EmR1826 Rule Text

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 processing plants on behalf of the FDA each year. The contract requires that states inspect under federal authority or equivalent state authority. Until the most recent federal fiscal year, contract inspections of food processing plants were conducted 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, 2018, unless ATCP 70 is revised to become equivalent in effect to the federal rule.

(2) In order to continue to perform inspections for the FDA and to 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 would have to obtain FDA credentials. Only those firms that are found to have significant violations would receive a summary of objectionable conditions (FDA form 483). A State of Wisconsin food processing plant inspection report (were one to be generated following an inspection conducted under the authority of the FDA) would need to be prepared separately from the Department’s current inspection reporting system and could not describe any violations or findings outside of the Department’s current regulatory scope. This duplicative and inconsistent process could generate inspection reports that could create confusion for firms.

(3) This emergency rule is necessary to:

- Harmonize Wisconsin regulations with those used by the federal government and by many 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.

- Forestall the need for DATCP inspection staff to obtain FDA credentials.

EMERGENCY RULE

  Section 1. Chapter ATCP 70.02 (11m) is created to read:

  (11m) “Facility” as used in s. 70.035 of this rule has the meaning given in 21 CFR 117.3.

  Section 2. Chapter ATCP 70.02 (22d) is created to read:

(22d) “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 that 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 upon publication, and remains in effect for 150 days. The department may seek to extend this emergency rule as provided in s. 227.24, Stats.

Dated this 22nd day of October, 2018.

WISCONSIN DEPARTMENT OF AGRICULTURE,

  TRADE AND CONSUMER PROTECTION

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By: Sheila Harsdorf, Secretary