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49 rows where part_number = 439 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 40:40:32.0.1.1.15.0.4.1 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | § 439.0 Applicability. | EPA | [63 FR 50424, Sept. 21, 1998] | (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… | |||||
| 40:40:32.0.1.1.15.0.4.2 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | § 439.1 General definitions. | EPA | [63 FR 50425, Sept. 21, 1998; 64 FR 48104, Sept. 2, 1999, as amended at 68 FR 12270, Mar. 13, 2003] | 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 means the laboratory testing of materials, methods, or processes on a small scale, such as on a laboratory worktable. (c) Cyanide (T) means the parameter total cyanide. (d) In-plant monitoring point means a location within a plant, where an individual process effluent can be exclusively monitored before it is diluted or mixed with other process wastewaters en route to the end-of-pipe. (e) Maximum daily means the highest allowable discharge of wastewater pollutants during a calendar day or any 24 hour period that reasonably represents a calendar day for purposes of sampling. (f) Maximum monthly average means the highest allowable average of daily discharges of wastewater pollutants over a calendar month, and is calculated as the sum of all daily values measured during a calendar month divided by the number of daily values measured during that month. (g) mg/L means milligrams per liter or parts per million (ppm) (h) Minimum level means the level at which an analytical system gives recognizable signals and an acceptable calibration point. (i) Nitrification capability means the capability of a POTW treatment system to oxidize ammonia or ammonium salts initially to nitrites (via Nitrosomonas bacteria) and subsequently to nitrates (via Nitrobacter bacteria). Criteria for determining the nitrification capability of a POTW treatment system are: bioassays confirming the presence of nitrifying bacteria; and analyses of the nitrogen balance demonstrating a reduction in the concentration of ammonia or ammonium salts and an increase in the concentrations of nitrites and nitrates. (j) Non-detect (ND) means a concentration value below the minimum level that can be reliably measured by the analytical method. (k) Pilot-scale operation means processing equipment being operated at an intermediate stage between laboratory-scale and full-scale operation f… | |||||
| 40:40:32.0.1.1.15.0.4.3 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | § 439.2 General monitoring requirements. | EPA | [68 FR 12271, Mar. 13, 2003] | (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. | |||||
| 40:40:32.0.1.1.15.0.4.4 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | § 439.3 General pretreatment standards. | EPA | [63 FR 50425, Sept. 21, 1998] | 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. | |||||
| 40:40:32.0.1.1.15.0.4.5 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | § 439.4 General limitation or standard for pH. | EPA | [68 FR 12271, Mar. 13, 2003] | 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. | |||||
| 40:40:32.0.1.1.15.1.5.1 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | A | Subpart A—Fermentation Products | § 439.10 Applicability. | EPA | [63 FR 50426, Sept. 21, 1998] | This subpart applies to discharges of process wastewater resulting from the manufacture of pharmaceutical products by fermentation. | |||
| 40:40:32.0.1.1.15.1.5.2 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | A | Subpart A—Fermentation Products | § 439.11 Special definitions. | EPA | [68 FR 12271, Mar. 13, 2003] | 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. | |||
| 40:40:32.0.1.1.15.1.5.3 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | A | Subpart A—Fermentation Products | § 439.12 Effluent limitations attainable by the application of the best practicable control technology currently available (BPT). | EPA | [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 BOD 5 , expressed as mass loading (lbs., kg) per day, must reflect not less than 90 percent reduction in the long-term average daily BOD 5 load of the raw (untreated) process wastewater, multiplied by a variability factor of 3.0. (1) The long-term average daily BOD 5 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 5 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 5 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 BOD 5 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 BOD 5 may be achieved by any of several, or a combination, of these practices. (b) The maximum monthly average limitation for TSS,… | |||
