21 CFR § 530.23 - Procedure for setting and announcing safe levels.

---
identifier: "/us/cfr/t21/s530.23"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 530.23 - Procedure for setting and announcing safe levels."
title_number: 21
title_name: "Food and Drugs"
section_number: "530.23"
section_name: "Procedure for setting and announcing safe levels."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "530"
part_name: "EXTRALABEL DRUG USE IN ANIMALS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 351, 352, 353, 355, 357, 360b, 371, 379e."
regulatory_source: "61 FR 57743, Nov. 7, 1996, unless otherwise noted."
cfr_part: "530"
---


# 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.