Small Business Environmental Roundtable – April 25, 2023

The next U.S. Small Business Administration, Office of Advocacy Environmental Roundtable will meet virtually to discuss the following topics, beginning at 10 AM on April 25, 2023. The meeting will be held using the Microsoft Teams platform.

Send your RSVP to David Rostker at David.Rostker@sba.gov. A meeting link will be provided to you when you RSVP.


AGENDA

10:00 AM – 10:30 PM
Proposed NESHAP for Ethylene Oxide Emissions Standards for Commercial Sterilization Operations: Residual Risk and Technology Review
Jonathan Witt, EPA Office of Air and Radiation

10:30 AM – 11:00 AM
Ethylene Oxide Proposed Interim Registration Review Decision
Jessie Bailey, Chemical Review Management, EPA Office of Pesticide Programs
Eric Miederhoff, Branch Chief, EPA Office of Pesticide Programs

11:00 AM – 11:30 AM
Q&A and Discussion

Roundtable meetings are open to all interested persons and are intended to facilitate an open and frank discussion about issues of interest to small business. These meetings are off the record and not intended for press purposes. Direct quotations of presenters or attendees may not be used without direct written approval of the person(s) making the statement. All press inquiries should be sent to Stephanie Fekete at Stephanie.Fekete@sba.gov. Agendas and presentations are available to all.


Office of Advocacy Small Business Environmental Roundtable
Issues for Discussion
April 25, 2023

Ethylene Oxide in Commercial Sterilization Operations

Ethylene Oxide is used on half of the sterilized medical devices in the United States. However, since 2016, when EPA updated its Integrated Risk Information System classification of ethylene oxide (EtO) as a carcinogen, EPA has been considering more stringent standards for the use of EtO and emissions of EtO from a range of industrial facilities. EPA is now preparing to release proposals under two separate programs that would significantly impact the use of EtO in commercial sterilization operations: emission standards under the Clean Air Act, and restrictions on use under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA intends to publish both actions in the Federal Register soon for public notice and comment.

EPA will present on these actions. There will be an opportunity for questions, as well as discussion. Perspectives from small commercial sterilization operations as well as small medical device manufacturers are welcome.

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