ML20196H008
| ML20196H008 | |
| Person / Time | |
|---|---|
| Issue date: | 06/10/1999 |
| From: | Paperiello C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| Shared Package | |
| ML20196G966 | List: |
| References | |
| NUDOCS 9907010318 | |
| Download: ML20196H008 (60) | |
Text
p pcung l p k* UNITED STATES NUCLEAR REGULATORY COMMISSION O f WASHINGTON, D.C. 20566 0001
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j "N'%,%#, # June 10, 1999 i
MEMORANDUM TO: Paul H. Lohaus, Director Office of State Programs -
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FROM: Carl J. Paperiello, Direct / -
Office of Nuclear Materia Safety and Safeguards
SUBJECT:
CONCURRENCE IN LE ER TO PENNSYLVANIA NMSS concurs in your letter to David Allard 'the Pennsylvania Bureau of Radiation ,
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Protection and in the attachment, " Completeness R view Comments on Draft Pennsylvania )
Application." We have only minor editorial commen s marked on the attached pages.
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Attachment:
As stated CONTACT: Paul F. Goldberg, NMSS/IMNS (301) 415-7842 i
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i a decommissioning that will be transferred to ensure a consistent view on the j implementation of decommissioning plans and requirements for the various sites.
V You should describe the responsibilities for decommissioning within the BRP, and in particular, which group will be responsible for complex decommissioning actions and SDMP sites.
4.1.3 Content of the Proposed Agreement The draft Pennsylvania Agreement follows the format and content of the standard A Gdcl ndbo td pv[ -
in Management Directive 5.8, " Proposed 274b Agreements with States, Exhibit 1. However, based on our review of the proposed Pennsylvania Agreeme t, we have identified two omissions, one of which is in the standard Agreement. Please add a provision to Article 11, that the Agreement does not provide for the discontinuance of any authority for mill tailings, i.e., Article 11, Section 6, should read:
"The regulation of byproduct materials as defined in Section 11e.(2) of the Act." Also, please insert in the brackets of Article Ill, "5 and 6." These items provide that the Agreement may be amended in the future to include sealed sources and devices and mill tailings. Therefore, revisions are necessary to both the standard Agreement in Management Directive 5.8 and the Pennsylvania Agreement. We have enclosed a markup of the standard Agreement for your use when making necessary revisions.
4.2 Regulatory Requirements Program Elements This portion of your application has already been reviewed and comments provided by a letter from Paul Lohaus to David Allard dated April 14,1999.
4.3 Licensing Program Elements 4.3.1 Procedures for the Technical Evaluation of Proposed Uses of RAM a.
The application does not include a description of the licensing program for
- seement materiallicenses, or a complete set oflicensing policies licensing procedures, forms, and guides that will be used in the licensing program. Your a
application includes licensing guides for the use of NARM material for academic g' kg institutions, laboratory and industrial use of small quantities, non-hu an broad scope, portable gauges, medical, and radiopharmacy. Section 4.3. of the /
Handbook recommends that the State submit its licensing proced es, including standard review plans and licensing guides for at least each of the Materials inspection Program (IMC 2800) license program codes for which an NRC license will be transferred. Please revise and include in the application your licensing procedures, including standard review plans and licensing guides, for each program code for which an NRC licensee will transfer to the Commonwealth.
Your procedures should specifically address the use of byproduct, source and special nuclear materialin quantities less than a critical mass. In responding to this item, you may find useful the Consolidated Guidance About Materials Licenses: Program-Specific Guidance (NUREG-1556 series).
Attachment YZia
c.
proposed arrangements for the continued authorization of NRC licensed activities to be transferred to the Commonwealth under the Agreement.
The application should incorporate administrative and program licensing procedu described in the above items that define how the program will function.
4.4 Inspection Program Elements 4.4.1 Procedures for inspecting Facilities Where RAM is Stored and Used-a.
The application does not include a description of the inspection Jr progra ja complete set of inspection policies, positions, forms and guides that used will in the program. Your application includes inspection field notes for medical broad scope, commercialirradiator, radiopharmacy, remote afterloading device, nuclear medicine, teletherapy, well logging, quality management program, radiopharmaceutical therapy, high dose afterloader, brachytherapy, eye applicators, gamma stereotactic radiosurgery, medical events and misadministrations, and LLW shipments. Section 4.4.1 recommends that the State include in the application its inspection procedures for all IMC 2800 license program codes for which an NRC licensee will be transferred. This includes your inspection procedures and field notes for each category of license issued by th NRC which will be transferred to the Commonwealth. The application should include your priority schedule for inspections by license type. In responding to this item, you may find IMC 2800 useful in describing the general materials inspection program including inspection frequencies. For addressing specific license categories, a useful guide is Inspection Procedures for Specific Materials Programs (IMC 87101 through 87120).
b.
The application did not include inspection procedures for decommissioning. The application should include inspection procedures that will be used for decommissioning and SDMP sites, including those for confirmatory surveys and in-process inspections. In responding to this item, you may find useful inspection Procedure (IP) 87104 Decommissioning Inspection Procedure for Material Licenses.
c.
The application did not provide information on laboratory facilities to be used b the Commonwealth other than for engineering properties of waste and independent environmental monitoring. The application should include your laboratory facilities that will be used for analysis of samples taken from sites, the kinds of radiological analyses it can perform, and the level of effort it can provide for routine inspections, reactive inspections, material incidants, and
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decommissioning confirmatory surveys.
= 4.4.2 !
j* Procedures Reports and for Assuring the Technical Quality ofInspections and Inspection l 4.4.3 Administrative Procedures for inspections l
Your application does not include procedures to assure technical quality and administrative control of inspections. Sections 4.4.2 and 4.4.3 recommend that these procedures include the following.
- a. j peer review, supervisory review and any other methods adopted to assure the quality of inspections and inspections reports; l b.
procedures for scheduling and tracking of inspections, assignment to inspectors, document preparation, quality assurance, signaturo, and timely transfer of inspection results to the licensee; and
- c. d cl b ?It i procedures for processing and tracking requests for conducting licensed activities under reciprocity. i i
The application should include your procedures for inspections. In addition to the items !
discussed above, your application should specifically discuss the scheduling and '
respective responsibilities for reviewing and issuing inspection and enforcement actions between the main office in Harrisburg and the three field offices. In responding to this item, you may find useful IMC 2800 and Processing of NRC Form 241... Inspection of Agreement State Licensees Operating under the Reciprocity Provisions of 10 CFR '
150.20 (IMC 1220).
4.5 Enforcement Program Elements The application includes standard procedures for encouraging compliance with, and enforcing, the regulations. It also includes a Memorandum of Understanding entered into with NRC in areas of mutual concem including transportation, regulation of a LLW disposal site, LLW packaging and shipping inspections, confirmatory environmental monitoring, and emergency information exchange. However, the application does not include administrative procedures for tracking routine and escalated enforcement actions. Please provide in the application your procedures for tracking enforcement actions.
4.6 Technical Staffing and Training Program Elements 4.6.1 Technical Staff Organization a.
Although the application includes biographies of many staff, your application does not include a complete analysis of the expected workload and establish an appropriate staffing plan. Although your analysis considered the nuinber of licenses to be transferred under the Agreement, it did not consider the distribution and type of licenses, except for the potential LLW disposal license. A i
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David J. Allard 2
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After you have an opportunity to review our comments, we y ould welcome the opportunity to meet with you to review the comments, discuss any questions you have concerning the review, the information needed, or steps involved in processing of tl te Agreement. Please contact me 1 at (301) 415-3340, or Dr. Stephen Salomon at (301) 415-22 68 to arrange the meeting. !
Sincere ly, PaulI . Lohaus, Director Office of State Programs
Enclosures:
As stated l
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i pistribution DIR RF DCD (SP05) F DR (YES)
DWhite, RI PGoldberg, IMNS JKennedy, DWM .
.JSheppard, DWM RBlanton, OSP GKim, 0GC DWeaver, IRO GPangburn, RI DCool, IMNS JHickey, DWM l Pennsylvania File DOCUMENT NAME: G:\SNS\PAAPPLRS.WPD *See previous concurrence.
T* receive a cop / of this docu,nont, Indicate in the box: "C" = Co)y without attachment /en losure "E" = Cop r with attachment / enclosure "N' = NMyb OFFICE OSP l NMSS:D l - RI:RA l lRO OGC 0%MptA NAME SNSalomon:kk CPaperiello HMiller I FCongel STreby PHLdhals '
DATE 05/24/99
- 06/ /99 06/07/99* 06/10/99
Volume 5, Governmental Relations and Public Affairs Proposed 274b Agreements With States
(. Handbook 5.8 Exhibit AN AGREEMENT BETWEEN THE UNITED STATES NUCLEAR REGULATORY COMMISSION AND THE STATE / COMMONWEALTH OF [ insert name of State)
FOR THE DISCONTINUANCE OF CERTAIN COMMISSION REGULATORY AUTHORITY AND RESPONSIBILITY WITHIN THE STATE / COMMONWEALTH PURSUANT TO SECTION 274 OF THE ATOMIC ENERGY ACT OF 1954, AS AMENDED 6
WHEREAS, The United States Nuclear Regulatory Commir.sion (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 enter into agreements with the Governor of any State / Commonwealth 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 hyproduct materials as defined in Sections 11e.(1) and (2) of the Act, source materials, and special nuclear materials in quantities not sufficient to form a critical mass; and, WHEREAS, The overnoe of the State / Commonwealth of [ insert name)is authorized under (cite enabling statute) to enter into this Agreement with the Commission; and, WHEREAS, The Governor of the State / Commonwealth of [ insert name) certified on [date),
that the State / Commonwealth of [ insert name) (hereinafter referred to as the State / Commonwealth) has a program for the control of radiation hazards adequate to protect public health and safety with respect to the materials within the State / Commonwealth covered by this Agreement, and that the State / Commonwealth desires to assume regulatory responsibility for such materials; and, WHEREAS, The Commission found on [date) that the program of the State / Commonwealth for the 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,
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Approved: November 21,1997 3
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! Proposed 274b Agreements With States Handbook 5.8
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Exhibit (continued) ,
WHEREAS, The State / Commonwealth and the Commission recognize the desirability and importance of cooperation between the Commission and the State / Commonwealth in the l
formulation of standards for protection against hazards of radiation and in assuring that i State / Commonwealth and Commission programs for protection against hazards of radiation will be coordinated and compatible; and, WHEREAS, The Commission and the State / Commonwealth recognize the desirability of the reciprocal recognition of licenses, and of the granting of limited exemptions from licensing of those materials subject to this Agreement; and, WHEREAS, This Agreement 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 Govemor of the I State / Commonwealth acting on behalf of the State / Commonwealth as follows:
ARTICLE l' Subject to the exceptions provided in Articles li, IV, and V, the Commission shall discontinue, as of the effective date of this Agreement, the regulatory authority of the Commission in the State / Commonwealth under Chspters 6,7, and 8, and Section 161 of the Act with respect to the following materials:
A. Byproduct materials as defined in Section 11o.(1) of the Act; I
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B. Byproduct materials as defined in Sc? tion 11s.(2) of the Act; C. Source materials:
D, Special nuclear materials in quantities not sufficient to form a critical mass.
E. The regulation of the land disposal of byproduct, source, or special nuclear waste
! materials received from other persons:
F. The evaluation of radiation safety information on sealed sources or devices.
l 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 II A. This Agreement does not provide for discontinuance of any authority and the Commission shall retain authority and responsibility with respect to: '
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! 'If the State / Commonwealth chooses not to regulate all categories of material listed in Article I, those categories where NRC will retain authority should be listed in Article it, A.
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l 4 Approved: November 21,1997
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Volume 5, Governmental Relations and Public Affairs l l Proposed 274b Agreements With States
/ Handbook 5.8 )
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Exhibit (continued) l
- 1. The regulation of the construction and operation of any production or utilization facility or any uranium enrichment f acility;
- 2. The regulation of the export from or import into the United States of i
' byproduct. source, or special nuclear material, or of any production or I utilization facility:
- 3. The regulation of the disposal into the ocean or see of byproduct, source, or special nuclear materials waste as defined in the regulations or orders of the Commission; l
- 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 information 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.8 S'c jl# O Go tk rey alwf/un of b producf M7t'wjb M 4 f.M"j , .
