ACC/TSCA Attack on IRIS: Formaldehyde, Chloroprene, EtO

Unfortunately, cancer-causing chemicals have their own lobby in Congress, the American Chemistry Council, ACC. Now, one of their own, Nancy Beck, is running the EPA Office of Chemical Safety and Pollution Prevention (OCSPP; the Toxics Office). The Toxics Office is charged with implementing the Toxic Substances Control Act (TSCA) as well as the pesticide regulatory laws FIFRA and FQPA.

TSCA: An Industry-Captured Office

In contrast to the industry-captured TSCA program, EPA’s Office of Research and Development (ORD) continues to receive favorable reviews for its implementation of chemical assessments through the Integrated Risk Information System (IRIS) program. It has been praised by the National Academies in two reviews (NAS 2018; NAS 2014), scientific experts around the world, and the U.S. Government Accountability Office (GAO 2019). IRIS assessments are generated through a transparent process that invites multiple opportunities for inter-agency review and public comment including from the chemical industry. The scientific studies supporting IRIS chemical assessments are published or otherwise publicly available, and the assessment is subjected to a rigorous public expert review prior to being finalized.

Given the differences in credibility and scientific accountability between the TSCA and IRIS chemical assessments, it is alarming that the recent GAO investigation reported that the EPA Administrator’s office is blocking IRIS assessments, while program office leadership is pulling staff from the IRIS program into the TSCA program: “…4 months after IRIS assessments were stopped from being released—28 of approximately 30 IRIS staff were directed to support implementation of [TSCA], with 25 to 50 percent of their time, according to officials” (GAO 2019). 

Making matters worse, the EPA Scientific Advisory Boards that have until now provided important public oversight and expert review of Agency science are also being captured by industry. An EPA directive from former Administrator Scott Pruitt now prohibits experts from serving on the SAB if they receive EPA research grants, which blocks Academic researchers and non-industry experts (Pruitt 2017). The SAB Standing Committee on Chemical Assessments now includes industry consultants like: Richard Belzer with clients ACC and Exxon Mobil; Harvey Clewell of Ramboll with clients ACC, DuPont, Dow, and Syngenta; and, Dennis Paustenbach who argued for the safety of asbestos on behalf of the auto industry. 

It is in this new climate of science-denial that the TSCA program stalled the Obama era proposed rules on methylene chloride, its toxic replacement NMP, as well as certain uses of trichloroethylene (TCE) as an aerosol degreaser and for spot cleaning in dry cleaning facilities (Dec 2016). The proposed bans for TCE and methylene chloride were informed by IRIS assessments. Just last week, the Toxics Office issued its rule on methylene chloride paint strippers that fails to protect workers—a vulnerable population it is required to protect under the TSCA law. At least four people have died from methylene chloride stripping products since the original ban was proposed. 

In an important test, the first draft TSCA chemical assessment under TSCA to be publicly released—for Pigment Violet 29—is, to paraphrase Thomas Hobbes, poor, nasty, brutish, and short. It is based on only 24 studies, all sponsored by industry (see ECHA Dossier), and none made fully available to the public (see EPA documents). Many of the data tables are redacted (blacked-out completely) for the key study that forms the basis of the risk estimate (see Repro/Devel tox screening test; see my blog and NGO coalition legal and scientific comments). The assessment also estimates low exposures to the public, and particularly workers, based upon absurd and unsupported assumptions about workplace exposures and conditions. It is especially appalling that EPA is relying exclusively on Sun Chemical 'personal communication' reports for workplace exposures and other workplace information, given that its manufacturing facilities have had two recent worker deaths that resulted in citations by OSHA for violating regulations (see comments from David Michaels).

Industry Attack on IRIS Assessments of Formaldehyde, Chloroprene, Ethylene Oxide

In a recent investigative report in The Intercept, Sharon Lerner identified the three biggest contributors to hazardous air pollution hotspots around the country—Chloroprene, Ethylene Oxide, and Formaldehyde (Lerner, Feb 21, 2019). If EPA protected communities from these three chemicals, it would reduce the cancer risk from air pollution by 91 percent. For many of these communities—largely low-income communities of color—the cumulative cancer risks from just these three chemicals are hundreds of times above background. 

By continuing to fail to consider the cumulative impacts of exposures to multiple chemicals from multiple sources, including current exposures from legacy uses, EPA assessments are failing to reflect the toxic reality that families suffer in every state in the country. Allowing toxic emissions and hazardous exposures using risk estimates that consider only one chemical at a time fails to address the real-world impacts of coal plants, refineries, cement kilns, chemical plants, metal smelters, incinerators, highways, truck routes, shipping channels, Superfund and other hazardous waste sites. 


The Toxics Office recently announced the first 20 chemicals it plans to assess as ‘high priority’ under TSCA. After having blocked the public release of the IRIS formaldehyde assessment (GAO 2019), it is alarming but not surprising that the Toxics Office now claims formaldehyde as its own, signaling  a ‘do-over’. Given how the Pigment Violet 29 assessment has turned out, it seems certain that the TSCA formaldehyde assessment will be a complete capitulation to industry demands to weaken the cancer risk estimates.

