ML18044A260

3/16/2018 Letter to S. Flaherty Minnesota Revised Final Regulations to Rats Id 2013-1, and Proposed Regulations to Rats Ids 2015-1, 2015-2, 2015-3, 2015-4, 2015-5, and Other Provisions Not Associated with a Rats Id

ML18044A260
Person / Time
Issue date:	03/16/2018
From:	Linda Howell Office of Nuclear Material Safety and Safeguards
To:	Flaherty S State of MN, Dept of Health
Beardsley M
Shared Package
ML18032A473	List: ML18032A518 ML18044A260
References
Download: ML18044A260 (16)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 March 16, 2018

Sherrie Flaherty, MHP, DC, Supervisor

Radioactive Materials Unit Minnesota Department of Health PO Box 64975 St. Paul, MN 55164-0975

Dear Dr. Flaherty:

We have reviewed the proposed and revised final regulations to the Minnesota Radioactive Materials Rules, Minnesota Rules, Chapter 4731, received by our office on January 29, 2018.

These regulations were reviewed by comparison to the equivalent U.S. Nuclear Regulatory

Commission (NRC) rules and Regulation Amendment Tracking System Identification Numbers (RATS IDs) 2013-1, 2015-1, 2015-3, 2015-4, 2015-5, and other provisions not associated with a RATS ID, as identified in the enclosed State Regulation Status (SRS) Data Sheet. We discussed our review of the regulations with you on March 13, 2018.

As a result of our review, we have four comments that have been identified in the enclosure. Please note that we have limited our review to regulations required for compatibility and/or health and safety. Under our current procedure, a finding that the Minnesota regulations meet the compatibility and health and safety categories of the equivalent NRC regulation may only be made based on a review of the final Minnesota regulations. However, we have determined that if your proposed regulations were adopted, incorporating our comments and without other significant change, they would meet the compatibility and health and safety categories established in the Office of Nuclear Material Safety and Safeguards (NMSS) Procedure SA-200, "Compatibility Categories and Health and Safety Identification for NRC Regulations and Other Program Elements."

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 NMSS Procedure SA-201, "Review of State Regulatory Requirements," please highlight the final changes, and provide a copy to Division of Materials Safety, Security, State, and Tribal Programs, NMSS.

The SRS Data Sheet summarizes our knowledge of the status of other Minnesota regulations, as indicated. Please let us know if you not e any inaccuracies, or have any comments on the information contained in the SRS Data Sheet. This letter, including the SRS Data Sheet, is posted on the NMSS State Communication Portal: https://scp.nrc.gov/rulemaking.html.

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 Michelle Beardsley, State Regulation Review Coordinator, at (267) 884-2305 (Michelle.Beardsley@nrc.gov ) or Lizette Roldan Otero at (817) 200-1596 (Lizette.Roldan@nrc.gov ). Sincerely,

/RA Paul Michalak for/

Linda Howell, Acting Deputy Director Division of Materials Safety, Security, State and Tribal Programs Office of Nuclear Material Safety

and Safeguards

Enclosures:

1. Compatibility Comments

2. Minnesota SRS Data Sheet

SUBJECT:

MINNESOTA REVISED FINAL REGULATIONS TO RATS ID 2013-1, AND PROPOSED REGULATIONS TO RATS IDS 2015-1, 2015-2, 2015-3, 2015-4, 2015-5, AND OTHER PROVISIONS NOT ASSOCIATED WITH A RATS ID

DISTRIBUTION: SP 07 DPiccarillo, RSAO

OFFICE ASPB ASPB OGC ASPB:BC MSTR:DD NAME LRoldan MBeardsley APessin NLO via email PMichalak PMichalak for LHowell DATE 2/9/18 2/13/18 3/13/18 3/16/18 3/16/18 ML18044A260 OFFICIAL RECORD COPY Package ML18032A473 COMPATIBILITY COMMENTS ON MINNESOTA PROPOSED REGULATIONS STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 1 4731.0406 Subpart 2 and 4731.0409

Subpart 2 71.17 71.101(b) and (c)(1) 2015-3 C Quality assurance requirements In part 4731.0406, Subpart 2 and part 4731.0409, Subpart 2, Minnesota needs to replace the references to NRC with their State agency as follows: "Subp. 2. Approved quality assurance program.

Except as otherwise provided in parts 4731.0400 to 4731.0424, the general license issued under subpart 1 applies only to a licensee who has a quality assurance program approved by the NRC [insert Minnesota agency]

as complying with Code of Federal Regulations, title 10, part 71, subpart H." Minnesota needs to make the change indicated above in order to meet the Compatibility Category B designation assigned to 10 CFR 71.17 and the Compatibility Category C designation assigned to 71.101(b) and (c)(1).

