BD maintains collaborative relationships with regulatory agencies, including U.S. EPA and state level environmental protection departments. We are in full compliance with all laws and regulations surrounding the safe use of ethylene oxide (EtO). All facilities have permits for EtO emissions, and BD operates in accordance with all requirements.
BD uses independent, third-party companies to test the effectiveness of our emission control technology. This is to ensure the safety of our operations and compliance with local, state and federal regulations, as well as a requirement in our air permit. In addition, we employ monitoring inside our facilities to ensure the safety of our employees and compliance with Occupational Safety and Health Administration (OSHA) regulations.
All BD facilities are fully compliant with annual emission reporting requirements, and historical emission data is publicly available through the U.S. Environmental Protection Agency (EPA).
BD is working closely with the Georgia EPD regarding the agency’s recent modeling of ethylene oxide (EtO) emissions for BD’s facility in Covington. On July 25, the Georgia EPD released a statement clarifying that the level of ethylene oxide (EtO) emissions at BD’s facility in Covington is within acceptable risk levels as defined by the U.S. Environmental Protection Agency (EPA).
Even though our current EtO emission controls are among the most effective in the industry, BD is continuously striving to improve air quality controls at our facilities. We are currently working closely with Georgia EPD to implement additional voluntary improvements to further reduce emissions in Covington and Madison. To achieve this, BD is working with industry partners and Georgia EPD to discover new system and process innovations that will further reduce EtO emissions at our facilities, which the company plans to implement as soon as designs are finalized and approved through the appropriate permitting processes.
Under the Clean Air Act, the U.S. EPA sets limits on certain air pollutants. The EPA has set emission standards for EtO under the National Emission Standards for Hazardous Air Pollutants (NESHAP) rule, which applies to commercial sterilization and fumigation operations. EPA is in the process of developing a new proposed rule on EtO emissions under NESHAP, and working with AdvaMed and others in our industry, we have engaged with U.S. EPA to provide information about the control technologies and process controls we deploy at EtO sterilization facilities, as well as the role of EtO sterilization to the healthcare system.
The FDA plays an important role in assuring that medical device manufacturers’ sterilization methods are properly validated, and the mode of sterilization is included as part of the FDA regulatory approval process for medical devices.
On July 15, the FDA launched an innovation challenge to identify new sterilization methods and technologies as an alternative to EtO and reduce EtO emissions. BD will be actively participating in this challenge in collaboration with other industry organizations, and we plan to participate in an FDA advisory committee meeting on this topic in November.
Under the Toxic and Hazardous Substances rule, OSHA sets permissible exposure limits for EtO for workers. Exposures to EtO are addressed in specific OSHA standards for general industry, shipyard employment, and construction.
AAMI provides consensus-based standards recognized and enforced by FDA.
ANSI provides consensus-based standards recognized and enforced by FDA.