions specified in Section 236.226. Ifit is determined that the requirements for issuance of a license under Section 236.225 have not been met, the Integration Team will prepare a notice ofintent to deny a license. The notice of intent will document the specific negative regulatory findings / bases that are in the SER. R/ 2

I (~' i) LJ The draft license and license conditions or draft notice ofintent to deny the license will be . 1 approved by the Director, Bureau of Radiation Protection. Comment resolution will be ! documented and the necessary revisions will be made by the Integration Team. 6.3 PREPAhATION OF COMMENT AND RESPONSE DOCUMENT Chapter 236.223(d) requires the depanment to provide a written response to public comments on the license application and on the testimony from the public hearing. These written responses will be issued by the depanment as part of the public record at the time the SER is released. The l separate activity of considering public comments as interrogatories is described in Section 5.4.2. The Pubhc Information Liaison Lead Worker is responsible for compiling all public comments and hearing testimony transcripts, and distributing them to the Chief, Nuclear Safety Division for assignment to responsible Lead Workers for preparation of responses. The Lead Workers will consult with the Reviewers of their section for suppon in preparing responses, as necessary. m Public comments / testimony on application sections addressing compliance with performance (G) objectives and technical requirements and proposed license conditions will be assigned to the Integration Team. The Lead Workers will submit all of the comments / testimony and their recommended draft responses for their sections of the application to the Chief, LLRW Section for review. The Chief, LLRW Section will direct the Integration Team to review the recommended response for adequacy and appropriateness. The Chief, Nuclear Safety Division will approve Integration Team findings. A comment response tracking system will be used in order to ensure that public comments are tracked and addressed. Similar public comments / testimony related to a common issue may be grouped into categories with one response prepared for each category. The Public Information Liaison must ensure, however, that each comment / testimony is addressed by a :sponse. Final responses to public comments will be contained in a Comment and Response document and it will be issued in conjunction with the SER. O 3

6.4 LICENSING DECISION AND PUBLIC NOTIFICATION / DISTRIBUTION The Director, Bureau of Radiation Protection will submit the licensing recommendation, the SER, the license and license conditions or the notice ofintent to deny a license and the Comment and Response Document to the Secretary for review. The Secretary's review and decision will be documented and any necessary revisions will be made by the Chief, Nuclear Safety Division with support from the LLRW licensing organization. The Department will notify the public ofits decision to issue or deny the license. The notification will be made in the Pennsylvania Bulletin, local media, newspapers of wide general circulation, and newspapers in the area where the regional facility is located. If the Secretary determines that the license will be issued, he/she will sign the license and the SER. The Secretary will direct the Director, Bureau of Radiation Protection to distribute the licensing documents to the applicant, the LLWAC, the host municipality and county, and other parties on the controlled distribution list. Signing of the license and license conditions will constitute the department's approval to begin construction of the facility. If the Secretary determines that the license will be denied, he/she will sign the notice ofintent to deny the license and the SER. The Secretary will direct the Director, Bureau ofRadiation Protection to distribute the notice ofintent to deny and supporting documentation to the applicant, the LLWAC, the host municipality and county, and other parties on the controlled distribution list. In accordance with Section 236.224(a), if the license application is rejected, the applicant may choose to submit a revised application. The application resubmittal shall be accompanied by a new application fee. 6.5 APPEALING THE LICENSING DECISION I l Under Section 307(i) of the Low-Level Radioactive Waste Disposal Act, a citizen of the Commonwealth, a host municipality, or e ~~x county may appeal the issuance of the license to the Environmental Hearing Board, which is required to handle the appeal in an expedited manner. The decision of the Environmental Hearing Board is appealable to the Commonwealth Court. 4

A 2. STATUTORY AND REGULATORY FRAMEWORK 2.1 STATUTORY AND REGULATORY REQUIREMENTS FOR APPLICATION REVIEW Requirements for licensing the LLRW disposal facility operator are identified in Section 308 of the Act. One of the requirements of Section 308 specifies that the department issue regulations relative to the procedure and requirements for licensing the regional facility operator. The department has promulgated the required regulations in Title 25 of the Pennsylvania Code, Chapter 236, Low-Level Radioactive Waste Management and Disposal. The requirements for licensing the regional disposal facility operator and the license application review procedures and standards are descrioed in Subchapter C of Chapter 236. Requirements for the content of the license application are specified in Sections 236.204 through 236.211. Review procedures and /

 ,,       standards are presented in Sections 236.221 through 236.227 and amendments / changes to the i
      )   license are contained in Sections 236.241 through 236.247, 2.2       LICENSING GUIDANCE The department will issue three licensing documents that are directly related to the low-level radioactive waste disposal facility action. Specific information to be provided in the license        I application and the format for presenting the information required to fulfill the licensing requirements of Subchapter C of Chapter 236 and the Act will be presented :- Format and Content of the Low-Level Radioactive Waste Disposal Facility License Application (analogous to NUREG 1199).

A companion document, Guidance for Review of the Low-Level Radioactive Waste Disposal Facility License Application (analogous to NUREG 1200), will facilitate the LLRW licensing organization's evaluation of the application. The document will be keyed to the chapters in the format and content document and it will address information such as acceptance criteria, applicable regulatory requirements and guidance, and regulatory findings. It is anticipated that

,n
    /

I

program to regulate a LLRW disposal facility in the Commonwealth. Section 301 of the Act further stipulates that the regulatory program goveming management and disposal of LLRW be consistent with the terms of the Agreement State Program authorized under Section 201 of the Radiation Protection Act. Section 301 of the Low-Level Radioactive Waste Disposal Act also authorizes the department to license the regional low' level waste disposal facility operator in accordance with Section 308 of the Act and the regulations promulgated under the Act. The regulations for licensing a LLRW disposal facility are established in Title 25 of the Pennsylvania Code, Chapter 236, Low Level Radioactive Waste Management and Disposal. NRC has found (February 4,1993 letter) that the Chapter 236 regulations are compatible with applicable federal regulations. 1.2 CONTENTS In addition to this Section, which identifies the statutory authority for regulating LLRW management and disposal activities within the Commonwealth, this document is composed of five sections. Section 2 identifies the specific statutory requirements, regulations, and regulatory guidance documents that govern the application review process. Section 3 describes the structure of the LLRW licensing organization. The program and methods for controlling the license application review are summarized in Section 4. The many steps of the license application review process are described in Section 5, beginning with receipt of the license application from the applicant. The final section (Section 6) describes preparation of the Safety Evaluation Report, license and license conditions or license denial, and a Comment and Response document. 2

688 Act 1984-147 LAWS OF PENNSYLVANIA No.1984-147 - AN ACT SB 987 Combining the radiation safety provisions of The Atomic Energy Development and Radiation Control Act and the Environmental Radiation Protection Act; empowering the Depanment of Environmental Resources to imp comprehensive Statewide radiation protection program; funher providing for the power of the Environmental Quality Board and for the duties of the Environmental Hearing Board; expanding the authority of the depanme regulate other radiation sources; providing for radiation emergency response; establishing requirements f of spent reactor fuel; establishing fees; providing penalties; making repeals; and authorizing and directing Depanment of Environmental Resources and the Governor to convey ownership to the Carl A. White Acid Mine Dminage Treatment Plant, situated in Washington Township, Indiana County, Pennsylvania, to the Count Indiana, subject to a right of reverter for stated conditions. TABLE OF CONTENTS j Chapter 1. General Provisions l Section 101. Shon title. l i Section 102. Legislative findings. Section 103. Definitions. Chapter 2. Federal-State Agreements Section 201. ' Federal-State agreements. Chapter 3. Radiation Protection Section 301. Powers and duties of Depanment of Environmental Resources. - Section 302. Powers of Environmental Quality Board. ) Section 303. Licensing and registration. Section 304. Records. . i Section 305. Inspection. Section 306. Conflicting laws. Section 307. Prohibited uses and acts. Section 308. Penalties. Section 309. Enforcement and abatement. Section 310. Liberal construction. Chapter 4. Fees Section 401. Licensing and registration fees. Section 402. Nuclear facility fees. Section 403. Creation ofspecial funds.  ! A

                                                                                                                          ]

l 689 SESSION OF 1984 Act 1984147 [ ^ ( Chapter 5. Radiation Emergency Response Program Section 501. Declaration of policy. Section 502. Response program. Section 503. Financial assistance program. I Chapter 6. Transportation of Spent Nuclear Fuel Section 601. General rule. Section 602. Escort requirements. Section 603. Authorization. Section 604. Radiation Transportation Emergency Response Plan. Chapter 7. Miscellaneous Provisions \ Section 701. Transition provisions. Section 702. Repeals. Section 703. Conveyance. Section 704. Effective date. 1

                                                                                                                         .1 l

The Gcneral Assembly of the Commonwealth of Pennsylvania hereby enacts as follows: ('Ni t CHAPTER I GENERAL PROVISIONS Q) Section 101. Short title. l This act shall be known and may be cited as the Radiation Protection Act.  ! Section 102 Legislative findings. The General Assembly hereby determines, declares and rinds that, since radiation exposure has the potential for l causing undesirable health effects, the citizens of the Commonwealth should be protected from unnecessary and harmful exposure resulting from use of radioactive materials, radiation sources, accidents involving nuCear power and radioactive material transportation. It is the pufpose of this act to: (1) Establish and maintain a comprehensive program of radiation protection in the Department of Environmental Resources. l' (2) Provide for the licensing and regulation in cooperation with the Federal Govemment. other State agencies  ! and appropriate private entities of radiologic equipment and procedures.

                                                                                                                          )

(3) Maintain a comprehensive environmental rrdiation monitoring program around nuclear power plants and at other locations throughout the Commonwealth. (4) Est2blish a nuclear safety program to rnake evaluations of all nuclear power plants in the Commonwealth. j such evaletions restricted to the specific use of the Secretary of Environmental Resources and his " authorized by i law for the purpose ofinforming the Governor, General Assembly and concerned and affected Federal, State and local govemment organizations. It is not the intent of the act to duplicate or conflict with any aspect of the exclusive Federal regulatory authority applicable to nuclear power plants and licensed plant operators but rather l 7% I I V

l 690 Act 1984147 a LAWS OF PENNSYLVANIA 1 to provide the Commonwealth with requisite, qualified professional nuclear expertise to maintain a c continuing awareness of nuclear power plant activities throughout this Comm'onwealth and t that expenise for the appropriate and authorized needs of the Commonwealth when such activities ma significant potential for consequences beyond the site of a nuclear power plant. Accordingly, e and directly stated. none of the provisions of Chapter 3 are applicable to nuclear power plants operators. (5) Maintain a technical emergency radiation response capability within the Department of Environmenta Resources, in conjunction with the Pennsylvania Emergency Management Agency, to respond to acciden nuclear power plants or at any other location throughout the Commonwealth. (6) Assume licensing and regulatory responsibility for radioactive materials from the Federal Government. This act shall not authorize the department to license or operate low-level radioactive waste disposal sites. (7) Carry out comprehensive remedial action programs. (8) Establish in the Pennsylvania Emergency Management Agency a comprehensive radiation emergency response program supported by fees from the nuclear industry. (9) Establish a Radiation Transportation Emergency Response Plan and procedures for notification of nuclear fuel shipments. Pennsylveni State Police escort and establishing fees. (10) Establish fees. l (11) Provide for notification by nuclear power facility operating licensees of municipalities within the vicir nuclear power facilities of unusual radioactisity. Section 103. Definitions. l The following words and phrases when used in this act shall have the meanings given to them in this section unless the context clearly indicates otherwise: O " Abatement." Any action deemed necessa. by the department to protect public health. safety or or wJf public (' or private property, re ulting from the use of a radiation source.

       " Agency." The Per .,1vania Emergency Management Agency.
       " Council." The Pennsylvania          Emergency Management Council.       " Department." The Depir,vut d Environmental Resources and its authorized representatives.
      " Director." The Director of the Pennsylvania Emergency Management /.,ency.
      " Electronic product radiation." Any radiation emitted by products subject to (he Radiation Control for Health and Safety Act of 1968 (Public Law 90-602,82 Stat. II 73).
      "NRC." The United States Nuclear Regulatory Commission or any predecessor or successor thereto.

1 i v l 1

691 SESSION OF 1984 Act 1984-147 (O.\j 4

          " Person." An individual, corporation, firm, associatior, public utility, estate, public or private institution, grou political subdivision of the Commonwealth, any other state or political subdivision or agency and any lega successor, representative. agent or of the forego.ng, other than the United States Nuclear Regulatory Commission or any :uccessor thereto. In any provision of this act prescribing a fine, imprisonment or nenalty, or any combination of tne foregoing, the term " person" the officers and directors of any corporation or other legal ha officers and directors.
         " PSP." The Pennsylvania State Pelice
         " Radiation." Any ionizing radiation or electronic product radiation.
         " Radiation Source." An apparatus or material. other than a nuclear power reactor and nuclear fuel located on a site, emitting or capable of emitting radiation.
         " Radiation source user " A person who owns or is responsible for a radiation source.
         " Secretary. The Secretary of Environmental Resources or his authorized representative.
         " Spent nuclear fuel." Fuel that has beer. withdrawn from a nuclear reactor following irradiation, the constituent elements of which have not been separated by processing.

CHAPTER 2 FEDERAL, STATE AGREEMENT'S 201. Federal. State agreements. The Governor, on behalf of this Commonwealth. is authorized to enter into agreements with Federal agencies for discontinuance of certain of the Federal Govemment's activities with respect to radiation protection and the assumption thereof by the Commonwealth. CHAPTER 3 i RADIATION PROTECTION g 301. Powers and duties of Department of Environmental Resources.

%                                                                                                                              j (a) Regulation in general - The department is hereby designated as the agency of the Commonwealth for the purpose of registration, licensing, regulation and control of radiation, radiologic procedures, radiation sources ar.d users of radiation sources but, notwithstanding anything in this act to the contrary shall not have the power to license or regulate telecommunications equipment in duplication of any activity regulated by the Federal Gov'-an 1.                                                                                                               l (b) EmA ,ces.-In accordance with the law of this Commonwealth, the department shall employee, compensate and prescribe 'e powers and duties of such individuals as may be necessary to carry out the provisions of this act.          l (c) I'owers and duties,-The department shall have the power and its duties chall be to:                                  {

I l I r% {G  ;

O 692 Act 1984-147 1.AW OF PENNSYLVANIA

   \                 '

(1) Develop and conduct programs for evaluation of hazards associated with the use of radiation sources and with radiation source users. (2) Develop and conduct comprehensive programs for the registration, licensing, control, management, regu and inspection of radiation sources and radiation soun:e users. (3) Prevent and remedy hazards associated with the misuse of any device emitting electronic product radiation. (4) Issue such orders or modifications thereof as may be necessary in con,Mnsn with proceedings under this act. (5) Carry out a comprehensive program of monitoring levels of radioactivity in Pennsylvania's environment, including all appropriate tests for alpha, beta and gamma levels in all appropriate media. Sites to be monitored shall include, but not be limited to. nuclear power reactor sites, other nuclear fuel cycle or research facilities, othe sites with a substantial potential for environmental radioactivity contamination and other locations in the Commonwealth recommended by other agencies of the Commonwealth. (6) Using personnel qualified by education, training and experience, enter nuclear power plants at times and in numbers as are reasonable under the circumstances to observe, identify and assess radiation safety issues for each nuclear power plant site in the Commonwealth. (7) Develop, prepare and submit to the Senate Environmental Resources and Energy Committee and House Conservation Committee, within two years of the effective date of this act, a plan to provide the department with independent monitoring capabilities at all nuclear facilities in the Commonwealth in order to identify events requiring remedial action to protect the public from radiation exposure. (8) Prepare a technical emergency radiation response plan for incorporation into the Pennsylvania Emergency Management Plan developed by the Pennsylvania Emergency Management Agency pursuant to Title 35 of the Pennsylvania Consolidated Statutes (relating to health and safety), and provide the capability for responding to emergencies at each nuclear power plant and at other important locations throughout the Commonwealth. 3j (9) Make available technical staff and equipment to : :termine levels of radiation in the environment and identify v emergency measures to protect the public from expos 're to such radiation in the event of an accident at a nuclear power plant, a transportation accident involving radicactive materials or any other condition or occurrence which necessitates radiation emergency assistance at any location in the Commonwealth. (10) Advise the Governor, the General Assembly and the general public with regard to nuclear safety, nuclear emergencies, radioective waste management, environmental monitoring results and other radiation control activities and consult and cooperate with the various departments, agencies and political subdivisions of the Commonwealth, the Federal Government, other states, interstate agencies, political subdivisions and with groups and individuals, including members of the public, concerned s  : I e_-

693 SESSION OF 1984 Act 1984-147

>A )

( with radiation safety and participate in matters before the Nuclear Regulatory Commission or its successor and appropriate agencies and courts of the United States. (11) Accept and administer loans, grants or other funds or gifts, conditional or otherwise, in fartherance of its functions, from any source, public or private, including the Federal Government. provided any funds received be subject to appropriation by the General Assembly. (12) Encourage, participate in or conduct studies, investigations, training. research, remedial actions and demonstrations relating to control, regulation and monitorir g f radiation sources. (13) Collect and disseminate information related to nuclear power, the control of radiation asources, r diation protection, emergency response and the effects of radiation exposure. (14) Establish special advisory committees as may be necessary to assist the department in drafti.g rules and regulations and to advise the department regarding implementation of specific porti-ons of the reguidons programs of the department. Each committee shall include members of the general public. Members of these committees may be reimbursed by the department for reasonable and necessary expenses incurred in connection with their duties at apprc ved by the secretary. (15) Issue registrations and licenses and specify the terms and conditions thereof. This is not intended to req registration and licenses of facilities and activities within the exclusive jarisdiction of the Nuclear Regulato Commission. (16) Require the payment of and collect fees established under Chapter 4 (17) Issue orders and institute proceedings in courts against any person or municipality to compel compliance wit this act, any rule or regulation, any order of the department or the terms and conditions of any registration or license. (18) Institute prosecutions against any person or municipality for violation of this act. (19) Assesscivilpenaltiespursuanttosectica308(e). (20) Prepare a report on environmer/.ai Miation levels, as determined by the monitoring program, on at least an annual basis. Copies of the r: port sha5 be submitted to the President pro tempore of the Senate and the Speaker 1 (_,/ the House of Representatives of the General Assembly and shall be made available to the general public. Th shall also contain a description and analysis of any emergency responses or other actions taken by the departmen under this act and any other information about environmental radiation or radiation emergencies which the { department deems to be of sufficient importance to call to the attention of the General Assembly and the citizens of the Commonwealth. (21) Administer a program, funded by the General Assembly, to assist in the decontamination of damaged nuclear power reactors. (22) Do any and all other acts not inconsistent with any provision of this act which it may deem necessary or proper for the effective enforcement of this act. 1 l l n)

 \/

l l

1 694 Act 1984-147 LAWS OF PENNSYLVANIA (OV) (d) Notification.-When ever the department ,in the course ofits powers and duties as set forth in subsecti (c), determines that Levels of radiation exceed the normal range of radioactivity in a given area, the shall immediately notify the Governor, the agency and the NRC and shall also report its findings to th shall subsequently public. submit a report on the occurrence to both the Govemor and the NRC and sh Section 302. Powers of Environmental Quality Board. (a) Powers and duties.-The Environmental Quality Board or its successor shall have the power an of this act. to adopt the rules and regulations of the department to accomplish the purposes and carry shall be (b) Review of fee structure.-The Environmental Quality Board or its successor shall review every four ye structure as authorized by sections 401 and 402(b). Section 303. Licensing and registration. (a) Authority.-The department is authorized to license radiation source users and register any radiation sources. (b) Exemption.-The department shall be exempt from the licensing and registration requirements of this act an authorized to exempt certain radiation sources and users from this act provided the department determines th j action will constitute an insignificant risk to the health and safety of the public and to persons exposed to rad sources. { (c) Approval of transfer.-No license issued under this act and no right to possess or utilize radiation sources by any license shall be assigned, or in any manner disposed of, without the approval of the department. (d) Termiand conditions of licenses.-The terms and conditions of all licenses issued under this actI) to amendment , revision or modification by rules, regulations or orders issued in accordance with this act. (e) Recognition of other licenses .-Rules and regulations promulgated under this act may provide for recogn other state or Federallicenses. ( Section 304. Records. (a) General rule.-Each person who possess or uses any radiation source shall maintain records relating to its receipt, storage, transfer or disposal. and such other records as the department may require, subject to any exemptions as may be provided by rules or regulations. (b) Personnel radiation exposure records.-Each person who possesses or uses a radiation source shall maintain appropriate recr,rds of radiation exposure, as mandated by the rules and regulations of the department. Copies o the these records and those required to be kept by subsection (a) shall be submitted to the department on written request. Any person possessing or using a radiation source shall furnish upon a reasonable request to each employee for whom personnel monitorin2 i s required or to the employee's representative, a copy of the employ personal exposurt record as the department, by rule or regulation, may prescribe. l i l (v)

695 SESSION OF 1984 Act 1984147 l Section 305. Inspection. (a) Authority.-The department or its duly authorized representatives shall have the power to enter at all reasonabl times with sufficient probable cause upon any public or private property, building, premise or place, for the purposes of determining compliance with this act, any license conditions or any rules, regulations or orders issued under this act. In the conduct of an investigation, the department or its duly -"thorized representatives shall have the authority to conduct tests, inspections or examinations of any radiation se r of any book, record, document or other physical evidence related to the use of a radiation source. (b) Search warrant.-An agent ur employee of the department may (  ? search warrant, to an issuing authority, for the purposes of testing, inspecting or examining any radiatic. any public or private property, building, premise, place, book, record or other physical evidence related to th6

                                                                                          <c of the radiation source. A warrant shall be issued only upon probable ceuse. It shall be sufficient probable caase to show any of the follo (1) The test, inspection or exaaination is pursuant to a general administrative plan to determine compliance with this act.

(2) The agent or employee has reason to believe that a violation of this act has occmed or may occur. (3) The agent or employee has been refused access to the radiation source, property, building, premise, place, book, record, document or other physical evidence related to tne use of the radiation source or has been prevented from conducting tests, inspections or examinations. Section 306. conflicting laws. Ordinances, resolutions or regulations now or hereafter in effect of the governing body of any age icy or political subdivision of this Commonwealth relating to radiation or radiation sources shall be superseded by this act if cuch ordinances or regulations are not in substantial conformity with this act and any rules and regulations issued hereunder. Section 307. Prohibited uses and acts. It shall be unlawful for any person to use, manufacture, produce, transport, transfer, bury, receive. acquire, own, possess or dispose of any radiation source in violation of this act. It shall be unlawful for any person to operate an s unregistered radiation source or to operate a radiation source or to administer a radiologic procedure without a license to do so where a license or registration is required by the department by rule or regulation. Section 308. Penalties. (a) Summary offense..Any person, other than a municipal official exercising his official duties, who violates any provisions of this act or any rules or regulations or order promulgated or issued hereunder commits a summary offense and shall, upon conviction, be sentenced to pay a fine not le s than $100 and not more than $1,000 for each separate offense and in default thereof shall be imprisoned for a term of not more than 30 days. All summary proceedings under this act may be brought before any districtjustice or magistrate in the county where the offense was committed and to s

                                                                        ~

l 696 Act 1984147 O) \U - LAWS OF PENNSYLVANIA that end jurisdiction is hereby conferred upon district justices and magistrates, subject to appeal by either part the manner provided by law. (b) Misdemeanor.-Any person, other than a municipal official exercising his official duties, who violates any provision of this act or any rule or regulation or order promulgated or issued hereunder, within two years after having been convicted of any summary offense under this act, commits a misdemeanor of the third degree an upon conviction, be sentenced to pay a fine of not less than $1,000 but not more than $25,000 for each separate often or imprisonment in the countyjail for a period of not more than one year, or both. (c) Felony..Any person who intentionally, knowingly or recklessly violates any provision of this act, or any rule or regulation or order of the department or any term or condition of any permit, and whose ads or omissions cause or create the possibility of a public nuisance or bodily harm to any person, commits a felony of the second degree and shall, upon conviction, be sentenced to pay a fine of not less than $2,500 but not more than $ 100,000 per day each violation, or to a term ofimprisonment of not less than one year but not more than ten years, or both. (d) Separate offense for each day. Each day of continued violation of any provision of this act or any rule or regulation or order promulgated or issued pursuant to this act shall constitute a separate offense. (e) Civil penalty.-In addition to proceeding under any other remedy available at law or in equity for a violation of this act or a regulation or order of the department promulgated or issued hereunder, the department may areas a civil penalty upon the person for the violation. This penalty may be assessed whether or not the violation was willful or negligent. The civil penalty shall not exceed $25,000 plus $5,000 for each day of continued violation. In determining the civil penalty, the department shall consider, where applicable, the willfulness of the violation, gravity of the violation, good faith of the person charged, history of the previous violations, danger to the public health and welfare, damage to the air, water, land or other natural resources of the Commonwealth or their uses, cost of restoration or abatement, savings resultant to the person in consequence of the violation and any other relevant ' facts. The person charged with the penalty shall then have 30 days to pay the proposed penalty in full or, if the A person wishes to contest either the amount of the penalty or the fact of the violation, to file within a 30-day period  ! (% an appeal of the action with the Environmental Hearing Board. Failure to appeal within 30 days shall result in a waiver of all legal rights to contest the violation or the amount of the penalty. Civil penalties shall be payable to the Commonwealth of Pennsylvania and shall be co!!ectible in any manner provided by law for collection of debts. If any person liable to pay a penalty neglects or refuses to pay the same after demand, the amount, together with interest and any costs that may accrue shall be a lien in f2vor of the Commonwealth upon the property, both real and personal, of the person, but only after same has been entered and docketed of record by the prothonotary of the county where the property is situated. The department may, at any time, transmit to prothonotaries of the respective counties i i I i v

697 SESSION OF 1984 A Act 1984147 certified copies of all such liens and it shall be the duty of each prothonotary to enter and docket the same of reco in his office and to index the same as judgments are indexed. without requiring the payment of costs as a condit precedent to the entry thereof. Section 309. Enforcement and abatement. j (a) Public nuisance.- Any violation of this act or of any mle, regulation or order of the department or of any ter condition of any license or registration issued under this act shall constitute a public nuisance. Any person committing the violation shall be liable for the costs of abatement of the nuisance. The Environmental Hear Board and every court of common pleas are hereby given jurisdiction over actions to recover the costs of the abatement. (b) Orders.-In addition to other remedies provided under this act or any other w, to aid in the enforcement of this act, the department may issue orders to persons as it deems necessary to protect health and safety. Them include an order modifying or revoking registrations or licenses, orders to cease unlawful activities or other acts involving radiation sources that are determined by the department to be detrimental to the public health and and such other orders as the department deems necessary to abate public nuisances. An order issued under this subsection shall take effect upon notice, unless the order specifies otherwise. An appeal to the Environmental Hearing Board shall not act as a supersedeas. It shall be the duty of any person to comply with any order issued under this subsection. Any person who fails to comply with an order issued under this subsection shall be guilty contempt and shall be punished in an appropriate manner by the Commonwealth Court. which court is hereby grantedjurisdiction, upon application by the department. (c) Injunction.-In addition to any other remedies provided for in this so, the department may institute a suit in equity in the name of the Commonwealth for an injunction to restrain a violation of this act or the rules, regulations or orders adopted or issued hereunder, or to restrain the maintenance or threat of a public nuisance. In any such proceeding the court shall, upon motion by the department, issue a prohibitory or mandatory preliminary injunction p ifit rinds that the defendant is engaging in unlawful conduct or is engaged in conduct which is causing immediate ! I b and irreparable harm to the public. The Commonwealth shall not be required to fumish bond or other security in connection with such proceedings. (d) Impoundment. etc.-The department shall have the authority to impound any radiation source or to take other actions as are necessary to abate a public nuisance wherever the department believes that this action is necess protect the health and safety cf the public. (e) Emergency orde .-Whenever the secretary rinds that an emergency exists requiring immediate action to protect the public health and safety, the secretary may issue an emergency order reciting the existence of the emergency a requiring that such action be taken as is necessary to meet the emergency. This order shall be effective immediately. Any person to whom this order is directed shall comply therewith immediately, unless a supersedeas is granted by the Environmental Hearing Board.

 \

l

1 I l 698 Act 1984-147 LAWS OF PENNSYLVANIA C/ (f) Revocation oflicenses or permits.-Repeated violations of any provisions of this act or any rules and regulation l of the department promulgated under the authority of this act or nonpayment of fees or penalties shall be cause for revocation oflicenses or permits issued by the department under this act. Section 310. Liberal construction. l The penalties and remedies prescribed by this so shall be concurrent and the existence of or exercise of any! shall not prevent the department from exercising any other remedy at law or in equity. No provision of this act or  ! any action taken by virtue of this act, including the granting of a registration or license, shall be construed as estopping the Commonwealth from proceeding in courts oflaw or equity to abate nuisances under existing law, nor shall this act in any other manner abridge or alter rights of action or remedies now or hereafter existing in equity under the common law or statutory law, criminal or civil. exercised by the Commonwealth or any person to enforce their rights or to abate any nuisance, now or hereafter existing. in any court of competentjurisdiction. CHAPTER 4 FEES Section 401. Licensing and registration fees. ) i The department shall, by rule and regulation. set reasonable annual fees for the registration of radiation sources and the licensing of radiation source users. These fees shall be in an amount at least sufficient to cover the costs of administering the programs. I Section 402. Nuclear facility fees. l (a) General Rule.- Persons engaged in the business oi producing electricity utilizing nuclear energy, operating , facilities for storing away-from-reactor spent nuclear fuel for others or fabrication of nuclear fuel or shipping spent nuclear fuel shall pay fees to cover the costs of the related to their activities as required by this act. (b) Department fees. Each person who has received a nuclear power reactor facility construction permit or (Q operating license from the NRC shall pay to the department within 30 days of the effective date of this so and by July 1 of each year an annual fee of $ 150,000 per power reactor, regardless of the number of reactors per site. (c) Agency fees.. (1) Each person who has received or has applied for a nuclear power reactor facility operating license from the NRC shall pay to the a one-time fee of $200,000 per site within 30 days of the effective date of this act and an annual fee of $100,000 per site payable by July I of each year, regardless of the number of power reactors per site. (2) Each person who has applied for or received a valid license from the NRC to operate an away-from spent fuel storage facility shall pay to the agency an annual fee of $30.000 per site payable by July I of each year. m i

699 SESSION OF 1984 Act 1984147 (3) Each person who has applied for or received a valid license from the NRC to operate a reactor fu facility shall pay to the agency an annual fee of $50,000 per site payable by July I of each year. (4) Each shipper of spent reactor fuel to, within, through or across the boundaries of this Commonwe pay to the agency a fee of SI,000 per shipment. payable prior to the proposed date ofshipment. (d) PSP fees.- (1) Each shipper of spent reactor fuel to, within ,through oc across the Commonwealth shall reimburse for escort service at the following rates: $20 per hour per officer and SM per mile for highway shipm shipments shall be based on a rate of $25 per hour per officer. If the shipment is canceled following PSP notification, the shipper shall compersate the PSP at an appropriate rate for four hours of officers' time. (2) The PSP may adjust the rates by regulation as prevailing wage rates and transportation costs chan (e) Penalties.-Any person violating any provision of this chapter shall be subject to the penalties and enforc provisions ofsection 309(10 and (b). Section 403. Creation ofspecial funds. (a) Radiation Protection Fund.-There is hereby created in the General Fund a restricted account to be know Radiation Protection Fund. Fen and penalties received under sections 401 and 402(b) shall be deposited in and are hereby appropriated to the department for the purpose ofcanying 'out its powers and duties under th (b) Radiation Emergency Response Fund.-There is hereby created in the General Fund a restricted account t known as the Radiation Emergency Response Fund. Fees received under section 402(c)(l), (2) and (3) s deposited in this fund as provided and are hereby appropriated to the agency for the purpose ofcanying out its responsibilities under Chapter 5. (c) Radiation Transportation Emergency Response Fund.-There is hereby created in the General Fund a rertri account to be known as the Radiation Transportation Emergency Response Fund. Fees received under section 402(c)(4) shall be deposited in this fund and are hereby appropriated to the agency for the purpose o its responsibilities under Chapter 6. CHAPTER 5 RADIATION EMERGENCY _ RESPONSE PROGRAM Section 501. Declaration ofpolicy, it is the policy of the General Assembly to protect the people of the Commonwealth against adverse health effects resulting from radiation accidents by establishing a mechanism for emergency preparedness to mitigate the eff of such accidents. The General Assembly rinds that it is appropriate for the nuclear industry in the Commonwealth to bear the costs associated with preparing and implementing plans to deal with the effects of nuclear accidents or incidents. k v

700 Act 1984-147 LAWS OF PENNSYLVANIA h (j' Section 502. Response program. In conjunction with the depanment, the agency shall develop a Radiation Emergency Response Pennsylvania Emergency Management Plan development by the agency pursuant to Title 35 of the Pen Statutes (relating to health and safety). Any volunteer organizations which are Incorporated i Program developed under the authority of this ad shallbe consulted prior to such incorporat Program shall include an assessment of potential nuclear accidents or incidents, the radiological con measures required to mitigate the effects of such accidents or incidents. The program shall include, but not be lirn (1) Development of a detailed fixed nuclear enterprise response plan for areas surrounding each facility, nuclear fabricator and away-from-reactor storage facility. The term " areas" shall b response zone designated by the NCR Emergency Response Plan applicable to each such fixed nuclear fac (2) Noti 6 cation by nuclear power facility operating of municipalities within the areas set fonh In paragra activity as defined in section 301(d). p) Training and equipping of State and local emergency r personnel. (4) Periodical facihty. exercise of the accident scenarios designated in the NRC Emergency Response Plan applic (5) Procurement of specialized supplies and equipment. (6) Provisions for financial assistance to municipalities, school districts, volunteer and State agencies as prov 503. Section 503. Financial assistance program. (a) General provisions -Applications by municipalities, school districts, volunteer organizations t and State conduct training or purchase protective supplies and equipment principally required to cany out the purpo shall be made to the which shall make the disbursements pursuant to regulations promulgated by the council. p (b) Reimbursement provisions.-Municipalities, school districts. volunteer organizations and State agen reimbursement of costs not previously recouped or to be reimbursed from other sources which were requ V) ( direct result of the preparation, establishment and testing of emergency response plans surrounding eac facility, for personnel costs, training expenses and protective supplies and equipment on or after March 29,1979. (c) Reports.- September I of each year, the agency shall submit a report on its operations for the preceding fisc and the General Assembly. The report shall include a summary of the activities of the Radiation Emergen activities pursuant to shipments of spent fuel, as provided for in Chapters 5 and 6. Livery, a well as a propos financial statement and a fisting of application I i l (m) , i 1 L.  !

E i 701 SESSION OF 1984 Act 1984-147 received and disbursements or reimbursements made to municipalities, school districts, volunteer organizations a State agencies pursuant to Chapters 5 and 6 and an analysis of the adequacy of fees established pursuant to sect 402(c). CHAPTER 6 TRANSPORTATION OF SPENT NUCLEAR FUEL Section 601. General rule. It is unlawfut for any person to transport upon the highways or rails of this Commonwealth any spent nuclear fuel unless that person notifies the agency in advance of transporting the spent nuclear fuel in accordance with 10 C. F. R. 71.5(a) and (b). Section 602. Escort requirements. All shipments of spent nuclear fuel to, withir, through or across the boundaries of the Commonwealth shall be escorted by the Pennsylvania State Police. Section 603. Authorization. Spent nuclear fuel shipments shall be authorized subject to the Commonwealth's authority to delay individual highway and rail shipments due to specific holiday or safety considerations including, but not limited to, weather, highway or rail conditions.

Section 604. Radiation Transportation Emergency Response Plan.

(a) Planning. The agency shall develop the Transportation Emergency Response Plan to respond to accidents involving the shipmer.t of spent fuel. The plan shall: (1) Incorporate local agencies and volunteer organizations along the pre-prescribed routes for transport of j spent fuel.

   ./

(2) Incorporate any Commonwealth agency responsible for protection of the health and safety of the public as necessary and approved by the specific agency. (b) Funding of State and local agencies.-Funds received under section 402(c)(4) shall be used to train and equip State and local agencies and volunteer organizations in accordance with regulations adopted by the council to implement the plan. CHAPTER 7 i i MISCELLANEOUS PROVISIONS Section 701. Transition provisions. All registrations. license and orders issued and regulations promulgated under the w of January 28,1966 (1965 P.Ll625, No.578), known as The Atomic Energy Development and Radiation Control Act, shall remain in full j force unless and until modified, amended, suspended or revoked and all appropriations, allocations, personnel, i agreements, leases, claims. demands and causes of action of any nature and equipment, riles, records, real estate, personal property and all other materials owned, used, employed or expended in connection with that act by the Department of Commerce are hereby transferred to the Department of Environmental Resources. l l l k l

                                                                                                                                  \
                                                                                                                                  )

702 Act 1984-147 p LAWS OF PENNSYLVANIA (  ! - Y/. Section 702. Repeals. The following acts are repealed: Act of January 28.1966 (1%5 P.L 1625. No,578), known as The Atomic Energy Development and Radiation Control Act. Act ofJuly 20,1979 (P.L 151, No.49), known as the Environmental Radiation Protection Act. Section 703. Conveyance. (a) Authority.-The Department of Environmental Resource with the approval of the Governor, is hereby authorized and directed on behalf of the Commonwealth 9: convey ownership in the building named the Carl A. White Acid Mine Drainage Treatment Plant, situated in Washington Township, Indiana County, Pennsylvani

• hereinafter referred to as the plant, to the County ofIndiana, Pennsylvania for the following purposes: T of Indiana, or its designee, shall utilize all or pan of the plant, whi i. is currently shut down, to treat brines produced from oil and gas wells, with the treatment of brines produced from oil and gas wells in the Commonwealth to be given priority in all respects; and, if and when directed by the department. shall utilize a maximum of 50% of the plant to treat abandoned mine acid discharge flowing in ik Crooked Creek Watershed.

if and when the department shall deem treatment of such abandoned mine acid discharg to be feasible. it sha!! notify the County of Indiana, or its designee, of the quantity of such discharges to be treated and the required quality of the effluent; provided, however, that such treatment shall not require the utilization of more than 50% of the plant. (b) Reversion.-If, for any reason whatsoever the County of Indiana, or its designee, shall discontinue the p utilization of the Carl A. White Acid Mine Drainage Treatment Plant for the treatment of oil and gas well brines.

j V or shall fail to treat any abandoned mine acid discharges which the depanment has detennined to be necessary feasible to treat, then, and in that ! vent, ownership and possession of the plant shall revert to the department, and the department shall have the option of continuing the operation of the plant for the treatment of abandoned mine acid discharge or of dismantling he plant. If, in the event of such reverter, the depanment shall elect to continue the operation of the plant for the treatment of abandoned mine acid discharge, it shall so notify the County of Indiana, or its designee, and the plant shall be returned to the depanment in the same condition that it was in when transferred to the county. The county, or its designee, shall bear any costs for returning the plant to said condition.

(e) Approval and execution.-The agreement of ownership shall be ) proved as provided by law and shall be executed by the Secretary of Environmental Resources in the name of the Commonwealth of Pennsylvania. (% (-)

703 SESSION OF 1984 Act 1984147 Section 704. Effective date. This act shall take effect in 15 days. Approved-The 10th day of July, A. D.1984. DICK THORNBURGH

SESSION OF 1985 Act 1985-120 $39 No.1985-120 AN ACT SB 417 Providing for an Appalachian States Low-Level Radioactive Waste Compact. The General Assembly of the Commonwealth ofPennsylvania hereby enacts as follows: ' Section 1. Agreement. The Commonwealth of Pennsylvania hereby solemnly covenants and agrees with the state of West V eligible states as defined in Article 5(A) of this compact and the United States of America, upon the enactment of concurrent legislation by the Congress of the United States and by the respective state legislatures, as follows: APPALACHIAN STATES LOW LEVEL RADIOACTIVE WASTE COMPACT Preamble Whereas, %e United States Congress, by enacting the Low-Level Radioactive Waste Policy Act (42 U. S. C. 2021 b 2021 d) has encouraged the use ofinterstate co:npacts to provide for the establishment and operation o facilities for regional management oflow level radioactive waste; Wherces, Under section 4(a)(1)(A) of the Low-Level Radioactive Waste Policy Act (42 U.S. C. Q 202id(a)(1)(A) each state is responsible for providing for the capacity for disposal oflow-level radioactive waste generated within its borders; Whereas, To promote the health, safety and welfare of residents within, the Commonwealth of Pennsylvania and other eligible states as defined in Anicle 5(A) of this compact shall enter into a compact for the regional management and disposal orlow-level radioactive waste. Now, therefore, the Commonwealth of Pennsylvania and the state of West Virginia and other cligible states hereby agree to enter into the Appalachian States Low-Level Radioactive Waste Compact. Aniclei Definitions . As used in this compact, unless the context clearly indicates otherwise: (a) " Broker" means any intermediate person who handles, treats, processes, stores, packages, ships or otherwise has responsibility for or possesses low-level waste obtained from a generator. (b)

• Carrier" means a person who transports low-level waste to a regional facility.

(c) " Commission" means the Appalachian States Low-Level Radioactive Waste Commission.

        $40                         Act 1985-120      LAWS OF PENNSYLVANIA (d) " Disposal" means the isolation oflow-level waste from the biosphere.

(e) " Facility" means any real or personal property within the region, and improvements thereof o and all plant structures, machinery and equipment acquired, constructed, operated or maintained for the management or disposal oflow-level waste. (f) " Generate" means to produce low-level waste requiring disposal. (g) " Generator" means a person whose activity results in the production oflow-level waste requiring dispo (h) " Hazardous life" means the time required for radioactive materials to decay to safe levels, as defin period I < the concentration of radioactive materials within a given container or package to decay to max!

• 9 permissible concentrations as defined by Federal law or by standards to be set by a host state whichever is more restrictive.

(i) " Host state" means Pennsylvania or other party state so designated by the Commission in accordance with Article 3 of this compact. " Institutional control period" means the time of the continued observation, monitoring and care of the regional facility following transfer of control from the operator to the custodial agency. (k) " Low level waste" means radioactive waste that: (1) is neither high-level waste or transuranic waste, nor spent nuclear fuel, nor by-product material as defined in Section n (e)(2) of the Atomic Energy Act of 1954 as amended;-and (2) is classified by the Federal Government as low-level waste, consistent with existing law; but does not include waste generated as a result of atomic energy defense activities of the Federal Government, as defined in Public Law 96-573, or Federal research and development activities. (1) " Management" means the reduction, collection, consolidation, storage, packaging or treatment of low-level waste. (m)" Operator" means a person who operates a regional facility. (n) " Party state" means any state that has become a party in accordance with Article 5 of this compact, (o) " Person" means an individual, corporation, partnership or other legal entity, whether public or private. (p) " Region" means the combined geographical area within the boundaries of the party states. (q) " Regional facility" means a facility within any party state which has been approved by the Commission for the disposal oflow-level waste. (r) " Shallow land burial" means the disposal oflow-level radioactive waste directly in subsurface trenches without additional confinement in engineered structures or by proper packaging in containers as determined by the law of the host state. (s) " Transuranic waste" means low-level waste containing radionuclides with an atomic number greater than 92 which are excluded from shallow land burial by the Federal Govemment. N

SESSION OF 1985 Act 1985-120 541 O Article 2 The Commission (A) Creation and Organization. (1) Creation - There is hereby created the Appalachian States Low-Level Radioactive Waste Commission. The Commission is hereby created as a body corporate and politic, with succession for the duration of this compact, as an agency and instrumentality of the govemments of the respective signato parties, but separate and distinct from the respective signatory party states. The Commission shall have central offices located in Pennsylvania. (2) Commission Membership - The Commission shall consist of two voting members from each party state to be appointed acce.. sing to the laws of each party state and two additional voting members from each host state to be appoimed according to the laws of each host state. Upon selection of the site of the regional facility, an additional voting anember shall be appointed to the Commission who shall be a resident of the county or municipality where the facility is to be located. The appointing authority of each party state shall notify the Commission in writing of the identities of the members and of any alternates. An alternate may vote and act in the member's absence. No member shall have a financial interest in any industry which generates low-level radioactive waste, any low-level radioactive waste regional facility or any .clated industry for the duration of the member's term. No more than one-half the members and alternates from any party's state shall have been employed by or be employed by a low-level waste generator or related industry upon appointment to or during thein t nure of office; provided, that no member shall have been employed by or be employed by a regionel facility operator. No member or alternate from any party state - shall accept employment from any regional facility operator or brokers for at least three years after leaving office. (3) Compensation - Members of the Commission and altemates shall serve without compensation q from the Commission but may be reimbursed for necessary expenses incurred in and incident to the performance of their duties. (V) (4) Voting Power - Each Commission member is entitled to one vote. Unless otherwise provided in this compact, affirmative votes by a majority of a host state's members are necessary for the Commission to take any action related to the regional facility and the disposal and management oflow-level waste within that host state. (5) Organization and Procedure - (a) The Commission shall provide for its own organization and procedures and shall adopt by-laws not inconsistent with this compact and any rules and regulations necessary to implement this compact. It shall meet at least once a year in the county selected to host a regional facility and-shall elect a chairman and vice chairman from among its members. In the absence of the chairman, the vice chairman shall serve. ( V)

542 Act 1985120 /n \ LAWS OF PENNSYLVANIA  ; Q - (b) All meetings of the Commission shall be open to the public with at least 14 days' advance noticel except that the chairman may convene an emergency meeting with less advance notice. Each municipality and county selected to host a regional facility shall be specifically notified in advance of all Commission meetings. All meetings of the Commissiorishall be conducted in a manner that substl conforms to the Administrative Procedure Act (5 U.Sa . Ch.5, Subch.ll. and Ch.7). The Commission may, by a two-thirds vote, including approval of a majority of each host state's Commission members,  ! hold an Executive Session closed to the public for the parpose of: considering or discussing legally privileged or proprietary information; to consider dismissal, disciplining of or hearing complaints or charges brought against an employee or other public agent unicss such person requests such public hearing; or to consult with its attomey regarding information or crategy in connection with specific - litigation. The reason for the Executive Session must be announced at least 14 days prior to the Executive Session, except that the chairman may convene an emergency meeting with less advance notice, in which case the reason for the Executive Session must be announced at the open meeting immediately subsequent to the Executive Session. All action taken in violation of this open meeting provision shall be null and void. (c) Detailed written minutes shall be kept of all meetings of the Commission. All decisions, liles, records ' and data of the Commission, except for information privileged against introductior, in judicial proceedings, personnel records and minute. of a properly convened Executive Session shall be open to public inspection subject to a procedure that substantially conforms to the Freedom ofInformation Act l (Public Law 89-554,5 U.S.C. # 552) and applicable Pennsylvania law and may be copied upon request and payment of fees which shall be no higher than necessary to recover copying costs. j (d) The Commission shall select an appropriate staff, including an Executive Director, to carry out the duties and functions assigned by the Commission. Notwithstanding any other provision of law, the Commission may hire and/or retain its own legal counsel. p (e) Any person aggrieved by a final decision of the Commission which adversely affects the legal rights, j (v) duties or privileges of such person may petition a court of competentjurisdiction, within 60 days after the Commission's final decision, to obtain judicial review of said final decisions. l (f) Liabilities of the Commission shall not be deemed liabilities of the party states. Members of the Commission shall not be personally liable for actions taken in their ofticial capacity. (B) Powers and Duties. The Commission: (a) Shall conduct research and establish regulations to promote a reasonable reduction of volume and curie content oflow-level wastes generated in the region. The regul m..ons shall be reviewed and, if necessary, revised by the Commissian at least annually'- O v

SESSION OF 1985 Act 1985-120 543 i (") (b) Shall ensure, to the extent authorized by Federal law, that low-level v.astes are safely disposed of withi the region -except that the Commission shall have no power or authority to license, regulate or otherwise develop a regional facility, such powers and authority being reserved for the host state (s) as permitted und the law. (c) Shall designate as " host states

• any party state which generates 25 percent or more of Pennsylvania!

volume or total curie content oflow-level waste generated based on a comparison of averages over three successive years, as determined by the Commission. This determination shall be based on volume or total ' curie content, whichever is greater. (d) Shall ensure, to the extent authorized by Federal law, that low-level waste packages brought into the  ! regional facility for disposal conform to applicable state and Federal regulations. Low-level waste brokers or generators who violate these regulations will be subject to a fine or other penalty imposed bj the Commission, including restricted access to a regional facility. The Commission may impose such fines and/or penalties in addition to any other pen-Ity levied by the party states pursuant to Article 4(D). (e) Shall establish such advisory committees as it deems necessary for the purpose of advising the Commission on matters pertaining to the management and disposal oflow-level waste. (f) May contract to accomplish its duties and, effectuate its powers subject to projected available resources. No contract made by the Commission shall bind a party state. (g) Shall prepare contingency plans for management and disposal of low-level waste in'the event any regional facility should be closed or otherwise unavailable. (h) Shall examine all records of operators of regional facilities pertaining to operating costs, profits or the assessment or collection of any charge, fee or surcharge and may make recommendations to the host state (s) which shall review the recommendations in accordance with its (their) own sovereige ,aws. (i) Shall have the power to sue and be sued subject to Article 2(A)($)(e) and may seek to intervene in any administrative orjudicial proceeding. l A (j) Shall assemble and make available, to the party states and to the public, information concerning low-level 1 waste management and disposal needs, technologies and problems. i (k) Shall keep current and annual inventories of all generators by name and quantity of low-level waste ' generated within the region, based upon information provided by the party states. Inventory information shall include both volume in cubic feet and total curie content of the low-level waste and all available information on chemical composition and toxicity of such wastes. (1) Shall keep an inventory of all regional facilities and specialized facilities, including, but not necessarily restricted to, information on their size, capacity and location, as well as specific wastes capable of being managed, and the projected useful life of each regional facility. A i I O

544 Act 1985120 O LAWS OF PENNSYLVANIA (m) Shall make and publish an annual report to the governors of the signatory party states and to th l detailing its programs, operations and finances, including copies of the annual budget and the in audit required by this compact. l (n) Notwithstanding any other provision of this compact to the contrary, rnay, with the unanimous l of the Commission members of the host state (s), enter into temporary agreements with nonpany s l other regional boards for the emergency disposal of low-level waste at the regional facility, if so authorize by law (s) of the host state (s), or other disposal facilities located in states that are not parties to this agreement. (o) Shall promulgate regulations, pursuant to host state law, to specifically govern and define exactly l ' would constitute an emergency situation and exactly what restrictions and limitations would be placed on temporary agreements. (p) Shall not accept any donations, grants, equipment, supplies, materials or sersices, conditional or otherwise, from any source, except from any Federal agency and from pany states which are cenified as being legal and proper under the laws of the donating pany state. (C) Budget and Operation. (1) Fiscal Year - The Commission shall establish a fiscal year which conforms to the fiscal year of the Commonwealth of Pennsylvania. (2) Current Expense Budget - Upon legislative enactment of this compact by two pany states and each ye until the regional facility becomes availab;e, the Commission shall adopt a current expense budget for its fisca year. The budget shall include the Commission's estimated expenses for administration. Such expenses shall be allocated to the pany states according to the following fcnnula: Each designated initial host state will be allocated costs equal to twice the costs of the other pany states, but such costs will not exceed $200,000. Each remaining party state will be allocated a cost of one half the cost of the initial host state, but such costs i p will not exceed $ 1 00,000. The pany states will include the amounts allocated above in their respective i I O budgets, subject to such review and approval as may be required by their respective budgetary processes. Such amounts shall be due and payable to the Commission in quarterly installments during the fiscal year. (3) Annual Budget Request - For continued funding of its activities, the Commission shall submit an annual budget request to each party state for funding, based upon the percentage of the region's waste generated in each state in the region, as reported in the latest available annual inventory required under Article 2(B)(k). l The percentage of waste shall be based on volume of waste or total curie content as determined by the  ! Commission. (4) Annual Report to include Budget - The Commissien shall prepare and include in the annual report a l budget showing anticipated receipts and disbursements for the ensuing year. l A f \ I v

I SESSION OF 1985 Act 1985-120 545 1 l Q (5) AnnualIndependent Audit. (a) As scon as practicable after the closing of the fiscal year, an audit shall be made of the financial accounts of the Commission. The audit shall be made by qualified certified public accountants selected by the Commission, who have no personal direct or indirect interest in the financial affairs of the Commission i ' or any of its officers or employees. The report of audit shall be prepared in accordance with accepted accounting practices and shall be filed with the chairman and such other officers as the Commission shall direct. Copies of the report shall be distributed to each Commission member and shall be made available for public distribution. (b) Each signatory party, by its duly authorized officers, shall be entitled to examine and audit at any time all of the books, documents, records, files and accounts and all other papers, things or property of the Commission. The representatives of the signatory parties shall have access to all books, documents, records, accounts, reports, files and all other papers, things or propeny belonging to or in use by the Commission and necessary to facilitate the audit; and they shall be afforded full facilities for verifying transactions with the balances or securities held by depositories, fiscal agents and custodians. Article 3 Rights, Responsibihties and Obligations of Party States (A) Regional Facilities. There shall be regional facilities sufficient to dispose of the low-level waste generated within the region. Each regional facility shall be capable of disposing of such low-level waste but in the form (s) required by regulations or license corditions. Specialized facilities for particular types of low-level waste management, reduction or treatment may not be developed in any party state unless they are in accordance with the laws and regulations of p such state and applicable Federal laws and regulations. (% (B) Equal Access to Regional Facilities. Each party state shall have equal access as other party states to regional facilities located within the region and accepting low-level waste, provided, however, that the host state may close the regional facility located within its borders when necessary for public health and safety. However, a host state shall send notification to the Commission in writing within three (3) days of its action and shall, within thirty (30) working days, provide in writing the reasons for the closing. (C) Initial Host State. Pennsylvania and party states which generated 25 percent or more of the volume or curies of low-level waste generated by Pennsylvania, based on a comparison of averages over the three years 1982 through 1984, an. designated as " initial host states" and are required to develop and host low-level waste sites as regional facilities. The percentage of waste from each state shall be determined by cubic foot volume or tc*j curie content,  ; whichever is greater. l L)

L 546 Act 1985-120 LAWS OF PENNSYLVANIA

 / \
   )  (D) Exemption From Being Initial Host State.

Party states which generated less than 25 percent of the volume or curies of low-level waste generated by Pennsylvania, based on a comparison of averages over the years 1982 through 1984, shall be exempt from initial host state responsibilities. These states shall continue to be exempt as long as they generate less than the 25 percent threshold over successive 3-year periods. Once a state generates an average of 25 percent or more of the volume or curies generated by Pennsylvania over a successive 3-year period, it shall be designated as a " host state" for a 30-year period by the Commission and shall immediately initiate development of a regional facility to be operational within five years. Such host state shall be prepared to a. cept at its regional facility low-level waste at least equal to that generated in the state. With Commission approval, any pany state may volunteer to host a regional facility. The percentage of waste from each state shall be determined by either a cubic foot volume or total curie content, whichever is greater. (E) Useful Life of Regional Facilities. Pennsylvania and other host states are obligated to develop regional facilities for the duration of this compact. All regional facilities shall be designed for at least a 30-year useful life. At the end of the facility's life, normal closure and maintenance procedures shall be initiated in accordance with the applicable requirements of the host state and the Federal Government. Each host state's obligation for operating regional facilities shall remain as long as the state continues to produce over a 3-year period 25 percent or more of the volume or curies oflow-Svel waste generated by Pennsylvania. (F) Duties of Host State, Each host state shall: (a) Cause a regional facility to be sited and developed on a timely basis. (b) Ensure by law, consistent with applicable state and Federal law, the protection and preservation of public health, safety and environmental quality in the siting, design, development, licensure or other regulatic :. operation, closure, decommissioning, long-term care and the institutional control period of the regional facility Q within the state. To the " tent authorized by Federal law, a host state may adopt more stringent laws, rules or g") regulations than required by Federal law. (c) Ensure and maintain a manifest system which documents all waste-related activities of generators, brokers, carriers and related activities of generators, brokers, carriers and operators, and establish the chain of custody of waste from its initial generation to the end of its hazardous life. Copies of all such manifests shall be submitted to the Commission on a timely basis. (d) Ensure that charges for disposal oflow-level waste at the regional facility are sufficient to fully fund the safe disposal and perpetual care of the regional facility and that charges are assessed without discrimination as, to the party state of origin. (e) Submit an annual report to the Commission on the status of the regional facility which contains projections of the anticipated future capacity. c)

SESSION OF 1985 Act 1985-120 m 547

  \

[Q (f) Notify the Commission immediately if any exigency arises requiring the possible temporary or permanent closure of a regional facility within the state at :t time earlier than was projected in the state's most recent annual report to the Commission. (g) Require that the iratitutional control period of any disposal facility be at. least as long as the hazardous life as defined in Article I (h), of the radioactive materials that are disposed at that facility. (h) Prohibit the use of any shallow land burial, as defined in Article 1(r), and develop altemative means for

                                                                                                                     ~

treatment, storage and disposal oflow-level weste. (i) Establish by law, to the extent not prohibited by Federal law, requirements for financial respons including, but not limited to: (i) Requirements for the purchase and main *; nance of adequate insurance by genemtors, brokers, carriers and operators cf the regional facility; (ii) Requirements for the establishment of a long-term care fund to be funded by a fee placed o . generators to pay for preventative or corrective measures oflow-level waste to the regional facility; and

           . (iii) Any further financial responsibility requirements that shall be submitted by generators, brokers, carriers and operators as deemed necessary by the host state.

(G) Duties ofParty State. Each party state: (a) Shall appropriate its portion of the Commision's initial and annual budgets as set out in Article 2(C)(2) and (3). (b) To the extent authorized by Federal law, shall develop and enforce procedures requiring low-level waste shipments originating within its borders and. destined for a regional facility to conform to volume reduction, packaging and transportation requirements and regulations as well as any other requirements specified by the regional facility. Such procedures shallinclude, but are not f:mited to: ,

]              (i) Periodic inspetions of packaging and shipping practices; (ii) Periodic inspe iions oflow-level waste containers while in custody of carriers; and (iii) Appropriate enforcement actions with respect to violations.

(c) To the extent authorized by Federal law, shall, after receiving notification from a host state or other person that a person in a party state has violated volume reduction, packaging, shipping or transportation l requirements or regulations, take appropriate action to ensure that violations do not recur. Appropriate action shall include, but is not limited to, the requirement that a bond be posted by the violator to pay the cost of repackaging at the regional facility and the requirement that future shipments be inspected. Appropriate action may also include suspension of the violator's use of the regional facility. Should such suspension be imposed, the suspension shall remain in effect until such time as the violator has, to the satisfaction of the party state imposing such suspension, complied with the appropriate requirements or regula- /~T

548 Act 1985-120 LAWS OF PENNSYLVANIA

/n   h (v)                     tions upon which the suspension was based and has taken appropriate action to ensure that such violation or violations do not recur.

(d) Shall maintain a registry of all generators and quantities generated within the state. (H) Liability. In the event ofliability arising from the operation of any regional facility and during and at clasure of that facility, each party state shall share in that liability in an amount equal to that state's share of the region's low-level waste disposed of at the facility. Ifsuch liability arises from negligence, malfeasance or neglect on the part of a host state's or any pany state, then any other host or party state (s) may make any claim allowable under law for that negligence, malfeasance or neglect. If such liability arises from a particular waste shipment or shipments to, or quantity of waste or condition at, the regional facility, then any host or party state may make any claim allowable under law for such liability. The percentage of waste shall be b . sed on volume of waste or total curie content. (I) Failure of Party State to Fulfill Obligations. A party state which fails to fulfill its obligations, including timely fundi g of the Commission, may have its privileges under the Compact suspended or its membership in the Compact revoked by the Commission and be subject to any other legal and equitable remedies available to the party state < Article 4 Prohibited Acts and Penalties (A) Prohibition. It shall be unlawful for any person to dispose oflow-level waste within the region except at a regional facility unless authorized by the Commission. (B) Waste Disposed of Within Region. After establishment of the regional facility (s), it shall be unlawful for any person to dispose of any low-level N waste within the region unless the waste was generated within the region or unless authorized to do so both by , the Commission and by law of the host state in which said disposal takes place. For the purposes of this N compact, waste generated within the region excludes radioe:tive material shipped from outside the party states to a waste management facility within the region. In determining whether to grant such authorization, the factors to be considered by the Commission shall include, but not be limited to, the following: (a) The impact on the health, safety and environmental quality of the citizens of the party states; (b) The impact ofimporting waste on the available capacity and projected life of the regional facility; (c) The availability of a regional facility appropriate for the safe disposal of the type of low level waste involved. 1 (C ) Waste Generated Within Region. ) Any and all low-level waste generated within the region shall be disposed of at a regional facility, except for specific cases agreed upon by the Commission, with the affirmative votes by a majority of the Commission members of the host state (s) affected by the decision. i

                                                                                                                                       )

l t k 1

[] SESSION OF 1985 Act 1985-120 549 (D) Liability. Generators, brokers and carriers of wastes, and owners and. operators of sites shall be liable for their acts, omissions, conduct or relationships in accordance with all laws relating thereto. The party states shall impose a fine for any violation in an amount equal to the present and future costs associated with correcting any harm caused by the violation and shall assess punitive fines or penalties ifit is deemed necessary. In addition, the host state sha!! bar any person who violates host state or Federal regulations from using the regional facility until that person demonstrates to the satisfaction of the host state the ability and willingness to comply with the law. (E) Conniet ofInterest. (1) Prohibitions - No commissioner, of6cer or employee shall: (a) Be financially interested either directly or indirectly, in a contract, sale, purchase, lease or transfer of real or personal property to which the Commission is a party. (b) Solicit or accept money or any other thing of value in addition to the expenses paid to him by the Commission for services performed within the scope of his official duties. (c) Offer money or ar.ything of value for or in consideration of obtaining an appointment, promotion or privilege in his employment with the Commission. (2) Forfeiture of Office or Employment - Any ofGeer or employee who shall wil;iully violate any of the provisions of this section shall forfeit his ofGce or employment. (3) Agreement Void - Any contract or agreement knowingly made in contravention of this section is void. (4) Criminal and Civil Sanctions - O Officers and employees of the Commission shall be subject, in addition to the provisions of this section, to such criminal and civil sanctions for misconduct in office as may be imposed by Federa! law and the law of the signatory state in which such misconduct occurs. Article 5 Eligibility, Entry Into Effect, Congressional Consent, Withdrawal (A) Eligibility. Only the States of Pennsylvania, West Virginia, Delaware and Maryland are eligible to become parties to this compact. (B) Entry into Effect. An eligible state may become a party state by legislative enactment of this compact or by executive order of the governor adopting this compact; provided, however, a state becoming a pany state by executive order shall cease to be a party state upon adjournment of the first general session ofits legislature convened thereafter, unless the legislature shall have enacted this compact before such adjournment. D 0

l i [ 550 Act 1985-120 LAWS OF PENNSYLVANIA b ' (C) Congressional Consent. l This compact shall take effect when it has been enacted by the legislatures of Pennsylvania and one or more eligible states. However, Article 4(B) and (C) shall not take effect until Congress has consented to this compa Every fifth year after such consent has been given, Congress may withdraw consent. (D) Withdrawal. A party state may withdraw from the compact by repealing the enactment of this compact, but no such withdrawal shall become effective until two years after enactment of the repealing legislation. If the withdrawing state is a host state, any regional facility in that state shall remain available to receive low-level waste generated within the region until five years after the effective date of the withdrawal. Article 6 Construction and Sevembility (A) Construction. The provisions of this compact shall be broadly construed to carry out the purposes of the compact, but the sovereign powers of a pany state shall not unnecessarily be infringed. (B) Severability, if any part or application of this compact is held invalid, the remainder, or its application to other situations or persons, shall not, be affected. Section 2. Repealer. All acts and parts of acts are repealed insofar as they are inconsistent with this act. Section 3. Effectuation by Governor. The Governor is authorized to take such action as may be necessary and proper in his discretion to efrectuate the compact and the initial organization and operation of the Commission. Section 4. Budgetary processes. s The tenn " budgetary processes" in Article 2(C)(2) of the compact shall be construed to include the presentation by the Commisdon of its proposed budget for each fiscal period to the Secretary of the Budget, in accordance with the rules and practices of the Commonwealth governing administrative agencies, for study and consideration by the Secretary of the Budget, and each such budget shall include a statement of moneys required to administer, manage and support the Commission during the ensuing fiscal period. The statement shall include any request for appropriation of funds by the Commonwealth and shall be accompanied by a tabulation of similar requests which the Commission makes or expects to make to each other signatory party, and the formula or factors upon which such respective requests are based. Further, the term " budgetary processes" as applied to the Commonwealth shall not be considered complied with until it includes appropriation by the General Assembly and the signing of the appropriation into law by the Governor,

  /%

i 1

SESSION OF 1985 Act 1985-120 551 Section 5 Effective date. This act shall take effect immediately. APPROVED-The 22nd day of December, A. D.1985. DICK THORNBURGH i I l i

Session of 1988 Act t9g8-12 31 s No.1988-12 l AN ACT SB 948 Providing for low-level radioactive waste disposal; further providing for powers and duties of the Department of Environmental Resources and the Environmental Quality Board; providing for the siting oflow-level radioactive waste ! disposal facilities and for the licensing of operators thereof; establishing certain funds and accounts for the benefit of host municipalities and the general public; establishing the Low-Level Waste Advisory Committee and providing for its powers and duties; providing for membership on the Appalachian States Low-Level Radioactive Waste Commission; requiring certain financial assurances; providing enforcement procedures; providing penalties; making repeals; and making appropriations. l TABLE OF CONTENTS Chapter 1. General Provisions I Section 101. Short title. Section 102. f.egislative findings. Section 103. Definitions. Chapter 3. Low-Level Waste Disposal Section 301. Powers and duties of the Department of Environmental Resources. Section 302. Powers and duties of the Environmental Quality Board. Section 30J. Generation, transportation, handling, management and disposal of low- i level waste. Section 304. Siting regulations. Section 303. Facility design and operational management regulations. Section 306. Operator-licensee designate selection. Section 307 Site selection. Section 308. Operator licensing. Section 309. Outercompact waste. Section 310. Permitting of generators, brokers and carriers. Section 311. Decommissioning. Section 312. Low-Level Waste Fund. ' Section 313. Long-Term Care Account. Section - 314. Regional Facility Protection Fund. Section 313. Fees, rates and surcharges. Section 316. Financial assurance and liability. Section 317. Low-Level Waste Advisory Committee. Section 318. Host and afTected municipality benefits and guarantees. Section 319. Rebuttable presumption. Section 320. Protection from contamination. Section 321. Low-level waste compaction. Section 322. Noncommercial low-level waste incinerators. Section 323. Limitation on actions.

32 Act 1988-12 LAWS OF PENNSYLVANIA Chapter 5. Enforcement and Penahies Section 501. Unlawfulconduct. Section 502. Inspection. Section 503. Conflicting laws. Section 504 Penakies. Section 505. Enforcement and abatement. Section 506. Construction of act. Section 507. Right of citizen to intervene in proceedings. Section 508. Citizen suits. Section 509. Whistle blower provisions. Chapter 7. Appalachian States Low-Level Radioactive Waste Commission Section 701. Appointment and qualification orcommissioners. Section 702, Authority of the commission. Chapter 9. Miscellaneous Provisions Section 901. Annual report. Section 902. Liberal construction. Section 903. Construction with other laws. Section 904. Appropriations. Section 905. Repeals. Section 906. Effcetive date. The General Assembly of the Commonwealth of Pennsylvania hereby enacts as follows: CHAPTER I GENERAL PROVISIONS Section 101. Short title. I This act shall be known and may be cited as the Low-Level Radioactive Waste Disposal Act. Section 102. Legislative findings. The General assembly hereby determines, declares and finds that low-level radioactive wastes are generated within the Commonwealth; that these wastes must be isolated for the full hazardous life of the wastes in order to protect the public health and safety; that the Low-Level Radioactive Waste Policy Amendments Act of 1985 requires each state to be i responsible for providing the availability of capacity for disposal of low-level wastes generated within its borders; that shallow land burial is prohibited under the terms of the Appalachian States Low-Level Radioactive Waste Compact; that the illegal disposal oflow-level radioactive waste poses severe risks to the heahh and safety of the public and the protection of the environment; that low-level radioactive waste disposal carried out in an environmentally \ i I j i

SESSION OF 1988 G Act 1988-12 33 b sound manner to protect the health and safety of the public is in the public interest; and acknowledging that the Department of Environmental Resources shall be the Commonwealth agency with these responsibilities. It is the purpose of this act to: (1) Implement Pennsylvania's duties and responsibilities arising under the Appalachian States Low-Level Radioactive Waste Compact. l (2) Establish and maintain, to the extent allowable under Federal law, a comprehensive and pervasive low-level waste disposal management, licensing and regulatory program in the Department of Environmental Resources for which all costs shall be borne by the low-level waste generators, brokers, carriers and the regional facility operator regulated by this act. (3) To the extent allowed under Federal law, require the minimization of the amount of icw-level waste generuted and the reduction of the volume and toxicity oflow-level waste requiring disposal. (4) Protect the public health, safety and welfare, and the environment from the short and long-term dangers of low-level waste and its transportation, management and disposal. (5) Establish an open public process to locate a regional facility in the Commonwealth, to determine the operator and disposal technology and to license the regional disposal facility.  ! (6) Provide for benefits and guarantees for communities affected by the establishment, operation and l presence of a low-level radioactive waste disposal facility. /O t (7) Assure the participation of the public and of elected and appointed officials at all levels of government in the decision making process, create a Public Advisory Committee and assist in public education efforts related to low-level waste disposal. (8) Prohibit shallow land burial of low-level radioactive waste; except that the department shall develop standards by regulation for the onsite handling and disposal of naturally occurring radioactive materials, ores and their waste products. l (9) Provide a comprehensive and effective strategy for the siting of commercial low-level waste compactors

                                                                                                                           )

and other waste management facilities, and to ensure the proper transportation, disposal and storage of low-level radioactive waste. (10) Assure that the low-level radioactive waste facility will be above grade of the land, unless other j designs proside significant improvement in recoverability, monitoring, public health and environmental protection. (II) Prohibit the commercialincineration of radioactive wastes. (12) Assure that waste disposed of at the regional facility does not include radioactive waste originating  ; outside the Appalachian Compact states except as otherwise provided in this act. (13) Provide that no low-level radioactive waste shall be disposed of at any disposal facility not licensed to accept low-level radioactive waste or at any municipal landfill or commercial incinerator, s sJ%

g 34 Act 1988-12 t.AWS OF PENNSYLVANIA (G Section 101 Dermitions. The following words and phrases when used in this act shall have the meanings given to them in this section unless the context clearly indicates otherwise:

            " Account." The Long-Term Care Account.
            "Affected municipalities." Any unit oflocal government other than the host municipality
 ~

designated as an affected municipality pursuant to ,section 318. AfTected municipalities may be counties, cities, boroughs, townships or school districts.

            " Appalachian Compact" or " compact." A compact entered into by Pennsylvania under the terms of the Low-Level Radioactive Waste Policy Amendments Act of 1985, and as comained in the Appalachian States Low-Level Radioactive Waste Compact Law.
           " Appalachian States Low-Level Radioactive Waste Compact Law." The act of December 22,1985 (P.L539, No. 20).

I

           " Atomic Energy Act of 1954." Public Law 83-703,68 Stat. 921,42 U.S.C. 6 201I et seq.
          " Broker." Any intermediate person who collects, consolidates, handles, treats, processes, stores, packages, ships or otherwise has responsibility for or possesses low-level waste.
           Carrier." A person who transports low-level waste from or to any generator or waste management facility or to a regional (scility.

G

• Commercial incinerator." An incinerator oflow-level radioactive waste, except one which incinerates waste at the site of generation or at which only waste generated within the compact, by the owner of the incinerator is incinerated.

         " Commission." The Appalachian States Low-Level Radioactive Waste Commission.
         " Compact states." The combined states including Pennsylvania which have entered into the Appalachian States Low-Level Radioactive Waste Compact,                                                         !
        " Curie." A unit ormeasure of radioactivity.

l

        " Custodial agency." The government entity designated by the Govemor other than the licensing                     '

agency responsible for the long-term monitoring and care of the regional facility.

        " Department." The Department of Environmental Resources of the Comrnonwealth.
        " Disposal." The isolation orlow-level waste from the biosphere.
        " Engineered structure." Man-made state-of-the-art barrier designed to provide additional measures for containment of rsdioactive waste from the environment, protection of the inadvertent intruder and stability of the disposal facility and designed to prevent any radioactive release.

Facility." Any real or personal preperty and improvements thereof or thereon, and any and all plants, structures, machinery and equipment, acquired, constructed, operated or maintained for the management or disposal oflow-level waste. G

 $    \
 \

v/

l l I SESSION OF 1988 m Act 1988-12 35 (j " fund." The Low-Level Waste Fund.

         " Generate." To produce low-level waste requiring disposal.
        " Generator." A person whose activity results in the production oflow level waste requiring disposal.                         t

• Hazardous life." The time required for radioactive materials to decay to safe levels of

                                                                                                                                      )

radioactivity, as defined by the time period for the concentration of radioactive materials within a given i container or package to decay to maximum permissible concentrations as defined by the Federal law or by standards to be set by the host state, whichever is more restrictive.

            " Hazardous wastes." As defined in the act of July 7,1980 (P.L.380, No.97), known as the Solid Waste Management Act, and regulations adopted thereunder.                                                     !
            " Host municipality." One or more city, borough, incorporated town or township, excludmg counties, in which the low-level waste disposal facihty will be constructed, as designated by the department pursuant to section 318.
            " Institutional control period." The time of the continued observation, monitoring and care of the regional facility following transfer of control from the operator to the custodial agency, which shall continue for the hazardous life of the waste.

• Low-level wast.e." Radioactive waste that:

(1) is not high-level radioactive waste, spent nuclear fuel, or byproduct msterial as defined in section 11(e)(2) of the Atomic Energy Act of 1954 (68 Stat. 922,42 U.S C. { 2014(c)(2)), waste generated as a result of atomic energy defense activities of the Federal Government, and waste for which the Federal Government is responsible under section 3(b)(1) of the Low-Level Radioactive Waste Policy Amendments Act of 1985, and g (2) is classbed by the Federal Government as low-level waste, consistent with the Low-Level Radiocctive Waste / ) Policy Amendments Act of1985;or (3) contains naturally occurring or accelerator-produced radioactive material, which is not excluded by paragraph (1) or(2).

         " Low-Level Radioactive Waste Policy Amendme .                    ' if 1985.

• Public Law 99-240,99 Stat.

1842,42 U. S. C. I 2021 b et seq.

         " Management." The reduction, collection, consolidation, storage, processing, incineration, separation, minimizatbn, compaction, segregation, solidification, evaporation, packaging or treatment oflow-level waste.
        " Operator." A person who operates a regional facility.-
        " Person." Any individual, corporation, partnership, association, public or private institution, cooperative enterprise, municipal authority, public utility, trust, estate, group, Federal Government or q,ney, other than the United States Nuclear Regulatory Commission or ar.y successor thereto, state institution and agency, or any other legal entity whatsoever which is recognized by law as the subject of rights and duties. In any provision of this act prescribing a fine, imprisonment or penalty, or any combination of the foregoing, the term

• person" shall include officers and directors of any corporation or other legal entity having officers and directors.

q 8

\v<)

36 Act 1988-12 LAWS OF PENNSYLVANIA h

              ' Protection Fund." The Regional Facility Protection Fund.
                " Radiation Protection Act? The act ofJuly 10,1984 (P.L.688, No.147).
                " Regional facility." A facility which has been approved by the commission and licensed under this act for the disposal oflow-level waste.
                " Secretary." The Secretary of Environmental Resources of the Commonwealth.
                " Separation? Segregation and isolation of all low-lesl radioactive waste in accordance with a waste classification system to be established by regulation by the department.
               " Shallow land burial." The disposal oflow-level radioactive waste directly in subsurface trenches without additional confinement in engineered structures and in proper packaging as determined under this act.
           "Zero release capacity." The ability not to release radioactivity.

CHAPTER 3 LOW-LEVEL WASTE DISPOSAL Section 301. Powers and duties of the Department of Environmental Resources. The department shall have the power and its duty shall be to: (1) Develop and implement a comprehensive program for the regulation of the generation, storage, handling, transportation, processing, minimization, separation, management and disposal of low-level radioactive waste to the extent allowable under Federal law or State law, whichever is more stringent. ( l (2) Implement a regulatory, inspection, enforcement and monitoring program consistent with the terms of (/ an agreement between the United States Nuclear Regulatory Commission and the Commonwealth, as provided for in section 201 of the Radiation Protection Act. and this act. (3) Enter into a contract with an operator-licensee designate to screen the State to locate potentially suitable sites, to study the sites in detail and to submit a license application to operate the regional facility. (4) License a regional facility operator in accordance with section 308 and regulations promulgated hereunder. (5) !ssue permits to generators, brokers and carriers of low-level waste for access to the regional facility in accordance with provisions of this act and with specific regulatious promulgated under this act. (6) Receive title to the land for use as a regional facility from the licensee for eventual transfer to the custodial agency or acquire land by eminent domain in the manner provided in the act of June 22,1964 (Sp. Sess., P.L.84, No.6), known as the Eminent Domain Code, if the operator. licensee designate cannot acquire the property prior to submitting an application to the depahment for a license. (7) Use Commonwealth property for the regional facility where such use is consistent with uses authorized under State law, (8) Provide for the licensing and regulation of a custodial agency for the long-term care and snonitoring of the regional facihty for the duration of the institutional control period in accordance J with regulations established by the Environmental Quality Board. l

SESSION OF 1988 Act 1988-12 37 (V) (9) Provide for the emergency care and monitoring of the regional facility, which may include the appointment of an intenm operator if the department determines that: (i) the licensee has failed to comply with the terms and conditions of the contract or is in violation of this act, regulation or heense conditions, pennits or orders issued under this act, or the Radiation Protection Act, and a threat exists to the health or safety of the public or the environment; or (ii) the licensee is in repeated or continuing violation of this act, regulations or the terms and conditions of any license, permit or order issued under this act, or the Radiation Protection Act. (10) Implement policies, including fee schedules and other incentives, to the extent authorized by the Appalachian Compact and State and Federa! law to reduce the volume and toxicity of low-level radioactive waste. (11) Promulgate regulations establishing a low-level radioactive waste classification system which shall take into consideration curie concentration, toxicity, hazardous life and prior treatment of wastes. (12) Promulgate regulations establishing standards for the hazardous life orlov -level waste which shall be at least as restrictive as Federal standards, (Ib Provide for emergency response capability in cooperation with the Pennsylvania Emergency Management Agency. (14) Do any and all other acts not inconsistent with the provisions of this act which are necessary and proper for the effective implementation and enforcement of this act and the Radiation Protection Act. Sm tion 302.

      \

g ) Powers and duties of the Environmental Quality Board. (a) Rules and regulations.-The En,ironmental Quality Board, exercising authority under section 1920-A of the act of April 9,1929 (P.Ll77, No.175), known as The Administrative Code of 1929, shall have the power and its duty shall be to adop' regulations developed by the department for the implementation of this act. These regulations shall include, but are not limited to: generation, transportation, handling, separation, minimization, treatment and disposal oflow-level radioactive waste; permit and license f es, standards and procedures; facility siting, includmg standards and siting regulations for new low a  % incinerators and compactors and for the regional facility; facility (Tign; maifest and reporting rL, .remens; facility operational management; financial responsibility assurance; public participation; host and affected municipality benefits and guarantees; monitoring and inspection; compliance and ;nforcement; - and any other regulatory requirements the department finds necessa:y or appropriate for the protection of the public health and the eavironment from' low-level radioactive wastes, provided that the provisions of any siting regulations adopted under this section shall not apply to any commercial compactor facility which obtained a license from the United States Nuclear Regulatory Commission authorizing operation pursuant to the Atomic Energy Act prior to the effective date of this act. 9 [ \ [ (v)

s [m ' 38 Act 1988-12 LAWS OF PENNSYLVANIA (b) Site selection.- (1) In addition to the authority to adopt regulations under this act, the Environmental Quality Board shall rnake the preliminary determination as to whether three proposed potentially suitable sites satisfy the applicable siting regu!Mions. (2) The effect of the board's preliminary approval of a site is to approve a potentially suitable site for funher study. This preliminary approval assures access for further study of the site, in accordance with section 307(f), and public participation, especially by the potential host municipality during the evaluation and study of a potentially suitable site. (1) TH board's preliminary site approval is not a final action regarding the potentially suitable site. The board's preliminary approval is appealable only to the extent the owner of the land which constitutes the site can demonstrate immediate end present damages from funher study activity to be undenaken on the site. The final determi% tion as to whether the potentially suitable site meets the siting regulations shall be made by the secretary after the furthei studies are completed, as part of the license application decision. (c) Procedure.-The board shall establish procedures, including appropriate public participation, goveming the preliminary site approval process. The public participation process shall include at least one public information meeting and one public hearing held by the board in each potential host municipality and an opponunity for comment -on the public record. The host municipality and host county shall have a

   .\

minimum of 180 days from the receipt of funds under section 318(a) to offer comments during the public panicipation process established under this section. (d) Technical assistance.- (1) The board may contract for the services of an independent consultant to asist the board in its review of all matters relating to the evaluation and preliminary approval of the sites proped and submitted to the board by the operator-licensee designate under the provisions of section 307 (2) The consultant shall be selected through a request-for-proposal process. The proposal shall include sufficient information to evaluate the consultant's expenise, competence and qualifications for assisting in the evaluation of the proposed sites.

         -(3) No consultant shall have a direct financial interest in any industry which generates low-level radioactive waste, any low-level radioactive waste regional facility or any associated industry, nor shall they have acted as a consultant to the deparunent in any matter involving low-level radioactive waste within five years from the date of this act. Any consultant which may have a potential conflict ofinterest as described in the act of July 19,1957 (P.L.1017, No.451), known as the State Adverse interest Act, the act of October 4, 1978 (P.L.883, No.170), referred to as the Public Official and Employee Ethics Law, or other applicable statute or executive order shall reveal and explain the potential conflict as part of the request-for-proposal process.

O ix.

        .m i          \
       \           p                     .

V SESSION OF 1988 Act 1988-12 39 Section 303.. Generation, transpc tstion, handling, management and disposal oflow-level waste. Each person who generates, transports, handles, manages or disposes oflow-level waste shall: (1) Maintsin records to identify the volume and radioactivity content oflow-Icvel waste generated and shipped, the method of transpo:tation, the origin and disposition ofsuch low-level waste, and such additional records as the department may require. (2) Furnish information as required by the department on such low-level waste to persons trotnsporting, managing, storing or disposing of such wastes. J (3) Use a manifest system as specified in section 310(a)(1) for all low-level waste transported. (4) Transport low-level waste for handling, management or disposal to the approved facilities which the generator or broker has designated on the manifest form. (5) Submit reports to the department quaneriy, listing the quantities, types and classes oflow-level waste generated during a particular time period. (6) Maintain such operation, train personnel and assure financial responsibihty for such handling or disposal operations to prevent adverse effects to the public health, safety and welfare and to the environment 4 and to prevent public nuisances.

      \           )                    (7) Immediately notify designated public agencies of any accident away from the site of generation O

involving potential or actual spill or accidental discharge of such waste, and take imr' ediate steps to contain and clean up the spill or discharge. (8) Separate all low level radioactive wastes in accordance with the waste classification system to be estallished by the department. Settion 304. Siting regulations. The department shall develop siting regulations which shall be designed to allow for screening of the State by the operator-licensee designate and the selection of three potentially suitable sites. The regulations shall also contain detailed site specific provisions which the operator-licensee designate shall use to evaluate a potentially suitable site approved for further study. Potentially suitable sites shall not have any slopes for the disposal area of more than 1507o as mapped on a scale of 1:24,000 with a contour interval of either 10 or 20 feet as available on published U.S.G.S. 7.5 minute quadrangles. The regulations shall include, but not be limited to, consideration for public health and safety, flooding, tectonics, protection of lands in the public tr: st, protection and exploitation and exploration of natural resources, demographics, transportation, wildlife, air quality, ecology, topography and hydrogeology. The regulations shall also provide that potentially suitable sites shall not be located where nearby facilities or activities could adversely impact the ability of the site to meet the above considerations or significantly mask the monitoring of the facility. The regulations shall be at least as stringent as those regulations adopted under the Atomic Energy Act of 1954. The

        *,a\

_ .. _.a

r

     .               40       Act 1988-12                  LAWS OF PENNSYLVANIA
 >      I
  \'/

Environmental Quality Board shall hold at least one public information meeting and at least one public hearing on the siting regulations, and shall solicit and take into consideration written public comments, prior to Gnal adoption. There shall be 30 days' public notice before any hearing. Notice shall, at a minimum, be provided in the Pennsylvania Bulletin and in newspapers ofgeneral circulation in each county. Section 305. Facility design and operational management regulations. The department shall establish by regulation minimum engineering design and operational management criteria for the regional facility. These criteria shall be in addition to those required by regulations adopted under the Atomic Energy Act -of 1954. Shallow land burial, as deified in this act, is prohibited. An above-land grade facility is required unless other designs provide significant improvement in recoverability, monitoring, public health and environmental protcetion. The facility shall have the goal of a zero release capacity. The criteria shall include, but not be limited to, provisions for enhanced containment, recoverability, long-term passive isolation, minimization of risks from water intrusion, protection from inadvertent intruders, monitoring and special requirements for various classes of wastes which shall include, but not be limited to, provisions for the segregation and recoverability of Class C waste. The Environmental Quality Board shall hold at least one public information meeting and at least one public hearing ors the regulations, and shall solicit and take into consideration written public comments, prior to final adoption. There shall be 30 days' public notice before the hearings. Notice shall, at a minimum, be provided in the p Pennsylvania Bulletin and in ne'sspapers of general circulation in each county. I Section 306. Operator-lice ,see designate selection. (a) Proposals.-The sr.:retary shall, through a request for-proposal process, select an operator-licensee designate. The p oposals shall include detailed methods to be used for site screening and selection of potentially suitat le sites; an explanation of how the operator plans to meet requirements of this act for public participation, including details of provisions for information to and solicitation of information from the public, the host municipality and the host coenty; the design of the proposed regional facility; the detailed site specific studies to be conducted to determine the environmental qualifications of the sites; a description of facility operational plans; a description of operator qualifications, including relevant experience, financial history, compliance history and current finar.cial and compliance status of the operator; details of the method of operating the regional facility; a proposed method to determine the impact of the regional fccility on the potential host and afTected municipalities; a proposal for a minimum host municipality benefits and guarantee package; a proposed fee schedule for disposal based on projected disposal costs and waste classification; and any other criteria the secretary may require. (b) 'Jualifications.- (1) The department shall develop standards for operator qualifications which shall be reviewed by the Low-Level Waste Public Advisory Committee prior to the start of the request-for-proposal process. The stan-O i h V

l l l O, [ SESSION OF 1988 Act 1988-12 di D ' dards shall include, but not be limited to, provisions for consideration of the following: (i) The relevant experience of the operator-licensee applicant. (ii) The financial history of the operator-licensee applicant. (iii) The compliance history of the operator-licensee applicant. In reviewing the applicant's compliance history, the department: (A) shall require the applicant to provide a record ofits compliance history with environmental protection statutes of the Commonwealth, other states and of the Federal Government, including, but not limited to, any violations of the provisions of this act, the Appalachian States Low-Level Radioactive Waste Compact Law, the Radiation Protection Act, or any other state or Federal statute relating to environment protection or to the t protection of public health, safety and welfare or any rule or regulation, order or any condition of any license issued by the department or any major violations, orders or consent decrees or similar administrative enforcement actions, or civil or criminal litigation 6 i olving the requirements above; and (B) may deny the applicant the opportunity for consideration as an operator if he has engaged in unlawful conduct, or if the applicant's partner, associate, officer, parent corporation, subsidiary corporation, contractor or agent has engaged in such unlawful conduct, or has shown a lack of ability or intention to comply with the requirements listed in clause (A), unless the applicant demonstrates to the satisfaction of the secretary that m the applicant has the ability and intention to cornply with requirements as referred to in clause (A). Evidence

                                                                                                                          )

of the ability and intention to comply with these requirements shall include, but not be limited to, evidence that: (1) the applicant does not have a pattern of major violations of the environmental requirements referred to in this section; (II) the applicant does not have a record of continuing violations of the environmental requiremec.ts referred to in this section. For the purpose of this subclause, a continuing violation includes, but is not limited to, a violation that is not being abated or removed or a violation where the applicant is not cooperating in good faith with the appropriate State or Federal environmental agency to remedy or abate the violation; (III) the applicant has complied or is complying with all orders or consent decrees of the department, or similar administrative enforcement actions of another state or of the Federal Govemment where pollution is being abated or removed; and (1) the applicant has made or is making full payment of any civil or criminal penalties imposed under the environmental statutes of the Commonweahh, another state or of the Federal Government. (2) In no event shall any person who has committed a criminal violation of any state or Federal environmental statute resulting in a conviction l

 /m                                                                                                                       :

I

                                                                                                                          )

42 Act 1988-12 LAWS OF PENNSYLVANIA t s Y)

• of a first deg:ce misderneanor or a felony, within ten years prior to the effective date of this act, be given an opportunity to be considered 6nder this act as an operator.

