21 CFR § 112.173 - What must be included in the Statement of Grounds in a petition requesting a variance?

---
identifier: "/us/cfr/t21/s112.173"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 112.173 - What must be included in the Statement of Grounds in a petition requesting a variance?"
title_number: 21
title_name: "Food and Drugs"
section_number: "112.173"
section_name: "What must be included in the Statement of Grounds in a petition requesting a variance?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "112"
part_name: "STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243, 264, 271."
regulatory_source: "80 FR 74547, Nov. 27, 2015, unless otherwise noted."
cfr_part: "112"
---


# 112.173 What must be included in the Statement of Grounds in a petition requesting a variance?

In addition to the requirements set forth in § 10.30 of this chapter, the Statement of Grounds in a petition requesting a variance must:

(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.