1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter B - FOOD FOR HUMAN CONSUMPTION
  5. Part 112 - STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION
  6. Subpart P - Variances
  7. 21 CFR § 112.178
21 CFR § 112.178
Under what circumstances may FDA deny a petition requesting a variance?
June 25, 2020
CFR

We may deny a variance request if it does not provide the information required under §112.173 (including the requirements of §10.30 of this chapter), or if we determine that the variance is not 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.

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§ 112.177 Can an approved variance apply to any person other than those identified in the petition requesting that variance?
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§ 112.179 When does a variance approved by FDA become effective?

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