B.a Notw thstanding this Agreement, the [ommission retains the following authorities pertaining to byproduct material as defined in Section 11o.(2) of the Atomic Energy
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, Act: //M [d, A
- 1. Prior to the termination of a State / Commonwealth license for such byproduct material, or for any activity that results in the production of such material, the Commission shall have made a determination that all applicable standards and requirements pertaining to such material have been met.
- 2. The Commission reserves the authority to establish minimum standards governing reclamation, long-term surveillance or maintenance, and ownership of such byproduct material and of land used as a disposal site for such material. Such reserved authority includes:
r a. The authority to establish terms and conditions as the Commission l determines necessary to assure that, prior to termination of any license for such byproduct material, or for any activity that results in the production of such material, the licensee shall comply with decontamination, decommissioning, and reclamation standards prescribed by the Commission; and with ownership requirements for ,
such materials and its disposal site, <
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1nclude only if the State is not authorized to conduct sealed source and device reviews I for purposes of registration for distribution. ;
I d 8 Article ll.B. is included in the agreement only if the State is authorized to regulate l
11e.(2) byproduct material.
%/ude- on/y il the SIst >s not " % r"cd 4 "'1"Id* l bypredaJ mdem/s as defined in sc e/;n, //et2) of 1Ae Ad
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Approved: November 21,1997 5
Volume 5, Governmental Relations and Public Aft' airs Proposed 274b Agreements With States Handbook 5.8 i
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- b. The authority to require that prior to termination of any license for such byproduct material or for any activity that results in the l production of such material, title to such byproduct material and its l disposal site be transferred to the United States or the I State / Commonwealth at the option of the State / Commonwealth l (provided such option is exercised prior to termination of the license);
l c. The authority to permit use of the surface or subsurface estates, or l both, of the land transferred to the United States or a i
State / Commonwealth pursuant to paragraph 2.b. In this section in a manner consistent with the provisions of the Uranium Mill Tailings l
Radiation Control Act of 1978, provided that the Commission determines that such use would not endanger public health, safety, welfare, or the environment;
- d. The authority to require, in the case of a license for any activity that produces such byproduct material (which license was in effect on November 8,1981), transfer of land and material pursuant to paragraph 2.b. in this section taking into consideration the status of j such material and land and interests therein, and the ability of the licensee to transfer title and custody thereof to the United States or a State / Commonwealth;
- e. The authority to require the Secretary of the Department of Energy, other Federal agency, or State / Commonwealth, whichever has ,
l custody of such byproduct material and its disposal site, to undertake such monitoring, maintenance, and emergency measures as are necessary to protect public health and safety, and other actions as the Commission deems necessary; and
- f. The authority to enter into arrangements as may be appropriate to essure Federal long term surveillance or maintenance of such byproduct material and its disposal site on land held in trust by the i United States for any Indian Tribe or land owned by an Indian Tribe <
l and subject to a restriction against alienation imposed by the United States.
ARTICLE lil' ,
With the exception of those activities identified in Article ll.A.1 through 4, this Agreement may be amended, upon application by the State / Commonwealth and approval by the Commission, to include one or more of the additional activities specified in Article 11, paragraphs [those activities not included in the agreementi, whereby the State / Commonwealth may then exert regulatory authority and responsibility with respect to those activities.
ARTICLE IV
- Delete this Article and renumber the remaining articles if the State / Commonwealth assumes authority over all categories of materials in Article 11.
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I 6 Approved: November 21,1997
Volume 5, Governmental Relations and Public Affairs Proposed 274b Agreements With States Handbook 5.8 Exhibit (continued) 9 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 or 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 1611 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 The Commission will cooperate with the State / Commonwealth and other Agreement States in the formulation of standards and regulatory programs of the State and the Commission for protection against hazards of radiation and to assure that Commission and State / Commonwealth programs for protection against hazards of radiation will be a coordinated and compatible. The State /Commonweatth agrees to cooperate with the ,
Commission and other Agreement States in the formulation of standards and regulatory programs of the State / Commonwealth and the Commission for protection against hazards of radiation and to assure that the State / Commonwealth's program will continue to be compatible with the program of the Commission for the regulation of materials covered by
{ this Agreement.
The State / Commonwealth and the Commission agree to keep each other informed of proposed changes in their respective rulow and regulations, and to provide each other the opportunity for early and substantive contribution to the proposed changes.
' The State / Commonwealth and the Commission agree to koop each other informed of events, accidents, and licensee performance that may have generic implication or otherwise be of regulatory interest.
ARTICLE Mj,[
The Commission and the State / Commonwealth agree that it is desirable to provide reciprocal recognition of licenses for the materials listed in Article I licensed by the other party or by any other Agreement State. Accordingly, the Commission and the i State / Commonwealth agree to develop appropriate rules, regulations, and procedures by j which such reciprocity will be accorded.
ARTICLE Mill l The Commission, upon its own initiative after reasonable notice and opportunity for hearing to the State / Commonwealth, or upon request of the Governor of the State / 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 Comrnission finds that (1) such termination or suspension is required to protect public heatth and safety, or (2) the l State / 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, j 1
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1 Volume 5, Governmental Relations and Public Affairs '
Proposed 274b Agreements With States j Handbook 5.8 i
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I 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 State / Commonwealth has failed to take necessary steps. The Commission shall periodically review actions taken by the State / Commonwealth under this Agreement to ensure compliance with Section 274 of the Act which requires a State / 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 jn' In the licensing and regulation of byproduct material as defined in Section 11e.(2) of the l Act, or of any activity which results in production of such material, the State / Commonwealth shall comply with the provisions of Section 274o of the Act. If in such licensing and regulation, the State / Commonwealth requires financial surety arrangements for reclamation or long-term surveillance and maintenance of such meterial, A. The total amount of funds the State / Commonwealth collects for such purposes shall be transferred to the United States if custody of such matosial and its disposal site is transferred to the United States upon termination of the State / Commonwealth license for such material or any activity which results in the production of such material. Such funds include, but are not limited to, sums collected for long-term surveillance or maintenance. Such funds do not, however, include monies held as surety where no default has occurred and the reclamation or other bonded activity has been performed; and ,
B. Such surety or other financial requirements must be sufficient to ensure compliance with those standards established by the Commission pertaining to bonds, sureties, and financial arrangements to ensure adequate reclamation and long-term management of such byproduct material and its disposal site.
ARTICLE E This Agreement shall become effective on [date), and shall remain in effect unless and until such time as it is terminated pursuant to Article Vill.
Done at [ City, State) this (dete] day of [ month], [ year].
FOR THE UNITED STATES NUCLEAR REGULATORY COMMISSION
, Chairman FOR THE STATE / COMMONWEALTH OF
, Governor
'Use Article IX only if the State is authorized to regulate 11e.(2) byproduct material.
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8- Approved: November 21,1997 '
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, a fw, DRApr (N.. . ..),
OSP Procedure Approval l J
Reviewing a Requestfor an Agreentent - SA-700 i Issue Date:
Expiration Date:
Richard L. Bangart Director, OSP Date: 1 Paul H. Lohaus Deputy Director, OSP Date: !
l Richard L. Blanton l Procedure Contact, OSP Date: l i
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l NOTE ,
The OSP Director's Secretary is responsiblefor the maintenance ofthis master copy
. document aspart of the OSP Procedure Manual. Any changes to theprocedure will be the )
l responsibility ofthe OSP Procedure Contact. Copies ofOSPprocedures will be distributedforl information.' l l
l ENCLOSU,u 2 L
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' Og Procedure
Title:
Il' age: 1of8 l
{ } Reviewing a Requestfor an Agreement 1,,,,y ,,,,
\,, / Procedure Number: SA-700 l
- 1. INTRODUCTION This procedure describes the objectives and processes for reviewing the request by a l State for an Agreement under Section 274b of the Atomic Energy Act of 1954, as l
amended (Act). As used in this procedure, the term " State" refers to either a State or a Commonwealth, however, care should be taken to assure that the proper term is used in the Agreement, Federal Recisle_r notices, and other official records. The procedure may also be used to guide the review of a request for an amendment to an existing Agreement.
II. OBJECTIVE A. Assure that each Agreement entered into is consistent with the provisions of Section 274 of the Act, Commission policy, NRC Management Directives, and other statutory, regulatory or policy requirements that may apply; B. Provide for the effective, efficient, and timely review of the request by a State for an Agreement, or for an amendment to an existing Agreement; and C. Provide an orderly transition in the discontinuance of regulatory authority by the NRC and assumption thereof by the State.
III. BACKGROUND Section 274 of the Act allows the Commission and a F(aM to enter into an Agreement under which the Commission discontinues regulatory aui irity, and the State concurrently assumes regulatory authority, over the uttegories of materials specified in the Agreement. The categories of materials that may be transferred are: (a) by-product materials as defined in Section 1le.(1) of the Act; (b) by-product materials as defined in Section 11e.(2) of the Act;(c) source materials as defined by Section 11z of the Act; (d) special nuclear materials (as defined in Section 1laa of the Act) in quantities not sufficient to form a critical mass (as defined in 10 CFR 150.11);(e) the regulation of the
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l SA-700: Reviewing a Requestfor an Agreement; Page: 2;of 7 Issue Date:
land disposal of byproduct, source, or special nuclear waste materials received from other persons; and (f) the evaluation of radiation safety information on sealed sources or devices containing byproduct, source, or special nuclear materials and the registration of the scaled sources or devices for distribution, as provided for in the regulations or orders j of the Commission. The State may choose to assume regulatory authority over any - - . '
combination of the categories. l l
In order for the Commission to enter into the Agreement, the State must have a program for the control of radiation hszards which is adequate to protect public health and safety 1 with respect to the materials specified in the Agreement, and which is compatible with the Commission's program for the regulation of the materials. The Governor of the State must certify to the Commission that the State has the required program and desires to assume the regulatory authority. The State must also submit sufficient information about its program to enable the Commission to find that the requirements of the Act are met. The certification and information together constitute the request for an Agreement.
There are two basic components to an Agreement State program. First, there must be a set oflaws and regulations which provide the framework. Second, there must be an effective organizational and administrative structure for the implementation and enforcement of the laws and regulations. In accord with Commission policy, the term
" regulations" as used in this procedure may include other forms of generic legally binding requirements, such as license conditions or orders, authorized under State law.
The program organizational structure may be in the form of a single State agency, a part of an agency, or portions of two or more agencies. In whichever case, as used in this procedure, the term " program" includes all organizational units with regulatory responsibility over the materials specified in the Agreement.
The basis for a finding by the Commission that a State's program is adequate and compatible is provided by the NRC staff assessment. The staff assessment should demonstrate that the State's program, as described in the request for an Agreement, satisfies the criteria in the policy statement " Criteria for Guidance of States and NRC in Discontinuance of NRC Regulatory Authority and Assumption Thereof by States Through Agreement," (46 FR 7540; January 23,1981), as amended on July 16,1981 (46 FR 36969), July 21,1983 (48 FR 33376). The information submitted by the State should also provide NRC with confidence that if the State's program is implemented as presented, a review of the program pursuant to Management Directive (MD) 5.6,
" Integrated Materials Performance Evaluation Program (IMPEP)" will likely find the State satisfactory for all applicable indicators.
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SA-700: Reviewing a Requestfar an Agreement ' Page: 3 of 7.
Issue Date:
IV. ROLES AND RESPONSIBILITIES A. The Review Steering Committee, consisting of the Director, Office of State Programs (OSP), and management representatives of the Office of Nuclear Material Safety and Safeguards (NMSS), Office of the General Counsel (OGC), the Incident
, Response Organization (IRO), and the afTected Region (onices), is responsible for determining that a State's request for an Agreement satisfies the criteria in the policy statement, and for recommending approval of the Agreement to the Commission. The Director of OSP, serves as chair of the steering committee.
B. The Review Team, consisting of the OSP project manager (PM) and staff from NMSS, OGC, IRO, the affected Region, and other NRC staff as assigned, is responsible for conducting the staff review in accordance with this procedure. The PM serves as team leader.
