ML18261A114

From kanterella
Jump to navigation Jump to search
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)
v • d • e


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.

C. Flynn 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

C. Flynn

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 PMichalak PMichalak for via email 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) § 71.21 2015-3 B General license: Use of foreign (4) 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 Enclosure 1

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, 2

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, 2015-5 B Standards for Protection Against Appendix G 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.

3

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 6 §289.251(f) §31.5(c)(13) 2007-3 B Certain detecting, measuring, (4)(H)(ii) 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).

4

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 Incoming Outgoing Notes State Adoption Letter Package 1991-1 Safety Requirements for Radiographic Equipment 01/10/1994 Final No Comments Texas has adopted Final Part 34 ML051520266 10/31/2005 Regulations equivalent to RATS ID:

55 FR 843 ML053050013 1997-5.

(Superceded by 1997-5) 1991-2 ASNT Certification of Radiographers none Not Required Not Required Texas has adopted Final Part 34 Regulations equivalent to RATS ID:

56 FR 11504 1997-5.

(Superceded by 1997-5) 1991-3 Standards for Protection Against Radiation 01/01/1994 Final No Comments Part 20 11/06/1997 56 FR 23360; 56 FR 61352; 57 FR 38588; 57 FR 57877; 58 FR 67657; 59 FR 41641; 60 FR 20183; 1991-4 Notification of Incidents 10/15/1994 Final No Comments Parts 20, 30, 31, 34, 39, 40 and 70 ML052060129 09/29/2005 56 FR 64980; ML052720491 1992-1 Quality Management Program and 01/27/1995 Not Required Not Required Texas has adopted Final Misadministrations Regulations equivalent to RATS ID:

Part 35 2002-2.

56 FR 34104 (Superceded by 2002-2) 1992-2 Eliminating the Recordkeeping Requirements none Not Required Not Required These regulation changes are not for Departures from Manufacturer's Instructions required to be adopted for purposes Parts 30 and 35 of Compatibility.

57 FR 45566 Enclosure 2

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

  • 1993-1 Decommissioning Recordkeeping and License 10/25/1996 Final Comments Termination: Documentation Additions [Restricted ML052060129 09/29/2005 areas and spill sites] ML052720491 Parts 30 and 40 58 FR 39628 Revised Final No Comments ML18234A459 10/16/2018 ML18234A448 1993-2 Licensing and Radiation Safety Requirements for 07/01/1996 Final No Comments Irradiators ML051520266 08/12/2005 Part 36 ML052280032 58 FR 7715 1993-3 Definition of Land Disposal and Waste Site QA 07/22/1996 Not Applicable Not Applicable Texas DSHS does not have Program responsibility for these regulations.

Part 61 See SRS sheet for Texas CEQ.

58 FR 33886 1994-1 Self-Guarantee as an Additional Financial none Final No Comments These regulation changes are not Mechanism ML062860025 11/21/2006 required to be adopted for purposes Parts 30, 40 and 70 ML063200232 of Compatibility.

58 FR 68726; 59 FR 1618 1994-2 Uranium Mill Tailings Regulations: Conforming 07/01/1997 Not Applicable Not Applicable Texas CEQ Responsibility NRC Requirements to EPA Standards Part 40 59 FR 28220 1994-3 Timeliness in Decommissioning Material Facilities 08/15/1997 Final No Comments Parts 30, 40, 70 ML052060129 09/29/2005 59 FR 36026 ML052720491 1995-1 Preparation, Transfer for Commercial Distribution, 01/01/1998 Final No Comments and Use of Byproduct Material for Medical Use 03/17/1999 Parts 30, 32 and 35 59 FR 61767; 59 FR 65243; 60 FR 322

3 RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 1995-2 Frequency of Medical Examinations for Use of 03/13/1998 Final No Comments Respiratory Protection Equipment ML051520266 10/31/2005 Part 20 ML053050013 60 FR 7900 1995-3 Low-Level Waste Shipment Manifest Information 03/01/1998 Final No Comments and Reporting ML112510357 11/22/2011 Parts 20 and 61 ML113000228 60 FR 15649; 60 FR 25983 1995-4 Performance Requirements for Radiography 06/30/1998 Final No Comments Texas has adopted Final Equipment ML051520266 10/31/2005 Regulations equivalent to RATS ID:

Part 34 ML053050013 1997-5.

