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| number = ML18296A368
| number = ML18296A368
| issue date = 11/02/2018
| issue date = 11/02/2018
| title = 11/02/2018, Letter to J. Daehler Massachusetts Final Regulations to Rats Ids 2011-1, 2012-4, 2013-2 and 2015-3
| title = Letter to J. Daehler Massachusetts Final Regulations to Rats Ids 2011-1, 2012-4, 2013-2 and 2015-3
| author name = Williams K
| author name = Williams K
| author affiliation = NRC/NMSS/DMSST/ASPB
| author affiliation = NRC/NMSS/DMSST/ASPB
| addressee name = Daehler J E
| addressee name = Daehler J
| addressee affiliation = State of MA, Dept of Public Health, Radiation Control Program
| addressee affiliation = State of MA, Dept of Public Health, Radiation Control Program
| docket =  
| docket =  
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=Text=
=Text=
{{#Wiki_filter:/RA Paul Michalak for/}}
{{#Wiki_filter:UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 November 2, 2018 Mr. Joshua E. Daehler, Supervisor Radioactive Materials Unit Radiation Control Program Massachusetts Department of Public Health Schrafft Center, Suite 1M2A 529 Main Street Charlestown, MA 02129
 
==Dear Mr. Daehler:==
 
We have reviewed the final revisions to the Massachusetts regulations 10 CMR 120.000, received by our office on September 20, 2018. 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, 2012-4, 2013-2, and 2015-3 as identified in the enclosed State Regulation Status (SRS) Data Sheet.
We discussed our review of the regulations with you on October 31, 2018.
As a result of our review, we have one comment that has 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 Massachusetts, 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 Massachusetts 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.
 
J. Daehler                                    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/
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. Massachusetts SRS Data Sheet
 
J. Daehler                               
 
==SUBJECT:==
MASSACHSETTS FINAL REGULATIONS TO RATS ID NUMBERS 2011-1, 2012-4 2013-2 AND 2015-3 DISTRIBUTION: SP 05 John Miller, RSAO Massachusetts File OFFICE      ASPB          ASPB              OGC    ASPB:BC        MSTR:DD NAME        SPoy        MBeardsley          IIrvin PMichalak    PMichalak for KWilliams DATE      10/16/18        10/16/18          10/31/18  11/2/18        11/2/18 ML18296A368                    OFFICIAL RECORD COPY      Package ML18264A222
 
COMPATIBILITY COMMENTS ON MASSACHUSETTS FINAL REGULATIONS STATE SECTION  NRC SECTION    RATS ID  CATEGORY  SUBJECT and COMMENTS 1  120.777    71.17          2015-3    B          General license: NRC approved package 120.780    71.21 General license: Use of foreign approved package Massachusetts equivalent regulations to 10 CFR 71.17 and 71.21 reference to Subpart A does not include their equivalent regulation to 10 CFR 71.8, i.e., 120.016 (L).
Therefore, Massachusetts needs to modify 120.777(C)(2) to include a reference to 120.016(L) such that it states, Each licensee issued a general license under 105 CMR 120.777(A) shall: (1) . . .; (2) Comply with the terms and conditions of the license, certificate, or other approval by the Nuclear Regulatory Commission, as applicable, and the applicable requirements of 105 CMR 120.016(L), 105 CMR 120.771 through 120.774 and 105 CMR 120.784 through 120.797; and And Massachusetts needs to modify 120.780(D) to include reference to 120.016(L) such that it states, Each licensee issued a general license under 105 CMR 120.780(A) shall: (1)
                                                  . . .; (2) Comply with the terms and conditions of the license, certificate, or other approval by the Nuclear Regulatory Commission, as applicable, and the applicable requirements of 105 CMR 120.016(L),
105 CMR 120.771 through 120.774 and 105 CMR 120.784 through 120.797; and Massachusetts needs to make the Enclosure 1
 
2 STATE SECTION NRC SECTION RATS ID  CATEGORY SUBJECT and COMMENTS above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 71.17 and 71.21.
 
