ML19241A274

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Letter to B. Goretzki Arizona Final Regulations 2011-1, 2011-2 2012-3 2012-4, 2015-1, 2015-2, 2015-3 2015-4 and 2015-5
ML19241A274
Person / Time
Issue date: 08/30/2019
From: Kevin Williams
NRC/NMSS/DMSST
To: Goretzki B
State of AZ, Dept of Health Services, Bureau of Radiation Control
Joe O'Hara,NRC/NMSS
Shared Package
ML19212A604 List:
References
Download: ML19241A274 (24)
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Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 August 30, 2019 Mr. Brian Goretzki, Director Bureau of Radiation Control Arizona Department of Health Services 4814 South 40th Street Phoenix, AZ 85040

Dear Mr. Goretzki:

We have reviewed the final revisions to the Arizona Administrative Code Chapter 7 Radiation Control regulations, received by our office on July 17, 2019. These regulations were reviewed by comparison to the equivalent U.S. Nuclear Regulatory Commission (NRC) rules and the requirements of Regulation Amendment Tracking System Identification Numbers (RATS IDs) 2011-1, 2011-2, 2012-1, 2012-3, 2012-4, 2015-1, 2015-2, 2015-3, 2015-4, and 2015-5; and other provisions not associated with a RATS ID (35.190, 35.290, and 71.13), as identified in the enclosed State Regulation Status (SRS) Data Sheet. We discussed our review of the regulations with you on August 28, 2019.

As a result of our review, we have six 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. We have determined that if these regulations are revised, 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 you revise your regulations to address our comments, 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 location of any changes made by Arizona, in response to our comments, 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 Arizona 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 Joe OHara at (301) 415-6854 (Joe.OHara@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

Enclosures:

1. Compatibility Comments
2. Arizona SRS Data Sheet
ML19241A274 (Letter)

ML19212A604 (Packge)

OFFICE MSST/SALB MSST/SALB MSST/SALB:BC MSST:DD NAME JOHara MBeardsley PMichalak (PMichalak for)

KWilliams DATE 8/19/19 8/28/19 8/30/19 8/30/19 COMPATIBILITY COMMENTS ON ARIZONA FINAL REGULATIONS STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 1

R9-7-448(E) 70.50(c)(2) 2015-1 C

Reporting requirements Arizona needs to delete the reporting submission time in R9-7-448(E) since it conflicts with the correction Arizona made to R9-7-448(D).

Arizona needs to make the above change to meet the Compatibility Category C designation assigned to 10 CFR 70.50(c)(2).

2 R9-7-1507 and R9-7-1510 10 CFR 71 2015-3 Various General comment: 10 CFR Part 71 Arizona incorporates by reference 10 CFR Part 71 subparts A, G, and H in sections R9-7-1507A., C.2.b., and R9-7-1510 D.3.b.ii. However, Arizona has written regulations for some of these requirements, e.g., 71.4, Definitions, 71.97, 71.101. This is not only duplicative, but can conflict with NRC regulations, and cause confusion to the licensee as to which regulations apply.

Arizona needs to either: a) incorporate all applicable Part 71 provisions by reference; b) write their own regulations for all applicable parts; or c) specify which regulations they are incorporating by reference and have written regulations for the provisions they are not incorporating by reference, but not both.

Arizona needs to revise their regulations as indicated above to meet the various Compatibility Categories assigned to 10 CFR Part

71.

2 STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 3

N/A 71.91(a) 2015-3 C

Records Arizona has omitted requirements contained in 10 CFR 71.91(a) from their regulations.

Arizona needs to adopt the requirements in 10 CFR 71.91(a) to meet the Compatibility Category C designation assigned to 10 CFR 71.91(a).

COMMENT STANDS FROM NRC LETTER DATED JUNE 26, 2017/

ML17163A240 4

R9-7-1510 (A)(2)(d) 71.91(b) 2015-3 NRC Records 10 CFR 71.91(b) has been changed from a Compatibility D requirement to a Compatibility NRC requirement.

Arizona needs to remove R9-7-1510 (A)(2)(d) from their regulations.

Arizona needs to make the above change to meet the Compatibility Category NRC designation assigned to 10 CFR 71.91(b).

COMMENT STANDS FROM NRC LETTER DATED JUNE 26, 2017/

ML17163A240.

5 R9-7-1510 A.2.e and f.

71.91(c) and (d) 2015-3 C

Records Arizona needs to delete the references to certificate holder and applicant for a certificate of complicance in section A.2.e. and f.

since the NRC is the sole authority for issuing a Certificate of Compliance.

and; Arizona needs to insert their Department instead of the Commission in section A.2.e.

3 STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS Arizona needs to make the above changes to meet the Compatibility Category C designation assigned to 10 CFR 71.91(c) and (d).

6 R9 1507A., and C.2.b.

R9-7-1510, D.3.b.ii.

71.11, 71.85 (a)-

(c), 71.91 (b),

71.101 (c)(2),

(d), and (e),

71.107, 71.109, 71.111, 71.113, 71.115, 71.117, 71.119, 71.121, 71.123, and 71.125, 2015-3 NRC 10 CFR Part 71 In the State sections noted in column 2, Arizona incorporates 10 CFR 71 subparts A, G, and H by reference.