2 4731.0420

Subpart 1 71.101(g) 2015-3 C Quality assurance requirements Minnesota needs to revise part 4731.0420, Subpart 1, Item D by replacing "item A" with "items A-C." One of the requirements of 10 CFR 71.101(g) is that the Agreement State's program must meet the requirements of 10 CFR 34.31(b). Item A of part 4731.4090, subpart 2 only corresponds to part of 10 CFR 34.31(b)(1). The remainder of 10 CFR 34.31(b)(1) (i.e., "replacement components meet design specifications") is covered in item B and 10 CFR 34.31(b)(2) is covered in item C, respectively, of part 4731.4090, subpart 2.

2 STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS Minnesota needs to make the change indicated above in order to meet the Compatibility Category C designation assigned to 10 CFR 71.101(g).

3 4731.2950 Subpart 2.F.

10 CFR Part 20 Appendix G 2015-5 B Standards for protection against radiation In Part 4731.2950, Subpart 2.F., Minnesota needs to remove the phrase Office of Information Resource Management and add in its place the phrase Office of the Chief Information Officer.

Minnesota needs to make the change indicated above in order to meet the Compatibility Category B designation assigned to 10 CFR Part 20, Appendix G.

4 4731.0419 71.97(a) NA B Advanced notification of shipment of irradiated fuel and nuclear waste Minnesota needs to include the NRC in these notifications so that an Agreement State licensee will notify the NRC of a shipment of licensed material that meets the requirements of 10 CFR 71.97(b), that would enter or cross through a non-Agreement State. Minnesota needs to make the change indicated above in order to meet the Compatibility Category B designation assigned to 10 CFR 71.97(a).

EDITORIAL COMMENT STATE SECTION 4731.0414 Preliminary Determinations Minnesota should revise its proposed language to part 4731.0414 by deleting the word "part" before "71.85" and replacing it with the word "section" or "§" as there is no "part 71.85" in NRC regulations.

Enclosure 2 STATE REGULATION STATUS State: Minnesota Tracking Ticket Number: 18-21 Date: 3/16/2018 [ # 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 Final ML050140452 No Comments 03/04/2005 ML050690100 Minnesota has adopted Final Regulations equivalent to RATS ID: 1997-5. 1991-2 ASNT Certification of Radiographers Part 34 56 FR 11504 (Superceded by 1997-5) none Not Required Not Required Minnesota has adopted Final Regulations equivalent to RATS ID: 1997-5. 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 Final ML050140452 No Comments 03/04/2005 ML050690100 1991-4 Notification of Incidents Parts 20, 30, 31, 34, 39, 40 and 70 56 FR 64980; 10/15/1994 Final ML050140452 No Comments 03/04/2005 ML050690100 1992-1 Quality Management Program and Misadministrations Part 35 56 FR 34104 (Superceded by 2002-2) 01/27/1995 Final ML050140452 No Comments 03/04/2005 ML050690100 Minnesota has adopted Final Regulations equivalent to RATS ID: 2002-2.

2 1992-2 Eliminating the Recordkeeping Requirements for Departures from Manufacturer's Instructions Parts 30 and 35 57 FR 45566 none Not Required Not Required These regulation changes are not required to be adopted for purposes of Compatibility.

1993-1 Decommissioning Recordkeeping and License Termination: Documentation Additions [Restricted areas and spill sites] Parts 30 and 40 58 FR 39628 10/25/1996 Final ML050140452 No Comments 03/04/2005 ML050690100 1993-2 Licensing and Radiation Safety Requirements for Irradiators Part 36 58 FR 7715 07/01/1996 Final ML050140452 No Comments 03/04/2005 ML050690100 1993-3 Definition of Land Disposal and Waste Site QA Program Part 61 58 FR 33886 07/22/1996 Not Applicable Not Applicable Minnesota does not have authority to regulate this material under its Agreement.

1994-1 Self-Guarantee as an Additional Financial Mechanism Parts 30, 40 and 70 58 FR 68726; 59 FR 1618 none Not Required Not Required These regulation changes are not required to be adopted for purposes of Compatibility.

1994-2 Uranium Mill Tailings Regu lations: Conforming NRC Requirements to EPA Standards Part 40 59 FR 28220 07/01/1997 Not Applicable Not Applicable Minnesota does not have the authority to regulate this material under its Agreement.

