July 10, 2000

Ms. Susan McClanahan, Supervisor

Radiation Control Unit

Division of Environmental Health

Minnesota Department of Health

121 E. Seventh Place, Suite 220

P. O. Box 64975

St. Paul, MN 55164-0975

Dear Ms McClanahan:

As requested, we have reviewed the Minnesota draft regulations Notices, Instructions and

Reports to Radioactive Material Workers; Inspections, Radiation Safety Requirements for

Irradiators, Radiation Safety Requirements for Nuclear Logging, Definitions (RAM) and

Definitions (General), which were provided on April 4, 2000. The regulations were reviewed by

comparison to the equivalent NRC regulations in 10 CFR Parts 19, 36, and 39. The definition

sections were reviewed by comparison to the NRC definitions in 10 CFR Parts 19, 20, 30, 32,

34, 35, 36, 40, 61, 70, 71 and 150. We discussed aspects of our review of these regulations

with you on May 1, 2000, and on May 30, 2000 by e-mail. In addition, discussions were held on

June 6, 2000 between Mr. Paul Lohaus, Director, Office of State and Tribal Programs (STP)

and Ms. Linda Bruemmer, Manager, Section of Asbestos, Indoor Air, Lead, and Radiation.

As a result of our review, we have identified 52 comments in the enclosure. A generic

comment on the use of the term “nuclear logging” instead of the term “well logging” is

included. However, we understand from the June 6, 2000 discussions between Mr. Lohaus

and Ms. Bruemmer that the State has decided to use the term “well logging.” We anticipate

evaluating this change as a part of our review of the proposed final Minnesota regulation

package.

Please note that we have limited our review to regulations required for compatibility and for

health and safety. These comments must be addressed to meet the compatibility and health

and safety categories established in the STP Procedure SA-200. Under our current procedure,

a finding that a State regulation meets the compatibility and/or health and safety categories of

the equivalent NRC regulation may only be made base on a review of the final State regulation.

However, we have determined that if your draft regulations were adopted incorporating the

comments and without other significant change, they would meet the compatibility and health

and safety categories established in STP Procedure SA-200.

We request that when the draft regulations are developed into proposed final regulations, a

copy of the proposed final regulations be provided to us for review. As requested in STP

Procedure SA-201, Review of State Regulations, (November 10, 1998), please highlight any

changes and send one copy in a computer readable format, if possible.
Susan McClanahan - 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 me at

(301) 415-2325 or Ms. Cardelia H. Maupin at (301) 415-2312 or by e-mail at chm@nrc.gov.

Sincerely,

/RA/

Frederick C. Combs, Deputy Director

Office of State and Tribal Programs

Enclosure:

As stated
Susan McClanahan - 2 -

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Response to incoming document: ML003706019

DOCUMENT NAME: C:\draftregulations 19 36 39 a~.wpd

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OFFICE STP STP OGC STP:DD

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DATE 06/14/00 06/14/00

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07/10/00

STP-NA-11
COMMENTS ON DRAFT MINNESOTA REGULATIONS

AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES

State

Regulation

NRC

Regulation

Category Subject and Comment

4730.0900,

Subpart I.

19.1 D Purpose

The references to the Atomic Energy Act should be removed from

this provision and the Minnesota statute should be inserted.

4730.0904 19.14 C Presence of Representative of Licensees and Workers During

Inspections

The paragraph (a) of 10 CFR Part 19.14 did not appear to be

included in the draft Minnesota regulations. If these provisions are

incorporated in a generic provision, please indicate. This

paragraph is designated a Compatibility C and the essential

objectives of the NRC provisions in 10 CFR should be adopted.

19.3 19.3 D Definition of Act

The references to the Atomic Energy Act should be removed from

this definition and the Minnesota statute should be inserted.

19.3 20.1003 A Definition of Airborne Radioactivity Area

The Minnesota definition includes an adoption by reference of

sections of 10 CFR. The sections are not referenced properly.

The adoption by reference should be revised to include, “Code of

Federal Regulations, Title 10, Part 20, Appendix B of Sections

20.1101 - 20.2401.” This definition is designated a Compatibility

Category A and should be essentially identical to the NRC

definition in 10 CFR.

