August 15, 2006

Ms. Beverly O. Hall, Chief

Radiation Protection Section

Division of Environment 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 Radiation Protection Regulations,

received by our office on July 17, 2006. These regulations were reviewed by comparison to the

equivalent Nuclear Regulatory Commission (NRC) rules in 10 CFR Parts 20, 30, 31, 32, 34, 35,

36, 39, 40, 61, 70 and 150 and the requirements of six amendments identified in the enclosed

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

you today, August 15, 2006.

As noted in All Agreement States letter STP-05-072, dated September 28, 2005, NRC staff will

continue to review Agreement State GL Device proposed and final rules but will hold in

abeyance any determination on those rules and compatibility of those rules, if the Agreement

State has the essential elements of the NRC’s rule and is more restrictive than the NRC’s rule.

For Agreement States without a GL Device rule or a GL Device rule less restrictive than the

NRC rules, the staff will factor this determination into results of the NRC’s review of the State’s

proposed and final rules and the compatibility findings during Integrated Materials Performance

Evaluation Program (IMPEP) reviews.

We note that the 14 comments including seven on the GL rule from the March 16, 2004 letter

were addressed. However, as a result of our re-review of the GL device rule against the

Compatibility Category B designation, we have seven new comments that have been identified

in the enclosure. Comments 3 and 6 indicate that the State’s regulations are more restrictive

than the NRC’s regulations, and there is no corrective action required for this comment at this

time. However, Comments 1, 2, 4, 5 and 7 indicate that the State’s regulations are less

restrictive than the NRC’s regulations, and they need to be addressed in the State’s future

rulemaking process. 

As a result of our review of the other rules, we have no comments. 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 State and Tribal Programs (STP) Procedure SA-200.

We request that when you revise your regulations to address our comments, a copy of the “as

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

“Review 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 STP.
Beverly O. Hall -2- August 15, 2006

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 STP website: http://www.hsrd.ornl.gov/nrc/rulemaking.htm. 

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 me, or Sandra Lai

at 301-415-4012 or by e-mail at SXL5@nrc.gov.

Sincerely,

\RA By KNSchneider For\

Dennis K. Rathbun, Deputy Director

Office of State and Tribal Programs

Enclosures:

As stated
Beverly O. Hall, Chief -2- August 15, 2006

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 STP website: http://www.hsrd.ornl.gov/nrc/rulemaking.htm. 

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 me, or Sandra Lai

at 301-415-4012 or by e-mail at SXL5@nrc.gov.

Sincerely,

\RA By KNSchneider For\

Dennis K. Rathbun, Deputy Director

Office of State and Tribal Programs

Enclosures: 

As stated

Distribution: SUNSI Review Complete

DIR RF( 6-200 ) DCD (SP06) : Publicly Available G Non-Publicly Available

PDR (YES_T) : Non-Sensitive G Sensitive

Response to Incoming Document: ML061990608

DWhite, SMinnick , RSAO; WRautzen, ASPO; SLai; BUsilton; North Carolina File

Document Name:E:\Filenet\ML062280005.wpd

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 STP OGC STP:DD

NAME SLai STreby KNSchneider for DKRathbun

DATE 7/25/06* 8/11/06* 8/15/06*

ML062280005 OFFICIAL RECORD COPY ML062280007Pkg. 
COMMENTS ON NORTH CAROLINA REGULATIONS

AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES 

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

1 15A

NCAC11.030

9(c)(4)

31.5(c)(4) 2001-1 B Certain detecting, measuring,

gauging, or controlling 

devices and certain devices for

producing light or an ionized 

atmosphere

North Carolina’s regulations require

records of tests for leakage of

radioactive material and tests for onoff mechanism to be maintained for 1

year; records for other testing to be

maintained for 2 years before

transferring or disposing the device. 

However, the NRC’s regulations

require all the records to be retained

for 3 years. 

North Carolina needs to revise the

record retention period in 15A

NCAC11.0309(c)(4) to meet the

Compatibility Category B designation

assigned to 10 CFR 31.5(c)(4).

