ML20210C748
| ML20210C748 | |
| Person / Time | |
|---|---|
| Issue date: | 07/02/1999 |
| From: | Blanton R NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | |
| Shared Package | |
| ML20210C741 | List: |
| References | |
| PROC-990702, NUDOCS 9907270028 | |
| Download: ML20210C748 (40) | |
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Handbook for Reviewing a Request for an Agreement I Date Office of State Programs U.S. Nuclear Regulatory Commission
Contact:
Richard L. Blanton loE7's?SES EE8c?
Request for an Agreement Handbook CONTENTS
- 1. INTRODUCTION 1.1 Purpose i
1.2 Scope l
- 2. BASIS -
l 2.1 Statutory requirements 1
2.1.1 Federal Statutes 2.1.2 State Statutes 2.2 Coiamission Policy Statements l
2.2.1 Policy Statement " Criteria for Guidance of States and NRC in Discontinuance ofNRC Regulatory Authority and Assumption Thereof by States Through Agreement" 2.2.2 Policy Statement " Principles and Policy for the Agreement State Program" 2.2.3 Policy Statement " Adequacy and Compatibility of Agreement State Programs" 2.3 Directives and Procedures
.2.3.1 Management Directive 5.6, " Integrated Materials Performance Evaluation Program (IMPEP)"
2.3.2 Management Directive 5.8, " Proposed 274b Agreements With States" 2.3.3 OSP Procedure SA-201, " Reviewing State Regulations" 2.3.4 OSP Procedure SA-200, " Compatibility Categories and Health and Safety Identification for NRC Regulations and Other Program Elements" 2.4 Other Considerations 2.4.1 Proprietary and Privacy Information 2.4.2 Qualifications of NRC staff 2.4.3 Submittal and effective dates of the Agreement 2.4.4 Form of the request 2.4.5 Questions 3.0 REVIEW PROCEDURES 3.1 Before the Letter ofIntent 3.2. Response to a Letter ofIntent 3.2 Receipt of a Draft Request l
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Request for an Agreement IIandbook CONTENTS, continued 3.3 Review of the Draft Request 3.4 Review of the Formal Request for an Agreement .
4 INFORMATION NEEDED AND EVALUATION CRITERIA 4.1. Legal elements 4.1.1 Authority to establish a program and enter an Agreement 4.1.2 Organization of the proposed program. .
4.1.3 Content of the proposed Agreement.
4.2 Regulatory requirements program elements. 1 4.2.1 Standards for protection against radiation.
4.2.2 Regulatory requirements with significant transboundary implications.
4.2.3 Regulatory requirements needed for an orderly pattern of regulation or which have particular health and safety significance.
4.3 -~ Licensing program elements.
4.3.1 Procedures for the technical evaluation of proposed uses of RAM 4.3.2 Procedures for the evaluation of radiation safety information on sealed sources or devices, and registration for distribution l
4.3.3 Procedure for conducting the technical evaluation of a proposed license for a low level radioactive waste land disposal site l 4.3.4 Procedure for conducting the technical evaluation of a proposed uranium or
. thorium recovery facility 4.3.5 Procedures for the assuring the technical quality oflicenses.
4.3.6 Administrative licensing procedures. ;
i 4.4 Inspection program elements. )
4.4.1 Procedures for inspecting facilities where RAM is stored or used 4.4.2 . Procedures for assuring the technical quality ofinspections and inspection reports.
4.4.3 Administrative procedures for inspections.
4.5 Enforcement program elements.
4.5.1 Routine enforcement procedures.
4.5.2 Escalated enforcement procedures.
4.6 Technical staffing and training program elements.
4.6.1 Technical staff organization.
4.6.2 Formal qualification plan.
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Request for an Agreement Handbook CONTENTS, continued 4.6.3 Qualifications of current technical staff.
4.7 Event and allegation response program elements -
4.7.1 Procedures for responding to events and allegations.
4.7.2 Procedures for identifying significant events and allegations, and for entering same into the Nuclear Materials Events Database.
4.8 Table 2- Summary ofInformation Required in State's Application For Agreement State Status Glossary Definitions 1
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i L t Request for an Agreement Handbook
- 1. INTRODUCTION 1.1 Purpose This handbook provides guidance for reviewing a request by a State for an Agreement. NRC
- staff uses the handbook for guidance in reviewing a request for an Agreement or an amendment to'an Agreement. A State' seeking an Agreement should use the handbook for guidance in preparing its request.
1.2 Scope; A request for an Agreemcat consists of a formal statement by the Governor and supporting
- information. This handbook describes the information that the NRC staff needs, and the criteria that staff uses to evaluate it. It also describes procedural details of the evaluation.
'Section 4 of the handbook addresses the specific information needed to assess each element of the State's program. The section discusses any specific conclusions that the staff must reach.
The team must, in addition, reach a general conclusion that all of the review criteria are satisfied.
- 2. BASIS The guidance in this handbook is based on the requirements of the Atomic Energy Act, the guidance set out in the Commission Policy statements on the Agreement State Program, applicable NRC Management Directives, and applicable Office of State Programs (OSP)
- Procedures.
2.1 Statutoryrequirements
' 2.1.1 Federal Statutes Section 274b of the Atomic Energy Act authorizes the Commission to enter an Agreement with
. the Govemor of a State. Section 274c of the Act specifies those regulatory authorities that must
- be reserved to NRC. Sections 274d though 274g specify the Commission actions and obligations with respect to the agreements. A State that proposes to regulate byproduct material as described in section 11(e).2 of the Act is subject to the additional requiremeets in Section 2740. It must also comply with the applicable requirements of the Uranium N.11 Tailings Radiation Control
- Act(UMTRCA). (
. 2.1.2 State Statutes
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Request for an Agreement Handbook Agreement States do not regulate materials for the NRC. Each Agreement State administers an independent regulatory brogram.~ The State agency designated to carry out the materials program must have authority under State law to perform its functions. The legal authority required
- depends on the categories ofmaterials that we transfer to the State in the Agreement.
2.2 Commission Policy Statements 2.2.11Polic'y Statement " Criteria for Guidance of States and NRC in Discontinuance of NRC Regulatory Authority and Assumption Thereof by States Through Agreement" The criteria policy statement describes the specific requirements that a State must meet for the Commission to approve an Agreement. It also provides the basis for the NRC staff assessment 1 of the proposed materials program. The criteria in the policy statement are incorporated into -
section 4 of the handbook. i The firit 28 criteria in the policy statement apply to all proposed Agreement State materials programs. The last seven criteria apply only to States that will regulate the tailings materials from uranium and thorium mills.
2.2.2 Policy Statement " Principles and Policy for the Agreement State Program" This policy statement describes the overall principles, objectives, and goals of the Commission's
-Agreement State Program. NRC stafT, when reviewing a request for an Agreement, must consider these principles, objectives, and goals. This policy statement is also called the
" umbrella" policy.
2.2.3 Policy Statement " Adequacy and Compatibility of Agreement State Programs"
- This policy defines the terms " adequate" and _" compatible" and describes a system of categories.
~ It also provides the basis for determining consistency required between NRC and the State program elements. The policy identifies the basic program elements necessary for an adequate State program. NRC uses the basic program elements in IMPEP reviews and in this handbook.
