ML20216J415

Rev 3 to Internal Procedure D.7, Procedure for Reviewing State Regulations

ML20216J415
Person / Time
Issue date:	09/08/1997
From:	Bangart R, Lohaus P, Salomon S NRC OFFICE OF STATE PROGRAMS (OSP)
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ML20216H586	List: ML20216H582 ML20216J415 ML20216J914 ML20216J923
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D.7, NUDOCS 9709170279
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State Agreements Program Standard Approval The attached Office of State Programs internal Procedure D.7, Revision 3, Procedure for Reviewing State Regulations is submitted for final approval.

WAa#1edw <Mr Steph6n N. Salordon, Physicist ' ' ' date b '

i M Paul H. Lohaus, Deputy Director, OSP ' Dale A4 f ~

v,rns f 0'} 0$ f f Ridhard L. Bangart, Director, O SP D' ate

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OFFICE OF STATE PROGRAMS INTERNAL PROCEDURES Post and Pre Agreement D.7 Procedure for Reviewing Regulations Review State Regulations

1. INTRODUCTION This procedure describes the objectives and process for review and comment on proposed and final State regulations.

II. OBJECTIVES The objectives of this procedure are:

A. Provide guidance for recommended use by States on preparation and submittal of proposed and final State regulations for NRC staff review.

1 B. Establish the procedures to be followed by NRC staff for review of State ragulations including the scope of review, staff responsibilities, timeliness, and products to be prepared and communicated to the State documenting the results of the review. ,

C. Provide guidance to NRC staff on whether differences identified in State regulations are significant.

111. BACKGROUND A. Each Agreement State has the responsibility to promulgate legally binding requirements that satisfy the compatibility requirement of Section 274 of the Atomic Energy Act of 1954, as amended. States generally fulfill that responsibility through promulgations of regulations. Because each Agreement State possesses detailed knowledge of its own regulations, Agreement States are best able to determine that their regulations are compatible with NRC regulations and where not compatible, for stating why they are not compatible.

B. Agreement States are requested to submit proposed amendments to their regulations, usually when they are published for public comment, for review and comment by NRC staff. Agreement States also are requested to submit final regulations for review and an NRC determination whether each regulation satisfies the compatibility and health and safety designation D.7.1 Revision 3 9/8/97

D 7 Procedure for Reviewing State Regulations associated with equivalent regulations of the Commission. This Office of State Programs (OSP) Internal Procedure D.7, Procedure for Reviewing State Regulations,is used for review.

C. In order to assure States have adequate time to promulgate compatible regulations within three years of the effective date of changes in NRC regulations, NRC staff prepares and publishes semiannually a Chronology of Amendments, included in the chronology is identification of each regulation change, the specific sections modified or established by the regulation change, the effective date of the change, and the compatibility or health and safety designation.

IV. GUIDANCE FOR USE BY STATES A. Agreement States and Non-Agreement States seeking Agreements should submit proposed and final regulations to the Deputy Director, OSP, for NRC staff review and specifically request comments.

B. Appendix A to this procedure provides guidance for recommended use by States on the form, content and process to be followed for preparation and submittal of proposed and final regulations to NRC staff for review. ,

C. The State,in its transmittalletter,is requested to identify the date comments are needed from NRC. The State is also requested to identify any significant difference between the State's regulation and the NRC equivalent regulation and the rationale for the difference.

V. GUIDANCE TO NRC STAFF A. Staff Responsibilities

1. The Director, OSP, has overall responsibility for the review and determination of the compatibility of Agreement State regulations.

The Deputy Director, OSP, has primary responsibility for coordinating the review of Agreement State regulations. The State Regulations Review Coordinator (Coordinator) is responsible for review project management and assuring overall quality control of the review process, for keeping the OSP Management Analyst informed when an

- Agreement State regulation is received so the status of the review can be tracked by the OSP Management Analyst through closure, for keeping the Chronology of Amendments up to-date and for preparing a " Summary Report of Regulation Compatibility" for each IMPEP team at the time of each State's IMPEP review. The Coordinator is also D.7.2 Revision 3 9/8/97

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D.7 Procedure for Reviewing State Regulations responsible for assuring consistency of reviews among reviewers and discussing potential delays or other potential problems with the Deputy Director or Director for resolution when necessary,

2. The Deputy Director, OSP, is designated to receive existing Agreement State regulations. Overall review project management responsibility is assigned to the Coordinator. Upon receipt, the Coordinator will first determine whether the Regional State Agreements Officer (RSAO) can conduct the review. If not, the Coordinator, in consultation with the Deputy Director, OSP, will assign review responsibility to one or more OSP staff depending on the complexity of the regulation package, or evaluate use of contractor assistance to complete the review. Review assignment should be cumpleted within three days of receipt. The Coordinator will confirm the OSP Management Analyst has received a copy of the incoming regulation review request from the State and willinform the Management Analyst of the assigned reviewer (s) and the due date requested by or negotiated with the State. The Management Analyst will enter the regulation review in the OSP Action Item Tracking System and the Agreement State regulation review data base (when available).

