June 18, 2010 

Terry Lindsey, Program Director 

Radiation Protection Services 

Oregon Health Services 

Department of Human Services 

800 NE Oregon Street, Suite 640 

Portland, OR 97232-2162 

Dear Mr. Lindsey: 

We have reviewed the proposed changes to the Oregon regulations, Requirements for 

Expanded Definition of Byproduct Material, received by our office on April 21, 2010. These 

regulations were reviewed by comparison to the equivalent Nuclear Regulatory Commission 

(NRC) rules in 10 CFR Parts 20, 30, 31, 32, 33, 35, 61, 150, and the requirements of the one 

amendment identified in the enclosed State Regulation Status (SRS) Data Sheet. We 

discussed our review of the regulations with Todd Carpenter on June 15, 2010. 

As a result of our review, we have five 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 Oregon 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 Oregon 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 Aas published@ regulations be provided to us for review. As requested in FSME 

Procedure SA-201, AReview 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 Oregon 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 (301) 415-2320 

(Kathleen.Schneider@nrc.gov) or Maria Arribas-Colon at (301) 415-6026 

(Maria.Arribas-Colon@nrc.gov). 

Sincerely, 

/RA A. Dias for/ 

Terrence Reis, Deputy Director 

Division of Materials Safety and State Agreements 

Office of Federal and State Materials and 

Environmental Management Programs 

Enclosures: 

As stated 
Enclosures: As stated 

Distribution: 

DIR RF (10-22) SUNSI Review Complete 

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

RErickson, RSAO : Non-Sensitive G Sensitive 

JKatanic, POC 

OR File 

DOCUMENT NAME: G:\DMSSA\SAISB\REGULATION TOOLBOX\States\Oregon\10-22 

Incoming Document: ML101110618 

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 Marribas KSchneider BJones DWhite/ AFD TReis 

DATE 05/27/10 05/28/10 06/09/10 06/18/10 06/18/10 

ML101390014 OFFICIAL RECORD COPY Package ML101390012 
COMPATIBILITY COMMENTS ON OREGON PROPOSED REGULATIONS 

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

1 333-120-

0550 (5) 

'20.2006 (e) 2007-3 B Transfer for disposal and manifests 

 

Oregon needs to insert the phrase “in 

accordance with 10 CFR Part 20 

Appendix G” after “...to the intended 

consignee.” 

Oregon needs to make the above 

change to 333-120-0550 in order to 

meet the Compatibility Category B 

designation assigned to Section 10 

CFR 20.2006 (e). 

2 333-102-

0190(8) 

'30.32(g) 2007-3 C 

Application for specific licenses 

Oregon omits “;or” in 333-102-0190 

(8)(b) which is the equivalent 

regulation to 30.32(g)(2). 

Oregon omits the phrase “the device; 

and” in 333-102-0190 (8)(c)(A) which 

is the equivalent regulation to 30.32 

(g)(3)(i). 

Oregon needs to make the above 

change to 333-120-0190 in order to 

meet the Compatibility Category C 

designation assigned to Section 10 

CFR 30.32(g). 

3 333-102-

0305 (29) 

'30.34(j) 2007-3 B Terms and conditions of licenses 

Oregon references to their regulation 

333-116-0220 (Labeling of Vials and 

Syringes) in 333-102-0305(29)(2)(a) is 

not equivalent to 10 CFR 32.72(a)(4). 

Oregon references to their regulation 

333-116-0165 (Possession, Use, 

Calibration, and Check of Instruments 

to Measure Dosages of Alpha- or 

Beta-emitting Radionuclides) in 333-

102-0305(29)(2)(b) is not equivalent 

to 10 CFR 32.72(c). 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

Oregon needs to correct the above 

references in order to meet the 

Compatibility Category B designation 

assigned to Section 10 CFR 30.34(j). 

4 333-102-

0285 (1)(b) & 

(2) 

'32.72 (a)(2)(i), 

(iii), (iv), (v), & (b) 

2007-3 B Manufacture, preparation, or 

transfer for commercial distribution 

of radioactive drugs, containing 

byproduct material for certain in 

vitro clinical or laboratory testing 

under general license 

Oregon omits the word “owner” and 

the phrase “preparation, propagation, 

compounding, or processing of a drug 

under 21 CFR 207.20(a)” in 333-102-

0285 (1)(b) equivalent to 10 CFR 

32.72 (a)(2)(i). 

