September 23, 2005

Robert E. Owen, Chief

Bureau of Radiation Protection

Department of Health

P.O. Box 118

Columbus, OH 43216-0118

Dear Mr. Owen:

We have reviewed the proposed changes to the Ohio regulations in Ohio Administrative Code

Chapter 3701:1-50 “Packaging and Transportation of Radioactive Material,” received by our

office on July 20, 2005. These regulations were reviewed by comparison to the equivalent

Nuclear Regulatory Commission (NRC) rules in 10 CFR Part 71 and the requirements of the

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

discussed our review of the regulations with Mike Snee on August 4, 2005.

As a result of our review, we have 14 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 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 provide a copy to STP.

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.

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 Jim Lynch

at (630) 829-9661 or by e-mail at jll2@nrc.gov.

Sincerely,

\RA By KNSchneider For\

Dennis Rathbun, Deputy Director

Office of State and Tribal Programs

Enclosures: 

As stated
September 23, 2005

Robert E. Owen, Chief

Bureau of Radiation Protection

Department of Health

P.O. Box 118

Columbus, OH 43216-0118

Dear Mr. Owen:

We have reviewed the proposed changes to the Ohio regulations in Ohio Administrative Code

Chapter 3701:1-50 “Packaging and Transportation of Radioactive Material,” received by our

office on July 20, 2005. These regulations were reviewed by comparison to the equivalent

Nuclear Regulatory Commission (NRC) rules in 10 CFR Part 71 and the requirements of the

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

discussed our review of the regulations with Mike Snee on August 4, 2005.

As a result of our review, we have 14 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 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 provide a copy to STP.

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.

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 Jim Lynch

at (630) 829-9661 or by e-mail at jll2@nrc.gov.

Sincerely,

\RA By KNSchneider For\

Dennis Rathbun, Deputy Director

Office of State and Tribal Programs

Enclosures: As stated

Distribution:

DIR RF (5-211) SISP Review Complete

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

: Non-Sensitive G Sensitive

Jlynch, RSAO Dsollenberger, ASPO BUsilton Ohio File

DOCUMENT NAME: E:\Filenet\ML052660013.wpd ML of Incoming Document:ML052020073

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 RIII STP OGC STP:DD

NAME JLynch WRautzen STreby DRathbun

DATE 09/8/05* 09/8/05* 09/21/05* 09/23/05*

ML052660013 OFFICIAL RECORD COPY
COMPATIBILITY COMMENTS ON OHIO PROPOSED REGULATIONS

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

1 50-05(A) 71.5(a) 2004-1 B Transportation of Licensed Material

The Ohio rule is missing the expanded

reference to DOT regulations (See the

Federal Register Final Rule Correction).

Ohio needs to add the DOT references to 50-

05(A) to meet the Compatibility Category B

designation assigned to Section 10 CFR

71.5(a).

2 50-05(A) 71.5(a) 2004-1 B Transportation of Licensed Material

The Ohio rule is missing the “Security plans”

reference in 71.5(a)(1)(vii) (See the Federal

Register Final Rule Correction).

Ohio needs to add the “Security plans” 

reference to 50-05(A) to meet the

Compatibility Category B designation

assigned to Section 10 CFR 71.5(a).

3 50-05(B) 71.5(b) 2004-1 B Transportation of Licensed Material

The Ohio rule is missing the paragraph “A

request for modification, waiver, or

exemption...”.

Ohio needs to add this paragraph to 50-05(B)

to meet the Compatibility Category B

designation assigned to Section 10 CFR

71.5(b).

4 50-26 71.13 2004-1 B Exemption of Physicians

The Ohio rule is significantly different, and

more restrictive, than 10 CFR 71.13.

Ohio needs to adopt 10 CFR 71.13 to 50-

05(B) to meet the Compatibility Category B

designation assigned to Section 10 CFR

71.13.

5 50-07(C)(3) 71.17(c)(3) 2004-1 B General License: NRC-Approved Package

The Ohio rule is missing the required

information to submit to the NRC before first

use of a package found in 10 CFR 71.17. 

Ohio needs to add this information to 50-

07(C)(3) to meet the Compatibility Category B

designation assigned to Section 10 CFR

71.17(c)(3).

6 50-09 71.20(e) 2004-1 B General License: DOT Specification

Container

The Ohio rule is missing the equivalent to

paragraph (e) which provides an expiration

date for the requirements of the section.

Ohio needs to add this information to 50-09 to

meet the Compatibility Category B

designation assigned to Section 10 CFR

71.20.
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

7 50-10 71.21(d)(2) 2004-1 B General License: Use of Foreign Approved

Package

Since Ohio states that this rule applies to

general licensees who have “a quality

assurance program approved by the United

States Nuclear Regulatory Commission”, Ohio

should reference Subpart H of Part 71 (or 50-

24 of their own rules), and state that licensees

are “exempt from design, construction, and

fabrication considerations”.