STATE REGULATION STATUS State: Massachusetts                                                                        Tracking Ticket Number: 18-55 Date: 11/02/2018
[ # 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        Massachusetts has adopted Final Part 34                                                                      03/03/1997        Regulations equivalent to RATS ID:
55 FR 843                                                                                        1997-5.
(Superceded by 1997-5) 1991-2      ASNT Certification of Radiographers              none          Not Required Not Required      Massachusetts 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                                                                      03/03/1997 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                                          03/03/1997 56 FR 64980 1992-1      Quality Management Program and                    01/27/1995    Final        No Comments        Massachusetts has adopted Final Misadministrations                                                            03/03/1997        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
 
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          No Comments Termination: Documentation Additions [Restricted                                03/03/1997 areas and spill sites]
Parts 30 and 40 58 FR 39628 1993-2  Licensing and Radiation Safety Requirements for    07/01/1996    Final          No Comments Irradiators                                                                      03/03/1997 Part 36 58 FR 7715 1993-3  Definition of Land Disposal and Waste Site QA      07/22/1996    Final          No Comments Program                                                                          03/03/1997 Part 61 58 FR 33886 1994-1  Self-Guarantee as an Additional Financial          none          Final          No Comments    These regulation changes are not Mechanism                                                                        03/03/1997    required to be adopted for purposes Parts 30, 40, and 70                                                                            of Compatibility.
58 FR 68726; 59 FR 1618 1994-2  Uranium Mill Tailings Regulations: Conforming      07/01/1997    Not Applicable Not Applicable Massachusetts does not have NRC Requirements to EPA Standards                                                              authority to regulate this material Part 40                                                                                        under its Agreement.
59 FR 28220 1994-3  Timeliness in Decommissioning Material Facilities  08/15/1997    Final          No Comments Parts 30, 40, and 70                                              ML062980638    11/30/2006 59 FR 36026                                                                      ML063380019 1995-1  Preparation, Transfer for Commercial Distribution, 01/01/1998    Final          No Comments and Use of Byproduct Material for Medical Use                                    09/21/1999 Parts 30, 32, and 35 59 FR 61767; 59 FR 65243; 60 FR 322 2
 
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                                  ML062980638  11/30/2006 Part 20                                                                        ML063380019 60 FR 7900 1995-3  Low-Level Waste Shipment Manifest Information      03/01/1998    Final        No Comments and Reporting                                                      ML062980638  11/30/2006 Parts 20 and 61                                                                ML063380019 60 FR 15649; 60 FR 25983 1995-4  Performance Requirements for Radiography            06/30/1998    Not Required Not Required Massachusetts has adopted Final Equipment                                                                                    Regulations equivalent to RATS ID:
Part 34                                                                                      1997-5.
60 FR 28323 (Superceded by 1997-5) 1995-5  Radiation Protection Requirements: Amended          08/14/1998    Final        No Comments Definitions and Criteria                                          ML062980638  11/30/2006 Parts 19 and 20                                                                ML063380019 60 FR 36038 1995-6  Clarification of Decommissioning Funding            11/24/1998    Final        No Comments Requirements                                                      ML062980638  11/30/2006 Parts 30, 40, and 70                                                            ML063380019 60 FR 38235 1995-7  Medical Administration of Radiation and Radioactive 10/20/1998    Final        No Comments  Massachusetts has not yet adopted Materials                                                                      09/21/1999  Final Regulations equivalent to Parts 20 and 35                                                                              RATS ID: 2005-2.
60 FR 48623 (Superceded by 2002-2 and 2005-2) 1996-1  Compatibility with the International Atomic Energy  04/01/1999    Final        No Comments  Massachusetts has not yet adopted Agency                                                                          09/21/1999  Final Regulations equivalent to Part 71                                                                                      RATS ID: 2004-1.
60 FR 50248; 61 FR 28724 (Superceded by 2004-1) 3
 
RATS ID NRC Chronology Identification                        Date Due for  Incoming    Outgoing    Notes State Adoption Letter      Package 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 Recordkeeping Requirements                                                      09/21/1999 Parts 20, 30, 40, 61, and 70 61 FR 24669 1997-1  Resolution of Dual Regulation of Airborne Effluents  01/9/2000      Final        No Comments of Radioactive Materials; Clean Air Act                                          09/21/1999 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                      ML062980638  11/30/2006 Agreement State                                                                  ML063380019 Part 150 62 FR 1662 1997-3  Criteria for the Release of Individuals Administered 05/29/2000    Final        No Comments Radioactive Material                                                ML062980638  11/30/2006 Parts 20 and 35                                                                  ML063380019 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) 1997-5  Licenses for Industrial Radiography and Radiation    06/27/2000    Final        No Comments Safety Requirements for Industrial Radiography                                  09/21/1999 Operations Parts 30, 34, 71, and 150 62 FR 28947 4
 
