Interim procedure SA 201 for comment

Office of Nuclear Materials Safety and Safeguards (NMSS) Procedure Approval

Review of State Regulatory Requirements

SA-201

Issue Date: Review Date:
Andrea Kock Division of Material Safety, Security, State, and Tribal Programs	Original signed by	Date:
Paul Michalak State Agreement and Liaison Programs Branch Division of Material Safety, Security, State, and Tribal Programs	Original signed by	Date:
Michelle Beardsley State Agreement and Liaison Programs Branch Division of Material Safety, Security, State, and Tribal Programs	Original signed by	Date:
ML

NOTE

Any changes to the procedure will be the responsibility of the NMSS Procedure Contact. Copies of the NMSS procedures are available through the NRC website.

1. INTRODUCTION

This procedure establishes the process for the NRC’s review and comment on proposed and final Agreement State regulations, other generic Agreement State legally binding requirements (LBR), and Suggested State Regulations (SSRs).

2. OBJECTIVES

1. To provide guidance for use by the Agreement States and those States applying for Agreement State status on the preparation and submittal of proposed and final State regulations, and other generic LBR (e.g., license conditions and orders); and for use by the Conference of Radiation Control Program Directors, Inc. (CRCPD) on the preparation and submittal of SSRs, for the U.S. Nuclear Regulatory Commission (NRC) staff review.

2. To establish the procedures to be followed by NRC staff for review of State regulations or other generic LBR, and SSRs including the scope of review, staff responsibilities, timeliness, and products to be prepared and communicated to the State or CRCPD documenting the results of the review.

3. To provide guidance to NRC staff on the significance of differences between State regulations, other generic LBR, or SSRs and NRC regulations.

4. To meet the following performance objectives:

1. The acceptance review of incoming packages should be completed within three days of receipt in the Agreement State Programs Branch (ASPB), Division of Materials Safety and State Agreements (MSST);

2. Incoming regulation submission packages that have been determined to be complete should be assigned to the reviewer within three days of the acceptance review, and the State notified accordingly;

3. The technical review should be completed within two weeks of review assignment.

4. Any concurrence from other offices such as the Office of the General Counsel (OGC) should be completed within two weeks of the request for concurrence. In a case involving the concurrence of more than one other office, the process will be carried out concurrently.

5. The State will be contacted before the final regulation review letter is sent, to relay any comments resulting from the review.

6. A final comment letter will be sent to the State both electronically and mailed within 60-120 days from the receipt of a complete package from the State. The goal is to complete 85% of State regulation review packages within 60 days of receipt of a complete package, and 100% within 120 days of receipt of a complete package.

3. BACKGROUND

1. Each Agreement State has the responsibility to promulgate LBRs that satisfy the compatibility requirement of Section 274 of the Atomic Energy Act of 1954, as amended. States generally fulfill that responsibility through promulgation of regulations. Each Agreement State possesses detailed knowledge of its own requirements; therefore Agreement States should determine whether their regulations or other generic LBR are compatible with NRC regulations, and where there are significant differences which could affect compatibility.

2. Agreement States, and all States seeking an Agreement with NRC, are requested to submit for NRC staff review, proposed amendments to their regulations or other proposed generic LBR. Such requests should usually be submitted when they are published for public comment. It is not mandatory that the State submit their proposed regulations; however it is encouraged to avoid the need to revise final regulations, once published.

3. Agreement States should submit final regulations or other final generic LBR for NRC review. The requested submittal should include requirements satisfying the compatibility and health and safety (H&S) designations associated with equivalent regulations of the Commission.

4. To assist States in promulgating compatible regulations or other generic LBR within three years of the effective date of changes in NRC regulations, NRC staff prepares and publishes a Chronology of NRC Amendments. Included in the chronology is identification of each regulation, the specific sections modified or established by the regulation change, the effective date of the change, and the compatibility or health and safety designation. This information is also found in the Regulation Toolbox on the NMSS website: https://scp.nrc.gov/regresources.html

4. ROLES AND RESPONSIBILITIES

NOTE: In the following, the word, “regulations,” also refers to “other generic legally binding requirements,” “license conditions” and the SSRs. The word State also refers to the CRCPD.

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

2. The Deputy Director, MSST, is designated to receive State regulations and has the responsibility for managing, reviewing and signing the NRC regulations review letter. This includes reviewer assignments, assignment of due dates, and changes to due dates. The Deputy Director also keeps the State Regulation Review Coordinator (SRRC) informed when an Agreement State regulation is received so the SRRC can track the status of the review through closure. The Deputy Director may designate the Branch Chief, State Agreement and Liaison Programs Branch, or the SRRC to carry out these responsibilities including signing the regulation review letter for the Deputy Director, as necessary.

3. The Branch Chief, ASPB is the first line supervisor for the SRRC. The Branch Chief may be designated by the Deputy Director to carry out the Deputy Director’s responsibilities, including reviewer assignments, or signature authority for the regulation review letter, as necessary.

