The statement of scope for this rule, SS 076-17, was approved by the Governor on August 4, 2017, published in Register 740A3, on August 21, 2017, and approved by Wisconsin Department of Agriculture, Trade and Consumer Protection Board, on September 21, 2017. This emergency rule was approved by the Governor on September 28, 2017.
DATCP Docket No. 17 – R - 05
September 28, 2017
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 ATCP 70, “Food Processing Plants” to incorporate by reference 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 in 21 CFR Part 117, Current Good Manufacturing Practice, Hazard Analysis and Risk based Preventive Controls for Human Food (that supersedes 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. Presently Wis. Admin. Code ATCP 70 is not deemed equivalent to 21 CFR Part 117 so 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 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 chs. ATCP 65 and 71 that apply, respectively, to dairy plants and food warehouses. Although DATCP, as part of a current ATCP 70 permanent rule process, is planning on adopting this language by reference, this permanent rule will not be adopted before the beginning of Federal fiscal year 2018, October 1, 2017. For the purposes of maintaining consistent standards for food processing plants subject to both FDA and state inspection, and performing FDA contract inspections using well-established procedures in Federal fiscal year 2018, applicable provisions of 21 CFR Part 117 must be adopted by reference in ATCP 70.
Statutes Interpreted
Statutes Interpreted: 97.29, Stats., “Food processing plants;”
Statutory Authority
Explanation of Statutory Authority
DATCP has broad general authority, under s. 93.07 (1), Stats., to adopt rules to implement programs under its jurisdiction. DATCP also has general authority under s. 97.09 (4), Stats., to adopt rules specifying standards to protect the public from the sale of adulterated or misbranded foods. DATCP has specific authority, under 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, 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 s. 97, Stats., and several administrative rule chapters, many of which mirror or reference federal statutes and regulations. Related administrative rules cover retail food establishments, dairy plants and farms, and food warehouses, as well as meat and poultry establishments.
Plain Language Analysis
DATCP has revised ATCP 70 by incorporating by reference 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, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food. 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 ATCP 70 is not currently equivalent to 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 ATCP 70. The lack of equivalence between ATCP 70 and 21 CFR Part 117 also means that DATCP cannot conduct FDA contract inspections under ATCP 70 as in the past. In order to do contract inspections after the start of the Federal fiscal year on October 1, 2017, DATCP would be required to adopt cumbersome credentialing and reporting procedures. 21 CFR Part 117 has already been adopted by reference in chs. ATCP 65 and 71 that apply, respectively, to dairy plants and food warehouses. Since the majority of Wisconsin food facilities subject to this Federal rule are licensed as food processing plants, similar adoption by reference has been proposed for the permanent rule ch. ATCP 70 that is now going through the standard approval process. Concurrent revision under the standard rule writing procedure will also ensure that the requirements for Wisconsin-licensed food processing plants that are not subject to the federal rule, i.e. are not a “facility” or “qualified facility”, are modernized. During the period in which this emergency rule is in effect, requirements in the currently existing ch. ATCP 70 will apply to these facilities. Federal and Surrounding State Programs
Federal Programs
