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September 2021 – Risky Business

Risky Business

US EPA Prepares to Release Cumulative Risk Guide by End of Year

US EPA recently resumed work on its guidelines for analyzing the cumulative risks from overlapping environmental hazards. The agency’s environmental justice plan is expected to be finalized by the end of the year. A draft of the “EPA Guidelines for Cumulative Risk Assessment Planning and Problem Formulation” document was peer-reviewed in July 2021, an agency spokesperson told industry publication Inside EPA. “EPA expects to complete these guidelines by the end of 2021.” The announcement marks the agency’s first indication in years that it is advancing the guidelines, which began during the George W. Bush administration as a follow-on to US EPA’s 2003 Framework for Cumulative Risk Assessment.

Environmental justice is an important issue that Erin Rodgers and Paula Beck of Environmental Standards had reported on earlier this year in an article featured in the March 2021 issue of The Standard. Environmental justice seeks to provide the same level of protection to all people, regardless of race or socioeconomic status, from harm due to environmental and health hazards. Specifically, the US EPA defines environmental justice as, “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.”

The pending guidance has been expected to include new science on how to assess risks posed by chemical mixtures and advice on how to account for the effects of non-chemical stressors in assessments. Consideration of such issues is critical in assessing  ̶  and mitigating  ̶  environmental health risks to poor and low-income communities, which often face complex combinations of chemical exposures and non-chemical stressors  ̶  attributes that contribute to a population’s susceptibility to exposure to environmental contaminants, such as age, lack of health care or neighborhood violence. But the US EPA staff has struggled to characterize socioeconomic and other non-chemical contributors to environmental risk, making it difficult for policymakers to adopt cumulative risk approaches.

Nevertheless, US EPA Administrator Michael Regan has made addressing the issue a crucial part of his environmental justice agenda. Regan has requested a review of legal authority to use cumulative risk or impact analyses to better account for the risk poor, minority, and other susceptible communities face. Development of the guide was once held up as part of Obama-era Administrator Lisa Jackson’s “EJ2014” environmental justice agenda but missed that administration’s September 2014 deadline for a public peer-review and appeared to lie dormant during the Trump years. However, according to the Inside EPA article, Regan could now use it in his efforts to expand consideration of cumulative impacts in agency decision-making, such as in permitting and enforcement decisions. It is unclear how the guidelines have changed since they were last in the public eye. The US EPA spokesperson says only that the recent “peer review comments are being addressed. The final document will then be reviewed and approved by the Agency’s Science and Technology Policy Council.”

Inside EPA’s article notes, “US EPA’s website describes the development of the guide as one of the ‘current projects’ underway at its Risk Assessment Forum (RAF) of staff Scientists tasked with adopting and implementing consistent risk assessment approaches across the agency but gives little detail on its contents.”

“EPA is developing additional guidelines for cumulative risk assessment (CRA) as defined and characterized in the EPA 2003 publication Framework for Cumulative Risk Assessment, an analysis, characterization, and possible quantification of the combined risks to health or the environment from multiple agents or stressors. The guidelines will arrange CRA methods into a structure based on EPA’s experience,” states the US EPA site. While RAF published the CRA framework in 2003, it has not issued new guidelines since the 1980s, which has frustrated some who have pushed the agency to embrace newer methods and approaches more quickly when performing risk assessments, particularly those designed to address multiple exposures.

Lawrence Martin, an RAF staffer, spoke about the guidance at the December 2012 Society for Risk Analysis annual meeting, where he expected that the guidance would “push the envelope of how cumulative risk assessment is performed at EPA.”

The Toxic Substances Control Act (TSCA) was rewritten in 2016, giving US EPA the opportunity  to consider susceptible populations in its chemical risk evaluations. Those populations have now become a focus for the Biden administration.

US EPA’s Office of Research and Development has continued research into methods of assessing the total environment through biomarkers and other tools. Throughout 2013 and into early 2014, the RAF’s cumulative risk panel hosted a series of webinars, often with visiting academics, on various cumulative risk research topics, intended in part to inform the development of the new guidelines. The agency also took public comment on how it can best undertake CRAs. The Inside EPA article notes that Martin, speaking at the Society for Risk Analysis’ annual meeting in 2013, said it received some 200,000 comments in response, with about half urging US EPA to act quickly on the issue.

Gerry Kirkpatrick, P.G.

Managing Partner