(3) If all applicants are found unacceptable by the secretary, the secretary shall recommend to the Governor, that the Govemor, with the advice and consent of the General Assembly, @ hall designate an agency or authority of the Commonwealth to operate the regional facility at the site selected by the secretary in compliance with all regulations of the department. (c) Procedure.-All proposals from potential site operator-licensee designates shall be open for public inspection and comment for at least 90 days prict to the selection of the operator by the secretary. Notice shall, at a minimum, be provided in the Pennsylvania Bulletin and in newspapers of wide general circulation of the availability of the proposals, and the proposals shall be available for public inspection. At least two public meetings shall be held in conjunction with the Low-Level Waste Advisory Committee to discuss the proposals. All written comments received during the comment period will be taken into consideration and become part of the public record. (d) Contract.-The secretary shall enter into a contract with the operator-licensee designate authorizing the I operator to complete the site screening process, the selection of three potentially suitable sites, the detailed evaluation of each potentially suitable site, and the license applica ion process, and to operate and close the regional facility only if issued a license from the department under this act. The contract shall include, but not be limited to, any applicable provisions of the proposal. The contract shall contain provisions regarding / {

$) funding sources to be utilized, for the facility, liability agreements, the establishment of a reasonable and

%")

adequate fee structure, expenses for events which are beyond the control of the operator-licensee designate

                                                                                                                              )

and cancellation or modification of the contract if the operator licensee designate is not complying with the provisions of the contract or is unable or unwilling to properly carry out the site screening and evaluation process. l (e) Appeal.-Any affected person may appeal the selection of the operator-licenece to the Environmental I Hearing Board based solely on the qualifications in this section of the operator-licensee designate. Section 307. Site selection. (a) Screening report. The operatoi-lit ensee designate shall conduct a study screening the Commonwealth for potentially suitable sites in accordance with the siting regulations adopted pursuant to section 304 and shall prepare a screening report which documents the findings of the study. A municipality or group of municipalities may, through their duly authorized governing body or bodies, request consideration as a potentially suitable site under this section. Such offering municipality or group of municipalities shall be included in the screening study to be conducted by the operator licensee designate, the screening report required by subsection (b) and the other applicable provisions of this section. (b) Submission.-The operator-licensee designate shall propose three potentially suitable sites and submit those sites to the Environmental Qual:ty Board for approval. The proposal shall be accompanied by: m I \ V

SESSION OF 1988 Act 1988-12 43 / i I b (1) the 'ite s screening report; (2) a site justiGcation explaining the reasons for choosing the potentially suitable sites compared to other sites considered; and (3) a study of the short-term and long-term environmental effects on the potentially-suitable sites and affected areas. (c) Social and economic impact study.-At the same time as the submission of the application for potentially suitable sites required in subsection (b), the cperator shall submit to the department a study of the short- and long term social and economic impacts of a regional facility on the municipalities surrounding the potentially suitable sites. The study shall include, but not be limited to, the impacts on tax revenue, public infrastructure, emergency management capabilities, compatibility with regional and local economic goals, other demographic characteristics, loss. of resources and social service demands. The study shall propose cach host municipality and affected municipalities. (d) Evaluation.-The department shall evaluate the proposal and submit conclusions and siting recommendations to the Environmental Quality Board. (c) Procedure. The Environmental Quality Board shall hold at least one public information meeting and on6 public hearing in each of the potentially suitable areas as required in section 302(c), evaluate the three proposed potentially suitable sites and determine if they satisfy the applicable siting regulations. If any site does not satisfy the applicable siting regulations, the board shall so inform the operator-licensee designate who shall propose another potentially suitable site and submit another site justification pursuant to subsection (b), and another social and ( \ economic impact study pursuant to subsection (c). If a proposed potentially suitable site satisfies the applicable siting regulations, the board shall give preliminary site approval to allow for further site evaluation. The board she'l make a determination that the screening process has identified three of the best potential locations in the host state, based on the administrative record before the board. The administrative record shall consist of the screening report, site justification report, the study ofshort-term and long-term environmental effects on the potentially suitable sites, the conclusions and siting recommendations of the department and the testimony presented at the board's public hearings and comments received during the comment period. (f) Preliminary approval.- (1) Upon the preliminary approval of the three sites by the Environmental Quality Board, the operator-licensee designate shall obtain access to those sites for further study. The operator-licensee designate shall 1 have the right to enter provided to a condemnor under section 409 of the act of June 22,1964 (Sp.Sess., P.L84 No.6), known as the Eminent Domain Code. (2) Property owners of any site which has received preliminary approval by the Environmental Quality Board, but which is not selected as the final site, shall have the rights of a condemnee under section 408 of the Eminent Domain Code, as are therein granted to condemnees subject to a q

    )

J __ a

44 Act 1988-12 LAWS OF PENNSYLVANIA r' evocation of condemnation proceedings. When the preliminary site has been rejected by the acti secretary in issuing a permit for another site, notice of such relinquishment shall be served upon the affected property owners in the same /aanner as provided for in a declaration of taking under the Eminent Domain Code. The alTected property owners shall be reimbursed by the operator-licensee designate for reasonable appraisal, attomey and engireering fees and other costs and expenses actually incurred because of the preliminary approval of the site by the Environmental Quality Board. Such damages shall be assessed by the court, or the court may refer the matter to viewers to ascertain and assess the damages sustaiaed by the affected property owners, whose award shall be subject to appeal as provided in the Eminent Domain Code. (g) Purchase of site.-Upon receiving a license to operate the regional facility at the site, the operator shall purchase the site and transfer title to all land to the Commonwealth. If the operator-licensee designate is unable to purchase the site, the Commonwealth shall acquire the site by eminent domain and the operator-licensee designate shall reimburse the Commonwealth for all costs of acquisition. (h) Final approval.-The issuance of a license by the secretary pursuant to section 308 shall constitute final approval of the site. The Commonwealth shall hold title to the land until at least the end of the institutional control period. (i) Appeal.-The issuance of the license is appealable to the Environmental Hearing Board pursuant to section 1921-A of the act of April 9,1929(P.L 177 No.175), known as The Administrative Code of 1929. This appeal shall take precedence over other appeals pending before the board and shall be handled in an I expedited manner. The decision of the board is tppealable to Commonwealth Court. A citizen of this Commonwealth, a host municipality or a host county, who or which makes an appeal on his or its own 1 chalf under this section, shall not be required to post a bond nor shall they be required to pay a fee for filing the appeal. Section 308. Operatorlicensing. (a) Regulations.-The department shall establish by regulation the procedure and requirements for licensing of the regional facihty operator. The regulation shall provide, without limitation: j (1) Authority forthe amendment, suspension or revocation of the license. (2) Consent for entry into the regional facility. (3) Requirements for the form of the application and the information to be provided. (4) Requirements for submission of a decommissioning plan for the regional facility. (5) Requirements that the application and all submissions be in writing and signed. (b) Further statements and inspections. The department may at anytime after the filing of the application, and before the expiration of the license, require further written statements and may make such inspections as i 1 I

SESSION OF 1988 Act 1988-12 45 the department deems necessary to determine whether the license should be granted, modified, suspended or revoked. All applications and statements shall be signed by the applicant or licensee. (c) Impact analysis.-The license applicant shall prepare a written analysis of the impact of such licensed activity. The analysis shall be available to the public at least 120 days before the commencement of hearings held pursuant to subsection (d) and shall include: (1) A detailed assessment of the radiological and non-radiological impacts to the public health and on the environment. (2) A detailed assessment of the impact on the quality and quantity of the surface and groundwater within a five-mile radius of the site. (3) Consideration of the short-term and long-term public health and environmentalimpacts from closure, decommissioning, decontamination and reclamation of facilities and sites associated with the licensed activities and management of any radioactive materials which wi!! remain on the site after such closure, decommissioning, decontamination and reclamation. These impacts shall include, but not be limited to, adverse effects due to prior activities and conditions, including water and air quality problems, a health survey of cancer and other disease rates and birth defects, and prior mining. (4) Consideration of the shon- and long-term social and economic impacts of the regional facility on the (N host municipality and affected municipalities, to create a minimum set of items to be considered as part of the host and affected manicipality benefit negotiations. At a minimum .he study should it.clude the impacts on local tax revenues, public infrastructure, emergency management capabilities and social service demands. (5) A pre-operational environmental radiation survey and a pre-operational health survey of cancer and other disease rates and birth defects within five miles of the site. (6) Justification for the choice of the proposed site over the other two potentially suitable sites. (d) Duty of secretary.-Before approving or disapproving the license application, the secretary shall provide: (1) The public with the opportunity to review and inspect the license application at a publicly available

   . location in the area where the regional facility is proposed to be located.

(2) A 90-day public comment period, one public information meeting and one public hearing, not within 30 days of each other, after adequate public notice, in the area where the regional facility is proposed to be located. A!! written comments and comments contained in a transcript of the hearing shall be considered in the secretary's decision on the application and become part of the public record. (3) A written determination of the action to be taken, including a response to comments, which is based upon findings included in the determination and upon evidence presented during the public comment period. (e) Terms and conditions oflicense. The terms and conditions of all licenses issued under this ret shall be subject to amer.dment, revision or mod-A

46 Act 1988-12 LAWS OF PENNSYLVANIA b ification by regulations or orders. The department shall provide by regulation for public notice of license amendment requests and for a public participation process. (f) Financial assurance.-No license shall be issued by the department unless the operator provides the financial assurances required by section 316. (g) License denial, suspension, etc. In carrying out this act, the secretary may deny, suspend, modify or revoke any license if he finds that the applicant or licensee has failed or continues to fail to comply with any provision of this act, the Appalachian States Low-Level Radioactive Waste Compact Law, the Radiation Protection Act or any other state or Federal statute relating to environmental protection or to the protection of the public health, safety and welf re; or any rule or regulation of the department; or any order of the department; or any condition oflicense issued by the department; or if the department finds that the applicant or licensee has shown a lack of ability or intention to comply with any provision of this act or of any acts referred to in this section, or any rule or regulation of the department or order of the department, or any condition of any license issued by the department as indicated by past or continuing violations. In the case of a corporate applicant or licensee, the department shall deny the issuarice of a license if the secretary finds that a principal of the corporation was a principal of another corporation which committed past violations of any of the above laws, unless the principal has demonstrated that the violations are not relevant to issuing the license or permit or there are other mitigating circumstances which demonstrate the applicant has the ability and intent to comply with the law. , Section 309. Out-of-compact waste. (a) Source of waste.-No low-level waste shall be accepted for disposal at the regional facility unless the waste was generated within the Appalachian Compact states or the commission has entered into a reciprocal contingency agreement for the emergency disposal of out-of-compact low-level waste. Waste generated within the Appalachian Compact states shall not include radioactive waste shipped from outside the Compact states to a waste genemtor or management facility within the Compact states. For the purposes of this section, an emergency shall include the temporary shutdown of a regional or state low-level radioactive waste disposal facility for a period of time which the commission reasonably projects will extend beyond the time when the low-level radioactive waste storage at the generator's facility and the disposal facility will reach maximum capacity, and additional storage would constitute a threat to the health and safety of the public or the environment. The reciprocal contingency agreement shall provide that the regional or state low-level waste disposal facility with the emergency will accept from the Appalachian Regional Facility or from generators, brokers or carriers licensed or permitted by the department, immediately at the termination of the emergency, an amount orlow-level radioactive waste equal to the volume and toxicity of the low-level radioactive waste shipped to the Appalachian Regional Facility during the err +ergency. f (

SESSION OF 1988 Act 1988-12 47 f

 \V>        .

(b) Approval of certain agreements. No agreement shall permit the disposal of out-of-compact waste for a period exceeding three months unless a continuation of the agreement is approved by the General Assembly or the Governor. The Speaker of the House of Representatives and the President pro tempore of the Senate shall cause to be placed on the calendars of the llouse and Senate a concurrent resolution approving the proposed continuation. If the General Assembly fails to approve or disapprove the concurrent resolution within ten legislative days or 30 calendar days, whichever occurs first, the Governor may approve the continuation of the reciprocal agreement by executive order The commission shall notify the General Assembly and the Governor when it has determined that a continuation of the reciprocal agreement is recommended and the date on which disposal will cease. (c) Limited permit.-The department shall review an application and shall issue a limited permit for each low-level waste generator from outside the compact that meets the criteria for use of the regional facility. The dep . nent shall only issue the permit upon a determination by the commission that an emergency exists in the state or region in which the pennittet is located. The permit shall not be valid for a period exceeding three months, unless a continuation is approved by the General Assembly or the Govemor as provided in subsection (b). Section 3 I . Permitting of generators, brokers and carriers. (a) Regulations.-The department shall provide by regulation for the permitting of generators, brokers and ! q carriers for access to the regional facility. Such regulations shall establish, without limitation: (!) Requirements for packaging, separation, waste form, routing, manifesting, financial assurance, record keeping, emergency planning and length of term of the permit. (2) Limits on the types, quantities and origins of radioactive waste allowed for disposal. (3) That each application for a permit or amendrnent shall be in writing and signed by the ' applicant. (4) The form of the application and the information it should contain. (5) Requirements for applicant's consent for entry to facilities, vehicles and equipment. (6) Procedures for suspension, revocation and amendment of permits. (7) That each generator have a plan for reduction of toxicity and volume with stated reduction goals. (8) Any other requirements the department deems necessary or proper to implement the provisions of this act and the Radiation Protection Act. (b) Issuance of permit.-Upon approval of the application and receipt of fees, the department shall issue a permit to the applicant as set forth in the application and furtherconditioned by the department as necessary. (c) Permit denial, suspension, etc.-In carrying out this act, the department may deny, suspend, modify or revoke any permit ifit finds that the applicant or permittee has failed or continues to fail to comply with any provision of this act, the Appalachian States Low-Level Radioactive Waste Compact Law, the Radiation Protection Act or any other state or Federal 7% r 1 (v/

48 Act 1988-12 LAWS OF PENNSYLVANIA

 'O statute relating to environmental protection or to the protection of the public health, safety and welfare; or any rule or regulation of the department; or any order of the department; or any condition of any permit or license issued by the department; or if the department finds that the applicant or permittee has shown a lack of ability or intention to comply with any provision of this act or any act referred to in this section, or ar.y rule or regulation of the department or order of the department, or any condition of any permit or license issued by the department as indicated by past or continuing violations. In the case of a corporate applicant or permittee, the department shall deny the issuance of a permit ifit finds that a principal of the corporation was a principal of another corporation which committed past violations of any of the above laws, unless the principal has demonstrated that the violations are not relevant to issuing the license or permit or there are other mitigating circumstances which demonstrate the applicant has the ability and intent to comply with the law.

Section 311. Decemmissioning. When the regional facility is to be closed, the department shall require that the regional facility is properly decommissioned by the operator-licensee, that all remaining property is transferred to the Commonwealth and that control is transferred to the custodial agency. The cost of decommissioning shall be borne by the operator-licensee. The department shall make a determination that the site has been properly decommissioned and that the site, along with the license responsibilities, is suitable for transfer to the l custodial agency, at which time the operator license shall be terminated. A decommissioning plan shall be I submitted, as part of the license application, be incorporated into the license and be periodically reviewed and amended as necessary over time. Section 312, Low-Level Waste Fund. (a) Establishment.-There shall be established within the State Treasury a separate account to be known as the Low-Level Waste Fund. i' (b) Deposits..All fines, penalties, fees and surcharges not designated for other purposes, collected under this act shall be paid into this fund. Additionally, all funds received from the United States Department of Energy or from the Appalachian Compact Commission or Compact states for low-level radioactive waste activities shall be deposited into the fund. (c) Appropriation and purpos_e.-Moneys in the fund, except those received from the United States Department of Energy, are hereby appropriated to the department on a continuing basis to be used, upon i approval of the Govemor, solely for the administration and enforcement of this act, for site development, for emergency operations, for any J-ability of the Commonwealth, and to repay the General Fund for any appropriation made to the fund.  ! Section 313. Long-Term Care Accourt. (a) Establishment. There shall be established within the fund an interest-bearing restricted account to be known as the long-Term Care Account. (b) Surcharges.-Surcharges on disposal rates shall be imposed by the department for the expected costs of activities under this account. V

(m \' SESSION OF 1988 Act 1988-12 49 (c) Purpose.-The account shall be used for no other purpose than to provide for the following: (1) The long-term care and monitoring for the duration of the institutional control period and any emergency or remedial work that might become necessary at any regional facility by the department or the custodial agency. (2) The assumption by the department or the custodial agency for early direct responsibility for the care and monitoring at the regional facility. (d) Appropriation.-All moneys in the account are hereby appropriated to the department on a continuing basis to carry out this section. Section 314. Regional Facility Protection Fund. (a) Establishment and purpose. There shall be established within the State Treasury a separate account to be known as the Regional Facility Protection Fund. All moneys in this fund are hereby appropriated to the department on a continuing basis for the following purposes: (I) To pay claims for personal injury and property damage against the Commonwealth, host municipality and host county arising from their responsibilities under this act. (2) To pay claims for personal injury and property damage against the regional facility licensee

,m                       made at any time after the termination of the license arising from operation of the regional facility.

(V ) (b) Administration-The Environmental Quality Board shall promulgate regulations, prepared by the department, to administer the Regional Facility Protection Fund. Such regulations shall include, but are not limited to, scope of coverage, further limits of liability, procedures for filing claims, presumptions and burdens of proof. (c) Deposics.-All surcharges on waste disposed of at the regional facility under section 315(c)(1)(iv) and all interest camed thereon shall be deposited is che Regional Facility Protection Fund. (d) Appeals.-All appeals from denial of a claim shall be to the Board of Claims. The department shall represent the Regional Facility Protection Fund in any such action. Section 315. Fees, rates and surcharges. (a) Establishment by department.-The department shall establish reasonable fees for licensing of the i operator-licensee designate and permitting of generators, brokers and carriers. In setting the fees, the { department shall consider disposal costs and classification of the waste. l (b) Approval of rates charged by operators.-The department shall require that all proposed rates charged by the operator, for the disposal of low-level waste in the regional facility be submitted to the department prior to their implementatiort The department shall determine if the rates are consistent with the fee structure established in the contract entered into under section 306(d) and may reqdre the operator to modify the proposed rates if the department determines that they are not consistent with the fee structur established in the contract entered into under section 306(d). The rates shall be based on actual disposal cost and waste

  ,m     classification. Rates shall be ade-
/      \

1 1 50 Act 1988-12 LAWS OF PENNSYLVANIA 1 O quate to assure protection of public health and safety and the environment, the retirement of facility debt plus i l an adequate retu r e capital invested and future site closure, and stabilization and decommissioning expenses. (c) Surcharges.- (1) The department shall assess surcharges on low-level radioactive waste disposed of at the regional facility as follows: (i) A surcharge imposed adequate to return to the General Fund over a five-year penod any appropriations expended by the department from the General Fund from July 1,1987, to the date the reFi onal facility begins e,)eration, and shall expire when the General Fund-is fully reimbursed. (ii) + .ontinuing surcharge imposed to be adequate to support the Commonwealth's expenses related to this act and the compact, including, but not limited to, the surveillance of packages, inspection, decontamination, decom nissioning and post-closure maintenance of the regional facility, record keeping systems and such other activities as the department finds necessary to ensure the safe operation of the regional facility. (iii)A surcharge imposed to be adequate to fund the Long-Term Care Account as provided in Se tion 313. (iv) A surcharge that shall be adequate to fund the Regional Facility Protection Fund to a level of l

 ,y                  not less than $100,000,000, indexed to increase with cost-of-living adjustments, upon the date of

/ i ( v, ) termination of the operator's license. (2) These surcharges and fees shall be reviewed aanually by the department to determine if they are adequare and revised accordingly. The tr-* hod shall be determined by regulation. (3) These surcharges shall be collected by the operator at no cost to the Commonwealth and shall be transmitted to the department no less frequently than monthly. (d) Host and afTected municipality benefits..The department shall review and approve all surcharges for host and affected municipality benefits as provided in section 318. Section 316. Financial assurance and liability. (a) Financial assurance requirements.-The department shall establish by regulation detailed financial assurance requirements for the operator for the operation, closure, post-closure monitoring and maintenance, and emeigencies related to the regional facility. (b) Proof of covera;e of all costs.-The operator shall, pra to receipt of a license, show that it either possesses the necessary funds or Las reasonable assurance of obtaining the necessary funds, or a combination of the two, to cover all estimated costs of conducting all licensed activities over the planned operating life of the regional facility, ircluding costs of construction and operation. (c) Emergency actions, closure, etc. The operator shall, prior to receipt of a license, provide assurance that sufficient funds are available to carry out emergency actions, site closure, decommissioning and stabilization, m accor-I' f I V

s l l SESSION OF 1988 Act 198812 51 dance with the financial assurance regulations atablished by the department. (d) Indemnification.- (1) Generators, brokers and carriers for which a permit is required under sections 309 and 310 shall comply with the financial assurance regulations established by the department. Each broker, carrier and generator shall hold the Commonwealth, the host municipality, host county and their agents harmless, defend and indemnify the Commonwealth, the host municipality, host county or their agents against any and all claims, actions, demands, liabilities and 'osses by reason of any injuiy or damage to person or property arising out of any handling, management, shipping, transportation or generation oflow-level waste, (2) The operator-licensee shall hold the Commonwealth, the host municipality, host cour.ry and their agents harmless, defend and indemnify the Commonwealth, host municipality and host county and their agents against any and all claims, actions, demands, liabilities and losses for personal injury or property damage at !aw and equity. (c) Limitations on liability.-In any action against the operator-licensee by any person for damages, there shall be no hmit to the operator-licensce's liability if it can be shown that the operator licensee acted in a manner that was negligent, grossly negligent, willful, reckless or intentional. In all other claims and actions for damages against the operator-licensee, there shall be a total and cumulative limit of liability which shall be no more than $100,000,000, plus the amount of insurance or other financial assurance applicable to the obligation or liability as required by the department. (f) Sovereign immunity.-No provision of this act shall constitute a waiver of sovereign immunity except as provided by 42 Pa.C.S. Ch. 85 Subch. B (relating to actions against Commonwealth parties). (g) Insurance..The operator shall provide evidence of commercial insurance or other financial assurance as approved by the department to compensate persons for bodily injury or property damage arising from sudden and non-sudden incidents from the operation of the facility. The department shall determine the minimum amount ofinsurance or financial assurance, but in no case shall the minimum amount be less than the capital

  " cost of the regional facility. For purposes of this subsection, ' capital wst" means the cost of bidding for, siting, acquiring, licensing, planning, developing, constructing, equipping and promoting the regional facility and improvements made over the aperating life of the facility.

Sect %n 317. Low-Level Waste Ad ory Committee. (a) Appointment.-The secretary shall appoint a Low-Level Waste Advisory Committee. The committee shall consist of at least 23 members,19 of whom shall represent local government, environmental, health, engineering, business, academic and public interest groups' and four members of the General Assembly, two from the Senate, one member from the majority party and one member from the minority party, or their designees, who shall be appointed by the President pro tempore, and two from tne House of Representatives, one from the majority party and one from the minority party, or their designees, who shall be appointed by the Speaker of the House of

I l l l 52 Act 1988-12 LAWS OF PENNSYLVANIA

 \v/      ikepresentatives. The secretary shall designate a representative of the department who shall b member of the committee. representatives of the host municipality and host county shall also be appointed as additional voting members of the committec. No member of the committee shall be employed by or hold a financial interest in the operator company or any ofits subsidiaries or parent companies, and no more than three of the members of the committee shall be employed by or hold a financial interest in a company which serves as a subcontractor to the operator company or in any entity that utilizes the regional facility for disposal ofits low-level radioactive wastes.

(b) Review of draft regulations, advice, etc.-The committee sha!! have an opportunity to review draft regulations under this act and advise the department prior to proposal. The committee shall have an opportunity to review and comment on operator selection, including the proposed standards developed by the department for the qualifications and compliance history of the operator. The committee may also advise the department regarding policies and issues related to the implementation of this act as may be submitted by the department to the committee for review. (c) Chairman..The committee shall elect a member to serve as chaim.an. (d) Policies and procedures.-The committee shall establish policies and procedures for the conduct of business which shall include a policy regarding potential conflicts ofinterest of members. (e) Meetings.-Meetings shall be held at least annually. After a site is designated, at least one meeting shall be held in the host municipality each year. ( (f) Expenses and support services.-Members shall serve without salary or compensation except for reimbursement by the department for reasonable and necessary expenses incurred in connection with their l duties as approved by the secretary. The department shall abo provide necessary administrative support services, budget and staff to the committee for the carrying out ofits responsibilities under this section. (g) Termination.-The Low-Level Waste Advisory Committee shall cease to exist when the department's i responsiLility for the regulation oflow-level radioactive waste is terminated. Section318. Host and affected municipality benefits and guarantees. (a) T'uniing for evaluation of proposal.-Upon submission of the potentia!!y suitable sites application to the Environn. ental Quality Board for approval, the depanment shall provide a reasonable amount of funds, not to exceed $100,000 per site, to the proposed host municipalities in the study under section 307(c), and, upon the request of such county, the department shall provide a reasonable amount of funds, not to exceed

     $100,000 per site, to the proposed host county in the study under section 307(c) to evaluate .he proposal submitted by the operator-licensee. The host municipality and the host county shall present Geir findings to the board not more than 180 days after receipt of funds under this subscuion. Strict accounting and verification of expenditures for activities related to this topic shall be provided by I   \

qj  ;

l l SESSION OF 1988 Act 1988-12 53

 ,f

( the potential host municipalities to the department in accordance with their municipal codes. AR unused moneys shall be returned to the depanment. (b) Funding for evaluation of application.-Upon receipt of a license application from the operator-licensee designates, the department shall provide a reasonable amount of funds, not to exceed $150,000, to the potential host municipality to carry out an independent evaluation of the application, and, upon the request of such county, the department shall proude a reasonable amount of funds, not to exceed $150,000, to the potential host county to carry out an independent evaluation of the application! The potential host municipality and county, within 180 days after receipt of funds under this subsection, shall present its findings to the department for inclusion in the licensing proceedings. Strict accounting and verification of expenditures for activities related to this topic shall be provided by the host municipality to the department in accordance with its municipal code. All unused moneys shall be returned to the depanment. (c) Additional members of advisory committee.-After the license application has been received, the potential host municipality and potential host county will be requcsted to nominate one additional member each to the department's Low-Level Waste Advisory Committee. (d) Petition for designation as affected municipality. Afler the license application has been received, a municipality may petition the depanment to be designated as an affected municipality. The depanment shall designate affected municipalities based upon, but not limited to, the contents of the petition. the results of the social and economic impact and environmental impact studies submitted as part of the potentially suitable { I she proposal under section 307, and the license application under section 308. This shall not preclude the

  ']

department from designating a municipality as affected even though the municipality has not submitted a petition. At least 30 days prior to taking final action, the department shall publish for comment in the Pennsylvania Bulletin a notice of its intent to grant or deny designation of a municipality as an affected municipality under this act, includirig the reasons for its action. (c) Designation as component oflicense.-The department shall designate host and affected municipalities as a part of the license. (f) Surcharge for municipalities.-With the approval of the department, the operator shall establish a reasonable surcharge on rates charged for waste disposed at the regional facility to be paid to the host municipality, host county and affected municipalities for the following purposes: (I) Trainir.g and equipping the first responding fire, police and ambulance services to handle anticipated emergency events at the regional facility or on the transportation routes serving the site within the host or affected municipalities. (2) Support for affected count / emergency management planning, training and central dispatch facihties as may be required to handle anticipated emergency events at the regional facility. (3) A minimum dollar amount guaranteed annually regardless of the volume of waste received at the regional facility and any additional (D U '

54 Act 198812 <-m LAWS OF PENNSYLVANIA

   )      amount per unit of waste (cubic foot, curie content or a combination of the two) the operator and J         ,

host municipality may agree upon. These funds will go directly to the host municipality. (4) Payment of school district and municipal property taxes for individuals whose primary residence is within two miles of the regional facility for the operational life of the facility. For purposes of this section, a primary residence is the property in which the owner resides for at least nine months of each year. Payments under this section shall be prorated based on the assessed value of property located within two miles of the facility. I (5) The hiring by the host municipality of two full-time qualified inspectors, as detennined by the department, to perforrn inspections of all activities at the regional facility under a written agreement with the department. The inspectors shall have the right of independent access to inspect any and all records and activities at the site and to carry out joint inspections with the department. The department shall respond immediately to any emergency complaint of the host municipality inspector. The department shall respond to any written complaint of the inspector within 24 hours. (6) The hiring, upon the request of the host county, of two full-time qualified host county inspectors, to perform inspections of all activities at the regional facility under a writt 1 agreement with the department. The inspectors shall have the same authority and responsibiliues as the host N municipality inspectors as outlined in paragraph (5) and .section 502. (7) The development of an educational program for host inspectors and interested parties. (8) Funds for the expenses incurred by an Environmental Advisory Council serving the host municipality or the affected municipalities, which has been set up pursuant to the act of December 21,1973 (P.L425, No.148), referred to as the Municipal Environmental Advisory Council Law, for the purpose of advising govemment agencies, elected officials and the public on matters dealing with the protection and conservatwn of the environment, including the immediate area of the disposal site. (g) Authority of municipality.-The host and affected municipalities' goveming bodies shall have the exclusive power, authority and duty to determine how to utilize any funds received under this section, provided that such expenditures or utilization shall be consistent with the provisions of the prevailing municipal code in effect at the time of the expenditure. (h) Additional duties of operator.-The operator shall also provide for the following: (1) An independent periodic well and surface water sampling program and soil and plant sampling program which will provide analyses for radioactive and specified chemical contamination for properties within three miles of the boundary of tue regional facility. Test results shall be supplied to the host or affected municipality, homeowner and the department. l

I l l em ( SESSION OF 1988 Act 1988-12 55

 \           '

l (2) An independent, continuous, air, well water, surface water er 1 soil sampling program which will provide analyses for radioactive and specified chemical contamination at the regional facility boundary. Test results shall be supplied to the host county, host municipality, afTected municipality landowners, homeowners and the depanment. (3) A propeny purchase program as follows: (i) Any landowner will be guaranteed the sale of his propeny or purchase by the site operator at propeny values immediately prior to the time operator-licensee designate's potentially suitable site application is submitted to the depanment, and any subsequent improvements since that date provided that the real property and improvements thereto are located within two miles from the boundary of the regional facility. (ii) The guarantee shall be in effect for a two-year period, this period to begin on the date of l issuance of the license by the department. (4) Prior to acceptance of waste at the regional facility, and every three years thereafter, the i operator will provide updated information for the health survey related to cancer and other disease rates and binh defects of the population within a five mile radius of the facility, and shall offer without charge whole-body radioactivity measurements and other measures appropriate to assess N the presence of internal radioactive emitters to all permanent residents within the host municipality or within five miles of the boundary of the regional facility. All data shall be provided to the individual with a full explanation of the results and copies made available to the host or affected municipality and the department. Tests other than the above shall also be made available, subject l to the approval of the department. Results of all such tests shall be considered confidential medical records. The department shall retain copies of all records provided to it. (i) Additional duties of depanment.-In addition, the department shall: ( (1) Submit all final inspection reports to the host municipahry and host county within five working days. (2) Notify the her unicipality and host county of all enforcement or emergency actions at the regional facility immediately. (j) Benefit sharing.-Where there are two or more host municipalities, the benefits under this section shall be shared according to an agreement to be reached between these host municipalities, if an agreement cannot be reached, the depanment will decide upon a final division of the benefits, which decision shall not be reviewable. (k) Local ordinances.-The host municipality shall have the authority to adopt reasonable ordinances, including, but not limited to, ordinances conceming the hours and days of operation of the facility and traffic. Such ordinances may be in addition to, but not less stringent than, not inconsistent with, and not in violation of any provision of this act, any regulation promulgated pursuant to this act or any license issued pursuant to this act. Such ordinances found to be inconsistent and not in substantial conformity with this act fm

 \
     \

shall be superseded pursuant to section 503. Appeals under this section may be brought before a court of competent jurisdiction.

 /

A

     \

56 Act 1988-12 LAWS OF PENNSYLVANIA Section 319. Rebuttable presumption. l (a) Liability of operator.-It shall be presumed as a rebuttable presumption of law that the operator of a regional facility is liable and responsible for all damages and radioactive contamination within three miles of the boundary of the regional facility without proof of fault, negligence or causation. (b) Defenses.-In order to rebut the presumption ofliability, the operator must affirmatively prove by clear and convincing evidence that the operator did not contribute to the damage, or, in the case of radioactive contamination, one of the following three defenses: (1) The radioactive contamination existed prior to any disposal operations on the site as determined by a pre-operational survey. (2) The landowner has refused to allow the operator access to conduct a pre-operational survey. (3) The radioactive contamination occurred as a result of some cause other than regional facility l operations. Section 320. Protection from contamination. (a) Water supply. The operator shall restore or replace any water supply which has been found or presumed pursuant to section 319 to be contaminated with radioactive material as a result of operations at the regional facility. (g) (b) Contamination i, general.-Any landowner experiencing radioactive contamination within three miles of the boundary of the regional facility may notify the department and request that an investigation be j conducted. Within ten days of such notification, the department shall investigate any such claims and shall, l within 60 days of the notification, make a determination, If the department finds that the radioactive contamination was caused by the operation of the regional facility or ifit presumes the operator of a regional j facility responsible for contamination then it shall issne such orders to the operator as are necessary to abate j the radioactive contamination and replacement of any contaminated water supply. l Section 321. Low-level waste compaction. (a) Siting regulations.-No license or permit to construct, alter, own or operate a commercial low-level radioactive waste compactor shall be issued until the Environmental Quality Boa-d has promulgated siting regulations for such facilities. No such license or permit shall be issued anless the applicant has demonstrated with clear and convincing evidence that the site selected for the commercial compactor l satisfies the siting regulations. This subsection shall not apply to any commercial compactor facility which obtained a license from the United States Nuclear Regulatory Commission authorizing opetution pursuant to l i the Atomic Energy Act of 1954 prior to the effective date of this act, provided that such compactor facility shai! comply with all applicable Federal and State requirements relating to operations and monitoring and shall obta:3 all applicable State environmental permits. For purposes of this section, a commercial cempactor is any compactor oflow-level waste except: A l V 1 1

SESSION OF 1988 A Act 1988-12 57 / \ \ D) . (1) One which compacts waste at the site of generation, including one situated on the premises of a hospital or res,earch laboratory. (2) One which only compacts waste generated by the facility owner. (3) A compactor which compacts waste at the regional facility. (b) Nonexclusive.-Nothing in this act shall preempt or prevent any political subdivision from enacting or enforcing ordinances otherwise within its powers to enact which are adopted pursuant to the political subdivisions' powers reserved under the act of January 8,1960 (1959 P.L2119, No.787), known as the Air Pollution Control Act, and other environmental protection statutes of this Commonwealth. Section 322. Noncommercial low-level waste incinerators. (a) Standards and regulations.-The department shall develop standards and siting regulations under this act for noncommercial low-level waste incinerators which shall include requirements for compliance with this act, the Atomic Energy Act of 1954, the Radiation Protection Act, the act of June 22,1937 (P. L 1987, No.394), known as The Clean Streams Law, the act ofJanuary 8,1%0 (1959 P.L2119, No.787), known as the Air Pollution Control Act, and the act of July 7,1980 (P.L380, No.97), known as the Solid Waste Management Act. (b) Existing facilities.-Those facilities which are licensed under Federal law to incinerate low-level radioactive waste on the effective date of this act may continue to operate. Section 323. Im \ Limitation on actions. ( j The provisions of any other statute to the contrary notwithstanding, actions for civil or criminal penalties v under this act or civil actions arising from conduct regulated under this act may be commenced at any time within a period of 20 years from the date the alleged wrongdoing is discovered. CHAPTER 5 ENFORCEMENT AND PENALTIES Section 501. Unlawful conduct. It shall be unlawful for any person: (1) To construct, aher, own or operate a low-level radioactive waste disposal facility without a license or in violation of a license or in violation of this act or the Radiation Protection Act. (2 ) To ship or transport low-level radioactive waste to the regional facility without first obtaining a permit. i as required by the act and any rule or regulation promulgated hereunder. (3) To generate, transport, handle, manage or dispose of low-level radioactive waste unless such person complies with this, act, the Radiation Protection Act and other state and Federal statutes relating to environmental protection, radiological protection and the protection of the public health, safety and welfare, and with the regulations of the department and the terms and conditions of any applicable permit, license or order of the department or other appropriate state or Federal agency. m (4) To deposit, inject, dump, spill, leak or place low-level radioactive waste so that low-level radioactive 1 l waste or a constituent oflow-level

58 Act 1988-12 R LAWS OF PENNSYLVANIA I \ radioactive waste enters the environment, is emitted into the air or is discharged into the waters of the Commonwealth, in violation of State or Federal statutes. (5) To refuse, hinder, obstruct, delay or threaten any agent or employee of the department or host municipality or host county inspector in the course of performance of any duty under this act, including, but not limited to, entry and inspection under any circumstances. (6) To cause or assist in the violation of any provision of this act, any rule, regulation, order, permit condition or license condition of the department under this act. (7) To incinerate low-level waste at a commercial incinerator. Section 502. Inspection. (a) Authority.-Host municipality and host county inspectors shall have the power to enter the regional facility, and the department or its duly authorized representatives shall have the power to enter each and every facility at any time for the purpose ofinspection and the power to enter at any time upon any public or private property, building, premises or place, for the purpose of detennining compliance with this act, any permit or license conditions or regulations or orders issued under this act. In the conduct of any investigation, the department or its duly authorized representatives shall have the authority to conduct tests and inspections and examine any book, record, document or other evidence related to the generation, management, transportation or disposal of low-level waste in the conduct of any investigation, the host g municipality inspector shall have the authority, at the regional facility, to conduct tests and inspections and I examine any book, record, document or other evidence related to the generation, managernent, transportation or disposal oflow-level waste. (b) Halt in operations.-The host municipality and host county inspectors, as authorized under section 318(f)(5) and (6), shall have the authority to halt operation of the facility if the inspector determines there is an immediate threat to health and safety. This halt in operations shall remain in effect until the department evaluates the situation and determines whether there is a continuing need for the halt in operations. If the

        . department determines there is no continuing need for the halt in operations, the host municipality has the right to appeal this determination to the Environmental Hearing Board, which shall consider the matter immediately.

(c) Search warrant.-An agent or employee of the department may apply for a search warrant, to an issuing authority, for the purposes of testing, inspecting or examining any radioactive material or any public or private property, building, premises, place, book, record or other evidence related to the generation, management, transpc.t or disposal oflow-level waste. The host municipality inspector may similarly apply for a search warrant to inspect at the regional facility, it shall be sufficient probable cause to show any of the following: (1) The test, inspection or examination'is pursuant to a general administrative plan to detennine compliance with this act. N v

SESSION OF 1988 Act 198812 59

           '(2) The agent, employee or inspector has reason to believe that a violation of this act has occurred occur.

(3) The agent, employee or inspector has been refused access to the low-level waste, property, building, premises, place, book, record, document or other evidence related to the generation, management, transport or disposal oflow-level waste, or has been prevented from conducting tests, inspections or examinations to determine compliance with this act. (4) The host municipality or host county inspector has made a written complaint to the department. (5) A landowner has experienced radioactive contamination within three miles of the boundary of the regional facility and he has notified the department pursuant to section 319. Section 503. Conflicting laws. Ordinances, resolutions or regulations of any agency or political subdivision of this Commonwealth relating to low-level waste shall be superseded by this act if such ordinances, resolutions or regulations are not in substantial conformity with this act and any rules or regulations or license requirements issued hereunder. . Section 504. Penalties. (a) Summary otTense.-Any ferson who violates any provisions of this act or any regulations or order promulgated or issued hereunde commits a summary offense and shall, upon conviction, be sentenced to pay a fine of not less than $ 100 nor more than 51,000 for each separate offense and in default thereof shall be imprisoned for a term of not more than 90 days. All summary proceedings under this act may be brought before any district justice or magistrate in the county where the offense was committed, and to that end jurisdiction is hereby confered upon districtjustices and magistrates, subject to appeal by either party in the manner provided by law. (b) Misdemeanor.-Any peson who violates any provision of this act or any regulation or order promulgated or issued hereunder, within two years after having been convicted of any summary offense mder this act, commits a misdemeanor of the third degree and shall, upon conviction, be sentenced to pay a fa of not less than 51,000 nor more than $25,000 for each separate offense or imprisonment in the county jail for a period of not more than one year, or both. (c) Felony.-Any person who intentionally, knowingly or recklessly violates any provision of this act or any regulation or order of the depamnent or any term or condition of any permit or license, and whose acts or omissions cause or create the possibility of a public nuisance or bodily harm to any person, commits a felony of the second degree and shall, upon conviction, be sentenced to pay a fine of not less than 52,500 nor more than $100,000 per day for each violation, or to a term ofimprisonment of not less than one year nor more than ten years, or both. (d) Separate offense for each day.-Each day of continued violation of any provisions of this act or any regulation or order promulgated or issued pursuant to this act or any term or condition of any permit or any license shall constitute a separate ofTense, u__

r l l l 60 Act 1988-12 LAWS OF PENNSYLVANIA I (' i (e) Civil penalty.- (1) In addition to proceeding under any other remedy available at law or in equity for a violation of this act or a regulation or order of the department promulgated or issued hereunder, the department may assess a civil penalty upon the person for the violation. This penalty may be assessed whether or not the violation was willful or negligent. The civil penalty shall not exceed $25,000 for each violation. (2) in determining the civil penalty, the department shall consider, where applicable, the willfulness of the violation, gravity of the violation, good faith of the person charged, history of the previous violations, danger to the public health and welfare, damage to the air, water, land or other natural resources of the  ! Commonwealth or their uses, cost of restoration or abatement, savings resultant to the person in consequence j of the violation and any other relevant facts. (3) The person charged with the penalty shall have 30 days to pay the proposed penalty in full ar, if the person wishes to contest either the amount of the penalty or the fact of the violation, to file within a 30, day period an appeal of the action with the Environmental Hearing Board. Failure to appeal within 30 days shall result in a waiver of all legal rights to contest the violation er the amount of the penalty. (4) Civil penalties shall be payable to the Commonwealth of Pennsylvania and shall be collectible in any manner provided by law for collection of debts. If any person liable to pay a penalty neglects or refuses to pay the same after demand, the amount, together with interest and any costs that may accrue, shall be a lien p in favor of the Commonwealth upon the property, both rent and personal, of the person, but only after same ( has been entered and docketed of record by the prothonotary of the county where the property is situated. The department may v any time, transmit to prothonotaries of the respective counties certified copies of all such liens, and it shall be the duty of each prothonotary to enter and docket the same of record in his office and to index the same asjudgments are indexed. Section 505. Enforcement and abatement, (a) Public nuisance. Any violation of this act or of any regulation or order of the department or of any term or condition of any license or permit issued under this act shall constitute a public nuisance. Any person committing the violation shall be liable for the costs of abatement of the nuisance. The Environmental Hearing Board is hereby given jurisdiction over actions to recover the costs of the abatement and civil penalties. (b) Orders.-In addition to other remedies provided under this act or any other act, to aid in the enforcement of this act, the department may issue orders to persons as it deems necessary to protect health and safety and the environment. These orders may include an order modifying or revoking licenses or permits, orders to cease unlawful activities or other acts involving low-level waste that are determined by the department to be detrimental to the public health and safety, orders prohibiting access to the regional facility and such other orders as the department deems necessary to abate public nuisances. An order issued under this subsection shall take effect upon notice, kO) v

SESSION OF 1988 Act 1988-12 61 U unless the order specifies otherwise. An appeal to the Environmental Hearing Board sha'l not automatically act as a supersedeas unless so granted by the board. It shall be the duty of any person to comply with any order issued under this subsection unless and until a supersedeas has been obtained. Any person who fails to comply with an order lawfully issued under this subsection shall be guilty of contempt and shall be punished in an appropriate manner by the Commonwealth Court, which court is hereby granted jurisdiction, upon application by the department. (c) Injunction.-In addition to any other remedies provided for in this act, the department may institute a suit in equity in the name of the Commonwealth for an injunction to restrain a violation of thh act or the regulations or order adopted or issued under this act or to restrain the maintenance or threat of a public nuisance. In any such proceeding the court sha!!, upon motion by the depanment, issue a prohibitory or mandatory preliminary injunction ifit finds that the defendant is engaging in unlawful conduct or is engaged in conduct which is causing immediate and irreparable harm to the public or the environment. The Commonwealth shall not be required to furnish bond or other security in connection with such proceedings. (d) Impoundment, etc.-The depanment shall have the authority to impound temporarily any low-lecal waste or to take other actions as are necessary to abate a public nuisance wherever the department beheves that this action is necessary to protect the health and safety of the public and the environment. (c) Emergency.-Whenever the department finds that an emergency exists requiring immediate action to protect the public health and safety or the environment, the depanment is authorized, without notice or

 )   hearing, to issue an order to any person reciting the existence of such emergency and requiring that appropriate action be taken to meet the emergency. Notwithstanding any provision of this act, such order              L shall be efrective immediately, unless a supersedcas is granted by the Environmental hearing Board.

Section 506. Construction of act. The penalties and remedies prescribed by this act shall be deemed concurrent, and the existence of or e2 -rcise of any remedy shall not prevent the depanment or any person from exercising any other remedy at law or in equity. No provision of this act or any action taken by vinue of this act, including the granting of a permit or heense, shall be construed as estopping the Commonwealth from proceeding in courts of law or equity to abate nuisances under existing law; nor shall this act in any other manner abridge or alter rights of action or remedies now or hereafter existing in equity or under the common law or statutory law, criminal or-civil, er.ercised by the Commonwealth or sy pson to enforce their right s or to abate any nuisance, now or hereafter existing, in any court of competentjurisdiction. Section 507. Right of citizen to intervene in proceedings

• Any G :n of this Commonwealth having an interest which is or may be adversely affected shall have the 1 right c:. ais own behalf, without posting bond, to intervene in any action brought pursuant to section 505(c).

2 (v) i j I i

62 Act 1988-12 A LAWS OF PENNSYLVANIA ( \

 \    ?         .
   'V          Section 508, Citizen suits.

(a) Authority to bring civil action.-Except as provided in subsection (c), any affected person may commence a civil action on his own behalf against any person who is alleged to be in violation of this act. (b) Jurisdiction.-The Environmental Hearing Board is hereby given jurisdiction over citizen sdt actions brought unde: this section against the department. Actions against any other persons under this section may be taken in a cut of competentjurisdi: tion. $uchjurisdiction is in addin no to any rights of action now or hereafter existing in equity, or under the common law or statutory law. (c) Notice.-No action may be commenced under this section prior to 60 days after the plaintiff has given notice of the violation to the secretary, to the host municipality and to any alleged violator of the act, of other environmental protection acts, or of the regulation or order of the department which has allegedly been violated, or if the secretary has commenced and is diligently prosecuting an administrative action before the Environmental Hearing Board, or a civil or criminal action in a court of the United States or a state to require compliance with such permit, standard, regulation, condition, requirement, prohibition or order. (d) Award of costs. The Environmental Hearing Board or a coun of competent jurisdiction, in issuing any final orc'er in any action brought pursuant to subsection (a), may award costs of litigation (including reasonable attorney and expert witness fees) to any party, whenever the board determines such award is appropriate.

 /n\

• t

  '         Section 509. Whistle blower provisions.

(a) Adverse action prohibited.-No employer may discharge, threaten or otherwise discriminate or retaliate against an employee regarding the employee's compensation, terms, conditions, location or privileges of employment because the employee or a person acting on behalf of the employee makes a good faith repon or is abort to report, verbally or in writing, to the employer or appropriate authority an instance of wTongdoing. (b) Discrimination prohibited.-No employer may discharge, threaten or otherwise discriminate or retaliate spinst an employee regarding the employee's compensation, terms, conditions, location or privileges of employment because the employee is requested by an appropriate authority to panicipate in an investigation, n

          ' nring or inquiry held by an appropriate authority or in a coun action.

, (c) Remedies.-The remedies, penalties and enforcement procedures for violations of this section shall be provided in the act of December 12,1986 (P.L 1559, No.169), known as the Whistle blower Law. (d) Definitions.-As used in this section, the following words and phrases shall have the meanings given to them in this subsection:

         " Appropriate authority." A Federal, state or local government body, agency or organization having jurisdiction over criminal law enforcement or regulatory violations; or a member, ofhcer, agent, representative or supervisory employee of the body, agency or organization, The term includes, but is not limited to, the department, host county, host municipality or other public agency whose functions include public health and safety.

r\ U) I

[mb SESSION OF 1988 O ' Act 1988-12 63

          " Employee." A person who performs a service for wages or other remuneration under a contract of hire, wntten or oral, express or implied, for an employer.
          " Employer." An operator of a low-level waste facility, a contractor developing such a facility or a contractor developing procedures or regulations associated with the Appalachian Compact low-level nuclear waste facility ' Good faith report." A report of conduct defmed in this section as wrongdoing which is made without malice or consideration of personal benefit and which the person making the report has reasonable cause to believe is true.
          " Wrongdoing." A violation which is not of a merely technical or minimal nature of a Federal or state statute, regulation, license, permit or order relating to the operation oflow-level waste facilities or relating to the preservation of the public health and safety in relation to such facilities.

CHAPTER 7 APPALACH'AN STATES LOW-LEVEL RADIOACTIVE WASTE COMMISSION Section 701. Appointment and qualification of commissioners. ( As an initial host state under the compact, Pennsylvania's delegation to the commission shall consist of five members. Upon passage of this act, the Governor shall immediately appoint four voting members and four attemates. Each of the members and altemates shall be appomted by and serve at the pleasure of the Governor and be confirmed by a majority vote of the members elected to the Senate. Each appointee shall be a resident and citizen of this Commonwealth at the time of his appointment and for the duration of his term. No appointre shall, for three years prior to oppointment, have a financial interest in or be employed by the operator of any low-level waste disposal facility, a subsidiary of the operator, parent company of the operator, a subcontractor of the operator, or in any corporanon that utilizes the facility for disposal of its wastes. No member or alternate shall accept employment from any regional facility operator, a subsidiary of l the operator, parent company of the operator, a subcontractor of the operator, any corpo,ation that utilizes the facility for disposal of its wastes, brokers or carriers during his term of office and three years after leaving office. In the event that a member or attemate resigns, the Govemor shall, subject to Senate confirmation, appoint a replacement to serve. Following selection of the site of the regional facility, the Governor shall appoint a voting member and alternate who shall be residents of the host municipality. The Governor shall notify the commission in writing of the identities of the members and the alternates. Section 702. Authority of the commission. (a) General rule.-The commission is authorized: (1) To enter into reciprocal contingency agreements with noncompact states or other regional boards for the emergency disposal oflow -level waste generated outside the compact region. Any such agreement shall 1

A / ' 64 Act 198812 V' LAWS OF PENNSYLVANIA include a provision that the quantity of waste for which the panies are responsible under the agreement shall be equal based on the volume of waste and/or total curie count. (2) To establish regulations to specifically govern and define exactly what would constitute an emergency which requires the disposal of out-of compact low-level waste at the regional facility. (3) To determine whether an emergency exists outside the compact region and that a contingency agreement should be implemented. (4) To request the General Assembly and the Govemor to approve an extension of a reciprocal-contingency agreement, and to provide the date when out-of-compact waste disposal will cease under the agreement. (b) Out-of-con pact waste.-No agreement shall permit the disposal of out-of-compact low-level waste for a period exceeding four months, unless an extension is granted by the General Assembly or the Governor. l CHAPTER 9 I MISCELLANEOUS PROVISIONS Section 901. Annual repon. The department shall provide an annual report to the General Assembly detailing all the current activities of the Appalachian Low-Level Waste Compact, compact commissioners and facility operators. The /

• n) depanment shall also include in the report a list of all low-level waste generators, brokers and carriers, the amounts of waste generated by each source by volume, toxicity, product and use, including curie content, hazardous life and radionuclide. A geographic breakdown shall also be included. The department shall also furnish financial statistics relating to all aspects of the Appalachian Compact and its associated facility. The department shall also furnish statistics relating to volume reduction, waste minimization, separation.and related processing.

Section 902. Liberal construction. The terms and provisions of this act are to be liberally construed so as to best achieve and effectuate the goals and purposes thereof. Section 903. Construction with other laws. (a) Other acts. This act shall be construed in pari materia with the Appalachian States Low-level Radioactive Waste Compact and the Radiation Protection Act. (b) Authority ofdepartment.-The authority given the department under this act over the regulation orlow-level radioactive waste shall be construed as complementary to the department's authority over radiation sources established under the Radintion Protection Act. This act shall not be construed to limit the department's authority under the Radiation Protection Act to license the generation, management, handling or transponation oflow-level waste. Section 904. Appropriations. l (a) Initial furidmg of program.-It is the intent of the General Assembly l i to fund this program initially through annual General Fund appropa >n

+)-

N for transfer to the Low-Level Waste Fund. l I i

(% SESSION OF 1988 v

  )               ,                                    Act 1988-12         65 (b) Disposition of General Fund appropriation.-The funds remaining of the appropriation made to the department for the low-level radioactive under section 213 of the act of July 3,1987 (P.L.459, waste control program No.9A), known as the General Appropriation Act of 1987, are hereby transferred to the Low-Level Waste Fund.

(c) Repayment of General Fund.-The sum appropriated under section 213 of the General Appropriation Act of 1987 for the low-level radioactive waste control program shall be repaid to the General Fund under section 315(c)(1)(i) of this act. Section 905. Repeals. (a) Absolute repeals. The following acts and parts of acts are repealed: Act of September 8,1959 (P.L.807, No.302), entitled "An act empowering the Department of Health to regulate the burial of radioactive material and to issue permits therefor; and prescribing penalties." Act of October 26,1959 (P.L 1380, No.480), entitled "An act empowering the Commonwealth to acquire land and operate burial grounds for the disposal of radioactive materials." (b) Inconsistent repeal. The following acts e.nd parts of acts are repealed insofar as they are inconsistent with this act: Act ofJuly 7,1980 (P.L380. No.97), known as the Solid Waste Management Act. (c ) Construction of section.-This section shall not be construed to repealjurisdiction over radioactive wastes that are also hazardous wastes under the Solid Waste Management Act, and it is hereby declared to be the icgislative intent of the Solid Waste Management Act to regulate such radioactive wastes that are also listed or charactenstic hazardous (N I wastes or are mixed with hazardous waste. lV Section 906. Effective date. This act shall take effect immediately APPROVED-The 9th day of February, A. D.1988. ROBERT P. CASEY G U

436 Act 1990-107 LAWS OF PENNSYLVANIA No.1990-107 AN ACT HB 1743 Creating a fee system to cover the costs related to the establishment of a low-level radioactive waste disposa regional facility in Pennsylvania and regulating certain low-level waste. TABLE OF CONTENTS Chapter 1. General Provisions Section 101. Shon uuc. Section 102. Legislative findings and purpose. Section 103. Definitions. Section 104. Regulation ofcertain waste. Chapter 3. Regional Facility Siting Fund Section 301. Regional Facility Siting Fund. Section 302. Fund contribution. Section 303. Reconciliation ofcontrol account. Section 304. Records and audits. Section 305. Default. Section 306. Withdrawal from Compact. Section 307. Panicipation in regulatory proceedings. Section 308. Retention of records. Section 309. Construction. Section 310. Expiration of fund. Chapter 5. Disclosure Statements Section 501 - Requiscnents. Section 502. Content. Section 503. Procedure. Section 504. Rules and regulations. I Chapter 11. Miscellaneous Provisions l Section 1101. Effective date. I The General Assemby of the Commonwealth of Pennsylvania hereby enacts as follows: l CHAPTERI. GENERAL PROVISIONS Section 101. Short title. This act shall be known and may be cited as the Low-Level Radioactive g Waste Disposal Regional Facility Act. j

(D SESSION OF 1990 ACT 1990-107 437 (] Section 102. Legislative findings and purpose. (a) Findings. -The General Assembly finds: (1) That the Low-Level Radioactive Waste Policy Amendments Act of 1985 and the Appalachian States Low-Level Radioactive Waste Compact Law, adopted pursuant thereto, require the Commonwealth to timely provide a regional facility for disposal of low-level radioactive waste generated within Compact member states; that the waste generators are required, under the terms of the Appalachian States Low-Level Radioactive Waste Compact Law and the Low-Level Radioactive Waste Disposal Act, to pay the costs of developing, establishing and operating the low-level radioactive waste disposal facility; and that such costs associated with preconstruction development of the facility are estimated to be approxi-mately $33,000,000. That those activities which generate low-level radioactive wastes requiring disposal (2) contribute to the health and welfare of the citizens of the Compact member states, and advance payment of funds by certain waste generators will enhance the timely availability of a disposal site and reduce the costs of waste disposal. (b) Purpose.-The Geneal Assembly therefore establishes that the purposes of this act are as follows: (1) To establish a low level radioactive waste disposal regional facility siting fund which would: (i) Require nuclear power reactor constructors and operators situated in this Commonwealth to pay to the Department of Environmental Resources funds to be utilized for reasonable and proper expenses, subject to limitations set forth herein, that are incurred p\ f by the department, its consultants and the selected regional facility operator in execution of b activitica required by section 307 of the Low-Level Radioactive Waste Disposal Act. Authorize a:.d encourage other potential users of the regional facility to make (ii) voluntary payments to the department for the purposes stated in subparagraph (i), (2) To provide for the recovery of an equitable portion of funds advanced by persons described under paragraph (1) by allowing them credits against surcharges to be billed to all waste depositors by the department. Section 103. Definitions. The following words and phrases when used in this act shall have the meanings given to them in this section unless the context clearly indicates otherwise:

            " Appalachian States Low-Level Radioactive Waste Compact Law." The act of December 22,1985(P.L.539,No.120).
            " Business concern." Any corporation, association, firm, partnership, or other form of commercial organization.
             " Contractor." A person who enters into a contract with the department to implement the Low Level Radioactive Waste Disposal Act.

(

em 438 Act 1990-107 LAWS OF PENNSYLVANIA (b \

• Contributor." A person who is mandated to make or who is voluntarily making contributions to the fnd.

t ebt liability." An obligation to repay funds advanced for the overall operations or the acquisition c refinancing of major assets of a contractor or contributor, excluding the obligation to repay nonaffiliated suppliers of materials, equipment, supplies or inventory entered into in the ordinary course of business.

             " Department." The Department of Environmental Resources of the Commonwealth.
            " Disclosure statement." A statement submitted to the department by a contributor or contractor as provided forin Chapter 5.
            " Fund." The Regional Facility Siting Fund created by this act.
            " Key employee " Any person employed by the contractor or the contributor in a supervisory capacity or empowered to make discretionary decisions with respect to the radioactive waste operations of the tusiness concern but shall not include employees exclusively engaged in the physical or mechanical collection, transportation, treatment, storage or disposal of radioactive waste.
           " Low-Level Radioactive Waste Disposal Act." The act of February 9,1988 (P. L. 31, No.12).
           " Low-Level Radioactive.              Waste Policy Amendments Act of 1985.11 PublicLaw99-240,99 Stat.1842,42U.S.C.{2021b et seg
           " Waste depositor." Any person disposing 3 flow-level radioactive waste in the regional facility during the operative period of this act.

n V Section 104. Regulation of certain waste. Low-level radioactive waste, as defined in the Low-Level Radioactive Waste Disposal Act, generated by any govemment agency or pursuant to a government contract or license, which was classified by the United States Nuclear Regulatory Commission as low-level radioactive waste as of January 1, 1989, whether or not such waste has been deregulated to below regulatory concern by the United States Nuclear Regulatory Commission or other Federal agency', shall only be disposed of at a waste facility licensed by or operated by or for a Federal Govemment agency or licensed by a state under an agreement with such an agency, for disposal of radioactive waste. Unless required under Federal law, the Commonwealth does not assume responsibility or ownership over these wastes by retaining jurisdiction over their storage and disposal. CHAPTER 3 REGIONAL FACILITY SITING FUND Section 301. Regional Facility Siting Fund. (a) Establishment.-There shall be established within the State Treasury an interest-bearing, nonlapsing, restricted account to be known as the Regional Facility Siting Fund. (b) Deposits.-All mandated and voluntary contributions under this act, together with actual interest earned on these contributions by the State Treasurer, shall be deposited into the fund. Separate accounting of contribu-(o

 ,       SESSION OF 1990 Act 1990-107        439

(  !' U tions and actual interest earned thereon shall be continuously maintained for purposes of implementing sections 306 and 310. (c) Appropriation and purpose.-Moneys in the fund -are hereby appropriated and, upon authorization of the Govemor, may be expended by the department on a continuing basis solely for the following purposes: (1) Reimbursement of expenses incurred by the regional facility operator for regional facility site selection, regional facility design and land purchase activities, but not to include any profit. (2) Fees paid by the department to consultants for the purpose of assisting the department in the implementation of the Low-Level Radioactive Waste Disposal Act. (3) Cost of the department for its expenses incurred in the implementation of the Low-Level Radioactive Waste Disposal Act. (d) Disbursements.-Each disbursement from the fund shall be deemed to be made from both contributions, and actual interest camed the: con, in the same proportion as each bears to the fund's total balance at the time ofsuch disbursement. Section 302, Fund contribution. (a) Maximum fund contribution.-The -sum of $33,000,000, exclusive of interest earned or imputed, shall be the maximum amount to be paid by mandated fund contributors. The actual amounts to be paid by mandated fund contributors shall be ratably reduced to the extent that the department determines that an amount less than 533,000,000 suffices for the purposes of this act, to the extent of voluntary contributions .

   '            received or reasonably anticipated, or to the extent of actual commitment, for the v}             purposes of this act, of financial resources by persons or organizations other than mandated or voluntary contributors. It is the intent of this section that no funds significantly m excess of those reasonably required to effectuate the. purposes of this act be paid into the fund.'

(b) Mandated fund contributors. - (1) Each person who is constructing or is operating in Pennsylvania, pursuant to a construction permit or operating license issued by the United States Nuclear l Regulatory Commission, one -or more of the nine nuclear power reactor facilities identified in this subsection, which are expected to produce electric energy for I commercial purposes and low-level radioactive waste for significant portions of the functional life of the regional facility, shall pay to the department a mandated contribution in the form of a fee for each such reactor facility in the cmount and at such time as follows: Date ofrequired payment Fee per reactor Not later than the 30th day following the effective date of this act $933,000 July 1,1991 $1,200,000 July-1,1992 $933,000 July 1,1993 $597,000 (2) The provisions of this subsection shall be applicable to the following nuclear power reactor facilities, which are producing or are reasonably m m

i 440 Act 1990-107

  /~~N                                            LAWS OF PENNSYLVANIA I    \

V anticipated to produce electric energy for commercial purposes and are generating or are reasonably anticipated to generate low-level radioactive waste throughout a significant portion of the functional life of the regional facility: (i) Beaver Valley - No.1 (ii) Beaver Valley - No. 2 (iii) Liraerick - No.1 (iv) Limerick - No. 2 (v) Peach Bottom No. 2'(vi) Peach Bottom No. 3 (vii) Susquehanna - No.1 (viii) Susquehanna - No. 2 (ix) Three Mile Island -No.1 (c) Voluntary fund contributors.-Any person, other than one required to make fund contributions pursuant to subsection (b), in an Appalachian States Compact member state who anticipates future use of the regional facility may, in one or more of the annual payment periods specified in subsection (b), make a voluntary contribution to the fund by payment to the depanment. Unless clearly stated otherwh, for 'he purposes of this act generally, and for the purposes of section 303 specifically, a person making such a voluntary contribution shall, to the extent of that contribution, be regarded without distinction as a mandated contributor. Such designation does not obligate or require future contributions by such persons. Voluntary contributions shall be applied by the department to reduce the fees of mandated contributors on a pro rata basis. O (d) Contributor reconciliation accounts.-At all times during the effective period of this act, the depanment shall maintain a reconciliation ledger consisting of a reconciliation account for each person making a contribution under this section. Contributions by such person, and the imputed interest accrued pursuant to subsection (e), shall be promptly debited to the contributor s reconciliation account. Fee payments, and imputed interest thereon, by a person who is a inandated contributor for more than one nuclear power reactor facility shall, for the purposes of this act, be merged in a single reconciliation account in the name of such person. (e) Imputed interest.-Mandated and voluntary contributions made under this section shall accrue imputed interest. Such interest shall be computed on an annual basis for the period beginning with the time of receipt of a contribution and ending on each successive June 30th. Such interest shall be simple annual interest at a rate equal to the rate then being imposed by the Department of Revenue for unpaid State taxes due and payable to the Commonwealth. It is the intent of this subsection to properly recognize the time value of funds contributed i so as to allow for inclusion of that additional imputed interest in fixing surcharges provided for by section 303. Accordingly, withdrawal from the fund and expenditure by the department of funds contributed under this section shall not be credited against, deducted from or otherwise cause to diminish the debit balance of contributors' reconciliation accounts on which imputed interest is accrued under this subsection. The

  \O) v

SESSION OF 1990 Act 1990-107 441 /m\ Q imputed interest required by this subsection is a separate and distinct calculation for the purpos of implementing section 303 and shall not, for- any be regarded as the actual interest on purpose or in any circumstance, amounts in the fund which may be eamed pursuant to section 301 (a). (f) Final value of contributions. For the purposes of determining surcharges and otherwise administering the provisions of section 303, the debit balance in each contributor's reconciliation account as of June 30,' 1994, together with imputed interest accrued thereon, shall be regarded as l the final reconciliation account vaiue of each. contributor, and the sum of all such contributor's I final reconciliation account values shall be regarded as the final reconciliation control account value. No further imputed interest shall be accrued after that date on the final reconciliation account value ofeach contributor's account. (g) Host Municipality Low-Level Radioactive Waste Fund.- (1)Each person who is constructing or is operating one or more of the nine nuclear power reactor facilities identified in subsection (b) shall pay to the host municipality of each such facility rive annual payments of $36,000 for each such facility. The first such annual { payment shall be paid 30 days afler the first day the regional facility began operation and was capable of accepting for ..posal waste from any waste. depositor. Each of the remaining four annual payments shall be paid at the end of four successive 12-month periods following the date on which the first annual payment was made. (2)For the purposes of this section only, the term " host municipality shall mean the municipality other than the county within which one or more of the nine nuclear power reactor facilities is located. In the event that such a facility is located within more than one such host municipality, each annual payment shall be equally divided among them. A host municipality may expend money received under this subsection for any purpose for which l the municipality is othenvise authorized by law to expend funds. Section 303. l Reconciliation of control account. (a) Intent.-It is the intent of this section to provide a procedure to assure that each fund contributor be provided credits, to the extent of its final reconciliation account value, against surcharges to be imposed on all waste depositors under section 315(c) of the Low-Level Radioactive Waste Disposal Act. (b) Reconciliation period for final reconciliation control account. -The final reconciliation account value of each contributor shall be reconciled over ten annual reconciliation periods against any surcharges on waste depositors imposed by the I department under section 315(c) of the Low-Level Radioactive Waste Disposal Act. The first 2nnil-gi reconciliation period shall commence with the first day of the first month of the fiflh calendar quarter during which waste is deposited in the regional facility. (c) Reconciliation credits.-For each annual reconciliation period, the depanment shall determine the revenue required by all surcharges to be imposed under section 315(c) of the Low-Level Radioactive Waste Disposal Act and add to such requirement an additional amount equal to one-tenth of O

44'! Act 1990107 LAWS OF PENNSYLVANIA Q - the final reconciliation control account value, the sum to be termed the annual reconciliation period revenue. An annual reconciliation period surcharge rate applicable to current reconciliation period disposal operations shall be then determined by dividing the annual reconciliation period revenue by the total volume and waste classification of waste deposited in the regional facility by all waste depositors during the preceding 12 months. The annual surcharge rate thus determined shall be multiplied by the volume and waste classification of waste deposited at the regional facility in the current reconciliation period by each waste depositor and the resulting surcharge assessed upon each such waste depositor. The surcharge assessment of such a waste depositor who is a fund contributor shall be credited in an amount up to one-tenth ofits final reconciliation account value. If, in any reconciliation period, the applicable surcharge assessment shall be less than one-tenth of the fund contributor's final reconciliation account value, the difference may be carried over and usable as additional credit against applicable surcharges in the next reconciliation period or alternatively applied to any permit fee imposed under section 315(a) of the Low-Level Radioactive Waste Disposal Act. Section 304.. Records and audits. (a) Records.-In addition to the panicular records and accounts specified elsewhere in this act, the department, at all times during the effective period of this act, shall maintain such additional records and accounts in such form and manner as will allow detailed review, examination and audit, by the Auditor General, of all monetary transactions pursuant to this

 /^   act.

( (b) Fiscal audits.-Within 120 days following June 30 of each of the fiscal years 1990 j through 1994 and the fiscal year in which the facility begins licensed operations, the i department shall furnish to each fund contributor three copies of a financial audit performed in accordance with generally accepted auditing standards compatible with the most intensive current practices of the Depanment of the Auditor General. Such audit shall be performed by the Department of the Auditor General. (c) Expenses.-The department may withdraw from the fund such amounts as are reawneb!y l i necessary and proper for reimbursement of audit costs. Section 305. Default. (a) Default.-For the purposes of this act, a default shall be deemed to be a material failure to timely make available for waste deposition a functioning regional facility conforming in all { material respects to applicable law. In addition to any other such circumstance or set of j circumstances, any of the following shall be deemed to be a default: (1)  ! Termination of the contract to be entered into by the department on or about May 1,1990, with a regional facility operator, prior to submittal to the department or the appropriate Federal agency of a license application for such a facility. l (2) Failure by the regional facility operator to commence physical construction of a regional facility by January 1,1996, at a site having final approval of the Secretary of Environmental Resources.

SESSION OF 1990 Act 1990-107 443

,m

/ Q) (3) Failure by the department t there has been a defaultional by facility the reg,o move operator. . forward to site approval and toopera (b) Declaration of default.-The Appalachian States Compact Commission may declare a default when a majority of both mandatory and voluntary fund contributors request such, setting forth. in a written declaration the circumstances constituting the default. (c) Special rights and remedies.- (1) Upon the declaration of default, the rights and remedies specified in this subsection shall be available to fund contributors, and duties specified by this subsection shall be imposed on the department. (2) Each fund contributor shall, within 60 days of declaration of default, be refunded a pro rata amount of unexpended contributions, including actual interest earned thereon, remaining in the fund in the proportion that each contributor's contributions to the date bears to the total contributions of all contributors to that date. Contributions in transit or received by the department on or after that date shall not be deposited in the fund, but shall be retumed to the sender. (3) The depanment shall refund to fund contributors all moneys, including the portion thereof attributable to actual interest camed thereon, previously released to the facility operator to the extent that the department has or will receive any or all of such moneys as a result of the default. From time to time, upon recovery of reasonable amounts of such moneys, the department shall refund these moneys to each fund contributor in the same pro rata proponion stated in paragraph (2). (d) Remedies preserved.-Nothing in this section shall be in any way constmed to limit the rights and p) \ remedies available to a fund contributor at law or equity. In no event shall the department or the Commonwealth be liable for unrecovered -expended portions of the fund. Section 306. Withdrawal from Compact. In the event that a Compact member state withdraws from the Compact before June 30,1994, any person in such Compact member state who has made voluntary contributions shall be entitled to a refund of such contributions, not to include any actual interest earned on such contributions. The department may, pursuant to section 303, impose additional fees on mandated contributors sufficient to provide the amount to be refunded. This refund shall be paid when such additional fees become available to the department. I Section 307. Participation in regulatory proceedings, (a) Department.-Upon request of any admitted party to a regulatory proceeding, including a l contributor that is a public utility, the department may agree to appear in proceedings before or present appropriate submittals to that contributor's public utility, regulatory body regarding the ' contributor's contribution to the fund. A contributor making such request shall Compensate the department. for its actual costs for travel, lodging and other out-of-pocket or administrative expenses l incurred in compliance with this i

\j

444 Act 1990-107 / LAWS OF PENNSYLVANIA (b) Affidavit.-If the department does not appear, it may submit an affidavit providing information relative to such contributions and surcharges relating to the fund and made or imposed under this act. Section 308. Retention ofrecords. The department shall retain, in a reasonably accessible form and place, all records Pertaining to contributions, nurcharges and reconciliations made under this act for a Period of seven Years beyond ' its termination. The department shall permit access to all records pertaining to contributions, surcharges and reconciliations made under this act. Section 309. Construction. i This act shall be construed in pari materia with the Appalachian States Low-Level Radioactive Waste Compact Law and the Low-Level Radioactive Waste Disposal Act. 1 Section 310. Expiration of fund. The fund shall expire one Year following the last day Of the tenth annual reconciliation period , Pursuant to section 303. Unexpended amounts then remaining in the fund attributable to actual l contributions, and exclusive of actual interest earned on such contributions, shall be refunded to each contributor in the proportion that each contributor's contributions to the fund bears to the total Of all l such contributions. Unexpended amounts then remaining in the fund attributable to actual interest { earned on contributions shall be transferred to the Low-Level Waste Fund, as established under the ' Low-Level Radioactive Waste Disposal Act. CHAPTER 5 v DISCLOSURE STATEMENTS Section 501. Requirements. In addition to any procedure, condition er information requirement of the Low-Level Radioactive Waste Disposal Act, every contractor or contributor shall file the disclosure Statement required under this chapter with the Attorney General. Section 502. Content. The disclosure statement shall include the following:

    . (1) The full name, business address and Federal tax identification number of a contractor or contributor or, if the contractor or contributor is a business concern, the full name, business address and Social Security number of all officers, directors, partners or key employees thereof and every person holding any equity in or debt liability of that business concern. If such business concern or its parent organization is a publicly traded corporation or the business concem is a subsidiary of a publicly traded corporation, the disclosure statement, with respect to the identity of its equity or debt holders, need only identify the beneficial owners of more than 5% of the equity in or debt liability of such business concem, except that:

(i) where the debt liability of such business concern or its parent organization or subsidiary is held by a chartered lending institution, the contractor or contributor need only supply the name and business address of the lending institution; or d

SESSION OF 1990 Act 1990-107 445 I ( * (ii) where a class ofequity secur9ies of such business concem or its parent organization on or subsidiary is registered on a national securities exchange. the contractor or contributor will be deemed in compliance with all the provisions of this section requiring the disclosure ofits equity and debt liabilities ofitself, its parent organization and subsidiaries, if the business concern supplies copies of any filings received by it, its parent organization and subsidiaries, of Schedule 13-D or Schedule 13-G pursuant to the Securities Exchange Act of1934 (48 Stat. 881,15 U.S.C. Q 78m(g)(1)). (2) The full name, business address and Social Security number of All officers, directors or partners of any business concem disclosed in the statement and the names and addresses of all persons holding any equity in or debt liability of any business concem so disclosed. If such business concern or its parent organization is a publicly traded corporation or if the business concem is a subsidiary of a publicly traded corporation, the disclosure statement, with respect to the identity of the business concem's equity or debt holders, need only identify the beneficial owners of more than 5% of the equity in or debt liability ofsuch business concem, except that: (i) where the debt liability of such business concern or its parent organization or subsidiary is held by a chartered lending institution, the contractor or contributor need only supply the name and business address of the lending institution; or (ii) where a. class of equity securities of such business concern or its parent organization or subsidiary is registered on a national securities exchange, the -contractor or contributor will be deemed in compliance with all the provisions of this section requiring the disclosure ofits equity and debt liabilities of itself, its parent organization and subsidiaries, if the business concem supplies copies of any filings received by it, its parent organization and subsidiaries, of Schedule 13-D or Schedule 13-G pursuant to the Securities Exchange Act of1934. V (3) The full name and business address of any company which collects, reports, treats, stores or disposes of radioactive waste and in which the contractor or contributor holds an equity interest. (4) A description of experience and credentials in, including any past or present licenses for, the collection, transportation, treatment, storage or disposal of radioactive waste possessed by the contractor or contributor, or, if the contractor or contributor is a business concem, by the key employees, officers, directors or panners thereof. (5) A listing and explanation of any civiljudgment orjudgment of sentence which was rendered within the previous ten years, pursuant to any Federal or State statute, or against any person required to be listed on the disclosure form, except for any Violation of 75 Pa.C.S. (relating to vehicles) or offense committed prior to the age of 18 for a natural person unless the natural person was tried as an adult, for the following offenses: (i) murder. (3 V

446 Act 1990-107 LAWS OF PENNSYLVANIA (,)\ * (ii) Kidnapping. (iii) Gambling. (iv) Robbery. (v) Bribery. (vi) Extortion. (vii) Criminal usury. (viii) Arson. (ix) Burglary. (x) Theft and related crimes. (xi) Forgery and fraudulent practices. (xii) Fraud in the ofTering, sale or purchase of securities. (xiii) Alteration ofmotor vehicle identification numbers. (xiv) Unlawful manufacture, purchase, use or transfer of firearms. (xv) Unlawful possession or use of destructive devices or explosives. (xvi) Violation of Federal or State laws goveming the sale or distribution of controlled , substances. (xvii) Violations of this act. (xviii) Perjury, false swearing or related offenses. ) (xix) Violations of 18 Pa.C.S. s 911 (relating to cormpt organizations). (xx) Violation of 18 U.S.C. Ch. 96 (relating to racketeer influenced and corrupt organizations). (xxi) Failure to pay Federal or State taxes. [ (xxii) Violation of the act ofOctober 28,1983 (P.L.176, No.45), known as the Antibid (, )T Rigging -Act. (xxiii) Violation of Federal or State antitmst r%tutes by the contractor or contributoi or its officers or members of the board Mdirectors. (6)With the exception of agencies of this Commonwealth, a listing of any agency, Federal or State, that has had or hut, regulatory responsibility over the contractor or contributor in connection with its collection, transportation, treatment, storage or disposal oflow-level radioactive waste. (7)Any other information the Attorney General may require that relates to the criminal record, competency, reliability or character of the contractor or contributor. Section 503. Procedure. (a) Investigative report.-The Attorney General shall, within 120 days of the receipt of the disclosure statement from the contractor or contributor, prepare and trans nit to the department an investigative report on the contractor or contributor, based in part upon the disclosure statement, l except that this deadline may be extended for a reasonable period of time, for good cause, by the Attorney General. The investigative report prepared by the Attorney General shall be evaluated by the department pursuant to sections 308(g) and 310(c) of the Low-Level Radioactive Waste Disposal Act under the continuing obligation of the department to evaluate the compliance history of the contractor and contributors covered by this act. In pre-

 /    )

N.] 1 m

SESSION OF 1990 Act 1990-107 447 ! \ V paring this report, the Attorney General may request and receive criminal history informatien from the Federal Bureau ofInvestigation and the Pennsylvania State Police. (b) Duty of contractors and contributors.-All contractors-and contributors shall have the continuing duty to provide any assistance or information requested by the Attorney General and to cooperate in any inquiry or investigation conducted by the Attorney General and in any inquiry, investigation or hearing conducted by the department. If, upon issuance of a formal request to answer any inquiry or produce information, evidence or testimony, any contractor or contributor refuses to comply, the agreement or contract with that person may be revoked by the department. (c) Fee.-The Attorney General may charge and collect, in accordance with a fee se' Jule adopted by regulation, such fees from contractors and contributors as may be necessary;over r the costs of enforcing this act. The fee shall be calculated on the basis of $100 t - each individual required to be listed in the disclosure statement or shown to have a beneficial interest other than an equity interest or debt liability in the business of the contractor or the contributor. The Attomey General may revise the fee by regulation. (d) Disclosure statement changes.-The contractor or contributor shall provide to the Attorney General, in writing, any changes to information in the disclosure statement or any supplemental information within 30 days of any change in information contained in the disclosure statement or receipt of the supplemental information. If a class of equity securities of the contractor or contributor, or its parent organization or a subsidiary of a publicly traded corporation, is registered on a national securities exchange, the contractor or contributor will be deemed in compliance with the requirements of this subsection, as to revised and supplemental disclosure of /

  )      holders ofits equity and debt liabilities, ifit supplies to the Attorney General, within 30 days of

(/ the receipt thereof, copies of any relevant Schedule 13-D or Schedule 13-G received by the contractor or contributor, or its parent organization or a subsidiary of a publicly traded corporation. (e) Enforcement.- (1) All contractors, contributors and persons required by section 502(2) to be listed on the disclosure form have a duty to cooperate in providing testimony, books, papers, correspondence, memoranda, agreements or any other documents or testimony needed to comply with this chapter. (2) The Attomey General, for the purpose of any investigation under this chapter, believing that a person or entity may be in possession, custody or control of documentary evidence or may have informati' 4 relevant to the subject matter of this chapter, may administer oaths or affirmation.,, subpoena witnesses, compel their attendance, take evidence and require the production of any books, papers, correspondence, memoranda, agreements or any other documents or records which the Attomey General deems relevant to the inquiry. (3) A request for information shall state the subject matter of the investigation, and shall describe the material to be produced with reason-n v

448 Act 1990-107 LAWS OF PENNSYLVANIA able particularity so as to fairly identify the documents demanded, provide a return date within which the material is to be produced and identify the member of the Attomey General to whom the material should be given. (4) The Attorney General may invoke the aid of a court of record of the Commonwealth for failure to obey a subpoena of a witness appearing before the < Attorney General or his representative, and the court may thereupon issue an order I rec,.iiring the person subpoenaed to obey the subpoena or give evidence or produce the books, records, accounts, papers, do,cuments or files relative to the matter in question. Failure to obey an order may be punished by the court as a contempt. Any motion to challenge a subpoena shall be filed with the court of record. Any appeal of the decision of the issuing authority shall be to the appropriate court of record. (5) If a contractor or contributor, after a diligent effort, cannot obtain the cooperation of persons required by section 502(2) to be listed on the disclosure form to provide the information required by this chapter and the information is not avail,.ble from other sources accessible to the public, the contractor or contributor shall provide the name or

                                                                                                                    )

names of such persons to the Attamey General. The contractor or contributor shal; provide an expla.iation of the mforn:ation requested, the steps taken to obtain the information and '.he response cf the person being asked to provide the information. The Attomey Genera' may us's the authority contained in this section to obtain the information requirea ic be included on the disclosure form. Section 504. Rules and regulations. The Environmental Quality Board, for the department, and the Attorney General shall have the atsthority to promulgate any rules or regulations necessary to implement the responsibilities given each of these agencies under this chapter. CHAPTER 11 MISCELLANEOUS PROVISIONS Section 1101. Effective date. This act shall take effect immediately. APPROVED-The 1Ith day ofJuly, A. D.1990. ROBERT P. CASEY

HISTORY OF PENNSYLVANIA RADIATION PROTECTION PROGRAM v) . Commonwealth interest in radiation protection began to emerge in the late 1930's in the area of industrial hygiene. In 1937 the Bureau ofIndustrial Hygiene in the Pennsylvania Department of Health was interested in the radiation exposure of radium dial painters. Radium was extensively used from the 1920s through the late 1950s in the manufacture self-luminous dials for clocks, watches, aircraft instruments, and other devices which needed to be read in the dark. ( It was the custom of dial painters to point the paint brush with their lips. This resulted in their I ingesting small quantities of the radium paint. (It doesn't take much, since a gram of Ra-226 is a Curie.) By the late 1930s it was becoming clear that the radium in the bones of the dial painters was inducing bone cancer in these workers. In 1937 the Bureau ofIndustrial Hygiene in the Pennsylvania Department of Health purchased a O Geiger counter from a Canadian firm for the purposes of estimating the radium bone burden in radium dial painters. The bone burden is related to radiation dose to these individuals. The technique used was to place the tube (detector) of the Geiger counter in the arm pit of the worker, thereby surrounding the detector with the bone of the ribs and the humerus (upper ann bone). The count rate is proportional to the bone burden which is proportional to bone dose. This technique was probably an ancestor of modem whole-body counting. In the 19S0s interest continued in the occupational exposure from medical and dental x-ray and radium used in the healing arts. The first radiation protection regulations were promulgated in 1958 as Article 433 of the state health code. An interesting feature of these regulations was attention paid to exposures other than occupational. They prohibited, for example, the use of shoe fitting fluoroscopes. Around that time, the Radiological Health Section was established in the Bmeau of Occupational Health in the Department ofHealth. \ IQt O I 09/10/98 History

1 n is The Shippingport A'.omic Power Station in Beaver County PA achieved criticality on December (V) 2,1957.. This represented the beginnings ofcommercial nuclear power in the United States. The reactor was owned by the Division of Naval Reactors in the Department ofDefense, and the turbines were owned by Duquesne Light Co. The facility was operated by Duquesne Light Co. The " button" to start up Shippingpon was pushed by President Eisenhower in Washington. The Admiral was intensely interested in the technology being used in a safe manner. one means cf demonstrating its safety with respect to the environment was his proposal to restrict liquid radioactive waste effluents to 10 per cent of the prevailing 10CFR20 limits. This restriction was inserted in the industrial waste permit issued by the state Sanitary Water Board. In 1960, a core melt accident occurred at the Westinghouse Waltz Mill test reactor in Westmoreland County. From what information remains of the event, the only interest the state had in the event was the disposition of two millian gallons ofcontaminated water generated during the accident. At least a ponion of the water was retained on site in lagoons, a condition /o V) which eventually lead to detectable Sr-90 in ground water plus contaminated soil. The site is cunently undergoing cleanup. In the early 1960s interest was growing about the health consequences of fallout from nuclear weapons in the atmosphere. The fallout concem lead to the infusion of federal money into state health agencies to establish environmental radiation laboratories and for radiological training of state health agency staff. The " Radiation Lab" was a part of the Occupational Health Lab. Early laboratory equipment included windowless proportional counters, thin window proportional counters (Beckman Wide Beta counters) and a 512 channel gamma spectroscopy system with a 4'lx41' sodium iodide detector. The proponional counters were located in a room behind the elevators on the south side of the ninth floor of the Health and Welfare Building. p k 2 v>/13/98 History

f% gJ I The original plan for the gamma spec system was to locate it with the other instruments. When the shielding material was about to be delivered to the ninth floor, some wise soul waved a of caution. The shielding in the existing Wide Beta systems was already three tons oflead. The gamma spec shield would have added about 10 tons of sheet steel. Rather thar. . ave the buildin list to the south, the gamma spec was located in the basement of the H&W building at the east end of the building. A significant feature of 1961 was the Lansdown project, conducted by the US DHEW. This project sought to decontaminate a house on Stratford Avenue in Lansdown PA. It had been the site of radium source manufacture by a physician. The house was remediated to a dose to occupants of about 50b millirem per year, not counting radon. The cost of the cleanup was around $120,000 in 1962 dollars. This project was to be revisited. Our first regional office was established in Philadelphia in 1964. The construction permit for Three Mile Island Unit I was submitted to the USAEC in 1966; and Unit 2, in 1969. Early 1966 marked the signing of the Atomic Energy Development and Radiation Control Act (P.L.1625) by Governor Scranton, at Peach Bottom Atomic Power Station (Unit 1). The Act was a child ofits times. It mimicked, to some extent, the federal Atomic Energy Act, by combining the regulation ofionizing radiation with the pursuit of the development of this new technology for the benefit of Pennsylvania. p 1 3 09/10/98 History

   )        A salient feature of the act enabled the state to enter into an " Agreement" with the (then) Atomi Energy Commission for the regulation ofcertain radioactive materials. The driving force in becoming an " Agreement" state was the expectation of a general improvement in delivery of radiation protection regulation and interface with the licensees, plus an identifiable stick for maintaining staff quality in the radiation program. (As oflate 1994, Pennsylvania is still not an
           " Agreement" State.)

Peach Bottom Atomic Power Station Unit I began operation in 1966. The facility was located on Conowingo Pond in southern York County. It was operated by Philadelphia Electric Company. The core was a high temperature gas cooled reactor using helium as the coolant with graphite moderator. The facility was shut down in 1972, as a result of Tropical Storm Agnes. The storm changed the design basis flood criteria for the site, changes which could not be accommodated. p ( A significant radiation protection event occurred in late 1967 with the Gulf accident. The event involved the accidental exposure of three workers at an accelerator at the Gulf Research Laboratory in Harmerville, Allegheny County. The underlying cause was an interlock which didn't. One worker received a mid-line whole body dose of over 500 radiation, with extremity doses of 6600 radiation to the feet and legs, and 8800 radiation to the handund forearms. He survived largely due to a bone marrow transplant donated by his identical twin brother. He eventually lost his extremities. The second worker received over 300 radiation mid-line whole body dose. The third got about 125 radiation. All three were protected from infection through the use of reverse isolation during their recovery. The net effect of the accident was significant change in the regulation of accelerators nationwide. l l 1 l 1 i (~h i (s.- ) i l 4 09/10/98 History t I

lQ Q Between 1956 and 1967, the Commonwealth is aware of 29 individuals who suffered acute accidental exposures to external radiation sources. Of these 29 individuals, 22 received exposures from analytical x-ray sources. Evaluation of these accidents revealed three causes; carelessness, inadequate instruction, and equipment failure. The only equipment failures found were due to deft tive shutters. In six of these caes, causes other than x-ray exposure initially were assigned as the reason for the observed symptoms. After evaluating these accidents, the Commonwealth disseminated 13 recommendations and eventually codified them into 15 regulations encompassing the use of analytical x-ray equipment. While these regulations have been revised over the years and are presently undergoing further revision, the basis of these regulations remains those initial 13 recommendations. Our regulations still require adequate training and instruction for the operator, the presence of safety and warning devices, and the periodic inspection of these devices. While it is not possible to regulate away carelessness, our regulations attempt to prevent access to the high radiation areas without some conscious effort by the individual. Our efforts appear to have been successful. Since 1972, there have been only three reported exposures from analytical x-ray equipment. In two of the exposures, students were permitted to operate diffraction equipment without adequate instmetion. The only instmetion given to one student was to ensure that the tube cooling system was operating properly. The third accident involved two individuals making repairs. The repairs required the removal of safety devices. As one individual was working with his hands next to the tube, the other individual turned the unit on. A serious radiation burn resulted. Perhaps lack of communication was at least partly to blame in this incident. Around this time, Pennsylvania began to acquire the title of the " Flagship of State Radiation Programs". The Pittsburgh regional office was established in 1968. v 5 09/10/98 History k

g (J In the 1967-69 dme frame Project Ketch, a venture by Columbia Gas and US Atomic Energy CommissMa, was a proposed underground detonation of nuclear devices for the formation of cavems for the storage ofnatural gas. The project was part of Project Gasbuggy in the Plowshares Program (peaceful uses ofatomic energy). The facility was to be sited near Renovo in Clinton County. Due in large part to public uproar, the project was eventually canceled. Just before Easter of 1969, Polyclinic Hospital in Harrisburg notified Radiation Health that they were in receipt of a broken technicium cow. A cursory investigation suggested that the device had probably been broken in shipment on board a passenger aircraft. The plane then continued to its next destination in New Jersey. The Jersey raddies were so advised, and subsequently impounded the plane for decontamination. Meanwhile, Radiation Health stafflocated and decontaminated the taxis used to transport the device from the airport to the hospital. An otherwise fine spring evening was spent decontaminating cargo which came in on the same flight as the device. The Bureau Director suited up and decontaminated the hospitals hot lab. lJ The summer of 1969 brought the H.B. Fowler project in Wayne. The project involved the l removal of radium contaminated soil from this old dial painting facility, at state expense. The soil was barreled and sent to an LLRW facility at West Valley, NY. Instead, it wound up at the Maxey Flats facility in Kentucky, which later became a Superfund site. I In 1969 the Radiological Health Section in the Bureau of Occupational Health was reg,anized into the Office of Radiological Health which reported directly to the Deputy Secretary for Environmental Health. The basis for this arrangement was the realization that the Department needed to deal with radiation in other environments in addition to the work place. I The Department of Environmental Resources was created in 1971. The new agency pulled together several existing organizations including the Environmental Health Deputate from the Department of Health, the entire former Department ofMines ar.d Mineral Industries, and the [n\ entire former Department of Forests and Waters. As pan of the transition, the phrase ( 6 09/10/98 History

        " Radiological Health" was changed to " Radiation Protection", as a means of signaling our I

departure from the Health Depadment. In 1971,, the US Atomic Energy Commission contracted with the Depanment for the monitor of nuclear power stations in the state. The contract was for the delivery of state generated data to serve as an Intercomparison with that of the licensees. The contract was gradually expanded to cover new facilities over the next decade. The Central Area Office was established in 1972. Tropical Storm Agnes in June of 1972 was a life marker for anybody living in the Susquehanna valley at the time. One outcome was the shut down of Peach Bottom Unit 1. As a result of the storm driven flooding of the Susquehanna, the design basis flood for Peach Bottom I was changed, a change which could not be accommodated financially. Another outcome of the stonn was a significant slow down in the construction ofTnree Mile Island. Most of the structures onsite were to be surrounded by a dike. At the time of the flood, the south end of the dike was not completed, the result being serious flooding of the site. The Radiation Lab got its first liquid scintillation system in 1071. Beginning in 1972, a lot of time was consumed by participation in the AEC hearings for  ; construction permits for Limerick Generating Station, and for Newbold Island. The latter was a i power station proposed for an island in the Delaware River, about a mile above Levittown PA. ' The application for Newbold Island was eventually withdrawn. 1 O l 7 09/10/98 History

t ) Beginning in early 1973, the Bureau cooperated with the Federal Government in the Nationwide (n d I Evaluation of X-ray Trends (N.E.X.T.) program for the collection of patient exposure data. One of our inspectors took it upon himself to expand on this effort and, between 1973 and 1975 collected data on breast exposures from 70 facilities in eastern Pennsylvania. He collected skin entrance exposure data (similar to the N.E.X.T. method) for a medium size, medium density j breast and found skin entrance exposures ranging from 0.25 to 47.0 Roentgens. Late in 1975, the Food and Drug Administration became interested in this data and they established the Breast Exposure - Nationwide Trends (B.E.N.T.) program. Pennsylvania participated in the B.E.N.T. program in the 1970s and was able to reduce exposure to the citizens of the Commonwealth from mammographic exposure. Then, a significant part of our effort went to convince physicians to switch from industrial non screen film to the relatively new film-screen systems. Many physicians were reluctant to change (q V; because of a loss of resolution. Dedicav.o mammography units were not common. We found one facility that was using a general purpose x-ray machine with a particularly low output. To compensate for this, they used a ten second exposure time. Since the timer on the unit could be set for no more than six seconds, they made two exposures. An initial exposure was made at four seconds followed by a second exposure at six seconds. Patient motion wer .abviously a problem, but, according to the technologist, the films were satisfactory. It is interesting to note that, in 1975, most physicians were not in favor of maamographic screening with the techniques that were then being used. With the doses needed at that time, they questioned whether more cancer would be produced than found. With the change in techniques over the years, the opposition to mammography screening faded. I jq I 8 09/10/98 History

y) Our first real radiation emergency plan for nuclear power station accidents was completed in i 1973. A novelty in the plan was its dependence on plant conditions rather than field measurements. The reasons for this philosophy included the stark reality that with a travel time of two hours to Peach Bottom, by the time we could get measurements the event could be long over. The other reason was that we really did not have suitable instruments. Another feature of the plan was the use of"home grown" Protective Action Guides. This was necessary since USEPA guidance was not published until 1975. A lesson in environmental monitoring was learned in 1974. A professor at the University of Pittsburgh, Ernest Sternglass, used pre-operational monitoring data for Beaver Valley to imply that the Shippingport reactor on the same site was contaminating the environment. This was not the case. The underlying cause of the problem was that the data was not scrutinized by the licensee (or anybody else) prior to or after publication. Among other things, fission product I-131 was reported as present in milk. The underlying activity was really a radon daughter. The tO w j v lesson is that any change in reported environmental radiation, especially fresh fission products, needs to be investigated. In late 1975, the Radiation lab acquired its first germanium detector, a 15% GeLi, along with an 8000 channel analyzer. The old sodium iodide detector continued in service. 1 The mid-70s were a hot bed ofproposed nuclear power projects. These included a liquid metal fast breeder reactor proposed by GPU. It was to be sited near Towanda. The application was later withdrawn. Another was a pair of high temperature gas cooled reactors known as Fulton Generating Station. The project was proposed by Philadelphia Electric, to be sited in southern Lancaster County. This application was also eventually withdrawn. The great interest in the future ofnuclear power lead to the consideration ofmining for uranium in some of the natural deposits in Pennsylvania. This interest prevailed until the seminal event of O 1979. V 9 09/10/98 History l

  ,3

(_v) The climate also began to suggest that the state should acquire a nuclear engineer for the evaluation of the many proposed projects. The first NE was Bill Dornsife, hired in 1975. The first radiation event to place Pennsylvania in the Doonsbury comic strip was the fallout episode of 1976. In late September an atmospheric test of a nuclear device was conducted by the Peoples Republic of China. The leading edge of the fallout arrived over the northeast United States the first Sunday of October, along with an intense low pressure system. The net effect was a lot of fission products being deposited via rainwater. None of this was detectable by air monitoring. The next day, workers at Peach Bottom arrived at work contaminated. (For obscure reasons, this facility used a portal monitor to check workers on the way into work. Portal monitors would be heard from again.) The utility sampled the rainwater in parking lot puddles, and found short lived fission products including I-132. (The I-132 was transported as 77-hr Te-132.) This led them to

  / N i             )    believe the contamination was from the plant, but the mystery was that nothing onsite was off normal. They were not aware of the weapons test. Non-essential workers were sent home.

