ML19224A407

Letter to J. Hyland Maine Proposed Regulations to Rats Ids 2011-1, 2012-2, 2012-3, 2012-4, 2013-1, 2013-2, 2015-1, 2015-2, 2015-3, 2015-4, 2015-5, 2018-1, and 2018-2

ML19224A407
Person / Time
Issue date:	09/30/2019
From:	Kevin Williams NRC/NMSS/DMSST
To:	Hyland J State of ME, Div of Environmental Health
BEARDSLY M/NMSS
Shared Package
ML19218A076	List: ML19218A106 ML19224A407
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Download: ML19224A407 (35)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 September 30, 2019 Jay Hyland, Manager Division of Environmental Health Maine Radiation Control Program 286 Water Street, 11 State House Station Augusta, ME 04333

Dear Mr. Hyland:

We have reviewed the proposed revisions to the Maine Rules Relating to Radiation Safety, received by our office on July 24, 2019. 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) 2011-1, 2012-2, 2012-3, 2012-4, 2013-1

[included in Maine proposed revisions although not noted in Maines letter], 2013-2, 2015-1, 2015-2, 2015-3, 2015-4, 2015-5, 2018-1, and 2018-2 as identified in the enclosed State Regulation Status (SRS) Data Sheet. We discussed our review of the regulations with Tom Hillman on September 30, 2019.

As a result of our review, we have 45 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 Maine 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 Maine 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 Maine 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. Hyland 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 Monica Ford at (610) 337-5214 (Monica.Ford@nrc.gov).

Sincerely,

/RA/ PMichalak 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. Maine SRS Data Sheet

J. Hyland

SUBJECT:

LETTER TO J. HYLAND, MAINE PROPOSED REVISIONS TO RATS ID 2011-1, 2012-2, 2012-3, 2012-4, 2013-1 2013-2, 2015-1, 2015-2, 2015-3, 2015-4, 2015-5, 2018-1, AND 2018-2 DISTRIBUTION: SP[05]

DIR RF (19-42)

MFord, RSAO MEFile OFFICE RI SALPB OGC SALPB:BC MSTR:DD NAME MFord MBeardsley CEngland NLO PMichalak KWilliams via email (PMichalakfor)

DATE 8/9/19 8/12/19 9/30/19 9/30/19 9/30/19 ML19224A407 OFFICIAL RECORD COPY Package ML19218A076

COMPATIBILITY COMMENTS ON MAINE PROPOSED REGULATIONS STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 1 D.1404.A 20.1404(a) 2011-1 C Alternate criteria for license termination Maine omits the following language from the beginning of D.1404.A(5):

Has provided sufficient financial assurance Maine needs to add the above language to the beginning of D.1404.A(5) in order to meet the Compatibility Category C designation assigned to 10 CFR 20.1404(a).

2 C.14.B 30.34(b) 2011-1 C Terms and conditions of licenses Maine needs to change the reference in C.14.B(1)(b) from C.25 to C.8.F.

Maine needs to make the above change to C.14.B in order to meet the Compatibility Category C designation assigned to 10 CFR 30.34(b).

3 C.8.F 30.35(e) 2011-1 H&S Financial assurance and recordkeeping for decommissioning Maine needs to remove the references to the NRCs regulations in C.8.F(5)(a)(ii) and replace them with the equivalent Maine regulations (D.1402 and D.1403).

Maine needs to make the above change in order to meet the Compatibility Category H&S designation assigned to 10 CFR 30.35(e).

4 C.8.F 40.36(d) 2011-1 H&S Financial assurance and recordkeeping for decommissioning

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS Maine needs to remove the references to the NRCs regulations in C.8.F(5)(a)(ii) and replace them with the equivalent Maine regulations (D.1402 and D.1403).

Maine needs to make the above change in order to meet the Compatibility Category H&S designation assigned to 10 CFR 40.36(d).

5 C.14.B 40.46 2011-1 C Inalienability of licenses Maine needs to change the reference in C.14.B(1)(b) from C.25 to C.8.F.

Maine needs to make the above change in order to meet the Compatibility Category C designation assigned to 10 CFR 40.46.

6 C.8.F 70.25(e) 2011-1 H&S Financial assurance and recordkeeping for decommissioning Maine needs to remove the references to the NRCs regulations in C.8.F(5)(a)(ii) and replace them with the equivalent Maine regulations (D.1402 and D.1403).

