The EPA curbs the use of a cancer-causing chemical

WASHINGTONPOST

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At the same time, the medical device industry warned that the rule could disrupt the supply of safe medical equipment at hospitals and clinics nationwide.
The rule targets emissions of ethylene oxide, an odorless, colorless gas that has been linked to several types of cancer, particularly lymphoma and leukemia.
The rule will apply to nearly 90 sterilization facilities that are owned and operated by roughly 50 companies, according to the EPA.
Those facilities will have to reduce ethylene oxide emissions by more than 90 percent, the agency said.
AdvertisementIn response to requests from the medical technology industry, however, facilities will have significantly more time to meet the requirements.
In January, the Food and Drug Administration announced that it also considers vaporized hydrogen peroxide to be a safe method of sterilization for medical devices.
Yet ethylene oxide has a unique ability to penetrate porous surfaces without causing any damage, according to the FDA.
“For many medical devices, sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device,” the agency says on its website.
AdvertisementAlthough medical sterilization facilities are scattered across the country, one plant in a Chicago suburb has sparked especially intense backlash.
On Thursday, Sen. Tammy Duckworth (D-Ill.) cheered the tougher restrictions on ethylene oxide, also known as EtO.

In an effort to lessen the exposure of underprivileged communities nationwide to harmful pollutants, the Environmental Protection Agency revealed stricter regulations on a carcinogen-causing gas used to sterilize medical equipment on Thursday. Get weekly tips for navigating life on a changing planet by subscribing to the Climate Coach newsletter. The final rule was criticized by some environmental and public health advocates as being too weak, claiming that low-income and minority communities, who are disproportionately affected, would not be sufficiently protected. The medical device industry also issued a warning, stating that the rule might cause nationwide hospitals and clinics to run out of safe medical supplies.

The regulation focuses on emissions of ethylene oxide, a colorless, odorless gas that has been connected to leukemia and lymphoma among other cancers. It demonstrates how environmental justice and supporting domestic supply chains, two of the Biden administration’s top priorities, are at odds with one another.

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Slashing fatal pollution in communities of color and low-income neighborhoods has been a top priority for Michael Regan, the first Black man to lead the EPA. He made public the proposed rule last year in Louisiana, where a stretch of 85 miles between New Orleans and Baton Rouge is referred to as “Cancer Alley” due to the large number of polluting industries, including those that manufacture ethylene oxide.

Regan said in a statement on Thursday that “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.”.

Approximately 50 companies own and operate approximately 90 sterilization facilities, to which the rule will apply, according to the EPA. According to the agency, those facilities will need to cut their emissions of ethylene oxide by more than 90%.

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Still, facilities will have a lot more time to comply in response to requests from the medical technology sector.

Every facility would have eighteen months to comply with the proposed rule. With the option to request a one-year extension, smaller facilities will have up to three years, while larger facilities will have up to two years under the final rule.

The Union of Concerned Scientists discovered in an analysis conducted last year that approximately 60 percent of the approximately 14 million residents who reside within five miles of ethylene oxide-emitting facilities are people of color. The percentage of low-income people is close to 31%.

The environmental group Union of Concerned Scientists’ senior analyst, Darya Minovi, expressed her disappointment at the postponed compliance deadlines.

“We requested a shortening of these deadlines in our comments to the agency,” Minovi stated. The truth is, they extended them and took the opposite course. And we are aware of the main beneficiaries. “.

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However, advocacy groups for medical technology have cautioned that a strict regulation might have disastrous effects on sterilization centers and patients’ access to life-saving supplies. Medical equipment shortages could result from the proposed rule forcing many sterilization facilities to close or halt operations, according to AdvaMed and the Medical Device Manufacturers Association’s public comments.

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AdvaMed President and CEO Scott Whitaker stated, “We just have to get this rule right or there’s going to be a huge — I would even say catastrophic — impact on the health care system.”.

Whitaker said he was still going over the rule with his team. However, he said that generally speaking, the coronavirus has demonstrated the value of robust supply chains for medical devices, particularly the PPE that was in high demand during the pandemic.

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Whitaker stated, “You can’t make high-risk regulatory moves that could result in supply chain issues or shortage issues because if we’re hit with another crisis, we’ll be in really bad shape.”. Since it is impossible to forecast when the next pandemic or public health incident will occur, the EPA must take that into consideration. “.

Roughly 50% of all U.S. S. medical supplies, such as feeding and breathing tubes, pacemakers, heart valves, and billions of syringes. The Food and Drug Administration declared in January that it also regarded vaporized hydrogen peroxide as a secure means of sterilizing medical equipment.

However, the FDA claims that ethylene oxide has a special capacity to pierce porous surfaces without harming them. According to the agency’s website, “ethylene oxide sterilization may be the only method that effectively sterilizes and does not damage the device for many medical devices.”.

Publicity.

While there are many medical sterilization facilities in the nation, a particular facility in a Chicago suburb has drawn particularly strong criticism. A 2018 Chicago Tribune investigation found that the Willowbrook, Illinois, Sterigenics facility was close to a high cancer rate. The plant closed in 2019 as a result of the ensuing controversy, which also resulted in a multimillion dollar settlement.

In 2018, the Democrats in Illinois requested that the EPA look into possible obstructions of the Sterigenics plant inspections by the Trump agency. Sen. Tammy Duckworth (Democrat, Illinois). rejoiced over the more stringent regulations imposed on ethylene oxide, or EtO.

“EtO emissions from commercial sterilization facilities have negatively impacted local communities’ public health for far too long and have dramatically raised the likelihood that locals will ever get cancer,” Duckworth stated in a statement.

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