GroundRules
21 CFR 510.206: Review of information supporting actions to establish or amend an import tolerance.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
- PART 510—NEW ANIMAL DRUGS
- Subpart C—Import Tolerances for Residues of Unapproved New Animal Drugs in Food
In establishing or amending an import tolerance, the Commissioner shall rely on data sufficient to demonstrate that a proposed tolerance is safe based on similar food safety criteria used by the Commissioner to establish tolerances for applications for new animal drugs filed under section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act. In establishing or amending an import tolerance, the Commissioner will give appropriate consideration to the anticipated residue concentrations and conditions of use of the new animal drug specified.
Collected 2026-08-27T02:24:47Z. Source file · JSON