4. The SRRC is responsible for the overall coordination, tracking, auditing and quality control of the regulation review process. As part of this responsibility, the SRRC: (1) audits the technical reviewer’s draft comment letter, and reviewer summary sheets to ensure technical and procedural consistency of reviews among reviewers; (2) addresses potential delays or other issues associated with specific regulation reviews; (3) maintains the Chronology of NRC Amendments; and (4) as designated by the Deputy Director and SALB Chief, the SRRC may also assign technical reviewers, due dates, and approve changes to due dates.

5. The Regional State Agreements Officer (RSAO) and NMSS staff are responsible for conducting the technical reviews of State regulations, as assigned.

6. Administrative support to the regulation review process includes the processing of all incoming and outgoing correspondence and review documents in the Agencywide Document Access and Management System (ADAMS),

5. GUIDANCE

This guidance applies to Agreement States, those States seeking an Agreement, and the Conference of Radiation Control Program Directors, Inc., (CRCPD), and pertains to the submittal of proposed and final State regulations to the U.S. Nuclear Regulatory Commission (NRC) staff for review. The NRC goal is to conduct a single review for proposed regulations, and a single review for final promulgated regulations to confirm they are compatible with equivalent NRC regulations. The NRC will not routinely conduct more than one review each of the proposed and final regulations. Although many States base their regulations on the CRCPD Suggested State Regulations (SSRs), until the SSRs are updated and reviewed with regard to compatibility and given federal concurrence by the 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.

1. The States

1. should submit and request NRC review for proposed and final regulations to the Deputy Division Director, MSST. States are encouraged to submit regulations electronically to the [email protected] mailbox as this is monitored. In accordance with NRC procedures, all incoming regulations will be entered into ADAMS.

2. should use the guidance provided on the Regulation Toolbox on the NMSS website. Sample letters on the form, content, and process to be followed for preparation and submittal of proposed and final regulations to NRC staff for review can be downloaded for use by both the States and technical reviewers.

3. should submit regulations to the NRC at least 60 days prior to the date by which comments are needed by the State.

4. should submit for review LBR or license conditions that a State proposes to adopt to meet the requirements of an NRC rule, using the same procedures as a State regulation review. In its submittal letter, the State should explain how the LBR or license condition meets the requirements of the NRC rule. States need only to submit license conditions for review that are intended to substitute for NRC rules. States should submit license conditions prior to implementation. The use of LBRs instead of promulgating a regulation amendment is documented on the State Regulation Status (SRS) sheet. An Agreement State should not add/implement any license conditions that have not been reviewed by the NRC.

5. The Program Director is also requested to describe any constraints that prevent the State from promulgating a rule that satisfies the compatibility or health and safety designation in a timely fashion and whether the program is examining removal of the constraints.

6. The State or CRCPD may be requested to submit 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. The State has the responsibility of demonstrating that the requirements adopted other than by regulation are legally binding on the licensee, e.g., license conditions, orders, or statements from Attorney Generals.

2. Before a regulation review can commence, all the required information described below needs to be supplied to MSST:

The State, in its transmittal letter, is requested to:

1. identify the specific regulation sections that are being changed using the tracked changes format;

2. identify the amendment(s) for which the State is submitting regulations using the name and RATS ID number. (Sample transmittal letters can be found in the Regulation Toolbox on the NMSS website);

3. include a cross reference table indicating:

1. the equivalent State to NRC regulations;

b) whether there is/are significant differences

between the State rule and the equivalent NRC

rule, and whether the Agreement State believes its

regulation satisfies the compatibility and health

and safety component criteria in Management

Directive 5.9, Adequacy and Compatibility of

Program Elements for Agreement State Programs; and

c) for those sections that are not compatible,

describe the State’s rationale for promulgating a

regulation that is not compatible with NRC’s regulation.

3. The sixty-day review period will begin following confirmation by the SRRC that all required information has been provided, and the State has been notified electronically that the submission has been accepted for review. A regulation submission package that is missing the required information may lead to delays in the review. The States are encouraged to contact the SRRC prior to submitting a package for review to ensure that all required items have been addressed.

4. Technical Reviewer Assignment

The Deputy Director (or designee) will normally assign review of a regulation to the Regional State Agreement Officer (RSAO). If the RSAO is not available or able to meet the projected due date because of competing priority work assignments, the Deputy Director (or designee) will assign the review to other NMSS staff or evaluate the use of contractor assistance. Reviews will normally be assigned within two days of receipt of a complete State package. The technical reviews should be completed within two weeks, however the SRRC may extend this period for large/complex regulation packages, or due to scheduling conflicts.

