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Technology Transfer Network - OAR Policy and Guidance





  • On October 31, 2006, the Environmental Protection Agency (EPA) proposed standards to reduce emissions of ethylene oxide from hospital sterilizers.
  • At hospital sterilizers, ethylene oxide is used to sterilize medical equipment. Today’s proposal covers all facilities nationwide.
  • This rule is a part of the 1999 Urban Air Toxics strategy to reduce air toxics in all areas of the country. Congress required EPA to develop this strategy in the Clean Air Act amendments of 1990.
  • This proposal requires all hospitals which do not control their emissions of ethylene oxide to reduce emissions by sterilizing full loads to the extent practical. Hospitals which route ethylene oxide to a control device are exempt from the management practice.
  • EPA estimates that the propose rule would prevent 5 tons per year of ethylene oxide emissions at a cost of less than $2 million per year.
  • Today’s action announces EPA’s proposed management practice and requests public comments.
  • EPA is requesting comment on this proposed action for 60 days following publication in the Federal Register. The Agency will hold a public hearing if requested to do so.

  • The Clean Air Act Amendments of 1990 require EPA to regulate sources of 187 listed toxic air pollutants. The Clean Air Act also requires EPA to identify industrial or “source” categories that emit one or more of these pollutants.
  • For major sources within each source category, the Clean Air Act required EPA to develop standards that restrict emissions to levels consistent with the lowest-emitting (also called best-performing) plants. Major sources are those that emit 10 tons a year or more of a single toxic air pollutant or 25 tons a year or more of a combination of air toxics. Facilities emitting below the major source threshold are considered “area sources.”
  • The Clean Air Act further required EPA to develop a strategy to identify and reduce emissions of these toxic air pollutants in urban areas. To meet that requirement, EPA published its Integrated Urban Air Toxics Strategy (Strategy) on July 19, 1999, in the Federal Register.
  • As part of the Strategy, EPA identified a list of the 33 air toxics that present the greatest threat to public health in the largest number of urban areas (see attached table for list of urban air toxics). Of these 33 urban air toxics, EPA has identified the 30 with the greatest contribution from smaller commercial and industrial operations or so-called “area” sources.
  • In the Strategy published July 19, 1999, EPA also identified 29 area source categories that contribute to the emissions of these 30 listed air toxics. Hospital sterilizers was one of the area source categories listed in the Strategy. Subsequent notices published on June 26 and November 22, 2002, added 41 source categories to the list of area sources.
  • EPA is proposing this rule today, as agreed upon with the Sierra Club, and will take final action by December 20, 2007.
  • Interested parties can download the notice from EPA's website on the Internet under recently signed rules at the following address: https://www3.epa.gov/ttn/oarpg/t3/fr_notices/hosp_strlzr_prop_110106.pdf
  • Today's proposed action and other background information are also available electronically in EPAs electronic public docket and comment system.
  • Today’s proposed action is also available at the EPA Docket Center (EPA/DC) Public Reading Room. However, due to recent flooding, the center is currently under construction, and public access will be limited until November 6, 2006. Please visit the following website frequently (https://www.epa.gov/epahome/dockets.htm) in order to receive the latest status concerning access to the Public Reading Room and access to docket materials during the construction period. Please call (202) 566–1744 between the hours of 8:30 A.M. and 4:30 P.M. Eastern Standard Time for more information.
  • Comments should be identified by Docket ID No. EPA-HQ-OAR-2005-0171 and submitted by one of the following methods:
    • Federal e-rulemaking portal (http://www.regulations.gov);
    • E-mail (a-and-r-docket@epa.gov);
    • Facsimile ((202) 566-1741);
    • Mail (Air and Radiation Docket and Information Center, Environmental Protection Agency, Mail Code: 6102T, 1200 Pennsylvania Avenue, NW, Washington, DC 20460).
  • For additional information, contact David Markwordt of the EPAs Office of Air Quality Planning and Standards at (919) 541-0837 or by e-mail at markwordt.david@epa.gov.

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