Effluent Guidelines

Pharmaceutical Manufacturing

Direct Final Rule

Fact Sheet; July 1998

EPA is publishing final effluent limitations guidelines and standards in the Federal Register that will control discharges of waterborne pollutants from the pharmaceutical manufacturing category to surface waters and publicly owned treatment works. These regulations were proposed on May 2, 1995 and the Agency published a Notice of Data Availability on August 8, 1997 which suggested responses to comments on the 1995 proposed regulations. At the same time, EPA is also publishing Maximum Available Control Technology (MACT) Standards for the Pharmaceutical Manufacturing Industry which will control air emissions of Hazardous Air Pollutants (HAPS) from pharmaceutical manufacturing sources in the Federal Register.

Background

On May 2, 1995, EPA proposed effluent guidelines and standards for the pharmaceutical manufacturing industry (60 FR 21592). On April 2, 1997 at 62 FR 15753, EPA proposed MACT Standards for the pharmaceutical manufacturing industry. On August 8, 1997 at 62 FR 42270, EPA published a Notice of Data Availability that presented revised technology options in light of the MACT proposal, announced the receipt of new data, suggested responses to some major comments on the proposal and presented the results of data analyses for review and comment. After considering the comments and data provided in response to the proposed regulations, EPA is publishing final BPT, BAT, NSPS, PSES, and PSNS for four subcategories of the pharmaceutical manufacturing categories: Subcategory A (Fermentation), Subcategory B (Natural Extraction), Subcategory C (Chemical Synthesis), and Subcategory D (Mixing, Compounding and Formulating).

Effect of Agency Action

Compliance with this final regulation is estimated to reduce the discharge of conventional, nonconventional and priority pollutants by at least 31.1 million pounds per year and to cost an estimated $39.4 million (post-tax, 1997 dollars) per year. One facility closure is projected to result. Monetized benefits of compliance with this final regulation range from $0.9 million to $14.0 million (1997 dollars) per year.

For More Information

Contact EPA's Pharmaceutical Manufacturing subject matter expert for more information.

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