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Effluent Guidelines
Pharmaceutical Manufacturing
Partial Withdrawal of Direct Final Rule
Fact Sheet; June 2003
EPA published a direct final rule and companion proposed rule on March 13, 2003, to amend a final rule establishing effluent guidelines and standards for the Pharmaceutical Manufacturing Point Source Category published on September 21, 1998. In this direct final rule, EPA clarified the date on which a discharger subject to the New Source Performance Standards (NSPS) and the Pretreatment Standards for New Sources (PSNS) would be subject to effluent limitations and pretreatment standards established in the 1998 regulation.
EPA also re-established a minimum concentration for the monthly average BOD5 limitation EPA inadvertently omitted from the Best Practicable Control Technology (BPT) requirements in two subcategories of the 1998 regulation and corrected an error in EPA's pass-through analysis from the 1998 rule. This correction deleted methyl Cellosolve (2- methoxyethanol) from the pretreatment standards in two subcategories and from Appendix A, Table 2, "Surrogate Parameters for Indirect Dischargers." Finally, the Agency made other non-substantive editorial and format changes such as removing redundancies and adding definitions.
The partial withdrawal of the direct final rule involves withdrawing the language in subsections (a) and (b) in sections 439.17, 439.27, 439.37, and 439.47 regarding the compliance schedule for new source indirect dischargers that commenced operations after November 21, 1988, and prior to November 20, 1998. More specifically, EPA received comment concerning the applicability of the 10-year protection period provided in section 306(d) of the Clean Water Act for new source facilities and is withdrawing the related provisions from the direct final rule. This withdrawal does not affect the re-establishment of the BOD5 monthly average under BCT or the deletion of methyl Cellosolve in the pretreatment standards in two subcategories.
Background on Pharmaceutical Manufacturing Regulations
- On September 21, 1998, EPA published final regulations in the Federal Register to establish effluent limitations, guidelines, and standards for the pharmaceutical manufacturing point source category (40 CFR Part 439).
- On March 13, 2003, EPA published a direct final rule amending the final rule and making editorial and format changes.
- EPA received adverse comment from one party who raised concerns over the applicability of the 10-year protection period provided in section 306(d) of the Clean Water Act for new source facilities.
- This action withdraws the 10-year period of protection regarding new source indirect dischargers in four sections of 40 CFR Part 439.
- This withdrawal does not affect the re-establishment of the BOD5 monthly average under BCT or the deletion of methyl Cellosolve in the pretreatment standards in two subcategories.
- This action will not add costs or benefits to those resulting from the September 1998 rule.
For More Information
Contact EPA's Pharmaceutical Manufacturing subject matter expert for more information.