ML19270A215
| ML19270A215 | |
| Person / Time | |
|---|---|
| Issue date: | 10/08/1981 |
| From: | Dircks W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| Shared Package | |
| ML19270A216 | List: |
| References | |
| REF-10CFR9.7, TASK-PIA, TASK-SE SECY-81-594, NUDOCS 8110270540 | |
| Download: ML19270A215 (53) | |
Text
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October B,1981
.,,(J" SECY-8wSY4 h
02 h(3@
POLICY ISSUE
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(Affirmation)
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For:
The Commissioners E' g-
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s From:
William J. Dircks Executive Director for Operations
Subject:
PUBLICATION OF " GUIDELINES FOR THE MANAGEMENT OF AGREEMENT STATE RADIATION CONTROL PROGRAMS"
Purpose:
To request Commission approval of a Federal Reaister Notice publishing " Guidelines for the Management of Agreement State Radiation Control Programs" in final form.
Discussion:
By memo to EDO dated June 25, 1981, SECY advised that the Commission disapproved Commission paper SECY-81-312 " Publication of Guidelines for the Management of Agreement State Radiation Control Programs." The memn provided the response sheets of all Commissioners including suggestions made by Commissioners Gilinsky and Ahearne and noted that all Commissioners agreed with those comments.
It was requested that a revised paper be submitted.
The staff has revised the " Guidelines" to reflect the comments made and the document is provided as.
In addition to the comments related specifically to the " Guidelines," Commission comments also contained a request that the staff undertake the development of more,bjective measures of State performance; specifically identified were such performance-based indicators as radiation worker exposure data, medical patient exposures, overexpcsure incidents, and population exposures.
The Commission also requested assura;ce that SP will monitor the Conference
Contact:
Donald A. Nussbaumer, OSP Extension 492-7767 h h o 02200g CF
1
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3 of Radiation Control Program Directors task force on State program evaluation.
SP has a representative on the task force and will evaluate its findings for application to the Guidelines, as appropriate.
The staff will evaluate the current guidelines with the objective of developing, to the extent practicable more objective or quantitative indicators.
With regard to performance-based indicators, it should be noted that a number of current guidelines are performance-based.
For example, recommended staffing levels are expressed in terms of a specified range of staff years of effort for every 100 licensas in effect.
NMSS recently prepared a report (NUREG-0819) containing 1978 data on effluent releases at major material licensee facilities, "A survey of Radioactive Effluent Releases from Byproduct Material Facilities." These kinds of data may be useful for the purpose of developing additional performance-based indicators.
We plan to pursue this aspect through our exchange of information program with the States.
If this approach is successful and contributes to the evaluation of Agreement State programs, we will pursue the search for and development of other performance-based indicators along these lines.
The Commission also requested the staff to evaluate the NRC regulatory program for materials against the proposed criteria.
We believe this issue should be divorced from the rest of this paper.
Tnere are a number of differences between the NRC and the State programs which would make this task very difficult.
It should be noted that the " Guidelines" were developed over several years through experience with State programs and are directly applicable to the States but not necessarily to the NRC.
For example, the bases for enabiing legislation and implementing regulations for NRC are quite different than for the Agreement States.
In addition, the differences of scale between the NRC program and most individual State programs makes the use of the current criteria to evaluate the NRC program tenuous at best.
. Evaluation of the NRC's regulatory program against the proposed criteria is expected to be complex and time consuming.
We estimate that by utilization of a contract study, a minimum of one year and at least
$300,000 would be necessary to perform a one time review against the proposed criteria with scope and content commensurate with our periodic reviews of Agreement State programs.
A more limited review could possibly be performed for about $100,000 with a time period less than a year.
Such a limited review could focus on certain key indicators subject to quantification such as numbers of staff, numbers of licensing actions, number of inspections and enforcement actions, and timeliness of those act'ans.
Such a limited review, howcVer, would not permit a review of the quality of licensing, inspection and enforcement actions, nor accompaniment of NRC inspectors.
Recommendation:
The Commission:
(a) Adoot the revised " Guidelines for the Management of Agreement State Radiation Control Programs" as a general statement of policy, and (b) Approve:
Publication of the enclosed Federal Recister notice concerning the " Guidelines for the Management of Agreement State Radiation Control Programs."
(c) Note that:
1.
