Enforcement and Inspection

EO Under Fire—the IRIS Dilemma

It looks to be a bumpy road ahead for any industry, primarily the synthetic chemical manufacturing industry (SOCMI), including petrochemical plants, dealing with ethylene oxide (EO).

At the heart of the controversy is the Integrated Risk Information System (IRIS) value for EO emissions.

The controversial IRIS

“IRIS is a research program that assesses chemical toxicity that EPA program offices use to develop regulations under federal laws such as the Safe Drinking Water Act, the (CAA), Superfund, and other laws. It operates outside the regulatory framework; therefore systems to ensure the scientific integrity of IRIS assessments are limited. Many of its findings have tended to be excessively cautious based on questionable and incomplete science,” states a study published by the Competitive Enterprise Institute (CEI).

The IRIS was created by the EPA in 1986.

“Environmental activists claim that the [EPA’s IRIS] represents the gold standard for risk assessment,” says the CEI study. “In reality, IRIS has a long history of sloppy research and lack of transparency that has advanced faulty and often counterproductive regulations that impose needless burdens on the public. In addition, poorly conducted IRIS assessments have sounded false alarms about risk and produced unwarranted health scares.”

The EPA IRIS value impacts more than federal regulations, as many states are developing their own restrictive EO standards based on the IRIS value, reports law firm Beveridge & Diamond PC.

Other states, such as Texas and the Texas Commission on Environmental Quality (TCEQ), have developed an independent Effects Screening Level (ESL) for EO that rates its risk as less than the risk determined by the EPA.

“Across multiple jurisdictions, toxic tort lawsuits cite to the IRIS value as a basis for establishing risk and causation,” Beveridge & Diamond notes. “Environmental groups are also sounding alarms on EO, seeking new rules and citing to environmental justice considerations. Indeed, the OIG’s own critiques of EPA derive from its assumptions that the IRIS value is correct.”

Analysts and IRIS critics assert a corrected EO assessment would provide better regulatory solutions for SOCMI.

TEJAS lawsuit

The Texas Environmental Justice Advocacy Services (TEJAS), et al. v. Regan, No.1:20-cv-03733-RJL is a good example of a lawsuit filed by environmental groups utilizing the EPA’s IRIS value to put the Agency under fire.

“In 2016, EPA scientists in the Integrated Risk Information System (IRIS) determined that (EO) has a risk value that is 30 times more potent than previously known and elevated this pollutant from a probable carcinogen to one known to be carcinogenic to humans,” states the TEJAS lawsuit.

When a program known to be “excessively cautious” in its findings determines “a risk value that is 30 times more potent than previously known,” it should be a signal for the EPA to take action, the lawsuit implies.

“Applying that new, higher cancer risk value along with other current cancer risk information in the 2018 National Air Toxics Assessment showed that there are community hot spots for cancer risk – places where cancer risk is higher than EPA’s own benchmark of presumed unacceptable cancer risk,” the TEJAS suit continues.

The EPA’s Office of Inspector General advised the Agency to communicate with communities exposed to EO-emitting chemical plants, including some that are SOCMI sources that the EPA identified as “high priority” due to the health risks.

“EPA continues to defend its controversial [IRIS] value for EO,” states a Beveridge & Diamond news alert dated December 7, 2021. “Although EPA finally – after years of delay – agreed to review its ‘use’ of the IRIS EO in the Miscellaneous Organic Chemical Manufacturing Residual Risk and Technology Review (MON RTR), the Agency (as well as states and plaintiffs’ attorneys) continues to forge ahead as though the IRIS value were uncontroverted. It is not.”

SOCMI health risks

The TEJAS lawsuit states that the EPA’s 2018 National Air Toxics Assessments (NATA) revealed extreme cancer risk hot spots from sources emitting “highly hazardous air pollutants” (HAP), such as EO, in Texas, Louisiana, West Virginia, and other states. When the NATA was issued, the “EPA committed to review the emission standards for synthetic organic chemical manufacturing plants to address this health threat, but it has failed to complete action fulfilling this promise,” according to the TEJAS suit.

The suit also expresses particular concern over the proposed Formosa Plastics petrochemical complex, which will include SOCMI units, to be located in St. James, Louisiana, an environmental justice community that has been nicknamed “Cancer Ally.”

“Hazardous air pollutants emitted by SOCMI sources can cause serious acute and chronic human health effects, including cancer, difficulty breathing, immune, developmental impacts, and other harm. EPA has long recognized that carcinogens have no safe level of human exposure and cancer risk is additive.  Prenatal exposure to carcinogens and other air pollutants and exposure during early childhood increases an individual’s lifetime cancer and other health risks due to greater vulnerability to harm from pollution during early stages of development,” the TEJAS lawsuit notes. “Socioeconomic disparities and related stressors increase vulnerability to carcinogenic and other toxic exposures.”

Industry takeaway

“Affected companies should take proactive steps now to identify, understand, and manage the risks in connection with increased attention on EO emissions as a result of new regulations, enforcement cases, and toxic tort litigation,” advises Beveridge & Diamond. “With all this momentum leading up to it, 2022 is poised to be another dynamic year of legal activity on EO.”

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