June 30, 2005

Mr. Edgar D. Bailey, C.H.P., Chief

Radiologic Health Branch

Division of Food, Drug & Radiation Safety

California Department of Health Services

P. O. Box 942732

Sacramento, CA 94234-7320

Dear Mr. Bailey:

We have reviewed the California license conditions that were submitted to address

10 CFR Part 36, “Licenses and Radiation Safety Requirements for Irradiators”, received by

our office on June 15, 2005. These license conditions were reviewed by comparison to the

equivalent NRC rules in 10 CFR 36 and the requirements of the one amendment identified in

the enclosed State’s Regulation Status (SRS) Data Sheet. We discussed our review of the

license condition with you on June 29, 2005.

As a result of our review, we have no comments. We have determined that the California

license conditions meet the compatibility and health and safety categories established in the

Office of State and Tribal Programs (STP) Procedure SA-200. 

The SRS Data Sheet summarizes our knowledge of the status of other California regulations or

legally binding requirements, 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 STP website: 

http://www.hrsd.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-Perez 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

Enclosures: 

As stated
June 30, 2005

Mr. Edgar D. Bailey, C.H.P., Chief

Radiologic Health Branch

Division of Food, Drug & Radiation Safety

California Department of Health Services

P. O. Box 942732

Sacramento, CA 94234-7320

Dear Mr. Bailey:

We have reviewed the California license conditions that were submitted to address

10 CFR Part 36, “Licenses and Radiation Safety Requirements for Irradiators”, received by

our office on June 15, 2005. These license conditions were reviewed by comparison to the

equivalent NRC rules in 10 CFR 36 and the requirements of the one amendment identified in

the enclosed State’s Regulation Status (SRS) Data Sheet. We discussed our review of the

license condition with you on June 29, 2005.

As a result of our review, we have no comments. We have determined that the California

license conditions meet the compatibility and health and safety categories established in the

Office of State and Tribal Programs (STP) Procedure SA-200. 

The SRS Data Sheet summarizes our knowledge of the status of other California regulations or

legally binding requirements, 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 STP website:

http://www.hrsd.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-Perez 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

Enclosures: As stated

SISP Review Complete

: Publicly Available G Non-Publicly Available

: Non-Sensitive G Sensitive

Distribution:

DIR RF [5-168] DCD (SP08) PDR (YEST) BUsilton

LMcLean, RSAO, RIV California File Response to Incoming Document: ML 051670371 

DOCUMENT NAME: E:\Filenet\ML051810407.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 KNS for DRathbun

DATE 06/20/05* 06/20/05* 06/28/05* 06/30/05*

OFFICIAL RECORD COPY
STATE REGULATION STATUS

State: California Tracking Ticket Num[One Amendment reviewed are identified by a i Date: June 30, 2005 at the beginning of each equivalent NRC regulation)

NRC Chronology Identification FR Notice

(Date Due For StateImplementation)

RATS ID

Propose(P) / Fina(F)1 Rule 

ML #5

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

ML022140

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

ML020030

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 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

ML022140

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

ML051670

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) 1994-2Timeliness in Decommissioning Material Facilities-Parts 30, 40, 70 59 FR 36026; (8/15/97) 1994-3Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for MedicalUse-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 Protection Equipment-Part 20 60 FR 7900; (3/13/98) 1995-2 F

ML020030

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

(3/1/98)

1995-3 F

ML020030
NRC Chronology Identification FR Notice

(Date Due For StateImplementation)

RATS ID

Propose(P) / Fina(F)1 Rule 

ML #5

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

ML020030

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-Part 71 60 FR 50248; 61 FR 28724;

(4/1/99)

1996-1

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

ML020030

Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air ActPart 20 61 FR 65120; (1/9/00) 1997-1 FML020030Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction Withinan Agreement State-Part 150

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

ML022140

Criteria for the Release of Individuals Administered Radioactive Material-Parts 20, 35 62 FR 4120; (5/29/00) 1997-3 F

ML020030

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 28947; (6/27/00) 1997-5

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

ML020030

Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 UreaPart 30 62 FR 63634; (1/02/01) 1997-7Deliberate Misconduct by Unlicensed Persons-Parts 30, 40, 61, 70, 71, 150 63 FR 1890; 63 FR 13773;

(2/12/01)

1998-1
NRC Chronology Identification FR Notice

(Date Due For StateImplementation)

RATS ID

Propose(P) / Fina(F)1 Rule 

ML #5

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

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

ML020030

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

ML020030

Radiological Criteria for License Termination of Uranium Recovery Facilities-Part 40 64 FR 17506; (6/11/02) 1999-1Requirements for Those Who Possess Certain Industrial Devices Containing ByproductMaterial 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

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 63750; (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 license

conditions32.52 (a) & 

Revision of the Skin Dose Limit-Part 20 67 FR 16298; (4/5/05) 2002-1Medical Use of Byproduct Material-Parts 20, 32, and 35 67 FR 20249; (10/24/05) 2002-2Financial 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
NRC Chronology Identification FR Notice

(Date Due For StateImplementation)

RATS ID

Propose(P) / Fina(F)1 Rule 

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 Polic

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

5. ADAMS ML Number6. Although these items are not required for purposes of compatibility, the State incorporate NRC regulations by reference on 10/9/98 which includ

Security Requirements for Portable Gauges Containing Byprodcut Material - Part 30 70 FR 2001; (7/11/08) 2005-1Medical Use of Byproduct Material - Recognition of Speciality Boards - Part 35 70 FR 16336; (4/29/08) 2005-2