June 30, 2008 

Robert Owen, Chief 

Bureau of Radiation Protection 

Ohio Department of Health 

246 North High Street 

Columbus, OH 43215 

Dear Mr. Owen: 

We have reviewed the proposed changes to the Ohio regulations, Medical Use of Radioactive 

Material, received by our office on May 14, 2008. These regulations were reviewed by 

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

30, 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 Michael 

Snee on June 30, 2008. 

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. Under our current procedure, a finding that the Ohio 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 Ohio 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 Aas published@ regulations be provided to us for review. As requested in FSME 

Procedure SA-201, AReview 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 Ohio 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. 
Robert Owen, 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 
Robert Owen, 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 (8-61) SUNSI Review Complete 

DCD (SP07) : Publicly Available G Non-Publicly Available 

JLynch, RSAO : Non-Sensitive G Sensitive 

MOrendi [OH] File 

DOCUMENT NAME: G:\DMSSA\SAISB\REGULATION TOOLBOX\STATES\OHIO\8-61\8-61.DOC 

 ML of Incoming Document: ML081370130 

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 SAISB OGC SAIS:BC MSSA:DD 

NAME MOrendi KSchneider BJones DWhite JLuehman

DATE 06/13/08* 06/13/08* 06/25/08* 06/30/08* 06/30/08* 

ML081820355 OFFICIAL RECORD COPY PKG. ML081820386
 COMPATIBILITY COMMENTS ON OHIO PROPOSED REGULATIONS 

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

1 3701:1-58-

21 

35.57 2005-2 B Training for experienced Radiation 

Safety Officer, teletherapy or 

medical physicist, authorized 

medical physicist, authorized user, 

nuclear pharmacist, and authorized 

nuclear pharmacist. 

Ohio omits authorized medical 

physicist and authorized nuclear 

pharmacist from the list of individuals 

listed in 3701:1-58-21 (A). 

Ohio needs to add these two terms to 

3701:1-58-21 (A) in order to meet the 

Compatibility Category B designation 

assigned to 10 CFR 35.57. 

2 3701:1-58-

32 

35.100 2005-2 

2006-1 

H&S Use of unsealed byproduct material 

for uptake, dilution, and excretion 

studies for which a written 

directive is not required. 

Ohio has a wrong reference at the 

end of paragraph (B)(2). It should 

read “... and paragraph (C)(1)(b)(vii) 

of rule 3701:1-58-36 of the 

Administrative Code. 

Also Ohio omits the essential 

elements of paragraph to 10 CFR 

35.100(b)(3). Ohio needs to adopt 

the essential elements of this 

paragraph. 

Ohio needs to make the above 

changes in order to meet the 

Compatibility Category H&S 

designation assigned to 10 CFR 

35.100. 

3 3701:1-46-

43 

32.72 2006-1 

2007-1 

B Manufacture, preparation, or 

transfer for commercial distribution 

of radioactive drugs containing 

byproduct material for medical use 

under part 35. 

Ohio deletes 3701:1-46-43(A)(2)(d) 

and also deletes a reference to in 

3701:1-46-43(B). 
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 

Ohio needs to keep section (A)(2)(d) 

and its reference in section (B) in 

order to meet the Compatibility 

Category B designation assigned to 

10 CFR 32.72. 
STATE REGULATION STATUS

State: Ohio Tra[4 amendment(s) reviewed is identified by a i Daat 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 

ML023250117 

No Comments 01/09/2003 ML030060349 

Ohio hequiva

1991-2 ASNT Certification of Radiographers 

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

none Final 

ML023250117 

No Comments 01/09/2003 ML030060349 

Ohio hequiva

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 

ML040920160 

No Comments 04/14/2004 ML041060011 

1991-4 Notification of Incidents 

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

10/15/1994 Proposed Comments 

07/26/2000 

1992-1 Quality Management Program and Misadministrations 

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

01/27/1995 Final 

ML061440106 

No Comments 06/08/2006 ML061590424 

Ohio hequiva

1992-2 Eliminating the Recordkeeping Requirements 

for Departures from Manufacturer's Instructions Parts 30, 35 57 FR 45566 

none Final 

ML061440106 

No Comments 06/08/2006 ML061590424 

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 Proposed Comments 

07/26/2000 

1993-2 Licensing and Radiation Safety Requirements for 

Irradiators Part 36 58 FR 7715 

07/01/1996 Final 

ML023250117 

No Comments 01/09/2003 ML030060349 

1993-3 Definition of Land Disposal and Waste Site QA Program 07/22/1996 Final No Comments 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

