[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: 40CFR439.52]

[Page 407-408]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 439_PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY
--Table of Contents
 
                           Subpart E_Research
 
Sec. 439.52  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.
    (b) The limitation for TSS is the same as specified in Sec. 
439.12(b).
    (c) The maximum monthly average limitation for COD, expressed as 
mass loading (lbs, kg) per day, must reflect not less than 74 percent 
reduction in the long-term average daily COD load of the raw (untreated) 
process wastewater, multiplied by a variability factor of 2.2. No 
facility shall be required to attain a limitation for COD that is less 
than the equivalent of 220 mg/L.
    (d) The long-term average daily BOD5 or COD mass loading 
of the raw process wastewater (i.e., the base number to which the 
percent reduction is applied) is defined as the average daily 
BOD5 or COD load during any calendar month, over 12 
consecutive months within the most recent 36 months.
    (1) To assure equity in the determination of NPDES permit 
limitations regulating discharges subject to this subpart, calculation 
of the long-term average daily BOD5 or COD load in the 
influent to the wastewater treatment system must exclude any portion of 
the load associated with solvents, except for residual amounts of 
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 or COD 
loading.
    (2) The practices of recovery, and/or separate disposal or reuse 
include: recovery of solvents from wastestreams; and incineration of 
concentrated solvent wastestreams (including tar still bottoms). This 
regulation 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 or COD may be achieved by any of 
several, or a combination, of these practices.
    (e) The pH must be within the range 6.0 to 9.0.

[63 FR 50436, Sept. 21, 1998, as amended at 68 FR 12274, Mar. 13, 2003]

                     Appendix A to Part 439--Tables

          Table 1--Surrogate Parameters for Direct Dischargers
               [Utilizing biological treatment technology]
------------------------------------------------------------------------
           Regulated parameters                  Treatability class
------------------------------------------------------------------------
Amyl alcohol..............................  Alcohols.
Ethanol \1\
Isopropanol \1\
Methanol \1\
Phenol
Isobutyraldehyde \1\......................  Aldehydes.
n-Heptane \1\.............................  Alkanes.
n-Hexane \1\
Diethylamine \1\..........................  Amines.
Triethylamine
Benzene...................................  Aromatics.
Toluene \1\
Xylenes \1\
Chlorobenzene
o-Dichlorobenzene
Chloroform \1\............................  Chlorinated Alkanes.
Methylene chloride \1\
1,2-Dichloroethane \1\
Ethyl acetate \1\.........................  Esters.
Isopropyl acetate
n-Amyl acetate
n-Butyl acetate
Methyl formate
Tetrahydrofuran \1\.......................  Ethers.
Isopropyl ether
Acetone \1\...............................  Ketones.
4-Methyl-2-pentanone (MIBK)
Ammonia (aqueous).........................  Miscellaneous. \2\
Acetonitrile
Methyl Cellosolve

[[Page 408]]


Dimethyl Sulfoxide
------------------------------------------------------------------------
\1\ These parameters may be used as a surrogate to represent other
  parameters in the same treatability class.
\2\ Surrogates have not been identified for the ``Miscellaneous''
  treatability class.


 Table 2--Surrogate Parameters for Indirect Dischargers (Utilizing Steam
                     Stripping Treatment Technology)
------------------------------------------------------------------------
     Regulated parameters                  Treatability class
------------------------------------------------------------------------
Benzene                         ........................................
Toluene \1\                     ........................................
Xylenes                         ........................................
n-Heptane                       High strippability.
Chloroform \1\                  ........................................
Methylene chloride \1\          ........................................
Chlorobenzene                   ........................................
------------------------------------------------------------------------
Ammonia (aqueous)               ........................................
Diethyl amine                   ........................................
Triethyl amine                  ........................................
Acetone \1\                     ........................................
4-methyl-2-pentanone            ........................................
n-Amyl acetate                  ........................................
n-Butyl acetate                 ........................................
Ethyl acetate                   Medium strippability.
Isopropyl acetate               ........................................
Methyl formate                  ........................................
Isopropyl ether                 ........................................
Tetrahydrofuran \1\             ........................................
1,2-dichloroethane              ........................................
o-Dichlorobenzene               ........................................
------------------------------------------------------------------------
\1\ These parameters may be used as a surrogate to represent other
  parameters in the same treatability class.


[63 FR 50437, Sept. 21, 1998; 64 FR 10393, Mar. 4, 1999, as amended at 
68 FR 12275, Mar. 13, 2003]