ML19224A407

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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:
References
Download: ML19224A407 (35)
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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.

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

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 via email PMichalak KWilliams (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 2015-3 Various 10 CFR Part 71 - Transportation 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) &

(7) 30.22 2012-4 B

Certain industrial devices 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 2015-2 2015-4 2018-2 Various 10 CFR Part 37 Maine incorporates 10 CFR Part 37 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)

(The Compatibility Category for 35.433(a) has changed from H&S to B).

H&S:

35.433(b),

(b)(1) and (b)(2)

D: 35.433(c)

Strontium-90 sources for ophthalmic treatments Maine needs to change paragraph (b) to paragraph (B) in G.433.A.

Maine needs to add the Agency between the two instances of Commission and or Agreement State in G.433.A(2)(a).

Maine needs to make the above changes in order to meet the Compatibility Category designations 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 State Adoption Incoming Letter Outgoing Package Notes 1991-1 Safety Requirements for Radiographic Equipment Part 34 55 FR 843 (Superceded by 1997-5) 01/10/1994 Final ML012710492 No Comments 12/11/2001 ML013520336 Maine has adopted Final Regulations equivalent to RATS ID:

1997-5.

1991-2 ASNT Certification of Radiographers Part 34 56 FR 11504 (Superceded by 1997-5) none Not Required Not Required Maine has adopted Final Regulations equivalent to RATS ID:

1997-5.

1991-3 Standards for Protection Against Radiation Part 20 56 FR 23360; 56 FR 61352; 57 FR 38588; 57 FR 57877; 58 FR 67657; 59 FR 41641; 60 FR 20183; 01/01/1994 Final ML012710492 No Comments 12/11/2001 ML013520336 1991-4 Notification of Incidents Parts 20, 30, 31, 34, 39, 40 and 70 56 FR 64980; 10/15/1994 Final ML012710492 No Comments 12/11/2001 ML013520336 1992-1 Quality Management Program and Misadministrations Part 35 56 FR 34104 (Superceded by 2002-2) 01/27/1995 Final ML012710492 No Comments 12/11/2001 ML013520336 Maine has adopted Final Regulations equivalent to RATS ID:

2002-2.

1992-2 Eliminating the Recordkeeping Requirements for Departures from Manufacturer's Instructions Parts 30 and 35 57 FR 45566 none Not Required Not Required These regulation changes are not required to be adopted for purposes of Compatibility.

2 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 1993-1 Decommissioning Recordkeeping and License Termination: Documentation Additions [Restricted areas and spill sites]

Parts 30 and 40 58 FR 39628 10/25/1996 Final ML012710492 No Comments 12/11/2001 ML013520336 1993-2 Licensing and Radiation Safety Requirements for Irradiators Part 36 58 FR 7715 07/01/1996 Not Applicablei Not Applicable Maine does not have any licensees subject to these regulations. (See SECY 95-112) 1993-3 Definition of Land Disposal and Waste Site QA Program Part 61 58 FR 33886 07/22/1996 Not Applicable Not Applicable Maine does not have authority to regulate this material under its Agreement.

1994-1 Self-Guarantee as an Additional Financial Mechanism Parts 30, 40 and 70 58 FR 68726; 59 FR 1618 none Not Required Not Required These regulation changes are not required to be adopted for purposes of Compatibility.

1994-2 Uranium Mill Tailings Regulations: Conforming NRC Requirements to EPA Standards Part 40 59 FR 28220 07/01/1997 Not Applicable Not Applicable Maine does not have authority to regulate this material under its Agreement.

1994-3 Timeliness in Decommissioning Material Facilities Parts 30, 40 and 70 59 FR 36026 08/15/1997 Final ML012710492 No Comments 12/11/2001 ML013520336

3 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 1995-1 Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use Parts 30, 32 and 35 59 FR 61767; 59 FR 65243; 60 FR 322 01/01/1998 Final ML012710492 No Comments 12/11/2001 ML013520336 1995-2 Frequency of Medical Examinations for Use of Respiratory Protection Equipment Part 20 60 FR 7900 03/13/1998 Final No Comments 11/24/1999 1995-3 Low-Level Waste Shipment Manifest Information and Reporting Parts 20 and 61 60 FR 15649; 60 FR 25983 03/01/1998 Final ML021830034 ML021990480 No Comments 08/27/2002 ML022400454 1995-4 Performance Requirements for Radiography Equipment Part 34 60 FR 28323 (Superceded by 1997-5) 06/30/1998 Final ML021830034 ML021990480 No Comments 08/27/2002 ML022400454 Maine has adopted Final Regulations equivalent to RATS ID:

1997-5.

