March 13, 2007

Paul S. Schmidt, Chief

Radiation Protection Section

Department of Health and Family Services

P.O. Box 2659

Madison, WI 53701

Dear Mr. Schmidt:

The Office of Federal and State Materials and Environmental Management Programs (FSME)

has reviewed your letter dated January 31, 2007, in response to our letter dated January 9,

2007, which transmitted our comments on Wisconsin’s radiation protection final rules in

Chapter HFS 157 “Radiation Protection.” In your letter, you disagreed with three of the 10

compatibility related comments we made regarding the final rules. We discussed our review of

the regulations with Cheryl Rogers and Jason Hunt on February 13, 2007.

The additional information provided in your letter has enabled us to verify that your regulations

meet the Compatibility Category B designation for Comment 8 from our January 9, 2007 letter. 

That comment is withdrawn. Regarding Comments 9 and 10, the Wisconsin rules combined

from 10 CFR 35.57(a)(1) and (2) into Chapter HFS 157.61(10). Paragraphs 35.57(a)(1) and (2)

identify certain medical professionals who are excepted from the training requirements in

§§35.50, 35.51, and 35.55. The medical professionals excepted by paragraphs 35.57(a)(1) and

(2) are defined based on both how they are identified in certain Agreement State and NRC

licenses, and when such licenses were issued. We acknowledge that Wisconsin became an

Agreement State on August 11, 2003, and that some of the reference dates in §35.57 refer to

time periods prior to 2003. However both §35.57 and HFS 157.61(10) refer to individuals who

may have been identified in licenses issued by other regulators (i.e. NRC or other Agreement

States) during these time periods. Therefore, the reference dates in paragraphs 35.57(a)(1)

and (2) are relevant and must be included in HFS 157.61(10) in order to meet the Compatibility

Category B criteria which requires adoption of an essentially identical rule.

The attached table shows the nine outstanding comments that need to be incorporated into

Wisconsin’s final regulations and the one withdrawn comment which requires no action by

Wisconsin.

The attached SRS Data Sheet summarizes our knowledge of the status of other Wisconsin

regulations and legal binding requirements, as indicated. The suggested updates to the SRS

Data Sheet will be made as you requested in your January 31, 2007 letter. Please let us know

if you note any additional 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://www.hsrd.ornl.gov/rulemaking/htm.
Paul S. Schmidt, Chief -2- March 13, 2007

If you have any questions regarding the review, 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 310-415-2320 (email: kxs@nrc.gov) or Jim

Lynch at 630-829-9661 (e-mail at jll@nrc.gov).

Sincerely,

\RA By S.W. Moore\

Scott W. Moore, Deputy Director

Division of Materials Safety and State Agreements

Office of Federal and State Materials and

Environmental Management Programs

Enclosure:

As stated
Paul S. Schmidt, Chief -2- March 13, 2007

If you have any questions regarding the review, 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 310-415-2320 (email: kxs@nrc.gov) or Jim

Lynch at 630-829-9661 (e-mail at jll@nrc.gov).

Sincerely,

\RA By S.W. Moore\

Scott W. Moore, Deputy Director

Division of Materials Safety and State Agreements

Office of Federal and State Materials and

Environmental Management Programs

Enclosure:

As stated

Distribution:

DIR RF (7-22) SUNSI Review Complete

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

JLynch, RSAO : Non-Sensitive G Sensitive

LBolling, ASPO [WI] File

DOCUMENT NAME: C:\FileNet\ML070720431.wpd ML of Incoming Document:ML

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 FCameron PRathbun SMoore

DATE 2/27/07* 2/27/07* 3/12/07* 3/13/07* 3/13/07*

ML070720431 OFFICIAL RECORD COPY
COMPATIBILITY COMMENTS ON WISCONSIN FINAL REGULATIONS

RESOLUTION OF JANUARY 31, 2007 LETTER

iComment Challenged

STATE SECTION NRC

SECTION

RATS ID CATEGORY SUBJECT and COMMENTS

1 157.09(2)(a)(2) 30.14 N/A B Exempt Concentrations

Wisconsin omits the paragraph “This exemption

does not apply to the transfer of byproduct material

contained in any food, beverage, cosmetic, drug, or

other commodity or product designed for ingestion

or inhalation by, or application to, a human being,”

from HFS 157.09(2)(a)(2).

 Wisconsin needs to add this paragraph to HFS

157.09(2)(a)(2) to meet the Compatibility Category B

designation assigned to 10 CFR 30.14.

2 157.09(2)(g) 30.21 N/A B Radioactive drug: Capsules containing carbon14 urea for “in vivo” diagnostic use for humans

Wisconsin references HFS 157.13(4)(I) in HFS

157.09(2)(g)(3). This reference to HFS 157. 13

(4)(I) does not match the reference to 10 CFR 32.21.

Either the correct reference needs to be inserted or

HFS 157.09(g) should reference 10 CFR 32.21.

Wisconsin needs to revise HFS 157.09(2)(g) to

reference 10 CFR 32.21 to meet the Compatibility

Category B designation assigned to 10 CFR 30.21.