Oregon omits 10 CFR 32.72(a)(2)(v) 

(A Positron Emission Tomography 

(PET) drug production facility 

registered with a State agency). 

Oregon needs to make the above 

changes in order to meet the 

Compatibility Category B designation 

assigned to Section 10 CFR 32.72 

(a)(2)(i), and (v). 

5 333-116-

0330 

'35.204 (a) 2007-3 H&S 

Permissible molybdenum-99 

concentrations 

Oregon did not revise 333-116-0330 

to include the equivalent requirements 

for strontium-82 found in 10 CFR 

35.204 (a)(2). 

Oregon needs to revise 333-116-0330 

to meet the Category H&S 

designation assigned to Section 10 

CFR 35.204(a). 
STATE REGULATION STATUS

State: Oregon Track[1 amendment(s) reviewed is identified by a i Date: 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 Final 

ML023450397 

No Comments 01/23/2003 ML030240463 

Oregoequiva

1991-2 ASNT Certification of Radiographers 

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

none Not Required Not Required Orego

equiva

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 No Comments 

11/13/1997 

1991-4 Notification of Incidents 

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

10/15/1994 Final 

ML023450397 

No Comments 01/23/03 ML030240463 

1992-1 Quality Management Program and Misadministrations 

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

01/27/1995 Final 

ML023450397 

No Comments 01/23/2003 ML030240463 

Oregoequiva

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 

ML023450397 

No Comments 01/23/2003 ML030240463 
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 Final 

ML023450397 

No Comments 01/23/2003 ML030240463 

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

Part 61 58 FR 33886 

07/22/1996 Final 

ML100600750 

No Comments 04/15/2010 ML100850065 

1994-1 Self-Guarantee as an Additional Financial Mechanism 

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

none Not Required Not Required 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 Orego

regulaAgree

1994-3 Timeliness in Decommissioning Material Facilities 

Parts 30, 40, 70 59 FR 36026 

08/15/1997 Final 

ML023450397 

No Comments 01/23/2003 ML030240463 

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 

ML023450397 

No Comments 01/23/2003 ML030240463 

1995-2 Frequency of Medical Examinations for Use of 

Respiratory Protection Equipment Part 20 60 FR 7900 

03/13/1998 Not Applicable1 Not Applicable Orego

subjecSECY

1995-3 Low-Level Waste Shipment Manifest Information and 

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

03/01/1998 Final 

ML023450397 

No Comments 01/23/2003 ML030240463 

1995-4 Performance Requirements for Radiography Equipment 

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

06/30/1998 Final 

ML023450397 

No Comments 01/23/2003 ML030240463 

Oregoequiva
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 

ML071870477 

No Comments 09/04/2007 ML072470108 

1995-6 Clarification of Decommissioning Funding Requirements 

Parts 30, 40, 70 60 FR 38235 

11/24/1998 Final 

ML063110122 

No Comments 12/21/2006 ML070030381 

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 

ML063110122 

No Comments 12/21/2006 ML070030381 

Oregoequiva2005-2

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 

ML071870477 

No Comments 09/04/2007 ML072470108 

OregoRegula2004-1

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 

ML023450397 

No Comments 01/23/2003 ML030240463 

1997-1 Resolution of Dual Regulation of Airborne Effluents of 

Radioactive Materials; Clean Air Act Part 20 61 FR 65120 

01/9/2000 Final 

ML071870477 

No Comments 09/04/2007 ML072470108 

1997-2 Recognition of Agreement State Licenses in Areas Under 

Exclusive Federal Jurisdiction Within an Agreement StatePart 150 62 FR 1662 

02/27/2000 Final 

ML023450397 

No Comments 01/23/2003 ML030240463 
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 