Since many sections of those subparts contain requirements that are designated as an NRC Compatibility Category, i.e., 10 CFR 71.11, 71.85 (a)-(c), 71.91 (b), 71.101 (c)(2), (d), and (e), 71.107, 71.109, 71.111, 71.113, 71.115, 71.117, 71.119, 71.121, 71.123, and 71.125, Arizona cannot incorporate them by reference.

Arizona needs to except those provisions from incorporation by reference as stated above to meet the Compatibility Category NRC designation assigned to 10 CFR 71.11, 71.85 (a)-(c), 71.91 (b), 71.101 (c)(2), (d), and (e), 71.107, 71.109, 71.111, 71.113, 71.115, 71.117, 71.119, 71.121, 71.123, and 71.125.

STATE REGULATION STATUS State: Arizona Tracking Ticket Number: 19-41 Date: 08/30/2019

[ # 14 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 ML042370896 No Comments 11/10/2004 ML043200721 Arizona 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 Final ML042370896 No Comments 11/10/2004 ML043200721 Arizona 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 No Comments 09/22/1997 1991-4 Notification of Incidents Parts 20, 30, 31, 34, 39, 40 and 70 56 FR 64980 10/15/1994 Final ML042370896 No Comments 11/10/2004 ML043200721 1992-1 Quality Management Program and Misadministrations Part 35 56 FR 34104 (Superceded by 2002-2) 01/27/1995 License Condition No Comments 01/15/1999 Arizona has not yet adopted equivalent regulations to RATS ID 2002-2.

2 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 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 Proposed ML15267A799 No Comments 11/06/2015 ML15267A795 No Comments 06/03/2016 ML16113A212 1993-2 Licensing and Radiation Safety Requirements for Irradiators Part 36 58 FR 7715 07/01/1996 Not Applicablei Not Applicable Arizona does not have any licensees subject to these regulations ( See SECY-95-112) 1993-3 Definition of Land Disposal and Waste Site QA Program Part 61 58 FR 33886 07/22/1996 Not Applicable1 Not Applicable Arizona 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 Not Required Not Required These regulation changes are not required to be adopted for purposes of Compatibility.

3 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 1994-2 Uranium Mill Tailings Regulations: Conforming NRC Requirements to EPA Standards Part 40 59 FR 28220 07/01/1997 Not Applicable Not Applicable Arizona 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 ML032750051 No Comments 11/20/2003 ML033240189 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 ML092590750 No Comments 11/12/2009 ML092870448 1995-2 Frequency of Medical Examinations for Use of Respiratory Protection Equipment Part 20 60 FR 7900 03/13/1998 Proposed ML15267A799 Final ML16113A289 No Comments 11/06/2015 ML15267A795 No Comments 06/03/2016 ML16113A212

4 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 1995-3 Low-Level Waste Shipment Manifest Information and Reporting Parts 20 and 61 60 FR 15649; 60 FR 25983 03/01/1998 Final ML092590750 No Comments 11/12/2009 ML092870448 1995-4 Performance Requirements for Radiography Equipment Part 34 60 FR 28323 (Superceded by 1997-5) 06/30/1998 Final ML042370896 No Comments 11/10/2004 ML043200721 Arizona 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 ML032750051 No Comments 11/20/2003 ML033240189 1995-6 Clarification of Decommissioning Funding Requirements Parts 30, 40 and 70 60 FR 38235 11/24/1998 Final ML032750051 No Comments 11/20/2003 ML033240189 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 Proposed No Comments 10/5/2000 Arizona has not yet adopted equivalent regulations to RATS IDs 2002-2 and 2005-2.

5 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 ML042370896 Comments 11/10/04 ML043200721 Arizona 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 ML032750051 No Comments 11/20/2003 ML033240189 1997-1 Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air Act Part 20 61 FR 65120 01/9/2000 Final ML032750051 No Comments 11/20/2003 ML033240189 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 ML042370896 No Comments 11/10/2004 ML043200721

6 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 1997-3 Criteria for the Release of Individuals Administered Radioactive Material Parts 20 and 35 62 FR 4120 05/29/2000 Final ML092590750 No Comments 11/12/2009 ML092870448 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 Final ML042180385 No Comments 11/10/2004 ML043200721 1997-6 Radiological Criteria for License Termination Parts 20, 30, 40 and 70 62 FR 39057 08/20/2000 Final ML032930364 No Comments 11/06/2003 ML033160544 1997-7 Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Urea Part 30 62 FR 63634 01/02/2001 Final ML032930364 No Comments 11/06/2003 ML033160544 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 ML042370896 No Comments 11/10/2004 ML043200721

7 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 regulations 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 regulations 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 ML042370896 No Comments 11/10/2004 ML043200721 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 ML032750051 No Comments 11/20/2003 ML033240189 1998-6 Transfer for Disposal and Manifests: Minor Technical Conforming Amendment Part 20 63 FR 50127 11/20/2001 Final ML032750051 No Comments 11/20/2003 ML033240189 1999-1 Radiological Criteria for License Termination of Uranium Recovery Facilities Part 40 64 FR 17506 06/11/2002 Not Required Not Required These regulations are not required to be adopted for purposes of Compatibility.