2.3 Directives and Procedures U 2.3.1 Management Directive 5.6, " Integrated Materials Performance Evaluation Program
= (IMPEP)"
. Management Directive (MD) 5.6 provides the process and criteria for the perio'dic reviews of Agreement State programs. We expect a new Agreement State to be adequate and compatible July 2,1999 2' .
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7 Request for an Agreement Handbook
- starting on the' effective date of the' Agreement. The NRC ctaff assessment must conclude that
~ the State's program, ifimplemented as described, would found satisfactory in all indicators.
IMPEP evaluates the performance of a State program. OSP should schedule the first review for approximately 18 months after the Agreement becomes effective. Otherwise, the State may not
! have completed enough regulatory actions to support an IMPEP finding.
' 2.3.2 Management Directive 5.8, " Proposed 274b Agreements With States"-
.OSP created MD 5.8 to guide both NRC and the' State in crafting an Agreement.1 The State should draft their proposed Agreement based.on the model Agreement in handbook 5.8. NRC does not require the State to follow the model strictly. However, deviations from the model will
. require additional supporting information and evaluation to assure the compatibility of the
' Agreement program. Significant deviations require special approval by the Commission.
'3.3 OSP Procedure SA-201," Reviewing State Regulations"
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%cedure SA-201 describes the process used by'the OSP staff to review Agreement State regulations. . A State seeking an Agreement must submit copies ofits regulations for review. The State may adopt generic legally binding requirements in place of regulations, if permitted by the State's administrative procedures. If the State adopts generic legally binding requirements in
' place of regulations, it must submit the requirements for review.
2.3.4 OSP Procedure SA-200," Compatibility Categories and Health and' Safety Identification for NRC Regulations and Other Program Elements" OSP categorized NRC regulations and program elements according to the " Policy Statement on
' Adequacy and Compatibility of Agreement State Programs." The criteria and process presented
~ in MD 5.9, which has the same title, was used. The Appendix to SA-200 lists each NRC regulation and program element and assigns a compatibility category.
2.4 OtherConsiderations
- 24.1 Proprietary and Privacy Information !
l L States should not need to submit proprietary information or information subject to the federal Privacy Act, or a State equivalent. All information needed to review a request for an Agreement
- should be in the public records of the State. NRC can protect proprietary or Privacy Act information if the State meets the requirements of 10 CFR Part 9. Before submitting infonnation ,
that the State wants to withhold, the State should discuss the matter with the Director of the NRC J
- Office of State Programs (OSP Director).
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@ l 2.4.2 Qualifihations of the NRC review team' -
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. One objective of this proced ire is to assure that a new Agreement State will pass an IMPEP review Because of this objective, the OSP project manager should qualify as an IMPEP team leader The other team members should qualify as IMPEP reviewers for each program element
- they review. The team should be qualified to conclude that the State would be satisfactory in all
' applicable indicators.- ,
, ~2.4.3 Schedule for piocessing the Agreement Table 1 gives a model schedule for reviewing a request for an Agreement that is based on recent
= experience.1The. actual time required to review a request' depends on the resolution ofissues q
unique to each Agreement. The team should start with the model schedule and update it periodically:
! The effective date of the Agreement is usually selected as a matter of convenience to both NRC and the State. The State should propose an effective date at least six months after they submit the .
formal request.
J 2.4.4' Form of the request The State may submit the request as electronic files or on paper. The request should be complete, including the Governor's letter of certification and the supporting information.
Electronic files may be in image format as PDF files, or in text format such as Wordperfect.- We will accept electronic files by Intemet.
If the State wants to submit the request on paper, it should submit one complete copy. NRC will tocan the request into the Agency Document Access and Management System (ADAMS) for
. distribution to the team. Photocopies of State laws, statewide procedures, etc., are acceptable if 4
- the quality of the copy is good enough to be scanned.
. TABLE 1 - PROCESSING SCHEDULE for NEW AGREEMENTS t . .
- Event time Elapsed times Event Weeks Weeks Part 1 - Review of the Request for an Agreement (27)
Receipt of draft request 0 0 Offices establish review team 3 3' Team concludes completeness review 3 6 July 2,1999 4 4 ,
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l Request foran Agreement Handbook A completeness comment letter mailed' 3 9
. Receipt of formal request 8- 17 Team review of formal request finished 8 25 Team completes negative consent Commission Paper, 2 27 including draft staff assessment and FR notice Part 2 - FR publication & public comment period (16)
NRC Offices concur on Commission Paper 3 30 EDO sends Paper to Commission 2 32 Commission gives negative consent 2 34 First publication in FR 1 35 Public comment period ends 4 39 Team analyzes comments; completes final assessment 4 43 Part 3 - Final processing and Commission approval (15)
NRC Offices concur on final assessment and paper 3 46 EDO signs paper 2 48 Commission SRM approving Agreement 4 52 Effective date of Agreement 4 56 2.4.5 Questions Questions about the program elements, review process, criteria, or progress of the review should be directed to the OSP project manager. The State may contact the team members directly about comments on specific program elements. Altemately, the question will be forwarded to the team member for response.
3.0 REVIEW PROCEDURES Before the Letter ofIntent 3.1 In response to requests for information, the RSAO should provide, or confirm that the State has, the following: 4
' presumes 2 week office concurrence July 2,1999 5
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- Request for an Agreement Handbook
- a. Copies of Sections 11 and 274 of the Act;,
- b. Copies of the " Suggested State Radiation Control Act," published by ths Council of State Governments;
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- c. Copies of the Commission policy statements, " Criteria for Guidance of States and NRC in Discontinuance ofNRC Regulatory Authority and Assumption Thereof by States Through Agreement," " Policy Statement on Adequacy and Compatibility of Agreement State Programs," and " Principles and Policy for the Agreement State Program";
- d. . Copies of Management Directive 5.6, " Integrated Materials Performance Evaluation Program (IMPEP)," and Handbook 5.6; Management Directive 5.8, " Proposed 274b Agreements with States," and Handbook 5.8; and Management Directive 5.9, " Adequacy and Compatibility of Agreement State Programs," and Handbook 5.9; and
.e. Copies of OSP Procedures SA-200, " Compatibility Categories and Health and Safety Identification for NRC Regulations and Other Program Elements," SA-201, " Reviewing State Regulations," and SA-700, " Reviewing a Request for an Agreement," and Handbook.
The RSAO or RSLO should assume the lead for responding to informal questions and requests i
. for additional information. The RSAO or RSLO may forward questions on specific subjects l
- (such as decommissioning) to other NRC staff for a response. The State should submit questions i regarding Commission policy or practice in writing to the OSP Director. !
3.2.' Response to a Letter ofIntent 3.2.1 When the Governor submits a letter ofintent, the OSP Deputy Director appoints the PM ;
fbr the review. The PM becomes the primary point of contact between the State and !
.NPC stafTs. The PM and the RSAO coordinate with other NRC staff to provide information requested by the State.
3.2.l~ The PM prepares a response acknowledging receipt of the letter ofintent. The response should be prepared for th signature of the Chairman of the Commission. l 3.2.2 The PM tracks the progress of the State in preparing the request for an Agreement. The PM provides current informaion about the State's progress to other NRC staff for budget i development and work planning.
