October 28, 2004

Mr. Robert Johnson, Manager

Radiation Health and Toxic Agents Branch

Cabinet for Health Services

275 East Main Street

Frankfort, KY 40621-0001

Dear Mr. Johnson:

We have reviewed the proposed changes to the Kentucky regulations, 902 KAR 100:072 “Use

of Radionuclides in the Healing Arts”, that were submitted to meet the changes to 10 CFR 35,

via your September 27, 2004 letter. Our review and comments are in response to the State’s

request for Nuclear Regulatory Commission (NRC) evaluation of the changes to Kentucky’s

radiation control rules that incorporated the amendments identified on the State’s Regulation

Data Sheet (SRS). These regulations were reviewed by comparison to the equivalent NRC

rules in 10 CFR Parts 20, 32 and 35. We discussed our review of the regulations with Matthew

McKinley of your staff on October 8, 2004, who explained that some of the provisions covered

by 10 CFR 35, are covered under 902 KAR 100:10. These applicable sections were also

reviewed and added to your initial regulation package. Mr. McKinley also provided information

regarding the pending changes to Parts 010, 019 and 073 mentioned in the attached comment

chart. 

As a result of our review, we have three comments. Please provide a final, amended version of

your regulations, showing the location of any changes made in response to our comments. If

there are any comments which Kentucky believes are in error, the State should identify the

section of the regulations that meet the designated compatibility category. Please note that we

have limited our review to the items required for compatibility and/or health and safety. 

The SRS Data Sheet summarizes our knowledge of other Kentucky regulations. 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 STP Web Site:

http://www.hsrd.ornl.gov/nrc/rulemaking.htm.

If you have any questions regarding the comments, the compatibility and health categories, or

any of the NRC regulations used in the review, please contact me or Sheri Minnick, Regional

Agreement States Officer, at (610) 337-5358 or SAM9@NRC.GOV.

Sincerely,

\RA By K.N. SCHNEIDER FOR\

Josephine M. Piccone, Deputy Director

Office of State and Tribal Programs

Enclosures: 

As stated
October 28, 2004

Mr. Robert Johnson, Manager

Radiation Health and Toxic Agents Branch

Cabinet for Health Services

275 East Main Street

Frankfort, KY 40621-0001

Dear Mr. Johnson:

We have reviewed the proposed changes to the Kentucky regulations, 902 KAR 100:072 “Use

of Radionuclides in the Healing Arts”, that were submitted to meet the changes to 10 CFR 35,

via your September 27, 2004 letter. Our review and comments are in response to the State’s

request for Nuclear Regulatory Commission (NRC) evaluation of the changes to Kentucky’s

radiation control rules that incorporated the amendments identified on the States Regulation

Data Sheet (SRS). These regulations were reviewed by comparison to the equivalent NRC

rules in 10 CFR Parts 20, 32 and 35. We discussed our review of the regulations with Matthew

McKinley of your staff on October 8, 2004, who explained that some of the provisions covered

by 10 CFR 35, are covered under 902 KAR 100:10. These applicable sections were also

reviewed and added to your initial regulation package. Mr. McKinley also provided information

regarding the pending changes to Parts 010, 019 and 073 mentioned in the attached comment

chart. 

As a result of our review, we have three comments. Please provide a final, amended version of

your regulations, showing the location of any changes made in response to our comments. If

there are any comments which Kentucky believes are in error, the State should identify the

section of the regulations that meet the designated compatibility category. Please note that we

have limited our review to the items required for compatibility and/or health and safety. 

The SRS Data Sheet summarizes our knowledge of other Kentucky regulations. 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 STP Web Site: 

http://www.hsrd.ornl.gov/nrc/rulemaking.htm

If you have any questions regarding the comments, the compatibility and health categories, or

any of the NRC regulations used in the review, please contact me or Sheri Minnick, Regional

Agreement States Officer, at (610) 337-5358 or SAM9@NRC.GOV.

