Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Environment, Manufacturing, and Critical Materials Subcommittee Chair Bill Johnson (R-OH), and Health Subcommittee Chair Brett Guthrie (R-KY) sent a letter to the White House today on the potential consequences of the Environmental Protection Agency’s (EPA) proposed regulations on the availability of ethylene oxide (EtO), which is needed for medical supply sterilization.

BACKGROUND 

• EtO is used as a gaseous sterilant to sterilize approximately half of all medical devices and 95 percent of all surgical kits in the United States.  
• On April 13, 2023, EPA published a number of proposals that would apply new restrictions for the use of EtO as a sterilant under the Clean Air Act and new air emissions standards for commercial sterilizers of EtO under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).  
• The subsequent comment period generated hundreds of submissions raising serious concerns about EPA’s proposals and how they would threaten to interfere with patient safety and disrupt our nation’s health care system.   
• According to the Food and Drug Administration (FDA), approximately 20 billion medical devices are sterilized each year using EtO and for most of these devices, EtO is the only validated and viable sterilization method. 
• Furthermore, the FDA has publicly reported that a significant share of medical devices in the U.S. exclusively rely on EtO as their primary sterilant and that the proposed EPA actions will disrupt the U.S. medical device supply chain. 

KEY QUOTE ON RISKS FOR PATIENTS 

“The FDA attests to the high scientific standards of EtO use as a sterilizer in preventing the growth of harmful microorganisms relative to other sterilization methods and acknowledges that inadequate sterilization can lead to life-threatening infections and poor health outcomes in patients seeking medical care. Furthermore, we share FDA’s concerns that EPA’s proposed actions will cause significant disruptions in patient access to emergency care, including surgery instrumentation and pacemakers, and threaten patient safety with increasing hospital-borne infections.” 

[…] 

“On June 27, 2023, the American Society for Health Care Engineering, the American Society for Health Care Risk Management, the Association for Health Care Resource and Materials Management, and the American Hospital Association wrote to the EPA to: 'Urge caution and thoughtfulness in EPA’s approach to avoid disrupting health care delivery through the unintentional fracturing of the already fragile medical device supply chain. Such fracturing could put patients at risk of serious harm . . . [s]pecifically, we are concerned that moving too quickly to implement and enforce new standards will result in the unexpected consequence of reducing EtO sterilization capacity, ultimately leading to delays in patient care.'" 

The members asked the White House to answer the following questions by October 13, 2023:

1. How do the National Economic Council (NEC) and the Domestic Policy Council (DPC) plan on ensuring that statutorily requirements for cost-benefit analysis are incorporated into the PID and NESHAP proposed rule?  
2. Are the EPA’s proposed interim decision and proposed rule consistent with the President’s economic policy objectives/domestic policy agenda as it relates to public health?   
3. Please identify how NEC/DPC plans to ensure that patient access to care will not be compromised by EPA’s proposed rules.  
4. How do you plan on fulfilling NEC/DPC’s role in implementing the President’s agenda as you consider these two EPA proposals?    
5. Will NEC/DPC commit to meeting directly with surgeons, hospitals, medical device manufacturers, and domestic sterilization facility manufacturers to understand better the feasibility of EPA’s proposed rules?  
6. Will you ensure domestic manufacturers have the necessary time to build compliance equipment for medical device sterilization, get it certified, and have it installed so as not to disrupt domestic medical device availability?  
7. What other roles will NEC/DPC play in mediating these proposed regulatory actions and preventing the damage they could cause?   
8. Is it the Biden administration’s position that one medical risk in just a few communities should be prioritized over greater medical risks for all Americans?  
9. Based on the number of devices that FDA has identified as requiring sterilization with EtO, and the potential need for revalidation for their treatment at a different level or with other substances, will the Biden administration need to shift resources away from products that are waiting to come to market to revalidate the existing medical product supply chain?  
10. We understand that the EPA recently settled a lawsuit from several plaintiffs, alleging that the EPA failed to review and revise as needed the NESHAP for EtO every eight years. How will this settlement impact the EPA’s proposed NESHAP rule?

CLICK HERE to read the full letter.