Maine needs to make the above change in order to meet the Compatibility Category H&S designation assigned to 10 CFR 70.25(e).

7 C.14.B 70.36 2011-1 C Inalienability of licenses Maine needs to change the reference in C.14.B(1)(b) from C.25 to C.8.F.

Maine needs to make the above change in order to meet the Compatibility Category C designation assigned to 10 CFR 70.36.

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 8 Part L 10 CFR Part 71 2012-2 Various 10 CFR Part 71 - Transportation 2015-3 Maine needs to make the following changes to Part L.

1) Maine needs to add the following sections to L.1.B: 71.11, 71.85(a)-(c),

71.91(b), 71.107, 71.109, 71.111, 71.113, 71.115, 71.117, 71.119, 71.121, 71.123, and 71.125.

2) Maine needs to change L.2 to read as follows:

Effect of Incorporation of 10 CFR Part 71 (effective date June 14, 2015). To reconcile differences between this part and the incorporated sections of 10 CFR Part 71 (relating to packaging and transportation of radioactive material),

the following words and phrases are substituted for the language in 10 CFR Part 71 as follows:

A. Where the words NRC, Commission, Nuclear Regulatory Commission, United States Nuclear Regulatory Commission, or Administrator of the appropriate Regional 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).

B. 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.

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

3) 10 CFR 71.9 employee protection also applies to violations of Maine Administrative Code in XXXXX.

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

Maine needs to make the above changes in order to meet the Compatibility Category designations assigned to 10 CFR 71.

9 E.5 34.20(a)(1) 2012-3 B Performance requirements for industrial radiography equipment Maine omits where the publication may be purchased from in E.5.A.

Maine needs to add the publication purchase information to E.5.A in order to meet the Compatibility Category B designation assigned to 10 CFR 34.20(a)(1).

10 C.3.C(1) 30.15(a)(2) 2012-4 B Certain items containing byproduct material Maine does not have equivalent regulation text to 10 CFR 30.15(a)(2)(iii) in C.3.C(1).

Maine needs to add equivalent text from 30.15(a)(2)(iii) to C.3.C(1) in order to meet the Compatibility Category B designation assigned to 10 CFR 30.15(a)(2).

11 C.3.C(6) & 30.22 2012-4 B Certain industrial devices (7)

Maine references C.7 as the equivalent to 10 CFR 32.30 in C.3.C(6) and C.3.C(7). However, 10 CFR 32.30 is a Compatibility Category NRC, so Maine should not have an equivalent regulation to 10

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS CFR 32.30. Therefore Maine needs to reference in accordance with a specific license issued under 10 CFR 32.30 in C.3.C(6) and C.3.C(7).

Maine needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 30.22.

12 C.11.C 32.26 2012-4 NRC Gas and aerosol detectors containing byproduct material:

Requirements for license to manufacture, process, produce, or initially transfer 10 CFR 32.26 is a Compatibility Category NRC, which means that Agreement States do not have authority for this activity. Maine states that a license will be issued if it meets the requirements in 10 CFR 32.26. Maine cannot issue this license as it needs to be issued by the NRC. Maine needs to delete Section C.11.C from its regulations.

Maine needs to make the above change in order to meet the Compatibility Category NRC designation assigned to 10 CFR 32.26.

13 C.11.D 32.51(a)(6) 2012-4 B Byproduct material contained in devices for use under § 31.5; requirements for license to manufacture, or initially transfer Maine omits an equivalent regulation to 10 CFR 32.51(a)(6) from C.11.D(1)(b).

Maine needs to add the equivalent language in order to meet the Compatibility Category B designation assigned to 10 CFR 32.51(a)(6).

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 14 C.11.E(3) 32.55 2012-4 B Same: Quality assurance, prohibition of transfer Maine needs to add the NRC or between equivalent general license of and an Agreement State in C.11.E(3).

Maine needs to make the above change in order to meet the Compatibility Category B designation assigned to 10 CFR 32.55.

15 C.11.E(5) 32.56 2012-4 B Same: Material transfer reports

1) Maine needs to remove the two references to 10 CFR 31.7 from C.11.E(5)(a) and replace it with C.6.D.

2) Maine needs to change the reference in C.11.E(5)(b) from C.11.F to C.11.E.

Maine needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 32.56.

