August 31, 2006

Robert E. Owen, Chief

Bureau of Radiation Protection

Ohio Department of Health

P.O. Box 118

Columbus, OH 43216-0118

Dear Mr. Owen:

By letter dated August 9, 2004, we sent you the results of our review of the final changes to the

Ohio regulations which were submitted to the NRC by letter dated July 1, 2004. These

regulations were reviewed by comparison to the equivalent Nuclear Regulatory Commission

(NRC) rules in 10 CFR Parts 30, 31, and 32, and the requirements of the General License (GL)

amendment identified in the enclosed State Regulation Status (SRS) Data Sheet. The review

we conducted omitted a specific review of Sections 10 CFR Parts 31.5 and 31.6. The text of

these sections was not revised by the GL amendment, but the compatibility designations were

changed from Compatibility Categories C and D respectively, to Category B. 

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 discussed our re-review of the GL Amendment with Michael Snee on August 23, 2006. 

Although we had no comments for the 2001-1 amendment stated in the August 9, 2004 letter,

as a result of our re-review against the Compatibility Category B designation, we have three

comments that have been identified in the enclosure. Comment 3 indicates that the State’s

regulation is more restrictive than the NRC’s regulation, and there is no corrective action

required for this comment at this point. However, Comments 1 and 2 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. We request that when a final amended version of Ohio

regulations are adopted and published in response to our comments, that 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 note that we have limited our review to regulations required for compatibility and/or

health and safety. 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 STP website: http://www.hsrd.ornl.gov/nrc/rulemaking.htm.
Robert E. Owen, Chief -2- August 31, 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 me, or Ms.

Jennifer Tobin at (301) 415-2328 or by e-mail at JCT1@nrc.gov.

Sincerely,

Dennis K. Rathbun, Deputy Director

Office of State and Tribal Programs

Enclosures: 

As stated
Robert E. Owen, Chief -2- August 31, 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 me, or Ms.

Jennifer Tobin at (301) 415-2328 or by e-mail at JCT1@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( 6-16 ) DCD (SP0 ) : Publicly Available G Non-Publicly Available

PDR (YES_T) : Non-Sensitive G Sensitive

Response to Incoming Document: ML041900134

JLynch , RSAO , DSollenberger ASPO BUsilton, Ohio File

Document Name:E:\Filenet\ML062370212.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 4/10/06* 4/27/06* 8/31/06*

ML062370212 OFFICIAL RECORD COPY MLPkg.ML062370213
COMMENTS ON PROPOSED OHIO REGULATIONS

STATE

SECTION

NRC

SECTION

RATS ID CATEGORY SUBJECT and COMMENTS

1 3701:

1-46-

05

31.5(c)(8)(ii

)

2001-1 B Certain detecting, measuring, gauging, or

controlling devices and certain devices for

producing light or an ionized atmosphere

The NRC requires a report to be furnished within

30 days after the transfer of a device to a

specific licensee or export. However, Ohio has

omitted the requirement of reporting such a

device within 30 days after it is exported. 

Also, NRC does not contain provision that

relieves a licensee from reporting a device that is

transferred to a specific licensee for a

replacement of the same model. However,

Ohio’s final regulations do not require report if

the device is transferred to the specific licensee

for a replacement of the same model. 

Ohio needs to add the requirement of reporting a

device that is exported to 3701:1-46-05(C)(8)(b),

and delete the phase “a report is not required if

the device is transferred to the specific licensee

for a replacement of the same model.” from its

regulations, to meet the Compatibility Category B

designation assigned to 10 CFR 31.5(c)(8)(ii).

2 N/A 31.5(c)(11) 2001-1 B Certain detecting, measuring, gauging, or

controlling devices and certain devices for

producing light or an ionized atmosphere

Ohio has omitted the requirement of 10 CFR

31.5(c)(11), regarding general license response

to information requests within 30 calendar days. 

Ohio needs to add the requirements of 10 CFR

31.5(c)(11) to 3701:1-46-05(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

3 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

Ohio has omitted the provisions 10 CFR

31.5(c)(13)(iv), regarding the applicability of the

registration requirements for the GL devices

licensed by an Agreement State or by the NRC,

that are used in Ohio for less than 180 days. 

Ohio’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.
STATE REGULATION STATUS

State: OHIO Tracking Ticket Nu[1 Amendment reviewed is identified by a i Date: August 31, 20

at the beginning of the equivalent NRC regulation]

NRC Chronology Identification FR Notice

(Date Due for State Implementation)

RATS ID

Proposed (P) Final (F)1 Rule 

LicenseCondition (LCML #4

Safety Requirements for Radiographic Equipment-Part 34 55 FR 843; (1/10/94) 1991-1 F

ML023250117

ASNT Certification of Radiographers-Part 34 56 FR 11504; (none) 1991-2 F

ML023250117

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

ML040920160

Notification of Incidents-Parts 20, 30, 31, 34, 39, 40, 70 56 FR 64980; (10/15/94) 1991-4 P Quality Management Program and Misadministrations-Part 35 56 FR 34104; (1-7/95) 1992-1 F