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

4 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 1995-7 Medical Administration of Radiation and Radioactive Materials Parts 20 and 35 60 FR 48623 (Superceded by 2002-2 and 2005-2) 10/20/1998 Final ML021830034 ML021990480 No Comments 08/27/2002 ML022400454 Maine has not yet adopted Final Regulations equivalent to RATS ID:

2005-2.

1996-1 Compatibility with the International Atomic Energy Agency Part 71 60 FR 50248; 61 FR 28724 (Superceded by 2004-1) 04/01/1999 Final ML021830034 ML021990480 No Comments 08/27/2002 ML022400454 Maine has not yet adopted Final Regulations equivalent to RATS ID:

2004-1.

1996-2 One Time Extension of Certain Byproduct, Source and Special Nuclear Materials Licenses Parts 30, 40 and 70 61 FR 1109 02/15/1999 Not Required Not Required These regulation changes are not required to be adopted for purposes of Compatibility.

1996-3 Termination or Transfer of Licensed Activities:

Record keeping Requirements Parts 20, 30, 40, 61 and 70 61 FR 24669 06/17/1999 Final No Comments 11/24/1999 1997-1 Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air Act Part 20 61 FR 65120 01/9/2000 Final ML012710492 No Comments 12/11/2001 ML013520336 1997-2 Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction Within an Agreement State Part 150 62 FR 1662 02/27/2000 Final ML012710492 No Comments 12/11/2001 ML013520336

5 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 1997-3 Criteria for the Release of Individuals Administered Radioactive Material Parts 20 and 35 62 FR 4120 05/29/2000 Final ML012710492 No Comments 12/11/2001 ML013520336 1997-4 Fissile Material Shipments and Exemptions Part 71 62 FR 5907 (Superceded by 2004-1) 02/10/2000 Not Required Not Required These regulation changes are not required to be adopted for purposes of Compatibility. (See STP-97-078) 1997-5 Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiography Operations Parts 30, 34, 71 and 150 62 FR 28947 06/27/2000 Final ML021830034 ML021990480 No Comments 08/27/2002 ML022400454 1997-6 Radiological Criteria for License Termination Parts 20, 30, 40 and 70 62 FR 39057 08/20/2000 Final No Comments 11/24/1999 1997-7 Exempt Distribution of a Radioactive Drug Containing One Micro curie of Carbon-14 Urea Part 30 62 FR 63634 01/02/2001 Final No Comments 11/24/1999 1998-1 Deliberate Misconduct by Unlicensed Persons Parts 30, 40, 61, 70, 71 and 150 63 FR 1890; 63 FR 13773 02/12/2001 Final ML021830034 ML021990480 No Comments 8/27/02 ML022400454

6 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 1998-2 Self-Guarantee of Decommissioning Funding by Nonprofit and Non-Bond-Issuing Licensees Parts 30, 40 and 70 63 FR 29535 07/01/2001 Not Required Not Required These regulation changes are not required to be adopted for purposes of Compatibility.

1998-3 License Term for Medical Use Licenses Part 35 63 FR 31604 (Superceded by 2002-2) 07/10/2001 Not Required Not Required These regulation changes are not required to be adopted for purposes of Compatibility. (See STP-98-074)

Maine has adopted Final Regulations equivalent to RATS ID:

2002-2.

