ML20207P929
| ML20207P929 | |
| Person / Time | |
|---|---|
| Issue date: | 11/06/1986 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | |
| References | |
| FRN-51FR41172, RULE-PR-MISC PR-861106, NUDOCS 8701200422 | |
| Download: ML20207P929 (42) | |
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ocuT uguger g 3ROPQ8ED iuSE R Sc. No ICC // s (SIFA4//72) :
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$ ab Ni ,5 Evaluation of Agreerent State Radiation Cent :
Proposed General Statenent of Policy AGENCY: U.S. Nuclear Regulatory Comission.
ACTION: Proposed revision to general statenent of policy.
SUMMARY
- The Nuclear Regulatory Comission proposes to revise its -
general statenent of policy, " Guidelines for NRC Review of Agreenent State Radiation Control Programs," December 4, 1981. The proposed revision to the Guidelines which was prepared by the NRC staff incorporate minor changes to the introduction, the indicators and the guidelines for acceptable practice by Agreement States. The statenent of policy informs the public of the indicators and guidelines which the Comission uses in reviewing Agreenent State radiation control programs.
The Conmission believes that the revisions are needed and is requesting coments on then. The Comission is also requesting coment on the g feasibility of developing a set of ob.iective perfornance indicators for
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l ; g various materials licensees.
ni e DATES: Coments are due on or before January 12 , 198 7.
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@ ADDRESSES: Written corrents may be subnitted to the Rules and Procedures Branch, Division of Rules and Records, Office of Administration, U.S. Nuclear Regulatory Comission, Washington, DC K' g f (j 20555. Coments may also be delivered to Roon 4000, Maryland National Bank Building, Bethesda, Maryland from 8:15 e.n. to 5:00 p.m. Monday C k! O SSi6.w suu. //}-ffgj g f~g 4 ll 7 h
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through Friday. Copies of comments received may be exanined at ths NRC Public Document Room, 1717 H Street, NW., Washington, DC.
FOR FURTHER INFORMATION CONTACT: Donald A. Nussbaumer, Office of State Programs, U.S. Nuclear Regulatory Conmission, Vashington, D.C. 20555, Telephone: 301-492-7767.
SUPPLEMENTARY INFORMATION: Section 274 of the Atonic Energy Act of 1954, as amended, (Act) &was enacted in 1959 to provide a statutory neans by which the NRC (then the AEC) could transfer to the States part of its regulatory authority. The nechanism for the transfer of the .
Comission's regulatory authority is by an agreement between the Governor of a State and the Comission. Thus far, 28 States have 1
entered into such agreements.'
Before entering into an agreement, the NPC is required to make a finding that the State's radiation control progran is adeouate to protect the public health and safety and is compatible with the Comission's program. Section 274j(1) of the Act reauires the NRC to periodically review such agreements and actions taken by the States under the l
agreements to insure compliance with the provisions of Section 274 of the Act. The purpose of.the policy statement is to establish the methods and guidelines the Comission will use in conducting the periodic reviews. Section 274j(1) of the Act also provides that the NRC l.
! nay tenninate an apreement with a State if the_ Comission finds that i
such termination is necessary to protect the public health and safety or I Alabama, Arizona, Arkansas, California, Colorado, Florida, l
l Georgia, Idaho, Iowa, Kansas, Kentucky, Louisiana, Maryland, l
Mississippi, Nebraska, Nevada, New llampshire, New Mexico, New York,
! North Carolina, North Dakota, Oregon, Rhode Island, South Caroline, Tennessee, Texas, Utah, and Washington.
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the State has not complied with one or nors o# the requirenents of Section 274. Under Section 274j(2) the Conmission has the authority to temporarily suspend an agreement under emergency conditions.
Findings of adequacy and compatibility are currently made by the NRC staff following reviews of individual Agreement State programs in accordance with the December 4, 1981 policy statenent. Such reviews are conducted on a frequency of 12 to 18 months. The results of each review are discussed with a senior management official, such as the State liealth Officer (or designee), and con #irmed by letter. Copies of these letters are placed in the NRC Public Document Roon. The Comission is also informed of the results of individual Agreement State reviews.
The NRC staff coment letters contain as an enclosure a sumary of the policy statement with emphasis on how connents concerning Category I and Category II 2 indicators affect staff findings of adequacy and compatibility. Staff findings of adeouacy and compatibility are offered 2
Category I Indicators are those that directly af#ect public health and safety (e.g., quality of licensing). Category II indicators are those program elements that can lead to Category I problems if not maintained (e.g., staffing level, laboratory support). The distinction between significant and minor Category I problems provides the staff sone flexibility when evaluating overall perfornance within an Indicator program area. For example, " Status of Inspection Progran" is a Category I Indicator and contains a guideline for addressing inspection backlogs when they occur. If there is a backlog in high priority insoections and the State has not developed a plan to reduce and monitor the backlog, then the backlog is considered to be a significant problem. If the State has a plan in place to reduce the backlog (with suitable goals and benchrarks) whose progress program nanagenent is monitoring, the problem can be characterized as ninor. If, in a subsequent review, there was lack of satisfactory progress in reducing the backlog, this would cause the staff to conclude the problem is significant.
