ML19085A178

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Letter to G. Perez California Final Regulations to Rats Id 2011-1
ML19085A178
Person / Time
Issue date: 03/28/2019
From: Kevin Williams
NRC/NMSS/DMSST
To: Perez G
State of CA, Dept of Health Services, Food, Drugs & Radiation Safety Div
O Hara J, NMSS/MSST 415-6854
Shared Package
ML19066A318 List:
References
Download: ML19085A178 (19)
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Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 March 28, 2019 Mr. Gonzalo L. Perez, Chief Radiological Health Branch Division of Food, Drug & Radiation Safety Californa Department of Health Services P.O. Box 997414, MS-7610 Sacramento, CA 95899-7414

Dear Mr. Perez:

We have reviewed the final revisions to the California regulations in California Code of Regulations Sections 30195.1, 30194, 30197.1-30197.7, 30253, and 30256, received by our office on March 6, 2019. These regulations were reviewed by comparison to the equivalent U.S. Nuclear Regulatory Commission (NRC) rules and Regulation Amendment Tracking System Identification Number (RATS ID) 2011-1 as identified in the enclosed State Regulation Status (SRS) Data Sheet. We discussed our review of the regulations with Phillip Scott on March 26, 2019.

As a result of our review, we have no comments. Please note that we have limited our review to regulations required for compatibility and/or health and safety. We have determined that the regulations, as adopted, 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.

The SRS Data Sheet summarizes our knowledge of the status of other California regulations, as indicated. Please let us know if you note 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 review results, 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 (301) 415-0275 (michelle.beardsley@nrc.gov) or Stephen Poy at (301) 415-7135 (stephen.poy@nrc.gov).

Sincerely,

/RA Paul Michalak for/

Kevin Williams, Deputy Director Division of Materials Safety, Security, State and Tribal Programs Office of Nuclear Material Safety and Safeguards

Enclosure:

California SRS Data Sheet

SUBJECT:

03/28/2019, LETTER TO G. PEREZ RE: CALIFORNIA PROPOSED REGULATIONS TO RATS ID 2011-1 DISTRIBUTION: SP[08]

DIR RF (19-22)

R Erickson, RSAO California File OFFICE ASPB ASPB OGC ASPB:BC MSTR:DD NAME SPoy MBeardsley NA PMichalak PMichalak for:

KWilliams DATE 3/25/19 3/26/19 NA 3/28/19 3/28/19 ML19085A178 (Letter)

OFFICIAL RECORD COPY Package ML19066A318

STATE REGULATION STATUS State: California Tracking Ticket Number: 19-22 Date: 03/28/2019

[ # 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 Not Required Not Required California has adopted Final Regulations equivalent to RATS ID:

1997-5.

Xx/

1991-2 ASNT Certification of Radiographers Part 34 56 FR 11504 (Superceded by 1997-5) none Not Required Not Required California 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 ML020030346 No Comments 03/18/2002 ML020780186 1991-4 Notification of Incidents Parts 20, 30, 31, 34, 39, 40 and 70 56 FR 64980 10/15/1994 Final No Comments 04/01/1998 1992-1 Quality Management Program and Misadministrations Part 35 56 FR 34104 (Superceded by 2002-2) 01/27/1995 Final ML103050179 No Comments 01/05/2011 ML103340424 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.

2 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 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 ML112970300 No Comments 01/20/2012 ML113330808 1993-2 Licensing and Radiation Safety Requirements for Irradiators Part 36 58 FR 7715 07/01/1996 License Condition ML051670371 No Comments 07/01/2005 ML051810407 1993-3 Definition of Land Disposal and Waste Site QA Program Part 61 58 FR 33886 07/22/1996 Not Applicablei Not Applicable California does not have any licensees subject to these regulations (See SECY-95-112) 1994-1 Self-Guarantee as an Additional Financial Mechanism Parts 30, 40 and 70 58 FR 68726; 59 FR 1618 none Final No Comments 04/01/1998 These regulation changes are not required to be adopted for purposes of Compatibility.

1994-2 Uranium Mill Tailings Regulations: Conforming NRC Requirements to EPA Standards Part 40 59 FR 28220 07/01/1997 Not Applicable Not Applicable California does not have 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 ML16034A230 Comments 05/24/16 ML16034A225 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 No Comments 11/16/1999

