ML20248D764

Confirms That Review of State of Il Radiation Control Program Scheduled for 900129-0209. App a Evaluation of Agreement State Radiation Control Program,State Review Guidelines & Questionnaire Encl

ML20248D764
Person / Time
Issue date:	09/27/1989
From:	Jeffery Lynch NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To:	Eastvold P ILLINOIS, STATE OF
References
NUDOCS 8910040390
Download: ML20248D764 (34)

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,,_ September 27,.1989.

4 Mr.' Paul Eastvold

. Illinois Department of Nuclear Safety

~1035~ Outer Park Drive Springfield, IL' 62704

Dear Mr. Eastvold:

.This will confirm our:recent discussion concerning the review of your Radiation Control Program scheduled for January 29 to February 9, 1990.

I am enclosing a list of questions entitled " Appendix A, Evaluation of

' Agreement State Radiation' Control Program, State Review Guidelines and Questionnaire." These questions have been revised.since our previous review and will become Appendix A to our report.

To facilitate the review process, please return a completed copy of'the document including the guidelines, questions and your answers to me prior to January 5, 1990. Also, Appendix A questions are provided on an enclosed-

' diskette.

Thank you for your cooperation and if you have questions, please contact me.

Sincerely,

'/s/ James L. Lynch James L. Lynch Agreement State Program Officer

Enclosure:

Evaluation of Agreement State .

Radiation Control Program l State Review Guidelines, and Questionnaire cc w/ enclosure:

Vandy L. Miller, Assistant Director for State Agreements Program Terry Lash, Ph.D., Director, Illinois Department of Nuclear Safety bec: ent Control Desk (SP01) i u i

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h APPENDIX A STATE REVIEW GUIDELINES AND STATE RESPONSES TO QUESTIONNAIRE

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APPENDIX A )

EVALUATION OF AGREEMENT STATE RADIATION CONTROL PROGRAM STATE REVIEW GUIDELINES AND QUESTIONNAIRE Name of State Program Date of NRC Review (Month, Year)

1. LEGISLATION AND REGULATIONS A. Leoal Authority (Category I)

NRC Guidelines: Clear statutory authority should exist, designating a State radiation control agency and providing for promulgation of regulations, licensing, inspection and enforcement. States regulating uranium or thorium recovery and associated wastes pursuant to the Uranium Mill Tailings Radiation Control Act of 1978 (UMTRCA) must have statutes enacted to establish. clear authority for the State to carry out the requirements.of UMTRCA.

Questions:

1. Please list all currently effective legislation that affects the radiation control program (RCP).

2. What changes have been made to the state's statutory authority to regulate agreement materials including LLW operations, since the last review? Please attach copies of the changes.

3. Please cite legislation if the State has the authority to:

a. apply civil penalties,

b. collect fees,

c. require performance bonds or sureties for decommissioning licensed facilities,

d. require performance bonds or sureties for clean-up of licensed facilities after a contamination accident,

e. require long term care funds for uranium mill or low-level waste facilities.

4. If any responses to the above question are negative, explain any plans the State may have regarding those issues.

B. Status and Compatibility of Regulations (Category I)

NRC Guidelines: The State must have regulations essentially identical to 10 CFR Part 19, Part 20 (radiation dose standards, effluent limits, waste manifest rule and certain other parts), Part 61

(technical definitions and requirements, performance objectives, financial assurances) and those required by  !

UMTRCA, as implemented by Part 40. The State should adopt other regulations to. maintain a high degree of i uniformity with NRC regulations. For those regulations l deemed a matter of. compatibility by NRC, State regula-tions should be amended as soon as practicable but no later-than 3 years. The RCP has established procedures for effecting appropriate amendments to State regu-lations in.a timely manner, normally within 3 years of adoption by NRC. Opportunity should be provided for the public to comment on-proposed regulation changes.

(Required by UMTRCA for uranium mill regulation.)

Pursuant to the terms of th2' Agreement, opportunity should be provided for the NRC to conment on draft changes in State regulations.

Questions:

1. What is the effective date of the last amendment of the state's-regulations that was made to maintain compatibility?

2.. Referring to the NRC chronology of amendments attached to this questionnaire identify those that have not been adopted by the State and explain the reason why they were not adopted and/or actions being taken to adopt them.

3. Describe your State's procedures for revising and adopting changes to regulations.

4. How is the public involved in the process?

5. At what stage does the NRC have the opportunity to comment on draft changes to State regulations?

II. ORGANIZATION A. Location of the Radiation Control Procram Within the Sta te Organization (Category 11)

NRC Guidelines: The RCP should be located in a State organization parallel with comparable health and safety programs. The Program Director should have access to appropriate levels of State management. Where regulatory responsibilities are divided between State agencies, clear understandings should exist as to division of responsibilities and requirements for coordination.

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1. Please attach a current dated organization chart (s) showing the position of the RCP within the State organization and its relationship to the Governor.

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2. Is the RCP on a-comparable level within the State organization with other health and safety programs so as to compete effectively for funds and staff?

3. JHas the RCP- program director experienced difficulty in obtaining access to. appropriate levels of State management? If so, explain.

B. -Internal' Organization of the RCP (Category II)

NRC Guidelines: The RCP should be organized with the view toward achieving an acceptable degree of staff efficiency, place appropriate emphasis on major program functions, and provide specific lines of supervision from program management for the execution of program policy. Where regional offices or other government.

agencies are utilized,1the lines of communication and administrative control between these offices and the central office (Program Director) should be clearly drawn to provide uniformity in licensing and inspection policies, procedures and supervision.

