At a glance
- The use of ethylene oxide (ETO) is the most common method for the terminal sterilization of medical devices in the USA, which are used to sterilize more than 20 billion that are sold each year. The most important thing is that about a third of health facilities, including hospitals, veterinary clinics and dentists, use ETO on site to sterilize medical devices and devices. These facilities may need additional ventilation and reduction devices, and breathing protection providers may be required. The health facilities probably have to be monitored to ensure that they are below the threshold of 0.1 ppm.
- In the decision, the use of ETO for other applications is listed, including museum, library and archive material; Cosmetics; Musical instruments; and bee hiking equipment. ETO is also used to roast and sterilize spices, dried herbs, processed vegetables and other spice materials in order to reduce pathogens.
- This preliminary decision is a brave step from the EPA, but its long -term effects remain uncertain because it expects further review and potential changes in the context of the new administration. Even if the decision is lifted, the affected industries have to deal with their far -reaching recommendations for professional security.
On January 14, 2025, the US Environmental Protection Agency of the Biden Administration (EPA) recorded a last-minute-prepared decision in the Federal register for his review of ethylene oxide (ETO) under the federal insecticide, Fungicide and Rodenizid Act (FIFRA). This decision was the final lawsuit under several of the EPA of the bid administration to fix ETO emissions epidemiological studies and animal data. In view of the time, the Biden administration probably hurried to make this interim decision before the transition to the Trump administration, which previously questioned the revised determination of ETO as a human carcinogen.
In 1966 the EPA first approved ethylene oxide as a sterilizer, mainly for the shift of medical devices. According to the US Food & Drug Administration, ETO is the most common method for the terminal sterilization of medical devices in the US billion Every year in the United States, 50% of all devices sold in the USA that require sterilization. How many have learned during the Covid 19 pandemic are subject to antimicrobial chemicals such as ETO of EPA registration, approval and regulation according to FIFRA. Despite its prevailing use, there is currently only one supplier of ETO and less than 200 registered commercial sterilizers in the United States. However, this number is expected to be submitted on the basis of the EPA regulation and numerous personal injury after the redesign of 2016.
What is the authority of the EPA to regulate ETO under FIFRA?
Under FIFRA, the EPA regulates a variety of activities in which registered pesticides such as ETO are involved in the protection of human health and the environment, including how and where pesticides are produced, pesticide identification and instructions for the use and permissible marketing claims in relation to the Advertising and the sale of registered pesticides. Pesticide registrations are also continuously subject to every 15 years to ensure that they comply with further developed standards in scientific knowledge, guidelines and practices.
The EPA began with the process of updating the pesticide registration of ETO in 2013. However, since additional information is necessary to conclude a registration check – in particular data on the employee's exposure and monitoring technologies – the EPA gave this “interim” declaration for implementation Immediate risk reduction measures determined, the recorded necessary to protect human health and the environment while additional data is collected.
What does the preliminary decision of the EPA require?
When granting this decision, the EPA claims a broad authority to regulate the use of ETO, although this is probably the responsibility of other federal authorities such as Osha. In particular, most of this decision is the attempt to reduce the permissible exposure limit (PEL) from OSHA for 1 ppm workers (8-hour-time-weight average) to 0.1 ppm.
According to EPA, this campaign is justified, since most Pels from Osha have not been updated since it was founded in 1971 due to the limited authority of Osha to do so. The EPA does not have this restriction. Therefore, the EPA claims that it can develop risk reduction measures to remedy the risks from the use of the pesticide of chemicals that Osha regulates, despite the potential divergence of Osha standards.
In addition to the establishment of an “EPA professional exposure limit”, the decision also identifies the requirements for monitoring, training and damage limitation for jobs with ETO, which traditionally takes into account the area of responsibility of OSHA.
The effects achieve far beyond the use of commercial sterilizers
However, ETO is used beyond commercial sterilisators. The use of ETO for several applications is listed in the decision, including museum, library and archive materials; Cosmetics; Musical instruments; and bee hiking equipment. ETO is also used to roast and sterilize spices, dried herbs, processed vegetables and other spice materials in order to reduce pathogens. The most important thing is that about a third of health facilities, including hospitals, veterinary clinics and dentists, use ETO on site to sterilize medical devices and devices. In fact, the EPA quotes the case of a hospital employee, in which leukemia was diagnosed shortly after employment as support for this decision. These facilities may need additional ventilation and reduction devices, and breathing protection providers may be required. The health facilities probably have to be monitored to ensure that they are below the threshold of 0.1 ppm.
Next Steps
The first step after this announcement is that ETO manufacturers submit label changes within 60 days for the review and approval of the EPA. After approval, the EPA collects additional data to make a final decision that is expected “within 8 years”. In particular, the EPA would like to collect data on potential exposure in stores downstream of the ETO treatment process, which can be exposed to ETO exhaust gas from the treated elements. The implementation and interpretation of this interim decision is left either to the incoming Trump management, which could possibly solve or reverse the exposure limits and reduction measures based on new data. If no changes are made, the issue of the final decision will be left to future administrations.
Diploma
This preliminary decision is a brave step from the EPA, but its long -term effects remain uncertain because it expects further review and potential changes in the context of the new administration. Even if the decision is made, the affected industries must deal with their far -reaching recommendations for professional security.