19.3 and

4730.0100

20.1003 A Definition of ALARA

This definition appears in two sections of Minnesota regulations,

19.3 and 4730.0100. Both definitions need to be revised to insert

the words “and licensed material” between “nuclear energy” and

“in.” This definition is designated a Compatibility Category A and

should be essentially identical to the NRC definition in 10 CFR.

4730.0100 20.1003 A Definition of Annual Limit on Intake or ALI.

Two different definitions of this term appear in section 4730.0100

of Minnesota regulations. Both definitions include an adoption by

reference of sections of 10 CFR. In both definitions, the 10 CFR

sections are not referenced properly. The adoption by reference

should be revised to include, “Code of Federal Regulations, Title

10, Part 20 Appendix B of Sections 20.1101 - 20.2401.” This

definition is designated a Compatibility Category A and should be

essentially identical to the NRC definition in 10 CFR.

19.3 20.1003 A Definition of Derived Air Concentration (DAC)

The Minnesota definition includes an adoption by reference of

sections of 10 CFR. The sections are not referenced properly.

The adoption by reference should be revised to include, “Code of

Federal Regulations, Title 10, Part 20, Appendix B of Sections

20.1101 - 20.2401.” This definition is designated a Compatibility

Category A and should be essentially identical to the NRC

definition in 10 CFR.
State

Regulation

NRC

Regulation

Category Subject and Comment

-2-

Not

applicable

20.1003 A Definition of Internal Dose

The Minnesota definition was not included in the proposed

Minnesota regulations. This definition is designated a

Compatibility Category A and should be essentially identical to the

NRC definition in 10 CFR.

19.3 20.1003 A Definition of Limits

The Minnesota definition includes an extra sentence at the end.

This sentence should be deleted. This definition is designated a

Compatibility Category A and should be essentially identical to the

NRC definition in 10 CFR.

19.3 20.1003 A Definition of Occupational Dose

The Minnesota definition includes an adoption by reference of a

section of 10 CFR. The section is not referenced properly. The

adoption by reference should be revised to include, “Code of

Federal Regulations, Title 10, Part 35, Section 35.75.” This

definition is designated a Compatibility Category A and should be

essentially identical to the NRC definition in 10 CFR.

4730.0100 20.1003 A Definition of Person

Three different definitions of this term appear in section 4730.0100

of Minnesota regulations. The second and third definitions should

be deleted. These definitions should be deleted because they

address areas of regulation that cannot be relinquished to the

State. This definition is designated a Compatibility Category A

and should be essentially identical to the NRC definition in 10

CFR.

4730.0100 20.1003 A Definition of Public Dose

The Minnesota definition includes an adoption by reference of a

section of 10 CFR. The section is not referenced properly. The

adoption by reference should be revised to include, “Code of

Federal Regulations, Title 10, Part 35, Section 35.75.” This

definition is designated a Compatibility Category A and should be

essentially identical to the NRC definition in 10 CFR.

4730.0100 20.1003 A Definition of Quality Factor

The Minnesota definition includes an adoption by reference of a

section of 10 CFR. The section is not referenced properly. The

adoption by reference should be revised to include, “Code of

Federal Regulations, Title 10, Part 20, tables 1004(b).1 and

1004(b).2 of §20.1004.” This definition is designated a

Compatibility Category A and should be essentially identical to the

NRC definition in 10 CFR.
State

Regulation

NRC

Regulation

Category Subject and Comment

-3-

4730.0100 20.1003 A Definition of Radiation

The Minnesota definition omitted the second sentence of the

definition. The Minnesota definition should be revised to include

this sentence. This definition is designated a Compatibility

Category A and should be essentially identical to the NRC

definition in 10 CFR.

Not

applicable

32.2 B Definition of Lot Tolerance Percent Defect

This definition was not included in the proposed Minnesota

regulations. This definition is designated a Compatibility Category

B and should be essentially identical to the NRC definition in 10

CFR.

Not

applicable

34.2 C Definition of Annual Refresher Safety Training

This definition was not included in the proposed Minnesota

regulations. This definition is designated a Compatibility Category

C and the essential objectives of the NRC term and definition in 10

CFR should be adopted.

19.3 34.2 B Definition of Certifying Entity

The Minnesota definition indicates “the requirements in appendix

A, Parts II and III of this part.” Because the terms and definitions

have been separated from the pertinent regulation sections, the

State should cite the appropriate portion of the Minnesota

regulation and delete the wording “of this part.” This definition is

designated a Compatibility Category B and should be essentially

identical to the NRC definition in 10 CFR.

