Notice of Hearings
Health and Family Services
Notice is hereby given that pursuant to s.
227.16 (1),
227.17 and
227.18, Stats., the Department of Health and Family Services will hold public hearings to consider the proposed repeal of ch. HSS 157 and creation of ch.
HFS 157 Radiation Protection, relating to the regulation of radiation producing devices and radioactive materials.
Hearing Information
The public hearings will be held:
Date and Time Location
October 26, 2001 Room 751
Friday 1 W. Wilson Street
1:00 p.m. to 4:00 p.m. Madison, WI
November 2, 2001 Rib Mountain Inn
Friday 4700 Rib Mountain Drive
12:30 p.m. to 3:30 p.m. Wausau, WI
November 6, 2001 Country Inn, Meadow Brook
Tuesday West Room
1:00 p.m. to 4:00 p.m. 2810 Golf Road
Waukesha, WI
The hearing sites are fully accessible to people with disabilities.
Analysis Prepared by the Department of Health and Family Services
Governor Thompson assigned the Department of Health and Family Services the responsibility of pursuing an agreement with the U.S. Nuclear Regulatory Commission (NRC) that will allow the state to assume regulatory (including judicial) authority over certain radioactive materials currently under federal jurisdiction. Under this agreement, Wisconsin would become an “agreement state" with the NRC and assume responsibility for licensing, inspecting and regulating the use of radioactive materials at 253 facilities statewide, excluding nuclear power reactors and federal facilities. Among other requirements, the NRC requires a potential agreement state to update their state radiation protection rules with a compatible version of current federal radiation protection regulations prior to signing the agreement transferring regulatory authority. The state rules must also establish a radioactive material licensing and inspection program that is at least as stringent as that of the NRC. This is the reason for and purpose of this proposed rulemaking order.
The proposed chapter HFS 157 is based upon an agreement state rule template called the “Suggested State Regulations for the Control of Radiation" (SSRCR) developed by the Conference of Radiation Control Program Directors, Inc. (CRCPD). The CRCPD is a national organization of state radiation control staff that supports and represents state radiation control programs. The SSRCR is developed with the involvement of federal radiation agencies, such as the Nuclear Regulatory Commission, the Food and Drug Administration and the Environmental Protection Agency. The SSRCR is also continually updated and used by most of the 32 existing agreement states to help meet federal requirements. Chapter
HFS 157 was also developed with the input of a 40-member rules advisory group representing a cross-section of the regulated user community.
The ch.
HFS 157 proposed rulemaking order would accomplish the following:
1. Retain the current requirement under s.
254.35, Stats. to register x-ray devices and propose no change to the annual $36 site fee and $30 (dental) or $44 (other) tube fees for x-ray producing devices.
2. Retain the registration requirement and associated $36 annual fee for naturally occurring and accelerator produced radioactive materials (NARM), currently under state jurisdiction, until Wisconsin becomes an agreement state. The registration requirement and associated fee would terminate at that point.
3. Establish a radioactive material licensing and inspection program equivalent to the NRC program, license application fees, annual fees, license amendment fees, reciprocity fee, enforcement structure and violation penalties for all radioactive materials not exempted from regulation, including NARM.
4. Establish a registration program and annual fee for certain generally-licensed devices that is equivalent to a new NRC generally licensed device registration requirement.
5. Establish radiation safety and regulatory requirements for all regulated uses of radioactive materials, including medical, industrial, research and academic, that are consistent with current radiation safety and regulatory requirements in Title 10 (energy), Code of Federal Regulations, Parts 20, 21, 33-36, 39, 40, 70, 71 and 150 and applicable portions of Title 49 (transportation), Code of Federal Regulations.
6. Update the radiation safety requirements for x-ray producing devices to reflect new technologies, current federal regulations and the input of an ad hoc advisory group consisting of a cross-section of regulated users.
7. Retain existing standards for radioactivity in community water systems.
Contact Person
To find out more about the hearings or to request a copy of the proposed rules, write, phone or e-mail:
Paul Schmidt
Radiation Protection Section
P.O. Box 2659
Madison, WI 53701-2659
608-267-4792 or, if you are hearing impaired, 608-267-7371
If you are hearing or visually impaired, do not speak English or have circumstances that might make communication at a hearing difficult, and if you require an interpreter or a non-English, large print or taped version of the hearing document, contact the person at the address or phone number given above at least 10 days before the hearing. With less than 10 days notice, an interpreter may not be available.
