After the Environmental Protection Agency (EPA) has taken on strict air emission controls for commercial sterilisators that have taken over ethylene oxide (ETO), it has now taken over further control over the exposure to ETO in the workplace, including the introduction of new employee exposure limits, the use of ETO use in sterilizing food Training requirements and the training of cosmetics who do the requirements of commercial sterilis servers and the training of requirements. These controls represent the next step in the EPA campaign to control exposure to poisonous chemicals.
In contrast to its earlier emission regulations, the EPA issued these controls as a review (ID) under the authority for insecticide, fungicide and rodenizid laws (FIFRA) for regulating pesticides. Since its main purpose has been anti-bacterial, ETO has been regulated as a pesticide since 1966 and registered under FIFRA in 1984. FIFRA gives the EPA the authority to review and reproduce pesticides and confirm the permissible uses and warning of their necessary labels. It also enables the EPA to provide preliminary knowledge and requirements, even though it has not completed its registration process.
The EPA started the repetition procedure for ETO in 2013, but must still have completed it. However, when the EPA focused on the control of the ETO in 2021, it began to consider an ID to limit the exposure. In 2023 there was an ID out of the draft in which the regulation and the environmental communities were invited. On January 5, 2025, the EPA published its final ID, which is not published in the Federal Register, but on the EPA website.
In the ID, the EPA leads strict limits to the commercial sterilizers. It limits the applicable usage for ETO by determining that ETO can no longer be used for museum, library and archive materials, cosmetics or musical instruments. The ID also limits ETO usage purposes for the sterilization of food, which says that it can generally no longer be used in completely or ground spices or spice materials, although it can be used for a specific list of such materials and can be used to treat another list of such materials if additional treatment is required. The ID further provides that the concentration boundaries should be applied by 2035, whereby the concentration for the sterilization of medical devices is restricted to 600 mg/l, unless the device design requires a greater level of concentration or has the permits of the US food and drug management (FDA) for higher values. After all, commercial sterilization systems must have separate heating, ventilation and air conditioning systems for offices and control rooms as well as for ETO processing areas.
The ID adds significant rules for the exposure of employees. It goes beyond the permissible exposure boundaries of the professional security and health authority (OSHA) and uses an eight-hour average exposure limit that is moving down over time. By December 31, 2027, the facilities must ensure that the eight -hour weighted limit is not more than 1.0 ppm, but by January 1, 2035, the exposure limit must be reduced to 0.1 ppm. The EPA accepts similar reductions for the short-term exposure limit and the EPA campaign level. Similarly, the EPA gives the employees the requirements of either using air/flight pirators or in specially closed ventilation device if they deal in tasks that affect a direct exposure to ETO such as connecting and separating ETO containers or discharging products from the sterilization chamber or the ventilation area. Finally, the ID requires continuous monitoring devices in both process and non-processing areas.
The ID also requests improved training and recording requirements. Training must include a discussion of the health effects of ETO exposure and the specific language that ETO is a carcinogen and describe the symptoms of acute and chronic exposure. The recording includes monitoring the ETO concentrations of the sterilisators, the exposure data of the employees, the surveillance results indoors and the training of the workers.
The ID presents similar strict rules for sterilizers in health facilities, including hospitals, veterinary facilities and dental practices. Such institutions may only use ETO in individual chamber sterilization devices that use emission production systems that restrict employees and public exposure. The ID also requires similar requirements for exposure and similar rules for respirators. The rule for training and recording is also similar.
The ID sets numerous new requirements for ETO use for commercial sterilizers and for the sterilizers in the healthcare system, and each of these requirements has different start and compliance data. Since the ID is not subject to the Federal Registers, these requirements may not be subject to the broad attention of the EPA regulations, but are just as dramatic and extensive. The EPA has published the ID in the last days of the bidges, and it is not clear whether the Trump administration will check the ID together with other late EPA regulations. It is clear that ETO users have significant additional requirements due to the ID and have to check and understand them.
Our aspiring contamination group pursues ETO developments and developments for other newly regulated contaminants.