C.F.R.
»
Title 21
» CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS › PART 500—GENERAL › Subpart E—Regulation of Carcinogenic Compounds Used in Food-Producing Animals
(a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue.
(b) The regulatory method must be able to confirm the identity of the marker residue in the target tissue at a minimum concentration corresponding to the Rm. FDA will determine the LOD from the submitted analytical method validation data.
(c) FDA will publish in the Federal Register the complete regulatory method for ascertaining the marker residue in the target tissue in accordance with the provisions of sections 409(c)(3)(A), 512(d)(1)(I), and 721(b)(5)(B) of the act.
(d) If the sponsor initially submitted a request for an import tolerance under § 510.205 of this chapter, FDA will make the complete regulatory method for ascertaining the marker residue in the target tissue publicly available pursuant to § 510.207(b) of this chapter.
(Approved by the Office of Management and Budget under control number 0910-0228)
[52 FR 49586, Dec. 31, 1987, as amended at 67 FR 78174, Dec. 23, 2002; 86 FR 52410, Sept. 21, 2021]
Notes of Decisions
Phibro Animal Health Corp. v. Califf (D.D.C. 2024).
“” See 21 C.F.R. § 500.88 (2024). As relevant here, the regulatory method must enable FDA to determine the point at which the residue of carcinogenic concern poses “no significant increase in the risk of cancer to the human consumer,” and must be sensitive enough to detect a…”
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