C. The Regional State Agreements Officer (RSAO) or Regional State Liaison Officer j (RSLO)is usually responsible fbr providing information to the State as requested
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prior to a formal declaration by the State ofits intent to seek an Agreement. l E. The Region and NMSS are responsible for coordinating the transfer oflicensee files from NRC to the State (see MD 5.8).
V. GUIDANCE A. When preparing a request for an Agreement, the State should consider the guidance in this procedure and in the Appendix to this procedure entitled, " Handbook for Reviewing a Request for an Agreement." The request should include all of the information identified in Section 4 of the handbook for each program element, as q appropriate for the categories of materials requested.
B. There is no legal requirement for a State to submit a letter declaring its intent to seek an Agreement. However, a letter ofintent signed by the Governor is requested 4 as a written commitment of State resources to the process of seeking an Agreement. l' Based on this State commitment, NRC can plan and commit its own resources to review the request for an Agreement, and subsequently to process and implement the Agreement. {
1 C. It is recommended that the State submit the request for an Agreement in draft form for the team to review for completeness prior to submitting a formal request signed by the Governor. However, only one detailed review, that of the Governor's formal
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! SA-700:: Reviewing a Requestfor an Agreement ~
Page: . 4 of 7 Issue Date:
request,is conducted.
- 1. The draft request should be submitted as a package containing complete supporting information for all program elements.
- 2. When a draft application is received, the Director, OSP, requests that the offices designate stafflevel contacts to serve on the review team, in accordance with MD 5.8.
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- 3. The team reviews the draft request only to identify any additional information needed for the detailed review of the formal Request. The team members provide comments and recommendations as appropriate.
- 4. The team prepares a letter to the State transmitting the comments and recommendations of the reviewers. The letter is signed by the Director of OSP 4 after concurrence by the offices.
- 5. The State should address the comments and recommendations of the reviewers as changes incorporated into the formal request. The State should then submit the formal request after it is signed by the Governor. '
D. When the formal request is receist.-d, the FM prepares a letter for signature by the Chairman acknowledging its receip . The review team conducts a detailed evaluation of the formal rgest ir, accordance with the procedures and criteria in the handbook.
- 1. If the State did r of submit a draft request, the Director, OSP, requests that the offices designaata+.Tlevel contacts to serve on the review team, in accordance with MD 5.8. If the State did submit a draft request, the team that reviewed the draft request will usually review the formal request.
- 2. If the team identifies deficiencies in the request, it prepares a letter to the State providing comments and recommendations. The letter is signed by the Director of OSP after concurrence by the offices. The response of the State is reviewed by the team.
E. The team should complete the following, to the extent practical, in parallel with the review of the formal request and the resolution of comments.
j 1. Prepare a draft staff assessment addressing each of the criteria in the policy
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Sk-700: Reviewing a Requestfor an Agreement Page: 5 of 7 Issue Date:
statement, as appropriate for the categories of materials covered by the ,
proposed Agreement. The assessment describes the findings of the review of l
the formal request, supplemented as required by revisions to the request in response to team comments.
- 2. Prepare a proposed Federal Recister notice, identifying the State and l describing briefly the proposed program. The description should include a summary of the draft staff assessment and should clearly identify any unique features or issues with the proposed Agreement. The text of the proposed Agreement must be attached, with a proposed effective date for the Agreement.
- 3. Coordinate with the Office of Public Affairs (OPA) to prepare a draft press release announcing the publication of the proposed Agreement in the Federal Recister.
- 4. Prepare a draft negative consent paper informing the Commission of the status of the request for an Agreement and the proposed schedule to complete the Agreement, including the publication of the proposed Agreement in the Federal Register.
- a. The paper should indicate that staff will forward the FR notice for publication ten days after the paper is signed by the Executive Director for Operations (EDO), unless the Commission directs otherwise.
- b. The paper should include as attachments the draft staff assessment, the proposed Federal Recister notice (including the proposed Agreement and a ;
summary of the draft staff assessment), proposed letters of notification to l the NRC Congressional Oversight Committees and the State's Congressional delegation, and the draft press release from OPA.
- 5. Prepare letters notifying interested Federal agencies, and the existing Agreement States, of the Federal Recister notice.
F. When the team completes the review of the formal request and the State addresses all comments, the Director, OSP, forwards the Commission paper with attachments to the offices for concurrence.
- 1. When office concurrence on the Commission Paper is received, it is forwarded through the Deputy Executive Director for Regulatory Programs (DEDR) to the EDO for signature.
j SA-700i Reviewing a Requestfor an Agreement Pese: 6 oi 7 Issue Date:
- 2. Ten days after the paper is signed by the EDO, SECY should issue an SRM clearing the staff to publish the Federal Recister notice. The PM forward the Federal Recister notice and the letters notifying Congress of the Federal Recister notice, to the Rules Review and Directives Branch, Division of Freedom ofInformation and Publications Services, Office of Administration (ADM). The letters notifying Congress are forwarded by ADM to the Office of Congressional Affairs (OCA).
- 3. When the Federal Reuister notice is published, a copy is attached to the letters notifying the Agreement States, and the interested government agencies. The letters are mailed by OSP. The PM informs OPA that the Federal Recister notice has been published.
G. The review team, to the extent practical in parallel with the publication of the proposed Agreement in the Federal Recister, prepares a Commission paper seeking approval of the Agreement.
- 1. The team receives public comments and prepares an analysis for inclusion in the paper.
- 2. The team completes the final staff assessment, considering the public comments. The completed assessment is attached to the paper. The PM requests a draft press release announcing the signing of the Agreement.
- 3. The paper must contain a brief discussion of staff coordination to resolve outstanding escalated enforcement cases and 2.206 petitions. Incomplete ,
escalated enforcement, outstanding orders, and Confirmatory Action Letters against the NRC licensees to be transferred should be summarized. The status of any SDMP or other sites in decommissioning should be discussed. The information provided to the State regarding closed out sites should be discussed.
- 4. Required attachments to the paper include:
- a. a draft letter to the cognizant Congressional Committees and the State's Congressional delegation announcing the approval and signing of the Agreement;
- b. a completed copy of the General Accounting Office form providing the notification required under the Small Business Regulatory Enforcement
i SA-700: Reviewing a Requestfor an Agreement Page: 7 ' oi 7:
Issue Date:-
and Faimess Act of1996 (SBREFA);
1
- c. a draft press release announcing the Agreement; and
- d. a draft Federal Recister notice announcing the approval and signing of the Agreement. i H. The PM determines the Governor's choice for signing the Agreement at a formal ;
ceremony or by correspondence, and if any special form is required for the l Governor's signature block. The usual signatory for the Commission is the Chairman.
- 1. If the Agreement is to be signed at a formal signing ceremony, the PM coordinates with the State staff and, through the DEDR, with the Chairman's l office for the date, time and place of the signing ceremony.
- 2. If the Agreement is to be signed by correspondence, the place at which the Chairman signs is Rockville, Maryland, and the place the Govemor signs is the State Capitol.
- 3. The place or places of signing are named in the Agreement. The effective date for the Agreement is decided on by the State and NRC staff, and put in the Agreement.
I. The Director, OSP, sends Commission paper and attachments to the offices for concurrence.
J. When office concurrence is received, the Director, OSP, forwards the Commission paper with attachments through the DEDR to the EDO for signature.
K. When the Commission approves the Agreement, the PM forwards the letters addressed to the Congressional Committees, the State's Congressional delegation, and the director of the General Accounting Office to ADM for dispatch. The PM alerts OPA to issue the public announcement. OPA may wish to coordinate public announcements with the State public relations staff, particularly if there is to be a signing ceremony.
j L. The PM coordinates with the Graphics Preparation Section of the Publishing l Services Branch, Information Management Division, Office of the Chief Information Officer, to have three formal Agreement documents prepared.
r SA-700: Reviewing a Requestfor an Agreement Page: 8 of 7 l <
Issue Date: ~
l When the Agreement has been signed by the Chairman and the Governor, the State
! retains one copy, the PM forwards one copy to SECY, and the third copy is retained for the OSP file.
l M. After the Agreement has been signed, the PM prepares letters from the Director, 1 OSP, notifying the interested agencies, NRC material licensees, and all Agreement and non-Agreement States of the effective date of the Agreement. The PM provides the new Agreement State program director copies of the notifications.
N. After the Agreement has been signed, the Region and NMSS transfer the license files to the new Agreement State.
O. The PM submits the Federal Recister notice of the signing of the Agreement to ADM for publication. Section 274e.(2) of the Act requires this notice to be published in the Federal Register within 30 days after the signing of the Agreement.
P. Approximately nine months after the Agreement becomes effective, the PM (usually re-designated as the ASPO) and the RSAO meet with the program management to discuss the State's implementation of the Agreement materials program. (See procedure SA-). Approximately 18 months after the Agreement becomes effective, the first IMPEP review is conducted. (See MD 5.6)
VI. APPENDICES
" Handbook on Reviewing a Request for an Agreement."
VII. REFERENCES
- 1. Sections 11 and 274 of the Atomic Energy Act of 1954, as amended.
I
- 2. Commission policy statement Criteriafor Guidance ofStates andNRC in Discontinuance ofNRC Regidatory Authority and Assumption Thereofby States Through Agreement, (46 FR 7540; January 23,19.81), as amended on July 16,1981 (46 FR 36969), July 21,1983 (48 FR 33376).
- 3. NRC Management Directive (MD) 5.6, Integrated Afaterials Performance Evaluation Program (IAfPEP), November 25,1997.
Handbook for Reviewing a Request for an Agreement i
Date l
Office of State Programs U.S. Nuclear Regulatory Commission
Contact:
Richard L. Blanton
E ..
4 4
Request for an Agreement Handbook I CONTENTS
- 1. INTRODUCTION 1.1 Purpose 1.2 Scope
- 2. BASIS 2.1 Statutory requirements 2.1.1 Federal Statutes 2.1.2 State Statutes 2.2 Commission Policy Statements 2.2.1 Policy Statement " Criteria for Guidance of States and NRC in Discontinuance of NRC Regulatory Authority and Assumption Thereof by States Through Agreement" 2.2.2 Policy Statement " Principles and Policy for the Agreement State Program" 2.2.3 Policy Statement " Adequacy and Compatibility of Agreement i State Programs" l 2.3 Directives and Procedures )
2.3.1 Management Directive 5.6," Integrated Materials Performance Evaluation Program (IMPEP)"
2.3.2 Management Directive 5.8," Proposed 274b Agreements With States" I 2.3.3 OSP Procedure SA-201, " Reviewing State Regulations" 2.3.4 OSP Procedure SA-200, " Compatibility Categories and Health
- and Safety Identificat;on for NRC Regulations and Other i
Program Elements" 2.4 Other Considerations 2.4.1 Proprietary and Privacy Information 2.4.2 Qualifications of NRC staff 2.4.3 Submittal and effective dates of the Agreement 2.4.4 Form of the request 2.4.5 Questions i
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Request for an Agreement flandbook !
l CONTENTS, continued 3.0 REVIEW PROCEDURES 3.1 Prior to the Letter ofIntent 3.2. Response to a Letter ofIntent 3.2 Receipt of a Draft Request 3.3 Review of the Draft Request 3.4 Review of the Formal Request for an Agreement 4 INFORMATION NEEDED AND EVALUATION CRITERIA 4.1 Legal elements 4.1.1 Authority to establish a program and enter in to an Agreement 4.1.2 Organization of the proposed program.
4.1.3 Content of the proposed Agreement. l l
4.2 Regulatory requirements program elements. i 4.2.1 Standards for protection against radiation.
4.2.2 Regulatory requirements with significant transboundary implications.
4.2.3 Regulatory requirements needed for an orderly pattern of regulation or which have particular health and safety significance.
4.3 Licensing program elements.
4.3.1 Procedures for the technical evaluation of proposed uses of RAM 4.3.2 Procedures for the evaluation of radiation safety information on sealed sources or devices, and registration for distribution l 4.3.3 Procedure for conducting the technical evaluation of a proposed l license for a low level radioactive waste land disposal site ]
4.3.4 Procedure for conducting the technical evaluation of a proposed uranium or thorium recovery facility 4.3.5 Procedures for the assuring the technical quality oflicenses. !
l 4.3.6 Administrative licensing procedures.