Sincerely,

\RA By K.N. SCHNEIDER FOR\

Josephine M. Piccone, Deputy Director

Office of State and Tribal Programs

Enclosures: As stated

Distribution:

DIR RF (4-270) DCD (SP06) PDR (YES_T) SMinnick RSAO JZabko ASPO BUsilton

Kentucky File Response to Incoming Document: ML042720262 DOCUMENT NAME:E:\Filenet\ML043030121.wpd

To receive a copy of this document, indicate in the box: "C" = Copy without attachment/enclosure "E" = Copy with

attachment/enclosure "N" = No copy

OFFICE Region I STP OGC STP:DD

NAME SMinnick JZabko STreby KNSchneider for JMPiccone

DATE 10/20/04* 10/20/04* 10/27/04* 10/28/04*

ML043030121 OFFICIAL RECORD COPY
COMPATIBILITY COMMENTS ON KENTUCKY REGULATIONS

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

1 Pending Part

019

20.1301 (a) and

(c)

2002-2

A

Dose limits for individual members

of the public

The State has referenced new rule

text for this section that is currently

undergoing revision and has not yet

been approved in the State. 

Consequently, there is no compatible

part in the State rule text for this

section at this time. 

The State needs to finish the

promulgation process for this rule

section and submit it to the NRC for

review to achieve compatibility for

this section in amendment 2002-2.

2 Pending Part

010

35.2 2002-2

B

Definitions

Authorized medical physicist 

Authorized nuclear pharmacist

Authorized user

Medical use

Prescribed dosage

Prescribed dose

Radiation safety officer

Sealed source

Treatment site

The State has referenced new rule

text for this section that is currently

undergoing revision and has not yet

been approved in the State. 

Consequently, there is no compatible

part in the State rule text for this

section at this time. 

The State needs to finish the

promulgation process for this rule

section and submit it to the NRC for

review to achieve compatibility for

this section in amendment 2002-2.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

3 Pending Part

072

35.6 2002-2

C

Provisions for the Protection of

human research subjects

The State has referenced new rule

text for this section that is currently

undergoing revision and has not yet

been approved in the State. 

Consequently, there is no compatible

part in the State rule text for this

section at this time. 

The State needs to finish the

promulgation process for this rule

section and submit it to the NRC for

review to achieve compatibility for

this section in amendment 2002-2.
STATE REGULATION STATUS

State: Kentucky [One amendment reviewed is identified Tracking Ticket by a i at the beginning of each equivalent NRC regulation.] Date: October 2

NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / ML 

Safety Requirements for Radiographic Equipment-Part 34 55 FR 843; (1/10/94) 1991-1 F ASNT Certification of Radiographers-Part 34 56 FR 11504; (none) 1991-2 

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; (1/1/94)

1991-3 F

P

Notification of Incidents-Parts 20, 30, 31, 34, 39, 40, 70 56 FR 64980; (10/15/94) 1991-4 F Quality Management Program and Misadministrations-Part 35 56 FR 34104; (1/27/95) 1992-1 F Eliminating the Recordkeeping Requirements for Departures from Manufacturer's InstructionsParts 30,35 57 FR 45566; (none) 1992-2 

Decommissioning Recordkeeping and License Termination: Documentation Additions[Restricted areas and spill sites]-Parts 30, 40 

58 FR 39628; (10/25/96) 1993-1 F 

Licensing and Radiation Safety Requirements for Irradiators-Part 36 58 FR 7715; (7/1/96) 1993-2 Definition of Land Disposal and Waste Site QA Program-Part 61 58 FR 33886; (7/22/96) 1993-3 Self-Guarantee as an Additional Financial Mechanism-Parts 30, 40, 70 58 FR 68726; 59 FR 1618

(none)

1994-1 F 

Uranium Mill Tailings Regulations: Conforming NRC Requirements to EPA Standards-Part 40 59 FR 28220; (7/1/97) 1994-2 

Timeliness in Decommissioning Material Facilities-Parts 30, 40, 70 59 FR 36026; (8/15/97) 1994-3 F Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for MedicalUse-Parts 30, 32, 35

59 FR 61767; 59 FR 6524360 FR 322; (1/1/98)

1995-1 F 

Frequency of Medical Examinations for Use of Respiratory Protection Equipment-Part 20 60 FR 7900; (3/13/98) 1995-2 F 

Low-Level Waste Shipment Manifest Information and Reporting-Parts 20, 61 60 FR 15649; 60 FR 25983

(3/1/98)

1995-3 P

ML013250

Performance Requirements for Radiography Equipment-Part 34 60 FR 28323; (6/30/98) 1995-4 Radiation Protection Requirements: Amended Definitions and Criteria-Parts 19, 20 60 FR 36038; (8/14/98) 1995-5 F 
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / ML P 

