FACT SHEET: Biden-Harris Administration Takes Action to Protect Communities from Dangers of Ethylene Oxide Pollution and Secure America’s Medical Supply Chains
In 2022, the President and First Lady reignited the Cancer Moonshot with the goals of reducing the cancer death rate in the United States by at least half by 2047—preventing more than 4 million cancer deaths—and improving the experience of people who are touched by cancer. The President also established a Cancer Cabinet to mobilize the entire Biden-Harris Administration in pursuit of these ambitious goals.
Today, the Biden-Harris Administration is announcing a critical action to bring us closer to achieving these goals and advance President Biden’s historic commitment to environmental justice. The Environmental Protection Agency (EPA) is issuing a final rule that will significantly strengthen and update Clean Air Act standards for ethylene oxide (EtO) emitted into the air from commercial sterilizing facilities. EtO is a highly potent carcinogen that can be particularly harmful to children and communities that are already overburdened by pollution. The new rule will safeguard public health by cutting emissions of EtO from these facilities by over 90 percent. This represents an important step to advance the Biden Cancer Moonshot’s efforts to prevent cancer before it starts by protecting communities around the country from cancer risk from EtO emitted at these facilities.
One of the uses of EtO is for medical device sterilization, a critical function that ensures a safe supply of medical devices for patients and hospitals. The Biden-Harris Administration believes securing our supply of medical devices is essential, and EPA worked closely with the Food and Drug Administration (FDA) to develop a final rule that protects communities located near sterilizing facilities while also mitigating and managing the potential risk of medical device shortages, or other unintended supply disruptions, to products Americans need to support positive health outcomes as sterilizing facilities adjust to the new standards in an orderly way.
The Clean Air Act authorizes the President to provide a compliance exemption for a facility subject to this type of emission standard for a period of up to two years “if the President determines that the technology to implement such standard is not available and that it is in the national security interests of the United States to do so.” The risk of unintended disruption to the supply of critical medical devices would implicate the national security interests of the United States; therefore, it would be appropriate to exercise this authority if a sterilizer of medical devices was working in good faith to come into compliance with the rule, but the technology to implement these standards was not available for installation in the facility.
The federal government will provide more information in the coming months about how such compliance exemptions from EPA’s commercial sterilization rule may be made available, if necessary.
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