June 27, 2007

Aaron Gantt, Director

Bureau of Radiological Health

Department of Health and Environmental Control

2600 Bull Street

Columbia, SC 29201

Dear Mr. Gantt:

We have reviewed the proposed changes to the South Carolina Radiological Health Rules,

R61-63, Radioactive Materials, Part II and Part IV, received by our office on May 7, 2007. 

These regulations were reviewed by comparison to the equivalent Nuclear Regulatory

Commission (NRC) rules in 10 CFR Parts 20, 30, 31, 32, and 35, and the requirements of the

four amendments identified in the enclosed State Regulation Status (SRS) Data Sheet. We

discussed our review of the regulations with James Pederson on June 26, 2007.

As a result of our review, we have five 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 South Carolina 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 South Carolina 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 “as published” regulations be provided to us for review. As requested in FSME

Procedure SA-201, “Review 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 South 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://www.hsrd.ornl.gov/nrc/rulemaking.htm.
Aaron Gantt, Director -2- June 27, 2006

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: kxs@nrc.gov) or

Randy Erickson at (817) 860-8143, (email: rre@nrc.gov). 

Sincerely,

/RA By D.White For/

Scott W. Moore, Deputy Director

Division of Materials Safety and State Agreements

Office of Federal State Materials and

Environmental Management Programs

Enclosures: 

As stated
Aaron Gantt, Director -2- June 27, 2006

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: kxs@nrc.gov) or

Randy Erickson at (817) 860-8143, (email: rre@nrc.gov). 

Sincerely,

/RA By D.White For/

Scott W. Moore, Deputy Director

Division of Materials Safety and State Agreements

Office of Federal State Materials and

Environmental Management Programs

Enclosures: 

As stated

Distribution:

DIR RF (7-39) SUNSI Review Complete

DCD (SP06) : Publicly Available G Non-Publicly Available

DJanda, RSAO : Non-Sensitive G Sensitive

MOrendi South Carolina File

DOCUMENT NAME: C:\FileNet\ML071780011.wpd 

 ML of Incoming Document:ML071310178

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 R-IV SAIS SAIS SAIS OGC SAIS:BC MSSA:DD

NAME RRErickson JRivera MOrendi KSchneider FCameron DWhite SMoore

DATE 6/08/07* 06/11/07* 06/11/07* 06/11/07* 06/21/07* 06/27/07* 06/27/07*

ML071780011 OFFICIAL RECORD COPY PKG.ML071730009
COMPATIBILITY COMMENTS ON SOUTH CAROLINA PROPOSED REGULATIONS

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

1 R.61-63,

Radioactive

Materials

Part 4

Section

4.22.1

35.55 2005-2 B Training for an authorized nuclear

pharmacist 

South Carolina's regulation states

"...who meets the requirements in

paragraph (b)(2) of this section.". 

This is an incorrect reference as there

is no section (b)(2) in South Carolina

regulation 4.22.1.

South Carolina uses the word 

“certification” instead of the word

"attestation" in South Carolina

regulation 4.22.3.

South Carolina needs to make the

above changes in this section in order

to meet the Compatibility Category B

designation assigned to Section 10

CFR 35.55.

2 R.61-63, 

Radioactive

Materials

Part 4

Section 4.23

35.57 2005-2 B Training for experienced Radiation

Safety Officer

South Carolina omits the word

“authorized” before medical physicist

and nuclear pharmacist in 4.23.1.

South Carolina needs to make the

above change in order to meet the

Compatibility Category B designation

assigned to 10 CFR 35.57.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

3 R.61-63, 

Radioactive

Materials

Part 4

Section 4.43

35.390 2005-2

2006-1

B Training for use of unsealed

byproduct material for which a

written directive is required.

South Carolina has omitted the

wording, “for which a written directive

is required;” after 4.43.2.2.7.1,

4.43.2.2.7.3, and 4.43.2.2.7.4.

South Carolina uses the word 

“certification” instead of the word

"attestation" in South Carolina

regulation 4.43.3. 

South Carolina needs to make the

above corrections in order to meet

the Compatibility Category B

designation assigned to Section 10

CFR 35.390.

4 R.61-63, 

Radioactive

Materials

Part 4

Section 4.44

35.392 2005-2

2006-1

B Training for the oral

administration of sodium iodide

I–131 requiring a written directive

in quantities less than or equal to

1.22 gigabecquerels

(33 millicuries). 

