1. A. An entity located or conducting business in this state that is subject to regulation under Articles 2 through 17 may request a variance from one or more requirements by submitting an application to the Department demonstrating that both of the following apply:

   1. 1. The variance is necessary in light of local growing conditions; and
   2. 2. The procedures, processes, and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated under Section 402 of the Federal Food, Drug, and Cosmetic Act and provide the same level of public health protection as the requirements of Articles 2 through 17.

2. B. The application shall include all of the following:

   1. 1. A statement that the variance is necessary in light of local growing conditions and that the procedures, processes, and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated under Section 402 of the Federal Food, Drug and Cosmetic Act and provide the same level of public health protection as the requirements of Articles 2 through 17;
   2. 2. A description of the variance requested, including the farms to which the variance would apply and the provision(s) of Articles 2 through 17 to which the variance would apply; and

   3. 3. Information demonstrating that the procedures, processes, and practices to be followed under the variance both:

      1. a. Are reasonably likely to ensure that the produce is not adulterated under Section 402 of the Federal Food, Drug, and Cosmetic Act; and
      2. b. Will provide the same level of public health protection as the requirements of Articles 2 through 17.
3. C. The Department shall review the application and, after review, may submit the application to FDA for consideration as prescribed by 21 CFR Part 112(P). The Department shall provide a response to the applicant indicating its decision on whether to submit the application to the FDA.

Historical Note

New Section made by exempt rulemaking at 26 A.A.R. 681, effective August 19, 2019; filed in the Office March 27, 2020 (Supp. 20-1).