The statement of scope for this emergency rule, SS 105-18, was approved by the Governor on August 29, 2018, was published in Register No. 753A2 on September 10, 2018, and was approved by the Board of Agriculture, Trade and Consumer Protection on September 20, 2018. This emergency rule was approved by the Governor on October 11, 2018.
DATCP Docket No. 18-R-06
October 22, 2018
WISCONSIN DEPARTMENT OF AGRICULTURE,
TRADE AND CONSUMER PROTECTION
EMERGENCY RULE
The Wisconsin department of agriculture, trade and consumer protection hereby proposes the following emergency rule to create ATCP 70.02 (15m) and (22m) and ATCP 70.035, relating to food processing plants and affecting small business.
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Analysis Prepared by the Department
of Agriculture, Trade and Consumer Protection
This emergency rule revises Wis. Admin. Code ch. ATCP 70, “Food Processing Plants”, so as to adopt certain provisions of an important Federal Food and Drug Administration (“FDA”) regulation that implements the requirements of the Food Safety Modernization Act (“FSMA”). This regulation is primarily located in 21 CFR Part 117, Current Good Manufacturing Practice, Hazard Analysis and Risk based Preventive Controls for Human Food. 21 CFR Part 117 superseded 21 CFR Part 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food). For the past several years, Wis. Admin. Code ch. ATCP 70 was deemed equivalent, in effect, to 21 CFR Part 110, which enabled the Department of Agriculture, Trade and Consumer Protection (“DATCP”) to conduct contract inspections on behalf of the FDA. Because of this regulatory equivalence, there have been consistent state and federal regulatory expectations for food processing plant operators. At the present time, however, Wis. Admin. Code ch. ATCP 70 has not yet been deemed equivalent to the new federal regulation that is 21 CFR Part 117. Accordingly, Wisconsin now lacks the regulatory authority to enforce requirements related to 1) training, 2) modernized Good Manufacturing Practices, 3) the hazard analysis and risk-based preventive controls system for ensuring food safety, and 4) implementation of a supply-chain program. These FDA regulatory requirements apply to many, but not all, licensed Wisconsin food processing plants that are under the jurisdiction of Wis. Admin. Code ch. ATCP 70. Furthermore, the lack of regulatory equivalence means that DATCP will not be allowed to conduct FDA contract inspections in the coming federal fiscal year and thereafter; instead, DATCP would be required to adopt cumbersome credentialing and reporting procedures in order to conduct the inspections. 21 CFR Part 117 has already been adopted by reference in Wis. Admin. Code chs. ATCP 65 and 71 that apply, respectively, to dairy plants and food warehouses. Although DATCP is planning to adopt this language by reference as part of a current Wis. Admin. Code ch. ATCP 70 permanent rule process, that permanent rule will not be adopted before the beginning of the 2019 federal fiscal year on October 1, 2018. For the purposes of maintaining consistent standards for food processing plants subject to both FDA and state inspection, as well as performing FDA contract inspections using well-established procedures in the 2019 federal fiscal, applicable provisions of 21 CFR Part 117 must be adopted by reference in Wis. Admin. Code ch. ATCP 70.
Statutes Interpreted
Statutes Interpreted: Wis. Stat. § 97.29, “Food processing plants.” Statutory Authority
Statutory Authority: Wis. Stat. §§ 93.07 (1), 97.09 (4), 97.29 (5).
