PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY Authority: 33 U.S.C. 1311, 1314, 1316, 1317, 1318, 1342 and 1361. Source: 48 FR 49821, Oct. 27, 1983, unless otherwise noted. General § 439.0 Applicability. (a) This part applies to process wastewater discharges resulting from the research and manufacture of pharmaceutical products, which are generally, but not exclusively, reported under SIC 2833, SIC 2834 and SIC 2836 (1987 Standard Industrial Classification Manual). (b) Although not reported under SIC 2833, SIC 2834 and SIC 2836, discharges from the manufacture of other pharmaceutical products to which this part applies include (but are not limited to): (1) Products manufactured by one or more of the four types of manufacturing processes described in subcategories A, B, C or D of this part, and considered by the Food and Drug Administration to be pharmaceutical active ingredients; (2) Multiple end-use products (e.g., components of formulations, chemical intermediates, or final products) derived from pharmaceutical manufacturing operations and intended for use primarily in pharmaceutical applications; (3) Pharmaceutical products and intermediates not subject to other categorical limitations and standards, provided the manufacturing processes generate process wastewaters that are similar to those derived from the manufacture of pharmaceutical products elsewhere (an example of such a product is citric acid); (4) Cosmetic preparations that are reported under SIC 2844 and contain pharmaceutical active ingredients, or active ingredients that are intended for the treatment of a skin condition. (These preparations do not include products such as lipsticks or perfumes that serve to enhance appearance, or provide a pleasing odor, but do not enhance skin care. Also excluded are deodorants, manicure preparations, shaving preparations and non-medicated shampoos that do not function primarily as a skin treatment.) (c) The provisions of this part do not apply to wastewater discharges resulting from the manufacture of the following products, or as a result of providing one or more of the following services: (1) Surgical and medical instruments and apparatus reported under SIC 3841; (2) Orthopedic, prosthetic, and surgical appliances and supplies reported under SIC 3842; (3) Dental equipment and supplies reported under SIC 3843; (4) Medical laboratory services reported under SIC 8071; (5) Dental laboratory services reported under SIC 8072; (6) Outpatient care facility services reported under SIC 8081; (7) Health and allied services reported under SIC 8091, and not classified elsewhere; (8) Diagnostic devices other than those reported under SIC 3841; (9) Animal feed products that include pharmaceutical active ingredients such as vitamins and antibiotics, where the major portion of the product is non-pharmaceutical, and the resulting process wastewater is not characteristic of process wastewater from the manufacture of pharmaceutical products; (10) Food and beverage products fortified with vitamins or other pharmaceutical active ingredients, where the major portion of the product is non-pharmaceutical, and the resulting process wastewater is not characteristic of process wastewater from the manufacture of pharmaceutical products; (11) Pharmaceutical products and intermediates subject to the provisions of 40 CFR part 414, provided their manufacture results in less than 50 percent of the total flow of process wastewater that is regulated by 40 CFR part 414 at the facility. [63 FR 50424, Sept. 21, 1998] § 439.1 General definitions. As used in this part: (a) The general definitions, abbreviations and methods of analysis in 40 CFR part 401 shall apply. (b) Bench-scale operation (c) Cyanide (T) (d) In-plant monitoring point (e) Maximum daily (f) Maximum monthly average (g) mg/L (h) Minimum level (i) Nitrification capability Nitrosomonas Nitrobacter (j) Non-detect (ND) (k) Pilot-scale operation (l) POTW (m) Process wastewater, (1) Trimethyl silanol, any active anti-microbial materials, process