"Anyone studying this issue can see that the EPA standard is impractical and does not meet the definition of good science,” said AdvaMed President and CEO Scott Whitaker. “The medical technology industry is committed to the safe and responsible use of EtO, even as we look for alternatives and ways to reduce EtO emissions. However, the EPA's risk standard sets an unreasonable threshold that will only threaten the continued availability of tens of billions of the EtO-sterilized medical technologies patients depend on.”
In comments on EPA’s proposed rule on the National Emissions Standards for Hazardous Air Pollutants (NESHAP) for Miscellaneous Organic Chemical Manufacturing sources, AdvaMed argues that EPA’s 2016 Integrated Risk Information System (IRIS) value for EtO should not be used for regulatory purposes. While the proposed rule does not apply to commercial sterilizers, it relies on the flawed IRIS value.
AdvaMed's full comments on the EPA proposed rule can be accessed here. Additional information on EtO and medical devices can be viewed here.