According to plan, PECO notified Radiation Protection, l Radiation Protection, being aware of the test, called around to other facilities able to do sampling. The outcome was that fission products were all over the state, that it could not have originated at Peach Bottom. The greatest concern was the contamination of the milk supply. The highest concentration found was 400 pCi/ liter, which was the highest ever found in PA, including the Three Mile Island Accident. BRP got a lot ofpress out of that event, g t )

   'V 10                                          09/10/98                                   History

In 1978 a geologist for DER contacted the Bureau about his observation of a lot of natural / \ Q radiation anomalies in a physiographic province known as the Reading Prong in south eastern PA. The BRP plan was to do some rudimentary field work, particularly in the food chain, to get some idea of the dose contribution from natural stuff, beginning in the spring of 1979. That indoor radon would be the real problem never dawned on us. The project was canceled due to the big event of 1979. The second event which brought PA into the Doonsbury strip, as well as the Funky Winkerbean strip, was the accident at Three Mile Island. It began at 04:00 on Wednesday March 28. Were it not for that event the Bureau might not have survived. (For a blow by blow account, please refer to Volume 1 of the Rogovin Report.) This event consumed all of the headquarters staff time for months. Almost all of the staff of the field offices were called in for temporary duty. The highest milk I-131 concentration detected as a result of the accident at TMI was about 20 pCi/l in nearby dairy herds. V A lesson leamed from the accident was the value of a Bureau presence at the site, in the form of a nuclear engineer very familiar with the operations of the facility and with its management. As fortune would have it, the Bureau NE had been recruited from the Architect-Engineering firm which built TMI-2. This lesson lead to the organization of the Division of Nuclear Safety with NEs each being assigned to follow a particular power station. In 1980, the Department was reorganized. To this time, organizations in the Department, which required laboratory support, had their own labs. The reorganization moved all of the labs into the Bureau of Laboratories. The year of 1980 saw the organization and operation of the Community Monitoring Program for the venting of accident generated Kr-85 at TMI. Accident related issues continued to draw staff attention for the rest of the decade. Personal injury suits are slated to be heard beginning in n ( \ 1995,16 years after the event. 1I 09/10/98 History 1

(: ( In respo.nse to the TMI accident, the first Radiation Protection Act was promulgated Govemor Thomburgh. The Act provided the means to fund the nuclearpower related activities of the Bureau by assessing fees from the nuclear utilities. It also specifically mandated most the Bureau activities, which assures its continuation. The Act also removed the atom development mandate from Department responsibilities. In the early 80s, the Westem Area Office was kept busy with the remediation of the Can facility. At a cost of$38 million,10% ofit state funds, and 90% federal, an old uranium processing facility related to the Manhattan Project, beevan through 1985. The effect of the project was the reduction in lung cancer risk from radon inhalation by one case per 100 years. Another event for the Western Area Office was the Jollytown caper of 1982, which involved a drill bit puncturing an Americium-241 source. A portal monitor again brought bad news in 1984 with the discovery of contaminated steel re-bars being brought on site at the DOE facility at Los Alamos NM. This lead to a nationwide campaign for more of the stuff, including items such as table legs. The source was steel imported from Mexico, which had been contaminated with Co-60. As a result of this occurrence, scrap yards and landfills began to install portal monitors. These devices continue to bring new business to the Bureau. The summer of 1984 brought new interest in the Lansdown house on Stratford Avenue. The house, along with the other halfof the duplex became a Superfund Site. The total cost there ran over $7 million. i I 1 12 09/10/98 History

l Another seminal event for the Bureau occurred on December 19,1984, again by a portal monitor. (s Notification was received from the chiefradii at Limerick, that a worker appeared to be coming to work contaminated. The contamination was natural. The utility had the worker's home checked, and found extremely high concentrations of rc. don there. The Limerick chief raddie reasoned correctly that the problem was not a utility problem, but rather a state problem. The radon story began with that phone call. In the early months of the radon project, attention was confined to Colebrookdale Township, adjoining Boyertown PA. A field office was established in Gilbensville. By the end of1985, the project included the entire Reading Prong and adjacent areas. By late 1986, the program began to go statewide. The big event of 1986 was the accident at Chemobyl in the USSR. It occurred on April 26. By the first week of May, fission product I-131 was detected throughout the milk supply ofPA, to concentrations of about 50 pCill. (As a point ofinterest, the accident was brought to world O\ (D attention following a report from Sweden that power station workers were coming to work contaminated. It was detected by the facility portal monitors.) In 1987 the Department was became involved in the remediation of a state owned facility at Quehanna in Clearfield County. The facility is administered by the Bureau of Forestry. It is contaminated with material left behind by previous tenants. NRC is requiring that the facility be remediated. This activity is ongoing. From 1988 to the present, the Bureau has been involved in the decommissioning of a GPU owned test reactor at Saxton, south of Huntington. Activities included a 1990 independent measurements project using insitu gamma spectroscopy to verify the decontamination of structures other than the reactor building. Special studies were also conducted by a DOE contractor in 1988 and 89 to determine whether contamination was detectable off site.

/^N                                                                                                        l 13                                        09/10/98                                  History

Again, in 1991, a portal monitor brought us more business. This time it was a load of oil and gas brine sludges tripping the monitor at a landfill. This brought us into the examination of naturally occurring radioactive material (NORM) in waste streams. (Work is ongoing.) The saga of Lart down continued in 1991, this time on Austin Avenue. A uranium / radium refining prccess which operated in the early decades of the century, led to the distribution of radium contamination of the facility itself, and many other structures in the neighborhood. This became yet another Superfund Site. l

                                                                                                             )

i s 1 I4 09/10/98 History

                       ,                             1!                               l                                                       !{ij 1

s e e c rn eni sO r

                                                                                  .dr                                                                                                                              1 eps   e                 a k

woes s _ a n I, _ dssr c - Boau t C _

              ~

QhPd ESeE g s n e _ e as e"- 1 C en ms w bS e =ee rn e W

                                       %r e

t rS u t Cr e a% C a C B ~ n .e

                                                                                                                                                                                            %m_

o e i < ,. e t . r c - u %d r E t e a n o r P ll le s l n u t a We Ca C w n.

                                                        .o
                                                        ,Cy
                                                               - es c

s n r o n tsr r ee eePf _is wO 5 o_ n n n. n a r e rh Lagala e i l Gec f a e t f eL n oRl ef eaop I e. ev s o r m m mm e e o nR wee SeG s re P. y e s n w

                                                                                                      -                            r P

o B -

• C A _

i r v yn mam n eea c r c e ns , _ rc s e a _ n E y synu e im n g o O l t s n i o f r DeCd a i t

 ,G                               e                                                                          i                  p g               e wn t

e a i O 1 g g g g n uy c e sh a _le F d i R i z t $ Ea ,c  ;

                                                                                                                                                        ~

n e n ~ a, il; a g

                                                                           ,                                                                                                                                    r m
                                                                           ,                                g                 sn
                                                                                                                                                                 -                e                           O e__eof 3                                 r re s

t

                                                                                                    ,f s                h t                          e m

re ey d og - r ti c _bsue r t

e. is c

a

                                                                                                                                                                 <Sa e         fekh a                    m a

I e e s na e r

                                                                                                                                     .e         ,Re e

a uee s eG r P. p C, R. u Bw h 6

                                                                                                                                                                -                B u

e i . D

                                                                                                                                                     ~
                            'e s

e e i a C h r

                                                                                                                                               .                      ,          se d

s n . n H

                                                                                                         ,                                                     d r                                    -
                                                                                                                                               .                                 md
                                                                                                                                               . g              .n e             e e yr=
                                                                                                         -                 T                 Wh e

n a DW y a v n _ v B W m a e r u

                                                                                                                                            ,S. y h

O t e mCr W e se reeA. s s a e e a l B _W* "t B_ e & y d e m g a W s u B- _ - _ _ n s r e e n fc fC_ i O l ey e h s

                                                                                                                                                             ,e

_r r

                                                                                                             .            u                         eg P                                                                                     ,

h g nc y se c. Q A w h e n a d. F i c e e e

                                                                                                                                           ,W e

R, s d e n r w a Ad S

                                                                                                            .n s

e c n w a ey . r e u n

                                                                                                  $                     c                                                  fn              e            b A                                                    o                             s h

c e c s e r,.csee t v t T , F 0S e u . , f e <dan m 8

 ,t                                                                                               e                                                                        v n

e e 9 n e a e n o p s T" r la E B / 0 n _ " 1 kla / 9 l1{t

2 3y -

                                                                                            ~.

b.: . I "l-.

= .

                                                                                                                    =

2 l

                                                                                                                    =
                                                                                                                                       .~.

N". = N 5 O I

                                                     =;

T s ..-

                                                                                                                    ==

t 7,. - C ll ,  ; E T O t Rr a ' T..- P h . 1 l. I"' .. . NC . n Ol a 1

                      =                                                                                                                              o To n I                 .                  .

i

                    -                       .                                                                                           .           t
 -   s             =
                         .             0    .
                                                                                                                                        .            a 1

z (< Ai a I t

                   =-
                          -           1 i

n a Diz ~

                                                                                                                                       -             g An a I

I - r Rg -' - "O. "

                                                                                                                  =                                O r     ~                                           O-                      ::  .

F  : O O b*-. -

                                                                                                                  ~                    .

U l l A = .  :. E = . R  :

                                                                                       -= = ,

U

                                                      ?:.

I B ,. O .= I /- d

                                                   .= :
                                                                   = =:,

g = .::. .

                                                   . ' =.g.
                                                                                                        =..  .

nv ( 8 9

                                                                                                                                                 /

0 1

                                                                                                                                                 /

9 ts,

3 O . r e g n a a r e g n n o r g n a e t n r e g n a t n a r e g n t n e m y a e g n r _ M M M eoM ps uyn sen t c e M ekM gs o aco eo on mdnn e ao m r n e a nn nwt c at Gnt ot n glr t get o n a o tra ac r s c a c aec ayt C. nr Mee nadm dJe P u e n Ytm nOe ay n r e aDt o Mac y vt e v ho P. f evP Mnm Mnr lp se n EJ vn O D v. ci o m P. eJ eh te T'a vP. pm. u aP tscto v a A n P.a n v d a n s n Soh vn E. r g E. R E. W E. W E. eTE g g g - e e e g ta g e e e R R R R R W R r e g a sna t a s n tpM oss mA n a ev s _ o i s o t c r e r 1 L. e Mins leu i Nt aa dt r in sa t c n i D as hf Lm t e o i t s n ae s n o c a r ca Moign e R d A oa r r t p e a r e sp tO r ut D.Fle k P ep O d l n A sa l r ec l ieia rn let a e. aO Fb ae ra h pr _ foF nD e . C f r t yy ._ u t e lee r en h 't s h b b nd e c e a teT r r lE a I C. ge We n oAC r nCl epa DPen l m m a e GM ml nF i e S ty u p e D R n e g e hR ct sn ea ot j is s s dog F e r R e bm oa Be T n o o

                        ~

O A i t _

             -                                                                                                                                a r                                                                                                                                         z i

v o n r e dr i n ni i a n g C o o ll i a g E g y M a s a e k s r f e kso ma lug r n s r n oo h p wt os am k we O OR t i Br De n o P. o r g i s d ar R. h r ic e e [ oh h C. mv

                                                                                                          'n a

l "P _ t s m R m #' E m n e E. v E t W E ew s n s E A _ t mh r t t s a u c p S p o r n e o s eS yi

                                                                 .t   s
                                                                 .ie JR D                                        e p

1

                                                             ;y L M.

ta R - u S t Rc ns C. oh v sta h c n lae E E Mp ' y S sn t s tei to c p Sa S m r s f o n n o I s ra e te eR 8 rg M t Au n m . m o C. v O n E 8 9

                                                                                                                                         /

0 1

                                                                                                                                         /

9

4 O

            ~

n _ i o _ t c t e o r _ P - l t a n no ei t mc nt el k le oo r a ot leis lia ts t t it ksi s nt v li r n gc n is ui k c s uyis t s oi ci t eic t osd si ica e iPv i o A. h LP y Hh

                                               .P S. hp P P luy h h s

insyM Wh o nng sh t inl J lel ht t r h et S. P Jh

                                                                              . Pt Phd E o e lt a    a a         b la     lua       nl t e oe r            n e e       h e           oe       ae      ho ec  ah                  n DH       icH          R H                                          o f     iR t

k g s a Ya un M PH J Ha t e D i t a at "O Ois t d e G ea

                     .M s m mgr t

n i z n a n a y r eRw a c e a re t k ict g r t g J s s ts it et bi f s P is ei ns t s r s aa t r es r c ai it ic ss mf h O jc ai wlc ei c i r oA di s t i ss Ri dc t oe ny oy Ly .s h sy S. ep oi oys t r ouo Mi v nar ot t A. P L dt h h B h Ah

                                              . P t

r h eP hh plt S. A t h h P MS en d o Wh Vh

                                                                                           .P a                                                           hl t       ui t pa uS Dis      ar la    nl   a       oae                              ylt e                              tr c v e ga n     w e                                     r e           o e a t

s ie d H DwH eH iH et R H im E t r h GoPr e re d A S C Du i aB n a l v y s n n e P O 8 9

                                                                                                 /

0 1

                                                                                                 /

9

5 O .

                                                        ~
                                                       =

n ':. o i s t c n t e i o ' - t oa r r 9_ I P e p - l taO -

                                                                  .r=                                        -

nd el -_ :3_ I

                                                                                                                      =.
                                                                                                      =r:: _.    :.

mie _

                                             =
                                                                                          ==-_

E- ~ 2 4- n o nF r_. i O o I t r - . a z i v o n  ; . i n ni a _

                                                                    =         ..-  =   ~.                                      g
                                                     =-

il I E g - r - f e - O oR t r y = 1 I t - ns - s r r. l e a

                       --                ~

e - mh i

                                                       -         ii m

a t t r a u l r o i l l p eS D c 1

c. ~ .

                                                '         t            .                                                           .

m .

                   =

l l O 8 9

                                                                                                                           /

0 1

                                                                                                                           /       __

9

6 _ O n i o _ t c t e _ o r _ P . l t a n no ei t _ c me nt n e oo o I t et s U r t l I t r I

                                                                                !    B n

a _ r ri g gi s nic ni ic ei s t c yi c s et s si sc k t - ss v P e oic i as h y ChP t i ss r e y ni s uy Hh hi s sy o ms z y a r sl iie yi D hP K P h th P hW _ nnR y yP uP rh y k e eP o r rh ch oh Rh k ih t alt r elt t Jlt tt d n Eo n el La e Te a Be a a u la r Mltae i k y gt rH e! H H H e H K H e eh Hc a i o Of a ais t r b nc te t a oi a te n ai s D h aMy h

                                     -        -        -        -       -        -         i z   _

SmP t d s a arht n . a _ na a n gl voa I r e I  ! H H U g - eRe PH t et n! r t nt at is vis r s t uc oc oi isi c eic s rs eci rmi s c O mfouh i r i _ As gs y ais yi s eh y s iays Ky bi y sy ay _ t i oh Gh e h r Dh t mP CP e P gP P Ph eP r eh BR a eh vh r oh eh h _ a u o kl t alt t ot llet ia Da e el a J la h la e Me Ge e ic e pas H H H H H Mh e e _ Du r i aB n a l v y s n n e P o 8 9

                                                                                         /

0 1

                                                                                         /

9 l

7 -) n i o t c t e o r P s n s n l ai o io t a r e t t p n a O e r dn mpe l iea i F ba r nO o f oF yn r ae y - t r o i rd te T r c c e r vl e S y i D ni t u s n n E F p e io t a i o D f n re r t t a nv t oo n i g l t ep nO e S. F d l ie ynM lt o ia csm r g n e k gr mc ediM aem gr Hnm bg uM a r i z n a e e R let l a ~ uig QEro r nb g aOro CKg Sr o r g r mR t l r a an h e c im Mno t r t eo irfiP AeL vn E MnP t W rov een aL E We P lm v En E O a r k v s c s t ar e pn t E n i B D - - - e e la n e t.s Dch n o ig e r as KA m a r gs oin3 t n e mr g r peg r r nr ioe v r - at R t cag Prb r eiM uhM ehM i u b e a ns n n o gF m aemg t nolc oRf i a nsg l hF o o em r Pp g a i t ai a0 aco r MnaP i sr nKr oo . l vS r sim t c itrd naA er vn ts F C. v eP n mv Ean io s P t iae v y i mP a E JE dmn aa E s d A W RJ _ n _ n e - P _ 8 oU 9 _

                                                                                         /

0 1

                                                                                         /
                                         .                                               9

8 O ~ n i o t c t e o r P l t a n no ei t y r mce n nt r ic e zy s t i s f ri e t sb ic s u u n ooo r ri g t ih Ky P f e yS Ph o k Pt i v P e ot h Ra l nh de alt r ah nnR Eo a r e eg v r a H e F e ca Ht e n o i l a n D i Of oita r t d na e t n h a n eM p om Kra mg t n a i t a z n a g eRc io J r t is t t t O r mf h t P s s k is i sc oi ri ei s c s c is r ou t t A dr y s h s hgyis n e ay a u o av ci ah M h uh GP P HP pas a ta Vr t yh t n ht h imh e e is n dl n e a ol a J e J a lt e Du r im d A H H H i aB A n a l v y s n n e P O 8 9

                                                                    /

0 1

                                                                    /

9

wO ' 6 ls 1 0 2 2 4 8 1 1 3 3 a 7 6 5 9 9 9 0, 38 7 1 1 t o 7, 4 2, 4 3, 6, 3, 5 9,5,6 8, 2, 1 2321 6 T $$$$$ $ 8 1 34 3 8 6 r e 1 1 1 2 1 ht 9 9 9 1 9 9 3 3 - O - - - - $ 3 - 3 37 3 nn oi to it a c 0 6 4 8 2 6 1 1 i ed t 8 6 5 3 6 9 d a o r n u 4 2, 2 9, 2, 6,741 5 5, 6, RPF 23 3 4 8 253 3 4 y t t i l i e g c d a u F B l a ) n 9 5 og 5 4 0 7 igind n 5 6 8 4 6 7 2 2, et ui 5 5 5, 7, 4 8, 0, I 1 1 ( RSF - - - $$ 1 1 1 1 2 3 l e v e l e 8 5 0 8 7 5 8 7 t 0 4 wsd o a n u 2, 0 0, 3, 3 8, 8 1, 71 890 8 3, 9 7, LWF 1 91 2 1 4 391 1 2 s n i o t gi a 7 l n r ip a t 9 r ed ar o

    /

6 n nr ep 3 3 1 3 0 3 e upp 1 5 5 1 53 1 8 9 GFOA $ - - - - $ - $ 5 46 5 9

                                                                                                                                 /

0 Y 1

                                                                                                                                 /

F 9 0 ly m b s r a r m e a e g) s s Y o K A r o r$ ( l a e s ir Ps d ri t P el nan na en m o 7 i osu GeP F r 9 6

                                                                                     /

t o 9 ch eT d&e t s er l d w Y 7 i s l r e a F 9-t n pes t F _ oi pne eh et o e r 1 T t r nw i c o - AFFInO n F l e n g 7 Poh l a a l e ni nt l b e nS s B b a ora re s l a l a ot d e l i r e pt eh t o i a in t u t a POO T v it v A ao eeeee uu uuu u e m A s s s ee e s e s nnnnn n m s s s s n d dal A nnn e l im RlA ee vvvvv ee ee e RRRRR eee e v e R U o c n d F n u e ee ppp x x x EEE E e p y U n s u 1

BIOGRAPHY - DAVID J. ALLARD, CHP Pennsylvania DEP Bureau of Radiation Protection RCSOB,13* Floor P.O. Box 8469 Harrisburg, PA 17105-8469 Tel.: 717.783.5403 Fax.: 717.783.8965 E-mail: allard. david @al.dep. state.pa.us Summary Mr. Allard is a Certified Health Physicist and Director of the Pennsylvania Department of Environmental Protection's Bureau of Radiation Protection (BRP). The BRP has the three main Divisions of Radiation Control, Nuclear Safety and Radon. As Director, Mr. Allard is responsible for management of the Bureau's programmatic aspects of: licensing and registration of radioactive materials and x-ray equipment, inspections performed by regional Field Offices, environmental monitoring around nuclear facilities, inspections and oversight of nuclear power plants, radiological emergency response, monitoring the generation and disposal oflow-level radioactive wastes, regulation and certification of firms performing radon testing and mitigation for the public, evaluating radon-prone areas, and public education and outreach efforts. Mr. Allard has been involved in the diverse aspects of government, industrial, medical and academic radiation protection for over 20 years, is active in many professional associations, serves on technical committees, and often lectures on a n variety of radiation protection topics. In recognition of his broad experience in radiation safety and organizational management, he was elected to the Board of Directors of the Health Physics Society in 1996, and presently serves as Director of External Affairs. Education M.S., Radiological Sciences and Protection, University of Massachusetts - Lowell,1984 B.S. (cum laude), Environmental Sciences, State University ofNew York at Albany,1977 A.A.S., Environmental Health Technology, Hudson Valley College,1975 Certified, American Board of Health Physics - Comprehensive Practice,1988, recertified 1992,1996 i Employment Experience 1999-present: Director, PA Bureau of Radiation Protection, Harrisburg, PA. Responsible for state-wide occupational and environmental radiation protection programs, radon programs, and low-level radioactive waste management. 1996-1999: Fnneipal / Medical Health Physicist, Allard Radiological Consultants, Inc., N. Chelmsford, MA. Responsible for client support of various radiation protection programs, audits,' raining, radiation / l x ray surveys and shielding designs, and radioactive waste management projects av, tasks. ' 1991-1996: . Senior (Consultant) Health Physicist, Arthur D. Little, Inc., Cambridge, MA. Responsible for managir.g and supporting government and commercial client projects related to radiation protection programs and radioactive waste management at DOE, DoD and other facilities. m 1

BIOGRAPHY - david J. ALLARD, CHP m / 3 ('" ) 1985-1991: Vice President / Radiation Safety Officer, TGM Detectors, Inc., Waltham, MA. Responsible for corporate radiation safety, employee training, gas-filled radiation detector design, engineering, testing, and business management. 1981-1985: Supervisor of Health Physics, Nuclear Metals, Inc., Concord, MA . Responsible for plant occupational and environmental radiation protection programs related to uranium processing and fabrication, training, and low-level radioactive waste management. 1977-1981: Medical Health Physicist / Assistant RSO, Albany Medical Center, Albany, NY. Responsible for the hospital and college radiation safety program related to x ray and radioactive material use, patient radiation dosimetry, and Instructor of Radiation Physics, Radiation Biology and Radioisotope Methodology. Professional Experience For Allard Radiological Consultants (ARC), Inc., Mr. Allard served as Physicist and Technical Director. He was involved with a variety of raJiation protection projects for both government and commercial clients. As a consultant medical health physicist, he maintained thorough familiarity with the application of DOE, NRC, EPA, DOT, FDA, FEMA, OSHA, and state regulations, orders, standards (i.e., ICRP, ICRU, NCRP) and iadustry best management practices (e.g., ANSI and IEEE standards, NRC Reg Guides, etc.) related to facility occupational and environmental radiation protection (RP) practices and programs. He is very skilled in the application of all types of radiation measurements, airborne radionuclide and radon monitoring. Mr. Allard has extensive experience with RP programs at academic, biotech, research, medical, industrial, g aerospace, accelerator, x-ray, reactor, fuel reprocessing, plutonium, uranium, tritium, waste disposal (LLW, ( HLW and TRU) and nuclear test facilities. For the DOE's Office of Oversight, Mr. Allard was a key v J technical support contractor in the areas of occupational and environmental radiation protection. He assisted in the proposed revision of 10 CFR 835 on occupational _ radiation protection. Recently for DOE he has performed comprehensive safety management evaluations (SME) of the occupational and/or environmental , RP programs at Hanford (1996), Fernald Environmental Management Project (1996), Pardex Plant (1996), j Brookhaven National Laboratory (BNL) (1997), Sandia National Laboratory (1997), Lawrence Limmore National Laboratory (1997), the Mound Plant (1998), and the Y-12 Plant (1998). Other support work included radiological event investigations at the West Valley HLW vitrification facility (1997) and BNL's High Fh:x Beam Reactor (1997). He recently participated in a DOE complex-wide emergency management (EM) review, and evaluated programs at the Nevada Test Site (2/98), Los Alamos National Laboratory (3/98) and Oak Ridge National Laboratory (4/98). During the EM review Mr. Allard evaluated various radiological event response scenarios during table-top exercises, drills and full site exercises. He also recently participated in a DOE complex-wide radiation protection program review, and evaluated occupational RP programs at the Mound Plant (6/98) and Y-12 Plant (8/98). In addition to his extensive DOE work, Mr. Allard supported numerous biotech, industrial, medical and academic institutions in the Boston area. He also deveioped a highly successful 40-hour short course on Fundamentals of Radiation Protection that he has taught numerous times for attendees from various DOE, NRC and other radiological facilities. More re ently, Mr. Allard taught a 16-hour Radiation Protection Program Auditing course. For Arthur D. Little,Inc., Mr. Allard served as Senior (Consultant) Health Physicist and performed various radiation protection projects for government and commercial clients. His role on commercial or DOE technical assistance projects, regulatory compliance / program reviews, and management audits / assessments involved a critical evaluation of a given site's occupational and/or enviromnental radiological protection program. Again, Mr. Allard was a key technical support contractor for DOE's Offices of Oversight and Environmental Audit in the areas of occupational and environmental radiation protection. Duration of  ; assignments were from several weeks to over a year of preparation and on-site work. In the occupational RP l l 2 i

BIOGRAPHY - DAVID J. ALLARD, CIIP (D l

 ")   area he evaluated 10 CFR 20, DOE Order 5480.11, RadCon Manual and 10 CFR 835 requirements. He has specifically evaluated programs and technical basis in the areas of: ALARA, internal dosimetry, external dosimetry, radiation generating devices, source control, instrument calibration, posting and labeling, recordkeeping and reporting, and employee and radiological control technician training. In the environmental RP area he evaluated DOE Order 5400.5 and (draft) 10 CFR 834 requirements for: various facilities and operations that release (or have the potential to) radioactive materials through various waste streams; monitoring and surveillance programs; air, water, soil, biota and other pathways for offsite or onsite dose impact; the positioning of radiological monitoring and sampling locations, equipment, procedures and calibrations; analytical techniques for sample analysis and quality assurance; offsite dose modeling and
                                                                                                                       )

calculation methodologies; measurement of direct external dose to the public; and the required programs, records and reports for the above. Additionally, he has evaluated the radioactive waste management programs at numerous commercial and DOE facilities. He has participated on radiation safety oversight projects at the following DOE facilities: Morgantown Enegy Center (1991), Idaho Mtional Engineering Laboratory (1991 and 1993), Los Alamos National Laboratory (1991), Laramie Energy Center (1992), Oak Ridge National Laboratory Y-12 Plant (1992 and 1994), Continuous Electron Beam Accelerator Facility (1993), Fernald Environmental Managem mt Project (1993 and 1994), Superconducting Super Collider (1994), Argonne National Laboratory 'Ves. (1993), Pinellas Plant (1994), Nevada Test Site Offsite Areas (1994), Hanford (1994), and Rocky Fh ts Plant (1995). He also assisted the DOE Oak Ridge IG Office in 1992 and 1993 with an investigation of mixed waste sent from Y-12 to a commercial hazardous waste disposal facility. Additionally, Mr. Allard was an environmental RP DOE mentor at the Hanford Tank Farms from October 1993 to November 1994. He also participated in the 1994 special EH review of the Savannah River Site's F-Canyon restart. Specifically, he reviewed the radiological occupational and environmental (n (_)

   )

impact of various plutonium solution and target processing vs. storage options at the SRS F-Canyon. L-<y, for DOE he developed performance objectives and criteria, and assessment protocols for both the occupational and environmental RP disciplines. For TGM Detectors, Inc., Mr. Allard served as Vice President and Radiation Safety Officer (RSO). His , responsibilities included the radiation safety and control program for various sealed sources (i.e., j californium-252, cesium-137, radium-226, uranium-238, etc.), which included radiation dosimetry, shielding design, leak testing, etc. Mr. Allard was responsible for various aspects of the design, development, engineering, and testing of TGM's specialized gas-filled radiation detectors such as geiger-mueller (GM) tubes / probes, borontrifluoride, helium-3 and x-ray proportional counters, rem, fission, ion and reactor control  ; chambers. Additionally, he performed several market studies and detector technology assessments for I product development and/or acquisition (e.g., helium-3 detector use in special nuclear materials safepards applications). He was also an integral member of the firm's business management team and directed :he activities of technical, clerical, and administrative support staff. Two major projects that Mr. Allard completed were an extensive evaluation of various GM tubes for radiological response characteristics with respect to various photon and beta fields, and the design of a large area GM probe for contamination monitoring with increased sensitivity to low level radioactivity. p ?

   \

3

BIOGRAPIIY - DAVID J. ALLARD, CIIP p For Nuclear '.fetals, Inc., Mr. Allard was the Supervisor of Health Physics. His occupational and environmental radiation protection program responsibilities included: radiation dosimetry and bioassay data review / interpretation, abnormal internal or external exposure investigations, regulatory affairs, NRC source and byproduct material license applications, radiation safety program implementation, in-plant and environmental radiological assessments, effluent monitoring, emergency response, radiation shielding design, radiation safety protocol and procedure development (e.g., instrument calibration, radiological survey, etc.), and directing activities of technical and clerical support staff with this major source material licensee (i.e., millions of pounds of depleted uranium onsite). Mr. Allard was involved with three major health physics projects. The first was an evaluation of the radiation qualities of the various mixed beta / gamma fields throughout NMI's facilities for the proper calibration of personnel dosimetry and portable instruments. Second, he performed an investigation and the retrospective dose calculations for a large cohort of workers  ! found to be working in a previously unknown high beta / gamma radiation field for which they were not properly monitored. Last, he performed an extensive operational facility-wide evaluation of uranium aerosols, specifically examining the particle size and simulated lung fluid solubility for proper bioassay interpretation and internal radiation dosimetry. For Nuclear Metals, Inc., Mr. Allard was Health Physicist / Compliance Engineer. His responsibilities included: a repackaging and inspection program for 10,000 backlogged 55-gallon drums of pyrophoric scrap uranium metal which involved shipment of five trailer loads of radioactive waste per day, regulatory afTairs with +he NRC, DOT, various state agencies and three :ommercial burial sites (i.e., SC, NV and WA), and directing the activities of technical and clerical support staff. Budget for shipment of backlogged and an additional 10,000 packages of waste from concurrent manufacturing was six million dollars. A large project Mr. Allard became involved with after the above series of waste shipments was a major radiological facility (n) v and soil survey and decontamination. For Albany Medical Center, Mr. Allard was the Radiation Therapy Dosimetrist/ Assistant Radiation Safety Officer. His responsibilities included: computerized patient dose calculations, manual dose calculations, various radiological physics measurements of photon fields from 10 kev to 4 MeV, preparation of radioactive sources for patient implantation, shield block preparation for patient treatment, accelerator and x-ray eqmpment quality assurance, overall radiation protection for a major medical complex, and supervision of technical and clerical support staff. Three major projects that Mr. Allard was involved with were: the evaluation of external radiation exposure levels during cesium-137 brachytherapy, the determination of the radiation response of film badge and TLD personnel dosimeters to low energy x-rays, and the evaluation of scattered x-rays for room shielding design. For Albany Medical Center, Mr. Allard was the Assistant Radiation Safety Officer. His responsibilities included: state regulatory affairs for this large broad scope medical licensee with several hundred laboratories and clinics using radioactive materials, radiological effluent monitoring, radiation safety program implementation and development, radiation emergency planning and response, update of the radiation safety manual, bioassay procedure development for various radionuclides, radiation shielding designs, radiation protection during cesium-137, iodine-125 and -131 therapy, radiological survey data review, annual inspection and measurement of various x-ray producing machines (i.e., therapy, diagnostic and analytical x-ray equipment) for patient and personnel protection, review of laboratory protocols for radionuclide use, review of protocols and dosimetry for experimental radiopharmaceuticals, instructor of radioisotope methodology / radiation physics / radiation biology, and supervision of technical and clerical support staff. O For Albany Medical Center, Mr. Allard was the Health Physics Technician for his first year of service. His

    ) responsibilities included: direct implementation of the radiation safety program for a 1000 bed major medical complex with Nuclear Medicine, Radiation Therapy and Diagnostic Radiology Departments, as well as a 4

BIOGRAPIIY - DAVID J. ALLARD, CIIP (p) medical college with several hundred laboratories using radionuclides in biomedical research, radiation and contamination surveys, decontamination of facilities and personnel, air sampling, instrument calibrations (i.e., liquid / solid scintillation detectors, GM tubes, ion chambers, proportional counters, etc.), radioactive waste processing (e.g., solid, liquid, and biological), rr"eillance of all incoming and outgoing packages containing radionuclides, implementation of externa. losimetry program, vendor supplied personnel dosimetry quality assurance, and all respective record keeping. j Professional Activities i Mr. Allard holds certifbdons froin the American Board of Health Physics (Comprehensive Practice) and the i National Registry of Mdiation Protection Technologists. He is an active member of the Health Physics Society (HPS), Americ:.n Association of Physicists in Medicine (AAPM), and several other professional societies. Mr. Allard was elected to the Board of Directors of the HPS in 1996 and appointed Dhector of External Affairs, a member of the IEEE/NPSS Nuclear Instruments and Detectors Committee, co-chair of the  ! ANSI /IEEE committee revising Standard 309 on test procedures for geiger-mueller counters, member of the l N43.2 ANSI committee revising the standard on radiation safety for x-ray diffraction and fluorescence l analysis equipment, had served on the State of Massachusetts Nuclear Incident Advisory Team (NIAT) for over 15 years, is past-president and past-secretary of the New England Chapter of the HPS, participant en the 1993 American Board of Health Physics Part I Exam Passing Point Panel, past member of the AAPM Task Group No. 9 reviewing NCRP Report No. 49 on x-ray facility shielding design, past-chtir of the HPS Affiliates Committee, past member of the HPS History Committee (and production lead and co-author of the XRay/ Radioactivity Centennial Calendar), was instrumental in developing the 1995 exhibit Xis For X-Ray p) (

'V at Boston Museum of Science, and co-chair of local arrangements for the 1995 Joint HPS/AAPM Annual Meeting in Boston. Mr. Allard was a guest on NPR's show Talk of the Nation - Science Friday in 1996 discussing the past, present and future uses of X rays.

Publications and Presentations Mr. Allard has authored professional papers on various subjects, numerous unpublished technical reports, i procedures and documents, and often lectures to peer, nonscientific and student groups on a wide range of topics and concerns. Some of his publications include the following: DOE reports co-authored from 1995 to 1998 and viewable on the WWW - http:// tis.eh. doe. gov /ov ersight/ reviews /em-voll .pdf http:// tis.eh. doe. gov / oversight / reviews /em-vol2.pdf http:// tis.ch. doe. gov / oversight / mound /miamisburg.pdf http:// tis.eh. doe. gov / oversight /llnl/llnl.html http:// tis.ch. doe. gov / oversight /sandia/ exec.pdf http:// tis.ch. doe. gov / oversight /bnl/bnl_ rep.pdf http:// tis.ch. doe. gov / oversight / reviews /bnl_297/bnl_ rep.pdf http:// tis.ch. doe. gov / oversight / evaluation /westvalley/westvalley.pdf http:// tis.ch. doe. gov / oversight /pantex/pantex_ rep.pdf http:// tis.eh. doc. gov / oversight /fernald/fer_ report 2.pdf ) j http:// tis.ch. doe. gov / oversight /hanford>han_ rep 2.pdf l http:// tis.eh. doe. gov / oversight /rockyflats/rky_ rep 2.pdf l p) ("

    "Re-evaluation of Scattered to incident Exposure Ratio implications for Diagnortic X-Ray Shieldmg Design," D.J. Allard and J.A. Dapolito, Report to AAPM hsk Group No. 9, N:>vember 1990. Presented at j

the 1995 Joint AAPM/HPS Annual Meeting. 5 l J

BIOGRAPliY - DAVID J. ALLARD, CIIP A

 /  \

U

      " Commercial Airline Crews - A New Category of Occupational Radiation Workers," DJ. Allard et al.,

Presented at the 1995 Joint AAPM/HPS Annual Meeting.

      " William David Coolidge - Inventor of the Modern X-Ray Tube," Presented at the 1995 Joint AAPM/HPS, NE Chapter of the HPS, and Radiological Society ofNorth America meetings, and the Franklin Institute.
      "The Construction and Evaluation of a Simple Probe for Direct Measurement of Tritium Surface Contamination," D.J. Allard and S.M. Burrill, Presented at the 1994 Health Physics Society Annual Meeting.
      " Effective Radiation Protection Program Auditing," D. J. Allard, et al., Presented at the 1993 Canadian Radiation Protection Association, Health Physics Society and American Association of Physicists in Medicine Annual Meetings.
      "A Radiation Safety Protocol for Analytical X-Ray Equipn':nt." D. J. Allard, Presented at the 1993 American Industrial Hygiene Conference.
      " Emerging Radiation Protection Issues and Regulatory Policy," D. J. Allard, Presented at the 1993 American Association for the Advancement of Science (AAAS) Annual Meeting.
      " External Dosimetry Considerationr Involving Operations With Uranium," D. J. Allard and S. M. Burrill, Health Physics, Vol. 62, No. 6,1992.

p ( "The Nitrogen-16 Gamma Radiation Response of Geiger-Mueller Tubes," D.J. Allard, et al., Proceedings of the 1992 Health Physics Society Midyear Symposium on Operational Radiation Measurements, and the May 1992 Proceedings of the 8th Congress of the International Radiation Protection Association.

      "An Improved Large Area Geiger-Mueller Probe," D.J. Allard and C.E. Doyle, Proceedings of the 1992 Health Physics Society Midyear Symposium on Operational Radiation Measurements.
      "An Evaluation of a Novel Glass Geiger-Mueller Tube Used for Counting Radioactivity in Liquids," D.J.

Allard, et al., Proceedings of the 1992 Health Physics Society Midyear Symposium on Operational Radiation Measurements.

      " Radioactivity in Zirconium Oxide Powders Used in Industrial Applications," J.L. Lischinsky, M.A. Vigliani and D.J. Allard, Health Physics, Vol. 60, No. 6,1991.
      "The Radiological Response Characteristics of Geiger-Mueller Tubes Commonly Used in Radiation Monitoring Instruments," D.J. Allard, Proceedings of the 1987 Health Physics Society Midyear Symposium on Reactor Health Physics, also in Nuclear Plant Joumal. Vol. 6, No. 2, March 1988.
      " Radiological Hazards Associated with Depleted Uranium Munitions," D.J. Allard, R.P. Harding, and J.L.

Lischinsky, U.S. Anny (APG) Training Manual, June 1985.

      " Shielding Chaveristics of Depleted Uranium Metal and Related Radiological Properties," DJ. Allard,               1 Medical Physic . Vol.12, No. 4,1985.

C\ ( / " Characteristics of Aerosols Generated at a Depleted Uranium Metal Fabrication Facility," D.J. Allard, et al., ILealth Physiq, Vol. 47, No.1,1984. 6 L --

BIOGRAPHY - DAVID J. ALLARD, CHP O " Beta Dosimetry Experiences at a Depleted Uranium Facility," D.J. Allard, et al., Proceedings of First International Symposium on Beta Dosimetry, NUREG/CP-0050, Published February 1983.

 " Quality Assurance for Commercially Supplied Personnel Dosimeters," D.J. Allard and L.C. Memoli, Proceedbgs of the 1980 Health Physics Society Midyear Symposium on Medical Health Physics.
 " Radiation Exposure Levels Associated with Cesium-137 Brachytnerapy," L.C. Memoli and D.J. Allard, Proceedings of the 1980 Health Physics Society Midyear Symposium on Medical Health Physics.

Allard-Bio doc (2/23/99) 7

John P. Winston 31397 Hwy,27 Guys Mills, PA 16237 l i (814)332-6135 (W) (814) 789-4684 (H) Objective: Career in Radiation Health Physics i I Professional Experience 1986 to Present Pennsylvania Bureau of Radiation Protection Pittsburgh, PA Radiation Health Physicist. Inspection of radiation sources covered under 25 PA Code; emergency response;SDMP projects; radon Education 1979 to 1983 Pennsylvania State University Universisy Park, PA BS / Environmental Science Organizations 1986. Conference of Radiation Control Program Directors, Inc. Currently a member of the Committee on Quality Assurance in Diagnostic X ray (H- 7) i I 1 09/10/98 Resume

James G. Yusko 123 Clubvue Drive West Mifflin, PA 15122 (412)442-4000 (W) (412) 941-1146 (H) Objective: To live well, be well-paid, and to retire rich Professional Experience 1980 to Present Pennsylvania Department of Environmental Protection Pittsburgh, Pennsylvania,15222-4745 Radiation Protection Program Manager. Manage Western Pennsylvania portion of Commonwealth's radiation program. Supervise eleven subordinate staff health physicists. Primary program functions are: inspecting facilities and users of radioactive materials and radiation-producing equipment, including MQSA mammography, advising users of optimal safety and quality assurance practices and procedures, with 1800 facilities in 22 counties; environmental monitoring and surveillance; indoor radon control, assessment, and mitigation; radiation emergency response. Develop radiation protection policies and regulations regarding assessment, control, and mitigation of radiation hazards. Supervise and review participation of(NRC) licensees undergoing decontamination and decommissioning efforts through the Site Decommissioning Management Plan of the Nuclear Regulatory Commission. Review and critique facility plans and activities, interface with citizens and government agencies. Direct state field monitoring tews during nuclear power plant radiological emergency exercises and drills, .( serve as bureau liaison at emergency operations facility. ) State site liaison officer to DEP and U.S. Department of Energy Canonsburg Uranium Mill Tailings . Remedial Action Project. Reviewed and cm.gued site design criteria, environmental assessments, impact I statements and technical documents; interface with citizens and government agencies. 1975 - 1980 Allegheny GeMral Hospital Pittsburgh, Pennsylvania,15212 Health Physicist . Radiation Protection Officer, i i Developed, managed, and effected an institution-wide program involved with suspects of radiation safety and regulatory compliance. Developed and instituted radiation safety policies and practices. Performed radiological surveys of all facilities and diagnostic and therapeutic equipment, including quality assurance determinations of filtration, linearity and output measurements, field coincidence, shield efficacy, patient exposure indexing. Performed licensir.g, registration and records-keeping activities. Performed radiological acceptance surveys on linear accelerators and teletherapy units.  ! Delivered radiation safety training lectures to personnel. Managed material inventory and radioactive wastes. Surveyed radioisotope laboratories, patients receiving radioactive materials, and personnel attending these patients. Radiological safety consultant to other medical facilities. 2 09/10/98 Resume l

                                                                                                                                 )

    '974 1975     University of Pittsburgh Pittsburgh, Pennsylvania,15261 Assistant Health Physicist.

Developed a training program for NRC Regulatory Guide 8.13. Performed bioassay and intemal dose assessments. Evaluated unusual extemal radiation exposures. Surveyed facilities and equipment, incoming and outgoing packages. Operated personnel dosimetry program. Inventoried scaled sources and analyzed leak tests. Calibrated ponable survey meters. Managed disposal of radioactive waste materials. Education 1971 to 1974 University ofPittsburgh Pittsburgh, Pennsylvania MS (Hyg.); Radiation Health, Graduate School of Public Health 1967 to 1971 Camegie Mellon University Pittsburgh, Pennsylvania B. S.. Physics, Mellon College ofScience Certification Comprehensive ceniGcation in Health Physics, American Academy of Health Physics originally cenified,1980; ceni0 cation extended through 2000 ) 3 09/10/98 Resume

1 s Organizations 1974- Health Physics Society (McLean, Virginia) plenary memh-r State ud Federal Lel;islation Committee,1996 - Strategic Plane; Committee, 1992-1995 Program Coa nice,1986 - 1989; chair,1987-1988 Annual Meeting Place Committee,1982 1985; chair,1983-1985 1991 - Govemment Section Health Physics Society member; President,1996 - President-elect, 1994-1996 Secretary - Treasurer, 1992 1994 1989- Conference of Radiation Control Program Directors, Inc. Frankfort, Kentucky Associate member j ->91 1995 Radioactivity in Resource Recovery (E-23) Committee,1991- chair, Western Pennsylvania Chapter, Health Physics Society Pittsburgh, Pennsylvania member; held all elective offices: Councilperson, Secretary-Treasurer, President-Elect, President; chaired or co-chaired topical symposia committees; Nominations committees, etc. 1988 - Susquehanna Valley Chapter, Health Physics Society Harrisburg, Pennsylvania member 1984 - Delaware Valley Society for Radiation Safety Philadelphia, Pennsylvania member l l Penn-Ohio Chapter, American Association ofPhysicists in Medicine Pittsburgh, Pennsylvan:a membe: i b 4 09/10/98 Resume

r l l Steven A. Bostjancic Q 2907 Homehurst Ave. Pittsburgh , PA 15234

                                                                                                                                    )
                                                                                                                                    )

(412)442 5824 (W)(412)881-0639(H)  ! 1 Objective - To acquire training necessary to support Pennsylvania's intention of becoming an agreement state with the U.S. Nrclear Regulatory Commission. Professional Experience I 1996 to Present Pennsylvania Dept. of Environmental Protection, Radiation Protection Program Pittsburgh, PA Radiation Health Physicist 1 - perform professional work in monitoring and controlling radiological health hazards to assure compliance with Federal and State rules and regulations regarding radiological protection. Plan and conduct inspections and surveys ofionizing radiation sources ; investigate hazardous conditions involving radiation producing equipment / materials. Successfully completed the NRC Applied Health Physics course, j 1994 - 1996 Pennsylvania Dept. of Environmental Resourecs, Water Management Program Pittsburgh, PA Water Quality Specialist - inspected facilities with NPDES discharge permits and reviewed their Discharge l Monitoring Reports to assure compliance with Federal and State rules and regulations. Investigated water pollution incidents and complaints. 1993 - 1994 Children's Hospital ofPittsburgh Pittsburgh, PA Neurophysiology Technician - performed somatosensory, auditory and visual evoked potentials in a j p diagnostic lab to provide pre-surgical baselines. Used baselines during surgical monitoring to inform ( surgeon of changes in patient's responses. N I 1990 -1993 Allegheny County Health Dept. I Pittsburgh, PA Environmental Hcalth Specialist I performed inspections of housing, schools, eating and drinking establishments, pools and septic systems to assure compliance with Health Dept. 's ru' :s and regulations. Took and passed National Environmental Health Association exam for registered Environmental Health Specialist, which included aspects of radiological health. j Education 1981 to 1988 University of Pittsburgh Pittsburgh, PA B.S. in Physics Organizations Conference of Radiation Control Program Directors, Health Physics Society - Western 1997- Pennsylvania Chapter a 5 D9MC/98 Resume

, Gertrude M. Swab l 461 Fountain Street Q Pittsburgh, PA !$238 (412)442-4227(W) 1 Objective - NRC Agreement State -Training & Resume. Professional Experience 1975 - Present Pennsylvania Dept. of Environmental Protection, Radiation Protection Program Pittsburgh, PA Radiation Protection Specialist including 22 years experience in environmental sampling, x-ray inspections of private practices and smaller hospitals, contract work (Level 2) for FDA, emergency response training for possible nuclear power plant accidents. 1973 - 1975 University of Pittsburgh - Microbiology Department Pi tsburgh, PA Research Assistant - worked vith Polio Virus, using Tritium and Carbon 14 in research. 1971_- 1973 University of Pittsburgh - Microbiology Department - Population Division Pittsburgh, PA Research Technician - worked with microscopic organisms using rabbits and culture media in research. 1968 University of Pittsburgh Pittsburgh, PA Research Technician - performed lung studies on rats. Education

 \ Al               University of Pittsburgh Pittsburgh, PA B.S. in Biology, Minor Chemistry l

I I I i O 6 09/10/98 Resume l l l

l Roben P. Scott I h 140 Heller Road Butler, PA 16001 j (412)352-1576 Objective - To demonstrate my qualifications to do agreement state work. Professional Experience 1995 to Present Pennsylvania Dept. of Environmental Protection, Radiation Protection Program Pittsburgh, PA Radiation Health Physicist - Coordinates the Mammography Quality Standards Act inspectior s of facilities l performing mammography in Westem Pennsylvania pursuant to the Commonwealth's contract with the 1 Food and Drug Administration. Personally performs inspections of 40 to 50 such facilities annually. Also inspects other users ofionizing radiation for compliance with Pennsylvania Regulations for Radiological Health. Participates in emergency response incidents involving radioactive products released to the ): environment from nuclear power plants or from transportation accidents. 1994 - 1995 Pennsylvania Dept. of Environmental Protection, Radiation Protection Program Pittsburgh, PA Environmental Protection Specialist - Inspected primarily medical facilities for compliance with Pennsylvania's Regulations for Radiological Health. Was trained to inspect mammography facilities under the Mammography Quality Standards Act. Became a certified Mammography Inspector March 31,1995. Successfdly completed FEMA courses Radiological Accident' Assessment - Plume Phase and Post Plume Phase. Involve nent in ' emergency response drills and activities as above. 4 - 1995 Pennsylvania Dept. of Environmental Protection, Radiation Protection Program 4 Pittsburgh, PA I Environmental Trainee - Following extensive on-the-job training began inspecting less  ; complex facilities for compliance with the Pennsylvania's Regulations for Radiological Health. These included dentists, podiatrists, chiropractors, veterinarians, and p ivate medical practices. Became familiar with emergency response plan for Beaver Va!!ey Nuclear Power Plant. Participated in quarterly drills for response at that plant. 1989 - 1993 Business Consultant

  ,               Pittsburgh, PA I assisted a multi-entity business computerize its accounting records. I provided advice on purchases, installed a modular integrated accounting package, and wrote custom database programs which facilitate data entry to the main system. I guided the accountant in initializing the system, converting the accounts, parallel testing, and setting up user security for the system. I trained system users, and then provide continuing software support.

1990- 1992 American GeneralInsurance Company I was a home service agent. American General writes life, accident, health and property I insurance. This position involved managing and servicing a portfolio of existing policies as j well as developing new clients. It sharpened my marketing and human relations skills. ' 1974 - 1989 Butler Farm Credit, ACA Butler, PA Butler Farm Credit is part of tM nationwide Farm Credit System which contributes the most significant source ofcredit to America's farmer *, ranchers, fisherman and rural residents. It provides credit and financially related services in a seven county area of Western j Pennsfi vania. Assets of$50 million. 1 7 09/10/98 Resume

l Education 969_ Pennsylvania State University University Park, PA B.S. in Animal Production 1990. . Butler County Community College Butler, PA Principles of Accounting Organizations 1997 Conference of Radiation Control Program Directors, Health Physics Society - Western Pennsylvania Chapter 1980- Director of PA Shorthorn Breeders Assn. 1980-1986 PA Milking Shorthorn Society Military 1973 Honorably discharged from the US Army as Specialist 5th Class Certifications MQSA MammographyInspector #2113 8 09/10/98 Resune

Christopher L. Rittiger

,CN                 500 Waterfront Dr.

( ) Pittsburgh, PA 15222 (412) 442-4223 (W) Professional Esperience 1985to Present Commonwealth of PA, DEP, BPJ Pittsburgh, PA Radiation Health Physicist II - Main job functions include: inspection of state licensed or registered radiation sources and radioactive materials, investigation ofinquiries or complaints from public concerning ionizing radiation and radiation safety 1983 - 1985 P. V. Anderson, Inc. Pittsburgh, PA Fixed Income Institutional Salesman - Sold municipal bonds to banks and other financial institutions Duquesne Light Co., BVPS Pittsburgh, PA Reactor Operator - Job entailed the operation of the power reactor at the control rooni ed sa assisting in other evaluations throughout the plant Education 1972 1976 Pennsylvania State University University Park, PA !f ]f Nm,e B.Sc. Biology Organizations 1997 Health Physics Society (National) and Westem PA Chapter (Local) McLean, VA 22101 and Pittsburgh, PA 15213 CRCPD Frankfort, KY 40601

 /\

l i s  ! xd 9 09/10/98 Resume

Michael J. Huskuliak (n)

 'v/

R.D. #1 Box 149A Avonmore, PA 15618 Professional Experience i 1994 to Present Department of Environmental Protection / BRP Pittsburgh, PA Radiation Health Physicist II - Duties: Perform inspections of state licensed or registered radiation sources and radioactive materials. Investigate inquiries or complaints from the public concerning radiological safety. Consult with the public on indoor radon levels, evaluating levels and interpreting results. Inform radiation source users on proper radiation safety procedures and radiological practices (e.g. shielding calculations and design, personnel certification requirements, dosimetry, image recording, quality assurance, and equipment quality control) for both diagnostic and therapeutic radiation sources. Conduct special surveys in conjunction or cooperation with the Federal government for national exposure research studies or projects (e.g. National Evaluation of x-ray Trends N.E.X.T Perform facility inspections required by the Food and Drug Administration in conjunction'with the Mammography Quality Standard j Act(MQSA). Respond to radiological accidents and perform all necessary air and ground surveys. l Represent state governments for special projects acting as liaison contact for the project (e.g., decontamination and decommissioning activities. 1991 - 1992 Applied Radiological Control Kennesaw, Georgia 1 i Health anr2 Safety Supervisor - Duties: Supervisor of the Health and Safety Department for Babcock and Wilcox during the decommissioning of their former fuel processing facility in Apollo, PA. Developed [^N techniques t nd procedures for radiological monitoring and surveillance. Investigated routine data and ( ) unusual oCCJrrences to assure ufe and hydenic working Conditions in accordance with OSHA and NRC

  d regulations Define, develop, audit and admad;*ered the industrial safety, radiological safety and environmr.ntal protection programs. Provided technical competence and expertise in the field ofindustrial hygiene, nealth physics and pollution prevention. Conducted formal emergency investigations and coordinated outside assistance, approved technical input for the preparation of health and safety manuals, and reviewed the safety and protection ramification of pmcess change, equipment installation, and operating procedure development.

j l I (A) m 10 09/10/98 Resume

577 1992 j P.AD Services / Bartlett Nuclear Pittsburgh, PA & Plymouth, Mass. A. N. S. I. 3.1 Senior Health Physicist Technician- Duties: Working for various contractors as a health physics technician in nuclear power stations throughout the country, I implemented radiation and industrial safety programs, supervised hazardous work, wrote safety procedures, developed respiratory protection programs, performed radiological surveys and chemical analysis ofliquid and gaseous discharges released to the environment, analyzed laboratory and environmental data. Decontaminated personnel and buildings. Instructed and evaluated personnel in radiation and industrial safety ou a college level Co-author of radiation safety manuals, developed competency-based training programs, operated computers, shipped and received radioactive materials in accordance with NRC and DOT regulations. Calibrated radiation detection instmments, and administered tasks necessary to support radiation control and logistic management activities associated with exposure tracking. Communicatedrequiredinformationandactedasaliaisonbetweenforeignand domestic departments and < calculated radiological engineering equations. Education 1971 to 1983 Edinborn State University Edinboro, PA Bachelor of Science, Geology Organizations 1997 Conference of Radiation Control Program Directors, Health Physics Society Western

   }           Pennsylvania Chapter Certifications 1996          MQSA MammographyInspector #2196 i

j

                                                                                                                            )

O 11 09/10/98 Resume

Paul J. Shuleski

/'                          153 Hanny Beaver Road
'g                         Hookstown, PA 15050 (412)442-5822 (W) (412) 899-2838 (H)

Objective: Career Advancement in the health physics and /or related fields. Professional Experience 1994 - Present Commonwealth of Pennsylvania Department of Environmental Protection, Bureau of Radiation Protection Pittsburgh, PA Rsdiation Health Physicist II. Inspects facilities with licensed or registered radiation sources and radioactive materials. Reviews facilities quality assurance programs and provides recommendations. Consalts with users on proper radiation safety practices and regulations. Responds to and investigates actual or potential radiation accidents or incidents. Responds to actual or simulated accidents at fixed nuclear power plants. Performs routine and special environmental or radiological monitoring. Trained and certified by the FDA as an inspector under the Mammography Quality Standards Act (MQSA). 1993 -1994 Ohio Valley Hospital Steubenville, Ohio Nuclear Medicine Technologist. Performed a variety of nuclear diagnostic imaging and therapy procedures. Conducted facility surveys equipment QA/QC and radioactive materials receipt and waste handling. Commonwealth of Pennsylvania Department of Environmental Resources, Bureau of Mining C)90-i s v 1992 McMurray, PA Hydrogeologist. Responsible for reviewing underground coal mining permit applications for geology, hydrogeology)I and groundwater monitoring programs. Coordinated reviews with other regulatory agencies and the public. Conducted groundwater loss investigations. 1989- 1990 0. H. Materials Corporation, Inc. Pittsburgh, PA Project Hydrogeologist. Prepared environmental project proposals , site investigations and reports. Data acquisit;on including soil borings, test pits, and related sampling 1981 - 1989 Natural Resource Management Corporation Pittsburgh, PA Regional Geology / Geophysics Manager. Responsible for the generation ofoil and gas drilling prospects, preparation of technical reports, economics and budgeting requirements to management. Supervise geotechnical staff Coordinated drilling projects with outside contractors. Performed well log and economic analyses. Field duties included sample studies, coring, supervision of well logging programs and seismic acquisition. 1979 - 1981 Consolidated Gas Supply Corporation Clarksburg, WV Geologist / Geophysicist. Responsible for prospect generation using geologic and seismic data. Conducted t' \ v) well site geologic studies, well logging and seismic acquisition. 12 09/10/98 Resume

1977-1979 TexacoInc. CentralProducing Midland,IX \ Exploration Geophysicist. Conducted seismic interpretation and prospect generation Planned and mana schmic acquisition and data processing. Education 1992 - 1993 Community College of A!!egheny County Pittsburgh, PA One year certificate program Nuclear Medicine Technology 1975 - 1976 New Mexico Institute of Mining and Technology Socorro, NM M.S> Geophysics 1970 - 1974 University of Scranton Scranton, PA B.S/ Physics Organizations 1993 Society of Nuclear Medicine, Technologist Section, Pittsburgh Ch:.pter Pittsburgh, PA 1997-Conference of Radiation Control Program Directors, Health Physics Society - Western Pennsylvania Chapter Certifications \ /

 ' r46           MQSA Mammography Inspector #2188 1993          Nuclear Medicine Technology Certification Board (CNMT) #016262 1993          American Registry of Radiological Technologists (ARRT)(N) #275298 i

l i l l l O Y l l 13 09/10/98 Resume

i Dwight A. Shearer 601 Jackson Road Ligonier, PA 15658 (412)442-5823 (W)(412)238 7191 (H) Professional Experience 1990 to Present Pennsylvania Department of Environmental Protection Pittsburgh, Pennsylvania Radiation Health Physicist H - Duties: Perform inspections ofstate licensed or registered radhtion sources and radioactive materials. Investigate inquiries or complaints from the public concerning radiological safety. Inform radiation source users on proper radiation safety procedures and radiological practices (e.g. shielding calculations and design, l personnel cenification requirements, dosimetry, image recording, quality assurance, and equipment quality control) for both diagnostic and therapeutic radiation sources. Inspect facilities that conduct radon related services within the Commonwealth. Conduct special surveys in conjunction or cooperation with the Federal govemment for national exposure research studies or projects (e.g. National Evaluation of X-ray Trends (N.E.X.T). Respond to radiological accidents and perform all necessary air and ground surveys. Represent state govemments for special projects acting ad liaison contact for the project (e.g., decontamination and decommissioning activities. 1993 to 1994 ALCOA ALCOA Center, Pennsylvania i

   '                  StaffAnalyst. Interacted with federal and state environmental agencies in proviewg analytical data from waste streams that would be leaving ALCOA sites. Also participated in the compani-s clean up of PCB's along with generating risk assessments.

j 1990 to 1992 Florida Institute of Phosphate Research Bartow, Florida Chemist. Designed and CO-researched a chemical process that cost effectively reduces impurities within  ! the phosphate ore separation process. Conduced research of radon mitigation through gypsum, and the possibilities of using various vegetative covering to reduce radon emissions. l l l 14 09/1098 Resume

i i Education 185 to 1990 Penn State University University Park, PA BS Chemistry. Sec. Ed. 1992 to 1994 University of Florida Gainesville, FL BS Environmental Engineering Organizations 1995 - Conference of Radiation Contro1 Program Directors,Inc. Frankfort, Kentucky Associate member Radioactive Waste Management (E-5) Committee Radon (E-25) Committee t

                                                                                     )
                                                                                     \

15 09/10/98 Resume I

  ,                      Ivna 0. Shanbaky

/ ,T 413 Park Road l Downingtown, PA (610)832-6032 (W) (610) 458-5037 (H) Professional Experience 1986 to Present Environmental Protection-Bureau of Radiation Protection Conshohocken, PA Regional Program Manager Delegates general work assignments, reviews inspections reports and associated correspondence prior to approval. Attends monthly managers meetings, quanerly statewide bureau meetings and monthly in house staff meetings. Interprets Radiological Health Regulations for staff and clients. Informs personnel of all updates of regulations or information peninent to theirjob duties. Tracks performance standards for each staff member. Prepare and discuss Performance Evaluations Environmental Protection -Bureau ofRadiation Protection 1982 to 1986 Conshohocken, PA t Radiation Health PhysicistIII Perform inspections to verify compliance with the Commonwealth of Pennsylvania radiological rules and regulations for the Eastern area of the State. Inspections for safe use of x-ray equipment by medical, industrial and academic users. Respond to radiological incidents involving personnel exposure to radiation or radioactive materials. Prepare reports ofinspections and investigations, documenting findings and (j ' conclusions in regards to condition which adversely affect or may adversely affect health and safety. ' Participate in Emergency Response drills to Nuclear Power Plants. l l 1972 to 1975 Department of Phannacology - Purdue University Lafayette,IN l i l Graduate Assistant Conducting research work on adrenal medulla using radioactive ions and other drugs. 1971 to 1971 Department of Entomology - Agricultural Research Institute Brazil Senior Toxicologist 1968 to 1971 Depanment of Entomology - Purdue University Lafayette, ]IN Graduate Student Rercarch on cenain aspects of toxicology of pesticides.

        \

f 16 09/10/98 Resume l l

l-Eduestion 1961 to 1964 Escola Agronomica Da Bahia Brazil BS - Life Science (Agricultural Engineer) 1968 to 1971 Purdue University Lafayette, IN - MS - Toxicology 1973 to 1975 Purdue University Lafayette,IN Ph.D. - Environmental Radiation Organizations tota Sigma Pi Purdue Alumni Association American Association of Physicists in Medicine (AAPM) Conference of Radiation Control Program Directors (CRCPD) I i 17 09/10/98 Resume

Kun Rutzmoser 23 71 Murray Avenue Huntingdon Valley, Pa.19006 (610) 832-6287 (W)(215) 947 8103 (H) Professional Emperience 1994 - Present The Pennsylvania Depanment of Environment Protection Bureau of Radiation Protection Conshohocken, PA Radiation Health physicist. Inspect licensed radiological facilities and radiological safety programs for compliance with Commonwealth rules and reFulations. prepare reports ofinspections and investigations, documenting ' findings and conclusions in regards to condition which adversely affect or may adversely affect health and safety. Participation in Emergency Response Drills to Nuclear Power Plants. 1992-1994 The Pennsylvania Depanment of Environment Protection Bureau of Radiation Protection Solid Waste Specialist. Conshohocken, PA Reviewed compliance histories, environmental assessments, and financial assurances for the regional municipal, residual, and hazardous waste permit application process. Participated in field visits meetings with applicants, engineers, consultants, chemists, and hydro-geologists as necessary for the permitting process. Maintained records ofinsurance and bond documents ofregional facilities for the purpose of coordinating with field inspectors to ensure compliance with depanmental regulations Drafted reports and documents, coordinated information with Harrisburg, and provided testimony as a Departmental witness in legal proceedings. 1986-1992 Marketing Representative - Represented several major imponers / manufactures serving the banking industry Established and maintained over 250 accounts. 1973 1986 Manager of Family Corporate Business -Responsibilities included business administration, production, sales, scheduling, purchasing, hiring, payroll, records keeping, and product development. 1972-1973 High School Science Instmetor Conducted classes in biology, chemistry, physics, homeroom, and religious Education. Additional teaching was done on a substitute basis (1981-1983). Education 1969 Robens Wesleyan College Nonh Chili, NY Bachelor of Science, General Science, minor Biology Military 1969-1972 United States Air Force-Served as a Commissioned Officer, Responsible for all vehicle assets on base and operation of vehicle maintenance facilities, command of 60 enlisted men. Served 3 years additional reserve duty, discharged at the rank of Captair. ( 18 09/10SB Resume

Joseph A Pryber

  /

Lee Park, Suite 6010 555 North Lane Conshohocken, PA 19428 Professional experience 1990-Present Commonwealth of Pennsylvania, Department of Environmental Protection, Conshohocken, PA Radiation Health Physicist , Conduct Mammography Quality Standards Act inspections of mammography facilities under state contract with FDA. Conduct state inspections to verify compliance with PA radiological rules and regulations for safe use ofisotopes and x-ray equiprnent by medical and industrial userr, Prepare repons to document findings and conclusions regarding conditions which have or may have an adverse effect on health and safety. Panicipate in nuclear power plant emergency response drills. Participate in investigations of possible radiological hazards to public as needed. 1979-1988 Gulf Nuclear,lnc.. Webster TX

                       '.aboratory Technician. Worked for a manufacturer of radioactive sealed sources used in industrial
                         . !iography and radioactive tracers used in well logging. Duties included production of radioactive      {

1 tracers,

                      , abration of survey meters, analysis ofleak tests, performance of weekly wipe tests, r. oil testing, air sampling , and assisting RSO . Last five years of employment supervised the NVLAP accredited thermoluminescent dosimetry department. Duties included calibration of analyzer and other QC testing in order to maintain accreditation.                                                                            j O

is Edu stion

 -'v) 1974-1978      Mercy aurst College, Erie, PA BA Biology / Chemistry Minor Certifications 1995           MQSA Certified Mammography inspector l

rh I \

  \       /

19 '09/10/98 Resume

Michael J. Pars 2902 Penn Square Road Norristown, PA 19401-1314 Home:(610)-275-4445 Work:(610)-832-6286 Objective: To obtain a Master of Science degree in Electrical Engineering. Education Villanova University, Villanova, Pennsylvania Subjects: C Programming Language, Circuit Analysis I, Digital Systems, Microcomputer Systems Wilkes University, Wilkes-Barre, Pennsylvania Subjects: Circuit Analysis II, Electronics II, Electromagnetics 1991 Rochester Institute ofTechnology, Rochester, New York Bachelor of Science, Major: Packaging Science Subjects: Calculus IV, Statistics II, FORTRAN, Modem Physics, Semiconductor Physics, Chemistry !!, Technical Communication Clarion University, Clarion, Pennsylvania Subjects: Physics !!, Chemistry 1. Calculus 11, Differential Equations Lycoming College, Williamsport, Pennsylvania

Subject:

Liberal Arts V Experience 1993 - Present Commonwealth of Pennsylvania, Department of Environmental Protection Southeast Field Office, Conshohocken, Pennsylvania Radiation Health Physicist 1. Perform State Inspections ofX-ray Machines and Nuclear Medicine facilities in private pt:ctices, hospitals and industrial settings. Compose letters infonning facilities of compliance status. Perform follow-up inspections venfy compliance. 1992 - 1993 Commonwealth of Pennsylvania, Department of Labor and Industry Lycoming County Job Center, Williamsport, Pennsylvania Clerk typist II. Performed intermediate clerical duties including: typing, word. processing, filing, data entry, copying and phone coverage. 1989 - 1990 Rochester Institute of Technology Department ofinformation Systems and Computing, Rochester, New York Computer Lab Assistant. Assisted computer users with system and programming problems in VAX mainframe and IBM computer systems. Used: Word Perfect, EVE, RunofT, FORTRAN,20/20 and Lotus 1-2-3. Was responsible for controlli printers, distributing user manuals and securing the lab at closing time. I 1 l 1986- 1987 RochesterInstitute of Technology Department of Educational Research and Development, Rochester, New York Clerical Assistant. Performed basic clerical duties including: typing filing, copying, mail sorting, word processing and da entry. 20 09/10/98 Resume i

1 i SpecialSkills Experience with C, FORTRAN, Assembly and BASIC computer languages. Honors Advanced placement for Calculus 1 Activities Amawur Radio Extra Class License l 21 09/10/98 Resume

Michael R. Cosgrove /O 1 I Commonwealth ofPennsylvania Department of Environmental Protection I Bureau of Radiation Protection 555 North Lane, Suite 6010 Conshohocken, PA 19428 (610) 832-6271 I l Summary of qualifications 1993 - present Company / Institution Name Commonwealth of Pennsylvania, Bureau ofRadiation Protection Health Physicist I i Education l j 1970-1974 B. S. Meteorology, The Pennsylvania State University l University Park, Pennsylvania 1985-1987 B. S. Ed. Mathematics, West Chester State University West Chester, Pennsylvania, Professional experience Five years inspecting x-ray registrants and state radioactive materials licensees for compliance with

  %                 Pennsylvania regulations.

Investigation ofincidents of radioactive contamination in the environment and the trash stream. Emergency response for nuclear power plants, field team for measurements of radioiodine and dose assessment. , j Please refer to attached sheets for additional training received while employed by the Bureau of Radiation ' Protection. 1 Additional professional activities I Assisted in the revision of regulations for the medical diagnostic use of x-ray radiation Professional memberships Associate member of Conference of Radiation Control Program Directors Languages French i I fO 22 09/10/98 Resume

Training Courses April 19 through 23,1993. Northwestern University, Evanston, Illinois, Robert McCormick School of Engineering and Applied Science. CES 240 Radiation Safety. See attached course description. July 17,1993. Linear Accelerators, by Jonathan Law, Atlantic City Hospital, Atlantic City, New Jersey. Course focused on radiation dose, and calibration oflinear accelerators used in cancer l'ierapy. Compliance with state regulations also addressed. March 4,5,1994. Kodak Imagewatch Program on F. tim Processing With Special Emphasis on Mammography, for the Medical Physicist, Engineer and QC Technologist. Two day course at Kodak Education Center, Rochester, New York. Course syllabus attached. August 8 through 12,1994. Radiological Accident Assessment-Plume Phase, Emergency Management Institute, Emmitsburg, Maryland. One week course dealing with power plant conditions leading to a radiological accident, overview of operation ofBoiling Water Reactors, Pressurized Water Reactors, plume transport modeling in the atmosphere and measurement of radioactivity with regard to dose to the public. August 29,30,31,1994. Hazardous Materials Training, at Valley Forge, Pa., provided by U. S. Environmental Protection Agency. First responder training, protective actions needed for public safety. N August 19 through 23,1994. Advanced Radiolegical Accident Assessment-Post Plome Phase, Emergency Management Institute, Emmitsburg, Maryland. One week course, se Tuential to Radiological Accident-Plume Phase, with emphasis on rnessuring and evaluating radic'ogical contamination after an accident. Ingestion pathways, Protective Action Guidance procedures. Using computer modeling to determine areas of radioactive contamination. Measurement of radioactivity and characterization of radioactive isotopes. October 20,1994. Radiation Instrumentation, provided by Rutgers University, Cook College, East Brunswick, New Jersey. Various instruments used in radiation measurement, Geiger-Mueller tubes, GeLi and Nal crystals, scintillation chambers, energy characteristics. October 27,1994. Environmental Risk Communication, provided by Rutgers University, Cook College. Communicating to the public risk factors in environmental and regulatory decision making. October 28,1994. Radon Measurement in Pennsylvania Schools, provided by Rutgers University, Cook College. Devices to use for short and long term testing of Radon, placement of detectors, evaluation of results. November 3,1994. Radon Resistant New Construction, provided by Rutgers University, Cook College. Methods of preventing radon from entering new structures, building design, ventilation, foundation construction. N 23 09/10/98 Resume

Training Course March 9,1995. Hostile Workplace, Dealing With Hostile Situations, provided by US Drug Enforcement, IRS, and USDA, at USDA offices in Creamery, Pennsylvania. Maintaining non threatening demeanor in dealing with possible violators, means of avoiding violent confrontation, methods of de-escalating hostility when dealing with peasible enforcement situations. 5-4-93 Safety film on Lyme and Tick Disease 6-17-93 Introduction to Enable 4.5 September 22,23,1995. Fluorescopy, Exposure, Injuries, and Interventional Procedures. Two day cot.se at the University of Virginia Medical Center in cooperation with the American Association of Physicists in Medicine. Dosimetry, patient exposure and means to limit radiation exposure, machine calibration parameters, and imaging as related to fluoroscopy in Interventional medical procedures, and regulatory concerns in related areas. January 24,1996. Nuclear Medicine Presentation and Seminar at Presbyterian Hospital, Philadelphia, 9:00 am to 3:00 pm. Safe handling ofisotopes, medical uses, radiation safety topics, linearity checks, constancy. on dose calibrator and other tools. February 1,1996. DuPont Seminar on Film Processing and Medical Imaging, presented by representatives from DuPont at SERO. Film screen combinations, speed, exposures needed, relation of kV and mA to exposure and image quality. August 14,1997. Radiological Emergency Response, independent study course on radiation and biological effects. August 17 22,1997. Radiological Emergency Response Operations, five day course at FEMA facility, Mount Weather, in Berryville, Virginia.' Isolation, public safety, use of survey meters and environmental samples to identify, isolate, and mitigate radiological emergencies. NRC Internal Desimetry, January 12 to 16, given at King ofPrussia NRC Inspector Training, March 9 through March 13,1998 in Pittsburgh, Pa. l 1

  .24                                                   09/10/98                                   Resume

9. .. . . . ._ . . . . . . _ _ .. .. . . . . .. . . . , . . .

Joseph A. Koshy '/] 15 Driftwood Drive Q Audubon, PA 19403 (610) 832 6025 Professional Experience' 1994 - Present Commonwealth ofPennsylvania Department of Environmental Protection Conshohocken, PA 19428 Radiation Health Physicist: Conduct state inspection to verify compliance with PA radiological rules and regulations for safe use ofisotopes and X-ray equipment by medical and industrial users. Prepare reports to document findings and conclusion regarding condition which have of may have an adverse effect on health and safety. Participate in nuclear power plant emergency response drill. Participate in investigation of possible radiological hazards to public as needed. Conduct Mammography Quality Standard Act inspection of mammography facilities under state contract with FDA. Education 1987 MS (PHYSICS) CMS College, Kerala, India Course work includes: Nuclear Physics, Quantum Mechanics, E.M. theory, Electronics,

                    - Cla:sical Mechar.i:s, Solid state Physics, Mathematical Physics, Atomic and Molecular spectroscopy.

Certifications MQSA Certified Mammography Inspector December 15,1995. I O 25 09/10/98 Resume i

George A.Karron [_h Radia: ion Health Physicist II \v) . Education 1955 Electrical Engineering (B.E.E.) New York University Majored in Electronics Engineering & Telecommunications Some Courses Taken: Boolean Algebra Electronic Circuit Design (Didactic & Laboratory) Tele::ommunication Theory (Didactic & Laboratory) i AC & DC Machine Design (Didactic & Laboratory) i Advanced Physics (High Energy Particles & Radiation) Qualitative & Analytical Chernistry Differential & Integni Calculus Advanced Differential Equations Microwave. Theory & Practice i Theory & Practice of Electric Power Transmission 1975-1980 Environmental Science (Ph.D. Track), Institute of Environmental Medicine, School of Medicine, New York University 1979 Environmental Science, MS, Institute of Environmental Medicine, School of Medicine, New York University Some Courses Taken: Radiation Physics (Didactic & Laboratory) Advanced Radiation Physics (Didactic & Laboratory) Advanced Statistics Radiochemistry (Didactic & Laboratory) Advanced Radiochemistry (Didactic & Laboratory) Environmental Radiatior (Didactic & Laboratory) Environmental Protection Issues (Theory & Practice) Toxicology Indu&ial Hygiene (Didactic & Laboratory) Aduaiced Industrial Hygiene (Didactic & Laboratory) Atmospheric Science (Didactic & Laboratory) Aerosol Theory (Didactic & Laboratory) Advanced Aerosol Theory (Didactic & Laboratory) Health Physics (Didactic & Laboratory) Advanced Health Physics (Didactic & Laboratory) / x ( i Q.] 26 09/10/98 Resuine

  \

j379 Environmental Science, MS, Institute of Environmental Medicine, School ofMedicine, New York University Some Courses Taken:(continued) Respiratory Physiology (Didactic & Laboiatory) Advanced Respiratory Physiology Nuclear Physics Nuclear Engineering Masters Thesis:

     "An Electronically-Controlled Pulse Aerosol Delivery System (PADS) for Investigating Respiratory Processes."

I used this system in an MS - Ph.D. research program on lung carcinogenesis for in-vivo and in-vitro study of particle deposition in the human lung, using radioactive tagged aerosols. Ph.D. Thesis:

    "A Passive Scintillation Crystal Array for Detection and Localization of Radiation Sources in the Body" (not completed).

I i l 1 l 27 09/10/98 Resume

Rebecca A. Hunter 1469 B Harvey Lane 4 Pottstown, PA 19465 610 326-6294 Professional Experience 1993 - Present Department of Environmental Protection Bureau of Radiation Protection As a Radiation Health Physicist I, my primary responsibility is to inspect x ray users and nuclear medicine depanments for compliance with the Pennsylvania Code ofRadiological Health. This includes scheduling and performing inspections, writing the reports, and corresponding with the  ; regulated community. I perform mammography inspections for the FL/. under the Mammography Quality Standards Act. I have panicipated in training for the emergency response team. In the event of a nuclear { j accident, the team takes air samples from specified locations to measure radioactivity. The results of such measurements help determine the course of action taken to ensure the health and welfare of the public. 1986 - 1993 Owen J. Robens School District Pottsgrove SchoolDistrict , As a substitute teacher I assumed the responsibilities of the regular teac;,er, teaching the lesson as provided, and if no plans available, improvising. Because ofmy excellent performance. OJR Middle School has refened students in danger of being retained to me for tutoring. My flexiliility and varied background have lead to teachers' requests for me in fields in which I am not cenified. Education d87 - 1991 West Chester Univenity PA Certification: Chemistry Education Cumulative average of 4.02 Dean's List, AAUW scholarship recipient 1972 - 1973 Kutztown State College BS in An Education Cumulative average of 3.51 Graduated with High Honor 1969 -1971 University of Maryland Field ofstudy: Fine Ans I l

                                                                                                                               '1 l

l 28 09/10/98 Resume l l

David A. Gaisior

/O                       R.D. 2 Box 2126

(' Fleetwood, PA 19522 215-926-3958 (H) 215-832-6037 (W) Professional Experience 1988 - Present Radiation Health Physicist for Pennsylvania Department of Environmental Protection inspect medical and dental X-ray units to assess compliance with state regulations regarding patient and operator safety. Inspect hospital nuclear medicine departments to assess compliance with state regulations. Perform follow-up radon gas measurements in private homes. Answer questions from the public about radon and other radiation safety issues. Operate, maintain, and calibrate various radiation and radon gas measuring equipment. Design, maintain, and troubleshoot databases and spreadsheets used by myselfand other office staff. 1988 Chemistry Technician for Pennsylvania Department of Environmental Protection Sample management - unpack and route incoming samples to correct lab areas for requested analyses. Assist and/or relieve oti.. r lab persennel in sample analysis. 1988 (p Substitute school teacher Mt. Union Area HS and Southern Huntingdon Area HS V) Served as a substitute teacher on an as-needed basis in all secondary subject areas. 1987 Student teacher Hollidaysburg Area Senior HS Served as a full time chemistry teacher. Taught four classed ofintroductory chemistry and one class of advanced chemistry. Responsibilities included course planning, lesson preparation and presentation, classroom control & discipline, student evaluation, and parent-teacher conferences. Education 1986 - 1987 Juniata Cellege Received Pennsylvania state teacher certification in chemistry education. 1986 - 1987 Huntingdon County Area Vocational Technical School Completed a 100 hour course on fundamentals of solid state electronics. 1981 - 1986 Pennsylvania State University B.S. in secondary education. 1981: Mt. Union Area Junior / Senior High Graduated - a:ademic track (O) v 29 09/10/98 Resume

Michelle Dyarman 15 Carrigan Ave. Spring City, PA 19475 (610) 948-1011 OBJECTIVE: An entry level position to utilize my training and experience with the opportunity for professional growth and I development. Professional Experience 1997 to Present Department Of Environmental Protection Radiation Health Physicist Perform inspections to verify compliance with the Commonwealth of Pennsylvania radiological rules and regulations for the Eastern area of the state. Perform inspections to verify the safe use ofisotopes by medical and industrial licensees. Participate in emergency response activities to assure protection of the public health and safety and the protection of the environment. Participate in emergency exercises to provide radiological support to the Commonwealth emer;;ency response operation. Prepare repons of inspections and investigations to document findings and conclusions regarding conditions which have or may have an adverse effect on health and safety. 1996 - 1997 Biological Manufacturing Technician - Wyeth-Ayerst Laboratories I Perform all aspects of sterile laboratory techniques involve in the production and manufacture ofinfluenza ^ vaccines from influenza virus. Perform laboratory reports as necessary and documentation of r11 laboratory procedures performed. Eduestion 1994 Bachelor of Science in Nuclear Medicine Science Incarnate Word College - San Antonio, Texas Dean's Honors List 1997 Pursing Master ofScience in Environmental Engineering Science Penn State - Great Valley Military 1982 1985 US Army - Field Artillery Meteorological Crew Member 1985 - 1996 Pennrylvania Army National Guard Field Artillery Meteorological Crew Member / Equipment Repair 1996 to present Ambulance Platoon Leader - Forward Support Medical Company O 30 09/10/98 Resume

   ~                    Teny W. Derstine 302 Schooner Mews

(/* ^) 1027 Valley Forge Road Devon, PA 19333 (610) 832-6036 (W) (610) 995-9346 (H) 1 Objective To Retain my challenging position as a radioactive materials regulator, and to allow for personal and . professional growth due to the plethora of training possibilities that should be available when full agreement state status has been awarded to the Commonwealth. Professional Experience 1988 - Present The Pennsylvania Department of Environment Protection Conshohocken, PA S.adiation Health Physicist. Assess licensed radiological facilities and radiological safety programs for compliance with Commonwealth rules and regulations. Prepare reports ofinspections and investigations, documenting findings and conclusions in regards to condition which adversely affect or may adversely affect health and safety. Maintain equipment inventory and calibration database for the DEP's Eastern Region. Assure public health and safety, as well as environmental protection, through panicipation in emergency (N response activities. D) t Education 1984 -1988 The Pennsylvania State University Park, PA Bachelor of Science Degree in Microbiology. { Organizations Associate member of The Conference of Radiatic4n Control Program Directors (CRCPD) l I l I o I \ () i 31 09/1a98 Resume

Larry S. J. Chang 1039 Dekalb St. ( Norristown, PA 19401 (610)832-6024 (W) (412) 276-8564 (H) ProfessionalExperience 1994.Present Bureau ofRadiation Protection Conshohocken, PA Health Physicist - Review of State Regulations, Review oflocation of Reg. Guides & Reference Material. Overall program orientation and Licensing, X-ray Inspection include Medical facilities and Industrial Radiograph, Emergency Response Drill to Nuclear Power Plants, Investigation ofRadioactive Waste sites, linear Accelerator inspection. Radioactive Material Inspection include Medical and Industrial used. 1988 1989 Blessing Hospital Quincy, IL. Determined appropriate treatment plans on ROCS computer, Set up and operated various radiation instruments including Mevatron 67 Linear Accelerator and Cobalt Teletherapy in clinical cancer treatme Simulated X-ray localization and film planning, Calibrated dosimetry machine, Constructed Block molding, prepared Cesium inventory and assisted isotope implant treatment, Constructed radiation protection safety compliance NRC regulation. Education 22 1983 Marshall University Huntingdon, W. VA MS, Physical Science 1971 1976 Tunghai University Taiwan, ROC BS, Physics Continuing Education 1984 1986 University of Pittsburgh of Post-Graduate Studies Pittsburgh, PA Radiation Health of Public Health School 1994 New York University ofPost-Graduate Medical School New York, NY. Radiation Physics and Biology Languages Fluentin Chinese and English 32 09/10/98 Resume

Bernard Au . }] 1324 Barton Drive

 *)                    Fort Washington, PA 19034 (610) 832-6034 (W) . (215) 643-5337 (H)

Objective: Protection of the public health and safety through inspection the safe use of X-ray equipmen and isotopes. Profesdonal Experience 1992 to Present Pennsylvania Dept. of Environment Protection l Radiation Health Physicist i Inspection the safe use of X-ray equipment by medical and Industrial users. Perform inspections to verif the safe use isotopes by medical anu industrial licensees. Education 1975 to 1977 Tennessee Technological University,

                    - Cookeville, TN MS Degree in Engineering Science.

1972 to 1974 Murray State University, Murray, KY MS Degree in Physics 78 to 1972 LaSalle University, Philadelphia, PA BA in Physics i b 1 '\ 33 09/10/98 Resume

Roy Kitzer ['T 276 Lancewood Place ( ) Greensburg, Penna.15601 (717)S40-5062 (W)(412) 837 9247 (H) Objective: Add credentials to agreement state staffing Professlorst Esperience ' 1965 To 1996 Westinghouse - 31 Years - Waltz Mill Site - Madison, Pa. Manager And RSO- Health And Safety Responsible for the establishment, supervision, and implementation ofALL programs in Radiological health, Industrial Hygiene, Occupational Health and Safety, Fire Prevention, Environmental Control, and Low Level Radioacti 'Naste Minimization and Disposition. Has COMPREHENSIVE knowledge of NRC and DOT Regulations, as well as other Agency Standards and Requirements, such as, EPA, OSHA, DEPIBRH, DOL, AND NVLAP. Prepares Radsafe, Health and Safety Procedures and Manuals, and Training Programs. Conducts and Supervises audits of acilities for compliance with Radiological, Health and Sal ety, Fire Prevention, and Environmental Standards. Participates on ALL Radsafe, Health, and Safety committees with Review and Recommenda. ion (~] responsibility for Operations regarding Licensing and Compliance. Manages Radsafe Staff ofI 0- 14 Professionals and Technicians. Manages Budget ant' Capital expenditures for about one (1) to (2) million dollars per year. Provides advise and interpretation for All Regulations, including, but not limited to :0 CFR 19,20,30,40, 50,61,70, end 71; 49 CFR 170-178; OSHA 1910 and 1926, EPA; and applicable Si ate and NVLAP requirements. 1996 to Present Bureau Of Radiation Protection - DEP - Harrisburg, Pa. Radiation Health Physicist i Regulates and Inspects Radiation Machines and Radioactive Materials, principally NORM and NARM, including LLR W and Radon, in Pennsylvania. Education 1964 to 1965 Rutgers University New Brunswick, New Jersey Master of Science in Radiation Health 1952 to 1956 Carnegie Institute of Technology Pittsburgh, Pennsylvania Bachelor of Chemical Engineering (j 34 09/10/98 Resume

i i f Organizations l I h CURI Board ofdirectors- 1982-1996 Health Physics Society 1967-1997 American Industrial Hygiene Association - 1970 - 1995 I Societies American IndustrialHygiene Nationaland Local Safety Council National and Local IndustrialHealth Foundation Local ACURI- Appalachian Compact LLRW Generators t 35 09/10/98 Resume

I i James Frederick Kopenhaver D 15II Miller Road I Dauphin, Pennsylvania 17018

\

Telephone -(717) 540-5056 (Work) l l Objective - To obtain employment when, my expertise and skills are challenged and needed. Professional Experience 1972 - Present Pennsylvania Department of Environmental Protection i One Ararat Boulevard Harrisburg Pa.17110  ! l Manage the Radiation Protection Program in the South-central and Northeentral regions of the Department of environmental Protection. Supervise the activities of five subordinates and review all work done by j them which includes, but is not limited to, the inspection of all state licensed and registered radiation j sources and radioactive material, Supervise the survey of homes and other buildingsfor radon. Conduct training courses and lectures for registrants and other interested groups as requested Consult with and advise radiation users concerning good health physics practice. Supervise the condi : tion of NEXT Mammography certification, and Federal Level 2 tests in the South-central and Norn -central regions. Supervise emergency response to accidents involving radiation and supervise the investigation of all accidents and high radiation e.posures. Train new employees in office and inspection procedures. Mutually establish goals e.o objectives with subordinates. Participate in all emergency response drills as  ! required. 1969 - 1971 Albert Einstein Medical Center Philadelphia, Pennsylvania j Position Held - Assistant Radiological Physicist _/ Duties: l Calibration and radiation surveys of diagnostic x-ray equipment. including special procedures equipment. Calibration of radiation surveys around, and maintenance of a Cesium-] 3 7 teletherapy unit,300 Kvp therapy unit, Cobalt-60 teletherapy unit. and a 4 Mev linear accelerator. Maintained a film badge i personnel monitoring system with approximately 150 users. Calibrate and maintain radiation survey and monitoring instruments. Calibration and maintenance of a Baldwin-Farmer Secondary Standard ionization type dosimeter. Preparation of depth dose, tumor-air ratio, scatter function, and back scatter tables for use with the radiation therapy equipment. Calculation of doses and iso-dose charts for patients who were to receive radiation therapy. Design and producJon ofirregular size and shape organ shields for radiation therapy patients. Monitoring and surveying oflaboratories, both research and clinical, that use radioactive material Consultation with physicians and technologists in areas concerning radiation safety. Lecture to student x-ray technologists on radiation safety. Maintain Radium and Cesium brachytherapy sources and calculate patient dose and time for removal. 1967 - 1969 Albert Einstein Medical Center i Philadelphia, Pennsylvania l Position Held - Assistant Radiological Physicist Research Assistant (half-time) Duties.-

                                                                                                                                 )

As a Research Assistant- Assist in research on the chemical protection ofred blood cells from ionizing i radiation, in vitro RNA synthesis by irradiated DNA, measurement of renal blood flow in dogs using xenon-133, and the chemical protection from ruliation of the kidneys ofrats. Y7ie work involved the use of x-ray equipment and several different radioisotopes. In addition to the research work some clinical j studies, such as thyroid function tests were done for the hospital nuclear medicine department. O l ( As a Radiological Physicist - Duties were the same as the Radiological Physicist duties listed above 36 09/10/98 Resume  ; i i

C66 1967

• Albert Einstein Medical Center Philadelphia, Pennsylvania Position Held - Research Assistant Duties:

The duties were the same as the' job description for research assistant listed in the previous job description Education 1971 to 1972 Rutgers. University New Brunswick, New Jersey Masterof Science in Health Physics 1962 to 1966 Albright College Reading, Pennsylvania Bachelor ofScience in Biology with a minor in Chemistry 1959 to 1962 A. D. Eisenhower Senior High School Norristown, Pennsylvania I I

                                                                                                                                    )

37 09/10/98 Resume

I [ John T. Maher L ])

   "'                       RDI Box 439 Landisburg, PA.17040 (717)S60-5064 (W) (717) 789-4357 (H)

Objective: Demonete education and training for U.S.N.R.C. Professional Experience 1989 - Present Pennsylvania Department of Environmental Protection Harrisburg, PA. Position Held -Radiation Health Phys 7cist 1I Duties: As a Radiation Health Physicist II, I perform radiation safety inspections of medical and industrial facilities that utilizing- ionizing radiation producing equipment and radioactive materials. I make detailed observations and measurements that require proficiency in the use of a variety of radiation detection field instrumentation to determine compliance status with Title 25 Pa. Code, its referenced Federal standards 10 CFR f f 1020.30,1020.3 1, and the Radiation Protection Safety Act, ofjuly 10,1984. I draw upon my knowledge of" National Council of radiation Protection" recommendation to evaluate operating procedures with the goal of reducing patient, population, operator and environmental exposures while incorporating more effective industrial and medical management strategies into these practices. I suggest improvements or solutions to deficiencies when ever possible. (-]) ( v I respond, evaluate and take appropriate actions for incidents and accidents involving radioactive material or radiation producing machines, including the evaluations of i i personnel exposures. Investigate complaints or discoveries that appear to be in violation of Pennsylvania Code, Title 25., Environmental Protection. participate in Drills, operate and maintain emergency radiation detection instrumentation and demonstrate Proficiency in these skills to Federal Observers during emergency response drills. 1987 - 1989 Pennsylvania Department of Environmental protection Harrisburg, PA. Position Held Radiation. Health Physicist I Duties: As a Radiation Health Physicist I performed a variety of duties required to evaluate Radon levels in homes in Pennsylvania and provide guidance to homeowners on radon dose reduction methods as well as structural modification to remove or limit radon entry. My duties also included the evaluation and testing of homes that have been modified to reduce radon levels. I operated, calibrated, maintained and deployed radon and radon daughter measurement, testing and counting equipment. These devices included but were not limited to, sodium iodide detectors, Lucus cells with scintillation counters, associated pumps and ancillary equipment, Micro-R meters, alpha tract detectors and charcoal canisters. My duties also included the participation in drills required of nuclear Power plants located in the south-central region. I am required to demonstrate proficiency in the use of radiologic environmental monitoring equipment used to assess exposure conditions and isotopic (j } [ dispositions in the event of a radiologic release. 38 09/10/98 Resume

784 1987 Pennsylvania Department of Environmental Protection Q Harrisburg, PA. Position Held -Radiation Protection Specialist Duties: As a Radiation Protection Specialist performed a variety of duties required in the operation and maintenance of the Bureau of radiation Protection's Environmental Radiation Surveillance Program. The primary emphasis of my position was the radiological monitoring of nuclear power plants, but monito?7ag did include radiological monitoring of other sources having an impact on the environmrnt 1973 - 1978 Coney Island Hospital Bronx, N. Y. Position Held Supervisor-- of Cardiovascular Special Procedures Duties: As The Supervisor of cardiovascular Special Procedures my prime responsibilities were the gathering and interpretation of physiological data obtained during cardiovascular catheterization, through the application j of mathematical and physical science techniques. Additionally I functioned as the radiation safety officer, monitoring individual exposures, insuring safe ] exposure practices and instructing staff on radiation safety practices-i Education j9 1992 Nova Southeastern University - Ft Lauderdale, Florida MS, Management Information Systems 1971 - 1973 State University of New York Broolayn, New York Bachdor c' Science, Radiological Science 1969 1971 Westchester Community College, S.U.N.Y-Vathaua, New York Associate of Applied Science, Radiologic Technology 1 I i i l v 39 09/10/98 Resume

Richard Janati 2225 Buttonwood Circle Harrisburg, PA 17110 Home (717) 657-9475 Work (717) 787 2147 Professional Experience 1994 to present Chief, Division of Nuclear Safety, Commonwealth of Pennsylvania, Department of Environmental Protection, Bureau of Radiation Protection Responsible for the overall implementation of the Commonwealth's nuclear safety oversight, nuclear power plant emergency response and low-level radioactive waste disposal programs. Presently, I supervise five nuclear engineers and two health physicists. 1991-1994 Acting Chief Nuclear Safety Section, Commonwealth ofPennsylvania, Department of Environmental Protection, Division of Nuclear Safety Supervised the Nuclear Safety Section and provided guidance to the staffconcerning nuclear plant safety, low-level radioactive waste (LLRW) packaging and transportation, and nuclear plant emergency preparedness planning. 1985-1993 Nuclear Engineer 11, Commonwealth of Pennsylvania, Department of Environmental Protection, Pureau of Radiation P.otection, Division of Nuclear safety Performed a general nuclear safety oversight review at the assigned power plants, including frequent on. site interactions and accompaniment of NRC resident and region based inspectors. Conducted inspections of LLRW packaging and ' transportation activities at the nuclear power plants and other major LLRW generators. Panicipated in emergency exercises and drills at 'the assigned power plants to maintain the ability to assess plant conditions during nuclear event or emergencies. 1984 1985 Utility Valuation Engineer, Commonwealth of Pennsylvania, Public Utility Commission, Bureau ofRates, Electric Division Performed comparative analysis of rate case elements, including fuel inventories, prices, materials and supplies, decommissioning expense estimates and accrual management. Developed data requests and interrogatories for submittal to the electric utilities. 1981-1983 Nuclear Fuel Safety and Licensing Engineer, Westinghouse Electric Corporation, Water Reactors Divisi.n, Nuclear Fuel Section 3 j i Participated in the reload design process and prepared the Reload Safety Evaluation reports for the ' assigned power plants. Participated in the utility presentations and the Nuclear Regulatory commission (NRC) regulatory meetings conceming Westinghouse fuel safety and licensing issues. 1980-1981 Research Assistant, University of Massachusetts-Lowell Research Center Assisted the Department staffin conducting various nuclear physics related experiments. I ? V. 40 09/10/98 Resume

Education sg77- 1980 University of Massachusetts - Lowell (1977-1980) Bachelor of Science Degree in Nuc! car Engineering 1982 - 1984 University of Pittsburgh Master ofScience Degree in Energy Resources and Technology Major course work in Nuclear Science and Technology Publications Co-authored the following published papers:

1. Impact of Transportation Considerations in the Selection of LLRW I

Repositories, presented at the Second International Conference on Radioactive Waste Management.  ! Winnipeg, Canada, September 1986.

