BDX · 10-Q · 2026Q2 · Full report

Ethylene Oxide Regulation

BECTON DICKINSON & CO · 2026-08-06 · Importance 40 · Surprise 42 · In source text

The EPA and state environmental regulators are increasing scrutiny of ethylene oxide emissions, which could require BD or its sterilization providers to install controls, limit usage, suspend operations, or incur additional costs. The EPA’s revised NESHAP for ethylene oxide sterilization facilities became effective April 5, 2024; although BD’s facilities received a two-year Presidential compliance exemption on July 17, 2025, BD continues implementing required facility changes and investing in new technologies. On March 17, 2026, the EPA proposed revisions to the NESHAP following its residual-risk and technology review, while a January 14, 2025 EPA pesticide registration review decision also requires additional ethylene oxide work practices. Regulatory interruptions or capacity limitations could disrupt sterilization and production of certain products, and BD may face civil litigation or other claims.

Key facts

• On July 17, 2025, the White House issued a Presidential Proclamation under the Clean Air Act exempting certain sterilization facilities for two years from compliance with the EPA’s revised NESHAP for ethylene oxide emissions to allow more time to design, procure, install and test new control technology and implement other changes. source
• On March 17, 2026, the EPA published the NESHAP: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review Reconsideration which proposes certain revisions to the April 5, 2024 rule. source
• Companies generally have two years from the April 5, 2024 effective date to comply with the new requirements of the revised NESHAP. source
• The MD&A states there has been increased regulatory focus on the use and emission of ethylene oxide in sterilization processes and that additional regulatory requirements may be imposed in the future that could adversely impact BD or its third-party sterilization providers. source
• The final NESHAP: Ethylene Oxide Emissions Standards for Sterilization Facilities regulation issued by the EPA became effective on April 5, 2024. source
• On January 14, 2025, the EPA published a Notice of Availability for a Pesticide Registration Review; Interim Registration Review Decision for Ethylene Oxide (ID) regulating the use of ethylene oxide as a sterilant. source

Impact estimates