' 3.2l ' Receipt of a Draft Request July 2,' 1999 6 4 f
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Request for an Agreement llandbook 3.2.1 When the State submits a draft request, a review team conducts a completeness review against the' program elements in Section 4 of the handbook. The team determines
. whether the information is of satisfactory quality and adequately addresses each of the required program elements. (See section IV.B in procedure SA-700 for the makeup of l the review team)- -
- a. . For each program element, the team celects one member as the principal reviewer for the element. The selection is based on the qualifications of the team members.
The principal reviewer evaluates the completeness of the draft request with
- respect to the element. All team members should concur on the evaluation.
- b. The team prepares a letter that' documents the result of the completeness review, and identifies any additional information needed. The OSP Director signs the letter. Address the letter to the State program director or other designated State contact.
3.2.2. The PM, RSAO, and the State program director or otherdesignated State staff contact should establish a time for periodic telephone conference calls. Subjects of the conference calls include progress of the review, issues identified during the review, and additional information needed.: Participants should include the PM, RSAO, review team members, and the State program director or other designated State contact. Other NRC and State staff should participate as appropriate. Plan the calls for every other week to start, then adjust the schedule as needed.
l 3.2.3. The PM and the RSAO should visit the State offices to gain first-hand knowledge of the State facilities and staff. The State program director and senior State staff members should visit both the NRC regional and headquarters offices. Other meetings should supplement the telephone conference calls.
i 3.2.4. The RSAO should coordinate to have State inspectors accompany NRC inspectors during inspections of the NRC licensee facilities that will transfer to the State under the Agreement. State license reviewers should work with NRC license reviewers on actions for licenses that will transfer to the State.
3.3 . - Review of the Formal Request for an Agreement 3.3.1- The State should address the review team's completeness comments by incorporating the needed information into the formal Request for an Agreement.
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- Request for an Agreement Handbook 3.3.2 The same team that reviewed the draft request for completeness should assess the formal request. The team may seled the same or different members as principal reviewers.
' Team members may discuss questions about the request directly with the State staff.
- a. For each program element, a principal reviewer assesses the program based on the
- information in the request. ' Use the criteria in section 4 of this handbook. All team members should concur with the assessment.
- b. When the State satisfies all applicable criteria for a program element, the team prepares a draft assessment for the applicable criteria.
- c. If the State does not satisfy a criterion, or the principal reviewer needs additional information, the team should generate a comment. The comment should describe the issue and, where practical, provide guidance to resolve the issue.
- d. The reviewers may also offer suggestions for strengthening the program.
Reviewers should give suggestions verbally to the State staff. The team should not include suggestions in written correspondence.
- e. If the review discovers a major issue, the team should notify the OSP Director immediately. Major issues are issues that raise serious questions about the adequacy or compatibility of the State program. The OSP Director or PM notifies the State program director or other designated State contact.
3.3.3 The team prepares a letter transmitting its comments on the formal request. The letter is from the OSP Director to the State program director or other designated State contact.
The State should address the comments by submitting revised pages or sections to the formal request. When the team receives the revisions, the review continues.
3.3.4 When the team concludes that all criteria are satisfied, it completes the draft staff assessment and the Commission paper. The paper should request negative consent to publish the proposed Agreement in the Federal Register. When the NRC offices concur on the paper, the review is complete. The proposed Agreement is then ready for publication.
4 INFORMATION NEEDED AND EVALUATION CRITERIA The information supplied in a request for an Agreement must support two findings by the Commission. First, the information must show that the State has a radiation control program adequate to protect public health and safety. Second, it must also show that the program will be compatible with the NRC materials program.
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Request for an Agreement Handbook The staff assessment documents the evaluation of the information by the review team. The assessment should describe how the program satisfies the Commission's criteria. Euka 4-9 d== ' r*%Mp betweerrthe pmguun Ama.e =d the otheris, 4.1 Legalelements In 1983, the Council of State Governments published a generic model Radiation Control Act in SuggestedState Legislation, Volume 42. The Council published other model radiation control legislation, but did not include legislation addressing low-level radioactive waste. States may, but are not required to, use the suggested State legislation as models for their own laws.
l 4.1.1 Authority to establish a program and enter an Agreement The Agreement States are independent regulators. Each State program must derive its authority from State law. The Commission does not delegate Atomic Energy Act authority to the States.
4.1.1.1 Information needed.
The State should submit the State laws that:
a, establishes the materials program and defines its structure.
- b. authorizes the Governor to enter an Agreement with the Commission.
c, authorizes the program to issue licenses.
- d. authorizes the program to impose additional requirements in the form oflicense conditions.
- e. authorizes the program to give exemptions from the licensure requirements.
- f. authorizes the program to recognize the licenses of otherjurisdictions.
- g. makes it unlawful to acquire, posses, store, use, transfer, or dispose of materials without a valid license, or to violate the conditions of a license, l
- i. authorizes the program to adopt regulations.
J. specifies the procedures and requirements for adoption of regulations, including public l participation.
I k. allows the program to impose requirements in the form of other generic legally binding l July 2,1999 9 L
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7 Request for an Agreement Handbook requirements, such as' orders.
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- 1. authorizes representatives of the program to enter premises and conduct inspections. i
- m. authorizes the program to require compliance with regulatory requirements by both licensees j
and unlicensed individuals.
- n. : authorizes the program to impose sanctions for violations of the regulations, orders, or
. license conditions.
The State should submit a copy _ ofits law that authorizes the regulation of a low-level radioactive
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waste disposal site. We need this only if the Agreement will cover land disposal sites.
The State should submit a copy ofits law that authorizes the regulation of urmium and thorium mill tailings. We need this only if the Agreement will cover the regulation of byproduct material
( as defined in section 11e.(2) of the Act.
4.1.1.2 Evaluation criteria The team nay use the Council of State Governments suggested legislation as guidance.
~ However, the State is not required to follow either the content or the format of the model legislation.
The State mu'st resolve any questions ofinterpretation of State law. NRC will accept interpretations provided by the State Attorney General, or other attorney designated as legal ,
advisor to the materials program.
j State law'must authorize the Governor to enter the Agreement. It must also designate a radiation I control agency and provide it the necessary legal authority to be effective.
State law must not create duplications, gaps or conflicts in regulation. This includes duplications, gaps or conflicts between the State and NRC, State agencies, or State and local i agencies. The law must not seek to regulate materials or activities reserved to NRC. l State law must authorize issuing licenses as the means of giving the authority to posses and use j materials. It should also authorize the reciprocal recognition of specific licenses issued by NRC l or other Agreement States.
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State law should authorize the use oflicense conditions to address matters unique to the licensee.
The law should allow license conditions to impose additional requirements when required to protect public health and safety. If the law restricts the use oflicense conditions, the State should July 2,1999 10' 11 I-
n Request for an Agreement Handbook L show that they can provide adequate protection under the restrictions. The protection should be L . at least equivalent to using license conditions and orders.
l ' The law should permit exemptions from licensing requirements if the exemptions do not adversely affect public health and safety. .This should include exemption from the requirement to obtain a license. The law should authorize exemptions from licensing substantially equivalent to q the following (or may be in regulations): H
- a. Prime contractors working for the U.S. Department'of Energy (DOE) at U.S.'
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, Govemment-owned or controlled sites; l- b. Prime contractors researching, developing, manufacturing, storing, testing, or transporting atomic weapons or components; 1 1 ( c. Prime contractors using or operating nuclear reactors or other nuclear devices in a U.S.