4.4 Inspection program elements. l 4.4.1 Procedures for inspecting facilities where RAM is stored or used 4.4.2 Procedures for assuring the technical quality ofinspections and inspection reports, 4.4.3 Administrative procedures for inspections.
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Request for an Agreement Handbook CONTENTS, continued 4.5 Enforcement program elements.
4.5.1 Routine enforcement procedures.
4.5.2 Escalated enforcement procedures.
l 4.6 Technical staffing and training program elements.
l 4.6.1 Technical stafforganization.
4.6.2 Formal qualification plan.
4.6.3 Qualifications of current technical staff.
4.7 Event and allegation response program elements 4.7.1 Procedures for responding to events and allegations.
4.7.2 Procedures for identifying significant events and allegations, and for entering same into the Nuclear Materials Events Database.
Glossary 1
Definitions
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Request for an Agreement Handbook
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- 1. INTRODUCTION
..1.1. Purpose
- i. ,
This handbook provides guidance to the NRC staff responsible for reviewing the request by a l ,
State for an Agreement as authorized by Section 274b of the Atomic Energy Act of 1954, as l
amended (Act). The staff should also use the handbook when reviewing a request for an
- amendment to an existing Agreement. The handbook identifies the information that NRC staff must review, and the criteria used to evaluate the information.
l l The handbook also provides guidance on the information that should be submitted with a request i for an Agreement, or an amendment to an existing Agreement.
l l 1.2 Scope-l l The information submitted in a request for an Agreement must be able to support two findings by the Commission. First, the information must show that the requesting State has a program for the control of radiation hazards that will be adequate to protect public health and safety. Second, i it must also show that the program will be compatible with the NRC materials program.
Section 4 of the handbook addresses the elements of an Agreement State program. The specific information needed to evaluate each element is described. Any specific conclusions which must be reached by the staff, in addition to the general conclusion that the review criteria are satisfied, are also discussed.
- 2. BASIS The guidance in this handbook is based on the requirements of the Act, the general guidance set out in the Commission Policy statemeats on the Agreement State Program, applicable NRC -
Management Directives, and OSP Procedures.
2.1 Statutory requirements 2.1.1. Federal Statutes Section 274b of the Act authorizes the Commission to enter into agreements with States. Section 274c.of the Act specifies those regulatory authorities which must be reserved to NRC. Sections 274d though 274g specify the Commission actions and obligations with respect to the agreements. A State that proposes to regulate byproduct material as described in section 11(e).2 I 06/15'/99 1 i
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of the Act is subject to the additional requirements in Section 2740, and must also comply with the applicable requirements of the Uranium Mill Tailings Radiation Control Act (UMTRCA).
2.1.2 State Statutes
. The Agreement States do not regulate materials on behalf of the NRC. Each Agreement State program administers an independent regulatory program. Each program must each have the authority under State law to carry out its regulatory functions. The authority required by a program depends on the categories of materials that are transferred to the State in the Agreement.
For details of the legal authority required, see section 4.1.
2.2 Commission Policy Statements l
2.2.1 Policy Statement " Criteria for Guidance of States and NRC in Discontinuance of NRC
- Regulatory Authority and Assumption Thereof by States Through Agreement" The criteria policy statement provides the basis for the NRC staff assessment of proposed Agreement materials program. The criteria in the policy statement are incorporated into the
" criteria for review" subsections of the relevant program elements in the handbook. The first 28 criteria in the policy statement apply to all proposed programs; the last seven criteria only apply to States that request the authority to regulate the tailings materials from uranium and thorium mills.
2.2.2 - Policy Statement " Principles and Policy for the Agreement State Program" l I'
Also referred to as the " umbrella" policy, this statement provides the overall principles, objectives, and goals of the Agreement State program. These principles, objectives, and goals must be considered by NRC staff when reviewing a request for an Agreement.
i 2.2.3 Policy Statement " Adequacy and Compatibility of Agreement State Programs" i This policy defines the terms " adequate" and " compatible." It provides the basis for determining the degree of consistency required by the program elements based on a system of categories. It also identifies the basic program elements necessary for an adequate program that are used in
! IMPEP reviews and in this handbook.
l 2.3 Directives and Procedures 2.3.1 Management Directive 5.6, " Integrated Materials Performance Evaluation Program 06/15/99 2 i
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I (IMPEP)"
Management Directive (MD) 5.6 provides the process and criteria for the periodic reviews of Agreement State programs. A new Agreement State is expected to be able to perform its regulatory functions in an adequate and compatible manner starting on the effective date of the
. Agreement. NRC staff, during'the review of a request for an Agreement, considers whether the..
State's proposed pigram, ifimplemented as described, would be found satisfactory in all
, indicators during the first IMPEP review. The first review will normally occur approximately 18 months aRer the Agreement becomes effective.
2.3.2 Management Directive 5.8, " Proposed 274b Agreements With States" 1 MD 5.8 was created to guide both NRC and the State in craRing an Agreement. A State seeking to enter into an Agreement should draft the text of the proposed Agreement based on the model Agreement in handbook 5.8. Strict adherence with the model is not required, however, significant deviations from the model will require additional supporting information and evaluation to assure the compatibility of the Agreement program, and may require special .
approval by the Commission.
2.3.3 OSP Procedure SA-201, " Reviewing State Regulations" Procedure SA-201 describes the process used by the OSP staff to review the regulations adopted by an existing or prospective Agreement State. A State seeking an Agreement must submit copies ofits regulations for review. The State may adopt generic legally binding requirements in place of regulations, if permitted by the State's ' administrative procedures. If generic legally
- binding requirements are adopted in place of regulations, copies of the alternate requirements ;
must be submitted for review. )
L 2.3.4 - OSP Procedure SA-200, " Compatibility Categories and Health and Safety Identification
~ for NRC Regulations and Other Program Elements"
. NRC regulations and program elements are categorized in accordance with the " Policy Statement :
on Adequacy and Compatibility of Agreement State Programs" using the criteria and process presented in MD 5.9, which has the same title. Each regulation and program element, and the category assigned to each, are listed in the Appendix to SA-200.
2.4 Other Considerations I
2.4.1 Proprietary and Privacy Information 06/15 /99 3 l
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Request for an Agreement Handbook l
In general, a State should not need to submit proprietary information or information protected by the federal Privacy Act, or a State equivalent, as part of the information supporting a request for L an Agreement. All of the infhrmation needed to review a request for an Agreement should be l- contained in the public records of the State. If, in an unusual case, it is necessary to submit proprietary or privacy information, it is possible for NRC to protect the information, if the requirements of 10 CFR Part 9 are met. Before submitting information or documents which the -
4 State desires to be withheld, the matter should be discussed with the Director of OSP. ,
l 2.4.2 Qualifications of NRC staff One objective of this procedure is to provide NRC with the confidence that the State program, if implemented as presented, would likely be found satisfactory for all applicable indicators in an IMPEP review. Because of this, the assigned project manager should be qualified and experienced as a team leader for IMPEP reviews. The other NRC staff reviewing the request should be qualified as IMPEP reviewers for the program elements reviewed. l l
2.4.3 Submittal and effective dates of the Agreement l . The effective date of an Agreement usually is selected to provide time to transfer license files from NRC to the State between the date the Agreement is signed and the date the Agreement becomes effective. Since the time required to complete the processing of an Agreement depends on the resolution ofissues which cannot always be foreseen, an effective date proposed at the time the formal request is submitted can not always be met. The proposed effective date should be at least six months aner the date the formal request is submitted.
The request should be submitted in draft prior to being formally submitted. Approximately six months should be allotted for NRC staff to review the dran, and for NRC and State staffs to resolve any issues in the dran request.
2.4.4 Form of the request The signed originals of the Governor's letter ofintent and the Governor's letter of certification should be submitted. The dran request, including a dran Governor's letter of certification, should be submitted by Intemet file transfer or on computer-readable medium. The formal request should be submitted on computer-readable medium. The State and the PM should !
coordinate the use of computer-readable media to ensure compatibility of the formats. l 2.4.5 Questions 1
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Questions about the program elements, the review process, the information needed for the
! review, the criteria used in the review, or the progress of the review, should be addressed to the Director of OSP or the OSP project manager.
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- 3.0 REVIEW PROCEDURES l
l 3.1 Prior to the Letter ofIntent l
l . In response to requests for information before the State submits a letter ofintent to enter into an
' Agreement, the RSAO should provide, or confirm that the State has, the following:
- a. Copies of Sections 11 and 274 of the Act;
- b. Copies of the Suggested State Radiation Control Act, as published by the Council of State Governments;
- c. Copies of the Commission policy statements, " Criteria for Guidance of States and NRC in Discontinuance ofNRC Regulatory Authority and Assumption Thereof by States l Through Agreement," as amended, " Policy Statement on Adequacy and Compatibility of i Agreement State Programs," and " Principles and Policy for the Agreement State
- l. Program;"
l d. A copy of Management Directive 5.6, " Integrated Materials Performance Evaluation Program (IMPEP)," and Handbook 5.6; Management Directive 5.8, " Proposed 274b Agreements with States," and Handbook 5.8; and Management Directive 5.9, " Adequacy and Compatibility of Agreement State Programs," and Handbook 5.9; and e.- Copies of OSP Procedures SA-200, " Compatibility Categories and Health and Safety Identification for NRC Regulations and Other Program Elements," SA-201, " Reviewing
- State Regulations,".and SA-700," Reviewing a Request for an Agreement," and Handbook.
l The RSAO should assume the lead for responding to any specific questions and requests for additional information submitted by the State.
3.2. ' Response to a Letter ofIntent 3.2.1 When a letter ofintent is submitted by the Governor, the Deputy Director, OSP, appoints the PM for the review. The PM is usually the primary point of contact with NRC staff.
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( The PM coordinates with the RSAO and other NRC staff to provide information requested by the State.
3.2.1 - The PM prepares a response acknowledging the letter ofintent. The response is usually signed by the Chairman of the Commission.
- 3.2.2 The PM tracks the progress of the State in preparing the request for an Agreement. The PM should be prepared to provide current information about the State's progress to other
- NRC staff for budget development and work planning.
3.2 Receipt of a Draft Request
'3.2.1 If the State submits a draft request as a package, the review team conducts a completeness review against the program elements to be addressed as specified in Section 4 of the L handbook. The completeness review is to determine if the information in the package is of satisfactory quality and addresses each of the required program elements. If the package is incomplete, the team prepares a letter to the State program director or other designated contact, signed by the Director of OSP, that identifies the additional information needed.~
3.2.2 If the State submits the draft request in parts, it should provide a plan showing dates when each part will be submitted. The PM then tracks the receipt of the parts against the plan.
When the information for each part is received, the review team conducts a completeness review for that part. If additional information is needed, a letter is prepared when all
' parts have been received.
3.2.3. The PM and the State program director or other designated State staff contact should
- establish a time for periodic telephone conference calls to discuss the progress of the review, issues identified during the review, end information needed by NRC or the State.
Participants on the calls should include the members of the review team, the RSAO (if
( not a member of the team), and the State program director or other designated State .
contact. Other involved NRC and State staff should participate as appropriate. The
' schedule should be biweekly to start. Calls may be skipped or added to the schedule as needed.
3.2.4. The conference calls should be supplemented with meetings between members of the NRC and State staffs. The PM and the RSAO should visit the State offices to gain first-hand knowledge of the State facihties and staff. The RSAO should coordinate to have d
State inspectors accompany NRC inspectors during inspections of the NRC licensee
. 06/15 /99 ,
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Request for an Agreement Handbook facilities which will transfer to the State under the Agreement. To the extent practicable, State license reviewers should work with, or in parallel to, NRC license reviewers on actions for licenses which will transfer to the State under the Agreement.