Questions:

1. Please attach current, dated copies of-the RCF organization charts. Include titles for all positions and names for incumbents. If applicable, include regional offices and contract agencies.

2. If regional offices or contract agencies are used:

a. To whom do regional or contract agencies personnel report administrative 1y?

b. To whom do regional or contract agencies personnel report technically?

3. If the RCP shares the program with or contracts with other agencies to administer the program:

a. Identify the agencies and indicate their responsibilities.

b. How are their responsibilities set out (e.g.

statutes, MOU, contract)?

c. To whom do their personnel report to administratively?

l d. To whom do their personnel report to technically?

l C. Lecal Assistance (Category II)

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NRC Guidelines: Legal staff should be assigned to assist the RCP or procedures should exist to obtain legal assistance expeditiously. Legal staff should be knowledgeable regarding the RCP program, statutes, and ,

i regulations.

Questions- l

1. Are legal staff members assigned to assist the RCP I or do procedures exist to obtain legal assistance expeditiously?

2. Is the legal staff knowledgeable regarding radioactive materials, the RCP, statutes, and regulations?

3. If legal assistance was utilized since last review, provide a brief summary of the circumstances.

D. Technical Advisory Committees (Category II)

NRC Guidelines: Technical Committees, Federal Agencies, and other resource organizations should be used to extend staff ,

capabilities for unique or technically complex problems.

A State Medical Advisory Committee should be used to provide broad guidance on the uses of radioactive drugs in or on humans. The Committee should represent a wide spectrum of medical disciplines. The Committee should advise the RCP on policy matters and regulations related to use of radioisotopes in or on humans. Procedures should be developed to avoid conflict of interest, even though Committees are advisory. This does not mean that representa-tives of the regulated community should not serve on advisory committees or not be used as consultants.

Questions:

1. What technical advisory committees have been established to assist the RCP?

2. Are regular meetings scheduled? If so, what is the frequency?

3. Please provide a list of the names and affiliations of the technical committee (s) members.

4. What procedures exist to avoid areas of conflict of interest by members of the committees?

5. If any advisory committee was utilized during the review period, please provide a brief summary of the circumstances.

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III. MANAGEMENT AND ADMINISTRATION-A. Ouality of Emercency Plannina (Category I)

NRC Guidelines: The State RCP'should have a written plan for response to such incidents as spills, overexposure, transportation accidents, fire or explosion, theft, etc. The Plan'should define the responsibilities and. actions to be taken by State-Agencies. The Plan should be specific as to persons responsible for initiating response actions, conducting operations and' cleanup..-Emergency communication procedures should be adequately established with appropriate local, county and State agencies. Plans should be distributed to appropriate persons and agencies. NRC should be provided the opportunity to comusit on the Plan while in draft form. The plan should be. reviewed annually by. Program staff for adequacy and to determine that content is current.

Periodic drills should be performed to test the plan.

Questions:

1. What written plan does the RCP use for response to incidents involving radioactive materials (other than. plans for fixed nuclear facilities)?

2.. According to the Plan, which State agency is responsible for:

a. initiating response actions?

b. conducting operations?

c. supervising cleanup?

3. Describe your emergency communications procedures.

4. Who is responsible for distributing the plan to the appropriate persons and agencies?

5. When was the emergency communication list last reviewed and/or revised? (Please attach a copy of the current list.)

6. Other than the communication list, when was the plan last updated?

7. At what stage is the NRC provided the opportunity to comment on the plan or the revision while it was in draft form?

8. When was the plan last reviewed to assure its content is up-to-date?

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9. When was a drill last performed to test the plan?

B. Budaet-(Category II)

NRC Guidelines: Operating funds should be sufficient to support program needs such as staff travel necessary to conduct an effective compliance program, including routine inspections, follow-up or special inspections (including pre-licensing visits) and responses to incidents and other emergencies, instrumentation and other equipment to support the RCP, administrative costs in operating the program including rental charges, printing costs, laboratory services, computer and/or word processing support, preparation of correspondence, office equipment, hearing costs, etc. as appropriate.

Principal operating funds should be from sources which provide continuity and reliability, i.e., general tax, license fees, etc. Supplemental funds may be obtained through contracts, cash grants, etc.

Questions:

1. Show the amount for funds for the RCP for the current fiscal year obtained from:

a. State general fund

b. Fees

c. Federal grants and contracts (identify)

d. Other

e. Total:

2. Show the total amounts in the current RCP budget allocated for:

a. Administration

b. Radioactive materials

c. X-ray

d. Environmental surveillance

e. Emergency planning

f. LLW regulation

g. Other (radon, non-ionizing, operator credentialing, etc. Please identify).

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3. What is the change in budget from the previous' year i

-and what-is the reason for the' change (new programs, change in emphasis,~ statewide reduction, etc.)?

Describe your fee system, if you~have one, and give 4.

the. percentage of cost recovery for the radioactive _l materials program. -Please attach a copy of the' fee l '-- schedule.

L L 5. Cverall, is the funding sufficient to support all of-the program needs? If not, specify the problem.

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. C. Laboratory Support (Category, II) j NRC' Guidelines: The RCP should have the laboratory support  :

capability inhouse, or readily available through established.  !

procedures, to conduct bioassays, analyze environmental samples, analyze samples collected by inspectors, etc., on a

- priority established by the RCP.

Questions:

1. Are laboratory services readily available in-house or  !

through other departments within the State organization?  !

2. If services are provided by other departments, discuss

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j the arrangements, supervision, charges and interdepartmental communications.