ML023450397 

No Comments 01/23/2003 ML030240463 

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 

ML073390164 

No Comments 12/20/2007 ML073540058 

1997-6 Radiological Criteria for License Termination 

Parts 20, 30, 40, 70 62 FR 39057 

08/20/2000 Final 

ML023450397 

No Comments 01/23/2003 ML030240463 

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 

ML063110122 

No Comments 12/21/2006 ML070030381 

1998-1 Deliberate Misconduct by Unlicensed Persons 

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

02/12/2001 Final 

ML023450397 

No Comments 01/23/2003 ML030240463 

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

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 

requireCompaOregoequiva
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

1998-4 Licenses for Industrial Radiography and Radiation Safety 

Requirements for Industrial Radiographic Operations Part 34 63 FR 37059 

07/09/2001 Final 

ML023450397 

No Comments 01/23/2003 ML030240463 

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 

ML073390164 

No Comments 12/20/2007 ML073540058 

1998-6 Transfer for Disposal and Manifests: Minor Technical 

Conforming Amendment Part 20 63 FR 50127 

11/20/2001 Final 

ML063110122 

No Comments 12/21/2006 ML070030381 

1999-1 Radiological Criteria for License Termination of Uranium 

Recovery Facilities Part 40 64 FR 17506 

06/11/2002 Not Applicable Not Applicable Orego

regulaAgree

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 

ML091750761 

Comments 07/14/2009 ML091820663 

2000-1 Energy Compensation Sources for Well Logging and 

Other Regulatory Clarifications Part 39 65 FR 20337 

05/17/2003 Final 

ML071870477 

No Comments 09/04/2007 ML072470108 

2000-2 New Dosimetry Technology 

Parts 34, 36, 39 65 FR 63750 

01/08/2004 Final 

ML063110122 

No Comments 12/21/2006 ML070030381 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

2001-1 Requirements for Certain Generally Licensed Industrial 

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

02/16/2004 Final 

ML071870477 

Comments 09/04/2007 ML072470108 

2002-1 Revision of the Skin Dose Limit 

Part 20 67 FR 16298 

04/05/2005 Final 

ML063110122 

No Comments 12/21/2006 ML070030381 

2002-2 Medical Use of Byproduct Material 

Parts 20, 32, 35 67 FR 20249 

10/24/2005 Final 

ML063110122 

No Comments 12/21/2006 ML070030381 

2003-1 Financial Assurance for Materials Licensees 

Parts 30, 40, 70 68 FR 57327 

12/03/2006 Final 

ML063110122 

No Comments 12/21/2006 ML070030381 

2004-1 Compatibility With IAEA Transportation Safety Standards 

and Other Transportation Safety Amendments Part 71 69 FR 3697 

10/01/2007 Proposed 

ML091940024 

Comments 08/11/2009 ML092100397 

2005-1 Security Requirements for Portable Gauges Containing 

Byproduct Material Part 30 70 FR 2001 

07/11/2008 Final 

ML063110122 

No Comments 12/21/2006 ML070030381 

2005-2 Medical Use of Byproduct Material - Recognition of 

Specialty Boards Part 35 70 FR 16336; 71 FR 1926 

04/29/2008 Final 

ML063110122 

No Comments 12/21/2006 ML070030381 

2005-3 Increased Controls for Risk-Significant Radioactive 

Sources (NRC Order EA-05-090)

70 FR 72128 

12/01/2005 License Condition 

ML052870028 

No Comments 10/18/2005 ML052930002 

2006-1 Minor Amendments 

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

03/27/2009 Final 

ML100600750 

No Comments 04/15/2010 ML100850065
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

2006-2 National Source Tracking System - Serialization 

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

02/06/2007 R2 

ML083570002 

No Comments 01/13/2009 ML083570028 

2006-3 National Source Tracking System 

Part 20 71 FR 65685, 72 FR 59162 

01/31/2009 R2 

ML083570002 License Condition ML083660132 

No Comments 01/13/2009 ML083570028 No Comments 01/22/2009 ML090120206 

2007-1 Medical Use of Byproduct Material - Minor Corrections 

and Clarifications Parts 32 and 35 72 FR 45147, 54207 

10/29/2010 

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 Final 

ML100600750 

No Comments 04/15/2010 ML100850065 

*2007-3 Requirements for Expanded Definition of Byproduct 

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

11/30/2010 Proposed 

ML101110618 

Comments 06/18/2010 ML101390012 

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 

ML080790556 

No Comments 03/27/2008 ML080870332 

2008-1 Occupational Dose Records, Labeling Containers, and 

Total Effective Dose Equivalent Parts 19, 20 72 FR 68043 

02/15/2011 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

2009-1 Medical Use of Byproduct Material – Authorized User 

Clarification Part 35 74 FR 33901 

09/28/2012