' Government-owned vehicle or vessel; and
- d. Any other prime contractor (or subcontractors) of DOE or NRC when the State and NRC
- jointly determine (i) that the terms of the contract provide adequate assurance that the contractor can accomplish the work without undue risk to public health and safety and (ii) that the law I~
authorizes the exemption.
The law must authorize the materials program to enforce regulations or generic legally binding requirements other than regulations. The law may authorize another agency (such as a board of
. health) to adopt the regulations. When appropriate, the law should provide for public participation.
- t. The law must authorize inspections of!icensee operations to ensure compliance with regulatory requirements. It should authorize inspections of unlicensed facilities to assess the risk resulting
. from accidents or environmental releases of materials. The law.should permit access at all reasonable times.
The law must provide authority to take prompt enforcement action, and should provide a variety
-! oflegal sanctions. The law should provide authority to suspend licenses and to impound materials. In cases of an imminent threat to public health and safety, the law should authorize immediate suspension without prior hearing.
- The law should authorize suspension or revocation of a license for repeated or continued L noncompliance. The authority to suspend or revoke a license may be conditioned on a prior L ,
administrative orjudicial hearing.- The program should also have authority'to seek injunctive relief, and refer licensees for criminal prosecution. The program should, but is not required, to <
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m- - Request for an Agreement Handbook have authority to impose civil or administrative monetary penalties. We do' not require States to use the same sanctions as NRC. ,
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'4.1.1.3 ' Additional evaluation criteria for low-level waste Agreements l The law must authorize appropriate restrictions on land ownership and use for an indefinite -
- period after closure of the site. '
'4.1.1.4 Additional evaluation criteria for 11e.(2) byproduct material Agreements ;
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. The law should clearly empower the program to carry out the requirements of the Uranium Mill i Tailings Radiation Control Act (UMTRCA). Specifically, the law should:
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' a. Authorize the program to regulate 11e.(2) byproduct material.
ge e should ass iliat u ici nt f ds w I avail b er the sts of th j
' decommissioning and long-term surveillance and maintenance. ;
- c. Require'the program, before' issuing an 11e.(2) byproduct material license, to do the
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following: ,
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.(1) ~give notice of the proposed licensing action and a public comment period,
, (2) ~ - during the comment period, accept written comments and hold a public hearing l with a transcript and cross examination, j (3) _ prepare a written decision based on evidence presented during the public l comment period. The decision must be subject to judicial review, (4)- prepare a written environmental analysis (see Section 7),
I (5) ' ban major construction before the completion of the written environmental 3 analysis. j
- d. Require the program to provide an opportunity for public participation through written comments or public hearings during rulemaking. The hould must also make rules subject to
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'e/ Require the program, before terminatin[an i l e.(2) byproduct 'niaterial license, to' do the
' followirig: -
l 7 L _ ;(1) transfer funds colledted for decommissioning and long-term surveillance and maintenance to the United States. The law must require this transfer when custody of the disposal site transfers to the United States. Funds transferred must include all funds collected from a licensee or its surety. The only exceptions are funds collected for decommissioning ifit is completed.
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-(2). choose whether or not'to take title to the disposal site and byproduct material.
(3) obtain a determination from the Commission that all applicable standards are L satisfied.
Since the following authorities are reserved to the NRC under UMTRCA, the State law must not:
L a. ! Authorize the program to establish minimum requirements governing the decommissioning for long-term surveillance and maintenance of the disposal site.
- bi Authorize the program to grant exemptions to the land ownership transfer requirements.
- c. LAuthorize the program to find that a licensee has complied with the standards and requirements for terminating a license.
' d. Authorize the program, after terminating the license, to require monitoring, maintenance, or emergeney measures, for the materials or the site,
- e. Authorize the program'to permit use of the surface or subsurface estate of the disposal site.
4.1.'2 ' Organization of the proposed program The organization of a materials program provides the basic structure and resources to conduct the program' activities. The program organization thus influences the ability of the program to protect public health and safety against radiation hazards.
L4.1.2.1. Information needed L The State should submit a concise narrative description of the materials program. The
~ description should reflect the applicable program elements in section 4 of this handbook. It E should contain cross-references the appropriate sections of the supporting information.
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. Organization charts should accompany ~the description, showing all organizational levels between '
L the Governor and the director of the program. They should also show the organizational structure of the program itself. The State should submit a copy of each MOU that will affect the materials program.
4.1.2.2 ' Evaluation criteria The program design must address all elements required to cover the materials in the Agreement.
The State may divide the program elements among separate agencies. In this case, the State must submit copies of the MOU's describing the responsibilities of each agency. MOU's should also describe the efforts to assure cooperation. The organization charts should clearly show the position of the program within the State government structure.
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, The program organization charts should show both the technical staff and support staff positions. j They should show positions assigned to the program both full-time and part-time. If the program ,
uses the. resources of another agency, the program narrative description should detail the '
relationship. The narrative description should also discuss any use of contract services and advisory bodies. (NOTE: the criteria for evaluation of the technical staff are in section 4.6.1)
~4.1.3. Content of the proposed Agreement.
An Agreement may transfer to a State the authority to regulate any one or more of the following Jmaterials within the State:
- a. Byproduct materials as defined in section 1 le(l) of the Atomic Energy Act,
- b. Byproduct materials as defined in section 1le(2) of the Atomic Energy Act,
- c. Source materials,
.d. Special nuclear niaterials, in quantities not sufficient to form a critical mass.
In addition, an Agreement may transfer to a State the specific authority to conduct one or more of i ~the following activities, which otherwise remain under NRC jurisdiction:
- a. The regulation of the land disposal of byproduct, source, or special nuclear waste ,
materials received from other persons, i l
- b. The evaluation of radiation safety information on sealed sources or devices containing
' byproduct, source, or special nuclear' materials and the registration of the sealed sources or devices for distribution, as provided for in the regulations or orders of the Commission. 4 July 2,1999 ' 14 i
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MD 5.8 contains a standard Agreement format and text. The standard Agreement is based on the transfer of all categories of materials (a so called " full Agreement"). Agreements that do not
. transfer all of the categories should delete the appropriate provisions'as shown in MD 5.8, Handbook.-
4.1.3.1 Information needed ~.
. The State should submit a proposed Agreement. The Agreement should contain the categories of j materials and specific authorities that the State wants to regulate. 1 The Agreement should follow the format and content of the standard Agreement in Exhibit 1 of-l MD 5.8, Handbc,ok. If the State does 'not follow the standard Agreement, it must explain why.
The explanation should describe the intent and the expected effect of the deviation.
4.1.3.2 Evaluation criteria .
. The proposed Agreement'must be consistent with the purpose of section 274 of the Atomic Energy Act. It must promote an orderly pattern of regulation. Nothing in it may create a duplication,' conflict, or gap in the nationwide program for the regulation of materials.
The Agreement should be consistent with the format and content of the standard Agreement in
- MD 5.8. The State should delete or modify articles in the standard Agreement only as shown in MD 5.8. Any other change requires additional information describing the need for the change
- and the expected res_ ult. Such changes may require separate approval by the Commission. The
'information submitted must provide a basis for the Commission to approve the change.