| 40:40:32.0.1.1.15.1.5.4 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | A | Subpart A—Fermentation Products | § 439.13 Effluent limitations attainable by the application of the best conventional pollutant control technology (BCT). | EPA | [63 FR 50426, Sept. 21, 1998] | 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 , TSS and pH are the same as the corresponding limitations in § 439.12. | |||
| 40:40:32.0.1.1.15.1.5.5 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | A | Subpart A—Fermentation Products | § 439.14 Effluent limitations attainable by the application of best available technology economically achievable (BAT). | EPA | [68 FR 12271, Mar. 13, 2003] | (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) 1 mg/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). | |||
| 40:40:32.0.1.1.15.1.5.6 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | A | Subpart A—Fermentation Products | § 439.15 New source performance standards (NSPS). | EPA | [68 FR 12272, Mar. 13, 2003] | (a) Any new source subject to this subpart must achieve the following standards: Performance Standards (NSPS) 1 mg/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. | |||
| 40:40:32.0.1.1.15.1.5.7 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | A | Subpart A—Fermentation Products | § 439.16 Pretreatment standards for existing sources (PSES). | EPA | [68 FR 12272, Mar. 13, 2003] | (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) 1 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(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). | |||
| 40:40:32.0.1.1.15.1.5.8 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | A | Subpart A—Fermentation Products | § 439.17 Pretreatment standards for new sources (PSNS). | EPA | [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] | 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: 1 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 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. | |||
| 40:40:32.0.1.1.15.2.5.1 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | B | Subpart B—Extraction Products | § 439.20 Applicability. | EPA | [63 FR 50430, Sept. 21, 1998] | This subpart applies to discharges of process wastewater resulting from the manufacture of pharmaceutical products by extraction. | |||
| 40:40:32.0.1.1.15.2.5.2 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | B | Subpart B—Extraction Products | § 439.21 Special definitions. | EPA | [68 FR 12272, Mar. 13, 2003] | 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 means 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. | |||
| 40:40:32.0.1.1.15.2.5.3 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | B | Subpart B—Extraction Products | § 439.22 Effluent limitations attainable by the application of the best practicable control technology currently available (BPT). | EPA | [63 FR 50430, Sept. 21, 1998, as amended at 68 FR 12273, 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 limitation for BOD 5 is the same as specified in § 439.12(a). No facility shall be required to attain a monthly average limitation for BOD 5 that is less than the equivalent of 45 mg/L. (1) The long-term average daily BOD 5 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 5 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 5 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 5 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 5 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… | |||
| 40:40:32.0.1.1.15.2.5.4 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | B | Subpart B—Extraction Products | § 439.23 Effluent limitations attainable by the application of the best conventional pollutant control technology (BCT). | EPA | [63 FR 50430, Sept. 21, 1998] | 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 , TSS and pH are the same as the corresponding limitations in § 439.22. | |||
| 40:40:32.0.1.1.15.2.5.5 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | B | Subpart B—Extraction Products | § 439.24 Effluent limitations attainable by the application of best available technology economically achievable (BAT). | EPA | [63 FR 50431, Sept. 21, 1998] | 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). | |||
| 40:40:32.0.1.1.15.2.5.6 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | B | Subpart B—Extraction Products | § 439.25 New source performance standards (NSPS). | EPA | [68 FR 12273, Mar. 13, 2003] | (a) Any new source subject to this subpart must achieve the following standards: Performance Standards (NSPS) 1 mg/L (ppm) (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. | |||
| 40:40:32.0.1.1.15.2.5.7 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | B | Subpart B—Extraction Products | § 439.26 Pretreatment standards for existing sources (PSES). | EPA | [68 FR 12273, Mar. 13, 2003] | 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) 1 mg/L (ppm). | |||
