February 26, 2008

Dewey Crawford, Administrator

Radiation Health Program

Cabinet for Health and Family Services

275 East Main Street, HS1C-A

Frankfort, KY 40621-0001

Dear Mr. Crawford:

We have reviewed the proposed changes to the Kentucky regulations 902 KAR Chapter 100,

received by our office on January 16, 2008. These regulations were reviewed by comparison to

the equivalent Nuclear Regulatory Commission (NRC) rules in 10 CFR Parts 20, 30, 32, 34, 35,

36, 39, 40, 61, 70, 71 and the requirements of the 12 amendments identified in the enclosed

State Regulation Status (SRS) Data Sheet. We discussed our review of the regulations with

Matthew McKinley on February 19, 2008.

As a result of our review, we have 17 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 Federal and State Materials and Environmental Management

Programs (FSME) Procedure SA-200.

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 FSME

Procedure SA-201, “Review of State Regulatory Requirements,” please highlight the final

changes, and provide a copy to Division of Materials Safety and State Agreements, FSME. 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 FSME website: http://www.hsrd.ornl.gov/nrc/rulemaking.htm.

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 Kathleen

Schneider, State Regulation Review Coordinator at (301) 415-2320 (email: kxs@nrc.gov) or

Monica Orendi at (301) 415-3938 (email: mlo1@nrc.gov).

Sincerely,

Robert J. Lewis, Director

Division of Materials Safety and State Agreements

Office of Federal and State Materials and

Environmental Management Programs

Enclosures: 

As stated
February 25, 2008

Dewey Crawford, Administrator

Radiation Health Program-Cabinet for Health and Family Services

275 East Main Street, HS1C-A

Frankfort, KY 40621-0001

Dear Mr. Crawford:

We have reviewed the proposed changes to the Kentucky regulations 902 KAR Chapter 100,

received by our office on January 16, 2008. These regulations were reviewed by comparison to

the equivalent Nuclear Regulatory Commission (NRC) rules in 10 CFR Parts 20, 30, 32, 34, 35,

36, 39, 40, 61, 70, 71 and the requirements of the 12 amendments identified in the enclosed

State Regulation Status (SRS) Data Sheet. We discussed our review of the regulations with

Matthew McKinley on February 19, 2008.

As a result of our review, we have 17 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 Federal and State Materials and Environmental Management

Programs (FSME) Procedure SA-200.

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 FSME

Procedure SA-201, “Review of State Regulatory Requirements,” please highlight the final

changes, and provide a copy to Division of Materials Safety and State Agreements, FSME. 

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

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 Kathleen Schneider,

State Regulation Review Coordinator at (301) 415-2320 (email: kxs@nrc.gov) or Monica Orendi

at (301) 415-3938 (email: mlo1@nrc.gov).

Sincerely,

\RA By ADWhite For\

Robert J. Lewis, Director

Division of Materials Safety and State Agreements

Office of Federal and State Materials and

Environmental Management Programs

Enclosures: As stated

Distribution:

DIR RF (8-2, 8-3, 8-4) SUNSI Review Complete

DCD (SP06) : Publicly Available G Non-Publicly Available

JKottan, RSAO : Non-Sensitive G Sensitive

MOrendi [KY] File ML of Incoming Document: ML080150503

DOCUMENT NAME: C:\FileNet\ML080560200.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 SAISB SAISB OGC SAIS:BC MSSA:DD

NAME MOrendi Kschneider BJones DWhite RLewis

DATE 01/30/08* 01/30/08* 02/13/08* 02/26/08* 02/26/08*

ML080560200 OFFICIAL RECORD COPY PKG.ML080560249

COMPATIBILITY COMMENTS ON KENTUCKY PROPOSED REGULATIONS
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

1 100:010

Section 1

(217)

35.2 2005-2

2006-1

B Definition Radiation Safety Officer

Kentucky omits paragraph (2) from its

definition of Radiation Safety Officer. [(2)

Is identified as a Radiation Safety Officer

on- (i) A specific ...]

Kentucky needs to add paragraph to of 10

CFR 35.2 definition of Radiation Safety

officer to its definition in order to meet the

Compatibility Category B designation

assigned to 10 CFR 35.2 Radiation Safety

Officer.

2 100:072

Section 64

35.50 2005-2

2006-1

B Training for a Radiation Safety Officer

Kentucky has used the words “written

certification” instead of the words “written

attestation”in their 100:072 Section 64 (4).

Kentucky needs to change the word

certification to attestation in order to meet

the Compatibility Category B designation

assigned to 10 CFR 35.50.

3 100:072

Section 65

35.51 2005-2

2006-1

B Training for an Authorized Medical

Physicist

Kentucky has used the words “written

certification” instead of the words “written

attestation”in their 100:072 Section 65

(2)(b).

Kentucky needs to change the word

certification to attestation in order to meet

the Compatibility Category B designation

assigned to 10 CFR 35.51.

4 100:072

Section 66

35.55 2005-2 B Training for an Authorized Nuclear

Pharmacist

Kentucky has used the words “written

certification” instead of the words “written

attestation”in their 100:072 Section 66

(2)(b).