Ohio needs to add this information to 50-10 to

meet the Compatibility Category B

designation assigned to Section 10 CFR

71.21(d)(2).

8 50-11(C)(1) 71.22(c)(1) 2004-1 B General License: Fissile Material

Ohio’s rule reads “Contain less than a type A

quantity of fissle material”. This leads to a

potential problem if the quantity transported is

exactly equal to a type A quantity of fissile

material. Paragraph (C)(1) should be

changed to read “Contain no more than a

Type A quantity of radioactive material; and” 

(See the Federal Register Final Rule

Correction).

Ohio needs to add this phrase to 50-11(C)(1)

to meet the Compatibility Category B

designation assigned to Section 10 CFR

71.22(c)(1).

9 50-12(C)(1) 71.23(c)(1) 2004-1 B General License: Plutonium-Beryllium

Special Form Material

Ohio’s rule reads “Contain less than a type A

quantity of material”. This leads to a potential

problem if the quantity transported is exactly

equal to a type A quantity of radioactive

material. Paragraph (C)(1) should read

“Contain no more than a Type A quantity of

radioactive material; and” (See the Federal

Register Final Rule Correction). 

Ohio needs to add this phrase to 50-12(C)(1)

to meet the Compatibility Category B

designation assigned to Section 10 CFR

71.23(c)(1).

10 50-18(B) 71.88(b) 2004-1 B Air Transport of Plutonium

Paragraph (B) uses language different than

that of 10 CFR 71.88. The phrase “The

requirements of paragraph (A) of this rule are

in addition to the requirments of 10 CFR

73.24.” should be changed to “Nothing in

paragraph (a) of this section is to be

interpreted as removing or diminishing the

requirements of 10 CFR 73.24 of this

chapter.” 

Ohio needs to add this phrase to 50-18(B) to

meet the Compatibility Category B

designation assigned to Section 10 CFR

71.88(b).
STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS

11 50-23 71.97 2004-1 B Advance Notification of Shipment of

Irradiated Reactor Fuel and Nuclear Waste

Paragraphs (A) and (C)(1) do not reference

that the advance notifications need to be

made to the governor of a State, or the

governor’s designee.

Ohio needs to add this information to 50-23 to

meet the Compatibility Category B

designation assigned to Section 10 CFR

71.97.

12 50-25(A) and

(D)

Part 71, Appendix A 2004-1 B Determination of A1 and A2

Paragraph (A) of the Ohio rule is different than

Appendix A to 10 CFR 71 (See the Federal

Register Final Rule Correction). The revised

language establishes the Terabecquerel

values as the regulatory standard.

Ohio needs to add this information to 50-25(A)

and (D) to meet the Compatibility Category B

designation assigned to Appendix A of 10

CFR 71.

13 50-25(A) and

(D)

Part 71, Appendix A 2004-1 B Determination of A1 and A2

The Ohio rule is missing the equivalent of

Appendix A (IV)(e) and (f) paragraphs

regarding the exempt activity concentration for

mixtures of radionuclides.

Ohio needs to add this information to 50-25(A)

and (D) to meet the Compatibility Category B

designation assigned to Appendix A of 10

CFR 71.

14 50-25, Table

25-2

Part 71, Appendix A,

Table A-2

2004-1 B Exempt Material Activity Concentrations

and Exempt Consignment Activity Limits

for Radionuclides

The Ohio rule is missing “footnote g” which

references unirradiated uranium.

Ohio needs to add this footnote to 50-25(A)

and (D) to meet the Compatibility Category B

designation assigned to Table A-2 in

Appendix A of 10 CFR 71.
STATE REGULATION STATUS

 State: OHIO [The one amendment reviewed is identified by a i Tracking Ticket Nuat the beginning of the equivalent NRC regulation.] Date: September 

NRC Chronology Identification FR Notice

(Date Due for State Implementation)

RATS ID

Proposed (P) Final (F)1 Rule 

ML #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 P

ML042230062

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

57 FR 45566; (none) 1992-2 P

ML042230062

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 StandardsPart 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 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

ML023180373

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

ML041240504

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 P

ML012500056

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

ML040920160
NRC Chronology Identification FR Notice

(Date Due for State Implementation)

RATS ID

Proposed (P) Final (F)1 Rule 

ML #4

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 MaterialsLicenses-Parts 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 P 

Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean AirAct-Part 20

61 FR 65120; (1/9/00) 1997-1 F

ML041240504FML041900134

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 P

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 

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 
NRC Chronology Identification FR Notice

(Date Due for State Implementation)

RATS ID

Proposed (P) Final (F)1 Rule 

ML #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. 

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

ML041240504NML041900134

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

ML012500049

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

ML023250117

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

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

ML041240504FML041900134

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 P

ML042230062

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

i Compatibility With IAEA Transportation Safety Standards and Other Transportation

Safety Amendments – Part 71.

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

ML052020573

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; (4/29/08) 2005-2