5. Technical Reviewer

1. Conducts a comparison of the State's regulation with the equivalent NRC

regulation to determine if the State's regulation is compatible. 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 the reviewer in determining when a difference is significant and should be included as a comment on the State's regulation can be found in Appendix A of this document, Management Directive 5.9, and NMSS Procedure SA-200.

2. Completes a review summary sheet (RSS) to document the review. The reviewer will indicate whether each of the State’s regulation differs from the NRC regulations, and the reviewer’s reasoning for generating or not generating a comment on the difference. An example review summary sheet is shown in Appendix B.

3. Limits review to those portions of a State's regulation that are being added or amended by the State's rulemaking action and identified in the transmittal letter. The reviewer should also limit review to those parts or sections of the regulation that are either required for compatibility or health and safety, as set out in NMSS Procedure SA-200 (i.e., Categories A, B, and C or H&S).

4. Consults, as necessary, for State regulations and SSRs, with other NRC offices to support completion of the regulation review based on issues raised during the review and their significance. When reviewing the regulations for States seeking an Agreement with the NRC, the reviewer shall follow NMSS Procedure SA-700, Processing an Agreement for coordination with other offices.

5. Prepares a draft formal “comment” or "no comment" letter to the State documenting the results of the 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 the Deputy Director, MSST. The standard format and content for the letter are contained in the sample letters found in the Regulation Toolbox on NMSS website). All letters should use the Regulatory Information Distribution System (RIDS) codes SP (05-08), corresponding to NRC Regions I-IV, on the concurrence sheet. Comments resulting from the review should be set out in an enclosure to the letter. A comment table with sample comments for reviewer use is shown in Appendix C.

6. Concurs in the comment letter and forwards it to the SRRC. The SRRC will conduct a quality assurance review and will concur on all letters within three days of receipt and send out the comment letter for other office concurrence.

7. Responds to questions or issues raised by OGC or other offices.

6. Legal Review

1. If requested by the SRRC, the OGC will perform a review of the technical reviewers’ determinations, including the draft letter, review summary sheets and any comments identified within;

2. OGC will provide “no legal objection” (NLO) to the review letter after all issues/comments that they have identified are resolved.

7. The State Regulation Review Coordinator (SRRC)

1. acts as point of contact for questions on and during the review process.

2. conducts a technical completeness review of incoming State transmittal letters and regulation packages within three days of the receipt of a review request;

3. electronically notifies the State acknowledging acceptance of the submission, once all required documents are received.

4. conducts a quality assurance review of all documents

5. serves as liaison between the State, the reviewer, and OGC throughout the review process. Facilitates preparation of a final letter and compatibility comment sheet, if applicable.

6. schedules meetings, as needed, with Division/Branch management and concurring offices to resolve any issues between the reviewer and concurring offices.

7. updates the SRS Data Sheet to reflect the current review and includes it as an enclosure to the comment letter. An example SRS sheet can be found in Appendix D.

8. prepares and requests review by OGC, if applicable. This request is sent electronically to the RIDS OGC mailbox, and contains the following information: date of request, package tracking number (assigned by the SRRC), requested date of response (typically two weeks), name of State program and program director, the package title, ADAMS package link, and the SRRC name and contact number.

9. if necessary, coordinates the request for consultant or contractor assistance in review of proposed or final State regulations in accordance with procedures established by NMSS. When requesting such assistance, the SRRC should:

1. Prepare a cover letter and attach the regulations package for forwarding to the consultant or contractor following the NMSS procedure.

2. 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.

8. A regulatory review process flowchart can be found in the Regulation Toolbox on the NMSS website. Appendix E contains a set of Frequently Asked Questions.

6. APPENDICES

Appendix A- Criteria For Comparing Regulations and Identifying Differences Appendix B -Sample Review Summary Sheet

Appendix C - Sample Comment Chart Appendix D - SRS Data Sheet

Appendix E - Frequently Asked Questions

7. REFERENCES

1. Chronology of NRC Amendments (latest) provided electronically to the States by All Agreement States Letter and posted on the NMSS website at: https://scp.nrc.gov/regresources.html. Links are provided to the Federal Register notice.

2. NRC Management Directive 5.9, Adequacy and Compatibility of Program Elements for Agreement State Programs.

3. 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.

4. NMSS Procedure SA-200, Compatibility Categories and Health and Safety Identification for NRC Regulations and Other Program Elements.

5. NMSS Procedure SA-700, Processing an Agreement

8. ADAMS REFERENCE DOCUMENTS

For knowledge management purposes, listed below are all previous revisions of this procedure, as well as associated correspondence with stakeholders, that have been entered into the NRC’s Agencywide Document Access Management System (ADAMS).

No.	Date	Document Title/Description	Accession Number
1	7/23/01	STP-01-059, Opportunity to Comment on Draft Revisions to STP Procedure SA-201	ML012050534
2	1/29/03	STP-03-010, Opportunity to Comment on Draft Revisions to STP Procedure SA-201	ML030290744
3	6/19/03	Final STP Procedure SA-201	ML031750279
4	8/07/03	Summary of Comments on SA-201	ML032190296
5	8/31/06	STP-06-080, Opportunity to Comment on Draft Revisions to STP Procedure SA-201	ML062440197

APPENDIX A

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.