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only when there are no significant problems in Category I Indicators.
If there are ninor Category I Indicator coments or Category II Indicator comments, the State is requested to respond to our coments in these areas.
When one or nore significant problems in Category I Indicators are found, the State, in addition to being asked to respond to any comments, is also infomed that no findings of adecuacy and conpatibility will be considered until a response to the coments has been received from the State and evaluated.
Since the December 4, 1981 policy statenent was issued this method of implenentation has been successful in helping Agreerent States maintain their prograns in an adequate and compatible nanner. From 1981 through 1985, 108 routine reviews of State prograns were performed. Full findings of adequacy and conpatibility were offered by the staff in 63 cases (58%). In 15 other cases, findings of adequacy were offered by the staff but not a finding of conpatibility (because of out-dated regulations)(14%). Withholding of both findings occurred in 30 cases (28%). In nost of these 30 cases, State responses to significant Category I coments were found by NRC staff to satisfactorily address i NRC concerns and NRC staff findings of adeauacy and conpatibility were subsequently offered. Follow-up reviews were perforned on 5 occasions.
In two instances, State actions to address significant Catecory I I coments were undertaken but subsequent NRC reviews disclosed additional i
j steps werr still needed to fully resolve Category I problens. In these cases, the States provided additional responses that ?!P.C staff found to be satisfactory. In no case did any Agreenent State's progran performance cause t'RC staff to recomend to the Commission that it institute proceedings to suspend or revoke all or part of an Agreenent.
NRC staff meet semi-annually with representatives of the Occupational Safety and Health Administration (OSHA) to review the status of the Agreement State program. This is done because the Occupational Safety and Health Act of 1970 does not apply when Federal agencies and State agencies acting under Section 274 of the Atomic Energy Act of 1954, as amended, exercise statutory authority to prescribe or enforce standards or regulations affecting occupational radiological safety or health.
While overall finplementation of the December 4,1981 policy statement has been satisfactory in assuring adequate and compatible Agreenent State prograns, the experience to date has identified some facets of the ,
policy statement that could benefit fron updating, clarifying or other minor modifications.
The guideline document contains six najor sections, each of which deals with a separate program element. These sections are: Legislation and Regulations, Organization, Managenent and Administration, Personnel, Licensing, and Compliance. Each program elenent contains " Indicators" which address specific functions within the progran element. One or more reconnended " Guidelines" are listed under each " Indicator."
The proposed policy statement revision spells out in somewhat greater detail NRC staff practices in handling findings of reviews, including specifying when staff offerings of adequacy and conpatibility nay be nade, and options available to the States and to the flRC staff when l review results preclude such offerings. The policy statement revision incorporates staff practices of informing the Conmission of the results of reviews of individual Agreenent State programs and cf placing copies of HRC review letters to the States into the NRC Public Document Roon.
Consolidated annual reports of all Agreenent State review findings in one document are no longer prepared, having been discontinued in 1982.
The policy statement no longer notes Comission interest in establishing a more quantitative basis for measuring the quality and consistency of NRC reviews. No public coments were received on this issue following issuance of the 1981 Policy Statenent. In 1983, the National Governors' Association report on the Agreement State program found that "the present NRC guidelines for evaluating Agreement State prograns are considered adequate and offer the proper degree of flexibility in reviewing State programs for adequacy and compatibility." FRC staff of the Offices of Nuclear Material Safety and Safeguards, the Office of Inspection and Enforcenent and the Office of State Prograns exchange considerable infomation on their respective activities. They have met ,.
to discuss the subject of objective measures of performance. The staff has concluded that the indicators and associated review guidelines used in reviewing Agreenent State programs are sufficiently objective and are consistent with the objectives the NRC staff uses in appraising its regional material licensing and compliance functions.
As an alternative to establishing objective performance indicators to assess the Agreement State regulatory prograns, the Comission has i
directed the staff, in conjunction with the Agreement States to exanine i
the feasibility of an objective performance indicator system for the various categories of materials licensees regulated by the Agreenent States and the NRC. The Comission believes such a svsten would provide a national data base on overexposures, nedical nisadministration etc.
and would be an indicator of how well the various Agreement States and the NRC ar'e doing their jobs. The Agreerent States and the public are
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l invited to express their views on the feasibility of developirg a set of objective perforrance indicators for raterials licensees and to provide
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suggestions of what would constitute suitable indicators.