Kentucky needs to change the word

certification to attestation in order to meet

the Compatibility Category B designation

assigned to 10 CFR 35.55.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

5 100:072

Section 68

35.190 2005-2

2006-1

B Training for Uptake, Dilution, and

Excretion Studies

Kentucky needs to remove 100:072

Section 68 (3)(a)(2) from its current

location and leave Section 68 (3)(a)(3)

where it is but recodify it to state (3)(a)(2). 

Also Kentucky has used the words

“written certification” instead of the words

“written attestation”in their 100:072

Section 68 (3)(b).

Kentucky needs to make the above

changes in order to meet the

Compatibility Category B designation

assigned to 10 CFR 35.190.

6 100:072

Section 69

35.290 2005-2

2006-1

B Training for Imaging and Localization

Studies

Kentucky has used the words “written

certification” instead of the words “written

attestation”in their 100:072 Section 69

(3)(b).

Kentucky needs to change the word

certification to attestation in order to meet

the Compatibility Category B designation

assigned to 10 CFR 35.290.

7 100:072

Section 70

35.390 2005-2

2006-1

B Training for the use of Unsealed

Byproduct Material for Which a Written

Directive is Required

Kentucky has used the words “written

certification” instead of the words “written

attestation”in their 100:072 Section

70(2)(b).

Kentucky needs to change the word

certification to attestation in order to meet

the Compatibility Category B designation

assigned to 10 CFR 35.390. (Please note

the word “certification appears twice in

Section 70(2)(b). Both instances need to

be changed to the word “attestation”)
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

8 100:072

Section 71

35.392 2005-2

2006-1

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)

Kentucky has used the words “written

certification” instead of the words “written

attestation”in their 100:072 Section

71(3)(c).

Kentucky needs to change the word

certification to attestation in order to meet

the Compatibility Category B designation

assigned to 10 CFR 35.392. (Please note

the word “certification appears twice in

Section 71(3)(c). Both instances need to

be changed to the word “attestation”.)

9 100:072

Section 72

35.394 2005-2

2006-1

B Training for the Oral Administration of

Sodium Iodide I–131 Requiring a

Written Directive in Quantities Greater

than 1.22 Gigabecquerels (33

millicuries)

Kentucky has used the words “written

certification” instead of the words “written

attestation”in their 100:072 Section

72(3)(d).

Kentucky needs to change the word

certification to attestation in order to meet

the Compatibility Category B designation

assigned to 10 CFR 35.394. (Please note

the word “certification appears twice in

Section 72(3)(d). Both instances need to

be changed to the word “attestation”. 

Also it appears that there is no Section 72

(3)(c) so this section may need to be

changes from (3)(d) to (3)(c).)

10 100:072

Section 73

35.396 2005-2

2006-1

B Training for the Parenteral

Administration of Unsealed Byproduct

Material Requiring a Written Directive

Kentucky has used the words “written

certification” instead of the words “written

attestation”in their 100:072 Section

73(4)(b).

Kentucky needs to change the word

certification to attestation in order to meet

the Compatibility Category B designation

assigned to 10 CFR 35.396. (Please note

the word “certification appears twice in

Section 73(4)(b). Both instances need to

be changed to the word “attestation”.)
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

11 100.072

Section 74

35.490 2005-2

2006-1

B Training for use of Manual

Brachytherapy Sources

Kentucky has used the words “written

certification” instead of the words “written

attestation”in their 100:072 Section

74(2)(c).

Kentucky needs to change the word

certification to attestation in order to meet

the Compatibility Category B designation

assigned to 10 CFR 35.490.

12 100:072

Section 75

35.491 2005-2

2006-1

B Training for Ophthalmic Use of

Strontium-90

Kentucky has used the words “written

certification” instead of the words “written

attestation”in their 100:072 Section

75(2)(c).

Kentucky needs to change the word

certification to attestation in order to meet

the Compatibility Category B designation

assigned to 10 CFR 35.491. 

13 100:072

Section 77

35.690 2005-2

2006-1

B Training for Use of Remote

Afterloader Units, Teletherapy Units,

and Gamma Stereotactic Radiosurgery

Units.

Kentucky has used the words “written

certification” instead of the words “written

attestation”in their 100:072 Section

77(2)(c).

Kentucky needs to change the word

certification to attestation in order to meet

the Compatibility Category B designation

assigned to 10 CFR 35.690. 

14 100:058

Section 9

32.72 2006-1 B Manufacture, Preparation, or

Transfer for Commercial Distribution

of Radioactive Drugs Containing

Byproduct Material for Medical Use

Under Part 35.

Kentucky omits 10 CFR 32.72 (a)(2)(iv) “

Operating as a nuclear pharmacy within a

Federal medical institution.” from its

regulations.

Kentucky needs to add the above to

100:058 Section 9 in order to meet the

Compatibility category B designation

assigned to 10 CFR 32.72.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

15 100:010

Section 1 (23)

35.2 2006-1 B Definitions: Authorized Medical

Physicist

Kentucky omits paragraphs (2)(ii) “A

medical use permit issued by a

Commission master material licensee”

and paragraph (2)(iv) “A permit issued by

a Commission master material license

broad scope medical use permittee.”