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

2. Differences that result from the State regulation being made applicable to sources of radiation not covered by the Atomic Energy Act, as amended (e.g., x-rays, naturally-occurring and accelerator-produced radioactive materials not covered by the Energy Policy Act of 2005);

3. Differences between the ordering and/or numbering of the subdivisions of the NRC and the State regulations;

4. 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;"

5. The omission of any portion of the text of an NRC regulation that provides an example, contains supplementary material, parenthetical information, or provides a reference to another regulation for the convenience of the reader;

6. 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, parenthetical information, or provides a reference to another regulation for the convenience of the reader;

7. 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,");

8. Any difference that results from the use of SI units for record keeping and reporting; and

9. Typographical and minor editorial or punctuation errors.

Appendix A (Continued)

2. DIFFERENCES THAT ARE SIGNIFICANT

In some cases, the difference in the wording between State and NRC regulations may significantly change the meaning and/or intent of the regulation and may, therefore, affect compatibility or the health and safety objectives of the regulation. The reviewer is also responsible for checking requirements that have been adopted by reference to ensure that the corresponding sections refer to the appropriate criteria.

For regulations with Category A and B compatibility designations, differences between NRC and State regulations are significant and result in incompatibility if the licensee actions required to satisfy the NRC regulation are not the same as the actions required to satisfy the corresponding State regulation for all phases of the licensee’s operations. Such a conclusion- that the text of the State regulation leads to a different interpretation than the text of the corresponding NRC regulation- would result in a finding that the State regulation does not meet the Category A or B designation. The reviewer should describe why the State's regulation leads to a different interpretation.

For regulations with a Category C compatibility designation, differences between NRC and Agreement State regulations are acceptable only if, despite such differences, the Agreement State has adopted the essential objectives of the corresponding NRC program element in order to avoid conflicts, duplication, gaps or other conditions that would jeopardize the orderly regulation of agreement materials on a nationwide basis. In the case of compatibility category C, the Agreement State may adopt regulations that are more restrictive than the NRC regulations. The reviewer should refer to the Statements of Consideration in the Federal Register Notice for each rulemaking for information regarding the objective of each regulation revision/addition.

For regulations with a Health and Safety designation, the Agreement State regulation must adopt the essential objectives of the corresponding NRC program element because of the health and safety significance of the program element. Please see Section VII of Management Directive 5.9 for definitions of “essential objective”, “conflict”, “duplication”, and “gap”. A conclusion that a State regulation does not reflect the essential objectives of the corresponding NRC regulation or the State's regulation creates a conflict, duplication or a gap would result in a finding that the regulation does not meet the Category C or Health and Safety designations. The reviewer should describe why the State's regulation does not reflect the essential objectives of the corresponding NRC regulation.

APPENDIX B

Sample Review Summary Sheet

Note: The italicized text represents sample entries and is guidance for determining text to be entered.

NRC	Section	State	Compatibility	Summary of	Is There a	Is the	Comments:
Section	Title	Section	Category	Amendment Change	Difference Between	Difference Significant	If Difference Exists, Why or
					State Text and NRC	Yes/No	Why Not Is The Difference
					Yes/No		Significant.
20.1003	Definitions	53.2 (1)	A	In Sec. 20.1003 the definition of Shallow-dose equivalent (Hs) is revised to read as follows:	NO
				Shallow-dose equivalent (Hs), which applies to the external exposure of the skin of the whole body or the skin of an extremity, is taken as the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2)
20.1701	Use of	4.1.2	H&S	Section 20.1701 is	YES	NO	The State uses a
	process or other engineering			revised to read as follows:			different word order, but the essential objectives
	controls			The licensee shall use, to the extent practical,			are met. Not a compatibility
				process or other			issue.
				engineering controls
				(e.g., containment,
				decontamination, or
				ventilation) to control
				the concentration of
				radioactive material in
				air.
39.49	Uranium sinker bars	4.2.3 (b)	C	Section 39.49 is revised to read as follows:	YES	YES	COMMENT # (corresponding to
							the letter’s
				The licensee may use a			comment table)
				uranium sinker bar in
				well logging			The State has
				applications only if it is			omitted this
				legibly impressed with			requirement.
				the words
				``CAUTION--RADIO			The State needs to
				ACTIVE-DEPLETED			add this
				URANIUM'' and			requirement to

``NOTIFY CIVIL AUTHORITIES (or COMPANY NAME) IF FOUND.''

their regulations to meet the Compatibility Category C designation assigned to 10 CFR 39.49.

