21 CFR § 556.1 - Scope.

---
identifier: "/us/cfr/t21/s556.1"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 556.1 - Scope."
title_number: 21
title_name: "Food and Drugs"
section_number: "556.1"
section_name: "Scope."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "556"
part_name: "TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD"
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. 342, 360b, 371."
regulatory_source: "84 FR 32993, July 11, 2019, unless otherwise noted."
cfr_part: "556"
---


# 556.1 Scope.

(a) The Federal Food, Drug, and Cosmetic Act requires an applicant seeking approval or conditional approval of a new animal drug to submit a proposed tolerance as part of its new animal drug application when such a tolerance is needed to assure that the proposed use of the new animal drug will be safe (see sections 512(b)(1)(H) and 571(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act). FDA assigns tolerances for animal drugs used in food-producing animals as part of the application approval process. Tolerances for approved and conditionally approved new animal drugs are codified in subpart B of this part.

(b) Compounds that have been found to be carcinogenic are regulated under subpart E of part 500 of this chapter.