Written comments received by mail or email at an above address no later than 5:00 p.m., November 30, 2001 will be given the same consideration as testimony presented at a hearing.
Fiscal Estimate
The proposed ch.
HFS 157 maintains existing registration fees for x-ray device users. The rulemaking order also proposes to maintain the existing registration program and $36 annual fee for naturally occurring and accelerator produced radioactive materials (NARM) until Wisconsin can become an agreement state with the U.S. Nuclear Regulatory Commission (NRC). At that point, the rulemaking order proposes to terminate the existing radioactive material registration requirement and associated $36 fee and, instead, regulate all radioactive materials through a licensing program. In addition, ch.
HFS 157 proposes a registration program for certain devices containing radioactive material, purchased under a general license, that is consistent with a new federal registration requirement for the same devices. This new generally licensed device registration requirement would not be implemented until Wisconsin can become an agreement state with the NRC.
The fee structure contained in the proposed rulemaking order would have the following economic impact on radioactive material licensing and generally licensed device registration fees if Wisconsin succeeds in becoming an agreement state with the NRC:
1. Reduce radioactive material licensing fees by a projected average of 40% (compared to 2001 NRC fees) for approximately 215 medical, industrial, and research facilities currently licensed and regulated by the federal government in Wisconsin, while maintaining regulatory quality and public safety.
2. Establish a $100 site fee and $50 per device annual registration fee for generally-licensed devices containing certain types and quantities of radioactive material. These devices are used primarily by manufacturing industries to measure flow through pipes, level of material in containers, thickness of materials or coatings, consistency and uniformity of materials and other parameters. The state fees would replace a $450 annual federal fee for a similar NRC mandated device registration program. The state registration fee will be lower than the federal fee for facilities with six or fewer devices ($400 state fee vs. $450 federal fee). Facilities that choose to specifically license their devices would be exempt from the registration requirement and associated fee. This option can reduce the regulatory cost for facilities with large numbers of devices.
3. Establish licensing fees for approximately 100 facilities utilizing naturally-occurring and accelerator-produced radioactive materials due to the proposed licensing requirement. The current Wisconsin annual radioactive material registration fee is $36. This $36 fee would be terminated, if Wisconsin becomes an agreement state, and replaced with licensing fees. Under the proposed rulemaking order, the fees to obtain a license would range from $200 to $5,000 (depending on type of license desired) for the existing facilities that only utilize NARM.
4. Establish licensing fees for 22 academic facilities (for example, Marquette University and the U.W. System campuses) that are currently licensed by the NRC but exempt from paying NRC fees. These academic facilities will require regulatory oversight necessitating cost recovery. This rulemaking order proposes an academic license category and a $1,000 annual fee to provide regulatory cost recovery and ensure continued educational and research use of radioactive materials. Academic facilities may choose a different type of license, depending upon the number and quantity of radioactive isotopes and type of use desired.
5. Increase licensing fees for 16 facilities, primarily businesses, which are classified as NRC small entities. Small entity status is based upon number of employees and annual revenue. NRC currently provides a radioactive material license to certain small entities at a reduced and subsidized cost of $500 per license. The proposed rulemaking order does not utilize the NRC small entity classification. Proposed state licensing fees would range from $1,400 to $5,000 for existing facilities classified as NRC small entities. Licensing fees in the proposed ch.
HFS 157 are based upon the department's estimate of its regulatory oversight costs.
Development of a Wisconsin radioactive materials licensing/inspection capability is projected to take 3-4 years. State regulation of radioactive materials currently under federal jurisdiction is expected to result in streamlined regulation and overall reduced cost to the regulated community, while maintaining public safety. The SFY 00-01 biennial budget bill approved the first phase of the agreement state effort by authorizing necessary statutory changes, 5.25 FTE position authority and a temporary 36% NRC license surcharge fee to fund development costs. The SFY 02-03 biennial budget request will address the second phase of program development. Program development is projected to conclude in the SFY 04-05 biennium.
The agreement state regulatory program will require 9.5 FTE and an SFY 2004 estimated operating budget of $906,589. Projected SFY 2004 personnel costs are $688,548 with total projected capital, supplies and services of $218,041. Estimated SFY 2004 operating revenue of $1,006,700 is derived by calculating the total annual license fee revenue from the existing NRC licensees and state materials registrants in Wisconsin using the fees in HFS 157. There is insufficient data available to calculate the fiscal effect of the application, amendment and other fees on SFY 2004 operating revenue.
