Sec. 2. Findings
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The Congress finds the following: Ethylene oxide is a human carcinogen that causes increased cancer risk at very low concentrations in air. The Environmental Protection Agency produced a cancer risk estimate due to ethylene oxide inhalation in 1985 and again in 2016. Due to significant advances in our scientific understanding of ethylene oxide carcinogenicity, the risk estimate increased by a factor of 30 over that period of time. The Environmental Protection Agency has not updated its National Emissions Standards for Hazardous Air Pollutants for ethylene oxide sterilization facilities or hospital ethylene oxide sterilizers since the 2016 risk estimate was published.
According to the Environmental Protection Agency’s most recent National Air Toxics Assessment, ethylene oxide is the biggest contributor to cancer risk in 93 out of the top 100 census tracts in the country with the highest cancer risk due to air pollution. In 58 of those tracts, the cancer risk due to ethylene oxide is greater than 100 cases per million people, the level at which the Agency considers an air pollutant to pose a public health threat beyond an ample margin of safety.
Section 112 of the Clean Air Act ( 42 U.S.C. 112 ) requires the Environmental Protection Agency to revise emissions standards for hazardous air pollutants no less often than every 8 years, yet the standard for ethylene oxide sterilization facilities was last updated in 2006 and the standard for hospital ethylene oxide sterilizers was last updated in 2007. In 2001, the Environmental Protection Agency eliminated the requirement that ethylene oxide sterilization facilities control emissions from their sterilization chamber vents.
Emissions from those vents are a significant contributor to the elevated cancer risk estimated in the National Air Toxics Assessment. The current National Emissions Standards for Hazardous Air Pollutants for ethylene oxide sterilizers and hospital ethylene oxide sterilizers do not protect public health with an adequate margin of safety.
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