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The proposed policy statenent revision p rmits NRC staff to extend the interval between reviews to approximately 24 months in cases when no significant Category I findings are identified. Since the issuance of the 1981 policy statenent, the NRC Agreenent State progran has been decentralized. State Agreenent Representatives are present in NRC Regions I, II, IV and V where 27 of the 28 Agreenent States are located.
These persons not only conduct the periodic reviews but are in frequent contact with the States in these regions and thus can closely nonitor events affecting the Agreement progran in the States. The selective extension of review intervals will permit more effective utilization of NRC resources for Agreenent State program activities.
l The format of the Indicators and Guidelines has been revised to nake it easier to print.
Under the Element, Legislation and Regulations, for the Indicator,
" Legal Authority," the guideline addressing cases when regulatory authorities are divided between State agencies has been noved to Organization Elenent under the Indicator, " Location of Radiation Control Progran Within State Organization," which is more appropri3.te.
The Category II Indicator, " Updating of Regulations" has been deleted and the guidelines under it moved to a renaned Category I Indicator,
" Status and Compatibility of Regulations," Lack of findings of compatibility have almost always been caused by out-of-date State regulations. Ilpdating of regulations has become a chronic problen for Agreement States, because State resources needed to draft revisions were not always available, because State adoption procedures for regulations have become increasingly conplex, and because the nodel Suggested State Regulations prepared by the Conference of Radiation Control Progran Directors, Inc. have not been updated in a tirely fashion to reflect
revisions to NRC regulations. Confusion has also aris n over the distinctions between the two Indicators and the differences in their categories.- The revision combines the two into a single Category I indicator, thus emphasizing 'the importance of keeping the regulations up to date. A minor change to the reference to 10 CFR Part 20 was made to include the waste manifest rule (10 CFR 20.311) as a ccmpatibility item.
A reference to 10 CFR Part 61 has been added to the guideline which highlights specific Parts of NRC regulations to which State reaulations should be essentially identical, a < ,
Under Management and Administration, for the Indicator, .
" Administrative Procedures," the guideline has been nodified and expanded to make clearer what is being sought with respect to these kinds of procedures. Confusion has crisen between " administrative" procedures and procedures called for in the guidelines in the technical areas of licensing, inspection and enforcement. Under " Management," a new guideline has been added that recommends periodic audits of State regional offices or other State agency offices when these are used in an Agreenent State program. A nunber of Agreenent State programs use regional offices or use other State or local anvernment staffs (usually for inspection).
l Under "Public Information," the guideline on availability of files to l the public has been modified to also note the need #or provisions to protect proprietary or clearly personal information fron public disclosure. Previously the guidelines only called for handling such information in accordance with State administrative orocedures. Some l
l recently enacted State "open records" legislation have in sone instances, caused chances to State administrative procedures that weaken l
or prevent protection of such information fron public disclosure. As a result, State radiation control prograns nay have difficulty in
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withholding individual personnal radiation exposure records or proprietary information relating to radiation safety when necessary to carry out their statutory responsibilities.
Under the Indicator, " Qualifications of Technical Staff," the guideline has been modified to make clear that it is desirable that the directors of radiation protection prograns possess appropriate technical qualifications.
Under the Indicator, " Staffing Level," the guideline containing the value 1.0 to 1.5 person-year per hundred licenses has been modified to nake clear that this staff-level guideline excludes professional effort expended for uranium mill, mill tailings and radioactive waste disposal regulation.
Under the Indicator, " Status of Inspection Progran," the inspection planning guideline has been modified to also address inspection backlogs. Inspection backlogs constitute the most prevalent problen in Agreement State prograns. NRC staff experience has been that wher States are asked to develop plans specifically for addressing backlogs, including setting of priorities and benchnarks, progress in controlling this problem is achieved.
Under the Indicator, " Inspection Frequency," modifications have been nede to the guideline to rake clear that the NRC inspection priority systen for'naterials is the minimum that is acceptable.
Under the Indicator, ":rspectinn Peports," revisions were made to the guideline to rore clearly icentify essential elements the repcrts should contain.
The Indicator, " Independent Measurements" has beIn retitled
" Confirmatory lieasurements." Minor revisions have been made to the guidelines, including addition of "nicro-R-meter" to the list of desirable instrumentation.
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11 Guidelines for NRC Review
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of Agreenent State Radiation Control Programs 1986.
Prepared by Office of State Programs, U.S. Nuclear Regulatory Comission, Washington, D.C. 20555.