1994-3 Timeliness in Decommissioning Material Facilities Parts 30, 40 and 70 59 FR 36026 08/15/1997 Final ML050140452 No Comments 03/04/2005 ML050690100 1995-1 Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use Parts 30, 32 and 35 59 FR 61767; 59 FR 65243; 60 FR 322 01/01/1998 Final ML050140452 No Comments 03/04/2005 ML050690100

3 1995-2 Frequency of Medical Examinations for Use of Respiratory Protection Equipment Part 20 60 FR 7900 03/13/1998 Final ML050140452 No Comments 03/04/2005 ML050690100 1995-3 Low-Level Waste Shipment Manifest Information and Reporting Parts 20 and 61 60 FR 15649; 60 FR 25983 03/01/1998 Final ML050140452 No Comments 03/04/2005 ML050690100 1995-4 Performance Requirements for Radiography Equipment Part 34 60 FR 28323 (Superceded by 1997-5) 06/30/1998 Final ML050140452 No Comments 03/04/2005 ML050690100 Minnesota has adopted Final Regulations equivalent to RATS ID: 1997-5. 1995-5 Radiation Protection Requirements: Amended Definitions and Criteria Parts 19 and 20 60 FR 36038 08/14/1998 Final ML050140452 No Comments 03/04/2005 ML050690100 1995-6 Clarification of Decommissioning Funding Requirements Parts 30, 40 and 70 60 FR 38235 11/24/1998 Final ML050140452 No Comments 03/04/2005 ML050690100 1995-7 Medical Administration of Radiation and Radioactive Materials Parts 20 and 35 60 FR 48623 (Superceded by 2002-2 and 2005-2) 10/20/1998 Final ML050140452 No Comments 03/04/2005 ML050690100 Minnesota has adopted Final Regulations equivalent to RATS IDs: 2002-2 and 2005-2.

1996-1 Compatibility with the International Atomic Energy Agency Part 71 60 FR 50248; 61 FR 28724 (Superceded by 2004-1) 04/01/1999 Final ML050140452 No Comments 03/04/2005 ML050690100 Minnesota has adopted Final Regulations equivalent to RATS ID: 2004-1.

4 1996-2 One Time Extension of Certain Byproduct, Source and Special Nuclear Materials Licenses Parts 30, 40 and 70 61 FR 1109 02/15/1999 Not Required Not Required These regulation changes are not required to be adopted for purposes of Compatibility.

1996-3 Termination or Transfer of Licensed Activities:

Record keeping Requirements Parts 20, 30, 40, 61 and 70 61 FR 24669 06/17/1999 Final ML050140452 No Comments 03/04/2005 ML050690100 1997-1 Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air Act Part 20 61 FR 65120 01/9/2000 Final ML050140452 No Comments 03/04/2005 ML050690100 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 Final ML050140452 No Comments 03/04/2005 ML050690100 1997-3 Criteria for the Release of Individuals Administered Radioactive Material Parts 20 and 35 62 FR 4120 05/29/2000 Final ML050140452 No Comments 03/04/2005 ML050690100 1997-4 Fissile Material Shipments and Exemptions Part 71 62 FR 5907 (Superceded by 2004-1) 02/10/2000 Not Required Not Required These regulation changes are not required to be adopted for purposes of Compatibility. (See STP-97-078)

Minnesota has adopted Final Regulations equivalent to RATS ID: 2004-1. 1997-5 Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiography Operations Parts 30, 34, 71 and 150 62 FR 28947 06/27/2000 Final ML050140452 No Comments 03/04/2005 ML050690100

5 1997-6 Radiological Criteria for License Termination Parts 20, 30, 40, and 70 62 FR 39057 08/20/2000 Final ML050140452 No Comments 03/04/2005 ML050690100 1997-7 Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Urea

Part 30 62 FR 63634 01/02/2001 Final ML050140452 No Comments 03/04/2005 ML050690100 1998-1 Deliberate Misconduct by Unlicensed Persons Parts 30, 40, 61, 70, 71 and 150 63 FR 1890; 63 FR 13773 02/12/2001 Final ML050140452 No Comments 03/04/2005 ML050690100 1998-2 Self-Guarantee of Decommissioning Funding by Nonprofit and Non-Bond-Issuing Licensees Parts 30, 40 and 70 63 FR 29535 07/01/2001 Not Required Not Required These regulation changes are not required to be adopted for purposes of Compatibility.