2 N/A 31.5(c)(7) 2001-1 B Certain detecting, measuring,

gauging, or controlling 

devices and certain devices for

producing light or an ionized 

atmosphere

North Carolina has omitted the

provision of 10 CFR 31.5(c)(7)

regarding the export of the device

containing byproduct material. 

Omitting this provision also caused a

missing reference to 10 CFR

31.5(c)(7) and the phrase “or export”

in 15A NCAC11.0309(c)(7).

North Carolina needs to adopt the

provision and add the equivalent

phrase and reference to 15A

NCAC11.0309(c)(7) to meet the

Compatibility Category B designation

assigned to 10 CFR 31.5(c)(7). 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

3 N/A 31.5(c)(7), (8) 2001-1 B Certain detecting, measuring,

gauging, or controlling 

devices and certain devices for

producing light or an ionized 

atmosphere

North Carolina has requirements for

the report to be furnished prior to

transfer in NCAC11.0309(c)(7)

instead of the 30-day transfer period

included in 10 CFR 31.5(c)(8)(ii).

North Carolina’s rule has the

essential elements of the NRC, but is

more restrictive than the NRC’s GL

rule. 

As noted in the September 28, 2005

All Agreement States Letter STP-05-

072, the determination on this

provision will be held in abeyance

until such time that the NRC

completes its review and response to

the Organization of Agreement State

petition and State of Florida’s request

on compatibility changes for the GL

rule.

4 15A

NCAC11.030

9(c)(7)(B)

31.5(c)(8)(ii)(B) 2001-1 B Certain detecting, measuring,

gauging, or controlling 

devices and certain devices for

producing light or an ionized 

atmosphere

North Carolina has omitted 

the phrase “(license number not

applicable if exported)” in 15A

NCAC11.0309(c)(7)(B) that appears

in 10 CFR 31.5(c)(8)(ii)(B). This

phrase provides a mechanism for

tracking this material into and out of

North Carolina jurisdiction.

North Carolina needs to add the

phrase “(license number not

applicable if exported)” to

NCAC11.0309(c)(7)(B) to meet the

Compatibility Category B designation

assigned to 10 CFR 31.5(c)(8)(ii)(B).
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

4 N/A 31.5(c)(8)(iii) 2001-1 B Certain detecting, measuring,

gauging, or controlling 

devices and certain devices for

producing light or an ionized 

atmosphere

North Carolina has omitted the

requirement in 31.5(c)(8)(iii)

regarding written approval of the

agency before transferring the device. 

North Carolina needs to adopt the

requirement to meet the Compatibility

Category B designation assigned to

10 CFR 31.5(c)(8)(iii). 

5 15A

NCAC11.030

9(c)

31.5(c)(11) 2001-1 B Certain detecting, measuring,

gauging, or controlling 

devices and certain devices for

producing light or an ionized 

atmosphere

North Carolina has omitted the

requirement of 10 CFR 31.5(c)(11),

regarding general license response to

information requests within 30

calendar days. 

North Carolina needs to add the

requirement to 15A NCAC11.0309(c),

to meet the Compatibility Category B

designation assigned to 10 CFR

31.5(c)(11). 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

6 N/A 31.5(c)(13)(iv) 2001-1 B Certain detecting, measuring,

gauging, or controlling 

devices and certain devices for

producing light or an ionized 

atmosphere

North Carolina does not have the

provision that relieves the licensee

from registering the devices if the

devices are used in areas subject to

NRC jurisdiction for a period less than

180 days in any calendar year.

North Carolina regulations in

NCAC11.0309(c)(ii) include additional

registration requirements not included

in 10 CFR 31.5(c)(13)(iv).

North Carolina’s rules have the

essential elements of the NRC, but

are more restrictive than the NRC’s

GL rule. 

As noted in the September 28, 2005

All Agreement States Letter STP-05-

072, the determination on this

provision will be held in abeyance

until such time that the NRC

completes its review and response to

the Organization of Agreement State

petition and State of Florida’s request

on compatibility changes for the GL

rule.

7 15A

NCAC11.030

9(d)

31.5(d) 2001-1 B Certain detecting, measuring,

gauging, or controlling 

devices and certain devices for

producing light or an ionized 

atmosphere

North Carolina uses the word

“distribution” instead of “import” after

“does not authorize” in 15A

NCAC11.0309(d).