Kentucky needs to add the above to

100:010 Section 1 (23) in order to meet

the Compatibility Category B designation

assigned to 10 CFR 35.2 definition

Authorized medical physicist. 

16 100:010

Section 1 (24)

35.2 2006-1 B Definition Authorized Nuclear

Pharmacist

Kentucky omits paragraphs (2)(ii) “A

permit issued by a Commission master

material licensee that authorizes medical

use or the practice of nuclear pharmacy”

and paragraph (2)(iv) “A permit issued by

a Commission master material license

broad scope medical use permittee that

authorizes medical use or the practice of

nuclear pharmacy.”

Kentucky needs to add the above to

100:010 Section 1 (24) in order to meet

the Compatibility Category B designation

assigned to 10 CFR 35.2 definition

Authorized nuclear pharmacist 

17 100:010

Section 1 (25)

35.2 2006-1 B Definition Authorized User

Kentucky omits paragraphs (2)(ii) “A

permit issued by a Commission master

material licensee that is authorized to

permit the medical use of byproduct

material” and paragraph (2)(iv) “A permit

issued by a Commission master material

license broad scope medical use

permittee that is authorized to permit the

medical use of byproduct material.”

Kentucky needs to add the above to

100:010 Section 1 (25) in order to meet

the Compatibility Category B designation

assigned to 10 CFR 35.2 definition

Authorized user.
STATE REGULATION STATUS

State: Kentucky [12 Amendments reviewed identified Tracking Ticket Numby a i at the beginning of the equivalent NRC requirement.] Date: February 25, 2

NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / LicCondition(LC) 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 

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 

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 

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

(3/1/98)

1995-3 P

ML080150
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / LicCondition(LC) ML #

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

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 F 

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 Within

an 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 
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / LicCondition(LC) ML #

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

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

(10/26/01)

1998-5 P

ML080150

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

ML080150

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

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

64 FR 42269; (none) 1999-2 

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

(2/2/03)

1999-3 P

ML080150

iEnergy Compensation Sources for Well Logging and Other Regulatory Clarifications-Part 39 65 FR 20337; (5/17/03) 2000-1 P

ML080150

iNew Dosimetry Technology-Parts 34, 36, 39 65 FR 63749; (1/8/04) 2000-2 P

ML080150

Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct Material -Parts 30, 31, 32

65 FR 79162; (2/16/04) 2001-1 LC for 32

(a) & (b)ML040550

iRevision of the Skin Dose Limit-Part 20 67 FR 1629; (4/5/05) 2002-1 P

ML080150

Medical Use of Byproduct Material-Parts 20, 32, 35 67 FR 20249; (4/24/05) 2002-2 P

ML042720

iFinancial Assurance for Materials Licensees – Parts 30, 40, 70 68 FR 57327 12/3/06 2003-1 P

ML080150
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / LicCondition(LC) ML #

iCompatibility With IAEA Transportation Safety Standards and Other Transportation Safety

Amendments – Part 71.

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

ML080150

iSecurity Requirements for Portable Gauges Containing Byproduct Material - Part 30 70 FR 2001; (7/11/08) 2005-1 P

ML080150

iMedical Use of Byproduct Material - Recognition of Specialty Boards - Part 35 70 FR 16336; 71 FR 1926

(4/29/08)

2005-2 P

ML080150

Increased Controls for Risk-Significant Radioactive Sources (NRC Order EA-05-090)6 70 FR 72128; (12/1/05) 2005-3 LC

ML053180

iMinor Amendments - Parts 20, 30, 32, 35, 40, and 70 71 FR 15005 (3/27/09) 2006-1 P

ML081050

National Source Tracking System - Serialization Requirements - Part 32 with reference to Part20 Appendix E

71 FR 65685 (2/6/07) 2006-2 

National Source Tracking System - Part 20 71 FR 65865, 72 FR 59162 

(01/31/09)

2006-3

Medical Use of Byproduct Material-Minor Corrections and Clarifications-Parts 32 and 35 72 FR 45147, 54207

(10/29/10)

2007-1

Exemptions From Licensing, General Licenses, and Distribution of Byproduct Material;Licensing and Reporting Requirements Parts- 30, 31, 32, 150

72 FR 58472 (12/17/10) 2007-2

Requirements for Expanded Definition of Byproduct MaterialParts 20, 30, 31, 32, 33, 35, 61, 150

72 FR 55864 (11/30/2010) 2007-3

Order Imposing Fingerprinting Requirements and Criminal History Records Check Requirements for Unescorted Access to Certain Radioactive MaterialNRC Order EA-07-305

72 FR 70901 (06/05/2008) 2007-4
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / LicCondition(LC) 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 

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

1995.

5. ADAMS ML Number6. By letter dated September 2, 2005, from Paul H. Lohaus, Director, Office of State and Tribal Programs, Agreement States were 

legally binding requirements satisfying the requirements of NRC Order EA-05-090.

Occupational Dose Records, Labeling Containers, and Total Effective Dose EquivalentParts 19, 20

72 FR 68043 (02/15/2011) 2008-1