---
kind: "section"
citation: "40 C.F.R. § 439.11"
title: "40"
number: "439.11"
heading: "Special definitions."
url: "https://uscodex.org/cfr/40/439.11"
---

# §439.11. Special definitions.


For the purpose of this subpart:

- (a) Fermentation means process operations that utilize a chemical change induced by a living organism or enzyme, specifically, bacteria, or the microorganisms occurring in unicellular plants such as yeast, molds, or fungi to produce a specified product.
- (b) Product means pharmaceutical products derived from fermentation processes.

## Notes

### Amendments

[68 FR 12271, Mar. 13, 2003]

### Authority

Authority: 33 U.S.C. 1311, 1314, 1316, 1317, 1318, 1342 and 1361.

### Source

Source: 48 FR 49821, Oct. 27, 1983, unless otherwise noted.

### Amendments

[68 FR 12271, Mar. 13, 2003]