8 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 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 regulations 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 ML032930364 No Comments 11/06/2003 ML033160544 2000-1 Energy Compensation Sources for Well Logging and Other Regulatory Clarifications Part 39 65 FR 20337 05/17/2003 Final ML032930364 No Comments 11/06/2003 ML033160544 2000-2 New Dosimetry Technology Parts 34, 36, and 39 65 FR 63750 01/08/2004 Final ML042370896 No Comments 11/1/2004 ML043200721 2001-1 Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct Material Parts 30, 31 and 32 65 FR 79162 02/16/2004 Final ML13101A341 No Comments 04/29/2013 ML13102A005 2002-1 Revision of the Skin Dose Limit Part 20 67 FR 16298 04/05/2005 Final ML092590750 No Comments 11/12/2009 ML092870448

9 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 2002-2 Medical Use of Byproduct Material Parts 20, 32 and 35 67 FR 20249 10/24/2005 Final ML13101A341 Revised Final ML17139D382 Comments 04/29/2013 ML13102A005 No Comments 6/26/2017 ML17139D381 2003-1 Financial Assurance for Materials Licensees Parts 30, 40 and 70 68 FR 57327 12/03/2006 Final ML092590750 No Comments 11/12/2009 ML092870448 2004-1 Compatibility With IAEA Transportation Safety Standards and Other Transportation Safety Amendments Part 71 69 FR 3697 10/01/2007 Final ML13101A341 Revised Final ML17139D382 Comments 04/29/2013 ML13102A005 No Comments 6/26/2017 ML17139D381 2005-1 Security Requirements for Portable Gauges Containing Byproduct Material Part 30 70 FR 2001 07/11/2008 Final ML092590750 No Comments 11/12/2009 ML092870448

10 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 2005-2 Medical Use of Byproduct Material -

Recognition of Specialty Boards Part 35 70 FR 16336; 71 FR 1926 04/29/2008 Final ML14232A635 Revised Final ML17139D382 Comments 10/17/2014 ML14232A317 No Comments 6/26/2017 ML17139D381 2005-3 Increased Controls for Risk-Significant Radioactive Sources (NRC Order EA-05-090) 70 FR 72128 12/01/2005 License Condition ML052630048 No Comments 09/21/2005 ML052640467 2006-1 Minor Amendments Parts 20, 30, 32, 35, 40 and 70 71 FR 15005 03/27/2009 Final ML14232A635 Revised Final ML17139D382 Comments 10/17/2014 ML14232A317 No Comments 6/26/2017 ML17139D381 2006-2 National Source Tracking System -

Serialization Requirements Part 32 with reference to Part 20 Appendix E 71 FR 65685 02/06/2007 Final ML092590750 No Comments 11/12/2009 ML092870448 2006-3 National Source Tracking System Part 20 71 FR 65685, 72 FR 59162 01/31/2009 Final ML092590750 No Comments 11/12/2009 ML092870448

11 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 2007-1 Medical Use of Byproduct Material - Minor Corrections and Clarifications Parts 32 and 35 72 FR 45147, 54207 10/29/2010 Final ML14232A635 Revised Final ML17139D382 Comments 10/17/2014 ML14232A317 No Comments 6/26/2017 ML17139D381 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 ML13101A341 No Comments 04/29/2013 ML13102A005 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 ML14232A635 No Comments 10/17/2014 ML14232A317 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 ML081330218 No Comments 05/28/2008 ML081490633 2008-1 Occupational Dose Records, Labeling Containers, and Total Effective Dose Equivalent Parts 19 and 20 72 FR 68043 02/15/2011 Final ML14232A635 No Comments 10/17/2014 ML14232A317

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 Final ML14232A635 Revised Final ML17139D382 Comments 10/17/2014 ML14232A317 No Comments 6/26/2017 ML17139D381

13 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes

14 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 ML15267A799 Final ML16113A289 No Comments 11/06/2015 ML15267A795 Comments 06/03/2016 ML16113A212

15 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes

16 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

- Written Reports and Clarifying Amendments Part 70 79 FR 57721, 80 FR 143 01/26/2018 Proposed ML17139D382 Final ML19212A610 Comments 6/26/2017 ML17139D381 Comment 08/30/2019 ML19212A604

17 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes

  • 2015-5 Miscellaneous Corrections, Parts 19, 20, 30, 32, 37, 40, 61, 70, 71 and 150 80 FR 74974 12/31/2018 Proposed ML17139D382 Final ML19212A610 No Comments 6/26/2017 ML17139D381 No Comments 08/30/2019 ML19212A604 2018-1 Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments, Parts 30, 32 and 35 01/14/2022

18 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 2018-2 Miscellaneous Corrections

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

  • N/A Other provisions not associated with a RATS ID 10 CFR 35.190, 35.290, and 71.13 N/A Final ML19212A610 No Comments 08/30/2019 ML19212A604 i IMPEP Team: verify that Arizona does not have any licensees subject to these regulations during each review.
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