March 16, 2004

Ms. Beverly 0. Hall, Acting Director

Division of Radiation Protection

Department of Environment and Natural Resources 

3825 Barrett Drive

Raleigh, NC 27609-7221

Dear Ms. Hall:

We have reviewed the proposed revisions to North Carolina Administrative Code, Chapter 11

(15A NCAC 11), Radiation Protection Regulations, received electronically by our office on

February 10, 2004. Our review and comments are in response to the State’s request for

Nuclear Regulatory Commission (NRC) evaluation of the changes to North Carolina’s

radiation control rules that incorporated the amendments identified on the States Regulation

Status Data Sheet (SRS). These regulations were reviewed by comparison to the equivalent

NRC rules in 10 CFR Parts 20, 30, 31, 32, 34, 35, 36, and 39 and the requirements of the 4

amendments identified in the enclosed SRS. We discussed our review of the regulations with

you on March 16, 2004.

As a result of our review, we have 14 comments and three editorial suggestions. Under our

current procedure, a finding that a State regulation meets the compatibility and health and

safety categories of the equivalent NRC regulation may only be made based on a review of

the final State regulation. Please provide a final amended version of your rules, showing the

location of any changes made, in response to our comments. If there are any comments

which the State believes are in error, the State should identify the section of their regulations

that meet the designated compatibility category. Please note that we have limited our review

to regulations required for compatibility and/or health and safety, but have determined that if

these regulations are adopted, incorporating our comments and without 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 the proposed regulations are adopted and published as final

regulations, 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 final changes and send one copy to STP in a computer readable format, if

possible.

The SRS Data Sheet summarizes our knowledge of other North Carolina regulations. 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 Web

Site: http://www.hsrd.orni.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 Lloyd Boiling, at 301-415-2327 or LAB@NRC.GOV.

 Sincerely,

\RA By C.H. Maupin\

Josephine M. Piccone, Deputy Director

Office of State and Tribal Programs

Enclosure: As stated
March 16, 2004

Ms. Beverly 0. Hall, Acting Director

Division of Radiation Protection

Department of Environment and Natural Resources 

3825 Barrett Drive

Raleigh, NC 27609-7221

Dear Ms. Hall:

We have reviewed the proposed revisions to North Carolina Administrative Code, Chapter 11

(15A NCAC 11), Radiation Protection Regulations, received electronically by our office on

February 10, 2004. Our review and comments are in response to the State’s request for

Nuclear Regulatory Commission (NRC) evaluation of the changes to North Carolina’s

radiation control rules that incorporated the amendments identified on the States Regulation

Status Data Sheet (SRS). These regulations were reviewed by comparison to the equivalent

NRC rules in 10 CFR Parts 20, 30, 31, 32, 34, 35, 36, and 39 and the requirements of the 4

amendments identified in the enclosed SRS. We discussed our review of the regulations with

you on March 16, 2004.

As a result of our review, we have 14 comments and three editorial suggestions. Under our

current procedure, a finding that a State regulation meets the compatibility and health and

safety categories of the equivalent NRC regulation may only be made based on a review of

the final State regulation. Please provide a final amended version of your rules, showing the

location of any changes made, in response to our comments. If there are any comments

which the State believes are in error, the State should identify the section of their regulations

that meet the designated compatibility category. Please note that we have limited our review

to regulations required for compatibility and/or health and safety, but have determined that if

these regulations are adopted, incorporating our comments and without 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 the proposed regulations are adopted and published, as final

regulations, 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 final changes and send one copy to STP in a computer readable format, if

possible.

The SRS Data Sheet summarizes our knowledge of other North Carolina regulations. 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 Web

Site: http://www.hsrd.orni.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 Lloyd Boiling, at 301-415-2327 or LAB@NRC.GOV.

 Sincerely,

\RA By C.H. Maupin For\

Josephine M. Piccone, Deputy Director

Office of State and Tribal Programs

Distribution:

DIR RF [4-27] DCD (SP07) PDR (YES_)

J Myers, ASPO North Carolina File Response to Incoming Document: ML040570448

DOCUMENT NAME: C:\ORPCheckout\FileNET\ML040760474.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 STP OGC STP:DD

NAME LBolling JZabko STreby JPiccone

DATE 2/27/04* 3/2/04* 3/11/04* 3/12/04*

ML040760474 OFFICIAL RECORD COPY
COMPATIBILITY COMMENTS ON NORTH CAROLINA PROPOSED REGULATIONS

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

1 15A NCAC

11.1620(a)(7)(

C)& (D)

20.1703(g)(3)&

(4)

1999-3 H & S Use of individual respiratory protection

equipment

The State has incorrect units in (7)(C)

“Carbon Monoxide (CO) content of ...”

The correct units are “10 ppm or less”;

and the limit for carbon dioxide has been

omitted in (7)(E). It should read “ Carbon

dioxide content of 1,000 ppm or less”

The State needs to accurately include

both of these items to achieve

compatibility. 

2 15A NCAC

11.1308(b)

39.35(b) 2000-1 C Leak testing of sealed sources

The State is missing the Agency approval

requirement for the leak test kit or

method.

The State needs to add the following:

“The leak test kit or method must be

approved by the Agency” as a new

second sentence to achieve

compatibility.

3 15A NCAC

11.1308(e)(1)(

5)

39.35(e)(5) 2000-1 C Leak testing of sealed sources

The State has omitted reference to

neutron emitting devices. 

