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The American Chemistry Council strongly objects to proposed reduction of ethylene oxide, which plays an important role in EV battery development and medical device sterilization.

Bruce Adams

April 12, 2023

5 Min Read
chemical plant in Louisiana's "cancer alley"
Giles Clarke/Getty Images News

A proposal from the Environmental Protection Agency (EPA) to strengthen standards for chemical and polymer plants would reduce the number of people with elevated cancer risk by 96% in communities surrounding chemical plants and cut more than 6,000 tons of toxic pollution per year, the agency said.

The proposal would “significantly reduce hazardous air pollutants from chemical plants, including the highly toxic chemicals ethylene oxide (EtO) and chloroprene,” said the EPA.

The initiative aims to advance President Biden’s commitment to end cancer as part of the Cancer Moonshot and to secure environmental justice and protect public health, including among communities that are most exposed to toxic chemicals. EPA Administrator Michael Regan made the announcement on April 6 in St. John the Baptist Parish, LA.

Living in the "shadows of chemical plants"

“For generations, our most vulnerable communities have unjustly borne the burden of breathing unsafe, polluted air,” Regan said. “When I visited St. John the Baptist Parish during my first Journey to Justice tour, I pledged to prioritize and protect the health and safety of this community and so many others that live in the shadows of chemical plants. I’m proud that this proposal would help deliver on that commitment and protect people from toxic air pollution in communities across the country. Every child in this country deserves clean air to breathe, and EPA will use every available tool to make that vision a reality.” 

Commenting on the proposal, the Plastics Industry Association (PLASTICS) told PlasticsToday that "PLASTICS' members are invested in the communities in which they operate and remain committed to social responsibility. Wherever companies are located, it's important for them to be a part of the community. We take human health very seriously, support science- and fact-based regulations, and will review the EPA's proposals."

Proposal seeks to reduce EtO production by 58 tons annually

EPA’s proposal would update several regulations that apply to chemical plants, including plants that make synthetic organic chemicals and polymers, such as neoprene. The updates would eliminate 6,053 tons of toxic emissions each year, which are known or suspected to cause cancer and other serious health effects, the agency said. The proposal seeks to reduce EtO production by 58 tons per year and chloroprene by 14 tons per year.

The rule also would reduce benzene, 1,3-butadiene, ethylene dichloride, and vinyl chloride, and lower emissions of smog-forming volatile organic compounds by more than 23,000 tons a year, the agency said.

Facilities that make, store, use, or emit EtO, chloroprene, benzene, 1,3-butadiene, ethylene dichloride, or vinyl chloride would be required to monitor levels of these air pollutants entering the air at the fence line of the facility. If annual average air concentrations of the chemicals are higher than an action level at the fence line, owners and operators would have to find the source and make repairs. The levels vary depending on the chemical. For EtO, EPA is proposing an action level of 0.2 micrograms per cubic meter of air. For chloroprene, the proposed action level is 0.3 micrograms per cubic meter of air.

EPA said it would make the monitoring data public through its WebFiRE database tool. These fence-line monitoring provisions are based on similar Clean Air Act requirements for petroleum refineries nationwide, which have been successful in identifying and reducing emissions of benzene for more than four years, according to the EPA.

EtO used to sterilize billions of medical devices each year

The American Chemistry Council (ACC) issued the following statement in response to the EPA’s proposed regulations.

“We recognize the concerns that communities have about their local environment and support increased access to accurate, up-to-date, and scientifically robust air monitoring data. We demonstrated this commitment by substantially enhancing community air monitoring in Harris County, Texas, through collaboration across government, industry, and local communities.

“Since the 1980s, total toxic releases and air emissions of criteria pollutants in the United States have fallen sharply, even as population and GDP have grown. From 2010 to 2020, Responsible Care facilities within the ACC membership have reduced [hazardous air pollutant] emissions by approximately 24 percent. According to EPA Toxic Release Inventory (TRI), chemicals to air have declined notably over the last 10 years, driving the decrease in total releases.

“We will be reviewing the proposals put forward by EPA before commenting in detail. However, we are particularly concerned with the EPA’s proposals regarding ethylene oxide. Ethylene oxide is a versatile compound that’s used to help make countless everyday products. Ethylene oxide plays an important role in the development of batteries for electric vehicles and is used to support agriculture as well as the oil and gas industry. Another important use of ethylene oxide is the sterilization of medical equipment. It is estimated that ethylene oxide sterilizes 20 billion medical devices each year, helping to prevent disease and infection. In fact, according to FDA, ‘For many medical devices, sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device during the sterilization process.

“We oppose any rulemaking that uses the EPA’s flawed IRIS value for ethylene oxide. ACC and others have detailed the severe science-based flaws with the IRIS value that resulted in an overly conservative value that is below background levels of ethylene oxide. In fact, the IRIS program’s proposed toxicity value is 19,000 times lower than naturally occurring levels of ethylene oxide found in the human body. Overly conservative regulations on ethylene oxide could threaten access to products ranging from electric vehicle batteries to sterilized medical equipment.

“We support strong, science-based regulations for our industry. But we are concerned that EPA may be rushing its work on significant rulemaking packages that reach across multiple source categories and could set important precedents. We will be engaging closely throughout the comment and review process.

“We look forward to working with EPA and other stakeholders to advance science-based air monitoring initiatives, helping to ensure that our world is safe and sustainable for generations to come,” concluded the ACC statement.

EPA will accept written comments for 60 days after the proposal has been published in the Federal Register and will hold a virtual public hearing. At the time of writing, it was scheduled for publication on April 13, 2023.

About the Author(s)

Bruce Adams

Bruce Adams is an experienced content creator and trade publishing veteran who has written extensively about the plastics, automotive aftermarket, hospitality, tire, rubber, mining, and construction industries.

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