wastewater from imperfect fermentation batches, and process area spills. Discharges containing such materials are not subject to the limitations and standards of this part. (2) Non-contact cooling water, utility wastewaters, general site surface runoff, groundwater (e.g., contaminated groundwaters from on-site or off-site groundwater remediation projects), and other non-process water generated on site. Discharges of such waters and wastewaters are not subject to the limitations and standards of this part. (n) Non-conventional pollutants (o) Surrogate pollutant (p) Xylenes [63 FR 50425, Sept. 21, 1998; 64 FR 48104, Sept. 2, 1999, as amended at 68 FR 12270, Mar. 13, 2003] § 439.2 General monitoring requirements. (a) Permit compliance monitoring is required for each regulated pollutant generated or used at a pharmaceutical manufacturing facility, except where the regulated pollutant is monitored as 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] § 439.3 General pretreatment standards. 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] § 439.4 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 manufacture of pharmaceutical products by fermentation. [63 FR 50426, Sept. 21, 1998] § 439.11 Special definitions. For the purpose of this subpart: (a) Fermentation (b) Product [68 FR 12271, Mar. 13, 2003] § 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 BOD 5 5 (1) The long-term average daily BOD 5 i.e. 5 (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 5 5 (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 BOD 5 (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 5 (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 1 (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 1 (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 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 BOD 5 [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: Effluent Limitations (BAT) Regulated parameter Maximum daily 1 Maximum monthly average 1 Ammonia (as N) 84.1 29.4 Acetone 0.5 0.2 4-methyl-2-pentanone 0.5 0.2 Isobutyraldehyde 1.2 0.5 n-Amyl acetate 1.3 0.5 n-Butyl acetate 1.3 0.5 Ethyl acetate 1.3 0.5 Isopropyl acetate 1.3 0.5 Methyl formate 1.3 0.5 Amyl alcohol 10.0 4.1 Ethanol 10.0 4.1 Isopropanol 3.9 1.6 Methanol 10.0 4.1 Methyl Cellosolve 100.0 40.6 Dimethyl sulfoxide 91.5 37.5 Triethyl amine 250.0 102.0 Phenol 0.05 0.02 Benzene 0.05 0.02 Toluene 0.06 0.02 Xylenes 0.03 0.01 n-Hexane 0.03 0.02 n-Heptane 0.05 0.02 Methylene chloride 0.9 0.3 Chloroform 0.02 0.13 1,2-dichloroethane 0.4 0.1 Chlorobenzene 0.15 0.06 o-Dichlorobenzene 0.15 0.06 Tetrahydrofuran 8.4 2.6 Isopropyl ether 8.4 2.6 Diethyl amine 250.0 102.0 Acetonitrile 25.0 10.2 1 (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] § 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 daily 1 Maximum monthly average 1 BOD 5 267 111 TSS 472 166 COD 1675 856 Ammonia (as N) 84.1 29.4 Acetone 0.5 0.2 4-methyl-2-pentanone 0.5 0.2 Isobutyraldehyde 1.2 0.5 n-Amyl acetate 1.3 0.5 n-Butyl acetate 1.3 0.5 Ethyl acetate 1.3 0.5 Isopropyl acetate 1.3 0.5 Methyl formate 1.3 0.5 Amyl alcohol 10.0 4.1 Ethanol 10.0 4.1 Isopropanol 3.9 1.6 Methanol 10.0 4.1 Methyl Cellosolve 100.0 40.6 Dimethyl sulfoxide 91.5 37.5 Triethyl amine 250.0 102.0 Phenol 0.05 0.02 Benzene 0.05 0.02 Toluene 0.06 0.02 Xylenes 0.03 0.01 n-Hexane 0.03 0.02 n-Heptane 0.05 0.02 Methylene chloride 0.9 0.3 Chloroform 0.02 0.13 1,2-dichloroethane 0.4 0.1 Chlorobenzene 0.15 0.06 o-Dichlorobenzene 0.15 0.06 Tetrahydrofuran 8.4 2.6 Isopropyl ether 8.4 2.6 Diethyl amine 250.0 102.0 Acetonitrile 25.0 10.2 1 (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] § 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 Maximum daily 1 Maximum monthly average 1 Ammonia (as N) 2 84.1 29.4 Acetone 20.7 8.2 4-methyl-2-pentanone 20.7 8.2 Isobutyraldehyde 20.7 8.2 n-Amyl acetate 20.7 8.2 n-Butyl acetate 20.7 8.2 Ethyl acetate 20.7 8.2 Isopropyl acetate 20.7 8.2 Methyl formate 20.7 8.2 Isopropyl ether 20.7 8.2 Tetrahydrofuran 9.2 3.4 Benzene 3.0 0.7 Toluene 