EPA proposes rules aimed at limiting cancer risks from exposure to chemical used in sterilization

The Environmental Protection Agency (EPA) on Tuesday proposed rules aimed at addressing the emissions of a cancer-causing chemical used in sterilization.

The EPA said Tuesday that its proposal would reduce emissions of the toxic substance, known as ethylene oxide, by 80 percent from current levels. The chemical is commonly used to sterilize spices and medical devices. 

The EPA on Tuesday proposed two rules: one aimed at protecting the general public from emissions from the sterilizers and a second aimed at protecting workers at the plants. 

Routine exposure to ethylene oxide in a workplace setting over a 35-year period leads to elevated cancer risks for as many as 10 percent of workers who apply the chemical at sterilization plants, the agency said Tuesday. 

It also found last year that communities who live near 23 sterilization facilities face elevated risks of cancer. Tomás Carbonell, an EPA deputy assistant administrator in the Office of Air and Radiation, told reporters Tuesday that the new proposal would reduce cancer risk in these communities to below what’s considered an elevated risk. 

The EPA estimates that currently, about 18,000 people have an elevated cancer risk of more than 1-in-10,000 due to exposure to ethylene oxide from sterilizers in their communities; it says that under the proposal that number would go down to zero. 

Exposure to the substance increases risks of white blood cell cancers and studies have also linked it to increased risk of breast cancer in women. 

Through a combination of the rules and a separate one proposed by the EPA last week aimed at addressing toxic chemical emissions more broadly at plants where the substances are manufactured, overall releases of ethylene oxide will be cut by 84 percent, said EPA Deputy Administrator Janet McCabe.

The EPA is proposing to require facilities to use stricter pollution controls and advanced monitoring methods. They would also be required to report the results of the monitoring to EPA twice per year. 

For workers, the agency is proposing to limit the amount of ethylene oxide that can be applied to medical devices, requiring certain controls like emissions capture technology and making workers wear personal protective equipment. 

It is also proposing prohibiting the use of the chemical in applications where alternatives can be used, including in museums, beekeeping, cosmetics and musical instruments.

AdvaMed, a trade group representing the medical technology industry, expressed concerns about the EPA’s proposals, including its 18-month timeline for implementation. 

“18 months to implement the… requirements is much too short. It could take many months for abatement equipment to arrive,” said Scott Whitaker, the group’s president and CEO, in a written statement.  

He also said that he believes the agency “appears to overstate” exposure risk for employees of sterilization plants. 

The agency found that implementing the emissions rule will cost the industry nearly $220 million in total capital investment. 

Environmental activists, on the other hand, praised the regulations as an important step for protecting public health, but some called for even more action. 

“This is huge and it’s the first step that we need and that we’ve been fiercely fighting for to protect the lives and health of kids an other impacted residents,” said Tricia Cortez, executive director of Rio Grande International Study Center – a local advocacy group in Laredo, Texas, which is one of the communities where the EPA has identified elevated risk due to the presence of a sterilizer plant. 

However, Cortez said, she hopes that the agency will ultimately finalize an even stronger rule that regulates offsite warehouses where companies send their products for off-gassing and includes monitoring at a plant’s fenceline so that communities know just how much of the toxins are making it beyond the facility’s borders. 

“There’s some really strong new requirements but we still have work ahead of us to make sure that the final rule is much, much stronger,” she said. 

This story was updated at 1:14 p.m.