60 FR 28323 (Superceded by 1997-5) 1995-5 Radiation Protection Requirements: Amended 08/14/1998 Final No Comments Definitions and Criteria 03/17/1999 Parts 19 and 20 60 FR 36038 1995-6 Clarification of Decommissioning Funding 11/24/1998 Final No Comments Requirements ML052060129 09/29/2005 Parts 30, 40 and 70 ML052720491 60 FR 38235 1995-7 Medical Administration of Radiation and Radioactive 10/20/1998 Final No Comments Texas has not yet adopted Final Materials ML051520266 10/31/2005 Regulations equivalent to RATS ID:

Parts 20, 35 ML053050013 2005-2.

60 FR 48623 (Superceded by 2002-2 and 2005-2)

4 RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 1996-1 Compatibility with the International Atomic Energy 04/01/1999 Final Comments Texas has adopted Final Agency ML052060129 09/29/2005 Regulations equivalent to RATS ID:

Part 71 ML052720491 2004-1.

60 FR 50248; 61 FR 28724 (Superceded by 2004-1) 1996-2 One Time Extension of Certain Byproduct, Source 02/15/1999 Not Required Not Required These regulation changes are not and Special Nuclear Materials Licenses required to be adopted for purposes Parts 30, 40 and 70 of Compatibility.

61 FR 1109 1996-3 Termination or Transfer of Licensed Activities: 06/17/1999 Final No Comments Part 30 only. Part 61 applies to Record keeping Requirements ML062860025 11/21/2006 TXCEQ.

Parts 20, 30, 40, 61 and 70 ML063200232 61 FR 24669 1997-1 Resolution of Dual Regulation of Airborne Effluents 01/9/2000 Final No Comments of Radioactive Materials; Clean Air Act 07/07/2000 Part 20 61 FR 65120 1997-2 Recognition of Agreement State Licenses in Areas 02/27/2000 Final No Comments Under Exclusive Federal Jurisdiction Within an ML063030232 11/27/2006 Agreement State ML063200389 Part 150 62 FR 1662 1997-3 Criteria for the Release of Individuals Administered 05/29/2000 Final No Comments Radioactive Material 07/07/2000 Parts 20 and 35 62 FR 4120 1997-4 Fissile Material Shipments and Exemptions 02/10/2000 Not Required Not Required These regulation changes are not Part 71 required to be adopted for purposes 62 FR 5907 of Compatibility. (See STP-97-078)

(Superceded by 2004-1)

5 RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 1997-5 Licenses for Industrial Radiography and Radiation 06/27/2000 Final No Comments Safety Requirements for Industrial Radiography 07/07/2000 Operations Parts 30, 34, 71 and 150 62 FR 28947 1997-6 Radiological Criteria for License Termination 08/20/2000 Final No Comments Parts 20, 30, 40 and 70 07/07/2000 62 FR 39057 1997-7 Exempt Distribution of a Radioactive Drug 01/02/2001 Final No Comments Containing One Micro curie of Carbon-14 Urea ML052060129 09/29/2005 Part 30 ML052720491 62 FR 63634 1998-1 Deliberate Misconduct by Unlicensed Persons 02/12/2001 Final No Comments Parts 30, 40, 61, 70, 71 and 150 ML063030232 11/27/2006 63 FR 1890; 63 FR 13773 ML063200389 1998-2 Self-Guarantee of Decommissioning Funding by 07/01/2001 Not Required Not Required These regulation changes are not Nonprofit and Non-Bond-Issuing Licensees required to be adopted for purposes Parts 30, 40 and 70 of Compatibility.

63 FR 29535 1998-3 License Term for Medical Use Licenses 07/10/2001 Not Required Not Required These regulation changes are not Part 35 required to be adopted for purposes 63 FR 31604 of Compatibility. (See STP-98-074)

(Superceded by 2002-2)

Texas has adopted Final Regulations equivalent to RATS ID:

2002-2.

6 RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 1998-4 Licenses for Industrial Radiography and Radiation 07/09/2001 Final No Comments Safety Requirements for Industrial Radiographic ML093110052 01/21/2010 Operations ML093520035 Part 34 63 FR 37059 1998-5 Minor Corrections, Clarifying Changes, and a Minor 10/26/2001 Final No Comments Policy Change 07/07/2000 Parts 20, 32, 35, 36 and 39 63 FR 39477; 63 FR 45393 1998-6 Transfer for Disposal and Manifests: Minor 11/20/2001 Final No Comments Technical Conforming Amendment 07/07/2000 Part 20 63 FR 50127 1999-1 Radiological Criteria for License Termination of 06/11/2002 Not Applicable Not Applicable Texas CEQ Responsibility Uranium Recovery Facilities Part 40 64 FR 17506 1999-2 Requirements for Those Who Possess Certain 10/04/2002 Not Required Not Required These regulation changes are not Industrial Devices Containing Byproduct Material to required to be adopted for purposes Provide Requested Information of Compatibility.

