AdvaMed Welcomes EPA Extension of Comment Period for Complex Medtech Sterilization Regulations, Says There's "Not Nearly Enough" Time to Review Proposals Critical to Public Health

Apr 10, 2023

WASHINGTON, D.C. – AdvaMed, the Medtech Association, today welcomed the U.S. Environmental Protection Agency (EPA) extension of 15 more days for public comment on two proposed updates to regulations governing the use of ethylene oxide (EtO) to sterilize half of all medical technology in the United States each year. Even more time would have been preferable, as the regulations could cause shortfalls of critical medtech supplies, AdvaMed said.

"We asked the EPA for an extension of the comment period by 60 days for their proposed rules governing the EtO sterilization of 20 billion medical technologies annually, and we appreciate the members of Congress who recognized the need for this extension and requested it of EPA as well," said AdvaMed President and CEO Scott Whitaker. "The agency's extension of the comment period by two weeks, while not nearly enough, is certainly welcome, and we appreciate EPA leadership's recognition that more time for comment on these complex regulations is warranted. The time necessary to get both of them right is critical to ensuring the new regulations don't create a public health crisis down the road."

The EPA today announced a 15-day extension of the comment period for the proposed air toxics rule for Ethylene Oxide (EtO) Commercial Sterilizers, as well as the proposed interim decision and draft risk assessment addendum under the Federal Insecticide, Fungicide, and Rodenticide Act. The EPA said, "Several State, local, and industry groups requested more time to review the proposals. Consequently, EPA is extending the comment deadline from June 12, 2023, to June 27, 2023."

Many medtech items can be sterilized only with EtO. Because the highly controlled EtO sterilization process is at capacity, regulations that require facilities to source and install highly specialized equipment under unusually short implementation timeframes could force temporary or long-term facility closures. The lost capacity could cause medtech shortfalls, causing delays in patient care. The FDA commissioner shares this concern.

The medtech industry urges technology-neutral solutions to meet the EPA's goals, which it shares and already provides, of ensuring the safety of communities near sterilization facilities and facility employees.

Earlier, AdvaMed urged the EPA to double the amount of time for public comment on the rule, from 60 days to 120 days. In January, Whitaker wrote to President Biden outlining four principles for the EtO regulations, including the potential threat to patient care if facilities shut down. The medtech industry will comment formally on the proposed regulations.

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AdvaMed, the Medtech Association, urges the Environmental Protection Agency (EPA) to heed concerns of medtech supply shortfalls under its proposed requirements on ethylene oxide (EtO) sterilization and consider the effects on patient care.

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