The ceneral statement of policy will become effective on the date of publication in the Federal Register.
2.
The States will be sent copies of the policy statement.
3.
The Subcommittee on Nuclear Regulation of the Senate Committee on Environment and Public Works; the Subcommittee on Energy and Environment of the House Committee on Interior and Insular Affairs; the Subcommittee on Energy and Commerce; and the Subcommittee on Environment, Energy and Natural Resources of the House Committee on Government Operations will be informed.
-4 4.
A public announcement will be issued when the policy statement is filed with the Office of the Federal Register.
5.
The " Guidelines" will be periodically amended as the staff develops improved guidance based on continuing experience by both NRC and the States in utilization of the " Guidelines."
(T Lt f N William ~d. Dircks Executive Director for Operations
Enclosure:
Federal Register Notice Commissioners' comment: or consent should be provided directly to th Office of the Secretary by c.o.b. Wednesday, October 28, 1981.
Commission Staff Office comments, if any, should be submitted to the Commissioners NLT October 21, 1981, with an information copy to the Office of the Secretary.
If the paper is of such a nature that it requires additional time for analytical review and comment, the Commissioners and the Secretariat shou'.o be apprised of when comments may be expected.
This paper is tentatively scheduled for affirmation at an open meeting during the week of November 2,1981.
Please refer to the appropriate Weekly Commission Schedule, when published, for a specific date and time.
DISTRIBUTION Commissioners Commission Staff Offices Exec Dir for Operations Exec Legal Director ACRS ASLBP Secretariat
4 6
ENCLOSURE
NUCLEAR REGULATORY COMMISSION Evaluation of Agreement State Radiation Control Programs; General Statement of Policy AGENCY:
U. S. Nuclear Regulatory Commission ACTION:
Final General Statement of Policy
SUMMARY
The Nuclear Regulatory Commission is adopting as a general statement of policy the recently revised " Guidelines for the fianagement of Agreement State Radiation Control Programs." This statement of policy is being issued to inform the States and the public of the criteria and guidelines which the Commission recommends for the management of Agreement State radiation control programs. The Commission intends to use the guidelines in its periodic evaluations of Agreement State Programs.
EFFECTIVE DATE:
This general statement of policy is effective on (date of publication).
FOR FURTHER INFORftATION CONTACT:
Donald A. Nussbaumer, Assistant Director for State Agreements Program, Office of State Programs, U. S. Nuclear Regulatory Commission, Washington, DC 20555 Telephone:
301-492-7767.
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SUPPLEMENTARY INFORMATION:
On October 3, 1980, the NRC published in the FEDERAL REGISTER as a proposed General Statement cf Policy its " Guide for Evaluation of Agreement State Radiation Control Programs."
(45 FR 65726-65734).
Interested persons were invited to submit written comments and suggestions on the proposed policy statement during the comment period which expired on December 22, 1980 (45 FR 80937, December 8, 1980).
Based on the comments received and the Commission's own evaluation, a number of changes have been made to the policy statement.
The purpose of the " Guide" has always been twofold, to assist the NRC staff in conducting the evaluations of the Agreement State radiation control programs and also to provide guidance to State management in the operati:n of an effective radiation control program.
With this purpose in mind, the " Guide" has been retitled " Guidelines for the t'anagement of Agreement State Radiation Control Programs." This document is organized in much the same manner as the former " Guide."
It contains six major sections, each of which deals with a separate program element.
These sections are: Legislation and Regulations, Organization, flanagement and Administration, Personnel, Licensing, and Compliance.
As in the former
" Guide" each program element contains " Indicators" which address specific functions within the program element.
A number of recommended " Guidelines" are listed under each " Indicator." The " Guidelines" replace the former
" Guides for Acceptable Practice."
The indicator " Legal Authority" has been taken out of the Org~anization section and combined with Pc lations to form a new section, Legislation and Regulations.
The underlJing authority granted the radiation control program in State lgislation together with implementing regulations form the foundation of any regulatory program and are essential to the effectiveness of that program.
A new indicator " Status of Regulations" has replaced
" Compatibility." The guidelines under the indicator " Status of Regulations" indicate that certain State regulations must be essentially identical to NRC regulations and that other regulations must have a high degree of uniformity with NRC regulations. This is basically what is meant by compatibility as it is applied to regulations With regard to the Organization section, the only significant change was the moving of the indicator Legal Authority, to a new section.
