January 9, 2007

Mr. Paul Schmidt, Chief

Radiation Protection Section, Division of Public Health

Department of Health and Family Services

PO Box 2659

Madison, WI 53701-2659

Dear Mr. Schmidt:

We have reviewed the final revision to the Wisconsin radiation protection rules, Chapter HFS 157,

“Radiation Protection,” and the changes you made to address the letter we sent you on November

27, 2002, received by our office on November 13, 2006. These regulations were reviewed by

comparison to the equivalent Nuclear Regulatory Commission (NRC) rules in 10 CFR Parts 20, 30,

32, 34, 35, 36, 39, 61, and 71 and the requirements of the five amendments identified in the

enclosed State Regulation Status (SRS) Data Sheet. We discussed our review of the regulations

with Cheryl Rogers on January 8, 2007.

As a result of our review, we have 10 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. We have determined that if these regulations are revised, 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 you revise your regulations to address our comments, 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 location of any changes made by

Wisconsin, in response to our comments, and provide a copy to Division of Materials Safety and

State Agreements, Office of Federal and State Materials and Environmental Management

Programs (FSME) (see letter FSME 06-94 dated October 6, 2006 for further information).

The SRS Data Sheet summarizes our knowledge of the status of other Wisconsin 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://www.hsrd.ornl.gov/nrc/rulemaking.htm. 
Mr. Paul Schmidt, Chief -2- January 9, 2007

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 (e-mail: kxs@nrc.gov,) or Cardelia H.

Maupin at 301-415-2312 (e-mail: chm1@nrc.gov ).

Sincerely,

Scott W. Moore, Deputy Director

Division of Materials Safety and State Agreements

 Office of Federal and State Materials and 

 Environmental Management Programs

Enclosures: 

As stated
Mr. Paul Schmidt, Chief -2- January 9, 2007

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 (e-mail: kxs@nrc.gov,) or Cardelia H.

Maupin at 301-415-2312 (e-mail: chm1@nrc.gov ).

Sincerely,

Scott W. Moore, Deputy Director

Division of Materials Safety and State Agreements

 Office of Federal and State Materials and 

 Environmental Management Programs

Enclosures: As stated

DIR RF 6-283 SUNSI Review Complete 

DCD (SP05) : Publicly Available G Non-Publicly Available

JLynch, RSAO MOrendi : Non-Sensitive G Sensitive

LBolling, ASPO Wisconsin File

DOCUMENT NAME: C:\FileNet\ML070090076.wpd ML of Incoming Incoming: ML063120323 MLO63120323

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 DILR SAIS OGC SAIS:BC MSSA:DD

NAME CMaupin KSchneider FCameron PRathbun SMoore

DATE 12/01/06* 12/01/06* 01/03/07* 12/21/06* 01/09/07*

ML[number] OFFICIAL RECORD COPY
COMPATIBILITY COMMENTS ON WISCONSIN FINAL REGULATION

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 address 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
STATE SECTION NRC

SECTION

RATS ID CATEGORY SUBJECT and COMMENTS

B designation assigned to 10 CFR 71 Appendix A. 

8 157.03(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.

Wisconsin needs to add this paragraph to its

definition of Radiation Safety Officer to meet the

Compatibility Category B designation assigned to

this definition in 10 CFR 35.2. 

9 157.61(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 designaiton assigned to 10 CFR

35.57(a)(1).

10 157.61(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.
STATE REGULATION STATUS

State: Wisconsin Tra[5 Amendments reviewed identified by a i Dat

at 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 Licenses-Parts30, 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 Urea-Part 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 Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct Material -Parts 30, 31, 32

65 FR 79162; (2/16/04) 2001-1 P8

ML012770

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

ML063120

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

ML060740

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

ML063120

iCompatibility with IAEA Transportation Safety Standards and Other Transportation Safety

Amendments - Part 71

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

ML063120

iSecurity 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

ML063120

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 da

8. 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) 2006-1