33 U.S.C. 1311, 1314, 1316, 1317, 1318, 1342 and 1361.
(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.
As used in this part:
(a) The general definitions, abbreviations and methods of analysis in 40 CFR part 401 shall apply.
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(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)
(o)
(p)
(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
(b) Unless noted otherwise, self-monitoring will be conducted at the point where the final effluent is discharged.
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.
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.
This subpart applies to discharges of process wastewater resulting from the manufacture of pharmaceutical products by fermentation.
For the purpose of this subpart:
(a)
(b)
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
(1) The long-term average daily BOD
(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
(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
(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
(c) Except as provided in paragraph (d) of this section, the limitations for COD are as follows:
(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:
(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.
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
(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:
(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).
(a) Any new source subject to this subpart must achieve the following standards:
(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.
(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:
(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).
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:
(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.
This subpart applies to discharges of process wastewater resulting from the manufacture of pharmaceutical products by extraction.
For the purpose of this subpart:
(a)
(b)
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
(1) The long-term average daily BOD
(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
(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
(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:
(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.
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
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).
(a) Any new source subject to this subpart must achieve the following standards:
(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
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:
Except as provided in 40 CFR 403.7, any new source subject to this subpart must achieve the following pretreatment standards:
This subpart applies to discharges of process wastewater resulting from the manufacture of pharmaceutical products by chemical synthesis.
For the purpose of this subpart:
(a)
(b)
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
(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).
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.
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).
(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.
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).
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:
(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.
This subpart applies to discharges of process wastewater resulting from the manufacture of pharmaceutical products by mixing, compounding and formulating operations.
For the purpose of this subpart:
(a)
(b)
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
(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).
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
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).
(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.
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:
Except as provided in 40 CFR 403.7, any new source subject to this subpart must achieve the following pretreatment standards:
This subpart applies to discharges of process wastewater resulting from pharmaceutical research.
For the purpose of this subpart,
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
(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
(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
(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
(e) The pH must be within the range 6.0 to 9.0.