| 40:40:32.0.1.1.15.2.5.8 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | B | Subpart B—Extraction Products | § 439.27 Pretreatment standards for new sources (PSNS). | EPA | [63 FR 50431, Sept. 21, 1998; 64 FR 48104, Sept. 2, 1999] | Except as provided in 40 CFR 403.7, any new source subject to this subpart must achieve the following pretreatment standards: 1 Mg/L (ppm). | |||
| 40:40:32.0.1.1.15.3.5.1 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | C | Subpart C—Chemical Synthesis Products | § 439.30 Applicability. | EPA | [63 FR 50431, Sept. 21, 1998] | This subpart applies to discharges of process wastewater resulting from the manufacture of pharmaceutical products by chemical synthesis. | |||
| 40:40:32.0.1.1.15.3.5.2 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | C | Subpart C—Chemical Synthesis Products | § 439.31 Special definitions. | EPA | [68 FR 12273, Mar. 13, 2003] | For the purpose of this subpart: (a) Chemical synthesis means using one or a series of chemical reactions in the manufacturing process of a specified product. (b) Product means any pharmaceutical product manufactured by chemical synthesis. | |||
| 40:40:32.0.1.1.15.3.5.3 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | C | Subpart C—Chemical Synthesis Products | § 439.32 Effluent limitations attainable by the application of the best practicable control technology currently available (BPT). | EPA | [63 FR 50431, Sept. 21, 1998, as amended at 68 FR 12273, 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 limitation for BOD 5 is the same as specified in § 439.12(a). (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). | |||
| 40:40:32.0.1.1.15.3.5.4 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | C | Subpart C—Chemical Synthesis Products | § 439.33 Effluent limitations attainable by the application of the best conventional pollutant control technology (BCT). | EPA | [63 FR 50432, Sept. 21, 1998] | 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. | |||
| 40:40:32.0.1.1.15.3.5.5 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | C | Subpart C—Chemical Synthesis Products | § 439.34 Effluent limitations attainable by the application of best available technology economically achievable (BAT). | EPA | [67 FR 12273, 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 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). | |||
| 40:40:32.0.1.1.15.3.5.6 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | C | Subpart C—Chemical Synthesis Products | § 439.35 New source performance standards (NSPS). | EPA | [68 FR 12273, Mar. 13, 2003] | (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. | |||
| 40:40:32.0.1.1.15.3.5.7 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | C | Subpart C—Chemical Synthesis Products | § 439.36 Pretreatment standards for existing sources (PSES). | EPA | [68 FR 12274, Mar. 13, 2003] | 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). | |||
| 40:40:32.0.1.1.15.3.5.8 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | C | Subpart C—Chemical Synthesis Products | § 439.37 Pretreatment standards for new sources (PSNS). | EPA | [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] | 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: 1 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 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. | |||
| 40:40:32.0.1.1.15.4.5.1 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | D | Subpart D—Mixing/Compounding and Formulation | § 439.40 Applicability. | EPA | [63 FR 50435, Sept. 21, 1998] | This subpart applies to discharges of process wastewater resulting from the manufacture of pharmaceutical products by mixing, compounding and formulating operations. | |||
| 40:40:32.0.1.1.15.4.5.2 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | D | Subpart D—Mixing/Compounding and Formulation | § 439.41 Special definitions. | EPA | [68 FR 12274, Mar. 13, 2003] | For the purpose of this subpart: (a) Mixing, compounding, and formulating operations means processes that put pharmaceutical products in dosage forms. (b) Product means any pharmaceutical product manufactured by blending, mixing, compounding, and formulating pharmaceutical ingredients. The term includes pharmaceutical preparations for both human and veterinary use such as ampules, tablets, capsules, vials, ointments, medicinal powders, solutions, and suspensions. | |||
| 40:40:32.0.1.1.15.4.5.3 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | D | Subpart D—Mixing/Compounding and Formulation | § 439.42 Effluent limitations attainable by the application of the best practicable control technology currently available (BPT). | EPA | [63 FR 50435, Sept. 21, 1998, as amended at 68 FR 12274, 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 limitation for BOD 5 is the same as specified in § 439.12(a). No facility shall be required to attain a monthly average limitation for BOD 5 that is less than the equivalent of 45 mg/L. (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). | |||
