EDF Health

Selected tag(s): IRIS

Finally—EPA takes steps to unify its approach to the evaluation of chemicals for cancer and non-cancer endpoints

Jennifer McPartland, Ph.D., is a Senior Scientist, and Lariah Edwards, Ph.D., is an EDF-George Washington University Postdoctoral Fellow

A recent article in Inside EPA ($) indicated that the US EPA’s Integrated Risk Information System (IRIS) will begin piloting a “unified approach” to the evaluation of chemicals for cancer and non-cancer endpoints. Specifically, it appears that the program intends to develop analyses demonstrating how a unified approach could work as supplements to some of its chemical assessments. This represents a major step forward in advancing the science of chemical assessment at EPA and is responsive to recommendations the scientific community and stakeholders have been making for years.

By way of background, chemical regulatory assessments generally assume that if a chemical is a genotoxic carcinogen, there is no exposure threshold for the effect. This means that across a diverse population, some level of risk for developing cancer exists at any level of exposure. Traditionally for all other toxicity endpoints, EPA and other regulatory agencies typically have assumed that there is a bright-line exposure threshold below which no adverse health effect will be seen.

This bifurcated approach to characterizing chemical hazards and risks is not scientifically supported. The assumption that there are “safe” exposure thresholds for all non-cancer endpoints ignores real-world variability in exposure and susceptibility across the human population.  This variability influences whether any particular person or group will experience an adverse effect, and includes such factors as: co-exposures to other chemical and non-chemical stressors and differences in susceptibility that may arise from things like genetic differences or underlying health conditions.

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Top takeaways from The Intercept’s investigation into Trump’s toxic rollbacks

Regulatory decisions by federal agencies in Washington often feel distant – bureaucrats moving paper in ways that don’t matter to regular people. But a devastating new story by reporter Sharon Lerner of The Intercept makes clear just how awful the Trump administration’s actions on chemical safety have been for average Americans.

Lerner shows that the Trump EPA has repeatedly bowed to industry lobbyists to allow dangerous chemicals to stay on or enter the market with little or no restrictions.

EPA’s actions are not abstract bureaucratic events to Angela Ramirez, who was diagnosed with breast cancer after years of living and working “near two facilities that were emitting a cancer-causing chemical called ethylene oxide.” EPA scientists knew “that exposure to ethylene oxide caused elevated rates of tumors in the brain, lungs, uterus, and lymph systems” – but under the Trump administration, following pressure from an industry trade group, EPA decided not to follow its own science deciding whether to limit the chemical.

Lerner reports that the Trump administration, stacked with political appointees who have worked, lobbied or advocated for the chemical, tobacco, and coal industries, has been systematically undermining EPA’s ability to use the best science and get the best expert advice to protect families. They’ve been attacking programs like the Integrated Risk Information System, or IRIS, which provides evidenced-based analysis to the government to make public health decisions.

From Texas to Delaware and across the country, Lerner shows the impact of an administration that seems entirely focused on doing the bidding of industry, rather than pursing its legal mission to protect public health. They are doing so both broadly – weakening a new chemical safety law –and in a series of individual chemical assessment decisions. “Each time we see one of these assessments, there are ways in which the science has been played with,” EDF’s Lead Senior Scientist Richard Denison told Lerner.

To read more about what Lerner calls “Trump’s cancer gang” and their attacks on science and public health, check out her full article.

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GAO affirms the Trump EPA’s political manipulation of the IRIS formaldehyde assessment

Richard Denison, Ph.D.is a Lead Senior Scientist.

I blogged last month about the Trump EPA’s corrupt actions to bury the long-awaited assessment of the carcinogen formaldehyde conducted by the agency’s Integrated Risk Information System (IRIS) program.  That post cited an article in the Wall Street Journal that noted a forthcoming report by Congress’ Government Accountability Office (GAO) that was expected to expose the suspect process used by conflicted political appointees at EPA to prevent public release and completion of that scientific assessment over the past 15 months.  We also noted disturbing indications that EPA intends to redo the assessment of formaldehyde under the Toxic Substances Control Act (TSCA), under the control of political appointees who came to EPA directly from the chemical industry’s main trade association and while there led its efforts to undermine IRIS.

GAO confirms in spades the concerted efforts by the agency’s political leadership to fabricate a rationale for abandoning the formaldehyde assessment, which has been ready for public and peer review since the fall of 2017.