North Carolina needs to replace the

word “distribution” by the word

“import” to meet the Compatibility

Category B designation assigned to

10 CFR 31.5(d). 
STATE REGULATION STATUS

State: NORTH CAROLINA [6 amendments reviewed identified by a i Trackin

at the beginning of the equivalent NRC requirement.] Date: A

NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / LicCondition(LC) ML #

Safety Requirements for Radiographic Equipment-Part 34 55 FR 843; (1/10/94) 1991-1 F ASNT Certification of Radiographers-Part 34 56 FR 11504; (none) 1991-2 

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; (1/1/94)

1991-3 F 

Notification of Incidents-Parts 20, 30, 31, 34, 39, 40, 70 56 FR 64980; (10/15/94) 1991-4 F Quality Management Program and Misadministrations-Part 35 56 FR 34104; (1/27/95) 1992-1 F Eliminating the Recordkeeping Requirements for Departures from Manufacturer's InstructionsParts 30,35 57 FR 45566; (none) 1992-2 

Decommissioning Recordkeeping and License Termination: Documentation Additions[Restricted areas and spill sites]-Parts 30, 40 

58 FR 39628; (10/25/96) 1993-1 F 

Licensing and Radiation Safety Requirements for Irradiators-Part 36 58 FR 7715; (7/1/96) 1993-2 F Definition of Land Disposal and Waste Site QA Program-Part 61 58 FR 33886; (7/22/96) 1993-3 F Self-Guarantee as an Additional Financial Mechanism-Parts 30, 40, 70 58 FR 68726; 59 FR 1618

(none)

1994-1 F 

Uranium Mill Tailings Regulations: Conforming NRC Requirements to EPA Standards-Part 40 59 FR 28220; (7/1/97) 1994-2 Timeliness in Decommissioning Material Facilities-Parts 30, 40, 70 59 FR 36026; (8/15/97) 1994-3 F Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for MedicalUse-Parts 30, 32, 35

59 FR 61767; 59 FR 6524360 FR 322; (1/1/98)

1995-1 F 
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / LicCondition(LC) ML #

Frequency of Medical Examinations for Use of Respiratory Protection Equipment-Part 20 60 FR 7900; (3/13/98) 1995-2 F Low-Level Waste Shipment Manifest Information and Reporting-Parts 20, 61 60 FR 15649; 60 FR 25983

(3/1/98)

1995-3 F 

Performance Requirements for Radiography Equipment-Part 34 60 FR 28324; (6/30/98) 1995-4 F Radiation Protection Requirements: Amended Definitions and Criteria-Parts 19, 20 60 FR 36038; (8/14/98) 1995-5 F Clarification of Decommissioning Funding Requirements-Parts 30, 40, 70 60 FR 38235; (11/24/98) 1995-6 F Medical Administration of Radiation and Radioactive Materials-Parts 20, 35 60 FR 48623; (10/20/98) 1995-7 F 10 CAR Part 71: Compatibility with the International Atomic Energy Agency-Part 71 60 FR 50248; 61 FR 28724

(4/1/99)

1996-1 F 

One Time Extension of Certain Byproduct, Source and Special Nuclear Materials LicensesParts 30, 40, 70 61 FR 1109; (none) 1996-2 

Termination or Transfer of Licensed Activities: Recordkeeping Requirements-Parts 20, 30, 40,61, 70

61 FR 24669; (6/17/99) 1996-3 F 

Resolution Dual Regulation of Airborne Effluents of Radioactive Materials;Clean Air Act-Part 20 61 FR 65120; (1/9/00) 1997-1 F Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction Withinan Agreement State-Part 150

62 FR 1662; (2/27/00) 1997-2 F 

Criteria for the Release of Individuals Administered Radioactive Material-Parts 20, 35 62 FR 4120; (5/29/00) 1997-3 F Fissile Material Shipments and Exemptions-Part 71 62 FR 5907; (none) 1997-4 Licenses for Industrial Radiography and Radiation Safety Requirements for IndustrialRadiography Operations-Parts 30, 34, 71, 150

