21 CFR § 121.1 - Applicability.

---
identifier: "/us/cfr/t21/s121.1"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 121.1 - Applicability."
title_number: 21
title_name: "Food and Drugs"
section_number: "121.1"
section_name: "Applicability."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "121"
part_name: "MITIGATION STRATEGIES TO PROTECT FOOD AGAINST INTENTIONAL ADULTERATION"
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. 331, 342, 350g, 350(i), 371, 374."
regulatory_source: "81 FR 34219, May 27, 2016, unless otherwise noted."
cfr_part: "121"
---


# 121.1 Applicability.

This part applies to the owner, operator or agent in charge of a domestic or foreign food facility that manufactures/processes, packs, or holds food for consumption in the United States and is required to register under section 415 of the Federal Food, Drug, and Cosmetic Act, unless one of the exemptions in § 121.5 applies.