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Amid the spotlight on President Donald Trump’s early moves, don’t overlook former President Joe Biden’s late-term environmental regulations that could have lasting impacts, especially on key sectors in Indiana.
On Jan. 14, the Biden administration’s Environmental Protection Agency posted a last-minute “interim” decision in the Federal Register for its review of ethylene oxide under the Federal Insecticide, Fungicide, and Rodenticide Act, or FIFRA.
This decision is the final action among several by the Biden administration’s EPA to address ethylene oxide emissions, following a re-assessment in 2016 by the Obama administration that reclassified ethylene oxide from a “probable” carcinogen (1985) to a “carcinogen” based on updated epidemiological studies and animal data. Given the timing, the Biden administration likely hastened to issue this interim decision before the transition to the Trump administration, which previously called into question EPA’s determination of ethylene oxide as a human carcinogen.
EPA regulates ethylene oxide under FIFRA for its use as a sterilizer, particularly for medical devices. Indiana, with approximately 200 hospitals and healthcare facilities, including numerous veterinary hospitals, stands to be significantly impacted by this rule. Known for its strong life sciences sector, Indiana is also home to several major medical device manufacturers and numerous smaller firms that produce a wide range of medical devices and technologies. The EPA’s decision could mean substantial operational changes for these facilities.
What is EPA’s authority?
Under FIFRA, EPA regulates a host of activities involving registered pesticides like ethylene oxide to protect human health and the environment, including, how and where pesticides are manufactured, pesticide labeling and directions for use, and allowable marketing claims concerning the advertising and sale of registered pesticides. Pesticide registrations are also subject to continuous review, typically every 15 years, to ensure they meet evolving standards in scientific knowledge, policies, and practices.
The EPA began updating ethylene oxide’s pesticide registration in 2013. However, because additional information—specifically data on worker exposure and monitoring technologies—is needed to complete a registration review, the EPA issued this “interim” decision to implement immediate risk mitigation measures deemed necessary to protect human health and the environment while additional data is collected.
New requirements
In issuing this decision, the EPA claims broad authority to regulate how ethylene oxide can be used, even if this encroaches on the jurisdiction of other federal agencies such as the Occupational Safety and Health Administration. Notably, the most significant part of this decision is its attempt to reduce OSHA’s permissible exposure limit for workers from 1 ppm (8-hour TWA) to 0.1 ppm.
According to EPA, this action is warranted because most OSHA exposure limits have not been updated since their establishment in 1971 due to OSHA’s limited authority to do so. EPA’s authority does not have this limitation. Therefore, EPA asserts it can develop risk mitigation measures to address risks from the pesticide uses of chemicals that OSHA regulates, despite potential divergence from OSHA’s standards.
In addition to establishing an “EPA Occupational Exposure Limit,” the decision also identifies monitoring, training, and mitigation requirements for workplaces where ethylene oxide is used, which is traditionally considered the purview of OSHA.
Indiana impacts
This determination is likely to have a significant impact on Indiana’s health care and life science sectors.
First and foremost, steps taken by the Biden Administration to regulate ethylene oxide could limit the availability of sterilization for medical devices manufactured in Indiana.
Moreover, approximately one-third of health care facilities, including hospitals, veterinary clinics, and dentists, use ethylene oxide onsite to sterilize medical devices and equipment. These facilities may need additional ventilation and abatement devices, and respirators may be required. Healthcare facilities will likely need monitoring to ensure they are below the 0.1 ppm threshold.
Next steps
The first step following this announcement is for ethylene oxide manufacturers to submit label amendments within 60 days for EPA review and approval. Once approved, the EPA will gather additional data to reach a final decision, which is expected “within 8 years.”
Specifically, EPA is looking to collect data on potential exposures in warehouses downstream of the ethylene oxide treatment process that may be exposed to ethylene oxide off-gassing from the treated items. The implementation and interpretation of this decision will be left to the incoming Trump administration, which could potentially loosen or reverse the exposure limits and mitigation measures based on new data.
Even if the incoming administration tries to undo this action, affected industries may be hesitant to back-slide in terms of the recommended measures absent a compelling overhaul of EPA’s reassessment of ethylene oxide.•
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H. Max Kelln is a partner at Faegre Drinker. Opinions expressed are those of the author.
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