ML18261A114

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Letter to C. Flynn Rats Ids: 1993-1, 2007-2, 2007-3, 2011-2, 2012-4, 2013-2, 2015-3, 2015-4, and 2015-5
ML18261A114
Person / Time
Issue date: 10/16/2018
From: Sabrina Atack
NRC/NMSS/DMSST
To: Flynn C
State of TX, Dept of State Health Services
O'Hara J
Shared Package
ML18234A448 List:
References
Download: ML18261A114 (21)
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Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 October 16, 2018 Mr. Chuck Flynn, Manager Radiation Group Division for Regulatory Services Texas Department of State Health Services P.O. Box 149347 Austin, TX 78714-9347

Dear Mr. Flynn:

We have reviewed the proposed revisions to the Texas Department of State Health Services regulations for Control of Radiation, 25 Texas Administrative Code (TAC), §289.251 relating to Exemptions, General Licenses, and General License Acknowledgements; §289.252 relating to Licensing of Radioactive Material; §289.253 relating to Radiation Safety Requirements for Well Logging Service Operations and Tracer Studies; §289.256 relating to Medical and Veterinary Use of Radioactive Material; and §289.257 relating to Packaging and Transportation of Radioactive Material, received by our office on August 21, 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) 1993-1, 2007-2, 2007-3, 2011-2, 2012-4, 2013-2, 2015-3, 2015-4, and 2015-5 as identified in the enclosed State Regulation Status (SRS) Data Sheet. We discussed our review of the regulations with Charlotte Sullivan on October 12, 2018.

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. Under our current procedure, a finding that the Texas 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 Texas 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 Texas 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 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 (301) 415-0275 Michelle.Beardsley@nrc.gov) or Stephen Poy at (301) 415-7135 Stephen.Poy@nrc.gov).

Sincerely,

/RA Paul Michalak for/

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

Enclosures:

1. Compatibility Comments
2. Texas SRS Data Sheet

SUBJECT:

RATS IDs: 1993-1, 2007-2, 2007-3, 2011-2, 2012-4, 2013-2, 2015-3, 2015-4, and 2015-5 DISTRIBUTION: SP 08 B. Tharakan, RSAO Texas File OFFICE ASPB ASPB OGC ASPB:BC MSTR:DD NAME Poy JOHara CEngland NLO via email PMichalak PMichalak for SAtack DATE 9/7/18 9/13/18 10/10/18 10/16/18 10/16/18 ML18261A114 OFFICIAL RECORD COPY Package ML18234A448 COMPATIBILITY COMMENTS ON TEXAS PROPOSED REGULATIONS STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 1

§289.257(i)

(4)

§ 71.21 2015-3 B

General license: Use of foreign approved package a) In Texas regulations

§289.257(i)(4)(B), it states the following:

Except as otherwise provided by this section, the general license applies only to a licensee who has a quality assurance program approved by the NRC as satisfying the applicable provisions of Title 10, CFR, Part

71.

Texas needs to revise this statement as follows:

Except as otherwise provided by this section, the general license applies only to a licensee who has a quality assurance program approved by the [insert Texas Agency] as satisfying the applicable provisions of [insert Texas equivalent regulations to 10 CFR 71]

b) In Texas regulations under

§289.257(i)(4)(D), it states the following:

This general license applies only to a licensee who:

(i) has a copy of the applicable certificate, the revalidation, and the drawings and other documents referenced in the certificate relating to the use and maintenance of the packaging and to the actions to be taken prior to shipment; and (ii) complies with the terms and conditions of the certificate and

2 STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS revalidation, and with the applicable requirements of this section. With respect to the quality assurance provisions of Title 10, CFR, Part 71, the licensee is exempt from design, construction, and fabrication considerations.

