EPA Fact Sheet
Direct^Final Rule to Amend Effluent Limitations Guidelines for the
Pharmaceutical Manufacturing Point Source Category
EPA is making minor changes to the effluent guidelines for Pharmaceutical Manufacturing. The
amendments: clarify the applicability dates for new dischargers; correct an inadvertent
omission and re-establish a minimum concentration for the monthly average BOD5 limitation;
and correct a calculation and delete methyl Cellosolve from some pretreatment standards.
Background
In 1998, EPA promulgated effluent limitations for the Pharmaceutical Manufacturing Point
Source Category. This regulation established effluent limitations guidelines, pretreatment
standards and new source performance standards under the Clean Water Act for the
pharmaceutical manufacturing industry.
In response to comments from the regulated community and after further review of the rule, the
Agency decided to make several minor changes. First, this direct final rule clarifies when
specific provisions apply to new sources. It eliminates confusion about when those facilities
(classified as new sources under the earlier version) are subject to the new, more stringent
standards of the 1998 rule. Second, two sections of the 1998 regulation unintentionally omitted a
maximum concentration for the monthly average BOD5 limitation. Third, EPA's analysis for the
1998 rule used an incorrect value for the Henry's Law Constant (HL) of methyl Cellosolve. This
caused the compound to be classified as a volatile organic compound (VOC), making it subject
to the 1998 pretreatment standards. The correct HL value for methyl Cellosolve indicates that it
is not a VOC, and this compound will not pass through publicly owned treatment works.
Therefore, methyl Cellosolve should be removed from the pretreatment standards.
Direct Final Rule
EPA is publishing this direct final rule without first proposing it. The amendments are non-
controversial and have no significant impact on the regulated community or the environment.
Except for the withdrawal of methyl Cellosolve from the pretreatment standards, the corrections
reflect actual practice. This rule will become effective 90 days after publication in the Federal
Register unless the Agency receives adverse comment within 30 days, in which case we will
withdraw the rule.
Additional Information
You can get more information about this direct final rule by contacting Dr. Frank Hund, U.S.
Environmental Protection Agency, Office of Science and Technology, 4303T, 1200
Pennsylvania Avenue, N.W., Washington, DC 20460. (e-mail: Hund.frank@epa.gov) You can
also find the complete text of the Federal Register notice on the Internet at

-------
http://epa.pov/ guide/pharm.html.

-------