September 23, 2008 

Terry L. O’Clair, P.E. Director 

Division of Air Quality 

Environmental Health Section 

Department of Health 

Gold Seal Center, 

918 E. Divide Ave. 

Bismarck, ND 58501-1947 

Dear Mr. O’Clair: 

We have reviewed the proposed changes to the North Dakota regulations Radiological Health 

Rules 33-10-01 through 33-10-22, except for Chapters 2, 6, 7, 8, 11, 15, and 16, dated August 

1, 2008. These regulations were reviewed by comparison to the equivalent Nuclear Regulatory 

Commission (NRC) rules in 10 CFR Parts 19, 20, 30, 31, 32, 34, 35, 36, 39, 40, 61, 70, 71, and 

150. We discussed our review of the regulations with Don Harman on September 23, 2008. 

As a result of our review, we have 12 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 North Dakota 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 North Dakota 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 North Dakota 

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. 
O’Clair 2 

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 

Shirley Xu at 301-415-7640 (Shirley.Xu@nrc.gov ). 

Sincerely, 

/RA K.N.Schneider for/ 

James Luehman, Deputy Director 

Division of Materials Safety and State Agreements 

Office of Federal and State Materials and 

Environmental Management Programs 

Enclosures: 

As stated 
O’Clair 2 

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 

Shirley Xu at 301-415-7640 (Shirley.Xu@nrc.gov ). 

Sincerely, 

/RA K.N.Schneider for/ 

James Luehman, 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 (8-77) SUNSI Review Complete 

DCD (SP05) : Publicly Available G Non-Publicly Available 

RErickson, RIV : Non-Sensitive G Sensitive 

DSollenberger, FSME 

WRautzen, FSME 

North Dakota File 

DOCUMENT NAME: P:\AGREEMENT STATE\NORTH DAKOTA\NORTH DOKOTA REVIEWLTR_PROPOSEDREGS_COMMENTS.DOC 

ML of Incoming Document: ML082210420 

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 SAIS SAIS OGC SAIS:BC MSSA:DD 

NAME S Xu K Schneider BJones D White J Luehman 

DATE 09/ 10 /08 09/ 10 /08 09/ 19 /08 09/ 23 /08 09/ 23 /08 

ML082530327 OFFICIAL RECORD COPY Package ML082670596
 COMPATIBILITY COMMENTS ON NORTH DAKOTA PROPOSED REGULATIONS 

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

1 33-10-21-01 '32.201 2006-2 B Serialization of nationally tracked 

sources 

North Dakota omits the reference to 

10 CFR 32.201 in this section from its 

regulations. 

North Dakota needs to adopt the 

essentially identical regulations in 

order to meet the Compatibility 

Category B designation assigned to 

10 CFR 32.201. 

2 33-10-21-01 §32.11 2007-2 NRC Introduction of byproduct 

material in exempt 

concentrations into products or 

materials, and transfer of 

ownership or possession: 

Requirements for license 

North Dakota adopts by reference of 

10 CFR 32.11 in section 33-10-21-01. 

 Due to a recent change in 

Compatibility, 10 CFR 32.11 is 

designated a Compatibility Category 

NRC. North Dakota needs to delete 

the reference to this section in their 

regulations. 

North Dakota needs to omit the 

reference to 10 CFR 32.11 from its 

regulations in order to meet the 

Compatibility Category NRC 

designation assigned to 10 CFR 

32.11. 

3 33-10-21-01 §32.12 2007-2 NRC Same: Records and material 

transfer reports 

North Dakota adopts by reference 10 

CFR 32.12 in section 33-10-21-01. 

Due to a recent change in 

Compatibility, 10 CFR 32.12 is 

designated a Compatibility Category 

NRC. North Dakota needs to delete 

the reference to this section in their 

regulations. 

North Dakota needs to omit the 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

reference to 10 CFR 32.12 from its 

regulations in order to meet the 

Compatibility Category NRC 

designation assigned to 10 CFR 

32.12. 

4 33-10-04.2-

01 

'20.2008 2007-3 B 

Disposal of certain byproduct 

material 

North Dakota omits reference to 10 

CFR 20.2008 in this section from its 

regulations. 