South Carolina uses the word 

“certification” instead of the word

"attestation" in South Carolina

regulation 4.44.1.5.

South Carolina needs to change the

word “certification” to “attestation” in

order to meet the Compatibility

Category B designation assigned to

Section 10 CFR 35.392(c)(3).
STATE SECTION

NRC SECTION

RATS ID

CATEGORY

SUBJECT and COMMENTS 5 R.61-63, Radioactive Materials Part 4 Section 4.45.1.5 35.394 2005-2 2006-1

B Training for the oral

administration of sodium iodideI–131 requiring a written directivein quantities greater than 1.22gigabecquerels (33 millicuries). South Carolina uses the word “certification” instead of the word"attestation" in South Carolinaregulation 4.45.1.5.South Carolina needs to change theword “certification” to “attestation” inorder to meet the CompatibilityCategory B designation assigned toSection 10 CFR 35.394(c)(3).
STATE REGULATION STATUS

State: South Carolina [4 amendments reviewed identified by a i Tracking T

at the beginning of the equivalent NRC requirement.] Da

NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Propose(P) / Fin(F) Rule LicenseConditio(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 

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 
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Propose(P) / Fin(F) Rule LicenseConditio(LC) ML 

Performance Requirements for Radiography Equipment-Part 34 60 FR 28323; (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 CFR 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 P Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction Within

an Agreement State-Part 150

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

ML003701

Criteria for the Release of Individuals Administered Radioactive Material-Parts 20, 35 62 FR 4120; (5/29/00) 1997-3 P

ML003701

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 P

ML003701

Radiological Criteria for License Termination-Parts 20, 30, 40, 70 62 FR 39057; (8/20/00) 1997-6 P Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 UreaPart 30 62 FR 63634; (1/02/01) 1997-7 PML003701Deliberate Misconduct by Unlicensed Persons-Parts 30, 40, 61, 70, 150 63 FR 1890; 63 FR 13773

(2/12/01)

1998-1 P

ML003701

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 P

ML020990
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Propose(P) / Fin(F) Rule LicenseConditio(LC) ML 

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) 1998-6 F 

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 ByproductMaterial to 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 F

ML030550

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

ML030550

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

ML030550

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

65 FR 79162; (2/16/04) 2001-1 R7,9

ML071310

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

ML051580

Medical Use of Byproduct Material-Parts 20, 32, and 35 67 FR 20249; 10/24/05 2002-2 F

ML051580

Financial Assurance for Materials Licensees – Parts 30, 40, 70 68 FR 57327; (12/3/06) 2003-1 F

ML070310

Compatibility With IAEA Transportation Safety Standards and Other Transportation SafetyAmendments – Part 71.

69 FR 3697; (10/01/07) 2004-1 F

ML070310

iSecurity Requirements for Portable Gauges Containing Byproduct Material - Part 30 70 FR 2001; (7/11/08) 2005-1 P

ML071310

iMedical Use of Byproduct Material - Recognition of Specialty Boards - Part 35 70 FR 16336; 71 FR 1926

(4/29/08)

2005-2 P

ML071310
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Propose(P) / Fin(F) Rule LicenseConditio(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 Policy State

Compatibility of Agreement State Programs,” III.1. Time Frame for Adoption of Compatible State Regulations, p. 6, SECY-95-112, May 3, 1

5. ADAMS ML Number6. By letter dated September 2, 2005, from Paul H. Lohaus, Director, Office of State and Tribal Programs, Agreement States were given 90 da

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

7. A re-review was completed on this item due to change in compatibility of 31.5 and 31.6. More information can be found in the All Agreeme

072.

8. RATS ID 2006-3 will not be considered under the Non-Common Performance Indicator “Compatibility Requirements” for IMPEP reviews un

National Source Tracking System is ready for use Revisions in the implementation date for Agreement States will be provided to the State

correspondence and the SRS sheet will be revised as appropriate.

9. R stands for proposed changes made to final regulations

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

ML052850

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

ML071310

National Source Tracking System - Serialization Requirements - Part 32 with reference to Part20 Appendix E

71 FR 65685 (2/6/07) 2006-2

National Source Tracking System - Part 20 71 FR 65865 (11/15/07) &

(11/30/07)

2006-38