June 19, 2006

Gary Butner, Acting Chief

Radiologic Health Branch

MS 7610

PO Box 997414

Sacramento, CA 95899-7414

Dear Mr. Butner:

The Office of State and Tribal Programs (STP) has reviewed your letter dated May 4, 2006. 

This letter was a response to our letter dated February 16, 2006, which transmitted our

comments on California’s proposed regulation addressing 10 CFR 30.21, “Radioactive Drug: 

Capsules Containing Carbon-14 Urea for In Vivo Diagnostic Use for Humans”. We discussed

our review of the regulations with Phillip Scott on June 16, 2006.

The additional information provided in your letter has enabled us to verify that your regulations

meet the essential objectives of the Compatibility Category B designation assigned to 10 CFR

Part 30.21. As a result of our review, we have no comments. Please note that we have limited

our review to regulations required for compatibility and/or health and safety. We have

determined that the regulations, as proposed, meet the compatibility and health and safety

categories established in the Office of State and Tribal Programs (STP) 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 STP

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

changes and provide a copy to STP.

The SRS Data Sheet summarizes our knowledge of other California 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 review, the compatibility and health and safety

categories, or any of the NRC regulations used in the review, please contact me, or Mr. Osiris

Siurano of my staff at (301)415-2307 or e-mail: OSP@NRC.GOV.

Sincerely,

\RA By KNSchneider For\

Dennis K. Rathbun, Deputy Director

Office of State and Tribal Programs

Enclosure:

As stated
June 19, 2006

Gary Butner, Acting Chief

Radiologic Health Branch

MS 7610

PO Box 997414

Sacramento, CA 95899-7414

Dear Mr. Butner:

The Office of State and Tribal Programs (STP) has reviewed your letter dated May 4, 2006. 

This letter was a response to our letter dated February 16, 2006, which transmitted our

comments on California’s proposed regulation addressing 10 CFR 30.21, “Radioactive Drug: 

Capsules Containing Carbon-14 Urea for In Vivo Diagnostic Use for Humans”. We discussed

our review of the regulations with Phillip Scott on June 16, 2006.

The additional information provided in your letter has enabled us to verify that your regulations

meet the essential objectives of the Compatibility Category B designation assigned to 10 CFR

Part 30.21. As a result of our review, we have no comments. Please note that we have limited

our review to regulations required for compatibility and/or health and safety. We have

determined that the regulations, as proposed, meet the compatibility and health and safety

categories established in the Office of State and Tribal Programs (STP) 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 STP

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

changes and provide a copy to STP.

The SRS Data Sheet summarizes our knowledge of other California 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 review, the compatibility and health and safety

categories, or any of the NRC regulations used in the review, please contact me, or Mr. Osiris

Siurano of my staff at (301)415-2307 or e-mail: OSP@NRC.GOV.

Sincerely,

\RA By KNSchneider For\

Dennis K. Rathbun, Deputy Director

Office of State and Tribal Programs

Enclosure: As stated

Sunsi Review Complete

: Publicly Available G Non-Publicly Available

: Non-Sensitive G Sensitive

Distribution:

DIR RF [6-133] DCD (SP08) PDR (YEST)

LMcLean, RSAO, RIV California File Response to Incoming Document: ML 061360365 

DOCUMENT NAME: E:\Filenet\ML061700392.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 STP STP OGC STP:DD

NAME OSiurano KNSchneider STreby KSchneider for DRathbun

DATE 06/02/06* 06/02/06* 06/08/06* 06/08/06*

ML061700392 OFFICIAL RECORD COPY ML061700418pkg.
STATE REGULATION STATUS

State: California Trackin[1 amendment reviewed is identified Date: 06/by a i at the beginning of each equivalent NRC regulation] 

NRC Chronology Identification FR Notice

(Date Due For StateImplementation)

RATS ID

Proposed(P) / Final(F)1 Rule / 

LicenseCondition(LC) ML #5

Safety Requirements for Radiographic Equipment-Part 34 55 FR 843; (1/10/94) 1991-1 P 

ML051670371

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

ML020030346

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) 1992-1Eliminating the Recordkeeping Requirements for Departures fromManufacturer's Instructions-Parts 30,35

57 FR 45566; (none) 1992-2 

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

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

ML022140223

Licensing and Radiation Safety Requirements for Irradiators-Part 36 58 FR 7715; (7/1/96) 1993-2 LC

ML051580164

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 EPAStandards-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
NRC Chronology Identification FR Notice

(Date Due For StateImplementation)

RATS ID

Proposed(P) / Final(F)1 Rule / 

LicenseCondition(LC) ML #5

Preparation, Transfer for Commercial Distribution, and Use of ByproductMaterial for Medical Use-Parts 30, 32, 35

59 FR 61767; 59 FR 65243;60 FR 322; (1/1/98)

1995-1 F 

Frequency of Medical Examinations for Use of Respiratory ProtectionEquipment-Part 20 