B. Review Guidance for Proposed and Final Regulations

1. OSP staff is responsible for completing reviews of all non Agreement State regulations submitted by States seeking to enter an Agreement with NRC using the same guidance as for Agreement States.

2. In some cases, the reviewer may need to consult with the Office of Nuclear Material Safety and Safeguards (NMSS) or other NRC offices as necessary to support completion of the review based on issues raised during the review and their significance. If requested, NMSS and OGC, or other NRC offices, review State regulations according to their own internal procedures. The Deputy Director should, if necessary, conduct meetings with commenting offices to resolve differing views.

3. In the case where a non-Agreement State has requested NRC comments on a proposed regulation that has been published by the State for public review and comment, the reviewer should request review of the regulation by NMSS, the Regional Of fice and OGC.

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a D.7 Procedure for Reviewing State Regulations

4. The reviewer is responsible for preparing the comment letter back to the State and obtaining the concurrence from OGC or other NRC offices when required.

5. Public Responsiveness Requirement The assigned staff reviewer is required to notify the State by phone or E-mail within two weeks of receipt of an Agreement State regulation package that it has been received and assigned for review. The notification should include whether the staff expects to be able to meet the State's requested date for comments if not, the staff should establish a revised date that is acceptable to the State, if an NRC consultant will conduct the review, the Coordinator will notify the State.

6. General Review Guidance The following references are usefulin the review of Agreement State regulations.

a. NRC Regulations Title 10 Chapter 1, Code of Federal Regulations, published by the Division of Freedom of Information and Publications Services, NRC, codified and reissued periodically,

b. The latest Chronology of Amendments provided to the States by All Agreement States letter,

c. Management Directive 5.9, Adequacy and Compatibility of Agreement State Programs, and associateri Handbook 5.9.

d. OSP Internal Procedure B.7 (Revision 1): Compatibility Categories and Health and Safety identification for NRC Regulations and Other Program Elements; and

e. Suggested State Regulations (that have received final approval by NRC).

7. Specific Review Guidance

a. The reviewer should normally limit review to those portions of a State's regulation that are being added or amended by the State's rulemaking action. The reviewer should also limit D.7.4 Revision 3 9/8/97

D_.7 Procedure for Reviewing State Regulations review to those parts or sections of the regulation that are either required for compatibility or health and safety as set out in OSP Internal Procedure B.7 (i.e., Categories A B, C or H&S).

b. The reviewer should conduct a comparison of the intent of the State's regulation with the equivalent NRC regulation to determine if the State's regulation is " essentially identical" (Category A and B) or meets the " essential objectives" (Category C and H&S) as defined in the glossary of Handbook 5.9. Differences that are identified, which either significantly change or affect the intent of the regulation, should be analyzed further and a determination made whether the regulation meets (or does not meet) the compatibility or health and safety objective of the equivalent NRC regulation.

Guidance to assist in determining when a difference is significant and should be included as a comment on the State's regulation is set out in Appendix B, Handbock 5.9, and OSP Internal Procedure B.7.

c. When the NRC staff has reviewed a previous version of the regulation, retrieve and review any comments returned to the Gtate on the subject regulations to examine how the State addressed the comments.

8. Contractor Assistance A request for consultant or contractor assistance in review of proposed or final State regulations care only be initiated by the OSP technical monitor, but requires the concurrence of the Director, OSP.

When using such assistance, the Coordinator should:

a. Prepare a cover letter and attach the regulations package for forwarding to the consultant or contractor following the instructions of the technical monitor, including the instruction to follow this procedure to conduct the review.

b. Evaluate the comments as the basis for development of a comment letter to the State upon return of the consultant's or contractor's review report.