3. Have there been any changes in the status of the laboratory support since the last review? If so, please explain.

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4. . If laboratory services'are'provided by a non-State j agency. 3 l

a. Discuss the contractual arrangements. l l

b. Is the party providing the service a State licensee?

c. If a State licensee provides the service or e]uipment, what are the costs?

5. Describe the capability of the laboratory as follows:

a. Can it qualitatively and quantitatively analyze low-energy beta emitters?

b. Can it qualitatively and quantitatively analyze alpha emitters?

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d. Can it handle samples in any physical form - wipes,  ;

liquids,. solids,' gaseous?.

e.- .Does the lab participate in a periodic.qualityf control program? HIf so,.please identify the.

program.

6. How much time does it take to obtain the~results from- j i

sample analyses on both a routine basis and on'an emergency basis? l

7. Please. attach a list giving the types and numbers of laboratory instrumentation and services available. q D. Administrative Procedures-(Category II) >

NRC Guidelines: The RCP should establish. written internal procedures to assure that the staff performs its' duties as required and to provide a high degree of uniformity and continuity in regulatory practices. i These' procedures should address internal. processing of license applications, inspection policies, l decommissioning and license termination, fee collection,  ;

contacts with communication media, conflict of interest i policies-for employees, exchange of information and other functions required of the program. Administrative-procedures are in addition to the technical procedures utilized in licensing,.and inspection and enforcement. ]

l Questions:

1. - Have administrative procedures and polices been ,

established, documented and made available to RCP  !

staff regarding:

a. Office administration, i

b. Receipt, assignment and tracking of license applications, l

c. Inspections (e.g., assignments, announcements of j inspections),  ;

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d. Terminating licenses and decommissioning ,

licensed facilities, i

e. Collecting fees, i

f. Responding to press inquiries,

g. Conflict of interest for RCP employees, j

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'h. Exchange-of-Information with NRC and Agreement States,

i. Distribution (as appropriate) to staff and licensees of All Agreement State Letters and Information Notices.

(Please have copies of these procedures available for review).

2. What other written administrative procedures have been developed?

3. Have copies of these procedures been distributed to regional offices and to other appropriate agencies?

4. How are personnel and regional offices (if applicable) kept informed of changes in regulatory policies and practices?

E. Manaaement (Category II)

NRC Guidelines: Program management should receive periodic reports from the staff on the status of regulatory actions (backlogs, problem cases, inquiries, regulation revisions). RCP management should periodically assess workload trends, resources and changes in legislative and regulatory responsibilities to forecast needs for increased staff, equipment, services and fundings. Program management should perform periodic reviews of selected license cases handled by each. reviewer and document the results.

Complex licenses (major manufacturers, large scope -

Type A Broad, or potential for significant releases to environment) should receive second party review (supervisory, committee, or consultant). Supervisory review of inspections, reports and enforcement actions should also be performed. When regional offices or other government agencies are utilized, program management should conduct periodic audits of these offices.

Questions:

1. How does management track the status of the licensing and inspection programs -- workloads, backlogs, problem cases, etc.?

2. How often are meetings held between program management and staff?

3. How often is a statistical tabulation of licenses, licensees, licensing actions, inspections due,

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performed and overdue, etc., prepared?

4. How does program management keep abreast of changes in legislative and regulatory responsibility?

5. What license review practices are followed for unusual or complex license applications?

6. How many management reviews of license cases were performed since the last review?-

7. Were all license reviewers included in the cases selected for management review?

8. How many field accompaniments of inspectors were conducted by program management?

9. Were all inspectors (including supervisors acting as inspectors or LLW inspectors, if applicable) accompanied by management during the review period?

10. Do all inspection reports receive supervisory review?

11. Does all enforcement correspondence receive supervisory review prior to dispatch?

12. If applicable, how many management audits were made of regional offices or other government agencies involved in the regulation of agreement materials?

(Please have reports of audits performed on regional offices or contract agencies available for review.)

F. Office Eauipment and Support Services (Category II)

NRC Guidelines: The RCP should have adequate secretarial and clerical support. Automatic typing and Automatic Data Processing and retrieval capability should be available to larger (300-400 licenses) programs. Similar services should be available to regional offices, if utilized. Professional staff should not be used for fee collection and other clerical duties.

la. Describe the secretarial and clerical support for the radioactive materials program, including if appropriate, any problem areas.

b. If your program has regional offices, discuss the clerical support for those offices.

c. In cases of unusual workloads or vacancies, can supplementary secretarial / clerical support be i-

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2. Describe the computer equipment available to the RCP.

3. What operating system do you use (i.e., MSDOS, UNIX, APPLE, etc.)?

4. What data base or spreadsheet programs do you use?

5. What word processing program (s) do you use?

6. Does your word processing program have the capability to process documents that may be transferred to and from and from the IBM 5520 system? (With the exception of Wordstar, most popular programs have this capability. This information can be found in your user manual index under "DCA" or " revisable format" files.)

7. What licensing functions are on your computer system?

8. What compliance functions are on your system?

9. Do you have a modem? If so, please describe how a connection can be made.

10. Are computers or terminals available to the professional staff, and ifso, what use is made of them?

11. Do you have access to a facsimile transmission unit?

If so, please identify it by name and type and provide the receive and verification (information) telephone numbers.

12. Describe the fee collection system and identify the staff resources assigned to it.

G. Public Information (Category II)

NRC Guidelines: Inspection and licensing files should be availabic to the public consistent with State administrative procedures. It is desirable, however, that there be provisions for protecting from public disclosure proprietary information and information of a clear personal nature. Opportunity for public hearings should be provided in accordance with UMTRCA and applicable State administrative procedure laws.