RATS ID NRC Chronology Identification                      Date Due for  Incoming    Outgoing    Notes State Adoption Letter      Package 1997-6  Radiological Criteria for License Termination      08/20/2000    Final        No Comments Parts 20, 30, 40, and 70                                          ML062980638  11/30/2006 62 FR 39057                                                                    ML063380019 1997-7  Exempt Distribution of a Radioactive Drug          01/02/2001    Final        No Comments Containing One Microcurie of Carbon-14 Urea                                    09/21/1999 Part 30 62 FR 63634 1998-1  Deliberate Misconduct by Unlicensed Persons        02/12/2001    Final        No Comments Parts 30, 40, 61, 70, 71, and 150                                ML062980638  11/30/2006 63 FR 1890; 63 FR 13773                                                        ML063380019 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)                                                                      Massachusetts has adopted Final Regulations equivalent to RATS ID:
2002-2.
1998-4  Licenses for Industrial Radiography and Radiation  07/09/2001    Final        No Comments Safety Requirements for Industrial Radiographic                  ML062980638  11/30/2006 Operations                                                                    ML063380019 Part 34 63 FR 37059 1998-5  Minor Corrections, Clarifying Changes, and a Minor 10/26/2001    Final        No Comments Policy Change                                                    ML062980638  11/30/2006 Parts 20, 32, 35, 36, and 39                                                  ML063380019 63 FR 39477; 63 FR 45393 5
 
RATS ID NRC Chronology Identification                      Date Due for  Incoming      Outgoing      Notes State Adoption Letter        Package 1998-6  Transfer for Disposal and Manifests: Minor          11/20/2001    Final          No Comments Technical Conforming Amendment                                    ML062980638    11/30/2006 Part 20                                                                          ML063380019 63 FR 50127 1999-1  Radiological Criteria for License Termination of    06/11/2002    Not Applicable Not Applicable Massachusetts does not have Uranium Recovery Facilities                                                                      authority to regulate this material Part 40                                                                                          under its Agreement.
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                                                  ML062980638    11/30/2006 Part 20                                                                          ML063380019 64 FR 54543; 64 FR 55524 2000-1  Energy Compensation Sources for Well Logging        05/17/2003    Final          No Comments and Other Regulatory Clarifications                                ML062980638    11/30/2006 Part 39                                                                          ML063380019 65 FR 20337 No Comments 2000-2  New Dosimetry Technology                            01/08/2004    Final          11/30/2006 Parts 34, 36, and 39                                              ML062980638    ML063380019 65 FR 63750 2001-1  Requirements for Certain Generally Licensed        02/16/2004    Final          No Comments Industrial Devices Containing Byproduct Material                  ML062980638    11/30/2006 Parts 30, 31, and 32                                                              ML063380019 65 FR 79162 6
 
RATS ID NRC Chronology Identification                      Date Due for  Incoming          Outgoing    Notes State Adoption Letter            Package 2002-1  Revision of the Skin Dose Limit                    04/05/2005    Final            No Comments Part 20                                                            ML062980638      11/30/2006 67 FR 16298                                                                          ML063380019 2002-2  Medical Use of Byproduct Material                  10/24/2005    Final            No Comments Parts 20, 32, and 35                                              ML062980638      11/30/2006 67 FR 20249                                                                          ML063380019 2003-1  Financial Assurance for Materials Licensees        12/03/2006    Final            No Comments Parts 30, 40, and 70                                              ML14007A051      03/06/2014 68 FR 57327                                                                          ML140070502004-1  Compatibility With IAEA Transportation Safety      10/01/2007    Final            Comments Standards and Other Transportation Safety                          ML14007A051      03/06/2014 Amendments                                                                          ML14007050 Part 71 69 FR 3697                                                        Revised Final    No Comments (not all previous 01/16/2015 comments were    ML14343A367 addressed)
ML14344A254 2005-1  Security Requirements for Portable Gauges          07/11/2008    Final            No Comments Containing Byproduct Material                                      ML120860009      05/03/2012 Part 30                                                                              ML120960551 70 FR 2001 2005-2  Medical Use of Byproduct Material - Recognition of  04/29/2008    Final            No Comments Specialty Boards                                                  ML14007A051      03/06/2014 Part 35                                                                              ML1400705070 FR 16336; 71 FR 1926 2005-3  Increased Controls for Risk-Significant Radioactive 12/01/2005    License          No Comments Sources (NRC Order EA-05-090)                                      Condition        10/04/2005 70 FR 72128                                                        ML080110677      ML052780024 7
 
