Pursuant to a Scope Statement approved by the Governor on March 3, 2017, the Department has already begun the process of revising Wis. Admin. Code Ch. ATCP 70 to reference 21 CFR 117. Performing this same revision in an emergency rule will harmonize the existing state and federal regulatory investigation and enforcement practices until the permanent rule-making process is completed. In short, it will prevent a “gap” from forming due to functional inequalities and inconsistencies between the Department’s framework and the FDA’s regulatory alternative. The permanent revision of Wis. Admin. Code Ch. ATCP 70 is not likely to reach the Legislature until at least December of 2017. By October of 2017, many Wisconsin food processing plants will be subject to the federal rules. In essence, an emergency rule revision will span the gap between the federal compliance date and the completion of the state permanent rule-making process. 2. Detailed description of the objective of the proposed rule:
This emergency rule will add federal definitions of “facility” and “qualified facility” and specify which requirements of 21 CFR 117 must be met by licensed food processing plants in these two federally-defined food business categories. 3. Description of the existing policies relevant to the rule, new policies proposed to be included in the rule, and an analysis of policy alternatives:
The Department’s regulatory foundation in the past was deemed the equivalent, in effect, to that of the FDA. This equivalency meant that food processing plant operators could come to expect consistent state and federal regulatory requirements, and that Department staff could efficiently perform food processing plant inspections under the FDA contract. A failure to revise Wis. Admin. Code Ch. ATCP 70 (in order to retain regulatory equivalency with the FDA) would lead to confusion for food processing plant operators and reduced efficiency for the Department’s food processing plant regulatory oversight. 4. Detailed explanation of statutory authority for the rule (including the statutory citation and language):
The Department has specific authority to adopt rules related to food grade standards in Wis. Stat. § 93.09 (1). Additionally, the Department has specific authority to promulgate rules related to food processing plants in Wis. Stat. § 97.29 (5). The Department has broad general authority, under Wis. Stat. § 93.07 (1), to adopt rules to implement programs under its jurisdiction. The Department 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. 5. Estimate of amount of time that state employees will spend developing the rule and of other resources necessary to develop the rule:
This emergency rule will take approximately 20 hours of staff time to develop.
6. List with description of all entities that may be affected by the proposed rule:
The rule will affect the majority of the state’s approximately 2,100 food processing plants.
7. Summary and preliminary comparison with any existing or proposed federal regulation that is intended to address the activities to be regulated by the proposed rule:
The proposed revision in Wis. Admin. Code Ch. ATCP 70 would make this rule equivalent to FDA rules already in effect, or soon to be in effect, for food facilities and qualified facilities. 8. Anticipated economic impact of implementing the rule (note if the rule is likely to have a significant economic impact on small businesses):
The Department expects the proposed emergency rule to have no negative economic impact on Wisconsin’s food processing industry. Industry is accustomed to consistent regulatory inspections conducted by Department staff enforcing state rules, Department staff under FDA contract, and federal staff. For some food processing plants, the complexity of inspections may increase, but this complexity would be consistent across federal and state inspections.
Contact Person:
Peter Haase, Director
Bureau of Food Safety and Inspection
Department of Agriculture, Trade and Consumer Protection
P.O. Box 8911
Madison, WI 53708-8911
Telephone: (608) 224-4711
