June 30, 2008 

Beverly Hall, Chief 

Radiation Protection Section 

Division of Environmental Health 

Department of Environment and Natural Resources 

3825 Barrett Drive 

Raleigh, NC 27609-7221 

Dear Ms. Hall: 

We have reviewed the final revision to the North Carolina regulations, Regulations for Protection 

Against Radiation, received by our office on May 30, 2008. These regulations were reviewed by 

comparison to the equivalent Nuclear Regulatory Commission (NRC) rules in 10 CFR Parts 20, 

30, 32, 35, 71, and the requirements of the five amendments identified in the enclosed State 

Regulation Status (SRS) Data Sheet. We discussed our review of the regulations with Lee Cox 

on June 30, 2007. 

As a result of our review, we have seven 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 North Carolina, 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 North Carolina 

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. 
Beverly Hall, Chief -2- June 30, 2008 

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 (email: 

kathleen.schneider@nrc.gov) or Monica Orendi at (301) 415-3938 (email: 

monica.orendi@nrc.gov). 

Sincerely, 

/ RA by ADWhite for / 

James G. Luehman, Deputy Director 

Division of Materials Safety and State Agreements 

Office of Federal and State Materials and 

Environmental Management Programs 

Enclosures: 

As stated 
Beverly Hall, Chief -2- June 30, 2008 

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 (email: 

kathleen.schneider@nrc.gov) or Monica Orendi at (301) 415-3938 (email: 

monica.orendi@nrc.gov). 

Sincerely, 

/ RA by ADWhite for / 

James G. 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 (8-63) SUNSI Review Complete 

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

JKottan, RSAO : Non-Sensitive G Sensitive 

MOrendi [NC] File 

DOCUMENT NAME: G:\DMSSA\SAISB\REGULATION TOOLBOX\STATES\NORTH CAROLINA\8-63.DOC 

 ML of Incoming Document: ML081680728 

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 SAISB SAIS OGC SAIS:BC MSSA:DD 

NAME MOrendi KSchneider BJones DWhite JLuehman 

DATE 06/16/08* 06/17/08* 06/25/08* 06/30/08* 06/30/08* 

ML081820322 OFFICIAL RECORD COPY PKG. ML081820322
 COMPATIBILITY COMMENTS ON NORTH CAROLINA FINAL REGULATIONS 

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

1 11.0104 

(129) 

35.2 2002-2 [B] Definition: Sealed source 

 

North Carolina’s definition of Sealed 

source is not essentially identical to 

NRC’s definition in 35.2. 

North Carolina needs to change their 

definition of Sealed source to be 

essentially identical to NRC’s 

definition in order to meet the 

Compatibility Category [B] designation 

assigned to 10 CFR 35.2 Definition 

Sealed source. 

2 N/A 35.49 2002-2 [C] Suppliers for sealed sources or 

devices for medical use 

North Carolina omits the essential 

objectives of 10 CFR 35.49 from its 

regulations. 

North Carolina needs to add the 

essential objective of 10 CFR 35.49 in 

order to meet the Compatibility 

Category [C] designation assigned to 

10 CFR 35.49. 

3 N/A 35.69 2002-2 H&S Labeling of vials and syringes 

North Carolina omits the essential 

objectives of 10 CFR 35.69 from its 

regulations. 

North Carolina needs to add the 

essential objectives of 10 CFR 35.69 

in order to meet the Compatibility 

Category H&S designation assigned 

to 10 CFR 35.69. 

4 N/A 35.400 2002-2 [C] Use of sealed sources for manual 

brachytherapy 

North Carolina omits the essential 

objectives of 10 CFR 35.400 from its 

regulations. 

North Carolina needs to add the 

essential objectives of 10 CFR 35.400 

to its regulations in order to meet the 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

Compatibility Category [C] designation 

assigned to 10 CFR 35.400. 

5 11.0318 (cc) 35.410 2002-2 H&S Safety instruction

North Carolina omits 10 CFR 35.410 

(a)(1) and (a)(2) from its regulation. 

North Carolina needs to add the 

above in order to meet the 

Compatibility category H&S 

designation assigned to 10 CFR 

35.410. 

