ML18253A164: Difference between revisions

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     .07(45)                                      material for uptake, dilution, and excretion studies for which a written directive is not required AL lists the wrong references in 420-3-26-.07(45)(b). AL needs to correct this provision to say an authorized user and who meets the requirements specified in 420-3-26-.07(51) or 420-Enclosure
     .07(45)                                      material for uptake, dilution, and excretion studies for which a written directive is not required AL lists the wrong references in 420-3-26-.07(45)(b). AL needs to correct this provision to say an authorized user and who meets the requirements specified in 420-3-26-.07(51) or 420-Enclosure


STATE SECTION NRC SECTION    RATS ID  CATEGORY SUBJECT and COMMENTS 3-26-.07(56) and 420-3                                                .07(51)(c)(1)(ii)(VII), or an individual
STATE SECTION NRC SECTION    RATS ID  CATEGORY SUBJECT and COMMENTS 3-26-.07(56) and 420-3                                                .07(51)(c)(1)(ii)(VII), or an individual AL needs to make the above change in order to meet the Compatibility Category H&S designation assigned to 10 CFR 35.100.
 
AL needs to make the above change in order to meet the Compatibility Category H&S designation assigned to 10 CFR 35.100.
AL did not address comments pertaining to 420-3-26-.07 in this rule making. AL will address this comment at a later date.
AL did not address comments pertaining to 420-3-26-.07 in this rule making. AL will address this comment at a later date.
COMMENT STANDS FROM NRC LETTER DATED AUGUST 19, 2016 and DECEMBER 27, 2016.
COMMENT STANDS FROM NRC LETTER DATED AUGUST 19, 2016 and DECEMBER 27, 2016.

Latest revision as of 17:33, 2 February 2020

Letter to D. Turberville Alabama Proposed Regulations to Rats Ids: 2015-3 and 2015-4; and Revised Final Regulations to Rats Ids: 2007-1, 2007-3, and 2013-2
ML18253A164
Person / Time
Issue date: 10/16/2018
From: Sabrina Atack
NRC/NMSS/DMSST
To: Turberville D
State of AL, Dept of Public Health, Office of Radiation Control
Beardsley M
Shared Package
ML18236A295 List:
References
Download: ML18253A164 (20)
v • d • e


Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 October 16, 2018 David Turberville, Assistant Director Office of Radiation Control Alabama Department of Public Health P.O. Box 303017 Montgomery, AL 36130-3017

Dear Mr. Turberville:

We have reviewed the proposed revisions to the Alabama regulations 420-3-26-.02, received by our office on August 23, 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) 2007-1, 2007-3, 2013-2, 2015-3, and 2015-4 as identified in the enclosed State Regulation Status (SRS) Data Sheet. We discussed our review of the regulations with you on October 11, 2018.

As a result of our review, we have four 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 Alabama 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 Alabama 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 Alabama 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.

D. Turberville 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 (267) 884-2305 (Michelle.Beardsley@nrc.gov) or Monica Ford at (610) 337-5214 (Monica.Ford@nrc.gov).

Sincerely,

/RA Paul Michalak for/

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

Enclosures:

1. Compatibility Comments
2. Alabama SRS Data Sheet

D. Turberville

SUBJECT:

ALABAMA PROPOSED REGULATIONS TO RATS IDS: 2015-3 AND 2015-4 AND REVISED FINAL REGULATIONS TO RATS IDS: 2007-1, 2007-3, AND 2013-2 DISTRIBUTION: SP[05]

[MFord], RSAO

[AL] File OFFICE RI ASPB OGC ASPB:BC MSTR:DD NAME MFord MBeardsley TBarczy NLO PMichalak PMichalak for via email SAtack DATE 9/5/18 9/5/18 9/25/18 10/16/18 10/16/18 ML18253A164 OFFICIAL RECORD COPY Package ML18236A295

COMPATIBILITY COMMENTS ON ALABAMA REGULATIONS STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 1 420-3 32.72 2007-1 B Manufacture, preparation, or

.02(10)(t) 2007-3 transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under Part 35.

AL omits an equivalent regulation to 10 CFR 32.72(b)(3). AL needs to add an equivalent regulation to 10 CFR 32.72(b)(3) to 420-3-26-.2(10)(t) to meet the requirements of a Compatibility Category B designation.

