Environmental Activists at Beyond Pesticides claim that the Trump Administration is trying to push out last-minute policies to protect producers of “toxic chemicals.” But don’t fall for the hype.
One of these so called “toxic chemicals” is ethylene oxide, which is a gas naturally formed by the human body, vegetation, and combustion. It’s also used in consumer products and as a sterilant for about half of all U.S. medical supplies, many of which cannot be sterilized any other way.
Ethylene oxide is regulated under the federal pesticide law because the law covers disinfectants, and it’s also regulated under the Clean Air Act to ensure emissions from these facilities pose little risk.
Right now, the EPA is simply reviewing the pesticide registration for ethylene oxide to ensure public safety, which federal law requires every 15 years. The greens allege that if EPA allows its continued use for medical product sterilization, it will endanger public health. In reality, the public exposure levels to ethylene oxide are too low to pose any significant risks, while its benefits to public health are substantial.
Regulatory bodies and scientific research entities around the world have deemed ethylene oxide emission levels from medical supply sterilization to be far too low to have any adverse impacts on human health.
Ethylene oxide risks have been overblown in the press in recent years, however, because an EPA research arm produced a highly flawed 2016 study about its risks. Based on that study, the agency’s air quality office ran models to assess areas around the nation where exposures might be higher than average, releasing a paper in 2018 that identified “high risk” communities. All these communities were located near medical sterilization plants, suggesting that emissions created elevated cancer risks.
Yet after measuring ethylene oxide in the air within these communities during 2018-2019, EPA eventually found the levels were not much different than other parts of the county. In other words, the idea that the communities faced higher risks was just plain wrong.
Numerous studies have examined ethylene-oxide concentrations in the ambient air near industrial facilities that use the chemical, such as sterilization operations and petrochemical plants utilizing it as a precursor. These concentrations have been compared to ethylene-oxide concentrations in the ambient air at locations far removed from facilities handling ethylene oxide, and what researchers have found is that there is no meaningful statistical difference between the datasets.
The air monitoring results confirm the effectiveness of the different facilities’ EtO emissions controls. The best available emissions control technology eliminates 99.999 percent of EtO emissions from the sterilization process.
Trzupek points out many cases where levels of ethylene oxide in the air around the medical sterilization facilities are even lower than levels found in remote towns.
Unfortunately, media hype based on the EPA study led state and local governments to actually close a number of medical supply sterilization facilities in 2019 and early 2020, which contributed to medical supply shortages during the COVID-19 crisis. Fortunately, the Food and Drug Administration was able to get all but one facility to reopen to help resolve shortages at the height of the COVID-19 crisis in March and April 2020.
In addition, trial lawyers are trying to leverage the issue to bring torts based on this junk science.
Rather than admit they were wrong, activists continue to push for elimination of ethylene oxide sterilization, even though the risks are low and there are no good alternatives for sterilizing many products. Given these realities, it’s imperative that EPA correct its faulty research.