EDF Health

FDA scientists push back on an industry-funded analysis about bioaccumulation and toxicity of short-chain PFAS

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 1, 2020

Tom Neltner, J.D., Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

Note to readers: As we all grapple with the grave global health challenge from COVID19, we want to acknowledge the essential services that professionals at the Food and Drug Administration (FDA) and in the food production, processing and retail industries provide in continuing to deliver food. In the meantime, we are continuing to work towards improved health protections – including reducing chemicals in food. We’ll plan to keep sharing developments that may be useful to you. In the meantime, please stay safe and healthy.

Last year, we reported on a sophisticated analysis performed by FDA’s scientists showing that 5:3 acid, a breakdown product of a short-chain PFAS known as 6:2 fluorotelomer (6:2 FTOH) was slow to be eliminated by the body. The authors concluded that the metabolite was an important biomarker for assessment of long-term exposure to 6:2 FTOH and showed potential bioaccumulative (aka biopersistence[1]) properties. The chemical 6:2 FTOH is a common starting substance in the manufacture of many PFAS polymers, including those used to greaseproof paper and paperboard. As a result, it is a major impurity in, and degradation product of, these polymers.

We are now reporting on two recent publications by the same group of FDA scientists (Kabadi et al.[2] and Rice et al.)[3] in which they not only confirmed their initial findings but also produced new evidence on the behavior of short-chain PFAS when they enter the body. The new evidence highlights:

  • Bioaccumulation: 6:2 FTOH is transformed by the body into several metabolites; one of them, called 5:3 acid, bioaccumulates, and the bioaccumulation is greater with lower exposure to 6:2 FTOH.
  • Toxicity: The toxicity of 6:2 FTOH is concerning and its risk to human health may have been significantly underestimated previously. Data on perfluorohexanoic acid (PFHxA), the industry’s proposed reference chemical for the short-chain PFAS class are not appropriate for assessing the potential health effects of 6:2 FTOH.

The FDA’s scientists reached these important conclusions after reviewing “recently received additional data on 6:2 FTOH and 5:3 acid” and more than a dozen reports on oral toxicity studies that “had been conducted and submitted by industry in support for food contact uses” of short-chain PFAS in addition to a study by the National Toxicology Program. They also called out flaws in industry-funded analyses that reached different conclusions.

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The Trump EPA is poised to grant the chemical industry yet another of its wishes under TSCA

By Richard Denison / Published: November 16, 2018

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

The chemical industry has long sought to have the Environmental Protection Agency (EPA) rubber-stamp as “safe” as many of its chemicals as possible without imposing any burden on the industry to develop the information needed to actually demonstrate safety.  It has repeatedly pushed for EPA to set aside large numbers of chemicals in commerce and ensure they don’t have to undergo evaluations of their potential or actual risk.

During the debate over reform of the Toxic Substances Control Act (TSCA), various industry associations advocated for an approach that would have required EPA to quickly review all chemicals in commerce using whatever information was available (which is virtually none for the great majority of such chemicals), and set aside as “low-priority” any that EPA could not demonstrate were harmful.[pullquote]It appears EPA is trying to install a new parallel process, outside of TSCA’s statutory boundaries, that EPA will use to set aside thousands of chemicals from any further review indefinitely and with no recourse for the public.[/pullquote]When that didn’t fly (more on this below), industry commenters demanded that, in promulgating its Prioritization Rule, EPA designate long lists of chemicals as low-priority without any review.  One of the few positives of that final rule was that it rejected those calls as well.

But lest you think the issue is settled, think again.  Leave it to the Trump EPA to find an even more devious way of granting the industry’s wish.   Read More »

Posted in Health policy, Industry influence, TSCA reform / Tagged , | Read 1 Response

In 2016 industry-funded paper, Dourson and Beck sought weaker standard for lethal paint stripper chemical

By Richard Denison / Published: October 26, 2017

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

[Use this link to see all of our posts on Dourson.]

[See clarification added on 10-26-17 in brackets below.]

The New York Times’ investigation “Why Has the E.P.A. Shifted on Toxic Chemicals? An Industry Insider Helps Call the Shots” published this past Sunday cited evidence that Nancy Beck – a political appointee in EPA’s chemical safety office who until May was a senior official at the American Chemistry Council (ACC) – is questioning the need for EPA’s proposed rule to ban the use of the deadly chemical dichloromethane (also called methylene chloride) in paint and coating removers.  These products are responsible for dozens of deaths in recent years.

The Times’ story also noted in its last paragraph that Beck and Michael Dourson – the Trump Administration’s controversial nominee to lead EPA’s chemical safety office – are co-authors on a 2016 paper that was funded by ACC.  That paper was published in the industry’s go-to journal, Regulatory Toxicology and Pharmacology, where Dourson has published most of his papers.

The paper is of interest and relevant for another reason as well:  Dourson and Beck assert that the acceptable risk levels EPA has set for 24 chemicals are all too stringent and should be relaxed by anywhere from 2.5 to 150 fold.  (Funny, isn’t it, how the numbers for all 24 chemicals all went in the same direction?)