3 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 1995-2 Frequency of Medical Examinations for Use of Respiratory Protection Equipment Part 20 60 FR 7900 03/13/1998 Final ML020030346 No Comments 03/18/2002 ML020780186 1995-3 Low-Level Waste Shipment Manifest Information and Reporting Parts 20 and 61 60 FR 15649; 60 FR 25983 03/01/1998 Final ML020030346 No Comments 03/18/2002 ML020780186 1995-4 Performance Requirements for Radiography Equipment Part 34 60 FR 28323 (Superceded by 1997-5) 06/30/1998 Not Required Not Required California 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 ML020030346 No Comments 03/18/2002 ML020780186 1995-6 Clarification of Decommissioning Funding Requirements Parts 30, 40 and 70 60 FR 38235 11/24/1998 Final No Comments 04/01/1998 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 ML103050179 Final ML103550423 No Comments 01/05/2011 ML103340411 No Comments 02/14/2011 ML110120070 Part 35 only Part 20 only

4 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 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 ML091240053 No Comments 06/11/2009 ML091470300 California has adopted Final Regulations equivalent to RATS ID:

2004-1 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 ML020030346 No Comments 03/18/2002 ML020780186 1997-1 Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air Act Part 20 61 FR 65120 01/9/2000 Final ML020030346 No Comments 03/18/2002 ML020780186 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 ML111740220 No Comments 08/24/2011 ML112130149 1997-3 Criteria for the Release of Individuals Administered Radioactive Material Parts 20 and 35 62 FR 4120 05/29/2000 Final ML103050179 Final ML103550423 No Comments 01/05/2011 ML103340411 No Comments 02/14/2011 ML110120070 Part 35 only Part 20 only

5 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 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) 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 Rii ML14139A065 Final ML15012A519 Comments 08/06/2014 ML14139A060 No Comments 02/09/2015 ML15012A465 1997-6 Radiological Criteria for License Termination Parts 20, 30, 40 and 70 62 FR 39057 08/20/2000 Final ML16034A230 Comments 05/24/16 ML16034A225 This regulation was previously reviewed and found acceptable (See NRC letter ML020780186),

however it was repealed on August 8, 2002, and CA is currently terminating licenses on a case by case basis 1997-7 Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Urea Part 30 62 FR 63634 01/02/2001 Final ML081080140 No Comments 05/13/2008 ML081340266 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 ML060340073 No Comments 03/09/2006 ML060670437

6 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 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) 1998-4 Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiographic Operations Part 34 63 FR 37059 07/09/2001 Final ML081160234 No Comments 06/19/2008 ML081710246 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 R2 ML14139A065 License Condition ML051580164 ML061790298 Final ML15012A519 No Comments 08/06/2014 ML14139A060 No Comments 07/18/2006 ML061990575 No Comments 02/09/2015 ML15012A465 Part 36 1998-6 Transfer for Disposal and Manifests: Minor Technical Conforming Amendment Part 20 63 FR 50127 11/20/2001 Final ML020030346 No Comments 03/18/2002 ML020780186

7 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 1999-1 Radiological Criteria for License Termination of Uranium Recovery Facilities Part 40 64 FR 17506 06/11/2002 Not Applicable Not Applicable California does not have 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 ML062210438 No Comments 08/31/2006 ML062490010 2000-1 Energy Compensation Sources for Well Logging and Other Regulatory Clarifications Part 39 65 FR 20337 05/17/2003 Final ML070920384 No Comments 04/23/2007 ML071140038 2000-2 New Dosimetry Technology Parts 34, 36 and 39 65 FR 63750 01/08/2004 Final ML081160234 Final ML070920384 License Condition ML051580164 ML061790298 No Comments 06/19/2008 ML081710246 No Comments 04/23/2007 ML071140038 No Comments 07/18/2006 ML061990575 Part 34 Part 39 Part 36 adopted by reference

8 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 2001-1 Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct Material Parts 30, 31 and 32 65 FR 79162 02/16/2004 R2 ML14139A065 License Condition for 32.52 (a) & (b)

ML040500440 Final ML15012A519 No Comments 08/06/2014 ML14139A060 No Comments 03/10/2004 ML040700191 No Comments 02/09/2015 ML15012A465 2002-1 Revision of the Skin Dose Limit Part 20 67 FR 16298 04/05/2005 Final ML062210438 No Comments 08/31/2006 ML062490010 2002-2 Medical Use of Byproduct Material Parts 20, 32 and 35 67 FR 20249 10/24/2005 R2 ML14139A065 Final ML15012A516 No Comments 08/06/2014 ML14139A060 No Comments 02/09/2015 ML15012A465 2003-1 Financial Assurance for Materials Licensees Parts 30, 40 and 70 68 FR 57327 12/03/2006 Final ML090210714 No Comments 02/06/2009 ML090260305

9 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 2004-1 Compatibility With IAEA Transportation Safety Standards and Other Transportation Safety Amendments Part 71 69 FR 3697 10/01/2007 Final ML091240053 No Comments 06/11/2009 ML091470300 2005-1 Security Requirements for Portable Gauges Containing Byproduct Material Part 30 70 FR 2001 07/11/2008 License Condition ML062920179 No Comments 11/09/2006 ML063130004 2005-2 Medical Use of Byproduct Material - Recognition of Specialty Boards Part 35 70 FR 16336; 71 FR 1926 04/29/2008 R2 ML14139A065 Final ML15012A519 No Comments 08/06/2014 ML14139A060 No Comments 02/09/2015 ML15012A465 2005-3 Increased Controls for Risk-Significant Radioactive Sources (NRC Order EA-05-090) 70 FR 72128 12/01/2005 License Condition ML081280851 No Comments 05/13/2008 ML081340260 California chose to revise its IC License Condition at the time of the Fingerprinting Order EA-07-305 License Condition Implementation.