Questions:

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1. Are licensing and. inspection files available-for inspection by'the public?

2. If so, what information may be withheld?

3. What written procedures and laws govern this?

Please provide reference citations.

IV. PERSONNEL A. Qualifications of Technical Staff (Category II)

NRC Guidelines: Professional staff should have a bachelor's degree or equivalent training in the physical and/or life sciences. Additional training and experience in radiation protection for senior personnel: including the director of the radiation protection program should be commensurate with the type of licenses issued and inspected by the State. Written job descriptions should be prepared so that professional qualifications needed to fill vacancies can be readily identified.

Questions:

1. Do all professional personnel hold a bachelor's degree or have equivalent training in the physical or life sciences?

2. What additional training and experience does the RCP director have in radiation protection?

3. What additional training and experience are required of the senior personnel?

4. Do written position descriptions describe the duties, responsibilities and functions of each professional position in the RCP and the qualifications needed by applicants for them? Please attach copies.

B. Staffina Level (Category II)

NRC Guidelines: Professional staffing level should be approximately 1-1.5 person-year per 100 licenses in effect. RCP must not have less than two professionals available with training and experience to operate RCP in i a way which provides continuous coverage and continuity.

For States regulating uranium mills and mill tailings current indications are that 2-2.75 professional person-years' of effort, including consultants, are needed to process a new mill license (including in situ mills) or major renewal, to meet requirements of Uranium Mill Tailings Radiation Control Act of 1978. This effort must include expertise in radiological matters,

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hydrology,. geology, and' structural engineering.

Questions:

1. _ ' Complete a table as below, . listing - the professional / technical person-years of effort applied to the agreement or radioactive material program by individual. -Include the name,~ position, fraction of time spent and-include the following areas: administrative / supervisor, inspection,,.

laboratory, regulation development, other).

Name Position Area of Effort FTE Total

2. Compute the professional / technical person-year effort of person-years per 100' licenses'(excluding mills and burial site licenses). Show calculation.

3. Is the staffing' level adequate to meet normal and special needs and backup? If not, explain.

C. Staff Supervision (Category II)

NRC Guidelines: Supervisory personnel should be adequate to provide guidance and review the work of senior and junior personnel. Senior personnel should review applications and inspect licenses independently,.

monitor work of junior personnel, and participate in the establishment of policy. Junior' personnel should be initially limited to reviewing license applications and inspecting small programs under close supervision.

Questions:

1. Identify the junior personnel and senior personnel.

2a. What duties are assigned to junior personnel?

b. How is their work monitored?

3. Is there adequate supervisory or senior guidance and direction for junior personnel?

4. How do senior personnel participate in the

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development of program policy?

D. Training (dategory II)

NRC Guidelines: Senior personnel should have attended NRC core courses in licensing orientation, inspection procedures, medical practices and industrial radiography practices. (For mill States, mill training should also be included.) The RCP should have a program to utilize specific short courses and workshops to maintain appropriate level of staff technical competence in areas of changing technology.

Questions:

1. List materials personnel and all of the training courses, workshops, seminars, symposia, etc. that your personnel have attended since the last review, and the source of the funding for the training (e.g., travel, per diem, tuition as applicable).

Source of Student Course Course Sponsor Dates Eundinq

2. Explain how new employees are trained.

3. If any of your RCP staff currently need NRC training, please identify the employees and the courses needed.

E. Staff Continuity (Category II)

NRC Guidelines: Staff turnover should be minimized by combinations of opportunities for training, promotions, and competitive salaries. Salary levels should be adequate to recruit and retain persons of appropriate professional qualifications. Salaries should be comparable to similar employment in the geographical area. The RCP organization structure should be such that staff turnover is minimized and program continuity maintained through opportunities for promotion.

Promotion opportunities should exist from junior level to senior level or supervisory positions. There also should be opportunity for periodic salary increases compatible with experience and responsibility.

Questions:

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1. Identify the RCP employees who have left the Agreement materials program since the last review and give the reasons for the turnovers. Also state whether the positions are presently vacant, filled (name replacement), abolished or other status.

2. List the RCP salary schedule:

Position Title Annual Salary Ranae

3. Compare your salary schedule with similar employment alternatives in the same geographical area, such as industrial, medical, academic employers or other State agencies.

4. Explain whether your salary schedule is adequate to recruit and retain staff.

5. What opportunities are there for promotion within the RCP organizational structure without a staff vacancy occurring?

V. L.ICENSING A. Technical Ouality of Licensino Actions (Category I)

NRC Guidelines: The RCP should assure that essential elements of applications have been submitted to the agency, and which meet current regulatory guidance for describing the isotopes and quantities to be used, qualifications of persons who will use material, facilities and equipment, and operating and emergency procedures sufficient to establish the basis for licensing actions. Relicensing visits should be made for complex and major licensing actions. Licenses should be clear, complete, and accurate as to isotopes, forms, quantities, authorized uses, and permissive or restrictive conditions. The RCP should have procedures for reviewing licenses prior to renewal to assure that supporting information in the file reflects the current scope of the licensed program.

Questions:

la. How many specific licenses are currently in effect?

b. Please attach numerical totals ofthe licenses in

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.each category.

. t 2a. How many?new-licenses (not amendments in entirety) l have-been issued since the last review. j

.b. How-many were major licenses? (She question 11 ~ for criteria.)

List the specific licenses (name.and license number) i 3.

that were terminated since-the last review. l 1

4. How many amendments were issued during the review n period?

5. . Identify unusual or complex licenses issued since

the last review, including name and license number. I

6. Note.any variances in licensing policies and {

l. procedures or exemptions from the regulations granted-since the last review.