2. Safety issues Related to Disposal of I 129 in a LLRW Repository, presented at tne Ninth Annual DOE Conference.

Denver, Colorado., August 1987.

3. Safety issues Related to the Disposal of C-14 in a LLRW Repository A State Perspective, presented at the National Conference on Radiation Control. )

i Nashville, Tennessee, May 1988. j Organizations 1 b 1.American Nuclear Society (ANS)

2. Conference of Radiation Control Program Directors (CRCPD) 3.LLRW Host State Technical Coordinating Committee (TCC)

V 41 09/10/98 Resume

                                                                                                                            ~l l

j l William P. Kirk !! A 256 Bahia Avenue Hershey, PA 17033 Education 1957 Pennsylvania State University BA (Science, History) 1965 University ofRochester - MS (Radiation Biology) 1974 University ofRochester i Ph.D. (Radiation Biology)  ! l Certifications American Board of Health Physics - 1968. Recert. 1981,1985,1989,1993 Professional Emperience 1957 - 1963 Commissioned Officer, US Navy August 1957, commissioned Ensign, USN 1957 - 1959 Assigned to USS Sigourney (DD-643). Setved as Engineering Officer Nuclear, Biological and chemical (NBCD) Officer, Damage Control Assistant, Command Duty Officer, officer of the Deck, etc. Responsible for administration of 120 men and operations maintenance of a destroyer engineering plant, electrical system, damage control etc. When acting as CDO or ODD, responsible for directing the actions of a 3,500 ton vessel and 300 man crew. 1960 Attended US Navy Instructor training at the Fleet Training Center, Norfolk, Va. 1 1960 - 1962 Instructor, US Naval Unit, US Army Chemical Corps School, Ft.14cCLettan, AL. Taught basic nuclear physics, nuclear weapons outputs and effects, chemical weapons, protective equipment / clothing and decontamination to classes of Navy and Marine Officers and senior EN. 1962 - 1963 Assigned to USS Okinawa (LPH-3) as Asst. CIC Officer Asst. Training officer, NBCD officer. ODD, etc. primarily responsible for conducting ship-s training program (1,500 men), for radar navigation, and bridge watch keeping duty on a 22,000 ton helicopter carrier. 1963 Discharged as Lieutenant, USN. 1963 - 1965 Graduate Assistant, Department ofRadiation Biology and Biophysics, School ofMedicine and Dentistry, University of Rochester, MY 14642. Completed MS. in Radiation Biology (Health Physics) with emphasis on radiation dosimetry using film and TLD.~ Acted as Laboratory instructor for Biological Effects of Radiation course including conducting . X, gamma, ultraviolet irradiation on animal and in vitro preparations, tracer chemistry experiments, and j auto radiography for student experiments. j m , i 42 09/10/98 Resume

  ' 65 - 1966.      Manager, Dosimetry Services, Applied Health Physics, Inc., Bethel Park, PA.

Performed R&D work with film and TLD with establishment of a film badge service and mail-order X machine calibration service as objectives. Developed x-ray spectrometer using TLD'S. Project terminated because of financial difficulties. Did Health Physics consulting in areas ofindustrial radiography, nuclear Laundry, hospital X-ray and isotope installations, and ore processing installations. Prepared license applications and procedures manuals for clients and conducted radiation safety survey. Acted as firm Radiation Safety Officer. 1966 - Consultant, Division of Radiological Health, USPHS, DHEW. Provided expertise in use ofTLD Dosimetry for Low dose-rate monitoring in the envirorment and for medical installations. Collaborated in the design and construction of a unique TLD reader capable of evaluating as low as a one mR gamma exposure with high precision. 1966 - 1988 Commissioned Officer, US Public Health Service; Commissioned as Health services Officer (0-4) 1966 Assigned to Technical Operations Branch, Division of Radiological Health, DHEW. As Chief, Radiation Surveillance Network CRSN), directed the operations of 80 fallout monitoring stations to keep track of radioactivity in air and precipitation in the US, territories, and South America, supervised operations of a 8-10 person laboratory that performed detailed radioassay on samples obtained by the network, and published results in Radiological Health Data & Reports. As a member of the staff of the Asst. Chief, TOB for technical Development, continued R&D in use of TLD in Low-Level radiation monitoring. [ '*17- 1968 Assigned to Environmental Surveillance and Control Program, National Center for Radiological Health, DHEW. Continued as Chief, RSM, with duties as above. Revamped and streamlined program, including complete automation of data handling. Network name changed to Radiation Alert Network (RAN) concurrently with change of emphasis in Laboratory staff to electronic product radiation. As staff. Operations Coordinator, Special Studies Laboratory, supervised dosimetry radioassay, etc. for projects evaluating radiation Levels in hospitals in areas of high natural radioactivity in Brazil and India, around reactors, and near color TV sets. Served as Project officer for several other PHS environmental radiation networks I tracking radioiodine in milk and bovine thyroids, radium in bone, and radiocesiumn and radiostrontium in foods. 1968 Certified by American Board of Health Physics. 1968 - 1971 Out-of-service trainee, Department ofRadiation Biology and Biophysics, School of Medicine and Dentistry, University of Rochester, NY I4642. Completed course work and preliminary examination for Ph.D. in Radiation Biology. Started thesis research in physiological behavior and radiation effects of 85 Kr administered to guinea pigs by inhalation. Transferred to EPA Eastern Environmental Radiation Laboratory, Montgomery, AL to complete thesis research while setting up a more extensive 85 Kr research program. 1970 Promoted to Senior Health Services Officer, USPHS 43 09/10/98 Resurr .

Supervisor,85 Kr Studies Section, Radiation (Q)97).1973

 'U                      Bio-effects Research Branch, Eastern Environmental Radiation Laboratory, Montgomery, AL Designed and supervised construction of experimental facility to use Large amounts of 85 Kr safely and house experimental animals and ancillary facilities. Completed Ph.D. research. Designed and supervised construction of a beta-infinite cloud 85 Kr exposure system, tested, the system, and conducted preliminary exposures with guinea pigs. Section consisted of a GS-Il Biologist, a GS-8 Biological Laboratory Technician, and a GS-5 Physical Science Technician. Project transferred to the National Environmental Research Center, Research Triangle Park, NC in July 1973.

1973 - 1975 Research Scientist, Toxicology Branch, Experimental Biology Laboratory, National Environmental Research Center, EPA, OTP, NC. Reestablished Kr-85 research project at NERC including design and supervising construction of a new exposure facility for 85 Kr and other toxic materials. Completed Ph.D. thesis and final examination in September 1973. Degree granted in February 1974. Continued research into hematopoietic efrects of inhalation exposure to 85 Kr and Lethality studies with several species of Laboratory animals exposed to 85 Kr in beta-infinite, cloud geometry. Served as Facility Safety Officer and NERC Radiation Safety Committee member for experimental Biology Laboratory. Acted as Asst. Chief, Toxicology Branch and assisted with the supervision of 35 people involved in investigating efrects of various combinations of tritium, heavy metals, microwaves, and pesticides on all levels of mammalian organizations from sub-cellular to whole animals. A ( /4 Changed PHS category to Senior Scientist I V 75 Promoted to scientist Director j l i 1975 - 1980 Chief, developmental biology Branch, experimental Biology Division, health Effects Research Laboratory, Environmental Research Center, EPA, Research triangle Park, NC. Directed / managed Branch portion of EBD's research program in effects of exposure to various combinations of non-ionizing radiation, ionizing radiation, heavy metals and pesticides on all levels of maintain organizations from sub-cellular to the whole animal. Directed 20-22 permanent employees, including 6-8 Ph.D.-s., and 15-20 other employees. Managed enrvuat budget of $1.5 - 2.0 million. l Determined proper mix of personnel and other resources to accomplish research objectives and made I recommendations to the Division Director. Interviewed candidates for positions and recommended j employment and promotion actions to Division Director. Negotiated ERD space requirements with I Laboratory management. Approved protocols, ensured timely completion of projects and reviewed' approved finished research reports. Ensured that Branch programs met Agency safety procedures. Continued to conduct own research program in 85 Kr bioeffects with emphasis on Late effects and I carcinogenesis in rats and guinea pigs.

                                                                                                                                  )

Chaired HERL animal Care Committee with, policy setting and oversight responsibility for ensuring that animal care provided under the Laboratory program met regulatory and statutory requirements. i Chaired the ERC Radiation Safety Committee with policy setting and oversight responsibility for ensuring that the radiation safety program at EPA, RTP, as executed by the ERC Radiation Safety Officer, met NRC requirements. (O / v) 44 09/10/98 Resume I

                                                                                                                                  )

(.-w\;80 Associate Director, Experimental sinology Division, health Effects Research Laboratory, Environmental Research Center, EPA, Research Triangle Park, NC. Assisted Division Director with management of Division (46 permanent,20-30 other employees inclu development of research strategy, work plans, staffing, budgets ($3-3.5 million), and reports. Negotiated resolution of space and personnel needs with the HERL Program Support Office, ORD Support Services office and various offices in OA/RTP. Advised and directed Branch Chiefs in resolution of administrative, personnel, and space needs. Acted as Division Director in that individual's absence. Directed the 85 Kr bioeffects research program that was conducted in the Division under interagency Agreement with the Department of-Energy. Prepared special reports as needed, including -Life-Span and Carcino-genesis" chapter in EPA-s microwave criteria document Biological Effects of Radio-frequency Radiation. Served as Of6ce of Research and Development representative on various working groups pertaining to ionizing radiation. Continued to chair HERL Animal Care Committee and ERC Radiation Safety Committee with responsibilities noted previously. 1980 - 1988 Director, Three Mile island Field Station, office of Radiation Programs, PS Environmental Protection Agency, Middletown, PA 17057. (Uroder Office ofMonitoring and Technical Support 7/80-9/81) Directed a program of environmental radiation surveillance and public information during recovery efforts for the crippled Unit 11 reactor at the Three Mile island Nuclear Generating Station. The Field Station staff ranged from 7-18 employees supplemented when necessary by personnel from EPA's Los Vegas or Montgomery Laboratories. The routine environmental radiation surveillance program included air monitoring (particulate, reactive gases, noble gases, tritilxn), water monitoring (precipitation, surface water, waits), and determination of gamma exposure with a TLD network and a 13 location real time system using pressurized ionization chambers with computerized data collection via dedicated telephone Lines. ' Had-Lead role in formulating Long term surveillance plans in cooperation with participating federal and state agencies. Modified these plans or developed new plans to meet specific activities conducted throughout the recovery operation. Evaluated data obtained from radiation monitoring and surveillance activities in reference to established standards and disseminated information to the general public through the news media and through personal meetings with elected officials, civic groups and/or other interested citizens. Maintained an office, open to the general public, where radiation data, exposure assessments, surveillance plans, etc., could be reviewed and/or discussed by the citizenry. Represented EPA in more than 150 public meetings. Established procedures and contacts whereby off site radiation monitoring data could be used as feedback to modify or terminate specific inplant activities to assure the health and safety of the public. 1988 - 1991 Manager. Radiological Services and RPI Radon Measurement Services, Radiation Physics, Inc., Carrolltown, PA 17010. Provided general Health Physics consulting services to a variety ofindustrial and medical clients including Licensing, training, surveys, audits etc. Operated a radon Laboratory to provide open-face and barrier type charcoal canister detectors to the public and radon testing industry. Provided comprehensive radon testing and diagnostic services to homeowners, Realtors-ors, builders, schools, and businesses using several types of passive detectors-and active instrumentation. Responsible for developing protocols, calibrations, QA/OC, employee safety program, and R&D on new methods and devices. Provided consultation on radon remediation for clients with their own construction capability. 1992 - 1996 Member, Special Science and Technology Resources (also known as Advanced Science and-Research Team (ASRT), Office of Deputy Secretary for Air and Waste Management, PA Department of (% environmental ( Resources, Harrisburg, PA 17105. Assigned to Bureau ofRadiation Protection as Assistant ( to the Director. 45 09/10/98 Resume

1993 -1994 Acting Director, Advanced Science and Research Team. 1995-1996 Acting Chief, Environmental Radiation Division, BRP 1996 - Present Chicf, Environmental Surveillance Section Division of Radiation Control. BRP (reorganizations) Responsible for providing expert-level advice and guidance relating to the identification, analysis, assessment, prevention, or abatement of environmental radiation and radioactivity hazards resulting from the release of radioactive materials in the environment, the exposure of the public from these sources and from Low frequency non-ionizing electromagnetic from electrical sources. Specific duties in job description involve designing, evaluating, overseeing, reviewing projects, and providing testimony and training regarding extent of exposure of public for radioactive materials in the environment, standards for release of remediated sites and levels of naturally occurring RAM below which no regulatory action is required, monitoring of and standards for non-ionizing radiation, decontamination of specific sites, reactor decommissioning, and low-level waste disposal. i Responsible for administration of the EPA State Indoor Radon Grant ($396,000 in 1992, S500,000 in 1993). Prepared applications, devised work plans, prepared RFP's and contracts, prepared and submitted monthly and annual reports. Appeared on TV programs and gave talks to professional organizations. I Participated in emergency drills for PA nuclear power plants in several capacities ir. eluding Incident Manager and Radiological Assessment Manager. Completed several FEMA, DOE, and NRC Emergency Response courses, g Acted as DER contact and coordinator for EMF issues. Collected Literature, prepared summaries, replied ' / to Legislative and public inquiries re ENF. Assembled reference material concerning hazards from and regulation ofnaturally occurring radioactive material (NORM). Established and chaired multi-bureau working group to investigate hazards associated with NO RM in PA and to develop a NORM policy for PA-DER.

ASRT activities irictixled reviewing vottxnirious comments-on a draft Multi-Media Toxics Strategy for DER and incorporating them into a revised document, with an implementation schedule, for management review; various personnel activities associated with selection and attempted hiring of a Toxicologist and an Environmental Economist (both at Ph.D. Level); and development ofdiscussion material relevant to future activities of the ASRT.

As Acting Chief Environmental Radiation Division, mantged the environmental monitoring program around nuclear power plants and other nuclear facilities as mandated by PA Radiation Protection Act; coordinated the reactivation of decommissioning plarwiing of the Commonwealth-owned facilities in the

                     -Quchama Wild Area now occupied and used by Permagrain Products,Inc. and formerly the site of 8-10 NRC Licenses under different entities; wrote policy for handling radioactive material discovered in municipal waste facilities using portal monitors; and maagd radiological emergency response activities for the Department.

i

\

46 l 09/10/98 Resume l l

l Memberships and Honors (]J Health Physics Society - National. Plenary member since 1965. Sympos!a Committee (1976-9, C 1977-9); State and Federal Legislation Committee (1985-8); Publie Information Committee (19 Co-Chairman,12th Annual Topical Symposium (Williamburg-Feb.1979) and r of committe on internal Dosimetry and Indoor Radon sponsored by DVSRS and the Susquehanna Valle Fellow Award,1988. Elected to Society Board ofDirectors for 1989-1992. Founding member and Steering Committee member for Radon Section. Chapter activities - currently a member of the Susquehanna Valley Chapter (founding member & member of Executive Council) Delaware Society for Radiation Safety, the North Carolina Chapter (Past President, President-elect) and the Baltimore-Washington Chapter. Previously a member of the Western New York, Western P and Alabama Chapters. Radiation Research Society. Sigma Xi (University of Rochester Chapter). I American Association for Advancement of Science. I American Public Health Association (1966-76,1985-present). Member ofRadiological Health Section and Environment Section. RH Section - Program Committee 1985 Program Chair 1988. Chair Elect Chair 1989-1991, immediate Past-Chair 1991-1992, Section Council 1992-4, Action Board represen 1993-5, Goveming Council 1994-6. Distinguished Service Award, Radiological Health Section 1994.  ! American Association of Radon Scientists and Technologists. National and Eastern Pennsylvan O (Charter rnember and Director, E.PA Chapter -1988-1992). Genii Chair,4th AnrKiat Fall Conference of A ARST, Camp liill, PA, Oct.4-6,1990. Commendation Medal, U.S public Health Service,1974 Consultant, Scientific Committee #38, National Council on Radiation Protection and Measurements. i 1917 Commissioned Officer's Association, Us public licalth Service. National and Worth Carolina Chapter. President. NC Chapter Central Pa. Chapter, American Nuclear Society. 1988 Bronze Medal, U.S. Environmental Protection Agency 1974 1980 Adjunct Associate Professor of Physics, North Carolina State University 1980 - Present Adjunct Assistant Professor of Radiology, MS liershey Medical Center, Pemsytvania State Universi liershey, PA. 1992 Present Bio-electromagnetic Society. 1994 Present Society for Risk Analysis. i l N 47 , 09/10/98 Resume

Publications and Reports 1 .. Kirk, W.P., J. Steiner, and T. Jackson,1966. -analysis of PAHO Air samples for July 1966 and Comparison with Previous PAHO Data and Selected US Data #' RSN-TOB Data Report 091366. Radiation Surveillance Network, Rockville Radiological Health Labuntory, US Public Health S DilEW, Sept.1966. Kirk, W.P. and T.S. Jackson, Jr., Oct.-Nov.1966. Special Reports Nos. B 13. " Gross Be and Fresh Fission Preducts in Pan American Health Organizations Air Samples.ll RSN-T 101966,102666,110066,111666, and i12366. Radiation Surveillance Network, Rockville Ra Health Laboratory, U.S. Public Health Service, DHEW. Kirk, W.P.,1972. "Kr-85: A Review of the Literature and an analysis of Radiation Hazards.- Environmental Protection Agency, Office of Research and Monitoring, Rockville, MD. Kirk, W.P.,1973. "In Vivo Behavior and Effects of Krypton-85 in Guinea Pigs.-- Ph.D. Th of Rochester, Rochester , NY. Kirk, W.P.,1974. ' Behavior of Kr-85 in Animals."In: The Noble Gases, Moghissi, A.A. and R. Eds. Messenger Graphics, Phoenix, Arizona. Kirk W.P. and D.A. Morken 1975 in Vivo Kinetic Behavior and whole Body Partition Coefficients for Kr. 85 in Guinea Pigs,'- HEALTil' PHYSICS 28:263. Kirk, W.P., P.W. Parish, and D.A. Morken,1975 "In Vivo solubility of Kr-85 in Guinea Pig fisslies,tt HEALTH PHYSICS 28:275. f \s Kirk, W.P., S.F. Rehnberg, D.A. Morken,1975, " Acute Lethality in Guinea Pigs Following Respiratory Exposure to Kr-85,- HEALTH PHYSICS 28:275. Kirk, W.P.,1980," Status Report, Kr-85 Health Effects Research, ' Experimental Biology Division, Health Effects Research-Laboratory, US Environ. Protection Agency, Research Triangle Park, NC 2T711. Kirk, W.P., 1983.111 131 in Thyroids in Meadow Votes Near Three Mite Island Nuclear Generating Ptentil,(resp. to Field, et at, HEALTH PHYSICS 41:297) j l HEALTH PHYSICS ":175.

                                                                                                               )

Kirk, W.P.,1983,

• Life Span and Carcinogenesist , Chapter in Biological Effects of Radiofrequency Radiation, J.A. Eider and D.F; Cahill, Eds. Health Effects Research Laboratory, Office of Research and Development, Environmental Research Center, Research Triangle Park, NC 2T711. Rept # EPA 660/8-83-026F.

Schneider, R.H., T.R. Lee, and W.P. Kirk,1967,-Radiation Exposure Rates from the Surfaces of Some ColorTelevision receivers."InitialReport, Special Studies Laboratory, Environmental Surveillance and Control Program, National Center for Radiological Health, US Public Health Service, DHEW. Drew R.T., W.P. Kirk, R.H. Schneider, and HJ.L. Rechen,1967, " External 1 Gamma Radiation

    -                                     Dose Measurements with thermoluminescent Dosimeters at the Morro de Ferro, State of Minas Gerais, Brazil, in August 1966.11 Internet Report, special Studies Laboratory, Environmental Surveillance and Control                                {

1 48 09/10/98 Resume

m Program. National Center for Radiological Health, US Public Ilealth Service, DHEW. i ' .Levine, H., W.P. Kirk, and IIJ.L Rechen,1967, -Plutonium and Strontium in Precipitation, August through March 1967. RAD. IIEALTH DATA REP. 8:574, - Schneider, R.H., W.P Kirk, J.F. Steiner, Jr., and HJ.L. Rechen,1968, " Photon Counter for the Measurement of ThermoLLaninescence.11 REV. SCI. INST. 39:1369. i Blanchard, R.L., J.A. Broadway E.L Sensintaffar, W.P. Kirk, B. Kahn, and AJ. Garrett,1983, An 1 Airborne Radioactive Effluent Study of the Savannah Riverflant , Eastern Environmental Radiation Facility, office of Radiation Programs, US Environmental Protection Agency, Montgomery, AL 36 As Chief, Radiation Surveillance Network (1966 8) and Director, TMI Field Station (1980-8) was  ! responsibic for several thousand reports of which about 300 were in the public domain and the balance directed to specific individuals. i { 1

 /~'N                                                                                                       l 1

1 i U 49 09/10/98 Resume

Michaeil. P. Murphy,Rrpt 92 Eddington Avenue (O), v

                          ,,Harrisburg, Pennsylyania 17111 717-564-4922(Home) 717-783-9734(Work)

Professional Experience Over twenty years of multifaceted Nuclear- and Radiation Protection Experience in -the Mili:a Commercial, Power Plant. and Govemment sectors- Current assignment Principal Engineer Beaver Valley 1987 - Present Nuclear Engineer II, Pennsylvania Department of Environmental Resources, Bureau of Radiation Protection, Division ofNuclear Safety. Involved in all aspects of the Development of the Appalachian Compact Low Level Radioactive Waste Disposal Facility, including Siting Plan, implementing Legislation, Regulations, Public Involvem Prospective Operators Compliance History Investigation. Nuclear Safety Section nuclear power principal engineer assignments at Peach Bottom, Limerick, and Beaver valley. 1994

                          " Temporary Assignment", Assistant to The Deputy Secretary for Air and Waste Management.

for necutive oversight for the Bureau of Radiation Protection, the Bureau of Air Quality Control, and Legitative Interface. 1987 to 1988 Senior Nuclear Consultant to the Govemor's Office of General Council and the Department of Environmental Resources Office of General Council for -the commonwealth of Pennsylvania's litig (mV) and negotiation with the Philadelphia Electric Company relating to problems at the Peach Bottom Nuclear Power Plant 1986 to 1987 Senior, Consultant and VP, Safety Management Associates, inic- assigned to Davis-Besse Nuclear Station to design, implement, and operate the Industry Opera Experience Assessment Program. Program was approved during the October 1986 audit by the institute fo Nuclear Power Operations (INPO). Also Fermi Unit 2 and Davis-Besse two-phase flow analysis of secondary systems for erosion corrosion prediction using state of the art computer models. Post Surry feed system pi-pe rupture response. 1981 to 1986 GPU Nuclear Inc. Three Mile Island Nuclear Station, Unit 2 Middletown, Pennsylvania Position: Senior Engineer, Safety Review Group 10-81 to 5-83, Initial Position Radiological Engineer III. 1979 to 1981 Independent Contractor, Senior Health Physics Technician Employed by the following companies: Chem-Nuclear Systems, Inc. Applied Radiological Control, Inc. -institute for Resource Management, Inc. -Numanco, Inc. 1978 to 1979 Virginia Electric and Power Company Surry Nuclear Power Plant, Surry, Virginia Position: Health Physics Technician /G i V 50 09/10/98 Resume

                                                                                                                                 )

f ~' ( .htilitary 1972 to 1978 United States Navy, Nuclear Power Program Petty officer Second Class Ship Assignments during this period:-USS Lexington CVT 16 -USS Nimitz CVN 68 Honorably Discharged Education 1973 US Naval Nuclear Power School Bainbridge, Maryland 1973 to 1974 Nuclear Power Plant Operatos's School DIG Reactor Prototype, Saratoga, New York Operator Qualified, NEC 3385 1976 to 1981 Capitol Radio Engineering Institute Washington, DC External Diploma Program Diploma Conferred, Nuclear, Engineering Technoiegy 1980 to 1981 Troy State University, Troy, Alabama Baccalaureate Degree, Summa Cum Laude Nuclear Science Management 1982 System Safety, Management Oversight and Rh 5 Tree (MORT), and Accident Investigation Workshop Ontario Hydro, Ontario, Csnada Q~s!84 Zenger, Miller Supervisor Development Program GPU Nuclear, Inc. Middletown, Penn. 1988 National Emergency Management Institute Nuclear Power Plant Accident Assessment Course 1994 US NRC, Health Physics and Radiation Protection i Course, Oak Ridge Associated Universities Oak Ridge, Tennessee, Organizations National Registry of Radiation Protection Technologist Publications

                   " Low Level Radioactive Waste Disposal Technology Developraent Through a Public Process",
                   " Transactions ofThe American Nuclear Society", Volume 60, Praented at 'the 1989 winter meeting of the American Nuclear Society, San Francisco, California O

V 51 09/10/98 Resume

Ronald J. Hamm f( RR#I Box 284 Allenwood, PA 17810 717-783-5919 (W) 717 547 6085 (H) Professional Experience 1997- present Department of Environmental Protection Harrisburg, Pa Radioactive Material Licensing 1985 - 1996 Susquehanna Health Systems Williamsport, Pa Radiation Oncology Manager 1965-1985 Divine Providence Hospital Williamsport, Pa. Administrative Director- Nuclear Medicine / Cancer Treatment Center Education 1973 1974 Harrisburg Hospital Harrisburg, Pa School of nuclear Medicine Technology-Squibb Academic Excellence Award

         '63-1965          Divine Providence Hospital I

Williamsport, Pa School of Radiologic Technology Organizations American Registry of Radiologic Technologists American Society of Clinical Pathologists Nuclear Medicine Technology Certification Board Pennsylvania Oncologic Society Society of Nuclear Medicine 4

    \J 52 09/1W98 Resume L., '

l Robert C. Maiers, P.E. O 5 708 Wooderest Avenue

                                    .Lititz, PA 17543 (717) 783-8979 (W) (717) 626-6803 (H)

Professional Experience 1992 to Present Pennsylvania Department of Environmental Protection Harrisburg, Pennsylvania Senior Nuclear Engineer. My responsibilities primarily focus on project management and contract management activities for the Low-Level Radioactive Waste Disposal Facility siting project. My ar tivities also concentrate on performance assessment issues conceming the design and construction of the Low-Level Radioactive Waste Disposal Facility to be located in Pennsylvania. To accomplish this i use computer models that analyze concrete degradation, contaminant transport, exposure pathways to the public, and the health risk that results from the exposure. I am a member of the Advanced Reactor Des Team which is composed of participants from Ohio, California, Virginia and Pennsylvania and am involved in the certification of the Westinghouse AP600 design. I am a back-up engineer for two nuclear power stations in Pennsylvania. I accompany Nuclear Regulatory Commission staff on selected inspections that ensure the health and safety of the public. I participate in emergency exercises and drills for nuclear facilities as a state representative and provide technical analysis for making protective action recommendations. 1981 -1990 Pennsylvania Power and Light Company Allentown, Pennsylvania p StafTAnalyst. My responsibilities included application and design of the meteorological monitoring and ( seismic monitoring systems utilized at the Susquehanna Steam Electric Station. In addition,I established

   \

environmental qualification of control valves used throughou: the facility. Major accomplishments included the development and maintennce of a computer data base to track all instruments installed in the facility. Education 1978 -1980 Penn State University Harrisburg, PA BS Environmental Engineering Technology 1990 - 1992 Penn State University Altoona, PA Associate of Engineering, Nuclear Engineering Technology Organizations 1995 - Present Registered as a Professional Environmental Engineer in Pennsylvania Member of the Pennsylvania Society ofProfessional Engineers Member of the National Society ofProfessional Engineers 53' 09/10/98 Resume

r e

  ,/ y f           I
  \          /                 Kenneth N. Singh PA Bureau of Radiation Protection PO Box 8469 liarrisburg, PA 17105-8469 Telephone:        717-787-2163 Experience Possess expertise in all areas of Radioactive Waste generation, processing, decontamination, packaging, transportation, storage ,$nd disposal. Have managed projects to track and determine {

l radioactive waste inventory and source term for the Commonwealth of Pennsylvania. Have I written several reports and papers in areas of radioactive waste ma :agement, decontamination, volume reduction, reactor decommissioning, etc. Also, provide engineering expertise in activities pertaining to the development of Pennsylvania Low-Level Radioactive Waste (LLRW) Disposal Facility. Develop plans and procedures for conducting inspection of LLRW generator facilities. Conduct inspections of LLRW packaging and transportation activities at Nuclear facilities. 1984 - Present Nuclear Engineer 11, PA Bureau of Radiation Protection, Department of Environmental Prntection, Harrisburg, PA. 1982 - 1983 Senior Engineer, G.P.U. Nuclear Corp., Parsippany, NJ. Senior Engineer, Rockwell Hanford Co., Hanford, WA. 1 (vJ78 - 1981 Also experienced in analysis, design, fabrication and installation ofcomponents, piping systems and relevant equipment in radwaste systems of nuclear reactors. Also prepared safety reports, )

   ,l                       engineering analysis reports, systein design description, etc. Wrote specifications for equipmen! !

and components to be procured and installed. 1982 - 1983 Senior Engineer, G.P.U. Nuclear Corp., Parsippany, NJ. 1978 - 1981 Smior Engineer, Rockwell Hanford Co., Hanford, WA. 1976 - 1978 Engineer 111, E.G. & G. Idaho, INEL, Idaho Falls, ID. Education l MS Mechanical Engineering - University of Kentucky, Lexington, KY. B.Sc. Mechanical Engineering - Aligarh M. University, Aligarh.

 !O)
  \ _./

54 09/10/98 Resume

Stuart R. Levin

                          ,,13 th Floor RCSOB                                                                                                 !

Harrisburg. PA 17120. (717) 787 5385 Professional Experience 1995 to Present Penesylvania Department of Environmental Protection l Harrisburg, PA 17105-8469  ! Chief, Division ofradiation Control Manages a statewide program for licensing statewide program for the registration ofx-ray equipment. Manages a statewide program for environ l monitorinh around nuclear' reactors and other facilities as needed. Establishes, with the concurrenc field staff, pegram priorities, policies and procedures , regarding the Division's programs. Assists in the l fonnulation of s'. ate regulations and legislation for the, control of radiation health and safety. Re radioactive material and x-ray inspection reports for consistency between the three field offices. Ass preparing budgetary estimates, departmental reports, and special projects and static's for vsarious federa agencies conceming the radiation protection program 1985 to 1995 DEP/ DER Harrisburg, PA ChiefRadioactive MaterialLicensing Section. Responsible for managing Pennsylvania's li occurring and accelerator-proouced radioactive snaterial (NARM). This includes issuing new license amendments for the medical and non-medical use of radioactive material. Other licensing ]d - guides and providing interpretation oflicensing matters to the staffand the public. r Responsible or providing personnel monitoring to the staff and keeping the record of their radiatio Acts as the Radiation Safety Officer or Site Radiation Safety Officer on the Department's two NRC Radioa Licenses. 1980 to 1985 Pennsylvania Department of Environmental Resources Harrisburg, PA 17105-8469 ChiefEmergency Section. Responsible Dr maintaining and improving the Bureau of Radiation Pl for Nuclear incidents. This included environmental monitoring techniques and sampling systems duri Responsible for devising health physics drills as per NUREG-0654 for the Bureau's staff. Respon written procedures to support rSe emergency plan. Directed the procurement of field radiation surve during emergencies. These activities required the knowledge ofevacuation/ shelter philosophy, evaluation o effects to large populations from radiation exposures and methods ofprevention. 1968 to 1980 Pennsylvania Department of Environmental Resources Pittsburgh, PA j Western Area Health Phpicist. Responsible for state radiation protection program in 23 westem Pennsylvania counties. Supervise 1 - 2 professional persons. Ir.spect colleges, hospitals, industries, and private practitioners who use radioactive material, and medical and industrial x ray equipment. Have given i radiation safety lectures to radiologic technologists and private practitioners. Have panicipated in the { U.S.P.H.S. National Evaluation ofx-ray Trends (NEXT), Dental Exposure Normalization Technique (DENT), and Breast Exposure Normalization Technique (BENT) programs. Have performed Federal Level 11 compliance tests on certified x ray equipment. Have cssisted the US Department of Energy in O

 #                  radon sampling program at the Canonsburg Industrial Park and environs. Other duties include the j

investigation of radiation overexposures to persons from x-rays and radioactive material. ' 55 09/10/98 Resume l l l

1963 to.1966 Monsanto Research Corporation, Mound Laboratory Miamisburg, Oil i Jssistant llcalth Physicist. Administrative assistant and technical advisor to the Health Physics S of a specific building. Supervised 7 - 9 health physics surveyors 80% of the time. Responsible fo physics activities in building and its radioisotope area during absence of supervisor from tl e area, building, or plant. Frequently made decisions on safe procedures for maintenance work. Occasionally acted as Decontamination Fe.eman during his absence (supervised 7 - 10 hourly workers). Occasiona 2nd shift health physics supervisor. Responsible for health physics orientation of new personnel i building. Spent 20% of time on technical projects including some shielding design for glove bo Member of building Safety Process Committee, and the building Emergency Brigade. Education 1958 to 1963 Virginia Polytechnic Institute and State University BlacAsburg, VA B.S. in Chemical Engineering

                      - Completed Co-operative Work Program with the US Public Health Service (Radiological Health) 1967 to 1968     University of Cincinnati Cincinnati, Oil MS in Nuclear Engineering
                     - US Public Heahh Service Fellowship Organizations 464 to present Health Physics Society Training Basic Radiological Heahh (U.S.P.H.S.) 1959 1959 to present Occupational Radiation Protection (U.S.P.H.S.) 1965                   .

Radiation Protection in Industrial Radiography (AEC) 1969 Orientation in Regulatory Practices and Procedures (AEC 1970 Fundamentab of Non-lonifng Radiation (U.S.P.H.S.) 1971 Radiological Emergency Response Operations (NRC by REECO) 1977 FEMA Dose Assessment - 1980 Medical Uses of Radionuclides (NRC/ORAU) 1985 External Dosimetry (HPS Summer School) 1986 Radon: Risks, implications and Technology 198'i (SVCHPS) USNRC Special Topics Workshop - Scaled Sources & Devices 1991 FEMA Radiological Accident Assessment 1992 FEMA Advanced Radiological Assessment 1992 USNRC RASCSAL Version 2.01992 s 56 09/10/98 Resume

Martin Vyenicio p 6138 Ann Street ( Harrisburg, PA 171 11 H(717) 558-0706 Objective To obtain a Radiation Protection position where extensive experience, educational background, and proven abilities will have valuable application. Personal Summary An articulate professional with extensive experience, a solid educational background, and demonstra record ofsuccess and achievement Offers the knowledge, skills, and experience necessary to be effective in administrativc, r

• ions, and e project management.

Summary of qualincation Radiation Protection : Possess over 25 years of Commercial Nuclear Power and US Navy Radiation Protection experience Working as a Technician and Supervisor at Nuclear Power Plants . . Experienced in all aspects of Radi Protection duties . Radioactive Material control and accountability ... Routine, outage, operatir.g, and emergency Radiation Protection responsibilities . . Served as Operations Support Center RP Supervisor for emergency response duties ... RP instrumentation calibration, testing and repair... All aspects ofjob coverage duties to include contamination, airborne and radiation surveys. Administrative / Operations / Project Management: Possess strong organizational skills... Budget preparation and admmistration . Budget analysis and proposal preparation .. Proven ability to create and implement effective systems for improving productivity while maintaining quality control ... Demonstrated ability in coordinating all aspects of projects from start-up to completion . . Report generations and interpretation ... Well developed technical skills. Human Relations / Personnel / Training & Development: Proven ability to lead people and manage systems Have supervised and coordinated worknow of more than 200 technicians and clerical personnel ... Personnel administration includes; staffing, and development, labor relations, contract administration Development and implementation of training programs in accordance with industry guidelines for accredited programs. Computer /So:

• ware / Hardware & LAN:

Research, testirig and implementation of computer hardware and scRware for office use. Well versed in major sof) ware ... word processors, spreadsheets, and relational database management systems. Using dbase 111+ designed and programmed timekeeping, scheduling, accounting, and personnel evaluation programs for customer specific applications. Desigr.ed and implemented Local Area Network for office use. Upgraded all office computer equipment as necessary to mainfain maximum efficiency. Proficient in all aspects ofInternet usage including basic HTML home page de"elopment. I V 57 09/10/98 Resume

i i Experience (f1986- 1997 ' BARTLETT NUCLEAR Site Coordinator - Hope Creek Nuclear Generating Station (8/97-12/97) Supervision and coordination of 80 RP technicians, dosimetry and decontamination personnel. Lead / Assistant Lead Sr. RP Technician (6/96-6/97) Providing direction to Sr. RP Technicians and coverage for various work activities during BWR an refueling outaEe5-Site Manager - Beaver Valley Power Station (6/90-5/96) Supervision and coordination of 26 Radiation Protection supervisors, and 200 technicians, do clerical personnel ... Developed vendor competency exams Responsible for personnel adminis stafGng and development, labor relations, and contract administration in support of utility goals and objectives Dudget analysis and proposals for additional utility services and equipment. Site Coordinator- Maine Yankee Atomic Power Station (1/90-6/90) Supervision and coordination of Radiation Protection supervisors, technicians, dosimetry, decon, and clerical personnel. O Site Coordinator- Peach Bottom Atomic Power Station (i 2/86-2/90) Supervisien and coordination of Radiation Protection supervisors, technicians and clerical personnel. Consultant - Hope Creek Nuclear Generating Station (2186-12/86) Procedure writer for RP instrumentation calibration, pre-operations checks and operation. 1980- 1985 G.P.U. NUCLEAR - Oyster Cr# ek Nuclear Generating Station Radiological Controls Field Operations Deputy Manager (1/82 to 4 85) Direct supervision of14 RP Supervisors, indirect supervision of 45 RP Technicians. Personnel administration, staf0ng and development, labor relations, and contract administration in support of departmental goals and objectives. Radiological Controls Coordinator for the emerEency operations roster. Group Radiological Controls Supervisor (10/80 to 12/81) Supervision of 20-40 RP Technicians. (O ( 58 09/1a98 Resume

I l ON GENERAL ELECTRIC COMPANY ( )I977 1980Per formed all aspects of Radiation Protection duties at the following commercial nuclear power TVA, Browns Ferry Station (1/80-2/80) GPU Nuclear, Oyster Creek Station (1/80-6/80) Georgia Power Co., E.L Hatch Station (4n9-Sn91 Ca.mlina Power & Light, Brunswick Station (3n9-4n9) TVA, Browns Fery Station (5n8-2n9) Georgia Power Co., E.I. liatch Station (3n8-4nS) Pacific Gas & Electric, Humboldt Station (1 In7-in8) Carolina Power & Light, Brunswick Station (9n7 1 In7) Tokyo Electric Co., Iukushima Station (7n7-9n7) Pacific Gas & Electric, Humboldt Station ($n7-6n7) Tokyo Electric Co., Fukushima Station (367-407) iu Various RP Contractor RP Companies Indiana & Michigan Power Co., DC Cook Station (4n6-5n6) Northern States Power, Prairie Island (3n6-406 lowa Electric Co., Duane Arnold Station ((306) Boston Edison Co., Pilgrim Station (In6/3/76) Yankee Atomic, Yankee Rowe Station (10n5-12n5) Northem States Power, Monticello Station (9n5-10/75) Iowa Electric Co., Duane Arnold Station (7/75 9n5) Maine Yankee Atomic, Maine Yankee Station (405-7n5) p Northern States Power, Monticello Station (In5-2n5) t Duke Power Co., Oconee Station (1 On4-12n4) Education i THOMAS EDISION STATE COLLEGE Working on completion of BS Degree in Nuclear Technology - Radiation Protection (30 credits needed for degree) Specialized Training Quality Control Workshops - A.S Golding i DECRSX1 1 M OS, Fortran IV, Spectran-F - Canberra Industries Managerial Development Supervisory Development & Labor Relations - ) BWR Technology and Advanced Radiation Frotection Courses General Electric Co. Military I US Navy Nuclear Power School . Nuclear Prototype School Engineering Laboratory Technician School Professional Memberships

• American Nuclear Society, member

 /    \

• IIcalth Physics Society, plenary member

( )

• National Registry of Radiation Protection Technologists 59 09/10/98 Resume

James F. Barnhart s Experience 1985 - present PA Department ofEnvironmental Protection (formerly known as DER) Bureau of Radiation Protection, PO Box 8469, Harrisburg, PA 17105-8469 717 787-2163

Title:

Radiation Health PhysleH 11 1985 1993 EnvironmentalRadiation Experience Performed radon air and water alpha and gamma radiation house and school surveys usi and passive radiation sampling instrumentation. Maintained and calibrated various radiation instrumentation. Participated in national and international radon proficiency and inter-calibrati

                          - programs.

Designed laboratory instrument interface and calculation algorithms with Lotus spreadsheet DBASE database software. Also designed several relational DBASE databases that interfaced wi mainframe ORACLE relationa! computer databases using SEQUEL Plus and DBASE macros. Performed data compilation, statistical reporting and calculation, and graphing of the Pennsylva radon-in-water sampling data and radon air data. Made several statewide maps of radon distribution Pennsylvania using ORACLE database and Atlas Graphics mapping software. Taught courses on radon diagnostics and worker dosimetry for DER certification courses. C Also was a guest lecturer at several college, high school, and middle school science classes nuclear and atomic physics and radiation science k Nuclear Safety Experience 1989. present Nuclear Emergency Response Experience Participate in several Nuclear Emergency Drills in various ro!!s. The drills involve knowledge of several nuclear power plant safety systems and their consequences if they fail and use of nuclear safety syste analysis and computer modeling to determine an off-site radiation dose to the public Total accumulative time I have spent on thesejobs since I been employed by DER is 12 months. 1994. present Low Level Radioactive Waste Experience I participate in several public meetings and do public letter response concerning the Low Level Radioa Waste Site establishment process as it relates to radioactive waste steam issues, environmenta issues, licensir.g and permitting issues, engineering safeguards, and radiation health physics issues. I did a detail isotope decay analysis of the of the projected radioisotopes in the Pennsylvania Low Level Nuclear Waste facility. This was pan of a Bureau ofRadiation team effort to assess risk to the public the Pennsylvania Low Level Nuclear Waste disposal facility. 6/95 to 12/95 Acting Emergency Planning Coordinator , Thisjob was responsible for the coordination of bureau ofradiation protection for the preparation and actuality of a nuclear power plant accident or a nuclear transportation accident. This job included f

 '                   reviewing nuclear power plant emergency plans, analyzing nuclear power plant safety systems, and organizing bureau personnel for Federal Emergency Management nuclear power plant accident drills.

60 09/10/98 Resume

\]J, [ Special Projects Sax on Nuclear Power Plant Decommissioning Survey - July and August i990. I was part of the Bureau team participating in the in situ gamma survey of the GPU Saxton Nu station in Saxton, Pa. Thisjob involved hands on experience in a decommissioning survey. Quehanna Nuclear Materials Cleanup Project - April 1095 until present. This is an ongoing project which I am a part time participant. This job involves review contractor to characterize the site and the procedure for removal of nuclear material contamination. EnvironmentalEngineering Experience Employer: Metcalf and Eddy Consulting Engineers, Inc., Boston, MA. 1978-1979

Title:

Assistant Representative Engineer Performed data review, erosion and watershed rainfall accumulation calculations, map revi cost benefit repair calculations, and inspection of subcontractors repair on the EPA funded S Evaluation Survey for A!!entown, PA. Education Training non. accredited (p) Course: Applied Health Physics, Oak Ridge Associate University - A 187 hour course given over a f V week period in fall 1989. This was an intensive course in applied health physics and nuclear safet Computer Courses: Advanced DOS, advanced database and spreadsheet, RESRAD (nuclear f decommissioni.1g software), and Arc Inf. mapping software. FormalAccreditedEducation 1976 B.S. Environmental Resource Management, Pennsylvania State University, University Park, PA. November 1976. My degree included 27 hours of undergraduate physics,24 hours of calculus and analytical geometry, and over 90 credits in environmental engineering, geography, biological and wildlife { sciences. j l 1995 MS Nuclear Engineering, University of New Mexico, Albuquerque, New Mexico. July 1995. A 36 credit hour graduate program in the college of Chemical and Nuclear engineering. Courses included t nuclear engineering, environmental radiation monitoring, particle interaction physics, FORTRAN Monti-Carlo nuclear core and shielding computer modeling, and a six credit hour thesis.

                                                                                                                   )

\v / 61 09/10/98 Resume

Louis Ray Urcluolo

  '                         4808 Peterborough Road Harrisburg, PA 17109 (787) 787-3720 f W1      (717) 545-4890 Professional Experience Bureau of Radiation Protection PO Box 8469 Harrisburg, PA 17105 I

I995 to present ChiefRadioactive MaterialLicensing Section i 1979 - l99$ Complianceinspector Primary function: Inspection of facilities using X-ray equipment and accelerator produced radioactive material in medicine, industry and research. 1975 - 1976 Other Duties: Assist in development of routine and emergency survey procedures and data for radiological emergencies. Calibrate survey equipment for gamma and airborne lodine measurement. Inst personnel in the use of radiation survey equipment. 1976 1978 Pan American World Airways Aerospace Division Cape Canaveral, Florida Sr. Health Phpicist- Supervisor ofhealth Phpics Section [ (' Provided all Health Physics services to NAS A and the U.S. Air Force for implementation of the the Kennedy Space Center and Cape Canaveral Air Force Station. Review and oversight of all rad major source launches (Voyager I & 2) coordinated multi-agency radiological contingency operation. Education 1967- 1971 Tufts University B.S. Cum Laude Astrophysics Medford. Massachusen:s l 1972 - 1974 University of Florida M. S. Health Physics Gainesville, Florida Organizations i 1975 to Present Health Physics Society Plenary Member McLean. Virginia l 4 62 09/10/98 Resume  ; i n_____... .

                                                                                                                             .I

r \ l RADIATION PROTECTION SPECIALIST

  ")

(O Definition: This is professional work in the monitoring and control of radiation and radiation producing equipment. An employee in this class performs a variety ofduties, within an assigned geographical area of the Commonwealth, involving the monitoring ofiadiation levels and regulation of facilities to insure compliance with the Commonwealth's rules and regulations governing radiation protection. Werk requires the application of these rules and regulations during the conduct ofinspections; investigations and enforcement activities. Work involves inspecting radiation sources used by hospitals, clinics, dentists, private practitioners, schooltland industries; or inspecting, calibrating, installing, maintaining, and repairing radiation detection and environmental sampling j ' equipment. Work includes investigating complaints involving exposure to radiation and investigating unusually high levels of radiation. Work also involves evaluating the methods and techniques utilized by personnel opera i radiation equipment and demonstrating improved methods and techniques designed to reduce exposure to radiation. Work also includes initiating enforcement and compliance action against violators; and providing information to special interest groups, Commonwealth, municipal and Federal officials and the public. Work includes considerable contact with users of radiation producing equipment, Commonwealth, and municipal ofGeials during the conduct of inspections, investigations, and enforcement activities to explain radiation protection rules and regulations and rnethods for their compliance. Work is assigned in the form of specific goals and objectives and the employee exercises considerable freedom in scheduling and completing the work. Work may ba reviewed in progress on new or difGcult assignments and is reviewed upon completion by a professional superior for completeness, technical accuracy, and quality. Examples Of Work: Inspects radiation sources such as x-ray equipment used by hospitals, clinics, dentists, private practitioners, schools, and industries to determine compliance with rules and regulations; determines workload, bean, orientation, KVP, MA, exposure time, operator protection, patient handling procedures, Glm sizes and distances used; and inspects the equipment for proper x-ray beam, collimation, calibration, and proper alignment. Calculates the level of radiction exposure received by the user by reviewing film badge records and radiation p expcaure reports including obtaining information on number of Sims taken per month, length of time per l (' exposure, location of operator to machine during x-ray and protective shielding used. Determines the level of radiation exposure received by the patient during various healing arts x-ray procedures by using radiation detection equipment. Determines radiation levels in areas housing radiation producing equipment of areas in close proximity to radiation producing equipment, while the equipment is being utilized, through the use of radiation detection equipment. Installs, calibrates and insures proper functioning of environmental sampling equipment such as air samplers. Performs routine preventative maintenance and major repair work on radiation detection and environmental sampling equipment including electrical and mechanical adjustments and maintaining service records and parts inventory. Investigates complaints involving radiation exposure, determines cause, how it could have been prevented, and recommends or imposes corrective measures to prevent a reoccurrence of the situation. l l l l l 1 l l l p b I 09/10/98 Job Descriptions t i

i RADIATION PROTECTION SPECIALIST (CONT.) l O

     /

Conducts Nationwide Evaluation ofX-Ray Trends (NEXT) and Exposure Normalization Techniques survey! to evaluate, operator technique and subsequent patient exposures; demonstrates techniques designed to l reduce patient exposure to radiation. Operates, calibrates and performs routine preventative maintenance to radiation detection and environmental { sampling equipment. l Collects air, water, milk and other environmental samples for radiological analysis. Removes and replaces particulate filters and charcoal cartridges from air samplers located near nuclear power plants; observes meters and records data. j Performs routine laboratory analysis ofradiological samples using standardized procedures and equipment; i{ calculates gross alpha and beta activity; reports unusual sample results to a professional supervisor. Determines compliance or non-compliance with rules and regulations; prepares appropriate letter advising I users of the results of the inspection, cites appropriate rules and regulations, and establishes time liniits for i their correction by referring to program policy guidelines. Provides advice to users of radiation produring equipment such as hospital and clinic personnel, and private practitioners on the proper use, protective devices, and safety precautions of radiation producing equipment.  ; Provides advice on radiation protection problems to co-workers and other Commonwealth agencies. Provides information to the public regarding program policies, procedures, Departmental rules and regulations either through telephone conversation o. ,,rrespondence. Interprets program policies, procedures, Departmentaliules and regulations for co-workers. Meets with representatives of Municipal, Federal, and Commonwea:th agencies to explain Department programs. Prepares letters, memer ndums, inspection reports and forms, and other correspondence to exchange information with facility v>erators, governmental officials, the public or supervisor. Operates a motor vehicle to travel to various work sites. Performs'similar work as requireo. g v} Required Knowledge. Skills,and Abilities: Knowledge of basic physical and biological principles relating to ionizing radiation and its effect. Knowledge of the Department of Environmental Resources' and Federal rules, regulations, policies, and procedures governing radiation protection. Knowledge of the precedures and techniques utilized in inspecting radiation sources used by hospitals, clinics, dentists, private practitioners, schools, and industries including determining workload, bear . orientation, KVP, MA, exposure time, operator protection, patient handling, film sizes and distances used, and proper collimation, calibration and alignment of the x-ray beam. Knowledge of the procedures and techniques utilized in investigating complaints involving exposure to radiation and investigating unusually high levels of radiation. Knowledge of the procedures and techniques utilized in conducting a radiation protection swvey. Knowledge of safety precautions required while condu: ting radiation inspections, investgations, and sun eys.

  ,m i

n

RADIATION PROTECTION SPECIALIST (CONT.) /^\ (j Knowledge of the standard enforcement procedures and appropriate Departmental policies for ensuring 1 enforcement and compliance with radiation protection rules and regulations. ' Knowledge of the common types of radiation producing equipment and sources. Knowledge of the proper application of radiation detection and environmental sampling equipment to various situations. Knowledge of Commonwealth and Departmental rules, regulations, policies and procedures goverring travel, lodging, expense vouchers, and reporting requirements. Ability to read, interpret and apply Departmental and Federal iules and regulations during the conduct of inspections, investigations and surveys. Ability to read and write English at the GED 5 level. Ability to perform mathematical calculations at the GED 5 level. Ability to meet with and secure the cooperation of hospital and clinic personnel, private practitioners, governmental officials, and coworkers to explain radiological health and safety requirements in the conduct ofinspections and in the investigation ofcomplaints. Ability to operate, calibrate, and perform routine preventative maintenance on radiation detection and environmental sampling equipment. Ability to operate, calibrate, perform routine maintenance and major repair work to radiation detection and environmental sampling equipment. Ability to demonstrate techniques designed to reduce patient exposure to radiation. Ability to explain both verbally and in written form the violation of radiation protection laws, rules and , regulations. i Ability to collect air, water, milk or other environmental samples for radiological analysis.  ! Ability to perform routine laboratory analysis of radiological samples using standardized procedures and equipment. A l Ability to establish and maintain effective working relationships with co-workers, supervisor, (O I Commonwealth and municipal officials, facility operators, and workers to facilitate inspections, investigations and surveys, Ability to operate a motor vehicle. Sufficient eye-hand motor coordination to operate, maintain, and repair radiation monitoring and environmental sampling equipment. Minimum Experience and Training: Successful completion of the training program for the Radiation Protection Trainee; or Any combination of experience and/or training which affords the applicant the required knowledge and abilities. Necessary Special Requirement: Possession of a valid motor vehicle operator's license as issued by the Commonwealth of Pennsylvania. v 3 09/10/98 Job Descriptions

NUCLEAR ENGINEER I g Definition: This is entry level professional work pertaining to the evaluation of design, construction, operation, and decommissioning of nuclear facilities within the Commonwealth. An employee in this class participates in the evaluation of the design, construction, operation, and decommissioning of a nuclear facility for conformance to engineering standards, Federal or State rules and regulations. Work includes traveling to participate in effectiveness and reliability features ofnuclear facilities and specific features to the facilities which affect plant safety; participating and assisting in on-site evaluation and inspection of nuclear plants. Work also includes participating in the review and evaluation of proposals for facilities' redesign and improvement to assure effective utilization and the attainment of safety requirement is assigned on a site basis or an individual-safeguard basis. Work is reviewed by a higher-level engineer for completeness, technical accuracy, and soundness of approach. Examples of Work: Participates in evaluation of nuc! car facilities' design, construction, operation, and 4 decommissioning to ascertair, whether they meet Federal and State safety requirements. Participates in Federal incocctions of nuclear facilities to assure that all applicable requirements are being m Participates in educating the public about nuclear safety. Reviews and evaluates industry and Federal-reports pertaining to safety or environmental impacts of nuclear facilities to ascertain whether the design, construction, operation, and decommissioning of these facilities provide reasonable ass arance of public health and safety. j Participates in the review and application for Federal permits and licenses for the construction, operation, alteration, and decomrnissioning of nuclear facilities affecting the Commonwealth. Prepares reports, letters, and memos relating to the ability of nuclear facilities and systems to operate in a manner so as to protect public health and safety. Provides consultation and assistance to other agency staffin the development and functioning of nuclear O facility emergency plans. i f V Provides assistance to the legal staff on matters of nuclear safety and environmental impact of nuclear facilities. Travels to and from work site. Performs related work as required. Required Knowledge, Skills, and Abilities: Knowledge of diverse aspects of design, construction, operation, and decommissioning of nuclear facilities. I Knowledge of environmental and safety issues related to nuclear facilities of their associated fuel cycles. I Knowledge of fundamental nuclear engineering specialties such as steady state and transient nucleonic, 1 thennal hydraulic response and heat transfer, fission processes and accompanying iadiation, radiological ' processes and accompanying radiation, radiological and structural design aspects of nuclear facilities. Ability to recognize and evaluate features ornucicar facilities which have an impact on plant safety and reliability; and to make recommendations regarding their acceptability in accordance with standard nuclear engineering practices. Ability to understand the concepts behind laws, regulations, and standards in the broad field of nuclear energy. Ability to read and write and :ommunicate orally in English. (Av)

NUCLEAR ENGINEER I(CONT.) Ability to perform-mathematical calculations at the GED 6-level. Ability to read and interpret Federal rules and regulations. i Ability to read and interpret Commonwealth and Departmental administrative rules, regulations, po and procedures. i Ability to prepare and deliver presentations to public, State, and local officials. Minimum Experience and Training: A bachelor's degree with major course work in nuclear ear enginee or Any equivalent combination of experience and training. l i I i 1 I l i 5, og/10/98 Job Descriptions

f f l j NUCLEAR ENGINEER 11 , /

    \

< ) Definition: This is advanced professional work pertaining to the evaluation of design, construction, operation, and decommissioning of nuclear-facilities within the Commonwealth. An employee in this class evaluates or causes to be evaluated those engineered safeguard, radioactive waste treatment, and other systems important to the safety of these facilities as to their effectiveness and reliability in protecting the citizens and their environment from the possible effects of abnormal operation or accident. This includes travel for the continuing evaluation of those systems important to safety that may require redesign and improvement, so as to assure the Commonwealth that these facilities can be operated safely and that state-of-the-art designs, materials, and construction techniques are being employed. Work includes providing expert testimony and assistance to legal staffin proceedings relating to matters of safety or environmental impact of nuclear facilities; providing consultation on the facility emergency plans; reviewing and evaluating technical reports dealing with diverse aspects of nuclear facilities and their related fuel cycles. Work is assigned on a site basis or on an individual safeguard basis. This individual has the authority to make technical decisions within the scope of his responsibilities. Work is reviewed by a supervisor for attainment of program goals and objectives, completeness, and results obtained. I I Examples of Work: Participates in the planning and e .elopment of systematic techniques for the evaluation of specific nuclear projects and systems. Reviews and evaluates industry and Federal reports pertaining to safety or environmental impact of nuclear facilities to ascertain whether the design, construction, operation, and decommissioning of these facilities provide reasonable assurance of public health and safety. Participates in Federal inspections or performs independent inspections of those facilities to which he may be assigned responsibility in order to provide practical and continuing assurance that all applicable requirements are being satisfied and good engineering practices are being adhered to. O Participates in informing the public about nuclear safety. ( Reviews and evaluates technical reports dealing with diverse aspects ofnuclear facilities and their fuel cycles. Participates in the interactions between Federal regulators and applicants for Federal permits and licenses for construction, operation, alteration, and decommissioning of nuclear facilities affecting the Commonwealth. Participates in the efforts of the nuclear engineering community toward optiinizing nuclear system safety and toward the furtherance of public education in matters relating to nucleer safety. - Provides consultation and assistance to other agency staffin the development and functioning of nuclear facility emergency plans. Prepares reports, letters and memoranda relating to the ability of nuclear facilities and systems to operate in a manner so as to protect public health and safety. l l l l l l [h

NUCLEAR ENGINEER II(CONT.)

 /m\

Evaluates nuclear facility design, construction, operation and decommissioning to ascertain whether they meet all applicable Federal and State requirements. Evaluates the validity of certain assumptions made in estimating the effectiveness and reliability of nuclear system components in mitigating the consequences of various system failure. Conducts on-the-job training tojunior engineers. Provides expert testimony and assistance in legal proceedings in matters related to nuclear safety. Travels to and from work sites. Performs related work as required. Required Knowledge. Skills, and Abilities: Knowledge of diverse aspects ofdesign, construction, operation,-and decommissioning light water nuclear reactors. Knowledge of the fundamental nuclear engineering specialties such as steady state and transient nucleonic, fluid dynamics, heat transfer, fission processes, fission products, and accompanying radiation, mechanical structural design aspects of nuclear plants. Knowledge of Federal rules and regulations concerning design, construction, and operation of nuclear facilities. Knowledge of diverse aspects of other environmental and safety issues related to nuclear facilities or their associated fuel cycles. Ability to recognize and evaluate features of nuclear facilities which have an impact on plant safety and reliability and to make responsible recommendations regarding their acceptability as per good nuclear practices. Ability to read and write and communicate orally in English. Ability to perform math-:matical calculations at the GED 6 level. Ability to prepare and - ayze technical reports. Ability to establis.. , maintain effective working relationships with associates, countemarts in various O agencies and agencies of other states, industry, professional and non-professional groups and organizations, i' and the general public. Ability to prepare and develop presentations to public officials and the general public. Minimum Experience and Training: Three years of experience in responsible nuclear systems safety analysis and a Master's Degree with major course work in nuclear engineering; or Five years of experience in responsible nuclear systems safety analysis and a Bachelor's Degree with major course work in an appropriate engineering or science field. or Any equivalent combination of experience and training. Necessary Special Requirement: Certain positions in this class will require licensure as-a professional engineer by the Commonwealth of Pennsylvania, or a reciprocaljurisdiction. These are positions where there can be no exemption from such licensare, as defined under Section 5, Exemption from Licensure, of the Professional Engineers Registration Law (as amended). s ( \

 \

v] 7 09/10/98 Job Descriptions

i l l p) ( V NUCLEAR ENGINEER SUPERVISOR Definition: This is supervisory professional work in the evaluation of design; construction, operation, and I

                                                                                                                               )

I decommissioning of nucicar facilities within the Cornmonwealth. An employee in this class plans, develops, and supervises a statewide program for the evaluation of the safety of nuclear facilities and coordinates this program with other radiation protection programs. Work involv travels in establishing standards and procedures for evaluation of nuclear facilities; assuring Commonwealth awareness and input into related matters affecting nuclear facilities and the nuclear fuel cycle; advising and consulting with representatives ofprofessional and key groups and regulatory agencies, such as the US Nuclear Regulatory Commission, on matters relating to nuclear facilities and the nuclear fuel cycle. Work also involves assigning work; reviewing work performance; evaluating employees' performance; preparing and sig employees' Performance Evaluation Reports; interviewing and recommending employee selection; re resolving employee grievances and complaints; approving leave requests; evaluating training needs of ) and demonstrating more efficient work methods to subordinates. Work is assigned in the form of broa{ goals and objectives, and the employee exercises considerable freedom in determining specific goals aj and program priorities. Freedom to act is limited only by broad Departmental policy, administrative directives,; appropriate State and Federal laws. Work is reviewed upon completion by a professional superior through rep and conferences for attainment of program goals and objectives, completeness, and overall program quali Examples of Work: Plans, develops, and supervises a state-wide program for the evaluation of safety of nuclear facilities and coordinates this program with other State radiation protection programs. Reviews proposed laws and regulations for possible impact on nuclear energy safety and recommends changes if necessary. Evaluates employees' work performance; prepares and signs employees' Performance Evaluation Reports. Receives grievances and complaints, conducts initial investigation into causes and conditions, discusses with employees,'and resolves or recomm-ds solutions to grievances and complaints. (O'b} Approves leave requests and revit maintains leave requests. aordinates' sick leave usage to determine if pattern of abuse exists; Exercises technical supervision and review over a staff of nuclear engineers who are assigned responsibility for review of specific nuclear facilities. Coordinates the efforts of committees and consultants as necessary for required analysis in various program phases. Establishes standards and procedures for review, evolution, and inspection of nuclear facilities. Assures Commonwealth awareness ana input into related matters affecting nuclear facilities and nuclear fuel cycle. Provides technical consultation and recommendations concerning policy decisions .o the appropriate Commonwealth officials on nuclear related matters. Advises and consults with representatives of professional and key groups and regulatory agencies, such as the US Regulatory Commission, on matters relating to nuclear facilities and the nuclear fuel cycle. V

V NUCLEAR ENGINEERING SUPERVISOR (CONT.) I s Develops and evaluates training programs' for nuclear engineering staff. Supervises the p anticipation in interactions between hi-s staff and Federal regulators and applicants for Federal permits and licenses for the construction, operation, alteration, and decommissioning of nuclear facilities affecting the Commonwealth. Participates in the efforts of nuclear engineering community toward optimizing nuclear system safety toward the furtherance of public education in matters of nuclear safety. Prepares, reviews, and evaluates reports relating to the ability of nuclear facilities and systems to opera manner's as to protect public health and safety. Provides consultation and assistance to other agency staffin the development and functioning of nuclear facility emergency plans. Provides expert testimony and assistance to legal staffin proceedings relating to matters of safety or environmental impact of nuclear facilities. Travels to and from work sites. Performs related work as required. Required Knowledge Skills, and Abilities: Knowledge of the techniques utilized in evaluating nuclear produc facilities. Knowledge of Federal rules and regulations concerning design, construction, and operation of nuclear facilities. Knowledge of diverse aspects of design, construction, operation and decommissioning oflight waterreactors. Knowledge of diverse aspects of other environmental and safety issues related to nuclear facilities or their associated fuel cycles. Knowledge of the fundamental nuclear engineering specialties, such as steady state and transient nucleonic, pI ( thermal hydraulic response and heat transfer, fission processes and accompanying radiation, in addition to associated mechanical, radiological, and structural design aspects of nuclear facilities. Skill in the supervision ofemployees. Ability to recognize and evaluate features of nuclear facilities which have an impact on plant safety and reliability; and to make responsible recommendations regarding their acceptability as per good nuclear engineering practices. Ability to establish and maintain effective working relationships with associates; counterparts in various Federal agencies and agencies of other states; counterparts in the industry sector; professional and non-professional groups and organizations; and the general public. Ability to understand the concepts behind laws, regulations, and standards in the broad field of nuclear energy. Ability to plan and direct a state-wide program for nuclear facility evaluation. Ability to read and write and communicate orally in English. Ability to perform mathematical calculations at the GED 6 level. Ability to read and interpret Federal mies and regulations. Ability to plan, organize, and assign work to subordinate engineers. Ability to evaluate employees' performance and prepare employee Performance Evaluation Reports. Ability to read and interpret co!!ective bargaining unit contracts applicable to the work performed by the unit. 1 Abi?y to read and interpret Commonwealth and Departmental administrative rules, regulations, policies, i and procedures. I n V) I j 9 09/10/98 Job Descriptions l

L i NUCLEAR ENGINEERING SUPERVISOR (CONT.) j Ability to evaluate employee training needs and request further education and training for subordinates. Ability to supervise work-activities of subordinate engineers effectively. Ability to prepare and deliver presentations to public cflicials. Minimum Experience and Training: Seven years of responsible experience in nuclear system safety analysis and a Master's Degree with major course work in nuclear engineering; or Nine years of responsible experience in nuclear system safety analysis and a Bachelor's Degree with major course work in an appropriate engineering or science field. or Any equivalent combination of experience and training. Necessary Special Requirement: Certain positions in this class will require licensure as a professional engineer by the Commonwealth of Pennsylvania, or a reciprocaljurisdiction. These are positions where there can be no i exemption from such licensure, as defined under Section 5, Exemption from Licensure, of the Professional l Engineers Registration Law (as-amended).

                                                                                                                     ]

l 1 l l 1

r [ NUCLEAR ENGINEERING SUPERVISOR (CONT.) Ability to evaluate employee training needs and request further education and training for subordinates. Ability to supervise work-activities of subordinate engineers effectively. Ability to prepare and deliver presentations to public officials. Minimum Experience and Training: Seven years of responsible experience in nuclear system safety analysis and a Master's Degree with major course work in nuclear engineering; or Nine years of responsible experience in nuclear system safety analysis and a Bachelor's Degree with major course work in an appropriate engineering or science field. or Any equivalent combination of experience and training. Necessary Special Requirement: Certain positions in this class will require licensure as a professional engineer by the Commonwealth of Pennsylvania, or a reciprocaljurisdiction. These are positions where there can be no exemption from such licensure, as defined under Section 5, Exemption from Licensure, of the Professional Engineers Registration Law (as-amended). I ' L-i l I 1 11 09/10/98 Job Des tiptions I

RADIATION IIEALTil PIIYSICIST I ( Definition: This is professional work in the control of radiological health hazards. An employee in this class independently plans and conducts inspections and surveys ofless complex radiological equipment and protective facilities to determine potential health hazards. Assignments may inc responsibility for analyzing laboratory results and preparing reports. Work assignments are received with little technical instruction and employees are responsible for determining compliance with Federal and state rules and regulations regarding radiological protection. The employee has the authority to make technical decisions within ' the assigned scope of responsibility but program goals and administrative policy emanate from a higher le Supervision may be exercised over a small number of technical employees. Work is reviewed by a highe physicist for technical quality, adherence to established standards and precedes, and for results obtained. Examples of Work: Plans and conducts inspections and surveys ofionizing radiological sources to determine compliance with radiological rules and regulations; surveys include: small users ofisotopes such as industrial radiography, x ray equipment, licensing and permit conditions. Prepares repons and makes recommendations on inspections and studies. Evaluates safety practices and equipment; demonstrates proper methods and techniques in the use of radiological equipment Conducts sampling of food, water, air and soil to determine levels of radioactivity, Interprets measurements of radiological equipment for degree of hazard. Provides information to users of radiological equipment and other interested persons on the laws and regulations governing radiation sources. Decontaminates radioactive areas concerned with a specific case, a particular incident, or an emergency. Performs related work as required. ( Required Knowledge, Skills, and Abilities: Knowledge of modern radiological health principles and practices as related to the recognition, control and elimination of radiological health hazards. Knowledge of the equipment and techniques used in the investigation, determination and analysis of radiation levels. Knowledge of state and Federal laws governing the use of radiation. I Skill in the use and maintenance of technical equipment used in the field of radiation. Ability to plan surveys and investigations to locate and properly identify radiological health hazards. Ability to recognize radiologier! health hazards. Ability to establish and maintain effective working relationships with associates; government, professional and non. professional groups; and the general public. Ability to communicate ideas clearly and concisely in oral and written form. Minimum Experience and Training: A bachelor's degree with major course work in the physical or radiological sciences or in engineering, supplemented by one year of graduate study in health physics or radiological health. Cenification by the American Board of Health Physics may be substituted for the required year ofgraduate study. l or Any equivalent combination of experience and training. 4

RADIATION IIEALTII PilYSICIST 2 h( Definition: This is advanced professional work the control of radiological health hazards. An employee in this class is responsible for conducting the more complex inspections and investigations, an directing a project in the central ofHce or in a geographical area of the state. Work encompasses inde planning and conducting surveys of more complex radiological equipment and of the larger faciliti the plans and specifications for these installations; or directs the environmental surveillance program facility. Work assignments are received with general instructions and the employee is respons selecting and interpreting applicable guidelines. The employee normally has the authority to make technical decisions within the assigned scope of responsibility. Work is reviewed upon completion by a profes for compliance with instructions and guidelines. Examples of Work: Plans and conducts surveys of more complex radiological equipment and oflarger facilities including hospital x-ray facilities and isotope laboratories. Reviews facility plans and specifications, including evaluating shielding design ofisotope facilities. Directs the environmental surveillance program at a particular facility consisting of pre-licensing inspec investigations and environmental sampling such as the Peach Bottom or the Three Mile Island nuclear reactors. Conducts environmental sampling in a geographical area of the state as part of the general environmental surveillance program. Assists in the selection of projects and in the conduct of research on the control, reduction and elimination of radiological health hazards. Assists in the development of emergency assistance plans. Performs related work as required. Required Knowledge, Skills, And Abilities: Knowledge ofmodern radiological health principles and practices as Og related to the recognition, control and climination of radiological health hazards. Knowledge of the equipment and techniques used in the investigation, determination and analysis o-E radiation levels. Knowledge of state and Federal laws governing the use of radiation. Knowledge of Department of Environmental Resources rules, regulations, and procedures relating to radiological health hazards. Ability to plan and conduct surveys and investigations to locate and properly identify radiological health hazards. i Ability to conduct applied research on a limited basis. Ability to prepare scientific and technical reports. Ability to recognize radiological health hazards. Ability to establish and maintain effective working relationships with associates, government, professional and non-professional groups, and the general public. Ability to communicate ideas clearly and concisely in oral and written form. Minimum Experience And Training: Two years ofexperience in professional radiological MIth work; and a bachelor's degree with major course work in the physical or radiological sciences or in engineering, supplemented by one year of graduate study in health physics or radiological health. Additional appropriate graduate study may be substituted for the experience required on a year-for-year basis. Certification by the American Board ofHealth Physics may be substituted for the required year of graduate study. or Any equivalent combination of experience and training. p O 13 09/10/98 Job Descriptions l l

RADIATION llEALTil PIlYSICIST3 1 Definition: This is advanced professional and supervisory work in the control of radiological health hazards. An employee in this class plans and directs the radiological program in a geographical area of the state. Work encompasses pre. licensing inspections of major facilities, evaluating accident and overexposure procedures and l l processes of a facility and directing the emergency action program in the area. Work assignments are received with l little or no technical instructions and employees are responsible for determining compliance with Federal and st I rules and regulations regarding radiation protection. The employee has the authority to make technical decisions within the assigned scope of responsibility but program goals and administrative policy emanate from a level. Supervision is exercised over subordinate physicists and technical personnel. Supervision is received from ' regional director or a higher level physicist who reviews completed work for technical quality, adherence to established standards and for program effectiveness. Examples Of Work: Plans and directs the radiological health program in a geographical area of the state which includes pre-licensing inspections, evaluating overexposure processes and procedures, directing various p and . projects and supervising professional and technical subordinates. Conducts inspections and surveys oflarge users ofisotopes including therapeutic medical clinics and services, industrial research facilities and encapsulation facilities; and of complex radiological equipment such as accelerators. Reviews reports ofinspections and surveys conducted by subordinates and recommends corrective action. Reviews plans and specifications of the most complex radiological installations. Conducts investigations of accident and overexposure to radiation. Provides training, consultation and assistance to subordinate personnel, other departmental members, and to industry and professional groups. Performs related work as required. U Required Knowledge, Skills. A: tbilities: Knowledge of modem radiological health principles and practices as related to the recognition, control a.J elimination of radiological health hazards. Knowledge of the equipment and techniques used in the investigation, determination and analysis of radiation levels. Knowledge of state and Federal laws governing the use of radiation. Knowledge of departmental rules, regulations and procedures relating to radiological health hazards. Knowledge of the principles and practices of-effective supervision. Ability to plan and direct surveys and investigations in a limited geographical area to locate and properly identify radiological health hazards. ' Ability to conduct applied research on a limited basis. Ability to plan and supervise the work of technical and professional subordinates. Ability to prepare and analyze scientific and technical reports. Ability to recognize radiological health hazards. Ability to establish and maintain effective working relationships with associates; government, professional and non-professional groups, and the general public. Ability to communicate ideas clearly and concisely in oral and written form. J l l l

RADIATION llEALTil PilYSICIST 3 (CONT.) l Minimum Experience And Training: Three years of experience in professional radiological health work; and a l bachelor's degree with major course work in the physical or radiological sciences or in engineering, suppl by one year of graduate study in health physics or radiological health. Additional appropriate gradua be substituted for the experience required on a year-for-year basis. Certification by the American Board of Heal I' Physics may be substituted for the required year of graduate study. l or Any equivalent combination of experience and training. 15 09/10/98 Job Descriptions

A RADIATION IIEALTil PIIYSICIST 4

      )

(' Of Definition: This is administrative and advanced professional work in the control of radiological health hazards. An employee in this class is responsible, in the centrai . Tee, for developing, organizing and directing phase of a statewide radiological program. Work includes directing the statewide inspection and compliance program of radiation sources and users, conducting research to develop the program and assisting in the formulatio l ofinspection and compliance criteria for radiation control; or includes formulating criteria for and directing statewide radiation surveillance prograrn and developing emergency plans for nuclear power reactors; or directs state licensing program of radiation sources which includes the human use ofisotopes by physicians or medical facilities. Assignments are received with general instructions and require the independent selection of course action for which well established or specific guidelines are not available, but duties are performed within establi departmental policies. Supervision is exercised over physicists and technicians. Supervision is received from director of the state radiological health program who reviews completed work for adherence to established sta and for program efrectiveness. Examples Of Work: Develops and directs a major phase of a statewide radiological control program; coordinates the program with other radiological health programs, Di;ects and exercises technical supervision over a staffof professional and technical personnel in the field and laboratory who are engaged in the surveillance, control and elimination of radiological hazards. Establishes standards for and supervises the design and construction of field and laboratory radiological exposure equipment; supervises a professional staff engaged in the inspection and investigation of radiation sources and users. Establishes standards for evaluating permit applications and licenses. Directs the statewide licensing program involving the development ofcriteria and standards for evaluating A license applications. (V') Conducts and assists in directing applied research and special studies in the methods of evaluating radiologica hazards and their control. Provides consultation to and participates in rendering a, stance during radiation emergencies, special problems and projects; determines state ofcompliance of real and potential radiation users and sources. Assists in the formulation of regulations and proposed legislation for the control of radiological health hazards. Advises and consults with representatives of management, lay and professional groups and regulatory agencies, such as the US Atomic Energy Commission, on matters relating to radiation control. Reviews reports for compliance with procedures, policies and regulations. Conducts and evaluates on the-job training programs for personnel. Performs related work as required. 1 L [V i l l I

/ \ RADIATION llEALTII PilYSICIST 4 (CONT.) \ ) .. Required Knowledge, Skills, And Abilities: Knowledge of modern radiological health principles and practices related to the recognition control and elimination ofradiological health hazards. Knowledge of the equipment and techniques used in the investigation, determination and analysis of radi Knowledge of state and Federal laws and regulations governing the use ofradiation. Knowledge of Department of Environmental Resources rules, regulations and procedures relating to radiological health hazards. Ability to understand the concept behind laws, regulations and standards in the field ofradiological health. Ability to plan and direct statewide surveys and investigations to locate and properly identify radiologic health hazards and effect appropriate controls. Ability to independently conduct applied research. Ability to plan and direct a staff of professional and technical personnel. Ability to establish and maintain effective working relationships with associates, professional and non-professional groups, and the general public. Ability to communicate ideas clearly and concisely in oral and written form. Minimum Experience And Training: Five years of experience in professional radiological health work, incl two years in a supervisory or administrative capacity; and a bachelor's degree with major course work in the physical or radiological sciences or in engineering, supplemented by one year of graduate study in health ph l radiological health. Additional appropriate graduate study may be substituted for the required non-superviso i non-administrative experience on a year-for-year basis. Certification by the American Board of Health Physic l be substituted for the required year ofgraduate study.

                                                                                                                           ]

/^\l t or Any equivalent combination of experience and training.  ! l l 1 l l ( 17 09/10/98 Job Descriptions

DIRECTOR, BUREAU OF RADIATION PROTECTION i / - U Definition: This is professional managerial work directing the activities of the Bureau of Radiation Protectica in the Department of Environmental Protection. The Bureau of Radiation Protection is responsible for the planning development, implementation, coordination and evaluation of statewide programs involving radiation source regulation and inspection, environmental radiation monitoring, nuclear plant safety, emergency radiation plan and response, radon monitoring, and low level radioactive waste disposal. The employee in this class directs, through subordinate managers, the activities of a professional and technical staff engaged in a variety of duties involving the statewide radiation protection program. Work involves determinin goals, objectives, and priorities for the radiation protection program; developing and implementing rules, regulations, policies, procedurcs, standards and guidelines to manage program activities; reviewing proposed legislation for possible impact on the program; and determining and preparing budgetary requests. An importa aspect of the work is dealing with federal, state and local officials and special interest groups on sensitive or controversial program issues. Work is assigned in the form of broad goals and objectives, and the employee exercises considerable independentjudgment in determining specific goals, objectives, and program priorities. Work is reviewed upon completion by the Deputy Secretary for Air, Recycling and Radiation Protection throug reports and conferences for attainment of goals and objectives and overall program quality. Examples Of Work: Directs, through subordinate managers, the planning, development, implementation, coordination, and evaluation of the statewide radiation monitoring, regulation and control programs. Directs the development of statewide policies, technical standards and procedures for permitting, monitoring, enforcement and technical assistance activities involving radiation protection programs. l Reviews and analyzes activity reports to determine work being performed, program trends, and program [m'l effectiveness. V Deselops and prepares budget and rebudget requests. N

DIRECTOR, DUREAU OF RADIATION PROTECTION (CONT.) Reviews proposed legislatior, for possible impacts on the radiation protection program and recommends wheth the Department should support or oppose the legislation. Plans and organius work, assigns work, determines work priorities, sets goals, and reviews work performan Interprets rules, regulations, policies, procedures, standards, and objectives of the organization or program subordinates. Provides advice to staff on unusual or difficult technical and managerial problems. Provides advice and information to govemment officials, industry representatives, regional program staff, an public regarding Departmental functions, programs, rules, regulations, policies and procedures. Represents the bureau or deputate in dealings with federal officials and other Commonwealth agencies. Develops and delivers speeches and presentations to special interest groups, legislators, media and the p bureau programs. Performs related work as required. Required Knowledge, Skills, And Abilities: ~ Knowledge of the Department of Environmental Protection's and federal laws, rules, regulations, policies and procedures governing radiation protection. - Knowledge of the principles, methods and techniques utilized in radiation protection programs. Knowledge of the applicable collective bargaining agreements. Skill in the supervision ofemployees. Ability to express ideas c'early and concisely, both orally and in writing. s 19 09/10/98 Job Descriptions

b DIRECTOR, BUREAU OF RADIATION PROTECTION (CONT.) () Ability to read hnd interpret Commonwealth and Departmental administrative rules, regulations, policies, and procedures. Ability to coordinate the work activities of the assigned programs and to resolve conflicts between the progra Ability to establish and maintain effective working relationships with associates, subordinates, public officials special interest groups, industry representatives, and the public. Minimum Experience and Training: A Masters degree in an engineering or scientific field related to radiation protection or health physics, and nine years ofprofessional experience in the radiation protection field. Four of the nine years of required experience must have included managerial and second-level supervisory experien or Any equivalent combination of education and experience which affords the applicant the required knowledge' skills, and abilities, and includes a minimum of four years of managerial and second-level supervisory exper Necessary Special Requirement: This position may require licensure as a Professional Engineer by the Commonwealth of Pennsylvania, or a reciprocaljurisdiction, where there can be no exemption from such licensure as defined in Section 5, Exemption from Licensure, of the Engiacer, Land Surveyor and Geologist Registration L (as amended). This position may require certification by the American Board of Health Physics. 1 i [~ N.

SYMO [ This table contains the year in uhich the experience / training was either started (ongoing) or completed l 1 l Personnel l Winston Yusko Scott ' Years with Department il 17 4 Rasic ongoing esperience and training Overall program orientation l 1986 1980 1993  ! Review of State Regulations 1986 1980 1993 Revicw oflocation of Reg. GuPes & reference material 1986 1975 1993 Inspection 1986 1980 199) Licensing 1986 1980 Transportation l 1986 1998 1998 ' DEP related esperience and training (canable of performing an inspection individually) .c Medical x-ray Mxhines 1986 1980 1995 Nuclear Medicine 1986 1975 1997 Medical Therapy 1991 19'? Industrial Radiography. 1987 1980 Irradiators Decommissioning (RESARD) 1994 1990 1996 Environmental Monitoring (EPP Drills, FEMA Training) 1987 1980 1995 investigations 1986 1980 Welllogging 1997 N RC Training Diagnostie & Therapeutic Nuclear Medicine 1988 1998

 \       Environmental Monitoring for Radiosttivity Air sampling of Radioactive. Material Respiratory Protection Transportation of Radioactive Material 1984       1998          1998
        ,tadiation Surveys Decommissioning irradiator Technology Safety Aspects of Welllogging 1997 Root Cause/ Incident investigation Applied Health Physics (6 week course)

Inspection Procedures 1998 1998 E ficctive Communication for inspectors (Write to the Point) 1995 1995 OSHA Indoctrination int. Dosimetry & W. D Counting leletherapy & Brachytherapy Safety Aspects of Industrial Radiography 1998 1994 Health Physics Technology Licensing Practices and Procedures 1998 1998 Emergency Response Training , RERO 1988 1998 ARIO Plume I" ase 1989 1980 1996 Post Plume Phase 1989 1996 lManseement Signature l l l l

 \

vl

1 SWRO This table contain s the year in which the experience / training was either star \ / V Personnel Swab Bostjancie Shuleski Years with Department 23 4 5 Rasic ongoir.g esperience and training Overall program orientation 1975 1996 1994 Review of State Regulations 1975 1996 1994 Review oflocation of Reg. Guides & reference material 1975 1996 1994 Inspection 1975 1996 1994 Licensing Transportation 1998 1998 DEP related esperience and training (capable of performing a n inspection individually) Medicai x-ray Machines 1975 1996 1995 Nuclear Medicine 1977 1998 1993 Medical 1herapy 1998 Industrial Radiography. Irradiators Decommissioning (RESARD) 1998 Environmental Monitoring (EPP Drills, FEM A Training) 1975 1998 1995 investigations 1998 Welllogging 1997 NRC Training M Diagnostic & Therapeutic Nuclear Medicine i 1993 Environmental Monitoring for Radioactivity Air sampling of Radioactive. Material Respiratory Protection Transportation of Radioactive Material 1998 1998 Radiation Surveys - Decommissioning irradiator Technology Safety Aspects of Welllogging 1997 Root Cause/ Incident Investigation Applied Health Physics (6 week course) 1996 Inspection Procedures 1998 1998 Effective Communication for inspectors (Write to the Point) 1995 OSHA Indoctriration int. Dosimetry & W. B Counting 1998 Teletherapy & Drachytherapy Safety r.spects of Industrial Rt " , fraphy Health Physi ~ Technology j Licensing Practices and Proceoures l Emergency Response Training M RERO 1998 1995 ARIO 1998 Plume Phase 1996 Post Plume Phase 1996 l g l Management Signature l l l l t k V

SWRO () D This table contains the year in which the experience / training was either star Personnel Huskulink Rittiger Angelo Years with Department 4 10 flasic ongoing caperience and training Overall program orientation 1994 1987 Review of State Regulations 1994 1987 Review oflocation of Reg. Guides & reference material Inspection 1094 1987 Licensing 1994 1987 Transportation 1987 1998 1998 1998 DEP related esperience and training tempable of performing an inspection individually) Medical a ray Mxhines 1995 1987 Nuclear Medicine 1996 1988 Medical Therapy Industrial Radiography. 1988 trradiators 1989 Decommissioning (RESARD) 1990 1987 1980 Environmental Monitoring (EPP Drills. FEM A Training) { 1987 1987 investigations i Wellloggmg 1987 j N RC Training [ \ Diagnostic & Therapeutic Nuclear Medicine (b Environmental Monitoring for Radioactivity 1987 Air sampling of Radioactive. Material 1987 Respiratory Protection l 1987 Transportation of Radioactive Material 1998 1998 Radiation Surveys Decommissioning 1987 Irradiator Technology Safety Aspects of Welllogging Root Cause/ Incident investigation Applied Health Physics (6 week course) thspecilon Procedures 1998 1998 Effective Communication for inspectors (Write to the Point! 1995 OSH A indoctrination 1987 Int. Dosimetry & W. D Ceunting Teletherapy & Brachytherapy Safety Aspects ofIndustrial Radiography 1987 1998 Health Physics Technology Licensing Practices and Procedures Emergency Response Training RERO 1995 ARIO Plume Phase Post Plume Phase 3 l Management Signature I l I I L n

SVmo (,m} This table contains the year in which the experience / training was either star Personnel Woods Shearer Andresky Years with Department 7 4 6 Na5Le e'ngoing esperience and training Overall program orientation 1988 1994 1993 Review of State Regulations 1988 1994 1993 Review oflocation of Reg Guides & reference material 1988 1994 1993 Inspection 1988 1094 1993 Licensing 1988 1993 Transportation 1988 1998 1993 DE P related es perience and training (espable of performing an inspection individually) Medical x-ray Machines 1988 1995 1993 Nuclear Medicine 1989 1996 1993 Medical Therapy 1989 1993 Industrial Radiography. 1989 1993 Irradiators 1990 1993 Decommissioning (RESARD) 1990 1993 Environmental Monitoring (EPP Drills, FEMA Training) 1988 1996 1993 investigations 1988 1993 Welllogging 190) NRC Training '

     )       Diagnostic & Therapeutic Nuclear Medicine 1

Environmental Monitoring for Radioactivity Air sampling of Radior.ctive. Material Respiratory Protection Transportation of Radioactive Material 1998 1989 Radiation Surveys . Decommissioning Irradiator Technology Safety Aspects of Welllogging Root Cause/Inr' ent investigation i Applied Healt, /hysics (6 week course) Inspection I-rocedures 1998 1998 EITeetive Cornmunication for inspectors (Write to the Point) 1995 OSHA Indoctrination Int. Dosimetry & W. D Counting 1998 Teletherapy & Brachytherapy Safety Aspects of Industrial Radiography 1998 1994 Health Physics Technology Licensing Practices and Procedures Emergency Responte Training RERO 1995 ARIO Plume Phase 1996 Post Plume Phase 1996 i 1 (N l Management Signature l f\ l l l L

1 ? SCRO v This table' contains the year in which the experience / training was either started (ongoing) or completed Maher Kopenhaver Kitzer Gardosik Years with Departmen' 14 25 2 5 Basic ongoing esperience and training ^ Overallprogram orientation 1989 1972 1996 Review of State Regulations 1992 1989 1972 1996 Review of location of Reg. Guides & reference material 1992 Inspection 1989 1972 1996 1992 1989 1972 1996, Licensing 1992 Transportation 1987 1973 1992 1975 1989 1992 UEP nisted esperiente and training itspsble of perfoming an inspecties individually) Medical a-ray Machines Nuclear Medicine 1971 1972 'l996 1992 1971 1972 Medical Therapy 1994 1971 1971 Industrial Radiography. Irradiators 1972 Decommissioning (RESARD) 1996 Environmental Monitoring (EPP Drills. FEMA training) 1989 1972 1794 investigations Welllogging NRC Training Diagnostic & Therapeutic Nuclear Medicine Q Environmental Monitoring for Radioactivity Air sampling of Radioactive. Material 1971 -1998 1986 Respiratory Protection Transportation of Radioactive Material 1998 1998 Radiation Surveys - Decommissioning irradiator Technology 1985 Safety Aspects of Welllogging Root Cause' Incident investigation Applied Health Physics (6 week course) 1985 1998 Inspection Procedures 1998 1988 l EITective Communication for inspectors (Write to the Point) ) 1996 1996 OSHA Indoctrination 1986 Int. Dosimetry & W. B Counting Teletherapy & Brachytherapy 1971 Safety Aspects of Industrial Radiography Health Physics Technology 1998 Licensing Praettees and Procedures 1973 E mergency Response Training # RERO ARIO Plume Phase 1990 1980 1997 1996 Post Plume Phase 1991 [ Management Sigrature i l l l l l k

SCRO m [\ }

      /

This table contains the year in which the experience / training was either s

  \~#

Personnel Peffer Years with Department 5 Basle ongoing experience and training Overall program orientation 1992 Review of State Regulations 1992 Review oflocation of Reg. Guides & reference material 1992 Inspection I992 Licensing 1992 Transponation 1992 DE P reimd neerience end scianine tempaide eri e, forming an snepecisen indi.id..riri Medical x-ray Machines . 1992 Nuclear Medicine 1992 Medical Therapy Indus;ial Radiography. Irradiators Decommissioning (RESARD) Environmental Monitoring (EPP Drills, FEMA training) Insestigations Wellloggine NRC Training / \ Diagnostic & Therapeutic Nuclear Medicine \ ) Environmental Monitoring for Radioactivity b# Air sampling of Radioactive. Material Respiratory Protection Transportation of Radioactive Material Radiation Surveys - Decomrnissioning irradiator Technology Safety Aspects of Welllogging Root Cause/ Incident Investigation Applied Health Physics (6 week course) Inspection Procedures 1998 Effective Communication for inspectors (Write to the Point) OSHA Indoctrination Int. Dosirnetry & W. B Counting Teletherapy & Brachytherapy Safety Aspects of Industrial Radiography llealth Physics Technology Licensing Practices and Procedures Emergency Response Training RERO ARIO Plume Phase 1996 Post Plume Phase

 ,C]    l Management Signature l      l v.