0.3 0.2 Xylenes 3.0 0.7 n-Heptane 3.0 0.7 n-Hexane 3.0 0.7 Methylene chloride 3.0 0.7 Chloroform 0.1 0.03 1,2-dichloroethane 20.7 8.2 Chlorobenzene 3.0 0.7 o 20.7 8.2 Diethyl amine 255.0 100.0 Triethyl amine 255.0 100.0 1 2 (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] § 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 parameter Pretreatment standards 1 Maximum daily discharge Average monthly discharge must not exceed Cyanide (T) 33.5 9.4 1 (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] Subpart B—Extraction Products § 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] § 439.21 Special definitions. For the purpose of this subpart: (a) Extraction (b) Product [68 FR 12272, Mar. 13, 2003] § 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 BOD 5 5 (1) The long-term average daily BOD 5 i.e. 5 (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 5 5 (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 5 (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: Effluent Limitations (BPT) Regulated parameter Maximum daily 1 Maximum monthly average 1 COD 228 86 1 (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 a monthly average limitation for COD corresponding 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 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 BOD 5 [63 FR 50430, Sept. 21, 1998] § 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) Regulated parameter Maximum daily 1 Maximum monthly average 1 BOD 5 35 18 TSS 58 31 COD 228 86 1 (b) 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 §§ 439.23 and 439.24. [68 FR 12273, Mar. 13, 2003] § 439.26 Pretreatment standards for existing sources (PSES). Except as provided in 40 CFR 403.7 and 403.13, any existing source subject to this subpart must achieve the following standards by September 21, 2001: Pretreatment Standards (PSES) Regulated parameter Maximum daily 1 Maximum monthly average 1 Acetone 20.7 8.2 n-Amyl acetate 20.7 8.2 Ethyl acetate 20.7 8.2 Isopropyl acetate 20.7 8.2 Methylene chloride 3.0 0.7 1 [68 FR 12273, Mar. 13, 2003] § 439.27 Pretreatment standards for new sources (PSNS). Except as provided in 40 CFR 403.7, any new source subject to this subpart must achieve the following pretreatment standards: Regulated parameter Pretreatment standards 1 Maximum daily discharge Average monthly discharge must not exceed 1 Acetone 20.7 8.2 2 n-Amyl acetate 20.7 8.2 3 Ethyl acetate 20.7 8.2 4 Isopropyl acetate 20.7 8.2 5 Methylene chloride 3.0 0.7 1 [63 FR 50431, Sept. 21, 1998; 64 FR 48104, Sept. 2, 1999] Subpart C—Chemical Synthesis Products § 439.30 Applicability. This subpart applies to discharges of process wastewater resulting from the manufacture of pharmaceutical products by chemical synthesis. [63 FR 50431, Sept. 21, 1998] § 439.31 Special definitions. For the purpose of this subpart: (a) Chemical synthesis (b) Product [68 FR 12273, Mar. 13, 2003] § 439.32 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 BOD 5 (b) The limitation for TSS is the same as specified in § 439.12(b). (c) The limitations for COD are the same as specified in § 439.12(c) and (d). (d) The limitations for cyanide are the same as specified in § 439.12(e), (f) and (g). [63 FR 50431, Sept. 21, 1998, as amended at 68 FR 12273, Mar. 13, 2003] § 439.33 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 § 439.32. [63 FR 50432, Sept. 21, 1998] § 439.34 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: (a) The limitations are the same as specified in § 439.14(a). (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). [67 FR 12273, Mar. 13, 2003] § 439.35 New source performance standards (NSPS). (a) Any new source subject to this subpart must achieve the same standards as specified in § 439.15(a). (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 § 439.33 and § 439.34. [68 FR 12273, Mar. 13, 2003] § 439.36 Pretreatment standards for existing sources (PSES). 