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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

Compliance Assistance Tool for Pharmaceutical Production, Pesticide Active Ingredient Production, and Miscellaneous Organic Chemical Manufacturing NESHAP: Comparison of Regulatory Requirements and Case Study Compliance Illustrations for Nondedicated Equipment

Compliance Assistance Tool for Clean Air Act Regulations: Subpart GGG of40 CFR NESHAPS for Source Category Pharmaceutical Production