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21 C.F.R. § 500.88   Regulatory method.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 500—GENERAL
Subpart E—Regulation of Carcinogenic Compounds Used in Food-Producing Animals

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§ 500.88   Regulatory method.

(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 R_m. 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.

(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]

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