3.3 Review of the Formal Request for an Agreement l 3.3.1 The State should address the review team comments on the completeness of the draft
! request by incorporating the needed information into the formal Request for an Agreement.-
3.3.2 The review team reviews the formal request using the criteria in section 4 of the l-handbook, as appropriate for the categories of materials requested. The team members j may communicate with the State staff directly to discuss questions about the request.
l a. If the team determines that the proposed program does not satisfy a criterion, or that additional information is needed to demonstrate that a criterion is satisfied, a comment is generated clearly describing the issue, and where practical, providing guidance to resolve the issue. The team may also offer suggestions for strengthening the proposed program to the State staff, but the suggestions should net be included in written correspondence,
- b. If major issues are identified (issues that raise significant questions on the adequacy or compatibility of the proposed program), the team should notify the State program director or other designated State contact. and the review steering committee, as early as practical. l l
3.3.3 The team prepares correspondence from the Director, OSP, forwarding the written j comments to the State program director or other designated State contact for response.
l
- a. The State should address and resolve issues identified in the formal request by l submitting revised pages or sections to the formal request. The review continues -
when the revis'ans are received.
3.3.4 When the team concludes that all comments on the request have been adequately addressed, the team completes the draft staff assessment and the Commission Negative Consent to publish paper with attachments. If the steering committee concurs, the review of the request is complete, and the proposed Agreement is ready for publication in the Federal Recister.
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( Request for an Agreement Handbook 4 INFORMATION NEEDED AND EVALUATION CRITERIA l
4.1 Legalelements In 1983, the Council of State Govemments published a generic model Radiation Control Act in Suggested State Legislation, Volume 42. Other generic model legislation related to radiation control was also published, but legislation addressing low-level radioactive waste was not included. States may, but are not required to, use the suggested State legislation as models further own laws.
l The OSP project manager conducts a preliminary review to identify and correlate the State legal elements to the elements of the model legislation. The formal review of the legal elements is conducted by OGC. Based on the review, NRC should be able to conclude that the State has the legal authority necessary to conduct an effective program.
4.1.1 Authority to establish a program and enter in to an Agreement The Commission may enter into an Agreement only if the State has the authority under its own laws to assume and exercise regulatory responsibility over the materials covered by the proposed Agreement. This authority is usually granted in the State laws which established the program.
Authority to posses and use materials is granted by licenses. License conditions are added as needed to address matters unique to the licensee and apply specific requirements not contained in regulations. Exemptions from specific licensing requirements, including the requirement to obtain a license, may be granted if the exemptions do not adversely impact on public health and safety. Reciprocal recognition of specific licenses issued by otherjurisdictions should be used to authorize a licensee of another State or the NRC to conduct the same activities authorized by the license within the licensee's homejurisdiction. In authorizing research and development, medical uses, or other activities involving multiple uses of materials, a materials program may provide a licensing means, such as broad scope licenses, for authorizing multiple uses of materials without evaluating each specific use.
Regulatory requirements are usually imposed by NRC in the form of regulations. The agreement States may impose regulatory requirements by adopting regulations or generic legally binding requirements other than regulations. The generic legally binding requirements other than regulations, if used, need to be established in a way that assures consistency in their application and avoids confusion on the part of either the licensees or the program staff.
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Periodic inspections oflicensee operations are essential to ensure compliance with regulatory
- ^
requirements. Inspections oflicensed or unlicensed facilities may also be required to assess the l risk to public health and safety resulting from accidents or environmental releases involving -
L materials.
l c Compliance with regulations, license conditions, and other generic legally binding requirements' L
may be enforced through a variety oflegal sanctions. Agreement States are not required to' L r utilize the same sanctions as NRC. Sanctions may include administrative remedies such as more frequent inspections,' enforcement conferences'with licensee management, orders requiring
[ corrective action, and the imposition of civil or administrative monetary penalties. For more
- serious cases, the sanctions may include the impoundment of materials, administrative hearings, the suspension, modification or revocation of the license, seeking injunctive relief, and referral for criminal prosecution.
Due to the long term hazards posed by a low level radioactive waste land disposal site, or a uranium mill tailings disposal site, any State which assumes the authority to regulate such a site
. must have the statutory authority to place continuing restrictions on the ownership and use of the land on which the ' site is located, after the site has been closed. The authority to select or approve a disposal site may be vested in an agency other than the agency having primary responsibility for program. However, the authority to license the site is an element of the program, regardless of which agency exercises the authority. If another agency will license a disposal site, that agency also must meet the legal authority criteria.
4.1.1.1 Information needed I h
The State should submit copies of the sections of State law that:
l'
- a. establish the program and define its structure b.~ authorize the Governor to enter into an Agreement with the Commission
- c. authorize the program to issue licenses ;
- d. authorize the program to impose additional requirements in the form oflicense conditions i . e. authorize the program to make exemptions from the licensure requirements
- f. - authorize the program to recognize the licenses of otherjurisdictions 06/15 /99" 9
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- g. make it unlawful to acquire, posses, store, use, transfer, or dispose of materials witliout a valid license, or to violate the conditions of any such license
- i. authorize the program to promulgate regulations j specify procedures for promulgation, including public participation i
L k. : allow the program to impose requirements in the form of other generic legally binding I
- requirements -
- 1. authorize representatives of the program to enter premises and conduct inspections 1
- m. authorize the program to require compliance with regulatory requirements
- n. authorize the program to impose sanctions The State should submit copies of the sections ofits law that authorize the assumption of regulatory responsibility for the licensing and regulating of a low level radioactive waste disposal
.' site, and the imposition of restrictions on ownership and use of the land after the site is closed, if the authority to regulate such a site under the Agreement is requested.
The State should submit copies of the sections ofits law that provide authority to impose requirements equivalent to the Uranium Mill Tailings Radiation Control Act of 1978, as amended, if the authority to regulate byproduct material (as defined in section 11e.(2) of the Act) is requested as part of the Agreement.
4.1.1.2 Evaluation criteria NRC staff may use the ' Council of State Governments suggested legislation as guidance when
" evaluating the content of, and authority granted by, State radiation control laws. However, there
+ .
is no requirement for a State to follow either the either the content or the format of the model
. legislation.. Any questions of the interpretation of State law must be referred back to the State for resolution. NRC will accept interpretations of State law provided by the State Attorney General,
- or other attorney specifically designated to be the legal advisor to the materials program. l l
State law must specifically authorize the Governor to enter into an Agreement with the i Commission. The law must also designate the agency or agencies that will have authority to carry out the program. There should be assurances in the law against duplications, gaps or ,
conflicts in regulation and licensing between the agencies within the State (including between l 06/15 /99 10 l l 1 l I
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Request for an Agreement Handbook State and local agencies), or between the State and NRC. There should be no provision oflaw which seeks to regulate materials or activities reserved to NRC.
The program must have the authority to issue licenses and require persons to obtain a license prior to conducting any activity for which a license is required.
The program must have the authority to promulgate regulations. If the State proposes to use generic legally binding requirements as alternatives to regulations, the State must demonstrate -
that the proposed alternatives are legally binding under State law. Where appropriate, provisions should exist for public participation.
A program must be authorized in individual cases to impose additional requirements to protect health and safety, and to grant necessary exemptions which will notjeopardize health and safety.
Exemptions substantially equivalent to the following should be authorized:
- a. Prime contractors performing work for the DOE at U.S. Government-owned or controlled sites;
- b. Prime contractors performing research in, or development, manufacture, storage, testing, or
. transportation of, atomic weapons or components thereof;
- c. Prime contractors using or operating nuclear reactors or other nuclear devices in a U.S.
Government-owned vehicle or vessel; and
- d. Any other prime contractor or subcontractor of DOE or NRC when the State and the NRC jointly determine (i) that, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety and (ii) that the exemption of such contractor or subcontractor is authorized by law.
l If State law or administrative procedures restrict the ability of the program to impose license
[ _ . conditions or orders, the State should provide information on the restrictions and demonstrate - -
l - that an equivalent level of protection can be provided under the restrictions.
l A program should have authority for the reciprocal recognition oflicensees of other Agreement l States and the NRC.
Methods oflicensing that differ from the NRC guidance may be acceptable, but the State must demonstrate that at least the same level of protection for public health and safety with respect to the regulation of the possession, use, transfer, and disposal of materials is provided by the 06/15/99 11
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L Request for an Agreement Handbook alternate model, and that the alternate model does not create a disorderly pattem of regulation nationwide. Inspectors representing the program must be able, under law, to access licensed premises and to conduct inspections at reasonable times. The access authority should extend to
- unlicensed premises such that the program may conduct inspections when there is reasonable cause to believe that materials may be present. The authority may be for the program acting
! either on its own accord, or in cooperation with other authorities. " Reasonable cause" should l . include both the unlicensed use of materials, and the presence of materials resulting from accidental or unauthorized environmental release.
l- The program must have the legal authority to take prompt enforcement action. The program should have authority to immediately suspend licenses and impound materials, without prior hearing, in cases of noncompliance which cause imminent threat to public health and safety. The program should also have authority to suspend or revoke a license for repeated or continued noncompliance. The authority may be conditioned on a prior administrative orjudicial hearing. l The program should also have authority to seek injunctive relief, and refer licensees for criminal prosecution. The program is not required to have authority to impose civil (administrative) penalties.
If the authority to regulate the disposal oflow-level radioactive waste at a land disposal site under the Agreement is requested, the program must have legal authority to adopt requirements for the licensing of a disposal site that are consistent with the concepts and guidance in 10 CFR !
Part 61. The statutory authority should include the authority to require appropriate restrictions 1 on land ownership and use for an indefinite period of time after closure of the site. If specific statutory authority does not exist, the State should submit a formal determination by the State's
- Attomey General that sufficient legal authority exists for the program to license a site and enforce the safety objectives, standards, and requirements equivalent to the essential objectives of10 CFR Part 61. l l
- If the State seeks authority over section 1 le.(2) byproduct material, it must have specific i i statutory authority for assumption of regulatory authority, and for 6e program to license a site l .
- and enforce the safety objectives, standards, and requirements equivalent to the essential objectives of 10 CFR Part 40, Appendix A. The statute., shall
L a; Provide authority to license and regulate 1le.(2) byproduct material,
- b. Provide authority to require an Ile.(2) byproduct material licensee to comply with the l requirements of Appendix A to 10 CFR Part 40, or equivalent State regulations for the ownership
! of the byproduct material and disposal sites for the byproduct material.
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- c. Provide authority to require a surety which is adequate to assure the completion of the decontamination, decommissioning, and reclamation of sites, structures, and equipment used in
- conjunction with the generation or disposal of I le.(2) byproduct material.
j
- d. Provide authority to establish the requirements for the decontamination, decommissioning, and reclamation of sites, structures, and equipment used in conjunction with the generation or
- disposal of I le.(2) byproduct material.
.1
- e. Pro' vide authority to require an 1le.(2) byproduct material licensee to provide adequate funds j to cover the costs for long-term surveillance and maintenance prior to the termination of the !
license. I
- f. Require, if the program collects funds from a licensee or its surety for long-term surveillance and ma'mtenance, the total amount of the funds collected be transferred to the Federal )
l Government, if custody of the I le.(2) byproduct material and its disposal site is transferred to the
, Federal Government upon termination of the license. (See 10CFR 150.32.) If no default has i occurred and the reclamation or other bonded activity has been performed, the funds are not to be j transferred to the Federal Government. ;
- g. Require that funds the program collects from an Ile.(2) byproduct material licensee or L its surety for long-term surveillance and maintenance shall be sufficient to ensure compliance l with the regulations the Commission establishes pursuant to Section 161X of the Atomic Energy Act, i
- h. Require, in the issuance of 11e.(2) byproduct material licenses, an opportunity for written
- comments, public hearing (with transcript) and cross examination.
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- i. Require, in the issuance of 1le.(2) byproduct material licenses, a written determination of the !
action to.be taken based upon evidence presented during the public comment period, and which l is subject tojudicial review.' !
, j. - Require, in the issuance of 11e.(2) byproduct material licenses, a written environmental '
analysis (see Section 5.6.6).
l k.- Require, in the issuance of 11e.(2) byproduct material licenses, a ban on major construction L - prior to completion of the written environmental analysis.
