EPA’s TSCA Assessment of PV29 a Legal and Scientific Mess

In response to EPA’s flawed assessment of Pigment Violet 29 (PV29), NRDC, Safer Chemicals Healthy Families (SCHF), Earthjustice, Environmental Health Strategy Center, and others worked together to submit to EPA extensive legal and technical comments. How badly did EPA mess up, and why should you care?

The Toxics Substances Control Act (TSCA) was revised in 2016 after years of bare-knuckled stakeholder negotiations during which NRDC,  Safer Chemicals Healthy Families (SCHF), and other public interest and public health allies worked expertly and tirelessly to make it as effective and health-protective as possible. Unfortunately, implementation of the new TSCA is taking place in the pro-polluter de-regulatory Trump Administration EPA with coal lobbyist Andrew Wheeler at the helm, and under the direct thumb (on the scale) of chemical industry lobbyist Nancy Beck, whose previous gig was with the American Chemistry Council—the industry trade group dead set on weakening the new law.

EPA is required by the TSCA law to identify a set of 10 chemicals which will be reviewed first, including the hazards, exposures, conditions of use and potentially exposed or susceptible subpopulations. There are some big name highly hazardous and even deadly chemicals in this first batch, including: methylene chloride; trichloroethylene (TCE) solvent linked to congenital heart defects and cancer; and asbestos.

The Trump EPA has already rolled back its proposed ban on the most deadly uses of the solvents, TCE and methylene chloride.

So, with the chemical industry Cancer Lobby leading from within, it is deplorable but not surprising that the first chemical risk evaluation to be released under the new TSCA is not based on science, but instead on conjecture, deceit, and denial.

The first risk evaluation out of the gate is Pigment Violet 29 (PV29) a rather obscure coloring chemical used in paints, plastics, and other industrial and consumer products including paint sets. EPA’s draft evaluation concludes that the chemical is unlikely to pose an unreasonable risk to human health or the environment (Docket EPA-HQ-OPPT-2018-0604-0001).

Here is a summary of why no one should feel comforted—or be fooled—by EPA’s conclusion:

  • EPA’s hazard assessment is based on only 24 industry-sponsored studies, none of which are publicly available for review. Short summaries are all that the public can see (they are online at Docket EPA-HQ-OPPT-2018-0604-0007). EPA has violated TSCA by shielding from the public the  full studies that it bases its assessment upon.
  • EPA has no studies of chronic exposures, cancer, neurodevelopmental effects, or endocrine effects. None.
  • For its dismissal of potential risks from inhaling PV29, EPA relies on two industry-sponsored acute studies that are classified as “not reliable” and “disregarded due to major methodological deficiencies” by the manufacturer that conducted the studies.
  • The longest study EPA has—which is the basis for the calculated risk estimate (the Point of Departure)—is the reproductive and developmental effects study, which is only 54 days long in total, and only examines the fetally exposed rodent pups until they are four days old, hardly enough time to see potential effects such as neurobehavioral deficits, endocrine effects, reproductive effects, or cancer. Effects including gross lesions are mentioned but dismissed by the study sponsor, BASF—the largest chemical company in the world—and by EPA.
  • EPA’s determinations of worker and consumer exposure for all PV29 uses are based on a single undocumented estimate of exposure that EPA obtained from “personal communication” with an industry representative at Sun Chemical Corporation, cited as “Mott 2017”. EPA’s PV29 assessment says, “It is not clear if the monitoring data were for C.I. Pigment Violet 29 or for total dust” (Draft PV29 Risk Evaluation p.29). This means that EPA has no idea of what other airborne contaminants may be present, or how they may interact with PV29 to affect its absorption, metabolism or other relevant properties.
  • EPA failed for two years to obtain any additional data on PV29, despite being given streamlined authority and a mandate to do so under the revised TSCA. 
  • EPA relied on its fatally flawed TSCA Systematic Review for the PV29 assessment, which favors industry-sponsored studies and is in conflict with established methods.

It is especially appalling that EPA is relying so heavily on Sun Chemical 'personal communication' reports for workplace exposure and other workplace information, given that its manufacturing facilities have had two worker deaths. Dr. David Michaels, former Secretary of OSHA, reported that, "A temporary worker was asphyxiated in November 2015 at Sun Chemical's South Carolina plant. In November 2011 , a worker in a different Sun Chemical facility was crushed by a bag of color toner. Both of these deaths resulted in citations by OSHA for violating regulations."(David Michaels, 2019) In his comments to EPA, Dr. Michaels notes that EPA's assessment is built on numerous unsubstantiated and inaccurate claims that would fail to protect workers and their families.

For all its flaws, data gaps, and uncertainties, EPA applies an Uncertainty Factor (UF) of only 100 (10 for interspecies and 10 for intraspecies differences). We identify at least another four 10X factors that EPA should have used had it followed its own Guidelines (making a total UF of 1 million); had EPA used even one additional 10X factor, its calculations would have shown PV29 to be unsafe.

EPA is ignoring some important warning signs regarding PV29 health concerns. The chemical is listed on authoritative government lists as a reproductive toxicant, “Suspected of damaging fertility or the unborn child,” based on modeled information (see DataCommons). The TEDX database of endocrine disrupting chemicals identifies publications in the US National Library of Medicine that report a potential for PV29-related chemicals (perylene and benzo-a-perylene) to have endocrine activity based on an analysis of their structural similarity to other endocrine disrupting chemicals.   

Moreover, the US public health agency ATSDR emphasizes that the class of chemicals  of which PV29 is a member (PAHs), are linked to cancer risks, harm to hematopoietic, immune, reproductive, and neurologic systems and developmental effects (ATSDR on PAHs).

In addition, given that PV29 is highly persistent and long-lasting in the environment, it is a serious concern that EPA is proceeding with its hazard evaluation of PV29 despite a complete lack of any long-term exposure studies.  

And this is only a small sampling of the many problems with EPA’s work on PV29. Given these many flaws, EPA should withdraw its draft risk evaluation for PV29 and recognize that insufficient evidence is available to determine whether it presents an unreasonable risk of injury to health or the environment.

In summary, EPA’s first draft risk evaluation under new TSCA is marred by multiple methodological, legal and moral flaws—with 9 more of these evaluations to come in the next few months. 

Importantly, if EPA finalizes it’s no unreasonable risk finding (and survives the legal challenges that are likely to follow) it will preempt states from taking further action on this chemical. But Congress never intended for EPA to preempt state action based on half-baked, shoddy and secret evaluations. The revised TSCA established clear standards for the Agency to meet in conducting its risk evaluations, and so far, EPA has failed miserably to meet those standards.

And, the mess isn’t just with EPA’s review of existing chemicals already on the market. EPA’s reviews of proposed New Chemicals are also not complying with the revised law, in several ways, including basing its decisions that new chemicals are unlikely to pose an unreasonable risk to health based upon unsupported assumptions that all workers will wear proper personal protective equipment, and that employers will follow all the (non-binding) requirements in a Materials Safety Data Sheet.

This is what environmental policy looks like when EPA’s Toxics office is run by the chemical industry: a blatant failure to meet even basic requirements of transparency or scientific merit; serving the interests of chemical manufactures while putting the health of people and the environment at risk. Pretty much what one would expect from the Trump Administration by now.

About the Authors

Jennifer Sass

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

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