• Changes current dairy plant rules (ATCP 80) to make them consistent with current federal standards. This includes minor technical changes related to pasteurization standards, thermometers and temperature readings, as well as updates to technical standards incorporated by reference (ATCP 80 Appendix). The updates refer to the latest editions of the 3-A Sanitary Standards and Accepted Practices published by the 3-A Sanitary Standards, Inc.
• Updates technical standards that are incorporated by reference in current weights and measures rules (ATCP 92). The updates refer to the latest editions (2006) of current weights and measures handbooks published by the National Institute of Standards and Technology.
Clarifies, per current statutes, that local weights and measures inspectors must be civil service employees (conforms rule to current statute).
Eliminates minor obsolete accounting provisions (in ATCP 105) related to the calculation of cigarette “cost" for purposes of the Unfair Sales Act (“minimum markup law").
Clarifies the relationship between DATCP's home improvement code (ATCP 110) and basement waterproofing code (ATCP 111), both of which apply to basement waterproofing services.
Clarifies prohibition against misleading charity claims in coupon book schemes (ATCP 131).
• Repeals current rules related to dairy cattle grades (ATCP 158), because the rules are obsolete and no longer used.
• Corrects typographical errors and cross-references, eliminates obsolete provisions, conforms rules to current statutes, creates clarifying notes, and makes other non-substantive drafting and organizational changes to current rules.
Pursuant to s.
227.21, Stats., DATCP will request permission from the Attorney General and the Revisor of Statutes to incorporate each updated technical standards by reference.
Fiscal Estimate
DATCP already exercises enforcement discretion, as described in this rule, so the effect will be minimal. Fines and forfeitures are paid to the state school fund, not DATCP. Other provisions of this rule will have no fiscal effect on DATCP or local units of government.
Business Impact
DATCP already exercises enforcement discretion, as described in this rule. The current exercise of discretion prevents unnecessary costs to small businesses. The codification of DATCP's current enforcement policy will not change that policy, or have a major additional impact on business. The other provisions of this rule will have no significant effect on business.
Federal Regulations
Several of the technical changes in this rule will make DATCP rules consistent with current federal standards. Otherwise, there are no existing or proposed federal regulations similar to this rule.
Surrounding State Programs
Surrounding states (Illinois, Indiana, Iowa, Michigan and Minnesota) do not have comparable rules, except that some use comparable technical standards.
Notice of Hearings
Health and Family Services
NOTICE IS HEREBY GIVEN that pursuant to ss.
227.11 (2) (a),
254.34 (1) (a),
254.35 (3) (g),
254.365 (4) and
254.37 (3), Stats., and interpreting ss.
254.31 to
254.45, Stats., and
42 USC 2011 to
2114, the Department of Health and Family Services will hold public hearings to consider the proposed creation, repeal, repeal and recreation and amendment of portions of chapter HFS 157 Radiation Protection, relating to the regulation of radiation producing devices and radioactive materials and affecting small businesses.
Hearing Date(s) and Location(s)
Tuesday, April 18, 2006, 10:00 - 11:30 a.m.
Medical College of Wisconsin
8701 Watertown Plank Rd. (Rm. HRC 1210)
Milwaukee, WI
Thursday, April 20, 2006, 10:00 - 11:30 a.m.
1 W. Wilson St.
Rm. B139
Madison, WI
Thursday, April 27, 2006, 10:00 - 11:30 a.m.
Westwood Conference Center
1800 W. Bridge St. (Atrium Room)
Wausau, WI
The hearing site is fully accessible to people with disabilities. 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.
Place Where Written Comments may be Submitted
Written comments may be submitted at the public hearing or submitted to the Department using the Wisconsin Administrative Rule Website at:
http://adminrules.wisconsin.gov or may be sent to:
Paul Schmidt, Chief
Radiation Protection Section
P.O. Box 2659
Madison, WI 53701-2659
608-267-4792
Deadline for Comment Submission
The deadline for submitting comments to the Department is 4:30 p.m., May 12, 2006.
Analysis Prepared by the Department of Health and Family Services
Under s.
254.34 (1) (a) Stats., the Department is responsible for developing and enforcing rules, including registration and licensing of sources of ionizing radiation to prohibit and prevent unnecessary radiation exposure. The Department is also responsible for maintaining compliance with the Agreement signed by Governor Doyle in 2003 and the Nuclear Regulatory Commission (NRC) that transferred regulatory authority over certain radioactive materials from the NRC to the state. Under the Agreement, the Department is responsible for licensing and inspecting radioactive materials commonly used in medicine, industry, research and education. NRC staff periodically evaluates the state regulatory program.
One of the requirements of this Agreement is Wisconsin's assurance that it will revise the radioactive material portions of ch.
HFS 157 within 3 years of any applicable changes in Title10 Code of Federal Regulations. Title 10 CFR has been revised since ch.
HFS 157 was last revised in 2002. Therefore, the Department proposes to modify the radioactive material requirements in ch.