9 Communication of the Review Results D.7.5 Revision 3 9/8/97

L D.7 kProcedure for Reviewing State Regulations. ,

a.c The reviewer should prepare a formal comment letter or *no - I comment" letter _ to the State documenting the results of the- 1 review. The letter should be addressed to the State Radiation

- Control Program Director unless State staff has specified otherwise, and should normally be prepared for signature by-4 the Deputy Director, OSP. . The standard format and content for the letter is set out in either Appendix C (for proposed ' ,

- regulations) or Appendix D (for final regulations).

r g b. Comments resulting form the review should be set out in an enclosure to the letter and should contain, as a minimum, the ,

following information:-

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1. Citation of the part or section of the State regulation reviewed;

11. Citation of the equivalent NRC regulation; ,

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t lii. Compatibility or_H&S category assigned to that section or part of the regulation; iv. NRC approved Suggested State Regulation (SSR),if 1 any; and

v. Description of the difference identified by the reviewer between the State and NRC regulation, significance of

' the difference (e.g., why it does not meet the assigned

, compatibility category), and description of at least one course of action the State could take to address the comment.-

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c. All offices participating in the review and OGC should be on concurrence. For reviaws conducted by the RSAO, tho~

concurrence of the Regional Counsel may be required following j Regional practice. The concurrence of OGC is always required.

l The Deputy Director, OSP, signs the comment letter prepared by the reviewer after concurrence by the Coordinator.

d. Allletters should use the Regulatory information Distribution System (RIDS) codes SP05 08, corresponding to NRC Regions I IV, on the concurrence sheet.

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D.7 2 Procedure for Reviewing Stata Regulations e.. After determining the compatibility of final regulations, the

- reviewer should provide the Information to the Coordinator.

.The Coordinator review N concurs on allletters.- The reviewer should ensure vist a copy of the letter is provided to 3 the OSP Management Analyst so that the compatibility determination can be entered and to update the status or close ,

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out the action in the tracking system.

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D.7 Procedure for Reviewing State Regulations APPENDICES -

Appondix A. Guidance for Recommended Use by Agreement States for Submitting Regulations for NRC Staff Review Appendix B. Criteria for Comparing Regulations and identifying Differences Appendix C. Sample Comment Le'tter for Proposed State Regulations Appendix D. Sample Comment Letter for Final State Regulations 4

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D.7 - Procedure for Reviewing State Regulations Appendix A GUIDANCE FOR RECOMMENDED USE BY AGREEMENT STATES FOR SUBMITTING REGULATIONS FOR NRC STAFF REVIEW

l. Introduction This guidance to Agreement States and States seeking an Agreement pertains to the submittal of proposed and final State regulations to NRC staff for review to confirm that they are compatible with equivalent regulations of the NRC. NRC's goalis to conduct a single review for proposed regulations and a single review for final promulgated regulations. Although many States base their regulations on Suggested State Regulations (SSRs), until the SSRs are updated and reviewed with regard to compatibility and approved by NRC, the State should not assume that

, State regulations based on SSRs are necessarily compatible. The NRC review process compares all State regulations with the equivalent regulations of the NRC and NRC approved final SSR.

II. State Submittal Guidance A. For proposed regulations at the draft stage or, preferably, the public comment stage, but not both, the Radiation Control Program Director, or designee (Director), in preparing and submitting proposed regulations, is requested to identify by line in/line-out text, or similar identification, the changes to NRC's regulations that are being incorporated into the State's regulations. The Director is requested to' identify at what point in the State's regulatory process NRC's review would be of most benefit to the State, i.e.,

either at the draft stage or the public comment stage, and is requested to have NRC review at that stage. For final promulgated regulation changes, the Director is requested to identify by line-in/line-out text, or similar identification, the changes made between the proposed regulation submitted above and the final regulation. The Director is requested to discuss how the

' State has addressed or incorporated NRC's comments on the proposed regulation. The Director is requested to submit an electronic version of the regulation, whenever possible, using a word processing software that is

- compatible with " Wordperfect 5.1" or higher.

B. The Director is requested to submit proposed regulations to the Deputy Director, OSP. The regulations are requested to be submitted at least sixty days before the State needs comments, or concurrently with the State-publication of the proposed regulations for public comment, whichever is D.7.9 Revision 3 9/8/97

.. v. c D.7 r Procedure for Reviewing State Regulations . ,

' earlier. Final regulations as officially adopted by the State are requested to be submitted to the Deputy Director, OSP, for review after the regulations l

. are published.. The Director is requested to identify the date by which the State needs comments from NRC in the transmittal letter.  !

