My colleague, Daniel Rosenberg and I both had the opportunity to present public comments on behalf of NRDC to the EPA Science Advisory Committee on Chemicals (SACC) that is providing peer review on EPA’s chemical risk assessments.
The Purple Pigment Political Elephant in the Room
The work of this advisory committee is so important because the Trump EPA is setting critical precedent with its risk evaluation of a purple coloring chemical called Pigment Violet 29 (PV29; CAS 81-33-4), used in paints, plastics, and many other consumer products. This is the first chemical to be assessed under the amended Toxic Substances Control Act (TSCA), and will therefore set the precedent for all the chemicals to follow (see details and updates from Safer Chemicals Healthy Families).
White House E.O. to Slash Science Advisory Committees
This committee is meeting just days after the White House June 14th Executive Order slashing federal advisory committees by at least one-third by September 30th. This order is a dangerous attack on scientific peer review, which is the cornerstone of scientific activities and public oversight. Rush Holt, chief executive of the American Association for the Advancement of Science (AAAS), was reported in TIME magazine a few days ago as saying, “he was concerned about the move to cut back on advisory panels, especially ones involved with health and the environment. ‘Advisory committees help the government become better informed, and making smart decisions should not be seen as optional or dispensable.“
An editorial in Nature, one of the premiere international science journals was even more direct: “Trump’s plan would make government stupid… ignoring, suppressing or manipulating science advice has been a pattern of this administration; now the very committees that provide that advice are being eliminated.”
Science and technical experts that are independent of the regulated industries that EPA policies impact are essential for providing course-corrections, re-directions, or even rejections of the scientific products that inform government activities, actions, and decisions. Whether we agree with government policies or not, it should be able to get the science right.
What the Experts Say: EPA Should Junk It and Start Over
Dr. David Michaels—an epidemiologist and professor at GW University and former OSHA head and author of the must-read book, Doubt is Their Product: How Industry's Assault on Science Threatens Your Health—also addressed the SACC committee today. He told them that now is a time for courage, to tell the Trump EPA that its work fails the basic test of credibility. He said, “This draft Risk Evaluation for PV 29 is not, in fact, a scientifically-based risk evaluation but an exercise in hand-waving, developed to justify a pre-ordained conclusion. It is so full of unsupported statements and unjustified assumptions that, as an advisory committee, you should advise the EPA to junk it and to start over.”
What We Don't Know About Pigment Violet 29
The Trump EPA determined that PV29, under all conditions of use, poses a low hazard to human health and environmental receptors, low solubility, low vapor pressure, low bioaccumulation potential, low absorption, limited environmental releases and low potential for resulting exposures. None of these findings are adequately supported by data—and several of the conclusions reached by EPA were done so by ignoring the Agency’s own risk assessment methods and guidelines.
Due to the lack of reliable data, a European assessment recently concluded that, “a reliable conclusion on the bioavailability of this substance is not possible based on the currently available data.” (see blog by Dr. Richard Denison for a discussion of the details).
EPA’s finding is based on two-dozen industry-sponsored studies that have not been made public (in violation of TSCA Section 14(b) which requires disclosure of health and safety studies), most of them incompletely reported out and some having substantial portions withheld from the public. There are no verifiable exposure or monitoring data, no hazard study lasting 90 days or longer, no reliable inhalation toxicity studies, and no reliable solubility information.
The lack of chronic hazard data is particularly disturbing. Using acute and sub-chronic data to predict chronic effects, particularly to sensitive or vulnerable populations, cannot be done with scientific confidence. It would be like trying to predict the chronic harm from repeated concussions in boxers, football players and other athletes from the effects of a single concussion.
Democratic Senators Udall, Booker, Markey, Merkley, and Whitehouse sent a letter to EPA on June 20 raising these same concerns—lack of public transparency, lack of data, and lack of scientific quality. The Senators identified the PV29 assessment as an example of the Trump EPA's failure to implement TSCA as Congress intended.
Why Pigment Violet 29 Matters
There are approximately 40 thousand chemicals in commerce, with about 3,300 (excluding polymers) of them high production volume chemicals, like PV29, used and /or imported at over 1 million pounds annually in the US. Less than 1 percent (several hundred) have been fully tested for toxicity; amended TSCA was passed by Congress to address exactly that problem. And, PV29 is the first—and therefore the most important and precedent setting—test case. That’s why the work to be done by the committee matters so much—it matters for the other 39 thousand chemicals, most of which will be like PV29 with very little toxicity data.
EPA Should Learn From Past Errors, Example of GenX
Trump EPA staff stated to the SACC committee members that it has ‘lots of experience’ using read-across, bridging, and QSAR methods to fill data gaps. While EPA is correct that it has plenty of experience in filling data gaps without data – largely in its New Chemicals Program—EPA has no evidence that its efforts result in a correct outcome. How would it know, since it never tracks or reviews its approvals? We only learn about problems when things go terribly wrong like with Dupont’s GenX Chemicals which EPA approved in 2008 through its New Chemicals Program based on industry-sponsored studies.
Now, EPA says, “Animal studies have shown health effects in the kidney, blood, immune system, developing fetus, and especially in the liver following oral exposure. The data are suggestive of cancer.” Too bad about all the people who have now been exposed to PFAS in their drinking water.
Wouldn’t it have been smarter to get those animal studies before approving it for food containers and other consumer products? Amended TSCA gives EPA the authority to request these data for PV29 and other chemicals—Congress intended for EPA to obtain these data—the SACC should direct them to do so, before making a risk determination.
Science Advisory Committee—Be Bold!
The public, workers and organized labor, consumers, parents, and environmental advocates are looking to EPA’s Science Advisory Committees to be thorough, thoughtful, rigorous, and scientifically accurate in its peer review of EPA’s work. We are relying on the nation's science advisors to be bold and show moral courage—tell EPA to junk its PV29 assessment and start over.
Dr. Lorenzo Tomatis, former Director of the International Agency for Research on Cancer, warned that serious public health consequences may follow if chemicals are misclassified as less toxic or non-toxic based on untested mechanistic hypotheses, poorly validated tests, or incomplete data sets. Retired NIEHS toxicologist Dr. Ron Melnick wrote that, “declaring a chemical as not hazardous, or reducing a level of health protection, should require validation, not speculation”.
The SACC committee should direct EPA that it cannot make a ‘no unreasonable risk’ determination without substantial, reliable, defensible evidence establishing that exposure to a substance will not result in adverse human or environmental effects under its conditions of use. Such determinations should be based on multiple lines of evidence from well-designed and well-conducted studies of adequate statistical power, adequate time to follow up (latency period), sufficiently sensitive life-stages, and sensitive species and strains of animal models in both sexes. Conjecture or limited data are not enough to support this determination. Instead, EPA must make an affirmative showing that no unreasonable risk exists.
If the SACC committee cannot come to a clear consensus on this issue, then those experts rejecting the Trump EPA’s safety determination should consider writing a Minority Report. They would be following a great tradition among physicians and environmental occupational health experts. Pediatricians Routt Reigert and Herb Needleman (a towering hero of public health best known for his groundbreaking work to protect children from lead poisoning) drafted the important Minority Report (see Appendix C of Science Advisory Report) that made clear their opposition to intentionally testing toxic pesticides on people for the purpose of weakening EPA pesticide regulations. Their report led to halting such studies, and eventually supported an EPA policy to prevent the use of the studies.
This is not simply a matter of how one sees the color purple—it is about how EPA will address the tens of thousands of chemicals that will follow.