Texas needs to revise

§289.257(i)(4)(D), to state the following:

Each licensee issued a general license under paragraph (a) of this section shall (1) Maintain a copy of the applicable certificate, the revalidation, and the drawings and other documents referenced in the certificate, relating to the use and maintenance of the packaging and to the actions to be taken before shipment; and (2) Comply with the terms and conditions of the certificate and revalidation, and with the applicable requirements of [insert Texas equivalent regulations].

Texas needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 71.21.

2

§289.257(o)

§ 71.91(a) 2015-3 C

Records In Texas regulations under

§289.257(o), it states the following:

For a period of 3 years after shipment, each licensee shall maintain, for inspection by the agency, a record of each shipment of radioactive material including the following where applicable:

After the phrase, a record of each shipment of radioactive material,

3 STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS Texas needs to include the phrase, not exempt under 289.257(f).

Texas needs to make the above change in order to meet the Compatibility Category C designation assigned to 10 CFR 71.91.

3 NA

§ 19.17(a) 2015-5 C

Inspections not warranted; informal review Texas did not submit their equivalent regulation to 10 CFR 19.17(a).

Texas needs to provide their equivalent regulation to 10 CFR 19.17(a) in order to meet the Compatibility Category C designation assigned to 10 CFR 19.17(a).

4 NA 10 CFR Part 20, Appendix G 2015-5 B

Standards for Protection Against Radiation Texas did not submit their equivalent regulation to 10 CFR Part 20, Appendix G.

Texas needs to provide their equivalent regulations in order to meet the Compatibility Category B designation assigned to 10 CFR 20, Appendix G.

5

§289.251(v)

§31.12 2007-3 C

General license for certain items and self-luminous products containing radium-226 Texas regulations state in part 289.251(v), by specific license issued in accordance with this section, it omitted that the specific license can also be issued by the NRC or another agreement state.

Texas needs to add that specific licenses can be issued by the NRC or another agreement state in order to meet the Compatibility Category C designation assigned to 10 CFR 31.12.

4 STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 6

§289.251(f)

(4)(H)(ii)

§31.5(c)(13) 2007-3 B

Certain detecting, measuring, gauging or controlling devices and/or an ionizing atmosphere.

Texas omits an equivalent regulation to 10 CFR 31.5(c)(13)(i).

Texas needs to provide an their equivalent regulation to 10 CFR 31.5(c)(13)(i) in order to meet the Compatibility Category B designation assigned to 10 CFR 31.5(c)(13).

STATE REGULATION STATUS State: Texas Department of State Health Services Tracking Ticket Number: 18-48 Date: October 16, 2018

[ 9 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 ML051520266 No Comments 10/31/2005 ML053050013 Texas 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 Texas 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 11/06/1997 1991-4 Notification of Incidents Parts 20, 30, 31, 34, 39, 40 and 70 56 FR 64980; 10/15/1994 Final ML052060129 No Comments 09/29/2005 ML052720491 1992-1 Quality Management Program and Misadministrations Part 35 56 FR 34104 (Superceded by 2002-2) 01/27/1995 Not Required Not Required Texas has adopted Final Regulations equivalent to RATS ID:

2002-2.

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.

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 ML052060129 Revised Final ML18234A459 Comments 09/29/2005 ML052720491 No Comments 10/16/2018 ML18234A448 1993-2 Licensing and Radiation Safety Requirements for Irradiators Part 36 58 FR 7715 07/01/1996 Final ML051520266 No Comments 08/12/2005 ML052280032 1993-3 Definition of Land Disposal and Waste Site QA Program Part 61 58 FR 33886 07/22/1996 Not Applicable Not Applicable Texas DSHS does not have responsibility for these regulations.

See SRS sheet for Texas CEQ.