The Agreement mu'st transfer regulatory authority over all licensees in each category of materials
- listed in the Agreement. The Commission must' separately approve the retention oflicensees
- within a transferred category. If the Agreement does not include all categories of materials and specific authorities, it should include the paragraph on amendments.
4.2 Regulatory requirements program elements '
~ Agreement States may use NRC regulations as models for their regulations. The State may also !
- use the SuggestedState Regulations (SSR), published by the Conference of Radiation Control
- Program Directors (CRCPD). The State may adopt the regulatory requirements in a State ;
2 specific format.
4.2.1_ Standards for protection against radiation i
' The standards for protection'against radiation include:
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a.- the dose limits for occupationally expdsed persons and' members of the public.
b.~ constraints and limits on the concentration and quantity of materials rd1 eased to the environment.
. c. technical definitions and terminology, units of radioactivity and radiation dose, and radiation symbols, labels and waming signs, a _
4.2.1.1 Information needed =
- The State should submit its regulations, or generic legally binding requirements, that prescribe the standards for protection against radiation.
If the State' wants to regulate the disposal oflow level radioactive' waste at a land disposal site, it should submit its regulation' equivalent to 10 CFR 61.41.
4.2.I'.2 Evaluation criteria The State standards for protection against radiation must satisfy the criteria for compatibility .
category'A. The criteria are given in the Handbook to MD 5.9. OSP Procedure SA-200, JAppendix A, lists th equivalent NRC regulations.
The standards must apply to all categories ofmaterials covered by the Agreement. They should
-also apply to all other sources of radiation regulated by the State.
The standards must require consideration of the total occupational dose to individuals.
[If the State adopts generic legally binding requirements other than regulations, it should assure consistency in their application. The' requirements should not confuse either the licensees or the regulatory program staff. The State must show that the alternative requirements are legally binding under State law.
4.2.2 Regulatory requirements with significant transboundary implications The regulatory requirements with significant transboundary implications are:
- a. regulations that affect the movement of materials across State borders,
- b. certain other regulations, such as the limits for quantities and concentrations of materials
' e'xempt from licensing, and the waste classification scheme in 10 CFR Part 61.
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' The State should submit its regulations, or generic' legally binding requirements, that prescribe
' the regulatory requirements with significant transboundary implications.
4.2.2.2 Evaluation criteria The State regulations th'a t may have signiEcant effect acrossjurisdictional boundaries must satisfy the criteria for compatibility category B. The criteria are given in the Handbook to MD g ' 5.9. OSP Procedure SA-200, Appendix A, lists the equivalent NRC regulations.
4.2.3 Regulatory requirements needed for an orderly pattern of regulation or which have particular health and safety significance.
The regulatory requirements needed for an orderly pattern of regulation or which have particular health and safety significance are:
- a. regulations whose essential objectives are needed to prevent undesirable consequences.
- Examples of such consequences are given in MD5.9, Handbook, Part II, section C.
- b. regulations needed for health and safety. Examples are given in MD5.9, Handbook, Part II, section E.
4.2.3.1 Information needed The State should submit its regulations, or generic legally binding requirements, that apply the 4
' essential objectives of the NRC regulations designated compatibility category C or D/H&S.
. If the State wants to regulate uranium and thorium mill tailings, it should submit a copy ofits
- requirements equivalent to 10 CFR Part 40, Appendix A..
L4.2.3.2 Evaluation criteria cThe State regulations or generic legally binding requirements needed for an orderly pattern of regulation, or which have particular health and safety significance, shall satisfy the criteria for compatibility category C. The criteria are given in the Handbook to MD 5.9. OSP Procedure SA-200, Appendix A, lists the equivalent NRC regulations. l
'4.3 Licensing program elements.
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< Request for an Agreement Handbook A State may adopt technical licensing procedures modeled on the NRC procedures, or those used by an existing Agreement State.1The CRCPD also has publications that may be useful in developing the State's procedures. The review team should be able to conclude that the State's
. technical licensing procedures will be protective of public health and safety.
' Nontechnica. administrative procedures are usually not key contributors to program performance.
The review tem usually reviews samples of these procedures. The team only needs to conclude that the State he written administrative procedures for licensing, and that they contain no !
- obvious major defects.-
- 4.3.ll Procedures for the technical evaluation of proposed uses cf RAM The technical procedut s address the health physics issues necessary to assure the safe storage and use of the licensed materials. They do not address license fees, license file maintenance, or other materials program administrative issues.-
4.3.1.1 Information needed
. The State should submit its technical licensing procedures. If not part of the procedure, the State
. should include standard review plans, checklists, and licensing guides.
' 4.3.1.2 Evaluation criteria The procedures should assure a thorough and equitable evaluation of the application. The procedures should cover each type license (by program code) for which an NRC licensee will
- transfer to the State. Guidance documents, or copies of the procedures, should be available to license applicants.
l The procedures should: !
- a. : address the applicant's facilities and safety equipment, training and experience in the use of the materials for the purpose requested, and proposed managerial controls.
- b. provide for information exchange between the program's inspection staff and licensing staff, as appropriate.
- c. specify.the required qualifications oflicense reviewers for each license program code.
- Alternately; the procedures may reference a staff qualification plan.
The team may use NRC procedures and consolidated guidance to evaluate the State procedures.
However, we 'do' not require States to adopt the NRC procedures and consolidated guidance. The July 2,1999 18 l' [
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' State procedures should provide the same level of detail as the equivalent NRC procedure. They should address all significant technical issues.-
= Properly qualified persons (normally licensed physicians) must direct the medical use of materials. Qualifications should include prescribed minimum training and experience in the
- medical use of radioisotopes or radiation. The training requirements should be ~similar to those in
. - )
, State procedures should provide guidance for the evaluation of technical issues m license applications. The issues evaluated include: places and conditions of storage; places and conditions of use, and decommissioning of facilities and equipment. Evaluation of the places of storage and use should address environmental considerations.
State procedures for evaluating the conditions of storage and use should address security against unauthorized removal, and safety equipment. Procedures for evaluating the conditions of use -
should address the following:
- a. ' qualification of users.
- b. licensee operating and emergency procedures.
- c. appropriate surveys.
'd. - personnel monitoring under the close supervision of technically competent individuals. i 1
1 e, preparations for transport.' I i
Pro'cedures for evaluating decommissioning should address decontamination, disposal, and any restrictions on the future uses of the property. The procedures should also address funding and I sureties.
In licensing research and development, medical uses, or other activity involving multiple uses of materials, the State may issue broad scope licenses without evaluating each specific use.
4.3.2 Procedures for the evaluation of radiation safety information on sealed sources or devices, and registration for distribution j
,- Sealed sources, and devices containing sealed sources, are commonly manufactured in one jurisdiction and used in others. Because of the transboundary implications, safety evaluations of the sources and devices should be conducted according to similar procedures nationwide.
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- 4.3.2.1 Information needed
' The State should submit its procedure for eval'u ating radiation safety information on sealed sources and devices (SS&D).
If the State will use contractor assistance in the evaluation, its procedures for the quality assurdnce of contractor performance should be submitted.
4.3.2.2 Evaluation criteria The State procedures should be essentially identical to the equivalent NRC procedures with l respect to:
- a. technicalissues evaluated.
- b. technical criteria used to decide the adequacy of the safety information provided.
- c. use of a concurrence review.
- d. content and format of the registration sheets.