SERO This table contains the year in which the esperience/ training was either started (ongoing) or Personnel Michelle Rutzmoser Parsl Cosgrove] Years with Department i 6 4 5 Rasle ongoing es perience and training Overall program orientation Review of State Regulations 1997 1992 1993 1993 1997 19^2 1993 Review oflocation of Reg. Guides & reference material 1993 Inspection 1997 1992 1993 1993 Licensing 1997 1992 la93 1993 Transportation 1994 1992 1994 1992 0E P imed nperience end erminins eespabie er perferimin in in.p,crin. indi.id sivi Medical x-ray Machines Nuclear Medicine 1997 1994 1993 1993 Medical Therapy 1993 1995 1994 1994 Industrial Radiography. 1903 trradiators 1998 1994 Decommissioning (RESARD) Environmental Monitoring (EPP Drills FEMA training) InvestiFations 1998 1995 1993 Welllogging 1997 1995 1994 N RC Training

                                                                                                             /

, Diagnostic & Therapeutie Nucicar Medicine ( Environmenta! Monitoring for Radioactivity Air sampling of Radioactive. Material Respiratory Protection Transportation of Radioactive Material Radiation Surveys . Decommissioning irradiato* Technology Safety Aspects of Welllogging Root Cause/ Incident investigation Applied Health Physics (6 week course) Inspection h vedures 1998 1998 EfTective Communication for Inspectors (Write to the Point) OSHA Indoctnnation 1994 Int. Dosimetry & W. B Counting 1998 1998 1998 Teletherapy & Brachytherapy Safety Aspects of Industrial Radiography Health Physics Technology Licensing Practices and Procetures Emergency Response Training M RERO ARIO 1997 Plume Phase Post Plume Phase 1995 1996 1994 1995 1996 1994 A jManseement Signature I  ! l l l

\

w 1 1 l I

SERO b This table contains the year in which the experience / training was either s N .)\ Personnel Prvber Koshy Gaisior Au Years with Department 7 3 9 5 Basic ongoing esperience and training Overall program orientation 1991 1994 1989 Review of State Regulations 1993 1991 1994 1989 Peview oflocation. of Reg. Guides & reference material 1993 1991 1994 1989 1993 Inspection 1991 1994 1989 1993 Licensing 1991 Transportation 1996 1996 1996 1906 t,{ ... d espe,$ence sad trainine <cipsbie of performine sa 6mpection ladi idus*19 Medical way Machines 1991 1994 1989 1993 Nuclear Medicine 1991 1994 1991 1994 Medical Therapy Industrial Radiography. l 1991 1996 frradiators Decommissioning (RESARD) 1995 Environmental Monitoring (EPP Drills FEMA training) 1993 1995 1990 1993 investigations 1 Well logging 1993 NRC Training Diagnostic & Therapeutic Nuclear Medicine Environmental Monitoring for Radioactivity Air sampling of Radioactive. Material Respiratory Protection Transportation of Radioactive Material Radiation Surveys . Decommissioning Irradiator Technology Safety Aspects of Welllogging Root Cause/ Incident Investigation Applied Health Physics (6 week course) Inspection Procedures 1998 EfTective Communication for Inspectors (Write to the Point) 1995 OSHA Indoctrination Int Dosimetry & W. B Counting 1998 1998 1998 Teletherapy & Brachytherapy Safety Aspects of Industrial Radiography Ucalth Physics Technology Licensing Practices and Procedures Emergency Response Training RERO 1992 1990 1996 ARIO Plume Phase 1992 1995 1990 1993 Post Plume Phase 1993 1995 1992 1993

  ,A     l Management Signature l                                                                                           I      l         l        l      l         I V

\

SERO This table contains the year in which the experience / training was either s Personnel Hunter Derstine Shanbaky Karron Years with Department 4 9 11 ;0 Basic ongoing experience and training Overall program orientation 1994 1989 1985 1986 Review of State Regulations 1993 1989 1985 1986 Review oflocation of Reg. Juides & reference material 1989 1985 1986 Inspection 1993 1989 1985 1986 Licensing Transportation 1986 1996 1985 1986 DEP reinied esperience and ersining unpsbie orperferining an inspects. Indi idusilyn Medical x-ray Machines 1994 1989 1983 1986 Nuclear Medicine 1996 1989 1985 1986 Medical herapy 1994 1986 Industrial Radiography. 1996 1994 1986 Irradiators 1995 1992 Decommissioning (RESARD) 1990 Environmental Monitoring (EPP Dnlis, FEMA training) 1994 1990 1992 1986 Investigationt 1986 Well logging NRC Training ' Diagnostie & Therapeutic Nuclear Medicine Environmental Monitoring for Radioactivity Air sampling of Radioactive. Material Respiratory Protection Transportation of Radioactive Material 1991 Radiation Surveys - Decommissioning 1990 Irradiator Technology Safety Aspects of Well logging Root Cause/ Incident investigation Applied Health Physics (6 week course) inspection Procedures 1998 1998 Effective Communication for Inspectors (Write to the Point) 1994 1995 1986 OSHA Indoctrination Int Dosimetry & W. B Counting 1998 Teletherapy & Brachytherapy 1996 1991 Safety Aspects of f +1ustrial Radiography 1994 1991 Health Physi:s Technology 1993 Licensing Practices and Procedures Emergency Response Training RERO 1997 1992 1992 1996 ARIO Plume Phase 1996 1990 1996 1996 Post Plume Base 1996 1990 1996 1996

  ]   l Management Signatur e l        l         l          l          l G

Cantral Offica This table contains the year in whlch the experience / training was eitner statted (ongoing) or completed Personnel % Lewm Urciuolo Hamm Kirk Janati Years with Depart,nent 30 22 2 7 13 Basic onening esperience and training Overall program orientation 1968 1975 1997 1992 Review of State Regulations ongoing ongoing ongoing ongoing Review oflocation of Reg. Guides & reference material ongoing ongoing ongoing ongoing inspection 1980 1995 Licensing 1995 ongoing Transportation 1995 ongoing DE P reizied esperience sad trinatne icspebie of perform.n sa inspee6 individesity> * [g Medical x-ray Machines 1980 1995 Nuc1 car Medieme 1985 ongoing Medical Therapy 1980 ,..igoing Industnal Radiography. 1980 ongoing irradiators Decommissioning (RES ARD) ongoing Environmental Monitoring (EPP Drills FEMA traming) ongoing ongoing ongoing l Investigations ongoing ongoing Well logging 1980

        % RC Training Diagnostic & Therapeutic Nuclear Medicine m     Environmental Monitoring for Radioactivity Air sampling of Radioactive. Matenal m;,.N Protection a ransportation of Radioactise Material 1998                       1986 Radiation Surveys Decommissioning Irradiator Technology Safety Aspects of Well logging Root Cause/ incident investigation Applied Health Physics (6 week courg ,

1998 Inspection Procedures 1983 EITectise Communication for inspectors (Write to the Point) OSH A Indoctnnation int. Dosimetry & W. B Counting Teletherapy & Brachytherapy 1998 1998 Safety Aspects ofIndustrial Radiography 1%9 1994 Health Physics Technology Licensing Practices and Pts:edures 1970 1996 Medical Uses of RadionFelides 1985 Health Physics Engineering 1996 HP Topical Review 1996

                                                                                                              ~       ~

Emergency Response Training RERO 1977 1988 ARIO 1997 Plume Phase 1992 1994 1997 1994 Post Plume Phase 1992 1989 1994 l Management Signature l l l l l { v Page 10

I Centrd Offico This table contains the year in which the experience / training was either s

 \               Personnel       '

Bamhart Maiers Murphy Smgh Years with Department 13 6 Il 14 Basic ongoing esperience and training Overall program orientation Review of State Re -lations Review oflocation vf Reg. Guides & reference material Inspection Licensing Transportation DEP *etawd esper6ence end ersialas fespable of performias sa lospection indMduale Medical x ray Machines Nuclear Medicine Medical Therapy industrial Radiography. Irradiators Decommissioning (RESARD) Environmental Monitonns (EPP Drills, FEMA training) Investigations Welllogging N RC Training Diagnostic & Therapeutic Nuclear Medicine 1994

     %        Environmental Monitoring for Radioactivity I     Air sampimg of Radioactive. Matenal N          Respiratory Protection Transportation of Radioactive Material 1998 Radiation Surveys - Decommissioning irradiator Technology Safety Aspects of Welllogging Root Cause/ Incident investigation Applied Health Physics (6 week course)                                                                     1994    1993 laspection Procedures Effective Communication for inspectors (Write to the Point)

OSHA Indoctrination int. Dosimetry & W. B Counting Teletherapy & Brachytherapy Safety Aspects ofIndustrial Radiography Health Physics Technology Licensing Practices and Procedures i Medical Uses of Radionuclides ' Health Physics Engineering HP Topical Review Emergency Response Training j 7CRO ARIO I Plume Phase I Post Plume Phase l l Management Signature l l l l l ('v / Page 11

Southeastern Region (SERO) Manufacturer Model Type Total Number l l Kiethley 36150 QTPi 17 36155 Q T Pi 1 Victoreen 06-526 Ion Chamber 15 06-525 Ion Chamber 1 07-473 3 07-457 4 07494 i PDAD 2 Ludlum 19 Gamma Scintillator 4 18 Ratemeter i Da'.a logger 3 Eberline E-120 GM 4 E-520 GM 3 PIC 6A LogIon 3 PIC 6B LogIon 1 MDH 1015 lon Chamber 17 3469 Ion Chamber 1 1647 lon Chamber 1 Dosimeter Corp. 5 Dosimeter 1 50 Dosimeter 1 870 Dosimeter 6 RTI Mini-X Plus KVP meter 7 PMX-IR KVP meter 2 ' Mini-X 110 KVP meter 1 Mini- X 110A KVP meter 5 PMXII KVP meter 4 RADECO 810 AirSampler 1 l H-810DC Air Sampler 2 Unfors QA 9002 KVP meter 9 Radcal 3036 i Nuclear Assoc. 18-2220 Mammo phantom 2 Holiday Industries Hi-3600-12 1 i 1 09/10/98 Equipment

,A > Southwestern Region (SWRO) Manufacturer Model Type Total Number Victoreen 303 Ion Chamber 1 89-55 Gamma 1 2000 A Charger 2 886-1 Alarming Dosimeter i Ludlum 19 Gamma Scintillator 8 43-65 Alpha 2 44 116 Beta 1 44-38 Beta Gamma 3 44 16 Gamma 3 44-9 Beta Gamma 3 44-1 Beta 1 42-4 Neutsun 1 44-10 Gan ma 5 44-17 Low E Gamma 2 42-9 Neutron 1 44-21 Low E Beta Gamma 2 HP 360 Beta 2 77-3 Teletector 1 44-40 Beta  ! 2241-2 Alpha 2 Eberline E-120 GM 17 E-520 GM 7 PIC 6A LogIon 4 PIC 6B Logion 1 140 N GM 2 HP 270 Bem Gamma 4 HP 210 Beta Game:a 3 HP 210L GM 2 HP 190A Beta Gamma 1 AC3 Alpha 2 RD 14 Alpha 1 PRM 4 Ratemeter 1 SAC 3 Alpha counter 1 SAC 4 Alpha counter 1 { SAM 2 Assay meter 3 PAC LS/,G Alpha 2 s RO 20 Ionization meter 2 j RO 2A lon chamber  ! l BC4 Beta - 1 j i O 2 09/10.98 Equipment

Southwestern Region (SWRO) Manufacturer Model Type Total Number Kiethley 36150 Q T Pi 6 36155 Q TPi 7 MDH 1015 Ion Chamber 14 1015 FB Ion Chamber 6 Dosimter Corp. 05 Dosimeter 1 0-2 Dosimeter 1 0-200 Dosimeter 1 0-100 Dosimeter 19 0-500 Dosimeter 15 1888B Dosimeter 11 Arrow Tech 0-20 Dosimeter 15 Stephens 0-5R Dosimeter 3 0-2R Dosimeter 5 0-200 Dosimeter  !

 ,       Bendix                  0-5            Dosimeter            !

XMA (X-Rite) 331 Densitometer 15  ! 334 Sensitometer 14 333 Sensitometer 5 RTI Mini-X Plus KVP meter 3 PMX-IR KVP meter 2 Mini-X KVP meter 6 PMXII KVP meter 3 Nuclear Assoc. 156 Mammo phantom i 18-220 Mammo phantom 2 0-1500mr Dosimeter 1 0-1000mr Dosimeter 1 06-525 Rad check 1 06-526 Rad check 7 06-505 Alarming dosimeter 3 FEMA CDV 750 6 Charger 13 CD Charger 3 Bieron Micro Rem micro meter 1 Micro Analyst micro rem meter 2 Micro Rem-Low Low energy 1 O G 3 09/10/98 Equipment

Southwestern Region (SWRO) Manufacturer Model Type Total Number RADCO H 810 Air sampler 3 RADECO H 809V-1 Airsampler 1 Johnson VP-2E Varipulser 1 GP 200 Beta Gamma 1 SNSP 2A Bem Gamma 1 GP-200X50 Beta Gamma 1 PPA 2T Beta. Gamma 1 DIG 5 Scalar timer 1 Capintec Head Phantom 1 PS-033 lon Chamber 1 Dia Rad 200 Dosimeter 7 PM5 lon Chamber  ! PC 4P CT lon Chamber i Dia Rad 100 Dosimeter 4 Explorium GR 130 Gamma Spectrometer 1 Atoka PDM 203 Pocket Dosimeter 3 Unifors 9004 KVP meter 1 N 9002 KVP meter 9 Trippe PV-1000FC Inverter 3 Micro Rad GL Scalar 3 Holiday HI3002 RF meter 1 H13600 ELF meter 1 HI 3602 ELF meter 1 i HI 3615 ELF meter 1 HI3550 Static Mag monitor 1 HI 1501 Microwave 1 Ohaus Port-o-Gram 1 Nucleus 5000 Analyzer 1 Pylon AB5 Radon 2 EG&G 925 Scint. Amplifier i EDA RDA 200 Alpha 1 G $ Shield 1 RAD Electric 089-RE 247 Voltage reader 1 T FInst 5500 Leak detector 1 BTI Microspec I MCA 1 t 4 09/10/98 Equipment

Southcentral Region (SCRO) Manufacturer Model Type Total Number Victorcen 303 Ion Chamber 5 886-1 Dosimeter 1 06 526 Ion Chamber 1 06 525 Ion Chamber 1 Ludlum 19 Gamma Scintillator 4 44 38 GM energy 3 61 Air Alpha meter 2 44-16 Gamma Scintillator 31 44-9 GM Frisker 4 43-2 Alpha Scintillator 1 43-9 Alpha Scintillator  ! Eberline E-120 GM S E-520 GM 3 ) PIC 6A Logion 4 ) HP 210 GM Frisker 3 HP 210L GM Frisker i RD 14 ' Alpha Scintillatet 1

• PRM 4 Ratemeter I SAM 2 Gamma Scintillator 2 PG2 Gamma Scintillator  !

DCA 1888 B Dosimeter 3 Ladsverk L-64 lon Chamber I Kiethley 36150 Q TPi 4 36155 Q T Pi 2 MDH 1015 lon Chamber 9 XMA (X-Rite) 331 Densitometer 7 334 Sensitometer 3 333 Sensitometer 5 RTI Mini-X KVP meter 3 PMXII KVP meter 2 6 5 09/10/98 Equipment

Southcentral Region (SCRO) Manufacturer Model Type' Total Number Johnson GSP 2A Gamma Scintillator i RADECO H 809 AirSampler 2 H 810 Air Sampler 3 Holiday HI3604 ELF meter i HI3603 VDT meter 1 H13616 Remote 1 Ohaus C501 Wt. Scalier 1 Pylon AB5 Radon 2 EG&G 916 A MCB ADC PC Boar 1 T FInst 5500 Leak Detector 1 i Nucleaus 5000 I Gamma Spect. 1

                                                                          )

6 09/10/98 Equipment

Central Office (CO) Manufacturer Model Type TotalNumber Victorcen 490 Thyac Gamma Scintillator 3 440 RF Ion Chamber 2 RadectrorIII LogIon 7 Ludlum 19 Gamma Scintillator 16 18 Ratemeter 2 15 Ratemeter 1 500 Pulse Generator 1 2218 Scalier 1 Eberline E 120 GM 25 E-520 GM 9 PIC 6A LogIon 10 PIC 6B LogIon 1 RD 14 Alpha Detector 4 SAC 3 Office Counter 2 PAC LSAG Alpha Scintillator 3 RO 2A lon Chamber i BC4 Bem i PRM 4 Ratemeter 2 PAC 3G Alpha 1 i V Kiethley 36150 Q T Pi 15 36155 Q T Pi 22 MDH 1015 Ion Chamber 1 1015 FB Ion Chamber 40 10X-6M Jon Chamber 1 XMA (X Rite) 331 Densitometer 29 334 Sensitometer 13 333 Sensitometer 16 RTI PMX-!R KVP meter 4 Mini-X KVP meter 26 PMXII KVP meter 10 Nuclear Assoc. 06-525 Rad Check 3 06-527 Rad Check 21 07-473 KVP meter 6 l 18-2220 Mammo phantom 9 BTI M AA-1 Spectrometer 1 l i i i 7 09/10S 8 Equipment I

i L I MEDICAL BROAD-SCOPE INSPECTION FIELD NOTES Region License No. Docket No. Licensee (Name & Address): Licensee Contact Telephone No.

                                                                                         )

Last Amendment No. Date of Amendment Date of Last Inspection Date ofThis Inspection Type ofInspection: () Announced () Unannounced () Routine ()Special () Initial () Re-inspection i Summary ofFindings and Action: () No violations, Clear $91 issued () Violation (s),591 issued ( ) Violation (s), Regional letter issued () Follow up on Previous violations Were non-cited violations identified during this inspection? ()Y()N Was proprietary information reviewed by or received by the inspector? ()Y()N Inspector Date (Signature) j 1 Approved Date (Signature) Broad-scope 1 i

1. INSPECTION HISTORY ( ) N/A-Initialinspection h.

B. Violations were identified during the last two inspections or two years, whichever is longer Response letter (s) or $91(s) dated C. Open violations from previous inspections: Requirement Violation Corrective Action Taken (Y/N) Open/ Closed D. Explain any previous violations not corrected or repeated ( ) N/A

2. ORGANIZATION AND SCOPE OF PROGRAM A. Organizational Structure

                   +     Individuals contacted during inspection Individuals present at exit meeting

1. Meets license requirements { UC )

2. Multiple authorized locations of use ()Y()N Ifyes, may use ATTACHMENT A as a guide for locations or lab (s) inspected

()Y()N and note lab numbers where violations are found: () N/A 3. Briefly describe scope of activities, including types and quantities of use involving byproduct material, frequency of use, stafisize, etc. l l l i 1 1 Broad-scope 2-

B. Licensee does limited distribution ofpharmaceuticals' under Part 35 license

         .          1. Indicate type ofoperation:

a. Registered or licensed with FDA as a drug manufacturer

b. Registered or licensed with State Agenc as a drug manufacturer

c. Licensed as a pharmacy by State Board of Pharmacy

d. Operating as a nuclear pharmacy within a Federal medical institution

2. Licensee distributes scaled sources ()Y ()N alpha and beta emitters ()Y ()N generators ()Y ()N

                           . photon critters             ()Y       ()N Remarks:

C. Research involving human subjects () N/A

1. Research is conducted, funded, supported, or regulated by another Federal Agency which has implemented Federal Policy for Protection ofHuman Subjects'? {35.61)

()Y()N _, if no, does licensee have license amendment a.:thorizing human research? {35.61) ()Y()N

2. 2 Licensee obtains informed consent from human subjects 7 (35.61)

()Y()N 1

3. Licensee obtains approval ofresearch activities frorn an Institutional Review Board?

{35.61) Remarks: i

               ' Iflicensee distributes radiopharmaceuticals to several facilities, the inspector should consider the need to complete the radiopharmacy fieldnotes.

2 Agencies: USDA, DOE, NAS A, HUD, DOJ, DOD, VA, EPA, HHS, DOT, Dept. of Commerce, . Consumer Product Safety Commission, International Development Cooperation Agency, Agency for Intemational Development, Dept. of Education, National Science Foundation j i Broad-scope 3

D. Radiation Safety Committee (33.13,14,15) ()N/A

1. Membership as specified (35.22(a)(1))

2. Meetings held quarterly (35.22(aX2)) ()Y()N

                     ' 3. Quorums established (35.22(aX3))

()Y()N

4. Has sufficient authority (35.23) ()Y()N

1. 36: erd ofCommittee meetings (35.22(aX4)) ()Y()N

6. Approve / disapprove credentials ofindividuals prior to allowing them to work as an authorized user or authorized nuclear pharmacist (35.22(bX2Xii))

7. Approve / disapprove, applications for use ( DC )

()Y()N ()Y()N Remarks: E. . Radiation Safety Officer

1. Appointed & on license (33.13,35.21(a), DC)

2. Fulfills duties per (35.21(b))

                                                                       ^

()Y()N

3. Has sufficient authority per (35.23)

()Y()N ()Y()N F. Radiation Safety Program

1. Minor changes pursuant to (35.31)

2. Records ofchanges maintained (35.31(b))

()N/A ()Y()N

3. ()Y()N Content and implementation reviewed annually by the licensee (20.1101(c),35.22(b)(6)) ()Y()N 4.

Rec'ords ofreviews maintained (20.2102) ()Y()N G. Use by authorizedindividuals (I/C ) If no, list name/ position ofindividual ()Y()N H. Mobile NuclearMedicine Service () N/A

1. Licensee operates services per (35.29,80}

2. Compliance with 20.1301 evaluated and met

()Y()N ()Y()N Any Amendments or Notifications since last inspection (35.13,14) ()Y()N Licensee has notified NRC within 30 days aAer RSO stops work or changes name, or mailing address changes (35.14(b)) ()N/A ()Y()N Remarks: Broad-scope 4

3. (O') . TRAINING, RETRAINING, AND INSTRUCTIONS TO-WORKERS A. Instructions to workers / students per {10 CFR 19.12) B. Individual's understanding ofcunent procedures and regulations is adequate ()Y()N C. Training program required {L/C ) ()Y()N ()Y()N

1. If so, briefly describe training program:

2. Training program implemented

3. Periodic training program required ()Y()N

4. Periodic training program implemented ()Y()N

5. Records maintained ()Y()N

()Y()N Remarks: D. Supervision ofindividuals 1. Supervised individuals' are instructed in preparation of material, principles and procedures for radiation safety and QM Program as appropriate {35.25(a)(1),35.25 b)(1)) 2. Licensee periodically reviews supervised individuals use of material and records kept to reflect use {35.25(a)(3)) (G k 4 3. Authorized nuclear pharmacist or user periodically review work and records of work of supervised individuals as it pertains to preparing byproduct material (35.25(b)(3)} Remarks: () N/A () Y() N E. Therapy training

1. Safety instruction {35.310,410, L/C } 1 I

a. Control ofpatient and visitors

b. Contamination and waste

()Y()N  !

c. Size / appearance ofsources

()Y()N

d. Handling / shielding of sources

() N/A () Y () N

e. RSO notification in emergency or death

() N/A () Y ()N

f. Records maintained (35.310(b),410(b))

()Y()N ()Y()N

2. Manufacturer's instructions available and followed {35.59(a),400)

()Y()N

3. Training for Operating and emergency procedures for HDR Remote Afterloaders

() N/A () Y () N 8 Applies to individuals that receive, possess, use, transfer, or prepare byproduct material for medical [] use under supervision of authorized nuclear pharmacist or user. Broad-scope 5

e [] F. Revised Part 20 V - Workers cognizant of requirements for:

1. Radiation Safety Program {20.1101)

2. Annualdoselimits {20.1301,1302) ()Y()N

3. New forms 4 and 5 ()Y()N

4. 10% monitoring threshold {20.1502)

()N/A ()Y()N

5. Dose limits to embryo / fetus and declared ()Y()N pregnant worker {20.1208)

6. Grave Danger Posting (20.1902)

() N/A () Y() N

7. Procedures for opening packages {20.1906) .

()N/A ()Y()N

8. Sewerdisposallimits {20.2003) ()N/A () Y()N

() N/A () Y() N NOTE-Deficiencies in Section 3.F, while not always a violation, should be brought to the attention oflicensee management at the exit meeting and in the cover letter transmitting the inspection report or NOV. Remarks:

4. FACILITIES A. Facilities as described in license application B. Storage areas ()Y()N

1. Materials secured from unauthorized removal or access {20.1801)

2. ()Y{)N Licensee controls and maintains constant surveillance oflicensed material not in s;orage{20.18021)

3. ()Y()N Lice uee uses process or other engineering controls for airborne concentrations, intern.' exposures in restricted areas, and volatiles / gases in storage

{20.I70s, 1702,35.90) 4 ()Y()N Maintenance program implemented for engineering controls (negative pressure, ventilation rates, filter changes, etc.) {35.20$(e), UC ) ()Y()N C. Describe any Self-contained dry-source-storage irradiators (Part 361 and/or survey instrument calibrators (model, radionuclide, activity, use, etc) ()N/A

1. Maintenance of safety-related components performed by authorized persons ( UC ) ()Y()N .

2. Access to keys and/or material controlled {20.1801,1802, UC }

()Y()N l

3. Access to high/very high radiation areas controlled E20.1601,1602, UC) ()Y()N

4. Adequate protection ofshield integrity, fire protection {UC}

    ' Remarks:

()Y()N 1 l O V Broad-scope . 6

5. EQUIPMENT

 ,m (y./              .A.      Dose calibrator - Photon-emitting radionuclides 1.

Possessed and used {35.50(a))

2. Constancy {35.50(b)(1)} ()Y()N

a. Performed daily prior to use

b. Dedicated check source used

()Y()N ()Y()N

3. Accuracy {35.50(b,)(2))

a. Performed at installation and annually

b. At least 2 sealed sources used

()Y()N ()Y()N

4. Linearity {35.50(b)(3))

a. Performed at installation and quarterly thereafter b.

()Y()N Includes range between 30 uCi and the highest dosage administered ()Y()N 5 Geometric Dependence {35.50(b)(4))

a. Performed at installation or relocation

b. Includes range of volumes and volume configurations used

()Y()N ()Y()N

,m

( 6. Dosage readings over 10 uCi mathematically corrected for geometry or \ linearity errors greater than + or - 10% ()N/A ()Y()N

7. Repaired or replaced when constancy or accuracy errors exceeded + or - 10%

8. Approved procedures followed (35.22,25,1/C)

()N/A ()Y()N

9. Records maintained and include identity of the individual performing the test.

{35.50(e)(2)) Remarks: [~T.s r \j Broad-scope 7

p B. Instrumentation - Alpha- or beta-emitting radionuclides () N/A (' . 1. List type of equipment used to assay alpha and beta particles:

2. Licensee has procedures for use ofinstrumentation (35.52(b))

()Y()N

3. Accuracy, linearity and geometric dependence tests are performed prior to initial use, periodically, and following repair, if applicable

                                   * {35.52(b)(1), UC }

()Y()N

4. Instruments are checked for constancy and proper operation at the beginning of each dayof use {35.52(b)(2), UC)

()Y()N

5. Appropriate action taken when calibration errors in excess oflimits are identified ( UC ) ()Y()N

6. Records maintained ( UC } ()Y()N Remarks:

C. Licensee uses generators ()Y()N 1. 2. Each cluste/ extract used for radiopharmaceuticals tested for Mo-99 breakthrough No radiopharmaceuticals administered with Mo 99 concentrations over ()Y()N 0.15 uCi per mci of Tc-99m 3. ()Y()N Records maintained {35.204(c)) () Y()N D. Syringes properly labeled and shielded {35.60} E. Vials kept in a shield {35.61)(a)} ()Y()N F. _()Y()N Vial shields labeled E35.61(b)) ()Y()N Remarks:

• Linearity and geometric dependence tests are not applicable ifliquid scintillation is used.

p Linearity is not applicable if sodium iodide is used. Broad scope 8 i i

6. MATERIALS A. Licensee measures activity ofeach dosage orphoton-emitting radionuclide prior to use {35.53(a))

()Y()N B. Licensee administers alpha- or beta-emitting radionuclides

                      !fyes,                                                                                    ()Y()N 1.

Lic:nsee receives unit doses and relies on assay data supplied by manufacturer or properly licensed organization {35.53(b)) 2. Licensee measures by direct measurements or combination of measurement and calculation each dosage of alpha or beta-emitting radionuclide prior to medical use {35.53(b))( ) Y ( ) N C. Unsealed material used under 35.100,200,or 300 are 35.100(b),35.200(b),35.300(b):

1. Obtained from manufacturer or properly licased organization AND/OR 2.

Prepared by authorized nuclear pharmacist or physician user or individual under the ()Y()N supervision of a authorized nuclear pharmacist or physician user ()Y()N D. Isotope, chemical form, quantity and use as authorized E31.ll,35.400,500, UC) ()Y()N Remarks: 1 E. Use of RAM l UC } g 1. Protective clothing worn r ()Y()N ( 2. 3. 4. Personnel routinely monitor their hands No eating / drinking in use/ storage areas ()Y()N ()Y()N No food, drink, or personal effcets kept in use/ storage areas

5. Proper dosimetry worn

()Y()N

6. Radwaste disposed in proper receptacles

()Y()N j

7. No pipetting by mouth

()Y()N ) ()Y()N ) F. Radioisotopes are used in research in accordance with current procedures ( UC } () Y() N  ; G. Leak tests and Inventories I 1. 2. Leak test performed on sealed sources and brachytherapy sources {35.59(b)) Leak test records in microcuries ()Y()N  !

3. Inventory of sealed sources and brachytherapy

()Y()N sources performed quarterly {35.59(g)}

4. ()Y()N Inventory performed promptly at the storage area after removing sources from a patient to ensure all sources taket from the storage area are returned )

{35.406(a))

5. Records maintained and signed by RSO {35.59,406)

()Y()N 4 Remarks: ()Y()N O Broad-scope 9

/

7. RADIATION SURVEYS 1 /" () N/A >

(%v) .A. Survey instruments 1. Appropriate opecable survey instrumentation possessed {35.120,220,320,420, UC ) or available {35.520, UC ) i

2. Calibrations {35.51(a),(b)) () N/A () Y () N i 1

a. Before first use, annually & after repairs

b. Approved calibration procedure followed to include check source

()Y()N reading determiaation {35.51(a)(3), UC }

c. ()Y()N Within 20% in each scale or decade ofinterest { UC } ()Y()N 3.

Records maintained {35.51(d))

4. Source-checked each day of use {35.51(c))

()Y()N ()Y()N B. Radiation surveys performed I. Daily in all areas where radiopharmaceuticals are prepared or administered {35.70(a))

2. Weekly in all areas where radiopharmaceuticals

()Y()N or waste is stored {35.70(b))

3. ()Y()N  ;

Weekly wipes in all areas where radicpharmaceuticals are prepared for use, administered or stored {35.70(eM

4. Quarterly in brachytherapy source storage area

()Y()N ()Y()N

  ,-                C. Triggerlevels {35.70(d),(g))

I (. / 1. Established

2. Exceeded ( ) Y ( ) '.4

3. Corrective action taken and documented

()Y()N ()Y()N D. Techniques can detect 0.1 mR/hr,2000dpm (35.70) E. Records n.aintained {35.70(h), DC ) ()Y()N l ()Y()N F. Protection of members of the public Note: See IN 94-09 for updated guidance on conflicts between Parts 20 and 35. 1. Licensee made adequase surveys to demonstrate either (1) that the TEDE to the individual likely to receive the highest dose does not exceed 100 mr:m in a year, or (2) that if an individual were continuously present in an unrestricted area, the external dose would not exceed 2 mrem in any hour and 50 mrem in a year {20.1301(a)(1),1302(b)) ()Y()N 2. Unrestricted area radiation levels do not exceed 2 mrem in any one hour (20.1301(a)(2)) I 3. Records maintained {20.2103,2107) ()Y()N l ()Y()N G. Describe licensee's survey requirements for research areas H. () N/A Research areas surveyed as required {20.1501(a), UC } I. Re.;earch area survey records maintained (20.2103, UC) ()Y()N ()Y()N l (\x,) Remarks:

  \ ./
    ~

l Broad-scope 10 i ( .

r l

8. . Patient Release

()N/A i THE FOLLOWINO GUIDANCE IS TO BE USED AFTER THE 1997 REVISION TO 10 CF5'.3 EFFECTIVE. IF USING THIS SECTION, DO NOT ANSWER ITEMS 9.C AND 10.C BELOW. A. B. Individuals released when "EDE less than 0.5 mrem E35.75(a)) ()Y()N Instructions on ALARA provided to individual when TEDE exceeds 0.1 rem (35.75(b)) () Y () N i C. Instructions to breast. feeding women included required information (35.75(b)) ()Y()N D. E. Release records maintained if35.75(c) criteria are not met (35.75(c)) ()Y()N Records ofinstruct;ons gis en to breast-feeding women maintained if required (35.75(d)) () Y () N

9. RADIOPH/.RMACEUTICAL THERAPY

() N/A A. Safety precautions implemented to inclade patient facilities, posting, stay times, patient safety guidance, release and contamination controls (35.315(a), UC } B. Area dose rate surveys and room contamination surveys (35.315(a)(4),(7)} () Y()N C. Release ofpatients containing radiopharmaceuticals () Y()N meets <5 mR/hr @ Im g <30 mci (35.75) D. () Y f. ) N RSO promptly notified if patient died or had a medical emergency (35.315(b)) ()N/A (i Y()N 2emarks: '

10. BRACHYTHERAPY

()N/A ( A. Safetv precautions implemented to include patient facilities, room posting, stry times, and area (w radiation level surveys (35.415, UC ) ()Y()N B. Patients surveyed immediately afer implant (35.406) C. Release ofpatients with permanent implants meets ()Y()N ()N/A ()Y()N l

                           <5 mR/hr @ Im (35.75) i D.         Patients surveyed immediately after removing the last temporary implant source (required for all manual, LDR, MDR, and HDR therapies)(35.404(a))              ()N/A    ()Y()N E.        Records maintained (35-404(b),406(d),415(a)(4))

()Y()N Remarks: 1 l l l l l

     \

Broad-scope  !! M

       ' i 1. RADIOACTIVE WASTE b

g . A. Disposal () N/A

1. Decay-in-storage

() N/A

a. Approved (20.2001,35.92, UC }

b. Procedures follow-d (35.92, UC )

()Y()N

c. Labels removed or defaced (20.1904,35.92)

()Y()N ()Y()N

2. Special procedures performed as required ( UC }

3. Liquid scintillation (LS) media and animal carcasses per (20.20051

()Y()N

4. Improper / unauthorized disposals (20.2001)

()N/A ()Y()N

5. Records maintained (20.2103(a),2108, UC }

()Y()N ()Y()N B. EfQents () N/A ,

1. Release into sanitary sewer (20.2003)

()N/A ()Y()N

a. Material is readily soluble or readily dispersible (20.2003(a)(1))

b. Monthly average release concentrations do not exceed

()Y()N App B, Table 2 values

c. No more than 5 Ci ofH-3, I Ci of C-14 and 1 Ci of all other radionuclides

()Y()N combined released in a year (20.2003(a)) d. ()Y()N Procedures to ensure representative sampling and analysis implemented (20.1501, UC) O ()Y()N

2. Release into septic tank (20.2003)

a. Within unrestricted limits (App B Table 2)

()N/A ()Y()N ()Y()N

3. Waste incinerated

() N/A a. b. License authorizes (20.2004(a)(3)} Licensee directly monitors exhaust ()Y()N c. ()Y()N Remarks: Airbome releases evaluated and controlled (20.1501,1701) ()Y()N

4. Control of air effluents and ashes (20.1101,1201,1301,1501,2001, UC }

see also IP 87102, RG 8.37] ()N/A a. Air effluent less than 10 mrem constraint limit (20.1101 } ()Y()N

b. If no, licensee reported appropriate information to NRC

l. Corrective actions implemented and on schedule

()Y()N ()Y()N

c. Description ofeffluent program

1. Monitoring system hardware adequate 2.

()Y()N Equipment calibrated as appropriate 3. ()Y()N Air samples /ssrnpling technique (i.e. charcoal, HEPA, etc.) analyzed

   }                                          with appropriate instrumentation

()Y()N Broad scope 12

C. Waste Management (% () N/A (V) . 1. 2. Waste compacted

                                     . Storage area (s)                                                                 ()Y()N

() N/A a. Protection from elements and fire {UC) ()Y()N b. Control of waste maintained (20.1801) ()Y()N c. Containers properly labeled and area properly posted {20.1902,1904)

d. Package integrity maintained {UC)

()Y()N ()Y()N 3. Packaging, Control and Tracking { App. F.IIII } {20.2006(d)) Note: The licensee's waste is likely to be Class A. a. Not packaged for disposal in cardboard or liberboard boxes {61.56(a)) b. Liquid wastes solidified, i.e., less than 1% freestanding liquid, and void spaces ()Y()N minimized E61.56(a),(b))

c. Does not generate harmful vapors (61.56)

()Y()N

d. ()Y()N Structurally stable (will maintain its physical dimensions and form under expected disposal conditions) (61.56(b))

e. ()Y()N Packages properly labeled { App. F.III.A.2)

f. ()Y()N Licercee conducts a QC program to ensure compliance with {61.55,56) and includes management evaluation of audits { App. F.lll.A.3 }

g. ()Y()N Shipments not acknowledged within 20 days after transfer are investigated and reported { App. F.III.A.8)

()N/A () Y()N (N i 4. Transfers to land disposal facilities ()N/A (d

a. Transferred to person specifically licensed to receive waste (30.41,20.2001(b))

() Y()N b. Each shipment accompanied by a manifest prepared as specified in Section I ofAppendix F {20.2006(b) and App. F.III.A.41

c. ()Y()N Manifests certified as specified in Section II ofAppendix F (20.2006(c))() Y ( ) N

d. Records of surveys and material accountability are maintained

{20.2103,2108) Remarks: ()Y()N 12. RECEIPT AND TRANSFER OF RADIOACTIVE MATERIAL A. Describe how packages are received and by whem (33.13, UC ) () N/A B. Written package opening procedures established and followed (20.1906(e)} ()Y()N C. All incoming pack ges with a DOT label wiped, unless exempted (gases and special form) {20.1906(b)(1)) D. Incoming packages surveyed E20.1906(b)(2), UC ) ()Y()N ()Y()N E. Monitoring in (C) and (D) above performed within time specified (20.1906(c)) ()Y()N F. Transfer (s) between licensees performed per {30.41) ()Y()N G. All sources surveyed before shipment and transfer (20.1501(a),49 CFR 173.475(i), UC } f\ ()Y()N (v) Broad-scope 13

H. Records of surveys and receipt' transfer maintained {20.2103(a),30.51)

            ~

()Y()N 1. Transfers within licensee's authorized users or locations performed as required { IJC ) ()N/A ()Y()N J. Arrangements made for packages containing quantities of radioactive material in excess of Type A quantity (20.1906(a)) ()Y()N K. Remarks: Package receipt / distribution activities evaluated for compliance with 20.1301 {20.1302) () Y (

13. TRANSPORTATION (10 CFR 71.5(a) acd 49 CFR 171-189) () N/A A. Licensee shipments are:

() delivered to common carriers ( ) transported in licensee's own private vehicle () both ( ) no shipments since last inspection B. Licensee retums radiopharmacy doses ()N/A ()Y()N

1. Licensee assumes shipping responsibility

2. ()Y()N O C. Packages If NO, describe arrangements made between licensee and radiopharmacy for shipping responsibilities:

1

1. Authorized packages used (173.415,416)

2. Performance test records on file

()N/A ()Y()N () N/A

a. DOT-7A packages {l73.415(a))

b. Special fonn sources (173.476(a))

()Y()N ()Y()N

3. Two labels (White-1, Yellow-II, Yellow-III) with TI, Nuclide, Activity, and Hazard Class

{172.403,173.441) 1. ()Y()N Properly marked (Shipping Name, UN Number, Package Type, RQ, "This End Up" (liquids), Name and Address ofconsignee) {172.301,306,310,312,324)

5. Closed and sealed during transport {173.475(f))

()Y()N ()Y()N D. Shipping Papers ()N/A

1. Prepa.ed and used (172.200(a))

2. ()Y()N Proper Shipping Name, Hazard Class UN Number, Quactity, Package Type, Nuclide, RQ, Radioactive Material, Physical and Chemical Form, Activity, Category oflabel.

TI, Shipper's Name, Certification and Signature, Emergency Response Phone Number,

                           " Limited Quantity" (if applicable), " Cargo Aircraft Only" (if applicable)

{l72.200-204) q 3. Readily accessible during transport {l77.817(e)) ()Y()N ()Y()N Broad-scope 14

14. PERSONNEL RADIATION PROTECTION

,a (V),               ,A.

B. Licensee performed exposure evaluation E20.150!! ()Y()N Lit ensee incorporated ALARA considerations in the Radiation Protection Program (35.20,20.1101(b)) ()Y()N C. External Dosimetry ()N/A 1. Licensee monitors workers (20.1502(a), UC )

2. ()Y()N

3. Extema! exposures account for contribe tions from airborne activity (20.1203) () Y()N Supplier Frequency 4

Supplier is NVLAP-approved (20.1501(c)) 5. Dosimeters exchanged at required frequency (UC ) ()Y()N ()Y()N D. Internal Dosimetry ()N/A 1 Licensee monitors workers (20.1502, UC } 2 Briefly describe licensee's program for monitoring and controlling internal ()Y()N exposures (20.1701,1702, UC ):

3. Aerosols and gases sampled (20.1204,35.2051 }

()Y()N 4. Monitoring / controlling program implemented (includes bioassays) ()Y()N (35.205(d),315(a)(8), UC )

5. Respiratory protection equipment (20.17031 )

()Y()N ()Y()N E. Repons r i (, -) 2.

1. Reviewed by Frequency Inspector reviewed personnel monitoring records for period to 3.

Prior dose de:erminer f-or individuals likely to receive doses (20.2104) * ()Y()N

4. Maxin.um exposures TEDE Other

5. Maximum CDEs Organ (s)

6. Maximum CEDE 7.

Licensee sums internal and external (20.1202) ()Y()N

8. TEDEs and TODEs within 20.1201 limits

9. NRC forms or equivalent (20.2104(d),2106(c))

()Y()N

a. NRC-4 () Y () N Complete:

b. Y()N NRC-5 () Y () N Complete: Y()N 10. Worker declar:d her pregnancy in writing during inspection period (review records) Ifyes, licensee in compliance with (20.1208) ()N/A ()Y()N and records maintained ()Y()N ()Y()N F. Who performed any PSEs at this facility (number of people involved and doses received) I20.1206,2!04(b),2105,2204) () N/A G. Records of exposures, surveys, monitoring, and evaluations maintained (20.2102,2103,2106,35.205(d),315(a)(8), UC } ()Y()N Remarks:

   ]

L.) Broad-scope 15

15. MISADMINISTRATIONS AND RECORDABLE EVENTS If misadministrations or recordable events (defined :n 35.2) have occurred since last inspe and the licensee's quality management program (QMP) using the existing guidance. (Referen 87103)

1. Event date Information Source

2. Notifications NRC Cps Center ()Y()N Region () Y()N Referring Physician ()Y()N in writing Patient ()Y()N

()Y()N If notification did not occur, why not:

3. Written Reports l35.331 a.' Submitted to Region within 15 days

b. Copy to patient within 15 days

()Y()N ()Y()N B. Records maintained (35.33(b)) ()Y()N Remarks:

16. _NRC INDEPENDENT MEASUREMENTS A. Survey instrument Serial No. Last calibration B. Inspector's measurements were compared to licensee's C. Describe the type, location, and results ofmeasurements:

()Y()N i 17 N_OTIFICATION AND REPORTS A. Licensee in compliance with {l9.131 (reports to individuals, public and occupational, monitored to show compliance with Part 20) ()None ()Y () N B. Licensee in compliance with (20.2201) (theft or loss) C. Licensee in compliance with (20.2202) (inci&nts) ()None()Y ()N I D. ()None ()Y ()N Licensee in compliance with (20.2203}(overexposures and high radiation levels)( ) None( ) Y ( ) N E. Licensee aware ofNRC Ops Center phone number F. Licensee in compliance with (20.2203)(Constraint on air emissions) ()Y()N ()None () Y() N O Broad-scope 16

r

                                                                                                                                    ]

I p 18.' POSTING AND LABELING t . A. NRC-3 " Notice to Workers" is posted (19.11} B. Parts 19,20,21, Section 206 of Energy Reorganization Act, procedures s.dopted ()Y()N pursuant to Part 21, and license documents are posted or a notice indicating where documents can be examined is posted (19.11,21.6} C. Other posting and labeling per {20.1902,1904} and the licensee is not exempted by ()Y()N (20.1903,1905} Remarks: ()Y()N

19. RECORDKEEPING FOR DECOMMISSIONING A.

Records ofinformation important to the safe and effective decommissioning of the facility maintained in an indepen&nt and identifiable location until license termination {30.35(g)} B. Records include a!! information outlined in {30.35(g)} ()Yl)N ()Y()M Remarks:

20. BULLETINS AND INFORMATION NOTICES s

A. Bulletins, Information Notices, NMSS Newsletters, etc., received by the licensec B. Licensee took appropriate action in res. pense to Bulletins, Generic Letters, etc. ()Y()N Remarks: ()Y()N  ! I

21. SPECIAL LICENSE CONDITIONS OR ISSUES A. Special license conditions or issues to be reviewed:

() N/A j B. Evaluation:

22. DEBRIEF WITH LICENSING STAFF Inspection findings discussed with licensing staff Items discussed: ()N/A ()Y()N ,

23. CONTINUATION OF REPORTITEMS

24. VIOLATIONS. NOVS. AND OTHER ISSUES l Note:

Briefly state (1) the requirement and (2) how and when the licensee violated the requirement. For non-cited violations, indicate why the violation was not cited. k l Broad-scope i 37

25. PERFORMANCE EVALUATION FACTORS O , Licensee (name & location) Inspector Inspection Date A. Lack of senior management involvement with the radiation safety program and/or Radiation Safety Officer (RSO) oversight B. RSO too busy with other assignments ()Y()N C Insufficientstaffing ()Y()N D. Radiation Safety Committee fails to meet or functions inadequately ()Y()N

E. Inadequate consulting services or inadequate audits ()Y()N F. FinancialInstability ()Y()N

()Y()N

   ' Remarks (consider above assessment and/or other pertinent PEFS):

Regional follow-up on above PEFs citations: A Broad-scope 18

ATTACIIMENTA LABORATORYINSPECTION FIELD NOTES

1. Date Authorized User (s)

2. location (s) Building

3. Room (s)

Person (s) Contacted 4. Describe scope oflab use (Nuclides, form, fquency, purpose, etc):

5. Training A. Frequency: Conducted by:

B. Individuals interviewed understand safety practices ()Y()N Remarks:

                                                                                                                     )

i

6. Surveys A. Types ofsurveys performed (daily, weekly, monthly, etc.)

B. Instrumentation properly calibrated and used C. Efficiency of counting system determined ()Y()N D. Hood airflow adequate and checked as required ()Y()N E. Records maintained: trigger levels established, area diagram, instrument used, ()N/A ()Y()N individual performing survey, results in proper units, decontamination performed as necessary, etc. k F. ()Y()N Inspector surveyed Results satisfactory ()Y()N ()N/A ()Y()N Remarks:

7. Receipt and Transfer 4

A. Incoming packages properly surveyed B. Interlaboratory transfers performed as specified in the license ()Y()N C. Records maintained ()N/A ()Y()N ()Y()N . Remarks: l i

                                                                                                                     )

8. Personr.el Dosimetry A. Appropriate dosimetry assigt ed and worn B. - - Results availablE to lab personnel

()N/A ()Y()N C. Bionssays performed ()Y()N ()N/A ()Y()N Remarks: Broad-scope 19 1 j i

I 1

9. Handling Waste g ,A. Procedures fo!! owed B. Proper storage (area, containers, labeling, etc.)

()Y()N C. Liquid / solid waste disposal ()Y()N D. Incineration ()Y()N E. Compaction ()N/A ()Y()N F. Sewer discharge ()N/A ()Y()N G. Records maintained ()N/A ()Y()N ()Y()N Remarks:

10. Inventory conducted Reccrds Maintained ()N/A ()Y()N

()Y()N Remarks: 1

11. Storage and use of RAM A. Adequate method to prevent unauthorized access B. Condition of areas acceptable ()Y()N  !

 ;             C.

Personnel wear disposable gloves and protective clothing while handling material ()Y()N ' N D. Hands monitored after procedures or before leaving ()Y()N E. No eating, drm' king, or smoking in use/ storage areas ()Y()N F. No food, drink, or penonal items stored in use/ storage areas ()Y()N G. Use of shielding / distance while using/ storing material ()Y()N H. RAM is under surveillance and control when not in storage in an unrestricted area () Y ()N ()Y()N Remarks: 1 1

12. Posting and Labeling A. NRC-3

• Notice to Workers" B.

Parts 19,20,21, Section 206 of Energy Reorganization Act, procedures for Part 21, ()Y()N  ! j and license documents or a notice indicating where documents can be examined C. Other posting and labeling requirements met ()Y()N i ()Y()N 1 Remarks: I

13. Violations Observed N l 1

Broad-scope 20

COMMERCIAL IRRADIATOR INSPECTION FIELD NOTES REGION Inspection Report No. License No. i Docket No. Licensee (name and address) j Telephone No. Licensee Contact Last Amendment No. Date ofAmendment I Priority: Program Code: Date of Last Inspection Date of This inspection Type ofInspection: ( ) Announced ( ) Unannounced ( ) Routine ( ) Special ( ( ) initial ( ) Re inspection Next Inspection Date ( ) Normal ( ) Extended ( ) Reduced Summary ofFindings and Action: ( ) No violations. Clear 591 or regionalletter issued ( ) Violations,591 orRegionalletterissued ( ) Previous Violations ( ) Action ( )No Action i I l Inspector- . Date Approved:  ! Date  ; i Irradiator j l

1. ORGANIZATION l

a. ' Management Structure (1) Plant Manager involved in safety program? [UC]

(2) Plant Manager sets safety goals / objectives? [UC] ()Y()N

                    ' (3) Adequate budget and resources are provided to the safety program?

()Y()N (4) Corporate management supports safety through site visits. program reviews, ()Y()N and site support?[UC] ()Y()N Remarks:

b. Radiation Protection (1) Radiation protection function is separate from plant operations? [UC] ()Y()N (2) A corporate policy exists which addresses radiation safety? [UC]

(3) A trained qualified RSO assigned? [UC] ()Y()N ()Y()N (4) Radiation Protection procedures have been written and approved (UC] ()Y()N Remarks:

 \

c. Authorized Users Authorized users are qualified through training? [UC]

()Y()N Remarks:

2. LICENSEE INTERNAL AUDITS

a. Does the Radiation Safety Officer (RSO) conduct radiation safety audits? [UC] ()Y()N Frequency

b. Does corporate management conduct audits / reviews? [UC]

()Y()N Frequency

c. Does the licensee conduct annual ALARA reviews? [UC] ()Y()N

d. Are audit and review findings discussed in safety meetings? [UC] ()Y()N Remar.ks:

Irradiator 2 i j

O\ ! ! 3. ' INSPECTION HISTORY d

a. Were violations. unresolved items or deviations identified in previous inspections? ()Y()N

b. Were licensee corrective actions adequate on previous inspection findings? ()Y()N Remarks:

4. TRAINING AND INSTRUCTIONS TO WORKERS

a. Initial Radiation Worker / Operator Training (1) A formal qualification / training program has been established and implemented. [UC]( ) Y ( ) N (2) Required tests administered. test scores satisfactory. and records retained. [UC]()Y()N (3) Training program is adequate for intended purpose and contains sufficient technical depth. [UC]

()Y()N (4) Management periodically reviews training program implementation. [UC] ()Y()N

b. Retraining Program (1) A formal program has been established to retrain radiation workers / operators.[UC] () Y ( ) N (2) Retraining records are retained and reflect adequate program implementation. [UC] ( ) Y ( ) N

c. General Training (1) Instruc+ ion to workers provided [19.12]

(Q ()Y()N (2) Instn: on provided to ancillary personnel (security, custodial maintenance, etc.) [UC] ( ) Y ( ) N Rem

5. RADIATION PROTECTION PROCEDURES

a. Have operating and emergency evacuating procedures been developed and implemented?[UC]

()Y()N

b. Are manufacturer's instructions for devices uu and available?[UC] ()Y()N

c. Does the licensee maintain a logbook for recording operational data? [UC] ()Y()N

d. Is access controlled to high radiation areas? [20.203C]

(1) postings (2) locks / barriers ()Y()N (3) inierlocks ()Y()N ()Y{)N

e. Are interlocks checked periodically for operability? [UC]

()Y() N

f. Are interlocks designed such that it is difficult to tamper or intentionally defeat them? [UC] ()Y()N

g. Are restricted areas established, posted, and properly controlled? [20.203] ()Y()N

h. Are security measures in place to control or protect materials -in storage? [20.207], ()Y()N

i. Is entrance key attached to hand held survey meter? [UC] ()Y()N Remarks:

[ \ U Irradiator 3

[T 6. MATERIALS, FACILITIES AND INSTRUMENTS I

a. Is the licensee in possession of the authorized type, quantity, and form of material? [UC] ( ) Y ( ) N  !

b. Are the materials being used as authorized? [UC] ()Y()N

c. Are appropriate survey meters on hand and operable? [UC] ()Y()N

d. Are survey meters calibrated at the required frequency? [UC] ()Y()N

e. Are fixed process or area monitors operable and calibrated at the required frequency?

[UC] ()Y()N

f. Is source shroud in place and in good repair? [UC] ()Y()N

a. Type ofirradiator: ( ) carrier ( ) tote ( ) pallet

b. Manufacturer Model:

i. Mode of operation: ( ) continuous ( ) batch Remarks:

         ' 7. SOURCE LOADING AND UNLOADING

a. l Are procedures da eloped and implemented [UC] ()Y()N

b. Are transfers of byproduct material proper? [30.41] ()Y()N

a. Are labels and packaging material appropriate? [71.5] ()Y(

 -((                   ).N

d. Are records of receipt. transfer, storage survey, and monitoring maintained? [30.51] ( ) Y ( ) N

e. Does licensee know the position (by serial number and activity)of all sources? [UC] ()Y()

N Remarks:

8. PERSONNEL PROTECTION - EXTERNAL i

1

a. Personnel monitoring control: minimize exposures, control of accumulated dose

[20.101.102,104,202] {)Y()N

b. Dosimetry supplier:

c. Frequencyofexchange:

d. Type of dosimeters:

e. Maximum exposures (W.B. and extrernity):

f. Number of persons monitored:

g. Surveys conducted [20.201] ()Y()N w h. Frequency, results. records [20.401] ()Y()N

i. Levels in Unrestricted Areas [20.105] ()Y()N

 .R Remarks:

Irradiator- 4

9. LEAK TESTS / SOURCE INTEGRITY EVALUATION 3 (m) b /.

                      .a.

Are leak tests and/or source integrity evaluations conducted? [UC] (1) Are the tests conducted at regular intervals? [UC] ' ()Y()N (2) 1s the testing method sufficient to detect leakage or ()Y()N source integrity problem?[UC]

b. Is a water chemistry program established and procedures developed? [UC]

()Y()N () Y() N (1) Have chemical parameters and sampling frequency been identified?[UC] ()Y()N (2) Have appropriate limits and action levels been established? [UC] ()Y()N (3) Does the chemical sampling program include the following? [UC] ()Y()N total and suspended solids (conductivity) PH ()Y()N pool clarity ()Y()N chlorides / fluorides ()Y()N ()Y()N

c. Is the pool cleanup and cooling system operated as designed?

d. Are demineralizers used for pool Cleanup? [UC]

()Y()N (1) Are demineralizers always in operation or are they used ()Y()N intermittently? [UC] ()Y()N (2) Are radiation monitors placed on or adjacent to the demineralizer? [UC] ()Y()N (3) Are alarm set points established for those monitors? [UC] ()Y()N e. (4) Does the monitor alarm in the control room? [UC] ()Y()N Are records maintained ofleak tests and source integrity? [UC] ()Y()N Remarks: O b 10. RELEASE OF EFFLUENTS [20.106] Does licensee evaluate:

a. waterleakage from pool?

b. effluent from regeneration of demineralizer? ()Y()N

c. poolsediment? ()Y()N d.

release of demineralizer to non'icensed service company? ()Y()N ()Y()N Remarks: I1. . TRANSPORTATION (10 CFR 71.5(a) and 49 CFR 171-189)

a. Licensee makes shipments ofRAM

b. Shipments are: ()Y()N ,

5 ( ) delivered to common carriers ( ) transported in licensee's own private vehicle ( )both p) ( Remarks ( ) no shipments since last inspection Remarks. l

  %)

Irradiator 5 i i i

1 I i i i (' Complete only ifshipments made since last inspection:

                'c.           Shipments (1) Authorized packages used [173.415,416]

(2) Package type used () Y()N() N/A (3) For DOT-7A packages. Performance test record on file [173.415(a)] ( ) Y ( ) N ( ) N/A , (4) For DOT-$r. packages. use is approved by NRC [173.416(a)] () Y() N()N/A (5) Other Type B packages used are approved [173.416(a)]  ! () Y ()N()N/A i (6) Licensee has COCs on file with NRC [71-12C(l)] ()Y() N()N/A (7) Licensee has a QA program appmved by NRC [71.12(b)] ) () Y() N() N/A i

                          - (8) For special form sources, performance test record on file [173.476(a)]( ) Y ( ) N ( ) N/A (9) Packages properly labeled [172.403,173.441]

(10) Packages properly marked [173.200] ()Y ()N()N/A , () Y () N() N/A j (11) Proper shipping papers prepared and used [172.200-204] ()Y() N() N/A ' (12) Shipping papers readily accessible during transport [177.817(e)] () Y() N()N/A (13) Vehicles placard as necessary [172.500. 504] (14) Cargo blocked and braced [177.842(d)] () Y() N() N/A () Y () N () N/A i (15) Any incidents reponed to DOT [171.15 16] () Y ()N() None Remarks. 12. O NOTIFICATIONS AND REPORTS Q a. To individuals [19.13] ()Y()N

b. Overexposures. excessive levels and concentrations, incidents [20.403,405] () Y() N() None

c. Personnel exposures and monitoring termination repons [20.407,408]

()Y() N()None i

d. Theft or loss oflicensed material [20.402] () Y()N()None i Remarks:

13. POSTING OF NOTICES a.

Parts 19,20, and 21, license and documents, procedures. and Notices of Violation [19-11,21.6]

b. Form NRC-3 [19-11]

()Y()N ()Y()N Remarks: I radiator 6

14. O . EMERGENCY PREPAJDNESS a. Has an emergency plan and general implementing, procedures been developed? [UC] b. Has the plan been coordinated with appropriate offsite support authorities? ()Y()N j (e.g. local government. Emergency medical. state health authorities) [UC] -()Y()N

c. 1 Are notification procedures adequate and up to date?

d. Are management. RSO, and offsite authorities listed on the notification procedure? ()Y()N [UC]

e. Are licensee employees trained in emergency response activities? [UC]

()Y()N f. Are drills conductedi[UC] ()Y()N If"Yes,"are the drills critiqued? ()Y()N g. Are offsite officials involved in drills and training? [UC] ()Y()N ()Y()N Remarks:

15. PRODUCT MONITORING a.

Has the licensee established a program for periodically monitoring irradiated products for potentialcontamination?[UC] If"Yes."does the program include: .()Y()N (1) direct radiation surveys?[UCJ (2) removable contamination surveys? [UC] ()Y()N

b. Have action limits been established for product contamination levels? [UC]

()Y()N

c. Are the licensee's survey techniques and methods sensitive enough to detect -

()Y()N the established contamination level? [UC] ()Y()N Remarks: 16. RECORDKEEPING FOR DECOMMISSIONING a. Records ofinformation important to the safe and effective decommissioning of the facility maintained in an independent and identifiable location until license termination [30.35(g)]

b. Records include all information outlined in [30.35(g)]

()Y()N ()Y()N Remarks. 17. NRC CONFIRMATORY MEASUREMENTS [10 CFR 20.105.201] ()N/A

a. Meter used:

b. Calibration Date:

c. SerialNo:

d. Describe measurements taken and results:

Irradiator  ?

l 18. INDEPENDENT INSPECTION EFFORT Scope of program: (Results) l 1 19. CONTINUATION OF REPORT ITEMS - USE BACK OF PAGE IF NECESSARY

20. LIST OF vlOLATIONS

     - 21.

PERFORMANCE EVALUATION FACTORS Licensee (name and address) Inspector Inspection Date

a. Lack of senior management involvement with the radiation safety program and/or Radiation Safety Officer (RSO) oversight  ;

b. ASO too busy with other assignments

()Y()N i

c. Insufficient staffing

()Y()N  ; ()Y()N i

d. Radiation Safety Committee fails to meet or functions inadequately

e. Inadequate consulting services or inadequate audits

()Y()N()N/A () Y()N()N/A Remarks (consider above assessment and/or other pertinent PEFS): Regional follow-up on above PEFS citation I i q . . Irradiator 8

                                                                                                         )

RADIOPHARMACY INSPECTION FIELD NOTES Region i Inspection Report No. License No. Docket No Licensee (Name & Address): Licensee Contact Telephone No. I Last Amendment No. Date of Amendment DIte of Last inspection D:te of This inspection ' Type ofInspection: () Announced () Unannounced () Routine ()Special () Initial () Reinspection Summary of Findings and Action: () No violations, Clear 591 issued l () Violation (s),591 issued ( ) Violation (s), Regional letter issued () Followup on Previcus Violations Were non-cited violations identified during this inspection? ()Y()N V as proprietary information reviewed by or received by the inspector? ()Y()N Inspector: Date (Signature) Approved: Date (Signature) j I Radiopharmacy 1

1. INSPECTION HISTORY

()N/A Initialinspection A. Violations were identified during the last two inspections or two years, whichever is longer B. NOV or 591 dated ()Y()N C. Licensees response to NOV dated g D. Open violations from previous inspections: ()N/A j Requirement Violation Status

                                                                                                                                        )

Corrective Action Taken (Y/N) Open/ Closed l E. Explain any previous violations not corrected or repeated () N/A

2. ORGANIZATION AND SCOPE OF PROGRAM A. Organizational Structure Describe O List individuals contacted during inspection j

l

                +       Individuals contacted during inspection Individuals present at exit meeting

1. Multiple authorized locations of use

()N/A If so, list locations inspected 2. Briefly describe scope of activities, including types and quantities ofuse involving byproduct material, frequency of use, statisize, # of group medical licensees and physic'ans served, work hours, etc.

3. Licensee distributes / redistributes l

1 sealed sources alpha and beta emitters ()Y()N  ! generators ()Y()N  ! photon emitters ()Y()N ()Y()N

4. Licensee is registere& licensed by FDA/ State Agency as a drug l

manufacturer or a nuclear pharmacy ()Y()N ] If yes, is registration / license cunent? ()Y()N { Rrdiopharmacy 2 I

                                                                                                                        )

B. Radiation Safety Officer Ci ( ) .l. Named on license [UC] ()Y()N 2. 3. Fulfills duties as described in license [UC] Ilas sufficient authority to carryout duties [UC)) ()Y()N ()Y()N C. Radiation Safety Program 1. Content and implementation reviewed annually by the licensee [20.1101(c), UC]

2. ()Y()N 3.

Records of reviews maintained [20.2102] Independent Audit Program [UC] ()Y()N ()N/A () Y () N (a) Audits conducted by (b) Frequency 4. Corrective actions taken in response to audit findings ( ) N/A ( ) Y ( ) N D. Use/ preparation by authorized individuals [UC] ()Y()N ITEMS I AND 2 APPLY TO LICENSED PHARMACIES OR PHARMACIES WIT 111N FEDERAL INST AND NOT TO FACILITIES THAT ARE REGISTERED / LICENSED BY FDA/ STATE AGENCY AS A DRUG MANUFACTURER 1. Authorized Nuclear Pharmacist (ANP) [32.72(b)] A. ANP must meet at least one criteria (1) Qualifies as nuclear pharmacist as defined in 35.2 [32.72(b)(!)] Identified as ANP on NRC or Agreement State nuclear pharmacy license ()Y()N Identified as ANP on permit issued by NRC or Agreement State Broad Scope license (2) ()Y()N (3) Listed on license [32.72(b)(2)(i)] ()Y()N Grandfathered - Listed as authorized user on a nuclear pharmacy licensed issued by NRC prior to 12/2/94 [32.72(b)(4)) ()Y()N

2. Drugs are prepared by ANP or individual under the supervision of an ANP [32.72(b)(1)]

()Y()N 3. Sufficient number of authorized users on staff to cover all shifts ()Y()N

4. Licensee has provided NRC with appropriate documentation to support ANP's credentials no later than 30 days after individual starts work as an ANP' [32.72(b)(5)] ()N/A ()Y()N Remarks:

i

          ' Not applicable iflicensee has obtained a license amendment listing individu*' 3s ANP. [35.72(b)(2)(ii)]

(v ) Radiopharmacy 3 l

3. TRAINING. RETRAINING, AND INSTRUCTIONS TO WORKERS _

(' 4. B. Instructjons to workers [19.12] ()Y()N Individual's understanding ofcurrent procedures and regulations is adequate (normal and emergency) C. Training program required2 [UC,30.33(a)(3)] ()Y()N ()Y()N

1. If so, briefly describe training program:

2. Training program implemented

3. Periodic training program required

()Y()N

4. Periodic training program implemented

()Y()N

5. Records maintained

()Y()N ()Y()N D. Supervision ofindividuals by authorized user in accordance with [UC] ()Y()N Supervising ANP periodically reviews work of supervised individuals and records kept to reflect work [UC] ()Y()N Authorized nuclear pharmacist present during drug preparation if required by State Board [UC] ()Y ()N Remarks: C . Revised Part 20

                 'A orkers cognizant of requirements for:

1. Radiation Safety Prrgram [20.1101]

2 2. Annual dose limits [20.1301,1302] ()Y()N

3. New forms 4 and 5

()Y()N

4. ()N/A ()Y()N 10% monitoring threshold [20.1502]

5. ()Y()N Dose limits to embryo / fetus and declared pregnant 6.

worker [20.1208] G. ave Danger Posting [20.1902] ()N/A ()Y()N 7. ()N/A ()Y()N Procedures for opening packages [20.1906] 8. ()N/A ()Y()N Sewer disposal limits [20.2003] ()N/A ()Y()N NOTE: Deficiencies in Section 3.E, while not always a violation, should be brought to the attention of licensee management at the exit meeting and in the cover letter transmitting the inspection report or NOV. Remarks: 4

• Inspector should consider reviewing training program for pharmacists, technicians, dispatchers, and drivers.

Radiopharmacy 4

 ' p\ 4 FACILITIES
      /    A.

Facilities as described in license application 130.33(a)(2)] B. Security - ()Y()N 1.

2. Materials secured from unauthorized removal or access()Y()N [20.1801]

Licensee controls and maintains constant surveillance oflicensed material not in storage [20.1802] ()Y()N C. Engineering Controls 1. Licensee uses process or other engineering controls far volatiles / gases in storage [20.1701, UC] 2. Maintenance program implemented for engineering ()Y()N controls (negative pressure, ventilation rates, filter changes, etc.)[UC]

3. . ()Y()N Ventilation rates in accordance with license limits [UC]

Frequency air filtration system checked: ()N/A ()Y()N Remarks:

5. EOUIPMENT A. Dose Calibrator - Photon-emitting radionuclides U,A

l. Possessed and used [32.72(c)] ()Y()N

2. Calibration procedures developed and followed [32.72(c)] )

()Y()N

3. Constancy [32.72(c)(2), UC]

a. Performed daily prior to use

b. Dedicated check source used

()Y()N ()Y()N

4. Accuracy [32.72(c)(1), UC]

a. b. Performed at installation, after repair and annually ()Y()N At least 2 sealed sources used ()Y()N

i. Linearity [32.72(c)(1), UC]

a. b. Performed at installation, after repair and quarterly Tested over range of use ()Y()N ()Y()N

6. Geometry Dependence [32.72(c)(1), UC]

a. Performed at installation or repair

b. Includes range of volumes and volume

()Y()N configurations used ()Y()N

7. Dosage readings mathematically corrected for linearity errors greater than *10% [UC]

()N/A()Y()N (0 D) Radiopharmacy 5

8. Dosage readings mathematically corrected for geometry errors [_\) greater than *2% [UC] i. () N/A ()Y()N

   ~'

9. Repaired or replaced when constancy or

• accuracy errors exceeded *10% [UC]

()N/A ()Y()N 10. Records maintained [UC] ()Y()N Remarks: B. Instmmentation - Alpha - or beta-emitting radionuclides () N/A 1. Calibration procedures developed and followed [32.72(c)] ()Y()N

2. List type of equipment used to assay alpha and beta particles: I 1

3. Constancy / proper operation [32.72(c)(2)]

a. Performed daily prior to use

()Y()N

4. Accuracy [32.72(c)(1), UC]

G a. Performed at installation, after repair, and periodically ()Y()N

5. Linearity [32.72(c)(1), UC] ( )N/A

a. Performed at installation, after repair, and periodically ()Y()N

6. Geometry Dependence [32.72(c)(1), UC] () N/A

a. Performed at installation, after repair, and periodically

b. Includes range of volumes and volume configurations used () Y()N

7. A ppropriate action taken when calibration errors in excess oflicense limits are identified [UC] ()N/A ()Y()N 8.

Records maintained [UC] ()Y()N Remarks: i (O) v' I I Radiopharmacy 6

7 C. Licensee use ofgenerators

 \                        1.      Each cluate/ extract used for radiopharmaceuticals tested for Mo-99 breakthrough [30.34(g), UC]

2. No radiopharmaceuticals distributed with Mo-99

()Y()N concentrations over 0.15 uCi per mci of Tc-96

3. Records maintained.[30.34(g), UC]

()Y()N

4. Frequency of generator receipt:

()Y()N Maximum activity of generator: D. Transport radiation shield (on transfers for distribution) labelled with radiation symbol, " CAUTION [or DANGER], RADIOACTIVE MATERIAL," name, and quantity at specified date and time) [32.72(a)(4)(i), UC] ()Y()N E. Syringes, vials, or other containers labelled with radiation symbol,

                        " CAUTION [or DANGER], RADIOACTIVE MATERIAL," and an identifier to correlate with the information on the transport radiation shield label [32.72(a)(4)(ii), UC]

()Y()N F. Syringes and vials kept in a shield [20.1101(b), UC] ()Y()N G. Appropriate shielding available for photon, and beta emitters [UC] ()Y()N Remarks: MATERIALS A. Isotope, chemical form, quantity and use as authorized [UC] B. lodine capsule compound performed ()Y()N Frequency: ()Y()N C. Preparation ofliquid radiciodine for distribution

1. lodine-131

2. Iodine-125

()Y()N ()Y()N 5

    ]        The time may be omitted for drugs with a halflife greater than 100 days.

Radiopharmacy 7 1 u

D. Use/ preparation of radionuclides / drugs [UC] (~ ,1. 2. Protective clothhg worn ()Y()N Personnel routinely monitor their hands and feet

3. No eating / drinking in use/ storage areas

                                                                                                    )Y()N 4.

No food, drink, or personal effects kept in use/ storage areas ()Y()N S. Proper dosimetry worn ()Y()N

6. Radwaste disposed in proper receptacles

()Y()N ()Y()N . Remarks:

7. EMERGENCY PROCEDURES A. Written emergency procedures established and posted [UC]

B. Decontamination kit stocked and present [UC] ()Y()N ()Y()N C. Leak tests and Inventories

1. Leak test performed on sealed sources [UC]

2. ()Y()N 3.

Leak test records in microcuries [UC] . Inventory of sealed sources performed quarterly [UC] ()Y()N

4. Records maintained & signed by RSO [UC]

()Y()N ()Y()N Remarks:

8. RADIATION SURVEYS A. Survey instruments used to show compliance with Parts 20 and 30

1. Appropriate operable survey instruments possessed or available [30.33(a)(2), UC]

()Y()N

2. Calibrations [20.1501(a), 30.33(a)(2), UC]

a. Before first use, annually & after repairs

b. Approved calibration procedure followed to include

()Y()N check source reading determination [UC] ()Y()N

c. Within 20% in each reale or decade ofinterest [UC] ()Y()N

3. ,

4. Records maintained [UC] Source-checked each day ofuse [UC] ()Y()N ()Y()N s Radiophannacy 8

B. Radiation surveys performed ( , 1. Daily in all areas where radiopharmaceuticals are prepared (rad levels)[UC]

2. Weekly in all areas where radiopharmaceuticals

()Y()N 3. or waste is stored (rad. levels)[UC] Weekly wipes in all areas *vhere radiopharmaceuticals ()Y()N ' are routinely prepared or stored [UC]

4. Proper corrective action taken ifcontamination/

()Y()N excess levels detected [UC]

5. Triggerlevels established [UC]

()Y()N

6. Vehicles used to transport radioactive

()Y()N materialsurveyed [UC] ()Y()N C. Techniques can detect 0.1 mR/hr,22OOdpm/100 CM2 [UC] ()Y()N D. Records maintained [UC] ()Y()N E. Protection ofmembers of the public 1. Licensee made adequate surveys to demonstrate either (1) that the TEDE to the individual likely to receive the highest dose does not exceed 100 mrem in a year, or (2) that ifan individual were continuously present in an unrestricted area, the external dose would not exceed 2 mrem in any hour and 50 mrem in a year [20.1301(a)(1),1302(b)]

2. ()Y()N )

Unrestricted area radiation levels do not exceed i 2 mrem in any one hour [20.1301(a)(2)]

3. Records maintained [20.2103,2107]

()Y()N ()Y()N Remarks:

9. RADIOACTIVE. WASTE A. Disposal  !

1. Decay-in-storage N/A

a. Approved [20.2001, UC]

b. ()Y()N c. Procedures followed[UC] ()Y()N Labels removed or defaced [20.1904] ()Y()N

2. Special procedures performed as required [UC]

3. Improper / unauthorized disposals [20.2001]

()Y()N  !

4. Records maintained [20.2103(a),2108, UC]

()Y()N j ()Y()N U* 1 Radiopharmacy 9 l

I B. EfTluen.s

1. Release to sanitary sewer [20.2003]

()N/A ()Y()N

a. Material is readily soluble or readily dispersible biologics [20.2003(a)(1)]

b. ()Y()N Monthly average re!-ase concentrations do not exceed App. B, Table 2 values c. ()Y()N No more than 5 Ci of H.3,1 Ci of C-14 and 1 Ci of all other d. radionuclides combined released in a year [20.2003] ()Y()N Procedures to ensure representative sampling and analysis implemented [20.1501, UC] ()Y()N

2. Release to septic tanks

[20.1301,2001,2002,2003] () N/A () Y () N

a. Within unrestricted limits

[Part 20 App B, Table 2, UC] ()Y()N

3. Air effluents and ashes controlled [20.1201,1301,1501 2001,2004, UC]

() N/A See also IP 87102, RG 8.371 a. Air effluent less than 10 mrem constraint limit [20.1101]()Y()N

b. If no, licensee reported ap;;ropriste information to NRC

()Y()N V 1. Corrective actions implemented and on scheduk ()Y()N

c. Description of efil-uent monitoring program 1.

2. Monitoring system hardware equipment adequate ()Y()N Equipment calibrated as appropriate ()Y()N

3. Air samples / sampling technique (i.e. charcoal HEPA, etc.)

analyzed with appropriate instrumentation ()Y()N Remarks: l C. Waste storage 1. 2. Protection from elements and fire [UC] ()Y()N 3. Control of waste maintained [20.1801] ()Y()N Containers properly labeled and area properly posted [20.1902,1904] 4. ()Y()N Pack. ige integnity adequately maintained [UCJ ()Y()H D. Records of surveys and material accoritability are maintained [20.2103,2108] ()Y()N Remarks: O kadiophannacy 10 i

I 10. RECEIPT AND TRANSFER OF RADIOACTIVE MATERIAL A. Recciep*.*

1. Written package opening procedures established 2.

and followed [20.1906(e)] ()Y()N All incoming packages with a DOT labeled, unless exempted (gases and special form) [20.1906(b)(1), UC] 3 () Y () tJ Incoming packages surveyed (rad. leveis) [20.1906(b)(2), UCJ  ;

4. Monitoring in (2) and (3), above, perfarmed

()Y()N ' within time specified [20.1906(c)]

5. ()Y()N Arrangements made for receipt of packages containing material in excess of Type A quantity [20.1906(a)]

()Y()N Remarks: B. Transfer

1. Radioactive drugs are measured (assayed) by direct measurement or combination of measurement and calculation prior to commercial distribution [32.72(c)] ()Y()N O

2. Transfer (s) between licensees performed per [30.41]

3. ()Y()N All sources surveyed before shipmc + and transfer [20.1501(a), 49 CFR 173.475(i), UC]

4. Records ofsurveys and receipt / transfer

()Y()N maintained [20.2103(a),30.51) ()Y()N Remarks: 11. TRANSPORTATION ' . CFR 71.5(a) and 49 CFR 171-189) A. Licensee shipments are: () delivered to common carriers ( ) transported in licenser *

• own private vehicle

() both l B. Licensee provides written safety / delivery instructions to drivers [UC] ()Y()N C. Licensee accepts returned radiopharmacy doses ()Y()N

                       ',       Licensee assumes shipping responsibility

z. If NO, describe arrangements made between licensee

()Y()N and client for shipping responsibilities: ekages from clients Rtdiopharmacy 11

 '                                         If YES, licensee provides written instructions jN                                          on returning shipments to customers [UC]

\ . ()Y()N

\

Incoming packages conform with licensee (phvmacy) procedures ()Y()N D. Packages () N/A 1. Authorized packages used [173.415,416]

2. Performance test records on file

()Y()N () N/A

a. DOT-7A packages [173.413(a)]

b. Special form sources [173.476(a)]

()Y()N ()Y()N

3. Two labels (White-1, Yellow-II, Yellow-III) with TI, Nuclide, Activity, and Hazard Class [172.403,173.441]

4. ()Y()N Properly marked (Shipping Name, UN Number, Package Type, RQ, "This End Up"(liquids), Name and Address of consignee)

[172.301,306,310,312,324]

5. ()Y()N Closed and sealed during transport [173.475(f)]

6. ()Y()N  ;

Packages properly braced and secured during shipment ()Y()N E. Shipping Papers

1. Prepared and used [172.200(a)]

2. ()Y()N Prom (Shipping,Name, Hazard Class, UN Number, Quantity, p)

( L/ Package Type, Nuclide, RQ, Radioactive Material, Physical and Chemical Form, Activity, Category oflabel, TI, Shippers Name, Certification and Signature, Emergency Response Phone Number,

                                  " Limited Quantity"(if applicable)," Cargo Airciaft Only" (if applicable)1 [172.200-204]

3. Readily accessible during transport E177.817(e)]

()Y()N () Y()N Remarks:

12. PERSONNEL RADIATION PRO'!ECTION A. Licensee performed exposare evaluation [20.1501]

B. Licensee implemented ALARA pr@ am [20.1101(b),L/C] ()Y()N ()Y()N C. External Dosimetry () N/A

1. Licensee monitors workers [20.1502(a), IJJ

2. External exposures account for contributions

()Y()N from airborne activity [20.1203] 3. () N/A () Y () N Supplier Frequency

4. Supplier is NVLAP approved 5[20.1501(c)] ) ()Y()N

   ; Does not apply to extremity monitors

,e~s k v Radiopharmacy 12

i

5. Dosimeters exchanged at required frequency [UC]

()Y()N D. Internal Dosimetry l () N/A

l. Licensee monitors workers [20.1502, UC]

2. )Y()N Briefly describe licensee's program for monitoring and controlling internal exposures [20.1701,1702, UC]:

3. Aerosols and gases sampled [UC]

()Y()N

4. Monitoring / control!ing program implemented

()Y()N (includes bioassays)[UC]

5. If respiratory protection equipment used, program meets

()Y()N requirements of20.1703 ()Y()N Remarks: 1 E. Reports I

1. Reviewed by Frequency

2. Inspector reviewed personnel monitoring records 1

i for period to

3. Prior dose determined fM individuals likely to receive doses [20.2104]

4 Maximum exposures TEDE _ SED ()Y()N l Other j

5. Maximum CDEs Organs '

6. V) 7. Maximum CEDE ~ 8. Licensee sums internal and er tern.:! [20.1202] TEDES, SDEs and TODEs within limits (20.1201] ()Y()N

9. NRC forms or equivalent [20.2104(o),2106(c)]

()Y()N

a. NRC-4 ()Y()N Complete: ()Y()N

b. NRC-5 ()Y()N Complete: ()Y()N 10.

Worker declared her pregnancy in writing during inspection period (review records) () N/A ()Y()N Ifyes, licensee in compliance with [20.1208] ()Y()N and records maintained [20.2106(e)] ()Y()N F. Who performed any PSEs at this f-cility (number of people involved and doses recei ved) [20.1206, 2104, 2105, 2204] G. ()N/A Records of exposures, surveys, monitoring, and evaluations maintained [20.2102,2103,2106, UC] ()Y()N Remarks: p t Radiopharmacy 13

i l 3. NRC INDEPENDENT MEASUREMENTS A. Survey instrument Serial No. Last calibration B. Inspectors measurements were compared to licensee's ()Y()N C. Describe the type, location, and results of measurements:

14. NOTIFICATION AND REPORTS A. Licensee in compliance with [19-13,30.50](reports to individels, public and occupational, monitored to show compliance with Part 20) ( ) N/A ( ) Y ( ) N B. Licensee in compliance with [20.2201,30.50](theft or loss)

C. () N/A () Y () N j Licensee in compliance with [20.2202,30.50)(incidents) D. Licensee in compliance with [20.2203,3030] ()N/A ()Y()N

                  - (overexposures and high radiation levels) g          E.        Licensee aware of NRC Ops Center phone number

()N/A ()Y()N F. Licensee in compliance with [20.2203) ()Y()N (Constraint on air emissions) ()N/A ()Y()N Remarks: I

15. MISADMINISTRATIONS A. Misadministrations have occurred that were attributed to pharmacy I

()Y()N B. Appropriate action taken to prevent recurrence ()N/A ()Y()N Remarks: i l l Radiopharmacy 14

1 l

16. POSTING AND LABELING

 /                                                                                                              j A.      .NRC-3 " Notice to Workers" is posted [19-11]

B. ()Y()N Parts 19,20,21, Section 206 of Energy Reorganization Act, procedures adopted pursuant to Part 21, and license documents are posted or a notice C. indicating where documents can be examined is posted [19-11,21.6] Other posting and labeling per [20.1902,1904] ()Y()N and the licensee is not exempted by [20.1903,1905] ()Y()N D. Emergency procedures [UC] ()Y()N Remarks:

17.  !

RECORDKEEPING FOR DECOMMISSIONING I A. Records ofinformatio important to the safe and effective decommissioning of the facility maintained in an independent and identifiable location until license termination [30.35(g)] B. ()Y()N i Records include all information outlined in [30.35(g)] ()Y()N Remarks: 3 BULLETINS AND INFORMATION NOTICES d A. Bulletins, Information Notices, NMSS Newsletters, etc., received by the licensee B. Licensee took appropriate actinn in response to ()Y()N Bulletins, Generic Letters, et () Y() N { Remarks:

19. SPECIAL LICENSE CONDITIONS OR ISSUES () N/A I A. Special license conditions or issues to be reviewed: I l

BEvaluation: l

20. CONTINUATION OF REPORTITEMS 2, i VIOLATIONS, NCVS. AND OTHER ISSUES  !

C i , Radiopharmacy. 15 l

1 1

4 Note: Bricfly state (1) the requirement and (2) how and when the licensee violated the requirement. For non-cited J violations, indicate why the violation was not cited.

22. DEBRIEF WITH LICENSING STAFF Inspection findings discussed with licensing staff

() N/A () Y() N Items discussed: 1

23. PERFORMANCE EVALUATION FACTORS Licensee Inspector (name & location) Inspection Date

{ A. Lack of senior manage:aent involvement with the radiation safety program and/or Radiation Safety Officer (RSO) oversight ()Y()N B. RSO too busy with other assignments C. Insufficient staffing ()Y()N p D. ()Y()N 1 Inadequate consulting services or inadequate audits f E. Financialinstability ()Y()N ) ()Y()N Remtrks (consider above assessment and/or other pert lnent PEFs): Regional follow-up c.) above PEFs citations:

                                                                                                                                       \

i l l l Radiopharmacy 16 i i

i I l G REMOTE AFTERLOADING DEVICE FIELD NOTES REGION Inspection Report Nc. License No. Licensee Name: Licensee Contact For Afterloaders: Telephone No. Program Code: ( ) 2230 High . Medium . and Pulsed-Dose Rate Remote AAerloaders ( ) 2231 Mobile High . Medium . and Pulsed-Dose Rate Remote Afterloaders ( ) Low. Dose Rate Afterloader

1. PROGRAM ADMINISTRATION A. Radiation Safety Committee (RSC) 1.

RSC approved use of afterloader and reviews use at RSC meetings (35.22) () Y()N()NA 2. RSC reviews use of afterloaders in annual program audit (35.22. 20.1101) () Y()N()NA

3. RSC has implementM corrective actions (UC)

() Y()N()NA B. Authorized Users l

1. Device used under supervision of an authorized user (UC)

2. Names of Users

()Y()N C. Scope of Program

1. Multiple places of use Ifyes. list locations ()Y()N Are all locations listed on license? (LC) () Y() N()MA

                                                                                                             \

2. Were onsite inspections performed at each location?

Ifno, explain () Y()N()NA l

3. Describe scope of the program (stafTsize, number ofprocedures performed, e,tc.) l i

l r i { Remote Afterloading 1 i

D. Training /3

                . I. Facility individuals received initial and periodic training a.10 CFR 19.12 training (19.12)

b. Proper use ofdevice (LC) ()Y()N

()Y()N

2. Individual (s) providing training are listed in license app?ication (LC)

Name ofindividual(s)- ()Y()N

3. Periodic retraining (interval <12 months) is provided to device operators (LC) ()Y()N

4. Operators, physicians. and medical physicists have been given emergency training including d y run (LC)

()Y()N

5. Briefly describe training / retraining program E. Reports and Notifications

1. Any mis-administrations

2. Ifyes. were they reported (35.33)

()Y()N

3. Any failures / problems ofdevice

()Y()N 4 If yes, were they reported under 10 CFR Part 21 ()Y()N () Y() N()NA

  ,            F.         Quality Management Plan (QMP) d I.         License has developed QMP (35.32)

2. Licensee has impamented QMP(3532)

()Y()N

3. ()Y()N Licer.see staff has n eceived training on QMP C5.25(4)(1))

()Y()N Rema ks

2. FACILITIES AND EQUIPMENT A. Facilities s

1. Physical Plant

a. General Requirements

1. Device. sources, and keys are stored against unauthorized use and removal (20.207.20.180) ()Y()N

2. Devices used in authorized locations

()Y()N

3. Ur.4athorized individual prevent from entering use area (LC) ()Y()N

4. Devices and places of use or storage properly posted (20.203.20.1902.20-1905)() Y ( ) N

5. Only one radiation device can be placed in operation at a time within one treatment room (LC) ()Y()N O

O Remote Afterloading 2

(, b. High, Medium, and Pulsed-Dose Rate Remote Afterloaders () Y() N() NA

  \                *

1. Use is limited to locations approved in License (LC)

2. Dedicated treatment rooms are equipped with continuous viewing

()Y()N and intercom-systems (LC)

3. Viewing and intercom systems are checked at the beginning of each

()Y()N day of use (LC)

4. Back-up system is available to observe patient's during ' treatment()Y()N

()Y()N (LC) If no. are treatments suspended

5. Electrical interlock systems are installed at each entry (LC)

()Y()N

6. Interlock is operational ()Y()N

()Y()N

7. Once activated door interlock must be reset (LC) ()Y()N

8. Interlock operation tested daily (LC)

9. Records ofinterlock operation are maintained for 3 years

()Y()N ()Y()N c. Low-Dose Rate Remote Afterloaders () Y () N ()NA

1. Devices are used in locations w.' thin a single building approved on license (LC)( ) Y () N

2. Portable shields are available for use (LC) ()Y()N

3. Licensee has capability to monitor patient during treatment (LC)

()Y()N Remarks B. Equipment i I fQ t I

l. Radiation Detection Equipment

a. Permanent radiation monitor - All remote afterloaders but low-dose rate

1. Monitor is installed in dedicated treatment room (LC) () Y () N ()NA Make: Model:

2. Monitor has/does the following (LC)  ;

i

                                                - Visible notice when source is exposed or p:rtially exposed ()Y()N
                                                - Visible to someone entenng room

()Y()N

                                                - Has separate backup power supply separate from power snply to afterloader

3. Monitor ;peration is checked daily before use (LC)

()Y()N

4. Records of monitor checks are maintained for 3 years

()Y()N ()Y()N

b. Portable Survey Instruments - All remote afterloaders

1. Meters required by 10 CFR 35.420

2. Meter range is adequate (LC)

()Y()N ()Y()N

3. Meters are calibrated before first use, annually and following repair (35.51)(LC)

()Y()N

4. Meter checked with dedicated check source daily before use (LC) ()Y()N

5. List meter model and range

  ,m J

'Q Remote Afterloading 3

b\ j 2. ARerloader (

a. Operation

1. ARerloaders authorized by license are used (LC) ()Y() N i 2. AAerloader and storage devices are properly labeled (LC) ()Y() N

3. Back-up battery (source retraction)is tested monthly for operation (LC)( ) Y ( ) N

4. Source position indicators are checked periodically (LC) ()Y() N

b. Maintenance

1. Only authorized individuals perform maintenance. repair and inspection (LC) ()'. ()N Name oforganization/ individual:

2. Records of maintenance, inspection and service maintained for duration ofdevice use(LC) ()Y()N

3. ARerloaders inspected annually (LC) ()Y()N Date oflast inspection:

r Manufacturer's schedule for service is followed (LC) ()Y()N Frequency: ( Date oflast service:

c. Calibration

1. Only qualified or authorized individuals perform calibrations (LC) ( ) Y () N

2. Device calibration measurements are performed following installation of new source and before patient treatment and monthly thereaAer(LC) ()Y()N Date oflast source replacement:

Date oflast monthly calibration:

3. Radioactive Sources

1. Approved sources are used/ possessed (LC) ()Y()N

2. Source homogeneity is confirmed (LC) ()Y()N

3. Source inventory are performed quarterly (LC) ()Y()N

4. Leak tests are performed semi-annually (LC)date of last test: ()Y()N

5. Source installation and replacement by authorized individuals only (LC)( ) Y ( ) N Name of organization / individual:

O Remote Afterloading , 4

4. Calibration / Dosimetry System

a. Dosimeuy system calibrated by NIST or AAPM lab. every two years (LC) ()Y()N Name ofcalibratioi lab Last date ofcalibrat in:

Rekarks III. OPERATIONS A. Onerating Procedures - All Devices

1. Procedures are posted (LC)

()Y()N

2. Procedures are identical or more restrictive than those submitted with license (LC)

3. Procedures are approved by RSC (LC)

()Y()N ()Y()N

4. Radiation survey of device and patient is performed to ensu.e source is retumed to shielded position (35-404(a)) (LC) ()Y()N

5. Records of radiation surveys maintained for three yean (35.404(b))(LC) ()Y()N B. High . Medium , and Pulsed-Dose Rate Remote Afterloaders

() Y()N()NA

1. At least one individual trained in safe use and emergency procedures is physically present while device in use (LC) ()Y()N

2. Authorized user and either medical physicist or RSO is physically present while device in use (LC) ()Y()N

3. Only patient is in treatment room during device use (LC) ()Y()N C. Low-Dose Rate Remote Afterloaders () Y ()N()NA

1. Device cperator trained -in emergency procedures is physically present or available by telephone during treatment (LC) ()Y()N

2. Medical physicist or RSO and authorized user available forprompt assistance in emergency (LC)

()Y()N

3. Written operating procedures are provided to nurses prior to device use (LC) () Y () N Remarks V

Remote Afterloading 5

n Ill. EMERGENCY ACTIONS

 /

I t' A. Procedures are posted in conspicuous location (LC) ()Y()N ( B. Individuals will carry radiation monitor if room monitor is non-functional (LC) ( ) Y ( ) N C. Licensee has responded to emergencies ()Y()N If yes, were authorized user and medical physicist or RSO notified ()Y()N If yes, was NRC notified (LC) ()Y()N D. Emergency source recosery equipment available (LC) ()Y ()N Remarks IV. RADIATION PROTECTION A. Radiation Levels in unrestricted areas are within limits (20.105. 20.1301) ()Y()N B. Radiation levels in unrestricted areas are monitored after source exchange / replacement or unit relocation (LC) ()Y()N Date oflast source exchange: Date ofradiation survey: C. Personnel monitoring is provided to appropriate individuals (LC,20.202. 20.1502) ()Y()N

 \         Remarks V,    WASTE DISPOSAL Sources transferred to authorized individuals (20301. 20.2001)                            ()Y()N()NA Name of organization:

Remarks VI. CONFIRMATORY MEASUREMENTS Detail location and results of confirmatory measurements I 1 Remote Afterloading 6

1 l

                                                                                                . I l

O WELL LOGGING INSPECTION FIELD NTES l

\           .