The section on Management and Administration has been revised in a number of areas.
The guidelines under Budget have been revised to list the specific program areas we feel require budgetary support.
A specific dollar range, however, has been deleted.
With the growing complexity of radiation control programs, (e.g., the additional requirement on States licensing uranium mills), inflation, and other considerations, it is becoming increasingly difficult to establish specific funding levels
which could be useful in comparing State programs. A number of points should be stressed: (1) There have been a number of occasions in the past where States have not met the f4RC's recommended guidelines and yet the overall program has functioned satisfactorily; (2) The States utilize a variety of accounting techniques and it has been difficult to develop a guideline that would be generally applicable to all States; (3) Past experience has shown that there is not a strong correlation between budget problems and problems in other program areas.
For example, in most States, salaries constitute a major part of the radiation control program budget.
There have been a number of cases where a State's cverall budget was within the recommended guideline but yet the salaries were too low to recruit and retain adequate staff.
Conversely, States with more than adequate salaries have had an overall budget below the recommended guideline.
Our conclusion is that the diversity of State programs and the variety of accounting techniques empicyed by the States makes the use of specific budget level guidelines of little value.
Other editorial changes have been made to t..e Management and Admini-stration section.
The indicator " Duties" has been changed to " Staff Supervision" which we feel more accurately expresses the subject of the guidelines.
We have eliminated " salaries" as a separate indicator, and have placed it under a new indicator " Staff Continuity." Salary levels are important only from the standpoint of being able to recruit and retain staff. The indicator " Recruiting" has been eliminated.
The guideline relating to job descriptions has been moved to " Qualifications." The guideline regarding vacancy notification procedures has been eliminated since, as pointed out by one commenter, State recruitment practices vary according to State personnel office procedures. Based on our experience, there does not appear to be any reason for recommending one recruitment practice over another.
Only minor changes have been made to the Licensing section.
Under
" Licensing Procedures" the guideline pertaining to the preliminary review of applications within 30 days of receipt has been eliminated.
The time needed to review an initial license application is a purely administrative matter.
An artificial time limit serves no useful purpose.
It is the quality of the licensing action that has a bearing on public health and safety. The timely review of licensee renewal applications may, however, be important. The recommended guideline pertaining to the issuance of license expiration notices to licensees 30-60 days prior to expiration has also been eliminated.
License renewal is the responsibility of the licensee. The issuance of expiration notices by the State is a purely administrative matter.
No significant changes have been made to the Compliance section.
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A number of changes have been made to the Categories assigned to various indicators.
Category III has been eliminated.
All guidelines previously included in Category III indicators have been moved to indicators in Category II.
Category III was therefore no longer needed.
The " Guidelines for the Management of Agreement State Radiation Control programs" will be used by the NRC staff during its onsite reviews of Agreement State programs.
Such reviews are conducted at approximately 18 month intervals or less if deemed necessary.
As a result of the rt iew of a State program, the NRC determines that the Agreement State's prograra is either:
(1)
Adequate to protect the public health and safety; or (2)
Inadequate to protect the public health and safety.
A program may be adequate to protect the public health and safety although in need of improvement in specified areas.
In some cases, the NRC may be unable to make a finding at the time of the review because of unresolved items or inadequate information necessitating a follow-up review.
In such cases, NRC follows up on these matters by correspondence, follow-up onsite reviews or at the time of the next regular scheduled review.
No significant items will be left unresolved over a prolonged period.
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A determination is also made that the program is either:
(1) Compatible with the NRC Regulatory program in areas related to the publir health and safety; or (2)
In~ 'mpatible with the NRC Regulatory program; or (3) NRC is unable to make a finding at the time of the review because of, unresolved items or inadequate information.
A dispositive finding is made at the time the staff submits a consolidated assessment to the Commission in an annual report on all Agreement States.
In making a finding of adequacy, the NRC considers areas of the State program which are critical to its primary function, i.e., protection of the public healt.5 and safety.