North Dakota needs to adopt the 

essentially identical regulations in 

order to meet the Compatibility 

Category B designation assigned to 

10 CFR 20.2008. 

5 33-10-03.1-

01 

'30.3(b) (1), (2), 

& (3) 

2007-3 NRC Activities requiring license 

North Dakota adopts by reference 10 

CFR 30.3(b) (1), (2), and (3) in section 

33-10-03.1-01. Due to a recent 

change in Compatibility, 10 CFR 

30.3(b) (1), (2), & (3) is designated a 

Compatibility Category NRC. North 

Dakota needs to delete the reference 

to these sections in their regulations. 

North Dakota needs to omit the 

references to 10 CFR 30.3(b) (1), (2), 

and (3) from its regulations in order to 

meet the Compatibility Category NRC 

designation assigned to 10 CFR 

30.3(b) (1), (2), and (3). 

6 33-10-21-01 '32.1 (c)(1) 2007-3 NRC Purpose and scope 

North Dakota adopts by reference of 

10 CFR 32.1 (c)(1) in section 33-10-

21-01. Due to a recent change in 

Compatibility, 10 CFR 32.1 (c)(1) is 

designated a Compatibility Category 

NRC. North Dakota needs to delete 

the reference to this section in their 

regulations. 

North Dakota needs to omit the 

reference to 10 CFR 32.1 (c)(1) from 

its regulations in order to meet the 

Compatibility Category NRC 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

designation assigned to 10 CFR 32.1 

(c)(1). 

7 33-10-07.2-

01 

'35.11 (c)(1) 2007-3 NRC License required 

North Dakota adopts by reference 10 

CFR 35.11 (c)(1) in section 33-10-

07.2-01. Due to a recent change in 

Compatibility, 10 CFR 35.11 (c)(1) is 

designated a Compatibility Category 

NRC. North Dakota needs to delete 

the reference to this section in their 

regulations. 

North Dakota needs to omit the 

reference to 10 CFR 35.11 (c)(1) from 

its regulations in order to meet the 

Compatibility Category NRC 

designation assigned to 10 CFR 

35.11 (c)(1). 

8 33-10-07.2-

01 

'35.13 (a)(1) 2007-3 NRC License amendments 

North Dakota adopts by reference 10 

CFR 35.13 (a)(1) in section 33-10-

07.2-01. Due to a recent change in 

Compatibility, 10 CFR 35.13 (a)(1) is 

designated a Compatibility Category 

NRC. North Dakota needs to delete 

the reference to this section in their 

regulations. 

North Dakota needs to omit the 

reference to 10 CFR 35.13 (a)(1) from 

its regulations in order to meet the 

Compatibility Category NRC 

designation assigned to 10 CFR 

35.13 (a)(1). 

9 33-10-04.2-

01 

'20.1905 (g) 2008-1 NRC Exemptions to labeling 

requirements 

North Dakota adopts by reference of 

10 CFR 20.1905 (g) in section 33-10-

04.2-01. Due to a recent change in 

Compatibility, 10 CFR 20.1905 (g) is 

designated a Compatibility Category 

NRC. North Dakota needs to delete 

the reference to this section in their 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

regulations. 

North Dakota needs to omit the 

reference to 10 CFR 20.1905 (g) from 

its regulations in order to meet the 

Compatibility Category NRC 

designation assigned to 10 CFR 

20.1905 (g). 

10 33-10-03.1-

01 

'30.21 (c) 

 

NRC Radioactive drug: Capsules 

containing carbon-14 urea for 

"in vivo" diagnostic use for 

humans 

North Dakota adopts by reference of 

10 CFR 30.21 (c) in section 33-10-

03.1-01. 10 CFR 30.21 (c) is 

designated a Compatibility Category 

NRC which North Dakota should not 

adopt by reference this section in their 

regulations. 

North Dakota needs to omit the 

reference to 10 CFR 30.21 (c) from its 

regulations in order to meet the 

Compatibility Category NRC 

designation assigned to 10 CFR 

30.21 (c). 