16 C.11.F(4) 32.59 2012-4 B Same: Leak testing of each source Maine needs to add the NRC or between equivalent regulations of and an Agreement State in the two locations that appear in C.11.F(4).

Maine needs to make the above change in order to meet the Compatibility Category B designation assigned to 10 CFR 32.59.

17 C.11.I(1)(f) 32.61(f) 2012-4 B Ice detection devices containing strontium 90; requirements for license to manufacture or initially transfer Maine needs to change (f)(3) to

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS (f)(iii) in C.11.I(1)(f)(ii).

Maine needs to make the above change in order to meet the Compatibility Category B designation assigned to 10 CFR 32.61(f).

18 C.11.I(2) 32.62(c), (d), (e) 2012-4 B Same: Quality assurance; prohibition of transfer

1) Maine needs to replace under an equivalent general license of an Agreement State with under an equivalent NRC or Agreement State general license in C.11.I(2)(e).

2) Maine needs to change (c)(2) to (c)(ii) in C.11.I(2)(e)(ii).

Maine needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 32.62(c), (d), and (e).

19 N/A 32.210 2012-4 B&C Registration of product information

1) Maine directly references 10 CFR 32.210 as a part of several other regulations. However, Maine does not directly adopt 10 CFR 32.210 by reference. Since Maine has the authority to regulate SS&D evaluations, Maine needs to include equivalent rule text or a specific adoption by reference in its regulations.

2) Additionally, Maine needs to state that a reference to the NRC means the Agency if adopting 10 CFR 32.210 by reference.

Maine needs to make the above changes in order to meet the Compatibility Category B and C designations assigned to 10 CFR

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 32.210.

20 N/A 32.211 2012-4 B Inactivation of certificates of registration of sealed sources and devices Maine does not have an equivalent regulation to 10 CFR 32.211. Since Maine has SS&D authority, this regulation is a Compatibility Category B.

Maine needs to adopt an equivalent regulation to 10 CFR 32.211 in order to meet the Compatibility Category B designation assigned to 10 CFR 32.211.

21 A.3.C 30.13 2013-1 B Carriers Maine needs to add or storage incident thereto to the end of A.3.C.

Maine needs to make the above change in order to meet the Compatibility Category B designation assigned to 10 CFR 30.13.

22 Part S 10 CFR Part 37 2013-1 Various 10 CFR Part 37 2015-2 2015-4 Maine incorporates 10 CFR Part 37 2018-2 by reference. Maine needs to make the following changes to Part S:

1) Add the following statement in S.1:

All of the requirements in Part S apply to both licensees and registrants. "Registrant" means any person who is registered with the Agency and is legally obligated to register with the Agency pursuant to article [XX and STATE Code chapter XXX]. "Registration" means the notification to the Agency of possession of a source of radiation and the furnishing of information with respect thereto, in accordance with

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

[Maine Code chapter XX].

2) Add the following substitutions to the list in S.2: A reference in 10 CFR part 37 to "license" includes "registration," a reference to "licensee" includes "registrant," a reference to "licensed" includes "registered," a reference to "licensed material(s)" includes "registered source of radiation," and a reference to "licensed radioactive material" includes "registered source of radiation."

3) Change S.2.L to reference the appropriate State of Maine Legislative Code.

4) Remove Licensing State from S.2.B.

Maine needs to make the above changes in order to meet the Compatibility Category designations assigned to 10 CFR Part 37.

23 C.2.C(10) 40.13(c)(10) 2013-2 B Unimportant quantities of source material Maine needs to add the NRC or between equivalent regulations of and an Agreement State in C.2.C(10).

Maine needs to add the NRC or between source material by and an Agreement State in C.2.C.(10)(b).

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

24 C.5.A 40.22(e) 2013-2 B Small quantities of source material Maine needs to add the NRC or

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS between equivalent regulations of and an Agreement State and between equivalent provisions of and an Agreement State in C.5.A.

Maine needs to make the above change in order to meet the compatibility category B designation assigned to 10 CFR 40.22(e).

25 C.21.E 40.54 2013-2 B Requirements for license to initially transfer source material for use under the small quantities of source material general license Maine needs to add the NRC or between equivalent regulations of and an Agreement State in C.21.E(1).

Maine needs to make the above change in order to meet the Compatibility Category B designation assigned to 10 CFR 40.54.

