New EPA Rule Deeply Concerning for Chemicals Industry

The American Chemistry Council (ACC) today issued a statement questioning key parts of a final rule by the US Environmental Protection Agency (EPA) on New Source Performance Standards for the Synthetic Organic Chemical Manufacturing Industry. Notably, the ACC expressed deep concern about the use of a “flawed toxicity value” as a benchmark for ethylene oxide (EtO) emissions.

The stated goal of the proposal that the EPA issued in April 2023 is to reduce emissions of hazardous air pollutants that may cause serious health effects in humans, including cancer.

“The biggest risk reductions from chemical plants would come from cutting EtO emissions from eight plants that currently pose the highest risk to surrounding communities in Texas and Louisiana,” the EPA said in the proposal from 2023. It would also require plants that use, produce, store, or emit any of what the agency calls six key air toxics — EtO, chloroprene, benzene, 1,3-butadiene, ethylene dichloride, and vinyl chloride — to conduct fence-line monitoring to protect “people who live near the facilities.” The — gulp! — 404-page final rule that will be submitted for publication in the Federal Register is now available online.

Rule undermines national priorities

The ACC said it is currently reviewing the details of the final rule, noting that it will have “significant implications” on the production of key chemistries such as EtO that support “national priorities like electric vehicle battery development, domestic semiconductor manufacturing, and healthcare access,” and, in fact, could undermine related legislation championed by the Biden Administration.

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Areas of concern for the ACC at this stage include the removal of delay of repair provisions that allow for common-sense periods of repair for small leaks as well as use of the Integrated Risk Information System (IRIS) as a benchmark for the toxicity value of EtO.

The IRIS value defies reason, said the ACC in its statement. “It is 23,000 times lower than naturally occurring levels found in the human body. Some of the new restrictions threaten to affect the production of chemistries that are needed for countless everyday products and are used in key industries, including agriculture, healthcare, semiconductors, and electric vehicle batteries. Unfortunately, the value’s continued application in this rule along with EPA’s reliance on outdated emissions data has led to a final rule-making based on inflated risks and speculative benefits,” said the ACC.

Provisions undercut jobs, domestic manufacturing

More broadly, the ACC expressed concern that these regulations are part of a larger trend, or, as the council put it, an “onslaught of chemical regulations being put forth by this administration.” The restrictions undercut American jobs, domestic manufacturing, and critical legislation passed under Biden. Under the current approach, supply of chemistries will constrict and the “country’s climate, infrastructure, and supply-chain priorities will suffer, as well,” said the ACC.

EtO requirements worry medtech sector

The medical sector has been following the evolution of EPA’s proposal very closely, as well, since EtO is widely used to sterilize medical devices. FDA estimates that about half of all medical equipment in the United States undergoes EtO sterilization, which amounts to some 50 million devices a day, reported sister media outlet MD+DI in a recent article covering the final rule. It is the only sterilization method available for many medical devices, added FDA.

The EPA did take into consideration industry concerns, and modified some of the original proposals. In particular, compliance requirements have been extended from 18 months to up to two years in the final rule for larger EtO sterilization facilities. Smaller operations will will have up to three years and can request a one-year extension.

Scott Whitaker, president and CEO of AdvaMed, a lobbying group representing the medical device industry, told MD+DI that the association appreciates the update and is currently reviewing the finalized regulations to ensure that they will not have “a negative impact on the healthcare system or the patients we serve."