manufacture of pharmaceutical products by fermentation.

[63 FR 50426, Sept. 21, 1998]

or

a surrogate parameter. Permit limits and compliance monitoring are not required for regulated pollutants that are neither used nor generated at the facility. Except for cyanide, for which an alternate monitoring requirement is established in subparts A and C of this part, a determination that regulated pollutants are neither used nor generated should be based on a review of all raw materials in use, and an assessment of the process chemistry, products and by-products resulting from each of the manufacturing processes. This determination along with a recommendation of any surrogate must be submitted with permit applications for approval by the permitting authority, reconfirmed by an annual chemical analysis of wastewater from each monitoring location, and measurement of a non-detect value for each regulated pollutant or its surrogate. Permits must specify that such determinations will be maintained in the facility's permit records with their discharge monitoring reports and will be available to regulatory authorities upon request.

(b) Unless noted otherwise, self-monitoring will be conducted at the point where the final effluent is discharged. (68 FR 12271, Mar. 13, 2003)

8 439.11 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, 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]

$ 439.3 General pretreatment stand

ards. Any source subject to this part that introduces process wastewater pollutants into a publicly owned treatment works (POTW) must comply with 40 CFR part 403. [63 FR 50425, Sept. 21, 1998]

$ 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 BODs, expressed as mass loading (lbs., kg) per day, must reflect not less than 90 percent reduction in the long-term average daily BOD, load of the raw (untreated) process wastewater, multiplied by a variability factor of 3.0.

(1) The long-term average daily BOD, load of the raw process wastewater (i.e., the base number to which the percent reduction is applied) is defined as the average daily BOD, 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 BOD, 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

$ 439.4 General limitation or standard

for pH. The pH must remain within the range 6.0 to 9.0 in any discharge subject to BPT, BCT or NSPS limitations or standards in this part.

[68 FR 12271, Mar. 13, 2003]

Subpart A-Fermentation Products $ 439.10 Applicability.

This subpart applies to discharges of process wastewater resulting from the

separate disposal or reuse. These residual amounts may be included in the calculation of the average influent BOD, 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 BODs 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 BOD, 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:

(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]

$ 439.13 Effluent limitations attainable

by the application of the best conventional pollutant control tech

nology (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 BODs, TSS and pH are the same as the corresponding limitations in 8 439.12. [63 FR 50426, Sept. 21, 1998] $ 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:

1

1

Ammonia (as N) Acetone 4-methyl-2-pentanone Isobutyraldehyde n-Amyl acetate n-Butyl acetate Ethyl acetate Isopropyl acetate Methyl formate Amyl alcohol

Ethanol Isopropanol Methanol Methyl Cellosolve Dimethyl sulfoxide Triethyl amine Phenol Benzene Toluene Xylenes n-Hexane n-Heptane Methylene chloride Chloroform 1.2-dichloroethane Chlorobenzene 0-Dichlorobenzene Tetrahydroturan Isopropyl ether Diethyl amine Acetonitrile

10.0

3.9 10.0 100.0

91.5 250.0

0.05 0.05 0.06 0.03 0.03 0.05 0.9 0.02 0.4 0.15 0.15 8.4

8.4 250.0 25.0

4.1 1.6 4.1 40.6 37.5 102.0

0.02 0.02 0.02 0.01 0.02 0.02 0.3 0.13 0.1 0.06 0.06 2.6

2.6 102.0 10.2

mgl (ppm).

(b) The limitations for COD are the same as specified in 8 439.12(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]

img/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 $8 439.13 and 439.14.

[68 FR 12272, Mar. 13, 2003]

$439.15 New source performance

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

PERFORMANCE STANDARDS (NSPS)

8 439.16 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)

0.5

Regulated parameter

Maximum

daily

Maximum monthly average

BODS TSS COD Ammonia (as N) Acetone 4-methyl-2-pentanone Isobutyraldehyde n-Amyl acetate n-Butyl acetate Ethyl acetate Isopropyl acetate Methyl formate Amyl alcohol Ethanol Isopropanol Methanol Methyl Cellosolve Dimethyl sulfoxide Triethyl amine Phenol Benzene Toluene Xylenes n-Hexane

111 166 856 29.4 0.2 0.2 0.5 0.5 0.5 0.5 0.5 0.5 4.1 4.1 1.6 4.1 40.6 37.5 102.0

Ammonia (as N)? Acetone 4-methyl-2-pentanone Isobutyraldehyde n-Amyl acetate n-Butyl acetate Ethyl acetate Isopropyl acetate Methyl formate Isopropyl ether Tetrahydroturan Benzene Toluene Xylenes n-Heptane n-Hexane

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]

0.7

Subpart B-Extraction Products

Methylene chloride

3.0

0.7 Chloroform

0.1

0.03 1,2-dichloroethane

20.7

8.2 Chlorobenzene

3.0 o-Dichlorobenzene

20.7

8.2 Diethyl amine

255.0 100.0 Triethyl amine

255.0 100.0 mg/L (ppm)

2 Not 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(1)) 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]

$ 439.20 Applicability.

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

(63 FR 50430, Sept. 21, 1998]

8 439.21 Special definitions.

For the purpose of this subpart:

(a) Extraction means process operations that derive pharmaceutically active ingredients from natural sources such as plant roots and leaves, animal glands, and parasitic fungi by chemical and physical extraction. (b) Product

any substance manufactured by an extraction process, including blood fractions, vaccines, serums, animal bile derivatives, endocrine products and medicinal products such as alkaloids that are isolated from botanical drugs and herbs.

8 439.17 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:

means

[68 FR 12272, Mar. 13, 2003]

33.5

9.4

Cyanide (T)
Mg/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

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

$ 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 BODs is the same as specified in 439.12(a). No facility shall be required to attain a monthly average limitation for BOD, that is less than the equivalent of 45 mg/L.

(1) The long-term average daily BODs load of the raw process wastewater (i.e., the base number to which the percent reduction is applied) is defined as the average daily BOD, load during any calendar month, over 12 consecutive months within the most recent 36 months, and must include one or more

on

to the lower concentration value must be applied. [63 FR 50430, Sept. 21, 1998, as amended at 68 FR 12273, Mar. 13, 2003]

$ 439.23 Effluent limitations attainable

by the application of the best con. ventional pollutant control tech

nology (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 § 439.22.

(63 FR 50430, Sept. 21, 1998)

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 BODs 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 BOD, 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 BOD, may be achieved by any of several, or a combination, of these practices.

(b) The limitation for TSS is the same as specified in § 439.12(b).

(c) Except for the provisions in paragraph (d) of this section, the limitations for COD are as follows:

$ 439.24 Effluent limitations attainable

by the application of best available technology economically achievable

(BAT). 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: Limitations for COD are the same as the corresponding limitations in 439.22(c) and (d).

[63 FR 50431, Sept. 21, 1998]

$ 439.25 New

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

PERFORMANCE STANDARDS (NSPS)