Region Inspection Report N. License N. Docket N. ' License (name and address) Telephone N. l License Contact  ! Date of Amendment l Last Amendment N. l Priority: ( ) 03110 - BPM /SNM Tracer and Scaled Sources ( ) 03111 - BPM /SNM Scaled Sources Only

                                                                                                  )

I () 03112 - BPM Tracers Only () Other-Date of Last inspection ( Date of This Inspection  ; (% \ Type ofinspection: N announced () unannounced l () i Routine () Special () Initial () Re-inspection () i Next Inspection Date Normal () Reduced Extended () () Summary of Findings and Action: N Violations, Ciear 591 or letter issued Violations,591 or letter issued Action on Previous Violations Inspector: Date Approved: Date i .V Well Logging 1

1. ORGANIZATION '

a. Briefly descri'oe management structure:

b. Individuals identified as responsible for radiation safety still hold those positions

2. INSPECTION HISTORY ( )N/A Initialinspection

a. I.ast inspection conducted on

h. Violations or deviations were identified

c. Response letter or 591 dated

d. Violations from Previous Inspection:

Requirement Violation Corrective Action Taken (Y/N) States

e. Any previous violations Not corrected Explain:

1 1 I Well Logging 2

3. f SCOPE OF PROGRAM (Number ofpeople, rate of use or quantities on Find, pla and use as authorized, proper users) [39.13(b)]

4. INTERNAL AUDITS OR INSPECTIONS Audi'.s conducted per [39.13(d)] or application .

If"Y":

a. Bywhom

b. Frequency Announced ( ) Unannounced ( )

c. Scope

d. Records maintained Y(-) N( )

e. Records reviewed Y( ) N()

f. Period reviewed:

Remarks: Inspection should in:lude interviews with audited well-logging supervisors as well as with the managers audits. WellLogging  ?

5. TRAININO, ANNUAL REVIEWS. INSTRUCTIONS TO WORKERS F10 CFR 39.13(b)!

a. .

Training program specified in IJC or application Inspection should veriff records of test results, including field exams of supervisors. [39.13(b) and 39.6!!]

b. . Describe scope of training program:

c. Annual reviews conducted. Records maintained. [39.13(b) and 39-61]

d. Period review:d:

Remarks (percent completed, tesu results, etc.): p e. Training provided, but Not covered above, such as on-the-hb training p Remarks: f. Instructions to workers in accordance with 19.12 and 39.61(a)(2) Remarks: Well Logging 4

6. RADIOLOGICAL PROTECTION PROCEDURES (m)

'v'              a, Operating and Emergency Procedures [10 CFR 39.63]

(1) Required by UC or application Y( ) N( ) (2) Procedures reviewed Y( ) (3) Appeared adequate N( ) Y( ) N( )

b. Equipment, such as remote handling tools and gloves, availa' ole and used Y( ) N( )

c. Changes in procedures since last inspection Y( ) N( )

d. If changes made, were they authorized?

Y( ) N( ) Remarks: 7. INSTRUMENTATION [10 CFR 39.33]

a. Type (s) of radiation survey instruments on hand as per UC. application or equivalen:

If"N." list changes:

,~

! t

b. Capability and availability of radiation survey instruments adequate for program [39.33(a),(b)] Y( ) N Ul

c. Instruments calibrated per[39.33(c)

Y( ) N( ) Remarks:

/~N

( ) v Well Logging 5

l l l

8. MATERIALS l f()h a. Radioactive material locked and secured to prevent unauthorized removal from:

(1) Restricted area [39.31(b)] Y( ) N( ) (2) Unrestricted area [20.207] Y( ) N( )

b. Licensed material Not stored with Explosives [39.31(b)(1)] Y( ) N( )

c. Method ofcontrol appears generally adequate Y( ) N( )

Remarks:

9. FACILITIFS l

a. Facilities (or field omee) described in letter or application Y( ) N( ) l

b. Facilities (or field omee) or temporary job sites inspected Y( ) N( )

c. Materials stored only at locations authorized by the license Y( ) N( )

Remarks: (3 i (

10. POSTING AND. LABELING

a. Posting and labeling in accordance with (20.203. 39.311 Y( ) N( )

b. Uranium sinker bars properly label.4 or stamped [39.491 Y( ) N( )

Remarks. j s,

 \     )
   %/

Well Logging 6

I 1. RECEIPT AND TRANSRFER OF MATERIAL

a. Procedures for picking up and receiving packages [20.205(b).(c)] Y() N()

(1) Incoming shipments monitored Y( ) N( )

                   ' (2) Records of monitoring maintained [20.401(b)]

(3) Records reviewed by NRC inspector Y( ) N( ) (4) Period reviewed: Y( ) N( )

b. Procedures for opening packages [20.205(d)]

Y( ) N( )

c. Records of receipt, transfer and inventory of material available [30.51(a),40.61(a).70.51(b)(1)]

(1) Records reviewed by NRC inspector (2) Period reviewed: Y( ) N( ) Y( ) N( )

d. Packages on hand meet lawling requirements [49 CFR 172.403]

e. Y( ) N( ) Reports to Commission required by I/C or regulation were submitted

f. Semiannual physical inventory conducted [39.37]

Y( ) N( ) i Remarks: Y( ) N( ) i 12. PERSONNEL RADIATION PROTECTION - EXTERNAL [10 CFR 39.65]

a. Film or TLD badge supplier:

b. Badge exchange frequency:

l

c. Reports reviewed by:

d. Records reviewed for period to by NRC inspector

e. NRC forms or equivalent:

(1) NRC-4 [20.102(b)] Y( ) N( ) Complete: Y( ) N( ) (2) NRC [20.401(a)] Y( ) N( ) Complete:Y( ) N( ) (3) Maximum exposures (mrem): i Well Logging 7

f. Pocket dosime:ers used C (1) Type used:

( . (2) Frequency of recharging: (3) Frequency ofreading:

g. Direct radiation surveys ofrestricted and/or unrestricted areas being made[39.67]

(1) Records of surveys being maintained Y( ) N( ) (2) Records of surveys reviewed Y( ) N( )

                             . (3) Period reviewed:                                                  Y( ) N( )

Y()N() Remarks: 13. PERSONNEL RADIATION PROTECTION. INTERNAL

a. Potential for exposure ofindividuals to airborne radioactive material or other internal hazard exists Y( ) N( )

(1) If"Y" does program for monitoring and control exist? (2) Programs for monitoring and control appear adequate Y()N()N/A Y()N()N/A

b. Smear surveys being conducted [20.201(b)]

Y( ) N( ) (1) Records of smear surveys reviewed (% (2) Period reviewed: Y( ) N( )

 ?

(3) Records appeared adequate Y( ) N( ) (4) Methods of performing and analyzing smears appear adequate Y( ) N( ) Y( ) N( )

c. Bioassay program required [39.45]

Y( ) N( ) (1)If"Y." was bioassay program reviewed? (2) Bioassay program appears adequate Y( ) N( ) N/A Y( ) N( ) N/A Remarks: s Well Logging 8

14. LEAK TESTS OF SEALED SOURCES [ 10 CFR 39.351 ' ['s . a. Conducted as required Y( ) N( ) ( ) .b. Records ofleak tests maintained

c. Period reviewed:

Y( ) N( ) Y( ) N( )

d. Records ofleak tests appear adequate Remarks:

Y( ) N( ) i 15. UTILIZAT!ON RECORDS [ 10 CFR 39 ]

a. Records contain all pertinent information Remarks:

i i

16. RADIOACTIVE WASTE CONTROL

a. Radioactive material unintentionally released to groundwater or aquifers and sanitary sewer system Y( )N( )

b. Exemption granted for unintentional releases {39.45(b)]

  ,m                                                                                                   Y ( )N ( )

( ) c. Records of releases or radioactive effluents maintained [20.401] Y( )N( )

 %J d.

If LLW is stored because access to a burial site has been denied. answer (1). (2). And (3) b (1) Adequate control of waste in storage is maintained (2) Package is labeled and package integrity is adequately maintained Y( )N( ) (3) Adequate records of surveys and material accountability are maintained Y( )N( ) Y( )N( )

e. Proper disposal records maintained for decay-in-storage Y ( )N( ) i Remarks:

17. DESIGN AND PERFORMANCE CRITERIA FOR SEALED SOURCES F10 CFR 39.4L

a. Sources meet design criteria Y ( )N( )

Remarks; i

 /   \
 \

v] j Well Logging 9 1 1 i

                                                                                                                      )

I 8. INSPECTION. MAINTENANCE, AND OPENING OF SOURCES OR SOURCE HOLDERS N [10 CFR 39.43] b'd) .

a. Licensee has program for inspection and maintenance of equipment Y ( )N( )

b. Equipment inspected both daily and semiannually Y( )N( )

c. Records ofinspection maintained

d. Stuck sources in source holders or repair, opening, modification done only by persons Y ( )N( )

specifically licensed Y ( )N( )

e. Use of radioactive markers in wells only ifindividual markers contain quantities of licensed material Not exceeding exempt quantities [39.47]

Y ( )N ( ) Remarks: 19. DOCUMENTS AND RECORDS REQUIRED AT FIELD STATIONS FIO CFR 39.731 a. Utilization records and-other documents located at field stations as required by regulation Y()N( ) Remarks: rm i l 20. Q DOCUMENTS AND RECORDS REQUIRED AT TEMPORARY JOB SITES [10 CFR39.75]  !

                                                                                                                       )

a. Documents and records maintained atjob sites as required by regulation Y ( )N( ) Remarks: I l [ t L Well Logging 10

21. NOTIFICATION OF INCIDENTS AND LOST SOURCES- ABANDONMENT SOURCES-FLO CFR 39.771: SOURCE RECOVERY MONITORING REQUIR

a. Contamination checks made during source recovery operations Y( ) N( )

b. NRC Notitied of niptured source Y( ) N( )

c. NRC Notified of abandoned sources Y( ) N( ) {

d. Abandoned wells properly placarded Y( ) N( )

e. Procedures for using scaled sources in wells without surface casing (39.51] Y( ) N( ) Remarks: 22. TRANSPORTATION [CFR 71.5(a) and 49 CFR 171-189]

a. Licensee makes shipments ofRAM Y( ) N( )

a. Shipments are:

( ) delivered to common carriers s ( ) transported in licensee's own private vehicle both ( ) N shipments since last inspection Remarks: Well Logging i1

r Complete only if shipments made since last inspection: C. Shipments (1) Authorized packages used [173.415,416] Y( ) N ( ) ~ N/A (2) Package type used l Y( ) N( ) N/A (3) For DOT-7A packages. performance test record on file [173.415(a)] Y( ) N( ) N/A  ; (4) For DOT-55 packages, use is approved by NRC [173.416(a)] Y( ) N()N/A  ! (5) Other Type B packages used are approved [173.416(a)) Y( ) N( ) N/A (6) Licensee has COCs on file with NRC [71.12',c)(1)] i Y( ) N( ) N/A (7) Licensee has a QA program approved by NRC [71.12(b)] Y( ) N( ) N/A (8) ' For special form sources, performance test record on file [173.476(a)] Y( ) N( ) N/A (9) Packages properly labeled [172.403.173.4411 Y( ) N( ) N/A (10) Packages properly marked (173.200] Y( ) N( ) N/A i (11) Proper shipping papers prepared and used [172.200-204] Y( ) N( ) N/A (12) Shipping papers readily accessible during transport [177.817(e)) Y( ) N( ) N/A (13) Vehicles placarded -as necessary [172.500. 504] Y( ) N( ) N/A { (14) Cargo blocked and braced (177.842(d)] Y( ) N( ) N/A  ! (15) Any incidents reported to DOT [171.15-16] Y( ) N( ) N/A  : Remarks: l O Well Logging 12

23. NOTIFICATIONS AND REPORTS

a. Licensee in compliance with 19.13 (reports to individuals)

Y( ) N( ) None

b. Licensee in compliance with 20.405 (overexposure)

Y( ) N( ) None

c. Licensee in compliance with 20-403 (incidents)

Y( ) N( ) None

d. Licensee in compliance with 20.402 (theft or loss)

Y( ) N( ) None Remarks: 4

24. POSTING OF NTICES

a. NRC-3 " Notice to Workers" is posted (19-11]

b. Parts 19,20. and 21 and license are posted or a Notice indicating where Y( ) N( ) documents can be examined is posted [19.11,21.6]

c. Other posting and labding per [20,203]

Y( ) N( ) Y( ) N( ) Remarks: i I l. Well Logging 13

21 BULLETINS AND INFORMATION NTICES

              .a. List applicable Bulletins and Information Notices issued during current year:

b. Bulletins, Information Notices, etc. received by licensee

c. Licensee took appropriate action in response to Bulletins and Infermation Notices Y( ) N( )

Y( ) N( ) Remarks:

26. ENVIRONMENTAL MONITORING PROGRAM

a. Environmental Monitoring Program required

b. If Environmental Monitoring Program is required:

Y( ) N( ) (1) Records reviewed (2) Period reviewed Y( ) N()N/A (3) Records appeared adequate Y( ) N( ) N/A Y( ) N ( ) N/A Remarks:

c. If Environmental Monitoring Program is Not required, briefly describe any existing program:

Well Logging 14

27. CONFIRMATORY MEASUREMENTS s\

                 ,a. Confirmatory measurements made by inspector Y( ) N( )

If"Y," answer the following:

b. Survey instrument used:

c. NRC Serial N.:

d. Last date ofcalibration:

e. Inspector's measurements were compared to licensee's Y( ) N( )

f. Describe the type and results of the confirmatory measurements:

28. RECORDKEEPING FOR DECOMMISSIONING N/A ( )

a. Records ofinformation important to the safe and effective decommissioning of the facility maintained in an independent and identifiable location until license termination [30.35(g)] Y( ) N( )

b. Records include all information outlined in (30.35(g)] Y( ) N( )

Remarks:

29. INDEPENDENT--INSPECTION EFFORT '

a. Remark on type ofindependent inspection effort conducted:

30. SECURITY

a. Direct surveillance maintained by logging supervisor / designee when source is not below ground or in shipping container Y( ) N( )

Remarks: i yV Well Logging 15

31. CONTINUNIION OF REPORT ITEMS USE BACK OF PAGE IF NECESSARY

32. LIST OF VIOLATIONS l

l l 1

33. PERFOlWANCE EVALUATION-FACTORS Licenste (Name&Imation)'

inspector

                                     ~

inspection Date

a. Lack ofsenior managment involvement with the radiation safety program and/or Radiation Safety Officer (RSO) oversight Y( ) N( )

b. RSO too busy v,ith other assignments Y( ) N( )

c. Insufficient staffing Y( ) N( )

d. Radiation !;afety Committee fails to meet or functions inadequately Y( )

N( ) N/A e.Inadequrte consulting sersices or inadequate audits Y( ) N()N/A i Remarks (consider above assessm ent and/or other pertinent PEFS): Regional follow-up on above PEFS citations: Well Logging 16

NUCLEAR MEDICINE INSPECTION FIELD NOTES kigion License No. Docket No. Licensee (Name & Address): Licensee Contact Telephone No. Last Amendment No. Date of Amendment Dite of Last inspection Date ofThis inspection Type ofInspection: () Announced () Unannounced () Routine () Special () Initial () Re-inspection 2mmary of Findings and Action: () No violations, Clear 591 issued () Violation (s),591 issued ( ) Violation (s), Regional letter issued () Follow up on Previous violations Were non-cited violations identitled during this ins,oection? ()Y()N Was proprietary information reviewed by or received by the inspector? ()Y()N 1 Inspectv , Date ik.gnature) Approved Date l NuclearMedicine I 1 l l l r.

h l. INSPECTION HISTORY V - A. () N/A - Initialinspection Violations were identified during the last two inspections or two years, whicheveris longer B. Response letter (s) or 591(s) dated ()Y()N C. Open violations from previous inspections: Status gquirement Violation Corrective Action Taken (Y/N) Open/ Closed D. Explain any previous violations not corrected or repeated () N/A

2. ORGANIZATION AND SCOPE C, ' SRAM A. Organizational Structure I

l

                    +      Individuals contacted during inspection Individuals present at exit meeting

1. Meets license requirements (L/C)

()Y()N 2. Multiple authorized locations of use ) N -Ifso, list locations inspected ( ) N/A

3. Briefly dese scope of activities, including types and quantities of use involving byproduct material, frequency of use, staff size, etc. )

i l i i i i l Nuclear Medicine 2 i l

i l i ( B. . Licensee does limited distribution of pharmaceuticals under Part 35 license' ()Y()N

1. Indicate type ofoperation:

__, a. Registered or licensed with FDA as a dmg manufacturer '

                                         ,__ b. Registered or licensed with State Agency as a drug manufacturer

__ c. Licensed as a pharmacy by State Board of Phansacy __ d. Operating as a nuclear pharmacy within a Federal medical institution

2. Licensee distributes sealed sources alpha $nd beta emitters ()Y()N i generators ()Y()N photon emitters t ) Y ()N

()Y()N Remarks: C. Research involving human subjects () N/A i 1. Research is conducted, funded, supported, or regulated by another Federal Agency which has implemented Federal Policy for Protection of Human Subject2 . (35.6) ()Y()N  ! If no, does licensee have license amendment authorizing human research? (35.6) ()Y()N h 2. Licensee obtains informed consent from human subjects? (35.6)

3. Licensee obtains approval of research activities from an Institutional Review

()Y()N i i Board? (35.6) ()Y()N Remarks: D. Radiation Safety Committee ()N/A

1. Membership as specified [35.22(a)(1)]

2. Meetings held quarterly [35.22(a)(2)]

()Y()N  : 3. ()Y()N , 4. Record maintained [35.22(a)(4)] ()Y()N 5. Quorums established [35.22(a)(3)] Has sufficient authority (35.23) ()Y()N 6. ()Y()N Approve /d.sapprove credentials ofindividuals prior to allowing them to work as an authorized user or authorized nuclear pharmacist [35.22(b)(2)(ii)] ()Y ()N l

                                                                                                                                                       )

j I Iflicensee distributes radiopharmaceuticals to several facilities, the inspector should consider the need to complete the radiopharmacy fieldnotes.

2. Agencies: USDA, DOE, NASA, HUD, DOJ, DOD, VA

                                                                         **A, HHS, DOT, Dept. of Commerce, Consumer Product Safety Commission, Intemat j l     [       Development Cooperation Agency, Agency forInternaf m evelopment, Dept. of Education, Nc%al Science foundation                             !

! \ i NuclearMedicine 3 - i L....

f E. Radiation Safety Officer

 .O \
                        , I.

l ('f 2. Appointed [35.21(a),900) Fulfills duties per [35.21(b)] ()Y()N l 3. Has sufficient authority per [35.23] ()Y()N ()Y()N F. Radiation Safeat Program

1. Minor changes pursuant to [35.31]

2. Records of changes maintained [35.31(b)]

()N/A ()Y()N

3. Content and implementation reviewed annually

()Y()N by the licensee [20.1101(c),35.22(b)(6)] (' Y()N 4 Records of reviews maintained [20.2102] {f Y()N G. Use by authorized individuals {UCl Compliance is established by meeting at least one criteria under each category. 1. Authorized Nuclear Pharmacist (35.13(b)] () N/A DOES NOT APPLY TO FAC!LITIES THAT ARE REGISTERED / LICENSED BY DA/ STATE AGENCY AS A DRUG MANUFACTURER AND DISTRIBUTION IS REGULATED UNDER PART 32 _ (a) Cenified by organization in 35.980 1 _ (b) Identified on NRC or Agreement State license n _ (c) Identified on permit issued by broad scope licensee ( _ (d) Listed on facility license ( 2. Authorized User [35.13(b)] _(a) Certified by organization in 35.910,920,930,940,950,960 _(b) Identified cu NRC or Agreement State license _(c) Identified on permit issued by broad scope licensee _(d) Listed on facility license

3. Radiation Safety Officer [35.13(c)] Listed on facility license ()Y()N Remarks:  !'

H. Mobile Nuclear Medicine Service () N/A

1. Licensee operates services per[35.29,80]

2. Cor.:pliance with 20.1301 evaluated and met

()Y()N ()Y()N I. Amendments since last inspection [35.13] ()Y()N f) k Nuclear Medicine 4

r

  /

i J. Noti 6 cations since last inspection [35.14] l [V} 1. Licensee has provided appropriate document . wto NRC for authorized nuclear pharmacists or user no later than 30 days af'er t the individual starts work [35.I4(a)] () N/A ()Y () N

2. Licensee has notified NRC within 30 days after authorized user or nuclear pharmacist or RSO stops work or changes name or licensee's mailing address changes [35.14(b)]

Remarks: () N/A ( )Y () N

3. TRAINING, RETRAINING. AND INSTRUCTIONS TO WORKERS A. Instructions to workers [19-12]

B. Individual's understanding of carrent procedures and regulations is adequate ()Y()N C. Training program required [L/C] ()Y()N 1. ()Y()N If so, brie 0y describe training program:

2. Training program implemented

3. Periodic training program required

()Y()N

4. Periodic training program implemented

()Y()N

5. Records maintained

()Y()N ()Y()N m D. Supervision ofindividuals by authorized user in accordance with [35.251] ()Y()N

1. Supervised individual' are instructed in preparation of material, principles and procedures for radiation safety and QM Program as appropriate

[35.25(a)(1),35.25(b)(I)] ()Y()N

2. Licensee periodically reviews supervised individuals use of material and records kept to reflect use [35.25(a)(3)] ()Y()N

3. Authorized nuclear pharmacist or user periodical!y review work and records of work of supervised individuals as it pertains to preparing byproduct materieif35.25(b)(3)] ()N/A ()Y () N Rer..a&.

3

    -.x      Applies to individuals that receive, possess, use, transfer, or prepare byproduct material for medical use urder supervision of authorized nuclear f         user.

C Nuclear Medicine 5 m

    }          E. Therapy training

() N/A l Safety instruction [35.310,410, UC] l l a. Control ofpatient and visitors

b. Contamination and waste

()Y()N

c. Size / appearance ofsources

()Y()N ()N/A ()Y()N

d. Handling / shielding ofsources  !

e. RSO notification in emergency or death

()N/A ()Y()N f. ()Y()N Records maintained [35.310(b),410(b)] ()Y()N 2. 3. Manufacturer's instructions available and followed [35.59(?),400] ()Y()N l Training for operating and emergency procedures F. Revised Part 20 for HDR Remote Afterloaders[UC] ()N/A ()Y()N j Workers cognizant of requirements for:

1. Radiation Safety Program [20.1101]

2. Annual dose limits [20.1301,1302]

()Y()N

3. New forms 4 and 5

()Y()N

4. 10% r onitoring threshold [20.1502]

()N/A ()Y()N

5. ()Y()N Dose limits to embryo / fetus and declared prqnant worker [20.1208] ()N/A ()Y()N I

6. Grave Danger Posting [20.1902]

7. Procedures for opening packages [20.1906j

()N/A ()Y()N  ! 8. ()N/A ()Y()N Sewer disposal limits [20.2003] () N/A () Y () N NOTE: Deficiencies in Section 3.F. while not always a violation, should be brought to the attention oflicer:see management at the exit meetir,g and ir. the cover letter transmitting the inspection report or NOV. Remarks: l

4. FAr1L_ITIES i

A. Facilities as described in license application B. Storage areas ()Y()N i 1. 2. Materials secured from unauthorized removal or access [20.1801] ()Y()N  ! Licensee controls and maintains constant surveillance oflicensed material not in storage [20.1802] 3. ()Y()N , Licensee uses process or other engineering controls for volatiles / gases l in storage [35.90] 4. ()Y()N Maintenance program implemented for engineering controls (negative pressure, ventilation rates, filter changes, etc.) [35.205(e), UC] ()Y()N Rernarks: 1 Nucle *.r Medicine 6 m

5. EOUIPMENT

 ,                 A. Dqse calibrator - Photon-emitting radionuclides L

1. Possessed and used [35.50(a)]

2. Constancy [35.50(b)(1)1 ()Y{)N

a. Performed daily

b. Dedicated check source usea

()Y()N ' ()Y()N

3. Acenracy [35.50(b)(2)] -

a. Performed at installation and annually

b. At least 2 sealed sources used

()Y()N ()Y()N 4 Linearity [35.50(b)(3)]

                                      . a. Performed at installation ar}d quarterly thereafter

b. Includes range between 30 uCi and the

()Y()N highest dosage administered  : ()Y()N '

5. Geometry Dependence [35.50(b)(4)]

a. Performed at installation or relocation

                                     . c. Includes range of volumes and velume configurations used

()Y()N ()Y()N

   ,                        6.

Dosage readings mathernstically corrected for geometry or linearity errors I greater than *10% [35.50(d)]_ () N/A () Y () N 7. Repaired or replaced when constancy or accuracy errors exceeded *10% [35.50(d)] () N/A () Y () N B. Approvea procedures followed [35.21,25,I/C]

9. ()Y()N Records maintained and include identity of the individual performing the test.

[35.50(e)(2),(e)(3),(e)(4)] ()Y()N Remarks: B. Instrumentation - Alpha- or beta-emitting radionuclidcs () N/A 1. List type of equipment used to assay alpha and beta particles:

2. Licensee has procedures for use of instru nentation [35.52(b)]

()Y()N Nuclear Medicine 7

3. Accuracy, linearity and gecmetric dependence tests are performed prior to initial use, O U 4 periodically, and following repair, if applicable * [35.52(b)(1), UC] Instruments are checked for constancy and proper operation at the beginning ofeach day ()Y()N of use [35.52(b)(2), UC] ()Y()N

5. Appropriate action taken when calibration errors in excess oflimits are identified [UC]

() N/A ()Y() N Remarks: I J C. Licensee uses generators

1. Each cluate/ extract used for radiopharmaceuticals i tested for Mo-99 breakthrough

2. No radiopharmaceuticals administered with Mo.99 concentrations

()Y ()N over 0.15 uCi per mci ofTc-99m

3. ()Y() N Records maintained [35.204(c)] ()Y() N D. Syringes properly labeled and shielded [35.60]

E. Vials kept in a shield [35.61(a)] ()Y () N F. ()Y () N Vial shields labeled [35.61(b)] ()Y() N Remarks: MATERIALS A. Licensee measures activity of each dosage of photon-emitting radionuclide prior to use[35M3(a)? ()Y() N B. Licensee administers alpha- or beta- emitting radionuclides Ifyes, ()Y()N

1. Licensee receives unit doses and relies on assay data supplied by manufacturer or properly licensed organization [35.53(b)] ()Y () N

2. Licensee measures by direct measurements or combination of measurement and calculation each dosage of alpha or beta-emitting radionuclide prior to medical use [35.53(b),UC] ()Y()N C. Unsealed material used under 35.100,200,or 300 are [35.100(b),35.200(b),35-300(b):

(1) Obtained from manufacturer or properly licensed organization AND/OR (2) Prepared by authorized nuclear pharmacist or physician user ur individual ()Y()N under the supervision of a authorized nuctor phant.acist or physician user [35.920] ()Y()N Remarks:

4. Note: Linearity and geometric dependence tests are not applicable ifliquid scintillation is used. Linearity is not applicable if sodi iodide is used. ,

I '/ Nucletr Medicine 8

n D. Isotope, chemical form, quantity and use as authorized (31.11,35.400,500, UC]( ) Y ( ) N V Remarks: E Use ofradiopharmaceuticals (UC)

1. Protective clothing worn

2. Personnel routinely monitor th:ir hands

()Y ()N

3. No eating / drinking in use/ storage areas

()Y() N

4. ()Y() N No food, drink, or personal effects kept in use/ storage areas

5. Proper dosimetry wem

()Y ()N

6. Radwaste disposed in proper receptacles

()Y() N ()Y() N F. Leak tests and Inventories 1. 2. Leak test performed on sealed sources and brachytherapy sources [35.59(S)] Leak test records in microcuries ()Y()N

3. Ins entory of scaled sources and brachytherapy

()Y()N sources performed quarterly [35.59(g)]

4. ()Y()N Inventory performed promptly at the storage area after removing sources from a patient and includes required information (35.406(a)) ()Y()N

5. Records maintained & signed by RSO [35.59,406]

()Y()N Remarks:

w. RADIATION SURVEY A. Survey instruments used to show compliance with Part 35 1.

Appropriate operable survey instruments possessed [35.120,220,320,4201 or available [35.520] ()N/A ()Y()N

2. Calibrations [35.51(a,b)]

a. Before first use, annually & after repairs

b. Approved calibration procedure followed to include check

()Y()N l i source reading determinatica[35.51(a)(3), UC] ()Y()N i

c. Within 20% in each sc;de or decade ofinterest [UC] ()Y()N 3.

4. Records maintained [35.51(d)] Source-checked each day of use [35.51(c)] ()Y()N

                                                                                                               ;)Y()N D. Radiation surveys performed

1. Daily in all areas where radiopharmaceuticals are prepared or administered [35.70(a)]

()Y()N

2. Weekly in all areas where radiophannaceuticals 3.

or waste is stored [35.70(b)] ()Y()N Weekly wipes in all areas where radiopharmaceuticals are routinely

  /'                         prepared, administered or stored [35.70(e)]

( 4 Quarterly in brachytherapy source storage area ()Y()N ()Y()N Nuclear Medicine 9

C. Trigger levels [35.701

 .A I      \
  \s' ,j                   .l.       Established

()i () N

2. Exceeded

3. Corrective action taken and documented

()Y()N ()Y()N D. Techniques can detect 0.1 mR/hr,2000dpm [35.70] E. Records maintained [35.70(h), UC] ()Y()N F. Protection of members of the public ()Y()N Note: See IN 94-09 for updated guidance on conflicts between Parts 20 and 35. 1. Licensee made adequate surveys to demonstrate either (1) that the TEDE to the individual likely to receive the highest dose does not exceed 100 mrem in a year, or (2) that if an individual were ccntinuously present in an unrestricted area, the extemal dose would not exceed 2 mrem in any hour and 50 mrem in a year [20.133)(a)(1),1302(b)]

2. ()Y()N Unrestricted area radiation levels do not exceed 2 mrem in any one hour [20.130l(a)(2)]

3. Records maintained [20.2103,2107]

()Y()N ()Y()N Remarks:

8. Patient Release

()N/A THE FOLLOWING GUIbANCE IS TO BE USED AITER THE 1997 REVISION OF 10 CFR 35.75 BECOMES FFECTIVE. IF USING THIS SECTION, DO NOT ANSWER ITEMS 9fC AND 10.C BELOW.

 \j\           A.

B. Individuals released when TEDE less than 0.5 rem [35.75(a)] Instructions on ALARA provided to individuals ()Y()N when TEDE exceeds 0.1 rem [35.75(b)] ()Y()N C. Instructions to breast. feeding women include required information [35.75(b)] D. ()Y()N E. Release records maintained if 35.75(c) criteria are met [35.75(c)] Records ofinstructions given to breast. feeding women maintained, ()Y()N ifrequired [35.75(d)] ()Y()N

9. RADIOPHARMACEUTICAL THERAPY

() N/A A. Safety precautions implemented to include patient facilities, posting, stay times, patient safety guidance, release and contamination controls [35.315(a), UC] B. ()Y()N Area dose rate surveys and room contamination surveys [35.315(a)(4), (7)] ()Y()N C. Release of patients <nntaining radiopharmaceuticals meets <5 mR/hr @ Im or < 30 mci [35.75] ()Y()N D. RSO promptly notified if patient died or had a medical emergency [35.315(b)] () N/A () Y ()N Remarks: F Nuclear Medicine 10

{ f#0. BRACHYTHERAPY ()N/A A. Sa'ety precautions implemented to include patient facilities, posting, stay times, and area radiation level surveys [35.415, UC] B. ()Y () N Patie nts surveyed immediately after implant [35.406] C. ()Y ()N Relt ase of patients with permanent implants meets 5 mR/hr @ Im [35.75] ()N/A ()Y()N D. Pat'ents surveyed immediately after removing the last temporary implant source (re quired for all manual, LDR, MDR, and HDR therapies) [35.404(a)) E. Records maintained [35-404(b),406(d),415(a)(4)] ()N/A ()Y()N ()Y() N Remarks:

11. RADIOACTIVE WASTE A. Disposal

1. Decay-in-storage N/A

a. Approved [20,2001,35.92, UC]

b. ()Y() N Procedures followed [35.92, UC] c. ()Y() N Labels removed or defaced [20.1904,35.92] O ()Y () N ( 2. Special procedures perfe med as required [UC]

k. 3. ()Y ()N Improper / unauthorized disposals [20.2001]

4. ()Y() N Records maintained [20.2103(a),2108, UC]

Remarks: ()Y() N B. Effluents

1. Release to sanitary sewer [20.2003]

                                                                                                            ~ () N/A () Y()N a.

b. Material is readily soluble or readily dispersible [20.2003(a)(1)] ()Yt)N Monthly average release concentrations do not exceed App. B, Table 2 values

c. No more than 5 Ci of H-3,1 Ci of C-14 and 1 Ci of all other radionuclides

()Y()N combined released in a year [20.2003] d. ()Y()N Procedures to ensure representative sampling and analysis implemented [20.150, UC] ()Y()N 2 Release to septic tanks [20.2003] ()N/A ()Y()N

a. Within unrestricted limits [ App B. Teble 2]

()Y()N f3 (%J ) Naclear Medicine 11 E _ ___ . _ . . .

3. Waste incinerated a -

a. () N/A () (() N License authorizes [20.2004(a)(3)] ()Y()N

b. Licensee directly monitors exhaust

                         -                                                                                           () Y () N Airborne releases evaluated and controlled [20.1501,20.1701]

()Y()N

4. Air effluents and ashes controlled [20.1101,1201,1301,15 )l,2001, UC] () N/A (See also IP 87102, RG 8.37) a.

b. Air efiluent less than 10 mrem constraint limit [20.1101] If no, licensee reported appropriate information to NRC ()Y()N ()Y()N

1. Corrective actions implemented and on schedule

()Y()N

c. Description ofeffluent program

1. Monitoring system nardware adequate 2.

()Y()N s Equipment calibrated as appropriate 3. ()Y()N Air samples / sampling technique (i.e. charcoal, HEPA, etc.)

                                                    . Analyzed with appropriate instrumentation Remarks:                                                                                      ()Y()N C.        Was*e storage f

i 1. 2. Protection from elements and fire [UC] ()Y()N

\                    3.

Control of waste maintained [20.1801] Containers properly labeled and area properly posted [20.1902,1904] ()Y()N 4 Package integrity adequately maintained [UC] ()Y()N ()Y()N D. Records of surveys and material accountability are maintained [20.2103,2108] () Y () N Remarks:

12. RECEIPT AND TRAN FER OF RADIOACTIVE MATERIAL A. Describe how packages are received and by whom:

( )N/A B. - Written package opening procedures established and followed [20.1906(e)] C. All incoming packtges with a DOT label -wiped, unless ()Y ()N exempted (gases and special form) [20.1906(b)(1)] D. Incoming packages surveyed [20.1906(b)(2),1sC) ()Y()N E. Monitoring in (C) and (D) perfonned within tirre ()Y()N 1 specified [29.1906(c)] F. Transfer (s) between licensees performed per [30.41] ()Y()N. [' O. All sources surveyed before shipment and transfer ()Y()N j ( {20.1501(a),49 CFR 173.475(i), UC] ()Y()N ' Nuclear Medica.e 12

[] (j H. Records of surveys and receipt / transfer maintained

                          , [20.2103(a),30.51]
                 !.                     Package receipt / distribution activities evaluated for

()Y()N compliance with 20.1301 [20.1302] ()Y ()N Remarks:

13. TRANSPORTATION (10 CFR 71.5(a) and 49 CFR 171-189) () N/A A. Licensee shipments are:

1 () delivered to common carriers ( ) transported in licensee's own private vehide () both () no shipments since last inspection B. Licensee retums radiopharrnacy doses () N/A () Y() N

1. Licensee assumes shipping responsibility

()Y()N

2. If NO, describe arrangements made between licensee and radiopharmacy for shipping responsib:lities:

[ C. Packages ()N/A l

1. l Authorized packages used [173.415,416]

2. Perforrrance test records on file

()N/A ()Y()N () N/A

a. DOT-7A packages [l73.415(a))

b. Spech! form sources [173.476(a)]

()Y()N i ()Y()N l

3. Two labels (White-1, Yellow-II, Yellow-Ill) with TI, Nuclide, Activity, and Hanrd Class [l72.403,173.441] ()Y()N

4. Properly marked (Shipping Name, UN Number, Package Type, RQ, "This End Up"(liquids), Name and Address of consigt.ee)

[l72.301,306,310,312,3241 5. ()Y()N Closed and sealed during transport [173.475(f)] ()Y()N D. Shipping Papers () N/A

1. Prepared and used [172.200(a)]

()Y()N

2. Proper SMpping Narne, Hazard Class, UN Number, Quantity, Package Type, No kJe, RQ, Radioactive Material Physical and Chemical Form, Activity, Category oflabel, TI, Shipper's Name, Cc.rtification and Signature, Emergency

      '                            Response Phone Number, " Limited Quantity" (if applicable), ' Cargo Aircraft Only" (if applicable))[172.200-204]                                       ()Y()N g                     3.          Readily e        ible during transport [177.817(e))

w ()Y()N 1 Nuclear Medicine 13

           .4.      PERSONNEL RADIATION PROTECTION A.       k,icensee performed exposure evaluation [20.1501) l                    B.

Licensee implemented ALARA program [35.20,20.1101(b)] ()Y()N ()Y()N C. Exterr.al Dosimetry ()N/A

1. Licensee monitors workers (20.!502(a), UC]

2. External exposures account for contributions from airborne activity

                                                                                                                  .()Y()N

[20.1203]

3. Supplier Frequency ()N/A ()Y()N

4. Supplier is NVLAP-approved [20.1501(c)]

5. Dosimeters exchanged at required frequency [UC]

()Y()N ()Y()N D. InternalDosimetry ()N/A 1. 2. Licensee monitors workers [20.1502 UC] ()Y()N Briefly describe licensee's program for monitoring and controlling internal exposures [20.1701,1702, UC]:

3. Aerosols and gases sampled [35.205]

4. Monitoring / controlling program implemented

()Y()N (includes bionssays)[35.315(a),205(d), UC]

5. Respiratory protection equipment [20.1703]

()Y()N ()Y()N Remarks: j E. Reports

1. Reviewed by - Frequency

2. Inspector reviewed personnel monitoring records 5 period to

3. PNor da: determined for individuals likely to receive doses [20.2104]

4. . Maximum exposures TEDE

()Y()N _ Other

5. Maximum CDEs Organs ,

6. Maximum CEDE 7.

8. Licensee sums intemal and external (20.1202] ()Y()N 9. TEDEs and TODEs within limits ['0.1201] NRC forms or equivalent [20.2104(d),2106(c)] ()Y()N

a. NRC-4 ()Y()N Complete: ()Y()N

b. NRC-5 ' () Y()N Complete: ()Y()N

10. Worker decfared her pregnancy in writing during inspection period (review records)

()N/A ()Y()N Ifyes, Ikensee in compliance with [20.12081 ()Y()N and recs. maintained [20.2106(e)] ()Y()N N Nuclear Medicine 14 4

i F. Who performed any PSEs at this facility (number ofpeople involved and doses received) l [ [20.1206,2104,2105,2204) ()N/A i( t L G. Records of exposures, surveys, monitoring, and evaluations maintained [20.2102, 2103, 2106, 35.205(d), 315(a)(8), I/C] ()Y()N

               .Remarice

15. MISADMINISTRATIONS AND RECORDABLE EVENTS () N/A 1

l A. If misadministrations or recordable events (defined in 35.2) have occurred since the last inspection, evalua licensee's quality managemera program (QMP) using the existing guidance. [ Reference TI 2800/02

1. Event date Infomaation Source

2. Notifications l . NRC Ops Center ()Y()N Region ()Y()N Referring Physician ()Y()N Patient ()Y()N

                       ' In writing                   ()Y()N If notification did not occur, why not:                                                                      !
     ]                  3.         Written Reports [35.33]

a. Submitted to Region within 15 days

b. Copy to patient within 15 days

()Y()N  ; ()Y()N B. Records maintained [35.33(b)) ()Y()N Remarks:

16. NRC INDEPENDENT MEASUREMEbtrS A. Survey instrument Serial No. Last calibration i

B. Inspector's measurements were compared to licensee's ()Y()N C. Describe the type, location, and results oh asurements: I s Nuclear Medicine 15

             . .e                                                                                                          __

f t

17. NOTIFICATION AND REPORTS 0 A.

( , Licensee in compliance with [19-13,30.50] (repons to individuals, public and occupational, monitored to show compliance with Part 20) B. Licensee in compliance with [20.2201,30.50] (theft or loss) ()N/A ()Y()N C. Licensee in compliance with [20.2202,30.50] (incidents) ()None() Y() N D. Licensee in compliance with [20.2203,30.50] ()None () Y () N overexposures and high radiation levels) E. Licensee aware ofNRC Ops Center phone number () None() Y()N F. Licensee in compliance with [20.22031 (Constraint on air emissions) ()Y()N ()None () Y ()N Remarks:

18. POSTING AND LABELING A. NRC-3 " Notice to Workers" is posted [19.11]

B. Parts 19,20,21, Section 206 of Energy Reorganization Act, procedures ()Y()N adopted pursuant to Part 21, and license documents are posted or a notice ihdicating where documents can be examined is posted {l9-11,21.6] C. ()Y()N

                     ' Other posting and labeling per [20.1902,1904] and the licensee is not exemped by [20.1903,1905]

()Y()N Remarks:

 /

U RECORDKEEPING FOR DCCOMMISSIONING A. Records ofinformation imponant to the safe and effective decommissioning of the facility maintained in an independent and identifiable locati on until license termination [30.35(g)] B. Records include all information outlined in [30.35(g)] ()Y()N ()Y()N Remarks:

20. BULLETINS AND INFORMATION NOTICES A. Bulletins, Information Notices, NMSS Newsletters, etc., received by the licensee B. Licensee took appropriate action in response to Bulletins, Generic Letters, etc.

()Y()N ()Y()N Remarks: P% Nuclear Medicine 16

I 1 l 1 l 21. I

x. SPECIAL LICENSE CONDITIONS OR ISSUES

( ) N/A

           /       A.       Special license conditions or issues to be reviewed:

1 B. Evaluation:

22. DEBRIEF WITil LICENSING STA.FF Inspection Gndings discussed with licensing staff

() N/A Items discussed:

23. CONTINUATION OF REPORTITEMS 1

24. VIOLATIONS. NCVS. AND OTHER ISSUES i

(7te:

           !                Brie 0y state (1) the requirement r.nd (2) how and when the licensee violated the requirement. For non-cit the violation was not cited.
 'O

25. PERFORMANCE EVALUATION FACTORS Licensee Inspector __

(name &locatio,) Inspection Date A. Lack ofsenior management involvement with the radiation safety program and/or Radiation Safety Officer (RSO) oversight B. RSO too buse with other assignments ()Y()N l C. Insufficient staffing ()Y()N 1 D. ()Y()N Radiation Safety Committee fails to meet or functions in adequately ()Y()N E. Inadequate consulting services or inadequate audits F. FinancialInstability ()Y()N ()Y()N Remarks (consider above assessment and/or other pertinent PEFs): ! / ( Dional,

           )       follow-up on above PEFs citations:

s_ Nuclear Medicine 17 I L _

b MEDICAL TELETHERAPY INSPECTION FIELD NTES Region Impection Report N. License N. Docket N. Licensee (Name & Address): Licensee Contact Telephone N. Last Amendment N. Date of Amendment

        ' Priority:    ( ) 02300 Teletherapy - Human Use

( )Other Teletherapy Date of Last Inspection Date ofThis Inspection

           \

pe ofInspection: anriounced () unannounced () Ruutine () Special () Initial () Re-inspection () Next Inspection Date Normal () Reduced () Extended () Summary of Findings and Action: N viola: ions, Clear 591 issued  ! Violation (s),591 issued Violation (s). Regional letter issued Follow up on Previous Violations Were Non-cited violations identified during this inspection? Y( ) N( ) 1 l

    ' Was proprietary information reviewed by or received by the inspector?              Y( )      N( )
     ' Inspector:                                  Date Approved:                                    Date

t. t I-k l

Teletherapy 1 L_ ___ -

1. INSPECTION HISTORY

 /    '\                                                                                                  ( )N/A-Initialinspection

( A. Violations were identified during the last two inspections or two Ye an w hichever is longer Y( ) ,N( ) B. Response letter (s) or 591(s) dated C. Open Violations from previous inspections: Requirement Violation Corrective Action Taken (Y/N) ptatus Open/ Closed D. Explain any previous violations Not corrected or repeated N/A ( )

2. ORGANIZATION AND SCOPE OF PROGRAM A. Organizational Structure gg )

(v) I

                      + Individuals contacted during inspection

• Individuals present at exit meeting I. Meets license requirements [IJC] Y( ) N( )

2. Multiple authorized locations of use Y( ) N( )

If so, list locations inspected N/A ( )

3. Briefly describe scope of activities. including type of Teletherapy unit, source activity, frequency of use, staff size. etc.

B. Radiation Safety Officer

1. Appointed [35.21(a),9001 Y( ) N( )

2. Fulfills duties per[35.21(b)]

3. Has sufficient authority per[35.23]

Y( ) N( ) Y( ) N( ) \ [^N

 \      )                                                                                      ,

O Teletherapy 2

C. Radiation Safety Program { ( }J. Minor changes 6 pursuant to [35.31

   'd

2. Records ofchanges maintained [35.31(b)]

Y( ) N( ) N/A Y( ) N ( ) N'A

3. Content and implementation reviewed annually by the licensee [20.1101(c) 35.22(b)(6)]

4. Y() N()N/A Records of reviews maintained [20.2102(a)(2)] Y( ) N ( ) N/A D. Authorized Users

1. Teletherapy Physicist

a. Named on license [UC]

b. Certified per [35.961(a)] OR meets requirements in [35.961(b)]

Y( ) N ( ) N/A Y( ) N()N/A

2. Authorized individuals [UC]

3. Visiting Authorized User Y( ) N ( ) N/A Y( ) N ( ) N/A

a. Written pennission [35.27(a)(1)]

b. Copy oflicense on file [35.27(a)(2)]

Y( ) N ( ) N/A Y( ) N( ) N/A

c. Performs only those procedures authorized on visitor's license [35.27(a)(3)] Y( ) N()N/A

d. Uses material under licensee's license for sixty days per year or less [35.27(b)] Y( ) N()N/A

e. Records maintained 3 years after last visit [35.27(c)]

Y( ) N()N/A E. Any Amendments or Notifications since last inspection [35.13.14] Y( ) N ( ) N/A Remarks: A) ( V

3. TRAINING, RETRAINING. AND INSTRUCTIONS TO WORKERS A. Instmetions to workers [19.121] Y ( ) N( ) N/A B. Individual's understanding of current procedures and regulations is adequate C. Training program implemented [35.610]

Y( ) N( ) N/A

1. Operating procedures [35.610(a)(1)]

Y ( ) N( ) N/A

2. Emergency procedures [35.610(a)(2)]

3. Periodic training required [UC]

Y( )N( ) N/A

4. Periodic training implemented Y()N()N/A

5. Records maintained Y( )N ( )N/A Y ( )N ( ) N/A D. Supervis.on ofindividuals b 3authorized user in accordance with [35.25]

E. Revised Part 20 Y ( )N ( ) N/A Y ( )N ( ) N/A Workers cognizant of requirements for: I

1. Radiation Safety Program [20.1101]

Y( ) N( ) N/A

2. Annual dose limits [20.1301.1302] Y( ) N( ) N/A

3. New forms 4 and 5 Y()N()N/A L/

Teletherapy 3 L

4. 10% monitoring threshold [20.1502] ) Y ( ) N

5. Dose limits to embryo / fetus and declared pregnant worker (20.12081

( .

6. Grave Danger Posting [20.1902] Y( ) N( ) N/A

7. Procedures for opening packages [20.1906]

Y( ) N( ) N/A Y{ ) N( ) N/A NTE: Deficiencies in Section 3.E. while Not always a violation, should be brought to the attention oflicensee management at the exit meeting and in the cover letter transmitting the inspection report or NV. Remarks.:

4. TELETHERAPY FACILITIES A. 1-acility

1. As described in license application

2. Provided with electrical interlock system (35.615(b)]

Y( ) N( ) N/A Y( ) N( ) N/A

3. Equipped with functioning beam condition indicator light [35.615(c)] Y( ) N( ) N/A

4. Provided with system to permit continuous observation ofpatient [35-615(e)] Y ( ) N( ) N/A B. Unit Operation

1. Console keys controlled adequately [UC]

Y( )N( ) N/A

2. Restricted to certain source head orientations and/or gantry angles [UC]

3. Ceases to operate in restricted orientations [UC]

Y( )N( ) N/A Y( )N( ) N/A  ; Remarks:

5. EQUIPMENT A. Dosimetry System  !

1. Calibrated system available for use [35.630(a)]

Y( ) N( ) N/A '

2. Calibrated by NIST or an AAPM-accredited lab within previous t a years Y( ) N( ) N/A~

and after servicing [35.630(a)(1)] OR calibrated by inter-comparison per [35.630(a)(2)] l 1 [ G Teletherapy 4

B. Facility equipped with permanent radiation monitor [35.615(d)) i, V'

      )                  .l. Monitor provides visible Notice ofmalfunction resulting in exposed source and is observable upon entry into the Teletherapy room [35.615(d)(1)] Y ( ) N ( ) N/A 2.

Monitor equipped with a functicnal backup power supply [35.615(d)(2)] Y( )N( ) N/A

3. ,

Monitor is checked each day of use prior to treatments [35.615(d)(3)] Y( )N( ) N/A 4 Records of monitor checks maintained [35.615(d)(4)]

5. Y( ) N( .) N/A If monitor malfunctioned, was survey meter used [35.615(d)(5)]

6. Monitor was repaired / replaced promptly [35.615(d)(6)] Y( )N( ) N/A Remarks: Y( )N( ) N/A

6. MATERIALS A. Isotope, chemical form, quantity and use as authorized [35.600, UC]

Y( )N( ) N/A B. Possession and use of depleted uranium as shielding as authorized C. Leak tests and Inventories Y( )N( ) N/A

1. Performed per [35.59(b). (c)]

Y( )N( ) N/A

2. Records maintained [35.59(d)] Y( )N( ) N/A Remarks:

O f h \M RECEIPT AND TRANSFER OF RADIOACTIVE MATERIAL N/A ( ) A. Package containing replacement source received by the licensee in accordance with [20.1906] B. Transfer oflicensed material per [30.41] Y( ) N( ) N/A Y( ) N( ) N/A C. Records maintained [30-Sl(a)) Y( ) N( ) N/A Remarks: A I\,s] Teletherapy 5

9 TELETHERAPY SERVICING A. Inspection and servicing performed following source replacement or at intervals Not to exceed 5 years [35.647(a)] Y( )N( ) N/A B. Licensee arranged for needed service identifi:d during the inspection Y ( ~) N ( ) N/A C. Service performed by persons specifically authorized to do so [35.647(b)] Y( )N( ) N/A Remarks: 9. RADIATION SURVEYS FOR TELiiTHERAPY FACILITIES A. Survey Instruments

1. Appropriate operable survey instruments possessed per [35.620]

2. Calibratedper[35.51] Y( )N( ) N/A Y( )N( ) N/A B.

Surveys conducted around source head (with source off) and in adjacent areas to treatment room (with source on) [35.641(a)) Y( )N( ) N/A

1. Prior to first patient treatment

 +

2. Afternewsourceinstallation Y( )N( ) N/A

3. Afler any changes in room shielding, location of the unit within room, or use Y( )N( ) N/A of the unit such that radiation levels outside the roem :ould increase Y( )N( ) N/A C.

Records .naintained [35.641(c)] D. Survey reports submitted to NRC [35.645]

                                                                                                               .Y ( ')   N( )

Y( ) N( ) E. Protection ofmembers of the public 1. Licensee made adequate surveys to demonstrate either (1) that the TEDE to the individual likely to receive the highest dose does Not exceed 100 mrem in a year, or (2) that if an individual were coatinuously present in an unrestricted area. The external dose would Not exceed 2 mrem in any hour and 50 mrem in a year [20.1301(a)(1).1302(b)] Y( )N( )

2. Unrestricted area radiation levels do Not exceed 2 mrem in any one hour

[20.1301(a)(2)]

3. Records maintained [20.2103,21]

Y( )N( ) Y( ) N( ) Remarks: l t ) l T;letherapy 6

 /      0.

TELETHERAPY FULL CALIBRATION k A. Licensee utilizes one of the proper procedures (SCRAD 'or TG-21) [35.632(d)] B. Performed prior to first patient use [35.632(a)(1)] Y( ) N( ) C. At intervals Not to exceed one year [35.632(a)(3)] Y( ) N( ) D. Whenever spot-checks indicate output differs from expected by to Y( ) N( ) [35.632(a)(2)(i)] E. After source exchange, relocation, and major repair or modification Y( ) N( ) [35-632(a)(2)(ii),(iii)] F. Performed with properly calibrated instrument Y( ) N( ) G. Includes: Y( ) N( )

1. Output measured within *3% of expected for the range of field seizes, range of distances, and compensations (wedges, filters, etc.)

[35.632(b)(1)]

2. Y( ) N( )

Coincidence of radiation field a. d field light lonlizer [35-632(b)(2)] Y( ) N( ) 3. Uniformity of radiation field and beam angle dependence [35.632(b)(3)]Y ( ) N( ) 4 5. Timer constancy and linearity o ver the range of use [35-632(b)(4)] On-off error [35.632(b)(5)] Y( ) N( )

6. Y( ) N( )

Accura y of all measuring and localization devices [35.632(b)(6)] Y( ) N( ) H. Output corrected mathematically, montnly for Co-60 and at six-month I. intervals for Cs-137 [35.632(e)) Records maintained per[35.632(g)] Y( ) N( ) Y( ) N( ) (O Remarks:

11. TELET14ERAPY SPOT CHECKS A. Periodic spot checks

1. Performed once each calendar month [35.634(a)] Y( ) N( )

2. Procedures established by Teletherapy physicist [35-634(b)] .

Y( ) N( )

3. Procedures followed Y( ) N( )

4. Teletherapy physicist reviews results' within 15 days [35.634(c)]

5. Performed with properly calibrated instrument Y( ) N( ) N/A Y( ) N( )

B. Output spot checks include:

1. Timer constancy and linearity over the range ofuse [35.634(a)(1)] Y( )N( )

2. On-offerror[35.634(a)(2)] Y( ) N( )

3. Coincidence of radiation field and field light localizer [35.634(a)(3)] Y ( ) N( )

4. Accuracy of all measuring and localization devices [35.634(a)(4)] Y( ) N( )

5. The Outpat for one :ypical set of operating conditions [35-634(a)(5)] Y ( ) N ( )

6. DifTerence benveen measured and er.pected output [35.634(a)(6)] Y( ) N( )

O U Teletherapy 7 l e

C. Safety spot checks include: e .l. Interlock systems E35.634MXI)] Y( ) N( )

2. Beam stops and dead-man switches E35-634(d)(2)]

3. Beam condition indicatorlights [35.634(d)(3)]

Y( ) N( ) Y( ) N( )

4. Viewing systems E35.634(d)(4)]

5. Treatment room doors,inside and out [35.634(d)(5)]

Y( ) N( ) Y( ) N( )

6. Electrical treatment doon with power shut off[35.634(d)(6)] Y( ) N( )

D. Licensee promptly repaired items found to be Not operating properly and did Not use unit until repaired [35.634(e)) E. Records maintained per E35.634(f)] Y( ) N( ) N/A Y( ) N( ) Remarks:

12. PERSONNEL RADIATION PROTECTION A. Dosimetry

1. Licensee monitors workers as required [20.1502]

2. Supplier Frequency Y( )N( )

3. Supplier is NVLAP - approved [20.1501(c)]

4. Dosimeters exchanged at required frequency [l/C]

Y( )N( )

5. Dosimetry records maintained [20.2103]

Y( )N( ) Y( )N( ) B. Reports

1. Reviewed by Frequency

2. Inspector reviewed personnel monitoring records for -

period to

3. Maximum exposures: TEDE Other

4. NRC forms or equivalent [20.2104(d). 2106(c)]

! a. NRC-4 Y( ) N( ) Complete: Y( ) N( )

b. NRC-5 Y( ) N( ) Complete: Y( ) N( )

5. Maximum exposures in compliance [20.1201) i Y( )N( ) j

6. Worker declared her pregnancy in writing during the inspection period (Review records) Y( )N( ) N/A If Y. licensee's in compliance [20.1208]

Y( )N( ) N/A and records maintained [20.2106(e)] Y( ) N( ) N/A C. Licensee has implemented an ALARA program [35.20,20.1101(b)] Y( )N( ) D. Who performed any PSEs at this facility (number of people involved and doses received) [20.1206,2105,2204] N/A ( ) l Teletherapy 8

E. Records of exposures. surveys, monitoring, and evaluations maintained Q [20.2102,2103. 2106,35.205(d) 315(a)(8). IJC]

• Y( ) N( )

Remarks: 1 l 1 13. MISADMINISTRATIONS AND RECORDABLE EVENTS N/A ( ) A. l If misadministration or recordable events (defined in 35.2) have occurred since the last inspection 1 evaluate the incidents) and the licensee's qua:ity management program (QMP) using the existing guid

1. Event date Inforraation Source

2. Notifications NRC Ops Center Y() N( ) Region Y( ) N( )

Referring Physician Y() N( ) Patient Y( )N( ) In writing Y( ) N( ) If Notification did Not occur, why Not-

3. Written Reports

       \

(V) a. Submitted to Region within 15 days

b. Copy to patient within 15 days Y( ) N( )

Y( ) N( ) B. Records maintained [33.33(b)] Y( ) N( )

14. NRC INDEPENDENT MEASUREMENTS A. Survey instrument Serial N. Last calibration B. Inspector's measurements were compared to licensee's C.

Describe the type, location. and results of measurements (Include surveys Y( ) N( ) around source head with source "off" and surveys in areas adjacent to i treatment room with source "on"):

15. NTIFICATION AND REPORTS N/A ( )

A. Licensee in compliance with [19.13,30.501 (reports to individuals, public and occupational, monitored to show comphance with Part 20) B. Licensee in comp?iance with [20.2201,30.50] (theft or loss) Y( ) N( ) N/A C. Licensee in compliance with [20.2202. 30.50] (incidents) Y( ) N( ) None D. Licensee in compliance with [20.2203,30.50] Y( ) N( ) None (overexposures and high radiation levels) E. Licensee aware of NRC Ops Center phone number Y( ) N( ) None

\

Y( ) N( ) Teletherapy 9

l l

16. POSTING AND LABELING N' ) A.

B. NRC-3 " Notice to Workers" posted [19.11] Y( )N( ) Emergency procedures posted at console [35.610(a)] C. arts 19. 20, 21. Section 206 of Energy Reorganization Act, procedures adopted Y( )N( ) pursuant to Part 21, and license documents are posted or a Notice indicating where documents can be examined is posted [19.11,21.6] D. Y( )N( ) Other posting and labeling per [20.1902.1904]and the licensee is Not exempted by [20.1903,1905] Y( )N( ) Remarks:

17. RECORDKEEPING FOR DECOM A.

Records ofinformation important to the safe and effective decommissioning of the facility maintained in an independent and identifiable location until license termination [30.35(g)] Y( )N( ) D. Records include all information outlined in[30.35(g)] Y( )N( ) Remarks: (n

 \

18. BULLETINS AND-INFORMATION NTICES i

! A. Bulletins,Information Notices. NMSS Newsletters, etc., received by the licensee l Y( ) N( ) l B. Licensee took appropriate action in response to Bulletins, Generic Letters, etc. Y( )N( ) Remarks:

19. SPECIAL LICENSE CONDITIONS OR ISSUES N/A ( )

A. Special license conditions or issues to be reviewed: B. Evaluation:

20. CONTINUATION OF REPORT ITEMS N/A ( )

e ( Tel; therapy 10

x21. VIOLATIONS. NCVS. AND OTHER ISSUES N/A ( ) Note: Briefly state (1) the requirement and (2) how and when the licensee violated the requirement. For Non-cited violations. indicate why the violation was Not cited.

22. PERFORMANCE EVALUATION FACTORS Licensee Inspector Inspection Date A. Lack of senior management involvement with the radiation safety program and/or Radiation Safety Officer (RSO) oversight B. RSO too busy with other assignment Y( ) N( ) )

C. Insufficient staffing Y( ) N( )  ! I Y( ) N( ) D. Radiation Safety Committee fails to meet or functions inadequately Y( ) N( ) E. Inadequate consulting services or inadequate audits Y( ) N( ) Remarks (consider above assessment and/or other pertinent PEFS):

     ,~

1

 \
   's l                  Regional follow-up on above PEFS citations:

1 i i 1 i V) Teletherapy 11

ATTACHMENTA U QUALITY MANAGEMENTPROGRAM (QMP) QM FIELD NOTEP

1. GENERAL A. Facility name(s):

B. License number (s): C. Docket number (s): D. Last inspection date(s): E. Current inspection date(s): F. Most recent QMP and certification received by NRC [35.32(e), (f)(2)] Date:

2. PREPARATION A. Be familiar, with the submitted QMP and arv modifications in preparation for '

inspection of the licensee's implemented QMP. Familiarization should focus upon awareness of the submitted program in order to compare the written program with the program as implemented.

3. MODALITIES O A. Identify licensee procedures and attach appropriate inspection module (s):

, Module: l i

1. Nal I-125 or I-13 t > 30 uCi and/or Therapeutic radiopharmaceutical other than NaI 2.

()Y()N High-Dose-Rate Remote Afterloading Brachytherapy ()Y()N

3. All Other Brachytherapy

4. Strontium-90 eye applicator

()Y()N

5. Teletherapy

()Y()N

6. Gamma Stereotactic Radiosurgery

()Y()N 7. ()Y()N Event (misadministration or other) ()Y()N 1 1 o i 1

4.

         .yAMPLING (Inspector random sample of each modality)

Total Written Directives Minimum Target Sample 1 to 5 All 5 to 100 5

        > 100                              5%

Total Total Target Number W.D* W.D* Sample Reviewed - Prev.Yr Curr.Yr

1. Nal 1 125 or1 131 > 30 uCi

2. Therapeutic Radiophannaceutical other than Na!

3. HDR remote afterloading brachytherapy

4. Other brachytherapy

5. Sr.90 eye applicator

6. Teletherapy

7. Gamma Stereotactic Radiosurgery

• Full Calendar Year If two (2) or more written directives are incomplete or missing, the review must be expanded to assess whether this is an isolated occurrence or represents a substantial failure of the QMP.

MODULE I

%                                          GREATER THAN 30 MICROCURIES Na! I 125 of I 131 AND RADIOPHARMACEUTICAL THERAPY

1. SUPERVISION A.

Supervised individuals) instructed in QMP applicable to the modality of use [35.25(a)(1)] ( ) Y ( ) List individuals) found to be inadequately trained:

2. Nat I-125 or I-131 > 30 uCi

()N/A OBIECTIVE I Number Missed A. A wrinen directive (order for a specific patient, dated & signed by authorized user (a.u.) or physician unfer super.ision of an a.u.) is prepared for each patient [35.32(a)(1)] ) ()Y()T B. Written directives, as applicable, contain required dosage information [35.21 ) ()Y()N: C. Exceptions to written directives are documented [ footnote to 35.32(a)(1)] () N/A

1. Written revisions

 ~

2. Oral revisions ()Y() N:

3. Oral directives

()Y() N: ()Y() N: OBJECTIVE 2 A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)] ()Y() N: Remarks: OBJECTIVE 3 (Does not apply) OBJECTIVE 4 A. Procedures implemented to verify, prior to administration, that the specific details are in accordance with written directive [35.32(a)(4)] ()Y() N: B. Procedures may include: (not requirements)

1. Dosage measured prior to adminLtration

2. Dosage confirmed just prior to administration

()Y()N ()Y()N C. Record of administration maintained in auditable form [35.32(d)(2)] ()Y() N: Remarks: .A U Module i 1

OBJECTIVE 5 A. Procedures implemented to ensure that unintended deviations are identified, evaluated, and corrective action taken [35.32(a)(5)] ( ) Y ( )1. 1.' Recordable event (s) self-identified since the last inspection [35.32(c),35-2] Dates of events: ()Y()N

2. Recordable events identified by inspector [35.32(c),35.2]

3. Misadministration resulted from the unintended

()Y()N deviation (Ifyes, also complete module 7) ()Y()N B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N C. Procedures may include:(not requirements)

1. Assemble relevant facts including cause

2. Identify conrective action to prevent recurrence

()Y()N

3. Retain a record ofitems I and 2

()Y()N ()Y()N D. Licensee reported misadministration (s) since the last inspection (Ifyes, also complete module 7)[35.33(a)] ()Y()N E. Licensee identified misadministrations that were at subsequently reported (Ifyes, also complete module 7)[35.33(a)] ( )Y()N Remarks:

3. . Therapeutic Radiopharmaceutical other than Na!

() N/A OBJECTIVE 1 A. A written directive (order for a specific patient, dated & signed by authorized user (a.u.) or physician under supervision of an a.u.) is prepared for each patient [35.32(a)(1)] ( ) Y ( ) N B. Written directives, a3 applicable, contain required information, radiopharmaceutical, dosage, and route of administration [35.2] ()Y()N C. Exceptions to wrinen directives are documented [ footnote to 35.32(a)(1)] () N/A

1. Wrinen revisions

2. Oralrevisions ()Y()N

3. Oral directives ()Y()N

()Y()N Module 1 2

OBJECTIVE 2 A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)]: ()Y()N Remarks: OBJECTIVE 3 (Does not apply) OBJECTIVE 4 A. Procedures implemented to verify, prior to administration, that the specific details are in accordance with written directive [35-32(a)(4)] ()Y()N B. Procedures may include: (not requirements)

1. Dosage measured prior to administration

2. Radiopharme.eutical, dosage and route of administrat.on confirmec

()Y()N immediately prior to administration ()Y()N C. Record of administration maintained in auditable form [35.32(d)(2)] ()Y()N OBJECTIVE 5 A. Procedures implemented to ensure that unintended deviations are identified, evaluated, and corrective action is taken [35.32(a)(5)] ()Y()N 1. Recordable event (s) self-identified since the last inspection [35.32(c),35.2] ' Dates ofevents: ()Y()N 2. Recordable events identified by inspector [35.32(c),35.2] 3. Misadrainistration resulted from the unintended ()Y()N deviation (Ifyes, also complete module 7) ()Y()N B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N C. Procedures may include: (not requirements)

1. Assemble relevant facts including cause

2. Identify corrective action to prevent recurrence ()Y()N

3. Retain a record ofitems I and 2

()Y()N ()Y()N D. Licensee reported misadministration (s) since the last inspection (If yes, also complete module 7) [35.33(a)] ()Y()N E. Licensee identified misadministrations that were not subsequently reported (Ifyes, also complete module 7)[35.33(a)] ()Y()N Remarks: \ Module 1 3

4. PERIODIC REVIEWS OF THE OMP (m

g'j

    \

A. Review conducted of the QMP at intervals no greater than 12 months [35.32(b)(1)] Date oflast review: ()Y()N B. Review includes a representative sample of all patient administrations including all recordable events and misadministrations [35.32(b)(1)(i)(ii)(iii)] ()Y()N The licensee should utilize a representative sampling process which embodies a valid statistical sampling methodology. Regulatory Guide 8.33 provides an example using the acceptance sampling tables of 10 CFR 32.110 and assuming an error rate of 2%. If the tables in 10 CFR 32.110 are used, any table is acceptable. C. If review identified recordable events or misadministrations not previously identified, the review was expanded by the licensee to ensure the events were isolated ()Y()N D. Licensee evaluated each review to determine the effectiveness of the QMP [35.32( E. Based on evaluation of reviews, the licensee made modifications to meet Objectives [35.32(b)(2)] ()Y()N F. Modifications sent to NRC within 30 days [35.32(e)] () N/A ()Y()N G. Records of reviews including evaluation and findings maintained for at least 3 years [35.32(b)(3)] ()Y()N f b 5. RESULTS OF REVIEW Briefly describe the overall implementation of the QMP and summarize the inspection findings. If necessary, use an attachment. l l l l l 1 Q

6. Time spent completing this module: hours l

p b Module 1 4 l

MODULE 2 /9 HIGH-DOSE-RATE REMOTE AFTERLOADING BRACHYTHERAPY N.] '  !

l. SUPERVISION A.

Supervised individuals instructed in QMP applicable to the modality of use [35.25(a)(1)] ()Y()N List individuals found to be inadequately trained:

2. OBJECTIVE I Number Missed A.

A written directive (arder for a specific patient, dated & signed by authorized user (a.u.) or physician under supervision of an a.u.)is prepared for each patient [35.32(a)(1)] ()Y()N: D. Written directives contain required information, isotope, treatment site, & total dose [35.2] ()Y()N: ___ C. Exceptions to written directives are documented [ footnote to 35.32(a)(1)] () N/A

1. Written revisions

2. Oral revisions ()Y()N:

e 3. Oral directives ()Y()N: I ()Y()N: k Remarks: i

3. OBJECTIVE 2 A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)]

()Y()N:

4. OBJECRVE 3 A. Procedures implemented to verify that final plans of treatment and related calculations are in accordance with written directives [35-32(a)(3)] ()Y()N:

B. Procedures may include: (not requirements) 1. Check ofdose calculations by an authorized user or a qualified person under supervision of an authorized user who whenever possible did not make the original calculations

2. ()Y()N Performing acceptance testing (based on licensee's specific needs &

applications) on each treatment planning or dose calculating computer program that could be used for dose calculations

3. Other, describe:

()Y()N (v\/ Remarks: i l

n ,

5. OBJECTIVE 4 A. Procedures implemented to verify, prior to administration, that the specific details are in 1

accordance with written directive [35-32(a)(4)] ()Y()N B. Procedures may include: (not requirements) 1

1. Plan of treatment prepared in accordance with the written directive

2. Person administering therapy treatment confinns ()Y()N the prescribt4 radioisotope, site, & total dose

3. Dwell times and positions verified prior to start of treatment

()Y()N 4. Verify source position using dummy sources or fixed geometry applicators ()Y()N prior to inserting scaled sources

5. ()Y()N Prompt record by the authorized user, of the treatment parameters and signing or initialing patient's chan or appropriate record

6. Other, describe: . ()Y()N C.

Record of administration maintained in auditable form [35.32(d)(2)] ()Y()N Remarks:

6. OBJECTIVE 5 A. Procedures implemented to ensure that unintended deviations are identified, evaluated, and corrective action taken [35.32(a)(5)]

1. Recordable event (s) self-identified since the last inspection [35.32(c),35.2] Dates of events: ()Y()N

2. Recordable events identified by inspector [35.32(c),35.2]

3. Misadministration resulted from the uninteaded

()Y()N deviation (If yea, also complete module 7) ()Y()N

• B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)]

()Y()N C. Procedures miay include: (not requirements)

1. Assemble relevant facts including cause

2. Identify corrective action to prevent s ecurrence

()Y()N

3. Retain a record ofitems I and 2

()Y()N ()Y()N D. Licensee reported misadministration (s) since the last inspection (ifyes, also complete module 7)[35.33(a)) ()Y()N E. Licensee identified misadministrations that were not subsequently reported (Ifyes, also complete module 7)[35.33(a)] ()Y()N Remarks: m i \

7. PERIODIC REVIEWS OF THE OMP k A.

V Review conducted of the QMP at intervals no greater than 12 months [35.32(b)(1)] Date oflast review: ()Y()N B. Review includes a representative sample of all patient administrations including all recordable events and misadministrations [35-32(b)(1)(i)(ii)(iii)] ()Y()N The licensee should utilize a rep. .nntative sampling process which embodies a valid statistical sampling methodology. Regulatory Guide 8.33 provides an example using the acceptance sampling tables of 10 CFR 32.110 and assuming an error rate of2%. If the tables in 10 CFR 32.110 are used. any table is acceptable. C. If review identified recordable events or misadministrations, not previously identified, the review was expanded by the licensee to ensure the events were isolated ()Y()N D. Licensee evaluated each review to determine the effectiveness of the QMP [35.3 E. Based on evaluation of reviews, the licensee made mod 0 cations to meet Objectives [35.32(b)(2)] ()Y()N F. Modifications sent to NRC within 30 days [35 32(e)] () N/A () Y () N G. Records of revu>s including evaluation and findings maintained for at least 3 years [33.32(b)(3)] ()Y()N b o 1 I

  \

l l

I

8. RESULTS OF REVIEW Briefly describe the overall implementation of the QMP and summarize the inspection findings. If necessary, use an attachment.

9. Time spent completing this module: hours

i' l l MODULE 3 l

    'd
       )                                                            BRACHYTIIERAPY                                                    l (OTHER THAN HDR REMOTE AFTERLOADING)

1. SUPERVISION A.

Supervised individual (s) instructed in QMP applicable to the modality of use [35.25(a)(1)] ( ) Y ( ) N List individuals) found to be inadequately trained: I

2. OBJECTIVE I Number A. Missed A written directive (order for a specific patient, dated & signed by authorized user (a.u.)

or physician under supervision of an a.u.) is prepared for each patient [35.32(a)(1)] ()Y()N B. Written directives contain required information [35.2]: 1. Prior to implantation: radioicotope, number of sources, and source strengths ()Y()N

2. l After implantation & prior to completion ofprocedure: radioisotope, site, '

total source strength & exposure time (or total dose) ()Y()N C. Exceptions to written directives are documented [ footnote to 35.32(a)-(l)] () N/A (q}

  ,                                   1.

2. Written revisions Oral revisions ()Y()N ()Y()N i x) 3. Oral directives ) ()Y()N j l Remarks: I

3. OBJECTIVE 2 A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)] ()Y()N l

4. OBJECTIVE 3 A. Procedures implemented to verify that final plans of treatment and related calculations are in accordtnce with written directives [35.32(a)(3)] ()Y()N B. Procedures ma include: (not requirements) 1.

Check of dose calculations by an authorized user or a qualified person under supervision of an authorized user who whenever possible did not make the original  ; calculations 2. ()Y()N Performing acceptance testing (based on licensee's specific needs and applications) on each treatment planning or dose calculating computer program that could be used for dose calculations

3. Other, describe:

()Y()N O Module 3 Brachytherapy 1 l t

5. OBJECTIVE 4

     \/                    ~

( A. Procedures implemented to verify, prior to administration, that the specific details are in accordance with written directive [3532(a)(4)] ()Y()N B. Procedures ma include: (not requirements)

1. Plan of treatment prepared in accordance with the written directive

2. Person administering treatment confirms prescribed radioisotope,

()Y()N number of sources, source strengths, treatment site, loading sequence,

                                        & total dose.

3. ()Y()N Verify source position using dummy sources or fixed geometry applicators prior to inserting sealed sources

4. Prompt record by the authorized user, of the number ofsources, the actual

()Y()N loading sequence of sources implanted (location of each scaled source in a tube, tandem, or cylinder) and signing or initialing the patient's chart or appropriate record 5. ()Y()N Ensure that source will not move or dislodge while implanted ()Y()N

6. Inspect implanted sources

()Y()N Frequency: Inspecting individual trained

7. Other, describe:

()Y()N C. Record of administration maintained in auditable form [3532(d)(2)] ()Y()N

 >A   s

6. OBJECTIVE 5

('s 'l A. Procedures implemented to ensme that unintended deviations are identified, evaluated, and corrective action is taken [35.32(a)(5)] ()Y()N

1. Recordable event (s) self-identified since the last inspection [35-32(c),35-21 ) ()Y()N Dates of events:

2. Recordable events identified by inspector [3532(c),35.2]

3. ()Y()N Misadministration resulted from the unintended deviation (Ifyes, also complete module 7) ()Y()N B. Procedures implemented to evaluate & respond witnin 30 days to each recordable event discovered [3532(c)] ()Y()N C. Procedures may include: (not requirements)

1. Assemble relevant facts including cause

2. Identify corrective action to prevent recurrence

()Y()N

3. Retain a record ofitems 1 and 2

()Y()N

                                                                                                                      .()Y()N D.       Licensee reported misadministration (s) since the last inspection (Ifyes, also complete module 7) [3533(a)]

()Y()N E. Licensee identified misadministrations that were not subsequently reported O (Ifyes, also complete module 7)[35-33(a)] Remarks: ()Y()N Module 3 Bmehytherapy 2

f O 7.

                *ERIODIC REVIEWS OF THE OM PROGRAM [10 CFR 35.32(b)]

k. Review conducted of the QMP at intervals no greater than 12 months [35.32(b)(1)]

Date oflast review: ()Y()N B. Review includes a . epresentative sample of all patient administrations including all recordable events s.d nisadministrations E35.32(b)(1)(i)(ii)(iii)] ()Y()N The licensee should utiliae a representative sampling process which embodies a valid statistical sampling methodology. Regulatory Guide 8.33 provides an example using the acceptance sampling tables of 10 CFR 32.110 and assuming an error rate of 2%. If the tables in 10 CFR 32.110 are used, any table is acceptable. C. If review identified recordable events or misadministrations not previously identified, the review was expanded by the licensee to ensure the events were isolated ()Y()N D. Licensee evaluat-d each review to determine the effectiveness of the QMP [35.32( E. Based on evaluation of reviews, the licensee made modifications to meet Objectives [35.32(b)(2)] ()Y()N F. Modifications sent to NRC within 30 days [35-32(e)] () N/A () Y () N G. Records of reviews including evaluation and findings p maintained for at least 3 years [35.32(b)(3)] ()Y()N

 \

8. RESULTS OF REVIEW Briefly describe the overall implementation of the QMP and summarize the faspection findings.

If necessary, use an attachment. a

9. Time spent completing this module: hours l

( O (s Module 3 Brachytherapy 3 1 j l j

MODULE 4 STRONITUM-90 EYE APPLICATORS -

1. SUSERVISION A.

Supervised individual (s) instructed in QMP applicable to the modality of use [35.25(a)(1)] () Y ( ) N List individual (s) found to be inadequately trained:

2. OBJECTIVE I Number Missed A. A written directive (order for a specific patient, dated & signed by authorized user (a.u.) or physician under supervision of an a.u.) is prepared for each patient [35.32(a)(1)] ( ) Y ( ) N B. Written directives contain required information, source strength, site, & exposure time or total dose [35.2] ()Y()N C. Exceptions to written directives are documented (footnote to 35.32(a)(1)]

l {)N/A l

1. Written revisions

2. Oral revisions

()Y()N

3. Oral directives

()Y()N ()Y()N Remarks:

3. OBJECTIVE 2 A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)] ()Y()N 4.

OBJECTIVE 3 A. Procedures implemented to verify that final plans of treatment and related calculations are in accordance with written directives [35.32(a)(3)] ()Y()N B. Procedures m-a-y include: (not requirements)

1. Plan of treatment prepared in accordance with the written directive 2.

()Y()N Assess quantity of material remaining after decay (decay chart or other method) ( ) Y ( ) N

3. Other, desenh:

Module 4 Strontium 90 Eye Applications I l.-

1

5. OBJECTIVE 4

                       ~

A. Procedures implemented to verify, prior to administration, that the specific details are in accordance with wrinen directive [35.32(a)(4)j ()Y()N B. Procedures may include: (not requirements)

1. Method used to time the administration

2. ()Y()N Person administering treatment confirms the prescribed site and the total dose, or source strength and exposure time

3. Other, describe: ()Y()N C.

Record of administration maintained in auditable form [35.32(d)(2)] ()Y()N Remarks:

6. OBJECTIVE 5 A. Procedures implemented to ensure that unintended deviations are identified, evaluated, and corrective action is taken [35.32(a)(5)] ()Y()N 1.

Recordable event (s) self-identified since the last inspection [35.32(c),35.2] Dates of events: ()Y()N

 \ '

2. Recordable events identified by inspector [35.32(c),35.2]

3. ()Y()N Misadministration resulted from the unintended deviation (Ifyes, also complete module 7) ()Y()N B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N C. Procedures ma include: (not requirements)

1. Assemble relevant facts including cause

2. Identify corrective action to prevent recurrence

()Y()N

3. Rett.in a record ofitems I and 2

()Y()N ()Y()N D. Licensee reported misadministration (s) since the last inspection (Ifyes, also complete module 7) [35.33(a)] ()Y()N E. Licensee identified misadministrations that were not subsequently reported (Ifyes, also complete module 7)[3533(a)] ()Y()N Remarks: l .O - l V Module 4 Strontium 90 Eye Applications 2 l l I

F i l t Q 7. PERIODIC REVIEWS OF THE OMP ! A. Review conducted of the QMP at intervals no greater than 12 months [35.32(b)(1)] Date oflast review: ()Y()N B. Review includes a representative sample of all patient administrations including all recordable events and misadministrations [35.32(b)(1)(i)(ii)(iii)] ()Y()N The licensee s%uld utilize a representative sampling process which embodies a valid statistical sa mpling methodology. Regulatory Guide 8.33 provides an example using the acceptance sampling tables of 10 CFR 32.110 and assuming an error rate of 2%. If the tables in 10 CFR 32.110 are used, any table is acceptable. C. If review identified recordable events or miradministrations not previously identified, the review was expanded by the licensee to ensure the events were isolated ()Y()N D. Licensee evaluated each review to determine the effectiveness of the QMP [35.32(b)(2)] E. Based on evaluation of reviews, the licensee made modifications to meet Objectives [35.32(b)(2)] ()Y()N F. Modifications sent to NRC within 30 days [35.32(e)] ()N/A ()Y()N G. Records of reviews including evaluation and findings l maintained for at least 3 years [35.32(b)(3)] ()Y()N

 'O

8. RESULTS OF REVIEW Briefly describe the overall implementation of the QMP and summarize the inspection findings. If necessary, use an attachment.

l l l l i i l

9. Time spent completing this module: hours G

Module 4 Strontium 90 Eye Applications 3 i

MODULE S TELETHERAPY

1. SUPERVISION A.

Supervised individuals instructed in QMPapplicable to the modality of use [35.25(a)(1)] ( ) Y List individuals found to be inadequately trained: { l l

2. OBJECTIVE I Number A. Missed A written directive (order for a specific patient, dated & signed by authorized user (a.u.)

or physician under supervision of an a.u.) is prepared for each patient [35.32(a)(1)] ()Y()N B. Written directives contain required information, total dose, dose pe r fraction, site, & overall treatment period [35.2] ()Y()N C. Exceptions to written directives documented [ footnote to 35.02(a)(1)] ( ) N/A

1. Written revisions

2. Oral revisions ()Y()N

3. Oral directives ()Y()N

()Y()N

3. OBJECTIVE 2

! C\

 ;             A.

Licensee uses more than one method to verify the patient's identity [35.32(a)(2)] ()Y()N

4. OBJECTIVE 3 A. Procedures implemented to verify that final plans of treatment and related calculations are in accordance with written directives [35.32(a)(3)] ()Y()N I B. Procedures may include: (not requirements)

1.

i Check of dose calculations by an authorized user or a qualified person under supervision ofan authorized user who whenever possible did not make the original calculations

2. ()Y()N Performing acceptance testing (based on heensee's specific needs and applications) on each treatment planning or dose calculating computer program that could be used for dose calculations

3. () Y()N Determining transmission factors for beam modifying devices before first use and after replacement of the source

4. Output measurements for treatment parameters not addressed in the most

()Y()N recent full calibration

5. Checking dose calculations administration in fractions (procedure should include

()Y()N consideration of number of fractions and specified time within which the check should be performed)

6. Other, describe: ()Y()N p Remarks:

t s Module 5 Teletherapy i

5. OBJECTIVE 4 A.

Procedures implemented to verify, prior to administration, that the specific details are in accordance with written directive [35-32(a)(4)] ()Y()N B. Procedures may include: (not requirements)

1. Plan of treatment prepared in accordance with the written directive 2.

Person administering treatment confinns the written directive and plan of treatment. ()Y()N At a minimum, the verification of treatment site and dose per fraction

3. Other, describe: ()Y()N C.

Record of each administration or fraction maintained in auditable form ()Y()N

6. OBJECTIVE 5 A.

Procedures implemented to ensure that unintended deviations are identified, evaluated, and corrective action is taken [35.32(a)(5)] ()Y()N 1. _ecordable event (s) self-identified since the last inspection [35.32(c),35.2] ()Y()N Dates ofevents:

                     '2.        Recordable events identified by inspector [35.32(c),35.2]

3. Misadministration resulted from the unintended ()Y()N \ deviation (Ifyes, also complete module 7) ()Y()N B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N C. Procedures my include: (not requirements)

1. Assemble relevant facts including cause

2. Identify corrective action to prevent recurrence

()Y()N

3. Retain a record ofitems I and 2

()Y()N ()Y()N D. Licensee reported misadministration (s) since the last inspection (Ifyes, also complete module 7) [35.33(a)] ()Y()N E. Licensee identified misadministrations that were not subsequently reported (Ifyes, also complete. module 7)[35.33(a)] ()Y()N { Remarks: i l i i Module 5 Teletherapy 2

7. PERIODIC REVIEWS OF THE OMP

                 . A.

d Review conducted of the QMP at intervals no greater than 12 months [35.32(b)(1)] Date oflast review: ()Y()N B. Review includes a representative sample of all patient administrations including al recordable events and misadministrations [35-32(b)(1)(i)(ii)(iii)] ()Y()N The licensee should utilize a representative sampling process whip embodies a valid statistica sampling methodology. Regulatory Guide 8.33 provides an example using the acceptance sampling tables of 10 CFR 32.110 and assuming an error rate of 2%. If the tables in 10 CFR 32.110 are used, any table is acceptable. C. If review identified recordable events or misadministrations not previously identified, the review was expanded by the licensee to ensure the events were isolated ()Y()N D. Licensee evaluated each review to determine the effectiveness of the Q E. Based on the evaluation of reviews, the licensee made modifications to meet Objectives [35.32(b)(2)] ()Y()N F. Modifications sent to NRC within 30 days [35.32(e)] ()N/A ()Y()N G. Records of reviews including the evaluation and findings maintained for at least 3 years [35.32(b)(3)] ()Y{)N Remarks:

8. RESULTS OF REVIEW Briefly describe the overall implementation of the QMP and summarize the inspection findings.

If necessary, use an attachment.

9. Time spent completing this module: hours i

m i 1 Module 5 Teletherapy 3 l

                                                                                                                        \

l l

MODULE 5 [] TELETHERAPY

 \' j,

l. SUPERVISION A.

Supervised individuals instructed i.o QMPapplicable to the modality ofuse [35.25(a)(1)] ( ) Y ( ) N List individuals found to be inadequately trained:

2. OBJECTIVE I Number A. Missed A written directive (order for a specific patient, dated & signed by authorized user (a.u.)

or physician under supervision of an a.u.) is prepared for each patient [35.32(a)(1)] ()Y()N B. Written directives contain required information, total dose, dose per fraction, site, & overall treatment period [35.2] ()Y()N C. Exceptions to written directives documented [ footnote to 35.32(a)(1)] ( ) N/A l

1. Written revisions

! 2. Oral revisions ()Y()N

3. Oraldirectives

()Y()N ()Y()N l 3. OBJECTIVE 2 m A. Licensee uses more than one method to verify the patient's identity [35.32(a)(2)] ()Y()N l 4 OBJECTIVE 3 l l A. Procedures implemented to verify that final plans of treatment and related calculations are in accordance with written directives [35.32(a)(3)] () Y()N - B. Procedures may include: (not requirements) 1. Check of dose calculations by an authorized user or a qualified person under supervision of an authorized user who whenever possible did not make the original calculations 2. ()Y()N Performing acceptance testing (based on licensee's specific needs and applications) on each treatment planning or dose calculating computer program that could be used for dose calculations

3. Determining transmission factors for beam modifying devices before first use

()Y()N and after replacement of the source

4. Output measurements for treatment parameters not addressed in the most

()Y()N recent full calibration 5. ()Y()N Checking dose calculations administration in fractions (procedure should include consideration of number of fractions and specified time within which the check should be performed)

6. Other, describe:

()Y()N

    ~N         Remarks:

V Module 5 Teletherapy 1

N. 5. OBJECTIVE 4 A. Procedures implemented to verify, prior to administration, that the specific details are in accordance with written directive [35-32(a)(4)] ()Y()N B. Procedures may include: (not requirements)

1. Plan of treatment prepared in accordance with the written directive

2. ()Y()N Person administering treatrnent confirms th written directive and plan of treatment.

