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Pharmaceutical Manufacturing Effluent Guidelines
The EPA promulgated the Pharmaceutical Manufacturing Effluent Guidelines and Standards (40 CFR Part 439Exit EPA’s website) in 1976 and amended the regulation in 1983, 1998, and 2003. The Effluent Guidelines are incorporated into NPDES permits for direct dischargers and permits or other control mechanisms for indirect dischargersindirect dischargersA facility that discharges pollutants to a publicly owned treatment works (municipal sewage treatment plant). (refer to Pretreatment Program).
On this page:
* Facilities Covered
* Guidance and Analytical Methods Documents
* Rulemaking History
* Additional Information
Facilities Covered
The regulation applies to facilities organized into the following five subcategories: * Fermentation Products (Subpart AExit EPA’s website) * Extraction Products (Subpart BExit EPA’s website) * Chemical Synthesis Products (Subpart CExit EPA’s website) * Mixing/Compounding and Formulation (Subpart DExit EPA’s website) * Research (Subpart EExit EPA’s website)
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 RuleExit EPA’s website (June 11, 2003)
Corrections regarding compliance dates - Direct Final RuleExit EPA’s website (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 RuleExit EPA’s website (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 the Pharmaceutical Manufacturing Effluent Guidelines, please contact Meghan Hessenauer (hessenauer.meghan@epa.gov) or 202-566-1040.
Effluent Guidelines
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