February 14, 2011 

Gary W. Butner, Branch Chief 

Radiologic Health Branch 

Division of Food, Drug and Radiation Safety 

California Department of Health Services 

P.O. Box 997414, MS-7610 

Sacramento, CA 95899-7414 

Dear Mr. Butner: 

We have reviewed the final revision to the California Radiation Control Regulations 30253, 

received by our office on December 21, 2010. These regulations were reviewed by comparison 

to the equivalent Nuclear Regulatory Commission (NRC) rules in 10 CFR Part 20 and the 

requirements of the seven amendments identified in the enclosed State Regulation Status 

(SRS) Data Sheet. We discussed our review of the regulations with Phillip Scott on February 9, 

2011. 

As a result of our review, we have 19 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. We have determined that if these regulations are revised, 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 you revise your regulations to address our comments, a copy of the Aas 

published@ regulations be provided to us for review. As requested in FSME Procedure SA-201, 

AReview of State Regulatory Requirements,@ please highlight the location of any changes made 

by California, in response to our comments, 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 California 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://nrc-stp.ornl.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 Kathleen 

Schneider, State Regulation Review Coordinator at 415-2320 (kathleen.schneider@nrc.gov) or 

Stephen Poy at 415-7135 (stephen.poy@nrc.gov). 

Sincerely, 

 /RA/ 

Terrence Reis, Deputy Director 

Division of Materials Safety and State Agreements 

Office of Federal and State Materials and 

Environmental Management Programs 

Enclosures: 

As stated 
[Concurrence Page] 

Enclosures: As stated 

Distribution: 

DIR RF (10-58) SUNSI Review Complete 

DCD (SP08) : Publicly Available G Non-Publicly Available 

RErickson, RSAO : Non-Sensitive G Sensitive 

JKatanic, POC [State] File 

DOCUMENT NAME: G:\DMSSA\SAISB\REGULATION TOOLBOX\States\California\10-58 

Incoming Document: ML103550423 

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 ASPB ASPB OGC ASPB:BC MSSA:DD 

NAME SPoy KSchneider BJones DWhite TReis 

DATE 01/14/11 01/24/11 02/03/11 02/14/11 02/14/11 

ML 110120096 OFFICIAL RECORD COPY Package ML110120070 

 
COMPATIBILITY COMMENTS ON CALIFORNIA FINAL REGULATIONS 

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

1 39.33 1998-5 C Radiation detection instruments 

State didn’t submit an amendment to 

Part 39. 

CA did not submit their equivalent 

regulation to 39.33 for review. 

CA needs to provide for review above 

equivalent regulation in order to meet 

the Compatibility Category C 

designation 10 CFR 39.33. 

2 32.72 2006-1 

2007-3 

B Manufacture, preparation, or 

transfer for commercial 

distribution of radioactive drugs 

containing byproduct material for 

medical use under Part 35 

California didn’t submit amendment to 

Part 32. 

California did not submit their 

equivalent regulation to 32.72 for 

review. 

California needs to provide for review 

above equivalent regulation in order 

to meet the Compatibility Category B 

designation 10 CFR 32.72. 

3 32.74 2006-1 B Manufacture and distribution of 

sources or devices containing 

byproduct material for medical use 

California didn’t submit amendment to 

Part 32. 

California did not submit their 

equivalent regulation to 32.74 for 

review. 

California needs to provide for review 

above equivalent regulation in order 

to meet the Compatibility Category B 

designation 10 CFR 32.74. 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

4 30.3 2007-3 C Activities requiring license 

California didn’t submit amendment to 

Part 30. 

California did not submit their 

equivalent regulation to 30.3 for 

review. 

California needs to provide for review 

above equivalent regulation in order 

to meet the Compatibility Category C 

designation 10 CFR 30.3. 

5 30.4 2007-3 C Definition: Consortium 

California didn’t submit amendment to 

Part 30. 

California did not submit their 

equivalent regulation to 30.4 for 

review. 

California needs to provide for review 

above equivalent regulation in order 

to meet the Compatibility Category C 

designation 10 CFR 30.4. 

6 30.15 2007-3 B Certain items containing byproduct 

material 

California didn’t submit amendment to 

Part 30. 

California did not submit their 

equivalent regulation to 30.15 for 

review. 

California needs to provide for review 

above equivalent regulation in order 

to meet the Compatibility Category B 

designation 10 CFR 30.15. 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

7 30.18 2007-3 B Exempt quantities 

California didn’t submit amendment to 

Part 30. 