The fiscal effect of an agreement state licensing and inspection program on units of government will be minimal since less than 36 state and local government agencies combined are expected to utilize radioactive materials that will require a license under HFS 157.
Initial Regulatory Flexibility Analysis
The proposed rulemaking order will affect a limited number of small businesses that utilize radioactive materials. The regulatory requirements for radioactive materials contained in the proposed ch.
HFS 157 are compatible with equivalent NRC regulations and will not require any new reporting or record keeping requirements, with the exception of an annual self-inspection form for generally licensed devices. This form is being proposed to improve user awareness of the regulatory requirements that apply to certain generally licensed devices that can contain large quantities of radioactive material. The department estimates that it will take about 10 minutes to complete this form.
Based on NRC licensee data, sixteen of the 253 radioactive material licensees in Wisconsin meet the definition of small business under s.
227.114 (1) (a), Stats. The department will be required to license and inspect current NRC facilities no less stringently than the federal government, and ensure equally high standards of public health and safety in the use of radioactive materials, regardless of facility size or small business classification. Facilities that are `small businesses' as defined in s.
227.114, Stats., cannot be exempted from the proposed fees, or receive a reduced fee, without jeopardizing the department's revenue needed to regulate facilities using radioactive materials. For this reason, the department is not proposing exemptions or alternatives for small businesses to the proposed license fee structure.
Notice of Hearing
Health and Family Services
Hearing Information
The public hearing will be held:
Date & Time Location
October 18, 2001 Room B155
Thursday 1 W. Wilson Street
9:00 a.m. to 12:00 p.m. Madison, WI
The hearing site is fully accessible to people with disabilities.
Analysis Prepared by the Department of Health and Family Services
The Department's proposed order updates the Department's rules for prevention and control of tuberculosis based on changes made to ss.
252.07 and
252.10, Stats., as created or amended in
1999 Wis. Act 9. These proposed rules would modify subch.
II of ch. HFS 145 to reflect and implement the changes to ch.
252, Stats., made by Act 9. The rulemaking order proposes principally the following changes:
• To specify laboratory procedures for identification of Mycobacterium tuberculosis;
• To specify how the Department will assist local health departments in administration and enforcement of confinement of patients with tuberculosis;
• To establish standards for certification of public health dispensaries;
• To specify record-keeping requirements for public health dispensaries.
• To specify services and reimbursement rates for public health dispensaries; and
The proposed rulemaking order expands the sections on public health dispensaries for the diagnosis and treatment of persons with or suspected of having tuberculosis. The expanded sections specify how the Department will certify public health dispensaries and which dispensary services the Department will reimburse. Local health departments and the Department are authorized by s.
252.10 (1), Stats., to establish public health dispensaries and the Department is authorized by s.
252.10 (6) (b), Stats., to reimburse the dispensaries at the medical assistance program rate for services specified in rule.
Contact Person
To find out more about the hearing or to request a copy of the proposed rules, write, phone or e-mail:
Tanya Oemig
Bureau of Communicable Diseases
P.O. Box 2969
Madison, WI 53701-2969
If you are hearing or visually impaired, do not speak English, or have circumstances that might make communication at a hearing difficult and if you, therefore, require an interpreter or a non-English, large print or taped version of the hearing document, contact the person at the address or phone number given above at least 10 days before the hearing. With less than 10 days notice, an interpreter may not be available.
Written comments received by mail or e-mail at an above address no later than 5:00 p.m., October 26, 2001 will be given the same consideration as testimony presented at a hearing.
Fiscal Estimate
These rules add specificity to the statutory requirements enacted by the Legislature and do not create new requirements that would affect expenditures or revenues. All costs of implementing the statutory requirements were taken into consideration by the Legislature during development of
1999 Wisconsin Act 9.
Initial Regulatory Flexibility Analysis
Some of the laboratories may be in hospitals that may be considered “small businesses" as defined under s.
227.114, Stats. However, the requirements contained in the proposed rules elaborate on changes made to ss.
252.07 and
252.10, Stats., that were created or amended in
1999 Wisconsin Act 9. Moreover, the Department considers the procedures specified in the proposed rules to be necessary for the preservation of the public's health. Consequently, the Department is not proposing variations from these procedures and requirements for laboratories that may be considered “small businesses."
Notice of Hearing