HFS 157.
In addition, the Department proposes to revise the portions of ch.
HFS 157 pertaining to x-rays to reflect new diagnostic and therapeutic technologies, experience with implementing the current rule, changes in comparable federal regulations in
21 CFR Part 1020, and input provided to the Department by an advisory group that included representatives of academic and medical facilities, radioactive materials users, x-ray users and large and small businesses.
Finally, the Department proposes to increase the annual site fee and the x-ray tube fee established under s.
254.35 (3), Stats., to address a projected operating deficit in the x-ray and registration and inspection program for state fiscal year (SFY) 2006 and beyond. To maintain program revenue sufficient to operate the x-ray registration and inspection program, the Department under s.
254.35 (3) (g), Stats., proposes to increase annual registration fees by increasing both the annual site fee and x-ray tube fee for installations required to be registered as follows:
Increase the annual site fee from $36 to $50 for all required registrants, including sites serving physicians and clinics, osteopaths and clinics, chiropractors, hospitals, podiatrists, veterinarian, industrial, educational facilities, research projects, and dental sites, and other sites required to be registered.
Increase the annual x-ray tube fee from $44 to $50 for all sites, except dental, serving physicians and clinics, osteopaths and clinics, chiropractors, hospitals, podiatrists, veterinarian, industrial sites, educational facilities, research projects, and other sites.
Increase the annual x-ray tube fee from $30 to $35 for dental sites.
The proposed revisions to chapter HFS 157 accomplish the following:
• Updates the radiation protection and regulatory requirements for radioactive materials to reflect changes in federal regulations in Title 10, Code of Federal Regulations Parts 19, 20, 31, 33-36, 39, 40, 70, 71 and 150 and applicable portions of Title 49 (transportation), Code of Federal Regulations.
•
Updates the radiation safety requirements for x-ray producing devices to reflect new technologies, current federal regulation and the input of an ad hoc advisory group representing a cross-section of regulated users.
•
Revises 7 of the 42 radioactive material license fee categories to reflect lessons learned after 1.5 years as an Agreement state. There is no fee increase associated with the materials fee category revision.
•
Increases x-ray registration fees to ensure sufficient operating revenue for the x-ray registration and inspection program. The last fee increase occurred in 1996. The x-ray registration and inspection program helps to minimize unnecessary radiation exposure to the general public and device operators by verifying that devices are functioning according to radiation protection requirements in ch.
HFS 157.
Pursuant to s.
227.21 Stats., the Department has requested permission from the Attorney General and the Revisor of Statues to incorporate by reference into ch.
HFS 157, the ANSI N432-1980 "Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography", published by the American National Standards Institute. These standards are cited in the proposed rules.
Initial Regulatory Flexibility Analysis
The Department is the state's radiation control agency and is required under ss.
254.34 (1) (a),
254.365 (4), and
254.37 (3), Stats., to promulgate rules pertaining to the use of radiation in Wisconsin. Specifically, the Department is required to promulgate and enforce rules pertaining to sources of ionizing radiation and for registration and licensing sources of ionizing radiation, and enforcement as may be necessary to prohibit and prevent unnecessary radiation exposure.
Sites of ionizing radiation (x-ray devices) are required under s.
254.35 (3), Stats., to register and pay annual registration fees, which consists of a site fee and a fee for each x-ray tube upon registration. The current registration fee is $66 for dental sites ($36 site fee; $30 for each x-ray tube) and $80 ($36 site fee; $44 for each x-ray tube) for all other required registrants, including sites serving physicians and clinics, osteopaths and clinics, chiropractors, hospitals, podiatrists, veterinarian, industrial sites, educational facilities, research projects, and other sites. These industries are represented in the North American Industry Classification System sectors 33-Manufacturing; 42- Wholesale Trade; 44-45 –Retail Trade; 54-Professional Scientific, and Technical Services; 61-Educational Services ; 62-Health Care and Social Assistance; 71- Arts, Entertainment, and Recreation; and 92-Correctional Facilities.
The Department's x-ray registration and inspection program is 100% fee supported by the annual registration fees authorized under s.
254.35 (3), Stats. At current fee levels, the Department projects a program deficit of $27, 770 in SFY 06 that will increase to $135, 310 in SFY 07 and continue to increase each subsequent fiscal year if fees are not increased. To maintain program revenue sufficient to operate the x-ray registration and inspection program, the Department under s.
254.35 (3) (g), Stats., proposes to increase annual registration fees by increasing both the annual site fee and x-ray tube fee for installations required to be registered as follows:
Increase the annual site fee from $36 to $50 for all required registrants, including sites serving physicians and clinics, osteopaths and clinics, chiropractors, hospitals, podiatrists, veterinarian, industrial, educational facilities, research projects, and dental sites, and other sites.
Increase the annual x-ray tube fee from $44 to $50 for all sites, except dental, serving physicians and clinics, osteopaths and clinics, chiropractors, hospitals, podiatrists, veterinarian, industrial sites, educational facilities, research projects, and other sites.
