Code of Federal Regulations (Last Updated: May 6, 2024) |
Title 40 - Protection of Environment |
Chapter I - Environmental Protection Agency |
SubChapter N - Effluent Guidelines and Standards |
Part 439 - Pharmaceutical Manufacturing Point Source Category |
Subpart A - Fermentation Products |
§ 439.11 - Special definitions.
Latest version.
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§ 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.
[68 FR 12271, Mar. 13, 2003]