1994-1 Self-Guarantee as an Additional Financial Mechanism Parts 30, 40 and 70 58 FR 68726; 59 FR 1618 none Final ML062860025 No Comments 11/21/2006 ML063200232 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 Texas CEQ Responsibility 1994-3 Timeliness in Decommissioning Material Facilities Parts 30, 40, 70 59 FR 36026 08/15/1997 Final ML052060129 No Comments 09/29/2005 ML052720491 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 03/17/1999

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 ML051520266 No Comments 10/31/2005 ML053050013 1995-3 Low-Level Waste Shipment Manifest Information and Reporting Parts 20 and 61 60 FR 15649; 60 FR 25983 03/01/1998 Final ML112510357 No Comments 11/22/2011 ML113000228 1995-4 Performance Requirements for Radiography Equipment Part 34 60 FR 28323 (Superceded by 1997-5) 06/30/1998 Final ML051520266 No Comments 10/31/2005 ML053050013 Texas 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 No Comments 03/17/1999 1995-6 Clarification of Decommissioning Funding Requirements Parts 30, 40 and 70 60 FR 38235 11/24/1998 Final ML052060129 No Comments 09/29/2005 ML052720491 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 Final ML051520266 No Comments 10/31/2005 ML053050013 Texas has not yet adopted Final Regulations equivalent to RATS ID:

2005-2.

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 ML052060129 Comments 09/29/2005 ML052720491 Texas 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 ML062860025 No Comments 11/21/2006 ML063200232 Part 30 only. Part 61 applies to TXCEQ.

1997-1 Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air Act Part 20 61 FR 65120 01/9/2000 Final No Comments 07/07/2000 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 Final ML063030232 No Comments 11/27/2006 ML063200389 1997-3 Criteria for the Release of Individuals Administered Radioactive Material Parts 20 and 35 62 FR 4120 05/29/2000 Final No Comments 07/07/2000 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)

5 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 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 No Comments 07/07/2000 1997-6 Radiological Criteria for License Termination Parts 20, 30, 40 and 70 62 FR 39057 08/20/2000 Final No Comments 07/07/2000 1997-7 Exempt Distribution of a Radioactive Drug Containing One Micro curie of Carbon-14 Urea Part 30 62 FR 63634 01/02/2001 Final ML052060129 No Comments 09/29/2005 ML052720491 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 ML063030232 No Comments 11/27/2006 ML063200389 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)

Texas has adopted Final Regulations equivalent to RATS ID:

2002-2.

6 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 1998-4 Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiographic Operations Part 34 63 FR 37059 07/09/2001 Final ML093110052 No Comments 01/21/2010 ML093520035 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 No Comments 07/07/2000 1998-6 Transfer for Disposal and Manifests: Minor Technical Conforming Amendment Part 20 63 FR 50127 11/20/2001 Final No Comments 07/07/2000 1999-1 Radiological Criteria for License Termination of Uranium Recovery Facilities Part 40 64 FR 17506 06/11/2002 Not Applicable Not Applicable Texas CEQ Responsibility 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 ML062750348 No Comments 11/21/2006 ML063200232 2000-1 Energy Compensation Sources for Well Logging and Other Regulatory Clarifications Part 39 65 FR 20337 05/17/2003 Final ML051520266 No Comments 11/30/2006 ML063340007

7 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 2000-2 New Dosimetry Technology Parts 34, 36 and 39 65 FR 63750 01/08/2004 Final ML093110052 No Comments 01/21/2010 ML093520035 2001-1 Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct Material Parts 30, 31 and 32 65 FR 79162 02/16/2004 Final ML120650638 No Comments 04/02/2012 ML120660270 Note: See RATS ID 2012-1 for the changes of compatibility review.

2002-1 Revision of the Skin Dose Limit Part 20 67 FR 16298 04/05/2005 Final ML102240370 No Comments 11/19/2010 ML102740009 2002-2 Medical Use of Byproduct Material Parts 20, 32 and 35 67 FR 20249 10/24/2005 R1 ML14258B117 Final ML15078A299 Comments 12/16/2014 ML14258A158 No Comments 05/26/2015 ML15078A285 2003-1 Financial Assurance for Materials Licensees Parts 30, 40 and 70 68 FR 57327 12/03/2006 Final ML112510357 No Comments 11/22/2011 ML113000228 2004-1 Compatibility With IAEA Transportation Safety Standards and Other Transportation Safety Amendments Part 71 69 FR 3697 10/01/2007 R1 ML14258B117 Final ML15078A299 No Comments 12/16/2014 ML14258A158 No Comments 05/26/2015 ML15078A285