Introduction Section 274 of the Atonic Energy Act was enacted by the Congress in
- 1959 to recognize the interests of the States in atonic energy, to clarify the respective responsibilities of State and Federal Governnents, and to provide a rechanism for States to enter into fornal agreenents with the Atonic Energy Comission (AEC), and later the fluclear Regulatory Comission (NRC), under which the States assume regulatory authority over byproduct, source, and small quantities of special nuclear raterials, collectively referred to as agreenent naterials. The nechanism by which the NPC discontinues and the States assume regulatory authority over agreenent naterials is an agreenent between the Governor of a State and the Comission. 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 Comission must perform an independent evaluation ard nake a finding that the State's progran is adeouate from the health and safety standpoint and compatible with the Comission's regulatory progran.
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Current Guidelines In 1981, the Comission published a major revision of the guide for review of Agreement State programs (two earlier revisions reflected primarily ninor and editorial changes). These Guidelines constitute Comission policy in the form of a document entitled " Guideline" for NRC Review of Agreement State Radiation Control Prograns." This docunent provides guidance for evaluation of operating Agreement State prograns based on over 20 years of conbined AEC-NRC experience in administering the Agreement State progran.
In 1985, Comission staff initiated ninor updating, clarifying and editoral changes reflecting the experience gained with the 1981 policy statement. The revised document will be used by the NRC in its continuing progran of evaluating Agreement State prcgrams.
The " Guidelines" contain six sections, each dealing with one of the essential elements of a radiation control program (PCP) which are:
Legislation and Regulations, Organization, Managenent and ,
Administration, Personnel, Licensing, and Compliance. Each section contains (a) a sumary of the general significance of the progran elements, (b) indicators which address specific functions within the progran element, (c) categories which denote the relative importance of each indicator, and (d) guidelines which delineate specific objectives or operational goals.
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 inportance in terms of the fundamental goal of a radiation control program, i.e. protection of the public health and safety. Therefore, the indicators are categorized in terms of their importance to the fundanental goal of protecting the public health and safety. Two categories are used. -
Category I - Direct Bearing on Health and Safety. Category I.
Indicators are:
o Legal Authority.
o Status and Compatibility of Regulations.
o Quality cf Energency Planning.
o Technical Ouality of Licensing Actions.
o Adequacy of Product Evaluations.
o Status of Inspection Prcoran.
o Inspection Frequency.
o Inspectors' Performance and Capability, o Responsa to Actual and Alleged Incidents.
o Enforcer.ent 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 one or more Category I indicator areas, then the need for improvements may be critical. Legislation and regulations together forn the foundation for the entire progran establishing the franework for the licersing and compliance prograns.
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 reoulatory agency is essential to assure protection of the public from radiation hazards associated with the proposed activities. Assuring that licensees fulfill the comitments made in their applications and that they observe -
the requirements set forth in the regulations is the objective of the conpliance program. The essential elements of an adeouate conpliance prograrn are (1) the conduct of onsite inspections of licensee activities, (2) the perfornance of these inspections by concetent staff, and (3) the taking of appropriate enforcenent actions. Another very important f3ctor is the ability to plan for, respond effectivelv to, and investigate radiation incidents.
Category II-Essential Technical and Administrative Support. Category II Indicators are:
o Location of Radiation Control Program Within State Organization, o Internal Organization of P.adiation Control Progran, o Legal Assistance, c Technical Advisory Connittees.
o Budget.
o Laboratory Support.
o Administrative Procedures.
o Management.
o Office Equipment and Support Services, o Public Infornation, o Qualifications of Technical Staff.
o Staffing Level.
o Staff Supervision.
o Training.
o Staff Continuity. -
o Licensing Procedures.
o Inspection Procedures, o Inspection Reports.
o Confirnatory Measurements.
These indicators address progran 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 progran areas, i.e. those that fall under Category I indicators. Category II indicators frequently can be used to identify l underlying problems that are causing, or contributing to, difficulties in Category I indicators.
It is the flRC's intention to use these categories in the following nanner. In reporting findings to State nanagerent, the NRC will l
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indicate the category of each comment made. If no significant Category I coments are provided, this will indicate' that the progran is adequate to protect the public health and safety and is compatible with _the NRC's program. If one or nore significant Category I coments are provided, the State will be notified that the progran deficiencies may seriously affect the State's ability to protect the public health and safety and that the need of improvenent in particular progran areas is critical.
The NRC would request an immediate response. If, following receipt and evaluation, the State's response appears satisfactory in addressing the significant Category I coments, the staff nay offer findings of -
adequacy and conpatibility as appropriate or defer such offering until the State's actions are examined and their effectiveness confinned in a subsequent review. If additional information is needed to evaluate the State's actions, the staff nay request the infomation through follow-up correspondence or perfom a follow-up or special, linited review. NRC staff nay hold a special meeting with appropriate State representatives.
No significant items will be left unresolved over a prolonged period.
The Commission will be informed of the results of the reviews of the individual Agreement State programs and copies of the review correspondence to the States will be placed in the NRC public Document Roon. If the State progran does not improve or if additional significant Category I deficiencies have developed, a staff findina that the program is not adequate will be considered and the NRC nay institute proceedings to suspend or revoke all or part of the Agreenent in accordance with Section 274j of the Act.