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- l. Require an opportunity be provided for public participation through written comments, public hearings, and judicial review of rules.
06/15 /99 13 L ;
Request for an Agreement Handbook The State statutes shall not:
- a. ' Authorize the establishment of minimum standards governing reclamation, long-term surveillance or maintenance, and ownership of the 11e.(2) byproduct material.
l - b. Authorize the determination that a 1le.(2) byproduct material licensee has complied with _
L . decontamination, decommissioning and reclamation standards, and ownership requirements for the termination of a licensed site at which byproduct material is present.
L- - -
- c. + Authorize th'e termination of any 11e.(2) byproduct material license, or for any activity that results in the production of I le.(2) byproduct material, unless title te such byproduct material and the disposal site is transferred to the Federal Government, or to tl.e State at the option of the State, provided such option is exercised prior to termination of the license.
d." Provide the authority to require monitoring, maintenance, or emergency measures after the license is terminated, for those materials and property for which the State has assumed custody pursuant to UMTRCA.
- e. Provide the authority to permit use of the surface or subsurface estate, or both, of the land L transferred to the United States or the State under the provisions of UMTRCA.
l 4.1.2 Organization of the proposed program. !
l The organization of a program provides the basic structure and resources to conduct the program
. activities. The program organization thereby affects the ability of the program to protect public j health and safety against radiation hazards.
_4.1.2.1 Information needed
" ,m The State should submit a detailed narrative description of the program. The descriptio )
& be accompanied by organization charts showing all organizational levels between the Govemor j and the director of the program, and the organizational structure of the program itself. The State !
l should submit copies of any .MOU with other State agencies that will affect the program.
-4.1.2.2 Evaluation criteria l
- The program must be' designed to protect the health and safety of the people against radiation hazards. If the program elements are divide among separate agencies, the State must submit copies MOU's describing the responsibilities of each agency, and the efforts to assure 1
06/15 /99 14 l
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l- Request for an Agreement Handbook cooperation. The organization charts should clearly show the position of the program within the State government structure.
The program narrative description and organization charts should indicate both the technical staff and support staff positions assigned to the program full-time, and those available to the program jf part-time. . If the program utilizes the resources of another program, the program narrative
- description should detail the relationship of the two programs. The narrative description should l also discuss any use of contract services and advisory bodies. (NOTE: the criteria for evaluation of the technical staffis given m section 4.6.1) 1 :
4.1.3 Content of the proposed Agreement. 1 An Agreement may transfer to a State the authority to regulate any one or more of the following materials within the State:
- a. Byproduct materials as defined in section Ile(l) of the Act,
- b. Byproduct materials as defined in section 11e(2) of the Act,
- c. Source materials, l
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- d. Special nuclear materials, in quantities not sufficient to form a critical mass.
I
- In addition, an Agreement may transfer to a State the authority to conduct one or more of the l following activities, which otherwise remain under NRC jurisdiction:
- a. The regulation of the land disposal of byproduct, source, or special nuclear waste j materials received from other person',,
j -
- b. The evaluation of radiation safety information 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 the regulations or orders of the Commission. .
If any authority is not included in the proposed Agreement, it may be transferred subsequently by i an amendment, or by a later Agreement. Each Agreement is deemed to incorporate, without the need specific reference, the provisions of Pub. L.86-373 (1959 amendments to the Act adding section 274) and Pub. L.95-604 (UMTRCA) and the related provisions of the Act.
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Request for an Agreement Handbook The standard Agreement in MD 5.8 contains the provisions that the Commission has determined to be necessary in an Agreement that transfers all of the categories of materials (a so called " full Agreement"). Agreements that do not transfer one or more of the categories of materials may
- . delete the appropriate provisions, as indicated in MD 5.8, Handbook. >
l 4.1.3.1 Information needed
- The State should provide a proposed Agreement specifying the categories of materials to be transferred. The proposed Agreement should follow the format and content of the standard Agreement contained in Exhibit 1 of MD 5.8, Handbook. Where the State wishes to deviate from the standard Agreement, an explanation of the intent and the expected effect of the deviation should be provided.
4.1.3.2 Evaluation criteria l The proposed Agreement must be consistent with the requirement of the Act to promote an i regulatory orderly pattern of regulation. Nothing in the proposed Agreement may create a l duplication. conflict, or gap in the nationwide program for the regulation of materials. The l Agreement must transfer regulatory authority for all licensees in each category of materials i
specified in the Agreement.
The proposed Agreement should follow the standard Agreement in MD 5.8. Articles in the standard Agreement should be deleted or modified only as indicated in MD 5.8. Deletion or modification any other article of the standard Agreement requires that additional information be provided describing the need for the specific change and giving a basis for the Commission to approve the change.
4.2 Regulatory requirements program elements.
The evaluation of the regulatory requirements elements should be undertaken primarily by OSP, with concurrence by OGC, NMSS, and the Region. NRC should be able to conclude that the State has a set of regulations and generic legally binding requirements that are consistent with those NRC regulations designated as category A, B, C, or D/H&S, in accordance with the appropriate criteria for the categories indicated in OSP Procedure SA-200.
4.2.1 Standards for protection against radiation.
It is critical to have nationwide uniformity on the standards for protection against radiation, in order to assure adequate protection of health and safety. The standards include those generally 06/15 /99 16
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- applicable regulations or other generic legally binding requirements which specify dose limits for occupationally exposed persons and members of the public, and include constraints and limits on the concentration and quantity of materials released to the air and the environment. The standards include the technical definitioas and terminology, units of radioactivity and radiation dose, and radiation symbols, labels and warning signs.
4.2.1.1 Information needed 1
The State should submit copies of the sections ofits regulations, or generic legally binding i L '
requirements, that adopt standards for protection against radiation equivalent to those NRC regulations in 10 CFR Part 20 designated as compatibility category A, as listed in OSP Procedure SA-200, Appendix A. The State should also submit the sections ofits regulations, or generic legally binding requirements, that adopt standards equivalent to 10 CFR 61.41, if the authority to l - regulate waste disposal is requested.
4.2.1.2 Evaluation criteria The State standards for protection against radiation shall satisfy the criteria for consistency with the equivalent NRC regulations specified for compatibility category A in MD 5.9, Handbook.
The standards shall apply to all categories of materials covered by the Agreement, and should apply to all other sources of radiation regulated by the State. The standards shall consider the total occupational dose to individuals, including doses from exposure to sources of radiation not regulated by the State.
4.2.2 Regulatory requirements with significant transboundary implications.
Regulatory requirements within a State which affect the movement of goods and services across jurisdictional boundaries can cause regulatory conflicts, duplications or gaps if the State requirements are not consistent with the equivalent regulatory requirements of a neighboring
- -jurisdictionc The regulatory requirements established by the U.S. Department of Transportation l
applicable to the preparation of materials for shipment are adopted by NRC and the Agreement l
4 States to assure nationwide uniformity. Other NRC regulatory requirements, such as the
~
regulatory requirements related to quantities and concentrations of materials exempt from licensing, and a waste classification scheme equivalent to that contained in 10 CFR Part 61,also have significant effects across jurisdictional boundaries.
4.2.2.1 Infonnation needed l
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The State should submit copies of the sections ofits regulations, or generic legally binding requirements, that adopt regulatory requirements related to the transportation of materials.
The State should also submit the sections ofits regulations, or generic legally binding requirements, that adopt the other regulatory requirements which have been identified as having significant effect across jurisdictional boundaries. These regulatory requirements are equivalent to those sections of 10 CFR Parts 20,30,31,32,34,36,39,40,61,70, and 150 designated as I compatibility category B, as listed in OSP Procedure SA-200, Appendix A. I 4.2.2.2 Evaluation criteria l
The State regulatory requirements which may have significant effect acrossjurisdictional boundaries shall satisfy the criteria for consistency with the equivalent NRC regulations specified for compatibility category B in MD 5.9, Handbook.
'4.2.3 Regulatory requirements needed for an orderly pattern of regulation or which have particular health and safety significance.
The Act requires an orderly pattern of regulation nationwide. To assure such a pattern and to avoid conflicts, duplications, and gaps in materials regulation, it is necessary for States to adopt the essential objectives of certain NRC regulations. For example, individuals likely to receive an occupational dose in excess of 100 mrem in a year should receive equivalent safety instruction in all jurisdictions. In addition, other NRC regulations address regulatory requirements that are particularly significant to health and safety, In order for a State program to be considered adequate, it is necessary to adopt the essential objectives of these NRC regulations as well.
4.2.3.1 Information needed The State should provide its regulations or generic legally binding requirements specifying i regulatory requirements addressing the essential objectives of those sections of 10 CFR Parts 19,
{
20,30,31,32,33,34,35,36,39,40,61,70,71, and 150 designated as compatibility category C, '
i or D/H&S, as listed in OSP Procedure SA-200, Appendix A.
1 4.2.3.2 Evaluation criteria l The State regulations or generic legally binding requirements needed for an orderly pattern of j regulation, or which have particular health and safety significance, shall satisfy the criteria for '
consistency with the equivalent NRC regulations specified for compatibility category C, or ,
category D/H&S, as appropriate, in MD 5.9, Handbook.
06/15 /99 18 L
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4.3 Licensing program elements.
The primary review of the State's procedures for evaluating proposed uses of materials, including license review plans, guides, and procedures to assure the quality oflicensing actions, should be conducted by the DNMS of the appropriate region, with the support of NMSS and OSP. The primary review of the State's procedures for conducting safety evaluations of sealed sources containing materials, and of devices containing materials in sealed sources, should be conducted by appropriately qualified staff of NMSS. Based on the reviews, NRC hould be able to conclude that the State procedures are adequate to assure that licenses or registration sheets r issued by the program will provide reasonable assurance of public health and safety.
Administrative procedures, such as a procedure for tracking the progress of a license application, usually are not reviewed in detail, since they usually are not key contributors to program performance. The NRC stafTneed only conclude that written administrative procedures for licensing have been adopted by the State program, and that program performance is unlikely to be negatively impacted by them.
4.3.1 Procedures for the technical evaluation of proposed uses of RAM It is generally necessary for a materials program to require the submission ofinformation on the potential hazards of a proposed use of materials, and the capability of the users, prior to authorizing receipt of the materials. There are, however, groups of materials and uses about which there is sufficient knowledge to permit possession and use without prior evaluation. These groups fall into two classes--those materials and uses which may be completely exempt from regulatory controls, and those materials and uses in which general license authorization is given without pre-evaluation of the individual possession or use.
The authority to license the initial transfer of materials to persons whose subsequent possession and use of the materials is exempt from regulatory controls is reserved to NRC.
4.3.1.1 Information needed The State should submit copies ofits licensing procedures, including standard review plans, and licensing guides. Procedures submitted should cover at least each of the IMC 2800 license program codes for which an NRC licensee will transfer to the State.
Bangart's changes made to here ...... .... .. ................. ............................... ....
4.3.1.2 Evaluation criteria 06/15 /99 19
l l' Request for an Agreement Handbook
' The program should use written procedures, including standard review plans, and licensing guides, to assure a thorough and equitable evaluation of the applicant's facilities and safety i equipment, training and experience in the use of the materials for the purpose requested, and proposed administrative controls. States should provide the written procedures to, or develop other guidance documents for use by, license applicants. The procedures should provide for
-information exchange between the inspection staff and the licensing staff, as appropriate.
Reviewers may use NRC procedures and consolidated guidance to evaluate the State procedures, however, States are not required to adopt the NRC procedures and consolidated guidance. The
- State procedures should provide approximately the same level of detail as the equivalent NRC procedure, and all significant technical issues should be addressed.
. The use of radioactive materials and radiation on or in humans must not be permitted except by .
properly qualified persons (normally licensed ph' ysicians) possessing prescribed minimum experience in the use of radioisotopes or radiation.
