The rollback
The rollback: EPA's March 2026 proposal to set aside the 2024 risk-based standards — the contested science.
Free field guide · PDF
EtO Sterilization2026 Field Guide
The rollback, the settlement, and the supply-chain stakes — with the regulatory practice you need.
- Devices/yr
- 20B
- EtO cut
- 99.99%
- Delay
- 2-yr
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The settlement
The settlement: the $700,000 Steri-Tech consent decree — 99.99% EtO reduction with continuity.
The supply-chain stakes
The supply-chain stakes: 20 billion devices a year, the closure risk, and the alternative-modality map.
Sources & scope
- epa.gov, EPA and DOJ Reach $700,000 Settlement with Puerto Rico Sterilizer (Sep 2026).
- cancertherapyadvisor.com, EPA Aims to Relax Emission Standards For Gas Used to Sterilize Medical Devices.
- medtechdive.com, Trump delays ethylene oxide emissions standards for device sterilizers.
This guide is market-access intelligence, not regulatory, environmental, or legal advice. EPA emission rules, enforcement actions, and sterilization standards change — professional review is required before business use.
Market Access Strategy Session
Sterilization on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your sterilization route — capacity risk, modality strategy, and regulatory tracking.
Professional review is required before business use.
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