ML061440106

Eliminating the Recordkeeping Requirements for Departures from Manufacturer'sInstructions-Parts 30,35

57 FR 45566; (none) 1992-2 F

ML061440106

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

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

Licensing and Radiation Safety Requirements for Irradiators-Part 36 58 FR 7715; (7/1/96) 1993-2 F

ML023250117

Definition of Land Disposal and Waste Site QA Program-Part 61 58 FR 33886; (7/22/96) 1993-3 

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-Part40

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 P Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material forMedical Use-Parts 30, 32, 35

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

1995-1 F

ML061440106

Frequency of Medical Examinations for Use of Respiratory Protection Equipment- Part 20 60 FR 7900; (3/13/98) 1995-2 F 

ML041240504
NRC Chronology Identification FR Notice

(Date Due for State Implementation)

RATS ID

Proposed (P) Final (F)1 Rule 

LicenseCondition (LCML #4

Low-Level Waste Shipment Manifest Information and Reporting-Parts 20, 61 60 FR 15649; 60 FR 25983

(3/1/98)

1995-3 F

ML040920160

Performance Requirements for Radiography Equipment-Part 34 60 FR 28323; (6/30/98) 1995-4 F

ML023250117

Radiation Protection Requirements: Amended Definitions and Criteria-Parts 19, 20 60 FR 36038; (8/14/98) 1995-5 F

ML040920160

Clarification of Decommissioning Funding Requirements-Parts 30, 40, 70 60 FR 38235; (11/24/98) 1995-6 P 

Medical Administration of Radiation and Radioactive Materials-Parts 20, 35 60 FR 48623; (10/20/98) 1995-7 P

ML042230062

10 CFR Part 71: Compatibility with the International Atomic Energy Agency-Part 71 60 FR 50248; 61 FR 28723

(4/1/99)

1996-1 P

ML010380259ML010870344

One Time Extension of Certain Byproduct, Source and Special Nuclear Materials LicensesParts 30, 40, 70 61 FR 1109; (none) 1996-2 P Termination or Transfer of Licensed Activities: Record Keeping Requirements-Parts 20,30, 40, 61, 70

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

Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air ActPart 20 61 FR 65120; (1/9/00) 1997-1 FML041900134 

FML041240504

Recognition of Agreement State Licenses in Areas Under Exclusive Federal JurisdictionWithin an Agreement State-Part 150

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

ML041240504

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

ML042230062

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 28948; (6/27/00) 1997-5 F

ML023250117

Radiological Criteria for License Termination-Parts 20, 30, 40, 70 62 FR 39058; (8/20/00) 1997-6 Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 UreaPart 30 62 FR 63634; (1/02/01) 1997-7 FML041240504 
NRC Chronology Identification FR Notice

(Date Due for State Implementation)

RATS ID

Proposed (P) Final (F)1 Rule 

LicenseCondition (LCML #4

Deliberate Misconduct by Unlicensed Persons-Parts 30, 40, 61, 70, 71, 150 63 FR 1890; 63 FR 13773

(2/12/01)

1998-1 P

ML010380259ML010870344

Self-Guarantee of Decommissioning Funding by Nonprofit and Non-Bond-IssuingLicensees- Parts 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 F

ML041240504

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

(10/26/01)

1998-5 

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

ML041900134

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

ML060580024

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

ML040920160

Energy Compensation Sources for Well Logging and Other Regulatory Clarifications-Part39

65 FR 20337; (5/17/03) 2000-1 F

ML023250117

New Dosimetry Technology-Parts 34, 36, 39 65 FR 63749; (1/8/04) 2000-2 F

ML023250117

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

65 FR 79162; (2/16/04) 2001-1 F8

ML041900134
NRC Chronology Identification FR Notice

(Date Due for State Implementation)

RATS ID

Proposed (P) Final (F)1 Rule 

LicenseCondition (LCML #4

1. For 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. ADAMS ML Number5. Ohio became an Agreement State effective 08/31/99. The State incorporated NRC regulations by reference 10/9/98 and therefore

were found compatible.

6. Although these items are not required for purposes of compatibility, the State incorporated NRC regulations by reference on 10/9/9

these items. 

7. 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.

8. 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 A

letter STP 05-072.

Revision of the Skin Dose Limit-Part 20 67 FR 1629; (4/5/05) 2002-1 P

ML042230062

Medical Use of Byproduct Material-Parts 20, 32, 35 67 FR 20249; (4/24/05) 2002-2 F

ML061440106

Financial Assurance for Materials Licensees – Parts 30, 40, 70 68 FR 57327 12/3/06 2003-1Compatibility With IAEA Transportation Safety Standards and Other Transportation SafetyAmendments – Part 71.

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

ML050200730

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)7 70 FR 72128; (12/1/05) 2005-3 LC

ML053120143

Minor Amendments - Parts 20, 30, 32, 35, 40, and 70 71 FR 15005 (3/27/09) 2006-1