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New EPA Rule Impacting Medical Device Sterilization: Strict Emissions Control, Compliance Certification, Reporting

A live 90-minute CLE video webinar with interactive Q&A

This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

Thursday, December 12, 2024 (in 5 days)

1:00pm-2:30pm EST, 10:00am-11:30am PST

(Alert: Event date has changed from 12/5/2024!)

or call 1-800-926-7926

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.

Description

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.

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Outline

  1. Introduction: history of the final EtO rule
  2. The final rule
    1. Purpose
    2. Covered entities
    3. Emissions control
      1. Varying standards
      2. Fugitive emissions
      3. Alternative compliance options
    4. Title V permitting
    5. Reporting and monitoring
    6. Fenceline and offsite warehouse monitoring
    7. Compliance timeline
    8. Enforcement
    9. Remaining questions; future rulemaking
  3. Impact on covered entities
  4. State law interaction
  5. Preparing for compliance
    1. Abatement equipment
    2. Permitting
    3. Supply chain issues
  6. Practitioner takeaways

Benefits

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?

Faculty

Rieser, David
David L. Rieser

Of Counsel
K&L Gates

Mr. Rieser has more than three decades of experience advising clients in all areas of environmental law, including...  |  Read More

Szabo, Aaron
Aaron L. Szabo

Government and Regulatory Affairs Attorney
Faegre Drinker Biddle & Reath

Mr. Szabo partners with clients to navigate complex environmental and energy issues. He provides advice on climate...  |  Read More

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