The Environmental Protection Agency (EPA) announced new limits on a gas widely used to sterilize medical devices called ethylene oxide (EO), as a suspected carcinogen, on March 14.
The agency first proposed new restrictions in 2023, recommending an 80 percent reduction in the use of the chemical. The new standards seek a reduction closer to 90 percent. The rule will impose new costs on manufacturers for monitoring and providing proof of reduction of emissions.
EO is used 20 billion times per year to sterilize medical devices ranging from pacemakers to catheters to ventilation equipment. It is generally used for devices that cannot be sterilized with steam, and the United States is the world’s leading producer, manufacturing more than four million tons annually.
Government Hair Splitting
The new rule stems from a 2020 revision of the Integrated Risk Information System (IRIS) toxicity value for inhalation unit risk estimate (URE) for EO, which was used in developing an updated National Emission Standards for Hazardous Air Pollutants rule for miscellaneous organic chemicals.
The EPA drew fire from the industry when it revised the URE from 0.000088 per µg/m3 to 0.005 per µg/m3, a risk increase of over fifty-fold.
An industry group, including Huntsman Petrochemical, petitioned the EPA to accept a vastly lower peer-reviewed risk assessment developed by the Texas Commission on Environmental Quality. The EPA ultimately rejected the request, triggering a petition to review on February 21, 2023, by the American Chemistry Council, Louisiana Chemical Association, and Huntsman Petrochemical.
Burden of Compliance
The EPA estimates the cost of compliance to medical equipment sterilization companies alone will be $220 million in one-time amortized costs, in addition to an ongoing annual burden of some $86 million.
It is unclear how the industry will shoulder the financial burden. Still, analysts predict that many smaller companies will be forced to exit the market, significantly reducing capacity in this medically essential sector. The rule will also impose similar burdens on other industries that use the chemical. Critics of the rule argue that the financial burden imposed by the rule is not justified by the estimated cancer risk, which remains speculative.
‘Likely To Cost Lives’
The cost of compliance will likely lead to shortages of lifesaving equipment and cost lives rather than save them while imposing yet another burden on the U.S. economy, says H. Sterling Burnett, Ph.D., director of the Arthur B. Robinson Center on Climate and Environmental Policy at The Heartland Institute, which publishes Health Care News.
“Ethylene oxide has been in use for decades and is the most widely used chemical to sterilize medical instruments and materials,” said Burnett. “It has saved millions, possibly billions of lives by preventing infections, yet now, after years of safe use the EPA wants to pull it based on its unjustified chemophobia.
“There is no evidence using ethylene oxide ever has or will induce cancer, outside of EPA’s computer models,” said Burnett. “Pulling this long-existing, safe product from the market will increase already soaring health care costs, and in the process increase the likelihood of infection from medical devices while making treatment unaffordable for the poor and middle class. No lives will be saved by the EPA’s harmful intervention in common medical practice, but it will likely cost lives.”
‘No Scientific Basis (for Change)’
Supporters of the new rule claim the carcinogenicity of EO justifies the onerous burden the rule will place on critical industries. Yet, the Toxicological Profile for Ethylene Oxide published by the U.S. Centers for Disease Control and Prevention (CDC) in August 2022 provided no proof of a link between EO exposure and cancer in humans.
“The carcinogenicity of ethylene oxide has been evaluated in a number of cohorts involved in ethylene oxide production and/or uses in sterilization,” states the CDC report. “Results from some cohort studies suggest that exposure to ethylene oxide may increase the risk of selected cancer types (e.g., lymphohematopoietic cancer, leukemia, breast cancer).”
The quality of the data backing the amended rule can be summed up in one concise statement, says Steve Milloy, the publisher of JunkScience.com and a member of The Heartland Institute’s board of directors.
“Per the CDC assessment of the human data on EO, there is no scientific basis for changing any standards,” said Milloy.
Lawsuit Status
The U.S. Court of Appeals for the District of Columbia heard oral arguments in Huntsman Petrochemical LLC v. EPA, on February 16. The U.S. Chamber of Commerce filed an amicus brief on behalf of the plaintiff urging the court to enforce core administrative-law principles and invalidate the EPA decision regulating EO emissions.
In its brief, the Chamber noted that IRIS analysis and its resulting value are not regulations, that no statute governs their preparation, that they are not adopted through notice-and-comment rulemaking, and that the relevant IRIS findings were not subjected to peer review.
According to The New York Times, the rule will impact 90 plants throughout the country, including Florida, Georgia, and Texas. EPA administrator Michael S. Regan affirmed the agency’s position.
“We have followed the science and listened to communities to fulfill our responsibility to safeguard public health from this pollution, including the health of children who are particularly vulnerable to carcinogens early in life,” said Regan, in a statement.
Kevin Stone (kevin.s.stone@gmail.com) writes from Arlington, Texas.