April 4, 2002

Mr. Paul 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:

As requested, we have reviewed the proposed regulations in Wisconsin Administrative Code,

Chapter HFS 157 entitled, “Radiation Protection,” dated September, 2001 and transmitted by

letter dated September 20, 2001. The proposed regulations will replace the referenced NRC

regulations currently in place. The regulations were reviewed by comparison to the equivalent

NRC regulations and the Suggested State Radiation Control Regulations of the Conference of

Radiation Control Program Directors, Inc. We discussed our review of the regulations with you

on January 8, 2002 and with Ms. Cheryl Rogers on January 22, 2002. 

As a result of our review, we have 68 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 a State regulation meets the

compatibility and health and safety categories of the equivalent NRC regulation may only be

made based on a review of the final State regulation. However, we have determined that if your

proposed regulations were adopted incorporating the 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, a copy of

the “as published” regulations be provided to us for review. Please include a redline/strike-out

version of the final document including indication of where the changes were incorporated. In

your cover letter, please include justification for any alternate solutions to the comments

showing how they meet compatibility with the NRC rules. We request that you submit the final

regulations 60 days prior to any deadline needed by the State for this review and if possible, in

an electronic format. If you have any questions about the regulation submission or review

process, you may reference STP Procedure SA-201, Review of State Regulations (November

10, 1998); this document can be found on the STP Website:

http://www.hsrd.ornl.gov/nrc/procfrm.htm

If you have any questions regarding the comments, the compatibility and health categories,

or any of the NRC regulations used in the review, please contact me or Lloyd Bolling at

(301) 415-2327 or LAB@NRC.GOV.

Sincerely,

/RA Josephine M. Piccone Acting for/

Paul H. Lohaus, Director

Office of State and Tribal Programs

Enclosure: 

As stated
Paul Schmidt

Distribution:

DIR RF (1-193) DCD (SP07) PDR (YES_)

SDroggitis

BUsilton

Wisconsin File Response to Incoming Document: ML012770029

 

 

DOCUMENT NAME: G:\LAB\Wisconsin-Proposed.wpd

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OFFICE RIII:RSAO STP OGC STP:DD STP:D

NAME LBolling:kk/gd JZabko J Lieberman JMPiccone PHLohaus

DATE 1/24/02 1/24/02 4/2/02 1/25/02 4/3/02 4/04/02
COMMENTS ON PROPOSED WISCONSIN REGULATIONS

AGAINST COMPATIBILITY AND HEALTH AND SAFETY CATEGORIES
State

Regulation

NRC

Regulation

RATS

ID

Category Subject and Comments

157.03 20.1003 A

A

B

B

A

(3) Absorbed dose (D) means the

mean energy imparted by ionizing

radiation to matter. Absorbed dose is

the quotient pf dE by dM, where dE is

the mean energy imparted by ionizing

radiation to matter of mass dM. This

does not change the definition. The SI

unit of absorbed dose is joule per

kilogram and is called the Gray. The

special name of the unit of absorbed

dose is the RAD. 1 Gy = 100 Rad. 

This definition needs to be changed to

be essentially identical to the 10 CFR

Part 20.1003 definition. 

(16) Airborne radioactivity area means

a room, enclosure or area in which

airborne radioactive materials exist in

concentrations that meet either of the

following criteria: . . . . 

Insert between materials and exist 

“, composed wholly or partly of

licensed material,”

(83) Critical group means the group of

individuals reasonably expected to

receive the greatest exposure to

radiation residual radioactivity for any

applicable set of circumstances. 

Delete “radiation” and add “residual

radioactivity.”

(139) Fit test means the use of a

protocol to qualitatively or qualitatively

evaluate the fit of a respirator on an

individual. Insert “or quantitatively”

between qualitatively and evaluate. 

(230) Nonstochastic effect means a

health effect, the severity of which

varies with the dose and for which a

threshold is believed to exist. 

Radiation-induced cataract formation

is an example of a nonstochastic

effect. (Also called a deterministic

effect) should be added to this

definition, as in 10 CFR Part 20.1003.
State

Regulation

NRC

Regulation

RATS

ID

Category Subject and Comments

B (294) Radiation safety officer - add

“the individual identified as the

radiation safety officer an agency

license” and who meets the applicable

Department requirements. 

