{"data":{"id":"us/21-cfr-1.1405","jurisdiction":"us","citation":"21 CFR 1.1405","heading":"Under what circumstances will FDA waive one or more of the requirements of this subpart for an individual entity or a type of entity?","body":"FDA will waive one or more of the requirements of this subpart when we determine that:\n(a) Application of the requirements would result in an economic hardship for an individual entity or a type of entity, due to the unique circumstances of the individual entity or type of entity;\n(b) The waiver will not significantly impair our ability to rapidly and effectively identify recipients of a food to prevent or mitigate a foodborne illness outbreak or to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act; and\n(c) The waiver will not otherwise be contrary to the public interest.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER A—GENERAL","PART 1—GENERAL ENFORCEMENT REGULATIONS","Subpart S—Additional Traceability Records for Certain Foods"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"232f615ef93b4252fbe453f38bf917ba4ff501bc3f66effe3b528c9984645cc1","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-1.1400","next":"us/21-cfr-1.1410"},"notice":"GroundRules: Original legal text. Not legal advice."}