26 C.21.F(3) 40.55(c) 2013-2 B Conditions of licenses to initially transfer source material for use under the small quantities of source material general license:

Quality control, labeling, safety instructions, and records and reports Maine needs to add NRC or before Agreement State in C.21.F(3) and (3)(i).

Maine needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 40.55(c).

27 C.21.F(4) 40.55(d) 2013-2 B Conditions of licenses to initially transfer source material for use under the small quantities of source material general license:

Quality control, labeling, safety

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS instructions, and records and reports Maine needs to add a reference to the NRC in each location that also mentions Agreement States in C.21.F(4). For example, in C.21.F(4)(i)(b), Maine needs to add NRC or before Agreement State provisions.

Maine needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 40.55(d).

28 C.21.F(5) 40.55(e) 2013-2 C Conditions of licenses to initially transfer source material for use under the small quantities of source material general license:

Quality control, labeling, safety instructions, and records and reports Maine needs to revise the end of C.21.F(5) to read, in a report to the Agency, the NRC, or an Agreement State.

Maine needs to make the above change in order to meet the Compatibility Category C designation assigned to 10 CFR 40.55(e).

29 N/A 70.50 2015-1 C Reporting requirements Maine cites D.2201.B in its crosswalk as an equivalent regulation to 10 CFR 70.50(c)(2), however overall D.2201 is not an equivalent section to 10 CFR 70.50.

Maine needs to add a regulation equivalent to 10 CFR 70.50 in order to meet the Compatibility Category C designation assigned to 10 CFR 70.50.

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 30 G.2 35.2 2018-1 B Definitions Maine needs to replace the Commission or an Agreement State with the Agency, the NRC, or an Agreement State in (2)(a) for the definition of Associate Radiation Safety Officer.

Maine needs to replace the Commission or an Agreement State with the Agency, the NRC, or an Agreement State in (2)(a) and replace a Commission or Agreement State with an Agency, Commission, or Agreement State in (2)(b) for the definition of Ophthalmic Physicist.

Maine needs to make the above changes in order to meet the Compatibility Category B designation assigned to the definitions of Associate Radiation Safety Officer and Ophthalmic Physicist in 10 CFR 35.2.

31 G.50 35.50 2018-1 B Training for radiation safety officer and associate radiation safety officer

1) Maine needs to remove the reference to paragraph E from G.50.A.

2) Maine needs to replace a Commission or an Agreement State license with an Agency, NRC, or Agreement State license in G.50.B(1)(b).

3) Maine needs to replace on on [sic]

a NRC or an Agreement State license with on an Agency, NRC, or Agreement State license in G.50.C(2). Maine also needs to replace a permit issued by a NRC or an Agreement State licensee with a

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS permit issued by an Agency, NRC, or Agreement State licensee in G.50.C(2).

Maine needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 35.50.

32 G.51 35.51 2018-1 B Training for an authorized medical physicist

1) Maine needs to replace the NRC or an Agreement State with the Agency, the NRC, or an Agreement State in two locations in G.51.A.

2) Maine deletes the words, the Agency from G.51.A.(2)(a), however those words should remain. Maine needs to restore those words.

3) Maine needs to change the word certification to attestation in the second sentence of G.51.B(2) so that it reads, The written attestation must be signed Maine needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 35.51.

33 G.55 35.55 2018-1 B Training for an authorized nuclear pharmacist Maine needs to add the Agency in two locations in G.55.A. Specifically, Maine needs to replace the Nuclear Regulatory Commission, or an Agreement State with the Agency, the NRC, or an Agreement State in G.55.A. Maine also needs to replace the NRC or an Agreement State with the Agency, the NRC, or an Agreement State in G.55.A.

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS Maine needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 35.55.

34 G.57 35.57 2018-1 B Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist.

Maine needs to add the Agency in line with each instance of Nuclear Regulatory Commission or an Agreement State throughout G.57.

Maine needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 35.57.

35 G.190 35.190 2018-1 B Training for uptake, dilution, and excretion studies.

1) Maine needs to delete and who meets the requirements in G.190.C(2) from G.190.A.

2) Maine needs to replace or equivalent Agreement State requirements with or equivalent NRC or Agreement State requirements in G.190.C(2)(i) & (ii).

3) Maine needs to remove paragraph (c)(1) from G.190.C.(2)(ii) and replace it with G.190(C)(1).