8 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 2005-1 Security Requirements for Portable Gauges Containing Byproduct Material Part 30 70 FR 2001 07/11/2008 Final ML093110052 No Comments 01/21/2010 ML093520035 2005-2 Medical Use of Byproduct Material - Recognition of Specialty Boards Part 35 70 FR 16336; 71 FR 1926 04/29/2008 R1 ML14258B117 Final ML15078A299 No Comments 12/16/2014 ML14258A158 No Comments 05/26/2015 ML15078A285 2005-3 Increased Controls for Risk-Significant Radioactive Sources (NRC Order EA-05-090) 70 FR 72128 12/01/2005 License Condition ML052240226 No Comments 12/12/2005 ML053420404 2006-1 Minor Amendments Parts 20, 30, 32, 35, 40 and 70 71 FR 15005 03/27/2009 R1 ML14258B117 Final ML15078A299 Comments 12/16/2014 ML14258A158 No Comments 05/26/2015 ML15078A285 2006-2 National Source Tracking System - Serialization Requirements Part 32 with reference to Part 20 Appendix E 71 FR 65685 02/06/2007 Final ML093110052 No Comments 01/21/2010 ML093520035 2006-3 National Source Tracking System Part 20 71 FR 65685, 72 FR 59162 01/31/2009 Final ML093110052 No Comments 01/21/2010 ML093520035

9 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 ML102240370 No Comments 11/19/2010 ML102740009

10 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 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 ML080350004 No Comments 02/13/2008 ML080440203 2008-1 Occupational Dose Records, Labeling Containers, and Total Effective Dose Equivalent Parts 19 and 20 72 FR 68043 02/15/2011 Final ML112510357 No Comments 11/22/2011 ML113000228 2009-1 Medical Use of Byproduct Material - Authorized User Clarification Part 35 74 FR 33901 09/28/2012 Final ML112510357 No Comments 11/22/2011 ML113000228 2011-1 Decommissioning Planning Parts 20, 30, 40 and 70 76 FR 35512 12/17/2015 Proposed ML14258B117 Final ML15078A299 No Comments 12/16/2014 ML14258A158 No Comments 05/26/2015 ML15078A285

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

12 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 2012-3 Technical Corrections Parts 30, 34, 40 and 71 77 FR 39899 08/06/2015 Proposed ML14258B117 Final ML15078A299 No Comments 12/16/2014 ML14258A158 No Comments 05/26/2015 ML15078A285

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

Written Reports and Clarifying Amendments Part 70 79 FR 57721, 80 FR 143 01/26/2018 Proposed ML15300A238 Final ML16076A353 No Comments 12/01/2015 ML15300A222 No Comments 06/16/2016 ML16076A350 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 ML15300A238 Final ML16076A353 No Comments 12/01/2015 ML15300A222 No Comments 06/16/2016 ML16076A350

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

14 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 ML18234A459 Comments 10/16/2018 ML18234A448 2018-1 Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments, Parts 30, 32 and 35 01/14/2022 N/A Parts 35.11, 35.63, 35.92 and 35.204 N/A Final ML112510357 No Comments 11/22/2011 ML113000228 N/A Parts 34 and 39 Not Associated with a Specific RATS N/A Final ML113340070 Comments 01/11/2012 ML113550343 N/A Parts 20, 30, 31, 32, 35, 70 and 71 Not Associated with a Specific RATS N/A Proposed ML14258B117 Final ML15078A299 Comments 12/16/2014 ML14258A158 Comments 05/26/2015 ML15078A285 Comments are regarding 10 CFR Parts 20.1403, 20.1405 and 31.12(c)(4).
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