APPENDIX C

COMPATIBILITY COMMENTS (STATE NAME)(PROPOSED or FINAL) REGULATIONS

STATE SECTION1		NRC SECTION	RATS ID	CATEGORY	SUBJECT and COMMENTS
FORMAT
0	State or SSR citation	NRC citation	See State Regulatio n Status Sheet	Compatibility Categories from SA-200 A, B, C, NRC or H&S	[CFR TITLE] Description of comment Action State must take to meet compatibility.
EXAMPLE COMMENTS
1	N/A	30.35(g), 40.36(f) 70.25(g)	1996-3	H&S	Financial assurance and recordkeeping for decommissioning [State] has omitted requirements for the transfer of records pertaining to decommissioning in their regulations. [State] needs to adopt the essential objectives of the requirements for the transfer of decommissioning records to the new licensee to meet the Category H&S designation assigned to Section 30.35(g), 40.36(f), and 70.25(g).
2	[State citation]	20.1003	2002-2	A	Definitions [State’s] proposed definition of “public dose” fit test” omits the phrase “does not include occupational dose” compared to NRC’s definition [State] needs to add the phrase to [state citation] to meet the Compatibility Category A designation assigned to Section 10 CFR 20.1003.
3	[State citation]	20.1003	1999-3	B	Definitions [State’s] proposed definition of “fit test” omits the phrase “or quantitatively” compared to NRC’s definition. Fit tests should also have protocols to provide quantitative results. [State] needs to add the phrase to [state citation] to meet the Compatibility Category B designation assigned to Section 10 CFR 20.1003.

STATE SECTION1		NRC SECTION	RATS ID	CATEGORY	SUBJECT and COMMENTS
4	[State citation]	20.1401	1997-6	C	General provisions and scope [State] has omitted the requirements of paragraph (d). This requirement mandates that the peak annual TEDE be calculated for the first 1,000 years after termination of the license. This requirement is important in determining the potential exposure to members of the public. [State] needs to add this paragraph to [State citation] to meet the Compatibility Category C designation assigned to Section 10 CFR 20.1401.

APPENDIX D

1. THE STATE REGULATION STATUS (SRS) DATA SHEET

The SRS Data Sheet is used by NRC staff to track the status of Agreement State regulations. If information is missing or differs from a State’s records, the Agreement State should add the missing information or changes and forward the revised SRS Data Sheet, with the supporting documentation, to the SRRC for amendment consideration. The regulation amendment tracking system (RATS) is an internal program used by MSST staff to track the status of State adoption of amendments equivalent to those made to the NRC regulations, and NRC’s review of those amendments.

SAMPLE STATE REGULATION STATUS (SRS) DATA SHEET

STATE REGULATION STATUS

State: Tracking Ticket Number:

Date:

[ # amendment(s) reviewed identified by a * at the

beginning of the equivalent NRC requirement.]

