mitigating risks of ethylene oxide litigation and
TRANSCRIPT
Mitigating Risks of Ethylene Oxide Litigation and Enforcement: EPA Action Under Biden AdministrationPrioritizing High-Risk Communities, Reducing EO Emissions, Addressing Environmental Justice Concerns
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TUESDAY, MAY 11, 2021
Presenting a live 90-minute webinar with interactive Q&A
Madeleine Boyer, Principal, Beveridge & Diamond, P.C., Austin, TX
Evynn M. Overton, Principal, Beveridge & Diamond, P.C., Baltimore, MD
Julius M. Redd, Principal, Beveridge & Diamond, P.C., Washington, DC
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Strafford
Mitigating Risks of Ethylene Oxide Litigation and Enforcement: EPA Action Under Biden Administration
May 11, 2021
Maddie Boyer, Principal, AustinEvynn Overton, Principal, BaltimoreJulius M. Redd, Principal, Washington, DC
Agenda1. EtO Basics
2. Regulatory Basis for Recent Focus on EtO
3. Litigation Risks and Strategies for Risk Management
4. EJ Overview and EtORelevance
Ethylene Oxide Basics
• EO, EtO, C2H4O
• Flammable, colorless gas
• Intermediate used to make other chemicals used in making a range of products, e.g., antifreeze, textiles, plastics, detergents and adhesives
• Used to sterilize equipment and plastic devices that cannot be sterilized by steam, such as medical equipment
• In the U.S., ethylene oxide is primarily produced in two states: Texas and Louisiana
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https://www.americanchemistry.com/ProductsTechnology/Ethyle
ne-Oxide/Product-
Tree.pdfPrivileged & Confidential | Attorney-Client Communication
Ethylene Oxide Basics
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• EPA/IARC/WHO classify as human carcinogen
• Harms brain and nervous system
• Irritant (eyes, nose, lungs)
• Handful of federal regulations
- Miscellaneous Organics NESHAP
- Commercial Sterilizers
• Some state standards
Health Risks Hazardous Air
Pollutant (HAP) under Clean Air Act
EPA RISK VALUE: IRIS
“IRIS” = Integrated Risk Information System
EPA issued new IRIS value in 2016;
0.1 ppt for one-in-one-million increased cancer risk
New value increased calculated cancer risk of low-level EO exposure by 1-2 orders of magnitude
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National Air Toxics Assessment (NATA)
• https://www.epa.gov/national-air-toxics-assessment
Map of cancer risks by census tract
Once new IRIS value for EO was input into NATA, several census tracts reflected greatly increased cancer risks from EO emissions
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NATA EO
MAP
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From “Ethylene Oxide Air Issues,” M. Koerber, Office of Air Quality Planning & Standards, November 7, 2019
Flaws with IRIS Value
• Numerous problems with methodology
• IRIS value cannot be directly challenged
• ACC submitted petition in 2018 to review
- EPA agreed to respond to challenges in rulemakings relying on the value
- EPA has yet to do so
- ACC Petition https://www.americanchemistry.com/EO/Request-for-Correction-uder-the-Information-Quality-Act-2014-NATA.pdf
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Implications of Flawed IRIS Value
• Continuing to propose (and finalize) rules
• Notifying communities with highest EO exposure based on NATA
• EPA Office of Inspector General Reports• Most recent report specifically points to Environmental Justice issues
EPA continuing to move forward
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Implications of Flawed IRIS Value
• EO Enhanced Enforcement
- RMP/General Duty investigations after EO releases
• 114 Information Requests (Region, Headquarters)
- Sterilizers
- New RTRs in Response to most recent OIG report?
• Going forward?
- Administrative or Judicial Enforcement
- Utilization of Supplemental Environmental Projects (SEPs)
- Potential for extra-regulatory injunctive relief (e.g., fenceline monitoring)
Federal Enforcement
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Implications of Flawed IRIS Value
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IRIS Value Has Been Catalyst for State Action
• Some using to create more stringent standards (Illinois)
- Requires site-specific caps for EtO for non-sterilizing facilities based on the EPA IRIS value
• Some issuing less stringent standards (Texas)
- TCEQ developed own study to counter EPA IRIS Value
- Long term ESL of 2.4 ppb
New State Rules
• Enforcement actions, including facility shutdowns
- IRIS value basis for litigation by state Attorneys General and Plaintiff’s lawsuits
Uptick In State Enforcement
Takeaways: Best Practices
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Monitor this area for developments
Engage on key regulatory developments
Be mindful of interplay between regulatory developments and litigation
Know your assets and your risks
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Litigation Risks and Strategies for Risk Management
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Litigation Risks and Strategies for Risk Management
• Facility data in the public sphere
• Permit analysis
• Overall facility compliance status
• Proximity to residential communities and EJ profile of communities
Understand Facility Risk Profile
Why is this important?
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Litigation Risks: Class actions
Sommerville v. Union Carbide Corporation et al.
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• “Defendant’s South Charleston Plant manufactures EtO and emits huge volumes of EtO gas every year.”
