PHARMACEUTICAL MANUFACTURING POLLUTANT CONTROL GUIDELINES

Executive Summary

PHARMACEUTICAL MANUFACTURING POLLUTANT CONTROL GUIDELINES will retain subcategories from the Environmental Protection Agency's 1983 final regulations based on Best Practicable Technology, EPA announced in a Dec. 16 Federal Register notice. The agency's final rule establishing "best conventional pollutant control technology" (BCT) effluent limitations guidelines denotes four subcategories for pollution control: fermentation; biological extraction; chemical synthesis; and formulation. In November 1982, EPA proposed to combine the four groups into one subcategory. After analysis of existing data, however, EPA says it agrees with objections to the 1982 proposal. The final regulation "would limit the discharge of five-day biochemical oxygen demand (BOD5) and total suspended solids (TSS) into waters of the U.S. by existing sources that conduct pharmaceutical manufacturing operations," EPA stated. The regulation also "maintains the acceptable pH range for pharmaceutical wastewater discharges." EPA said the regulation does not cover facilities which engage only in pharmaceutical research (chemical, biological or microbiological). EPA noted that BCT limitations are assessed "in light of a two-part 'cost reasonableness' test." The first test "compares the cost for private industry to reduce its conventional pollutants to the costs for similar levels of reduction at publicly owned treatment works" and the second "examines the cost effectiveness of additional treatment beyond BPT" (Best Practicable Technology). EPA said it originally proposed BCT effluent limitation guidelines more stringent than the BPT effluent limitation guidelines. However, EPA stated, "none of the BCT candidate technologies pass the recently promulgated BCT cost test in any of the subcategories. Thus, final BCT effluent limitation guidelines are being established equal to existing BPT effluent limitation guidelines for all four subcategories." The agency also noted that it has made changes to its pharmaceutical treatment plant costing methodology since the 1982 proposal. EPA referred to the New Source Performance Standards (NSPS) model plant costs in which the agency "used subcategory average data, i.e. flow, influent and effluent BOD5 and TSS concentrations." BPT and BCT individual plant cost methodology differs from NSPS methodology only in that EPA used data supplied by individual plants when available and subcategory average data when individual plant data were not available.