Clarification of Decommissioning Funding Requirements-Parts 30, 40, 70 60 FR 38235; (11/24/98) 1995-6 P Medical Administration of Radiation and Radioactive Materials-Parts 20, 35 60 FR 48623; (10/20/98) 1995-710 CFR Part 71: Compatibility with the International Atomic Energy Agency-Part 71 60 FR 50248; 61 FR 28723

(4/1/99)

1996-1 F 

One Time Extension of Certain Byproduct, Source and Special Nuclear Materials LicensesParts 30, 40, 70 61 FR 1109; (none) 1996-2 

Termination or Transfer of Licensed Activities: Recordkeeping Requirements-Parts 20, 30, 40,61, 70

61 FR 24669; (6/17/99) 1996-3 

Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air ActPart 20 61 FR 65120; (1/9/00) 1997-1 F Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction Withinan Agreement State-Part 150

62 FR 1662; (2/27/00) 1997-2 F

ML010780

Criteria for the Release of Individuals Administered Radioactive Material-Parts 20, 35 62 FR 4120; (5/29/00) 1997-3 F Fissile Material Shipments and Exemptions-Part 71 62 FR 5907; (none) 1997-4 

Licenses for Industrial Radiography and Radiation Safety Requirements for IndustrialRadiography Operations-Parts 30, 34, 71, 150

62 FR 28948; (6/27/00) 1997-5 F

ML010780

Radiological Criteria for License Termination-Parts 20, 30, 40, 70 62 FR 39058; (8/20/00) 1997-6 F Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 UreaPart 30 62 FR 63634; (1/02/01) 1997-7 F Deliberate Misconduct by Unlicensed Persons-Parts 30, 40, 61, 70, 150 63 FR 1890; 63 FR 13773

(2/12/01)

1998-1 F 

Self-Guarantee of Decommissioning Funding by Nonprofit and Non-Bond-Issuing LicenseesParts 30, 40, 70 63 FR 29535; (none) 1998-2 

License Term for Medical Use Licenses-Part 35 63 FR 31604; (none) 1998-3 Licenses for Industrial Radiography and Radiation Safety Requirements for IndustrialRadiographic Operations-Part 34

63 FR 37059; (7/9/01) 1998-4 F

ML010780

Minor Corrections, Clarifying Changes, and a Minor Policy Change-Parts 20, 35, 36 63 FR 39477; 63 FR 45393

(10/26/01)

1998-5

Transfer for Disposal and Manifests: Minor Technical Conforming Amendment-Part 20 63 FR 50127; (11/20/01) 1998-6 P

ML013250

Radiological Criteria for License Termination of Uranium Recovery Facilities-Part 40 64 FR 17506; (6/11/02) 1999-1
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / ML 

1. Or other generic Legally Binding Requirements.2. (Y/N) Y means “Yes,” there are comments in the review letter that the State needs to address. 

N means “No,” there are no comments in the review letter.

3. Not required means these regulations are not required for purposes of compatibility.4. A State need not adopt a specific regulation if the State has no licensees that would be subject to that regulation. See: “Final Polic

Adequacy and Compatibility of Agreement State Programs,” III.1. Time Frame for Adoption of Compatible State Regulations, p. 6, 1995.

5. ADAMS ML Number

Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct Materialto Provide Requested Information-Part 31

64 FR 42269; (none) 1999-2 

Respiratory Protection and Controls to Restrict Internal Exposure-Part 20 64 FR 54543; 64 FR 55524

(2/2/03)

1999-3

Energy Compensation Sources for Well Logging and Other Regulatory Clarifications-Part 39 65 FR 20337; (5/17/03) 2000-1New Dosimetry Technology-Parts 34, 36, 39 65 FR 63749; (1/8/04) 2000-2Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct Material -Parts 30, 31, 32

65 FR 79162; (2/16/04) 2001-1 F Only

Reviewed licenseconditions 32.52 (a) & 

Revision of the Skin Dose Limit-Part 20 67 FR 1629; (4/5/05) 2002-1iMedical Use of Byproduct Material-Parts 20, 32, 35 67 FR 20249; (4/24/05) 2002-2 P

ML042720

Financial Assurance for Materials Licensees – Parts 30, 40, 70 68 FR 57327 12/3/06 2003-1Compatibility With IAEA Transportation Safety Standards and Other Transportation SafetyAmendments – Part 71.

69 FR 3697; (10/01/07) 2004-1