For additional criteria, see the IMPEP'SS&D indicator (non-common performance indicator 2) in MD 5.6, Handbook (dated November 25,1997 or later).
l o The review team may use NRC's consolidated guidance about applications for sealed source and device evaluation and registration in NUREG-1556, Volume 3, as a guide.
4.3.3 Procedure for conducting the technical evaluation of a proposed license for a low-level l radioactive waste land disposal site The technical evaluation of a land disposal site for low-level radioactive waste has significant health and safety implications. It requires substan_t!al resources beyond those needed for conducting routine licensing evaluations. If the State will regulate a site, it should have the resources and procedures to conduct a site evaluation, even if NRC will transfer an established site.
L : If NRC will not transfer a licensed sits or an application for a site license, and there is no reasonable expectation of an application for a license being submitted in the foreseeable future,
. the State _may assume the authority without having the resources and procedures in place. In this case, information showing that the State has the authority to acquire the resources and adopt
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, Request for an Agreement Handbook l appropriate procedures before undertaking the evaluation of an application, accompanied by the conceptual description of the program; is sufficient.
! 4.3.3.1 -Information needed ,
The State should submit a concise description ofits program for regulating a land disposal site.
p ! The description should include a discussion of the resources available to the program. The State should also submit its procedures for conducting the technical evaluation.
If the State proposes to use contractor assistance in the evaluation, procedures for the quality
- assurance of contractor performance should be submitted.
4.3.3.2 Evaluation criteria l The State procedures should contain the same level of detail as the NRC procedures in NUREG-1200.' However, we do not require the procedures to be identical if they address all significant objectives. The State procedures should be consistent with the NUREG with respect to the following:
- a. technical issues evaluated.
L
. b. qualifications of the personnel performing evaluations.
- c. . assuring the quality of the licensing action.
4.3.4 Procedure for conducting the technical evaluation of a proposed uranium or thorium recovery facility The technical evaluation of a uranium or thorium recovery facility has significant health and safety implications. It requires substantial resources beyond those needed for conducting soutine licensing evaluations. If the State will regulate a site, it should have the resources and procedures to conduct a site evaluation, even if NRC will transfer an established site.
L If NRC will not transfer a licensed site or an application for a site Sense, and there is no reasonable expectation of an application for a license being submitted in the foreseeable future, the State may assume the authority without having the resources and procedures in place. In this case, information showing that the State has the authority to acquire the resources and adopt -
l appropriate procedures before undertaking the evaluation of an application, accompanied by the conceptual description of the program, is sufficient.
4.3.4.1 Information needed July 2,1999 21 l
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l Request for an Agreement Handbook The State should submit a concise description ofits program for regulating 11(e).2 byproduct material.. The description should include a discussion of the resources available to the program.
E The State should also submit its procedures for condecting the technical evaluation.
- If the State will use contractor assistance in the evaluation, it should submit procedures for
' assuring the quality of contractor performance.
t-4.3.4.2 Evaluation criteria The State procedures should contain the same level of detail as the equivalent NRC procedures.
However, we do not require the procedures to be identical to ours if they address all significant
' technical issues. The State procedures should be consistent with the NRC procedures with respect to the following:
- a. technicalissues evaluated.
b.' qualifications of the personnel performing evaluations.
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- c. assuring the quality of the lice.ising action.
2 4.3.5 ' Procedures for the assuring the technical quality oflicenses.
Secondary review' oflicense applications adds value to, and helps assure the integrity of, the application evaluation process. Peer and supervisory review are commonly used. Larger programs may use a committee to conduct reviews of selected application evaluations recently completed. Other forms of efrective qualit,y assurance are acceptable.
L4.3.5.11 Infonnation r.eeded
- The St ite should submit its procedures that address peer review, supervisory review, and any other method to assure the quality oflicensing actions.
4.3.5.2 Evaluation criteria The State should have written licensing procedures that provide some form of review for licensing quality. We do not prefer a particular form or method.' The procedures should reflect the organization of the State program and any special requirements of State law.
.4.3.6 Administrative licensing procedures.
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The routine operation of the program requires administrative processing oflicenses beyond the technical evaluations.' Written procedures describing the administrative processhg steps are
' useful to assure that all procedural requirements are completed. They may become critical if L there is an unexpected tumover of senior staff.
NRC and the State should arrange the transfer to produce the least interference with licensed activities or the processing oflicense applications: Generally, States recognize transferred NRC licenses, including licenses' under timely renewal, as State licenses. They continue those licenses in effect until they issue State licenses as replacements.
' 4.3.6.1' Information nee'ded The State should submit its administrative procedures for licensing. The procedures should address the following:
- a. receipt oflic' ensing actions.
- b. ' assignment oflicensing actions to technical evaluators.
3 c. license document preparation.
- d. tracking of action progress.
- e. the signing of completed licenses.
~ f. transmittal of the signed license to the licensee.
- g. . license file maintenance.
The State should describe its arrangements for continued authorization of NRC licensed activities
- as they transfer to the State.
4.3.6.2 Evaluation criteria -
. The, State should have program specific written procedures to guide licensing program staff. The procedures should reflect the program organization and any special requirements of State law -
L(i.e.. who can sign licenses). Since these procedures do not require a thorough review, the team
.p. . may review a selected sampling of the procedures insteadc h The State should provide for the continued operation of transferred NRC licensees.
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A State may adopt technical inspection procedures. modeled on IMC 2800, or the procedures of an existing Agreement State. The CRCPD also has publications that may be useful in ,
developing the State's procedures.
- Nontechnical administrative procedures, ~s uch as a procedure for assigning inspections to inspectors, are usually not key contributors to program performance. The review team usually reviews samples of these procedures. The team only needs to conclude that the State has written :
? administrative procedures for inspections, and that they contain no obvious major defects.
4.4.1 Procedures for inspecting facilities where RAM is stored or used -
The technical inspection procedures should address the scheduling ofinspections and the i different kinds ofinspections (i.e., routine, reactive, etc.). They should also address the performance ofinspections. The procedures should not address administrative matters, such as inspection fees. !
L The procedures should provide the form and guidance for inspection reports. They should also provide for notice to the licensee whether or not it is in compliance.
4.4.1.1 Information needed The State should submit inspection procedures, including inspection report formats, checklists,
- status reports, etc. Procedures' submitted should cover all NRC license program codes of.
licensees that will transfer to the State.
The State should also submit its priority schedule for inspections by program code.
4.4.1.2 Evaluation criteria !
g The State should perform inspections following written procedures that address inspection activities appropriate to the category oflicensee being inspected.
The State should relate inspection frequency to the amount and kind of material and type of
' operation licensed. Routine inspections should not be less frequent than NRC inspections as listed in IMC 2800, enclosure A. 1 Inspection procedures should provide for information exchange between the inspection staff and .
the licensing staff, as appropriate. i
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l l r (l Request for an Agreement Handbook l . The team may use NRC inspection procedures as guidance to evaluate the State inspection l . procedures. The State procedures should provide approximately the same level of detail as the equivalent NRC procedure. However, the procedures are not required to be uniform if they
' address all significant technical issues. ' We do not require states to adopt the .NRC procedures.
L The procedures should provide the notice to the licensee in a short period, usually within 30 days after the inspection.