Maine needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 35.190.

36 G.290 35.290 2018-1 B Training for imaging and localization studies

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS Maine needs to add NRC or between or equivalent and Agreement State requirements in G.290.C(2)(i) and in G.290(C)(2)(ii).

Maine needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 35.290.

37 G.390 35.390 2018-1 B Training for use of unsealed byproduct material for which a written directive is required

1) Maine needs to remove and G.390.B(2) from G.390.A.

2) Maine needs to add NRC or between or equivalent and Agreement State in G.390.B(2)(a) &

(b).

3) Maine needs to replace paragraph (b)(1) with G.390.B(1) in G.390.B(2)(b).

Maine needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 35.390.

38 G.392 35.392 2018-1 B Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)

Maine needs to add NRC or between or equivalent and Agreement State in G.392.C(3)(a) &

(b).

Maine needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 35.392.

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 39 G.394 35.394 2018-1 B Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries)

Maine needs to add NRC or between or equivalent and Agreement State in G.394.C(3)(a) &

(b).

Maine needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 35.394.

40 G.396 35.396 2018-1 B Training for the parenteral administration of unsealed byproduct material requiring a written directive Maine needs to add NRC or between or equivalent and Agreement State in G.396.B(2),

(3)(a), & (3)(b).

Maine needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 35.396.

41 G.433 35.433 2018-1 B: 35.433(a) Strontium-90 sources for (The ophthalmic treatments Compatibility Category for Maine needs to change paragraph 35.433(a) (b) to paragraph (B) in G.433.A.

has changed from H&S to Maine needs to add the Agency B). between the two instances of Commission and or Agreement H&S: State in G.433.A(2)(a).

35.433(b),

(b)(1) and Maine needs to make the above (b)(2) changes in order to meet the Compatibility Category designations D: 35.433(c) assigned to 10 CFR 35.433.

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 42 G.490 35.490 2018-1 B Training for use of manual brachytherapy sources Maine needs to add NRC or between or equivalent and Agreement State in G.490.B(3)(i) &

(ii).

Maine needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 35.490.

43 G.491 35.491 2018-1 B Training for ophthalmic use of strontium-90 Maine needs to delete who meets the definition of an authorized user in Part A.2 for the same uses or from G.491.B(3).

Maine needs to make the above change in order to meet the Compatibility Category B designation assigned to 10 CFR 35.491.

44 G.590 35.590 2018-1 B Training for use of sealed sources and medical devices for diagnosis Maine needs to add NRC or between or equivalent and Agreement State in G.590.B.

Maine needs to make the above change in order to meet the Compatibility Category B designation assigned to 10 CFR 35.590.

45 G.690 35.690 2018-1 B Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units Maine needs to add NRC or between or equivalent and Agreement State in G.690.B(3)(i) &

(ii).

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS Maine needs to make the above changes in order to meet the Compatibility Category B designation assigned to 10 CFR 35.690.

STATE REGULATION STATUS State: Maine Tracking Ticket Number: 19-42 Date: 09/30/2019

[ # 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 Maine has adopted Final Part 34 ML012710492 12/11/2001 Regulations equivalent to RATS ID:

55 FR 843 ML013520336 1997-5.

(Superceded by 1997-5) 1991-2 ASNT Certification of Radiographers none Not Required Not Required Maine 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 ML012710492 12/11/2001 56 FR 23360; 56 FR 61352; 57 FR 38588; 57 FR ML013520336 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 ML012710492 12/11/2001 56 FR 64980; ML013520336 1992-1 Quality Management Program and 01/27/1995 Final No Comments Maine has adopted Final Misadministrations ML012710492 12/11/2001 Regulations equivalent to RATS ID:

Part 35 ML013520336 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 ML012710492 12/11/2001 areas and spill sites] ML013520336 Parts 30 and 40 58 FR 39628 1993-2 Licensing and Radiation Safety Requirements for 07/01/1996 Not Applicablei Not Applicable Maine does not have any licensees Irradiators subject to these regulations. (See Part 36 SECY 95-112) 58 FR 7715 1993-3 Definition of Land Disposal and Waste Site QA 07/22/1996 Not Applicable Not Applicable Maine does not have authority to Program regulate this material under its Part 61 Agreement.