Among these 24 chemicals is the paint-stripping chemical dichloromethane (aka methylene chloride).  This chemical is a particularly concerning one:  It is a likely carcinogen and is linked to numerous other chronic health impacts, but it is also acutely and tragically lethal.   Dourson and Beck call for EPA’s standard for the chemical to be relaxed to a level that is 8.3 times less protective. [Clarification added 10-26-17:  This factor applies to EPA’s ingestion standard (reference dose); Dourson and Beck’s proposed adjustment to EPA’s inhalation standard (reference concentration) was 2.5-fold less protective.]

The Times article makes clear that, despite her prior work on this chemical while at ACC, and the fact that this chemical is made by numerous ACC companies, Beck has not recused herself from making decisions about its risk and regulatory responses – decisions that are being considered at EPA even as I write.  Indeed, as I noted earlier this week, her astounding ethics agreement gives her wide latitude to work on issues in which ACC has financial interests in order to ensure those interests are taken into account.

In Dourson’s nomination hearing held by the Senate Environment and Public Works Committee on October 4, he was repeatedly asked if he would, if confirmed, recuse himself from work on chemicals he had been paid by industry to work on, and he repeatedly refused to say he would do so.

One more reason that Michael Dourson should not be entrusted with our health and the Senate should reject his nomination to head EPA’s toxics office.

Just yesterday, Dourson’s nomination was voted out of the committee by an 11-10 vote.  The fight over his nomination now moves to the full Senate.

 

Posted in Health policy, Health science, Industry influence, TSCA reform / Tagged , | Comments are closed

No end to chemicals for which the Trump nominee to head EPA’s toxics office has conflicts of interest

By Richard Denison / Published: October 16, 2017

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

[My colleague Ryan O’Connell assisted in the research described in this post.]

[Use this link to see all of our posts on Dourson.]

In a series of earlier posts to this blog, we have described and documented numerous conflicts of interests that Michael Dourson, the Trump Administration’s nominee to head EPA’s toxics office, would bring to the job if he is confirmed.

(A vote on his nomination by the Senate Environment and Public Works Committee is currently scheduled for this Wednesday at 10am EDT.  If he is voted out of committee, a majority vote of the full Senate would then be required for his nomination to be confirmed.)

Dourson has worked on dozens of toxic chemicals under payment from dozens of companies.  Two consistent patterns emerge when his reviews are examined:  The process he typically uses to conduct his reviews is riddled with conflicts of interest.  And his reviews typically result in him recommending “safe” levels for the chemicals that are weaker, often much weaker, than the established standards in place at the time of his reviews.

If confirmed, Dourson would oversee most of the chemicals and companies he has worked on and with.  The chemicals include numerous pesticides coming up for review shortly under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as well as three chemicals that are among the first 10 EPA is now considering under the recently amended Toxic Substances Control Act (TSCA).

To further gauge the impact Dourson could have if confirmed, we have looked a bit farther down the road.  TSCA requires EPA to be conducting risk evaluations on at least 20 chemicals by December 2019.  At least half of those chemicals are to be drawn from EPA’s so-called Work Plan for Chemical Assessments.

Using information available on the website of Dourson’s company, Toxicology Excellence for Risk Assessment (TERA), as well as his published papers, we compared the list of chemicals he/TERA have worked on to those on the EPA Work Plan.  We found that 22 chemicals overlap.  We then examined each chemical Dourson or TERA worked on to determine whether Dourson or TERA was paid for their work by their manufacturers or industrial users of those chemicals.   Read More »

Posted in Health policy, Health science, Industry influence, TSCA reform / Tagged | Comments are closed

Modus operandi: How EPA toxics nominee Dourson carries out his work for the chemical industry

By Richard Denison / Published: September 18, 2017

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

[Use this link to see all of our posts on Dourson.]

I’ve now examined dozens of papers and reports that EPA toxics nominee Michael Dourson and his firm, Toxicology Excellence for Risk Assessment (TERA), have published on chemicals over the past 15-20 years.  A remarkably consistent pattern of how Dourson conducts his paid work for the chemical and pesticide industries emerges from this examination.  I’ll use one example below to illustrate, but most or all of the steps I’ll describe have been followed over and over again.   Read More »

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Dourson’s go-to journal for publishing his industry-funded papers is, well, also industry-funded

By Richard Denison / Published: August 9, 2017

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

[My colleague Ryan O’Connell assisted in the research described in this post.]

[Use this link to see all of our posts on Dourson.]

In a recent post I noted our initial findings from a review of published papers of Michael Dourson, the Trump Administration’s nominee to head the office at the Environmental Protection Agency (EPA) charged with implementing the Toxic Substances Control Act (TSCA).  That review has shown that Dourson has been paid by dozens of companies and trade associations for work on dozens of their chemicals – including many of the same chemicals he will be charged with reviewing and regulating should he be confirmed.

Our review is uncovering additional curious features of Dourson’s published papers.  Read More »

Posted in Health policy, Health science, Industry influence, TSCA reform / Tagged | Comments are closed