157.03 20.1003 A (413) Very high radiation area means

an area, accessible to individuals, in

which radiation levels from radiation

sources external to the body could

result in an individual receiving an

absorbed dose in excess of 5 Gy (500

rad) in one hour at one meter from a

source of radiation or one meter from

any surface that the radiation

penetrates. Insert the 10 CFR Part 20

highlighted text.

157.03 40.4 B (406) Unrefined and unprocessed ore

means ore in its natural form prior to

any processing, such as grinding,

roasting or , beneficiating or refining. 

Insert “, beneficiating or” between

roasting and refining. If it is not

possible to use beneficiating, an

alternative approach could be to use

the phrase “altering the ore from its

natural state.” 

157.03 20.1005 A (87) Curie means a unit of quantity of

radioactivity. One curie (Ci) is that

quantity of radioactive material that

decays at the rate of 3.7E+10

transformations per second (tps). The

definition should be changed to be

essentially identical to 10 CFR Part

20.1005. 
State

Regulation

NRC

Regulation

RATS

ID

Category Subject and Comments

157.03 34.3 C

C

(153) Hands-on Experience - This

definition adds a substantial amount of

clarifying information to the definition. 

However, it does not include

conducting surveys. The additional

information does not apply to all of the

places in the regulations that “handson experience” appears. The

definition needs to be changed to

match the definition in 10 CFR Part 34

with all of the additional information

moved into the chapter, suggested

part HFS 157.44 (3). 

(294) Radiation Safety Officer - This

definition was written generically to

describe the RSO for many different

places sited in HFS 157. In order for

this definition to meet compatibility as

used for radiographic operations, the

RSO must be defined as stated in 

10 CFR 34.3, specifying “RSO for

industrial radiography,” due to the fact

there is a difference in training

between an industrial radiography

RSO and other RSOs.

157.04(2)(a),

(d)

30.12 B Corrected text - exemptions granted to

U.S. DOE and U.S. NRC prime

contractors and sub-contractors for

handling Atomic Energy Act material is

a Commission only decision. In (a),

delete “sources of radiation” and insert

“byproduct material, source material

and special nuclear material.” In (d),

delete “the state and” and “jointly,” and

make determine(s) plural. 

157.09(2)(a) 30.14(b) &

(c)

B Exempt concentrations - paragraphs

(b) on import ban and (c) on

manufacturing restrictions are missing

and should be added. 

157.09(2)(c)

(12)

30.19 B Not essentially identical. Should follow 

10 CFR 30.19.

157.09(2)(c)

(13)

30.20 B Not essentially identical. Should follow 

10 CFR 30.20.

157.09(2)(c)

(15)

30.21(d) B Not essentially identical. Should

include 10 CFR 30.21(d). 

157.11(1)(c)

(1)

40.25 C Insert between manufactured & either,

“or initially transferred.”
State

Regulation

NRC

Regulation

RATS

ID

Category Subject and Comments

157.13(4) 30.32(g) C Should require the use of registered

SS&Ds.

157.13(4)(d)

(1)

32.51 B Insert “initially” between “or &

distribute” . . . .

157.13(4)(d)

(2)

32.51(a)(4),

(5)

B Text missing. Insert equivalent to 

10 CFR 32.51(a)(4)&(5).

157.13(4)(d)

(3)

32.51(b) B Text missing. Insert equivalent to 

10 CFR 32.51(b)(1-10).

157.13(4)(d)

(5)

32.51a B Due to recent substantive changes to

Part 32, it is recommended that 

10 CFR 32.51a be copied verbatim.

157.13(4)(d)

(5)

32.52 B Due to recent substantive changes to

Part 32, it is recommended that 

10 CFR 32.52 be copied verbatim.

157.13(4)(g)

(5)

32.71(e) B Possible wrong reference “HFS

157.23(1)”, should be “HFS

157.30(1).” 

157.13(4)(i) 32.72(d) B Missing text. Insert a new paragraph,

“Nothing in this section relieves the

licensee from complying with

applicable FDA, other Federal, and

State requirements governing

radioactive drugs.”

157.13(4)(j) 32.72 B Deleted this subsection and insert 

10 CFR 32.72 text. In 10 CFR this

subsection, HFS 157.13(j), has been

subsumed into 10 CFR 32.72. 

157.13(4)(k)

(3)

32.74(a)(3) B Delete the following text, “provided

that the labeling for sources that do

not require long term storage may be

on a leaflet or brochure that

accompanies the source.”

157.13(4)(k)

(4)

32.74(b)(2)

(i-x)

B Missing text. Insert 10 CFR

32.74(b)(2) text on acceptance testing

for leakage of RAM.

157.13(4)(L)

(4)(b)

40.35(b) B Missing text. Insert “or initial

transferor,” between manufacturer & of

the. Insert “or initially transferred”

between manufactured, & the fact.

157.13(6)(b) 34.13(b) C Missing text. Insert “and

radiographers assistants” between

radiographers & that.
State

Regulation

NRC

Regulation

RATS

ID

Category Subject and Comments

157.13(6)(i) 34.13(i) C Survey meters require 6-month

calibrations and for alarm ratemeters

the requirement is 12 months. 

157.13(11)(c)

(1)

30.36(c)(1) H&S Insert “decommissioning” and delete

“decontamination.”

157.22(2)(a) 20.1202(a) A Missing text. Insert “by meeting one of

the conditions in paragraph (b) of this

section and the conditions of

paragraph (c) and (d) of this section”

between doses & under.

157.22(2)(d) 20.1202(d) A Corrected and missing text. Insert

“and ,to the extent practical, account

for intakes . . . .” Delete “estimate.”

157.22(4)(a) 20.1204(a) A Missing text. Insert “suitable and

timely” between “take &

measurements.”

157.22(8) 20.1208 A This section requires a high degree of

compatibility with 10 CFR Part 20. It is

recommended that 20.1208 text be

inserted and the existing text be

deleted.

157.23(1)(b) 20.1301(b) A Corrected text. Delete “restricted” and

insert “to controlled areas...”

157.23(2)(a) 20.1302(a) H&S Missing text. Insert “unrestricted and

controlled areas..”

157.29(2)(c) 20.1902(c) A Corrected text. Delete “words

Extreme Danger, Very High Radiation

Area or”

20.1403 C Criteria for License Termination under

Restricted Conditions - Wisconsin has

chosen to omit this requirement due to

potential State liability. The State

believes that a facility and lands must

be decontaminated to unrestricted use

levels or the existing license should be

maintained. 

157.33 20.1406 C Need to adopt 10 CFR 20.1406.
State

Regulation

NRC

Regulation

RATS

ID

Category Subject and Comments

157.36(1)(a),

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

34.20 B The ANSI reference N43.9-1991 does

not match the ANSI reference in 

10 CFR 34.20 stated as N432-1980. 

NRC has not accepted the newer

guidance because there are

endurance test requirements in the

1991 standard that are less restrictive

than the 1980 standard.

157.36(1)(a)

(3)

34.20(b)(3) B Does not allow for minor changes. 

157.41(2)(a) 34.31(b)(1) C Does not address replacement

components, see 10 CFR 34.31(b)(1).

157.45(11) &

157.44(6)

34.47 & 

34.83

C Needs to reflect the new requirements

concerning dosimetry detailed in 34.47

and 34.83. 

34 App A B State did not cover Appendix “A”?

157.59 Part 35 Variable It is recommended that Wisconsin

follow the format of the draft final rule,

since it is expected to be implemented

at the time that the agreement

becomes effective. 

157.73(1)(a) 36.1 (b) &

(c)

C Subchapter VII is missing the

quantitative values and irradiator types

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

157.73(1)(a)1 36.21(a)(1) B Section HFS 157.73(1)(a)1 does not 

accurately state the requirement in 

10 CFR 36.21(a)(1). Should add,

“Must have a certificate of registration

issued by NRC or an Agreement

State.”

157.73(7) 36.33 H&S The effective date of July 1, 1993

needs to be inserted into HFS 

157.73 (7), (a)&(c) as stated in 

10 CFR 36.33(a).

157.51 (1) 39.15

(3)&(4)

C Section HFS 157.51 (1) omits two

requirements found in 10 CFR 39.15,

(3) & (4). These requirements relate

to the radiation monitoring and

contamination control requirements

necessary following the loss of a

source.
State

Regulation

NRC

Regulation

RATS

ID

Category Subject and Comments

157.52 (4) 39.33 C Section HFS 157.52 (4) omits “...and

temporary job sites.” As written, the

regulation allows work at temporary

job sites to be conducted without

proper survey equipment.