58 FR 33886 1994-1 Self-Guarantee as an Additional Financial none Not Required Not Required These regulation changes are not Mechanism 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 Maine 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 ML012710492 12/11/2001 59 FR 36026 ML013520336 2

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 1995-1 Preparation, Transfer for Commercial Distribution, 01/01/1998 Final No Comments and Use of Byproduct Material for Medical Use ML012710492 12/11/2001 Parts 30, 32 and 35 ML013520336 59 FR 61767; 59 FR 65243; 60 FR 322 1995-2 Frequency of Medical Examinations for Use of 03/13/1998 Final No Comments Respiratory Protection Equipment 11/24/1999 Part 20 60 FR 7900 1995-3 Low-Level Waste Shipment Manifest Information 03/01/1998 Final No Comments and Reporting ML021830034 08/27/2002 Parts 20 and 61 ML021990480 ML022400454 60 FR 15649; 60 FR 25983 1995-4 Performance Requirements for Radiography 06/30/1998 Final No Comments Maine has adopted Final Equipment ML021830034 08/27/2002 Regulations equivalent to RATS ID:

Part 34 ML021990480 ML022400454 1997-5.

60 FR 28323 (Superceded by 1997-5) 1995-5 Radiation Protection Requirements: Amended 08/14/1998 Final No Comments Definitions and Criteria ML021830034 08/27/2002 Parts 19 and 20 ML021990480 ML022400454 60 FR 36038 1995-6 Clarification of Decommissioning Funding 11/24/1998 Final No Comments Requirements ML021830034 08/27/2002 Parts 30, 40 and 70 ML021990480 ML022400454 60 FR 38235 3

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 1995-7 Medical Administration of Radiation and Radioactive 10/20/1998 Final No Comments Maine has not yet adopted Final Materials ML021830034 08/27/2002 Regulations equivalent to RATS ID:

Parts 20 and 35 ML021990480 ML022400454 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 Maine has not yet adopted Final Agency ML021830034 08/27/2002 Regulations equivalent to RATS ID:

Part 71 ML021990480 ML022400454 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 Record keeping Requirements 11/24/1999 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 ML012710492 12/11/2001 Part 20 ML013520336 61 FR 65120 1997-2 Recognition of Agreement State Licenses in Areas 02/27/2000 Final No Comments Under Exclusive Federal Jurisdiction Within an ML012710492 12/11/2001 Agreement State ML013520336 Part 150 62 FR 1662 4

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 1997-3 Criteria for the Release of Individuals Administered 05/29/2000 Final No Comments Radioactive Material ML012710492 12/11/2001 Parts 20 and 35 ML013520336 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 ML021830034 08/27/2002 Operations ML021990480 ML022400454 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 11/24/1999 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 11/24/1999 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 ML021830034 8/27/02 63 FR 1890; 63 FR 13773 ML021990480 ML022400454 5

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 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) Maine 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 ML012710492 12/11/2001 Operations ML013520336 Part 34 63 FR 37059 1998-5 Minor Corrections, Clarifying Changes, and a Minor 10/26/2001 Final No Comments Policy Change ML021830034 08/27/2002 Parts 20, 32, 35, 36 and 39 ML021990480 ML022400454 63 FR 39477; 63 FR 45393 1998-6 Transfer for Disposal and Manifests: Minor 11/20/2001 Final No Comments Technical Conforming Amendment ML021830034 08/27/2002 Part 20 ML021990480 ML022400454 63 FR 50127 1999-1 Radiological Criteria for License Termination of 06/11/2002 Not Applicable Not Applicable Maine does not have the authority Uranium Recovery Facilities to regulate this material under its Part 40 Agreement.

64 FR 17506 6

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 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 ML021830034 08/27/2002 Part 20 ML021990480 ML022400454 64 FR 54543; 64 FR 55524 2000-1 Energy Compensation Sources for Well Logging 05/17/2003 Final No Comments and Other Regulatory Clarifications ML021830034 08/27/2002 Part 39 ML021990480 ML022400454 65 FR 20337 2000-2 New Dosimetry Technology 01/08/2004 Final No Comments Parts 34, 36 and 39 ML012710492 12/11/2001 65 FR 63750 ML013520336 2001-1 Requirements for Certain Generally Licensed 02/16/2004 Final Comments Industrial Devices Containing Byproduct Material ML031500588 08/31/2006 Parts 30, 31 and 32 ML062370173 65 FR 79162 Revised Final No Comments ML15175A312 07/14/2015 ML15175A306 2002-1 Revision of the Skin Dose Limit 04/05/2005 Final No Comments Part 20 ML031500588 10/31/2003 67 FR 16298 ML033040387 7