7a. Do you require licensees.to submit contingency  ;

plans? (

Reference:

All Agreement and Non-Agreement l State lotter dated May 21, 1987, or NUREG 0767). l I

b. List the licensees (name and license number) who are subject to contingency plans requirements and the status of their plans (approved, under review, 1 etc.).

Ba. What criterion does the State use to determine the '

need for a relicensing visit?

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b. How many relicensing visits were made during this i review period? If so, explain. ']

9. How do you ensure up-to-date information has been l submitted prior to a license renewal? l

10. Has the State taken any specia; licensing action 1 with respect to licensees operating under multiple l jurisdiction? t

11. Prepare a table as below showing the State's major licensees with name, number and type.

1 INCLUDE: j 1

o Broad (Type A) Licenses ,

o LIW Disposal Licenses o LLW Processing and Brokers o Major Manufacturers and Distributors o Uranium Mills o Large Irradiators (Pool Type or Other)

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o Radiopharmacies-P oi Other Licenses With a Potential Significance for fli Environmental Impact j a m. '

o other Licensees You Consider to be " Major" ~

' Licensees Name License Number _ Type j

'l B. . Adequacy _of Product Evaluations.(Categor;r I)'  !

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I NRC Guidelines:. RCP evaluations of manufacturer's or distributor's data on sealed sources and devices: l outlined in NRC, State, or appropriate ANSI Guides, .

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should be sufficient to assure integrity and safety for  !

users. The RCP should review manufacturer's information on labels and brochures relating to radiation health and safety,Lassay, and calibration procedures for adequacy.  ;

Approval documents for sealed source or device designs should be clear, complete and accurate as to isotopes, forms, quantities, uses, drawing identifications, and  !

permissive or restrictive conditions. i l

Questions:

1. List new and revised SS&D registrations of sealed l sources and devices issued during the review period?  !

I SS&D Name Type l Registry of- of Number Manufacturer, Device  ;

Distributor or i or User Source  !

(Custom ,

Evaluation)  !

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2. How many SS&D evaluations have been made for which  ;

registry documents have not yet been issued?

3. What guides and procedures are used to evaluate registry applications? l i

4. Please describe the procedures for supervisory review of SS&D registrations.

. F . 1 Sa. Do you have any pressing concerns about any  ;

sources / devices / products currently authorized for distribution including-to persons e.ther generally licensed or exempt from licensing?

b. If so, identify the items by manufacturer's name and {

model number and describe your concerns.

C. Licensina Procedures (Category II)

NRC Guidelines: The RCP should have internal licensing guides, checklists, and policy memoranda consistent with .

current NRC practice. License applicants.(including applicants for renewals) should be furnished copies of applicable guides and regulatory positions. The present l compliance status of licensees should be considered in licensing actions. Under the NRC Exchange-of-Information program, evaluation sheets, service licenses, and licenses authorizing distribution to general licensees and persons exempt from licensing  ;

should be submitted to NRC on a timely basis. Standard j license conditions comparable with current NRC standard license conditions should be used to expedite and ,

provide uniformity in the licensing process. Files l should be maintained in an orderly fashion to allow l fast, accurate retrieval of information and t

documentation of discussions and visits.  !

Questions:

1. Are current NRC Regulatory Guides furnished to reviewers?

2. Do your reviewers use the standard review plans, ,

model licenses, etc., that are furnished in the NRC Fuel Cycle Policy and Guidance Directives FC xx-xx?

3. Are checklists used by the reviewers maintained in the files?

4. What internal licensing guides and procedures has the State developed?  ;

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5. What licensing guides and regulatory positions are furnished to new and renewal license applicants?

6. How do reviewers determine the present compliance status of licensees when considering licensing actions?

7. For what length of time are licenses issued? ,

8. Explain how soon-to-expire licenses are tracked to l l

assure either timely applications are received or i

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9. What mechanism exists to assure that SS&D l registrations and service licenses issued by the State are distributed to the NRC?

10. Have you developed your own standard license conditions, and if so, when were they_ reviewed and updated? Please provida copies for review.

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11. How do you verify that your standard conditions are comparable to the current NRC conditions?

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12. How is your SS&D registry kept current? l

13. Describe the system used to advise licensees of pertinent changes in regulations and regulatory j

procedures,

14. Describe your procedures for maintaining the license 1 files (How are files and folders arranged? Are telephone contacts and visits documented? Who is responsible for filing materials in folders?). l j

15. Are there opportunities for license reviewers to accompany inspectors?

i VI. COMPLIANCE l A. Status of Inspection Program (Category I)

NRC Guidelines: The State RCP should maintain an inspection program adequate to assess licensee compliance with State regulations and license i l

conditions. The RCP should maintain statistics which are adequate to permit Program Management to assess the status of the inspection program on a periodic basis.  ;

Information showing the number of inspections conducted, l the number overdue, the length of time overdue and the I priority categories should be readily available. There ,

should be at least sem! annual inspection planning for l the number of inspections to be performed, assignments to senior vs. junior staff, assignments to regions, identification of special needs and periodic status reports. When backlogs occur the program should develop and implement a plan to reduce the backlog. The plan should identify priorities for inspections and establish target dates and milestones for assessing progress.

Questions:

1. How is statistical information maintained about the inspection program to permit periodic assessment of its status by RCP management?

