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:
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Download: ML18187A352 (19)
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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.

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

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 via email PMichalak PMichalak for 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 Section 17 100:072 Section 2 35.690 N/A B

Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units 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, 070, 072, 100, 142 10 CFR Parts 34, 35, 39, 61, and 71 N/A Various Kentucky needs to add the following to Section 2 in 100:022, 070, 072, 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

2 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.

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 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 No Comments 03/15/1996 Kentucky 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 Kentucky 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 No Comments 04/17/1998

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adopt 10 CFR Parts 34 and 39 by reference 1992-1 Quality Management Program and Misadministrations Part 35 56 FR 34104 (Superceded by 2002-2) 01/27/1995 Final No Comments 03/15/1996

2 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 1992-2 Eliminating the Recordkeeping Requirements for Departures from Manufacturer's Instructions Parts 30 and 35 57 FR 45566 none Not Required Not Required Kentucky has adopted Final Regulations equivalent to RATS ID:

1997-5.

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 No Comments 03/15/1996 1993-2 Licensing and Radiation Safety Requirements for Irradiators Part 36 58 FR 7715 07/01/1996 Not Applicablei Not Applicable Kentucky 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 Applicable1 Not Applicable Kentucky does not have any licensees subject to these regulations. (See SECY-95-112) 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 regulations 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 Kentucky does not have authority to regulate this material under its Agreement.

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

  • 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 Proposed ML18170A181 No Comments 04/17/1998 Comments 07/27/2018 ML18170A180 Kentucky submitted proposed regulations that adopt 10 CFR Part 35 by reference 1995-2 Frequency of Medical Examinations for Use of Respiratory Protection Equipment Part 20 60 FR 7900 03/13/1998 Final No Comments 04/17/1998

1997-5.

4 RATS ID NRC Chronology Identification Date Due for State Adoption Incoming Letter Outgoing Package Notes 1995-5 Radiation Protection Requirements: Amended Definitions and Criteria Parts 19 and 20 60 FR 36038 08/14/1998 Final No Comments 04/17/1998 1995-6 Clarification of Decommissioning Funding Requirements Parts 30, 40 and 70 60 FR 38235 11/24/1998 R2 ML12213A254 No Comments 09/14/2012 ML12234A371 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

  • 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 Proposed ML18170A181 Comments 06/21/2000 Comments 07/27/2018 ML18170A180 Kentucky has not yet adopted Final Regulations equivalent to RATS ID:

2004-1.

Kentucky submitted proposed regulations that adopt 10 CFR Part 71 by reference 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 regulations are not required to be adopted for purposes of Compatibility.

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

  • 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 Proposed ML18170A181 No Comments 06/21/2000 Comments 07/27/2018 ML18170A180 Kentucky submitted proposed regulations that adopt 10 CFR Part 61 by reference 1997-1 Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air Act Part 20 61 FR 65120 01/9/2000 Final No Comments 04/17/1998 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 ML010780156 No Comments 03/30/2001 ML010890409

  • 1997-3 Criteria for the Release of Individuals Administered Radioactive Material Parts 20 and 35 62 FR 4120 05/29/2000 Final Proposed ML18170A181 No Comments 04/17/1998 Comments 07/27/2018 ML18170A180 Kentucky submitted proposed regulations that adopt 10 CFR Part 35 by reference 1997-4 Fissile Material Shipments and Exemptions Part 71 62 FR 5907 (Superceded by 2004-1) 02/10/2000 Not Required Not Required These regulations are not required to be adopted for purposes of Compatibility. (See STP-97-078)

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

  • 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 ML010780156 Proposed ML18170A181 Comments 03/30/2001 ML010890409 Comments 07/27/2018 ML18170A180 Kentucky submitted proposed regulations that adopt 10 CFR Parts 34 and 71 by reference 1997-6 Radiological Criteria for License Termination Parts 20, 30, 40 and 70 62 FR 39057 08/20/2000 Final No Comments 06/21/2000 1997-7 Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Urea Part 30 62 FR 63634 01/02/2001 Final No Comments 04/17/1998
  • 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 Proposed ML18170A181 No Comments 06/21/2000 Comments 07/27/2018 ML18170A180 Kentucky submitted proposed regulations that adopt 10 CFR Parts 61 and 71 by reference 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
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