| 40:40:32.0.1.1.15.4.5.4 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | D | Subpart D—Mixing/Compounding and Formulation | § 439.43 Effluent limitations attainable by the application of the best conventional pollutant control technology (BCT). | EPA | [63 FR 50436, Sept. 21, 1998] | 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 , TSS and pH are the same as the corresponding limitations in § 439.42. | |||
| 40:40:32.0.1.1.15.4.5.5 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | D | Subpart D—Mixing/Compounding and Formulation | § 439.44 Effluent limitations attainable by the application of best available technology economically achievable (BAT). | EPA | [68 FR 12274, 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 BAT: The limitations for COD are the same as specified in § 439.22(c) and (d). | |||
| 40:40:32.0.1.1.15.4.5.6 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | D | Subpart D—Mixing/Compounding and Formulation | § 439.45 New source performance standards (NSPS). | EPA | [68 FR 12274, Mar. 13, 2003] | (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. | |||
| 40:40:32.0.1.1.15.4.5.7 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | D | Subpart D—Mixing/Compounding and Formulation | § 439.46 Pretreatment standards for existing sources (PSES). | EPA | [68 FR 12274, Mar. 13, 2003] | 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) 1 mg/L (ppm). | |||
| 40:40:32.0.1.1.15.4.5.8 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | D | Subpart D—Mixing/Compounding and Formulation | § 439.47 Pretreatment standards for new sources (PSNS). | EPA | [63 FR 50436, Sept. 21, 1998; 64 FR 48104, Sept. 2, 1999] | Except as provided in 40 CFR 403.7, any new source subject to this subpart must achieve the following pretreatment standards: 1 Mg/L (ppm). | |||
| 40:40:32.0.1.1.15.5.5.1 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | E | Subpart E—Research | § 439.50 Applicability. | EPA | [63 FR 50436, Sept. 21, 1998] | This subpart applies to discharges of process wastewater resulting from pharmaceutical research. | |||
| 40:40:32.0.1.1.15.5.5.2 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | E | Subpart E—Research | § 439.51 Special definitions. | EPA | [68 FR 12274, Mar. 13, 2003] | For the purpose of this subpart, product means products or services resulting from research and product development activities. | |||
| 40:40:32.0.1.1.15.5.5.3 | 40 | Protection of Environment | I | N | 439 | PART 439—PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY | E | Subpart E—Research | § 439.52 Effluent limitations attainable by the application of the best practicable control technology currently available (BPT). | EPA | [63 FR 50436, Sept. 21, 1998, as amended at 68 FR 12274, 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 limitation for BOD 5 is the same as specified in § 439.12(a). No facility shall be required to attain a monthly average limitation for BOD 5 that is less than the equivalent of 45 mg/L. (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 or COD mass loading of the raw process wastewater ( i.e., the base number to which the percent reduction is applied) is defined as the average daily BOD 5 or COD load during any calendar month, over 12 consecutive months within the most recent 36 months. (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 or COD load in the influent to the wastewater treatment system must exclude any portion of the load associated with solvents, except for residual amounts of 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 5 or COD loading. (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 NPDE… | |||
| 9:9:2.0.2.4.46.0.40.1 | 9 | Animals and Animal Products | III | E | 439 | PART 439—ACCREDITATION OF NON-FEDERAL LABORATORIES FOR ANALYTICAL TESTING OF MEAT, POULTRY, AND EGG PRODUCTS | § 439.1 Definitions. | FSIS | (a) Accredited Laboratory Program (ALP). The voluntary Food Safety and Inspection Service (FSIS) program in which non-Federal laboratories are accredited as capable of performing analyses with the level of quality that is necessary to maintain accreditation in the program, on samples of raw or processed meat, poultry, and egg products, and through which a proficiency testing sample program for quality assurance is conducted. (b) Food chemistry. Analysis of raw or processed meat or poultry products for the components moisture, protein, fat, and salt. (c) Initial accreditation proficiency testing sample. A sample provided by the FSIS ALP to a non-Federal laboratory to determine