[Code of Federal Regulations]
[Title 40, Volume 27]
[Revised as ofJuly 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR439.22]

[Page 406-407]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 439--PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY--Table of Contents
 
                     Subpart B--Extraction Products
 
Sec. 439.22  Effluent limitations attainable by the application of the best practicable control technology currently available (BPT).

    Except as provided in 40 CFR 125.30 through 125.32, any existing 
point source subject to this subpart must achieve the following effluent 
limitations representing the application of BPT:
    (a) The limitation for BOD5 is the same as specified in 
Sec. 439.12(a). No facility shall be required to attain a monthly 
average limitation for BOD5 that is less than the equivalent 
of 45 mg/L.
    (1) The long-term average daily BOD5 load of the raw 
process wastewater (i.e., the base number to which the percent reduction 
is applied) is defined as the average daily BOD5 load during 
any calendar month, over 12 consecutive months within the most recent 36 
months, and must include one or more

[[Page 407]]

periods during which production was at a maximum.
    (2) To assure equity in the determination of NPDES permit 
limitations regulating discharges subject to this subpart, calculation 
of the long-term average daily BOD5 load in the influent to 
the wastewater treatment system must exclude any portion of the load 
associated with separable mycelia and solvents, except for residual 
amounts of mycelia and solvents remaining after the practices of 
recovery and/or separate disposal or reuse. Residual amounts of these 
substances may be included in the calculation of the average influent 
BOD5 loading.
    (3) The practices of recovery, and/or separate disposal or reuse 
include: physical separation and removal of separable mycelia; recovery 
of solvents from wastestreams; incineration of concentrated solvent 
wastestreams (including tar still bottoms); and broth concentration for 
disposal other than to the treatment system. This part does not prohibit 
the inclusion of such wastes in raw waste loads in fact, nor does it 
mandate any specific practice, but rather describes the rationale for 
determining NPDES permit limitations. The effluent limitation for 
BOD5 may be achieved by any of several, or a combination, of 
these practices.
    (b) The limitation for TSS is the same as specified in 
Sec. 439.12(b).
    (c) Except for the provisions in paragraph (d) of this section, the 
limitations for COD are as follows:

                       Effluent Limitations (BPT)
------------------------------------------------------------------------
                                                               Maximum
               Regulated parameter                 Maximum     monthly
                                                  daily \1\  average \1\
------------------------------------------------------------------------
COD.............................................        228         86
------------------------------------------------------------------------
\1\ mg/L (ppm)

    (d) If the maximum monthly average COD concentration in paragraph 
(c) of this section is higher than a concentration value reflecting a 
reduction in the long-term average daily COD load in the raw (untreated) 
process wastewater of 74 percent multiplied by a variability factor of 
2.2, then a monthly average limitation for COD corresponding to the 
lower concentration value must be applied.

[63 FR 50430, Sept. 21, 1998, as amended at 68 FR 12273, Mar. 13, 2003]