Medical device sterilizers will face new limits on ethylene oxide (EtO) emissions and new requirements for worker protection, according to a pair of proposals issued by the EPA. The new limits are part of a broader series of actions by the agency to reduce exposure to the chemical, which it said can increase cancer risks over the course of a career or a lifetime.
Companies will have 18 months to install the required pollution controls after the EPA issues a final rule.
AdvaMed, of which MichBio is a state affiliate, along with other medical device trade groups have claimed that too-stringent requirements could limit patients’ access to medical devices. The national group warned that closure of even a small percentage of sterilization facilities due to EtO emission violations could harm patient access to health care.
AdvaMed sent letters (here and here) to the EPA requesting 60 additional days for public comment on the proposed NESHAP rule and the proposed interim registration review decision (PID) and draft risk assessment addendum for EtO.