RATS ID NRC Chronology Identification                    Date Due for  Incoming          Outgoing    Notes State Adoption Letter            Package 2006-1  Minor Amendments                                  03/27/2009    Final            No Comments Parts 20, 30, 32, 35, 40, and 70                                ML14007A051      03/06/2014 71 FR 15005                                                                        ML140070502006-2  National Source Tracking System - Serialization  02/06/2007    License          No Comments Requirements                                                    Condition        02/16/2007 Part 32 with reference to Part 20 Appendix E                    ML070360500      ML070470063 71 FR 65685 2006-3  National Source Tracking System                  01/31/2009    Final            No Comments Part 20                                                          ML102850241      11/10/2010 71 FR 65685, 72 FR 59162                                                          ML102990077 License          No Comments Condition        10/20/2008 ML082760641      ML082800024 2007-1  Medical Use of Byproduct Material - Minor        10/29/2010    Final            No Comments Corrections and Clarifications                                  ML14007A051      03/06/2014 Parts 32 and 35                                                                    ML1400705072 FR 45147, 54207 2007-2  Exemptions From Licensing, General Licenses, and 12/17/2010      Final            Comments Distribution of Byproduct Material: Licensing and                ML14007A051      03/06/2014 Reporting Requirements                                                            ML14007050 Parts 30, 31, 32, and 150 72 FR 58473                                                      Revised Final    No Comments (not all previous 01/16/2015 comments were    ML14343A367 addressed)
ML14344A254 8
 
RATS ID NRC Chronology Identification                    Date Due for  Incoming          Outgoing    Notes State Adoption Letter            Package 2007-3  Requirements for Expanded Definition of Byproduct 11/30/2010    Final            Comments Material                                                        ML14007A051      03/06/2014 Parts 20, 30, 31, 32, 33, 35, 61, and 150                                          ML1400705072 FR 55864 Revised Final    No Comments (not all previous 1/16/2015 comments were    ML14343A367 addressed)
ML14344A254 2007-4  Order Imposing Fingerprinting Requirements and    06/05/2008    License          No Comments Criminal History Records Check Requirements for                  Condition        04/14/2008 Unescorted Access to Certain Radioactive Material                ML080800501      ML081050505 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                              ML120860009      05/03/2012 Parts 19 and 20                                                                    ML120960551 72 FR 68043 2009-1  Medical Use of Byproduct Material - Authorized    09/28/2012    Final            No Comments User Clarification                                              ML14007A051      03/06/2014 Part 35                                                                            ML1400705074 FR 33901
*2011-1 Decommissioning Planning                          12/17/2015    Proposed          No Comments Parts 20, 30, 40, and 70                                        ML16285A473      10/26/2016 76 FR 35512                                                                        ML16285A472 Final            No Comments ML18264A253      11/02/2018 ML18264A222 9
 
RATS ID NRC Chronology Identification                        Date Due for  Incoming    Outgoing    Notes State Adoption Letter      Package 2011-2  Licenses, Certifications, and Approvals for Materials 11/14/2014    Proposed    No Comments Licensees                                                            ML14344A254 01/16/2015 Parts 30, 36, 39, 40, 70, and 150                                                ML14343A367 76 FR 56951                                                          Final ML16070A231 No Comments 04/11/2016 ML16070A227 2012-1  Change of Compatibility of 10 CFR 31.5 and 31.6      01/25/2015    Final      No Comments (See RATS ID: 2001-1 for Rule text)                                  ML14007A051 03/06/2014 77 FR 3640                                                                      ML140070502012-2  Advance Notification to Native American Tribes of    08/10/2015    Proposed    Comments Transportation of Certain Types of Nuclear Waste                    ML14344A254 1/16/2015 Part 71                                                                          ML14343A367 77 FR 34194                                                          Final ML16070A231 No Comments 04/11/2016 ML160702272012-3  Technical Corrections                                08/06/2015    Proposed    No Comments Parts 30, 34, 40, and 71                                            ML14344A254 01/16/2015 77 FR 39899                                                                      ML14343A367 Final ML16070A231 No Comments 04/11/2016 ML16070227
*2012-4 Requirements for Distribution of Byproduct Material  10/23/2015    Proposed    Comments Parts 30, 31, 32, 40, and 70                                        ML16285A473 10/26/2016 77 FR 43666                                                                      ML16285A47 Final      No Comments ML18264A253 11/02/2018 ML18264A222 10
 
