2025-01471Presidential Document

President Tackles Obscure Chemical Most People Can't Pronounce

Published Date: 1/17/2025

Presidential Document

Summary

The government is rolling out new air pollution rules for places that sterilize medical products using ethylene oxide (EtO), a chemical linked to cancer risks. These rules help protect communities, especially kids, by cutting harmful emissions while making sure hospitals keep getting the medical supplies they need. Sterilization facilities must upgrade their equipment soon, which might cost money but will make the air safer for everyone.

Analyzed Economic Effects

4 provisions identified: 2 benefits, 1 costs, 1 mixed.

Presidential exemptions up to two years

Commercial sterilizers may seek a Presidential exemption from an EtO standard under 42 U.S.C. 7412(i)(4) if they can show control technology is unavailable and that, despite due diligence, they cannot comply before the deadline and a shutdown would likely cause a serious disruption to the medical product supply. Exemptions may be no longer than two years; requests must be filed no earlier than 12 months and no later than 4 months before the compliance deadline. The memorandum sets review timelines: EPA must confirm receipt within 30 days, set a 15‑day deadline for any missing information, provide a recommendation to the Council on Environmental Quality no later than 30 days after EPA has all information, CEQ should advise the President generally within 45 days, EPA must notify the applicant within 10 days after a Presidential grant or denial, and EPA must publish facility and duration information within 60 days of any grant.

Sterilizers must install EtO controls

If your facility sterilizes medical products using ethylene oxide (EtO), you must meet the EPA EtO Rule (Final Rule issued April 5, 2024) by installing demonstrated pollution‑control technology and meeting the Rule's compliance deadlines set under section 112 of the Clean Air Act.

HHS to spur alternatives and report in two years

The Secretary of Health and Human Services, in consultation with EPA, shall consider steps to spur innovation to reduce EtO exposure, expand access to safe alternative sterilization methods that do not depend on EtO, and strengthen medical‑supply‑chain resilience, and must provide a report on progress to the Chairman of the Council on Environmental Quality within 2 years of this memorandum.

EPA must assist and disclose exemption details

If a facility receives a Presidential exemption, EPA shall provide technical assistance to help the facility achieve compliance, seek assurances that the facility will use best efforts to install required technology as soon as practicable, and inform CEQ when installation is complete. EPA must also publicly notify when a request is submitted and, within 60 days of a granted exemption, publish the name, location, and duration of the exemption and submit the required report to Congress.

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Key Dates

Effective Date
Published Date
1/16/2025
1/17/2025

Department and Agencies

Department
Independent Agency
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