Premier Comments on Proposed Rule Amending the National Emission Standards for Hazardous Air Pollutants

Premier submitted comments to the Environmental Protection Agency (EPA) on a proposed rule amending the National Emission Standards for Hazardous Air Pollutants (NESHAP) which aims to strengthen and update Clean Air Act standards for ethylene oxide (EtO) emissions from commercial sterilizing facilities.

Premier is equally dedicated to weighing environmental responsibilities with our ability to sustain patient care across the country. For years, Premier has called for the EPA to expeditiously define what “good” looks like in this space and provide a sufficient timeframe for medical device sterilizers to meet those standards. Development of national standards is critical to provide certainty, ensure rational decision-making that is in the best interest of potentially impacted communities, and ensure critical medical supplies are available for patient care. Given the intense supply chain pressures our nation has faced during the pandemic, building towards true domestic resiliency requires us to think cohesively about how national standards and regulations support that goal.

Today, EtO sterilization capacity for medical devices is extremely limited, particularly in the U.S., and any disruption creates risk of significant shortages of essential medical devices. Therefore, Premier raised significant concerns that the EPA’s proposed rule does not adequately balance the need to protect and enhance environmental stewardship in the communities we serve with preventing medical device shortages and downstream impact to patient care. Premier’s comments focused on opportunities to better balance these needs and proactively mitigate potential medical device shortages through public-private collaboration.