RATS ID	NRC Chronology Identification	Date Due for State Adoption	Incoming Letter	Outgoing Package	Notes
1991-1	Safety Requirements for Radiographic Equipment Part 34 55 FR 843 (Superceded by 1997-5)	01/10/1994
1991-2	ASNT Certification of Radiographers Part 34 56 FR 11504 (Superceded by 1997-5)	none
1991-3	Standards for Protection Against Radiation Part 20 56 FR 23360; 56 FR 61352; 57 FR 38588; 57 FR 57877; 58 FR 67657; 59 FR 41641; 60 FR 20183;	01/01/1994
1991-4	Notification of Incidents Parts 20, 30, 31, 34, 39, 40, 70 56 FR 64980	10/15/1994
1992-1	Quality Management Program and Misadministrations Part 35 56 FR 34104 (Superceded by 2002-2)	01/27/1995
1992-2	Eliminating the Recordkeeping Requirements for Departures from Manufacturer's Instructions Parts 30, 35 57 FR 45566	none
1993-1	Decommissioning Recordkeeping and License Termination: Documentation Additions [Restricted areas and spill sites] Parts 30, 40 58 FR 39628	10/25/1996
1993-2	Licensing and Radiation Safety Requirements for Irradiators Part 36 58 FR 7715	07/01/1996
1993-3	Definition of Land Disposal and Waste Site QA Program Part 61 58 FR 33886	07/22/1996
1994-1	Self-Guarantee as an Additional Financial Mechanism Parts 30, 40, 70 58 FR 68726; 59 FR 1618	none
1994-2	Uranium Mill Tailings Regulations: Conforming NRC Requirements to EPA Standards Part 40 59 FR 28220	07/01/1997
1994-3	Timeliness in Decommissioning Material Facilities Parts 30, 40, 70 59 FR 36026	08/15/1997
1995-1	Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use Parts 30, 32, 35 59 FR 61767; 59 FR 65243; 60 FR 322	01/01/1998
1995-2	Frequency of Medical Examinations for Use of Respiratory Protection Equipment Part 20 60 FR 7900	03/13/1998
1995-3	Low-Level Waste Shipment Manifest Information and Reporting Parts 20, 61 60 FR 15649; 60 FR 25983	03/01/1998
1995-4	Performance Requirements for Radiography Equipment Part 34 60 FR 28323 (Superceded by 1997-5)	06/30/1998
1995-5	Radiation Protection Requirements: Amended Definitions and Criteria Parts 19, 20 60 FR 36038	08/14/1998
1995-6	Clarification of Decommissioning Funding Requirements Parts 30, 40, 70 60 FR 38235	11/24/1998
1995-7	Medical Administration of Radiation and Radioactive Materials Parts 20, 35 60 FR 48623 (Superceded by 2002-2 and 2005-2)	10/20/1998
1996-1	Compatibility with the International Atomic Energy Agency Part 71 60 FR 50248; 61 FR 28724 (Superceded by 2004-1)	04/01/1999
1996-2	One Time Extension of Certain Byproduct, Source and Special Nuclear Materials Licenses Parts 30, 40, 70 61 FR 1109	02/15/1999
1996-3	Termination or Transfer of Licensed Activities: Record keeping Requirements Parts 20, 30, 40, 61, 70 61 FR 24669	06/17/1999
1997-1	Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air Act Part 20 61 FR 65120	01/9/2000
1997-2	Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction Within an Agreement State Part 150 62 FR 1662	02/27/2000
1997-3	Criteria for the Release of Individuals Administered Radioactive Material Parts 20, 35 62 FR 4120	05/29/2000
1997-4	Fissile Material Shipments and Exemptions Part 71 62 FR 5907 (Superceded by 2004-1)	02/10/2000
1997-5	Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiography Operations Parts 30, 34, 71, 150 62 FR 28947	06/27/2000
1997-6	Radiological Criteria for License Termination Parts 20, 30, 40, 70 62 FR 39057	08/20/2000
1997-7	Exempt Distribution of a Radioactive Drug Containing One Micro curie of Carbon-14 Urea Part 30 62 FR 63634	01/02/2001
1998-1	Deliberate Misconduct by Unlicensed Persons Parts 30, 40, 61, 70, 71, 150 63 FR 1890; 63 FR 13773	02/12/2001
1998-2	Self-Guarantee of Decommissioning Funding by Nonprofit and Non-Bond-Issuing Licensees Parts 30, 40, 70 63 FR 29535	07/01/2001
1998-3	License Term for Medical Use Licenses Part 35 63 FR 31604 (Superceded by 2002-2)	07/10/2001
1998-4	Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiographic Operations Part 34 63 FR 37059	07/09/2001
1998-5	Minor Corrections, Clarifying Changes, and a Minor Policy Change Parts 20, 32, 35, 36, 39 63 FR 39477; 63 FR 45393	10/26/2001
1998-6	Transfer for Disposal and Manifests: Minor Technical Conforming Amendment Part 20 63 FR 50127	11/20/2001
1999-1	Radiological Criteria for License Termination of Uranium Recovery Facilities Part 40 64 FR 17506	06/11/2002
1999-2	Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct Material to Provide Requested Information Part 31 64 FR 42269	10/04/2002
1999-3	Respiratory Protection and Controls to Restrict Internal Exposure Part 20 64 FR 54543; 64 FR 55524	02/02/2003
2000-1	Energy Compensation Sources for Well Logging and Other Regulatory Clarifications Part 39 65 FR 20337	05/17/2003
2000-2	New Dosimetry Technology Parts 34, 36, 39 65 FR 63750	01/08/2004
2001-1	Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct Material Parts 30, 31, 32 65 FR 79162	02/16/2004
2002-1	Revision of the Skin Dose Limit Part 20 67 FR 16298	04/05/2005
2002-2	Medical Use of Byproduct Material Parts 20, 32, 35 67 FR 20249	10/24/2005
2003-1	Financial Assurance for Materials Licensees Parts 30, 40, 70 68 FR 57327	12/03/2006
2004-1	Compatibility With IAEA Transportation Safety Standards and Other Transportation Safety Amendments Part 71 69 FR 3697	10/01/2007
2005-1	Security Requirements for Portable Gauges Containing Byproduct Material Part 30 70 FR 2001	07/11/2008
2005-2	Medical Use of Byproduct Material - Recognition of Specialty Boards Part 35 70 FR 16336; 71 FR 1926	04/29/2008
2005-3	Increased Controls for Risk-Significant Radioactive Sources (NRC Order EA-05-090) 70 FR 72128	12/01/2005
2006-1	Minor Amendments Parts 20, 30, 32, 35, 40 and 70 71 FR 15005	03/27/2009
2006-2	National Source Tracking System - Serialization Requirements Part 32 with reference to Part 20 Appendix E 71 FR 65685	02/06/2007
2006-3	National Source Tracking System Part 20 71 FR 65685, 72 FR 59162	01/31/2009
2007-1	Medical Use of Byproduct Material - Minor Corrections and Clarifications Parts 32 and 35 72 FR 45147, 54207	10/29/2010
2007-2	Exemptions From Licensing, General Licenses, and Distribution of Byproduct Material: Licensing and Reporting Requirements Parts 30, 31, 32, 150 72 FR 58473	12/17/2010
2007-3	Requirements for Expanded Definition of Byproduct Material Parts 20, 30, 31, 32, 33, 35, 61, 150 72 FR 55864	11/30/2010
2007-4	Order Imposing Fingerprinting Requirements and Criminal History Records Check Requirements for Unescorted Access to Certain Radioactive Material NRC Order EA-07-305 72 FR 70901	06/05/2008
2008-1	Occupational Dose Records, Labeling Containers, and Total Effective Dose Equivalent Parts 19, 20 72 FR 68043	02/15/2011
2009-1	Medical Use of Byproduct Material – Authorized User Clarification Part 35 74 FR 33901	09/28/2012
2011-1	Decommissioning Planning Parts 20, 30, 40, 70 76 FR 35512	12/17/2015
2011-2	Licenses, Certifications, and Approvals for Materials Licensees Parts 30, 36, 39, 40, 70, and 150 76 FR 56951	11/14/2014
2012-1	Change of Compatibility of 10 CFR 31.5 and 31.6 (See RATS ID: 2001-1 for Rule text) 77 FR 3640	01/25/2015
2012-2	Advance Notification to Native American Tribes of Transportation of Certain Types of Nuclear Waste Part 71 77 FR 34194	08/10/2015
2012-3	Technical Corrections Part 30, 34, 40 and 71 77 FR 39899	08/06/2015
2012-4	Requirements for Distribution of Byproduct Material Parts 30, 31, 32, 40 and 70 77 FR 43666	10/23/2015
2013-1	Physical Protection of Byproduct Material, 10 CFR Parts 20, 30, 32, 33, 34, 35, 36, 37, 39, and 71 78 FR 16922	03/19/2016
2013-2	Distribution of Source Material to Exempt Persons and to General Licensees and Revision of General License and Exemptions, 10 CFR Parts 30, 40, and 70 78 FR 32310	08/27/2016
2015-1	Domestic Licensing of Special Nuclear Material – Written Reports and Clarifying Amendments Part 70 79 FR 57721, 80 FR 143	01/26/2018
2015-2	Safeguards Information - Modified Handling Categorization, Change for Materials Facilities Parts 30, 37, 73, and 150 79 FR 58664, 80 FR 3865	01/28/2018

