US 21 CFR Part 556 — tolerances for new animal drugs in food-producing animals

In the United States, residue limits for veterinary (new animal) drugs in food are set as tolerances under 21 CFR Part 556. Per § 556.1 Scope, 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 is safe.

Each substance sub-section in Part 556 (e.g., § 556.xxx) lists the commodity (target food-producing animal tissue), the tolerance (in ppm / µg/g), and the relevant § 500.4(d) regulatory status. This is the US analogue to the EU 2377/90 MRL framework and China GB 31650.

Scope note: 21 CFR 556 targets food-producing animals; companion-animal pet food relevance is indirect (animal-derived ingredient residue controls).

Source: pdf-raw/vet-drug-mrl/us_cfr_556.xml (eCFR 21 CFR Part 556, first-hand).

Claims (verified C1 substrings of source_file)

• § 556.1 Scope.
• The Federal Food, Drug, and Cosmetic Act requires an applicant seeking approval or conditional approval of a new animal drug
• 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