Part 61 58 FR 33886 

10/09/1998 

1994-1 Self-Guarantee as an Additional Financial Mechanism 

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

none Final No Comments 

10/09/1998 

1994-2 Uranium Mill Tailings Regulations: Conforming NRC 

Requirements to EPA Standards Part 40 59 FR 28220 

07/01/1997 Final No Comments 

10/09/1998 

1994-3 Timeliness in Decommissioning Material Facilities 

Parts 30, 40, 70 59 FR 36026 

08/15/1997 R1 N 7/26/00 

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 

ML061440106 

No Comments 06/08/2006 ML061590424 

1995-2 Frequency of Medical Examinations for Use of 

Respiratory Protection Equipment Part 20 60 FR 7900 

03/13/1998 Final 

ML041240504 

No Comments 06/14/2004 ML041670402 

1995-3 Low-Level Waste Shipment Manifest Information and 

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

03/01/1998 Final 

ML040920160 

No Comments 04/14/2004 ML041060011 

1995-4 Performance Requirements for Radiography Equipment 

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

06/30/1998 Final 

ML023250117 

No Comments 01/09/2003 ML030060349 

Ohio hequiva

1995-5 Radiation Protection Requirements: Amended Definitions 

and Criteria Parts 19, 20 60 FR 36038 

08/14/1998 Final 

ML040920160 

No Comments 04/14/2004 ML041060011 

1995-6 Clarification of Decommissioning Funding Requirements 

Parts 30, 40, 70 60 FR 38235 

11/24/1998 R1 No Comments 

07/26/2000 

1995-7 Medical Administration of Radiation and Radioactive 

Materials 

10/20/1998 Proposed 

ML042230062 

No Comments 10/14/2004 

Ohio hRegula
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

Parts 20, 35 60 FR 48623 (Superceded by 2002-2 and 2005-2) 

ML042890002 2005-2

1996-1 Compatibility with the International Atomic Energy Agency

Part 71 60 FR 50248; 61 FR 28724 (Superceded by 2004-1) 

