[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: 40CFR439.12]
[Page 399-400]
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. 439.12 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 maximum monthly average limitation for BOD5,
expressed as mass loading (lbs., kg) per day, must reflect not less than
90 percent reduction in the long-term average daily BOD5 load
of the raw (untreated) process wastewater, multiplied by a variability
factor of 3.0.
(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 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
[[Page 400]]
separate disposal or reuse. These residual amounts 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 waste streams; incineration of concentrated solvent
wastestreams (including tar still bottoms); and concentration of broth
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 maximum monthly average limitation for TSS, expressed as
mass loading (lbs., kg) per day, must be calculated as 1.7 times the
BOD5 limitation determined in paragraph (a) of this section.
(c) Except as provided in paragraph (d) of this section, the
limitations for COD are as follows:
Effluent Limitations (BPT)
------------------------------------------------------------------------
Maximum
Maximum monthly
Regulated parameter daily \1\ average
\1\
------------------------------------------------------------------------
COD............................................... 1675 856
------------------------------------------------------------------------
\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 the monthly average limitation for COD corresponding to the
lower concentration value must be applied.
(e) The effluent limitations for cyanide are as follows:
Effluent Limitations (BPT)
------------------------------------------------------------------------
Maximum
Maximum monthly
Regulated parameter daily \1\ average
\1\
------------------------------------------------------------------------
Cyanide (T)....................................... 33.5 9.4
------------------------------------------------------------------------
\1\mg/L (ppm).
(f) When monitoring for cyanide at the end-of-pipe is impractical
because of dilution by other process wastewaters, compliance with the
cyanide effluent limitations in paragraph (e) of this section must be
demonstrated at in-plant monitoring points pursuant to 40 CFR 122.44(i)
and 122.45(h). Under the same provisions, the permitting authority may
impose monitoring requirements on internal wastestreams for any other
parameter(s) regulated by this section.
(g) Compliance with the limitation in paragraph (e) or (f) of this
section may be achieved by certifying to the permit issuing authority
that the facility's manufacturing processes neither use nor generate
cyanide.
[63 FR 50426, Sept. 21, 1998, as amended at 68 FR 12271, Mar. 13, 2003]