EPA sets limits on carcinogenic gas used to sterilize medical devices

The Environmental Protection Agency is imposing new limits on emissions of ethylene oxide, a colorless gas that is widely used to sterilize medical equipment and is also a carcinogen.

The regulation, expected to be finalized Thursday, would force sterilizing factories and other facilities that use ethylene oxide to install pollution controls to reduce emissions of the gas by about 90 percent.

It would be the first time in twenty years that the government has tightened limits on the amount of gas that can escape from a production facility.

Ethylene oxide is used in a number of products, but is applied to about half of the medical equipment made in the United States to reduce the risk of infection.

When inhaled, the gas can irritate the eyes, nose, throat and lungs, and has been linked to lymphoid and breast cancer, as well as damage to the brain, nervous system and reproductive system.

Michael S. Regan, the EPA administrator, said the rule would significantly reduce health risks to people living near sterilization facilities, calling it “historically strong.” He said the rule is part of President Biden’s “Cancer Moonshot” effort to improve cancer prevention.

The rule would affect about 90 sterilization plants in many states, including many in California, Georgia, Florida, Texas, Puerto Rico and in the Northeast. Nearby communities have become increasingly concerned about the risk of cancer, and environmental groups have sued the EPA to force it to implement stricter controls.

“Today marks an important step forward in regulating toxic ethylene oxide emissions from commercial sterilization facilities, but there is still much work to be done,” said Patrice Simms, vice president at Earthjustice, a nonprofit that led the lawsuit. He cited community groups “whose years of advocacy have led to increased regulation of an industry that has polluted our communities while cleaning our medical equipment.”

Nearly 13 million people live near these facilities, which disproportionately pose a risk to poor and minority communities. according to an analysis by the Union of Concerned Scientists, an environmental group

“We have followed the science and listened to communities to fulfill our responsibility to protect public health from this pollution, including the health of children who are particularly vulnerable to carcinogens at a young age,” Mr Regan said in a statement.

The Biden administration has made tackling the pollutant a key part of its pledge to improve conditions in communities disproportionately affected by pollution.

Medical technology groups say ethylene oxide is the only effective method of sterilizing devices such as catheters, wound dressings and surgical equipment. They warned that the EPA rule would interrupt patient care because of the cost and time required to meet the stricter standards.

Scott Whitaker, the president and CEO of AdvaMed, a group that lobbies on behalf of the interests of medical device makers, said in a statement Wednesday that the group is not opposed to updating ethylene oxide standards. But, he said, facilities must have sufficient time and flexibility in the types of pollution controls they use.

“We will view the rule through that lens and remain hopeful that these changes will not negatively impact the health care system or the patients we serve,” Mr. Whitaker said.

Mr. Regan said his agency strives to strike a balance between lowering cancer risk in neighboring communities while maintaining the capacity of facilities to sterilize products before they are shipped, usually to medical distribution companies. The rule ensures a process “that safeguards our nation’s critical supply of sterilized medical equipment,” Mr. Regan said.

Agency officials said they tried to address industry concerns in the final version of the regulation. This would give facilities more time than originally anticipated to comply with the new standards.

The rule will take effect as soon as it is published in the Federal Register, which will likely happen this month. After that, the facilities would have two years to implement monitoring and contamination checks. They would have an additional 180 days to demonstrate compliance, and in some circumstances they could request an extension from states and the EPA.

Most commercial sterilizers will also be required to conduct ongoing emissions monitoring and submit quarterly reports to the government.

Chemical manufacturers have already done that sued the EPA. on the updated hazard assessment for ethylene oxide, an analysis used to inform the regulations. The medical device industry also lobbied the agency to adopt a less protective standard.

The new rule is part of a series of regulations the Biden administration is writing regarding ethylene oxide.

Another rule, expected to be finalized within weeks, would reduce hazardous air pollutants from chemical plants, including ethylene oxide. That rule would apply to more than 200 facilities across Texas and Louisiana; elsewhere along the Gulf Coast; the Ohio River Valley; and West Virginia. It would update a number of regulations governing emissions from chemical plants, some of which have not been tightened in nearly two decades.