ML17354A063

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Letter to W. Irwin Vermont Proposed Regulations
ML17354A063
Person / Time
Issue date: 01/09/2018
From: Kevin Williams
Division of Materials Safety, Security, State, and Tribal Programs
To: Irwin W
State of VT, Dept of Health
Beardsley M
References
Download: ML17354A063 (17)
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Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 January 9, 2018 William Irwin. Sc.D., CHP, Chief Office of Radiological Health Vermont Department of Health 108 Cherry Street P.O. Box 70 Burlington, VT 05402

Dear Dr. Irwin:

We have reviewed the proposed revisions to the Vermont regulations Chapter 6, Subchapter 5 - Radiological Health Rule, received by our office on November 27, 2017.

These regulations were reviewed by comparison to the equivalent U.S. Nuclear Regulatory Commission (NRC) rules as identified in the enclosed State Regulation Status (SRS) Data Sheet. We discussed our review of the regulations with you on January 4, 2018.

As a result of our review, we have 21 comments that have been identified in the enclosure.

Please note that we have limited our review to regulations required for compatibility or health and safety. The NRC requests that Vermont provide updated proposed regulations for review.

Under our current procedure, a finding that the Vermont 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 Vermont regulations.

The SRS Data Sheet summarizes our knowledge of the status of other Vermont 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.

W. Irwin 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/

PMichalak for KWilliams Kevin Williams, Deputy Director Division of Material Safety, State, Tribal and Rulemaking Programs Office of Nuclear Material Safety and Safeguards

Enclosures:

1. Compatibility Comments
2. Vermont SRS Data Sheet

W. Irwin

SUBJECT:

VERMONT PROPOSED REGULATIONS. DATED: JANUARY 9, 2018 DISTRIBUTION: SP[05]

DIR RF (VT 18-11)

MFord, RSAO

[VT] File OFFICE RI ASPB OGC ASPB:BC MSTR:DD NAME MFord/JMiller MBeardsley LShrum NLO PMichalak PMichalak for KWilliams DATE 12/19/17 12/20/17 01/04/18 1/09/18 1/09/18 ML17354A063 OFFICIAL RECORD COPY Package ML17331A819

COMPATIBILITY COMMENTS ON VERMONT PROPOSED REGULATIONS STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 1 Various Various Various N/A General Comments

1) Vermont regulations sections 6.4.1.2 and 6.4.1.3, state: Each sealed sourceapproved by the Department, a state or the NRC.

Vermont needs to replace a state with an Agreement State.

2) Vermont incorporates NRC regulations by reference, but also includes some of these same regulations as text. This results in a duplication of requirements.

Vermont needs remove the following sections from its regulations:

1) In Section 1.3 delete the definitions for: License, Licensee, Pharmacist, Physician, and Special Nuclear Material.
2) 4.2.1(equivalent 30.12)
3) 6.4 (Multiple Parts 35.67, 39.35)
4) 6.5.1 (remove reference to radiation sources)
5) 6.7.7 (20.2202(c); need to clarify if this is just for radiation producing machines)
6) 7.2 - 7.5 (19.11)
7) 12.5 - 12.5.3.2 (Part 30)
8) 12.7.2 (70.39)
9) 12.7.3 (32.71)
10) 12.12.1 - 12.12.1.5.2 (150.20)
11) 12.12.3 (31.6)
12) 18.4 - 18.4.6.6 (71.97)
13) 18.5 (37.77)

Comments stand from NRC letter dated October 25, 2017/ML17172A626.

Enclosure 1

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 2 1.2.5 19.3, Regulated 19 D/NRC Regulated entities 1.3 entities 7.6.1 Vermont incorporates the definition of Regulated Entities in 10 CFR 19.3 by reference in sections 1.2.5, 1.3, and 7.6.1. Vermont needs to exclude this definition from incorporation by reference. If Vermont wishes to have an equivalent regulation, Vermont should include a new definition citing activities under Vermont authority in section 1.3.

Vermont needs to make the above change in order to meet the Compatibility Category D/NRC designations assigned to 10 CFR 19.3 Definition: Regulated Entities.

Comment stands from NRC letter dated October 25, 2017/ML17172A626 3 1.2.5 19.11 19 C, except Posting of notices to workers 7.2 portions of 7.6.1 paragraph Vermont incorporates all of 10 CFR (a), and all 19.11 by reference in sections 1.2.5 of and 7.6.1. Vermont needs to paragraphs specifically exclude the portions of (b) and paragraph (a), and all of paragraphs (e) are (b) and (e) which are reserved to the designated NRC from incorporation by reference.

as NRC. In addition, Vermont incorporates 10 CFR 19.11 by reference and includes duplicative requirements for posting notices to workers in section 7.2. Vermont needs to revise their equivalent regulations to exclude either 10 CFR 19.11 or Vermont regulations section 7.2, to eliminate the duplication of requirements.

