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Federal regulations · Through 2026-08-25 · Newer source version available

40 CFR 439.11: Special definitions.

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Where this section sits in the code
  1. Title 40—Protection of Environment
  2. CHAPTER I—ENVIRONMENTAL PROTECTION AGENCY
  3. SUBCHAPTER N—EFFLUENT GUIDELINES AND STANDARDS
  4. PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY
  5. Subpart A—Fermentation Products

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.

Collected 2026-08-27T02:26:04Z. Source file · JSON

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