Increase the annual x-ray tube fee from $30 to $35 for dental sites.
An analysis of the Department's facility registration data shows that the 2,152 registered dental facilities average 4 x-ray tubes per site at a current cost of $120 ($30 x 4) in annual x-ray tube fees and $36 in site fees for an approximate total of $156 per year (or $13 per month) in annual registration fees. Under the proposed fees increase, dental facilities with 4 x-ray tubes per site will pay $140 ($35 x 4) in annual x-ray tube fees and $50 in site fees for an approximate total of $190 per year (or $16 per month) in annual registration fees; an increase of $34 per year. Dental sites account for over 45% of the registered facilities and over 58% of the x-ray tubes, and at least 85% of these facilities may be considered small businesses.
Veterinary services (431 facilities); chiropractors (901 facilities), and podiatrists (119 facilities) average 1 x-ray tube per site at a current cost of $44 ($44 x 1) in annual x-ray tube fees and $36 in site fees for an approximate total of $80 per year (or $7 per month) in annual registration fees. Under the proposed fees increase, these facilities will pay $50 ($50 x 1) in annual x-ray tube fees and $50 site fee for an approximate total of $100 per year (or approximately $8 per month) in annual registration fees; an increase of approximately $20 per year. Veterinarians, chiropractors, and podiatrists account for 30% of the registered facilities and 10.5% of the x-ray tubes and at least 85% of these facilities may be considered small business. Industrial applications; sites serving physicians and clinics and osteopaths and clinics; hospitals; educational facilities; research projects; and other sites including those with security installations, account for the remaining 25% of the registered facilities and 31% of the x-ray tubes. Some or all of these facilities are not small businesses as defined in s.
227.114 (1), Stats.
Based on an analysis of the average gross annual revenues (as given in the 2002 Economic Census) of dental facilities, chiropractic facilities, veterinary facilities, and podiatry facilities, the proposed increase in annual registration fees represents a less than 1% decrease in gross annual revenues of these small businesses.
Annual registration fees have not been increased since SFY1997. The proposed increase in fees will increase program revenues by approximately $140, 614 if implemented in SFY 07 and ensure adequate program funding thru at least SFY 10. Adequate funding of the x-ray registration and inspection program is important because this program helps to minimize unnecessary radiation exposure to the general public and device operators by verifying that devices are functioning according to the radiation protection requirements in ch.
HFS 157, state statutes, federal statutes and regulations, and the radiation protection policy stated in s.
254.33, Stats. If the annual registration fees are not increased the Department would be forced to terminate staff and reduce the frequency in which x-ray inspection are conducted. Reduced inspection frequency is linked to higher rates of non-compliance with radiation safety requirements. Faulty x-ray equipment or x-ray equipment not used as required increases the risk of injuries to skin and organ tissue, and cancer.
Small Business Regulatory Coordinator
Rosie Greer
608-266-1279
Fiscal Estimate
Under s.
254.34 (1) (a), WI Stats., the Department of Health and Family Services is responsible for developing and enforcing rules, including registration and licensing of sources of ionizing radiation, to prohibit and prevent unnecessary radiation exposure. Sources of ionizing radiation include x-ray producing devices. The Department assesses an annual site registration fee, plus a fee for each x-ray tube, that supports the Department's x-ray registration and inspection program. The Department is authorized under s.
254.35 (3), Stats., to increase the fee by rule. The current x-ray registration fees are as follows:
Physicians and clinics, osteopaths, chiropractors, hospitals: $36 site fee, $44 for each x-ray tube
Podiatric or veterinary site: $36 site fee, $44 for each x-ray tube
Dental site: $36 site fee, $30 for each x-ray tube
Industrial, research or other site: $36 site fee, $44 for each x-ray tube.
Since the last fee increase in 1996, program costs have increased annually due to inflation. Revenue from current fees is not sufficient to cover current operating expenses. To meet current costs, the Department is proposing to increase the annual x-ray site registration and x-ray tube fees, as follows:
Increase the site fee to $50 from $36.
For all sites other than dental sites, increase the x-ray tube fee to $50 from $44.
For dental sites, increase the x-ray tube fee to $35 from $30.
As indicated, revenue from current fees is not sufficient to cover current operating expenses. The Department projects a deficit of ($27,770) in SFY 06 increasing to ($135,310) in SFY 07 with no fee increase. The proposed fee increase will nearly eliminate the deficit by SFY 07 and fully eliminate it in SFY 08. The net effect of this rule will be to provide sufficient revenue for the x-ray registration and inspection program to operate as authorized by state law.
The device-based fee structure has the least impact on small business. For example, a dental office with one x-ray tube would pay an additional $19 in annual fees as a result of the proposed fee increase ($66 current; $85 proposed). A medical, chiropractic or podiatry office with one x-ray tube would pay an additional $20 in annual fees as a result of the proposed fee increase ($80 current, $100 proposed).