4.4.2 Prhedures for assuring the technical quality ofinspections anu inspection reports.
- Secondary review ofinspection reports adds value to, and helps assure the integrity of, the inspection process. Peer and supervisory review are commonly used. Larger programs may use a committee to conduct reviews of selected inspections recently completed. Other forms of effective quality assurance are acceptable.
4.4.2.1. Information needed The S' tate should submit its procedures addressing peer review, supervisory review, and any
. other method to assure the quality ofinspections and inspection reports.
4.4.2.2 Evaluation criteria The State should also have written procedures to guide program staff. We do not prefer any particular form or method. The procedures should reflect the organization of the State program and any special requirements of State law.
4.4.3' < Administrative procedures for inspections.
T !
' ; The routine operation of the program requires administrative processing of an inspection report
- after the inspector has written it. . Written procedures describing the administrative processing steps are useful to assure that all procedural requirements are completed. They may become critical if there is an unexpected turnover of senior staff.
t
'4.4.3.1 - Information needed The State should submit its inspection program administrative procedures.
f 413.2 Evaluation criteria =
a
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[ .Rhuest for en Agreement Handbook Ths State should have program specific written procedures. The procedures should reflect the organization of the State program and any special requirements of State statute (i.e., public l disclosure or confidentiality).
Since these procedures do not require a thorough review, the ieam may review a selected sampling of the procedures instead..
/4.5 Enforcement program elements.-
- A State may adopt enforcement procedures modeled on the NRC procedures, or those used by another' Agreement State. The CRCPD also has publications that may be useful in developing .
the State's procedures.
4.5.1 Routine enforcement procedures.
! Routine enforcement procedures are the actions the program takes in response to any violation.
These actions include a notice of the violation to the licensee. Escalated enforcement actions supplement them for serious or repeated violations.
L 4.5.1.11 Information needed
- The State should submit its procedures for routine enforcement actions.
4.5.1.2 ' Evaluation criteria.
. The State should have procedures for assuring the fair and impartial administration of regulatory
. law. They should scale the actions to the seriousness of the violation.-
1
- The procedures should establish' standard methods of communicating sanctions to the licensee.
1The State should give written notice using standardized wording and fonnat. Legal counsel 1 should review the wording and format.
The procedures should include a means for tracking the completion of enforcement actions.
L4.5.21 Escalated enforcement procedures.
. For. serious or repeated violations of regulatory requirements, the program should use escalated
- enforcement. Escalated enforcement actions usually supplement the routine actions. Escalated enforcement actions may include:
'a. ' administrative or civil monetary penalties. .
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- b. - the modification, suspension, or revocation of the license.
- c. ' referral for criminal prosecution.
4.5.2.1 ~ Information needed The State should submit its procedures for escalating enforcement actions.
4.5.2.2. Evaluation criteria - 9 + '
The State should scale the sanctions in escalated enforcement cases to the seriousness of the violation. The sanctions should be more severe than routine enforcement.
. The procedures should address notifying the licensee of proposed escalated enforcement actions.
The notice should be written, using standard wording and format when practical.
~
The enforcement program element manager, or higher, should sign notices of escalated enforcement.
Escalated enforcement actions should be coordinated with legal counsel.
' 4.6' Technical staffing and training program elements.
The State should adopt technical staffing standards similar to NRC's standards. The State may
. adopt training and qualification procedures modeled on NRC's procedure in IMC 1246, or on the ,
report of the OAS/NRC working group. I l
- To e aluate some complex cases, the staff may need to be supplemented by consultants or staff !
from other State agencies. l 1
4'.6.1 Technical staff organization.
The State should conduct an analysis of the expected workload, and establish an appropriate ;
. staffing plan. The analysis should consider the number, distribution, and sizes of the licensees !
that will transfer under the Agreement. It should also consider if the State will: evaluate the l
- radiation safety information on sealed sources or devices containing materials and register the ;
sealed sources or devices for distribution; license a low level radioactive waste land disposal site;
. license uranium or thorium recovery facility subject to the requirements of UMTRCA; or will )
s license major manufacturers, universities with major research programs, or other large scale materials users.
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The State should submit its program staffing plan, includmg orgamzation charts. The staffing
. plan should show the number of staff members assigned to specific responsibilities, such as .
' license review and inspection. It should estimate the workload for the licensees that will transfer, and tlie other duties of the program.
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- e 4.6.1.2 - Evaluation criteria
- The State must staff the program with enough qualified personnel. The staff must consist of at R least two individuals.
. We have no criteria for the number of staff required, but the experience of existing Agreement I States should be considered. Depending on training and experience, Agreement State programs typically employ one to 1.5 technical staff members per 100 active licenses. Waste disposal sites or uranium mills require additional staff. The distribution of staff should be based on workload estimates that are consistent with NRC experience.
The State workload estimate should be based on the State's organization, policies, practices, and l procedures. The State should not create a staffing plan based solely on the NRC staffing plan.
4.6.2 - Formal qualification plan.
The ability to conduct an effective material program depends on having enough trained and !
experienced staff members. Since retirements and other normal events cause the departure of !
staff members, there must be a plan for staff replacement.
4.6.2.1 ' Information needed -
The State should submit its position descriptions, and its plan for the formal qualification of )
technical staff members. !
4 L4.6.2.2 Evaluation criteria Each technical staff position should require a bachelor's degree in the physical or life sciences, or !
engineering. An equivalent combination of education and experience may substitute for the '
degree.
The program should have a written qualification plan. It should address job specific training and i experiences The plan should specify the qualification procedures, including times for completing ;
- requirements and the credentialing of qualified individuals. The plan should meet the training l
July 2,1999 28 k4
. Request for an Agreement Handbook and qualification requirements in the BAS /NRC working group recommendations. IMC 1246 may be used as general guidance. , .
4.6.3 Qualifications of current technical staff.
s The program staff qualifications should' cover both routine functions and emergency cases._The i
- - . distribution of staff qualifications and the distribution oflicensees transferred should match. For {
example, there should be enough inspectors qualified to inspect industrial radiography licensees that a backlog ofindustrial radiography inspections will not develop.
'4.6.3.l- Information needed.
.-The State should submit the resume of each current member of the technical staff. The resume i should, as a minimum, show the educational level, experience, and any speciality training. For staff members admitted into training courses not yet completed, submit the course name or l
. description and scheduled dates.
4.6.3.2 Evaluation criteria.
Except for some junior positions, all staff members should meet the progrants own qualification requirements.
The review team may consider the State's experience working with NRC inspectors and license reviewers. It may also consider experience regulating non-Agreement materials and machine-produced sources ofradiation.
~ 4.7 Event and allegation response program elements
= A State may adopt event and allegation response procedures modeled on NRC procedures, or those used by another Agreement State. The procedures for reporting events to NRC should be modeled on OSP procedure SA-300.
1 4.7.1 - Procedures for responding to events and allegations
- The program must have written procedures for responding to materials events within the State. l The response capability may be part of another organization, such as a response organization for !
1 fixed nuclear facilities. However, it is still part of the materials program under the Agreement.
The program should have written procedures for responding to allegations of violations of regulatory requirements. The program does not need to have criminal investigatory capability !
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.1 Request for an Agreement Handbook within the program or its parent agency. 'Ifit does not, then it should have procedures for call
. appropriate authorities needed.