4730.0100 34.2 A Definition of Gray

This provision references Minnesota section on “Units” and this

section was not provided. This definition is designated a

Compatibility Category A and should be essentially identical to the

NRC definition in 10 CFR. Accordingly, we were unable to

determine that the definition is essentially identical to that of NRC.

Not

applicable

34.2 C Definition of Hands-On Experience

This definition was not included in the proposed Minnesota

regulations. This definition is designated a Compatibility Category

C and the essential objectives of the NRC term and definition in 10

CFR should be adopted.

19.3 34.2 B Definition of Independent Certifying Entity

The Minnesota definition indicates “the requirements in appendix

A of this part.” Because the terms and definitions have been

separated from the pertinent regulation sections, the State should

cite the appropriate portion of the Minnesota regulation and delete

the wording “of this part.” This definition is designated a

Compatibility Category B and should be essentially identical to the

NRC definition in 10 CFR.
State

Regulation

NRC

Regulation

Category Subject and Comment

-4-

Not

applicable

34.2 C Definition of Radiographer

This definition was not included in the proposed Minnesota

regulations. This definition is designated a Compatibility Category

C and the essential objectives of the NRC term and definition in 10

CFR should be adopted.

Not

applicable

34.2 B- for States

that authorize

radiographer’s

assistant

D- for other

States

Definition of Radiographer’s Assistant

This definition was not included in the proposed Minnesota

regulations. This definition is designated a Compatibility Category

B for States that authorize radiographer’s assistants. If the State

of Minnesota plans to authorize the use of radiographer’s

assistants, then this definition should be adopted, and should be

essentially identical to the NRC definition in 10 CFR.

Not

applicable

34.2 C Definition of Radiographic Operations

This definition was not included in the proposed Minnesota

regulations. This definition is designated a Compatibility Category

C and the essential objectives of the NRC term and definition in

10 CFR should be adopted.

4730.0100 34.2 B Definition of Radiography

In the 10 CFR regulations industrial radiography and radiography

are used interchangeably and have the same definition. In the

Minnesota regulations, the two terms have different definitions.

The Minnesota definition of industrial radiography is compatibility

with 10 CFR; the definition of radiography is not. This definition is

designated a Compatibility Category B and should be essentially

identical to the NRC definition in 10 CFR.

19.3 20.1004 and

34.2

A Definition of Quality Factor

The Minnesota definition includes an adoption by reference of a

section of 10 CFR. The section is not referenced properly. The

adoption by reference should be revised to include, “Code of

Federal Regulations, Title 10, Part 20, Section 20.1004.” This

definition is designated a Compatibility Category A and should be

essentially identical to the NRC definition in 10 CFR.

19.3 34.2 B Definition of Independent Storage Container

The Minnesota definition includes an extra phrase “in accordance

with the manufacturer’s guidance....” This phrase should be

deleted. This definition is designated a Compatibility Category B

and should be essentially identical to the NRC definition in 10

CFR.
State

Regulation

NRC

Regulation

Category Subject and Comment

-5-

19.3 35.2 B Definition of Authorized Medical Physicist

Draft final amendments to "Medical Use of Byproduct Material," 10

CFR Part 35, went before the Commission on May 3, 2000, for

approval as a final regulation. It is expected that this definition

will be designated a Compatibility Category B in the final

amendments. However, please note that these amendments are

not final and, as such, are subject to change. Please keep abreast

of the regulation change and conform your definition to the final

regulation.

19.3 35.2 B Definition of Authorized Nuclear Pharmacist

Draft final amendments to "Medical Use of Byproduct Material," 10

CFR Part 35, went before the Commission on May 3, 2000, for

approval as a final regulation. It is expected that this definition

will be designated a Compatibility Category B in the final

amendments. However, please note that these amendments are

not final and, as such, are subject to change. Please keep abreast

of the regulation change and conform your definition to the final

regulation.

19.3 35.2 B Definition of Authorized User

Draft final amendments to "Medical Use of Byproduct Material," 10

CFR Part 35, went before the Commission on May 3, 2000, for

approval as a final regulation. It is expected that this definition

will be designated a Compatibility Category B in the final

amendments. However, please note that these amendments are

not final and, as such, are subject to change. Please keep abreast

of the regulation change and conform your definition to the final

regulation.