GAO’s report is out, and yesterday it featured prominently at a Senate hearing at which top GAO officials testified.  That testimony confirms in spades the recounting in our earlier blog post of the concerted efforts by the agency’s political leadership to fabricate a rationale for abandoning the formaldehyde assessment, which has been ready for public and peer review since the fall of 2017.

In the wake of the GAO report, Senator Carper and other members of Congress from both houses have sent a letter to EPA Administrator Andrew Wheeler calling on him to complete the formaldehyde assessment and release documents pertaining to potential ethical and scientific integrity policy violations by EPA political appointees.

I won’t further rehash our earlier post, but will simply post a key excerpt from the hearing, an exchange between Senator Tom Carper (DE) and Mark Gaffigan, Managing Director for Natural Resources and Environment at GAO.  I’ll highlight some key passages in which GAO describes what its investigation found.

EXCERPT FROM YESTERDAY’S GAO TESTIMONY   Read More »

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The Trump EPA’s actions on formaldehyde can be summed up in one word: Corrupt

Richard Denison, Ph.D.is a Lead Senior Scientist.

Today, Heidi Vogt at the Wall Street Journal reported on the systematic efforts by the Trump Administration to derail chemical assessments under the Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS).   

Decisions are being made as I write by conflicted EPA political appointees, not only to derail the beleaguered IRIS assessment for the carcinogen formaldehyde, but to transfer any further assessment of the chemical to be under the control of those same political appointees.

The WSJ article cites an upcoming report by Congress’ Government Accountability Office (GAO) that notes “EPA leadership in October directed the heads of the agency’s various programs to limit the number of chemicals they wanted IRIS to study or continue researching.  Nine of 16 assessments were then dropped, including one that looked at whether exposure to formaldehyde increases the risk of leukemia that ‘has been drafted and is ready to be released for public comment.’ ”  The chemical industry has long sought to undermine the findings of numerous governmental authorities that have identified the dangers posed by formaldehyde, one of the industry’s biggest cash cows.

IRIS itself has also long been a target of the chemical and allied industries, including those well represented by EPA political appointees who are now able to drive the assault on IRIS from inside the agency.

This post will provide more of the backstory to the WSJ’s excellent reporting.  It reveals additional decisions being made as I write by conflicted political appointees, not only to derail the beleaguered IRIS assessment for formaldehyde, a known human carcinogen, but to transfer any further assessment of the chemical to be under the control of those same political appointees.  What is happening here we believe is ripe for further investigation.   Read More »

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EPA IRIS program receives high marks from the National Academies

Jennifer McPartland, Ph.D., is a Senior Scientist and Ryan O’Connell is a High Meadows Fellow with the Health Program.

Last week the National Academy of Sciences (NAS) published its review of the Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) program, concluding that the program has made strong progress in implementing NAS’ earlier recommendations. As noted by the chair of the NAS committee that led the review, “The changes in the IRIS program over such a short period of time are impressive.”

As I’ve blogged about before, IRIS is a non-regulatory program that provides critical chemical reviews and scientific expertise that help ensure the water we drink, the air we breathe, and the land where we live, work, and play are safe. Offices across EPA and elsewhere in the federal government rely on IRIS, as do states, local governments, and affected communities (see here and here).

“The changes in the IRIS program over such a short period of time are impressive.”

The new NAS report comes four years after its 2014 review, which noted the substantial progress made by IRIS in addressing recommendations from a more critical 2011 review of a draft IRIS assessment of formaldehyde. It is worth noting that half of the committee members involved in the new IRIS review served on the committee that authored the 2011 review.   Read More »

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The Big Squeeze: Dangers for public health lurk in recent EPA re-org efforts

Jennifer McPartland, Ph.D., is a Senior Scientist with the Health Program.

Over the past several months, the Environmental Protection Agency (EPA) has made or proposed a number of distressing shifts in offices or staff that support critical chemicals-related activities and scientific research. The programs affected include the Integrated Risk Information System (IRIS) program, the Safer Choice program, and the National Center for Environmental Research (NCER). Not coincidentally, each of these programs has been in the crosshairs of certain segments of industry and its allies in Congress and the Administration.

This blog post briefly reviews the proposed or implemented shifts and their implications.   Read More »

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