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e-CFR data is current as of November 24, 2020

Title 40Chapter ISubchapter NPart 439 → Subpart A


Title 40: Protection of Environment
PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY


Subpart A—Fermentation Products


Contents
§439.10   Applicability.
§439.11   Special definitions.
§439.12   Effluent limitations attainable by the application of the best practicable control technology currently available (BPT).
§439.13   Effluent limitations attainable by the application of the best conventional pollutant control technology (BCT).
§439.14   Effluent limitations attainable by the application of best available technology economically achievable (BAT).
§439.15   New source performance standards (NSPS).
§439.16   Pretreatment standards for existing sources (PSES).
§439.17   Pretreatment standards for new sources (PSNS).

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§439.10   Applicability.

This subpart applies to discharges of process wastewater resulting from the manufacture of pharmaceutical products by fermentation.

[63 FR 50426, Sept. 21, 1998]

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§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]

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§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 daily1 Maximum monthly average1
COD1675856

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 daily1 Maximum monthly average1
Cyanide (T)33.59.4

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.

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

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§439.13   Effluent limitations attainable by the application of the best conventional pollutant control technology (BCT).

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 BCT: Limitations for BOD5, TSS and pH are the same as the corresponding limitations in §439.12.

[63 FR 50426, Sept. 21, 1998]

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§439.14   Effluent limitations attainable by the application of best available technology economically achievable (BAT).

(a) 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 BAT:

Effluent Limitations (BAT)

Regulated parameter Maximum daily1 Maximum monthly average1
Ammonia (as N)84.129.4
Acetone0.50.2
4-methyl-2-pentanone0.50.2
Isobutyraldehyde1.20.5
n-Amyl acetate1.30.5
n-Butyl acetate1.30.5
Ethyl acetate1.30.5
Isopropyl acetate1.30.5
Methyl formate1.30.5
Amyl alcohol10.04.1
Ethanol10.04.1
Isopropanol3.91.6
Methanol10.04.1
Methyl Cellosolve100.040.6
Dimethyl sulfoxide91.537.5
Triethyl amine250.0102.0
Phenol0.050.02
Benzene0.050.02
Toluene0.060.02
Xylenes0.030.01
n-Hexane0.030.02
n-Heptane0.050.02
Methylene chloride0.90.3
Chloroform0.020.13
1,2-dichloroethane0.40.1
Chlorobenzene0.150.06
o-Dichlorobenzene0.150.06
Tetrahydrofuran8.42.6
Isopropyl ether8.42.6
Diethyl amine250.0102.0
Acetonitrile25.010.2

1mg/L (ppm).

(b) The limitations for COD are the same as specified in §439.12(c) and (d).

(c) The limitations for cyanide are the same as specified in §439.12(e), (f) and (g).

[68 FR 12271, Mar. 13, 2003]

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§439.15   New source performance standards (NSPS).

(a) Any new source subject to this subpart must achieve the following standards:

Performance Standards (NSPS)

Regulated parameter Maximum daily1 Maximum monthly average1
BOD5267111
TSS472166
COD1675856
Ammonia (as N)84.129.4
Acetone0.50.2
4-methyl-2-pentanone0.50.2
Isobutyraldehyde1.20.5
n-Amyl acetate1.30.5
n-Butyl acetate1.30.5
Ethyl acetate1.30.5
Isopropyl acetate1.30.5
Methyl formate1.30.5
Amyl alcohol10.04.1
Ethanol10.04.1
Isopropanol3.91.6
Methanol10.04.1
Methyl Cellosolve100.040.6
Dimethyl sulfoxide91.537.5
Triethyl amine250.0102.0
Phenol0.050.02
Benzene0.050.02
Toluene0.060.02
Xylenes0.030.01
n-Hexane0.030.02
n-Heptane0.050.02
Methylene chloride0.90.3
Chloroform0.020.13
1,2-dichloroethane0.40.1
Chlorobenzene0.150.06
o-Dichlorobenzene0.150.06
Tetrahydrofuran8.42.6
Isopropyl ether8.42.6
Diethyl amine250.0102.0
Acetonitrile25.010.2

1mg/L (ppm)

(b) The limitations for cyanide are the same as specified in §439.12(e), (f) and (g).

(c) Any new source subject to the provisions of this section that commenced discharging after November 21, 1988, and prior to November 20, 1998, must continue to achieve the standards specified for this section in the 1988 edition of 40 CFR part 439, until the expiration of the applicable time period specified in 40 CFR 122.29(d)(1), after which the source must achieve the standards specified in §§439.13 and 439.14.

[68 FR 12272, Mar. 13, 2003]

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§439.16   Pretreatment standards for existing sources (PSES).

(a) Except as provided in 40 CFR 403.7 and 403.13, any existing source subject to this subpart must continue achieving the standards for cyanide specified in paragraph (c) of this section and must achieve the following standards by September 21, 2001:

Pretreatment Standards (PSES)

Regulated
parameter
Maximum daily1 Maximum monthly average1
Ammonia (as N)284.129.4
Acetone20.78.2
4-methyl-2-pentanone20.78.2
Isobutyraldehyde20.78.2
n-Amyl acetate20.78.2
n-Butyl acetate20.78.2
Ethyl acetate20.78.2
Isopropyl acetate20.78.2
Methyl formate20.78.2
Isopropyl ether20.78.2
Tetrahydrofuran9.23.4
Benzene3.00.7
Toluene0.30.2
Xylenes3.00.7
n-Heptane3.00.7
n-Hexane3.00.7
Methylene chloride3.00.7
Chloroform0.10.03
1,2-dichloroethane20.78.2
Chlorobenzene3.00.7
o-Dichlorobenzene20.78.2
Diethyl amine255.0100.0
Triethyl amine255.0100.0

1mg/L (ppm)

2Not applicable to sources that discharge to a POTW with nitrification capability.

(b) Sources that discharge to a POTW with nitrification capability (defined at §439.1(i)) are not required to achieve the pretreatment standard for ammonia (as N).

(c) The limitations for cyanide are the same as specified in §439.12(e), (f) and (g).

[68 FR 12272, Mar. 13, 2003]

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§439.17   Pretreatment standards for new sources (PSNS).

Except as provided in 40 CFR 403.7, any new source subject to this subpart must achieve the same standards as specified in §439.16.

(a) Sources that discharge to a POTW with nitrification capability (defined at §439.2(i)) are not required to achieve the pretreatment standard for ammonia (as N).

(b) The pretreatment standards for cyanide are as follows:

Regulated parameterPretreatment standards1
Maximum daily dischargeAverage monthly discharge must not exceed
Cyanide (T)33.59.4

1Mg/L (ppm).

(c) When monitoring for cyanide at the end-of-pipe is impractical because of dilution by other process wastewaters, compliance with the cyanide standards in §439.17(b) must be demonstrated at in-plant monitoring points pursuant to 40 CFR 403.6(e)(2) and (4). Under the same provisions, the permitting authority may impose monitoring requirements on internal wastestreams for any other parameter(s) regulated by this section.

(d) Compliance with the standards in paragraph (b) or (c) of this section may be achieved by certifying to the permit issuing authority that a facility's manufacturing processes neither use nor generate cyanide.

[63 FR 50429, Sept. 21, 1998; 64 FR 10393, Mar. 4, 1999; 64 FR 48104, Sept. 2, 1999, as amended at 68 FR 34832, June 11, 2003]

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