Formaldehyde is used in the production of petrochemicals including agrochemicals like Roundup made by Monsanto and others. In the US, 727 industrial facilities release a total of over 19 million pounds of formaldehyde as environmental pollution. The testimony of Dr. Wilma Subra details the impact on communities, human suffering, and industry failure to control this carcinogen.


A successful demonstration of the IRIS methods can be seen in the IRIS Chloroprene Assessment (IRIS 2010) and the Response to the Request for Correction by Denka Performance Elastomers (IRIS 2018). Denka—the main producer of chloroprene—argued based on an industry sponsored model from Kenneth Mundt at Ramboll Environ and lacking any new data, that EPA should weaken its inhalation risk estimate by 150-fold, reduce the cancer classification from “likely” to “suggestive”, and withdraw the Reference Concentration (RfC) completely. IRIS’ 54-page scientific response also notes that its assessment was, “reviewed by internal science experts within EPA, by science reviewers from other federal agencies, and by the White House, and it was externally peer reviewed by independent experts including opportunity for public comment. EPA notes that many of the topics and assertions raised by [Denka] in the [Request for Correction] were considered by agency and external peer reviewers during assessment development and external peer review because DuPont (the former owner of the La Place Louisiana facility that currently produces chloroprene) provided extensive comments during the public comment period.” In other words, Denka tried to argue away the cancer risks with no new data and nothing new to say, bolstered by its friends in Congress

Ethylene Oxide

The ACC sent EPA a Request for Correction of the 2014 National Air Toxics Assessment (NATA), immediately after the data was released in 2018 asking that the IRIS assessment of ethylene oxide (EPA 2016), which forms the basis of the NATA cancer risk estimates, be withdrawn. ACC is arguing that it is a less potent carcinogen, and that, “the alleged elevated cancer risk driven by EO in the 2014 NATA has already caused alarm in some communities around facilities with EO emissions” that could have been avoided had EPA reduced the cancer unit risk estimate (ACC, p. 6).

The IRIS assessment is based on workplace epidemiologic studies—breast cancers in women workers, exposed through the normal course of earning a living and supporting a family. The human data is strengthened by rodent studies with evidence of cancer in blood and breast tissue, and cellular evidence that ethylene oxide is genotoxic and mutagenic. The IRIS assessment took 10 years to complete (from 2006 to 2016), including interagency review, external review, Science Advisor Board review, and multiple opportunities for industry and the public to comment (see details including industry interference in the NRDC ‘Delay Game’ report). All industry and public comments have been considered by the EPA and SAB. The IRIS experts even published the key findings and addressed scientific issues (Jinot et al 2018). ACC and the ethylene oxide industry have no new data and nothing new to say. It is past time for communities to be protected from harmful industrial pollutants.

Product Defense: Ramboll Consultants

In addition to his work to attack the IRIS Ethylene Oxide assessment, Ramboll Environ’s Kenneth Mundt previously published an ACC-funded article denying a link between formaldehyde and leukemia (Mundt et al 2017). About 10 years earlier, Mundt was reported in the Washington Post as having buried evidence showing low exposures to chromium were toxic, going so far as to withhold the data from the Occupational Safety and Health Administration (OSHA) during its rulemaking process. Like his work on formaldehyde and ethylene oxide, Mundt’s chromium study was also funded by the ACC. The Washington Post reported, “Kenneth Mundt…did not have an explanation for why he ultimately lumped workers together differently than they were in the initial, unpublished version—a change that blended the intermediate-exposure workers with the low-exposure workers and resulted in a finding of no risk. Mundt said he was under no pressure from his industry sponsors to doctor the data.” (Rick Weiss, Washington Post, Feb 24, 2006). No pressure except an increased likelihood of more paid work, I suppose.

As a consultant for Philip Morris and the tobacco industry, Mundt attacked the National Cancer Institute’s findings that low-tar cigarettes could cause lung cancer (see 2016 investigative series by David Heath).

Incredibly, Ramboll now has a seat at the table with Harvey Clewell on the EPA SAB Standing Committee to review its Chemical Assessments.


The research of EPA’s Office of Research and Development (ORD), which houses the IRIS program and the National Center for Environmental Assessment (NCEA), provides critical scientific expertise and support for regulatory and non-regulatory programs across EPA. For example, ORD has already initiated research programs and methods development to address cumulative risk impacts from multiple exposures. These and other scientific and technical programs need to be advanced, resourced, and protected.

Instead of addressing the industrial sources of its air pollution, the chemical industry and its allies at the TSCA program are attacking the IRIS assessments, scavenging off IRIS resources to staff up the industry-captured TSCA program, shifting the balance of the SAB from non-industry to industry members. Under these conditions it is inevitable that chemical assessments will be weakened, regulatory safeguards will be gutted, and preventable human suffering will rise.

Below Graphic: Moiz Syed, with permission from The Intercept, A Tale of Two Toxic Cities by Sharon Lerner, Feb 2019. 

Graphic from The Intercept, Feb 24, 2019. Sharon Lerner

About the Authors

Jennifer Sass

Senior Scientist, Federal Toxics, Health and Food, Healthy People & Thriving Communities Program

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