19.3 35.2 C Definition of Prescribed Dosage

Draft final amendments to "Medical Use of Byproduct Material," 10

CFR Part 35, went before the Commission on May 3, 2000, for

approval as a final regulation. It is expected that this definition

will be designated a Compatibility Category C in the final

amendments. However, please note that these amendments are

not final and, as such, are subject to change. Please keep abreast

of the regulation change and conform your definition to the final

regulation.

19.3 35.2 B Definition of Radiation Safety Officer

The new “Medical Use of Byproduct Material,” 10 CFR Part 35,

went before the Commission on May 3, 2000, for approval as a

final regulation. This definition is designated a Compatibility

Category B and should be essentially identical to the NRC

definition in 10 CFR. Please keep abreast of the regulation

change and conform your definition to the final regulation.
State

Regulation

NRC

Regulation

Category Subject and Comment

-6-

4730.1100 39 C Generic Comment: The term “well logging” has been replaced by

“nuclear logging.” In addition, the State has suggested the use of

the term “nuclear well logging.” The State should either adopt the

term “well logging” or “wireline services” for the purpose of

compatibility. This term is designated a Compatibility C and the

essential objectives of the NRC provisions in 10 CFR should be

adopted, which includes the adoption of a widely accepted term

which will not create conflict, duplication or gaps or other

conditions that would jeopardize an orderly pattern in the

regulation of agreement material on a nationwide basis.

Not

applicable

39.2 B Definition of Energy Compensation Source

This definition was not included in the proposed Minnesota

regulations. This definition is designated a Compatibility Category

B and should be essentially identical to the NRC definition in 10

CFR. This definition is added to the NRC regulations as a result of

amendment, “Energy Compensation Sources for Well Logging

and Other Regulatory Clarifications,” (65 FR 20337, April 17,

2000), effective May 17, 2000. This definition is assigned a

Compatibility Category B because the sources are routinely

transported across jurisdictional boundaries for use. It is adopted

essentially identical to assure uniform regulation.

Not

applicable

39.2 B Definition of Tritium Neutron Generator Target Source

This definition was not included in the proposed Minnesota

regulations. This definition is designated a Compatibility Category

B and should be essentially identical to the NRC definition in 10

CFR. This definition is added to the NRC regulations as a result of

amendment, “Energy Compensation Sources for Well Logging

and Other Regulatory Clarifications,” (65 FR 20337, April 17,

2000), effective May 17, 2000. This definition is assigned a

Compatibility Category B because the sources are routinely

transported across jurisdictional boundaries for use. It is adopted

essentially identical to assure uniform regulation.

4730.1100.5 39.13 C Specific Licenses for Well Logging

See Generic Comment Above

4730.1100.7 39.15 C Agreement With Well Owner or Operator

See Generic Comment Above

4730.1105 39.35 C Leak Testing or Sealed Sources

We were unable to determine the compatibility of this provision.

This provision references Minnesota section “4730.0155" and this

section was not provided.
State

Regulation

NRC

Regulation

Category Subject and Comment

-7-

Not

applicable

39.53 C Energy Compensation Source

This provision was not included in the proposed Minnesota

regulations. This provision is assigned a Compatibility Category

C. Agreement States should adopt the essential safety objectives

of this provision, and should be no less stringent than the NRC

provisions. This provision is added as a result of amendment,

“Energy Compensation Sources for Well Logging and Other

Regulatory Clarifications,” (65 FR 20337, April 17, 2000), effective

May 17, 2000.

Not

applicable

39.55 C Tritium Neutron Generator Target Source

This provision was not included in the proposed Minnesota

regulations. This provision is assigned a Compatibility Category

C. Agreement States should adopt the essential safety objectives

of this provision, and should be no less stringent than the NRC

provisions. This provision is added as a result of amendment,

“Energy Compensation Sources for Well Logging and Other

Regulatory Clarifications,” (65 FR 20337, April 17, 2000), effective

May 17, 2000.

4730.1121 39.61 B Training

Paragraph (b) of this provision needs to be revised by deleting the

term “nuclear logging” and inserting the term “well logging.” This

provision is designated a Compatibility Category B and should be

essentially identical to the NRC provisions in 10 CFR.

