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Executive Summary

TOXIC RELEASE CONTROL BILL COULD IMPAIR DRUG MFRS.' OPERATIONS, the Pharmaceutical Mfrs. Assn. (PMA) maintained in a July 1 letter to Rep. Waxman (D-Calif.), a cosponsor of the legislation. The bill (HR 2576) "could impair the ability of our member firms to develop and manufacture the many medical products critically necessary for effective health care in this country," PMA President Mossinghoff asserted. In our view, Mossinghoff wrote, "the provisions of HR 2576 inappropriately mandate regulatory requirements for a large group of chemicals with little or no scientific validation as to their relative toxic characteristics." The legislation, introduced May 22 by Reps. Wirth (D-Colo.), Waxman and Florio (D-NJ), would apply to any substance which is released into the air and "causes or contributes to air pollution which may reasonably be expected to result in an increase in mortality or an increase in serious irreversible or incapacitating reversible illness." The bill also provides a preliminary list of 85 specific hazardous substances that may be released into the air. In addition, the bill gives the Environmental Protection Agency (EPA) authority to promulgate "leak control requirements; monitoring requirements; vapor recovery requirements; and other design, equipment, work practice, and operational requirements" applicable to devices and systems operated by mfrs. It also establishes a permit program for new or modified stationary sources of airborne toxic waste. Mossinghoff said that pharmaceutical production relies on a variety of chemical and biological processes which result in frequent changes in the particular emissions from the mfrs.' production units. The bill "would require a separate application for a permit from EPA or a designated state for a modification in the emissions from an individual unit of any of the chemicals listed in section 102. Since EPA must provide a formal adjudicatory hearing on all permit applications, the potential for delay is enormous," PMA maintained. A backlog in the permit application system could lead to temporary shutdowns of manufacturing facilities, the assn. asserted. "Such potential disruptions cannot be justified when the delays are caused by regulation of air emissions that have not even been determined to be hazardous."

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