whether the laboratory's analytical capability meets the standards for acceptance into the program. The concentration or presence of the targeted analyte(s) and the composition of the components in the sample is unknown to the laboratory. (d) Inter-laboratory accreditation maintenance proficiency testing sample. A sample provided by the FSIS ALP to an accredited laboratory to assist in determining whether the laboratory is maintaining acceptable analytical performance for a given analyte or component. The concentration or presence of the targeted analyte(s) and the composition of the components in the sample is unknown to the laboratory. (e) International Organization for Standardization (ISO) 13528. ISO 13528:2015(E) Corrected version 2016, “Statistical methods for use in proficiency testing by interlaboratory comparison,” October 15, 2016, or updated versions. (f) Probation. The period commencing with official notification to an accredited laboratory that it no longer satisfies the ALP performance requirements specified in this part and ending with official notification that accreditation is fully restored, is suspended, or is revoked. (g) Refusal of accreditation. An action taken by FSIS when a laboratory that is applying for accreditation is denied the accreditation. (h) Responsibly connected. Any individual, or en… | ||||||
| 9:9:2.0.2.4.46.0.40.2 | 9 | Animals and Animal Products | III | E | 439 | PART 439—ACCREDITATION OF NON-FEDERAL LABORATORIES FOR ANALYTICAL TESTING OF MEAT, POULTRY, AND EGG PRODUCTS | § 439.5 Applications for accreditation. | FSIS | (a) Participation in the ALP is voluntary. Application for accreditation must be made on designated paper or electronic forms provided by FSIS, or otherwise in writing, by the owner or manager of a non-Federal analytical laboratory. Application forms may be obtained by contacting the ALP at ALP@usda.gov. The forms must be sent to the ALP or may be submitted electronically. The application must specify the kinds of accreditation sought by the owner or manager of the laboratory. A laboratory whose accreditation has been refused or revoked for performance reasons may reapply for accreditation after 60 days from the effective date of that action and must provide written documentation specifying what corrections were made and illustrate to FSIS that the corrections are effective or would reasonably be expected to be effective. (b) At the time that an application for accreditation is filed with the ALP, the laboratory must submit fees payable to the U.S. Department of Agriculture by check, bank draft, money order, or other form of payment accepted by the U.S. Department of Agriculture, in the amount specified by FSIS as directed in 9 CFR 391.5, along with the completed application for the accreditation(s). (c) An application for accreditation will not be processed or allowed to advance, without further procedure, if the accreditation fee(s) is delinquent. (d) FSIS will issue a bill annually in the amount specified by FSIS in 9 CFR 391.5 for each accreditation held and are due by the date required. Bills are payable to the U.S. Department of Agriculture by check, bank draft, money order, or other form of payment accepted by the U.S. Department of Agriculture. | ||||||
| 9:9:2.0.2.4.46.0.40.3 | 9 | Animals and Animal Products | III | E | 439 | PART 439—ACCREDITATION OF NON-FEDERAL LABORATORIES FOR ANALYTICAL TESTING OF MEAT, POULTRY, AND EGG PRODUCTS | § 439.10 Criteria for obtaining accreditation. | FSIS | (a) Analytical laboratories may be accredited for the analyses of foodborne indicator and pathogen analytes, or a specified chemical residue or a class of chemical residues, in raw or processed meat, poultry, and egg products. Analytical laboratories also may be accredited for the analyses of food chemistry components in raw or processed meat and poultry products. (b) Accreditation will be granted only if the applying laboratory successfully satisfies FSIS requirements that are stated in this part. (c) To obtain FSIS accreditation, an analytical laboratory must: (1) Be supervised by a person holding, at a minimum, a bachelor's degree in biology, chemistry, microbiology, food science, food technology, or a related field. (i) For food chemistry accreditation, the supervisor must also have one year of experience in food chemistry analysis, or equivalent qualifications. (ii) For chemical residue accreditation, either the supervisor or the analyst assigned to analyze the sample must also have three years of experience determining analytes at or below part per million levels, or equivalent qualifications. (iii) For indicator organisms or pathogen accreditation, either the supervisor or the analyst assigned to analyze the sample must also have three years of experience in foodborne