Department of Agriculture, Trade and Consumer Protection
P.O. Box 8911
Madison, WI 53708-8911
Telephone: (608) 224-4711
Rule comments will be accepted up to two weeks after the last public hearing is held on this rule. Hearing date(s) will be scheduled after this rule is presented to the Board of Agriculture, Trade and Consumer Protection.
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Finding of Emergency
(1) The FDA recently replaced 21 CFR Part 110 with 21 CFR Part 117. DATCP’s administrative rule for food processing plants (ATCP 70) is equivalent in effect to 21 CFR Part 110, but not to 21 CFR Part 117. Wisconsin performs over two hundred contract inspections of food processing plants for the FDA each year. The contract requires that states inspect under federal authority or equivalent state authority. Currently contract inspections of food processing plants are done under equivalent Wisconsin authority but this will no longer be possible under the new FDA contract with Wisconsin that goes into effect on October 1, 2017, unless ATCP 70 is revised to become equivalent in effect to 21 CFR Part 117. (2) In order to continue to perform inspections under contract with the FDA and meet contractual requirements – without the emergency rule - inspections would have to be performed under the FDA’s regulatory authority. This would mean that DATCP’s inspection staff must obtain FDA credentials, a lengthy and intrusive process, and follow FDA procedures for reporting and data management. Any reports generated under FDA’s authority would become the property of the FDA. Only firms with significant violations would receive a summary of objectionable conditions (FDA form 483). Any state report that could be shared with the firm would have to be composed separately and would not include any violations or findings which are outside of the current regulatory scope. Thus, a firm inspected by DATCP under contract and having violative conditions related to 21 CFR Part 117 requirements, would only receive a state report that doesn’t reflect all federal rule violations. The firm would merely be informed of having violated federal law via an FDA 483 form and teachable moments where DATCP can work with Industry toward a common food safety goal would be lost. Industry confusion would likely increase in this situation, and the educational value of inspections done by DATCP under FDA contract would likely decrease. (3) If DATCP cannot adopt this emergency rule revision of ch. ATCP 70, many Wisconsin food processing plants would face inconsistent state and federal regulatory requirements. (4) This emergency rule is necessary to:
• Harmonize Wisconsin regulations with those used by the Federal government and many of the other states.
• Maintain State of Wisconsin control over inspection reports written in Wisconsin’s food processing plants when doing FDA contract inspections.
• Allow DATCP to more fully and transparently communicate all regulatory findings with industry, specifically, to eliminate the risk of the food processing plant operator not being informed in writing of violations of 21 CFR Part 117 requirements that cannot be cited on a state report and are not serious enough to warrant a written Federal report. • Eliminate the time and expense of DATCP inspection staff completing the FDA credentialing process.
EMERGENCY RULE
Section 1. Chapter ATCP 70.02 (15m) is created to read: Section 2. Chapter ATCP 70.02 (22m) is created to read: (35m) “Qualified facility” as used in s. 70.035 of this rule has the meaning given in 21 CFR 117.3. Section 3. Chapter ATCP 70.035 is created to read: ATCP 70.035 Federal requirements. (1) Qualified facilities. A food processing plant which is also a qualified facility shall comply with the requirements of this chapter and applicable requirements of 21 CFR 117.
(2) Facilities. A food processing plant that is a facility, but is not a qualified facility, shall meet the requirements of this chapter and applicable requirements of 21 CFR 117.
Section 4. Effective date: This emergency rule takes effect on October 1, 2017, and remains in effect for 150 days. The department may seek to extend this emergency rule as provided in s. 227.24, Stats.