11 33-10-03.1-

01 

'30.34 (d)(e)(1) 

and (e)(3) 

 

NRC Terms and conditions of 

licenses 

North Dakota adopts by reference 10 

CFR 30.34 (d), (e)(1) and (e)(3) in 

section 33-10-03.1-01. 10 CFR 30.21 

(c) is designated a Compatibility 

Category NRC, which North Dakota 

should not adopt by reference this 

section in their regulations. 

North Dakota needs to omit the 

reference to 10 CFR 30.34 (d), (e)(1) 

and (e)(3) from its regulations in order 

to meet the Compatibility Category 

NRC designation assigned to 10 CFR 

30.34 (d), (e)(1) and (e)(3). 

12 33-10-17-01 '40.41 (f) 

 

H&S Terms and conditions of 

licenses 

North Dakota does not adopt by 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

reference 10 CFR 40.41 (f) this 

section of its regulation. 

North Dakota needs to embody the 

essential objectives of the 

requirements for terms and conditions 

in order to meet the Compatibility 

Category H&S designation assigned 

to 10 CFR 40.41(f). 
STATE REGULATION STATUS

State: North Dakota Tra[10 amendment(s) reviewed is identified by a i Da

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 

ML031010635 

No Comments 04/28/2003 ML031220151 

North Regula1997-5

1991-2 ASNT Certification of Radiographers 

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

none Final 

ML031010635 

No Comments 04/28/2003 ML031220151 

North 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 No Comments 

10/17/97 

1991-4 Notification of Incidents 

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

10/15/1994 Final 

ML031010635 

No Comments 04/28/2003 ML031220151 

1992-1 Quality Management Program and Misadministrations 

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

01/27/1995 Final 

ML031010635 

No Comments 04/28/2003 ML031220151 

North Regula2002-2

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 

ML031010635 

No Comments 04/28/2003 ML031220151 
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 Not Applicable1 Not Applicable North 

license(See S

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

Part 61 58 FR 33886 

07/22/1996 Not Applicable1 Not Applicable North 

license(See S

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 North 

regulaAgree

1994-3 Timeliness in Decommissioning Material Facilities 

Parts 30, 40, 70 59 FR 36026 

08/15/1997 Final 

ML031010635 

No Comments 04/28/2003 ML031220151 

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 

ML031010635 

No Comments 04/28/2003 ML031220151 

1995-2 Frequency of Medical Examinations for Use of 

Respiratory Protection Equipment Part 20 60 FR 7900 

03/13/1998 Final 

ML031010635 

No Comments 04/28/2003 ML031220151 

1995-3 Low-Level Waste Shipment Manifest Information and 

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

03/01/1998 Final 

ML031010635 

No Comments 04/28/2003 ML031220151 

1995-4 Performance Requirements for Radiography Equipment 

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

06/30/1998 Final 

ML031010635 

No Comments 04/28/2003 ML031220151 

North 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 

ML031010635 

No Comments 04/28/2003 ML031220151 

1995-6 Clarification of Decommissioning Funding Requirements 

Parts 30, 40, 70 60 FR 38235 

11/24/1998 Final 

ML031010635 

No Comments 04/28/2003 ML031220151 

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 

ML031010635 

No Comments 04/28/2003 ML031220151 

North Regula2005-2

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 

ML031010635 

No Comments 04/28/2003 ML031220151 

North Regula2004-1

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 

ML031010635 

No Comments 04/28/2003 ML031220151 

1997-1 Resolution of Dual Regulation of Airborne Effluents of 

Radioactive Materials; Clean Air Act Part 20 61 FR 65120 

01/9/2000 Final 

ML031010635 

No Comments 04/28/2003 ML031220151 

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 

ML031010635 

No Comments 04/28/2003 ML031220151 
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 

ML031010635 

No Comments 04/28/2003 ML031220151 

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 

ML031010635 

No Comments 04/28/2003 ML031220151 

1997-6 Radiological Criteria for License Termination 

Parts 20, 30, 40, 70 62 FR 39057 

08/20/2000 Final 

ML031010635 

No Comments 04/28/2003 ML031220151 

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 

ML031010635 

No Comments 04/28/2003 ML031220151 

1998-1 Deliberate Misconduct by Unlicensed Persons 

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

02/12/2001 Final 

ML031010635 

No Comments 04/28/2003 ML031220151 

1998-2 Self-Guarantee of Decommissioning Funding by Nonprofit 

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

07/01/2001 Final 

ML031010635 

No Comments 04/28/2003 ML031220151 

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 

requireCompaNorth Regula2002-2
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 