For example, a State that does not have qualified personnel, fails to take adequate licensing actions or has no inspection program, would not be considered to have a program adequate to protect the public health and sifety. Basic radiation protection standards, such as exposure limits, also directly affect the States' ability to protect public health and safety. The NRC feels that it is important to strive for a high degree of uniformity in technical definitions and terminology, particularly as related to units of measurement and
-8 Maximum permissible doses and levels of radiation and radiation dose.
concentrations of radioactivity in unrestricted areas as specified in 10 CFR Part 20 are considered to be important enough to require States to be essentially equivalent in this area in order to protect public health Certain cdministrative procedures, such as those involving and safety.
the licensing of products containing radioactive material intended for If no interstate commerce, also require a high degree of uniform ty.
serious performance problems are found in an Agreement State program aad if its standards and program procedures are compatible with the NRC In a case program, a finding of acequacy and compatibility is made.
where a State has not formall, updated radiation standards in important not deficient, a State could areas, but other areas of the program era It is be found to be adequate but not compatible with the NRC program.
also possible that a State program could have up-to-date regulations, all proper procedures, and adequate staff, but still fail to perform the necessary work.
In this case, a program could be found to be inadequate to protect the public health and safety, yet compatible with the Commission's In the worst case, a program can be found to be both inadequate program.
and incompatible with the NRC program.
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" Guidelines for the Management of Agreement State Radiation Control Programs" 1981 Prepared by Office of State Programs U.S. Nuclear Regulatory Commission Washington, D.C. 20555
4 INTRODUCTION Section 274 of the Atomic Energy Act was enacted by the Congress in 1959 to recognize the interests of the States in atomic energy, to clarify the respective responsibilities of State and Federal Governments, and to provide a mechanism for States to enter into formal agreements with the Atomic Energy Commission ( AEC), and later the Nuclear Regulatory Commission (NRC), under which the States assume regulatory authority over byproduct, source, and small quantities of special nuclear materials, collectively referred to as agreement materials.
The mechanism by which the NRC discontinues and the States assume regulatory authority over agreement materials is an agreement between the Governor of a State and the Commission.
Before entering into an Agreement, the Governor is required to certify that the State has a regulatory program that is adequate to protect the public health and safety.
In addition, the Commission must perform an independent evaluation and make a finding that the State's program is adequate from the health and safety standpoint and compatible with the Commission's regulatory program.
Current Guidelines In 1980, the NRC staff initiated a major revision of the guide for review of Agreement State programs (two earlier revisions reflected primarily minor and editorial changes).
This was necessitated by changes in NRC licensing and compliance policy, the Uranium Mill Tailings Radiation
Control Act of 1978 and inflationary impacts on budgeting.
In view of increased public interest in radiation control matters and the Agreement State program, the Commission has published these,uidelines, which con-r stitute Commission policy in the form of a document entitled " Guidelines for the Management of Agreement State Radiation Control Programs." This document provides guidance for evaluation of operating Agreement State programs based on 20 years of combined AEC-NRC experience in administering the Agreement State program.
The " Guidelines" are intended for use by State management in the day to day operation of their programs and in self evaluation of the program's performance.
The document will also be used by the NRC in its continuing program of evaluating Agreement State programs.
The " Guidelines" contain six sections, each dealing with one of the essential elements of a radiation control program (RCP) whicn are:
Legislation and Regulations, Organization, Mandgement and Administration, Personnel, Licensing, and Compliance.
Each section contains (a) a summary of the general significance of the program elements, (b) indicators which address specific functions within the program element, (c) categories which denote the relative importance of each indicator, and (d) guidelines which delineate specific objectives or ope' itional goals.
O s
Categories of Indicators The indicators listed in this document cover a wide range of program functions, both technical and administrative.
It should be recognized that the indicators, and the guidelines under each indicator, are not of equal importance in terms of the fundamental goal of a radiation control program, i.e. protecting the public health and safety.
Therefore, the indicators are categorized in terms of their importance to the fundamental goal of protecting the public health and safety.
Two categories are used.
Category I - Direct Bearina on Health and Safety Category I Indicators are:
o Legal Authority o
Status of Regulations a
Quality of Emergency Planning Technical Quality of Licensing Actions c
Adequacy of Product Evaluations o
o Status of Inspection Program o
Inspection Frequency Inspectors' Performance and Capability o
Response to Actual and Alleged Incidents o
o Enforcement Procedures
These indicators address program functions which directly relate to the State's ability to protect the public health and safety.
If significant problems exist in several Category I indicator areas, then the need for improvements may be critical.
Legislation and regulations together fom the foundation for the entire program, '.:stablishing the framework for the licensing and compliance programs. The technical review of license applications is the initial step in the regulatory process.