The State procedures should provide guidance for the evaluation of technical issues in license applications. The issues to be evaluated include: places and conditions of storage; places and conditions of use, and decommissioning. Evaluation of the places of storage and use should
' address environmental considerations. 1 Evaluation of the conditions of storage and use should address security against unauthorized removal, and safety equipment. Evaluation of the conditions of use should address the 1 qualification of users, operating and emergency procedures, appropriate surveys and personnel I monitoring under the close supervision of technically competent individuals, and the j preparations for transport. Evaluation of decommissioning should address decontamination, I disposal, and funding. l 4.3.2 Procedures for the evaluation of radiation safety information on sealed sources or
= devices, and registration for distribution Sealed sources, and devices containing sealed sources, are commonly used in jurisdictions other - ,
than the one where the source and device is manufactured. Because of the transboundary l implications, evaluations of the safety of the sources and devices need to be conducted in i accordance with procedures that are relatively uniform nationwide. Based on its nationwide resources, NRC has taken the lead role in developing evaluation procedures. !
4.3.2.1 Information needed 06/15 /99 20 l
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The State should submit a copy ofits procedures for the evaluation of radiation safety information on sealed sources and devices (SS&D). The procedures should be equivalent to the NRC's consolidated guidance about applications for sealed source and device evaluation and registration in NUREG-1556, Volume 3. If the State proposes to use contractor assistance in the 4 evaluation, procedures for the quality assurance of contractor performance in accordance with NRC evaluation procedures or equivalent, should be submitted.
4.3.2.2 Evaluation criteria -
D HThe State procedures should be essentially identical to the equivalent NRC procedures with respect to technical issues evaluated, technical criteria used to determine the adequacy of the safety information provided, use of a concurrence review, and the content and format of the registration sheets. For additional criteria, see the IMPEP SS&D indicator (non-common performance indicator 2) in handbook 5.6 (dated November 25,1997 or later).
I 4.3.3 Procedure for conducting the technical evaluation of a proposed license for a low level radioactive waste land disposal site The technical evaluation of a proposed low-level radioactive waste land disposal site is an ;
- optional program element with significant health and safet,. aplications, and substantial additional resource requirements. If the State requests sucl. uthority under the Agreement,it should have the necessary procedures to conduct a waste site evaluation which addresses the essential objectives of the concepts and safety requirements specified in 10 CFR Part 61.
However, if NRC does not have a licensed site, or an application for a site license, that will transfer to thejurisdiction of the State, and there is no reasonable expectation of an application for a license being submitted in the foreseeable future, the State may assume the regulatory authority without having detailed procedures in place. In this case, a certification that the State will develop appropriate procedures before undertaking the evaluation of an application, accompanied by the conceptual description of the program is sufficient.
4.3.3.1 Information needed The State should submit copies ofits procedures, or its certification ofintent and program
. description. If the State proposes to use contractor assistance in the evaluation, procedures for L the quality assurance of contractor performance in accordance with NRC evaluation procedures or equivalent, should be submitted.
4.3.3.2 Evaluation criteria 06/15 /99 21
Request for an Agreement Handbook The State shoul' d have procedures which provide the same level of detail as the NRC procedures in NUREG-1200, however, the procedures are not required to be identical as long as all significant objectives are addressed. The State procedures should be consistent with the NUREG
.with respect to technical issues evaluated, qualifications of the personnel performing evaluations, and foi assuring the quality of the licensing action.
4.3.4 Procedure for conducting the technical evaluation of a proposed uranium or thorium -
recovery facility 4.3.4.1 Information needed :
The technical evaluation of a proposed uranium or thorium recovery facility subject to the requirements of UMTRCA is an optional program element with significant health and safety implications, and substantial additional resource requirements, if the State requests such authority under the Agreement, it should have the necessary procedures to conduct a site evaluation which addresses the essential objectives of the concepts and safety requirements specified in 10 CFR Part 40, Appendix A. However, if NRC does not have a licensed site, or an application for a site license, that will transfer to the jurisdiction of the State, and there is no reasonable expectation of an application for a license being submitted in the foreseeable future, the State may assume the regulatory authority without having detailed procedures in place. In this case, a certification that the State will develop appropriate procedures before undertaking the evaluation of an application, accompanied by the conceptual description of the program insufficient.
4.3.4.2 Evaluation criteria The State should have procedures which provide the same level of detail as the equivalent NRC procedure, however, the procedures are not required to be identical as long as all significant technical issues are addressed. The State evaluation procedures should be consistent with the NRC procedures with respect to technical issues evaluated, qualifications of the personnel
. performing evaluations, and for assuring the quality of the licensing action.
4.3.5 Procedures for the assuring the technical quality oflicenses.
Secondary review oflicense applications adds value to, and helps assure the integrity of, the application evaluation process. Peer and supervisory review are commonly used. Larger programs may use a committee to conduct reviews of selected application evaluations recently completed. Other forms of effective quality assurance are acceptable.
06/15 /99 22 i.
Request for an Agreement Handbook 4.3.5.1 Information needed '
The State sh'ould submit copies ofits procedures that address peer review, supervisory review, l
and/or any other method adopted by the program to help assure the quality oflicensing actions.
4.3.5.2 Evaluation criteria- j
- The State should have written licensing procedures which provide some form of review for 3 licensing quality. No particular form or method is preferred. The procedures should reflect the f- + organization of the State program and any special requirements of State statute.
4.3.6 Administrative licensing procedures.
Appropriate arrangements need to be made by NRC and the State to ensure that there will be minimal interference with or interruption oflicensed activities or the processing oflicense applications, by reason of the transfer of regulatory authority. Generally, States recognize existing NRC licenses, including licenses for which timely applications for renewal have been filed, and continue those licenses in effect until State licenses are issued as replacements.
The routine operation of the program requires administrative processing oflicenses beyond the technical evaluations.--Written procedures describing the administrative processing steps are useful to assure that all procedural requirements are completed, and may become critical in the ;
event of an unexpected tum-over of senior staff. -
4.3.6.1 Information needed The State should submit its proposed arrangements for the continued authorization of NRC licensed activities to be transferred to the State under the Agreement.
The State should submit copies ofits administrative procedures for receipt oflicensing actions, l
. - . , tracking, assignment to technical evaluators, license document preparation, quality assurance, a j signature, and transmittal of the signed license to the bcensee.
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l_ . 4.3.6.2 Evaluation criteria j i
The State should provide for the continued operation of activities licensed by NRC that are l transferred to the State, i i
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06/15 /99 23 i
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y The State should also have program specific written procedures to guide licensing program staff.
The procedures should reflect the organization of the State program and any special requirements of State statute (i.e., who can' sign licenses). Since these procedures do not require a thorough review, a selected sampling of the procedures may be reviewed instead.
4.4 Inspection program elements.
The review of the State's inspection procedures should be undertaken primarily by the DNMS of the appropriate region, with the support of NMSS and OSP. Based on the review, NRC should be able to conclude that the inspection procedures are adequate to assure that inspections conducted by the State program will be likely to capture significant violations of regulatory requirements.
Administrative procedures, such as a procedure for assigning inspections to inspectors, usually are not evaluated in detail, since they usually are not key contributors to program performance.
l The NRC staff need only conclude that written administrative procedures for inspection have
- been adopted by the State program, and that program performance is unlikely to be negatively impacted by them, 4.4.1 Procedures for inspecting facilities where RAM is stored or used j Periodic inspections at licensed facilities are essential to ensure licensee compliance with l regulatory requirements. Inspections need to be timely, thorough, objective, orderly, and I i
proportional in depth to the risk associated with the licensed use of materials, amount of materials authorized by the license, and the licensee's past performance, if appropriate. The I inspections need to be thoroughly documented in the inspection reports. Licensees are entitled to be advised of the results ofinspections and to notice as to whether or not they are in compliance.
This information should be provided in a short period of time, usually within 30 days after the
! inspection. The procedures should be reviewed by the NRC Regional inspection staff.
4.4.1.1 Information needed The State should submit copies ofits inspection procedurcs, including inspection report formats, checklists, etc. Procedures submitted should cover at least each category oflicense issued by NRC to a licensee which will transfer to the State. The State should also submit its priority schedule for inspections by license type.
4.4.1.2. Evaluation criteria 06/15 /99 24
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l Inspection should be performed in accordance with written procedures which address inspection activities appropriate to the category oflicensee being inspected. The frequency ofinspection should be related directly to the amount and kind of material and type of operation licensed, and l it should not be less than the frequency of NRC inspections for the type of operation licensed, as indicated in IMC 2800, enclosure A. Inspection procedures should provide for information
! exchange between the inspection staff and the licensing staff, as appropriate.
Reviewers may use NRC inspection procedures as guidance to evaluate whether the State procedures address all major components of the inspection. The State procedures should provide approximately the same level of detail as the equivalent NRC procedure, however, uniformity of the procedures is not required as long as all significant technical issues are addressed. States are l not required to adopt the NRC procedures.
4.4.2 Procedures for assuring the technical quality ofinspections and inspection reports.
l Secondary review ofinspection reports adds value to, and helps assure the integrity of, the l
inspection process. Peer and supervisory review are commonly used. Larger programs may use a committee to conduct reviews of selected inspections recently completed. Other forms of )
L effective quality assurance are acceptable.
l 4.4.2.1 Information needed L The State should submit copies ofits procedures that address peer review, supervisory review, and/or any other method adopted by the program to help assure the quality ofinspections and j inspection reports.
l 4.4.2.2 Evaluation criteria l
The State should also have written procedures to guide p.ogram staff. No particular form or l method is preferred. The procedures should reflect the organization of the State program and any !
special requirements of State statute. l L
4.4.3 . Administrative procedures for inspections.
. The routine operation of the program requires program specific processing ofinspection reports after they are written. Written administrative procedures des:ribing the processing steps are useful to assure that all procedural requirements are completed, and may become critical in the !
event of an unexpected turn-over of senior staff.
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l Request for an Agreement Handbook 4.4.3.1 Information needed The State should submit copies its inspection program element administrative procedures.
4.4.3.2 Evaluation criteria The State should have program specific written procedures. The procedures should reflect the organization of the State program and any special requirements of State statute (i.e., public disclosure or confidentiality). Since these procedures do not require a thorough review, a !
i selected sampling of the procedures may be reviewed instead.
4.5 Enforcement program elements.
The evaluation of the State's enforcement program elements should be undertaken primarily by the DNMS of the appropriate region, with the support of NMSS and OSP.
The NRC staff should be able to conclude that the enforcement procedures are adequate to assure that licensees will face appropriate enforcement action for violations of regulatory requirements, I particularly those that cause undue risk to public health and safety. )
4.5.1 Routine enforcement procedures.
Materials programs use a number of different sanctions in seeking licensee compliance with regulatory requirements. Generally, the sanctions are scaled to the seriousness of the violation.
For the least serious, a notice of violation may be issued to which the licensee must respond describing how and when the licensee expects to achieve compliance. For more serious violations, a follow-up inspection or an early re-inspection may be scheduled. Civil penalties in scaled amounts may be assessed. The licensee may be required to attend an enforcement conference to discuss the violations in person with agency managers.
4.5.1.1 Information needed The State should submit its procedures for routine enforcement actions.
4.5.1.2 Evaluation criteria .
State procedures for assuring the fair and impartial administration of regulatory law, including provision for management conferences or administrative hearings where appropriate, should be
- incorporated into the procedures for routine enforcement actions against licensees. The 06/15 /99 26
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procedures should be scaled to the seriousness of the violation, but no standard of scaling is established.
- l. . The procedures should establish standard methods of communicating sanctions to the licensee.
, . Written notice should be given using standardized wording and format.' The wording and format should be reviewed by legal counsel.
The procedures should include a means for tracking the completion of enforcement actions.
4.5.2 Escalated enforcement procedures.
For more serious or repeated violations of regulatory requirements, the program should utilize escalated enforcement, which may include administrative or civil monetary penalties, the modification, suspension, or revocation of the license, or referral for criminal prosecution.
4.5.2.1 Information needed The State should submit copies ofits procedures for escalating enforcement actions.
4.5.2.2 Evaluation criteria
- State procedures for assuring the fair and impartial administration of regulatory law, including provision for public notification and participation at administrative orjudicial hearings where appropriate, should be incorporated for escalated enforcement actions against licensees. The sanctions should be scaled to the seriousness of the violation, and should generally provide more severe sanctions than routine enforcement.