AL omits no later than 30 days after the date that the licensee allows, under paragraphs 420-3 .02(10)(t)(2)(ii)(I) and (III), the individual to work as an authorized nuclear pharmacist from the end of 420-3-26-.02(10)(t)(5)(v).

AL needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 32.72.

COMMENT STANDS FROM NRC LETTERS DATED AUGUST 19, 2016 AND DECEMBER 27, 2016.

AL states in an enclosure to its letter dated August 21, 2018 that no changes were made to address this comment.

2 420-3 35.100 2007-3 H&S Use of unsealed byproduct

.07(45) material for uptake, dilution, and excretion studies for which a written directive is not required AL lists the wrong references in 420-3-26-.07(45)(b). AL needs to correct this provision to say an authorized user and who meets the requirements specified in 420-3-26-.07(51) or 420-Enclosure

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 3-26-.07(56) and 420-3 .07(51)(c)(1)(ii)(VII), or an individual AL needs to make the above change in order to meet the Compatibility Category H&S designation assigned to 10 CFR 35.100.

AL did not address comments pertaining to 420-3-26-.07 in this rule making. AL will address this comment at a later date.

COMMENT STANDS FROM NRC LETTER DATED AUGUST 19, 2016 and DECEMBER 27, 2016.

3 420-3 40.13 2013-2 B Unimportant quantities of source

.02(3) material Alabama references the incorrect NRC regulation in 420-3 .02(3)(c)(10)(ii). Alabama needs to change the reference from Section 40.42 of 10 CFR Part 40 to Section 40.52 of 10 CFR Part 40.

Alabama needs to make the above change in order to meet the Compatibility Category B designation assigned to 10 CFR 40.13(c)(10)(ii).

4 420-3 10 CFR Part 71 2015-3 Various 10 CFR Part 71 Transportation

.02(21)

Alabama needs to delete 420-3 .02(21)(b)(1)(i) and (ii) and replace them with the following:

(i) Where the words NRC, Commission, Nuclear Regulatory Commission, United States Nuclear Regulatory Commission or Administrator of the appropriate Regional 2

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS Office appear in 10 CFR Part 71, substitute the words [State]

Department/Agency except when used in 10 CFR 71.5 (b), 71.10, 71.17(c)(3), and (e),

71.85(c), 71.88(a)(4),

71.93(c), 71.95, 71.97(c),

(c)(3)(iii), and (f).

(ii) The terms certificate of compliance, compliance holder or applicant apply to the NRC as they are the sole authority for issuing a package Certificate of Compliance.

(iii) 10 CFR 71.9 employee protection also applies to violations of [State]

Administrative Code in XXXXX.

(iv) Alabama form number XXXX, Notice to Employees, must be posted instead of NRC Form 3 that is specified in 10 CFR Part 71.

Alabama needs to make the above change in order to meet the various Compatibility Category designations assigned to 10 CFR Part 71.

3

STATE REGULATION STATUS State: Alabama Tracking Ticket Number: 18-50 Date: October 16, 2018

[ 5 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 Letter Package Adoption 1991-1 Safety Requirements for Radiographic Equipment 01/10/1994 Final No Comments Alabama has adopted Final Part 34 04/02/1994 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 Alabama 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 11/19/1997 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 04/02/1994 56 FR 64980 1992-1 Quality Management Program and 01/27/1995 Final No Comments Alabama has adopted Final Misadministrations 04/02/1994 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 Letter Package Adoption 1993-1 Decommissioning Recordkeeping and License 10/25/1996 Final No Comments Termination: Documentation Additions [Restricted 06/05/1998 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 06/05/1998 Part 36 58 FR 7715 1993-3 Definition of Land Disposal and Waste Site QA 07/22/1996 Not Applicablei Not Applicable Alabama does not have any Program licensees subject to these Part 61 regulations. (See SECY-95-112) 58 FR 33886 1994-1 Self-Guarantee as an Additional Financial none Final No Comments These regulation changes are not Mechanism 06/05/1998 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 Alabama does not have authority to NRC Requirements to EPA Standards regulate this material under its Part 40 Agreement 59 FR 28220 1994-3 Timeliness in Decommissioning Material Facilities 08/15/1997 Final No Comments Parts 30, 40 and 70 06/05/1998 59 FR 36026 1995-1 Preparation, Transfer for Commercial Distribution, 01/01/1998 Final No Comments and Use of Byproduct Material for Medical Use 06/05/1998 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 Letter Package Adoption 1995-2 Frequency of Medical Examinations for Use of 03/13/1998 Final No Comments Respiratory Protection Equipment 06/05/1998 Part 20 60 FR 7900 1995-3 Low-Level Waste Shipment Manifest Information 03/01/1998 Final No Comments and Reporting 06/05/1998 Parts 20 and 61 60 FR 15649; 60 FR 25983 1995-4 Performance Requirements for Radiography 06/30/1998 Not Required Not required Alabama 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 06/05/1998 Parts 19 and 20 60 FR 36038 1995-6 Clarification of Decommissioning Funding 11/24/1998 Final No Comments Requirements 06/05/1998 Parts 30, 40 and 70 60 FR 38235 1995-7 Medical Administration of Radiation and Radioactive 10/20/1998 Final No Comments Alabama has adopted Final Materials 08/29/2000 Regulations equivalent to RATS IDs Parts 20 and 35 2002-2 and 2005-2 60 FR 48623 (Superceded by 2002-2 and 2005-2) 3