RATS ID NRC Chronology Identification                    Date Due for  Incoming    Outgoing    Notes State Adoption Letter      Package 2013-1  Physical Protection of Byproduct Material, 10 CFR 03/19/2016    Proposed    No Comments Parts 20, 30, 32, 33, 34, 35, 36, 37, 39, and 71                ML15127A416 06/29/2015 78 FR 16922                                                                  ML15127A375 Final ML16070A231 No Comments 04/11/2016 ML16070A227
*2013-2 Distribution of Source Material to Exempt Persons 08/27/2016    Proposed    Comments and to General Licensees and Revision of                        ML16285A473 10/26/2016 General License and Exemptions,                                              ML16285A472 Parts 30, 40, and 70 78 FR 32310                                                      Final      No Comments ML18264A253 11/02/2018 ML18264A222 2015-1  Domestic Licensing of Special Nuclear Material -  01/26/2018    Final      No Comments Written Reports and Clarifying Amendments                        ML16285A473 10/26/2016 Part 70                                                                      ML16285A472 79 FR 57721, 80 FR 143 2015-2  Safeguards Information - Modified Handling        01/28/2018    Proposed    No Comments Categorization, Change for Materials Facilities                  ML15127A416 06/29/2015 Parts 30, 37, 73, and 150                                                    ML15127A375 79 FR 58664, 80 FR 3865                                          Final ML16070A231 No Comments 04/11/2016 ML16070A227
*2015-3 Revisions to Transportation Safety Requirements  07/13/2018    Proposed    Comments and Harmonization with International Atomic      *extended to  ML17059D085 03/28/2017 Energy Agency Transportation Requirements        08/15/2020                ML17059D084 Part 71                                          See STC 17-060 80 FR 33987                                                      Final      Comments ML18264A253 11/02/2018 ML18264A222 11
 
RATS ID NRC Chronology Identification                        Date Due for  Incoming    Outgoing    Notes State Adoption Letter      Package Final      No Comments 2015-4  Miscellaneous Corrections                            09/02/2018    ML16070A231 04/11/2016 Parts 37 and 40                                                                ML1607022780 FR 45841 Final 2015-5  Miscellaneous Corrections                            12/31/2018    ML16070A231 No Comments Parts 19, 20, 30, 32, 37, 40, 61, 70, 71, and 150                              04/11/2016 80 FR 74974                                                                    ML160702272018-1  Medical Use of Byproduct Material - Medical Event    01/14/2022 Definitions, Training and Experience, and Clarifying Amendments Parts 30, 32, and 35 12}}

Latest revision as of 07:42, 30 November 2019

Letter to J. Daehler Massachusetts Final Regulations to Rats Ids 2011-1, 2012-4, 2013-2 and 2015-3
ML18296A368
Person / Time
Issue date: 11/02/2018
From: Kevin Williams
NRC/NMSS/DMSST/ASPB
To: Daehler J
State of MA, Dept of Public Health, Radiation Control Program
O'Hara J
Shared Package
ML18264A222 List:
References
Download: ML18296A368 (17)


Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 November 2, 2018 Mr. Joshua E. Daehler, Supervisor Radioactive Materials Unit Radiation Control Program Massachusetts Department of Public Health Schrafft Center, Suite 1M2A 529 Main Street Charlestown, MA 02129

Dear Mr. Daehler:

We have reviewed the final revisions to the Massachusetts regulations 10 CMR 120.000, received by our office on September 20, 2018. 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, 2012-4, 2013-2, and 2015-3 as identified in the enclosed State Regulation Status (SRS) Data Sheet.

We discussed our review of the regulations with you on October 31, 2018.

As a result of our review, we have one comment that has 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 Massachusetts, 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 Massachusetts 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.

J. Daehler 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/

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. Massachusetts SRS Data Sheet

J. Daehler

SUBJECT:

MASSACHSETTS FINAL REGULATIONS TO RATS ID NUMBERS 2011-1, 2012-4 2013-2 AND 2015-3 DISTRIBUTION: SP 05 John Miller, RSAO Massachusetts File OFFICE ASPB ASPB OGC ASPB:BC MSTR:DD NAME SPoy MBeardsley IIrvin PMichalak PMichalak for KWilliams DATE 10/16/18 10/16/18 10/31/18 11/2/18 11/2/18 ML18296A368 OFFICIAL RECORD COPY Package ML18264A222

COMPATIBILITY COMMENTS ON MASSACHUSETTS FINAL REGULATIONS STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 1 120.777 71.17 2015-3 B General license: NRC approved package 120.780 71.21 General license: Use of foreign approved package Massachusetts equivalent regulations to 10 CFR 71.17 and 71.21 reference to Subpart A does not include their equivalent regulation to 10 CFR 71.8, i.e., 120.016 (L).

