Fresh Rules for Safe Spices: EPA Proposes Regulations on Toxic Gas Sterilization
Breaking News: US EPA Proposes New Restrictions on Cancer-Causing Chemical Ethylene Oxide, Promising Safer Air for Communities
The US Environmental Protection Agency (EPA) took a significant step on Tuesday to protect communities from the cancer-causing chemical ethylene oxide by proposing a set of new restrictions on facilities that use the toxic gas for sterilizing medical devices and spices. The proposed rules, which are yet to be finalized, aim to reduce ethylene oxide emissions by 80%, bringing them below the Clean Air Act standard for elevated cancer risk.
This move comes after a 2018 EPA report revealed that dozens of communities across the nation faced elevated cancer risks due to trace amounts of ethylene oxide released into the air during the sterilization process. The EPA's Integrated Risk Information System (IRIS) program conducted a two-decade long review of the toxicity of ethylene oxide, which led to the conclusion that the chemical is more dangerous than previously understood.
The proposed rules are a crucial step towards better aligning regulations with the actual cancer risk posed by ethylene oxide. In combination with a set of proposed rules issued by the EPA last week that would impose new controls on facilities that manufacture ethylene oxide, the two sets of rules would result in an estimated 84% reduction (equivalent to 77 tons) of ethylene oxide emissions per year compared to 2020 levels, according to EPA Deputy Administrator Janet McCabe.
Environmental watchdog groups have applauded the proposed restrictions, but some have expressed concerns that they may not go far enough to protect vulnerable communities, particularly those that are low-income and disproportionately composed of people of color. Darya Minovi, a senior research scientist at the Union of Concerned Scientists, commended the EPA for issuing proposed standards that are based on their own scientists' recommendations, but urged the agency to widen the scope of the rules to cover a larger range of facilities, including off-site warehouses that store recently sterilized equipment and continue to release ethylene oxide into the air without being regulated for their emissions.
Minovi also stressed the importance of requiring fenceline monitors, which constantly read the air outside of facilities to ensure that toxic gas is not drifting into neighboring communities. This would provide an additional layer of protection for communities living near facilities that use ethylene oxide.
However, the proposed rules have also faced pushback from some quarters. Chemical manufacturers sued the EPA in February over its updated hazard assessment for ethylene oxide, advocating for a less protective standard developed by the Texas Commission on Environmental Quality. AdvaMed, a group that represents the interests of medical device manufacturers, expressed concerns that more regulations could result in treatment delays for patients if sterilization facilities are forced to close. The EPA, on the other hand, maintains that some commercial sterilizers have already implemented the planned changes and that the proposed 18-month timeline for compliance is an accelerated timeframe under the Clean Air Act.
The EPA's proposed rules would apply to 86 commercial sterilization facilities in the United States that use ethylene oxide gas to fumigate spices and medical devices. The EPA estimates that approximately 20 billion medical devices, including catheters, gloves, and surgical gowns, which are mostly single-use and disposable items used in healthcare, are sterilized using ethylene oxide. The US Food and Drug Administration is actively exploring alternatives to the use of the gas, according to the EPA.
In issuing the proposed rules, the EPA aims to strike a balance between lowering cancer risks for impacted communities and workers who use ethylene oxide while preserving critical sterilization capabilities. The agency acknowledges that the proposed rules are long overdue and are based on updated scientific recommendations, but some stakeholders have called for further measures to ensure the safety of communities living near facilities that use ethylene oxide. As the EPA moves towards finalizing the rules.
experts argue that finding alternatives to ethylene oxide for sterilization may take time and further research.
The proposed rules by the EPA are seen as a significant step towards addressing the long-standing concerns of communities exposed to ethylene oxide gas. However, environmental watchdog groups and advocates for impacted communities argue that more needs to be done to fully protect vulnerable populations, especially those who are low-income and people of color.
Darya Minovi, a senior researcher scientist at the Union of Concerned Scientists, welcomed the proposed regulations but emphasized that they are long overdue and should cover a larger range of facilities, including off-site warehouses that store recently sterilized equipment. These facilities can also release ethylene oxide into the air and pose a risk to nearby neighborhoods. Minovi also stressed the importance of implementing fenceline monitors that constantly measure the air outside of facilities to prevent toxic gas from drifting into communities.
Jaime Rukstales, a member of the grassroots advocacy group Stop EtO in Lake County, Illinois, one of the communities impacted by ethylene oxide pollution, called for tougher restrictions on all types of facilities that affect the health of communities. Rukstales pointed out that some off-site warehouses have registered high levels of ethylene oxide due to off-gassing of sterilized products, highlighting the need for comprehensive regulations to address all potential sources of emissions.
While the proposed rules have been applauded by environmental groups and impacted communities, the chemical manufacturing industry has expressed concerns. AdvaMed, a group that advocates for the interests of medical device manufacturers, warned that additional regulations could lead to treatment delays for patients if sterilization facilities are forced to close. However, the EPA has emphasized that sterilizers have 18 months to comply with the proposed rules, which it considers to be an accelerated timeframe under the Clean Air Act.
The EPA also acknowledged that some commercial sterilizers have already taken action to control ethylene oxide emissions, particularly through exhaust vents known as "back vents." However, only a portion of sterilizers are effectively controlling fugitive emissions, which are ethylene oxide that escapes or leaks into the room air. This highlights the need for further efforts to fully address the issue.
The proposed rules are part of a broader effort by the EPA to align regulations on the production and use of ethylene oxide with the known cancer risks associated with the chemical. The EPA issued another set of proposed rules last week that would impose new controls on facilities that manufacture ethylene oxide, with the combined effect of both sets of rules expected to result in an 84% reduction in ethylene oxide emissions compared to 2020 levels.
The EPA's proposed rules come after a two-decade long review of the toxicity of ethylene oxide by scientists in the Integrated Risk Information System (IRIS) program. The findings of the review revealed elevated cancer risks in communities exposed to ethylene oxide gas, prompting the need for tighter controls on facilities that use the chemical.
The issue of ethylene oxide emissions and their impact on public health has been a contentious one, with some arguing for stricter regulations to protect communities, and others expressing concerns about the potential impact on the medical device industry. However, the EPA has emphasized that its proposed rules are aimed at striking a balance between reducing cancer risks for impacted communities and workers while preserving critical sterilization capabilities.
The EPA's proposed restrictions on ethylene oxide emissions have the potential to significantly reduce the release of this cancer-causing chemical into the air, and protect communities from its harmful effects. While there are differing opinions and concerns from various stakeholders, it is clear that addressing the risks associated with ethylene oxide is crucial to safeguarding public health and the environment.