ML18187A352

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7/27/2018 Letter to M. Mckinley Kentucky Proposed Regulations to 10 CFR Parts 33, 34, 35 (and Other Teletherapy Requirements), 39, 61 and 71
ML18187A352
Person / Time
Issue date: 07/27/2018
From: Sabrina Atack
NRC/NMSS/DMSST
To: Mckinley M
State of KY, Cabinet for Health and Family Services
Beardsley M
Shared Package
ML18170A180 List:
References
Download: ML18187A352 (19)


Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 July 27, 2018 Matthew W. McKinley, Administrator Radiation Health Program Cabinet for Health & Family Services 275 East Main Street, HS1C-A Frankfort, KY 40621 0001

Dear Mr. McKinley:

We have reviewed the proposed revisions to the Kentucky regulations 902 KAR 100, received by our office on June 19, 2018. These regulations were reviewed by comparison to the equivalent U.S. Nuclear Regulatory Commission (NRC) rules 10 CFR Parts 33, 34, 35 (and other teletherapy regulations), 39, 61 and 71 as identified in the enclosed State Regulation Status (SRS) Data Sheet. We discussed our review of the regulations with Eric Perry on July 26, 2018.

As a result of our review, we have three 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 Kentucky 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 Kentucky 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 Kentucky 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.

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

Enclosures:

1. Compatibility Comments
2. Kentucky SRS Data Sheet

M. McKinley

SUBJECT:

22/22/2018 LETTER TO M.MCKINLEY RE: KENTUCKY PROPOSED REGULATIONS TO 10 CFR PARTS 33, 34, 35 (AND OTHER TELETHERAPY REQUIREMENTS), 39, 61 AND 71 DISTRIBUTION: SP[05]

MFord, RSAO

[KY] File OFFICE RI ASPB OGC ASPB:BC MSTR:DD NAME MFord MBeardsley TBarczy NLO PMichalak PMichalak for via email SAttack DATE 7/5/18 7/5/18 7/26/18 7/27/18 7/27/18 ML18187A352 OFFICIAL RECORD COPY Package ML18170A180

COMPATIBILITY COMMENTS ON KENTUCKY PROPOSED REGULATIONS STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 1 100:017 35.690 N/A B Training for use of remote Section 17 afterloader units, teletherapy units, and gamma stereotactic 100:072 radiosurgery units Section 2 KY adopts 10 CFR 35.690 by reference in 100:072 and additionally specifies training requirements in 100:017 Section 17. The requirements listed in 100:017 Section 17 are less restrictive than 35.690 and in conflict with 100:072 therefore it should be removed.

KY should delete 100:017 Section 17 from its regulations. In order to meet the Compatibility Category B designation assigned to 10 CFR 35.690.

2 100:022, 10 CFR Parts N/A Various Kentucky needs to add the following 070, 072, 34, 35, 39, 61, to Section 2 in 100:022, 070, 072, 100, 142 and 71 100, and 142: Reference to the NRC/ Commission or an Agreement State shall be deemed to reference the Cabinet for Health and Family Services, Department for Public Health, Radiation Health Branch; the NRC; or an Agreement State.

Kentucky needs to add this language in order to meet the various compatibility category designations assigned to 10 CFR Parts 34, 35, 39, 61, and 71.

3 100:070 10 CFR Part 71 N/A Various Kentucky needs to add the following to Section 2 of 100:070.

1) Where the words NRC, Commission, Nuclear Regulatory Commission, United States Nuclear Regulatory Commission or Administrator of the Enclosure 1

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS appropriate Regional Office appear in 10 CFR Part 71, substitute the words the Cabinet for Health and Family Services, Department for Public Health, Radiation Health Branch 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).

2) 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.
3) Kentucky form number XXXX, Notice to Employees, must be posted instead of NRC Form 3 that is specified in 10 CFR Part 71.

Kentucky needs to add the above language in order to meet the various compatibility category designations assigned to 10 CFR Part 71.

2

STATE REGULATION STATUS State: Kentucky Tracking Ticket Number: 18-44 Date: 7/27/2018

[ 25 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 Kentucky has adopted Final Part 34 03/15/1996 Regulations equivalent to RATS ID:

55 FR 843 1997-5.

(Superceded by 1997-5) 1991-2 ASNT Certification of Radiographers none Not Required Not Required Kentucky 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 04/17/1998 56 FR 23360; 56 FR 61352; 57 FR 38588; 57 FR 57877; 58 FR 67657; 59 FR 41641; 60 FR 20183;

  • 1991-4 Notification of Incidents 10/15/1994 Final No Comments Parts 20, 30, 31, 34, 39, 40 and 70 03/15/1996 56 FR 64980; Proposed Comments Kentucky submitted proposed ML18170A181 7/27/2018 regulations that adopt 10 CFR Parts ML18170A180 34 and 39 by reference 1992-1 Quality Management Program and 01/27/1995 Final No Comments Misadministrations 03/15/1996 Part 35 56 FR 34104 (Superceded by 2002-2)

Enclosure 2

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 1992-2 Eliminating the Recordkeeping Requirements none Not Required Not Required Kentucky has adopted Final for Departures from Manufacturer's Instructions Regulations equivalent to RATS ID:

Parts 30 and 35 1997-5.

57 FR 45566 1993-1 Decommissioning Recordkeeping and License 10/25/1996 Final No Comments Termination: Documentation Additions [Restricted 03/15/1996 areas and spill sites]

Parts 30 and 40 58 FR 39628 1993-2 Licensing and Radiation Safety Requirements for 07/01/1996 Not Applicablei Not Applicable Kentucky does not have any Irradiators licensees subject to these Part 36 regulations. (See SECY-95-112) 58 FR 7715 1993-3 Definition of Land Disposal and Waste Site QA 07/22/1996 Not Applicable1 Not Applicable Kentucky does not have any Program licensees subject to these Part 61 regulations. (See SECY-95-112) 58 FR 33886 1994-1 Self-Guarantee as an Additional Financial none Not Required Not Required These regulations are not required Mechanism to be adopted for purposes of Parts 30, 40 and 70 Compatibility.