4.7.1.1 Information needed-The State should subrnit its procedures for responding to events and allegations.
4.7.1.2 Evaluation criteria o
- Event response procedures should be consistent with, but need not be identical to NRC procedures. The procedures should address the following:
- a. limmediate response and actions to mitigate an event.
b'.j follow-up inspections and enforcement actions
- c. notifications to licensing staff.
'd. reports to the incident file,
- e. notifications to other affected licensees of generic problems.
- Allegation procedures should address response, follow-up and closeout. They should also provide for protection of the identity of a person making an allegation when requested. The procedures should also provide for the protection of other sensitive information.
.4.7.2 Procedures for reporting materials events NRC has established a database (NMED) of materials events, including incidents, accidents, and
- medical misadministrations. The States must report to NMED all events that NRC regulations (or equivalent State regulations) require the licensees to report.
4.7.2.1 Information needed The State should submit its procedures for generating event reports. It should also submit its ;
procedures for entering reports in the NMED database. j 4.7.2.2 - Evaluation criteria ' l i
l The State procedures should assign responsibility for the completion of the reports, and for i assuring the quality of the reports. They should specify times for completion of the reports and j i
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Request for an Agreement Handbook submitting them to NRC. The procedures should provide guidance for identifying abnormal
" occurrences.
IThe procedures should contain criteria for identifying reportable events. They should guide forwarding reports (notification, follow up, and closeouts) to NRC for inclusion in NMED. The State procedures should be consistent with the OSP Procedure SA-300 Handbook, Nuclear Material Event Reporting in the Agreement States.
. 4.8 : Summary ofInformation Required in State's Application For Agreement State Status Handbook Submission from State Reference NRC Document or Model
' Section '- Document 4.1.1 Sections of State Law with authority Council of State Governments to establish program and enter into an SuggestedState Legislation,1983; Agreement Statement of Principles and Policy for y the Agreement State Program 4.1.2 Detailed narrative description of Recent Agreement State Application; radiation protection program MD 5.9; SA-200, Appendix B 4.1.3 - Proposed Agreement MD5.8 a
- 4.2 - Regulations or legally binding MD 5.9, SA-200, Appendix A; Title 10 requirements that adopt radiation - CFR Parts 19,20,30,31,32,33,34, protection standards and other- 35,36,39,40,61,70,71, and 150; essential objectives ofNRC- SSR's 3 regulations 4.3.1. Licensing procedures for technical general: SA-104, NUREG-1556 series, evaluation of RAM uses decommissioning: MARSSIM, DG-4006, NUREG-0241, NUREG-5849
.4.3.2 Procedures for evaluating SS&D NUREG-1556, Volume 3 I
4.3.3 Procedures for evaluating LLRW- NUREG-1199,1200 and 1300; disposal site NUREG-1274 4.3.4 ~ Procedures for evaluating uranium or Uranium Recovery Program Policy and thorium recovery facility Guidance Directive System 4.3.5 ' Procedures for review oflicensing SA-104 quality- l l July 2,- 1999 31
Request for an Agreement Handbook Handbook Submission from State Reference NRC Document or Model Section Document 4.3.6 Administrative procedures for Recent Agreement State Application handling licensing actions
'4.4.1 Inspection procedures and report SA-101 and 102,IMC 2800,IMC 1220 formats and IP 87101 through 87120 4.4.2 - Procedures for review ofinspection IMC 2800 and SA-102 quality 4.4.3 Administrative procedures for IMC 2800 inspections
-4.5.1 Procedures for routine enforcement NUREG-1600 and IMC 2800 actions 4.5.2 Procedures for escalated enforcement NUREG-1600 and IMC 2800 actions >
4.6.1 Program staffmg plan Recent Agreement State Application
._4.6.2 Formal qualification plan for IMC 1246 or NRC/OAS Training technical staff Working Group Recommendations for Agreement State Training Programs 4.6.3 - Qualifications of current technical Recent Agreement State Application staff 4.7.1 Procedures for responding to general: SA-105 incidents and allegations allegations: MD 8.8 incidents:IMC 1300-1303 and 1330 4.7.2 Procedures for reporting materials SA-300, Appendix A events to NMED July 2,1999 32 L
References Request for an Agreement IIandbook Glossary AEOD NRC Omce for Analysis and Evaluation of Operational Data CFR Code of Federal Regulations i l
CRCPD Conference of Radiation Control Program Directors DG Draft regulatory guide DNMS Division of Nuclear Materials Safety (NRC regional orgcnization units)
FTE Full Time Equivalent of personnel effort IMC NRC Inspection Manual Chapter IP NRC Inspection Procedure MD NRC Management Directive MOU Memorandum of Understanding NMED Nuclear Materials Event Database NMSS NRC Omce of Nuclear Materials Safety and Safeguards NARM Naturally occurring or accelerator produced materials (not subject to the Act)
NRC United States Nuclear Regulatory Commission SA OMce of State Programs Agreement States Procedure SSR's SuggestedState Regulations, published by the CRCPD OGC NRC Omce of the General Counsel OSP NRC Omce of State Programs {
RSAO Regional State Agreements OMcer (NRC staff)
UMTRCA Uranium Mill Tailings Radiation Control Act of 1978, as amended l July 2,1999 34 z
p References Request for an Agreement Handbook Definitions As used in this document:
i Act - means the Atomic Energy Act of 1954, as amended.
Com. mission - means the United States Nuclear Regulatory Commission Civil penalty - means a monetary fine imposed and collected by the materials program, or by apparent agency. Also known as an " administrative fine."
Generic legally binding requirement - means a legally enforceable statement, limited in the extent ofits application, that implements or interprets law or describes procedural requirements, and that is adopted in accordance with the administrative procedures of the promulgating jurisdiction. Examples are license conditions or orders. Generic legally binding requirements differ from regulations in that they are directed to a specifically identified constituency. To be considered generic, however, the requirements should be made effective upon all members of j any class oflicensees or other persons upon which a regulation would have efTect. I License - includes registrations, permits, and certifications. l l
License application - means the formal request for a new license, a license renewal, or a license !
amendment, as appropriate, made in accordance with the administrative licensing procedures of thejurisdiction.
l t
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References Request for an Agreement Handbook Materials - generally means byproduct, source, and special nuclear materials, as defined in the Act. However, if appropriate to the context, it may include naturally occurring or accelerator produced radioactive materials, if such radioactive materials are regulated by the same program I
designated to regulate byproduct, source, and special nuclear materials under The agreement. )
' Program - means the organization within ajurisdiction that is specifically dedicated to the regulation of materials. It may be a separate organizational unit, or a subunit of an organization with wider responsibilities. It may also consist of the sum of the materials program elements
~
distributed over several organizations. The NRC materials program consists primarily of NMSS and the DNMS of each region, but includes the support activities provided by other NRC Offices 1
as required.
I Memorandum of Understanding - means any formal statement of cooperation between agencies.
L The term " Letters of Agreement" is equivalent.
. Procedure - means a written statement delineating the steps in an activity, may include
" policy" statements.. ,
l Radiation - means ionizing radiation only.
Regulation - means a legally enforceable statement of general applicability that implements or i l- interprets law or describes procedural requirements, and that is adopted in accordance with the
- administrative procedures of the promulgating jurisdiction. The term " rule" is equivalent.
July 2,1999. 36
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