C. With both proposed or final regulation, the Director is requested to document  !

- whether the Agreement State believes its regulation. satisfies the compatibility and health and safety component criteria in Handbook 5.9 and

, the assigned compatibility and health'and safety component designations set t out in OSP Internal Procedure B.7 (Revision 1): Compatibility Categories and Health and Safety identification for NRC Regulations and Other Program

- Elements. The staff reviews State regulations based on this guidance and the 4

guidance set out in Appendix B to this procedure. If the regulation does aqt satisfy the compatibility and health and safety designation, the Director is requested to identify those sections and to describe the State's rationale for oromulgating a regulation that is not compatible with NRC's regulation. The Director is requested also to describe any constraints that prevent the State from promulgating a rule that satisfies the compatibility or health and safety- -

designation and how the constraints will be removed, if possible.

D. The State may be requested to submit some additional relevant information,.

as necessary, such as a copy of the State regulations package, public proceedings, advisory committee comments, and public comments that influenced the text of the final regulations, y

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D.7 - Procedure for Reviewing State Regulations Appendix B CRITERIA FOR COMPARING REGULATIONS AND IDENTIFYING DIFFERENCES

1. DIFFERENCES THAT ARE NOT SIGNiFICANT in most cases, the following differences between State and NRC regulations are not significant and do NOT affect compatibility or the health and safety objectives of the regulation. These differences do not need to be identified or commented on.

A.- Differences that do not result in Agreement State licensees being subject to a requirement different from the equivalent NRC requirement.

B. Differences that result from the State regulation being made applicable.to sources of radiation not covered by the Atomic Energy Act (e.g., x rays, naturally occurring and accelerator produced radioactive materials);

C. Differences between the ordering of the subdivisionA of the NRC and the State regulations; D. The substitution of terms with the same meaning (where the use of essentially identical terms is not required) according to the editorial style of the State, i.e., "shall" or "must," " rule" or " regulation," " Commission" or

" agency," " device" or " equipment:"

1 E. The omission of any portion of the text of an NRC regulation that provides an example, contains supplementary material, or provides a reference to another regulation for the convenience of the reader; F. . The incorporation, as a requirement in the State regulation, of any portion of the text of an NRC regulation that provides an example, contains supplementary material, or provides a reference to another regulation for the

onvenience of the reader; G. Modifications to punctuation that do not change the meaning of the text, i.e., changing a semicolon (";") to a conjunction followed by a comma

("and,"); and H. Any difference that results from the use o' SI units for record keeping and reporting.

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D.7 Procedure for Reviewing State Regulations

• ll. DIFFERENCES THAT ARE SIGNIFICANT in s sme cases, the difference in the wording between State and NRC regulations ma) significantly change or affect the intent of the regulation and may therefore affeat compatibility or the health and safety objectives of the regulation. For .

regulttions with Category A and B compatibility designations, the differences or changes are significant if licensee actions to satisfy the NRC equivalent regulation are not the same as those actions required to satisfy the Agreement State regulation for all phases of the licensee's operations. For regulations with a Category C compatibility designation or a health and safety designation, the changes or differences in an Agreement state regulation are acceptable only if an Agreement State licensee must take the same action neeoed to satisfy the NRC-equivalent regulation, or must take actions in addition to those required to satisfy the NRC-equivalent regulation.

A conclusion that the text of the State regulation leads to a different interpretation than the text of the equi: "qt NRC regulation, for regulations designated Category A or 8, would result in a fino.og that the regulation does not meet the Category A or B designation. The reviewer s.1ould describe why the State's regulation leads to a different interpretation. ,

A conclusion that the regulation does not reflect either the essential objective of the NRC regulation or the State's regulation creates a conflict, duplication or a gap would result in a findlag that the regulation does not meet the Category C or Health and Safety designation. Please see Section Vil of Handbook 5.9 for definitions of essential objective, conflict, duplication, and gap.

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D.7 Procedure for Reviewing State Regulations Appendix C Sample Comment Letter for Proposed State Regulations Notes: _ alternate text shown in isdline to be substituted as appropriate italicized text is guidance for determining text to be entered Name, Title Address

Dear Mr. (Ms } Name:

As requested, we have reviewed the proposed regulations (/dentify the regulat/ons us/np the same title or description given by the State), (give date of regulations or cover letter date // regulations era undated). The regulations'were reviewed by comparison to the equivalent NRC regulations in 10 CFR Part_ isection' number).iWe'also"discussedfour ieviedof,the regul_ationsLwith (neme of Store personjontacte4on (dete)l As a result of our review we have no (number of c'omments) comments {that'ha e been identified in the~ enclosure). (Please note that we have _ limited ~ourfrevie%'o regulations required for compatibil_itpland/or health and safety.) Under our current procedure, a finding that a State regulation meets the compatibility and health and safety categories of the equivalent NRC regulation may only be made based on a review of the final State regulation. However, we have determined that if your proposed regulations were adopted (incorporating the comm'entsiand) without (u.gsr) significant change, they would meet the compatibility and health and safety categories established in OSP Internal Procedure B 7.