The evaluation of applicant qualifications, facilities, equipment, and procedures by the regulatory agency is essential to assure protection of the public from radiation hazards associated with the proposed activities.
Assuring that licensees fulfill the commitments made in their applications and that they ob.rve the requirements set forth in the regulations is the objective of the compliance program.
The essential elements of an adequate compliance program are (1) the conduct of onsite inspections of licensee activities, (2) the performance of these inspections by competent staff, and (3) the taking of appropriate enforcement actions.
Another very important factor is the ability to plan for, respond effectively to, and investigate radiation incidents.
Category II - Essential Technical and Administrative Support Category II Indicators are:
o Updating of Regulations Location of Radiation Control P.rogram Within State Organization o
Internal Organization of Radiation Control Program o
o Legal Assistance o
Technical Advisory Committees o
Budget o
Laboratory Support o
Administrative Procedures o
Management Office Equipment and Support Services o
o Public Information Qualifications of Technical Staff o
o Staffing Level o
Staff Supervision o
Training o
Staff Continuity o
Licensing Procedures o
Inspection Procedures o
Inspection Reports o
Independent Measurements These indicators address program functions which provide essential technical and administrative support for the primary program functions.
Good performance in meeting the guidelines for these indicators is essential in order to avoid the development of problems in one or more
of the principal program areas, i.e. those that fall under Category I indicators.
Category II indicators frequentiy can be used to identify underlying problems that are causing, or contributing to, difficulties in Category I indicators.
It should be recognized that the categorization pertains to the significance of the overall indicator and not to each of the guidelines within that indicator.
For example, " Technical Quality of Licensing Actions" is a Category I indicator.
The review of license applications for the purpose of evaluating the applicant's qualifications, facilities, equipment, and procedures is essential to assuring that the public health and safety is being protected.
One of the guidelines under this ii.dicator concerns prelicensing visits.
The need for such visits depends on the nature of the specific case and is a matter of judgement on the part of the licensing staff. The success of a State program in meeting the overall objective of the indicator does not depend on literal adherence to each recommended guideline.
General NRC Policy _
The " Guidelines for the Management of Agreement State P.adiation Control programs" will be used by the NRC staff during its onsite reviews of Agreement State programs.
Such reviews are conducted at approximately A
18 month intervals, or less if deemed necessary.
As a result of the review of a State prcgram, the NRC determines that the Agreement State's program is either:
(1) Adequate to protect the public health and safety; or (2)
Inadequate to protect the public health and safety.
A program may be adequate to protect the public health and safety although in need of improvement in specified areas.
In some case, the NRC may be unable to make a finding at the time of the review oecause of unresolved items or inadequate information necessitating a follow-up review.
In such cases, !!RC follows up on these matters by correspondence, follow-up onsite reviews or at the time of the next regularly scheduled review.
t;o significant items will be left unresolved over a prolonged period.
A determination is also made that tne program is either:
(1) Compatible with the NRC Regulatory program in areas related to the public health and safety; or (2)
Incompatible with the NRC Regulatory program; or NRC is unable to make a finding at the time of the review because of unresolved items or inadequate information. A dispositive finding is made at the time the staff submits a censolidated assessment to the Commission in an annual report on all Agreement States.
_g.
In making a finding of adequacy, the NRC considers areas of the State program which are critical to its primary function, i.e., protection of the public health and safety.
For example, a State that does not have qualified personnel, fails to take licensing actions or has no inspection program, would not be considered to have a program adequate to protect the public health and safetsafety.
Basic radiation protection standards, such as exposure limits, also directly affect the States' ability to protect public health and safety. The NRC feels that it is important to strive for a high degree of uniformity in technical definitions and terminology, particularly as related to units of measurement and radiation Maximum permissible doses and levels of radiation and concentrations dose.
of radioactivity in unrestricted areas as specified in 10 CFR Part 20 are considered to be important enough to require States to be essentially equivalent in this area in order to protect public health and safety.
Certain administrative procedures, such as those involving the licensing of products containing radioactive material intended for interstate commerce, also require a high degree of uniformity.
If no serious performance problems are found in an Agreement State program and if its standards and program procedures are compatible with the NRC program, a finding of adequacy and compatibility is made.
In a case where a < tate has not formally updated radiation standards in important areas, but other areas of the program are not deficient,'a State could be found to be adequate but not compatible with the NRC program.