Therefore, Massachusetts needs to modify 120.777(C)(2) to include a reference to 120.016(L) such that it states, Each licensee issued a general license under 105 CMR 120.777(A) shall: (1) . . .; (2) Comply with the terms and conditions of the license, certificate, or other approval by the Nuclear Regulatory Commission, as applicable, and the applicable requirements of 105 CMR 120.016(L), 105 CMR 120.771 through 120.774 and 105 CMR 120.784 through 120.797; and And Massachusetts needs to modify 120.780(D) to include reference to 120.016(L) such that it states, Each licensee issued a general license under 105 CMR 120.780(A) shall: (1)

. . .; (2) Comply with the terms and conditions of the license, certificate, or other approval by the Nuclear Regulatory Commission, as applicable, and the applicable requirements of 105 CMR 120.016(L),

105 CMR 120.771 through 120.774 and 105 CMR 120.784 through 120.797; and Massachusetts needs to make the Enclosure 1

2 STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 71.17 and 71.21.

STATE REGULATION STATUS State: Massachusetts Tracking Ticket Number: 18-55 Date: 11/02/2018

[ # 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 Massachusetts has adopted Final Part 34 03/03/1997 Regulations equivalent to RATS ID:

55 FR 843 1997-5.

(Superceded by 1997-5) 1991-2 ASNT Certification of Radiographers none Not Required Not Required Massachusetts 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 03/03/1997 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 03/03/1997 56 FR 64980 1992-1 Quality Management Program and 01/27/1995 Final No Comments Massachusetts has adopted Final Misadministrations 03/03/1997 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

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 No Comments Termination: Documentation Additions [Restricted 03/03/1997 areas and spill sites]

Parts 30 and 40 58 FR 39628 1993-2 Licensing and Radiation Safety Requirements for 07/01/1996 Final No Comments Irradiators 03/03/1997 Part 36 58 FR 7715 1993-3 Definition of Land Disposal and Waste Site QA 07/22/1996 Final No Comments Program 03/03/1997 Part 61 58 FR 33886 1994-1 Self-Guarantee as an Additional Financial none Final No Comments These regulation changes are not Mechanism 03/03/1997 required to be adopted for purposes Parts 30, 40, and 70 of Compatibility.

58 FR 68726; 59 FR 1618 1994-2 Uranium Mill Tailings Regulations: Conforming 07/01/1997 Not Applicable Not Applicable Massachusetts does not have NRC Requirements to EPA Standards authority to regulate this material Part 40 under its Agreement.

59 FR 28220 1994-3 Timeliness in Decommissioning Material Facilities 08/15/1997 Final No Comments Parts 30, 40, and 70 ML062980638 11/30/2006 59 FR 36026 ML063380019 1995-1 Preparation, Transfer for Commercial Distribution, 01/01/1998 Final No Comments and Use of Byproduct Material for Medical Use 09/21/1999 Parts 30, 32, and 35 59 FR 61767; 59 FR 65243; 60 FR 322 2

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 ML062980638 11/30/2006 Part 20 ML063380019 60 FR 7900 1995-3 Low-Level Waste Shipment Manifest Information 03/01/1998 Final No Comments and Reporting ML062980638 11/30/2006 Parts 20 and 61 ML063380019 60 FR 15649; 60 FR 25983 1995-4 Performance Requirements for Radiography 06/30/1998 Not Required Not Required Massachusetts has adopted Final Equipment Regulations equivalent to RATS ID:

Part 34 1997-5.

60 FR 28323 (Superceded by 1997-5) 1995-5 Radiation Protection Requirements: Amended 08/14/1998 Final No Comments Definitions and Criteria ML062980638 11/30/2006 Parts 19 and 20 ML063380019 60 FR 36038 1995-6 Clarification of Decommissioning Funding 11/24/1998 Final No Comments Requirements ML062980638 11/30/2006 Parts 30, 40, and 70 ML063380019 60 FR 38235 1995-7 Medical Administration of Radiation and Radioactive 10/20/1998 Final No Comments Massachusetts has not yet adopted Materials 09/21/1999 Final Regulations equivalent to Parts 20 and 35 RATS ID: 2005-2.

60 FR 48623 (Superceded by 2002-2 and 2005-2) 1996-1 Compatibility with the International Atomic Energy 04/01/1999 Final No Comments Massachusetts has not yet adopted Agency 09/21/1999 Final Regulations equivalent to Part 71 RATS ID: 2004-1.