Category II comments concern functions and activities which support the State program and therefore would not be critical to the State's ability to protect the public. The State will be asked to respond to these comments and the State's actions will be evaluated during the next regular program review.
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 irdicator. 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 indicator concerns prelicensing visits. The need for such visits depends on the nature of the specific case and is a natter of judgment on the part of the licensing staff. The success of a State progran in meeting the overall objective of the indicator does not depend on literal adherence to each reconnended guideline.
The " Guidelines for NRC Review of Agreenent State Radiation Control Programs" will be used by the NPC staff during its onsite reviews of Agreement State prograns. Such reviews are conducted at approximately 18 nonth intervals, or less if deemed necessary. If there are no significant Category I connents, the staff nay extend the interval between reviews to approxicately 24 nonths.
In naking a finding of adeouacy, the NRC considers areas of the State program which are critical to its prinary function, i.e.,
protection of the public health and safety. For example, a State that is not carrying out its inspection program, or fails to respond to significant radiological incidents would not be considered to have a progran adequate to protect the public health and safety. Basic radiation protection standards, such as exposure linits, also directly affect the States' ability to protect public health and safety. The PRC 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 dose. Maxinun permissible doses and levels of radiation and concentratiers 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 procedures, such as those involving the licensing of products containing radioactive material intended for interstate comnerce, also require a high degree of unifornity. If no serious performance problems are found in an Agreenent State progran and if its standards and progran procedures are conpatible with the NRC progran, a finding of adequacy and conpatibility
.is made.
PROGRAM ELEMENT: LEGISLATION AND REGULATIONS The effectiveness of any State radiation control program (RCP) is dependent upon the underlying authority granted the RCP in State legislation, and implemented in the State regulations. Regulations provide the foundation upon which licensing, inspection, ard enforcement decisions are made. Regulations also provide the standards and rules within which the regulated must operate. Periodic revisions are necessary to reflect changing technology, improved knowledge, current recommendations by technical advisory groups, and consistency with NRC -
r regulations. Procedures for providing input to the NRC on proposed changes to NRC regulations are necessary to assure consideration of the State's interests and requirenents. The public and, in particular, affected classes of licensees should be granted the opportunity and tine to connent on rule changes.
Indicators and Guidelines legal Authority (Category I) o Clear statutory authority should exist, designating a State radiation control agency and providing for promulgation of regulations, licensing, inspection and enforcement.
o States regulating uranium or thorium recovery and associated wastes pursuant tn the Uranium Mill Tailings Radiation Control Act of
a 1978 (UMTRCA) must have statutes enacted te establish clear authnrity for the State to carry out the requirements of UMTRCA.
Status and Compatibility of Regulations (Category I) o The State must have regulations essentially identical to 10 CFR Part 19, Part 20 (radiation dose standards, effluent limits, waste nanifest rule and certain other parts), Part 61 (technical definitions and requirements, perfomance objectives, financial assurances) and those required by UMTRCA, as implemented by Part 40.
o The State should adopt other regulations to maintain a high degree of unifomity with flRC regulations.
o For those regulations deemed a natter of compatibility by NRC, State regulations should be amended as soon as practicable but no later than 3 years.
o The RCP has established procedures for effecting appropriate amendments to State regulations in a timely ranner, normally within 3 years of adoption by NRC.
o Opportunity should be provided for the public to coment on proposed regulation changes (Required by UtiTRCA for uranium mill regulation.)
21-o Pursuant to the terms of the Agreenent, opportunity should be provided for the NRC to coment on draft changes in State regulations.
PROGRAM ELEMENT: ORGANIZATION The effectiveness of any State RCP may be dependent upon its location within the overall State organizational structure. The RCP should be in a position to compete effectively with other health and safety prograns for budget and staff. Progran management must have access to individuals or groups which establish health and safety program -
priorities. The RCP should be organized to achieve a high degree of efficiency in supervision, work functions, and communications.
Indicators and Guidelines Location of Radiation Control Program Within State Organization (Category II) o The RCP should be located in a State organization parallel with comparable health and safety prograns. The Program Director should have access to appropriate levels of State nanagerent, o Where regulatory responsibilities are divided between State agencies, clear understandings should exist as to division of responsibilities and requirements 'or coordination.
Internal Organization of Padiation Control Progran (Category II) o The RCP should be organized with the view toward achieving an acceptable degree of staff efficiency, place appropriate enphasis on najor program functions, and provide specific lines of supervision fron progran nanagement for the execution of program policy.
o Where regional offices or other government agencies are utilized, the lines of comunication 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.