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 (b) of this section and must achieve the standards specified in § 439.16(a) by September 21, 2001. (a) Sources that discharge to a POTW with nitrification capability (defined at § 439.1(i)) are not required to achieve the standards for ammonia (as N). (b) The standards for cyanide are the same as specified in § 439.12(e), (f) and (g). [68 FR 12274, Mar. 13, 2003] § 439.37 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 § 439.36. (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 parameter Effluent limitation 1 Maximum daily discharge Average monthly discharge must not exceed Cyanide (T) 33.5 9.4 1 (c) When monitoring for cyanide at the end-of-pipe is impractical because of dilution by other process wastewaters, compliance with the cyanide pretreatment standards in paragraph (b) of this section 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 standard 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 50434, Sept. 21, 1998; 64 FR 10393, Mar. 4, 1999; 64 FR 48104, Sept. 2, 1999, as amended at 68 FR 34832, June 11, 2003] Subpart D—Mixing/Compounding and Formulation § 439.40 Applicability. This subpart applies to discharges of process wastewater resulting from the manufacture of pharmaceutical products by mixing, compounding and formulating operations. [63 FR 50435, Sept. 21, 1998] § 439.41 Special definitions. For the purpose of this subpart: (a) Mixing, compounding, and formulating operations (b) Product [68 FR 12274, Mar. 13, 2003] § 439.42 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 BOD 5 5 (b) The limitation for TSS is the same as specified in § 439.12(b). (c) The limitations for COD are the same as specified in § 439.22(c) and (d). [63 FR 50435, Sept. 21, 1998, as amended at 68 FR 12274, Mar. 13, 2003] § 439.43 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 BOD 5 [63 FR 50436, Sept. 21, 1998] § 439.44 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: The limitations for COD are the same as specified in § 439.22(c) and (d). [68 FR 12274, Mar. 13, 2003] § 439.45 New source performance standards (NSPS). (a) Any new source subject to this subpart must achieve the same standards as specified in § 439.25(a). (b) 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 § 439.43 and § 439.44. [68 FR 12274, Mar. 13, 2003] § 439.46 Pretreatment standards for existing sources (PSES). Except as provided in 40 CFR 403.7 and 403.13, any existing source subject to this subpart must achieve the following standards by September 21, 2001: Pretreatment Standards (PSES) Regulated parameter Maximum daily 1 Maximum monthly average 1 Acetone 20.7 8.2 n-Amyl acetate 20.7 8.2 Ethyl acetate 20.7 8.2 Isopropyl acetate 20.7 8.2 Methylene chloride 3.0 0.7 1 [68 FR 12274, Mar. 13, 2003] § 439.47 Pretreatment standards for new sources (PSNS). Except as provided in 40 CFR 403.7, any new source subject to this subpart must achieve the following pretreatment standards: Regulated Pretreatment standards 1 Maximum daily Average monthly discharge must not exceed 1 Acetone 20.7 8.2 2 n-Amyl acetate 20.7 8.2 3 Ethyl acetate 20.7 8.2 4 Isopropyl acetate 20.7 8.2 5 Methylene chloride 3.0 0.7 1 [63 FR 50436, Sept. 21, 1998; 64 FR 48104, Sept. 2, 1999] Subpart E—Research § 439.50 Applicability. This subpart applies to discharges of process wastewater resulting from pharmaceutical research. [63 FR 50436, Sept. 21, 1998] § 439.51 Special definitions. For the purpose of this subpart, product [68 FR 12274, Mar. 13, 2003] § 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 BOD 5 5 (b) The limitation for TSS is the same as specified in § 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 BOD 5 i.e., 5 (1) To assure equity in the determination of NPDES permit limitations regulating discharges subject to this subpart, calculation of the long-term average daily BOD 5 5 (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 BOD 5 (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 Dimethyl Sulfoxide 1 2 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 [63 FR 50437, Sept. 21, 1998; 64 FR 10393, Mar. 4, 1999, as amended at 68 FR 12275, Mar. 13, 2003]