Comment stands from NRC letter dated October 25, 2017/ML17172A626 2

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 4 1.2.5 19.13 19 C Notification and reports to 7.6.1 individuals In their equivalent regulations to 10 CFR 19.13(a), Vermont needs to replace the phrase Nuclear Regulatory Commission regulation 10 CFR part 19 with their equivalent regulation.

Comment stands from NRC letter dated October 25, 2017/ML17172A626 5 1.2.5 19.14(a) 19 NRC Presence of representatives of 7.6.1 licensees and workers during inspections Vermont adopts 10 CFR 19.14(a) by reference in section 7.6.1. Vermont needs to add 10 CFR 19.14(a) to section 7.6.2 in order to not adopt it by reference.

Vermont needs to make the above change in order to meet the Compatibility Category NRC designation assigned to 10 CFR 19.14(a).

6 1.2.6.1 20.1003 20 A Definition: Special Nuclear Material In the definition of special nuclear material in 10 CFR 20.1003, the word Commission should remain and should not mean the Vermont Department of Public Health as stated in section 1.2.6.1.

Vermont needs to make the above change in order to meet the Compatibility Category A designation assigned to 10 CFR 20.1003 Definition: Special Nuclear Material.

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STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 7 12.5.1 30.70 30 B Schedule A - exempt Tables 1a/1b concentrations table Vermont adds radionuclides to 10 CFR 30.70 Schedule A, Exempt concentrations, in Tables 1a and 1b of Vermonts regulations. This makes Vermonts regulations less restrictive than the NRCs regulation.

Vermont needs to delete Tables 1a and 1b in order to meet the Compatibility Category B designation assigned to 10 CFR 30.70.

8 12.5.3.1 30.71 30 B Schedule B - exempt quantity table Tables 2a/2b Vermont adds radionuclides to 10 CFR 30.71, Schedule B, in Tables 2a and 2b of Vermonts regulations.

This makes Vermonts regulations less restrictive than the NRCs regulation.

Vermont needs to delete Tables 2a and 2b in order to meet the Compatibility Category B designation assigned to 10 CFR 30.71.

9 12.7.1.2 32.24 32 B Same: Table of organ doses Vermont excludes 10 CFR 32.24 from incorporation by reference in section 12.7.1.2. VT needs to remove this reference from section 12.7.1.2 in order to adopt 10 CFR 32.34 by reference.

VT needs to make the above change in order to meet the Compatibility Category B designation assigned to 10 CFR 32.24.

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STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 10 1.2.6.9 32.59 32 B Same: Leak testing of each source Vermont needs to add 10 CFR 32.59 to section 1.2.6.9 in order to incorporate it by reference.

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

11 12.9.1 40.4 40 Various Definitions 1.2.5.12 In sections 1.2.5.12 and 12.9.1, Vermont does not incorporate 10 CFR 40.4 by reference. Several definitions in 10 CFR 40.4 are required for compatibility and should be included in Vermonts adoption by reference.

It should be noted that by not adopting 10 CFR 40.4 by reference, some previously made comments were resolved since they were category NRC. VT will need to use this letter in conjunction with the October 25, 2017 letter to ensure that the comments are appropriately addressed.

12 1.2.5 40.13(c)(5)(iv) 40 NRC Unimportant quantities of source material Vermont incorporates 10 CFR 40.13(c)(5)(iv) by reference in section 1.2.5.

Vermont needs to specifically exclude this regulation from incorporation by reference in section 1.2.5 in order to meet the Compatibility Category NRC designation assigned to 10 CFR 40.13(c)(5)(iv).

Comment stands from NRC letter dated October 25, 2017/ML17172A626.

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STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 13 1.2.5.12 40.31(j), (k), (l), 40 NRC Application for specific licenses 12.9.1 & (m)

VT incorporates 10 CFR 40.31(m) by reference in sections 1.2.5.12 and 12.9.1.

VT needs to not adopt this regulation by reference in order to meet the Compatibility Category NRC designation assigned to 10 CFR 40.31(m).

Comment stands from NRC letter dated October 25, 2017/ML17172A626.

14 12.9.1 40.41(d), (e)(1), 40 NRC Terms and conditions of licenses (e)(3), (g) & (h)

Vermont incorporates 10 CFR 40.41(h) by reference in section 12.9.1.