At a minimum, the verification of treatment site and dose per fraction

3. Other, describe: ()Y()N C.

Record of each administration or fraction maintained in auditable fonn ()Y()N

6. OBJECTIVE 5 A.

Procedures implemented to ensure that unintended deviations are identified, evaluated, and corrective action is taken [35.32(a)(5)] ()Y()N 1. Recordable event (s) self-identified since the last inspection [35.32(c),35.2] ()Y()N Dates of events:

2. Recordable events identified by inspector [35.32(c),35.2]

()Y()N (j s-j 3. Misadministration resulted from the unintended deviation (If Ms, also complete module 7) ()Y()N B. Procedures implemented to evaluate & respond within 30 days to each recordable event discovered [35.32(c)] ()Y()N C. Procedures may include: (not requirements)

1. Assemble relevant facts including cause '

2. Identify corrective action to prevent recurrence

()Y()N 3. ()Y()N Retain a record ofitems I and 2 ()Y()N D. Licensee reported misadministration (s) since the last inspection (If yes, also complete module 7) [35.33(a)] ()Y()N E. Licensee identified misadministrations that were not subsequently reported (If yes, also complete. module 7)[35.33(a)] ()Y()N Remarks: %d ) Module 5 Teletherapy 2

7. PERIODIC REVIEWS OF THE OMP g

                         . A.

('v) Review conducted of the QMP at intervals no greater than 12 months [35.32(b)(1)] Date oflast review: ()Y()N B. Review includes a representative sample of all patient administrations including all recordable events and misadministrations [35-32(b)(1)(i)(ii)(iii)] ()Y()N The licensee should utilize a representative sampling process which embodies a valid statistical sampling methodology. Regulatory Guide 8.33 provides an example using the acceptance sampling tables of 10 CFR 32.110 and assuming an error rate of 2%. If the tables in 10 CFR 32.110 are used, any table is acceptable. 1 C. If review identified recordable events or misadministrations not previously identified, the review was expanded by the licensee to ensure the events were isolated () Yt D. Licensee evaluated each review to determine the efTectiveness of the QMP [35 E. Based on the evaluation of reviewa, the licensee made modifications to meet Objectives [35.32(b)(2)] ()Y()N F. Modifications sent to NRC within 30 days [35.32(e)] () N/A ( ) Y ( ) N G. Records of reviews including the evaluation and findings maintained for at least 3 years [35.32(b)(3)] ()Y()N rg Remarks:

 /      \

( )

 %.J

8. RESULTS OF REVIEW )

Briefly describe the overall implementation of the QMP and summarize the inspection findings. If necessary, use an attachment. l 1 l l i

9. Time spent completing this module: hours p.

7  % _ j Module 5 Teletherapy 3 I

[' MODULE 6 GAMMA STEREOTACTIC RADIOSURGERY

                 !.                           SUPERVISION A.

Supervised individuals instructed in QMP applicable to the modality of use [35.25(a)(1)] ( ) Y ( ) N List individuals fo md to be inadequately trained: s

2. OBJECTIVE I Number Missed i A.

A written directive (order for a speciGc patient, dad & signed by authorized user (a.u.) or physician under supervision of an a.u.) is prepar-d for each patient [35.32(a)(1)] ()Y()N B. Written directives contain required information, target coordinates, collimator size, plug pattern, and total dose [35.2] ()Y()N C. Exceptions to written directives are documented [ footnote to 35.32(a)(I)] () N/A

1. Written revisions

2. Oral revisions ()Y()N

3. Oral directives ()Y()N

()Y()N Remarks: ( V*) 3. OBJECTIVE 2 A. Licensee uses more than one method to verify the patients identity [35.32(a)(2)] ()Y()N 4 OBJECTIVE 3 A. Procedures implemented to verify that final plans of treatment and related calculations are in accordance with written directives [35-32(a)(3)] ()Y()N B. Procedures m' include: (not requirements) 1. Check of dose calculations by an authorized user or a qualified person under supervision of an authorized user who whenever possible did not make the original calculations ()Y()N 2. Performing acceptance testing (based on licensee's speci6c needs and applications) i on each treatment planning or dose ulculating computer program that could be used for dose calculations

3. Plan of treatment prepared in accordance with the written directive

()Y()N  ! ()Y()N 4 Imaging and localization precision assured ()Y()N

a. Stereotactic frame aligned and affixed

b. Imaging films correctly centered & labeled

()Y()N ()Y()N A

  /
          \

Y

                                                                                                                                                                       \

Module 6 Steretactic I

['T 5. Verify correct helmet & plug pattern selected ( . G. Verify computer generated dose calculations were correctly entered into unit ()Y()N b and that the computer print out shows correct data for the patient were used in the calculations

7. Other, descr;be: ()Y()N Remarks:

5. OBJECTIVE 4 A.

Procedures implemented to verify, prior to administration, that the specific details are in accordance with written directive [35.32(a)(4)] ()Y()N B. Procedures may include: (not requirements) 1. Check of treatment parameters by an authorized user or a qualiGed person under supervision of an authorized user who whenever possible did not make the original calculations

2. Verify stereotactic frame coordinates on the patient's skull match the

()Y()N plan of treatment 3. Person administering treatment conGrms prescribed target coordinates, ()Y()N collimator size, phag pattern, and total dose prior to administration 4. Prompt record of treatment parameters and signing or initialing of the ()Y()N patient's chart or appropriate record

5. Other, describe: ()Y()N C.

Record of administration maintained in auditable form [35.32(d)(2h ()Y()N Remarks:

6. OBJECTIVE 5 A.

Procedures implemented to ensure that unintended deviations are identi6ed, evaluated, and corrective action is taken [35.32(a)(5)] ()Y()N 1. Recordable event (s) self-identified since the last inspection [35,32(c),35.2] ()Y()N Dates ofevents: 2. Recordde events' identined by inspector [35.32(c), 35.2] 3. Misadministration resulted from the unintended ()Y()N deviation (Ifyes, also complete module 7) ()Y()N B. Procedures implerr.ented to evaluate & respond within 30 days to each recot dable event discovered [35.32(c)] ()Y()N C. Procedures may include:(not requirements) J 1. Assemble relevant facts including cause

2. Identify corrective action to prevent recurrence ()Y()N

()Y()N

 \q 4

3. Retain a record ofitems I and 2

()Y()N V i Module 6 Steretactic 2 l

                      - _ _ _ _ _ _ _ _                                                                                                            i

D. i ' Licensee reported misadministration (s) since the last inspection (Ifyes, also complete module 7) [35.33(a)) (O) v E. ()Y()N ' Licensee identified misadministrations that were not subsequently reported (If yes, also complete moduh 7)[35.33(a)) ()Y()N 1 Remarks:

7. PERIODIC REVIEWS OF THE OMP A.

Review conducted of the QMP at intersals no greater than 12 months [35.32(b)(1)] ()Y()N Date oflast review: B. Review includes a representative sample of all patient administrations including all recordable events and misadministrations E35.32(b)(1)(i)(ii)(iii)] ()Y()N The licensee should utilize a representative sampling process which embodies a valid statistical sampling methodology. Regulatory Guide 8.33 provides an example using the acceptance sampling tables of10 CFR 32.110 and assuming an error rate of 2%. If the tables in 10 CFR 32.110 are used, any table is acceptable. C. If review idatified recordable events or misadministrations not previously identified, the review was expanded by the licensee to ensure the events were isolated ()Y()N D. Licensee evaluated each review to determine the effectiveness of the QMP [35. E. l (nv} Based on the evaluation of reviews, the licensee made modifications to meet Objectives [35.32(b)(2)] () N/A () Y () N F. Modifications sent to NRC within 30 days [35.32(e)] () N/A () Y ()N G. Records of reviews including evaluation and findings maintained for at least 3 years [35.32(b)(3)]: ()Y()N

8. RESULTS OF REVIEW Briefly describe the overall implementation of the QMP and summarize the inspection findings.

If necessary, use an attachment.

9. Time spent completing this module: hours n

v Module 6 Steretactic 3

r MODULE 7 Q

 '\     /              '

MEDICAL EVENTS AND MISADMINISTRATIONS U

l. GENERAL A. Modality ofevent or misadministration:

B Therapeutic or diagnostic event: C Date ofevent: D Date of discovery: E Identified by: F. Licensee implemented a QMP for this modality [10 CFR 35.32] ()Y()N

2. TRAINING AND SUPERVISION A.

Supervised individuals instructed in radiation safety principles appropriate to their use of byproduct material [35.25(a)(1)] ()Y()N B. Supervised individuals instruc q s QMP applicable to the modality of use [35.25(aj(1)J List individuals found to be inadequately trained: ()Y()N

3. DESCRIPTION OF EVENT A.

Event classified as misadministration [35.2] ()Y()N (A () l B. Ifyes, which paragraphs under 35.2 best describes the event: Describe secuence of events leading to misadministration: C. If not a misadministration, describe the event: D. Number of patients or others exposed / overexposed: E. Time period: F. Occupational workers exposed Ifyes, describe: ()Y()N

                                                                                                                         )

(

 \(")\

x_- Module 7 Events and Misadministration 1

{ G. Licensee evaluation and actions

             .           1. Calculated prescribed and actual doses Prescribed:                                                       ()Y()N Actual:

2. Evaluated effect on patient

3. Corrective actions taken to prevent recurrence

()Y()N

4. It' licensee did not evaluate or take action, reason provided:

()Y()N ! 4. EVALUATION OF THE EVENT A. Cause ofevent

1. Human error

2. Patient intervention

()Y()N

3. Mechanical error ()Y()N

()Y()N

a. Manufacturer / vendor:

b. Serial number:

c. Model number:

Remarks: 4 Computer software error

a. Manufacturer / vendor:

b. Version:

c. Serial number:

d. Model number:

Remarks:

5. Failure to follow QMP a.

b. Authorized user [35.32(a)] Supervised individual [35.32(a)(2)] ()Y()N ()Y()N Describe: B. Root cause(s) and contributing factor (s) that led to this incident:

1. Identified by licensee:

I

2. Evaluated by inspector (See IP 81103):

i Module 7 Events and Misadministration 2 l l l 1 1

5. NOTIFICATIONS

                  .A.

NRC's Operations Center within next calendar day after discovery [35.33(a)(!)] ( ) Y ( ) N Report Number and date: B. Referring physician and Patient within 24 hours after discovery [35.33(a)(3)] ()Y()N (Referring physician may inform the licensee either that he will inform the ()Y()N patient: or that, based on medicaljudgement, telling the patient would be harmful) C. If patient was notified, patient also notified in writing within 15 days after discovery [35.33(a)(4)] If not within 15 days, date notified: ()Y()N What information was provided in the report: D. If patient was not notified, the licensee notified the responsible relative or guardian If no, licensee documentedjustification for decision ()Y()N ()Y()N Remarks: E. Record of misadministration (s) retained [35.33(b)] The record must contain: Names ofallindividuals involved Patient's Social Security number / identification number All documents and correspondence associated with event A brief description of event including why it occurred, efrect on the patient, improvements needed to prevent recurrence, actions taken to prevent recurrence. Remarks: F. Licensee identified misadministrations that were not subsequently reported . [35.3(a)] ()Y()N Ifyes, briefly describe the reasons for not reporting: 1 Module 7 Events and Misadministration 3 J i

( G. Inspectoi identified misadministrations that the licensee failed to identify [35.2.35.33) ()Y()N H. Licensee submitted written report to NRC within 15 days after discovery (35.33(a)(2)] ()Y()N Remarks:

6. CONSULTANTS A. At the time ofinspection, NRC medical or scientific consultant is reviewing this esse (See MD 8.10)

Name ofconsultants: ()Y()N B. If not, Ne has been referred to a NRC consultant Name ofconsultants: ()Y()N 1 I

7. Time spent completing this module:  !

hours

 ' Module 7 Events and Misadministration                4 l

f% I I . PENNSYLVANIA DEPARTMENT OF ENVIRONMENTAL PROTECTION BUREAU OF RADIATION PROTECTION DIVISION OF NUCLEAR SAFETY LOW-LEVEL RADIOACTIVE WASTE SHIPMENT HIGHWAY ROUTE CONTROLLED QUANTITY Shipments oflow-level radioactive waste (LLRW) containing Highway Route Controlled Quantity (HRCQ) h meet some extra regulations contained in 49 CFR 172.203; 177.825,827 and 842. Fill this fonn in for HRCQ shipments, and attach it as a supplement to the LLRW Shipment Inspection Report

1. Date Inspection

2. Name of Shipper 3.

Basic description includes the words " Highway Route Controlled Quantity".

4. Package containing HRCQ has a Radioactive Yellow HIlabel.

5. Vehicle transporting HRCQ package is properly placarded.

6. Driver of the vehicle is covered under a radiation protection olan that complies with 49 CFR 172, p subpart 1. D) 7 Vehicle would be operated on approved preferred routes. 8. If the shipment contains two or more packages' bearing Radioactive Yellow M or 11 labels in the same vehicle, they must be separated by distances tabulated in 49 CFR 177.842. Yes No Not Applicable

9. If the Inspector finds any violations or non-compliance issues, they should be described in Section I of the LLRW Inspection Report.

 %Y LLRW Shipment                                           I

1 PENNSYLVANIA DEPARTMENT OF ENVIRONMENTAL PROTECTION BUREAU OF RADIATION PROTECTION DIVISION OF NUCLEAR SAFETY LOW-LEVEL RADIOACTIVE WASTE SHIPMENT INSPECTION REPORT Report No. A. GeneralInformation

1. D:te ofinspection

2. Name of Shipper

3. Name of Carrier

4. Destination 5.

Verify Advanced Notification to the State (s) (Type B packages only - 10 CFR 71.971

6. Package (s) o be Shipped I

Cask HIC Liner Drum (s) Box (es) Other(Specify)

7. Number of Packages

8. Method of Shipment: Exclusive Use Non-Exclusive Use

9. Transport Vehicle: Open Closed B.

Shipping Papers [49 CFR 172.200 through 204, and other references as noted] 1. Shipping papers prepared and readily accessible [49 CFR 177.817)

2. Proper shipping name, hazard class and identification number

3. Waste Description

4. Quantities: total weight (Ibs)(Kg) total volume (cu. ft.)(cu.m) total activity (Ci)(TBq)

5. Highway Route controlled quantity Yes No ifyes, fill out and attach form (Supplement A)

6. Radionuclides identified 7.

Activity of each of the radionuclides H-3, C-14, Tc-99 and I-129 shown [10 CFR 20. Appendix F] LLRW Shipment 2 i

                                                                                                                )

8. Waste classified and characterized properly [ 10 CFR 61.55,61-561 (Check documentation for waste classification and characterization to determine accuracy)

9. Description orchemical/pbysical form 10.

Reportable Quantities (RQ) indicated, if applicable i 1. Appropriate category oflabel applied to each package, if applicable 12. Transportation Index (TI) assigned to each package bearing Radioactive Yellow-II or III labels

13. Shipper's certification and signature 14.

Instructions provided to carrier- Exclusive Use Shipments only [49 CFR 173.441,4271 C. Packaging / Package Inspection [49 CFR 173.403,410 through 417,421 through 4351 1. Type of packaging used is limited by the activity ofits radioactive contents. Check that packaging is appropriate for the activity of radioactive material. Type of Package (s) being Shipped: Type A Type B Strong Tight Excepted Package Industrial Package (IP) IP-1 IP-2 IP-3 2. NRC and DOT regulations require that documents pertaining to packaging test performance and engineer be maintained by the shipper. Check that these test records and other documentation are on file. Current NRC cenification and approval documents are on file [ 10 CFR 71.12]

3. Package Integrity [49 CFR 173.475,412]

Package has no visible damage or leakage Packaging closure devices such as gaskets, lids, etc. are installed and secured Security seals are intact Package (s) surveyed for radiation and contamination levels D. Labeling, Marking and Placarding Inspection

1. Labeling: Proper labels are required on packages a provided in 49 CFR 172.403, unless excepted.

Check that: Packages are correctly labeled with Radioactive White I, or Radioactive Yellow II or III labels Two proper labels are affixed to opposite sides of the package

                                         " Contents" and ' Activity" are entered on the labels Transport Index is entered on Radioactive Yellow H or Radioactive Yellow HI labels LLRW Shipment                                                    3

(. . . . .

2. Marking: Appropriate markings are required on packages, as provided by 49 CFR 172.301,304,310, ] / 10CFR 20. Appendix F. Check that: Packages are marked properly, i.e., proper shipping name, identification number, consigneI consignor's name and address, etc. Gross weight marked if package mass exceeds 1 10 pounds (50 kilograms) Waste class identified as A/B/C, Stable /rJnstable As applicable, check that packages are also marked: Type A or Type B Radioactive LSA, RQ Radioactive SCO, RQ

3. Placarding: 49 CFR 172.504,507 etc. specify that proper placards are required on each end and side j

of the vehicle for packages containing: Exclusive use shipments of LSA or SCO packages Highway route controlled quantity Radioactive Yellow IIIlabel w E. Radiation Levels [49 CFR 173.441,427; 177.8421 Ensure that the shipper surveys the shipment for radiation levels using proper instnaments. Review the shipper's survey map (s). Check that the radiation levels do not exceed

1. Exclusive Use Vehicles:

200 mR/h (2 mSv/h) at contact on the ex emal surface of the package (open transport vehicle) 1,000 mR[h (10 mSv/h) at contact on the external surface of the package (closed transport vehicle) 200 mR/h (2 msvih) at contact on outer surface of the vehicle 10 mR/h (O. I mSv/h) at any point 2 meters (6.6 ft) from the vehicle 2 mR/h (0.02 mSv/h) in any normally occupied space in the vehicle (e.g., the cab) 2.Non-Exclusive Use Vehicles 200 mR/h (2mSv/h) at contact on the extemal surface of the package _ Transport Index does not exceed 10 2 mR/h (0.02 mSv/h) in any normally occupied space in the vehicle (e.g., the cab) Total 71 of all packages on the vehicle does not exceed 50 i LLRW Shipment 4 I l

c l

3. LSA and SCO packages

  ,rh,

( , I Rem /h (10 mSv/h) at any point 3 meters (10 ft) from the unshielded material F. Radioactive Contamination Contro! [49 CFR 173.443] The level of non-fixed radioactive contamination on the external surfaces of each package reasonably achievable. The shipper should wipe areas of about 300 cm2 on the extemal surfaces fixed contamination. Check that the contamination levels do not exceed 22 dpM/CM2 or 0.4 Bq/cM2 (beta & gamm Highest Contamination Detected cpm Background Reading epm Difference (Above Background) cpm Divide by Instrument Efficiency (0.10) Divide by wipe area (300 CM2) dpm/CM2 (Bq/cM2) G. Vehicle inspection

   ,ew                     Verify that the shipper inspected the vehicle for contamination upon arrival.

( ) Verify that vehicle was inspected for safety by the shipper before shipment departure. C/ S hipmentisbraced,securedortieddowninvehicle[49CFR 173.427,44 I ;177.8341 RADIATlON SURVEY (Transport Vehicle) Surface mR/h (mSv/h) j 2 meters ___ mR/h (mSv/h) l Cab / Sleeper Surface (bottom) Surface mR/h (mSv/h mR/h (mS;,h) mR/h (msvih) 2 meters mR/h (msvlh) ' Surface mR/h (mSv/h) 2 meters mR/h (m v/h)

   ,r m i     \
  \-)

LLRW Shipment 5 I-

H. Instruments Used -

1. The shipper must use proper instruments for measuring radiation levels and non-rixed Contamination Check that the shipper used proper instruments '

Check that Le calibration of the instruments had not expired.

2. The Inspector should enter the following information regarding his instruments.

Instrument (s) - Serial Calibration Expiration Type No. Date Dose Rate Instrument f Contamination Instrument

1. Results ofInspection

l. Violations /Non-Compliance t

2. Comments

3. Inspectors Name l

1 i l LLRW Shipment 6

PENNSYLVANIA DEPARTMENT OF ENVIRONMENTAL PROTECTION BUREAU OF RADIATION PROTECTION GUIDANCE TO ACADEMIC INSTITUTIONS APPLYING FOR RADIOACTIVE MATERIAL LICENSES

1. INTRODUCTION This guide describes the information needed to evaluate license applications for use of naturally occurring and accelerator-produced radioactive material (NARM) at academic institutions. It is intended only as general guidance and should not be considered as containing all the information that may be required for a particular application.

II. FEES An application fee is required for all specific licenses and must be submitted with any NEW application. The applicant should refer to Chapter 218 of the Pennsylvania Regulations for Radiation Protection to determine the amount of fee that sh9uld accompany the application. Review of the application will not begin until the proper fee is received by the Department. The check or money order r should be made payable to the Department of Environmental Protection. In the case of an application for renewal or amendment, a fee should NOT be submitted with the application. All current licensees will be billed according to the expiration month of their current license. III. COMPLETING THE APPLICATION All items of the application should be completed in sufficient detail to allow the Department to make a realistic review of the institution's program for safe use of radioactive materials in education and research. The application must be submitted in duplicate (including all statements), and an additional complete copy must be retained by the applicant since the license issued will require adherence to the procedures and limitations set forth in the application. Submission ofincomplete information will result in delays because of the correspondence necessary to obtain supplemental information. Applications should be mailed to: Radioactive Material Licensing Bureau of Radiation Protection Pennsylvania Department of Environmental Protection P. O. Box 8469 Harrisburg, PA 17105-8469 License Academic 1

r l l

 /^'s         Since the space on the application (ER-BRP-01) is rather limited, additional sheets

! V should be used when necessary. Specific items of the application are listed below with explanations: Item 1 - The applicant is the institution. Item 1c - List all locations where radioactive material is to be used. Give street addresses, and building names. Item 2 - For a department, the department's name is listed below the institution's name. Item 3 - Self-explanatory. Item 4 - List all faculty or staffpersonnel who will use or directly supervise the use of radioactive material. Item 5 - The Radiation Safety Officer (RSO) is the person designated as { responsible for the radiation safety program and maintenance of the license and associated records, and is the primary contact with the Department in administering the license. That person must have the authority to set radiation safety policy, suspend activities deemed unsafe, and require and direct remedial action when necessary. ( (s/ Item 6A - List by isotope, such as " Sodium-22," " Radium-226," etc. Item 6B - If radioactive material is contained in a sealed source, give manufacturer's name and model number of source. If material is not sealed, give chemical form (such as " sodium iodide") or physical form (such as " gas," " metal,"

           " accelerator targets," " plated foils," etc.)

Show total maximum number of millicuries to be possessed at any one time for each form listed. Includ mtal activity for material in storage, in use, or as waste. Item 7 - Describe the t. of the particular form. If used in a devici give the make and model number of d. / ice. If used in animals, field applications, classroom experiments, or demonstrations, please specify. Items 8 through 10 - Self-explanatory. Item 11 - For the portable survey instruments, describe how often, how, and by whom the instruments will be calibrated. If they are to be calibrated at the institution a detailed description of how the instruments will be calibrated fbr all meter scales must be given. Instruments should be calibrated at intervals not exceeding one year. 1( p) U License Academic 2

Items 12 and 13 - Self explanatory. Item 14 - See sections IV and V. Item 15 - A complete description of the specific methods for waste disposal of radioactive material. A licensee may dispose of waste by:

1. Transfer to a person properly licensed to receive such waste.

2. Release into a sanitary sewer in conformance with Chapter 219.

3. Release into the air in conformance with Chapter 219.

4. Disposal oflimited concentrations ofiodine-123 accordance with Chapter 219.

NOTE: No licensee may dispose of radioactive waste material by incineration, release to septic tanks, or burial in the soil unless specifically authorized by the Depa2tment. Item 16 - The application must be signed by a person duly authorized to commit the institution to the performance of the activities as specified in the application. IV. RADIATION SAFETY PROCEDURES {i The applicant must submit radiation safety procedures which are to be followed by all persons who are to use the radioactive material. A copy of the procedures must be provided to all named users and made available to all under their supervision who are to use radioactive material, including students. The radiation safety procedures should cover the following items: A. Procedures for the control and management of the radiation safety program including a description of the duties and the authority of the RSO and the responsibilities of the users. The procedures should adequately address normal work schedules, night schools, vacation schedules, and summer sessions. B. Procedures for ordering radioactive material, for receipt of materials during off-duty hours, and for notification of responsible persons upon receipt of radioactive material. These procedures should be adequate to ensure that possession limits are not exceeded, that radioactive material is secured against unauthorized removal at all times, and that ra&t'on levels in unrestricted areas do not exceed the limits specified in the 25 PA Code Chapter 219. O o License Academic 3

C. Procedures for examining incoming packages for leakage, contamination, or

 /'~ -         damage, and for safely opening packages. The monitoring should be performed as
 \

s'oon as practicable after receipt of the package ofradioactive material (see Chapter 219.52 for requirements.) The procedures may vary depending upon the quantity of radioactive material received, but should, at a minimum, include instructions for surveying packages, wearing gloves while opening packages, and checking packing mr.terial for contamination after opening. D. A description of training required for laboratory personnel and/or students who are involved in or associated with the use of radioactive material. The description should include the form of training (formal course work, lectures, etc.), the duration of training, and the subject matter included. The training program should be of sefficient scope to ensure that all personnel receive adequate instruction for safe use ofradioactive material involved. E. General instructions to be followed by laboratory personnel and/or students while working with radioactive material. These instmetions should:

1. Outline control procedures for obtaining permission to use radioactive material at the institution; give limitations on quantity to be handled per student, or allowed per experiment, etc.

2. Explain what laboratory apparel to wear and what equipment to use.

3. Prescribe limitations and conditions relative to handling liquid or loose radioactive material and what laboratory equipment to use in working with them.

For example, explain what materials and what operations should be confined to radiochemical fume hoods or gloveboxes. Indicate what shielding or remote handling equipment will be employed when hard beta and/or gamma emitting materials are used.

4. Describe routine survey and monitoring procedures to be followed for contamination control.

5. Give instructions concerning movement of materials between rooms or in halls or corridors, if applicable.

6. Explain requirements for storage of materials, labeling of containers, and identification of areas where radioactive material is used. Explain where and how contaminated articles and glassware are to be handled and stored.

1

7. Specify personnel monitoring devices to be used and where to obtain them.

l Provide instmetions on recording exposure results. t License Academic 4

I J

8. Indicate waste disposal procedures, limitations for disposal ofliquid or solid p wastes, and procedures for waste storage. If the program involves experiments in '

V animals, outline instmetions on cleaning animal quarters and handling excreta and carcasses for disposal.

9. Explain what records are to be kept on materials use and disposal.

10. Explain the precautions against mouth pipetting, the need to use absorbant paper on lab surfaces, and prohibitions against smoking or eating in restricted areas.

i

11. Describe the bioassay procedures to be followed if millicurie amounts of iodine-123 are to be used in uncontained form. (A biosssay guide may be obtained from the U. S. Nuclear Regulatory Commission).

12. Describe the method to be used for leak testing sealed sources. If they are R be tested by the licensed users, a detailed description must be provided of the leak test procedure. These tests must be made each six months, and records must be maintained of each test.

F. Include a copy of the emergency procedures which are to be posted in all laboratory areas where radioactive material is used. These instructions should O include a description ofimmediate action to be taken in order to prevent i contamination of personnel and work areas, and the telephone numbers of the responsible persons to be notified in case of an emergency. I G. Describe, if radioisotopes will be used in animals; (1), the animal housing facilities; (2), the instructions provided to animal caretakers for the handling of animals and animal waste carcasses, (3), the cleaning and decontamination of animal cages; and (4), the procedures for ensuring that animal rooms will be locked or otherwise secured unless attended by authorized users of radioactive material. H. Describe the routine survey program, including the areas to be surveyed, the levels ofcontamination considered to be acceptable, and provisions for maintaining records of surveys. The individual user should supplement the surveys performed by the radiation safety staff. Laboratories using higher activities with regular use patterns should be surveyed for contamination at the end of each working day and a record should be kept of such surveys (also see Section V). f% (V ) License Academic 5

i ) V. METHODS AND FREQUENCY FOR CONDUCTING RADIATION ( ) SURVEYS Q) ' A. INTRODUCTION When radioactive material is handled in the form ofsolutions or powders, as may occur in a laboratory, both radiation surveys and contamination surveys should be i performed to prevent unnecessary radiation exposure to personnel and to prevent the spread of contamination throughout the facility. Radiation surveys are perfonned using a radiation survey meter, and contamination surveys are performed by taking wipe samples from surfaces in the facility that are likely to be contaminated. 1 l B. FREQUENCY OF SURVEYS The frequency of surveys depends upon the amount and type ofradioactive material used. Listed below are examples which may be useful in determining how often to perform surveys. The greater the work load, the more often the surveys should be performed.

1. Low Level Areas - Not less than once a month - Areas such as where in vitro I tests are performed, samples analyzed, etc. (samples usually less than 100 microcuries each).

G

2. Medium Level Areas - Not less than once a week - Areas where millicurie amounts of material are handled.

3. High Level Areas - Not less than once a day - Areas used for storage of active solutions, preparation ofmaterials, fume hoods, etc. (usually curie amounts).

C. METHODS OF SURVEYS Suggested methods for performing these two types of surveys are given below. Records of these surveys must be maintained for inspection by the Department and for reference to determine whether the radiation levels or the contamination levels remain constant or increase over a period of time. 1

 \

m] License Academic 6

l l l

1. Radiation Level Surveys - A survey meter capable of measuring levels as low as 0.1 mR/h should be used and the results recorded on a standard form showing v lo' cation, date, person performing survey, instmment used, exposure levels, and corrective action taken, if any. A sketch of the area should be used to make an easily prepared and easily understood survey record when annotated with this information.

2. Contamination Level Surveys - A series of wipes using filter papers or swatches of cloth should be taken from those surfaces where contamination could be expected to exist or where radiation levels are fairly high. (Areas where solutions I are prepared, incoming packages received, pipetting is performed, etc., are areas that may be contaminated.) The wipes should be numbered or labeled and their location indicated on the sketch record as described above. The wipes should each be rubbed over a surface area of about 100 square centimeters to maintain a consistent means ofdetermining the amount of removable contamination. The wipes may be counted using a gamma scintillation well counter, a geiger counter, I or any other detector capable of detecting the small amount of contamination on the sample. (A civil defense CDV-700 meter using an open beta window should be adequate.)

D. ACCEPTABLE LIMITS . I

1. Radiation Levels - In no area that is unrestricted (uncontrollec) should radiation levels exist such that a person could receive 500 mR in any one year,100 mR in 3

' any seven consecutive days, or 2 mR in any one hour. If such areas are found, measures should be taken to eliminate the excessive radiation levels. Additional shielding or relocation of radioactive material may be required. For restricted areas, the applicant should establish acceptable radiation levels that are as low as reasonably achievable (ALARA).

2. Contamination Limits - If the wipe samples counted indicate more than 1,000 disintegrations per minute (dpm), the area should be cleaned until the contamination has been removed. Since it is difficult to determine exactly when a wipe sample has 1,000 dpm, it is recommended that, when such samples show an easily detectable amount of activity above background, the contaminated areas be cleaned. This action should help prevent the spread of contamination and ingestion of activity by personnel whose hands or clothing become contaminated.

i I l i b License Academic 7 l I

PENNSYLVANIA DEPARTMENT OF ENVIRONMENTA L PROTECTION BUREAU OF RADIATION PROTECTION GUIDE FOR THE PREPARATION OF LICENSE APPLICATIONS FOR THE  ! LABORATORY AND INDUSTRIAL USE OF SMALL QUANTITIES OF RADIOACTIVE MATERIAL I. Introduction This guide describes the type ofinformation that the Bureau ofRadiation Protection staff needs to evaluate a license application for the limited non-human use ornaturally occurring and accelerator-produced radioactive material (NARM). An application for laboratory and industrial uses ofmillicurie amounts of NARM material must be submitted in duplicate on the " Application for Radioactive Material License" BRP-01. The application forms with supporting documents should be mailed to the address specified at the top of ER-BRP-01. Applications for amendment to existing radioactive material licenses may be submitted on ER-BRP-01 or by a letter stating the same information as specified f on that form. The applicant should retain an additional copy of his application for his own files, once his application has been approved, since he will be committed to operate under the procedures which he has submitted. II. License Fees An application fee is required for all specific licenses and must be submitted with any NEW application. The applicant should refer to Chapter 218 of the Pennsylvania Regulations fg Radiation Protection t determine the fee that shouM accompany the application. Review of t! fplication will not begin until the proper fee is received by the Departmer ' .4 check or money order should be made payable to the Department of En : onmental Protection. In the case of an application for renewal or amendment, a fee should NOT be submitted with the application. All current licensees will be billed according to the expiration month of their current license. (D O License Laboratory and Industrial - 1

III. Ir.structions For Completing The Application The separate items of the application are discussed below: . Items 1 and 2 - Specify the applicant corporation or other legal entity by name and address ofprinciple office. Individuals should be designated as the applicant only if the use of the radioactive material is not connected with the individual's employment with a corporation or other entity. If the applicant is an individual, the individual should be specified by full name and address, including state and zip code. Also include the telephone number which the Department may use to contact the applicant. Specify the street address of the location of use if the address differs from the one given in item 1(A). If use is to be at more than one location, the specific address of each should be given. D scribe the exetnt of use and the facilities and equipment at each location. A post office box address is not acceptable. Item 3 - Self-explanatory. Item 4 - Specify the names of the persons who will directly supervise the use of radioactive material or who will use radioactive material without supervision. A resume' of the training and experience of each person who will directly supervise l the use of material, who will use material without supervision, or who will have responsibilities for radiation safety should be submitted. The resume'should include the information shown in Items 8 and 9. Item 5 - Specify the name of the person who will be designated as the radiation safety officer. This person should be responsible for implementing the radiation safety program and therefore readily available to the users in case of difficulty and should be trained and experienced in radiation protection and in the use and handling of radioactive materials. In a small program not requiring a full-time radiation safety officer, the duties of the radiation safety officer may be assigned to one of the persons named under item 4. Note, however, that it must be established that the person acting as radiation safety officer will have the opportunity to devote sufficient time to the radiation safety aspects of the program for the use ofradioactive materials. )

                                                                                                        ]

l Items 6 - Describe the NARM by isotope, chemical and/or physical form, and activity in millicuries or microcuries. A separate possession limit for each nuclide should be specified. Possession limits requested should cover the total anticipated inventory, including stored materials and waste, and should be commensurate with the applicant's needs and facilities for safe handling. License Laboratory and Industrial -2

 'N                Item 7 - The use to be made of the radioactive materials should be clearly

/ described. Sufficient detail should be given to allow a determination of the ) p

                  ' otential for exposure to radiation and radioactive materials both of those working with the materials and of the public.
                                                                                                     )

Items 8 and 9 - Self-explanatory. List for cach individual named in items 4 and 5. Item 10 - For each radiation detection instrument provide the information requested in item 10. The instrumentation should be appropriate for the radionuclides listed in item 6. Item 11 - If the applicant proposes to calibrate his survey instruments, a detailed description ofplanned calibration procedures should be submitted. If the applicant intends to contract out the calibration ofinstruments the name, address, and NRC, Agreement State, or licensing state license number of the firm should be specified together with the frequency of calibration. Item 12 - Describe the method of monitoring personnel exposure (film badges, TLD, etc.) and personnel monitoring supplier. Chapter 219.32(b) requires the use of an accredited NVLAP dosimetry processor under certain conditions. (,) NOTE: Lists of NVLAP accredited personnel monitoring suppliers are available from the Department upon request. If millicurie amounts of activity are used at one time, confirm that ring badges will be used by persons handling those amounts of activities. Item 13 . Facilities - Self-explanatory. Item 14 Radiation Safety Procedures- The applicant's Radiation Safety Procedures must be submitted in duplicate with serially numbered pages and must include the following items as appropriate for the uses desired.

1. A description of the radiation safety program management.

2. A description of the functions of the RSO, the Radiation Safety Committee and the program for periodically checking the use of radioactive material to assure that proper safety procedures are followed. (The committee or RSO should have authority to set radiation safety policy to stop any use ofradioactive material deemed unsafe and to require remedial action by users.)

.l License Laboratoryand Industrial 3

 ,                 3. Method of receiving radioactive material, promptly notifying responsible

(  % persons, monitoring it for contamination, and storing it securely. Receipt of 'd inaterials after normal working hours should be specifically addressed.

4. Method ofrecording the receipt, authorized use, transfer, inventory, and disposal ofradioactive material.

5. Method ofrestricting access to radioactive material to authorized users. Also, method of controlling access to restricted areas, radiation areas, and high radiation areas.

6. Procedures for storing, logging in and out, and returning to storage sealed sources.

7. Procedures for leak testing sealed sources.

8. A description of the routine visual and radiation surveys to be made of areas where radioisotopes are used and stored.

9. General laboratory rules for preventing contamination when handling uncontained radioactive material.

f) ( ,/

10. Method of coping with spills, radiation incidents, and facility and personnel contamination.

Item 15. A description of the specific method for managing and disposing of  ! radioactive wastes. Wastes may be disposed of by transfer to a licensed waste disposal firm, by release into a sanitary sewer in accordance with 25 PA Code Sections 219.63 and 219.65, and by segregation and storage until activity has decayed. Describe how the waste will be monitored to assure decay to acceptable levels and to assure that labels are removed prior to release to the trash. Disposal by incineration must be specifically authorized by the Department. Item 16 - The application must be signed and dated by the applicant or an individual duly authorized by the applicant to act for or on the applicant's behalf. Unsigned and undated applications will be returned to the applicant. Retain one copy for your files and mail the license applications and appropriate fee to: Radioactive Material Licensing Bureau ofRadiation Protection DEP P.O. Box 8469 i rm \ Harrisburg, PA 17105-8469 l License Laboratory and Industrial 4

PENNSYLVANIA DEPARTMENT OF ENVIRONMENTAL PROTECTION [] V ' BUREAU OF RADIATION PROTECTION GUIDE FOR THE PREPARATION OF A BROAD LICENSE APPLICATION FOR NON-MEDICAL USE I. INTRODUCTION This guide describes the type ofinformation needed to evaluate an application for a broad license for receipt, possession, use, and transfer of naturally occurringag accelerator-produced radioactive material (NARM). The applicant should carefully read the regulations. This guide does not substitute for an understanding of the regulations.

1. 25 PA CODE 215, " General Provisions."

2. 25 PA CODE 217, " Licensing of Radioactive Material."

3. 25 PA CODE 218, " Fees".

4. 25 PA CODE 219, " Standards for Protection Against Radiation."

5. 25 PA CODE 220, " Notice, Instmetions and Reports to Workers; Inspections."

II. FEES ,m An application fee is required for all specific licenses and must be submitted with any NEW application. The applicant should refer to Chapter 218 of the Pennsylvania ' Regulations for Radiation Protection to determine the amount of fee that should accompany the application. Review of the application will not begin until the proper l fee is received by the Department. The chek or money order should be made payab!e to the Department of Environmental Protection. The fee for a broad license is $1530 per year. In the case of an application for renewal or amendment, a fee should NOT be submitted with the application. All current licensees will be billed according to the expiration month of their current license. III. FILING AN APPLICATION The information submitted must be sufficient to allow the Department of Environmental Protection (DEP) to determine that the proposed equipment, facilities, procedures, and controls are adequate to protect health and minimize danger to life and property. Information submitted should pertain to the specific activities for which authorization is sought and should be complete. Submission ofincomplete information will result in delays because of the correspondence necessary to obtain supplemental information. V License Non-Medical 1

mw-Applications should be mailed to: R&dioactive Material Licensing Bureau ofRadiation Protection DEP P. O. Box 8469 Harrisburg, PA 17105-8469 Since licensees are required to comply with Department mies and regulations, license conditions, and the content of the submitted application, at least one copy of all information submitted to DEP should be kept by the applicant for reference. l IV. NARM MATERIAL APPLICATION FORM ER-BRP-01 l ' Three copies of the application Form ER-BRP-01 should be completed following the instructions provided with the form. Two copies should be mailed and one kept by the applicant. Since the space provided on the fbrm is limited, additional sheets should be appended as necessary. Supplementa' information should be labeled to identify the applicant and reference the items for which infonnation is being given. The following comments deal with the indicated items of the Form ER-BRP-01. Item 1 - Applicant and Locations of Use: The applicant corporation or other legal j i entity should be specified by name and mailing address in Item 1(a). The actual Jtes of use should be given in 1(c). Permanent facilities described in 1(a) and 1(c) should be identified by street address, city, state, and zip code. Attach additional properly keyed sheets if more space is needed. Item 4 - Individual Users: Not applicable for a broad license. Item 5 - Radiation Safety Officer: Provide the name of the RSC. Items 6 through 15: Please use the NRC Regulatory Guide 10.5, " Applications for Type A Licenses for

             ' Broad Scope."

I If the applicant / licensee has an NRC License or is applying for a new NRC License then the applicant / licensee may use the same application information with the exception of the isotopelist. l I

    - License Non-Medical                                         2 1

o V. AMENDMENT AND RENEWAL OF LICENSES c)

     \

Applications for amendment of existing licenses should be filed in the same manner as initial applicatioas or may be filed in letter form. The application should clearly identify the license which is to be amended by license number. The exact nature of the requested changes should be specified and additional supporting information, as necessary, should be provided. Licenses are normally issued for a period of five (5) years. If an application for license renewal is filed thiny (30) days or more before license expiration, the existing license remains in effect until the renewal application has been finally acted upon by DEP. Renewal applications should contain complete and up-to-date information concerning the applicant's current program. References to previously submitted documents should be clear and specific and specify the document by date and indicate pertinent information by page and paragraph. j l I l f3

                                                                                                       )

l I i f i License Non-Medical 3

N PENNSYLVANIA DEPARTMENT OF ENVIRONMENTAL PROTECTION BUREAU OF RADIATION PROTECTION GUIDE FOR THE PREPARATION OF LICENSE APPLICATIONS FOR THE USE OF SEALED SOURCES IN PORTABLE AND SEMIPORTABLE GAUGING DEVICES I. INTRODUCTION This guide describes the type ofinformation needed to evaluate an application for a specific license for receipt, possession, use, and transfer of NARM material contained in portable and semiportable gauging devices such as moisture-density gauges and X-ray fluorescence analyzers. The Depadment's regulations, listed below, apply to naturally occurring and accelerator-produced radioactive material (NARM) licenseus and should be used in conjunction with this guide. The applicant should carefully read the regulations. This guide does not substitute for an understanding of the regulations.

1. 25 PA CODE 215, " General Provisions."

O 2. 25 PA CODE 217, " Licensing of Radioactive Material."

3. 25 PA CODE 218, " Fees".

4. 25 PA CODE 219, " Standards for Protection Against Radiation."

5. 25 PA CODE 220, " Notice, Instructions and Reports to Workers; Inspections."

6. 25 PA CODE 230, " Packaging and Transportation of Radioactive Material" II. FEES An application fee is required for all specific licenses and must be submitted with any NEW application. The applicant should refer to Chapter 218 of the Pennsylvania Regulations for Radiation Protection to determine the amount of fee that should accompany the application. Review of the application will not begin until the proper fee is received by the Department. The check or money order should be made payable to the Department of Environmental Protection.

In the case of an application for renewal or amendment, a fee should NOT be submitted with the application. All current licensees will be billed according to the expiration month of their current license. O License Scaled Sources 1

III. FILING AN APPLICATION p\ V The information submitted must be sufficient to allow the Department of Environmental Protection (DEP) to determine that the proposed equipment, facilities, procedures, and controls are adequate to protect health and minimize danger to life and property. Information submitted should pertain to the specific activities for which authorization is sought and should be complete. Submission ofincomplete information will result in delays because of the correspondence necessary to obtain supplemental information. Applications should be mailed to: Radioactive Materia' Licensing Bureau of Radiation Protection DEP P. O. Box 8469 Harrisburg, PA 17105-8469 Since licensees are required to comply with Department rules and regulations, license conditions, and the content of the submitted application, at least one copy of all information submitted to DEP should be kept by the applicant for reference. IV. NARM MATERIAL APPLICATION FORM ER-BRP-01 O(/ Three copies of the application Form ER-BRP-01 should be completed following the instructions provided with the form. Two copies should be mailed and one kept by the applicant. Since the space provided on the form is limited, additional sheets should be appended as necessary. Supplemental information should be labeled to identify the applicant and reference the items for which information is being given. The following comments deal with the indicated items of the Form ER-BRP-01. Item 1 - Applicant and Locations of Use: The applicant corporation or other legal entity should be specified by name and mailing address in Item 1(a). Individuals j ' should be designated as the applicant only if they are acting in a private capacity and the use ofNARM material is not connected with their employment with a corporation or other legal entity. The actual sites of use should be given in 1(c). Permanent facilities such as field office storage areas for the gauges or devices should be identified in 1(c) by street address, city, and state. Ifyou will conduct operations at temporaryjob sites, you may specify "temporaryjob sites in Pennsylvania." I Attach additional properly keyed sheets if more space is needed. Item 4 - Individual Users: Employees who will use your device under the supervision m of a responsible individual named in Item 5 do not need to be designated by name. [a I The following information should be provided: License Scaled Soun.es 2

j p 1. A commitment that each employee will complete the device manufacturer's 5

  \j             trairling program before being permitted to use the device.

2. If training other than that given by the device manufacture will be provided to employees, a description of the attemative training, including the topics covered in the training, the time to be spent on each topic, and the name and qualifications of the instructor. The training should be equivalent to that provided in the device manufacturer's training program. DEP does not consider a training program adequate if the only qualification of the instructor is completion of the device manufacturer's training program. An instructor should have training in radiation safety equivalent to completion of an 80-hour course in radiation safety principles and practices and should have experience in the use of the device.

3. A commitment that records documenting the training of each employee will be maintained for 2 years from the date the training is completed.

Item 5 Radiation Safety Officer: If multiple users will be listed in Item 4, a radiation safety officer should be named in Item 5. A statement should be included with the application outlining the named individual's duties and responsibilities. The radiation safety officer is expected to coordina:e the safe use of the nuclear gauging devices and ensure compliance with the requirements of 2. PA CODE 215,217,218, (])

 /

219,220,230, and the Pennsylvania Hazardous Material Transportation regulations (67 PA Code 403). Typical duties of the radiation safety officer should include: (a) To assure that radioactive materials possessed under the license conform to the materials listed on the license. (b) To assure that use of the devices, particularly in the field, is only by individuals authorized by the license. (c) To assure that all users wear personnel monitoring equipment, such as film badges or thermoluminescence dosimeters (TLD), when required. (d) To assure that gauges are properly secured against unauthorized removal at all times when they are not in use. (e) To serve as a point of contact and give assistance in case of emergency (gauge damage in the fie'd, fire, theft, etc.) to assure that proper authorities, for example, local police, and DEP personnel, are notified promptly in case of accident or damage to gauges. p ,

 \

License Scaled Sources 3

(f) To assure that the terms and conditions of the license, such as periodic leak tests, t^s are met and that the required records, such as personnel exposure records, leak test h records, etc., are periodically reviewed for compliance with DEP regulations, requirements, and license conditions. Item 6 - Materials: Each sealed source to be used in a given gauge or device should be specified by isotope (for example, cobalt-57, radium 226, etc.), manufacturer and model number of each source and activity in either millicuries or microcuries. The total number of each of the listed model number sou ces must be specified. Item 7 - Uses: The manufacturer's name and model number of each gauge or device utilizing the sources listed in Item 6 must be specified and keyed to the listed sources. In addition, the purpose for which the gauges or devices will be used must be stated, for example, " Moisture-density gauges to be used for measuring moisture and surface censity of construction materials." Items 8 & 9 Qualifications of Personnel: Individual Responsible for Radiation Safety Program-Their Training and Experience Section 217.52(b)(1) of 25 PA Code Chapter 217 specifies that you must be qualified by training and experience to use the material for the purpose requested in such a ( (]f manner as to protect health and minimize danger to life or property before DEP approves an application for a license. You should provide the following information about the individual who will be responsible for your radiation safety program (" responsible individual"). The title of the individual is not important. Whether the responsible individual is called radiation safety officer (RSO), radiation protection officer (RPO), supervisor, etc., is not critical. It is important that the person responsible for the program be named. The individual responsible for your radiation safety program, as a minimum, should have completed the device manufacturer's training program or should have received equivalent training. If the responsible individual has completed or will complete the device manufacturer's program, you should state in your application the title of the course, where and when (specific date) the course was completed, and the name of the course instructor. If the responsible individual has received training other than that provided by the device manufacturer, you should state where and when (specific dates) the training was received, the topics covered in the training, and the narre and qualifications of the training instmetor. The instructor should have training equivalent to completion of an 80-hour course in radiation safety principles and practices and should have o experience in the use of portable gauging devices. As a minimum, the topics covered (u- ) in the training should include radiation safety principles and practices for using the License Scaled Sources 4

' device, regulatory requirements pertaining to the use of the device, and instructions

  ,             and practice in using the device.

U ltems 10 & 11 Radiation Detection Instruments: You do not need to have a radiation survey meter to make surveys during routine use of the device as long as you have made the commitment that personnel will wear a film badge or a thermoluminescent dosimeter when using the device. l_ tem 12 - Personnel Monitoring; Section 219.72 of 25 PA Code Chapter 219 specifies that personnel monitoring equipment be used by individuals entering restricted areas who receive or are likely to receive a dose in excess of10% of the dose specified in section 219.31(a) of 25 PA Code Chapter 219 for adults. The specified doses for adults are 5 rem per year to the whole body,50 rem to the extremities or to the skin of the whole body,15 rem to the eye. (Note: the dose limits for minors under age 18 and the fetus of declared pregnant women is 10% of the adult limits. Individuals under 18 years of age and declared pregnant women need to use personnel monitoring equipment if they receive or are likely to receive a dose in excess of 1% of the doses specified for adults.) All your personnel should wear either a film badge or thermoluminescent dosimeter (TLD) when they use the device. State the type ofpersonnel monitoring equipment you will use and the frequency at which the film badges or TLDs will be changed. f V} The changes should be made at intervals not to exceed I month for film badges and 3 months for TLDs. NOTE: Chapter 219.32(b) requires the use of an accredited NVLAP dosimetry processor under certain conditions. A list of NVLAP accredited personnel suppliers are available from DEP upon request. Item 13 - Facilities and Equipment: Section 217.52(b)(2) of 25 PA Code Chapter 217 states that an application will be approved if, among other things, the applicut's proposed equipment and facilities are adequate to protect health and minimize danger to life or property. Therefore, you should provide information concerning your equipment and facilities. Also, { 219.51 of 25 PA Code Chapter 219 requires that licensed material stored in an unrestricted area be secured from unauthorized removal from the place of storage and that licensed material in an unrestricted area and not in storage be tended under the constant surveillance and immediate control of the licensee. l l O (. License Scaled Sources 5 \_

You should state that the device will be stored in a locked enclosure such as the

 /

( transport vehicle, store room, closet, shed, etc., in a way that will prevent access by unauthorized persons. It is not necessary to provide specific descriptions of the potential storage locations. You should keep in mind that the device needs to be in storage or physically watched by an authorized user at all times. It is not acceptable for a device to be oained to a post or left lying unattended at the place of use during lunch s. breaks, because the device would then be accessible to unauthorized persons. Item 14 - Radiation Protection Program: Procedures should be established to ensure compliance with the provisions of 25 PA CODE, Chapter 219, " Standards for Protection Against Radiation," and Chapter 220, " Notices, Instructions and Reports to Workers, Inspections." The applicant should submit a copy of his written radiation safety and emergency procedures provided to his users of the gauges or devices, such as: (a) Safety measures to be used in transporting the devices in the applicants' vehicle (for example, fully secured within the transportation vehicle and away from the passenger compartment). Transportation activities must be carried out in accordance with the requirements of the Pennsylvania Department of Transportation regulations. O (h (b) Means of preventing unauthorized access, use or removal of the gauges from temporaryjob sites. (c) Means of r; anting unauthorized use or removal of gauges from the designated place (s) of storage. (d) Emergency procedures to be followed in case of accidents involving damage or loss of the gauges or devices, including names and telephone numbers of the individual (s) within the applicant's organization who should be notified and whe would, in turn, notify the local police, and DEP. (e) Specific instructions to the users informing them that any maintenance on the gauges involving dismantling, removal of source holder (s) etc., must not be performed by the user and must only be performed by the manufacturer of the device, unless the applicant has specifically requested authority for performing maintenance in the application. If the applicant wishes to be authorized to perform maintenance and repair on gauges and devices involving access to the source holders, and/or dismantling of the shielding or shutter devices, specific information on the step-by-step procedures to be followed including radiation safety precautions must be supplied. In addition, the names of the personnel and the specific pertinent training of the personnel who will be performing such maintenance and repair must be given. License Scaled Sources 6

( 1 r Leak Testing Sealed Sources g ( As s licensee, you must perform such tests as DEP deems appropriate or necessary under section 215.13 of 25 PA Code Chapter 215. DEP requires tests to determine whether or not there is any leakage from the radioactive source in the device. The leak test should be performed at 6-month intervals. The measurement of the leak-test sample should be quantitative and the instrumentation should be sufficiently sensitive to detect 0.005 microcurie of radioactivity. The options for leak-testing are:

1. Engage the services of a consultant or commercial facility to take samples, evaluate the samples, and repon the results to you.

2. Use a commercial leak-test kit. You take the smear and send the smear to the kit supplier, who reports the results to you.

3. Perform the entire leak-test sequence yourself, including taking the smears and measurement.

For Option 1, specify the name, address, and license number of the consultant or (] U commercial organization. For Option 2, specify the kit model numbc. and the name, address, and license number of the kit supplier. In your application, you should state that the test samples will be taken by the individuals specified in Items 4 and 5. For Option 3, specify how the test sample will be taken and the instrumentation that will be used for measurement. An instrument capable ofmaking quantitative measurements should be used. Hand-held survey meters will not normally be considered adequate for measurements. Include a sample calculation for conversion of the measurement data to microcuries. You should also specify the individual who will make the measurement and his or her qualifications. The individual should have prior experience in making quantitative measurements and this experience should be documented in your application. 1 i Maintenance You should state that any maintenance you will perform (such as cleaning) will also be done with the radioactive source in the safe shielded position. You may not do l any maintenance unless the source is safely shielded. To take the radioactive source i 1 p) (mj out of the device, you must have special training and procedures, use a radiation survey meter, and take appropriate radiation safety precautions. Your license must l License Scaled Sources 7 l

specifically authorize any maintenance, repair, etc., that would involve removing the source from the device or taking the source out of the safe shielded position. (O)

• Transportation of Devices to Field Locati_ons The transportation oflicensed material as referenced in 25 PA Code Chapter 230 must also be carried out in accordance with the applicable requirements of the Pennsylvania Department of Transponation (PennDOT), 67 PA Code 403 for Hazardous Material.

It is your obligation to obtain a copy of the PennDOT regulations on transportation of radioactive materials. The requirements for package labeling are identical to Subpart E of 49 CFR Part 172 of the U.S. DOT regulations. General requirements for shipping and packaging radioactive material are identical to Subpart I of 49 CFR Part 173 of the U.S. DOT regulations. You should state that packaging and transport of the device will be carried out in accordance with applicable PennDOT regulations. Operating and Emergency Procedures You should provide your personnel with written operating and emergency (N

 \

procedures and you should state to the Department that you will provide the procedures to each person who uses the device. It is not necessaiy to submit the detailed operating and emergency procedures to DEP for review. However, you should state that your procedures include the following topics, and you should list the topics covered in your procedures.

1. Use ofpersonnel monitoring. All personnel who use the device should wear their  !

personal dosimeters when they are working with the device.

2. Use of the device. Step-by-step procedures for the use of the device.

3. Storage of the device. Procedures for storage of the device when it is not in use or under the physical sun eillance of a user.

4. Transportation. Procedures for transporting devices to and from work sites.

5. Leak-testing. Procedures for performing a leak test if the test will be done by individuals other than those specified in Items 4 and 5 ofyour application.

6. Emergency procedures. Steps for workers to take, including individuals to be notified.

I License Scaled Sources 8

Item 15 - Waste Disposal: Because of the nature of the licensed material contained in lf devices, your only option for disposal is to transfer the material to an authorized recipient as specified in section 217.101(a) of 25 PA Code Chapter 217. You should state that disposal will be by transfer of the radioactive material to a licensee r specifically authorized to possess it. Authorized recipients are the original supplier of the device, a commercial finn

licensed by DEP, NRC, or an Agreement State to accept radioactive waste from other persons, or another specific licensee authorized to possess the licensed material. No t

one else is authorized to dispose ofyour licensed material. V. AMENDMENT AND RENEWAL OF LICENSES l l Applications for amendment of existing licenses should be filed in the same manner as initial applications or may be filed in letter form. The application should clearly identify the license which is to be amended by license number. The exact nature of the requested changes should be specified and additional supporting information, as necessary, should be provided. Licenses are normally issued for a period of five (5) years. If an application for license renewal is filed thiny (30) days or more before license expiration, the existing license remains in effect until the renewal application has been finally acted upon by DEP. Renewal applications should contain complete and up-to-date information concerning the applicant's current program. References to previously submitted documents should be clear and specific and specify the document by date and indicate pertinent information by page and paragraph. l l 1 I License Scaled Sources 9 1 l

l l PENNSYLVANIA DEPARTMENT OF ENVIRONMENTAL PROTECTION BUREAU OF RADIATION PROTECTION GUIDE FOR THE PREPARATION OF LICENSE APPLICATIONS FOR THE MEDICAL USE OF RADIOACTIVE MATERIAL i 1 I. Introduction l This guide describes the type ofinformation that the Bureau ofRadiation l Protection staff needs to evaluate a license application for the limited medical use of naturally occurring and accelerator-produced radioactive material (NARM). An application for medical uses ofNARM material must be submitted in duplicate on the " Application for Radioactive Material License - Medical Human Use" ER-BRP-01.1. Physician training requirements are listed 25 PA Code Chapter 224, i Subchapter J. Applications for amendment to existing radioactive material licenses may be submitted on ER-BRP-01.1 or by a letter stating the same information as specified on that form. The applicant should retain an additional copy of his application for liis own files, once his application has been approved, since he will be committed to operate under the procedures which he has submitted. Mail the license applications to: l l l Bureau of Radiation Protection ! Pennsylv~ania Department of Environmental Protection P. O. Box 8469 Harrisburg, PA 17105-8469 i II. License Fees An application fee is required for NEW licenses and must be submitted with the application. The applicant should refer to Chapter 218 of the Pennsylvania Regulations for Radiation Protection (25 PA Code) to determine the amount of fee j that should accompany the application. Review of the application will not begin ' until the proper fee is received by the Department. The check or money order should be made payable to the Department ofEnvironmental Protection. i l Do not submit a fee for a license renewal or amendment. All cunent licensees will receive their annual invoice during the expiration month of their current license. License Medical I

III. Instructions For Completing The Application s The separate items of the application are discussed below: Item 1 -If a physician is requesting use of radioactive material at his own office, then he is named as the applicant. Ifradioactive material is to be stored and used at an institution, the institution is named as the applicant. This guide covers the use of all NARM at institutions and private practices. Items 2 through 4 - Self-explanatory. Item 5 - To use radioactive material in humans, an individual must be licensed in accordance with the laws of the Commonwealth of Pennsylvania to dispense and use dmgs in the practice ofmedicine, and have basic and clinical radioisotope training and experience commensurate with the proposed use of radioactive material. Acceptable training and experience are specified in 25 PA Code Chapter 224, Subchapter J. All nuclear medicine procedures must be supervised by a suitably licensed and trained nuclear medicine physician. Item 6 - The Radiation Safety Officer (RSO) is the person designated to be responsible for the day to day radiation safety program as described in Section 224.52. He maintains ^all records required by the Department's regulations. He also , is the primgry contact with the Department of Environmental Protection on matters pertaining to the license and the use ofradioactive materials. The RSO's training and experience with the types and quantities ofradioactive materials for which a license is being requested should be submitted. Items 7 through 10 - Self-explanatory Item 11 - See 25 PA Code Chapter 224 for the groups ofmedical uses of radioactive material. Check the appropriate box ifgroup uses are desired. If the - applicant has extensive experience in the diagnostic use ofradioactive materials, he may request all routine diagnostic uses for that group. Section 224.151 consists of uptake, dilution, and excretion studies. Section 224.201 consists ofimaging and localization studies. Ifyou need more than 200 microcuries of material listed under Section 217.46(a), _ you must indicate the amount desired. Item 12 - Include all calibration / reference sources which are greater than the quantities listed in Section 224.104.  ; i f License Medical 2

Note: If the applicant desires to use xenon-127, a description must be submitted of [3 the systems that will be used to prevent the exhaled or leaked gas from ( contaminating the environment and the facility. Also, submit procedures to protect personnel administering the material. For DTPA as an aerosol, provide the maximum activity to be used in the aerosol generator at any one time, the manufacturer make/model number of the device to be used, confirmation that the manufacturer's protocol will be followed, and disposal procedures for contaminated apparatus. Items 13 through 16. Self. explanatory. Item 17. State how often and by whom the survey instmments will be calibrated and describe how corrections are made for the energy of the isotopes being used. Item 18- Method of monitoring personnel exposure (film badges, TLD, etc.) and personnel monitoring supplier. If mtflicurie amounts of activity are used at one time, confirm that ring badges will be used by persons handling those amounts of activities. Lists of personnel monitoring suppliers accredited by NAVLAP are available from the Department upon request. Item 19- Facilities - Self-explanatory. A Item 20. Radiation Sr f-ty Procedures - The applicant's RaCation Sa .y rocedures must be submitted in duplicate with serially numbered pages and must clude the following items as appropriate for the uses desired. ALTERNATIVELY If the applicant / licensee has an NRC License or is applying for a new NRC icense then the applicant / licensee may: 9 Incorporate into the Pennsylvania license application, the appropriate Appendices from NRC REG GUIDE 10.8, Revision 2. Follow the directions given in Section 1.1.2 of RG 10.8, REV 2 for the inclusion of the appendices into the PA license application.

1. A description of the radiation safety program management. If the applicant is an institution, they must establish a Radiation Safety Committee as required by Section 244.53.

(m\ C/ License Medical 3

2. A description of the functions of the RSO, the Radiation Safety Committee and

[_ C the program for periodically ch ckir g the use ofradioactive material to assure that propei safety procedures are followed. The committee or RSO should have authority to set radiation safety policy to stop any use ofradioactive material deemed unsafe and to require remedial action by users.

3. Method of receiving radioactive material, promptly notifying responsible persons, monitoring it for contamination, and storing it securely. Receipt of materials (such as generators) after normal working hours should be specifically addressed.

4. Method of recording receipt, authorized use, transfer, inventory, and disposal of radioactive material. This should include records to indicate that only authorized users are ordering procedures.

5. Method of restricting access to radioactive material to authorized users. Also, method of controlling access te restricted areas, radhition areas, and high radiation areas.

6. Procedures for storing, logging in and out, and returning to storage sealed sources that are used for therapy. Also, the procedures for handling sources, including descriptions of special equipment used to minimize exposure (such as carriers, remote handling tools, L-blocks, etc.)

A.-

7. For sealed sources of radioactive material, a description of the frequency and method that will be used to leak test the sources. For example, if a commercial kit is used, name the supplier. If the applicant wishes to test his own sources for leakage % procedures for wiping, counting, converting to microcuries, etc. must be submn A . 8. A description of the routine visual and radiation surveys to be made of arc <s where radioisotopes are used and stored (see Appendix A).

l l

9. General laboratory niles for preventing contamination when handling '

uncontained radioactise material (see Appendix B). l

10. Method of coping with spills, radiation incidents, and facility and personnel contamination.

I 1. If radioactive materials are used for therapy, list the instructions given to nurses I who will attend patients containing radioactive material. These instructions should 1 assure proper protection of other patients, nursing personnel, and visitors. l ( \</)) License Medical 4

e

12. Procedures for performing radiation surveys about patients containing therapeutic quantities of gamma emitting radioisotopes and for restricting the area v about'each patient. Also, provide procedures for surveying patients and rooms to verify that all temporary implants have been removed prior to the patient's release from the hospital.

13. Procedures for calibration of dose calibrators, in accordance with manufacturer, the American National Standards Institute (ANSI), or U. S. Nuclear Regulatory Commission (NRC) recommendations for constancy, linearity, geomety, and accuracy. Also, procedures for quality assurance ofother diagnostic and imaging equipment used with radioactive material.

14. Technologists - If the radioactive materials are not to be used and handled exclusively by the licensed physician, describe the supervisory program as required by Section 224.55.

Item 21. A description of the specific method for managing and disposing of radioactive wastes. Wastes may be disposed of by transfer to a licensed waste disposal firm, by release into a sanitay sewer in accordance with the regulations, and by segregation and storage until activity has decayed. Describe how the waste will be monitored to assure decay to acceptable levels and to assure that labels are removed prior to release to the trash. Disposal by incineration must be specifically

 /9       authorized by the Department.

U Item 22 - If the application is for an institution, hospital, or medical center, it must be signed by its director, or chief executive officer. Unsigned and undated applications will be returned to the applicant. Retain one copy for your files. I Item 23. If the application is for a private practice, it should be signed by a semor partner or the president. i I i l I

 'p)                                                                                              i
   )

License Medical 5

PENNSYLVANIA DEPARTMENT OF ENVIRONMENTAL PROTECTION

       ,                          BUREAU OF RADIATION PROTECTION REGULATORY GUIDE SUPPLEMENT LICENSE APPLICATIONS FOR THE MEDICAL USE OF RADIOACTIVE MATERIAL If the applicant / licensee has an NRC License or is applying for a new NRC License then the applicant / licensee may:

Incorporate into the Pennsylvania license application, the appropriate Appendices from NRC REG GUIDE 10.8 Revision 2. Follow the directions given in Section 1.1.2 of RG 10.8, REV 2 for the inclusion of the appendices into the PA license application. O O l Supplement Medical Use I l i U

V

  ,s
   -                                                   Appendix A
 /
     }

METHODS AND FREQUENCY FOR CONDUCTING RADIATION SURVEYS

1. Introduction When radioactive material is handled in the form of solutions at hospitals, both radiation surveys and contamination surveys should be performed to prevent unnecessary radiation exposure to personnel and to prevent the spread of contamination throughout the facility.

Radiation area surveys are performed using an appropriate radiation survey meter, and contamination surveys are performed by taking wipe samples from surfaces in the facility f I that are likely to be contaminated and counting the samples with a suitable detector. II. Frequency of Surveys The frequency of surveys depends upon the amount and type ofradioactive material used. Listed below are examples which may be useful in determining how often to perform surveys. The greater the work load, the more often the surveys should be { i performed. ' A. Low Level Areas - Not less than once a month - Areas where in vitro tests are performed, dilution and excretion samples analyzed, etc. (Samples usually less than 100 microcuries each.) O V B. Medium Level Areas - Not less than once a week - Areas where technetium-99m is injected, patients imaged, etc. C. High Level Areas - Not less than once a day - Areas used for storage of active solutions, preparation of kits, elution of generators, preparation of therapeutic doses, etc. III. Methods of Surveys Suggested methods for performing two types of surveys are given below. Records of these surveys are required for inspection by the Agency and should be maintained for reference to determine whether the radiation levels or the contamination levels remain constant or increase o'Jer a period of time. t l \ O  : 1 4

/] V ' Appendix A continued A. Radiation Area Surveys - A survey meter capable of measuring levels as low as 0.1 mR/h should be used and the resu's recorded on a standard form showing location, date, person performing survey, instrument used, exposure levels, and corrective action taken, if any. A sketch of the area should be used to make an easily pre - ' ud easily understood survey record when annotated with this informat W Methods and Frequency For Conducting Radiation Surveys B. Contamination Surveys - A series of wipes using filter papers or swatches of cloth should be taken from those surfaces where contamination could be expected to exist or where radiation levels are fairly high. (Areas where doses are drawn up, incoming packages are received, pipetting is performed, etc. are areas that may be contamim.ted.) The wipes should be numbered or labeled and the location where they are taken shown on the sketch as described above for the radiation survey. The wipes should each be mbbed over a surface area of abod 100 square centimeters when taking the wipe to maintain a consistent means of determining the amount of removable contamination. The wipes may be counted using a gamma scintillation well counter, a geiger counter, or any other detector capable of detecting the small amount and type of contamination on the samp!e. The amount of removable activity should be recorded in activity units (dpm, bequerels, Or microcuries) per unit area if above acceptable limits (see IV. below). Calculations for converting instrument readings to activity is usually required. If the reading is less than acceptable limits, the instrument reading may be recorded. IV. Acceptable Limits A. Radiation Levels - In no area that is unrestricted (uncontrolled) should r?diation  ! levels exist such that a person could receive 500 mR in any one year,100 mR in any seven consecutive days, or 2 mR in any one hour. If such areas are found to exist, measures should be taken to eliminate the excessive radiation levels. Additional shielding or relocation of radioactive material may be required. In restricted areas, the exposure limits do not apply since personnel are monitored to determine their exposure. However, levels should be reduced to the minimum where practicable to reduce exposure. If visitors are allowed in restricted areas, their exposure should be as low as reasonably achievable. In the case of visitors to patients, no visitor should exceed 100 mrem total dose for all visits to a patient. B. Contamination Limits - The Table shown below is copied from USNRC REG GUIDE 10.8, Revision 2.

?O V

Appendix A continued 0 - Recommended action levels in dpm/100 cm2 for surface contamination by radiopharmaceuticals P-32, Co-58, Fe 59 Co-60, Se-75, Sr-85 Cr 51,Co-57 In 111, I-123, I-125 Ga-67, Tc-99m I-131, Yb-169, Au-198 Hg 197, TI-201 unrestricted areas, personal clothing 200 2,000 restricted areas, protective clothing used only in restricted areas, skin 2,000 20,000 O o b

m l

 /~N Appendix B GENERAL GUIDELINES FOR SAFE USE OF PADIOACTIVE MATERIAL IN A NUCLEAR MEDICINE LABORATORY The following is an example of typical rules that could be specified for a medical laboratory using or preparing radioactive material for human diagnostic studies. The applicant is encouraged to develop his own set of such rules which are specific to his needs and reflect his actual laboratory situation. Use of material which may become airbome (aercsols, xenon-133, iodine-l?5/131) will necessitate additional rules, as will therapeutic preparation and use of radiopharmaceuticals and sealed sources. Rules should be written in the form of directions to be followed by employees.

I

1. Wear laboratory coats or other protective clothing at all times in areas where radioactive materials are used.

2. Wear disposable gloves at all times while handling radioactive materials.

3. Monitor hands and clothing for contamination after each procedure or before leaving the area.

 /]    4. Always use syringe shields for routine preparation ofpatient doses and administration

! (j to patients, except in circumstances such as pediatric cases when their use would compromise the patient's well-being.

5. a. Do not eat, drir.k, smoke, or apply cosmetics in any area where radioactive material is stored or used.

b. Do not store food, drink, or personal effects with radioactive material.

6. a. Assay each patient dose in the dose calibrator prior to administration. Do not use any doses that differ from the prescribed dose by more than 10 percent, execpt for prescribed dosages ofless than 10 microcuries.

b. For all doses, check the patient's name, the radionuclide, the chemical form, and the activity against physician's written order.

7. Wear personnel monitoring devices (film badge or TLD) at all times while in areas where radioactive materials are used or stored. These devices should be wom at chest or i waist level. Personnel monitoring devices, when not being wom to monitor occupational l

exposures, should be stored in a designated low background area, as should the control ' badge. b v  : 1 1 I

Appendix B (Continued) m J -

8. Wear TLD finger badges during elution ofgenerator and preparation, assay, and injection of radiopharmaceuticals.

9. Dispose of radioactive waste only in specially labeled and properly shielded receptacles.

10. Neverpipette by mouth.

I 1. Survey generator, kit preparation, and injection areas for contamination after each procedure or at the end of the day, Decontaminate if necessary.

12. Confine radioactive solutions in covered containers plainly identified and labeled with name of compound, radionuclide, date, activity, and radiation level, if applicable.

13. Always transport radioactive materialin shielded containers.

14. Work over surfaces which are easily cleaned or covered with disposable absorbent coverings when handling open solutions of radioactive material. Work only in designated restricted use areas. Procet 'olatile radioactive materials under fume hoods or in glove boxes when possible.

1 I l l l l l l l l l i l

 \

. I l l

PENNSYLVANIA DEPARTMENT OF ENVIRONMENTAL PROTECTION BUREAUOFRADIATIONPROTECTION . GUIDANCE FOR COMPLIANCE WITH 25 PA CODE, RADIOLOGICAL HEALTH REGULATIONS SECTIONS 219.52(c) AND 224.108(e) Section 219.52(c): "Thc licensee, upon receipt of a package of radioactive material, shal! monitor the extemal surfaces of the package for radioactive contaminatien caused by leakage of the radioactive contents." ( Guidance If the PA licensee has an NRC license, they are considered to be in compliance if they are complying with 10 CFR 20,205 until the effective date of the new 10 CFR 20. After the effective date of the new 10 CFR 20, the licensee must be in compliance with 10 CFR 20.1906. ' If the PA licensee has no NRC license, then the survey required by 219.52(c) must be conducted if(l), the package has evidence ofpotential contamination, such as packages that are cmshed, wet or damaged; or (2), the package is labeled as containing radioactive material. Section 224.108(e): "A licensee sh_all survey for removable contamination each day of use the areas where radiopharmaceuticals are routinely prepared for use or administered and each week where radioactive materials are stored." Guidance PA licensee's will be considered in compliance with 224.108(e) if they are (1), complying with 224.108(a); and (2), if or when radiation levels exceed the licensee's trigger levels, wipes were taken to determine if the levels were due to contamination. If the PA licensee has an NRC license, the same criteria as above will apply. O

C MEDICAL USES OF ACCELERATOR-PRODUCED RADIOACTIVE MATERIAL UPTAKE, DILUTION AND EXCRETION 25 PA CODE SECTION 224.151 Use of prepared radiopharmaceuticals for certain diagnostic studies involving measure nents of uptake, dilution and excretion (does not include uses involving imaging and tumor localizations). (1) Cobalt-57 as labeled cyanocobalamin. (2) lodine-123 as sodium iodide or sodium iodohippurate. (3) Any radioactive material in a radiopharmaceutical and for a diagnostic use involving measurements of uptake, dilution, or excretion for which the FDA has accepted a "New Drug Application" (NDA), an approved " Product Licensing Application"(PLA), or for which FDA has accepted a " Notice of Claimed Investigational exemption for a New Drug"(IND).

   }

Radioactive Material Licensing Bureau of Radiation Protection Department of Environmental Protection P. O. Box 8469 Harrisburg, Pennsylvania 17105-8469 i l U

 /'                                       MEDICAL USES OF l t   -

ACCELERATOR-PRODUCED RADIOACTIVE MATERIAL IMAGING AND LOCALIZATION 25 PA CODE SECTION 224.201 Use of radiopharmaceuticals, generators and reagent kits for imaging and tumor localizations. (1) Fluorine-18 in solution. (2) Gallium-67 as citrate. (3) Krypton-81m as a gas from a Rubidium-81 generator. (4) Indium-111 as DTPA or oxyquinoline (oxine). (5) Iodine-123 as sodium iodide, sodium iodohippurate, or iofetamine HCL. (6) Thallium-201 as chloride. (7) Xenon-127 as a gas. (8) Strontium-82/ Rubidium-82 generators for the clution of Rubidium-82 as chloride. i (9) Any radioactive material in a diagnostic radiopharmaceutical or a generator or a { reagent kit for preparation and diagnostic use of a radiopharmaceutical containing radioactive material for which the FDA has accepted a "New Drug Application" (NDA), an approved " Product Licensing Application" (PLA), or for which FDA has accepted a

    " Notice of Claimed Investigational exemption for a New Drug" (IND).

Radioactive Material Licensing Bureau of Radiation Protection Department of Environmental Protection P. O. Box 8469 Harrisburg, Pennsylvania 17105-8469 O i

l PENNSYLVANIA DEPARTMENT OF ENVIRONMENTAL PROTECTION

                    ,              BUREAU OF RADIATION PROTECTION l

v GUIDE FOR THE PREPARATION OF LICENSE APPLICATIONS FOR , NUCLEAR PHARMACY OPERATIONS I. Introduction This guide describes the type ofinfonnation that the Bureau ofRadiation Protection staff needs to evaluate a license application for the operation of a nuclear pharmacy as i related to the use of naturally occurring and accelerator-produced radioactive material (NARM). An application for nuclear pharmacy operations must be submitted in duplicate on the

          " Application for Radioactive Material License" BRP-01. The application forms with supporting documents should be mailed to the address specified following Item #16.

Applications for amendment to existing radioactive material licenses may be submitted on ER-BRP-01 or by a letter stating the same information as specified on that form. The applicant should retain an additional copy of his application for his own files, once his [' ( application has been approved, since he will be committed to operate under the procedures which he has submitted. II. License Fees An application fee is required for all specific licenses and must be submitted with any NEW application. The applicant should refer to Chapter 218 of the Pennsylvania Regulations f_oro Radiation Protection to determine the fee that should accompany the I application. A nuclear pharmacy is classified under Section 218(c)(1)(i). Review of the application will not begin until the proper fee is received by the Department. The check or money order should be made payable to the Department of Environmental Protection. l In the case of an application for renewal or amendment, a fee should NOT be submitted with the application. All current licensees will be billed according to the expiration raonth of their current license. ) l l rN License Nuclear Pharmacy 1

( \ 111. Instructions For Completing The Application The separate items of the application a-r discussed below: Item 1 - Specify the applicant corporation or other legal entity by name and address ofprinciple office. Also include the telephone number which the Department may use to contact the applicant. Specify the street address of the location of use if the address differs from the one given in item 1(A). If use is to be at more than one location, the specific address of each should be given. Describe the extent of use and the facilities and equipment at each location. A post office box address is not acceptable. The address on the license will be that listed in Item 1(C) if the applicant is out-of-state. Item 2 - Not applicable. Item 3 - Self-explanatory. t Item 4 - Specify the names of the radiopharmacists who will dispense radiopharmaceuticals at the facility. I V NOTE: Before completing Item 4, see APPENDIX A for Acceptable Training For Users. Submit a complete resume' of the education and experience of each radiopharmacist, with a confirmation that each is licensed in the Commonwealth of Pennsylvania. If persons other than radiopharmacists are to handle or process { radioactive material, a description of the minimum training that will be provided l to them should be submitted with theirjob descriptions.

                                                                                                    )

Item 5 - Specify the name of the person who will be designated as the radiation - safety officer (RSO). This person should be responsible for implementing the radiation safety program and therefore readily available to the users in case of ' difficulty and should be trained and experienced in radiation protection and in the use and handling of radioactive materials. Items 6 - Describe the NARM by isotope, chemical and/or physical form, and activity in millicuries or microcuries. A separate possession limit for each nuclide should be specified. Possession limits requested should cover the total anticipated inventory, including stored materials and waste, and should be o commensurate with the applicant's needs and facilities for safe handling. License Nuclear Phannacy 2

Item 7 - The use to be made of the radioactive materials should be clearly described. Sufficient detail should be given to allow a determination of the \ potential for exposure to radiation and radioactive materials both of those working with the materials and of the public. Items 8 and 9 - NOT APPLICABLE. Refer to item 4 and APPENDIX A. Item 10 - For each radiation detection instrument provide the information requested in item 10. The instrumentation should be appropriate for the radionuclides listed in item 6. Item 11 - If the applicant proposes to calibrate his survey instruments, a detailed description ofplanned calibration proceiures should be submitted. If the eplicant intends to contract out the calibration ofinstruments the name, address, and NRC, Agreement State, or licensing state license number of the firm should be specified together with the frequency of calibration. Item 12 - Describe the method ofmonitoring personnel exposure (film badges, TLD, etc.) and personnel monitoring supplier. Chapter 219.32(b) requires the use of an accredited NVLAP dosimetry processor under certain conditions. NOTE: Lists of NVLAP accredited personnel monitoring suppliers are available from the Department upon request. If millicurie amounts of activity are used at one time, confirm that ring badges will be used by persons handling those amounts of activities. Item 13 . Facilities - In addition to the information required, submit a detailed, scaled drawing of the facility and, and indicate the type ofconstruction (e.g., wood, brick, etc.). If the building is multi-story, indicate the location of the radiophannacy. Designate on the sketch restricted and unrestricted areas (e.g., restrooms, break rooms, clerical offices). Indicate the type and proximity of neighboring facilities. Ifradioiodine will be processed, include a detailed description of the hood and filter system to be used to prevent the spread of iodine inside or outside the facility. Also show air flow patterns on the facility drawing, indicating locations ofintake and exhaust. Describe the method of stack sampling and filter change. Item 14 Radiation Safety Procedures - The applicant's Radiation Safety Procedures must be submitted in duplicate with serially numbered pages and O must include the following items as appropriate for the uses desired. License Nuclear Phannacy 3

1. A description of the radiation safety program management, including a description of the duties and authority of the RSO. Explain how the RSO will be

( c'ontacted should a problem occur during routine operations.

2. Method of receiving radioactive material, promptly notifying responsible .

persons, monitoring it for contamination, and storing it securely. Receipt of I materials after normal working hours should be specifically addressed.

3. Method of recording the receipt, authorized use, transfer, inventory, and disposal of radioactive material.

4. MethoC Jrestricting access to radioactive material to authorized users. Also, method of controlling access to restricted areas, radiation areas, and high radiation areas, l

5. Procedures for storing, logging in and out, and returning to storage sealed sources.

6. A description of the routine radiation surveys to be made of areas where radioisotopes are used and stored.

7. General laboratory rules for preventing contamination when handling uncontained radioactive material.

8. Describe the bioassay procedures to be followed ifmillicurie amounts of radiciodine or hydrogen-3 will be used in non-encapsulated form. (The appropriate NRC REG GUIDE may be referenced). l

9. Describe the procedures for operational and maintenance checks of fume hoods and glove boxes, including their exhaust systems and the monitoring procedures for release to the atmosphere.

10. Describe the emergency procedures to be followed in the event of a radioactive material spill, a fire, or other emergency. Address emergency procedures for accidental releases ofgases if bulk quantities of xenon-133 or xenon-127 are to be authorized. Also address vehicle accident procedures, instructions to be carried on vehicles, and any emergency kits.

I1. Procedures for Preparing and Dispensing Radiopharmaceuticles In addition to the information required by the application, the applicant should also submit procedures for preparing and dispensing radiopharmaceuticals. These procedures should include at least the following: a License Nuclear Pharmacy 4

A. A description of the methods for preparing, performing quality control testing j on, and dispensing the various types of radiopharmaceuticals. Describe those to b'e bought in bulk and subdivided, thon to be made from kits, etc. B. A sample of the labeling to be put on the product and on the shipping container. C. The method to be used to assure that the radiopharmaceutical is authorized to be received by the recipient. D. The method ofproviding the proper dose at the time of use and the method of calculating the dose expiration time. E. Records to be kept of radiophannaceuticals prepared and dispensed. F. A sample of the prescription form to be used. G. Records of the receipt and transfer of radioactive material. H. Quality control checks to be used to assure proper doses are dispensed. I. Confirmation that only FDA-approved suppliers will be used. I J. A description of the method to be used for shipping and transporting radioactive material, and a statement that such procedures are in accordance with the Pennsylvania Department of Transportion regulations. Item 15. A description of the specific method for managing and disposing of radioactive wastes. Wastes may be disposed of by transfer to a licensed waste disposal firm, by release into a sanitary sewer in accordance with 25 Pa. Code Sections 219.63 and 219.65, and by segregation and storage until activity has decayed. Describe how the waste will be monitored to assure decay to acceptable levels and to assure that labels are removed prior to release to the trash. Disposal by incineration must be specifically authorized by the Department. License Nuclear Pharmacy 5

Item 16 - The application must be signed and dated by the applicant or an individual duly authorized by the applicant to act for or on the applicant's behalf. Unsigned and undated applications will be retumed to the applicant. Retain one copy for your files and mail the license applications and appropriate fee to: Radioactive Material Licensing . Bureau of Radiation Protection PA Department Environmental Protection P. O. Box 8469 Harrisburg, PA 17105-8469 { Appendix A i ACCEPTABLE TRAINING FOR USERS

1. Previous approval as an authorized user by an Agreement State, Licensing State or the NRC.

OR

2. Board certification in nuclear pharmacy by the Board ofPharmaceutical Specialty, American Pharmaceutical Association or Board certification in radiochemistry and radiopharmacy by the American Board of Science in Nuclear

( Medicine are also recognition of acceptable training. AND

3. Successful pharmacist licensure in the Commonwealth ofPennsylvania.

1 I l l l l l l f k License Nuclear Phannacy 6

93

• f' O .

NOTE: Th ' ' Pages still need to be imported into e zerosoft format. O O , ~ -- - _ _ _ . _

En sr.P.oi. i:REv.e/92 " A " COMMONWEALTH OF PENNSYLVANIA l 'T lt b - -- DEPARTMENT OF ENVIRONMENTAL PROTECTION BUREAU OF RADIATION PROTECTION (,- -d -R g ~s APPLICATION FOR RADIOACTIVE MATERIAL LICENSE - MEDICAL - ( )

 \s       )                                                     HUMAN USE                                                              t This application form is limited to use by persons desiring a license for medical use of radium, and accelerator produce rcdioisotopes.

Ucenses for the medical use of radium, etc. will be issued to individual physicians and to institutions. Ucenses so is tre limited to the individual or institution to whom issued and licensees are subject to the terms and conditions of th This application must be completed in full and signed by the applicant or his authorized representative, an plicable, by an administrative officer of the institution where the radioactive materialis used. Information contained i previous applications filed with the department may be incorporated by reference provided references are cle Use supplemental sheets where necessary. Mail two copies to: Radiation Protection, Pennsylvania Department o vironmental Protection, P. O. Box 8469, Harrisburg, Pennsylvania 17105-8469.

1. Applicant's Name (Hospital & Department or 2.

Individual Physician) O If this is an application for renewal or amendmen-please check box and give the number of the Pennsylvania license being renereed or amended.

3. Mailing Address 4 Area Code and Telephone Number Zip Code

5. Name of individuals using or directly supervising the use of Sources. For each individual, please list PA. MD/DO Uc and experience in the human use of radium, etc., was received. (Physicians in superivsing physician is named). Submit resume and preceptor statements where applicable.

,O (J}

6. Name of Radiation Safety Officer (Name one individual. If same as applicant, write "same".)

7. Material will be stored at: (Please specify address if different from above)

8. Material v.;il be ased at: (Please speci;y address if different from above)

9. Is the material subject to transportation by car? d YES O NO 10 . For Institutionel Ucense Applicants:

Na'm'es of Radioisotope Committee Members: Does hospital have a Radiation Safety Committee? O YES O NO Does it review radium use? O YES O NO Has this license application been approved by the committee? O YES O NO fs I \ V SUBMIT IN DUPLICATE

                                                                                                                          -,.e<,.--..-<

PAGE 2 ' 11. RADIDACTIVE MATERIAL FOR MEDICAL USE N . . -. ..U MAXIMUM (\, ) ITEMS PossEsstoN

• RA'>toACTIVE MATERIAL ,

DEslPED UMITs usTED IN: 'X" (IN MILUCuRIEst 25 PA Code i 217.46(a) for in Vitro Studies 25 PA Code i 224.151 AS NEEDED 25 PA Code i 224.201 AS NEEDED RADIUM 226 (25 PA Code 224.301) 12. rsfgrence RADIOACTIVE standards authorized MATERIAL under ChapterFOR USES NOT L.JTED IN ITEM 11. (Sealed sources a . ,d used for ca 224.104 NEED NOT BE LISTED) CHEMICAL MAX 1 MUM NUMBER ELEMENT AND MASS NUMBER AND/OR OF MILUCURIES DESCRIBE PURPOSE OF USE PHYSICAL FORM OF EACH FORM 13. Investigative proposal for experimental or non-routine use is appended. O YES O NO 14 If material will not be obtained in precalibrated form for oral administration or in precalibrated form for parent administration, describe identification, processing, and standardization procedures:

15. BRACHYTHERAPY Inventory and Source Control. Please specify the procedures to be followed to insure appropriate sources are selected, properly loaded and inserted, and properly recovered. Indicate what type o ecords and logs will be kept. If persons other than the applicant user handle the sources in the course of a atment, such as source preparation or removal of sources from the patient, identify these persons or their job titles, their activities with the sources, and their training and experience.

SUBMIT IN DUPLICATE

                                      .                              PAGE 3 16.

List radiati:n d3 tecti:n survsy m;t:rs by type, (irn chamb:r, GM counter, Scintill:ti:n detector, scanner, c mera etc.) manufEcturcr, m:d:l, numb;r available and date of last calibration. Ie i .-,r-*-- # G. Method, frequency, & standards used in calibrating instruments listed above: '

                                                                                                                         ....._m   *j 18.

Specify personnel monitoring provided persons handling radioactive material (Film badge, dosimeter, or moluminescent dosimeter; and name of Supplier). INFORMAT!ON TO BE SUBMITTED ON ADDITIONAL SHEETS IN DUPLICATE 19. Facilities fume hoods, and etc.equipment. Describe laboratory facilities and remote handling equipment, storage co Explanatory sketch of facility is attached O YES O NO { { 20. Radiation protection program. Describe the radiation protection program including control measures. If appl! I covers realed sources, submit leak testing procedures where applicable, name, training, and experience of person to the of perform leak tests, and arrangements for performing initial radiation survey, servicing, maintenance and r source. , 21. Waste Disposal. lf a commercial waste disposal service is employed, specify name of company. Otherwise, sub-mit detailed description of methods which w"! be used for disposing of radioactive wastes and estimates of the typs and amount of activity involved. l

22. Institutional Certification (Recuired when radioactive materials are stored or used in Hospitals)

[ j' The Administrative Office of this Institution approves the proposed use of radioactive material as described in th q) application. I Date By Title

23. Private Practice Certification The applicant and any official executing this certificate on behalf of the applicant named in item 1 certify th this application is prepared in conformity with Title 25. Rules and Regulations, Article V. Radiological Health and that allinformation contained herein, including any supplements attachec' hereto,is true and correct to the best of our knowledge and belief.

Apphcant named an item i Dete By: r.o. er e.mtving arrici.i

       \

V SU!MIT IN DuPLIC ATE

ER-BRP-01 Rev.10/78 ,,.,,,,,.. COMMONWEALTH OF PENNSYLVANIA } DEPARTMENT OF ENVIRONMENTAL PROTECTION l i BUREAU OF RADIATION PROTECTION , (. _ . _ . . *A , /3 APPLICATION FOR RADIOACTIVE MATERIAL LICENSE ~ (Q ATHROUGH LICENSE. INFORMATION CONTAINED IN PREVIOUS APPLIC 15 MAY BE INCORPORATED BY REFERENCE PROVIDED REFERENCES ARE CLEAR AND SPECIFIC. i CHEETS WHERE NECESSARY. ITEM 16 MUST BE COMPLETED ON ALL APPLICATIONS. Mall TWO COPIES BUREAU OF TO: RADI ATION PROTECTION, PENNSYLV ANI A DEPARTMENT OF ENVIRONMENTAL PROTECTION,'P.O. BOX 8469, HARRISBURCs,f PENNSYLVANI A UPON APPROVAL OF THl3 APPLICATION, THE APPLICANT WILL RECEjVE A R,ADIDACTIVE MATERIAL LICENSE. 1, (A) NAME & STREET ADDRESS OF APPLICANT (INST 3-TUTION, FlRM, PE RSON, ETC. INCLUDE ZlP CODE.) (C) STREET ADDRESS (S) AT WHICH RADIOACTIVE MA-TERIAL WILL BE USED (IF DIFFERENT FROM 1 (A). INCLUDE ZIP CODE.) (8) 8USINESS TELEPHONE (INCLUDE ARE A CODS) 2. DEPARTMENT TO USE RACsOACTIVE MATERIAL 3. PREVIOUS LICENSE NUM B E R(3) (IF THIS IS AN AP-PLICATION FOR RENEWAL OF OR AMENDMENT TO A LICENSE, PLEASE INDICATE AND CIVE NUM8ER.) A. INDlVIDU AL USER (S) (NAME & TITLE OF INDIVIDUAL (S) h. WHO WILL USE OR DlRECTLY SUP E RVISE USE OF R ADI ATION SAFETY OFFICER (NAME OR PERSON RADIOACTIVE MA T E RI AL. GIVE TRAINING & EX- DESIONATED AS RADIATION SAFETY OFFICER IF OTHER PERIENCE IN ITEMS 8 & 9.) THAN INDIVIDUAL USER. ATTACH

SUMMARY

OF HIS TRAINING & EXPEREINCE A8 IN ITEMS 8 & 8.) (A) R ADIOACTIVE MATE RIAL (E LEMENTS AND MASS (8) CHEMICAL AND/OR PHYSICAL FORM & MAXIMUM NUM8ER OF MI'L LICURlES

%                NUMPER OF E ACH)                           OF E ACH CHEMICAL AND/OR PHYSICAL FORM THAT YOU wtLL POSSESS AT ONE TIME. (IF SEALED SOURCES (S), At.SO STATE NAME OF MANUFACTUR ER, MODEL NUMBER, NUMBER OF SOURCES, AND MAXIMUM ACTIVITY PER bOURCE.)