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Letter Package Adoption 1996-1 Compatibility with the International Atomic Energy 04/01/1999 Final No Comments Alabama has not yet adopted RATS Agency 08/29/2000 ID 2004-1 in final.

Part 71 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 Recordkeeping Requirements 08/29/2000 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 08/29/2000 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 08/29/2000 Agreement State Part 150 62 FR 1662 1997-3 Criteria for the Release of Individuals Administered 05/29/2000 Final No Comments Radioactive Material 08/29/2000 Parts 20 and 35 62 FR 4120 4

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Letter Package Adoption 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 08/29/2000 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 08/29/2000 62 FR 39057 1997-7 Exempt Distribution of a Radioactive Drug 01/02/2001 Final No Comments Containing One Microcurie of Carbon-14 Urea 06/05/1998 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 10/01/2001 63 FR 1890; 63 FR 13773 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) Alabama has adopted Final Regulations equivalent to RATS IDs 2002-2.

5

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Letter Package Adoption 1998-4 Licenses for Industrial Radiography and Radiation 07/09/2001 Final No Comments Safety Requirements for Industrial Radiographic 08/29/2000 Operations Part 34 63 FR 37059 1998-5 Minor Corrections, Clarifying Changes, and a Minor 10/26/2001 Final No Comments Policy Change 08/29/2000 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 08/29/2000 Part 20 63 FR 50127 1999-1 Radiological Criteria for License Termination of 06/11/2002 Not Applicable Not Applicable Alabama does not have authority to Uranium Recovery Facilities regulate this material under its Part 40 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 ML021090092 04/25/2002 Part 20 ML021160517 64 FR 54543; 64 FR 55524 6

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Letter Package Adoption 2000-1 Energy Compensation Sources for Well Logging 05/17/2003 Final No Comments and Other Regulatory Clarifications ML062000076 08/10/2006 Part 39 ML062220014 65 FR 20337 2000-2 New Dosimetry Technology 01/08/2004 Final No Comments Parts 34, 36 and 39 ML062000076 08/10/2006 65 FR 63750 ML062220014 2001-1 Requirements for Certain Generally Licensed 02/16/2004 Final No Comments Industrial Devices Containing Byproduct Material ML062000076 08/10/2006 Parts 30, 31 and 32 ML062220014 65 FR 79162 2002-1 Revision of the Skin Dose Limit 04/05/2005 Final No Comments Part 20 ML052940420 11/08/2005 67 FR 16298 ML053120389 2002-2 Medical Use of Byproduct Material 10/24/2005 Final No Comments Parts 20, 32 and 35 ML062000076 08/10/2006 67 FR 20249 ML062220014 2003-1 Financial Assurance for Materials Licensees 12/03/2006 Final No Comments Parts 30, 40 and 70 ML062000076 08/10/2006 68 FR 57327 ML062220014 2004-1 Compatibility With IAEA Transportation Safety 10/01/2007 Final Comments Standards and Other Transportation Safety ML14293A397 12/16/2014 Amendments ML14290A377 Part 71 69 FR 3697 Revised Final No Comments ML16203A187 08/19/2016 ML16203A174 7

