Effluent Guidelines: Pharmaceutical Manufacturing - Development Document for Final Effluent Limitations Guidelines and Standards

EPA-821-R-98-005; September 1998

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This document can be downloaded in its entirety (PDF) (1.6 MB, 468 pages) or by individual sections as listed below.

• Table of Contents (PDF) (49 K, 18 pages)
• Section 1: Introduction (PDF) (22 K, 9 pages)
  • An introduction to the Technical Development Document, including the legal authority, background, and scope of the final Pharmaceutical Manufacturing Point Source Category Effluent Limitations Guidelines and Standards.
• Section 2: Summary (PDF) (30 K, 14 pages)
  • A brief summary of the subcategorization of the industry, applicability of the rule, and the pollutants regulated under BPT, BCT, and BAT effluent limitations guidelines, and NSPS, PSES, and PSNS.
• Section 3: Industry Description (PDF) (300 K, 56 pages)
  • A description of the pharmaceutical manufacturing industry including a summary of the data and information EPA has collected to develop revised effluent limitations guidelines and standards.
• Section 4: Industry Subcategorization (PDF) (41 K, 19 pages)
  • Discussion and results of the subcategorization analyses performed for the pharmaceutical manufacturing industry.
• Section 5: Water Use and Wastewater Characterization (PDF) (69 K, 31 pages)
  • A summary of water use and sources of wastewater, volume of wastewater generated, water conservation measures, and wastewater characterization from pharmaceutical manufacturing processes.
• Section 6: Pollutants Selected for Regulation (PDF) (45 K, 21 pages)
  • Identifies pollutants likely to be discharged in pharmaceutical manufacturing process wastewaters, and discusses the pollutants and pollutant parameters being regulated under BPT, BCT, and BAT effluent limitations guidelines and NSPS, PSNS, and PSES.
• Section 7: Description of the Control and Treatment Options (PDF) (141 K, 47 pages)
  • Describes the control and treatment options considered for promulgation of BPT, BCT, BAT, NSPS, PSES, and PSNS effluent limitations guidelines and standards, including pollution prevention measures and major wastewater treatment technologies used by the industry.
• Section 8: Performance of the Control and Treatment Options (PDF) (194 K, 65 pages)
  • Discusses the treatment performance data available for treatment options.
• Section 9: Pollutant Reduction Estimates (PDF) (63 K, 29 pages)
  • Presents estimates of raw and current pollutant discharge loads from the industry, along with estimates of the pollutant discharge loads and load removals after implementation of each of the treatment options considered.
• Section 10: Costs of Technology Bases of Regulations (PDF) (89 K, 45 pages)
  • Presents the estimated engineering costs associated with installing and operating each the technologies included in the treatment options.
• Section 11: Regulatory Options Selection (PDF) (24 K, 10 pages)
  • Discusses the final selected regulatory options and presents the factors considered in determining the selected options for BPT, BAT, NSPS, PSES, and PSNS.
• Section 12: Nonwater Quality Environmental Impacts (PDF) (52 K, 26 pages)
  • Discusses potential nonwater quality environmental impacts of the final regulatory options, including energy consumption, air emissions, and solid waste generation.
• Section 13: Best Practicable Control Technology (BPT) (PDF) (21 K, 9 pages)
  • Discusses the application of the final BPT effluent limitations guidelines.
• Section 14: Best Conventional Technology (PDF) (24 K, 11 pages)
  • Discusses the BCT cost test methodology and application of the final BCT effluent limitations guidelines.
• Section 15: Best Available Technology Economically Achievable (BAT) (PDF) (33 K, 16 pages)
  • Discusses the application of the final BAT effluent limitations guidelines.
• Section 16: New Source Performance Standards (NSPS) (PDF) (31 K, 15 pages)
  • Discusses the application of the final NSPS.
• Section 17: Pretreatment Standards for Existing Sources (PSES) and Pretreatment Standards for New Sources (PSNS) (PDF) (56 K, 27 pages)
  • Discusses the results of the POTW pass-through analysis to determine pollutants regulated by PSES and PSNS, and discusses the application of the final PSES and PSNS.