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 2002-2 Medical Use of Byproduct Material 10/24/2005 Final No Comments Parts 20, 32 and 35 ML031500588 10/31/2003 67 FR 20249 ML033040387 2003-1 Financial Assurance for Materials Licensees 12/03/2006 Final Comments Parts 30, 40 and 70 ML100192011 06/18/2010 68 FR 57327 ML101200008 Revised Final No Comments ML19170A349 06/27/2019 ML19170A344 Revised Final No Comments ML19210D830 08/02/2019 ML19210D817 2004-1 Compatibility With IAEA Transportation Safety 10/01/2007 Final Comments Standards and Other Transportation Safety ML100192011 06/18/2010 Amendments ML101200008 Part 71 69 FR 3697 Revised Final No Comments ML19170A349 06/27/2019 ML19170A344 Revised Final No Comments ML19210D830 08/02/2019 ML19210D817 2005-1 Security Requirements for Portable Gauges 07/11/2008 Final No Comments Containing Byproduct Material ML100192011 06/18/2010 Part 30 ML101200008 70 FR 2001 8

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 2005-2 Medical Use of Byproduct Material - Recognition of 04/29/2008 Final Comments Specialty Boards ML100192011 06/18/2010 Part 35 ML101200008 70 FR 16336; 71 FR 1926 Revised Final No Comments ML19170A349 06/27/2019 ML19170A344 Revised Final No Comments ML19210D830 08/02/2019 ML19210D817 2005-3 Increased Controls for Risk-Significant Radioactive 12/01/2005 License No Comments Sources (NRC Order EA-05-090) Condition 11/10/2005 70 FR 72128 ML053130012 ML053180036 2006-1 Minor Amendments 03/27/2009 Final Comments Parts 20, 30, 32, 35, 40 and 70 ML100192011 06/18/2010 71 FR 15005 ML101200008 Revised Final No Comments ML19170A349 06/27/2019 ML19170A344 Revised Final No Comments ML19210D830 08/02/2019 ML19210D817 2006-2 National Source Tracking System - Serialization 02/06/2007 Final No Comments Requirements ML100192011 06/18/2010 Part 32 with reference to Part 20 Appendix E ML101200008 71 FR 65685 9

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 2006-3 National Source Tracking System 01/31/2009 Final No Comments Part 20 ML100192011 06/18/2010 71 FR 65685, 72 FR 59162 ML101200008 License No Comments Condition 12/05/2008 ML083220254 ML083290277 2007-1 Medical Use of Byproduct Material - Minor 10/29/2010 Final Comments Corrections and Clarifications ML100192011 06/18/2010 Parts 32 and 35 ML101200008 72 FR 45147, 54207 Revised Final No Comments ML19170A349 06/27/2019 ML19170A344 Revised Final No Comments ML19210D830 08/02/2019 ML19210D817 2007-2 Exemptions From Licensing, General Licenses, and 12/17/2010 Final Comments Distribution of Byproduct Material: Licensing and ML100192011 06/18/2010 Reporting Requirements ML101200008 Parts 30, 31, 32 and 150 72 FR 58473 Revised Final No Comments ML19170A349 06/27/2019 ML19170A344 Revised Final No Comments ML19210D830 08/02/2019 ML19210D817 10

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 ML100192011 06/18/2010 Parts 20, 30, 31, 32, 33, 35, 61 and 150 ML101200008 72 FR 55864 Revised Final Comment ML19170A349 06/27/2019 ML19170A344 Revised Final Comment ML19210D830 08/02/2019 ML19210D817 2007-4 Order Imposing Fingerprinting Requirements and 06/05/2008 Final No Comments Criminal History Records Check Requirements for ML100192011 06/18/2010 Unescorted Access to Certain Radioactive Material ML101200008 NRC Order EA-07-305 72 FR 70901 License No Comments Condition 05/06/2008 ML081230585 ML081260717 2008-1 Occupational Dose Records, Labeling Containers, 02/15/2011 Final Comments and Total Effective Dose Equivalent ML100192011 06/18/2010 Parts 19 and 20 ML101200008 72 FR 68043 Revised Final No Comments ML19170A349 06/27/2019 ML19170A344 Revised Final No Comments ML19210D830 08/02/2019 ML19210D817 11

