National Emission Standards for Hazardous Air Pollutants for Source Categories: Pharmaceuticals Production

This action promulgates national emission standards for hazardous air pollutants (NESHAP) to reduce air emissions of hazardous air pollutants (HAP) from existing and new facilities that manufacture pharmaceutical products. The Agency intends that this promulgated rule will have a common technology basis with a rule promulgated this date under the Clean Water Act (CWA) and published elsewhere in this issue of the Federal Register; this will allow coordinated and cost effective compliance planning by the industry. The standards implement section 112 of the Clean Air Act (CAA) as amended in 1990. The standards apply to major source facilities which produce pharmaceutical products. The major HAP emitted by facilities covered by this final rule 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.