pathogen analyses or equivalent qualifications. (2) Demonstrate the capability to achieve quality assurance levels that are within acceptable limits as determined by evaluation that is consistent with ISO 13528 for the analysis of initial accreditation proficiency testing samples, in the analyte category for which accreditation is sought. FSIS and some Association of Official Analytical Collaboration (AOAC) International analytical test procedures are acceptable for use in this program. FSIS procedures may be found on the U.S. Department of Agriculture (USDA) FSIS website at www.fsis.usda.gov. AOAC procedures may be found on the AOAC website at www.aoac.org. (3) Complete a second set of proficiency testing samples if the results of… | ||||||
| 9:9:2.0.2.4.46.0.40.4 | 9 | Animals and Animal Products | III | E | 439 | PART 439—ACCREDITATION OF NON-FEDERAL LABORATORIES FOR ANALYTICAL TESTING OF MEAT, POULTRY, AND EGG PRODUCTS | § 439.20 Criteria for maintaining accreditation. | FSIS | (a) Criteria. To maintain accreditation, an analytical laboratory must fulfill the requirements of this section. (b) Records. To demonstrate traceable and appropriate application of equipment, standards, procedures, analysts, and approvals related to accreditation, an accredited laboratory must: (1) Maintain laboratory quality control records for the most recent three years that samples have been analyzed. (2) Maintain complete records of the receipt, analysis, and disposition of samples for the most recent three years that samples have been analyzed. (3) Maintain in a secure electronic format or in a standards book, all records, readings, and calculations for prepared standards. Entries are to be dated and the analyst identified at the time of the entry, and manual calculations verified and documented by the supervisor, or by the supervisor's designee, before use of the standard. The standards records are to be retained for three years after the last recorded entry. The certificates of analysis are to be kept on file for purchased standards for at least the period of time that the materials are in use. (4) Maintain records of instrument maintenance and calibration. The records are to be retained for three years after the last recorded entry. (5) As provided in paragraph (e) of this section, records are to be made available for review by any duly authorized representative of the Secretary of Agriculture, including ALP personnel or their designees. (c) Inter-laboratory accreditation maintenance proficiency testing sample. (1) An accredited laboratory must analyze inter-laboratory accreditation maintenance proficiency testing samples and return the results to the ALP by the due date, which is usually within approximately three weeks of sample receipt. This must be done whenever requested by FSIS and at no cost to FSIS. (2) Results must be those of the accredited laboratory. Analyses of proficiency testing samples must not be contracted out by the accredited laboratory. (d) Corporate changes. The AL… | ||||||
| 9:9:2.0.2.4.46.0.40.5 | 9 | Animals and Animal Products | III | E | 439 | PART 439—ACCREDITATION OF NON-FEDERAL LABORATORIES FOR ANALYTICAL TESTING OF MEAT, POULTRY, AND EGG PRODUCTS | § 439.50 Refusal of accreditation. | FSIS | Upon a determination by the FSIS Administrator (Administrator), a laboratory will be refused accreditation for the following reasons: (a) A laboratory will be refused accreditation for failure to meet the requirements of the ALP as stated in this part. (b) A laboratory will be refused accreditation if the laboratory or any individual or entity responsibly connected with the laboratory has been convicted of, or is under indictment for, or has charges on any information brought against them in a Federal or State court concerning any of the following violations of law: (1) Any felony. (2) Any misdemeanor based upon acquiring, handling, or distributing of unwholesome, misbranded, or deceptively packaged food or upon fraud in connection with transactions in food. (3) Any misdemeanor based upon a false statement to any governmental agency. (4) Any misdemeanor based upon the offering, giving or receiving of a bribe or unlawful gratuity. (5) Altering any official sample or analytical finding; or substituting any analytical result from any other laboratory and representing the result as its own. | ||||||