Legal Assistance (Category U) o Legal staff should be assioned to assist the PCP or procedures should exist to cbtain legal assistance expeditiously. Legal staff should be knowledgeable regarding the RCP progran, statutes, and regulations.
Technical Advisory Committees (Category II) o Technical Cemittees, Federal Agencies, and other resource organizations should be used to extend staff capabilities for unique or technically cenplex problems, o A State itedical Advisory Connittee should be used to provide broad guidance on the uses of radicactive drugs in or on humans. The
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Comittee should represent a wide spectrun of medical d'isciplines. The Comittee should advise the PCP on policy matters and regulations related to use of radioisotopes in or on humans.
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o Procedures should be developed to avoid conflict of interest, s
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even though Comittees are advisory. This does not nean that i representatives of the regulated community shoulc' not serve on advisory comittees or not be used as consultants. d
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7 71 PROGRAM ELEMENT: MANAGEMENT AND ADMINISTRATION State RCP nanagement must be able to neet 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 infornation to the public are necessary. Procedures to provide feedback to supervis. ion on status and activities of the RCP are recessary. Adequatefacilities, f equipment and support services are needed for optimun utilization of personnel resources. Laboratory support services should be administered by the RCP or be readily available through established administrative l procedures.
In order to meet progran goals, a State P.CP nust have adequate budgetary support. ThetotalPCPbudgetrustprovideadeauatefundsforsalaridE, travel costs associated with the compliance progran, laboratory and survey instrumentation and other equipment, and other administrative I
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costs. The program budget rust reflect. annual charges in the number and complexity of applications and licenses, and the increase in costs due to normal inflation.
Indicators and Guidelines Quality of Emergency Planning (Category I) o The State RCP should have a written plan for response to such incidents as spills, overexposures, transpnrtation accidents, fire or Aj explosion, theft, etc. '
7 Ifi o The Plan should define the responsibilities and actions to be taken by State agencies. The Plan should be specific as to persons responsible for initiatirg respnnse actions, cnnducting operations and cleanup.
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o Emergency connunication procedures should be adequately established with appropriate local, county and State agencies. Plans should be distributed to appropriate persons and agencies. NRC should c
be provided the opportunity to comment on the Plan while in draft form.
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, o The plan should be reviewed annually by Progran staff for N
l\* adequacj and to deternine that content is current. Periodic drills should be perforned to test the plan.
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i Budget (Category II) o Operating funds should be sufficient to support progran 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 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, o 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.
Laboratory Support (Category II) o The RCP should have laboratory support capability inhouse, or readily available through established procedures, to conduct bioassays, analyze environmental sanples, analyze s6nples collected by inspectors, etc. on a priority established by the RCP.
Administrative Procedures (Category II) o The RCP should establish written internal policy and edministrative procedures to assure that program functions are carried i
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out as required and -to provide a high degree of unifomity and continuity in regulatory practices. These procedures should address internal processing of license applications, inspection policies, decommissioning and license temination, fee collection, contacts with communication media, conflict of interest policies for employees, exchange-of-infomation and other functions required of the progran.
Administrative procedures are in addition to the technical procedures utilized in licensing, and inspection and erforcenent.
Management (Category II) -
o Progran managenent should receive periodic reports from the staff an the status of regulatory actions (backlogs, problem cases, inquiries, regulation revisions).
o 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.
o Progran nanagement should perfom periodic reviews of selected license cases handled by each reviewer and document the results.
Complex licenses (major nanufacturers, large scope-Type A Broad, potential for significart releases to environment) should receive second party review (supervisory, cornittee, consultant). Supervisory review of inspections, reports and enforcement actions should also be perfomed.
o When regional offices or other governnent agencies are utilized, program management should conduct periodic audits of these offices.
Office Equipnent and Support Services (Category II) o The RCP should have adequate secretarial and clerical support.
Automatic typing and Automatic Data Processing and retrieval capability should be available to larger (greater than 300-400 licerses) programs.
Similar services should be available to regional offices, if utilized. -
0 Professional staff should not be used for fee collection and other clerical duties.
Public Infornation (Category II) o Inspection and licensing files should be available to the public consistent with State adninistrative procedures. It is desirable, however, that there be provisions for protecting from public disclosure proprietary information and information of a clearly personal nature.
i o Opportunity for public hearings should be provided in accordance with UMTRCA and applicable State avninistrative procedure laws.
PROGRAM ELEMENT: PERSONNEL The RCP must be staffed with a sufficient number of trained personnel.
The evaluation of 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 nunber to assure licensing, inspection, and enforcement actions of appropriate quality to assure protection of the public health and safety. Periodic training of existing staf' is necessary to maintain capabilities in a rapidly changing technological environment. Program management personnel nust be qualified to exercise adequate supervision in all aspects of a State radiation control program.
