New EPA Rule Impacting Medical Device Sterilization: Strict Emissions Control, Compliance Certification, Reporting
Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
Intermediate
- work Practice Area
Environmental
- event Date
Thursday, December 12, 2024
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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This CLE webinar will guide environmental practitioners through the U.S. EPA's long-awaited final rule regulating the use of ethylene oxide (EtO) by commercial sterilizers. The panel will discuss the rule's stricter emissions control standards, new reporting requirements, and best practices for assisting clients to prepare for compliance.
Mr. Rieser has more than three decades of experience advising clients in all areas of environmental law, including legislative, regulatory, compliance, and law enforcement matters, corporate, commercial, and real estate transactions, governmental and private cost-recovery actions, environmental insurance coverage, and remediation of contaminated sites. He serves Fortune 100 and mid-sized companies operating in a broad range of industries, including power generation, chemicals, petroleum, steel, food and consumer products, financial services, and waste management. In the legislative and regulatory arena, Mr. Rieser has represented trade associations, industry groups, and individual companies in numerous matters involving the U.S. EPA and the Illinois Environmental Protection Agency. He also represented power generating companies in permitting and administrative proceedings, and prepared responses to agency requests for information regarding CAA issues. An experienced litigator, Mr. Rieser has argued cases in federal and state courts, including a recent victory in the U.S. Circuit Court of Appeals for the Seventh Circuit, in which he represented a coalition seeking to preserve commercial navigation in the Chicago waterways. Other matters have included cost recovery and enforcement actions.
Mr. Szabo partners with clients to navigate complex environmental and energy issues. He provides advice on climate change, traditional air pollution and chemicals, as well as general administrative and environmental issues. Mr. Szabo has more than a decade of experience in federal environmental and energy policy. His executive branch career spanned three presidential administrations, during which time he counseled decisionmakers on environmental, energy and natural resource statutes and regulations; analyzed regulatory policies to identify potential legal issues; researched and evaluated proposed legislation to respond to congressional reports and prepare testimony; and acted as liaison with other federal agencies and state, local and tribal representatives. Mr. Szabo was involved in the development of multiple significant EPA climate and air regulations, including the Clean Power Plan, and oil and natural gas methane regulations. He also worked on the Council on Environmental Quality’s National Environmental Policy Act’s updated regulations and federal sustainability policies.
The EPA recently released its long-awaited final rule regulating EtO emissions by commercial sterilizers who use the chemical to sterilize medical equipment. The final rule, effective Apr. 5, 2024, differs significantly from the April 2023 proposed rule and results in costly restrictions and compliance obligations for covered entities.
The final rule includes stricter emissions standards for chamber sterilization vents and aeration room vents, as well as new standards for previously unregulated emissions sources such as chamber exhaust vents and room air admissions, also known as "fugitive emissions." However, the standards vary based on the size of the facility, the amount of EtO used, and the date of the startup of the source. The rule also provides for alternative compliance methods through combined emissions streams.
Additionally, the final rule changes the way commercial sterilizers will certify their compliance with emissions control requirements. The rule requires the use of EtO continuous emissions monitoring systems, with exceptions for small users of EtO, and the electronic submission of compliance reports, performance test reports, and performance evaluation reports through the EPA's Central Data Exchange.
Listen as our expert panel guides environmental practitioners through the EPA's final rule governing the use of EtO by commercial sterilizers. The panel will discuss the new emissions control standards, reporting requirements, and questions left open by the rule. The panel will also address the impact the final rule will have on covered entities and offer best practices for preparing for compliance.
- Introduction: history of the final EtO rule
- The final rule
- Purpose
- Covered entities
- Emissions control
- Varying standards
- Fugitive emissions
- Alternative compliance options
- Title V permitting
- Reporting and monitoring
- Fenceline and offsite warehouse monitoring
- Compliance timeline
- Enforcement
- Remaining questions; future rulemaking
- Impact on covered entities
- State law interaction
- Preparing for compliance
- Abatement equipment
- Permitting
- Supply chain issues
- Practitioner takeaways
The panel will review these and other important issues:
- How does the final EtO rule differ from the April 2023 proposed rule?
- What emissions control standards are set by the final rule?
- How do the emissions control standards vary based on the size of the facility and the amount of EtO used?
- What alternative compliance methods are allowed by the final rule?
- What are the final rule's reporting requirements?
- How can counsel help their clients prepare for compliance now?
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