Pharmaceuticals Production Industry: National Emission Standards for Hazardous Air Pollutants (NESHAP)
Rule Summary
These national emission standards for hazardous air pollutants (NESHAP) apply to major source facilities which produce pharmaceutical products. The major HAP emitted by these facilities include methylene chloride, methanol, toluene, and hydrogen chloride. Methylene chloride is considered to be a probable human carcinogen and the other pollutants can cause noncancer health effects in humans. The promulgated rule is estimated to reduce HAP emissions from existing facilities by 22,000 megagrams per year (Mg/yr) (24,000 tons per year [tons/yr]). It also reduces volatile organic compound (VOC) emissions.
Rule History
04/02/1997 - Proposed rule and notice of public hearing
09/21/1998 - Final rule
01/05/2000 - Notice of proposed settlement; request for public comment
04/10/2000 - Proposed rule; amendments
08/29/2000 - Final rule; amendments
08/02/2001 - Final rule and direct final rule; corrections and amendments
05/13/2005 - Proposed rule; amendment
05/13/2005 - Direct final rule; amendments
10/21/2010 - Proposed rule; and supplemental notice of proposed rulemaking
04/21/2011 - Final rule
Additional Resources
Basis and Purpose Document for the proposed NESHAP for Pharmaceuticals Production
Summary of Public Comments and Responses for Final NESHAP for Pharmaceuticals Production
Fact Sheet: Proposed Air Toxics Rule for Pharmaceutical Production
Compliance
Title V Permit for Merck Sharp and Dohme Quimica in Barceloneta, Puerto Rico
Inspection Checklist for Pharmaceuticals MACT Standard 40 CFR Part 63