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 § 112.180
21 CFR § 112.180
Under what circumstances may FDA modify or revoke an approved variance?
June 25, 2020
CFR

We may modify or revoke a variance if we determine that such 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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§ 112.179 When does a variance approved by FDA become effective?
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§ 112.181 What procedures apply if FDA determines that an approved variance should be modified or revoked?

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