October 20, 2010 

Richard A. Haynes, PE, Director 

Division of Waste Management 

Bureau of Land & Waste Management 

South Carolina Department of Health 

 and Environmental Control 

2600 Bull Street 

Columbia, South Carolina 29201-1708 

Dear Mr. Haynes: 

We have reviewed the final revision to the South Carolina Radiological Health Rules R.61-63, 

Radioactive Materials, ATitle A@, received by our office on September 15, 2010. These 

regulations were reviewed by comparison to the equivalent Nuclear Regulatory Commission 

(NRC) rules in 10 CFR Parts 19, 20, 30, 31, 32, 33, 35, 61 and 150, and the requirements of four 

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

discussed our review of the regulations with Susan Jenkins on October 14, 2010. 

As a result of our review, we have three 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 “as 

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 South 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 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://nrc-stp.ornl.gov/rulemaking.html. 
-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 Stephen Poy at (301) 415-7135 (stephen.poy@nrc.gov). 

Sincerely, 

/RA/ 

Terrence Reis, Deputy Director 

Division of Materials Safety and State Agreements 

Office of Federal and State Materials and 

Environmental Management Programs 

Enclosures: 

As stated 
[Concurrence Page] 

Enclosures: As stated 

Distribution: 

DIR RF (10-46) SUNSI Review Complete 

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

DJanda, RSAO : Non-Sensitive G Sensitive 

MBeardsley, POC 

SC File 

DOCUMENT NAME: G:\DMSSA\SAISB\REGULATION TOOLBOX\States\South Carolina\10-46 

Incoming Document: ML102571587 

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 ASPB ASPB OGC ASPB:BC MSSA:DD 

NAME Stephen Poy Kathleen Schneider BJones Duncan White Terrence Reis 

DATE 10/05/10 10/05/10 10/12/10 10/20/10 10/20/10 

ML102770400 OFFICIAL RECORD COPY Package ML102770336 
 COMPATIBILITY COMMENTS ON SOUTH CAROLINA FINAL REGULATIONS 

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

1 2.5.7.3 30.32(g)(3) 2007-3 C Application for specific licenses 

South Carolina lists the wrong 

references in 2.5.7.3. 2.5.7.3 should 

read, ”For sources or devices 

containing naturally occurring or 

accelerator produced radioactive 

material manufactured prior to 

November 30, 2007 that are not 

registered with the NRC under the 

provisions of 10 CFR 32.210 or with 

an Agreement State, and for which 

the applicant is unable to provide all 

categories of information specified in 

32.210(c), the applicant must 

provide:” 

South Carolina needs to make the 

above change in order to meet the 

Category C designation assigned to 

10 CFR 30.32. 

2 2.7.5.2.5.5

 

32.72(b)(5)(v) 2007-3 B Manufacture, preparation, or 

transfer for commercial distribution 

of radioactive drugs, containing 

byproduct material for certain in 

vitro clinical or laboratory testing 

under general license 

South Carolina omits the phrase in 

(b), “recognized Indian tribe before.” 

 

South Carolina needs to make the 

above change in order to meet the 

Category B designation assigned to 

10 CFR 32.72. 

3 2.11.11.4 30.36(k)(4) N/A H&S Expiration and termination of 

licenses and decommissioning of 

sites and separate buildings or 

outdoor areas 

South Carolina lists the wrong 

references in 2.11.11.4. 2.11.11.4 

should read, ”Records required by 

RHA 3.34.5 and 3.34.7 have been 

received.“ 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

South Carolina needs to make the 

above change in order to meet the 

Category H&S designation assigned 

to 10 CFR 30.36. 
STATE REGULATION STATUS

State: South Carolina Tra[4 amendment(s) reviewed is identified by a i Dat

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 

06/14/1995 

South Regula1997-5

1991-2 ASNT Certification of Radiographers 

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

none Not Required Not Required South 

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 

06/14/1995 

1991-4 Notification of Incidents 

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

10/15/1994 Final No Comments 

06/14/1995 

1992-1 Quality Management Program and Misadministrations 

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

01/27/1995 Final No Comments 

06/14/1995 

South 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 No Comments 

08/25/1999 
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 Final No Comments 

08/25/1999 

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

Part 61 58 FR 33886 

07/22/1996 Final No Comments 

06/14/1995 

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 South 

to reguAgree

1994-3 Timeliness in Decommissioning Material Facilities 

Parts 30, 40, 70 59 FR 36026 

08/15/1997 Final No Comments 

08/25/1999 

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 

08/25/1999 

1995-2 Frequency of Medical Examinations for Use of 

Respiratory Protection Equipment Part 20 60 FR 7900 

03/13/1998 Final No Comments 

08/25/1999 

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 

08/25/1999 

1995-4 Performance Requirements for Radiography Equipment 

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

06/30/1998 Final No Comments 

08/25/1999 

South 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 No Comments 

08/25/1999 

1995-6 Clarification of Decommissioning Funding Requirements 

Parts 30, 40, 70 60 FR 38235 

11/24/1998 Final No Comments 

08/25/1999 

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 

08/25/1999 

South Regula2002-2 

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 No Comments 

08/25/1999 

South 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 No Comments 

08/25/1999 

1997-1 Resolution of Dual Regulation of Airborne Effluents of 

Radioactive Materials; Clean Air Act Part 20 61 FR 65120 

01/9/2000 Final 

ML080170513 

No Comments 02/11/2008 ML080390388 

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 

ML072200323 

No Comments 08/23/2007 ML072340245 
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 