62 FR 28947; (6/27/00) 1997-5 F 

Radiological Criteria for License Termination-Parts 20, 30, 40, 70 62 FR 39057; (8/20/00) 1997-6 F Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 UreaPart 30 62 FR 63634; (1/02/01) 1997-7 F i Deliberate Misconduct by Unlicensed Persons-Parts 30, 40, 61, 70, 150 63 FR 1890; 63 FR 13773

(2/12/01)

1998-1 F

ML061990
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / LicCondition(LC) ML #

Self-Guarantee of Decommissioning Funding by Nonprofit and Non-Bond-Issuing LicenseesParts 30, 40, 70 63 FR 29535; (none) 1998-2 License Term for Medical Use Licenses-Part 35 63 FR 31604; (none) 1998-3 Licenses for Industrial Radiography and Radiation Safety Requirements for IndustrialRadiographic Operations-Part 34

63 FR 37059; (7/9/01) 1998-4

i Minor Corrections, Clarifying Changes, and a Minor Policy Change-Parts 20, 35, 36 63 FR 39477; 63 FR 45393

(10/26/01)

1998-5 F

ML061990

Transfer for Disposal and Manifests: Minor Technical Conforming Amendment-Part 20 63 FR 50127; (11/20/01) 1998-6 F 8/19/04

ML042320

Radiological Criteria for License Termination of Uranium Recovery Facilities-Part 40 64 FR 17506; (6/11/02) 1999-1 

Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct Materialto Provide Requested Information-Part 31

64 FR 42269; (none) 1999-2 

i Respiratory Protection and Controls to Restrict Internal Exposure-Part 20 64 FR 54543; 64 FR 55524

(2/2/03)

1999-3 F

ML061990

i Energy Compensation Sources for Well Logging and Other Regulatory Clarifications-Part 39 65 FR 20337; (5/17/03) 2000-1 F 

ML061990

i New Dosimetry Technology-Parts 34, 36, 39 65 FR 63750; (1/8/04) 2000-2 F 

ML061990

i Requirements for Certain Generally Licensed Industrial Devices Containing ByproductMaterial - Parts 30, 31, 32

65 FR 79162; (2/16/04) 2001-1 F

ML061990

Revision of the Skin Dose Limit-Part 20 67 FR 16298; 4/5/05 2002-1 F 6/27/05

ML061790

Medical Use of Byproduct Material-Parts 20, 32, and 35 67 FR 20249; 4/24/05 2002-2Financial Assurance for Materials Licensees – Parts 30, 40, 70 68 FR 57327 12/3/06 2003-1 F 6/27/05

ML061790

Compatibility with IAEA Transportation Safety Standards and Other Transportation SafetyAmendments - Part 71

69 FR 3697; (10/01/07) 2004-1
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / LicCondition(LC) ML #

1. Or other generic Legally Binding Requirements.2. (Y/N) Y means “Yes,” there are comments in the review letter that the State needs to address. 

N means “No,” there are no comments in the review letter.

3. Not required means these regulations are not required for purposes of compatibility.4. A State need not adopt a specific regulation if the State has no licensees that would be subject to that regulation. See: “Final Polic

Adequacy and Compatibility of Agreement State Programs,” III.1. Time Frame for Adoption of Compatible State Regulations, p. 6, 1995.

5. ADAMS ML Number6. By letter dated September 2, 2005, from Paul H. Lohaus, Director, Office of State and Tribal Programs, Agreement States were giv

legally binding requirements satisfying the requirements of NRC Order EA-05-090.

Security Requirements for Portable Gauges Containing Byproduct Material - Part 30 70 FR 2001; (7/11/08) 2005-1Medical Use of Byproduct Material - Recognition of Specialty Boards - Part 35 70 FR 16336; 71 FR 1926

(4/29/08)

2005-2

Increased Controls for Risk-Significant Radioactive Sources (NRC Order EA-05-090)6 70 FR 72128; (12/1/05) 2005-3 LC

ML052720

Minor Amendments - Part 20,30,32,35,40 and 70 71FR15005; (3/27/09) 2006-1