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2. Prepare a table as below, indicating the Inspection 3 Priority,Lthe: total number of licenses in each priority,.the scheduled reinspection frequency, and the number of inspections made in each priority for the review period.

l InspecElon . Number Scheduled Number.of Priority Licenses Freauency Insee ctions

3. Prepare a table (or tables) as below which. identify the State Inspection' Priority 1, 2, and 3 licenses with overdue inspections.' Include the inspection priority, the due date, and the number of months the inspection is overdue. (If list is extensive, a comparable. computer printout is acceptable.)'The list should include initial inspections that are overdue.

Due Months Licensee Priority Date Overdue

4. Prepare a table as below indicating the total number of overdue license inspections for all lower priorities.

Inspection Priority Number Overdu e

5. If there are overdue inspections, describe or attach a copy of your plan for eliminating it. Identify priorities, target dates and procedures for measuring progress. Include, as appropriate, copies of memoranda to the RCP staff regarding the plan.

6. Project the number of inspections needed to be done annually to meet your inspection priorities and to

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eliminate your overdues, if any.

7. How are inspection schedules planned and how are the l dates and personnel assignments made?

8. How are initial inspections identified when they become overdue?

9a. Describe your inspection priorities for inspecting terminated licenses,

b. How many of these inspections are pending at this time?

c. How many were inspected aince the last review?

10a.How many reciprocity notices were received in the review period?

b.How many reciprocity inspections were conducted in the review period?

11. How many field inspections of radiographer were performed in the review period?

B. Inspection Freauency (Category I)

NRC Guidelines: The RCP should establish an inspection priority system. The specific frequency of inspections should be based upon the potential hazards of licensed operations, e.g., major processors, broad licensees, and industrial radiographer should be inspected approximately annually -- smaller or less hazardous operations may be inspected less frequently. The minimum inspection frequency including for initial inspections should be no less than the NRC system.

Questions:

1. Please attach a copy of the State's priority system.

2. How are inspection priorities assigned to licenses?

3. Is the priority noted in the license file?

4. Discuss any variances in the State's priorities from the NRC priority system and the reasons for the variances.

5. Describe the State's policy for unannounced inspections and exceptions to the policy.

5 Describe the State's policy for conducting follow-up

inspections.

7. Identify any individual licensees or groups of licenses for which the State is inspecting more frequently due to compliance problems. Please discuss the nature of those problems.

C. Inspector's Performance and Capability (Category I)

NRC Guidelines: Inspectors should be competent to evaluate health and safety problems and to determine compliance with State regulations. Inspectors must demonstrate to supervision an understanding of regulations, inspection guides, and policies prior to independently conducting inspections. The compliance supervisor (may be RCP manager) should conduct annual field evaluations of each inspector to assess perfor-mance and assure application of appropriate ana consistent policies and guides.

Questions:

1. How do new inspectors become qualified to conduct independent inspections since the last review?

2. Prepare a table showing the number and types of supervisory accompaniments made during the review period. Include:

Supervisor Inspector License Cateaorv Date

3. Did all inspectors receive at least one accompaniment by the compliance supervisor during the review period? If not, explain.

D. Responses to Incidents and Alleced Incidents (Category I)

NRC Guidelines: Inquiries should be promptly made to evaluate the need for onsite investigations. Onsite investigations should be promptly made of incidents requiring reporting to the Agency in less than 30 days (10 CFR 20.403 types). For those incidents not ]'

requiring reporting to the Agency in less than 30 days, investigations should be made during the next scheduled inspection. Onsite investigations should be promptly  ;

made of non-reportable incidents which may be of l i

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significant public interest and concern, e.g.

transportation accidents. Investigations should include in-depth reviews of circumstances and'should be completed on a high priority basis. When appropriate,

' investigations should include reenactments and time-study measurements (normallyLwithin a few. days).

Investigation-(or inspection) results should be documented and enforcement action taken when appropriate. State licensees and the NRC should be notified of pertinent information about any incident which could be relevant to other licensed operat3ons (e.g., equipment failure, improper operating procedures). Information on incidents involving failure of equipment chould be provided to the. agency responsible for evaluation of the device for an assessment of possible generic design deficiency. The RCP should have access to medical consultants when needed.to diagnose or treat radiation injuries. The RCP

~ should use other technical consultants for special problems when needed.

Special Note: The criteria for reporting. radioactive materials events are set out in All Agreement States letter from D.-Nussbaumer dated July 22, 1986:

o Abnormal Occurrences: These are the most significant events. In addition to an early telephone notification to the regional office, a written report from the State is needed for inclusion in.the Quarterly Report submitted by NRC to Congress (AOR). Criteria-for reporting and guidance on content of reports can be found in any AOR.

o Telephone Reports: These are events for which NRC would like to receive early telephone notification.

Typically, these include incidents requiring prompt or 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> notification by licensees to States or events that receive significant media attention.

o Other Reportable Incidents: These are events for which reports are equired of the licensees to the State.

Questions:

1. What criteria is used to determine the need for and timeliness of onsite inspections of reported incidents?

L 2. How many reports of incidents and alleged incidents were received during the review period?

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3. How many onsite inspections of incidents were l ,

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s conducted during the period?

4. How.many inspections of incidents revealed an incident occurred which required NRC notification, either by telephone or by written report? (Refer to July 22, 1986 All Agreement State Letter for definition.)

5. Please have summaries available of the events identified in questions 2 and 4 above. Use the incident summary forms attached for this purpose.

6. If not included in the response to question 5 above please attach a summary of reports of Icaking scaled sources. Please identify the source by manufacturer, model number, age of source (if available), date of leak test and leak test result.

7. Did any incidents involve equipment or source failure or operating procedures that were deficient but were approved? If so, how and when were State licensees and the NRC notified of pertinent information relevant to other licensed operations?