APPENDIX E

FREQUENTLY ASKED QUESTIONS (FAQs)

1.Q What do the Compatibility Categories mean?

A On the basis of the 1997 Commission Policy Statement on Adequacy and Compatibility and Management Directive 5.9, NRC program elements (including regulations) can be placed into four compatibility categories. In addition, NRC program elements also can be identified as having particular health and safety significance or as being reserved solely to the NRC.

Compatibility Category A - program elements that are basic radiation protection standards and scientific terms and definitions that are necessary to understand radiation protection concepts. The program elements adopted by an Agreement State should be essentially identical to those of NRC to provide uniformity in the regulation of agreement material on a nationwide basis.

Compatibility Category B - program elements that apply to activities that have direct and significant transboundary implications. An Agreement State should adopt program elements essentially identical to those of NRC.

Compatibility Category C - program elements that do not meet the criteria of Category A or B, but the essential objectives of which an Agreement State should adopt to avoid conflict, duplication, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a nationwide basis. An Agreement State should adopt the essential objectives of the NRC program elements, but may be more restrictive.

Compatibility Category D -program elements that do not meet any of the criteria of Category A, B, or C, and do not need to be adopted by Agreement States for purposes of compatibility.

Health and Safety - program elements that are not required for compatibility (i.e., Category D), but that have been identified as having a particular health and safety role (i.e., adequacy) in the regulation of agreement material within the State.

Although not required for compatibility, the State should adopt program elements in this category, based on those of NRC, that embody the essential objectives of the NRC program elements because of particular health and safety considerations.

NRC (Areas of Exclusive NRC Regulatory Authority)- program elements that address areas of regulation that cannot be relinquished to Agreement States and should not be adopted by Agreement States.

2.Q What kind of program elements are reserved to NRC (that is, what NRC regulations should not be adopted by the Agreement States)?

