§439.11. Special definitions.
40 C.F.R. § 439.11
For the purpose of this subpart:
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.
Product means pharmaceutical products derived from fermentation processes.
Notes, amendments, and revision history
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]