We request that when the proposed regulations are adopted and published as final regulations, a copy of the "as published" regulations be provided to us for review. As requested in our All Agreement States Letter SP 96-027, "Reauest to Hiahlicht Chances to Aareement State Reaulations Submitted to NRC for Compatibility Review" (March 1, 1996), please highlight the final changes and send one copy in a computer readable format, if possible.

If you have any questions regarding the comments, the compatibility and health and safety categories, or any of the NRC regulations used in the review, please contact me or /give name of reviewer or other contact / of my staff at (301) 415 2322.

Sincerely,

, Deputy Director Office of State Programs Enclosure!]

As stated D.7.13 Revision 3 9/8/97

D.7 + Procedure for Reviewing State Regulations-i Distribution:

DIR RF [ Task Numberi DCD (SP Number)

Management Analyst (Other staff as needed) PDR (YESf)

(Statel File DOCUMENT NAME: G:\RSAO/OSP Staff ID\STATELET.RSAO/OSP Staff ID 13 tocorre e copy of this document, bdecate M the bou: 'C' = Copy without ettschment/ enclosure *E' = Copy with ettschment/ enclosure 'N' = No copy OFFICE OSP l OSP l OSP:DD l OGC l OSP:D l NAME RSAO/OSP STAFF Coordinator DATE DATE DATE DATE DATE DATE OSF' FILE CODE: SP-AG-IState]

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D.7. Procedure for Reviewing State Regulations Appendix D i Sample Comment Letter for Final State Regulations Notes: alternate text shown in Iedline; to be substituted as appropriate

/tallc/ zed text is guidance for determining text to be entered ,

Name, Title Address

Dear Mr. (Ms~.) Name:

.We have reviewed the final (name of State) regulations (Identify the regulations using the

- title or description given by the State), which became offective on (effective date of the regularlons). The regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Part _ (sectioriinumber) [We also discussed ourjevioisof,.the jegulationsJwith)nerne bf State person contacted)Lon (date))

(If there are comments, use the following:)$

As"a res'u lt of the"NRC teview weihave' identified (nbipher"6f comments) cornmentsTas enclosed.' These comments must be addreased to meet the com'patibility;andfealth'and safety categories established. in OSP Internal Procedure'8 7) ,

(If there are no comments, use the following:)

As a result of the NRC review, we have determined that the (name of State) regulations, as adopted, meet the compatibility and health and safety categories established in OSP Internal Procedure B 7.

If you have any questions regarding the comments, the compatibility and health and safety categories, or any of the NRC regulations used in the review, please contact me or (give name of reviewer or other contact) of my staff at (301) 415 2322.

Sincerely,

, Deputy Director Office of State Programs uneisarei; As stated D.7.15 - Fievision 3 -

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D.7_- Procedure for Reviewing State Regulations COMMENTS ON (PROPOSED or FINAL) (State namel REGULATIONS AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES State NRC NRC Approved Category Reaulation Reaulation SSR (if anyl Sublect and Comments B 04.1 14 20,2006 Transfer for Disposal and Manifests (excluding Appendix F) Paragraph E was omitted from Appendix G, 10 CFR 20 (60 FR 25983). Unless the missing paragraph is adopted, the regulation would not meet the compatibility criterion of a program element with transboundary implications.

C 5.10 34.25 Leak Testing, Repair, Tagging, Opening, Modification, and Replacement of Sealed Sources RH 5.10 requires the labeling of exposure devices, while the equivalent NRC regulation in 10 CFR 34.25(e) requires the labeling of sealed sources not fastened to or contained in exposure devices. Regulatory requirements for the labeling of exposure devices are found in 10 CFR 34.20(b) and the equivalent State regulation RH 5.5.2. As a result, the State regulations do not meet the compatibility criteria with respect to the requirements for labeling of sealed sources not fastened to or contained in exposure devices. Consequently, RH 5.10.5 should be amended to incorporate the essential objectives of the text of 10 CFR 34.25(e).

D.7.16 Revision 3 9/8/97