A	Areas of exclusive NRC regulatory authority are those areas of regulation that cannot be relinquished to the Agreement States under a Section 274b. agreement. The following listing are examples of NRC regulations that should not be adopted by Agreement States:
	10 CFR Part 10 - Criteria and procedures for determining eligibility for access to restricted data or national security information or an employment clearance 10 CFR Part 11 - Criteria and procedures for determining eligibility for access to or control over special nuclear material 10 CFR Part 50 - Domestic licensing of production and utilization facilities
	Agreement States should check SA-200 for the comprehensive listing of those regulations reserved to the NRC.
3.Q	How does NRC staff evaluate the regulation submission from the State?
A	The assigned NRC reviewer compares the State regulation text to the corresponding NRC regulation as outlined in the State’s letter of submission. The review will be more timely and efficient if the State includes a cross reference document in their regulation submission showing the correspondence between rule sets (see example below):

State Section	Subject	10 CFR Section
KAS 28-35-135a	Industrial Radiography Definitions	34.3

4.Q	About how long does it usually take to get a response from NRC?
A	The NRC staff goal is to complete 85% of the reviews within 60 days of receipt of a completed package and 100% of the reviews within 120 days of receipt of a completed package. If NRC staff encounters or anticipates a delay in the response, they will contact the individual indicated on the submission package, with the expected completion date.
5.Q	What is the SRS data sheet?
A	NRC maintains a State Regulation Status (SRS) data sheet for each Agreement State. The SRS data sheet is used by NRC staff to track the status of program elements (i.e., regulations and other legally binding requirements) submitted to NRC for review. The Integrated Materials Performance Evaluation Program (IMPEP) teams also use the SRS data sheets to assist in the team’s evaluation of adequacy and compatibility for Agreement State programs. The SRS for each State can be found on the NMSS web site at: https://scp.nrc.gov/.
6.Q	How do I find out what regulations my State is expected to adopt to be found dequate and compatible for the upcoming IMPEP review?
A	The State’s SRS sheet contains the status of the State’s submissions and NRC’s review results. The SRS sheet is updated after the completion of each regulation package review conducted by NRC. The SRS sheet also contains all rulemaking amendments that the State needs to address.

7.Q What does it mean if the SRS sheet has boxes not filled in?

A Blanks on the SRS sheet usually mean that the NRC staff has not received proposed or final regulations to review. If there is a blank and the State believes that the entry is in error, please contact the State Regulation Review Coordinator to discuss a correction to the SRS sheet.

8.Q What are LBRs?

A LBR is the abbreviation for legally binding requirements and may be used as a method to adopt compatibility or health and safety program elements. Examples of such legally binding requirements may include license conditions (including licensee commitments referenced in "tie-down" conditions), orders, or other mechanisms determined by the State to be legally binding and enforceable. The State has the responsibility of demonstrating that requirements adopted other than by regulation are legally binding. If allowed by State law, LBRs can be adopted in many instances in a shorter time frame that regulations.

9.Q Can a State adopt NRC or other federal regulations by reference when appropriate.

A Agreement States can adopt NRC regulations by reference if authorized by State administrative law. This approach can be an efficient and effective method for adopting and maintaining compatibility regulations with the NRC within the usual three-year time frame. However, the State will still need to submit the final regulations for NRC review.

10.Q How long does an Agreement State have to adopt and implement a new NRC Amendment?

A Unless specified differently in the Federal Register, the Agreement State has three years from the effective date of the amendment to adopt and implement the revised regulation, or six months for program elements.

11.Q What does it mean when the Compatibility Category has “[ ]” around it?

A The brackett “[ ]” means that the requirements of the 10 CFR section may be adopted or implemented in other provisions of the State regulations rather than the radiation control requirements. For example, many Agreement States have State Department of Transportation regulations that implement all the requirements of 49 CFR on transportation use within the State. The State should supply the references and the cross walk to show that the requirements have been adopted. NRC staff will still need to review the State regulations to verify that the compatibility/health and safety requirements have been adopted.

12.Q What does a “non-applicable” status mean on the SRS sheet?

A This entry on the SRS sheet means that the specific State is not required to adopt the amendment because it is not included in the Agreement State’s regulatory authority under their 274b Agreement with the NRC. For example, a State without uranium mill authority does not have to adopt uranium mill tailings regulations or revisions to the uranium mill tailings requirements.

13.Q What is an acceptance review and why is it done?

A When MSST receives the regulation submission from the State, the State Regulation Review Coordinator reviews the package to ensure that all of the components needed for review are submitted. If the submission is complete, NRC sends a verification e-mail to the State program acknowledging the receipt, and the staff member assigned to review the package.

14.Q What is a Review Summary Sheet (RSS) and how is it filled out?

A An RSS is the documentation of the review of the State regulations against the NRC regulations completed by the technical reviewer. The RSS will document inconsistencies between NRC and State regulations. These documents are for internal use only.

15.Q Are the SSRs automatically compatible with NRC regulations?

A No, although the NRC provides resource staff to the CRCPD SSR working groups, until the SSRs are reviewed with regard to compatibility and health and safety and approved by NRC, the State should not assume that the SSRs are necessarily compatible. A listing of those SSR Parts that have been approved by NRC can be found on NMSS website at: https://scp.nrc.gov/special/regs/crcpd_regs.html.