Pharmaceutical Manufacturing Effluent Guidelines
The EPA promulgated the Pharmaceutical Manufacturing Effluent Guidelines and Standards (40 CFR Part 439) in 1976 and amended the regulation in 1983, 1998 and 2003. The Effluent Guidelines are incorporated into NPDES permits for direct dischargersA point source that discharges pollutants to waters of the United States, such as streams, lakes, or oceans., and permits or other control mechanisms for indirect dischargersA facility that discharges pollutants to a publicly owned treatment works (municipal sewage treatment plant). (refer to Pretreatment Program).
Facilities Covered
The regulation applies to facilities organized into five subcategories:
- Fermentation Products
- Extraction Products
- Chemical Synthesis Products
- Mixing/Compounding and Formulation
- Research
Guidance and Analytical Methods Documents
- Guidance Document (2006)
Assists permit writers and pretreatment coordinators in developing appropriate NPDES permits and pretreatment requirements for pharmaceutical facilities - Approved Analytical Methods for Pharmaceutical Pollutants
Rulemaking History
2003 Amendment
- Partial withdrawal of Direct Final Rule (June 11, 2003)
Corrections regarding compliance dates - Direct Final Rule (March 13, 2003)
Clarification of compliance dates; correction to effluent limitations; additional definitions
1998 Amendment
Major revision of BPT, BAT, NSPS, PSES, and PSNS for Subparts A-D
- Final Rule (September 21, 1998)
- Development Document
Describes industry processes, pollutants generated, available control and treatment technologies, the technical basis for the final rule, and costs of the rule - Economic Analysis
1983 Amendment
- Final Rule (October 27, 1983)
BAT, NSPS, PSES, PSNS; revised BPT
1976 Initial Rulemaking
- Interim Final Rule (November 17, 1976)
Initial BPT limitations
Additional Information
For additional information regarding Pharmaceutical Manufacturing Effluent Guidelines, please contact Meghan Hessenauer (hessenauer.meghan@epa.gov) or 202-566-1040.