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.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth