EPA on Thursday announced new regulations to slash releases of a cancer-causing compound used by dozens of medical equipment sterilization plants, often located in heavily populated and marginalized communities.
The final rule is the latest of a series for various industries, including many chemical manufacturers, to account for a 2016 finding that ethylene oxide was much more dangerous than previously thought.
The rule, stronger in some respects than a draft released last year, will eventually cut emissions of ethylene oxide by sterilization facilities by more than 90 percent, according to an agency forecast.
Many of those plants are located in neighborhoods or near schools. When the new regulations are fully in effect, EPA predicts that they will reduce the lifetime cancer risk for all nearby residents below a key Clean Air Act threshold of one additional cancer case per 10,000 people.
While manufacturers had predicted that tighter standards could ultimately affect health care by cutting into supplies of safely sterilized medical equipment, some plants have at least partially begun implementation of the new requirements, according to EPA.
“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,” agency Administrator Michael Regan said in a news release.
But to the dismay of some environmental advocates, the agency in some cases will also allow more compliance time than the 18 months previously proposed, with smaller facilities getting up to three years with the possibility of a one-year extension on top of that. EPA also rebuffed calls to order fence-line air monitoring for ethylene oxide around the plants, although most operators will ultimately have to track and publicly report their emissions.
“The fight isn’t over,” said Darya Minovi, a senior research analyst with the Union of Concerned Scientists, which last year reported that about 14 million people lived within 5 miles of sterilization or chemical plants that release ethylene oxide. Almost 60 percent of those were people of color, the group found. According to a separate EPA analysis, Latinos are particularly vulnerable, mainly because Puerto Rico is home to seven sterilization facilities.
A rule years in the making
The new regulations are the first update to hazardous air pollutant standards for the commercial sterilization industry since 1994.
They arrive a decade after a statutory deadline for EPA to complete a review of their adequacy and more than seven years after the 2016 finding that ethylene oxide was dozens of times more carcinogenic than previously thought.
When that higher “risk value” became publicly known in 2018, it led to public protests around some sterilization facilities and an avalanche of litigation. Early last year, one company announced a $408 million deal to settle more than 800 lawsuits.
Even so, EPA’s bid to toughen the rules drew stiff opposition from the medical supply industry, with some critics predicting that higher compliance costs could force smaller plants to close and that the 2016 finding was flawed.
Among the groups taking that latter position was the Advanced Medical Technology Association. While association staffers were still reviewing the new regulations Thursday morning, President and CEO Scott Whitaker said in a statement that the group is hopeful that they “will not have a negative impact on the healthcare system or the patients we serve.”
Among other provisions contained in the rule, sterilization plants will have to do more to control ethylene oxide emissions that stem from building leaks, strengthen existing venting standards and provide “continuous clean air protection” even when equipment breaks down, according to EPA summary.
In all, the final requirements are projected to cut annual ethylene oxide releases by 21 tons, compared to a 19-ton reduction predicted under the draft versionreleased last April.
The upfront capital compliance costs are projected to be $313 million, significantly higher than the $220 million forecast for the draft. The new regulations apply to 88 existing plants and two under construction. The EPA analysis notes that their parent companies have combined average annual sales of almost $16 billion.
Ethylene oxide, a colorless gas, is classified as a hazardous air pollutant until the Clean Air Act. EPA labels it a “highly potent” carcinogen with links to a higher odds of breast cancer and some blood cancers.
The compound, employed to sterilize everything from heart valves to catheters, is nonetheless valuable because it kills germs but doesn’t corrode rubber and other materials used in those devices, according to industry comments. By EPA’s count, it’s used to scrub about 20 billion pieces of medical equipment each year or roughly half the total. Some plants also use ethylene oxide to disinfect some spices and dried herbs.
Threat to health care?
While the Food and Drug Administration recently approved hydrogen peroxide as an acceptable substitute, industry organizations had earlier argued that the lack of ready alternatives to ethylene oxide meant that EPA’s plans posed a broader threat to Americans’ health care.
The Medical Device Manufacturers Association, for example, predicted that stricter regulations could lead to “fewer operations, fewer wellness and pediatric checkups, and longer wait times for life-changing procedures,” according to the group’s comments filed last June on EPA’s initial proposal. Efforts to get comment from the association Thursday on the final rule were not immediately successful.
At the Department of Health and Human Services, the parent agency of FDA, Secretary Xavier Becerra pledged continued cooperation with EPA “to achieve our shared goals of lowering EtO exposure while also mitigating potential risks of medical device shortages.”
Ethylene oxide is also widely used in the chemical manufacturing industry, which accounts for the bulk of emissions and is already vigorously fighting tougher regulations.
Under a lawsuit brought early last year, for example, Huntsman Petrochemical and other industry players challenged EPA’s reliance on the higher risk value to tighten ethylene oxide standards for about 200 organic chemical plants. A three-judge panel on the U.S. Court of Appeals for the District of Columbia Circuit recently heard oral arguments on the suit; a decision is expected within the next few months.
But because medical sterilization plants are often located in residential communities, as opposed to industrial parks, EPA under President Joe Biden’s administration mounted an unusual outreach campaign to alert nearby residents to the potential risks. The agency also faced pressure from environmental groups to strengthen its regulations, with a lawsuit settlement setting a deadline for the tighter standards to be made final this month.
Representing those groups in the litigation was Earthjustice.
“This is a victory for our clients, whose years of advocacy led to increased regulations on an industry that has polluted our communities while cleaning our medical equipment,” Patrice Simms, Earthjustice’s vice president for healthy communities, said in a statement Thursday. “We look forward to reviewing these rules and ensuring that they are fully and effectively implemented.”
