November 27, 2002

Mr. Paul S. Schmidt, Chief

Radiation Protection Section

Division of Public Health

Department of Health & Family Services

P. O. Box 2659

Madison, WI 53701-2659

Dear Mr. Schmidt:

We have reviewed the final regulations in Wisconsin Administrative Code, Chapter HFS 157

entitled, “Radiation Protection,” which became effective on August 1, 2002. The regulations

were reviewed by comparison to the equivalent NRC regulations. We discussed our review

of the regulations with you and with Ms. Cheryl Rogers on September 17, 2002. 

As a result of the NRC review, we have identified 33 comments, as enclosed. These comments

must be addressed to meet the compatibility and health and safety categories established in the

Office of State and Tribal Programs (STP) Procedure SA-200.

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) 415-3340 or Lloyd Bolling at (301) 415-2327 or LAB@NRC.GOV.

Sincerely,

/RA Paul H. Lohaus for/

Josephine M. Piccone, Deputy Director

Office of State and Tribal Programs

Enclosure: 

As stated
Paul S. Schmidt 2 November 27, 2002

Distribution:

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SSmith

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OFFICE STP C STP C OGC N STP:DD C N

NAME LBolling:gd JZabko

(DMSollenberger for)

SATreby JMPiccone

(DMSollenberger for)*

 

DATE 9/19/02 

11/26/02

9/19/02 11/22/02 9/19/02* 

11/27/02 

(PHLohaus for)

OFFICIAL RECORD COPY
COMMENTS ON PROPOSED WISCONSIN REGULATIONS

AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIE

State

Regulation

NRC

Regulation

RATS

ID

Category Subject and Comments

157.03(13)Definitions

35.2 [C] (13) Agreement State - Correct text- delete “42 USC 2201” & retain “subs

act of 1954, as amended.”

157.03(294)Definitions

35.2 B (294) Radiation Safety Officer - This definition should reference ss HFS 1

157.09(2)(a)(2) 30.14 B Exemptions of radioactive material other than source material - Delete cu

manufacturer, processor or producer of a product or material is exempt fif he transfers radioactive material contained in a product or material in cthose in Appendix A and introduced into the product or material by a liceissued by the department, an agreement state, or the NRC expressly aut

157.09(2)(c) 30.15(a) B Exempt items - Correct text - “Except for persons who apply radioactive 

or incorporate radioactive material into the following products, or initially 

the following products, a person is exempt from this subchapter if the petransfers, owns or acquires any of the following products:”

157.09(2)(c)(12) 30.19 B Self-luminous products..... - Correct text - adopt text essentially identical 

157.09(2)(c)(13)(a)

30.20(a) B Gas and aerosol detectors.... - Insert “or initially transfer for sale or distrib

“gas.” Insert ”processed, produced” between “manufactured” & “or”.... 

157.09(2)(c)(15) 30.21 B Radioactive drugs: Capsules containing carbon-14 urea for “in vivo” diag

text - adopt text essentially identical to 10 CFR 30.21. 

157.13(4)(d)(1) 32.51 B Licensing the manufacture and distribution of devices to persons genera

157.11(2)(b).1 - Insert “initially” between “or” & ”distribute” . . & between “

157.13(4)(d)(2)

32.51(a)(4),(5)

B Licensing the manufacture and distribution of devices to persons genera

157.11(2)(b) - Text missing. Insert equivalent to 10 CFR 32.51(a)(4)&(5)

157.13(4)(d)5.1. 32.51a(e) B Licensing the manufacture and distribution of devices to persons genera

157.11(2)(b) - Correct text - 1. If a notification of bankruptcy has been ma

the license is to be terminated, a person licensed under this paragraph sdepartment, and to the appropriate regulatory agency, NRC or other Agr

at the devices location, records of final disposition required under subd. P

157.22(8)(c) 20.1208 A Dose Equivalent to an embyro or fetus - missing text - insert “equivalent” 
State

Regulation

NRC

Regulation

RATS

ID

Category Subject and Comments

157.33(3)(a)3.a.& b.