1998-3 License Term for Medical Use Licenses Part 35 63 FR 31604 (Superceded by 2002-2) 07/10/2001 Not Required Not Required These regulation changes are not required to be adopted for purposes of Compatibility. (See STP-98-074)

Minnesota has adopted Final Regulations equivalent to RATS ID: 2002-2. 1998-4 Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiographic Operations Part 34 63 FR 37059 07/09/2001 Final ML050140452 No Comments 03/04/2005 ML050690100 1998-5 Minor Corrections, Clarifying Changes, and a Minor Policy Change Parts 20, 32, 35, 36 and 39 63 FR 39477; 63 FR 45393 10/26/2001 Final ML050140452 No Comments 03/04/2005 ML050690100 1998-6 Transfer for Disposal and Manifests: Minor Technical Conforming Amendment Part 20 63 FR 50127 11/20/2001 Final ML050140452 No Comments 03/04/2005 ML050690100

6 1999-1 Radiological Criteria for License Termination of Uranium Recovery Facilities Part 40 64 FR 17506 06/11/2002 Not Applicable Not Applicable Minnesota does not have the authority to regulate this material under its Agreement.

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 Not Required Not Required These regulation changes are not required to be adopted for purposes of Compatibility.

1999-3 Respiratory Protection and Controls to Restrict Internal Exposure Part 20 64 FR 54543; 64 FR 55524 02/02/2003 Final ML050140452 No Comments 03/04/2005 ML050690100 2000-1 Energy Compensation Sources for Well Logging and Other Regulatory Clarifications Part 39 65 FR 20337 05/17/2003 Final ML050140452 No Comments 03/04/2005 ML050690100 2000-2 New Dosimetry Technology Parts 34, 36 and 39 65 FR 63750 01/08/2004 Final ML050140452 No Comments 03/04/2005 ML050690100 2001-1 Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct Material Parts 30, 31 and 32 65 FR 79162 02/16/2004 Final ML050140452 No Comments 03/04/2005 ML050690100 2002-1 Revision of the Skin Dose Limit Part 20 67 FR 16298 04/05/2005 Final ML050140452 No Comments 03/04/2005 ML050690100 2002-2 Medical Use of Byproduct Material Parts 20, 32 and 35 67 FR 20249 10/24/2005 Final ML050140452 No Comments 03/04/2005 ML050690100 2003-1 Financial Assurance for Materials Licensees Parts 30, 40 and 70 68 FR 57327 12/03/2006 Final ML073201223 No Comments 12/14/2007 ML073470558

7 2004-1 Compatibility With IAEA Transportation Safety Standards and Other Transportation Safety Amendments Part 71 69 FR 3697 10/01/2007 Final ML073201223 No Comments 12/14/2007 ML073470558 2005-1 Security Requirements for Portable Gauges Containing Byproduct Material Part 30 70 FR 2001 07/11/2008 Final ML073201223 No Comments 12/14/2007 ML073470558 2005-2 Medical Use of Byproduct Material - Recognition of Specialty Boards Part 35 70 FR 16336; 71 FR 1926 04/29/2008 Final ML073201223 No Comments 12/14/2007 ML073470558 2005-3 Increased Controls for Risk-Significant Radioactive Sources (NRC Order EA-05-090) 70 FR 72128 12/01/2005 License Condition ML053220236 No Comments 11/18/2005 ML053220444 2006-1 Minor Amendments Parts 20, 30, 32, 35, 40 and 70 71 FR 15005 03/27/2009 Final ML073201223 No Comments 12/14/2007 ML073470558 2006-2 National Source Tracking System - Serialization Requirements Part 32 with reference to Part 20 Appendix E 71 FR 65685 02/06/2007 Final ML090550203 No Comments 03/23/2009 ML090760101 2006-3 National Source Tracking System

Part 20 71 FR 65685, 72 FR 59162 01/31/2009 Final ML090260708

License Condition ML090260708 No Comments 03/23/2009 ML090760101

No Comment 02/06/2009 ML090290322 2007-1 Medical Use of Byproduct Material - Minor Corrections and Clarifications Parts 32 and 35 72 FR 45147, 54207 10/29/2010 Final ML090550203 No Comments 03/23/2009 ML090760101

