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CFR > Title 40 - Protection of Environment > CHAPTER I—ENVIRONMENTAL PROTECTION AGENCY > SUBCHAPTER N—EFFLUENT GUIDELINES AND STANDARDS (Parts 400–471) > PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY > SUBPART A—Fermentation Products (§439.10 to §439.17) > 439.12—Effluent limitations attainable by the application of the best practicable control technology currently available (BPT).

CFR

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 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)
Regulated parameter Maximum daily 1 Maximum monthly average 1
COD 1675 856
1mg/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)
Regulated parameter Maximum daily 1 Maximum monthly average 1
Cyanide (T) 33.5 9.4
1mg/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.

Code of Federal Regulations

[63 FR 50426, Sept. 21, 1998, as amended at 68 FR 12271, Mar. 13, 2003]
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 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)
Regulated parameter Maximum daily 1 Maximum monthly average 1
COD 1675 856
1mg/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)
Regulated parameter Maximum daily 1 Maximum monthly average 1
Cyanide (T) 33.5 9.4
1mg/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.

Code of Federal Regulations

[63 FR 50426, Sept. 21, 1998, as amended at 68 FR 12271, Mar. 13, 2003]
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