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Dems seek to force EPA action on ethylene oxide monitoring

July 30, 2020 By Nancy Crotti

Ethylene oxide

(Image from U.S. Occupational Health and Safety Administration)

Democrats in both houses of Congress have introduced legislation that would force the U.S. Environmental Protection Agency to better monitor emissions of ethylene oxide (EtO) from plants that manufacture the toxic gas or use it to sterilize medical devices.

The Public Health Air Quality Act of 2020, sponsored by Sen. Tammy Duckworth (Ill.) and Rep. Lisa Blunt Rochester (Del.), would require immediate EPA action to monitor emissions at “facilities contributing to high local cancer rates and other health threats from dangerous pollutants.” The list includes eight medtech sterilization plants included among 25 EPA-designated, EtO-using or -producing facilities:

  • An Edwards Lifesciences plant in Anasco, Puerto Rico.
  • A B. Braun Medical plant in Hanover, Pa.
  • A Becton Dickinson plant in Covington, Ga.
  • Sterigenics plants in Willowbrook, Ill., Smyrna, Ga., and Santa Teresa, N.M.
  • A Medline Industries plant in Waukegan, Ill.
  • Midwest Sterilization Corp. plants in Laredo, Tex., and Jackson, Mo.
  • A Terumo plant in Lakewood, Colo.
  • A Viant Medical plant in Grand Rapids, Mich.

The Sterigenics Willowbrook plant and the Viant plant in Michigan are now closed. The EPA considers 22 of the 25 facilities as contributing to an elevated estimated cancer risk equal to or greater than 100 in 1 million at the census-tract level. All the medtech sterilization facilities on the list are considered commercial operations and fall into this category. The three facilities whose emissions the EPA considers pose a greater cancer risk are industrial EtO sites.

The bill would:

  • Require the EPA to implement immediate fenceline monitoring for toxic air pollutants at “facilities contributing to high local cancer and other health threats from dangerous pollutants,” including EtO, within 4 months and for at least a 2-year period. Air monitoring data and any actions taken using the data would have to be made public, and the EPA would have to update emission test methods and emission factors if necessary based on new air data.
  • Ensure that fenceline monitoring and continuous emission monitoring are part of national emission standards for chemical, petrochemical, and other sources of fugitive toxic air pollution.
  • Require the EPA to issue rules to use the best available method of fenceline monitoring and corrective action within 1 year.
  • Add at least 80 new NCore multipollutant monitoring stations in communities where needed to protect people with asthma and other health conditions and from COVID-19. Deploy at least 1,000 new air quality sensors in communities affected by air pollution and COVID-19 to boost and complement the National Ambient Air Quality Standards monitoring network and increase communities’ access to information about air quality.

Medline Industries resumed sterilization operations at its Waukegan, Ill., plant in March, following state certification of the company’s $10 million in emission-control upgrades. Earlier in March, officials in Cobb County, Ga., allowed an Atlanta Sterigenics EtO plant to reopen for 21 days to sterilize devices and products needed during the coronavirus outbreak, then extended that permission indefinitely “in light of the ongoing pandemic health crisis and emergency orders.” The county and the company agreed to indefinitely postpone a court hearing on the county’s request for a temporary restraining order to halt plant operations.

Duckworth and Blunt Rochester are focusing their legislation on protecting Black residents who live and work near EtO plants in their states.  Illinois state officials ordered the Sterigenics Willowbrook plant to close in February 2019 over EtO emissions concerns. The company subsequently decided against reopening it. New Castle County in northern Delaware is the site of a Croda chemical plant had an accidental EtO release in November 2018.

“Black Americans and other communities of color are dying at disproportionate rates during this pandemic, in part because of the long-term, cumulative health consequences and complications associated with toxic air pollution from facilities located in their neighborhoods,” Duckworth said in a news release. “We must do everything we can to protect these fenceline and front-line communities.”

“In the midst of a global health pandemic which attacks the respiratory system, we’ve seen in incredibly stark terms the compounding dangers of polluted air for front-line communities,” added Blunt Rochester. “But the truth is that these communities have been subject to unsafe air for decades and have suffered the long-term health consequences and complications because of it.”

The EPA identified EtO as a “new and significant driver of cancer risk” in its 2014 National Air Toxics Assessment (NATA). It released that information in 2018, acknowledging it was based on emission inventories reported for 2014 and prompting backlash from the medtech industry. In March, an EPA inspector general recommended opening a channel of communication between government officials and people who live near the plants, prompting objections from EPA administrator Andrew Wheeler.

The inspector general’s office said it developed its list using data from EPA-generated lists of facilities that contributed to elevated estimated cancer risks at the census-tract level in the 2014 NATA, census block-level measurements and information from EPA-designated regions. Census tracts are small, relatively permanent statistical subdivisions of a county with boundaries that normally follow visible features, such as roads and streams. Census tracts ideally contain about 4,000 people and 1,600 housing units.

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