ML031010635 

No Comments 04/28/2003 ML031220151 

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 

ML031010635 

No Comments 04/28/2003 ML031220151 

1998-6 Transfer for Disposal and Manifests: Minor Technical 

Conforming Amendment Part 20 63 FR 50127 

11/20/2001 Final 

ML031010635 

No Comments 04/28/2003 ML031220151 

1999-1 Radiological Criteria for License Termination of Uranium 

Recovery Facilities Part 40 64 FR 17506 

06/11/2002 Not Applicable Not Applicable North 

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 Final 

ML031010635 

No Comments 04/28/2003 ML031220151 

These requireCompa

1999-3 Respiratory Protection and Controls to Restrict Internal 

Exposure Part 20 64 FR 54543; 64 FR 55524 

02/02/2003 Final 

ML031010635 

No Comments 04/28/2003 ML031220151 

2000-1 Energy Compensation Sources for Well Logging and 

Other Regulatory Clarifications Part 39 65 FR 20337 

05/17/2003 Final 

ML031010635 

No Comments 04/28/2003 ML031220151 

2000-2 New Dosimetry Technology 

Parts 34, 36, 39 65 FR 63750 

01/08/2004 Final 

ML031010635 

No Comments 04/28/2003 ML031220151 
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 

ML031010635 

No Comments 08/31/2006 ML062410064 

2002-1 Revision of the Skin Dose Limit 

Part 20 67 FR 16298 

04/05/2005 Final 

ML031010635 

No Comments 04/28/2003 ML031220151 

2002-2 Medical Use of Byproduct Material 

Parts 20, 32, 35 67 FR 20249 

10/24/2005 Final 

ML031010635 

No Comments 04/28/2003 ML031220151 

2003-1 Financial Assurance for Materials Licensees 

Parts 30, 40, 70 68 FR 57327 

12/03/2006 

2004-1 Compatibility With IAEA Transportation Safety Standards 

and Other Transportation Safety Amendments Part 71 69 FR 3697 

10/01/2007 Proposed 

ML082210420 

No Comments 09/23/2008 ML082530327 

2005-1 Security Requirements for Portable Gauges Containing 

Byproduct Material Part 30 70 FR 2001 

07/11/2008 Proposed 

ML082210420 

No Comments 09/23/2008 ML082530327 

2005-2 Medical Use of Byproduct Material - Recognition of 

Specialty Boards Part 35 70 FR 16336; 71 FR 1926 

04/29/2008 Proposed 

ML082210420 

No Comments 09/23/2008 ML082530327 

2005-3 Increased Controls for Risk-Significant Radioactive 

Sources (NRC Order EA-05-090)

70 FR 72128 

12/01/2005 License Condition 

ML052620195 

No Comments 09/26/2005 ML052690322

2006-1 Minor Amendments 

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

03/27/2009 Proposed 

ML082210420 

No Comments 09/23/2008 ML082530327
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 Proposed 

ML082210420 

Comments 09/23/2008 ML082530327 

2006-3 National Source Tracking System 

Part 20 71 FR 65685, 72 FR 59162 

01/31/2009 Proposed 

ML082210420 

No Comments 09/23/2008 ML082530327 

2007-1 Medical Use of Byproduct Material - Minor Corrections 

and Clarifications Parts 32 and 35 72 FR 45147, 54207 

10/29/2010 Proposed 

ML082210420 

No Comments 09/23/2008 ML082530327 

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 

ML082210420 

Comments 09/23/2008 ML082530327 

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 

ML082210420 

Comments 09/23/2008 ML082530327 

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 

ML081130312 

No Comments 05/02/2008 ML081230204 

2008-1 Occupational Dose Records, Labeling Containers, and 

Total Effective Dose Equivalent Parts 19, 20 72 FR 68043 

02/15/2011 Proposed 

ML082210420 

Comments 09/23/2008 ML082530327 

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