[Code of Federal Regulations]
[Title 40, Volume 29]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR439.11]

[Page 399]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 439_PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY
--Table of Contents
 
                     Subpart A_Fermentation Products
 
Sec. 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]