Code of Federal Regulations Title 21. Food and Drugs § 21.112.173 What must be included in the Statement of Grounds in a petition requesting a variance?

(a) Provide a statement that the applicable State, tribe, or foreign country has determined 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 to provide the same level of public health protection as the requirements of this part;

(b) Describe with particularity the variance requested, including the persons to whom the variance would apply and the provision(s) of this part to which the variance would apply;

(c) Present information demonstrating 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 (21 U.S.C. 342) and to provide the same level of public health protection as the requirements of this part.