---
kind: "section"
citation: "21 C.F.R. § 530.23"
title: "21"
number: "530.23"
heading: "Procedure for setting and announcing safe levels."
url: "https://uscodex.org/cfr/21/530.23"
---

# §530.23. Procedure for setting and announcing safe levels.

- (a) FDA may issue an order establishing a safe level for a residue of an extralabel use of an approved human drug or an approved animal drug. The agency will publish in the Federal Register a notice of the order. The notice will include:
  - (1) A statement setting forth the agency's finding that there is a reasonable probability that extralabel use in animals of the human drug or animal drug may present a risk to the public health;
  - (2) A statement of the basis for that finding; and
  - (3) **A request for public comments.**
- (b) A current listing of those drugs for which a safe level for extralabel drug use in food-producing animals has been established, the specific safe levels, and the availability, if any, of a specific analytical method or methods for drug residue detection will be codified in [§ 530.40](/cfr/21/530.40.md).

## Notes

### Authority

Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 351, 352, 353, 355, 357, 360b, 371, 379e.

### Source

Source: 61 FR 57743, Nov. 7, 1996, unless otherwise noted.