The procedures should establish methods of communicating sanctions to the licensee. . Written
- notice should be given, using standardized wording and format when practical. Written communications regarding escalated enfhreement actions should be coordinated with legal
. counsel, and signed by the program manager or a person higher in the State organization. -
The procedures should include a means for tracking the completion of enforcement actions (may not be necessary in smaller programs).
4.6 . Technical staffing and training program elements.
The evaluation of the program's staffing and training program elements should be undertaken primarily by OSP, with the support of NMSS and the DNMS of the appropriate region.
06/15 /99- 27
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l Request for an Agreement Handbook The evaluation of applications for licenses and the inspection oflicensees requires a technical staffincorporating adequate training and experience relevant to the type and level of radioactivity
~ in the use to be evaluated and inspected. The technical staff needs the competency to evaluate
. radiological hazards, radiation levels, contamination levels, concentrations of materials in air and water, the condition of shielding, and the use of management controls in assuring adherence to l . safety procedures.
Each technical staff member needs training and experience in the general principles and practices of radiation protection, measurements of radiation, and the selection, use and calibration of
~ radiation instruments."In order to evaluate some complex cases, the program staff may need to l be supplemented by consultants or other State agencies with expertise in laboratory design, geology, hydrology, water quality, radiobiology and engineering disciplines.
l The NRC staff should be able to conclude that the program's current staff, staffing plan, and
.]
formal qualification plan are adequate for the projected workload under the Agreement.
4.6.1 Technical stafforganization.
The State should conduct an analysis of the expected workload, and establish an appropriate staffing plan. The analysis should consider the number, distribution, and sizes of the licensees to l be transferred under the Agreement. It should also consider if the State will: evaluate the radiation safety information on sealed sources or devices containing materials and register the sealed sources or devices for distribution; license a low level radioactive waste land disposal siM; a license uranium or thorium recovery facility subject to the requirements of UMTRCA; or will license major manufacturers, universities with major research programs, or other large scale materials users. !
4.6.1.1. Information needed The State should submit copies ofits program stafling plan, including organization charts. The
]I stalling plan or chart should indicate the number of staff assigned to specific responsibilities, i such as license review and inspection. The State should also describe the anticipated workload l for the number and types oflicensees to be regulated, and the other responsibilities of the l program. )
1 4.6.1.2 Evaluation criteria The program shall be staffed with a sufficient number of trained personnel. The stafishall consist of at least two individuals. There is no requirement for a specific FTE per number of 06/15 /99 28 l
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1 licenses, but the experience ofexisting Agreement States with similar programs should be considered. Depending on the level of training and experience, existing Agreement State programs typically employ approximately I to 1.5 technical staff FTE per 100 active licenses other than waste disposal sites or uranium mills. The distribution of staff should be based on L . workload estimates which are reasonably consistent with NRC experience.
The State workload estimates should be based on the State's own organization, policies,
- practices, and procedures. Due to the differences between the State and NRC programs, the State should not create a staffing plan based solely en NRC staffing.
4.6.2 Formal qualification plan.
The ability to conduct an effective materials program depends on having a sufficient number of l
trained and experienced staff members. Since normal events such as retirements cause the i- turn-over of qualified staff members, there needs to be an organized means to hire and qualify I
replacements for anticipated stafflosses.
4.6.2.1 Information needed
-The State should submit copies ofits position descriptions, and its plan for the formal l
qualification of technical staff members.
4.6.2.2 Evaluation criteria.
i Each technical staff position should require a bachelor's degree in the physical or life sciences, such as physics, chemistry, biology, or engineering, or an equivalent combination of education and experience.
The program should have a written plan to assure that technical staff are qualified by job specific l training and experience. The plan should specify the training required by position, and
[.. .. procedures for application of the plan, including time frames for completion and a means for . .;
formal identification of qualified individuals. The plan should meet the training and requirements in the OAS/NRC working group recommendations. The NRC formal qualification program in IMC 1246 may be used as general guidance.
4.6.3 ! l Qualifications of current technical staff.
The program should have a composite of skills either in its employ or at its command, not only for routine functions, but also for emergency cases.
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! 4.6.3.1 Information needed.
Copies of the rdsumds of the current members of the program technical staff should be submitted.
The rdsumds should, as a minimum, show the educational level, experience, and any speciality training. For staffmembers that have been accepted for participation in NRC training courses not yet completed, the course name or description and dates should also be provided.
4.6.3.2 . Evaluation criteria.
- Except for a limited number ofjunior positions, each staff member should meet the program's -
own qualification requirements. The reviewers may also consider the State staffs experience -
working with NRC inspectors and license reviewers, and in regulating non-Agreement materials and machine-produced sources of radiation.
4.7 Event and allegation response program elements
' The evaluation of the State's events response elements should be undertaken primarily by the DNMS of the region, with the support of NMSS, and OSP.
Based on the evaluation, NRC staff should be able to conclude that the event and allegation response procedures are adequate to assure that the program will identify and respond appropriately to events and allegations, particularly those that involve significant risk to public health and safety.
4.7.1 Procedures for responding to events and allegations.
The program must have the capability to respond to materials events within the State. The
, capability may be part of another organization, such as a response organization for fixed nuclear facilities, however, it is still part of the materials program under the Agreement.
. The program should be able to respond to allegations of violations of regulatory requirements ..._,-
whether due to negligence or wrongdoing. The program does not need to have criminal l investigatory capability within the program or its parent agency, but should have procedures for referral to appropliate authorities as needed.
4.71.1 Information needed l . The State should stbmit copies ofits procedures for responding to events and allegations.
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4.7.1.2 Evaluation criteria I The procedures should be consistent with, but need not be identical to NRC procedures. The procedures should address immediate response, actions to be taken to mitigate an event, follow-up inspections, enforcement actions, notifications to licensing staff, reports to the
. incidents file, notifications to NRC and notifications to other affected licensees in the case of generic problems.
4.7.2 Procedures for reporting material events identifying abnormal occurrences and allegations, and for entering event reports into the Nuclear Materials Events Database.
In order to assure the regulatory effectiveness there needs to be an interchange ofinformation on reports ofincidents and violations. NRC has established a database (NMED) of materials events, including incidents, accidents, and medical misadministrations. The States are required to enter reports of all events for which licensees are required by NRC regulations (or State equivalents) to ,
file reports into NMED.
l 4.7.2.1 Information needed !
l The State should submit procedures for identifying appropriate events and entering them into !
' NMED. The procedures should address who will be responsible for completion of The procedures, and the time frames for completion.
I 4.7.2.2 Evaluation criteria l
The materials program procedures should contain criteria for identifying reportable events, and forwarding reports (notification, followup and closeout) to NRC for inclusion in NMED.
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References Request for an Agreement Ilandbook Glossary AEOD NRC Office for Analysis and Evaluation of Operational Data CFR Code of Federal Regulations
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DNMS Division of Nuclear Materials Safety (NRC regional organization units)
FTE Full Time Equivalent of personnel effort
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IMC NRC Inspection Manual Chapter j i
MD NRC Management Directive MOU Memorandum of Understanding NMED Nuclear Materials Event Database NMSS NRC Office of Nulear Materials Safety and Safeguards NARM Naturally occmring or accelerator produced materials (not subject to the Act)
NRC United States Nuclear Regulatory Commission OGC NRC Office of the General Counsel OSP NRC Office of State Programs RSAO Regional State Agreements Officer (NRC staff)
UMTRCA Uranium Mill Tailings Radiation Control Act of 1978, as amended 06/15 /99 32
References Request for an Agreement Handbook 1
Definitions As used in this document: 1 Act - means the ' Atomic Energy Act of 1954, as amended.
I Commission - means the United States Nuclear Regulatory Commission Civil penalty - means a' monetary fine imposed and collected by the materials program, or by apparent agency. Also known as an " administrative fine."
Generic legally binding requirement - means a legally enforceable statement, limited in the extent ofits application, that implements or interprets law or describes procedural requirements, and that is adopted in accordance with the administrative procedures of the promulgating jurisdiction. Examples are license conditions or orders. Generic legally binding requirements differ from regulations in that they are directed to a specifically identified constituency. To be considered generic, however, the requirements should be made effective upon all members of any class oflicensees or other persons upon dhich a regulation would have effect.
License - includes registrations, permits, and certifications.
License application - means the formal request for a new license, a license renewal, or a license amendment, as appropriate, made in accordance with the administrative licensing procedures of thejurisdiction.
Materials - generally means byproduct, source, and special nuclear materials, as defined in the Act, liowever, if appropriate to the context, it may include naturally occurring or accelerator
. produced radioactive materials, if such radioactive materials are regulated by the same program i designated to regulate byproduct, source, and special nuclear materials under The agreement. l
. Program - means the organization within ajurisdiction that is specifically dedicated to the regulation of materials. It may be a separate organizational unit, or a subunit of an organization ;
2 with wider responsibilities. It may also consist of the sum of the materials program elements distributed over several organizations. The NRC materials program consists primarily of NMSS and the DNMS of each region, but includes the support activities provided by other NRC Offices as required.
l Memorandum of Understanding - means any formal statement of cooperation between agencies.
The term " Letters of Agreement" is equivalent.
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Procedure - means a written statement delineating the steps in an activity, may include
" policy" statements.
Radiation - means ionizing radiation only.
Regulation - means a legally enforceable statement of general applicability.that implements or
- interprets law or describes procedural requirements, and that is adopted in accordance with the -
administrative procedures of the promulgating jurisdiction. The term " rule" is equivalent.
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SUMMARY
OF INFORMATION NEEDED IN STATE AGREEMENT APPLICATION Handbook Submission from State
Reference:
NRC Docum6nt or Section Model Document 4.1.1 - Sections of State Law with authority to Council of State Governments establish program and enter into an suggested legislation; Agreement . Statement of Principles and Policy for the Agreement State Program 4.1.2 - Detailed narrative description of Recent Agreement State Application; radiation protection program - MD 5.9; SA-200, Appendix B 4.1.3 Proposed Agreement MD 5.8 4.2 - Regulations or legally binding MD 5.9; SA-200, Appendix A:
requirements that adopt radiation Title 10 CFR Parts ,20,30,31,32,33,34, protection standards and other 35,36,39,40,61,70,71 and 150 essential objectives of NRC regulations and SSRs 4.3.1 Licensing procedures for technical general: SA-104, NUREG-1556 series, evaluation of RAM uses decommissioning: MARSSIM, DG-4006, NUREG-0241, NUREG-5849 4.3.2 Procedures for evaluating SS&D NUREG-1556, Volume 3 4.3.3 Procedures for evaluating LLW NUREGs-1199,1200 and 1300 and disposal site NUREG-1274 4.3.4 Procedures for evaluating uranium or Uranium Recovery Program Policy and thorium recovery facility Guidance Directive System I 4.3.5 Procedures for review of licensing SA-104 quality 4.3.6 Administrative procedures for handling Recent Agreement State Application licensing actions 4.4.1 Inspection procedures and report SA-101 and 102, IMC 2800, IMC 1220 formats and IP 87101 through 87120 l 4.4.2 Procedures for review of inspection IMC 2800 and SA-102 quality 4.4.3 Administrative procedures for IMC 2800 inspections 4.5.1 Procedures for routine enforcement NUREG-1600 and IMC 2800 j actions 4.5.2 Procedures for escalated enforcement NUREG-1600 and IMC 2800 4 actions ENCLOSURE 3 J
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Handbook Submission from State
Reference:
NRC Document or Section Model Document 4.6.1 Program staffing plan Recent Agreement State Application 4.6.2 Formal qualification plan for technical IMC 1246 or NRC/OAS Training staff Working Group Recommendations for Agreement State Training Programs 4.6.3 Qualifications of current technical staff Recent Agreement State Application i
4.7.1 Procedures for responaing to incidents general: SA-105 l and allegations allegations: MD 8.8 I incidents: IMC 1300-1303 and 1330 f 4.7.2 Procedures for reporting events, SA-300, Appendix A identifying AOs, and NMED reporting MD: Management Directive SA: OSP Procedure SSRs: CRCPD's Suggested State Regulations l
DG: Draft Regulatory Guide {
IMC: Inspection Manual Chapter I IP: Inspection Procedure l
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