• “Since at least 1978, the South Charleston Plant has emitted multiple tons of EtO into the air every year.”
• “These emissions contaminate the air in communities in proximity to the South Charleston Plant.”
Somerville v Union Carbide Corporation, et al, Class Action Complaint and Demand for Jury Trial, Fig. 1
Litigation Risks: State AG’s office claims
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“The NATA data shows … residents in the census tract
likely suffering the most exposure to EtO have a cancer risk of 214.5543
per 1 million, which is far in excess of the national
average (approximately 30 per 1 million), and that this increased risk is due to EtO
exposure.”
“Defendants have reported emitting hundreds of
thousands of pounds of EtOfrom the Santa Teresa Plant
from 1989 to 2016, including at least 10,000
pounds of EtO per year from 2005 to 2013.”
“Such permits would not relieve Defendants from the
obligation to otherwise comply with State law, including Defendants’
common-law duties to the State, the local community in and around Santa Teresa, and the New Mexico public
in general.”
New Mexico v. Sterigenics U.S. et al.
Litigation Risks: Toxic tort
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• Target EO producers and users
• Allege health effects resulting from exposure to EO emissions
Recent suits filed in Louisiana
Voorhies Law Firm
Litigation Risks: Likely focus on EPA’s top 25+
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Litigation Risks: News reporting and public data
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Intercepted: Trump EPA Helped Erase
Records of Cancer-Causing Pollution
(theintercept.com)
• “We have something in this country, the EPA has something called the Toxics Release Inventory. And in 1986, the EPA began requiring any facility that put out certain dangerous chemicals in their emissions to report how much they were releasing.”
• “We started looking over the TRI reports for all the big emitters of ethylene oxide. And it turns out that 12 of the facilities had retroactively revised their reports downward — in many cases, by a whole lot. And when you add up all the changes that were made together, it was a disappearance [laughs] of almost 270,000 pounds.”
Strategies for Risk Management: Understand Your Data in the Public Sphere
Pulled from EPA’s TRI database
Strategies for Risk Management: Correct Your Data in the Public Sphere
Example pulled from EPA’s ECHO database
Strategies for Risk Management: Understand the Facility’s EJ Profile
• EPA provides demographic information on its ECHO database
• The screening tool allows for toggling between a one-mile radius and a three-mile radius
• Provides information on age, income, education-level and race
Example pulled from EPA’s EJSCREENER
EJ Origins and Key Milestones
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EJ Origins and Key Milestones
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1982: Warren County,
NC Protest re: PCB Landfill
1987: Toxic
Wastes and Race Report
1994: Executive
Order 12898
2021: President
Biden prioritizes EJ in fed.
policy
The “What”: Defining EJ & Key Terms
U.S. Environmental Protection Agency: “Environmental justice (EJ) is the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation and enforcement of environmental laws, regulations and policies.”
California Code, GOV § 65040.12 (e): “[F]air treatment of people of all races, cultures, and incomes with respect to the development, adoption, implementation, and enforcement of environmental laws, regulations, and policies.”
United Nations Development Programme: “[A] mechanism of accountability for the protection of rights and the prevention and punishment of wrongs related to the disproportionate growth on the poor and vulnerable in society from rising pollution and degradation of ecosystem services, and from inequitable access to and benefits from the use of natural assets and extractive resources.”
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Meaningful Involvement
Fair Treatment
EJ
Early Biden Administration EJ Actions
Executive Order on Tackling the Climate Crisis
at Home and Abroad (January 2021)
• All-of-government approach• Revises EO 12898 to enhance
agency accountability• Increases emphasis on federal
EJ-specific enforcement• Improves access to data in
frontline and fencelinecommunities
• Targets investments for EJ communities
HIGHLIGHTS
• EPA to “strengthen enforcement of environmental violations with disproportionate impact on underserved communities”
• DOJ to ensure “comprehensive attention” to EJ nationwide
• Attorney General, in conjunction with EPA, other agencies, to develop an EJ enforcement strategy
• EPA to create a community notification program to monitor and provide real-time data on pollution in frontline, fenceline communities
A New EJ Era
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Litigation and Enforcement in EJ Communities
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Putting EJ Into PracticeUse the Best Tools Available
EJSCREEN –EPA GIS Tool
•EJ Indexes, combining environmental and demographic indicators
State-Based GIS Tools
•CalEnviroScreen (considers cumulative impacts; likely model for new CEQ EJSCREEN Update)
•NJ Environmental Justice Mapping Tool
Qualitative Data & Groundtruthing
•Site visits, community engagement, and consultation with community leaders to give data nuance
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This presentation is not intended as, nor is it a
substitute for, legal advice. You should consult with
legal counsel for advice specific to your circumstances.
This presentation may be considered lawyer advertising
under applicable laws regarding electronic
communications.
Thank You!
Privileged & Confidential | Attorney-Client Communication
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Maddie Boyer
Principal, Austin
512.391.8010
Julius M. Redd
Principal, Washington, DC
202.789.6069
Evynn Overton
Principal, Baltimore
410.230.1335