Explanation of Statutory Authority
DATCP has broad general authority, under Wis. Stat. § 93.07 (1), to adopt rules to implement programs under its jurisdiction. DATCP also has general authority under Wis. Stat. § 97.09 (4) to adopt rules specifying standards to protect the public from the sale of adulterated or misbranded foods. DATCP has specific authority, under Wis. Stat. § 97.29 (5) to adopt rules establishing fees; setting facility construction and maintenance standards; setting standards for the design, installation, maintenance, and cleaning of equipment and utensils; personnel sanitation; food handling and storage; and sanitary production and processing of food, food sources, and labels. Related Statutes and Rules
Since the transfer of the Department of Health Service’s (DHS) Food Safety and Recreational Licensing unit in July 2016 to DATCP, the latter agency has regulated food from farm to table. Once it leaves the farm, food is almost entirely the responsibility of DATCP’s Division of Food and Recreational Safety (DFRS). Food is specifically regulated under subchapter II of Wis. Stat. § 97 and several administrative rule chapters, many of which mirror or reference federal statutes and regulations. Related administrative rules cover retail food establishments, dairy plants, farms, food warehouses, as well as meat and poultry establishments.
Plain Language Analysis
DATCP seeks to revise Wis. Admin. Code ch. ATCP 70 by adopting certain provisions of federal regulations that implement the requirements of FSMA and are found in 21 CFR Part 117, Current Good Manufacturing Practice, Hazard Analysis and Risk based Preventive Controls for Human Food. Specifically, the emergency rule revision adds federal definitions of “facility” and “qualified facility” and specifies which requirements of 21 CFR Part 117 must be met by licensed food processing plants that are in these two federally-defined food business categories. 21 CFR Part 117 supersedes 21 CFR Part 110. For the past several years, Wis. Admin. Code Ch. ATCP 70 was deemed to be equivalent in effect to 21 CFR Part 110. This equivalency enabled the Department to conduct contract inspections on behalf of the FDA under state authority. Given the equivalent regulatory foundation, contract inspections have always reinforced consistency in state and federal regulatory expectations for food processing plant operators. Because Wis. Admin. Code ch. ATCP 70 is not currently the equivalent of 21 CFR Part 117, Wisconsin now specifically lacks the regulatory authority to enforce federal requirements related to 1) training, 2) modernized Good Manufacturing Practices, 3) the hazard analysis and risk-based preventive controls system for ensuring food safety, and 4) implementation of a supply-chain program. These FDA regulatory requirements apply to many, but not all, licensed Wisconsin food processing plants that are under the jurisdiction of Wis. Admin. Code ch. ATCP 70. The lack of equivalence between Wis. Admin. Code ch. ATCP 70 and 21 CFR Part 117 also means that DATCP cannot conduct FDA contract inspections under Wis. Admin. Code ch. ATCP 70, as in the past. In order to do contract inspections after the start of the 2019 federal fiscal year (which begins on October 1, 2018), DATCP would be required to adopt cumbersome credentialing and reporting procedures. 21 CFR Part 117 has already been adopted by reference in Wis. Admin Code chs. ATCP 65 and 71 that apply, respectively, to dairy plants and food warehouses. The permanent rule-making for Wis. Admin Code ch. ATCP 70 that is now in process contemplates that 21 CFR Part 117 will also be adopted into ATCP 70. The effect of this adoption will be to extend the provisions of 21 CFR Part 117 to all Wisconsin-licensed food processing plants, including those that are not specifically subject to the federal rule, that is, the processing plants that are not technically a “facility” or a “qualified facility.” During the period until the permanent rule is adopted (including the time in which this emergency rule, if adopted, is in effect), the requirements in the currently existing Wis. Admin. Code ch. ATCP 70 will continue to apply to these processing plants. Federal and Surrounding State Programs
Federal Programs
Food processing plants in Wisconsin that participate in interstate commerce are subject to the requirements of the Food, Drug and Cosmetic Act, as well as the federal regulations written to enforce these statutory requirements. The adoption of FSMA into law in 2011 was followed by the mandated development of several new federal regulations. The major part of federal regulations affecting Wisconsin food processing plants is 21 CFR Part 117 (Current Good Manufacturing Practice, Hazard Analysis and Risk based Preventive Controls for Human Food). Surrounding State Programs
Food processing facilities in Michigan, Iowa, and Minnesota are licensed and regulated similarly to those in Wisconsin. Illinois food processors are regulated only by the FDA.