Vermont needs to specifically exclude this regulation from incorporation by reference in section 12.9.2 in order to meet the Compatibility Category NRC designation assigned to 10 CFR 40.41(h).

Comment stands from NRC letter dated October 25, 2017/ML17172A626.

15 12.9.1 40.52 40 NRC Certain items containing source material; requirements for license to apply or initially transfer Vermont incorporates 10 CFR 40.52 by reference in section 12.9.1.

Vermont needs to add 10 CFR 40.52 to section 12.9.2 so that it is not adopted by reference in order to meet the Compatibility Category NRC designation assigned to 10 CFR 40.52.

Comment stands from NRC letter 6

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS dated October 25, 2017/ML17172A626.

16 12.9.1 40.53 40 NRC Conditions for licenses issued for initial transfer of certain items containing source material:

Quality control, labeling, and records and reports Vermont incorporates 10 CFR 40.53 by reference in section 12.9.1.

Vermont needs to add 10 CFR 40.53 to section 12.9.2 so that it is not adopted by reference in order to meet the Compatibility Category NRC designation assigned to 10 CFR 40.53.

Comment stands from NRC letter dated October 25, 2017/ML17172A626.

17 12.9.1 40.56 40 NRC Restrictions on the use of Australian-obligated source materials Vermont incorporates 10 CFR 40.56 by reference in section 12.9.1.

Vermont needs to add 10 CFR 40.56 to section 12.9.2 so that it is not adopted by reference in order to meet the Compatibility Category NRC designation assigned to 10 CFR 40.56.

Comment stands from NRC letter dated October 25, 2017/ML17172A626.

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STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 18 1.2.5 Part 40, 40 NRC APPENDIX A, III. Site and 12.9.1 Criterion 11A-F Byproduct Material Ownership Vermont incorporates 10 CFR Part 40, Appendix A, Criterion 11 by reference in sections 1.2.5 and 12.9.1. Vermont needs to specifically exclude this regulation from incorporation by reference.

Comment stands from NRC letter dated October 25, 2017/ML17172A626.

19 1.2.5 Part 40, 40 NRC APPENDIX A, IV. Long-Term Site 12.9.1 Criterion 12 Surveillance Vermont incorporates 10 CFR Part 40, Appendix A, Criterion 12 by reference in sections 1.2.5 and 12.9.1. Vermont needs to specifically exclude this regulation from incorporation by reference.

Comment stands from NRC letter dated October 25, 2017/ML17172A626.

20 1.2.6.1 71.17 71 B General license: NRC approved package Vermont states in Section 1.2.6.1 that a reference made to the NRC or Commission means the Vermont Department of Health. However Vermont should note that in 10 CFR 71.17(c)(3), the submission required before the first use of a NRC approved package should be sent to the NRC, ATTN: Document Control Desk, Director, Division of Spent Fuel Storage and Transportation, Office of Nuclear Material Safety and Safeguards, using an appropriate method listed in § 71.1(a), the licensee's name and license number and the package identification number specified in the package approval.

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STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS Comment stands from NRC letter dated October 25, 2017/ML17172A626. The reference has now been moved from 1.2.7.1 to 1.2.6.1.

21 18.2.2 71.91(b) 71 NRC Records Vermont does not incorporate all of 10 CFR 71.91 by reference in section 18.2.2.

Vermont needs to incorporate 10 CFR 71.91 by reference, but specifically exclude only 10 CFR 71.91(b) from incorporation by reference in section 18.2.2 in order to meet the Compatibility Category NRC designation assigned to 10 CFR 71.91(b).

Comment stands from NRC letter dated October 25, 2017/ML17172A626.

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STATE REGULATION STATUS State: Vermont Tracking Ticket Number: 18-11 Date: 01/09/2018 Vermont Submittal Description Incoming Outgoing Notes Letter Package Proposed Enabling Legislation ML15222A313 Comments Vermont Statute for Ionizing and Nonionizing Radiation Control 8/5/2015 8/31/2015 ML15222A300 Revised Proposed Enabling Legislation ML16028A214 No Comments Vermont Statute for Ionizing and Nonionizing Radiation Control 1/25/2016 03/04/2016 ML16028A209

Vermont Submittal Description Incoming Outgoing Notes Letter Package

Vermont Submittal Description Incoming Outgoing Notes Letter Package

Vermont Submittal Description Incoming Outgoing Notes Letter Package

Vermont Submittal Description Incoming Outgoing Notes Letter Package

IMPEP review team: please ensure that Vermont does not have licensees/plans for these facilities.

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