3 157.53(1)(a)(2) 39.61 N/A B Requirements for Personnel Safety

The Wisconsin regulation includes the requirement

to completed a course recognized by the

department, the NRC, another agreement state or a

licensing state. This requirement makes HFS

157.53(1)(a)(2) more restrictive than 10 CFR 39.61.

Wisconsin needs to omit the requirements for

completion of a course in order to meet the

Compatibility Category B designation assigned to 10

CFR 39.61.

4 157.03(197m,

198, 199, 200)

71.4 2004-1 B Definition- Low Specific Activity

The definition of LSA-III omits the reference to meet

requirements of 10 CFR 71.77 ‘Qualification of LSA-III

material’.

Wisconsin needs to add the appropriate reference

corresponding to 10 CFR 71.77 to the definition of
STATE SECTION NRC

SECTION

RATS ID CATEGORY SUBJECT and COMMENTS

LSA-III to meet the Compatibility Category B

designation assigned to Low Specific Activity in 10

CFR 71.4.

5 157.92 (3)(a) 71.5(a) 2004-1 B Transportation of Licensed Material

Wisconsin omits the reference to “DOT regulations 49

CFR parts 107, 171 through 180, and 390 through

397" from HFS 157.92(3)(a)(1).

The State has not adequately addressed the comment

regarding the inclusion in the introductory paragraph,

provisions that the licensee shall comply with the

applicable requirements of DOT regulations in 49 CFR

Parts 107, 171 through 180, and 390 through 397,

appropriate to the mode of transport, and the licensee

shall particularly note DOT regulations in the following

areas. Wisconsin needs to include the revisions noted

above to meet the Compatibility Category B

designation assigned to 10 CFR 71.5.

Wisconsin needs to add the above reference to this

section to meet the Compatibility Category B

designation assigned to 10 CFR 71.5(a).

6 157.92 (3)(b) 71.5(b) 2004-1 B Transportation of Licensed Material

Wisconsin incorrectly references the DOT regulations

in HFS 157.92(3)(b). The reference should be

changed to read “...49 CFR parts 107, 171 through

180, and 390 through 397...”.

Wisconsin needs to revise the DOT reference in HFS

157.92(3)(b) to read 49 CFR parts 107, 171 through

180, and 390 through 397 to meet the Compatibility

Category B designation assigned to 10 CFR 71.5(b).

7 157 Appendix O Appendix

A Part 71

2004-1 B Determination of A1 and A2

It was stated in a May 2006 letter that in Appendix O,

Subsection II, Wisconsin makes reference to values in

Table VII for values that may be used without

department approval. The correct table is Table VIII.

Also, Wisconsin did not include equivalent provisions

for the following 10 CFR Part 71, Appendix A

Subsections: II(b), II(c), III(e) and III(f). Wisconsin

indicated that they will be correcting these items in

their next rule making.

Wisconsin needs to change HFS 157 Appendix O to

correct the Table reference in Subsection II and add

subsections equivalent to 10 CFR 71 Appendix A II(b),

II(c), III(e), and III(f) to meet the Compatibility Category

B designation assigned to 10 CFR 71 Appendix A.
STATE SECTION NRC

SECTION

RATS ID CATEGORY SUBJECT and COMMENTS

i8 157.03(294) 35.2 2005-2 B Definition - Radiation Safety Officer 

Wisconsin’s definition of Radiation Safety Officer

omits the requirements of paragraph (2) in the 10

CFR 35.2 definition of Radiation Safety Officer.

This comment was withdrawn based on

information provided in Wisconsin’s January 31,

2007 letter.

i9 157.61(10)(a) 35.57

(a)(1)

2005-2 B Training for Experienced Radiation Safety Officer,

Teletherapy or Medical Physicist, Authorized

Medical Physicist, Authorized User, Nuclear

Pharmacist, and Authorized Nuclear Pharmacist

Wisconsin adds “...authorized medical physicist...” to

paragraph (a). Also Wisconsin does not include the

phrasing “before October 24, 2002" in 157.61(10(a).

Wisconsin needs to change 157.61(10)(a) to remove

the phrase “authorized medical physicist” and add

“before October 24, 2002" to meet the Compatibility

Category B designation assigned to 10 CFR

35.57(a)(1).

Comment Stands

i10 157.61(10) 35.57

(a)(2) 

2005-2 B

Training for Experienced Radiation Safety Officer,

Teletherapy or Medical Physicist, Authorized

Medical Physicist, Authorized User, Nuclear

Pharmacist, and Authorized Nuclear Pharmacist

Wisconsin omits 10 CFR 35.57(a)(2) from its

regulations.

Wisconsin needs to add this section to HFS 157.61(10)

to meet the Compatibility Category B designation

assigned to 10 CFR 35.57.

Comment Stands
STATE REGULATION STATUS

State: Wisconsin Tracking Ticket Nu[3 Amendments were reviewed and identified by a i Date: March 13, 20at the beginning of the equivalent NRC requirement.] 

NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / ML 

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

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

Notification of Incidents-Parts 20, 30, 31, 34, 39, 40, 70 56 FR 64980; (10/15/94) 1991-4 Quality Management Program and Misadministrations-Part 35 56 FR 34104; (1/27/95) 1992-1 Eliminating the Recordkeeping Requirements for Departures from Manufacturer's InstructionsParts 30, 35 57 FR 45566; (none) 1992-2 Decommissioning Recordkeeping and License Termination: Documentation Additions[Restricted areas and spill sites]-Parts 30, 40 

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

Licensing and Radiation Safety Requirements for Irradiators-Part 36 58 FR 7715; (7/1/96) 1993-2 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-Part 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 Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for MedicalUse-Parts 30, 32, 35

59 FR 61767; 59 FR 65243;60 FR 322; (1/1/98)

1995-1

Frequency of Medical Examinations for Use of Respiratory Protection Equipment-Part 20 60 FR 7900; (3/13/98) 1995-2 Low-Level Waste Shipment Manifest Information and Reporting-Parts 20, 61 60 FR 15649; 60 FR 25983;

(3/1/98)

1995-3 

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

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / ML 

Radiation Protection Requirements: Amended Definitions and Criteria-Parts 19, 20 60 FR 36038; (8/14/98) 1995-5 Clarification of Decommissioning Funding Requirements-Parts 30, 40, 70 60 FR 38235; (11/24/98) 1995-6 Medical Administration of Radiation and Radioactive Materials-Parts 20, 35 60 FR 48623; (10/20/98) 1995-7 10 CFR Part 71: Compatibility with the International Atomic Energy Agency-Part 71 60 FR 50248; 61 FR 28724;

(4/1/99)

1996-1 

One Time Extension of Certain Byproduct, Source and Special Nuclear Materials LicensesParts 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 

Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air ActPart 20 61 FR 65120; (1/9/00) 1997-1 Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction Within

an Agreement State-Part 150

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

Criteria for the Release of Individuals Administered Radioactive Material-Parts 20, 35 62 FR 4120; (5/29/00) 1997-3 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 28947; (6/27/00) 1997-5

Radiological Criteria for License Termination-Parts 20, 30, 40, 70 62 FR 39057; (8/20/00) 1997-6Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 UreaPart 30 62 FR 63634; (1/02/01) 1997-7 Deliberate Misconduct by Unlicensed Persons-Parts 30, 40, 61, 70, 71, 150 63 FR 1890; 63 FR 13773;

(2/12/01)

1998-1 

Self-Guarantee of Decommissioning Funding by Nonprofit and Non-Bond-Issuing LicenseesParts 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 
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / ML 

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 Radiological Criteria for License Termination of Uranium Recovery Facilities-Part 40 64 FR 17506; (6/11/02) 1999-1 Requirements for Those Who Possess Certain Industrial Devices Containing Byproduct Materialto 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 

Energy Compensation Sources for Well Logging and Other Regulatory Clarifications-Part 39 65 FR 20337; (5/17/03) 2000-1 New Dosimetry Technology-Parts 34, 36, 39 65 FR 63750; (1/8/04) 2000-2 iRequirements for Certain Generally Licensed Industrial Devices Containing ByproductMaterial - Parts 30, 31, 32

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

ML070530

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

ML063120

iMedical Use of Byproduct Material-Parts 20, 32, 35 67 FR 20249; (10/24/05) 2002-2 F

ML070530

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

ML063120

Compatibility with IAEA Transportation Safety Standards and Other Transportation SafetyAmendments - Part 71

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

ML063120

Security Requirements for Portable Gauges Containing Byproduct Material - Part 30 70 FR 2001; (7/11/08) 2005-1 F

ML063120

iMedical Use of Byproduct Material - Recognition of Specialty Boards - Part 35 70 FR 16336; 71 FR 1926

(4/29/08)

2005-2 F

ML070530

Increased Controls for Risk-Significant Radioactive Sources (NRC Order EA-05-090)7 70 FR 72128; (12/1/05) 2005-3 LC

ML052560
NRC Chronology Identification FR Notice

(State Due Date)

RATS ID

Proposed / Final (F)

Rule / ML 

1. Or 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. A State need not adopt a specific regulation if the State has no licensees that would be subject to the regulation. See: “Final Policy Statem

Agreement State Programs,” III.1.Time From For Adoption of Compatible State Regulations, p. 6, SECY-95-112, May 3, 1995.

5. ADAMS ML Number.6. Wisconsin became an Agreement State effective 08/11/03. The State incorporated NRC regulations 08/01/02 and these regulations were 

7. By letter dated September 2, 2005, from Paul H. Lohaus, Director, Office of State and Tribal Programs, Agreement States were given 90 da8. A re-review was completed on this item due to the change in compatibility category of 31.5 and 31.6. More information can be found in the 

STP 05-072.

Minor Amendments - Parts 20, 30, 32, 35, 40, and 70 71 FR 15005 (3/27/09) 2006-1National Source Tracking System - Serialization Requirements - Part 32 with reference to Part20 Appendix E

71 FR 65685 (2/6/07) 2006-2 

National Source Tracking System - Part 20 71 FR 65865 (11/15/07) &

(11/30/07)

2006-3