8 2007-2 Exemptions From Licensing, General Licenses, and Distribution of Byproduct Material: Licensing and Reporting Requirements Parts 30, 31, 32 and 150 72 FR 58473 12/17/2010 Final ML090550203 No Comments 03/23/2009 ML090760101 2007-3 Requirements for Expanded Definition of Byproduct Material Parts 20, 30, 31, 32, 33, 35, 61 and 150 72 FR 55864 11/30/2010 Final ML090550203 No Comments 03/23/2009 ML090760101 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 License Condition ML080530108 No Comments 03/12/2008 ML080720050 2008-1 Occupational Dose Records, Labeling Containers, and Total Effective Dose Equivalent Parts 19 and 20 72 FR 68043 02/15/2011 Final ML090550203 No Comments 03/23/2009 ML090760101 2009-1 Medical Use of Byproduct Material - Authorized User Clarification Part 35 74 FR 33901 09/28/2012 Final ML113202693 No Comments 12/21/2011 ML113400191 2011-1 Decommissioning Planning Parts 20, 30, 40 and 70 76 FR 35512 12/17/2015 Proposed ML14234A134

Final ML15237A085 No Comments 10/21/2014 ML14232A319

No Comments 10/15/2015 ML15236A292

9 2011-2 Licenses, Certifications, and Approvals for Materials Licensees Parts 30, 36, 39, 40, 70 and 150 76 FR 56951 11/14/2014 Proposed ML14234A134

Final ML15237A085 No Comments 10/21/2014 ML14232A319

No Comments 10/15/2015 ML15236A292 2012-1 Change of Compatibility of Parts 31.5 and 31.6 (See RATS ID: 2001-1 for Rule text) 77 FR 3640 01/25/2015 Proposed ML14234A134

Final ML15237A085 No Comments 10/21/2014 ML14232A319

No Comments 10/15/2015 ML15236A292 2012-2 Advance Notification to Native American Tribes of Transportation of Certain Types of Nuclear Waste Part 71 77 FR 34194 08/10/2015 Proposed ML14234A134 Final ML15237A085 No Comments 10/21/2014 ML14232A319 No Comments 10/15/2015 ML15236A292

• 2012-3 Technical Corrections Parts 30, 34, 40 and 71 77 FR 39899 08/06/2015 Proposed ML14234A134

Final ML15237A085

Revised Final ML18032A474 No Comments 10/21/2014 ML14232A319

Comment 10/15/2015 ML15236A292 No Comments 03/16/2018 ML18032A473

10 2012-4 Requirements for Distribution of Byproduct Material Parts 30, 31, 32, 40 and 70 77 FR 43666 10/23/2015 Proposed ML14234A134

Final ML15237A085 No Comments 10/21/2014 ML14232A319

No Comments 10/15/2015 ML15236A292

• 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 Proposed ML14234A134

Final ML15237A085

Revised Final ML18032A474 Comments 10/21/2014 ML14232A319

Comments 10/15/2015 ML15236A292

No Comments 03/16/2018 ML18032A473 2013-2 Distribution of Source Material to Exempt Persons and to General Licensees and Revision of General License and Exemptions Parts 30, 40, and 70 78 FR 32310 08/27/2016 Proposed ML14234A134

Final ML15237A085 No Comments 10/21/2014 ML14232A319 No Comments 10/15/2015 ML15236A292

• 2015-1 Domestic Licensing of Special Nuclear Material - Written Reports and Clarifying Amendments

Part 70 79 FR 57721, 80 FR 143 01/26/2018 Proposed ML18032A474 No Comments 03/16/2018 ML18032A473

• 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 Proposed ML18032A474 No Comments 03/16/2018 ML18032A473

11 *2015-3 Revisions to Transportation Safety Requirements and Harmonization with International Atomic Energy Agency Transportation Requirements Part 71 80 FR 33987 07/13/2018

• extended to 08/15/2020 See STC 17-060 Proposed ML18032A474

Comments 03/16/2018 ML18032A473

• 2015-4 Miscellaneous Corrections, Parts 37 and 40 80 FR 45841 09/02/2018 Proposed ML18032A474 No Comments 03/16/2018 ML18032A473

• 2015-5 Miscellaneous Corrections, Parts 19, 20, 30, 32, 37, 40, 61, 70, 71 and 150 80 FR 74974 12/31/2018 Proposed ML18032A474 Comments 03/16/2018 ML18032A473 N/A Provision corresponding to Parts 19, 20, 30, 31 35 not associated with specific RATS IDs N/A Proposed ML14234A134

Final ML15237A085 Comments 10/21/2014 ML14232A319 No Comments 10/15/2015 ML15236A292

• N/A Provisions corresponding to Parts 30, 35, 70, 71 150 not associated with specific

RATS IDs N/A Proposed ML18032A474

Comment 03/16/2018 ML18032A473 Comment re: 71.97(a)