---
kind: "section"
citation: "21 C.F.R. § 12.20"
title: "21"
number: "12.20"
heading: "Initiation of a hearing involving the issuance, amendment, or revocation of a regulation."
url: "https://uscodex.org/cfr/21/12.20"
---

# §12.20. Initiation of a hearing involving the issuance, amendment, or revocation of a regulation.

- (a) A proceeding under section [409(f)](/cfr/21/409.md?p=f), [502(n)](/cfr/21/502.md?p=n), [512(n)(5)](/cfr/21/512.md?p=n-5), [701(e)](/cfr/21/701.md?p=e), or [721(d)](/cfr/21/721.md?p=d) of the act or section [4](/cfr/21/4.md) or [5](/cfr/21/5.md) of the Fair Packaging and Labeling Act may be initiated—
  - (1) By the Commissioner on the Commissioner's own initiative, e.g., as provided in [§ 170.15](/cfr/21/170.15.md) for food additives; or
  - (2) **By a petition—**
    - (i) In the form specified elsewhere in this chapter, e.g., the form for a color additive petition in [§ 71.1](/cfr/21/71.1.md); or
    - (ii) If no form is specified, by a petition under [§ 10.30](/cfr/21/10.30.md).
- (b) If the Commissioner receives a petition under [paragraph (a)(2)](#a-2) of this section, the Commissioner will—
  - (1) If it involves any matter subject to [section 701(e)](/cfr/21/701.md?p=e) of the act or section [4](/cfr/21/4.md) or [5](/cfr/21/5.md) of the Fair Packaging and Labeling Act, and meets the requirements for filing, follow the provisions of [§ 10.40 (b) through (f)](/cfr/21/10.40.md?p=b..f);
  - (2) If it involves a color additive or food additive, and meets the requirements for filing in §§ [71.1](/cfr/21/71.1.md) and [71.2](/cfr/21/71.2.md), or in §§ [171.1](/cfr/21/171.1.md), [171.6](/cfr/21/171.6.md), [171.7](/cfr/21/171.7.md), and [171.100](/cfr/21/171.100.md), publish a notice of filing of the petition within 30 days after the petition is filed instead of a notice of proposed rulemaking.
- (c) [Reserved]
- (d) The notice promulgating the regulation will describe how to submit objections and requests for hearing.
- (e) On or before the 30th day after the date of publication of a final regulation, or of a notice withdrawing a proposal initiated by a petition under [§ 10.25(a)](/cfr/21/10.25.md?p=a), a person may submit to the Commissioner written objections and a request for a hearing. The 30-day period may not be extended except that additional information supporting an objection may be received after 30 days upon a showing of inadvertent omission and hardship, and if review of the objection and request for hearing will not thereby be impeded. If, after a final color additive regulation is published, a petition or proposal relating to the regulation is referred to an advisory committee in accordance with [section 721(b)(5)(C)](/cfr/21/721.md?p=b-5-C) of the act, objections and requests for a hearing may be submitted on or before the 30th day after the date on which the order confirming or modifying the Commissioner's previous order is published.

## Notes

### Amendments

[44 FR 22339, Apr. 13, 1979, as amended at 64 FR 399, Jan. 5, 1999]

### Authority

Authority: 21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 42 U.S.C. 201, 262, 263b-263n, 264; 15 U.S.C. 1451-1461; 5 U.S.C. 551-558, 701-721; 28 U.S.C. 2112.

### Source

Source: 44 FR 22339, Apr. 13, 1979, unless otherwise noted.

### Amendments

[44 FR 22339, Apr. 13, 1979, as amended at 64 FR 399, Jan. 5, 1999]