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PA EPA ANNOUNCES FIRST FLEXIBLE PERMITTING AIR TOXIC RULE
Release Date: 07/31/98
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FOR RELEASE: FRIDAY, JULY 31, 1998
EPA ANNOUNCES FIRST FLEXIBLE PERMITTING AIR TOXIC RULE
As part of EPA's flexible, common sense approach to environmental regulation, the Agency today announced a final rule significantly reducing emissions of air toxics from the pharmaceutical production industry. Air toxics are those pollutants known or suspected of causing cancer, birth defects or other serious health effects. The pharmaceutical manufacturing process consists mainly of chemical production operations used to produce drugs and medication. The regulation, which will affect about 100 existing facilities nationwide and any new plants built in the future, would reduce methylene chloride and other air toxic emissions by about 24,000 tons annually -- a 65 percent reduction from current levels. This is EPA’s first air toxic rule that allows a flexible approach to air pollution permitting. The pharmaceutical industry frequently undergoes changes in its operations to make different products. In order to avoid costly, time-consuming revision of air pollution permits every time a plant changes its production process, the facility will be allowed to choose from a menu of permit options already pre-approved by the permitting authority and reviewed by EPA and the public. Today’s regulation also demonstrates EPA’s commitment to making pollution prevention an integral part of regulatory actions whenever possible: Pharmaceutical facilities will have an alternative option for complying with the rule requirements, generally involving reduction in use of toxic solvents during the manufacturing process, rather than the traditional method of reducing emissions from the stack. This new option, if utilized, must result in an equivalent amount of overall toxic reduction. Today’s action also contains a common sense principle called "emissions averaging," that would allow facilities flexibility to vary the level of control among certain sources in order to achieve the required emission reductions. Plants may find it more cost-effective to over-control certain emission sources and undercontrol others, the overall result being equivalent or greater emission reduction at less cost. Existing pharmaceutical plants must comply with today’s rule within three years; new facilities must comply immediately on startup of operations. The final regulation will appear soon in the Federal Register, but can be read immediately on the internet under “Recent Actions” at website: https://www.epa.gov/ttn/oarpg. For further technical information on the regulation, contact Randy McDonald at 919-541-5402. Besides today’s action, EPA will issue regulations reducing air toxics from over 170 different industries by the year 2000.R-102 ###
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