Ethylene Oxide Emissions Class Actions: Challenging or Defending Risk Assessment Testing Methodologies
Presenting and Cross-Examining Scientific Evidence Linking Ethylene Oxide Emissions in the Community to Reported Health Issues

Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
Intermediate
- work Practice Area
Class Action and Other Litigation
- event Date
Thursday, March 20, 2025
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
-
This 90-minute webinar is eligible in most states for 1.5 CLE credits.
This CLE webinar will discuss how to challenge or defend ethylene oxide (EtO) risk assessment testing methodologies often relied on in class actions seeking medical monitoring for an increased risk of developing cancer. The panel will also address the best use of expert testimony in these cases.
Faculty

Dr. Alex LeBeau is the owner of Exposure Assessment Consulting, LLC in Orlando, FL, where he offers toxicology, industrial hygiene, risk assessment, and public health consulting services. Over his thirteen-year career, he has evaluated environmental and occupational exposures and has performed toxicological evaluations of chemicals and biological agents. Dr. LeBeau has also performed human health risk assessments of contaminated sites using U.S. EPA and state regulatory guidelines and has monitored remediation activities at those sites. In order to evaluate the exposure impacts on building occupants, he has performed indoor environmental quality assessments, including Legionella and water quality assessments, at healthcare, residential, and industrial facilities. Dr. LeBeau has been a co-author on industry guidance for COVID-19 issues. He has been retained as a testifying expert witness and provided consultation on several occupational and environmental exposure claims. Finally, Dr. LeBeau has authored safety assessments on consumer products, including antimicrobial pesticide registration dossiers, Generally Recognized as Safe (GRAS) determinations for food ingredients following U.S. FDA regulations for scientific procedures, and submitted a health claim petition to the FDA that was successfully accepted by the agency.

Mr. Kelln draws from his wide-ranging experience and unique, energetic brand of client service to develop creative solutions to environmental problems. He has been at the epicenter of today’s most significant environmental issues, including “Waters of the United States,” climate change, sewer overflows and impacts from historic lead contamination. Mr. Kelln helps clients of all sizes come up with practical solutions to compliance with state and federal environmental laws, defending agency actions, and shepherding clients through environmental issues in transactions. He draws upon his in-depth knowledge of the Clean Air Act, Clean Water Act, CERCLA, RCRA, and other state and federal environmental laws to “cut to the chase” of any matter and strive for swift outcomes. Mr. Kelln is frequently called upon to lend his assistance to many of the country’s largest manufacturing companies and facilities.

Mr. Gannon maintains a national practice focused on complex environmental and toxic tort litigation matters. While he focuses primarily on environmental litigation, Mr. Gannon also applies his litigation background to resolve associated regulatory issues, advise on transactions involving environmental matters, and recover insurance dollars on behalf of policyholders facing critical loss exposure. Through his emphasis on litigation and enforcement involving critical infrastructure and emerging chemicals of concern, Mr. Gannon is well-versed in helping clients make reasoned judgments in complicated situations.

Mr. Johnston is an experienced trial lawyer, litigator, and appellate advocate practicing primarily in the areas of pharmaceutical products, toxic tort, and insurance. With over 26 years of experience, he has tried cases to verdict or obtained judgment for clients in courts throughout the U.S. Called upon to solve clients’ most challenging problems, Mr. Johnston often handles high-profile, landmark cases, presenting cutting-edge litigation theories and defenses for some of the largest companies in the country. He also represents smaller companies and individuals with significant matters. Mr. Johnston is a frequent author and lecturer on litigation issues and developments.
Description
First discovered in the mid-1800s, EtO is a colorless, odorless compound used (1) to make ethylene glycol and a host of consumer products and (2) to sterilize and/or fumigate sensitive products: e.g., certain medical equipment, plastics, and dried herbs and spices. The U.S. EPA recently lowered its acceptable ambient EtO exposure levels. This change was implemented based on risk assessment and other methodologies, which have faced significant criticism from industry experts, the scientific community, and state agencies.
The EPA's recent changes have spawned numerous class action and personal injury lawsuits by individuals living in proximity to facilities that use EtO. This often demands medical monitoring as a remedy. The strength of any particular claim depends on the quality of the scientific evidence attempting to link EtO emissions in the community to reported health issues, so counsel on both sides must thoroughly understand and be able to challenge the weaknesses or defend the strengths of different testing methodologies and the resulting data.
The scientific problem is complex. A few attempts have been made to assess the risk of ambient EtO exposure. Scientific disagreements exist over which of the many methodologies most accurately measure EtO risk. No consensus exists as to whether EtO can cause damage, nor as to the weight of evidence that would be needed to demonstrate at what levels of exposure damage might occur. Defendants have argued that the risk assessment methodology used to measure EtO risk lacks precision and have urged that the EPA adopt the Texas Commission on Environmental Quality's risk value for EtO as an alternative.
Listen as this panel of attorneys and experts reviews and offers guidance on how to evaluate risk assessment testing and methodologies in EtO class actions seeking medical monitoring.
Outline
- Introduction
- What is EtO?
- Sources of EtO
- Risk estimation methodologies
- Regulatory actions by EPA and causation
- Class certification issues
- Types of damages
- Predominance
- Evidentiary issues and burdens
- Federal Rule 702
- State court standards
Benefits
The panel will review these and other key issues:
- What is the most recent challenge to the EPA's EtO regulations?
- Why is a scientific understanding of exposure critical to understanding the risk?
- Under what policies might defendants find insurance coverage for EtO claims?
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