Impact of National Emission Standards for Hazardous Air Pollutants (NESHAP) for Ethylene Oxide Commercial Sterilizers on the U.S. Spice Industry

On March 14, 2024, the U.S. Environmental Protection Agency (EPA) announced final amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for ethylene oxide (EtO) emitted from commercial sterilization facilities. This final rule is one of a series of coordinated actions that EPA is taking to reduce exposure to EtO. EPA’s Office of Pesticide Programs is also working on a forthcoming set of new worker safety mitigation measures for EtO, which will also address the continued authorization of EtO on spices and is expected to come out later this year.

In the final NESHAP rule, EPA is tightening emissions limits, requiring total enclosure capture systems, imposing new controls of chamber exhaust, aeration room vents, and sterilization chamber vents, and establishing new monitoring and reporting requirements.

On Thursday, April 4, ASTA presented this webinar. To hear a summary of the final rule and discussion on its implications for spice companies using EtO, click the link below to view the recording.

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David Howe

Chief Operating Officer, Cosmed Group, Inc.

David Howe is the Chief Operating Officer of Cosmed Group, Inc. For more than thirty years, Cosmed Group has developed and deployed pasteurization technologies for the agricultural and food manufacturing industries and provided sterilization services and equipment for medical device manufacturers. The company has installed more than one hundred sterilization and pasteurization systems worldwide.

As COO of the company, Mr. Howe oversees multiple facilities providing contract services for post-harvest agricultural commodities, including nuts, spices, and dried fruits. He directs the sales of equipment to food and medical device manufacturers. Mr. Howe has developed technologies using steam, dry heat, methyl bromide, ozone, ethylene oxide, and propylene oxide. He is a co-inventor of US Patent 6800246, “Bulk decontamination and determination of materials in a sub-atmospheric saturated steam environment.”

Before working in the food pasteurization division of Cosmed Group, Mr. Howe spent years in medical device sterilization. He participated in the construction of five contract sterilization facilities. During that time, his responsibilities included managing production and quality departments, process validation, and cGMP/QSR compliance.

Among other professional affiliations, Mr. Howe is a member of the International Association of Food Protection, the American Spice Trade Association, where he formerly served on the Board, the Ethylene Oxide Sterilization Association and is a long-time member of the Association for the Advancement of Medical Instrumentation.

He has enjoyed a close working relationship with several U.S. regulatory agencies, including the Food and Drug Administration, the Department of Agriculture and the Department of State.

Elizabeth “Liz” Alice Och

Attorney, Hogan Lovells LLP

Liz Och is a commercial litigator in the Denver office of Hogan Lovells, where she represents clients in complex environmental litigation matters across the United States. She counsels clients in all stages of a case, from initial case assessment through trial; she also has experience with both government and internal compliance investigations. Liz is quick to learn her clients’ industries and motivations to identify pragmatic, business-minded solutions. Clients value Liz’s leadership, team-mindedness, and project-management skills. Liz has experience litigating cases arising under the federal environmental laws, including the Clean Air Act and the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Her work includes representation of facilities using ethylene oxide in sterilization processes across the United States.

Liz earned an M.S. from the University of Michigan School of Natural Resources and Environment in 2014,
J.D. from the University of Michigan Law School, cum laude, in 2013 and B.A., from Northwestern University, in 2010.