California did not submit their 

equivalent regulation to 30.18 for 

review. 

California needs to provide for review 

above equivalent regulation in order 

to meet the Compatibility Category B 

designation 10 CFR 30.18. 

8 30.20 2007-3 B Gas and aerosol detectors 

containing byproduct material

 

California didn’t submit amendment to 

Part 30. 

California did not submit their 

equivalent regulation to 30.20 for 

review. 

California needs to provide for review 

above equivalent regulation in order 

to meet the Compatibility Category B 

designation 10 CFR 30.20. 

9 30.32 2007-3 B,C Application for specific licenses 

California didn’t submit amendment to 

Part 30. 

California did not submit their 

equivalent regulation to 30.32 for 

review. 

California needs to provide for review 

above equivalent regulation in order 

to meet the Compatibility Category B 

and C designation 10 CFR 30.32. 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

10 30.34 2007-3 B,H&S Terms and conditions of licenses 

California didn’t submit amendment to 

Part 30. 

California did not submit their 

equivalent regulation to 30.34 for 

review. 

California needs to provide for review 

above equivalent regulation in order 

to meet the Compatibility Category B 

and H&S designation 10 CFR 30.34. 

11 30.71 2007-3 B Schedule B 

California didn’t submit amendment to 

Part 30. 

California did not submit their 

equivalent regulation to 30.71 for 

review. 

California needs to provide for review 

above equivalent regulation in order 

to meet the Compatibility Category B 

designation 10 CFR 30.71. 

12 30.72 2007-3 H&S Schedule C 

California didn’t submit amendment to 

Part 30. 

California did not submit their 

equivalent regulation to 30.72 for 

review. 

California needs to provide for review 

above equivalent regulation in order 

to meet the Compatibility Category 

H&S designation 10 CFR 30.72. 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

13 31.5 2007-3 B Certain detecting, measuring, 

gauging, or controlling devices 

and/or an ionizing atmosphere 

California didn’t submit amendment to 

Part 31. 

California did not submit their 

equivalent regulation to 31.5 for 

review. 

California needs to provide for review 

above equivalent regulation in order 

to meet the Compatibility Category B 

designation 10 CFR 31.5. 

14 31.12 2007-3 C General license for certain items 

and self-luminous products 

containing radium-226 

California didn’t submit amendment to 

Part 31. 

California did not submit their 

equivalent regulation to 30.12 for 

review. 

California needs to provide for review 

above equivalent regulation in order 

to meet the Compatibility Category C 

designation 10 CFR 31.12. 

15 32.57 2007-3 B Calibration or reference sources 

containing americium-241 or 

radium-226: Requirements for 

license to manufacture or initially 

transfer 

California didn’t submit amendment to 

Part 32. 

California did not submit their 

equivalent regulation to 32.57 for 

review. 

California needs to provide for review 

above equivalent regulation in order 

to meet the Compatibility Category B 

designation 10 CFR 32.57. 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

16 32.58 2007-3 B Same: labeling of devices 

California didn’t submit amendment to 

Part 32. 

California did not submit their 

equivalent regulation to 32.58 for 

review. 

California needs to provide for review 

above equivalent regulation in order 

to meet the Compatibility Category B 

designation 10 CFR 32.58. 

17 32.59 2007-3 B Same: Leak testing of each source 

California didn’t submit amendment to 

Part 32. 

California did not submit their 

equivalent regulation to 32.59 for 

review. 

California needs to provide for review 

above equivalent regulation in order 

to meet the Compatibility Category B 

designation 10 CFR 32.59. 

18 32.71 2007-3 B Manufacture and distribution of 

byproduct material for certain in 

vitro clinical or laboratory testing 

under general license 

California didn’t submit amendment to 

Part 32. 

California did not submit their 

equivalent regulation to 32.71 for 

review. 

California needs to provide for review 

above equivalent regulation in order 

to meet the Compatibility Category B 

designation 10 CFR 32.71. 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

19 32.102 2007-3 B Schedule-C prototype tests for 

calibration or reference sources 

containing americium-241 

California didn’t submit amendment to 

Part 32. 

California did not submit their 

equivalent regulation to 32.102 for 

review. 

California needs to provide for review 

above equivalent regulation in order 

to meet the Compatibility Category B 

designation 10 CFR 32.102. 
STATE REGULATION STATUS

State: California 

 Tracking Ticke

[7 amendment(s) reviewed is identified by a i Date: February 

at the beginning of the equivalent NRC requirement.] 

RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

1991-1 Safety Requirements for Radiographic Equipment 

Part 34 55 FR 843 (Superceded by 1997-5) 

01/10/1994 Not Required Not Required Califor

Regula1997-5

1991-2 ASNT Certification of Radiographers 

Part 34 56 FR 11504 (Superceded by 1997-5) 

none Not Required Not Required Califor

Regula1997-5

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 

ML020030346 

No Comments 03/18/2002 ML020780186 

1991-4 Notification of Incidents 

Parts 20, 30, 31, 34, 39, 40, 70 56 FR 64980; 

10/15/1994 Final No Comments 

04/01/1998 

1992-1 Quality Management Program and Misadministrations 

Part 35 56 FR 34104 (Superceded by 2002-2)

01/27/1995 Final 

ML103050179 

No Comments 01/05/2011 ML103340424 

1992-2 Eliminating the Recordkeeping Requirements 

for Departures from Manufacturer's Instructions Parts 30, 35 57 FR 45566 

none Not Required Not Required These 

requireCompa

1993-1 Decommissioning Recordkeeping and License 

Termination: Documentation Additions [Restricted areas and spill sites] Parts 30, 40 58 FR 39628 

10/25/1996 Final 

ML022140223 

Comments 08/22/2002 ML022350054 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

1993-2 Licensing and Radiation Safety Requirements for 

Irradiators Part 36 58 FR 7715 

07/01/1996 License Condition 

ML051670371 

No Comments 07/01/2005 ML051810407 

1993-3 Definition of Land Disposal and Waste Site QA Program 

Part 61 58 FR 33886 

07/22/1996 Not Applicable1 Not Applicable Califor

subjecSECY

1994-1 Self-Guarantee as an Additional Financial Mechanism 

Parts 30, 40, 70 58 FR 68726; 59 FR 1618 

none Final No Comments 

04/01/1998 These 

requireCompa

1994-2 Uranium Mill Tailings Regulations: Conforming NRC 

Requirements to EPA Standards Part 40 59 FR 28220 

07/01/1997 Not Applicable Not Applicable Califor

regulaAgree

1994-3 Timeliness in Decommissioning Material Facilities 

Parts 30, 40, 70 59 FR 36026 

08/15/1997 

1995-1 Preparation, Transfer for Commercial Distribution, and 

Use of Byproduct Material for Medical Use Parts 30, 32, 35 59 FR 61767; 59 FR 65243; 60 FR 322 

01/01/1998 Final No Comments 

11/16/1999 

1995-2 Frequency of Medical Examinations for Use of 

Respiratory Protection Equipment Part 20 60 FR 7900

03/13/1998 Final 

ML020030346 

No Comments 03/18/2002 ML020780186 

1995-3 Low-Level Waste Shipment Manifest Information and 

Reporting Parts 20, 61 60 FR 15649; 60 FR 25983 

03/01/1998 Final 

ML020030346 

No Comments 03/18/2002 ML020780186 

1995-4 Performance Requirements for Radiography Equipment 

Part 34 60 FR 28323 (Superceded by 1997-5) 

06/30/1998 Not Required Not Required Califor

Regula1997-5
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

1995-5 Radiation Protection Requirements: Amended Definitions 

and Criteria Parts 19, 20 60 FR 36038 

08/14/1998 Final 

ML020030346 

No Comments 03/18/2002 ML020780186 

1995-6 Clarification of Decommissioning Funding Requirements 

Parts 30, 40, 70 60 FR 38235 

11/24/1998 Final No Comments 

04/01/1998 

*1995-7 Medical Administration of Radiation and Radioactive 

Materials Parts 20, 35 60 FR 48623 (Superceded by 2002-2 and 2005-2) 

10/20/1998 Final 

ML103050179 Final ML103550423 

No Comments 01/05/2011 ML103340411 No Comments 02/14/2011 ML110120070 

Part 35 Part 20 

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 

ML091240053 

No Comments 06/11/2009 ML091470300 

CaliforRegula2004-1 

1996-2 One Time Extension of Certain Byproduct, Source and 

Special Nuclear Materials Licenses Parts 30, 40, 70 61 FR 1109 

02/15/1999 Not Required Not Required These 

requireCompa

1996-3 Termination or Transfer of Licensed Activities: Record 

keeping Requirements Parts 20, 30, 40, 61, 70 61 FR 24669 

06/17/1999 Final 

ML020030346 

No Comments 03/18/2002 ML020780186 

1997-1 Resolution of Dual Regulation of Airborne Effluents of 

Radioactive Materials; Clean Air Act Part 20 61 FR 65120 

01/9/2000 Final 

ML020030346 

No Comments 03/18/2002 ML020780186 

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 

ML102160676 

No Comments 09/28/2010 ML102300157 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