60 FR 50248; 61 FR 28724 (Superceded by 2004-1) 3

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 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 Recordkeeping Requirements 09/21/1999 Parts 20, 30, 40, 61, and 70 61 FR 24669 1997-1 Resolution of Dual Regulation of Airborne Effluents 01/9/2000 Final No Comments of Radioactive Materials; Clean Air Act 09/21/1999 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 ML062980638 11/30/2006 Agreement State ML063380019 Part 150 62 FR 1662 1997-3 Criteria for the Release of Individuals Administered 05/29/2000 Final No Comments Radioactive Material ML062980638 11/30/2006 Parts 20 and 35 ML063380019 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) 1997-5 Licenses for Industrial Radiography and Radiation 06/27/2000 Final No Comments Safety Requirements for Industrial Radiography 09/21/1999 Operations Parts 30, 34, 71, and 150 62 FR 28947 4

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 1997-6 Radiological Criteria for License Termination 08/20/2000 Final No Comments Parts 20, 30, 40, and 70 ML062980638 11/30/2006 62 FR 39057 ML063380019 1997-7 Exempt Distribution of a Radioactive Drug 01/02/2001 Final No Comments Containing One Microcurie of Carbon-14 Urea 09/21/1999 Part 30 62 FR 63634 1998-1 Deliberate Misconduct by Unlicensed Persons 02/12/2001 Final No Comments Parts 30, 40, 61, 70, 71, and 150 ML062980638 11/30/2006 63 FR 1890; 63 FR 13773 ML063380019 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) Massachusetts has adopted Final Regulations equivalent to RATS ID:

2002-2.

1998-4 Licenses for Industrial Radiography and Radiation 07/09/2001 Final No Comments Safety Requirements for Industrial Radiographic ML062980638 11/30/2006 Operations ML063380019 Part 34 63 FR 37059 1998-5 Minor Corrections, Clarifying Changes, and a Minor 10/26/2001 Final No Comments Policy Change ML062980638 11/30/2006 Parts 20, 32, 35, 36, and 39 ML063380019 63 FR 39477; 63 FR 45393 5

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 1998-6 Transfer for Disposal and Manifests: Minor 11/20/2001 Final No Comments Technical Conforming Amendment ML062980638 11/30/2006 Part 20 ML063380019 63 FR 50127 1999-1 Radiological Criteria for License Termination of 06/11/2002 Not Applicable Not Applicable Massachusetts does not have Uranium Recovery Facilities authority to regulate this material Part 40 under its Agreement.

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 ML062980638 11/30/2006 Part 20 ML063380019 64 FR 54543; 64 FR 55524 2000-1 Energy Compensation Sources for Well Logging 05/17/2003 Final No Comments and Other Regulatory Clarifications ML062980638 11/30/2006 Part 39 ML063380019 65 FR 20337 No Comments 2000-2 New Dosimetry Technology 01/08/2004 Final 11/30/2006 Parts 34, 36, and 39 ML062980638 ML063380019 65 FR 63750 2001-1 Requirements for Certain Generally Licensed 02/16/2004 Final No Comments Industrial Devices Containing Byproduct Material ML062980638 11/30/2006 Parts 30, 31, and 32 ML063380019 65 FR 79162 6

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 2002-1 Revision of the Skin Dose Limit 04/05/2005 Final No Comments Part 20 ML062980638 11/30/2006 67 FR 16298 ML063380019 2002-2 Medical Use of Byproduct Material 10/24/2005 Final No Comments Parts 20, 32, and 35 ML062980638 11/30/2006 67 FR 20249 ML063380019 2003-1 Financial Assurance for Materials Licensees 12/03/2006 Final No Comments Parts 30, 40, and 70 ML14007A051 03/06/2014 68 FR 57327 ML140070502004-1 Compatibility With IAEA Transportation Safety 10/01/2007 Final Comments Standards and Other Transportation Safety ML14007A051 03/06/2014 Amendments ML14007050 Part 71 69 FR 3697 Revised Final No Comments (not all previous 01/16/2015 comments were ML14343A367 addressed)

ML14344A254 2005-1 Security Requirements for Portable Gauges 07/11/2008 Final No Comments Containing Byproduct Material ML120860009 05/03/2012 Part 30 ML120960551 70 FR 2001 2005-2 Medical Use of Byproduct Material - Recognition of 04/29/2008 Final No Comments Specialty Boards ML14007A051 03/06/2014 Part 35 ML1400705070 FR 16336; 71 FR 1926 2005-3 Increased Controls for Risk-Significant Radioactive 12/01/2005 License No Comments Sources (NRC Order EA-05-090) Condition 10/04/2005 70 FR 72128 ML080110677 ML052780024 7

