STATE OF WISCONSIN
DEPARTMENT OF SAFETY AND PROFESSIONAL SERVICES
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IN THE MATTER OF RULEMAKING : ORDER OF THE
PROCEEDINGS BEFORE THE : DEPARTMENT OF SAFETY
DEPARTMENT OF SAFETY AND : AND PROFESSIONAL SERVICES
PROFESSIONAL SERVICES : ADOPTING RULES
:(CLEARINGHOUSE RULE 19-085)
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ORDER
An order of the Department of Safety and Professional Services to repeal SPS 220.12 (1) (title), (2) and (3), and 220.13; to amend SPS 220.03 (8), and 220.11 (2); to repeal and recreate SPS 220.04 and SPS 220 Appendix A; and to create SPS 220.04 (note), 220.045 and 220.11 (note), relating to tanning facilities.
Analysis prepared by the Department of Safety and Professional Services.
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Statutes interpreted: s. 463.25, Stats. Statutory authority: s. 463.25 (12), Stats. Explanation of agency authority: Section 463.25 (12) states that the department “may promulgate rules necessary to administer this section.” Related statutes or rules: Chapter 440, Department of Safety and Professional Services, and chs. SPS 1 to 9 outline the Department of Safety and Professional Services’ uniform administrative procedures for issuing licenses and disciplinary actions against licensees. Plain language analysis: 2015 Wisconsin Act 55 transferred responsibility for regulating tanning facilities from the Department of Health Services (DHS) to the Department of Safety and Professional Services (DSPS), effective January 1, 2016. DHS 161 and 161 Appendix were renumbered SPS 220 and 220 Appendix at that time. This rule will align administrative provisions transferred from DHS with DSPS’s processes, and modernize the rule to reflect current practice for ensuring the safe and sanitary use of tanning devices. Section 1 amends SPS 220.03 (8) to revise the definition for “Tanning device” to refer to the definition given in s. 463.25 (1) (b), Stats. Section 2 repeals and recreates SPS 220.04 to remove outdated references to fees and to clarify that fees for tanning facility permits will be established by the department under its authority in ss. 440.03(9)(a) and 440.05(1), Stats., to remove a provision relating to the process for approving or denying applications for tanning facility permits as duplicative of the department’s existing procedures found in SPS 4, and to create requirements to receive or maintain a tanning facility permit license, including that tanning facility permit applicants and permit holders must not have been convicted of a felony while engaged in the practice of operating a tanning facility, and must comply with department orders to correct, or take substantial steps approved by the department to correct, violations of any sanitary or other rule of the department within the time limit stated by the department in a notification of violation. These rules are necessary to make the chapter consistent with department administrative processes and to ensure the public health and safety in tanning facilities. Section 3 creates a note in SPS 220.04 with contact information for obtaining a tanning facility license application.
Section 4 creates SPS 220.045 providing for the tanning facility permit expiration date.
Section 5 amends SPS 220.11 (2) to provide that the department may inspect a facility upon receipt of an injury report received under SPS 220.11 if the department determines an establishment presents a hazard to public health and safety.
Section 6 creates a note with contact information for filing an injury report required under SPS 220.11.
Section 7 repeals SPS 220.12 (1) (title).
Section 8 repeals SPS 220.12 (2) and (3), aligning the rule with the department’s uniform procedures for denying, suspending, or revoking credentials found in chs. SPS 1 to 9, and ch. 440, Stats. Section 9 repeals SPS 220.13 as the penalty is already provided for in statute.
Section 10 repeals and recreates SPS 220 Appendix A to modernize the table and clarify that the information in the appendix is based on the Fitzpatrick Skin Type Scale, which is a recognized public health tool for classifying skin types to determine a person’s potential reaction to solar radiation.
Summary of, and comparison with, existing or proposed federal regulation:
Performance standards for sunlamp products--21 CFR 1040.20 establishes performance standards for sunlamp and sunlamp products and includes equipment requirements related to radiant power of sunlamps, timer systems, and protective eyewear. The regulation requires manufacturers to display a warning statement on sunlamp products similar to the statement Wisconsin state law requires tanning facility operators to post near each device. 21 CFR 1040.20 also requires users’ instructions to include information for determining the correct exposure time and schedule for persons according to skin type. Medical device classification--21 CFR 878.4635 regulates the manufacture of sunlamp products and ultraviolet lamps intended for use in sunlamp products. In 2014, the Food and Drug Administration (FDA) revised 21 CFR 878.4635 to reclassify sunlamp and ultraviolet (UV) lamps from low-risk (class I) to moderate-risk (class II) medical devices. As part of that reclassification, FDA placed additional controls on the manufacture of sunlamps and UV lamps to protect public health, such as performance testing, software validation, and demonstration that the device is biocompatible and safe to use. 21 CFR 878.4635 includes two warning label requirements. First, sunlamp or UV lamp manufacturers are required to include a warning in user instructions, catalogs, and other product-related documents stating that the products should not be used by people under the age of 18, who have skin lesions or open wounds, who have or have a history of skin cancer or who have been regularly evaluated for skin cancer. Second, FDA also requires sunlamp products to carry a “black-box warning” stating that the product should not be used by people under age 18. FDA requires “black-box warnings” on products the agency determines to present a significant risk. This is a labeling requirement and does not prohibit the use of sunlamp products by people under age 18. FDA’s “black-box warning” requirement for sunlamp products applies to both new products and units currently in use. Although manufacturers may provide labels to tanning facility operators for products currently in use, if a sunlamp product manufacturer is out of business, then the operator is responsible for acquiring or creating the “black- box warning” label for products used in their tanning facility.
Proposed federal regulations -- The FDA is proposing to restrict the use of sunlamp products to people age 18 years old and older, and require that they sign a risk acknowledgement certification before use, and then every 6 months, that states that they have been informed of the risks to health that may result from use of sunlamp products.
The FDA also solicited comments on a proposal to amend 21 CFR parts 1000 through 1010 and 21 CFR 1040.20 to update performance standards to reflect current science for sunlamp products and ultraviolet lamps and require more effective communication regarding the risks posed by these products. Comparison with Wisconsin law --Wisconsin state law currently restricts use of sunlamp products to users age 16 or older, which is lower than the proposed federal restriction.
Wisconsin requires users to sign a statement acknowledging receipt of certain information related to tanning risks. Wisconsin requires tanning equipment to be in compliance with 21 CFR 1040.20.