ML072200323 

No Comments 08/23/2007 ML072340245 

1997-4 Fissile Material Shipments and Exemptions 

Part 71 62 FR 5907 (Superceded by 2004-1) 

02/10/2000 Not Required Not Required These 

requireCompaSouth Regula2004-1

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 

ML072200323 

No Comments 08/23/2007 ML072340245 

1997-6 Radiological Criteria for License Termination 

Parts 20, 30, 40, 70 62 FR 39057 

08/20/2000 Final 

ML080170513 

No Comments 02/11/2008 ML080390388 

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 

ML072200323 

No Comments 08/23/2007 ML072340245 

1998-1 Deliberate Misconduct by Unlicensed Persons 

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

02/12/2001 Final 

ML072200323 

No Comments 08/23/2007 ML072340245 

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 

requireCompaSouth 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 

ML072200322 

No Comments 09/25/2007 ML072680002 

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 

ML072200322 

No Comments 09/25/2007 ML072680002 

1998-6 Transfer for Disposal and Manifests: Minor Technical 

Conforming Amendment Part 20 63 FR 50127 

11/20/2001 Final No Comments 

08/25/1999 

1999-1 Radiological Criteria for License Termination of Uranium 

Recovery Facilities Part 40 64 FR 17506 

06/11/2002 Not Applicable Not Applicable South 

to reguAgree

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 Not Required Not Required These 

requireCompa

1999-3 Respiratory Protection and Controls to Restrict Internal 

Exposure Part 20 64 FR 54543; 64 FR 55524 

02/02/2003 Final 

ML030550104 

No Comments 03/12/2003 ML030720133 

2000-1 Energy Compensation Sources for Well Logging and 

Other Regulatory Clarifications Part 39 65 FR 20337 

05/17/2003 Final 

ML030550104 

No Comments 03/12/2003 ML030720133 

2000-2 New Dosimetry Technology 

Parts 34, 36, 39 65 FR 63750 

01/08/2004 Final 

ML030550104 

No Comments 03/12/2003 ML030720133 
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 

ML080300391 

No Comments 02/26/2008 ML080560369

2002-1 Revision of the Skin Dose Limit 

Part 20 67 FR 16298 

04/05/2005 Final 

ML051580125 

No Comments 06/30/2005 ML051810477 

2002-2 Medical Use of Byproduct Material 

Parts 20, 32, 35 67 FR 20249 

10/24/2005 Final 

ML051580125 

No Comments 06/30/2005 ML051810477 

2003-1 Financial Assurance for Materials Licensees 

Parts 30, 40, 70 68 FR 57327 

12/03/2006 Final 

ML070310150 

No Comments 02/23/2007 ML070520002 

2004-1 Compatibility With IAEA Transportation Safety Standards 

and Other Transportation Safety Amendments Part 71 69 FR 3697 

10/01/2007 Final 

ML070310150 

No Comments 02/23/2007 ML070520002 

2005-1 Security Requirements for Portable Gauges Containing 

Byproduct Material Part 30 70 FR 2001 

07/11/2008 Final 

ML073340385 

No Comments 01/02/2008 ML080020336 

2005-2 Medical Use of Byproduct Material - Recognition of 

Specialty Boards Part 35 70 FR 16336; 71 FR 1926 

04/29/2008 Final 

ML073340385 

No Comments 01/02/2008 ML080020336 

2005-3 Increased Controls for Risk-Significant Radioactive 

Sources (NRC Order EA-05-090)

70 FR 72128 

12/01/2005 License Condition 

ML052850130 

No Comments 10/13/2005 ML052870003 

2006-1 Minor Amendments 

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

03/27/2009 Final 

ML073340385 

No Comments 01/02/2008 ML080020336 
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 Final 

ML102571587 License Condition ML102571587 

No Comments 10/20/2010 ML102770366 No Comments 10/20/2010 ML102770366 

*2006-3 National Source Tracking System 

Part 20 71 FR 65685, 72 FR 59162 

01/31/2009 Final 

ML102571587 License Condition ML082960009 

No Comments 10/20/2010 ML102770366 No Comments 11/10/2008 ML083010017 

2007-1 Medical Use of Byproduct Material - Minor Corrections 

and Clarifications Parts 32 and 35 72 FR 45147, 54207 

10/29/2010 Proposed 

ML101100037 

No Comments 07/07/2010 ML101530439 

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 

ML101100037 

No Comments 07/07/2010 ML101530439 

*2007-3 Requirements for Expanded Definition of Byproduct 

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

11/30/2010 Final 

ML102571587 

Comments 10/20/2010 ML102770366 

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 

ML080730310 License Condition ML090500020 

No Comments 03/27/2008 ML080870445 No Comments 03/10/2009 ML090540009 

For the LicensFor the Licens
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 Final 

ML102571587 

No Comments 10/20/2010 ML102770366 

2009-1 Medical Use of Byproduct Material – Authorized User 

Clarification Part 35 74 FR 33901 

09/28/2012 Proposed 

ML101100037 

No Comments 07/07/2010 ML101530439