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

59 FR 28220 2

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 1994-3 Timeliness in Decommissioning Material Facilities 08/15/1997 Final No Comments Parts 30, 40 and 70 04/17/1998 59 FR 36026

  • 1995-1 Preparation, Transfer for Commercial Distribution, 01/01/1998 Final No Comments and Use of Byproduct Material for Medical Use 04/17/1998 Parts 30, 32 and 35 59 FR 61767; 59 FR 65243; 60 FR 322 Proposed Comments Kentucky submitted proposed ML18170A181 07/27/2018 regulations that adopt 10 CFR Part ML18170A180 35 by reference 1995-2 Frequency of Medical Examinations for Use of 03/13/1998 Final No Comments Respiratory Protection Equipment 04/17/1998 Part 20 60 FR 7900
  • 1995-3 Low-Level Waste Shipment Manifest Information 03/01/1998 R2 No Comments and Reporting ML12213A254 09/14/2012 Parts 20 and 61 ML12234A371 60 FR 15649; 60 FR 25983 Proposed Comments Kentucky submitted proposed ML18170A181 07/27/2018 regulations that adopt 10 CFR Part ML18170A180 61 reference 1995-4 Performance Requirements for Radiography 06/30/1998 Final No Comments Kentucky has adopted Final Equipment 03/15/1996 Regulations equivalent to RATS ID:

Part 34 1997-5.

60 FR 28323 (Superceded by 1997-5) 3

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 1995-5 Radiation Protection Requirements: Amended 08/14/1998 Final No Comments Definitions and Criteria 04/17/1998 Parts 19 and 20 60 FR 36038 1995-6 Clarification of Decommissioning Funding 11/24/1998 R2 No Comments Requirements ML12213A254 09/14/2012 Parts 30, 40 and 70 ML12234A371 60 FR 38235 1995-7 Medical Administration of Radiation and Radioactive 10/20/1998 Materials Parts 20 and 35 60 FR 48623 (Superceded by 2002-2 and 2005-2)

  • 1996-1 Compatibility with the International Atomic Energy 04/01/1999 Final Comments Kentucky has not yet adopted Final Agency 06/21/2000 Regulations equivalent to RATS ID:

Part 71 2004-1.

60 FR 50248; 61 FR 28724 (Superceded by 2004-1) Proposed Comments Kentucky submitted proposed ML18170A181 07/27/2018 regulations that adopt 10 CFR Part ML18170A180 71 by reference 1996-2 One Time Extension of Certain Byproduct, Source 02/15/1999 Not Required Not Required These regulations are not required and Special Nuclear Materials Licenses to be adopted for purposes of Parts 30, 40 and 70 Compatibility.

61 FR 1109 4

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

  • 1996-3 Termination or Transfer of Licensed Activities: 06/17/1999 Final No Comments Record keeping Requirements 06/21/2000 Parts 20, 30, 40, 61 and 70 61 FR 24669 Proposed Comments Kentucky submitted proposed ML18170A181 07/27/2018 regulations that adopt 10 CFR Part ML18170A180 61 by reference 1997-1 Resolution of Dual Regulation of Airborne Effluents 01/9/2000 Final No Comments of Radioactive Materials; Clean Air Act 04/17/1998 Part 20 61 FR 65120 1997-2 Recognition of Agreement State Licenses in Areas 02/27/2000 Final No Comments Under Exclusive Federal Jurisdiction Within an ML010780156 03/30/2001 Agreement State ML010890409 Part 150 62 FR 1662
  • 1997-3 Criteria for the Release of Individuals Administered 05/29/2000 Final No Comments Radioactive Material 04/17/1998 Parts 20 and 35 62 FR 4120 Proposed Comments Kentucky submitted proposed ML18170A181 07/27/2018 regulations that adopt 10 CFR Part ML18170A180 35 by reference 1997-4 Fissile Material Shipments and Exemptions 02/10/2000 Not Required Not Required These regulations are not required Part 71 to be adopted for purposes of 62 FR 5907 Compatibility. (See STP-97-078)

(Superceded by 2004-1) 5

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

  • 1997-5 Licenses for Industrial Radiography and Radiation 06/27/2000 Final Comments Safety Requirements for Industrial Radiography ML010780156 03/30/2001 Operations ML010890409 Parts 30, 34, 71 and 150 62 FR 28947 Proposed Comments Kentucky submitted proposed ML18170A181 07/27/2018 regulations that adopt 10 CFR Parts ML18170A180 34 and 71 by reference 1997-6 Radiological Criteria for License Termination 08/20/2000 Final No Comments Parts 20, 30, 40 and 70 06/21/2000 62 FR 39057 1997-7 Exempt Distribution of a Radioactive Drug 01/02/2001 Final No Comments Containing One Microcurie of Carbon-14 Urea 04/17/1998 Part 30 62 FR 63634
  • 1998-1 Deliberate Misconduct by Unlicensed Persons 02/12/2001 Final No Comments Parts 30, 40, 61, 70, 71 and 150 06/21/2000 63 FR 1890; 63 FR 13773 Proposed Comments Kentucky submitted proposed ML18170A181 07/27/2018 regulations that adopt 10 CFR Parts ML18170A180 61 and 71 by reference 1998-2 Self-Guarantee of Decommissioning Funding by 07/01/2001 Nonprofit and Non-Bond-Issuing Licensees Parts 30, 40 and 70 63 FR 29535 6