September 8, 2009 

George F. Johns, Supervisor 

Radioactive Materials Unit 

Minnesota Department of Health 

P.O. Box 64975 

St. Paul, MN 55164-0975 

Dear Mr. Johns: 

We have reviewed the proposed changes to the Minnesota Department of Health regulations on 

Radiation Safety, Chapter 4731, received by our office on July 31, 2009. These regulations 

were reviewed by comparison to the equivalent Nuclear Regulatory Commission (NRC) rules in 

10 CFR Parts 20, 34, and 35, as identified in the enclosed State Regulation Status (SRS) Data 

Sheet. We discussed our review of the regulations with you on August 27, 2009. 

As a result of our review, we have two 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 Minnesota 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 Minnesota 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 Minnesota 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 Kathy Schneider, 

State Regulation Review Coordinator at 301-415-2320 (kathleen.schneider@nrc.gov) or Jim 

Lynch at 630-829-9661 (james.lynch@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 
George F. Johns, Supervisor 

Radioactive Materials Unit 

Minnesota Department of Health 

P.O. Box 64975 

St. Paul, MN 55164-0975 

Dear Mr. Johns: 

We have reviewed the proposed changes to the Minnesota Department of Health regulations on Radiation Safety, 

Chapter 4731, received by our office on July 31, 2009. These regulations were reviewed by comparison to the 

equivalent Nuclear Regulatory Commission (NRC) rules in 10 CFR Parts 20, 34, and 35, as identified in the 

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

August 27, 2009. 

As a result of our review, we have two 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 Minnesota 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 Minnesota 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 Minnesota 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://nrcstp.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 Kathy Schneider, State Regulation Review Coordinator at 301-

415-2320 (kathleen.schneider@nrc.gov) or Jim Lynch at 630-829-9661 (james.lynch@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 

Distribution: 

DIR RF (9-34) SUNSI Review Complete 

DCD (SP07) : Publicly Available G Non-Publicly Available 

JLynch, RIII : Non-Sensitive G Sensitive 

AMccraw, ASPB 

SXu, ASPB 

MN File 

DOCUMENT NAME: G:\DMSSA\SAISB\REGULATION TOOLBOX\States\Minnesota\9-34 

Incoming Document: ML092120032 

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 RIII ASPB OGC ASPB:BC MSSA:DD 

NAME JLynch KSchneider BJones DWhite/kns TReis 

DATE 8/13/09 08/ 10 /09 08/ 25 /09 09/ 08 /09 09/ 08 /09 

ML 092260265 OFFICIAL RECORD COPY Package ML092260264
 COMPATIBILITY COMMENTS ON MINNESOTA PROPOSED REGULATIONS 

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

1 4731.4525

 

35.3045(c)-(d) N/A C Report and notification of a medical 

event 

Minnesota changed the medical event 

written report requirement to the 

State, and to the referring physician, 

from 15 days to 30 days. 

The difference in written report 

requirements does not meet the 

essential objective of obtaining the 

medical event information and 

providing the information to the 

referring physician in a timely manner 

(i.e., not longer than 15 days after the 

medical event). 

 

Minnesota needs to adopt the 

essential objectives of the 15-day 

written reporting requirement to meet 

the Category C designation assigned 

to Section 35.3045. 

2 4731.4526 35.3047(c)-(f) N/A C Report and notification of a dose to 

an embryo/fetus or nursing child 

Minnesota changed the embryo/fetus 

or nursing child written report 

requirement to the State, and to the 

referring physician, from 15 days to 30 

days. 

The difference in written report 

requirements does not meet the 

essential objective of obtaining the 

embryo/fetus or nursing child dose 

information and providing the 

information to the referring physician 

in a timely manner (i.e., not longer 

than 15 days after the dose was 

received). 

 

Minnesota needs to adopt the 

essential objectives of the 15-day 

written reporting requirement to meet 

the Category C designation assigned 

to Section 35.3047. 
STATE REGULATION STATUS

State: Minnesota Tra[Proposed amendments reviewed are not associated Dawith a specific RATS ID] 

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 

ML050140452 

No Comments 03/04/2005 ML050690100 

MinneRegula1997-5

1991-2 ASNT Certification of Radiographers 

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

none Not Required Not Required Minne

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 

ML050140452 

No Comments 03/04/2005 ML050690100 

1991-4 Notification of Incidents 

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

10/15/1994 Final 

ML050140452 

No Comments 03/04/2005 ML050690100 

1992-1 Quality Management Program and Misadministrations 

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

01/27/1995 Final 

ML050140452 

No Comments 03/04/2005 ML050690100 

MinneRegula2002-2

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 

ML050140452 

No Comments 03/04/2005 ML050690100 
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 