1998-4 Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiographic Operations Part 34 63 FR 37059 07/09/2001 Final ML012710492 No Comments 12/11/2001 ML013520336 1998-5 Minor Corrections, Clarifying Changes, and a Minor Policy Change Parts 20, 32, 35, 36 and 39 63 FR 39477; 63 FR 45393 10/26/2001 Final ML021830034 ML021990480 No Comments 08/27/2002 ML022400454 1998-6 Transfer for Disposal and Manifests: Minor Technical Conforming Amendment Part 20 63 FR 50127 11/20/2001 Final ML021830034 ML021990480 No Comments 08/27/2002 ML022400454 1999-1 Radiological Criteria for License Termination of Uranium Recovery Facilities Part 40 64 FR 17506 06/11/2002 Not Applicable Not Applicable Maine does not have the authority to regulate this material under its Agreement.

7 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 1999-2 Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct Material to Provide Requested Information Part 31 64 FR 42269 10/04/2002 Not Required Not Required These regulation changes are not required to be adopted for purposes of Compatibility.

1999-3 Respiratory Protection and Controls to Restrict Internal Exposure Part 20 64 FR 54543; 64 FR 55524 02/02/2003 Final ML021830034 ML021990480 No Comments 08/27/2002 ML022400454 2000-1 Energy Compensation Sources for Well Logging and Other Regulatory Clarifications Part 39 65 FR 20337 05/17/2003 Final ML021830034 ML021990480 No Comments 08/27/2002 ML022400454 2000-2 New Dosimetry Technology Parts 34, 36 and 39 65 FR 63750 01/08/2004 Final ML012710492 No Comments 12/11/2001 ML013520336 2001-1 Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct Material Parts 30, 31 and 32 65 FR 79162 02/16/2004 Final ML031500588 Revised Final ML15175A312 Comments 08/31/2006 ML062370173 No Comments 07/14/2015 ML15175A306 2002-1 Revision of the Skin Dose Limit Part 20 67 FR 16298 04/05/2005 Final ML031500588 No Comments 10/31/2003 ML033040387

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

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

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

11 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 2007-3 Requirements for Expanded Definition of Byproduct Material Parts 20, 30, 31, 32, 33, 35, 61 and 150 72 FR 55864 11/30/2010 Final ML100192011 Revised Final ML19170A349 Revised Final ML19210D830 Comments 06/18/2010 ML101200008 Comment 06/27/2019 ML19170A344 Comment 08/02/2019 ML19210D817 2007-4 Order Imposing Fingerprinting Requirements and Criminal History Records Check Requirements for Unescorted Access to Certain Radioactive Material NRC Order EA-07-305 72 FR 70901 06/05/2008 Final ML100192011 License Condition ML081230585 No Comments 06/18/2010 ML101200008 No Comments 05/06/2008 ML081260717 2008-1 Occupational Dose Records, Labeling Containers, and Total Effective Dose Equivalent Parts 19 and 20 72 FR 68043 02/15/2011 Final ML100192011 Revised Final ML19170A349 Revised Final ML19210D830 Comments 06/18/2010 ML101200008 No Comments 06/27/2019 ML19170A344 No Comments 08/02/2019 ML19210D817

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

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

  • 2012-2 Advance Notification to Native American Tribes of Transportation of Certain Types of Nuclear Waste Part 71 77 FR 34194 08/10/2015 Proposed ML19218A082 Comments 09/30/2019 ML19218A076
  • 2013-2 Distribution of Source Material to Exempt Persons and to General Licensees and Revision of General License and Exemptions Parts 30, 40 and 70 78 FR 32310 08/27/2016 Proposed ML19218A082 Comments 09/30/2019 ML19218A076

Written Reports and Clarifying Amendments Part 70 79 FR 57721, 80 FR 143 01/26/2018 Proposed ML19218A082 Comments 09/30/2019 ML19218A076

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

  • 2015-3 Revisions to Transportation Safety Requirements and Harmonization with International Atomic Energy Agency Transportation Requirements Part 71 80 FR 33987 07/13/2018
  • 2018-1 Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments, Parts 30, 32 and 35 01/14/2022 Proposed ML19218A082 Comments 09/30/2019 ML19218A076
  • 2018-2 Miscellaneous Corrections -

Organizational Changes Parts 37, 40. 70 and 71 12/21/2021 Proposed ML19218A082 Comments 09/30/2019 ML19218A076 i IMPEP Team: verify that Maine does not have any licensees subject to these regulations during each review.

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