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 2009-1 Medical Use of Byproduct Material - Authorized 09/28/2012 Final Comments User Clarification ML100192011 06/18/2010 Part 35 ML101200008 74 FR 33901 Revised Final No Comments ML19170A349 06/27/2019 ML19170A344 Revised Final No Comments ML19210D830 08/02/2019 ML19210D817

• 2011-1 Decommissioning Planning 12/17/2015 Proposed Comments Parts 20, 30, 40 and 70 ML19218A082 09/30/2019 76 FR 35512 ML19218A076 2011-2 Licenses, Certifications, and Approvals for Materials 11/14/2014 Final No Comments Licensees ML15175A312 07/14/2015 Parts 30, 36, 39, 40, 70 and 150 ML15175A306 76 FR 56951 2012-1 Change of Compatibility of 10 CFR 31.5 and 31.6 01/25/2015 Final Comments (See RATS ID: 2001-1 for Rule text) ML15175A312 07/14/2015 77 FR 3640 ML15175A306 Revised Final Comment ML19170A349 06/27/2019 ML19170A344 Revised Final No Comments ML19210D830 08/02/2019 ML19210D817 12

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

• 2012-2 Advance Notification to Native American Tribes of 08/10/2015 Proposed Comments Transportation of Certain Types of Nuclear Waste ML19218A082 09/30/2019 Part 71 ML19218A076 77 FR 34194

• 2012-3 Technical Corrections 08/06/2015 Proposed Comments Parts 30, 34, 40 and 71 ML19218A082 09/30/2019 77 FR 39899 ML19218A076

• 2012-4 Requirements for Distribution of Byproduct Material 10/23/2015 Proposed Comments Parts 30, 31, 32, 40 and 70 ML19218A082 09/30/2019 77 FR 43666 ML19218A076

• 2013-1 Physical Protection of Byproduct Material 03/19/2016 License No Comments Part 37 only Parts 20, 30, 32, 33, 34, 35, 36, 37, 39 and 71 Condition 03/01/2016 78 FR 16922 ML16054A817 ML16054A808 Proposed Comments ML19218A082 09/30/2019 ML19218A076

• 2013-2 Distribution of Source Material to Exempt Persons 08/27/2016 Proposed Comments and to General Licensees and Revision of ML19218A082 09/30/2019 General License and Exemptions ML19218A076 Parts 30, 40 and 70 78 FR 32310

• 2015-1 Domestic Licensing of Special Nuclear Material - 01/26/2018 Proposed Comments Written Reports and Clarifying Amendments ML19218A082 09/30/2019 Part 70 ML19218A076 79 FR 57721, 80 FR 143 13

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

• 2015-2 Safeguards Information - Modified Handling 01/28/2018 Proposed Comments Categorization, Change for Materials Facilities ML19218A082 09/30/2019 Parts 30, 37, 73 and 150 ML19218A076 79 FR 58664, 80 FR 3865

• 2015-3 Revisions to Transportation Safety Requirements 07/13/2018 Proposed Comments and Harmonization with International Atomic Energy *extended to ML19218A082 09/30/2019 Agency Transportation Requirements 08/15/2020 ML19218A076 Part 71 See STC 17-060 80 FR 33987

• 2015-4 Miscellaneous Corrections 09/02/2018 Proposed Comments Parts 37 and 40 ML19218A082 09/30/2019 80 FR 45841 ML19218A076

• 2015-5 Miscellaneous Corrections 12/31/2018 Proposed Comments Parts 19, 20, 30, 32, 37, 40, 61, 70, 71 and 150 ML19218A082 09/30/2019 80 FR 74974 ML19218A076

• 2018-1 Medical Use of Byproduct Material - Medical Event 01/14/2022 Proposed Comments Definitions, Training and Experience, and Clarifying ML19218A082 09/30/2019 Amendments, Parts 30, 32 and 35 ML19218A076

• 2018-2 Miscellaneous Corrections - 12/21/2021 Proposed Comments Organizational Changes ML19218A082 09/30/2019 Parts 37, 40. 70 and 71 ML19218A076 i

IMPEP Team: verify that Maine does not have any licensees subject to these regulations during each review.

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