It is also possible that a State program could have up-to-date regulations, all proper R
9 procedures, and adequate staff, but still fail to perform the necessary work.
In this case, a program could be found to be inadequate to protect the public health and safety, yet compatible with the Commission's program.
In the worst case, a program can be found to be both inadequate and incompatible with the NRC program.
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_10 GUIDELINES LEGIS(.ATION AND REGULATIONS The effectiveness of any State radiation control program (RCP) is dependent upon the underlying authority granted the RCP in State legis-lation, and implemented in the State regulations.
Regulations provide the foundation upon which licensing, inspection, and enforcement decisions are made.
Regulations also provide the standards and rules within which the regulated must operate. Periodic revisiens are necessary to reflect changing technology, improved knowledga, current reconmendations oy technical advisory groups, and consistency with NRC regulations.
Pro-cedures for providing input to the NRC on proposed changes to NRC regulations are necessary to assure consideration of the State's interests and requirements. The public and, in particular, affected classes of licensees should be granted the opportunity and time to concent on rule changes.
Indicators Category Guidelines I
Clear statutory authority should Legal Authority exist, designating a State radiation control agency and providing for promulgation of regulations, licensing, inspection ana enforce-ment.
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.
Where regulatory responsibilities are divided between State agencies, clear understandings should exist as to division of respon-sibilities and requirements for coordination.
Status of Regulations I
The State must have regulations essentially identical to 10 CFR Part 19, Part 20 (radiation dose standards and effluent limits),
and those required by UMTRCA, as ih.plemented by Part 40.
The State should adopt other regulations to naintain a high degree of uniformity with NRC regulations.
-. =
Updating of Reguldtions II The RCP has established procedures for effectilg appropriate amendments to State regulations in a ticely manner, normally within 3 years of adoption by NRC. For those regulations deemed a matter of compatibility by NRC, State regulations should be amended as soon as practicable but no later than 3 years.
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 the Agreement, opportunity should be provided for the NRC to comment on draft changes in State re..lations.
ORGANIZATICN The effectiveness of any State RCP may be dependent upon its location The RCP should be in within the overall State organizational structure.
a position to compete effectively with other health and safety programs for budget and staff.
Program management must have access to individuals The RCP or groups which establish health and safety program priorities.
should be organized to achieve a high degree of efficiency in supervision, work functions, and communications.
Guidelines Indicators Category The RCP should be located in a State Location of Radiation II organization parallel with comparable Control Program Within health and safety progr ams.
The State Organization Program Director should have access to appropriate levels of State management.
The RCP should be orgenized with the Inte nal Organization of II view toward achieving an acceptable Radiation Control Program degr?e 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.
Wnere regicnal offices are utilizss, the lines of communication and adminis-trative control between the regions and the central office (Program Director) should be clearly drawn to provide uniformity in inspection policy, pro-cedures and supervision.
Legal Assistance II 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 regulations.
Technical Advisory Com-II Technical Committees, Federal Agencies, mittees and other resource organizations should be used to extend staff capabilities for unique or technically complex problems.
4 e
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 represert 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 adviso ry.
This does not mean that representatives of the regulated community should not serve on advisory committees or not be used as consultants.
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MANAGEMENT AND ADMINISTRATION State RCP management must be able to meet program goals through strong, direct leadership at all levels of supervision.
Administrative procedures are necessary to assure uniform and appropriate treatment of all regulated parties. Procedures for receiving information on radiological incidents, emergency response, and providing information to the public are necessary.
Procedures to provide feedback to supervision on status and activities of the RCP are necessary.
Adequate facilities, equipment and support services are 'needed for optimum utilization of personnel resources.
Laboratory support services should be administered by the RCP or be readily available through established administrative procedures.
In order to meet program goals, a State RCP must have adequate budgetary support. The total RCP budget must provide adequate funds for salaries, travel costs associated with the compliance program, laboratory and survey instrumentation and other equipment, and other administrative costs.
The program budget must reflect annual changes in the number and complexity of applications and licenses, and the increase in costs due to normal inflation.
Indicators Category Guidelines Quality of Emergency I
The St3te RCP should have a written Planning plcr. ror response to such incidents
- -_=~
17-as spills, overexposures, transportation accidents, fire or explosion, theft, etc.