*1997-3 Criteria for the Release of Individuals Administered 

Radioactive Material Parts 20, 35 62 FR 4120 

05/29/2000 Final 

ML103050179 Final ML103550423 

No Comments 01/05/2011 ML103340411 No Comments 02/14/2011 ML110120070 

Part 35 Part 20 

1997-4 Fissile Material Shipments and Exemptions 

Part 71 62 FR 5907 (Superceded by 2004-1) 

02/10/2000 Not Required Not Required These 

requireCompa

1997-5 Licenses for Industrial Radiography and Radiation Safety 

Requirements for Industrial Radiography Operations Parts 30, 34, 71, 150 62 FR 28947 

06/27/2000 Final 

ML081160234 

Comments 06/19/2008 ML081710246 

1997-6 Radiological Criteria for License Termination 

Parts 20, 30, 40, 70 62 FR 39057 

08/20/2000 This re

and foML 02repealcurrenby cas

1997-7 Exempt Distribution of a Radioactive Drug Containing 

One Micro curie of Carbon-14 Urea Part 30 62 FR 63634 

01/02/2001 Final 

ML081080140 

No Comments 05/13/2008 ML081340266 

1998-1 Deliberate Misconduct by Unlicensed Persons 

Parts 30, 40, 61, 70, 71, 150 63 FR 1890; 63 FR 13773 

02/12/2001 Final 

ML060340073 

No Comments 03/09/2006 ML060670437 

1998-2 Self-Guarantee of Decommissioning Funding by Nonprofit 

and Non-Bond-Issuing Licensees Parts 30, 40, 70 63 FR 29535 

07/01/2001 Not Required Not Required These 

requireCompa
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

1998-3 License Term for Medical Use Licenses 

Part 35 63 FR 31604 (Superceded by 2002-2) 

07/10/2001 Not Required Not Required These 

requireCompa

1998-4 Licenses for Industrial Radiography and Radiation Safety 

Requirements for Industrial Radiographic Operations Part 34 63 FR 37059 

07/09/2001 Final 

ML081160234 

No Comments 06/19/2008 ML081710246 

*1998-5 Minor Corrections, Clarifying Changes, and a Minor Policy 

Change Parts 20, 35, 36 63 FR 39477; 63 FR 45393 

10/26/2001 Final 

ML103050179 Final ML020030346 Final ML103550423 License Condition ML051580164 ML061790298 

Comments 01/05/2011 ML103340411 No Comments 03/18/2002 ML020780186 No Comments 02/14/2011 ML110120070 No Comments 07/18/2006 ML061990575 

Part 35 Part 20 2002-2Part 20 Part 36 Requirbeen r

1998-6 Transfer for Disposal and Manifests: Minor Technical 

Conforming Amendment Part 20 63 FR 50127 

11/20/2001 Final 

ML020030346 

No Comments 03/18/2002 ML020780186 

1999-1 Radiological Criteria for License Termination of Uranium 

Recovery Facilities Part 40 64 FR 17506 

06/11/2002 Not Applicable Not Applicable Califor

regulaAgree
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

1999-2 Requirements for Those Who Possess Certain Industrial 

Devices Containing Byproduct Material to Provide Requested Information Part 31 64 FR 42269 

10/04/2002 Not Required Not Required These 

requireCompa

1999-3 Respiratory Protection and Controls to Restrict Internal 

Exposure Part 20 64 FR 54543; 64 FR 55524 

02/02/2003 Final 

ML062210438 

No Comments 08/31/2006 ML062490010 

2000-1 Energy Compensation Sources for Well Logging and 

Other Regulatory Clarifications Part 39 65 FR 20337 

05/17/2003 Final 

ML070920384 

No Comments 04/23/2007 ML071140038 

2000-2 New Dosimetry Technology 

Parts 34, 36, 39 65 FR 63750 

01/08/2004 Final 

ML081160234 Final ML070920384 LC ML051580164 ML061790298 

No Comments 06/19/2008 ML081710246 No Comments 04/23/2007 ML071140038 No Comments 07/18/2006 ML061990575 