The State needs to add “or neutron”

between alpha- and -emitting to achieve

compatibility. 

4 15A NCAC

11.1324(c)(1)(ii

)

& (d)(9)

39.77(a)(c) & (d) 2000-1 C Notification of incidents: 

abandonment procedures for

irretrievable sources 

There is no regulation allowing the

abandonment of an irretrievable source,

because of immediate threat to public

health and safety and prior to receiving

Agency approval. 

The State needs to include this

requirement to meet compatibility.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

5 ???? 30.34(a)(b)(c) 2001-1 C Terms and conditions of licenses

The State does not have an equivalent

section which covers terms and

conditions for specific licenses.

The State needs to add this section to

achieve compatibility.

6 ???? 30.34(h) 2001-1 H & S Terms and conditions of licenses

The State does not have a section which

addresses bankruptcy issues for general

licensees.

The State needs to include this section to

achieve compatibility.

7 15A NCAC

11.0309(c)(7)

31.5(c)(8)(iii) 2001-1 B Certain measuring, gauging or

controlling devices

The State has omitted the requirement in

(c)(8)(iii) that requires written Agency

approval before transferring the device to

any other specific licensee not

specifically identified in this section.

The State needs to add this section in

order to achieve compatibility.

8 15A NCAC

11.0309(c)

(11)

31.5(c)(13) 2001-1 B Certain measuring, gauging or

controlling devices

The State has used the incorrect

reporting time requirements. 

To achieve compatibility, in section

(c)(11) the State needs to delete

“when required by the Agency” and

add “within 30-days”.

The State does not intend to grant

reciprocity to GL’s from other

jurisdictions. This is contrary to

Compatibility Category “B” for this

entire requirement.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

9 15A NCAC

11.0309(c)

(15)

31.5(c)(15) 2001-1 B Certain measuring, gauging or

controlling devices

The State has omitted the two year

exemption for devices in storage.

To achieve compatibility, in section

(c)(15), the State needs to add the

following sentence, “Devices kept in

standby for future use are excluded

from the two-year time limit if the

general licensee performs quarterly

physical inventories of these devices

while they are in standby.”

10 15A NCAC

11.0310(4)

32.51(a)(4)(5) 2001-1 B Byproduct material contained in

devices for use under §31.5: 

Requirements for license to

manufacture or initially transfer

The State has omitted the

requirement for including a serial

number in registration.

In section .0310 (4), the State needs

to add “and serial....” after “...device,

model...’, to achieve compatibility.

11 15A NCAC

11.0310(8)(a)

32.52 2001-1 B Same: Material transfer reports

and records

The State has omitted the jurisdiction

requirements of 32.52.

After “Rule .0111...”, the State needs

to add ”or to the Agreement State

with jurisdiction over the general

licensee.” Also, add “For general

licensees in NRC jurisdiction” before

“the information.....”, to achieve

compatibility.

12 15A NCAC

11.0523(a)

(11)

34.83(d) 2000-2 C Records of personnel monitoring

procedures

The State has omitted part of the

record retention requirements of this

section.

To achieve compatibility, the State

needs to add the following sentence:

“Records of estimates of exposures

as a result of: off-scale personal

direct reading dosimeters, or lost of

damaged personnel dosimeters until

the Agency terminates the license.”
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

13 ???? 36.55(a) 2000-2 H & S Personnel monitoring

The State has omitted this section.

The State need to include this section

to achieve compatibility.

14 15A NCAC

11.1316(c)

39.65(a) 2000-2 C Personnel monitoring

The State has omitted the time

requirements for dosimeter

processing.

To achieve compatibility, the State

needs to add the following sentence

“After replacement, each personnel

dosimeter must be promptly

processed”
Editorial Suggestions

1. 15A NCAC 11.0104 Definitions - (99) spelling “Pressure”. Also in (143) after (SAR) add, “or airline

respirator”.

 2. 15A NCAC 11.1620(a) after intakes, add, “of radioactive material,...” and (a)(6) spelling “provide”.

3. 15A NCAC 11.0309(c)(12)(F) delete second “of”.
STATE REGULATION STATUS

State: NORTH CAROLINA [Four amendments reviewed are identified by a  Trackinat the beginning of each equivalent NRC regulation.] Date: 0

NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / 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 

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 
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / ML 

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 of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air ActPart 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 Deliberate Misconduct by Unlicensed Persons-Parts 30, 40, 61, 70, 150 63 FR 1890; 63 FR 13773

(2/12/01)

1998-1 P

ML020990

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

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

(10/26/01)

1998-5 P

ML020990

Transfer for Disposal and Manifests: Minor Technical Conforming Amendment-Part 20 63 FR 50127; (11/20/01) 1998-6Radiological Criteria for License Termination of Uranium Recovery Facilities-Part 40 64 FR 17506; (6/11/02) 1999-1 
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / 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 

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

1995.

5. ADAMS ML Number

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

64 FR 42269; (none) 1999-2 

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

(2/2/03)

1999-3 P 2/18/0

ML040560

Energy Compensation Sources for Well Logging and Other Regulatory Clarifications-Part 39 65 FR 20337; (5/17/03) 2000-1 P 2/18/0

ML040560

New Dosimetry Technology-Parts 34, 36, 39 65 FR 63750; (1/8/04) 2000-2 P 2/18/0

ML040560

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

65 FR 79162; (2/16/04) 2001-1 P 2/18/0

ML040560

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