The Plan should define the responsibili-ties 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.
Em'.rgency communication procedures should be adequately established with appro-priate local, county and State agencies.
Plans should be distributea to appro-priate persons and agencies.
t1RC should be provided the oppor-tunity to comment on the Plan while in draft form.
The plan should be reviewed ar.nually by Program staff for adequacy and to determine that content is current.
Periodic drills should be performed to test the plan.
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Bedget II Operating funds should be sufficient to support program needs such as:
staff travel necessary to the conduct of an effective compliance program, including routine inspections, followup or special inspections (including pre-licensing visits) and responser 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 opereting funds should be from sources which provide continuity and reliability, i.e., general tax, licens,e fees, etc. Supplemental funds may be obtained through contracts, cash grants, etc.
_19 Laboratory Support II The RCP should have the capa-bility in-house, or readily avai.lable through established procedures, laboratory support to conduct bioassays, analyze environmental samples, analyze samples collected by inspectors, etc.
on a priority established by the RCP.
Administrative Procedures II The RCP shcald establish written internal procedures to assure that staff performs its duties as required and to provide a high degree of uniformity and contiruity in regulatory practices.
These procedures should address internal processing of license applications, inspection policies and procedures, decommissioning, and c ther functions required of the program, tianagement II Program management should receive periodic reports from the staff on the status of regulatory actions (back[ogs,problemcases, 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, potential for signi-ficant releases to environment) should receive second party review (supervisory) committee, consultant).
Superviso ry review of inspections, reports and enforcement actions should also be performed.
Office Equipment II The RCP should have adequate secretarial and Support Services and clerical support.
Automatic typing and Automatic Data Processing ant' retriev-7 capability should be available to larger (>300-400 licenses) programs.
Similar services should be available to regional offices, if utilized.
' Public Information II Inspection and licensing files should be available to the public consistent with State administrative procedures.
Opportunity for public hearings should be provided in accordance with UMTRCA and applicable State administrative procedure laws.
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. PERSONNEL The The RCP must be staffed with a sufficient number of trained personnel.
evaluation cf license applications and the conduct of inspections require staff with,in-depth training and experience in radiation protection and related subjects. The staff must be adequate in number to assure licensing, inspection, and enforcement actions of appropriate quality to assure protection of ae public health and safety.
Periodic training of existing staff is necessary to maintain capabilities in a rapidly changing tech-nological environment.
Program management personnel must be qualified to exercise adequate supervision in all aspects of a State radiation control
~
program.
Indicators Category Guide for Acceptable Practice Qualifications of II Professional staff should have bachelor's Technical Staff degree or equivalent training in the physical and/or life sciences.
Additional training end experience in radiation protection for senior persennel should be commensurate with the type of licenses issued and inspected by the State.
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Written job descriptions should be prepared so that professional qualifications needed to fill vacancies can be readily identified.
Staffing Level II 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 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 insitu mills) or major renewal, to nieet requirements of Uranium Mill Tailings Radiation Control Act of 1978. This effort must include expertise in radiological matters, hydrology, geology, and structural engineering.*
- Additional guidance is provided in the Criteria for Guidance of States and NRC in Discontinuance of NRC Regulatory Authority and Assumption Thereof Sy States Through Agreement.
' Staff Supervision II 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.
Trcining II Senior personnel should have attended NRC core courses in licensing orienta-tion, 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.
Staff Continuity II 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 pro-fessional 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 w.n experience and respon-sibility.
o LICENSING It is necessary in licensing byproduct, source, and special nuclear materials that the State regulatory agency obtain information about the proposed use of nuclear materials, facilities and equipment, training and experience of personnel, and operating procedures appropriate for determi,,ing that the applicant can operate safely and in compliance with the regulations and license conditions. An acceptable licensing program includes:
preparation and use of internal licensing guides and policy memoranda to assure technical quality in the licensing program (when appropriate, such as in small programs, NRC Guides may be used); pre-licensing inspection of com-facilities; and the implerentation of administrative procedures tc.msure documentation and maintenance of adequate files and records.
Indicators Category Guidelines Technical Quality of I
The RCP should assure that essential Licensing Actions 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.
Prelicensing 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.
Adequacy of Product I
RCP evaluations of manufacturer's or distributor's data on sealed Evaluations sources and devices outlined in NRC, State, or appropriate ANSI Guides, should be sufficient to
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assure integrity and safety for users.