6 11.0117 10 CFR 71 

 

2004-1 NRC Compatibility With IAEA 

Transportation Safety Standards 

(TS-R-1) and Other Transportation 

Safety Amendments 

North Carolina adopted 10 CFR 71 in 

its entirety in 11.0117, including all 

sections reserved to NRC jurisdiction. 

 North Carolina’s regulations should 

not include sections designated 

Compatibility Category NRC as 

incorporated by reference

North Carolina needs to add 71.14(b), 

71.19, 71.31, 71.33, 71.35, 71.37, 

71.38, 71.39, 71.41, 71.43, 71.45, 

71.51, 71.55, 71.59, 71.61, 71.63, 

71.64, 71.65, 71.71, 71.73, 71.74, 

71.75, 71.77, 71.101(c)(2), (d), and 

(e), 71.107, 71.109, 71.111, 71.113, 

71.115, 71.117, 71.119, 71.121, 

71.123, and 71.125 to a list of items 

not incorporated by reference in 

11.0117 in order to meet the 

Compatibility Category NRC 

designation assigned to the above 

listed sections. 

7 11.0117 Multiple Multiple NRC Incorporation by reference 

North Carolina incorporates many 

sections of the 10 CFR which have 

regulation authority delegated to the 

NRC and not North Carolina. 

North Carolina needs to either remove 

these sections or list specific 

provisions which are not incorporated 

by reference in order to meet the 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

Compatibility Category NRC 

designation assigned to sections of 

the 10 CFR that are delegated NRC 

authority. 
STATE REGULATION STATUS

State: North Carolina Tra[5 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 No Comments 

8/18/00 

North Regula1997-5

1991-2 ASNT Certification of Radiographers 

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

none Not Required Not Required 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 

10/25/1995 

1991-4 Notification of Incidents 

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

10/15/1994 Final No Comments 

08/18/2000 

1992-1 Quality Management Program and Misadministrations 

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

01/27/1995 Final No Comments 

08/18/2000 

North Final RID: 200

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 No Comments 

08/18/2000 

1993-2 Licensing and Radiation Safety Requirements for 

Irradiators Part 36 58 FR 7715 

07/01/1996 Final No Comments 

08/18/2000 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

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

Part 61 58 FR 33886 

07/22/1996 Final No Comments 

08/18/2000 

1994-1 Self-Guarantee as an Additional Financial Mechanism 

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

none Final No Comments 

08/18/2000 

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 

to reguAgree

1994-3 Timeliness in Decommissioning Material Facilities 

Parts 30, 40, 70 59 FR 36026 

08/15/1997 Final No Comments 

08/18/2000 

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 

08/18/2000 

1995-2 Frequency of Medical Examinations for Use of 

Respiratory Protection Equipment Part 20 60 FR 7900 

03/13/1998 Final No Comments 

08/18/2000 

1995-3 Low-Level Waste Shipment Manifest Information and 

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

03/01/1998 Final No Comments 

08/18/2000 

1995-4 Performance Requirements for Radiography Equipment 

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

06/30/1998 Final No Comments 

08/18/2000 

North Regula1997-5

1995-5 Radiation Protection Requirements: Amended Definitions 

and Criteria Parts 19, 20 60 FR 36038 

08/14/1998 Final No Comments 

08/18/2000 

1995-6 Clarification of Decommissioning Funding Requirements 

Parts 30, 40, 70 60 FR 38235 

11/24/1998 Final No Comments 

08/18/2000 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

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 No Comments 

08/18/2000 

North Final RIDs: 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 No Comments 