7. DESCRIBE PURPOSE FOR WHICH RADIOACTIVE MATERIAL WILL BE USED. (IF RA .,10 ACTIVE MATERIAL IS IN THE FORM OF A SEALED SOURCE, INCLUDE THE MAKE AND MODEL NUMBER OF THE STOP NGE CONTAINER AND/OR DEVICE IN WHICH THE SOURCE WILL BE STORED AND/OR USED.) s

                                                                                  ^

e O

                                                                                 . ~ '.
                                                                                    'W      y

( e ts b,* "

                                                                      .,,,     ^ y) . .           -

49 (CONTINUED ON REVERSE SIDE)

ER-BRP-481:11/87 . ** COMMONWEALTH OF JENNSYLVANIA  :" W- 9 DEPARTMENT OF ENVIRONMENTAL RESOURCES BUREAU OF RADIATION PROTECTION , 'DRA_ U'1J b

p. '

CERTIFICATE - USE OF RADIOACTIVE SOURCE FOR3

                                                                                                                                      &A MEASURING, GAUGING, OR CONTROLLING DEVICE 25 PA Code Section 217.42 establishes a general license authorizing commercial and industrial firms, researt.h, educa-tional and medical institutions, individuals in the conduct of their business, and State or local govemment agencies to possess radioactive material in certain measuring, gauging, or controlling devices. Possession of radiosctive material under Section 217.42 is not authorized until the firm, institution, individual, or agency has filed Fcan ER-BRP-481 and received from the Department a validated copy of Form ER-BRP-481 with a certification number.

O O

3. I hereby file Form ER-BP" 481 pursuant to Section 217 for use of radioacti e materials in a measuring, gaug-ing, or controlling L svice.

4. To be completed by rae Bureau of Radiation Protection.

INSTRUCTIONS

1. Submit this form in triplicate to:

Bureau of Radiation Protection P;nnsy!vania Departme.it of Environmental Resources P. O. Box 2063 H:rrisburg, PA 17120

2. Please print or type the name and address (including ZIP CERTIFICATION NUMBER code) of the institution, individual, t1rm, or agency for whom Dr for which this certification form is filed. Position the first (Mhe address beyond the right dot. (At BRP, a(Leeve certificationitter of tothe this space blank . number address be assigned by BRP)below the lef number will be assigned and a validated copy of Form ER-BRP-481 will be returned.)

l

5. N:me and title of the individual responsible for leak testing the source.

6. Equipment and method to be used for leak testing the source. -

7. C:rtification:

I her;by certify that:

a. All information in this' certificate is true and complete.

b. Appropriate radiation measuring equipment is available to perform the leak tests required under the general license of Section 217.42. The individual who will perform the leak tests is qualified to perform such tests.

c. I have read ano understand the provisions of Section 217.42 of 25 PA Code Chapter 217 (reprinted on the reverse side of this form); and I understand that I am required to comply with those provisions as to all radioactive material received, acquired, possessed, used, or transferred under the generallicense for which this certificate is filed with the Bureau of Radiation Protection.

DIt2: By:

/~N d

J name and title of person filing form j - WARNING 18 PA Consolidated Statutes Section 49o4(a) states: A person commits a misdemeanor of the second degree if with intent to mislead a pub'ic servant, in performing his official function. he:

1. Makes any written falso statement which he does not believe to be true;

2. Submits or invites reliance on any writing which he knows to be forged, altered, or otherwise lacking in authenticity; or

3. Submits or invites reliance on any sample, specimen, map, boundary mark. or other object which he knows to be f alse.

e e ER BRP-482:10/87 COMMONWELTH OF PENNSYLVANIA  ? DEPARTMENT OF ENVIRONMENTAL RESOURCES i SUREAU OF RADIATION PROTECTION . ___y,,,.A e e

u. _

CERTIFICATE - MEDICAL USE OF RADIOACTIVE MATERIAL UNDER GENERAL LICENSE 25 PA Code Sectson 217.45 establishes a general Scense authorizing physicians to possess certain quantraes of the accelerator. p Cobalt 57 for the measurement of intestinal absorption of cyanocobalamin. Possession of radioactive material under Section 217.45 la not authorized until the physician has filed Form ER-BRP-482 and received from the Department a validated copy of ER-BRP-482 with a certification number assigned. WSTRUCTIONS Submit this form in triplicate to: Bureau of Radiation Protection, Pennsylvania Department of Environmental Resources, P. O. Box Harrisburg, PA 17120. A certification number will be assegned and a validated copy of Form ER BRP-428 will be returned. Please Print or type your name and address (including ZIP codel, within and below the two dots, e e camncAtion Nuussa: (if this is ariinitial certification, leave this space blank - number to be assigned by BRP. If this is a change of information from a previous general license, include your certification number. I cm a duly licensed physician authorized to dispense' drugs in the practice of medicine in the Commonwealth of Pennsylvania. My license number is: CERTIFICATE I hereby certify that: .

1. All information in this certificate is true and compbte.

2. I have the appropriate radiation measurir g instruments to carry out the diagnostic procedures for which I will use radioactive material under the generallicense of Section 217.45 and I am competent in the use of such instruments.

3. I understand that Department regulations require that any change in the information on this certificate be reported to the Bureau cf Radiation Protection within 30 days from the date of such change.

4. I have read and understand the provision of 25 PA' Code Section 217.45 (reprinted on the reverse side of this form) and I understand that I am required to comply with those provisions as to all radioactive material which I receive, possess, use, or transfer under j the general license for which this certificate is filed with the Bureau of Radiation Protection., l I

i D::ts: By: l (Signature of apphcent) l WARNueG . Is PA Coneohdated Statutee $setson de044e) stetee: A person conwwwte a moedemeanor of the second degree if with intent to mieleod a pub #c servent. in performen0 his offical function. he:

1. Makes any wntten falso statement which he does not homewe t be true: '

2. Submete er imntes rehence on any writing which he knows to be forged, altered. or otherwise lacking in authentactry; or

3. Suberuts er imates reliance on any semple. specimen. men, boundary mark. or other obpect which he knows to be fosse.

ER BRP 483:11/87 0 (, COMMONWEALTH OF PENNSYLVANIA DEPARTMENT OF ENVIRONMENTAL RESOURCES BUREAU OF RADIATION PROTECTION L. _ A F"~~T~""'~ ?'

                                                                                                                                    --%,,        .)    s n                    CERTIFICATE - IN VITRO TESTING WITH RADIOACTIVE MKTERl[~

V UNDER GENERAL LICENSE 5 PA Code Section 217.46 establishes a general license authorizing physicians, clinical laboratories, hospitals, and vettrinarians in the practice of veterinary medicine to possess certain small quantities of radioactive material for in vitro clinical or laboratory tests not involving the internal or external administration of the radioactive material of the radiation th:refrom to human beings or animals. Possession of radioactive material under Section 217.46 is not authorized until th3 physician, clinicallaboratory, hospital, or veterinarian in the practice of veterinary medicine, has filed Form ER-BRP-483 and received from the Department a validated copy of Form ER-BRP-483 with a certification number. O e

3. I hereby apply for a t.ertification number pursuant to Sec-tion 217.46 for use of radioactive materials for (please check one block only):

O a. Myself, a duly licensed physician authorized to dispense drugs in the practice of medicine. INSTRUCTIONS . a e namd cHnical lakatom O c. The above named hospital. ,

1. Submit this form in triplicate to: O d. Veterinarian in the practice of veterinary medicine.

Bureau of Radiation Protection Pcnnsylvania Department of Environmental Resources 4 To be completed by the Bureau of Radiation Protection. P. O. Box 2063 . Harrisburg, PA 17120

2. Pl:ase print or type the name and address (including ZIP gode) of the physician, clinical laboratory, hospital, or CERTIFICATION NUMBER

( lterinarian in the practice of veterinary medicine for whom (,)for which this certification form is filed. Positien the first I:tter of the address below the left dot and do not extend (if this is an initial registration. leave this space blank . number to be bzyond the right dot. (At BRP a certification number will assigned by BRP. If this is a change of information from a previous be assigned and a validated copy of Form ER-BRP-483 will generailicense, include your certification number.) be returned.)

5. If place of use is different than address in item 1, please give complete address:

6. Csrtification:

s. All information in this certificate is true and complete.

b. The generallicensee has appropriate radiation measuring instruments to carry out the tests for which radioactive material will be used under the generallicense of Section 217.46. The tests will be performed only by personnel competent in the use of the instruments and in the handling of the radioactive materials.

c. I understand that Department regulations require that any change in the information on this certificate be reported to the Bureau of Radiation Protection within 30 days from the effective date of such change,

d. I have read and understand the provisions of Section 217.46 of 25 PA Code Chapter 217 (reprinted on the reverse side of this form); and I understand the generallicensee is required to comply with these provisions as to all radioac-tive material received, acquired, possessed, used, or transferred under the generallicense for which this certificate is filed with the Bureau of Radiation Protection.

Dste: By: name and title of person filing form WARNING 13 PA Consolidated Statutes Section 4904(a) states: j A person commits a misdemeanor of the second degree if with intent to mislead a public servant. in performing his official function, he: -

1. Makes any written falso statement which he does not believe to be true;

2. Submits or invites reliance on any writing which he knows to be forged, aftered or otherwise lacking in authenticity; or

3. Submits or invites reliance on any sample, specirnen. rnap. boundary mark. or other object which he knows to be false.

ER-BRP-314:11/87 COMMONWEALTH OF PENNSYLVANIA o 4 DEPARTMENT OF ENVIRONMENTAL PROrrECTION y - ~'" Y ] BUREAU OF RADIATION PROTECTION j CERTIFICATE OF DISPOSITION OF MATERIALS o. * (As aw. MUST BE Comp 6sted ' " " * ~ ~ ^ ~ v UCENSEE NAME AND ADDRESS UCENSE NUMBER , UCENSE EXPIP.ATION DATE The licensee or any individual executing this certificate on behalf of the licensee certify that: (Check and/or complete appropriate item (s) below.) 0 1. No matsriais have been procured by licensee. O 2. All materials procured and/or possessed by licensee under license number shown above, have been transferred to: which has NRC license number; O 3. All materials procured and/or possessed bylicensee under license number shown above have been trans . ferred to: which has license number; issued by ,

     -3'             an Agreement State pursuant to Section 274 of the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974, or a licensing state.

O 4. Materials have been disposed of in the following manner. (Describe specific disposa/ procedures - if additional space is needed, use reverse side.) PLEASE RETURN To: CERMFY1NG oFFICIA( { Pureau of Radiation Protection SIGNATURE Pennsylvania Department of Environmental PROTECTION P. O. Box ',8469 Harrisburg, PA '17j0S DATE

i O .. NOTE: These remaining pages still need to be imported into the Microsoft format. O I

        *1cmaoJ Uoso.zarg ay) olu! papodug aq o; paan IIps saBud Buru!sma.1 asay1 :1LON c0

l I i

              ~                                                l O   .

l

                                                               )

I GUIDE TO PENNSYLVANIA PUBLIC OFFICIAL AND EMPLOYEE ETHICS LAW STATE EIIIICS COMMISSION 309 Finance Building Harrisburg, PA (717)783-1610 Toll free- 800-932-0936 (Mailing Address)

                                          . P.O. Box 11470 Harrisburg, PA 17108-1470 Rev.4/93 0      .

4RD

                                                                                                                        .,' cl .. . . m, . n ~,                                                        '
                                                                                       ~ l C. A-).y:,     '                *
                                                                                                                                                                                                                   ,     p
                                                                        ,1, : ' .', 0.b 6.i'j,;'(?ti:d.lVi;f). ,f<d M.

j.>J. ,l,,*..n

                                                                                                                                                                .                                      , l; : .;:. .,p,
                                                                                                                                                                               ;. , ;3,1,,:.. ..,'.                           '.,,,,.,

a ,.'- 9 yfg,,q:,k..W.,, gs;.; ? %.y._ < ,, , . . . .

                    . . _                                                                                                                                   t-                                    ,            ,       ,       ,                 . g~.. -~,.

9 '.,s - K. $. ,. ; GV,... .

p

    ' ??                          .'4
   .a.                                  g       ..

7

                               .43(1:.
 ?.h                               [
 .M)TNI.                                                           
   .Ti'$f83$2%                                                                                                                                            -

CONTENTS 4 4.'.:i W ' 5) .i,$MS%y . _. MM%$j?dMiT%r.: J/ , -

                                . v'p .:' '.;'. . . ;                                      .*]Wgg-                                                                     Introduction . . . . . . . . . . . . . . . . . . . . .           . ...    .1
   .o                                                                                                                                                                 Commission Composition. ..                         . .... .. .             .1 h
  'y.                    ' . > ; vp .                           ..

Commission Member and Employee Restrictions. I

                     '* w =

k;$? r Commission Powers and Duties. .. . . .. .1

m. y; yp.%s Public Officials /Public Employees ... .. 2 t'

Filing a Financial Interest Statement. . . . 4

            ,..,..       * ~ t'"

r. . Requesting an Opinion . . . . . .. ... . 8 Restricted Activities . . . . . . . . . . . . . . . . . . .9 o..... . , . - Filing a Complamt . . . . . . . . . . . . . . . . . . . . . .. 13 ij'!b$j Misce!!aneous Information . ... . .... . .17

..I:            vft,
 ?E lfEh srl

, h Ybh ., . !'ki! h *hh ,.M,2 'Y,, p

  - v!; > mldTj                    ,e u.,. SA             y, _                 _
                                                             .s r .      ,
                                                                                 .T.*7                      *"
                                                                                                                                               -  ~'
                         -.              + -      ' Ai.
                                    .          ,: . , Q . ,y{;. -: ,'- *.' ")yd-ef*p:  .
                                                                                           *L t. *,a**
                                                                                                  ?                             ,..
                                    -* 4 *ii;*;) & ? .i fjf."?. k{fs R% N
    . 6-
                               .,.J.,

7.

                                                .MTN                       M
                                           .y ;.86.; y,(.u.;g,p,$7.M[ 7"h',                                       ')..3 r'*.f 'g ,
                                                                                                                                          ^         '
                                                                                                                   ~~ - . - _, -, .
                                                                                                                                    , I.
                                                                                                                               *gt 9              s  'f
                                                                                                                                   .e M

m 6

                                                                                                                                     "E                                                                   i
                 . . - _                           ._           -_                                .. . . - - -               --,L                       m-~ -                    -
                                                                                                                                                                                                 - - ~ ~ ~ - - ~ ~ ~ ~ - - - - - - -

4 e M

                                                        .                                                                    .        i.         ,
                                                          ,   ' ; .. w;. .*;. j {  ,           ;                        . ;;c.        '
                                                                                                                                     .g    .
                                                                       . 4.;'l'   ' v . 9 , :/;.., . . .,
           ~
                                                   .'^
                                                   *r.r,.Ga&d!n.U'..i b &,. ,.;n . ih                         - - . . n. :uc'.

\v. 1 .. INTROD.UCTION The State Public Official and Employe Ethics Law, Act 170 of 1978, 65 P.S. Section 401 et. seq., originally became effective January 1,1979. The law was amended and reenacted on June 26,1989 by Act 9 of 1989. The law provides that public office is a public trust and any effort

       ;                                                                                            to realize personal financial gain through public office is a j                                                                                             violation of that trust. The Act was passed to strengthen the faith and confidence of the people of the State in their government. The Act established the State Ethics Commission to administer and enforce the provisions of
     ;                                                                                      .       the Act and to provide guidance regarding the standards established by the Act.

COMMISSION COMPOSITION The Ethics Law provides that the State Ethics Comminion shall be comprised of seven members who are cogmzant of the responsibilities and burdens o,f public service. Three Comminion members are appointed by the Governor, only two of whom may be of the same political party. One member each is appointed by the President Pro "Ihmpore of the Senate, the Minority leader of the Senate, the Speaker of the House, and the Minority Leader of the House. All are appointed without confirmation. Commission members are eligible to serve two full three. A year terms. COMMISSION MEMBER AND EMPLOYEE RESTRICTIONS Comminion members and employees may not hold or campaign for any other public office, hold office in any political party or political committee, actively participate or contribute in any political campaign, have served as an officer in a political party for.one year prior to appointment, influence any decision by a governmental

   ,                                                                                              body, except as a member of the Commission, or be employed by the Commonwealth or a political subdivision in any other capacity.

COMMISSION POWERS AND DUTIES

• Render prospective advisory opinions to present or former public officials and public employees, their appointing authority or employer regarding such individual's duties and responsibilities under the Ethics 1 Law.

1

             .- . . .  . ,  -.v ,         ..,   n.- -, > v s        --eny- - * ~ . . . . .                , . . . .. . - . . . . . . . .     . . . . .
                                                                                                                                                                          \

N

                                                                          .s._

                                                                                                                                                                  +
                                      . ;y.y-ip%. ..
                                                                  .r.,          .. . s.. .y .
                                ..,9:a
                                       ...m..
                                                                     . .           7- ~- , ,, . ;
                                                                                                 ..,                ;            .x   n  .
                                                                                                                                               . ,y . g , .Q;. ,

s. ..

                    .       ..:..u  . A . M ,.J.3h? M._ -anZEs';5e                                               C::..a.:.=.x:.:.s.a.':.a..'..,

h L .. '. . x

• Receive and review Financial Interest Statements of members of advisory boards that have no authority penons required to file; inspect such statements to to expend public funds other than reimbursement for asce tain whether any reporting person has failed to personal expense, or to otherwise exercise the power file such statement or has filed a deficient statement. of the State or any political subdivision thereof.
• Prescribe forms for filing.

B. "Public employee." Any individual employed by the

• Accept and file information voluntarily supplied that Commonwealth or a polith:al subdivision who is

   ,                 exceeds the requirements of the Law.                                                              responsible for taking or recommending official

• Preserve staterrents and reports filed with the action of a non-ministerial nature with regard to:

Commission for a period of 5 years. * (1) contracting or procurement;

• Make statements available for public inspection and copying. (2) administering or monitoring grants or subsidies; (3) planning or zoninc
• Maintain a master index of statements filed with the Commission. (9 a.nspecting, Heensing, regulating w sucHting any
• Instruct other state and local agencies in the pen #3 w maintenance of systems which facilitate public access (5) any other activity where the official action has to such statements. an economic impact of greater than a de
• Investigate aHeged violations of the Ethics Law and . =aimus nature on the interests of any person.

   ..              issue decisions in relation to said investigations.                                                "Public employee" shall not include individuals who l

• Prepare and publish an annual report, prepare and are employed by the State or any political subdivision publish special reports, educational materials, and thereof in teaching as distinguished from l technical studissltp fu tier the pury,oses of the Law. ad==etrative duties.
• Hold hearings, talie testimony, issue subpoenas and C. "randview " Any individual who seeks nomination

                - compel the atuadaa~ of witnesses.                                                                  or election to public office by vote of the electorate,

• Prescribe rules and regulations to implement the other than a judge of elections, inspector of elections i provisions of the Ethics Law. (See 51 PA. Code 11.1 or official of a political party, whether or not such  !

                  'I'8'94                                                                                            individual is nominated or elected. An individual shall be deemed to be seeking nomination or election

• Hold at least two public hearings each year to seek to such officeif he has:

input from persons and orraairations who represent individuals subject to the Ethics Law. (1) mind a mWtion w inade an expendkure or given his const for any other person or

PUBLIC OFFICIALS /PUBLIC committee to receive a contribution or make an expenditure for the purpose of influenemg his l EMPLOYEES .

nomination or election to such office, whether or Who is subject to the provisions of the law: not the individual has announced the specific I l The State Ethics Law applies generally to public officials office for which he will seek nomination or election at the time the coc/.nbution is received and pubhc employees. Candidates and nominees for public office or employment are also subject to certain or the expenditureis made; or provisions in the Law. The Law defines each of the (2) taken the action necessary under the laws of this effected categories: Commonwealth to qualify himself for A. "Public Official." Any person elected by the public n aw n to m ch o m ce. or elected or appointed by a governmental body, or The term shall include individuals nominated or an appointed official in the Eaecutive, Legislative or elected as write-in candidates unless they resign such Judicial Branch of the State or any political nomination or elected office within 30 days of having subdivision thereof, provided that it shall not include been nominated or elected. 2 3 O .-.-.._

                                                         - m-         ...w w..m
                                                                              .                         .    ..     ..... .. ~..._ . ,
                                        .a 4
                             .s                                ,                             ,

d

                                                            ,.,    N,...,                                          . .
                                                                                                                          ?:   , h. . . . ;, ,,.
                             .?
                                                             +

o .

                                                        ~;*     .,

_~ n Y *R&h . 4=:a.-Wi$55 b.

                                                                                                   .HM.'.N wa'b h.b: . .: :.:. .. . . . .~.. '-                 .+

D. " Nominee." Any person whose name has been Incumbent county and local public officials (who are I submitted to a public official or governmental body NOT candidates) including authority members file vested with the power to finally confirm or reject ONLY with their political subdivision. proposed appointments to public office or employment. Incumbent Commonwealth Eneestive Branch public officials and appolated members of boards and FILING A FINANCIAL INTEREST C'"' unions (Enece6w Branch) Ele witn the State

          .i                                                                                               Ethics Commission, with the Governor s Office, and STATEMENT                                                 with the Department, Agency, Board or Commission l

The Public Official and Employee Ethics Law requires . to which they are appointed or elected. public officials, employees, candidates and nominees to focumbent Commonwealth Imglstative Branch public file statements of their personal financialinterests for the officials fde with the State Ethics Comminion and prior calendar year. . with the Chief Clerk of the House of Representatives

1. Who Most File: All public employees employed by or the Secretary of the Senate, whichever applies the Commonwealth or by a political subdivision who Incumbent Commonwealth public officials of are responsible for taking or recommending officia! ).a.r==d==* state agencies file with the State Ethics non-ministerial (requiring judgment and discretion) Comgaaion AND,with, the agency with which they action concerning contracting or procurement; are associated. <

j administering or monitoring grants or subsidies; planning or zoning; inspecting, licensing, regulating Other public officials file with the State Ethics Commission and their agency; other public employees or auditing any person; or any other activity of official action. Refer to the Pennsylvania Code, Title f4 ody wis &eir '8"*I'

         .                $1 for moreinformation.                                                         Gubernatorial and state-level nonunces file with the State Ethics Comnussion and with the Senate Caucus Oubernatorial nominees who nced Senate                                         Secretary in charge of Executive Nominations.

Y confirmation. County and local-level nominees file with the State, county and local level nominees. governing authority of the political subdivision and, Candidates for state, county and local public office. if different, with the official or body vested with the power of confirmation. Elected state, county and local public officials.- 1 Candidates for a state-level public office file with the i Appointed state, county and local public officials ' State Ethics Conunission and append a copy to the who have the authority to expend public funds or petition to appear on the ballot. otherwise exercise the power of the state or a political

subdmsson. Mh fn lodlevel public office file with the governing authority of the political NOTE: Public officials shall not include members of , subdivision in which he is a candidate AND append a advisory boards having no authority to expend public copy to the petition to appear on the ballot.

funds or to otherwise exercise the power of the state or a political subdivision. 9,4g,,;, ,,,,lulates (including winners) not seeking office through the nomination petition process shall Persons who serve as full or part-time solicitors are file ONLY with the State Ethics Commission for required to file a Statement of Financial Interests. state-level office and ONLY with the governing

2. Where to File: Employees of the Commonwealth file authority of se pditical subdivision for ennty or ONLY with their respective agency, department or locaMent ofnce.

bureau personnel office. 3. When to Fue: Public employees and public officials,

                                                                               ...                     who are not candidates - NO later than May I of Employees of county and local political subdivmons file ONLY with the governing authority of their                                each year a position is held and of the year after political subdmss,on.

leaving a positin. Officials appcimed between January I and May 1 file 4 NO later than .. fay 1.

                               . .. .. . . . . . . . . ~ . . . . . . . . . ..
                                                                           . . - -                          .w.        .~              -.

h Y

                                                                                                 ,        ..0
                                                                                                                       ,, .y -           .
              .                         . e. L      :.;,O ..u:1. . .       w.'.L.a,. .    .:ul.'. Z.*a.d'. . 'ik u u.. .                               .: ..

bj Officials appointed after May I file within 15 days of being appomted. Sources and value of gifts of $200 or more and the circumstances thereof. Gifts from family members Gubernatorial nominees file NO LATER THAN 10 and certain friends are exempt. (A gift is defined as days before confirmation. anything that is received without consideration of Candidates file on or before the last day for filing a '9"* " 8***' ** *b petition to appear on the ballot for election. The source and amount of payments for Write.in winners of nominations or elections shall file ramputadon, Wgbg w huptamy expemes within 30 days of having been nominated or elected cxceeding $500 in the course of a s,mgle c:currence unless such person resigns such nomination or elected made in connection with public office or office within that period of time. employment. Such payments from a governmental body or associadons of public officials / employees in NOTE: Only one (1) financial statement is required . which such officials / employees officially serve are for each year. If multiple positions are held, a copy exempt. of the form must be filed for each position in the ~ appropriate locale. Any office, directorship or employment of any nature whatsoever in any business.

4. What to File: Filers are required to disclose financial Financial interest in any legal entity engaged in information concerning the prior calendar year. No business for profit. (5% or more interest in a business dollar amounts are required for any of these items entity is considered a financial interest).

except for gifts and certain reportable expense reimbursements. The information pertains only to the Identity of any financ. ialinterest m. a business which filer and inclum.s: has been i 2nsferred to a membei of the filer's immediate family (parent, spouse, child, brother, The name, address, public position, or the office sister) during the prior calendar year.

          * "I                  '" "         I'

5. Where to Obtain Fories: The State Ethics

[ The occupation or profession of the filer. Commission,308 Finance Bnilding, P.O. Box 11470, ( Real estate interests in which the Commonwealth or a political subdivision is involved. Harrisburg, PA 171081470, '.h County Board of Election Offices, and local political s,ubdivisions. Creditors owed in excess of $5,000 and the interest Also other sources announced at time of the distribution of fctms. rate thereon except those relating to the Wacipal or secondary residence of.the filer. Loans extended 6. Penalty for Failure 'to File: Any person who is between members of the immediate family need not required to file a statement of financialinterests and

• fails to do so may be found guilty of a misdemeanor and may be fined not more than $1,000.00 or Sources of income totaling $1,000 or more. Include

                                                                                      .          imprisoned for not trore than one year or be both employers, and all other sources of $1,000 or more                                      fined and imprh (gross income). Include any payrent, fee, salary' expense, allowance, forbearance, forgiveness,                                            Failure by a canoO           2 file shall be a fatal defect to mterest, dividend, royalty, rent, capital gain, reward, a petition to appear on the ballot.'.

severance payment, prize winning, including tax No public official shall be allowed to take the oath of exempt income. DO NOT INCLUDE: gifts, office, continue upon hi: duties or be compensated governmentally mandated payments, retirement, from public funds unless such statement has been i pension or annuity payments funded totally by filed. contributions of the official. Any public efficial or employee who is required to NOTE: The n;overnmental body on which a filer file a statement and does not do so or files a deficient serves must be listed here if income in excess of statement may be penalized $25 per day for each day

        $1,000 has been received.

said statement is delinquent or deficient up to $250. 6 7 m . . . . . _ . . . . _ . . , . - . . . . , , - - , . . - . . ............. ..... . ... . . s M

9 3, . ..

                                                                               .e
                                                                                                    .J.       o    .   .! y.
                                                                                                                                 . .w . .     .
                                                                     ..s
                                                                               . , .    ,(y, *        ;\       .
                         .,' ' . .             . ' . .:2..:    .:  O .s.;;.ej.&k.L ??.t;0l 2:;'..a._c !                                 -..: . ..             .

Publiclaspection of HosocialInterest Statements Counsel where Commission precedent. court Financial Interest Statements on file with the State cases, the Act or regulations provide it basis Ethics Commission will be available fur public upon which to render such advice. An advice can l inspection and copying between the hours of 8:00 usuauy be issued to a person within 21 working A.M. and 5:00 P.M. Monday through Friday days of their request. In some cases, however, l (excluding Legal Holidays). There is a charge of 25c the O- :%n may extend the time. An advice j per page. may be appealed to the full Commission. All statements must be made available for public b) In cases where there is no precedent, an opinion inspection and copying at an amount not to exceed will be issued by the Comminion members. actual costs. Upon receipt of the request, the requestor and l the subject, if different, w;il be advised of the REQUESTING AN OPINION j date, time, and place of the Commission i . .. . The State Ethics Commission is authorized to issue meeting. Said individuals may attend this meeting and make a presentation. An opinion prospective , advisory opinions regardmg the duties and may be appealed to the Commonwealth Court of respnsibilities of public officials and public employees subject to the Ethics Law. Pennsylvania by a party in interest. I. Wbe May Itequest as Opinios: Any person subject to 4. W the Advice or Opinion be Public: j the act may request an opinios about their own ne final advice or opinion will be available to the obligations. An opinion may also be requested by the public as an official Commmion ruling. The person l authorized representative of such persen or by the requesting the advice or opinion may, however,' appointing authority or employer of such person. require that the ruling contain such deletions and

2. How Does One Itagessi as Advisory Opimise: Write changes as shah be necessary to protect the identity of to the State Ethics Commission and provide the the person involved.

I'U'*I'8 I"I ~

5. What Is ne Effeet Of As Opimies Of the a) Name, address, and phone number of the person Commissies:

who is the subject of the request and if different, the name, address and phone number of the a) If you have requested an opinion and acted in person initiating the request, good faith on the opinion that was issued to you, b) De name of the governmental boify with which you may not be subjected to criminal or civil penahies, provided you have truthfuuy disclosed the subject serves and the name or title of such au materN facts, person's public office or positson. c) If the requestor is the appointing authority, b) An addce of the Commission is a complete l employer or representative of the subject of the defense in any enforcement pMy sedated . request, delineate the nature of such , by the Com n anpidence of good fadin i

                    ,,g,,;,g;E'                                                          I                   any other a@vn or crnnmal proceeding af t advice was requested at least 21 working days d) The nature and duties of the subject's office or f                    prior to taking the action described in the request job. Include an organization chart, bylaws of the and the material facts are as stated in the organization and a job description.                                                       request.

c) List the relevant material facts and circumstances surrounding the request. RESTRICTED ACTIVITIES

3. How is the Request Processed:

The Public Official and Employees Ethics Law provides a) The Commission will advise within 14 days certain restricted activities in which public officials and whether an advice or opinion can be issued. An employees may not engage. These restrictions provide the advice is issued by the Commission's Chief basis upon which Commission tulings are issued. 8 9

                                                                                                      . . .. . ~.. . . . .         .. .... . v .       .

t

m-,

                                                                            . ,'r, 7.'      '. . .            '

OW *b' -

                                 ..l... . . . .
                                                    .u.2.-.a:.c..u..:. L

• M N % 'i g ; d ('.Y **d * '

                                                                                                                                              .-~....:..           ..

s Restricted ~ Activities. (2) This subsection shall not prohibit: (a) No public official or public employee shall engage in (i) Paymenis received pursuant to an conduct that constitutes a conflict of interest. A employment agreement in existence prior to

                                                                                                                                                                      )

conflict of interest is defined as use by a public the time a person becomes a candidate or is i official or public employee of the authority of his notified by a member of a transition team, a office or employment or any confidentialinformation search committee or a person with received through his holding public office or appointive power that he is under , employment for the private pecuniary benefit of consideration for pitlic office or makes himself, a member of his immediate family or a application for public employment. business with which he or a member of his immediate (ii) Receipt of a salary, fees, severance payment

           ,               family is associated. " Conflict" or " conflict of or proceeds resulting from the sale of a interest" does not include an action having a de minimis economic impact or which affects to the                                            person's interest in a corporation, professional corporation, partnership or same degree a class consisting of the general public or other entity resultirg from termination or a subclass consisting of an industry, occupation or withdrawal therefrom upon the assumption other group which includes the public official or or acceptance of public office or public employee, a member or his immediate family                                           employment.

I or a business with which he or a member of his immediate family is associated. (3) Payments made or received pursuant to paragraph (2)(i) and (ii) shall not be based on the (b) No person shall offer or give to a public official, agreement, written or otherwise, that the vote or public employee or nominee or candidate for public official action of the prospective public official office or a member of his immediate family or a or employee would be mfluenced thereby. ' business scith which he is associated, anything of (f) No public official or public employee or his spouse or monetary value, including a gift, loan, political child or any business in which the person or his contribution, reward or promise of future  ; emplo~yment based on the offeror's or donor's spouse or child is associated shall enter into any { understanding that the vote, official action or  ! contract valued at $500 or more with the J governmental body with which the public official or judgment of the public official or public employee or i public employee is assoc'.ated or any subcontract nominee or candidate for public office would be

                                                                                           ,             valued at $500 or more wth ny person who has been influenced thereby.

I* l awarded a contract with the governmental body with (c) No public official, public employee or nominee or which the public official or public employee is j candidate for public office shall solicit or accept, ' associated, unless the c)ntract has been awarded

      '                                                                                                  through an open and pub 0c process, including prict anythmg of .nonetary value, includmg a gift, loan, political cont.ibution, reward, or promise of future              l' public notice and subsequent public disclosure of all employment based on any understanding of that                     I proposals considered and contrsets awarded. In such public official, public employee or nominee that the                             a case, the public official or public employee shall not I              have any supervisory or overall responsibility for the vote, official action, or judgement of the pubhc                  '

official or public employee or nominee or candidate ' implementation or administration of the contract. for public office would be influenced thereby. Any contract or subcontract made in violation of this subsection shall be voidable by a court of competent (d) (1) No public official or public employee shall jurisdiction if the suit is commenced within 90 days accept an honorarium, of the malu,ng of the contract or subcontract. (e) (1) No person shall solicit or accept a severance (g) No former public efficial or public employee shall payment or anything of monetary value represent a person, with promised or actual contingent upon the assumption or acceptance of compensation, on any matter before the public office or employment. governmental body with which he has been associated for one year after he leaves that body. 10 33

                                                                                 ....~~~......~+.>~.~..~                                . - - - . . - -    . - ~
               \

(G Y

                               .:- . . :.a: 1.w - , n ; f+,[' .j.W m.Q                                                                 ,L

_. .e , f't ,

                                                                                                                                                                                         ~i.;.
                                                                                                                                      %w ",          ~ -:   -

(h) No pe/ son shall use for any commercial purpose FILING A COMPLAINT information copied from statements of financial 1. Who May File a Complaint: interests required by this act from lists compiled from such statements. Any individual may file ~ a complaint concerning alleged violations of the Act. (i) No former executive. level State employee may for a 2. Ilow Do I file a Complaint: period of two years from the time that he terminates his State employment be employed by, receive Complaint forms are available upon request from the compensation from, assist or act m a representative Commission. The complaint should state the name, capacity for a business or corporation that he actively job or office held by the alleged violator and a participates m recruiting to the Commonwealth of description of the facts which a*e alleged to constitute Pennsylvania or that he actively participated in a violation. Complaints must be sworn. inducing to open a new plant, facility or branch in 3. What Constitutes A Vioistion of the Act: the Commonwealth or that he actively participated in Any activity that is " Restricted" by Section 3 (supra) inducing to expand an existent plant or facility within of the Act, or by the Commission's regulations. The the Commonwealth, provided that the above Commission can review any complaint to determine prohibition shall be invoked only when the whether the activity is specifically prohibited, but it

       ,             recruitment or inducement is accomplished by a grant or loan of money from the Commonwealth to the                                                                                      would be impossible to address each and every situation in this pamphlet.

business or corporation recruited or induced to

a. The Commission will initially acknowledge (j) Where voting conflicts are not otherwise addressed receipt of a complaint.

by the Constitution of Pennsylvania or by any law, . I rule, regulation, order or ordinance, the following b. If the matter is not within the Commission's l procedure shall be employed. Any public official or lurisdictign or if the complaint lacks sufficient public employee, who in the discharge of his official information, it will not be processed and the duties, would be required to vote on a matter that complainant so notified. \ would result in a conflict of interest shall abstain c. The Commission may initiate either a from voting and, prior to the vote being taken, preliminary or full investigation. A preliminary l publicly announce and disclose the nature of his investigation must be completed within 60 days l interest as a public record in a written memorandum and either terminated or opened as a full

 !                 filed with the person responsible for recording the                                                                                         investigation.

l minutes of the meeting at which the vote is taken,

d. The complainant will be notified within 72 hours j provided that whenever a governing body would be unable to take any action on a matter before at of the commencement of a fullinvestigation and because the number of members of the body required both the complainant and subject of the to abstam from votmg under the provisions of this investigation will be notified every 90 days section makes the majonty or other legally required thereafter of the status of the matter.

l , vote of approval unattainable, then such members e e. The subject of an investigation must be notified shall be permitted to vote if disclosures are made as prior to the initiation of such investigation of the otherwise provided herein. In the case of a three. allegations agamst said person. member governing body of a political subdivision. f. If after a preliminary investigation the matter is where one member has abstained from voting as a terminated, both the complainant and subject of result of a conflict ofinterest, and the remaining two the inquiry will be notified. If a complaint is members of the governing body have cast opposing frivolous, the Commission must so state. votes, the member who has abstained shall be permitted to vote to break the tie vote if disclosure is g. If a fullinvestigation has been conducted, upon made as otherwise provided herein. the conclusion of the field investigation the 12 33

                     .                                                     . .. .. _.              ..-..,_ _ ........ .;              - . ~ . . . .             _ , . . . , _ _ , .              . . _ _ . . . . .    ,_

e M

                                                                 .       p,                     .          .                    ~.                   , Yr '    *
                                                                ~
                                                                    .i      --            .
                                                                                               ;. &0h i . ;.

• S.Y: v  :..w.r, N-.:.u.... . . ^.* . -

subject of the complaint will be issued a findings responding to an investigation or prosecution by the report containing the relevant finding of fact. law enforcement official or agency; Such reports must be issued within 360 days of . the initiation of the full investigation. The Testifying under oath before a governmental body or subject of the investigation must respond to said a similar body of the United States of America; report within 30 days after the issuance thereof. Such other exceptions as the commission, by

h. Upon completion of the field investigation and regulation, may direct.

the issuance of and response to the findings report, the subject will be afforded a full and 7. Are There Any Protections For A Complainant Or fair opportunity to challenge the findings and Witness: l j allegations. Such may include evidentiary hearings and arguments oflaw, No public official or public employee shall discharge any official or employee or change his official rank,

i. Upon the conclusion of the investigation and all grade or compensation, or deny him a promotion, or other proceedings, the Commission will issue a  !

threaten to do so, for filing a complaint with or l final order containing findings of fact and providing information to the commission or testifying conclusions of law. Final orders issued by the in any commission proceedmg. Commission may be appealed to the . Commonweakh Court of Pennsylvania. Any person who engages in such retaliatory activity is guilty of a misdemeanor and,in addition to any other

5. Will the Complaint be Coefidential:

penalty provided by law, shall be fined not more than All Commission proceedags and records relating to 31,000 or imprisoned for not more than one year, or an investigation are confidential until a final be both fined and imprisoned. determination is made by the Commission. The final order is a pubhc record. All other file material 8. What is A Wrongful Use Of Act: p remams confidential. 'Ihe identity of a complainant. A complainant may be civilly liable for a wrongful i( however, may be released by the Commission if it is , use of act if: ' determined that there has been a wrongful use of the Act. (See infra) The complaint was frivolous (filed in a grossly

6. Are There Any Circumstances Under Which A negligent manner without a basis in law or fact) or w thout probable cause and made primarily for a '

j Person May Discuss Or Acknowledge The Existence purpose other than that of reporting a violation of

                      .                Of An Investigation:

this Act; or A person may disclose o,r acknowledge to another matters that are otherwise confideitial when the He publicly disclosed or caused to be disclosed that a l matter pertains to: .i complaint against a person had been fl!sd with the Commission. Final orders l A person who signs a complaint alleging a violation Comnu. .ssion public hearings l of this act has probable cause for doing so if he Seeking advice oflegal counsel , reasonably believes in the existence of the facts upon Appealing a commission order which the claim is based and either: Communicating with the commission or its staff, in Reasonably believes that under those facts the the course of a preliminary inquiry, investigation, complaint may be valid under this act; or hearing or petition for reconsideration by the Believes to this effect in reliance upon the advice of C0"""858083 i

                                                                                                       .               counsel, sought in good faith and given after full Consulting with a law enforcement official or agency                             disclosure of all relevant facts within his knowledge             <

for the purpose of initiating, participating in or and information. I 14 15 p . . . . . . . . . . . . . . . . . ~ , . . . . . . - , . . , . . . . - . , . . . , - . . . M

                                         . , . ' , . . '< ;:[ ' , * ; ' -
                                                                                                                                                ... .i ,.           ,, . . ,_
                                           .%..ja.l .                        . -
                                                                                    .l.'.-.z.,..'i

9. Does's Wressfully Accused Public Official Have Any person who violates the confidentiality o'f a Amy Recourse: Commission proceeding (investigation)is guilty of a If a public official or public et.iployee has reason to misdemeanor and may be fined not more than $1,000 believe a complaint was fr.volous or publicly and/or imprisonment for not more than a year.

disclosed (a wrongful use of act) such person may ^887 person who wilfulh affirms or swears in regard request the Commission to investigate said matter. to any material matter before the Commission

                                                ..                                                               Investigative proceedmg is guilty of a felony and shall if the Commission determines that there has been a be fined not more than $5,000 and/or imprisoned for wrongful use of act, the identity of the complamant                                not more than 5 years. ~

4 may, upon request of the subject, be released. . .. In addition to any other civil or cru. .mnal penalty j If the Commission determines that there has been no provided for in the Act, failure to timely file a wrongful use of act, the subject may appeal such Statement of Financial interest or filins of a deficient decision to the Commission at which time the subject statement may result in a penalty of $25 per diem up must show cause why the complainant violated such to $250. provisions. NOTE: A public official of a political subdivision if it has been determined that there has been a who acts In good faith reliance on a written, non. wrongful use of act, the subject may bring ad action confidential opinion of the political subdivision i for such and he may recover for the following: solicitor shall not be subject to the criminal or treble

    !                       (1) The harm to his reputation by a defamatory                                     dannage penalties of the law.

i matter alleged as the basis of the proceeding. IMPORTANT: Certain activities which have occurred

   !                        (2) The expenses, including any reasonable attorney                               pr to se ef                 date of Act 9 of im, pune 26, fees, that he has reasonably incurred in
                                                                                                               .989) will still be governed by and subject to the 4

proceedings before the comminion. provisions of Act 170 of 1978. Questions regarding such circumstances should be directed to a (3) Any specific pecuniary loss that has resulted representative of the State Ethics Commission. from the prc-# ;:. ) (4) Any emotional distress that has been caused b'y MISCELLANEOUS INFORMATION

,                                 the proceedings.

Additional information is available from the State Ethics f (5) Any punitive damages according to law in C. ; = ion including: appropriate cases. Consolidated Rulings Digest ~

10. What are the Pesalties for Violating the Act? l Annual Report Violations of Section 3(a), (b) and (c) are felonies and .

C'---d lon Decisions can result in a fine of $10,000 and/or imprisonment I for not more than five years. Violations of section l 3(d) through (j), section 4 or 5(a) are misdemeanors j and can result in a fine of $1,000 and/or imprisonment of not more than one year. Any person 8 who obtains financial' gain from violating any provisions of the act can be ordered to pay three times the financial gain into the State 'Reasury or the treasury of the political subdivision. Any person who obtains a financial gain in violation of the Act in addition to the above penalties may be required to make restitution plus interest to the appropriate governmental body. 16 17 l

      . . . . . . . . . .                    . . . . _ . . . . . . . . . . . .     ..           i.-... ....... _._,. . ... .. ... .. ....                           .

o Y

C, I ro LadGil,Ler

                                                      '                                                                                                          cet-Ch.11                             GENERAL PROVISIONS                                 51611.1 CIIAPTER 11. GENERAL PROVISIONS Sec.
                                                .                11.1.       Definitions.

11.2. Construction.

• 11.3. Statute of limitations.

Source The provisions of this Quper 11 adopted April 23.1993. eNective April 24,1993. 23 Pa.B. 2os7 unless otherwise noemd. I 11.1. Definitions. The following words and terms, when used in this part, have the following rneanings, unless the canant clearly indicates otherwise. Arl'hhanal definitions are set forth in the act. Aes "Ibe act of June 26,1989 (P.L. 26, No. 9) (65 P.S. (( 401-413), known as the Pubhc Official and Employee Ethics Law (65 P.S. (( 401,- 413). Admin 4rsering or momsoring grant.r-Directing, supervising or approving the expenditure or reimbursement of grant funds or monitoring another person's or organiyarian's " ..g of grant funds.'Ihe term does not include compil. ing exp=~'*-==. comparing actual to planned empenditures or reimbursements, l prepanng comparative reports or completing grant proposals or reimbursement f., ,. forms under specific duection.

                           '" 'w " . . ;                             Advice-A'darsenvc of the Qief Counsel of ther c
                         ,'F'yl7,

=% issued under section 7(ll) of the act (65 P.S. j 407(11)) and based exclusively on prior

   ,)

Cr -- ' - -= opinions, the act, regulanons promulgated under the act and court opinions which laserpret the act. See section 402 of the act (65 P. S. { 402). APPosasing amWThe person who is vested with the power to appoint, hire or ter====ee if the power is vested in a governmental body, a majority vote of a quorum of that body constitutes the .yyvindug authority. Andas-A review of stalements of financial interests to determine compliance with the act and to provide nachaie=1 assistance in its attrainistrataan. Chairperson 'Ibe Osirperson of the Conmussion. I Ch'The term includes adopted and biological children. Clear and convincing proof-To a degree which requires more than a pre-ponderance of the evulence but less than beyond a reasonable doubt. Consussion-The State Ethics Commission of the Commonwealth.

                             .                                       C-. *- %-Aa appomted and seated member of the C--                           *M=

Cosprmation "Ibe power vested in a person or governmental body to l approve the nomination of persons l CondracJing or procarement-Awarding a contract or making a decision to i purchase by the preparation of requests for bids and proposals, the solicitation  ; i 11-1 (219715) No. 264 Nov. 96 l

51 i 11,1 STATE ETHICS COMMISSION Pt. I

                               ~ .
                                                                                                                                                .c and evaluation of proposals or the selection of a vendor. De term does n include contracting or purchasing through master contracts or purchasi schedules already awarded.

De minimis economic impact-An economic consequence which has an insignificant effect.

                                       '                Director-An officer acting as an agent for a business who is authorized to regulate, manage and direct alone or in conjunction with other officers.

( L Docket-The official assignment of a file number to a matter submitted to the Commission. Election-ne term includes primary, special or general elections. Employed by-Used in any capacity, with or without compensation. His definition is only used in the context of section 6(d)(5) of the act (65 P.S.

                                                    $ 406(d)(5)).

Emplayer-One who uses the services of others and pays their wages, sala-ries or other compensation. '

                                                     ' Filed-Official papers are filed on the date they are physically received at the Cammi" ion Office whether delivered by United States mail, express car-rier, hand delivery or by Facsimile Service (FAX). See i 19.1 (relating to forms; filing) for additional requirements when filing a Statement of Financial

_ Interests by Facsimile Service (FAX).

                                   '            . . Governing authoriry'-Be body empowered to enact ordinances, appropria-
                                 '                tions and resolutions.or to otherwise govern a subordinate ~ body.                        *
                                                    . Gross. netli tence-The failure to perform a manifest duty in reckless disre-
           . C gy;                     '        gard of the consequences or a gross want of care and regard for the rights of others as tojustify the presumption of willfulness and wantonness.

Inspecting, licensing, regulating or auditing-ne normal meanings of the terms apply, but the terms do not include activities which are exclusively inter-nal in nature, such as auditing the internal process of an organization..and clerical andi xnal activities in issuing permits and licenses. - local-Governrnental units other than the Commonwealth or counties. Ofice-De position of president, vice president, secretary, tn:asurer and other positions designated as an office in the bylaws of the business. , Opinion-A directive of the Commission issued pursuant to section 7(10) of the act setting forth a public official's or public employe's duties under the act. Planning or zonint-An action which is directed by a planning commission, J

   '                                            zoning board, department, agency or governmental body which involves the                   .',.

regulation of real property. Politicalsubdivislom-A county, city, borough, incorpo ated town, township, school district, vocational school, county institution district and an authority, eritity or body organ: zed by the aforementioned. 4 Public employe-I1-2 (219716) No.264 Nov. M c.,,,n,a,eim c u.sr m O 1' .

Ch.11 GENERAL PROVISIONS 51011.1 p - - (i) "Ihe term includes an individual who is employed by the Common-

              '                                   wealth or a political subdivision and who is responsible for taking or recom-mending official action of a nonministerial nature with regard to one or more of the following:

(A) Contracting or procurement. -

                                  .                     (B) Administering or monitoring grants or subsidies.

(C) Plasming or zoning.

     ,                                                  (D) Inspecting, licensing, regulating or auditing a person.

(E) Other activities in which the official action has greater than a de minimis economic impact. (ii) 'Ibe following criteria will be used,in part, to determine whether an individual is within the definition of "public employe": (A) 'Ihe individual normally performs his responsibility in the field without onsite supervision. (B) The individual is the immediate supervisor of a person who nor-mally performs his responsibility in the field without onsite supervision.

                                                      .(C) The individual is the supervisor of a highest level field office.

(D) ,h individual has the authority to make final decisions. (E) "Ibe individual has the authority to forward or stop recommenda-tions from being sent to the person or body with the authority to make final decisions. (F) "Ibe individual prepares or supervises the preparation of final rec-ommendations. (G) The individual makes final technical recommendations. (H) 'Ibe individual's recommendations or actions are an inherent and recurrmg part of his position.

 ")    ,                                               (I) "Ihe individual's recommendations or actions affect organizations other than his own organization.

(iii) 'the term does not include individuals who are employed by the Commonwealth or a political subdivision cf the Commonwealth in teaching as distingmshed from sdministrative duties. (iv) Persons in the following positions are generally considered public employes: (A) Executive and special directors or assistants reporting directly to the agency head or governing body. (B) Commonwealth bureau directors, division chiefs or heads of equivalent organization elements and other govemmental body department heads. (C) Staff attomeys engaged in representing the department, agency or other governmental bodies. (D) Engineers, managers and secretary-treasurers acting as managers, police chiefs, chief clerks, chief purchasing agents, grant and contract 11-3 (219717) No. 264 Nov. 96 I g M

                          ,                             51 i 11.1                                                               STATE ETHICS COMMISSION Pt. I managers, administrative officers, housing and building inspectors, inves-tigators, auditors, sewer enforcement officers and zoning officers in all govemmental bodies.

(E) Coun administrators, assistants for fiscal affairs and deputies for

• the minorjudiciary.

                                 '-                                                                         (F) School superintendents, assistant superintendents, school business managers and principals.

(G) Persons who repon directly to heads of executive, legislative and h'~ independent agencies, boards and commissions except clerical personnel. (v) Persons in the following positions are generally not considered pub-lic employes: (A) City clerks, other clerical staff, road masters, secretaries, police officers, maintenance workers, constmetion workers, equipment operators and recreation directors. (B) Law clerks, court criers, court reponers, probation officers, secu-rity guards and writ servers. (C) School teachers and clerks of the schools. Public ofcial-A person elected by the public or elected or appointed by a governmental body, or an appointed official in the Executive, Legislative or Judicial Brarch of the Commonwealth or a political subdivision thereof. De

     -                                              term does not include members of advisory boards that have no authority to expend public funds other than reimbursement for personal expense, or to exercise otherwise the power of the Commonivealth or a political subdivision i

thereof.

                                                                        . (i)                                      De following criteria will be used to determine if the exception in this paragraph is applicable:
     .                                                                                      (A) De body will be deemed to have the power to expend public funds if the body may commit funds or may otherwise make payment of moneys, enter into contracts, invest funds held in reserves, make loans or grants, bonow money, issue bonds, employ staff, purchase, lease, acquire or sell real or personal property without the consent or approval of the governing body and the effect of the power to expend public funds has a greater than de mmtmis economic impact on the interest of a person.

(B) . %e body will be deemed to have the authority to otherwise exer-cise the power of the Commonwealth or a political subdivision if one of the following exists: (I) De body makes binding decisions or orders adjudicating sub- J stantive issues which are appealable to a body or person other than the governing authority. '.

                 ,'                                                                              (II)                 ne body exercises a basic power of govemment and performs essential governmental functions.

(III) %e goveming authority is bound by statute or ordinance to accept and enforce the rulings of the body. I1-4 ' (219718) No.264 Nov. 96 c.,,,,= im c a e%,, l

               ~

O

1

                                             ,.                                Ch.11 GENERAL PROVISIONS 51 { 11.1 t                      (IV) The body may compel the governing authority to act in accor-
                        ..                                                                dance with the body's decisions or restrain the goveming authority

• acting contrary to the body's decisions.

                                       "            *   *                                     (V)    The body makes independent decisions which are effective without approval of the governing authorityl
                                                      >                                      (VI) "Ihe body may adopt, amend and repeal resolutions, rules, regulanons or ordinances.

(VII) The body has the power of eminent domain or condemnation. (Vill) The enabling legislation of the body indicates that the body i established for exercising public powers of the Commonwealth or a political subdivision. (ii)

                                                                                               'Ibe term does not include judges and inspectors of elections, n publics and political party officers.

(iii) 'lhe term generally includes persons in the following offices: (A) !a-6's of offices filled by nomination of the Governor and confirmarian of the Senate. (B) Heads of executive, legislative and independent agencies, boards and coggniteinne (C) Members of agencies, boards and commissions appointed by the . General Assembly or its officers. r- (D) Persons appointed to positions designated as officers by the Com-monwealth or its political subdivisions. (E)

                               ..                              --                               Members of municipal, industrial development, housing, parking and similar authorities.
                                  .'i.(., .
                                              ,                                    ,  (F) Members of zoning hearing boards and similar quasi-judicial bod-n g
             .                                                                        (G) Members of the public bodies meeting the criteria in paragraph (i)(A).

Requessor-The person seeking an advice or opinion from the Commission. Respondent ~Ibe person who is the subject of a complaint, inquiry or inves-tigation. Service--Official papers are deemed served on the date of United States postmark if delivered by United States mail, the pickup date if delivered by express carrier or the date received from the Commission if hand delivered or transmitted by FAX. Stag ~Ihe Executive Director, the chief counsel, investigators and other per-sonnel as may be employed by or assigned to assist the Commission. Sworn complaint-A complaint on a form promulgated by the Commission

                             '                                              or its equivalent which is notanzed and contains the provision that the com-plaint is signed under the penalty of perjury.

Unannounced write-in-candidate-An individual who is not a " candidate as defined in the act and who received sufficient write-in votes on election day to be elected to or nominated for an office.. Il-5 (229187) No. 272 Jul. 97

 \

5

51 i 11.2 STATE EnllCS COMMISSION Pt.1 Vice Chairperson-De Vice Chairperson of the Commission. E

                                  . '.                                                      Source The provisions of this I 11.1 amended September 20.1996 effective September 21,1996.26
     .                                         PAB. 4524. Inunediately preceding text appean at serial pages (178957) to (1789621                   l, Law Reviews
                                           ,      .%mmaries ofSelected Agencies: Ethics Commission. 4 Widener 1. Public L 845 (l995).

I 11.2. Construction. U Because public confidence in government can best be sustained by assuring the  ; people of the impartiality and honesty of public officials, this title shall be liber-ally construed to promote complete financial disclosure as specified in the act. { 11.3. Statute oflimitations. The Commission may investigate a violation of the act within 5 years of its occurrence.De occurrence transpires when an act is complete or requires no fur-ther action. His title does not apply to violations committed prior :o the effective date of the act, and causes of action initiated for the violations shall be governed by the prior law and title, which are continued in effect for that purpose as if this title were not in force. For the purposes of this title, a violation was committed prior to the effective date of the act if any elements of the violation occurred prior thereto. [_' ' Q..

                 ?

[Next page is 131.) Il-6 - (229188) No.272 Jul. 97 ew ,6 8 m7 c - - u .thaa,% G 4

         .      -                 "                                         i Ch.13            OPINIONS AND ADVICES OF COUNSEL
                                   .                            --                                                                                                                     51 Q 13.1
                                                                                                                                                                              ~

CHAPTER 13. OPINIONS AND ADVICES OF COUNSEL

                                                        .* *.                                          Sec.

13.1. General provisions. j

                                                                 ,       .,                            13.2. Advice of counsel,
                  *                                                   "-                                                                                                                         l
                        .                       J.'                                                    13.3. Opinions.
                                                                '                 /.                   13.4. Intervention.
                                                                  -              I
                                                                                            . ':       13.5. Public access.

Source "ne provisions of this Chapter 13 adopted April 23. 1993, effective April 24. 1993, 23 Pa.B. 2007, unless otherwise noted, i 13.1. General provisions. (a) An advice or an opinion may be requested by a public official or public employe as to his own conduct or by the authorized representative of the persc 1, his present employer, or appointing authority of the person through majority action of the appointing authority, if applicable. (b) The requestor shall provide the following information in writing: (1) The name, address and phone number of the person who is the subject of the request and if different, the name, address and phone

                                                                               ,'                        number of the person initla:ing the request.

f. y (2) The name of the governmental body with which the subject s J.s -

                                                          ~'                                            serves and the name or' title of the person's public office or position.
                                          "                                                                (3) If the requestor is the appointing authority, employer or representative of the subject of the request, the nature of the relationship.

(4) The nature and duties of the subject's office or job. Include an organization chart, bylaws of the organization, if available, and a job description. (5) List the relevant facts and circumstances surrounding the request. (c) The requestor may ask that an ' opinion or advice be issued under  !

                                                                                                 ' either section 7(10) or (11) of the act (65 P. S. I 407(10) and (!!)).                        1 (d) The Commission will decide, within 14 days, whether an opinion                        {

or advice should be issued and will so advise the requestor. ' (e) If a requestor seeks an opinion and is advised that an advice shouid be issued or if the requestor seeks an advice and is advised that an l opinion should be issued, the requestor may either withdraw the request by notifying the Commission within 14 days of the date of receiving notice under subsection (d) or may elect to have the opinion or advice issued as docketed by the Commission. (f) Advices and opinions are matters of public record except as provided in this section. 13 1 (19661I) No. 249 Aug. 95

                                                                                                                                                                                ~

i . ,

                                                                         ,                                  51 $ 13.2                STATE ETHICS COMMISSION
                                                                                              .                                                                                                                Pt.1
                                                                                  ~
                                         .                                                                     (g)
                                                                             %,                                       A requestor may seek a coulidential advice or opinion in writing at the time of the request or within 7 days of notification of docketing as an edvice or opinion.

(h) A confidential advice or opinion will be publicly filed but will

                                                   '                                                      contain deletions and changes to preserve the confidentiality of the
                                                                       .                ,,.-.             requestor's or subject's identity.
                                                                                  ,~                         (i) The files relating to a confidential advice or opinion will not be

• public and will so remain unless teleased by the requestor or the public 61 official or public employe who is the subject of the advisory.

(j) If a Petition for Review or other legal pleading is filed in a court of law regarding a confidential advice or opinion, the files will become public on the date that the Commission record is transmitted to court or on the date the responsive pleading, motion, application or other legal

                                                                                          '             document is filed by the Commission, whichever date comes first, unless the court directs otherwise.

(k) Documents and submissions to the Commission relating to a request for an opinion or an appeal of an advice shall be made at least 7 days prior to the meeting of the Commission during which the appeal or

y. opinion will be reviewed.

cross sermaces [,. Thts section cited la si Pa. Code i 13.s (relatins to public access).

                                                                           . .                                                                                                                                         f. ,

l c",,[/^ l 13.2. Advice of counsel. C' (a) Xdykie of counsel will be based exclusively on one or more of the folloWing authorities: (1) Prior Commission opinions. (2) The act. (3) This title. (4) Court opinions interpreting the act. (b) The Chief Counsel will issue the advice on behalf of the Commission within 21' working days after receipt of the request, but the time may be extended for good cause. (c) Clarification of an advice may be requested in cases where the original advice was' incomplete, inconsistent or unclear. ,- (d) Requests for clarification shall be filed within the 30-day period normally applicable for appealing an advice to the Commission. [J--

                                                              *                                        (c) The timely filing of a request for clarification will toll the
                                                           '                                       applicable period for appealing ..o n 'vice to the Commission.

(f) Supplemental advice may i.a requested in cases in which additional facts are ;;esent or circumstances have changed from those in the original -

                                               ,                                                  request.

( 13-2 ) (196612)No. 249 Aug. 95 c.,m, , e im c ,,a e e ,, s

                                                                                                               .                        Ch.13                    OPINIONS AND ADVICES OF COUNSEL                        51613.3
                                                                                                      ~
    ]

i (g) An advice of counsel may be appealed to the Commission by the requestor or the subject of the request.

                    ,                                                    ..                                                                 (h) An appeal from an advice to the Commission shall be in writing

[ ;e and filed within 30 days of the issuance of the advice.

                                .*                                                                                                         (i) An appeal from an advice will be considered by the Commission
                               ~'                                                          "
                                                                                                         ' /.* . ' , ' . . '

after which an opinion will be issued either affirming, modifying or

                                 ,                                                                                             I
                                                                                                        .             '.               reversing the original advice.

(j) Reconsideration may be requested under i 21.29 (relating to finality; reconsideration) of an opinion disposing of an appeal of an advice if the request is rded within 30 days of the issuance of the opirdon. (k) An advice shall be a complete defense in an enforcement proceed. ing initiated by the Commie < ion, and evidence of good faith conduct in another civil or criminal proceeding, if the requestor, at least 21 working days prior to the alleged violselon, requested written advice from the ('a==i==naa in good faith, disclosed truthfully the material facts and committed the acts complained of either in reliance on the advice or because of the failure of the Commission to provide advice within 21 days

                                                                                                  , , ,                              of the request or the later extended time.

Searce

                                                                                                                    '                    The provisions of this i 13.2 amended May 5.1995, effective May 6.1995. 25 Pa.B.

1777. Innaanhanaly precedens test appears at serial pages (17s964) to (17s965), t .. .f "A . -:- '

                                                                                                                                    $ 13.3. Opledoes.

(a) ' Opinions shall be issued under the provisions in section 7(10)'of the act (65 P. S. I 407(10)). (b) Requests for Commission opinions will be considered in accor-dance with the procedures outlined in il 23.1 - 23.6. (c) A party may request that the Commission reconsider an opinion in

                                                                                                            '                      accordance with i 21.29 (relatmg to finality; reconsideration). The request shall be filed within 30 days of the service of the opinion and contain a decaded explanation of the reasons in support of the request.

(d) Reconsideration may be granted in the discretion of the Commis-sion under i 21.29(e). I l I (c) A person whc, acts in good faith on an opinion issued to him by the 9aimission will not be subject to criminal or civil penalties for so acti. g, if the material facts are as stated in the opinion request. semece The provisions of this I 13.3 amended May 5.19^5. effective May 6,1995. 25 Pa.B.

                           ,                                                                                                     1777. Immediately precedans text appears at serial page (17s965).

13-3 (196613) No. 249 Aug. 95

                                                                                                                                                                                                                     .~ . . . . . .

k

                        ,          ,,                                  ;        S1913.4              STATE ETHICS COMMISSION s ,a.e.           . . -

Pt. ! 13.4. Intervention. y (a) A person who is not a party in an advice or opinion request or ' reconsideration thereof, may file a petition to intervene if the person has an interest. One or more of the following criteria will be utilized to

                                        * ,' Y .

determine whether a person has an interest: (1) A right conferred by Federal or State law.

                                               ' - ' . e, (2) An interest which may be affected and which is not adequately represented.

i (3) An issue of public importance. y (b) A person shall apply for intervention within 14 days prior to the Commission meeting if the opinion will be reviewed or decided. The Commission may grant an application at any time prior to the meeting, but only for good cause shown. (e) Ari application for intervention shall include the facts which establish the nature of the alleged right or interest and the grounds for 8 intervention. De application shall also address the facts if they are deficient or incorrectly stated, and the relevant issues of law. The application may cite authority in support of the advocated position.

         .                                           b'                         (d) The Commission will review applications for intervention to determine whether a grant of intervention is appropriate.
    .           .;                                                             (e) A person may file an amicus brief which shall be received within 14            -

days prior to the Commission meeting. (s'

                            ,             ,,            .'                  $ 13.5 Public necess.
                                             . ' ~l '                          (a) Subject to i 13.l(h) and (i) (relating to general provisions), the Cornmiccion's advisories, letters requesting advisories, files and informa-tion submitted to the Commission relating to a request are public records and will be available for public inspection and reproduction during normal business hours.

(b) ne Commission will transmit, free of charge, copies of each

                                                                          ' order, advice and opinion which has become a matter of public record quarterly to the law library of each county, one public library in each county, the State Library, the State Senate Library, each authority appointing Commission members under this act, the Pennsylvania Associ-ation of County Commissioners, the Pennsylvania Association of Bor-oughs, the Pennsylvania Association of Township Supervisors, the Penn-             .-

sylvania State Association of Township Commissioners, the Pennsylvania

                                             '                            School Boards Association and the Pennsylvania League of Cities.

(c) The Commission may charge a fee for additional copies at a rate f'.:.

                                                                                                                                                             <i
                                                   '                      not to exceed actual cost.
     .                                                                      (d) A digest and index of Commission opinions may be published and
                              ,                                           disseminated annually.

[Next pase is 15-l.] 13-4 (196614) No. 249 Aug. 95 come, e im c u /me O eI- g

                             ,                          Ch.15           STATEMENTS OF FINANCIAL INTERESTS                           S1 Q 15.1
                              ~

CIIAPTER 15.. STATEMENTS OF FINANCIAL

          ..                                                                      INTERESTS, APPLICABILITY
                          -'       '                    sec.

15.1. Federal officials, employes and candidates. 15.2. Public officials and public employes. 15.3. Candidates / nominees. s Source

                                                                                                                                                )

The provisions of this Chapter !! adopted April 23, 1993 effective April 24, 1993. 23 Pa.B. 2087, unless otherwise noted. 9 15.1. Federal officials, employes and enadidates. (a) Federal officials, employes and candidates are not required to file the Statement of Financial Interests with regard to their Federal position. (b) Federal officials, employes and candidates who serve with the Commonwealth or a political subdivision as part of an exchange or comparable program are required to file a Statement of Financial laterests. I 15.2. Public officials and public employes. (a) Public officials and employes shall file a Siatement of Financia! Interests for the precedmg calendar year by May I of each year during which they hold office or a position and by May I for the year after they

                     , .                            leave the position.

(b) A public official may not take the oath of office, continue upon

• his duties or receive compensation for hosding office unless a Statement of Financial Interests has been filed.

(c) Public officials in State level offices shall file with the Commission and'as follows: (1) Executive branch public officials, board and commission mem-bers shall file with the Governor's office. (2) Legislative branch public officials shall file with either the Chief Clerk of the House of Representatives or the Secretary of the Senate, depending upon in which body the official serves. (3) Independent agency public officials and other public officials shall file with their agency. (d) Public employes of the Commonwealth shall file with the State agency with which they are employed. (e) County and local officials, and employes, . shall file with the governing body of the political subdivision in which they serve or are employed. 15-1 (178967) No. 225 Aug. 93

                                                                                                                 .t      e

51015J STATE ETHICS COMMISSION Pt.I

                                                                                                                                       ,r *
                                   '                      (f) In an election year, public officials, public employes who are candidates, shall, in addition, file at the times and locations required candidates.

(g) Full- or part-time solicitors are required to' file Statements of Financial Interests. (h) If a ' law firm or engineering firm is designated solicitor or engineer, the persons primarily responsible for providing the services in ( I, the firm are responsible for filing a Statement of Financial Interests. - 9 15.3. Candidates / nominees. (a) A can'didate for State level public office shall file a Statement of Financial Interests with the Commission on or before the last day for filing a petition to appear on the ba!!ot and a copy of the Statement shall be appended to the petition. (b) A candidate for county and local public office shall file a Statement of Financial Interests with the governing authority of the

                                      ~            political subdivision wherein the candidate is seeking office on or before the last day for filing a petition to appear on the ballot and a copy of the Statement shall be appended to the petition.

(c) A candidate running for office as a substitute nominee shall file a  ; Statement of Financial Interests on or before the last day for filir.g a -

                           ,                      substitute nomination certificate as follows:

(1) A nominee for State level office shall file tre Statement with the Commission and a copy shall be appended to the substitute nominstion certificate. (2) A nominee for county or local level public office shall file ne Statement with the governing authority of the political subdivisiou wherein the person is seeking office and a copy of the Statement shall be appended to the substitute nomination certificate. (d) An independent candidate not running in a primary election shall file a Statement of Financial Interests on or before the last day for filing a petition to appear on the ballot for election. The filing shall be made in accordance Wh subsections (a) and (b). (e) A write-in-candidate shall file a Statement of Financial Interests within 30 days of having been nominated or elected unless the person

                                                                                                                                   /'

declines the nomination or office within that period of time.

i. ~

                         +

(I) The Statement shall be filed with the Commission for State level ' public office and with the governing authority of the political subdivi-sion wherein the person has been elected or nominated for county or local level office. (178%8)No.225 Aug. 93 15-2 ~l cw,n, e im c u yp, ,w l O e N

                                ,                                        Ch.15           STATEMENTS OF FINANCIAL INTERESTS                 51515.3

_ s

                                                       '           4 g             ..

(2) For the purposes of calculating the 30-day period during which the Statement of Financial Interests shall be filed, the time shall commence on the date that the apnropriate board of elections certifies

                  . .         *

• the individual as the winner of a nomination or election.

(f) A petition to appear on the ballot will not be accepted unless a

                                               '/,      , c,-

copy of the Statement of Financial Interests is attached thereto.

                                          ,          i (g) A nominee for public office shall file a Statement of Financial Interests for the preceding calendar year at least 10 days prior to the date of approval or rejection by the confirming body.

(1) A nominee for Commonwealth positions requiring Senate confir-mation shall file with the Commission and the Secretary of the Senate. (2) A nominee for county or local level public office shall file with the governing authority of the political subdivision in which the person is a nominee and, if different, with the official or body vested with the power of confirmation. I a N 15-3 (178%9) No. 225 Aug. 93 l . i e V e 1 ' \

     ;           .. -              'v.              (.,,.       _

3 . 4

                                   ,        ;,-    . .          .'. 3 -
                            ,                                        , . . 4              ,
                     *                                    ,               .s.    -

s . ,

                                       .                                                                                                                                 I e
                       , ,           .         ,                  . s          .

s. . ..

                                                        . . .                      i,, <-

. c .. f [Next page is 171.) *

                           .                                                                                                                                          s.
                                                                                                                                                                        ~...

15-4 (178970)No.225 Aug. 93 cere4,ese c ====.tia eth w 4 9 4 *

                                                                                              .                                                                     I      %

N 4

I a' Ch.17 FINANCIAL INTERESTS, CONTENT

                                 -                                                                                                                     51617.1 r

(] ., CliAPTER 17. STATEMENTS OF FINANCIAL INTERESTS, CONTENT see. 17.1. General. , . ~- 17.2. Real estate.

                                          .           'M            '

17.3. Creditors. 17.4. Income. 17.5. Gifts. 17.6. Expense reimbursement. 17.7. Office, directorship and employment. 17.8. Financial business interest. 17.9. Transferred business interests. 17.10. Reporting in multiple categories. Source The provisions of this Chapter 17 adopted April 23, 1993, effective April 24, 1993, 23 Pa.B. 20s7, unless otherwise noted.

                                               ,                        f 17.1. General.

The person required to ille shall list the following general identification information: (~ (1) The full name and address of the public official, public employe or candidate. (2) The county of residence. 6 . '. p - (3) The position sought or held, and name of the governmental body associated with the position sought or held. ( , (4) An occupation or profession.

                                                                       $ 17.2. Real. estate.

(a) The person required to file shall list direct or indirect interests in real estate as follows: (1) Real estate sold or leased to the Commonwealth or its agencies or political subdivisions. (2) Real estate purchased or leased from the Commonwealth, or its agencies or political subdivisions. (3) Real estate which is subject to condemnation pr~~Hage by the Commonwealth or its agencies or political subdivisions. (b) Real estate interests include ownership in the form of title, as fiduciary, by option agreement, partnership or corporate share, casement,  ; trustee-beneficiary type interests or other forms of interest in realty. (c) An indirect interest in real estate constitutes any business entity, the

                    ,                                                 assets of which are 80% or more in real property.

17-1 (178971) No. 225 Aug. 93 1 I l J ' l e N \

                                                                                                                                                                       \

51917.3 STATE ETHICS COMMISSION rt.1 9 17.3. Creditors. (a) Each creditor to whom is owed in excess of $5,000 or the amount as adjusted under section 5(d) of the act (65 P. S. I 405(d)) and i 19.5 (relating to reporting threshold adjustments) shall be reported. (b) Mortgages, home equity loans or other loans secured by a primary

                                                 or secondary residence of the person filing need not be reported.

(c) A joint obligation with other persons, for which the filer is 3 responsible only for a proportional share that is less than the reporting ' ' threshold, is not required to be reported. (d) The joint obligation of a husband and wife sha!! be reported if within the reporting threshold. (e) An obligation within the reporting threshold for which a person acts as a guarantor for the person required to file shall be reported. (f) Loans or credit between the person required to f9e and the person's spouse, parents, children, brothers or sisters are excluded. (g) No dollar amounts cre required. (h) The interest rate for a reportable obligation sha!! be indicated. (i) A reportable creditor shall be identified by name and address.

                             ' ~

Cross Referescas This section cited in 51 Pa. Code i 19.5 (relating to reporting threshold adjustments). 9 17.4. Income. ' 1 (a) The name and address of a direct or indirect source of income, . . including employers, in the aggregate of $1,000 or more or the amount as adjusted under section 5(d) of the act (65 P. S. I 405(d)) and i 19.5 (relating to reporting threshold adjustments) shall be reported unless the disclosure would require the divulgence of confidential information protected by statute or existing professional codes of ethics or common law privileges. (b) Income from the securities of a particular business equaliiig or exceeding the reporting threshold, capital gains and dividends equaling or exceeding the reporting threshold shall be listed. (c) If the income generated equals or exceeds the reporting threshold, mutual funds and other financial plans for individuals may be reported as a single source if the individual has no authority to buy or sell particular assets in the fund. (d) An individual or an individual and a spouse who has an investment portfolio, with a broker, other than a mutur' emd, shall list individually [.- M.

• the income from each asset to which suba . in (b) applies if the asset may be bought and sold by the individual or by the individual and a spouse.

Cross References TMs section: cited in 51 Pa. Code i 19.5 (relating to reporting threshold adjustments). 17-2 (178972)No. 225 Aug. 93 cens a, e im c . ta f oe, wit O (  %>

i. . Ch.17 FINANCIAL INTERESTS, CONTENT 51017.5 i 17.5 Gifts.

         ,,                                                     (a) The narr.e and address of the source of a gift valued in the aggregate at $200 or more or the amount as adjusted under section 5(d) of
                       '                                     the act (65 P. S. 6 405(d)) and.i 19.5 (relating .to reporting threshold
                                                  ~

adjustments) shall.be reported.

                                    . [.              ,

(b) The amount of the gift as well as the circumstances surrounding it shall be reported. (c) A gift from a spouse, parent, parent by marriage, sibling, chil:1, grandchild, other family member or friend is not required to be reported when the circumstances surrounding the gift indicate the motivation for the action was a personal or family relationship. (d) The term " friend," under this section, does not include a registered lobbyist or an employe thereof. Crees Referseems This section cited la $1 Pa. Code i 19.5 (relatins to reportins threshold adjustrnents). g 17.6. Expense reimbursement. (a) The name and address of the source and the amount of a payment for or reir:bursement of actual expenses for transportation and lodging or hc.p9 lity received in connection with public office or employment where the actual expenses for transportation and lodging or hospitality exceed

                                                           $500, or the amount as adjusted under section $(d) of the act (65 P. S.

I 405(d)) and i 19.5 (relating to reporting threshold adjustments), in the

                                    ~

courre of a single occurrence shall be reported. (b) This subsection does not apply to expenses reimbursed by a governmental body, or to expenses reimbursed by an organization or association of public officials or employes of political subdivisions which the public official or employe serves in an official capacity. (c) The reporting requirement shall be based upon the actual expense amount. Cross References This section cited in 51 Pa. Code i 19.5 (relatins to reportins threshold adjustments), i 17.7. Office, directorship and employment. A public official, public employe or candidate shall disclose the name and address of the business entity with which he is associated and the position held, whether the person required to disclose is an officer, director, fiduciary or partner-limited or general. 17-3 (178973) No. 225 Aug. 93 W 4.

51617.8 STATE ETHICS COMMISSION Pt.I e 17.8. Financial business laterest. (a) A financial interest in a legal entity engaged in business for pro

                           . -                shall be reported. Financial interest means more than either 5% of the
                       -                      equity of the business, or 5% of the assets of the ' economic interest in indebtedness.

(b) A financial interest in a business and employment by the same # business shall be listed in both categories of the Statements of Financialf Interests. 1., '.

                                            $ 17.9. Transfernd business laterests.
                                              - (a) A financialinterest in a business with which the reporting person is or has been associated during the preceding calendar year which has tr.en transferred to a member of the person's immediate family; that is, a parent, spouse, child, brother or sister, shall be reported.

(b) Financial interests comprise more than 5% of the equity of the business or more than 5% of the assets of the econor.de interest in indebtedness. (c) Transfer includes a conveyance whether or not written or otherwin

                         .                 recorded.
                                          $ 17.10. Reporting la multiple categories.

The required disclosure of information in one category does not excuse t

                                    -     the nondisclosure of that information in other categories when so                     -

required. Therefore, the same information may be required in more than

              ,                           one category.

0 l l r b 1 (Next pase is 19-11 17-4 (178974) No. 225 Aug. 93 c.,m e im c ra of r y, e

Ch.19 FINANCIAL INTERESTS, MISCELLANEOUS 51019.1 CIIAPTER 19. STATEMENTS OF FINANCIAL INTERESTS, MISCELLANEOUS See. 19.1. Forms.

             '                                                                  19.2.       Period covered.
                                                    ,                           19.3.       Laie or deficient filings.

l /- '

                                                                        '.      19.4.       Availability of statements of financial interests.
                                                                  .             19.5.       Reporting threshold adjustments.

Source ne provisions of this Chapter 19 adopted April 23,1993, effective April 24,1993,23 Pa.B. 2087, unless oiberwise soied. I 19.1. Forms; filing. (a) Public officials, public employes and candidates shall file Form SEC 1, as published and revised by the Commission. (b) The Statement of Financial Interests form is available at the Commission, the State Board of Elections, the County Board of Elections and other locations as conditions warrant. The postal address of the Commission is: State Ethics C==Wion, Post Ofrace Box 11470, Harrisburg, Pennsylvania 17108-1470. The

        '                                                   ' '               office of the Commission is located in Room 309, Finance 53uilding, Capitol Complex, Harrisburg Pennsylvania, (717) 783-1610, (800) 932-0936.
                                                    ..                            (c) Additional sheets may be attached to the Statement of Financial Interests i'

form if more space is required.

                  .                              s                  '
                                   ,,                                        ,,(d) A Statement of Financial Interests sent by FAX transmission is filed on
                                                         .                   the date the c=            =% receives the faxed copy if the Commission receives the O#       '

signed original within 5 business days thereafter. If the Commission does not receive the signed original within 5 business days from the date of receiving the famed copy, the Statement of Financial Interests is filed on the date the Commis-sion receives the signed original. Source De provisions of this i 19.1 amended September 20,1996, effective September 21.1996,26 Pa.B. 4524. lawawly pecedmg sex appears at serial page (178975). Crees References Ris section cited in 51 Pa. Code i 11.1 (relating to definitions). i 19.2. Period covered.

                                                                                'Ibe Star;rnent of Financial Interests requires information for the full calendar year immediately precedmg the year in which the Statement of Financial Inter-ests is filed.

19-1 (219721) No. 264 Nov. 96 s

• 6

l ) l l I

                              ,               51019J                        STATE ETHICS COMMISSION                             Pt. I l

f .s ) l 6 19.3. Late or deficient filings. (a) If an audit or inspection determines that a required filing is deficient or that a required filing has not been made, the Commission will provide written notice to the individual required to file, detailing the deficiency and the penalties for deficient filing or failure to file.

                          '                   (b) ' If a complaint is received alleging that a required filing is deficient or has A

• not been made, the Commission may elect to proceed in the matter under this section rather than through the investigative procedures of Chapter 21 (relating to investigations).

(' * -' l (1) Upon election, the complainant will be notified of the decision as well as the fmal resolution of the matter. (2) . In determining whether to proceed under this section, the Commission may consider whether. (i) 'Ihe deficient filing or failure to file was intentional. (ii) The filer had prior notice of the requirements of the act. (iii) The filer has in the past complied with the act. l (c) 'Ihe individual notified in accordance with subsection (a) has 20 days 3 from the mailing date of the notice to correct deficiencies or to file a Statement I

         '                                 of Financial Interests. If an individual fails to file or to correct his statement within that time, the Commission will review the matter to determine whether a civil penalty is appropriate under the act.

(d) If the Commission determines that a penalty is appropriate, it will issue a (t '. ) rule to show cause, notifying the individual of his deficiency under the act and of ' the grounds for the mle and of his opportunity to respond in writing to the rule. c.

                     ,                    If cause is not shon, the rule and penalty therein become absolute.

(e) '!he Commission may assess a penalty of not more than $25 per day for

       '                                 the time a Statement of Fint.ncial Interests remains delinquent up to a maximum of $250 total.

l (f) "Ihe penalty in subsection (d) is in addition to other penahies provi&d by law and the filing of a Statement of Financial Interests in accordance with sub-section (a) does not otherwise vitiate the failure to comply with the act. Cross Referinces

                                            'This section cited in 51 Pa. Code l 21.1 (relatins to complaints).

I 19.4. Availability of Statements of Financial Interests. (a) Statements of Financial Interests filed with the Commission under thc. act are available for public inspection and copying at a charge not to exceed actual da. cost at the office of the Commission in Harrisburg, Pennsylvania between the

                ,'                     hours of 8 a.m. and 5 p.m., weekdays.

' * (b) A governmental body required to maintain Statements of Fm' ancial Inter-  ; ests shall make them available for public inspection and copying during regular . , . business hours. 4 19-2 (219722) No.264 Nov. 96 cwse s sm e - w .n, ,,w l l

                         ~                             .

     ,                         . . . -.                                   Ch.19              FINANCIAL INTERESTS, MISCELLANEOUS 51919.5
                                                            ,.-~.

p ~ ' ( (c) Statements of Financial Interests more than 1 year old will be made

                 "                                                        available for public inspection and copying within 2 working days after the

• request has been made for the Statements. De Statements will be kept on file for 5 years.

I 19.5. Reporting threshold adjustments.

                                          '                                 (a) On a biennial basis commencing in January 1991, the Commission will review and may increase the threshold dollar amounts in (( 17.3(a),17A(a),

17.5(a) and 17.6(a). (b) ne Commission will base the increases upon a review of the National Consumer Price Index as published by the United States Department of Labor or other relevant indices. (c) Ac Comrmssion may hold a hearing to receive testirramy or informauon regardmg the eppuriste rate ofincreases. (d) Upon final determination of the appropnate reportag increases, the Com-mission will publish a schedule of the increases in the Pesarylvania Balleria in 2 successive months and take other action deemed necessary to dissemmate the information.

           -                                                               (e) De effective date of threshold increases shall be delayed a sufficient period of time to allow publication of the information to afford affected individu.

als the opportunity to comply therewith and relevant Commission forms shall be revised accordingly. -

                                 '                                                                              Cass References
                                                                      ' 'Ihis n=reian ciend in 51 Pa. Code i 17.3 (relating to crednors); 51 Pt. Code i 17.4 (relating to
                            +
                                                                               ); 51 Pa. Code i 17.5 Delseing to gins); 51 Pa. Code $ 17.6 (selatin6 to expense repuburse.

musa).

                          ~,

19-3 (219723) No. 264 Nov. 96 O s k . y

s

                                                                 . ' . ' . , ' , .. a,.
                                                         .               i                                                                                                                 (
                                                 * .       .,       .                      i
                                                                                '.4..,

e.

     .                                                                       ~.
      .                                                               L

(.

                                                              , .* j 1

I I 4 1 f N'- t (Next page is 21 1.) . 3

                                                                                                                                                                                         ~

(219724) No.264 Nov. 96 c.p,nsu a im a.__ _ s/ Psensph

                                                     .a
                                                                                                                             .                                        O
                                                                                                  ' g.                                               ,
                                                                                                                                                                <               t.     ,

9

                                              '.M'3                                                  Ch. 21                           INVESTIGATIONS                                51921.1

.I f.

y. CHAPTER 21. INVESTIGATIONS

                                                                  >q                                                                       GENERAL sec.
                                                .             . ',.j',                              21.1. Complaints.

[c.,

                    ~                               '

I -

' 21.2. Initiation ofinvestigation by the Commission.

                                                                                       ,,           21.3. Preliminary inquiries.

21.4. Frivolous complaints; complaints without probable cause, disclosure of complaints. 21.5. Conduct of investigations. l HEARINGS

                                                                                                 21.21. General.
                                                                        ,                          21.22. Discovery.

21.23. ,5 cope of hearing. 21.24 Hearing officer. 21.25. Conduct of the hearing.

                 ~

21.26. Motions. 21.27. Briefs. 21.28. Decision. [. ~ 21.29. Finality; reconsideration.

                                                                                   .

• 21.30. Effect of order.

L .. I s '. ' . . *. w N ~ ' The provisions of this Chapter 21 adopted April 23. 1993, effective April 24. 1993. 23 Pa.B. 2087 unless otherwise noted. Cross References This sec* ion cited la 31 Pa. Code i 19.3 (relatins to late or deficient Elinss). GENERAL l 21.1. Consplanets. (a) A complaint alleging a violation of the act shall contain the name, position or office held by the respondent ar.d the basis of the complaint which would delineate the facts and circumstances of the alleged violation.

                                                                               '                    (b) A complaint shall be sworn and signed by the complainant.

(c) The identity of the complainant will remain confidential unless

                                          .,                                                    there is a wrongful use of the act.

(d) The Commission will acknowledge, in writing, the receipt of the complaint. (e) The Commission through its Executive Director will review com-plaints and proceed onlyif the complaint: 21-1 (178979) No. 225 Aug. 93 D

                                     .                                                                                                                              4

• ana ,

e a

51 { 21.2 STATE ETHICS COMh!ISSION Pt.1 (1) Contains sufficient information. '

                                                                                                                                             \

I (2) Is sworn and signed. (3) Is within the Commission's jurisdiction.

                           #            *                (4) Concerns an alleged violation of the act having a greater than de minimis economic impact.

(f) A complaint'not meeting the requirements of subsection (e) ivill be X- f~ dismissed without prejudice to renle if the requirements are satisfied. ( (g) Upon the receipt of a complaint which satisfies the criteria of subsection (c), the Commission, through its Executive Director, will initiate a preliminary ingtiry. If the preliminary inquiry establishes reason to 1.:lieve that the act was violated, the Commission, through its Executive Director, may initiate a full investigation. (h) A complainant will be notified of the dismissal of a complaint i tmder subsection (f). (i) In the case of sworn complaints alleging a violation of the Statements of Financial Interests filing requirements, the Commission may el ect to proceed under i 19.3 (relating to late or deficient filings), in which event this chapter does not apply.

                             ,.                      (j) This section supersedes i Pa. Code i 35.9 (relating to formal complaints generally).

( g 21.2. Inhistion of lavestigation by the Commission. ' The Commission through its Executive Director may, on its own

               -             -                 motion, conduct a preliminary inquiry regarding an alleged violation of the act.

I 21.3. Preliminary inquiries. 1 (a) A preliminary inquiry will be terminated or opened as a full investigation within 60 days of the initiation thereof. A preliminary inquiry is considered initiated at the time when it is officially docketed. (b) The Commission will keep information, records and proceedings relating to a preliminary inquiry confidential, The Commission will, however, have the authority to refer the case to law enforcement officials during a preliminary inquiry or any time there4fter v.itiiout providing .. notice to the subject of the inquiry. (c) If, after preiirninary inquiry, there is reason to believe that the act [ . has been violated, the Executive Director will commence an investigation. An investigation w!!! be considered commenced when the respondent is l notified under i 21.5(b) (relating to conduct of investigations). 1 (d) The Commission, through its Executive Director, will close the preliminary inquiry if:

                                                                                                                                      ~

2b2 (178980)No.225 Aug. 93 cm,,,eeimc- ur/reet O e k  %

[ 1 l

                         ;. ., -                      Ch.21                       INVESTIGATIONS                      51521.4
                              ~

f (1) The occurrence giving rise to the complaint is not within the k ,, purview of the act as having been committed and completed prior to the act. (2) The occurrence giving rise to the complaint is clearly not within the purview of the act. (3) The respondent is not a person subject to the act. l ,

   .                                                     (4) There is no reason to believe that the act has been violated.

(5) The violation complained of has a de minimis economic impact. (c) If the preliminary inquiry is closed, the Commission will notify the complainant and the respondent. I 21.4. Frivolous complaints; complaints without probable cause; disclosure of complaints. (a) If a public official or public employe has reason to believe a complaint is frivolous due to its having been filed in a grossly neghgent manner without basis in law or fact, or without probable cause and made primarily for a purpose other than that of reporting a violation of the act, or that a person has publicly disclosed or caused to be disclosed that a complaint against the public official or public employe has been filed with

                                       '          the Commission, the public official or public employe shall notify the Comminion and the Commission, through its Executive Director, will conduct an investigation.
                       '                             (b) These matters will be processed by the Commission in accordance
                                     ,           with Chapter 25 (relatms to wrongful use of the act).

OI '

 &                                               i 21.5. Conduct ofinvestigations.

(a) Within 72 hours of the commencement of an investigation, the complainant will be provided notification thereof by first class mail. (b) The respondent will be provided with a general statement of the alleged violation of the act and other applicable statutes under investiga-tion. Service of the notice is complete upon mailing which will be by certified or registered mail. (c) The complataant and respondent will be notified of the status of the investigation every 90 days until it is complete. (d) The Commission may employ or be assigned staff, including > attorneys, investigators and hearing officers, as may be required to

                 ~                              properly investigate, review and dispose of complaints and investigations.

(c) The Executive Director, staff counsel, director of investigations and  ! special investigators have the authority to conduct interviews, take statements, receive and inspect documents and records and otherwise

                                     ,         obtain evidence and gather information by lawful means.

21-3 (178980 No. 225 Aug. 93 l I l l t 1 no

51921.5 STATE ETHICS COMMISSION Pt.I

                               ~

i~ (f) Commission staff members identified in subsection (e) are desi nated to administer oaths or affirmations for the purpose of obtaini voluntary sworn statements with regard to matters which may properly come before the Commission. (g) A person having possession or control of documents or records

                 *                          deemed relevant to an investigation that the Commission is authorized to       e conduct may be required to produce the materials for inspection by ('

subpoena served by the members of the Commission staff designated in subsection (e). These Commission staff members have the right to retain or have access to subpoenaed documents and records for a reasonaole period, and to make copies thereof. (h) The Commission may authorize one or more members of the Comminion staff designated in subsection (c) to obtain by subpoena the sworn statement of a person deemed to have information relevant to an investigation that the Commission is authorized to conduct. (1) Sworn statements may be conducted by and before one or more of the staff members in subsection (e). (2) Testimony received in the preparation of a sworn statement will be under oath or affirmation administered and recorded by a stenogra-pher. l (3) The authority 'to question a witness appearing for a sworn I statement will be limited to staff members taking the sworn statement, '

                   ,     .                      .the hearing officer and counsel for the witness.

(4) Persons permitted to be in attendance at the preparation of a sworn statement will be limited to staff members of the Commission, j the hearing officer, the witness, counsel for the witness and a j stenographer. l (5) A witness giving a sworn statement may object to a question if it is irrelevant or privileged. l j (6) A witness subpoenaed by the Commission is entitled to compen-sation as fixed by 42 Pa.C.S. I 5903 (relating to compensation and expenses of witnesses). (i) Subpoenas issued under subsection (g) or (h) will be authorized by the Commission and signed by the Chairperson or Vice Chairperson. Subpoenas may be served by a person empowered to do so or ks l designated by the Executive Director. [,e (j) Within 180 days of commencing the investigation, the Commission will do one of the following: M (1) Terminate the investigation and notify the complainant and respondent. (2). Rule upon a request for an extension by the Executive Director, upon a showing of need, not to exceed 90 days. 21-4 (178982)No.225 Aug. 93 c.,rn,w e im c ua en ,% e

Ch.21 INVESTIGATIONS 51 f 21.21

                                  '~

g (i) The granting of or denial of a request for an extension requires

     )                                               a majority vote of a quorum of the Commission.
   /

(ii) A maximum of two extensions may be granted. (iii) A findings report will be issued within 180 days after the

                                       -               commencement of an investigation or within the time period of a granted extension.}}