| 9:9:2.0.2.4.46.0.40.6 | 9 | Animals and Animal Products | III | E | 439 | PART 439—ACCREDITATION OF NON-FEDERAL LABORATORIES FOR ANALYTICAL TESTING OF MEAT, POULTRY, AND EGG PRODUCTS | § 439.51 Probation of accreditation. | FSIS | Upon a determination by the Administrator, a laboratory will be placed on probation for the following reasons: (a) If the laboratory fails to complete more than one inter-laboratory accreditation maintenance proficiency testing sample analysis within 12 consecutive months, unless written permission is granted by the Administrator. (b) If the laboratory does not respond to ALP inquiries related to its participation in the program or fails to meet any of the requirements or criteria set in this part. (c) If the laboratory does not successfully demonstrate the maintenance of quality assurance capabilities including its results from inter-laboratory accreditation maintenance proficiency testing samples. ALP evaluation criteria are based on the ISO 13528 standard, to include performance evaluation by z score statistics. | ||||||
| 9:9:2.0.2.4.46.0.40.7 | 9 | Animals and Animal Products | III | E | 439 | PART 439—ACCREDITATION OF NON-FEDERAL LABORATORIES FOR ANALYTICAL TESTING OF MEAT, POULTRY, AND EGG PRODUCTS | § 439.52 Suspension of accreditation. | FSIS | A laboratory will be suspended from the program if probation status is not rectified according to program requirements stated in this part. The accreditation of a laboratory will be immediately suspended if the laboratory or any individual or entity responsibly connected with the laboratory is indicted or has charges on information brought against them in a Federal or State court for any of the following violations of law. A laboratory must notify the ALP within 30 calendar days if any of these situations occur. (a) Any felony. (b) Any misdemeanor based upon acquiring, handling, or distributing of unwholesome, misbranded, or deceptively packaged food or upon fraud in connection with transactions in food. (c) Any misdemeanor based upon a false statement to any governmental agency. (d) Any misdemeanor based upon the offering, giving or receiving of a bribe or unlawful gratuity. (e) Altering any official sample or analytical finding; or substituting any analytical result from any other laboratory and representing the result as its own. | ||||||
| 9:9:2.0.2.4.46.0.40.8 | 9 | Animals and Animal Products | III | E | 439 | PART 439—ACCREDITATION OF NON-FEDERAL LABORATORIES FOR ANALYTICAL TESTING OF MEAT, POULTRY, AND EGG PRODUCTS | § 439.53 Revocation of accreditation. | FSIS | A laboratory will have its accreditation revoked from the program if suspension status is not rectified. The accreditation of a laboratory will also be revoked for the following reasons: (a) An accredited laboratory will have its accreditation revoked if the Administrator determines that the laboratory or any responsibly connected individual or any agent or employee has: (1) Altered any official sample or analytical finding; or (2) Substituted any analytical result from any other laboratory and represented the result as its own. (b) An accredited laboratory will have its accreditation revoked if the laboratory or any individual or entity responsibly connected with the laboratory is convicted in a Federal or State court of any of the following violations of law. A laboratory must notify the ALP within 30 calendar days if any of these situations occur. (1) Any felony. (2) Any misdemeanor based upon acquiring, handling, or distributing of unwholesome, misbranded, or deceptively packaged food or upon fraud in connection with transactions in food. (3) Any misdemeanor based upon a false statement to any governmental agency. (4) Any misdemeanor based upon the offering, giving or receiving of a bribe or unlawful gratuity. | ||||||
| 9:9:2.0.2.4.46.0.40.9 | 9 | Animals and Animal Products | III | E | 439 | PART 439—ACCREDITATION OF NON-FEDERAL LABORATORIES FOR ANALYTICAL TESTING OF MEAT, POULTRY, AND EGG PRODUCTS | § 439.60 Notifications and hearings. | FSIS | Accreditation of any laboratory will be refused, suspended, or revoked under the conditions previously described in this part. The owner or operator of the laboratory will be sent written notice of the refusal, suspension, or revocation of accreditation by the Administrator. In such cases, the laboratory owner or operator will be provided an opportunity to present, within 30 days of the date of the notification, a statement challenging the merits or validity of such action and to request an oral hearing with respect to the denial, suspension, or revocation decision. An oral hearing will be granted if there is any dispute of material fact joined in such responsive statement. The proceeding will be conducted thereafter in accordance with the applicable rules of practice, which will be adopted for the proceeding. Any such refusal, suspension, or revocation will be effective upon the receipt by the laboratory of the notification and will continue in effect until final determination of the matter by the Administrator. |
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title_name TEXT,
chapter TEXT,
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