08/18/2000 

North Final RID: 200

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 No Comments 

08/18/2000 

1997-1 Resolution of Dual Regulation of Airborne Effluents of 

Radioactive Materials; Clean Air Act Part 20 61 FR 65120 

01/9/2000 Final No Comments 

08/18/2000 

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 No Comments 

08/18/2000 

1997-3 Criteria for the Release of Individuals Administered 

Radioactive Material Parts 20, 35 62 FR 4120 

05/29/2000 Final No Comments 

08/18/2000 

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 No Comments 

08/18/2000 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

1997-6 Radiological Criteria for License Termination 

Parts 20, 30, 40, 70 62 FR 39057 

08/20/2000 Final No Comments 

08/18/2000 

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 No Comments 

08/18/2000 

1998-1 Deliberate Misconduct by Unlicensed Persons 

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

02/12/2001 Final 

ML061990608 

No Comments 08/15/2006 ML062280005 

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 

requireCompa

1998-4 Licenses for Industrial Radiography and Radiation Safety 

Requirements for Industrial Radiographic Operations Part 34 63 FR 37059 

07/09/2001 Final 

ML062840118 

No Comments 10/23/2006 ML062970032 

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 

ML061990608 

No Comments 08/15/2006 ML062280005 

1998-6 Transfer for Disposal and Manifests: Minor Technical 

Conforming Amendment Part 20 63 FR 50127 

11/20/2001 Final 

ML042320535 

No Comments 09/02/2004 ML042460091 

1999-1 Radiological Criteria for License Termination of Uranium 

Recovery Facilities Part 40 64 FR 17506 

06/11/2002 Not Applicable Not Applicable North 

to reguAgree

1999-2 Requirements for Those Who Possess Certain Industrial 10/04/2002 Not Required Not Required These 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

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

requireCompa

1999-3 Respiratory Protection and Controls to Restrict Internal 

Exposure Part 20 64 FR 54543; 64 FR 55524 

02/02/2003 Final 

ML061990608 

No Comments 08/15/2006 ML062280005 

2000-1 Energy Compensation Sources for Well Logging and 

Other Regulatory Clarifications Part 39 65 FR 20337 

05/17/2003 Final 

ML061990608 

No Comments 08/15/2006 ML062280005 

2000-2 New Dosimetry Technology 

Parts 34, 36, 39 65 FR 63750 

01/08/2004 Final 

ML061990608 

No Comments 08/15/2006 ML062280005 

2001-1 Requirements for Certain Generally Licensed Industrial 

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

02/16/2004 Final 

ML061990608 

Comments 08/15/2006 ML062280005 

2002-1 Revision of the Skin Dose Limit 

Part 20 67 FR 16298 

04/05/2005 Final 

ML061790305 

No Comments 08/04/2006 ML062160419 

i2002-2 Medical Use of Byproduct Material 

Parts 20, 32, 35 67 FR 20249 

10/24/2005 Final 

ML081680728 

Comments 06/30/2008 ML081820320 

2003-1 Financial Assurance for Materials Licensees 

Parts 30, 40, 70 68 FR 57327 

12/03/2006 Final 

ML061790305 

No Comments 08/04/2006 ML062160419 

i2004-1 Compatibility With IAEA Transportation Safety Standards 

and Other Transportation Safety Amendments Part 71 69 FR 3697 

10/01/2007 Final 

ML081680728 

Comments 06/30/2008 ML081820320 

i2005-1 Security Requirements for Portable Gauges Containing 

Byproduct Material Part 30 70 FR 2001 

07/11/2008 License Condition 

ML081680728 

No Comments 06/30/2008 ML081820320 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

i2005-2 Medical Use of Byproduct Material - Recognition of 

Specialty Boards Part 35 70 FR 16336; 71 FR 1926 

04/29/2008 Final 

ML081680728 

No Comments 06/30/2008 ML081820320 

2005-3 Increased Controls for Risk-Significant Radioactive 

Sources (NRC Order EA-05-090)

70 FR 72128 

12/01/2005 License Condition 

ML052720130 

No Comments 10/04/2005 ML052780077 

2006-1 Minor Amendments 

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

03/27/2009 

2006-2 National Source Tracking System - Serialization 

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

02/06/2007 Not Applicable1 Not Applicable North 

02/16/that thapplicaML070

i2006-3 National Source Tracking System 

Part 20 71 FR 65865, 72 FR 59162 

01/31/2009 License Condition 

ML081680728 

No Comments 06/30/2008 ML081820320 

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 

2007-3 Requirements for Expanded Definition of Byproduct 

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

11/30/2010 

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 

ML080660061 

No Comments 03/20/2008 ML080800385 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

2008-1 Occupational Dose Records, Labeling Containers, and 

Total Effective Dose Equivalent Parts 19, 20 72 FR 68043 

02/15/2011 

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