Part 31 64 FR 42269 1999-3 Respiratory Protection and Controls to Restrict 02/02/2003 Final No Comments Internal Exposure ML062750348 11/21/2006 Part 20 ML063200232 64 FR 54543; 64 FR 55524 2000-1 Energy Compensation Sources for Well Logging 05/17/2003 Final No Comments and Other Regulatory Clarifications ML051520266 11/30/2006 Part 39 ML063340007 65 FR 20337

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

Parts 30, 31 and 32 ML120660270 65 FR 79162 2002-1 Revision of the Skin Dose Limit 04/05/2005 Final No Comments Part 20 ML102240370 11/19/2010 67 FR 16298 ML102740009 2002-2 Medical Use of Byproduct Material 10/24/2005 R1 Comments Parts 20, 32 and 35 ML14258B117 12/16/2014 67 FR 20249 ML14258A158 Final No Comments ML15078A299 05/26/2015 ML15078A285 2003-1 Financial Assurance for Materials Licensees 12/03/2006 Final No Comments Parts 30, 40 and 70 ML112510357 11/22/2011 68 FR 57327 ML113000228 2004-1 Compatibility With IAEA Transportation Safety 10/01/2007 R1 No Comments Standards and Other Transportation Safety ML14258B117 12/16/2014 Amendments ML14258A158 Part 71 69 FR 3697 Final No Comments ML15078A299 05/26/2015 ML15078A285

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

9 RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 2007-1 Medical Use of Byproduct Material - Minor 10/29/2010 Final No Comments Corrections and Clarifications ML102240370 11/19/2010 Parts 32 and 35 ML102740009 72 FR 45147, 54207

10 RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 2007-4 Order Imposing Fingerprinting Requirements and 06/05/2008 License No Comments Criminal History Records Check Requirements for Condition 02/13/2008 Unescorted Access to Certain Radioactive Material ML080350004 ML080440203 NRC Order EA-07-305 72 FR 70901 2008-1 Occupational Dose Records, Labeling Containers, 02/15/2011 Final No Comments and Total Effective Dose Equivalent ML112510357 11/22/2011 Parts 19 and 20 ML113000228 72 FR 68043 2009-1 Medical Use of Byproduct Material - Authorized 09/28/2012 Final No Comments User Clarification ML112510357 11/22/2011 Part 35 ML113000228 74 FR 33901 2011-1 Decommissioning Planning 12/17/2015 Proposed No Comments Parts 20, 30, 40 and 70 ML14258B117 12/16/2014 76 FR 35512 ML14258A158 Final No Comments ML15078A299 05/26/2015 ML15078A285

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

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

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

  • 2015-3 Revisions to Transportation Safety Requirements 07/13/2018 Proposed Comments and Harmonization with International Atomic *extended to ML18234A459 10/16/2018 Energy Agency Transportation Requirements 08/15/2020 ML18234A448 Part 71 See STC 17-060 80 FR 33987

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

  • 2015-5 Miscellaneous Corrections, 12/31/2018 Proposed Comments Parts 19, 20, 30, 32, 37, 40, 61, 70, 71 and 150 ML18234A459 10/16/2018 80 FR 74974 ML18234A448 2018-1 Medical Use of Byproduct Material - Medical Event 01/14/2022 Definitions, Training and Experience, and Clarifying Amendments, Parts 30, 32 and 35 N/A Parts 35.11, 35.63, 35.92 and 35.204 N/A Final No Comments ML112510357 11/22/2011 ML113000228 N/A Parts 34 and 39 Not Associated with a Specific N/A Final Comments RATS ML113340070 01/11/2012 ML113550343 N/A Parts 20, 30, 31, 32, 35, 70 and 71 Not Associated N/A Proposed Comments with a Specific RATS ML14258B117 12/16/2014 ML14258A158 Final Comments Comments are regarding 10 CFR ML15078A299 05/26/2015 Parts 20.1403, 20.1405 and ML15078A285 31.12(c)(4).
Retrieved from "https://kanterella.com/w/index.php?title=ML18261A114&oldid=2216628"