The RCP should review manufacturer's information in labels and brochures relating to radiation health and safety, assay, 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 restictive conditions.
Licensing Procedures II The RCP should have internal licensing guides, checklists, and policy memoranda consistent with current flRC practice.
License applicants (including appli-cants 'f',r renewals) should be furnished
'opies of applicable guides and regulatory positions.
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-29 The present compliance status of licensees should be considered in licensing actions.
Under the NRC Exchange-cf-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 license conditions comparable with current NRC standard license conditions should be used to expedite and provide uniformity in the licensing process.
Files should be maintained in an orderly fashion to allow fast, accurate retrieval of informa-tion and documentation of discussions and visits.
R
.s COMPLIANCE Periodic inspections of licensed operations are essential to assure that activities are being conducted in compliance with regulatory requirements and consistent with good safety practices.
The frequency of inspections depends on the amount and the kind of material, the type of operation licensed, and the results of previous inspections.
The capability of maintaining and retrieving statistical data on the status of the compliance program is necessary.
The regulatory agency must have the necessary legal authority for prompt enforcement of its regulations.
This may include, as appropriate, administrative remedies, orders requiring corrective action, suspension or revocation of licenses, the impounding of materials, and the imposing of civil or criminal penalties.
Indicators Category Guidelines Status of Inspection I
State RCP should maintain an Program inspection program adequate to assess licensee compliance with State regulations and license 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, the number overdue, the length of time overdue and the priority categories should be readily available.
At least semiannual inspection planning for number of inspections to be performed, assignments to senior vs. junior staff, assignments to regions, identification of special needs and periodic status reports.
I The RCP should establish an Inspection Frequency 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 radiographers should be inspected approximately annually--smaller or less hazardous operations may be inspected less frequently.
The minimum inspection frequency should be consistent with the NRC system.
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Inspectors' Performance I
Inspectors should be competent to evaluate health and safety and Capability 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 performance and assure application of appropriate and consistent policies and guides.
Response to Actual and I
Inquiries should be promptly made to evaluate the need for Alleged Incidents onsite investigations.
Onsite investigations should be promptly made of incidents O
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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 significant public interest and concern, e.g. transportation accidents.
Investigations should include indepth reviews of circumstances and should be completed on a high priority basis. When appropriate, investigations should include reenactments and time-study measure-ments (normally within 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 operations (e.g.,
equipment failure, improper operating procedures).
Information on incidents involving failure of equipment should 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.
4 Enforcement Procedures I
Enforcement Procedures should be sufficient to provide a substantial m
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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 re-occurrence (normally 20-30 days). The inspector and compliance supervisor should review licensee responses.
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Licensee responses to enforcement letters should be promptly acknowledge 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 adninistration of the radiation control program.
Inspection guides, consistent II Inspection procedures with current 11RC guidance, should be used by inspectors to assure uniform and complete inspection practices and provide technical e
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guidance in the inspection of licensed programs. The NRC-Agreement States Guides may be used if properly supplemented by policy memoranda, agency inter-pretations, 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, assuring exit interviews with management, and issuing appropriate notifi-cation of violations of health and safety problems.
Procedures should be established for maintaining licensees' compliance histories, Gral briefing'of supervision or t:
senior inspector should be performed upon return froc
[onroutineins?ecticns, s
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i For States with separate licensing and inspection staffs, procedures should be established for feedback of information to license reviewers.
Inspection Reports II 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 indicatfra the substance of discussions with licensee management and licensee's response.
Reports should uniformly and adequately document the results of inspecticas and identify areLL cf the licer.see'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.
Independent Measurements II Independent measurements should be sufficient in number and type to ensure the licensce's control of materials and to validate the licensee's measurements.
RCP instrumentation should be adequate for surveying license operations (e.g., survey meters, air samplers, lab counting equipment for smtars, identification of isotopes, etc.).
r,M Survey Meter:
0-20 mr/hr Ion Chamber Survey Meter: several r/hr Neutron Survey Meter:
Fast & Thermal Alpha Survey Meter:
0-100,000 c/m Air Samplers:
H1 and to Volume
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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.
Dated at Washington, DC this day of 1981.
FOR THE NUCLEAR REGULATCRY COMf11SS10N Samuel J. Chilk Secretary of the Commission
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