8. Was information on incidents involving failure of equipment or sources provided to the agency responsible for evaluation of the device for an assessment of possible generic design deficiency?

Please provide details.

9. If the RCP utilized medical or technical consultants for an emergency during the review period, please describe the circumstances.

10. Describe the procedures for looking into allegations or other reports of possible wrong doing by licensees, for example,

a. Protecting the identity of allegers or persons requesting that their identities not be made available for public disclosure.

b. Obtaining documentation (e.g., signed statements, copies of records).

c. Obtaining the services of persons with specialized training and experience such as conducting and documenting formal interviews.

d. Obtaining necessary legal counsel for inquires into wrong doing.

e. Guidance for staff when allegations or

. .a. .

inspections disclose the possibility of willful violations of regulatory requirements or other evidence of criminal wrong doing.

Please attach copies of these procedures.

11. In.the review period, are there any cases involving possible criminal wrong doing that were looked into or are presently undergoing review?

E. Enforcement Procedures (Category I)

NRC Guidelines: Enforcement Procedures should be sufficient to provide a substantial deterrent to licensee noncompliance with regulatory requirements.

Provisions for the levying of monetary penalties are recommended. Enforcement letters should be issued within 30 days following inspections and should employ appropriate regulatory language clearly specifying all items of noncompliance and health and safety matters identified during the inspection and referencing the appropriate regulation or license condition being violated. Enforcement letters should specify the time period for the licensee to respond indicating corrective actions and actions taken to prevent recurrence (normally 20-30 dayc). The inspector and compliance supervisor should review licensee responses.

Licensee responses to enforcement letters should be promptly acknowledged as to adequacy and resolution of previously unresolved items. Written procedures should exist for handling escalated enforcement cases of varying degrees. Impounding of material should be in accordance with State administrative procedures.

Opportunity for hearings should be provided to assure impartial administration of the radiation control program.

Questions:

1. What enforcement measures are available to the State to provide a deterrent to licensee noncompliance with regulations or license provisions?

2. Are there written procedures establishing severity levels for violators? Please attach a copy.

3. Are there written procedures for escalated enforcement? Please attach a copy.

4. If the RCP can apply civil penalties, have procedures been established to determine when they apply and the amounts? Please attach a copy.

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0 5. Describe the' State's provisions for criminal

. penalties.

6. Are enforcement letters issued within 30 days following inspections?

7. Do you have a standard format for enforcement letters?

8. How are recommendations differentiated from items of-non-compliance in the letters?

9. Do the letters reference the appropriate regulation or license condition being violated?'

10. What time period is specified in the enforcement letters for the licensee to respond with corrective actions,taken?

11. Do inspectors write enforcement letters? If so, do the letters undergo supervisory review before they are sent to the licensee?

12. Who reviews licensee responses?

13. What is the time limit for the State's acknowledgement of licensee responses and what tracking system exists for assuring resolution of the items of non-compliance and unresolved items?

14. Does the State have the authority to impound radioactive material?

15. Can the State issue Orders, including Emergency Orders?

16. Do State administrative procedures permit the opportunity for hearings in major enforcement cases?

17. Describe the State's policy for conducting follow-up inspections.

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18. If during the review period the State has issued orders, applied civil penalties, sought criminal penalties, impounded sources, or held formal enforcement hearings, identify.these cases and attach a summary of the circumstances and results.

19. Have any compliance problems occurred involving licensees operating under multiple jurisdiction or under reciprocity? If so, please identify the licenses and explain if other Agreement States and NRC were advised.

F. Inspection Procedures (Category II)

NRC Guidelines: Inspection guides, consistent with current NRC guidance, should be used by inspectors to assure uniform and complete inspection practices and provide technical guidance in the. inspection of licensed programs. NRC Guides may be used if properly supple-mented by policy memeranda, agency interpretations, etc.

Written inspection policies should be issued to establish a policy for conducting unannounced inspections, obtaining corrective action, following up and closing out previous violations, interviewing workers and observing operations, assuring exit interviews with management, and issuing appropriate notification of violations of health and safety problems. Procedures should be established for maintaining licensees compliance histories. oral briefing of supervision or the senior inspector should be performed upon return from nonroutine inspections. ,

i For States with separate licensing and inspection staffs, procedures should be established for feedback of information to license reviewers.

Questions:

1. Do you use inspection guides that are specific to categories of licensecs?

2. Has the RCP developed its own inspection guides or does it use NRC guides?

3. Discuss the use of inspection policy memoranda, interpretations, etc., to supplement inspection guides.

4. Are there written policies and procedures for:

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a. unannounced inspections?

b. obtaining corrective action?

( c. following-up and closing out previous citations of violations?

d. interviewing workers?

e. observing operations?

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f. exit interviews with management?

g. issuing notices of violations and findings of health and safety problems?

Please have copies of these procedures available for

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a w the reviewer.

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5. Describe the procedures for maintaining licensee's colopliance histories.

6. Explain your policy for supervisors debriefing inspectors upon return from inspections.

7. What procedures are there for providing feedback of compliance information to licensing?

G. Inspection Reports (Category II)

NRC Guidelines: Findings of inspections should be documented in a report describing the scope of inspections, substantiating all items of noncompliance and health and safety matters, describing the scope of licensees' programs, and indicating the substance of discussions with licensee management and licensee's response. Reports should uniformly and adequately document the results of inspections and identify areas of the licensee's program which should receive special attention at the next inspection. Reports should show the status of previous noncompliance and the independent physical measurements made by the inspector.