Part 34 Part 39 Part 36 

2001-1 Requirements for Certain Generally Licensed Industrial 

Devices Containing Byproduct Material Parts 30, 31, 32 65 FR 79162 

02/16/2004 Proposed 

ML102160676 License Condition for 32.52 (a) & (b) ML040500440 

Comments 09/28/2010 ML102300157 No Comments 03/10/2004 ML040700191 

Partial Part 3

2002-1 Revision of the Skin Dose Limit 

Part 20 67 FR 16298 

04/05/2005 Final 

ML062210438 

No Comments 08/31/2006 ML062490010 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

*2002-2 Medical Use of Byproduct Material 

Parts 20, 32, 35 67 FR 20249 

10/24/2005 Final 

ML103050179 Final ML103550423 

Comments 01/05/2011 ML103340411 Comments 02/14/2011 ML110120070 

Part 35 Part 20 Requirbeen r

2003-1 Financial Assurance for Materials Licensees 

Parts 30, 40, 70 68 FR 57327 

12/03/2006 Final 

ML090210714 

No Comments 02/06/2009 ML090260305 

2004-1 Compatibility With IAEA Transportation Safety Standards 

and Other Transportation Safety Amendments Part 71 69 FR 3697 

10/01/2007 Final 

ML091240053 

No Comments 06/11/2009 ML091470300 

2005-1 Security Requirements for Portable Gauges Containing 

Byproduct Material Part 30 70 FR 2001 

07/11/2008 License Condition 

ML062920179 

No Comments 11/09/2006 ML063130004 

2005-2 Medical Use of Byproduct Material - Recognition of 

Specialty Boards Part 35 70 FR 16336; 71 FR 1926 

04/29/2008 Final 

ML103050179 

Comments 01/05/2011 ML103340411 

2005-3 Increased Controls for Risk-Significant Radioactive 

Sources (NRC Order EA-05-090)

70 FR 72128 

12/01/2005 License Condition 

ML081280851 

No Comments 05/13/2008 ML081340260 

CaliforConditFingerConditlicense ML053sent 1ML053
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

*2006-1 Minor Amendments 

Parts 20, 30, 32, 35, 40 and 70 71 FR 15005 

03/27/2009 Final 

ML103050179 Final ML103550423 

No Comments 01/05/2011 ML103340411 Comments 02/14/2011 ML110120070 

Part 35 Part 20 Requirhave n

2006-2 National Source Tracking System - Serialization 

Requirements Part 32 with reference to Part 20 Appendix E 71 FR 65685 

02/06/2007 License Condition 

ML070360575 

No Comments 02/16/2007 ML070470007 

*2006-3 National Source Tracking System 

Part 20 71 FR 65685, 72 FR 59162 

01/31/2009 Final 

ML103550423 

No Comments 02/14/2011 ML110120070 

2007-1 Medical Use of Byproduct Material - Minor Corrections 

and Clarifications Parts 32 and 35 72 FR 45147, 54207 

10/29/2010 Final 

ML103050179 

Comments 01/05/2011 ML103340411 

Part 35 Requirreview

2007-2 Exemptions From Licensing, General Licenses, and 

Distribution of Byproduct Material: Licensing and Reporting Requirements Parts 30, 31, 32, 150 72 FR 58473 

12/17/2010 Proposed 

ML102160676 

No Comments 09/28/2010 ML102300157 

Partial Parts 3
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

*2007-3 Requirements for Expanded Definition of Byproduct 

Material Parts 20, 30, 31, 32, 33, 35, 61, 150 72 FR 55864 

11/30/2010 Final 

ML103050179 Final ML103550423 

Comments 01/05/2011 ML103340411 Comments 02/14/2011 ML110120070 

Part 35 Part 2Requirand 15

2007-4 Order Imposing Fingerprinting Requirements and Criminal 

History Records Check Requirements for Unescorted Access to Certain Radioactive Material NRC Order EA-07-305 72 FR 70901 

06/05/2008 License Condition 

ML081280851 

No Comments 05/13/2008 ML081340260 

*2008-1 Occupational Dose Records, Labeling Containers, and 

Total Effective Dose Equivalent Parts 19, 20 72 FR 68043 

02/15/2011 Final 

ML103550423 

No Comments 02/14/2011 ML110120070 

2009-1 Medical Use of Byproduct Material – Authorized User 

Clarification Part 35 74 FR 33901 

09/28/2012 

1 IMPEP Team: verify that California does not have any licensees subject to these regulations during each review.