Indicators and Guidelines Oualifications of Technical Staff (Category II) o Professional staff should have bachelor's degree or equivalent training in the physical and/or life sciences. Additional training and experience in radiation orotection for senior personnel including the director of the radiation protection progran should be commensurate with the type of licenses issued and inspected by the State.
o .Written job descriptions should be prepared so that professional cualificaticrs needed to fill vacancies can be readily identified.
l Staffing Level (Category II) o 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 a way which provides continuous coverage and continuity.
o 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 nill license (including in situ nills) or major renewal, to meet requirements of Uranium Mill Tailings Radiation Control Act of 1978. This effort must include expertise in radiological natters, hydrology, geology, and structural engineering.1 Staff Supervision (Category II) o Supervisory personnel should be adequate to provide guidance and review the work of senior and junior personnel, o Senior personnel should review applicatiers and inspect licenses independently, ronitor work of junior perser.nel, and participate in the establishment of policy.
1 Additional guidance is provided in the Criteria for Guidance of States and NRC in Discontinuance of HRC Regulatory Authority and Assumption Thereof by States Through Agreenent (46 FR 7540, 36969 and 48 FR33376).
o Junior personnel should be initially limited to reviewing license applications and inspecting small'prograns under close supervision.
Training (Category II) o Senior personnel should have attended NRC core courses in licensing orientation, inspection procedures, medical practices ~and industrial radiography practices. (For nill States, nill training should also be included.)
o The RCP should have a progran to utilize specific short courses and workshops to maintain appropriate level of staff technical competence in areas of changing technology.
Staff Continuity (Category II) o Staff turnover should be mininized by conbinations of opportunities for training, promotions, and competitive salaries.
o Salary levels should be adequate to recruit and retain persons of appropriate professional qualifications. Salaries should be comparable to similar employnent in the geographical area.
o The RCP organization structure shculd be such that staff turnover is mininized and progran continuity naintained through opportunities for promotion. Promotion opportunities should exist from junior level to
m senior. level or supervisory positions. There also should be opportunity for periodic salary increases compatible with experience and responsibility.
PROGRAM ELEMENT: LICENSING It is necessary in licensing byproduct, source, and special nuclear naterials that the State regulatory agency obtain information about the proposed use of nuclear naterials, facilities and equipment, training and experience of personnel, and operating procedures appropriate for determining 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 prograns, NRC Guides may be used);
prelicensing inspection of complex facilities; and the inplenentation of administrative procedures to assure documentation ard maintenance of adequate files and records.
Indicators and Guidelines Technical Quality of Licensing Actions (Category I) o _
The RCP should assure that essential elements of applications have been submitted to the agency, and that these elements neet current l' regulatory guidance for describing the isotopes and quantities to be i
used, qualifications of persons who will use material, facilities and equipment, and operating and energency procedures sufficient to
- establish the basis for licensing actions.
o Prelicensing visits should be made for complex and major licensing actions.
o Licenses should be clear, complete, and accurate as to isotopes, forns, quantities, authorized uses, and permissive or restrictive conditions.
o 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 Evaluatiens (Category T) o RCP evaluations of nanufacturer's or distributor's data on sealed sources and devices outlined in NRC, State of appropriate ANSI Guides, should be sufficient to assure integrity and safety for users.
o The RCP should review nanufacturer's information in labels and brochures relating to radiation health and safety, assay, and calibration procedures for adequacy.
o 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 conditinns.
Licensing Procedures (Category II) o The RCP should have internal licensing guides, checklists, and policy memoranda consistent with current NRC practice, o License applicants (including applicants for renewals) should be furnished ccpies of applicable. guides and regulatory positions.
o The present compliance status of licensees should be considered in licensing actions, o Under the NRC Exchange-of-Infomation progran, evaluation sheets, service licenses, and licenses authorizing distribution to .
general licersees should be submitted to NRC on a timely basis.
o Standard license conditions comparable with current NRC
- 'tandard s license conditions should be used to expedite and provide unifomity in the licensing process.
o Files should be maintained in an orderly fashion to allow fast, accurate retrieval of infomation and documentation of discussions and visits.
PROGRAM ELEMENT: COMPLIAtlCE 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 naterial, 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 progran is necessary. The regulatory agency nust have the necessary legal authority for pronpt enforcenent 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 inpesing of civil or crininal penalties.
Indicators and Guidelines Status of Inspection Progran (Category I) o State RCP should maintain an inspection program adequate to assess licensee compliance with State regulations and license conditions.
o The RCP should raintain statistics which are adequate to permit Program Managerent to assess the status of the inspection procran on a periodic basis inferration showing the nurber of inspections
-conducted, the number overdue, the length of time overdue and the priority categories should be readily available, o, 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. 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.