04/01/1999 Not Required Not Required Ohio h

equiva

1996-2 One Time Extension of Certain Byproduct, Source and 

Special Nuclear Materials Licenses Parts 30, 40, 70 61 FR 1109 

02/15/1999 R1 No Comments 

07/26/2000 

1996-3 Termination or Transfer of Licensed Activities: Record 

keeping Requirements Parts 20, 30, 40, 61, 70 61 FR 24669 

06/17/1999 R1 No Comments 

07/26/2000 

1997-1 Resolution of Dual Regulation of Airborne Effluents of 

Radioactive Materials; Clean Air Act Part 20 61 FR 65120 

01/9/2000 Final 

ML041900134 

No Comments 08/09/2004 ML042220269 

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 

ML041240504 

No Comments 06/14/2004 ML041670402 

1997-3 Criteria for the Release of Individuals Administered 

Radioactive Material Parts 20, 35 62 FR 4120 

05/29/2000 R1 No Comments 

07/26/2000 

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 

ML023250117 

Comments 01/09/2003 ML030060349 

1997-6 Radiological Criteria for License Termination 

Parts 20, 30, 40, 70 62 FR 39057 

08/20/2000 Final No Comments 

10/09/1998 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

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 

ML041240504 

No Comments 06/14/2004 ML041670402 

1998-1 Deliberate Misconduct by Unlicensed Persons 

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

02/12/2001 R1 

ML010380259 ML010870344 

No Comments 12/12/01 ML013530072

1998-2 Self-Guarantee of Decommissioning Funding by Nonprofit 

and Non-Bond-Issuing Licensees Parts 30, 40, 70 63 FR 29535 

07/01/2001 Final No Comments 

10/09/1998 

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 

requireCompaOhio hequiva

1998-4 Licenses for Industrial Radiography and Radiation Safety 

Requirements for Industrial Radiographic Operations Part 34 63 FR 37059 

07/09/2001 Final 

ML041240504 

No Comments 06/14/2004 ML041670402 

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 No Comments 

10/09/1998 

1998-6 Transfer for Disposal and Manifests: Minor Technical 

Conforming Amendment Part 20 63 FR 50127 

11/20/2001 Final 

ML041900134 

No Comments 08/09/2004 ML042220269 

1999-1 Radiological Criteria for License Termination of Uranium 

Recovery Facilities Part 40 64 FR 17506 

06/11/2002 Final 

ML060580024 

No Comments 04/13/2006 ML061030457 

1999-2 Requirements for Those Who Possess Certain Industrial 

Devices Containing Byproduct Material to Provide Requested Information Part 31 

10/04/2002 Not Required Not Required These 

requireCompa
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

64 FR 42269 

1999-3 Respiratory Protection and Controls to Restrict Internal 

Exposure Part 20 64 FR 54543; 64 FR 55524 

02/02/2003 Final 

ML040920160 

No Comments 04/14/2004 ML041060011 

2000-1 Energy Compensation Sources for Well Logging and 

Other Regulatory Clarifications Part 39 65 FR 20337 

05/17/2003 Final 

ML023250117 

No Comments 01/09/2003 ML030060349 

2000-2 New Dosimetry Technology 

Parts 34, 36, 39 65 FR 63750 

01/08/2004 Final 

ML023250117 

No Comments 01/09/2003 ML030060349 

2001-1 Requirements for Certain Generally Licensed Industrial 

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

02/16/2004 R1 

ML070950457 

Comments 04/27/2007 ML071150004 

2002-1 Revision of the Skin Dose Limit 

Part 20 67 FR 16298 

04/05/2005 Final 

ML061440106 

No Comments 06/08/2006 ML061590424 

2002-2 Medical Use of Byproduct Material 

Parts 20, 32, 35 67 FR 20249 

10/24/2005 Final 

ML061440106 

No Comments 06/08/2006 ML061590424 

i2003-1 Financial Assurance for Materials Licensees 

Parts 30, 40, 70 68 FR 57327 

12/03/2006 R1 

ML081370130 

No Comments 06/30/2008 ML081820355 

2004-1 Compatibility With IAEA Transportation Safety Standards 

and Other Transportation Safety Amendments Part 71 69 FR 3697 

10/01/2007 Final 

ML063170453 

No Comments 12/15/2006 ML063490049 

2005-1 Security Requirements for Portable Gauges Containing 

Byproduct Material Part 30 70 FR 2001 

07/11/2008 Final 

ML071010099 

No Comments 04/25/2007 ML071150005 

i2005-2 Medical Use of Byproduct Material - Recognition of 

Specialty Boards Part 35 70 FR 16336; 71 FR 1926 

04/29/2008 Proposed 

 ML081370130 

Comments 06/30/2008 ML081820355 
RATS ID NRC Chronology Identification Date Due for 

State Adoption 

Incoming Package 

Outgoing Package 

Notes 

2005-3 Increased Controls for Risk-Significant Radioactive 

Sources (NRC Order EA-05-090)

70 FR 72128 

12/01/2005 License Condition 

ML053120143 

No Comments 11/10/2005 ML053180026 

i2006-1 Minor Amendments 

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

03/27/2009 Proposed 

 ML081370130 

Comments 06/30/2008 ML081820355 

2006-2 National Source Tracking System - Serialization 

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

02/06/2007 Proposed 

ML070380488 

No Comments 03/06/2007 ML070650102 

Ohio r06-110 no liceML070

2006-3 National Source Tracking System 

Part 20 71 FR 65865, 72 FR 59162 

01/31/2009 Proposed 

ML070380488 

No Comments 03/06/2007 ML070650102 

i2007-1 Medical Use of Byproduct Material - Minor Corrections 

and Clarifications Parts 32 and 35 72 FR 45147, 54207 

10/29/2010 Proposed 

 ML081370130 

Comments 06/30/2008 ML081820355 

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 

ML080460449 

No Comments 03/12/2008 ML080720077 

2008-1 Occupational Dose Records, Labeling Containers, and 

Total Effective Dose Equivalent Parts 19, 20 72 FR 68043 

02/15/2011 
1 R stands for proposed revisions to Final Regulations 

2 IMPEP Team: verify that Ohio does not have any licensees subject to these regulations during each review.