20.1404 C Alternate Criteria for a Decommissioning Possession-Only License Term

licensee may decommission a facility and maintain a decommissioning palternate criteria greater than the dose criterion specified in sub. (2) of thlicensee:” Missing text - between (3)(a)3. a. & b. insert a new sentence “

practical, restrictions on site use in minimizing exposures at the site;”This is needed since Wisconsin does not allow restricted site release. 

157.33 20.1406 C Radiological criteria for license termination - Need to adopt 10 CFR 20.1

157.36(1)(a),(1)(b)(9), & (2)

34.20 B Performance requirements for industrial radiography equipment - The AN

not match the ANSI reference in 10 CFR 34.20 stated as N432-1980. N

guidance because there are endurance test requirements in the 1991 stathan the 1980 standard.

157.36(1)(a)(1) 34.20(b)(1) B Performance requirements for industrial radiography equipment - correct 

source assembly,” this section pertains only to radiographic exposure de

157.36(1)(a)(3) 34.20(b)(3) B Performance requirements for industrial radiography equipment - Does n

Should use 10 CFR 34.20(b)(3) text.

157.41(2)(a) 34.31(b)(1) C Procedures - Does not address replacement components, see 10 CFR 3

157.44(3)(c)(2) 34.43(c)(3) B Training - correct text - delete “or oral.”

157.45(11)(c) &157.44(6)

34.47 & 34.83

C Records of personnel monitoring - Needs to reflect the new requirements 

34.47 and 34.83 re: NAVLAP. 

157.52(10) 39.41 B Design, performance and certification criteria for sealed sources used in 

HFS 157.52(10) is missing many elements of 10 CFR 39.41. This sectioand therefore must be essentially identical to 10 CFR 39.41. The section all of these requirements.

157.53(1) 39.61(c) B Training - missing text - add requirement for annual safety reviews for log

assistants.

157.53(1)(a)(1)&(2)

39.61(a)(4) B Training - delete text - oral examinations are not allowed for logging supe

157.55(1)(d) 39.67(e) C Radiation surveys - correct text - delete “, except those using hydrogen-3

157.61(8)(b)(1) & (2)

35.51 B Training for authorized medical physicist - Add new lead sentence - “Exc

157.61(10), the licensee shall require the authorized medical physicist to 

Delete text - “or an equivalent training program approved by the NRC,” in 35.51(b)(2) equivalent text.

157.61(9)(a) 35.55 B Training for authorized nuclear pharmacist - Missing text - after NRC, ad
State

Regulation

NRC

Regulation

RATS

ID

Category Subject and Comments

157.61(10)(b) 35.57 B Training for experienced Radiation Safety Officer, Teletherapy or medica

nuclear pharmacist - Correct text - change “and” to “thru” between ss. HF

157.62(3)(b)(2)(a)

35.63 H&S Determination of dosages of unsealed radioactive material for medical us

another Agreement State.”

No equivalentSections

Subpart J35.900 thru35.981

D Training and experience requirements - These requirements are compat

should be adopted for consistency and uniformity either through regulatiorequirements. 

157.72(2) 35.3047 C Report of a dose to an embryo or fetus or a nursing child - Correct text - 

compatible with Part 35. The State should adopt 35.3047 in its entirety.

157.73(1)(a) 36.1 (b) & (c) C Performance criteria for sealed sources - Subchapter VII is missing the q

types stated in 10 CFR 36.1 (b) and (c).

Appendix GSection III (a)(2)

Appendix G Part20(3)(a)(2)

B Requirements for transfer of low-level radioactive waste for disposal at la

manifests - Missing “Greater than Class C.”

Appendix HSection I(b)(4)

61.55(a)(2) (iv) B Classification and characterization of low-level radioactive waste - Sectio

text, “Waste that is not generally...”

 Appendix P Schedule C

30.72

H&S Quantities of radioactive materials requiring consideration of the need fo

responding to a release - Insert “-68“ after Germanium