4730.1135 39.75 C Documents & Records Required at Temporary Job Sites

See Generic Comment Above

4730.1137 39.77 C Notification of Incidents, Abandonment Procedures for

Irretrievable Sources

See Generic Comment Above

19.3 40.4 and

150.3(i)

A Definition of Special Nuclear Material

The Minnesota definition needs to be revised to be compatible

with NRC authority in this area. The State should delete the

phrase “and any other material that the Commissioner, pursuant to

the provisions of section 51 of the act, determines to be special

nuclear material.” The State should insert the following phrase

“and any other material the Nuclear Regulatory Commission,

pursuant to the provisions of section 51 of the Atomic Energy Act

of 1954, as amended, determines to be special nuclear material.”

This definition is designated a Compatibility Category A and

should be essentially identical to the NRC definition in 10 CFR.
State

Regulation

NRC

Regulation

Category Subject and Comment

-8-

Not

applicable

61.2 C Definition of Disposal

This definition was not included in the proposed Minnesota

regulations. Although the State is not pursuing low-level waste

authority, this definition is needed because of its association with

Appendix G to Part 20, “Requirements for transfers of Low-level

Radioactive Waste Intended for Disposal at Licensed Land

Disposal Facilities and Manifest.” This definition is designated a

Compatibility Category C and the essential objectives of the NRC

term and definition in 10 CFR should be adopted.

Not

applicable

61.2 C Definition of Hazardous Waste

This definition was not included in the proposed Minnesota

regulations. Although the State is not pursuing low-level waste

authority, this definition is needed because of its association with

Appendix G to Part 20, “Requirements for transfers of Low-level

Radioactive Waste Intended for Disposal at Licensed Land

Disposal Facilities and Manifest.” This definition is designated a

Compatibility Category C and the essential objectives of the NRC

term and definition in 10 CFR should be adopted.

Not

applicable

61.2 B Definition of Land Disposal Facility

This definition was not included in the proposed Minnesota

regulations. Although the State is not pursuing low-level waste

authority, this definition is needed because of its association with

Appendix G to Part 20, “Requirements for transfers of Low-level

Radioactive Waste Intended for Disposal at Licensed Land

Disposal Facilities and Manifest.” This definition is designated a

Compatibility Category B and should be essentially identical to the

NRC definition in 10 CFR.

19.3 71.4 B Definition of Fissile Material

The Minnesota definition includes an adoption by reference of a

section of 10 CFR. The section is not referenced properly. The

adoption by reference should be revised to include, “Code of

Federal Regulations, Title 10, Part 71, Section 71.53.” This

definition is designated a Compatibility Category B and should be

essentially identical to the NRC definition in 10 CFR.

Not

applicable

71.4 B Definition of Packaging

This definition was not included in the proposed Minnesota

regulations. This definition is designated a Compatibility Category

B and should be essentially identical to the NRC definition in 10

CFR.

19.3 71.4 B Definition of Type B Package

The Minnesota definition includes an adoption by reference of a

section of 10 CFR. The section is not referenced properly. The

adoption by reference should be revised to include, “Code of

Federal Regulations, Title 10, Part 71, Section 71.13.” This

definition is designated a Compatibility Category B and should be

essentially identical to the NRC definition in 10 CFR.
State

Regulation

NRC

Regulation

Category Subject and Comment

-9-

19.3 71.4 B Definition of Special form Radioactive Material

The Minnesota definition includes an adoption by reference of a

section of 10 CFR. The section is not referenced properly. The

adoption by reference should be revised to include, “Code of

Federal Regulations, Title 10, Part 71, Section 71.75.” This

definition is designated a Compatibility Category B and should be

essentially identical to the NRC definition in 10 CFR.

19.3 71.4 B Definition of Transport Index

The Minnesota definition includes an adoption by reference of a

section of 10 CFR. The section is not referenced properly. The

adoption by reference should be revised to include, “Code of

Federal Regulations, Title 10, Part 71, Section 71.59.” This

definition is designated a Compatibility Category B and should be

essentially identical to the NRC definition in 10 CFR.

19.3 71.4 B Definition of Type A Quantity

The Minnesota definition indicates “the requirements in appendix

A of this part.” Because the terms and definitions have been

separated from the pertinent regulation sections, the State should

cite the appropriate portion of the Minnesota regulation and delete

the wording “of this part.” This definition is designated a

Compatibility Category B and should be essentially identical to the

NRC definition in 10 CFR.