ML050140452 

No Comments 03/04/2005 ML050690100 

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

Part 61 58 FR 33886 

07/22/1996 Not Applicable Not Applicable Minne

regulaAgree

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 Minne

to reguAgree

1994-3 Timeliness in Decommissioning Material Facilities 

Parts 30, 40, 70 59 FR 36026 

08/15/1997 Final 

ML050140452 

No Comments 03/04/2005 ML050690100 

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 

ML050140452 

No Comments 03/04/2005 ML050690100 

1995-2 Frequency of Medical Examinations for Use of 

Respiratory Protection Equipment Part 20 60 FR 7900 

03/13/1998 Final 

ML050140452 

No Comments 03/04/2005 ML050690100 

1995-3 Low-Level Waste Shipment Manifest Information and 

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

03/01/1998 Final 

ML050140452 

No Comments 03/04/2005 ML050690100 

1995-4 Performance Requirements for Radiography Equipment 

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

06/30/1998 Final 

ML050140452 

No Comments 03/04/2005 ML050690100 

MinneRegula1997-5
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 

ML050140452 

No Comments 03/04/2005 ML050690100 

1995-6 Clarification of Decommissioning Funding Requirements 

Parts 30, 40, 70 60 FR 38235 

11/24/1998 Final 

ML050140452 

No Comments 03/04/2005 ML050690100 

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 

ML050140452 

No Comments 03/04/2005 ML050690100 

MinneRegula2002-2 

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 

ML050140452 

No Comments 03/04/2005 ML050690100 

MinneRegula2004-1

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 

ML050140452 

No Comments 03/04/2005 ML050690100 

1997-1 Resolution of Dual Regulation of Airborne Effluents of 

Radioactive Materials; Clean Air Act Part 20 61 FR 65120 

01/9/2000 Final 

ML050140452 

No Comments 03/04/2005 ML050690100 

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 

ML050140452 

No Comments 03/04/2005 ML050690100 
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 

ML050140452 

No Comments 03/04/2005 ML050690100 

1997-4 Fissile Material Shipments and Exemptions 

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

02/10/2000 Not Required Not Required These 

requireCompaMinneRegula2004-1

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 

ML050140452 

No Comments 03/04/2005 ML050690100 

1997-6 Radiological Criteria for License Termination 

Parts 20, 30, 40, 70 62 FR 39057

08/20/2000 Final 

ML050140452 

No Comments 03/04/2005 ML050690100

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 

ML050140452 

No Comments 03/04/2005 ML050690100 

1998-1 Deliberate Misconduct by Unlicensed Persons 

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

02/12/2001 Final 

ML050140452 

No Comments 03/04/2005 ML050690100 

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 

requireCompaMinneRegula2002-2
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 

ML050140452 

No Comments 03/04/2005 ML050690100 

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 

ML050140452 

No Comments 03/04/2005 ML050690100 

1998-6 Transfer for Disposal and Manifests: Minor Technical 

Conforming Amendment Part 20 63 FR 50127 

11/20/2001 Final 

ML050140452 

No Comments 03/04/2005 ML050690100 

1999-1 Radiological Criteria for License Termination of Uranium 

Recovery Facilities Part 40 64 FR 17506 

06/11/2002 Not Applicable Not Applicable Minne

to reguAgree

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 

ML050140452 

No Comments 03/04/2005 ML050690100 

2000-1 Energy Compensation Sources for Well Logging and 

Other Regulatory Clarifications Part 39 65 FR 20337 

05/17/2003 Final 

ML050140452 

No Comments 03/04/2005 ML050690100 

2000-2 New Dosimetry Technology 

Parts 34, 36, 39 65 FR 63750 

01/08/2004 Final 

ML050140452 

No Comments 03/04/2005 ML050690100 
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 

ML050140452 

No Comments 03/04/2005 ML050690100 

2002-1 Revision of the Skin Dose Limit 

Part 20 67 FR 16298 

04/05/2005 Final 

ML050140452 

No Comments 03/04/2005 ML050690100 

2002-2 Medical Use of Byproduct Material 

Parts 20, 32, 35 67 FR 20249 

10/24/2005 Final 

ML050140452 

No Comments 03/04/2005 ML050690100 

2003-1 Financial Assurance for Materials Licensees 

Parts 30, 40, 70 68 FR 57327 

12/03/2006 Final 

ML073201223 

No Comments 12/14/2007 ML073470558 

2004-1 Compatibility With IAEA Transportation Safety Standards 

and Other Transportation Safety Amendments Part 71 69 FR 3697 

10/01/2007 Final 

ML073201223 

No Comments 12/14/2007 ML073470558 

2005-1 Security Requirements for Portable Gauges Containing 

Byproduct Material Part 30 70 FR 2001 

07/11/2008 Final 

ML073201223 

No Comments 12/14/2007 ML073470558 

2005-2 Medical Use of Byproduct Material - Recognition of 

Specialty Boards Part 35 70 FR 16336; 71 FR 1926 

04/29/2008 Final 

ML073201223 

No Comments 12/14/2007 ML073470558 

2005-3 Increased Controls for Risk-Significant Radioactive 

Sources (NRC Order EA-05-090)

70 FR 72128 

12/01/2005 License Condition 

ML053220236 

No Comments 11/18/2005 ML053220444 

2006-1 Minor Amendments 

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

03/27/2009 Final 

ML073201223 

No Comments 12/14/2007 ML073470558 
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 Final 

ML090550203 

No Comments 03/23/2009 ML090760101 

2006-3 National Source Tracking System 

Part 20 71 FR 65685, 72 FR 59162 

01/31/2009 Final 

ML090260708 License Condition ML090260708 

No Comments 03/23/2009 ML090760101 No Comment 02/06/2009 ML090290322 

2007-1 Medical Use of Byproduct Material - Minor Corrections 

and Clarifications Parts 32 and 35 72 FR 45147, 54207 

10/29/2010 Final 

ML090550203 

No Comments 03/23/2009 ML090760101 

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 

ML090550203 

No Comments 03/23/2009 ML090760101 

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 

ML090550203 

No Comments 03/23/2009 ML090760101 

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 

ML080530108 

No Comments 03/12/2008 ML080720050 

2008-1 Occupational Dose Records, Labeling Containers, and 

Total Effective Dose Equivalent Parts 19, 20 72 FR 68043 

02/15/2011 Final 

ML090550203 

No Comments 03/23/2009 ML090760101 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

N/A 10 CFR Part 35 Proposed 

ML092120032 

Comments 09/08/2009 ML092260264