157.52(4) 39.33 C Section HFS 157.52 (4) omits the

requirement for having other available

calibrated instruments capable of

detecting low level radiation and

contamination that may be

encountered with a ruptured source,

as per 10 CFR 39.33 (b).

157.52(5)(b) 39.35 (b) C Section HFS 157.52(5)(b) omits the

requirement that the leak test must be

“performed using a leak test kit or

method approved by the NRC or

State” as written 10 CFR 39.35 (b).

157.52(10) 39.41 B Section HFS 157.52(10) is missing

many elements of 10 CFR 39.41. This

section is a compatibility B category

and therefore must contain all of the

essential objectives of 10 CFR 39.41. 

The section needs to be rewritten

including all of these requirements.

Appendix J 39.61(e)(1)

(iii) & (e)(5)

B Appendix J is missing the subjects 

“hazzards of exposure to radiation” as

stated in 10 CFR 39.61(e)(1)(iii) and

“case histories of well logging

accidents” in 39.61(e)(5).

157.53(1)(a)

(1)

39.61(a)(4) B Should delete the allowance for an

“oral” test.

157.53(1)(a)

(3)

39.61(a)(3) B Section HFS 157.53(1)(a)(3) is

missing the on the job training

requirements.

157.92(3)(b) 71.5(b) B Missing Text. Insert “A request for

modification, waiver, or exemption

from those requirements, and any

notification referred to in those

requirements must be filed with the

Department (Wisconsin).”
State

Regulation

NRC

Regulation

RATS

ID

Category Subject and Comments

157.94 71.87(g) &

(k)

B Missing text. Insert two new

paragraphs, “For fissile material, any

moderator or neutron absorber, if

required, is present and in proper

condition” and “Accessible package

surface temperatures will not exceed

the limits specified in 71.43(g) at any

time during transportation.”

Appendix B 30.71

Schedule B

B Exempt Quantities Table - the

following Appendix B radionuclides are

not listed in either the Suggested State

Regulations or 10 CFR: 

Cs-129, Co-57, Ga-67, Ge-68, Au195, In-111, I-123, Fe-52, K-43, 

Rb-81, Na-22, Y-87, Y-88. What is the

technical basis for adding these

radionuclides to Appendix B? Delete

“Note 1.”

Appendix G Appendix G 

Part 20

B Missing definitions. Insert definitions

for: ”disposal, disposal site, land

disposal facility.”

Section III(d)(2) - corrected text, delete

“the department authorizes their

disposal” and insert “license

termination.”

Section III(d)(3) - corrected text, insert

“, unless notified by the shipper that

the shipment has been canceled.”

Appendix G

Section III

(a)(2)

Appendix G 

Part 20

(3)(a)(2)

B Missing “Greater than Class C.”

Appendix H 61.55 B Section I(b) Classes of waste - Missing

text, insert new paragraph compatible

with 10 CFR 61.55(a)(2)(iv). 

Appendix I Appendix B 

Part 30

B Missing text, insert Gold-198 100

microcuries and Gold-199 100

microcuries. What is the technical

basis for adding Sodium-22? 
State

Regulation

NRC

Regulation

RATS

ID

Category Subject and Comments

Appendix O Appendix A

Part 71

B Section IV(a) & (b) corrected text, use

NRC format for these formulae in

order to maintain nationwide

consistency.

Table IV, corrected text - insert

1.5x10-3 for the specific activity of 

Bi-205. Delete the exponent “x10+4”

for the specific activity of Cd-113m. 

Appendix P Schedule C

30.72

H & S Corrected text - insert Carbon-14 

(Non-CO2).

Insert Germanium-68 0.01 release

fraction and 2,000 Ci quantity. 

Change Iodine-124 to Iodine-125.

Insert mixed corrosion products 0.01

release fraction and 10,000 Ci quantity

between mixed fission products and

mixed radioactive waste.

Insert Irradiated material, Solid noncombustible 0.001 release fraction and

10,000 Ci quantity. 

Appendix Q 30.32(i)(4) H & S Contents of an Emergency Plan -

Section k. Corrected text - it is

required that offsite response

organizations be provided up to 

60-days to review and comment on the

licensee’s emergency plan before it is

submitted to the Department. Section

k. should amended accordingly.