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Letter Package Adoption 2005-1 Security Requirements for Portable Gauges 07/11/2008 Final No Comments Containing Byproduct Material ML13176A135 09/18/2013 Part 30 ML13176A123 70 FR 2001 License Condition Comments ML081960176 07/28/2008 ML082100083 2005-2 Medical Use of Byproduct Material - Recognition of 04/29/2008 Final No Comments Specialty Boards ML062000076 08/10/2006 Part 35 ML062220014 70 FR 16336; 71 FR 1926 2005-3 Increased Controls for Risk-Significant Radioactive 12/01/2005 License Condition No Comments Sources (NRC Order EA-05-090) ML052570218 09/15/2005 70 FR 72128 ML052620319 2006-1 Minor Amendments 03/27/2009 Final Comments Parts 20, 30, 32, 35 40 and 70 ML13176A135 09/18/2013 71 FR 15005 ML13176A123 2006-2 National Source Tracking System - Serialization 02/06/2007 Final Comments Requirements ML13176A135 09/18/2013 Part 32 with reference to Part 20 Appendix E ML13176A123 71 FR 65685 2006-3 National Source Tracking System 01/31/2009 Final No Comments Part 20 ML13176A135 09/18/2013 71 FR 65685, 72 FR 59162 ML13176A123 License Condition No Comments ML082820556 10/21/2008 ML082820596 8

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

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

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Letter Package Adoption 2011-2 Licenses, Certifications, and Approvals for Materials 11/14/2014 Final No Comments Licensees ML15127A281 06/11/2015 Parts 30, 36, 39, 40, 70 and 150 ML15127A276 76 FR 56951 2012-1 Change of Compatibility of 01/25/2015 Final Comments Parts 31.5 and 31.6 ML15127A281 06/11/2015 (See RATS ID: 2001-1 for Rule text) ML15127A276 77 FR 3640 Revised Final No Comments ML16203A187 08/19/2016 ML16203A174 2012-2 Advance Notification to Native American Tribes of 08/10/2015 Final Comments Transportation of Certain Types of Nuclear Waste ML16076A374 04/22/2016 Part 71 ML16076A369 77 FR 34194 Revised Final No Comments ML16203A187 08/19/2016 ML16203A174 2012-3 Technical Corrections 08/06/2015 Final Comments Parts 30, 34, 40 and 71 ML14293A397 12/16/2014 77 FR 39899 ML14290A377 Revised Final Comments ML16203A187 08/19/2016 ML16203A174 11

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Letter Package Adoption 2012-4 Requirements for Distribution of Byproduct Material 10/23/2015 Final Comments Parts 30, 31, 32, 40 and 70 ML14293A397 12/16/2014 77 FR 43666 ML14290A377 Revised Final Comments ML16203A187 08/19/2016 ML16203A174 Revised Final No Comments ML16314E173 12/27/2016 ML16314D996 2013-1 Physical Protection of Byproduct Material 03/19/2016 Proposed Comments Parts 20, 30, 32, 33, 34, 35, 36, 37, 39 and 71 ML15252A268 10/15/2015 78 FR 16922 ML15252A240 Final Comment Comment is regarding 30.13 ML15323A029 12/16/2015 ML15323A030 Revised Final No Comments ML16203A187 08/19/2016 ML16203A174

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Letter Package Adoption 2015-1 Domestic Licensing of Special Nuclear Material - 01/26/2018 Proposed No Comments Written Reports and Clarifying Amendments ML18052B061 03/16/2018 Part 70 ML18052B059 79 FR 57721, 80 FR 143 2015-2 Safeguards Information - Modified Handling 01/28/2018 Proposed No Comments Categorization, Change for Materials Facilities ML18095A804 4/27/2018 Parts 30, 37, 73 and 150 ML18095A803 79 FR 58664, 80 FR 3865 Final No Comments ML18186A523 07/17/2018 ML18186A519

  • 2015-3 Revisions to Transportation Safety Requirements 07/13/2018 Proposed Comments and Harmonization with International Atomic Energy *extended to ML18236A301 10/16/2018 Agency Transportation Requirements 08/15/2020 ML18236A295 Part 71 See STC 17-80 FR 33987 060

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