60 FR 7900; (3/13/98) 1995-2 F

ML020030346

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

(3/1/98)

1995-3 F

ML020030346

Performance Requirements for Radiography Equipment-Part 34 60 FR 28323; (6/30/98) 1995-4 P

ML051580164

Radiation Protection Requirements: Amended Definitions and Criteria-Parts 19,20 

60 FR 36038; (8/14/98) 1995-5 F

ML020030346

Clarification of Decommissioning Funding Requirements-Parts 30, 40, 70 60 FR 38235; (11/24/98) 1995-6 F 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-Part71

60 FR 50248; 61 FR 28724;(4/1/99)

1996-1

One Time Extension of Certain Byproduct, Source and Special NuclearMaterials Licenses-Parts 30, 40, 70

61 FR 1109; (none) 1996-2 

Termination or Transfer of Licensed Activities: Recordkeeping RequirementsParts 20, 30, 40, 61, 70 61 FR 24669; (6/17/99) 1996-3 FML020030346 Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials;Clean Air Act-Part 20

61 FR 65120; (1/9/00) 1997-1 F

ML020030346

Recognition of Agreement State Licenses in Areas Under Exclusive FederalJurisdiction Within an Agreement State-Part 150

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

ML022140223

Criteria for the Release of Individuals Administered Radioactive MaterialParts 20, 35 62 FR 4120; (5/29/00) 1997-3 FML020030346 Fissile Material Shipments and Exemptions-Part 71 62 FR 5907; (none) 1997-4 Licenses for Industrial Radiography and Radiation Safety Requirements forIndustrial Radiography Operations-Parts 30, 34, 71, 150

62 FR 28947; (6/27/00) 1997-5 P

ML051670371

Radiological Criteria for License Termination-Parts 20, 30, 40, 70 62 FR 39057; (8/20/00) 1997-6 F 
NRC Chronology Identification FR Notice

(Date Due For StateImplementation)

RATS ID

Proposed(P) / Final(F)1 Rule / 

LicenseCondition(LC) ML #5

ML020030346 

i Exempt Distribution of a Radioactive Drug Containing One Microcurie of

Carbon-14 Urea-Part 30

62 FR 63634; (1/02/01) 1997-7 P

ML06025053005/04/06 -ML061360365

Deliberate Misconduct by Unlicensed Persons-Parts 30, 40, 61, 70, 71, 150 63 FR 1890; 63 FR 13773;

(2/12/01)

1998-1 F

ML060340073

Self-Guarantee of Decommissioning Funding by Nonprofit and Non-BondIssuing Licensees- Parts 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 forIndustrial Radiographic Operations-Part 34

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

ML051670371 

Minor Corrections, Clarifying Changes, and a Minor Policy Change-Parts 20, 35,36

63 FR 39477; 63 FR 45393;(10/26/01)

1998-5 F

ML020030346

Transfer for Disposal and Manifests: Minor Technical Conforming AmendmentPart 20 63 FR 50127; (11/20/01) 1998-6 FML020030346 Radiological Criteria for License Termination of Uranium Recovery FacilitiesPart 40 64 FR 17506; (6/11/02) 1999-1Requirements for Those Who Possess Certain Industrial Devices ContainingByproduct Material to 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 P

ML060100445

Energy Compensation Sources for Well Logging and Other RegulatoryClarifications-Part 39

65 FR 20337; (5/17/03) 2000-1 P

ML053530133

New Dosimetry Technology-Parts 34, 36, 39 65 FR 63750; (1/8/04) 2000-2 P

ML053530133
NRC Chronology Identification FR Notice

(Date Due For StateImplementation)

RATS ID

Proposed(P) / Final(F)1 Rule / 

LicenseCondition(LC) ML #5

PML051580164

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

65 FR 79162; (2/16/04) 2001-1 LC for 32.52

(a) & (b)ML003696531

Revision of the Skin Dose Limit-Part 20 67 FR 16298; (4/5/05) 2002-1 P

ML060100445

Medical Use of Byproduct Material-Parts 20, 32, and 35 67 FR 20249; (10/24/05) 2002-2 P

ML060100445

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

69 FR 3697; (10/01/07)

2004-1

Security Requirements for Portable Gauges Containing Byprodcut Material -Part 30

70 FR 2001; (7/11/08) 2005-1
NRC Chronology Identification FR Notice

(Date Due For StateImplementation)

RATS ID

Proposed(P) / Final(F)1 Rule / 

LicenseCondition(LC) ML #5

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 Policy Statement on 

Compatibility of Agreement State Programs,” III.1. Time Frame for Adoption of Compatible State Regulations, p. 6, SECY-95-112, May 3, 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 giv

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

Medical Use of Byproduct Material - Recognition of Speciality Boards - Part 35 70 FR 16336; 71 FR 1926

(4/29/08)

2005-2

 Increased Controls for Risk-Significant Radioactive Sources (NRC Order EA-05-090)7

70 FR 72128; (12/1/05) 2005-3 LC

ML053060120