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Effluent Guidelines
Pharmaceutical Manufacturing Point Source Category
Permit Guidance Document
Fact Sheet; EPA# 821-F-05-006; January 2006
EPA prepared a guidance document to help permit writers and pretreatment coordinators develop wastewater discharge permits and pretreatment requirements for pharmaceutical manufacturing facilities.
Background
On September 21, 1998, we revised existing regulations for the pharmaceutical industry to control both effluent discharges and air emissions (40 CFR Part 439). Wastewater regulations apply to facilities with operations in these subcategories:
- fermentation
- extraction
- chemical synthesis
- mixing, compounding and formulating
Direct discharging facilities with operations in these four manufacturing subcategories were required to comply with the 1998 regulations by November 20, 1998, and existing indirect discharging facilities had to comply no later than September 21, 2001.
Purpose of the Guidance Document
This guidance addresses questions raised by permit writers and control authorities who issue National Discharge Elimination System (NPDES) permits and enter into pretreatment agreements. This document is intended solely as guidance, and is not a regulation nor does it impose legally binding requirements. In the event of a conflict with any statute or regulation, this document would not be controlling.
Summary of Information Included in the Guidance
The guidance includes the following types of information:
- scope of the 1998 regulation
- new pollutants covered by the rule
- the model process technologies upon which the rule is based
- where facilities must demonstrate compliance
- the numerical effluent limitations guidelines and standards that apply
- the permit issuance process
- case studies showing the development of NPDES permits in each subcategory
- instructions for finding additional information
- glossary of terms
For More Information
Contact EPA's Pharmaceutical Manufacturing subject matter expert for more information.
Permit Guidance Document - Pharmaceutical Manufacturing Point Source Category (EPA/821-8-04-003).