Inspection Frequency (Category I) o 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, and industrial radiographers should be inspected approximately annually-smaller or less hazardous operations may be inspected less frequently. The minimun inspection frequency including for initial inspections should be no less than the NRC system.
Inspectors' Performance and Capability (Categnry I) o Inspectors should be competent to evaluate health and safety problems and to deternine corpliance with State regulations. Inspectors must demonstrate to supervision an understanding of regulations, inspection guides, and policies prior to independently conducting inspections.
o The compliance supervisor (may be RCP ranager) should conduct annual field evaluations of each inspector to assess perfornance and assure application of appropriate and consistent policies and. guides.
Response to Actual and Alleged Incidents (Category I) o Inquiries should be promptly made to evaluate the need for onsite investigations.
o Onsite investigations should be promptly nade of incidents requiring reporting to the Agency in less than 30 days. (10 CFR 20.403 types.)
o For those incidents not requiring reporting to the Agency in less than 30 days, investigations should be made during the next scheduled inspection.
o Onsite investigations should be promptly nade of non-reportable incidents which nay be of significant public interest and concern, e.g., transportation accidents.
o Investigations should include indepth reviews of circumstances and should be completed on a high priority basis. When appropriate, investigations should include reenactnents ard tine-study neasurements (normally within a few days). Investigation (or inspection) results should be docunented and enforcement action taken when appropriate.
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o State licensees and the NRC should be notified of. pertinent infomation about any incident which could be relevant to other licensed operations (e.g., equipment failure, inproper operating procedures).
o 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.
o The RCP should have access to nedical consultants when needed to diagnose or treat radiation injuries. The RCP should use other technical consultants for special problems when needed.
Enforcenent Procedures (Category I) o Enforcement Procedures should be sufficient to provide a substantial deterrent to licensee ncncompliance with regulatory requirenents. Provisions for the levying of monetary penalties are reconnended, o Enforcement letters should be issued within 30 days following inspections and should employ appropriate regulatory language clearly i
specifying all items of noncompliance and health end safety natters identified during the inspection and referencing the appropriate regulatiertor license condition being violated.
o Enforcenent letters should specify the tine period for the license to respond indicating corrective actions ano actions taken to l
prevent re-occurrence (nomally 20-30 days). The inspector and I
compliance supervisor should review licensee responses.
o Licensee responses to enforcenent letters should be promptly acknowledged as to adecuacy and resolution of previously unresolved itens.
o Written procedures should exist 'or handling escalated enforcement cases of varying degrees.
o Impounding of material should be in accordance with State administrative procedures.
o Opportunity for hearings should be provided to assure impartial administration of the radiation control progran.
Inspection Procedures (Category II) o Inspection guides consistent with current flRC guidance, should be used by inspectors to assure uniform and complete inspection 3
practices and provide technical guidance in the inspection of licensed prograns. NRC Guides nay be used if properly supplemented by policy memoranda, agency interpretations, etc.
1 o Written inspection policies should be issued to establish a policy for conducting unannounced inspections, obtaining corrective action, following up and closing out previnus violations, interviewing workers and observing operations, assuring exit interviews with management, and issuing appropriate notification of violations of health and safety problems.
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o Procedures should be established for naintaining licensees' compliance histories, o Oral briefing of supervisors or the senior inspector should be perfomed upon return from nonroutine inspections.
o For States with separate licensing and inspection staffs procedures should be established for feedback of information to license reviewers.
Inspection Reports (Category II) o Findings of inspections should he documented in a report describing the scope of inspections, substantiating all items of noncompliance and health and safety natters, describing the secpe of licenses' programs, and indicating the substance o# discussions with licensee management and' licensee's response, o Reports should unifomly and adequately dccument the result of inspections including confirmatory measurements, status of previous noncompliance 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 results of confirnatory neasurements made by the inspector.
Confirmatory Measurements (Category II) o Confirmatory neasurements should be sufficient in number and type to ensure the licensee's control of materials and to validate the licensee's measurements.
o RCP instrumention should be adequate for surveying license operations (e.g., survey meters, air samples, lab counting equipment for smears, identification of isotopes, etc).
o RCP instrumentation should include the following types: GM Survey Meter, 0-50 nr/hr; Ion Chamber Survey Meter, several r/hr; micro-R-Survey meter; Neutron Survey Meter, Fast and Thermal; Alpha Survey Meter, 0-1000,000 c/n; Air Samplers, Hi and to Volume; Lab Counters, Detect 0.001 uc/ wipe; Veloneters; Smoke Tubes; Lapel Air samplers.
o 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.
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o Agency instrunents used for surveys and confimatory measurements should be calibrated within the same time interval as required of the licensee being inspected.
Dated at Washington, DC this
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day of Ok NN FOP THE NilCLEAR REGULAT0F,Y COMMISSION ch.. .
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'}5amuel J. Chil R Secretary of 1he Comission i
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