The United States Environmental Protection Association has proposed regulations that require new and existing major sources engaged in the manufacture of pharmaceutical products to reduce their emissions of hazardous air pollutants ("HAPs") to the levels achievable by maximum achievable control technology ("MACT"), taking into consideration health and environmental impacts, energy requirements and the cost of achieving the emission reductions. Generally, a "major source" is any facility that emits or has the potential to emit at least 10 tons of any one HAP per year or at least 25 tons of any combination of HAPs per year.
The major HAPs emitted by pharmaceutical production facilities subject to this proposal include methylene chloride, methanol, toluene and hydrogen chloride. Some of these pollutants are considered to be carcinogenic and all can cause toxic health effects. USEPA estimates that implementation of the proposed rule will reduce HAP emissions by 65% from current levels and will result in a total annual cost to the industry for existing and new sources of approx-imately $62 million and $11 million, respectively.