Questions:

1. Describe the format (s) used by the RCP for documenting inspections.

2. Do the reports document:

a, the entrance and exit discussions held with license management?

b. follow-up of previous citations of violations?

c. results of interviews of workers?

d. results of observations of operations?

e, confirmatory measurements conducted by the inspector?

f. areas of the licensee's program needing special Ptten*(on at the next inspection?

g. the items of non-compliance found in the inspection?

H. Confirmatory Measurements (Category II)

NRC Guidelines: Confirmatory measurements should be l

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- sufficient in-number'and type to ensure the licensee's control of materials and to validate the licensees measurements. RCP instrumentation should be adequate for surveying license operations (e.g. , survey meters, air samplers, lab counting equipment for smears, identification of isotopes, etc.). RCP instrumentation should include the following types:

GM Survey Meter:. 0-50 mr/hr Ion Chamber Survey Meter: up to several R/hr Neutron Survey Meter: Fast & Thermal Alpha: Survey Meter: 0-100,000 c/m Air Samplers: Hi and Low Volume Lab Counters: Detect 0.001 uc/ wipe Velometers-Smoke tubes Lapel Air _ Samplers

- Instrument calibration services or facilities should be readily available and appropriate for instrumentation used. Licensee equipment and facilities should not be used unless under a service contract. , Exceptions for other State Agencies, e.g. a State University, may be made. Agency instruments should be calibrated at intervals not greater than that required to licensees being inspected.

Questions:

1. Discuss the State's policy for conducting confirmatory measurements as a part of each inspection (e.g., air samples, wipe samples, air

. flows, dose rates).

2. List the equipment that is readily available to the RCP for surveying licensed operations and conducting appropriate confirmatory measurements.

3. Describe the method used for calibrating survey instruments and the frequency of calibration.

VII. OTHER ASPECTS OF THE STATE'S RADIATION CONTROL PROGRAM A. Non-Aareement Sources of Radiation Questions:

1. Are the licensing and inspection procedures for NARM the same as for agreement materials?

B. Environmental Monitorina Program Questions:

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I 1. To indicate the scope of the environmental monitoring programs undertaken specifically to evaluate the. environmental radiological impacts of State licensed' facilities describe:

a. the' licensee (name, license number and type of operation),

b. types of media sampled ..

Lc. the number and locations of stations sampled

d. the frequency _of sample collection

e. the analyses run on each type of sample

2. How is such data used in your licensing and inspection programs for these State licenses?

Please attach copies of any summaries or periodic reports relating to this aspect of your environmental surveillance program.

C. Other Areas This section of the review is for.the use of either the

. reviewer or the RCP to address issues pertaining only to the individual State, to new areas of concern, or to generic or: State-specific issues raised by NRC staff.

Questions:

1. Have there been any applications or approvalr for incineration, compacting or for methods of LLW disposal not provided.for in the regulations (i.e.,

10 CFR 20.302 requests)? If so, please list the applicant and nature of application and status.

2. Is the State-making any effort during inspections of nuclear pharmacies to observe the licensee conducting the required molybdenum breakthrough tests, i.e., what is the State doing in addition to record reviews to establish compliance or noncompliance with the requirement?

L 3a. Is the State mounting any special effort to look at

' the possibility of reconcentration of radionuclides in sanitary sewers and sewerage treatment plants as part of the regular inspection program? If so, please describe.

b. If reconcentration of radionuclides in sanitary t-sewers or sewerage treatment plants has been found, L please identify the site and licensee.

4. How does the RCP handle inspection findings concerning industrial safety hazards? (Reference A/S letter dated January 18, 1989.)

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, a Sa. 3M has reported not all of their customers returned static eliminators that were subject to recall. Are you aware of this?

b. If such customers were located in your State, please provide a summary of any actions taken by the RCP to locate the users, etc. (Note: We recognize that by this date the Po-210 has significantly decayed and reduced the potential hazard. The information is requested because of its relevance to the question of maintaining a system to adequately account for GL devices.)

INCIDENT REPORTING CHECK LIST

1. Type of Incident or Alleged Incident:

27 Was an investigation conducted by your staff?

Date Initiated:

3. Did the investigation reveal: (check all appropriate blocks)

[ ] Loss of package effectiveness or contamination?

[ ] Theft or loss of licensed material?

[ ] Overexposure of individual to radiation or radioactive material?

[ ] Excessive levels of radiation or concentrations of RAM?

[ ] Safety failure of GL devices?

[ ] Equipment failure that could occur on similar licensed devices?

[ ] Leaking source?

[ ] Misadministration?

[ ] Transportation incident?

[ ] Uranium mill occurrence?

[ ] Possible criminal violations?

If any boxes are checked or if the event is newsworthy, review the criteria for telephone reporting Agreement State Materials Events to the NRC Regional Office (see All Agreement State letter dated July 22, 1986 and December 23, 1988). A description of the incident should he summarized as follows for the next NRC review.

(Use extra sheets if necessary.)

SUMMARY

OF EVENT Licensee: License No.:

Location of event:

Description of event:

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Isotooe: Amount:

Date: Date of Report to RCP:

Identify any other licensees involved:

Licensee: License'No.: ,

Jurisdiction:

Reciprocity Licensee: Y /N Describe clean-up actions taken the RCP?

What radiation measurements were taken by the RCP?

What other action was required of the RCP?

-What action was taken to notify the NRC, other Agreement States or licensees?

Is the case closed?

Is-record of incident in RAM files?

What enforcement action was taken?

NAME OF PERSON PREPARING THIS

SUMMARY

DATE l