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 2006-1 Minor Amendments 03/27/2009 Final No Comments Parts 20, 30, 32, 35, 40, and 70 ML14007A051 03/06/2014 71 FR 15005 ML140070502006-2 National Source Tracking System - Serialization 02/06/2007 License No Comments Requirements Condition 02/16/2007 Part 32 with reference to Part 20 Appendix E ML070360500 ML070470063 71 FR 65685 2006-3 National Source Tracking System 01/31/2009 Final No Comments Part 20 ML102850241 11/10/2010 71 FR 65685, 72 FR 59162 ML102990077 License No Comments Condition 10/20/2008 ML082760641 ML082800024 2007-1 Medical Use of Byproduct Material - Minor 10/29/2010 Final No Comments Corrections and Clarifications ML14007A051 03/06/2014 Parts 32 and 35 ML1400705072 FR 45147, 54207 2007-2 Exemptions From Licensing, General Licenses, and 12/17/2010 Final Comments Distribution of Byproduct Material: Licensing and ML14007A051 03/06/2014 Reporting Requirements ML14007050 Parts 30, 31, 32, and 150 72 FR 58473 Revised Final No Comments (not all previous 01/16/2015 comments were ML14343A367 addressed)

ML14344A254 8

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 2007-3 Requirements for Expanded Definition of Byproduct 11/30/2010 Final Comments Material ML14007A051 03/06/2014 Parts 20, 30, 31, 32, 33, 35, 61, and 150 ML1400705072 FR 55864 Revised Final No Comments (not all previous 1/16/2015 comments were ML14343A367 addressed)

ML14344A254 2007-4 Order Imposing Fingerprinting Requirements and 06/05/2008 License No Comments Criminal History Records Check Requirements for Condition 04/14/2008 Unescorted Access to Certain Radioactive Material ML080800501 ML081050505 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 ML120860009 05/03/2012 Parts 19 and 20 ML120960551 72 FR 68043 2009-1 Medical Use of Byproduct Material - Authorized 09/28/2012 Final No Comments User Clarification ML14007A051 03/06/2014 Part 35 ML1400705074 FR 33901

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 2011-2 Licenses, Certifications, and Approvals for Materials 11/14/2014 Proposed No Comments Licensees ML14344A254 01/16/2015 Parts 30, 36, 39, 40, 70, and 150 ML14343A367 76 FR 56951 Final ML16070A231 No Comments 04/11/2016 ML16070A227 2012-1 Change of Compatibility of 10 CFR 31.5 and 31.6 01/25/2015 Final No Comments (See RATS ID: 2001-1 for Rule text) ML14007A051 03/06/2014 77 FR 3640 ML140070502012-2 Advance Notification to Native American Tribes of 08/10/2015 Proposed Comments Transportation of Certain Types of Nuclear Waste ML14344A254 1/16/2015 Part 71 ML14343A367 77 FR 34194 Final ML16070A231 No Comments 04/11/2016 ML160702272012-3 Technical Corrections 08/06/2015 Proposed No Comments Parts 30, 34, 40, and 71 ML14344A254 01/16/2015 77 FR 39899 ML14343A367 Final ML16070A231 No Comments 04/11/2016 ML16070227

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 2013-1 Physical Protection of Byproduct Material, 10 CFR 03/19/2016 Proposed No Comments Parts 20, 30, 32, 33, 34, 35, 36, 37, 39, and 71 ML15127A416 06/29/2015 78 FR 16922 ML15127A375 Final ML16070A231 No Comments 04/11/2016 ML16070A227

  • 2015-3 Revisions to Transportation Safety Requirements 07/13/2018 Proposed Comments and Harmonization with International Atomic *extended to ML17059D085 03/28/2017 Energy Agency Transportation Requirements 08/15/2020 ML17059D084 Part 71 See STC 17-060 80 FR 33987 Final Comments ML18264A253 11/02/2018 ML18264A222 11

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package Final No Comments 2015-4 Miscellaneous Corrections 09/02/2018 ML16070A231 04/11/2016 Parts 37 and 40 ML1607022780 FR 45841 Final 2015-5 Miscellaneous Corrections 12/31/2018 ML16070A231 No Comments Parts 19, 20, 30, 32, 37, 40, 61, 70, 71, and 150 04/11/2016 80 FR 74974 ML160702272018-1 Medical Use of Byproduct Material - Medical Event 01/14/2022 Definitions, Training and Experience, and Clarifying Amendments Parts 30, 32, and 35 12