---
kind: "section"
citation: "21 C.F.R. § 500.88"
title: "21"
number: "500.88"
heading: "Regulatory method."
url: "https://uscodex.org/cfr/21/500.88"
---

# §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 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)](/cfr/21/409.md?p=c-3-A), [512(d)(1)(I)](/cfr/21/512.md?p=d-1-I), and [721(b)(5)(B)](/cfr/21/721.md?p=b-5-B) of the act.
- (d) If the sponsor initially submitted a request for an import tolerance under [§ 510.205](/cfr/21/510.205.md) 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)](/cfr/21/510.207.md?p=b) of this chapter.

## Notes

### Amendments

[52 FR 49586, Dec. 31, 1987, as amended at 67 FR 78174, Dec. 23, 2002; 86 FR 52410, Sept. 21, 2021]

### Source

Source: 52 FR 49586, Dec. 31, 1987, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 360b, 371, 379e.

### Source

Source: 40 FR 13802, Mar. 27, 1975, unless otherwise noted.

### Amendments

[52 FR 49586, Dec. 31, 1987, as amended at 67 FR 78174, Dec. 23, 2002; 86 FR 52410, Sept. 21, 2021]