The original license condition can be seen at ML053060120. The response letter sent 11/04/2005 can be seen at ML053080246.

10 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 2006-1 Minor Amendments Parts 20, 30, 32, 35, 40 and 70 71 FR 15005 03/27/2009 R2 ML14139A065 Final ML15012A519 No Comments 08/06/2014 ML14139A060 No Comments 02/09/2015 ML15012A465 Note: changes to Part 40 and 70 are not required for compatibility.

2006-2 National Source Tracking System - Serialization Requirements Part 32 with reference to Part 20 Appendix E 71 FR 65685 02/06/2007 License Condition ML070360575 No Comments 02/16/2007 ML070470007 2006-3 National Source Tracking System Part 20 71 FR 65685, 72 FR 59162 01/31/2009 Final ML103550423 No Comments 02/14/2011 ML110120070 2007-1 Medical Use of Byproduct Material - Minor Corrections and Clarifications Parts 32 and 35 72 FR 45147, 54207 10/29/2010 R2 ML14139A065 Final ML15012A519 No Comments 08/06/2014 ML14139A060 No Comments 02/09/2015 ML15012A465

11 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 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 R2 ML14139A065 Final ML15012A519 No Comments 08/06/2014 ML14139A060 No Comments 02/09/2015 ML15012A465 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 R2 ML14139A065 Final ML15012A519 No Comments 08/06/2014 ML14139A060 No Comments 02/09/2015 ML15012A465 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 ML081280851 No Comments 05/13/2008 ML081340260 2008-1 Occupational Dose Records, Labeling Containers, and Total Effective Dose Equivalent Parts 19 and 20 72 FR 68043 02/15/2011 Final ML103550423 No Comments 02/14/2011 ML110120070

12 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 2009-1 Medical Use of Byproduct Material - Authorized User Clarification Part 35 74 FR 33901 09/28/2012 Proposed ML14139A0652 Final ML15012A519 No Comments 08/06/2014 ML14139A060 No Comments 02/09/2015 ML15012A465

13 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 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 ML18065B098 No Comments 04/19/2018 ML18065B082 2012-3 Technical Corrections Parts 30, 34, 40 and 71 77 FR 39899 08/06/2015 Proposed ML18065B098 No Comments 04/19/2018 ML18065B082 2012-4 Requirements for Distribution of Byproduct Material Parts 30, 31, 32, 40 and 70 77 FR 43666 10/23/2015 Proposed ML14139A0652 Final ML15012A519 No Comments 08/06/2014 ML14139A060 No Comments 02/09/2015 ML15012A465 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 License Condition ML15216A474 Revised License Condition ML15281A285 Proposed ML18065B098 Revised Proposed ML18324A655 Comments 08/31/2015 ML15216A443 No Comments 11/03/2015 ML15281A277 Comments 04/19/2018 ML18065B082 No Comments 01/03/2019 ML18324A651 Part 37 only.

Part 37 only.

14 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 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 ML19015A163 Comments 01/28/2019 ML19015A145 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 ML18065B098 Revised Proposed ML18324A655 No Comments 04/19/2018 ML18065B082 No Comments 01/03/2019 ML18324A651 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 ML15216A474 Revised License Condition ML15281A285 Proposed ML18065B098 Revised Proposed ML18324A655 No Comments 08/31/2015 ML15216A443 No Comments 11/03/2015 ML15281A277 No Comments 04/19/2018 ML18065B082 No Comments 01/03/2019 ML18324A651

15 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 2015-3 Revisions to Transportation Safety Requirements and Harmonization with International Atomic Energy Agency Transportation Requirements Part 71 80 FR 33987 07/13/2018

Organizational Changes 10 CFR Parts 37, 40. 70 and 71 12/21/2021

16 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes N/A Parts 35.13, 35.14, 35.24, 35.27, 35.57 and 35.2024 License Condition ML111400455 No Comments 07/11/2011 ML111740678 i IMPEP Team: verify that California does not have any licensees subject to these regulations during each review.

ii R stands for revisions to final rule.

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