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.

Read More »

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Peer reviewers of EPA’s TCE report must affirm that the key risk is fetal heart damage

By / Published: April 1, 2020

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

Last week, the EPA Science Advisory Committee on Chemicals (SACC) conducted a virtual peer review meeting for the Agency’s draft risk evaluation of trichloroethylene (TCE). As expected, there was substantial discussion on the appropriateness of EPA’s decision to make risk determinations based on immune endpoints rather than fetal cardiac malformations (FCMs). Unfortunately, the review panel lacked anyone with specific expertise in cardiac development.

During the meeting, many of the peer review panelists signaled an initial inclination toward supporting EPA’s decision to use immune endpoints for risk determinations. However, panel members also noted with serious concern the recent investigations that have uncovered political influence exerted on EPA that led it to base the risk determinations in the draft risk evaluation on immune endpoints instead of FCMs.

Stepping back from the specifics of the discussions last week, it is important to understand the longstanding basis and support for EPA’s reliance on FCMs, the unprecedented nature of EPA’s decision to now move away from it, and the adverse implications of the decision for EPA’s ability to adequately manage the risks of TCE to all relevant subpopulations.

This decision is a major departure from thoroughly peer-reviewed science, fails to protect the most sensitive populations as mandated by TSCA, and deviates dramatically from existing Agency guidance. These concerns, discussed at length in EDF’s comments in the TCE Docket, are briefly summarized below:  Read More »

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EPA’s draft risk evaluation of trichloroethylene contains major scientific flaws that understate the chemical’s risk and demand robust review

By / Published: March 19, 2020

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

Yesterday Environmental Defense Fund (EDF) filed comments on the Environmental Protection Agency’s draft risk evaluation for the highly toxic chemical trichloroethylene, or TCE.

This draft, readers will recall, is the document that the Trump White House forced EPA to dramatically weaken just prior to public release, as reported in detail by Elizabeth Shogren of Reveal News.

It is also the document that EPA seems intent on subjecting to a rushed peer review next week in a 4-day virtual meeting of the Scientific Advisory Committee on Chemicals (SACC) – despite numerous reasons why, in the midst of the current COVID-19 public health crisis, such a meeting simply will not provide the robust scientific review that this draft warrants.  EDF has urged EPA to postpone the SACC review so that it can be done under circumstances that are conducive to a proper review and fair to SACC members and stakeholders who would like to participate.

EDF submitted comments yesterday in order to meet the very tight deadline EPA set for comments if they are to be considered by the SACC.  Our comments raise numerous scientific deficiencies in EPA’s draft.  These flaws arise from a host of unwarranted and unsupported assumptions and methodological approaches that systematically lead EPA to understate the risks posed by this chemical to pregnant women, infants and children; to workers; to consumers; to the public; and to the environment.

Exposure to TCE is ubiquitous, coming from ambient and indoor air, vapor intrusion from contaminated sites, groundwater and drinking water wells, and food – yet EPA’s draft ignores or downplays each of these exposure sources and pathways.

It is vital that the current public health crisis caused by COVID-19 not be allowed to compromise the quality and integrity of scientific assessments of other critical public health risks we face.

Below I summarize some of the major concerns in EPA’s draft that we address in detail in our comments.  Read More »

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EPA needs to postpone next week’s peer review of its draft risk evaluation of trichloroethylene

By / Published: March 16, 2020

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

As we all deal with an emerging major health crisis, it is critical that the quality of ongoing work on other issues vital to protecting public health is not sacrificed or compromised as a result.  Given this, we strongly urge EPA to postpone next week’s peer review of its draft risk evaluation of trichloroethylene.

A few short weeks ago, EPA issued a draft risk evaluation for a highly toxic chemical, trichloroethylene or TCE.  The draft is many hundreds of pages long (thousands of pages counting supplemental files).  EPA also scheduled the peer review by the Scientific Advisory Committee on Chemicals (SACC) for next week, March 24-27.

Even before the COVID-19 crisis, the time frame EPA provided for getting meaningful expert review of this important document was already questionable.  Now it is simply untenable.

As of now, EPA intends to proceed with the meeting as a virtual meeting.  While traveling to a meeting next week should of course be off the table, proceeding with a virtual meeting at this point is asking far too much of SACC members and their families and will clearly lead to a severely compromised peer review.  Consider, for example:

  • SACC members who are dealing with their own and their families’ health and well-being, are now being asked to spend dozens of hours over 4 days next week trying to participate in the virtual meeting. We all know how hard that is to do under normal circumstances.  It is unrealistic and unfair to expect it under our current circumstances.
  • Some SACC members are themselves members of the public health community that are responding to the COVID-19 crisis.
  • Many or most SACC members are faculty at colleges and universities, and hence are likely already grappling as part of their day jobs with a shift to online teaching.
  • SACC members are being expected to have found the time in these recent chaotic days to have read these massive documents, draft initial comments and be prepared to discuss all of this next week.
  • Stakeholders are preparing comments for the SACC’s consideration, which are due this Wednesday. SACC members are expected to review these materials on top of everything else.
  • Stakeholders from health and labor groups who have been participating in the risk evaluation process by providing comments to the SACC as well as EPA are presently consumed with addressing COVID-19 issues facing their members and constituents.

As we are learning in real time during this unfolding health crisis, ensuring there is sound expert input into public health decisions is absolutely essential.  We cannot let the current crisis result in a weakening of the quality and credibility of scientific input on other important public health issues.

EPA needs to promptly postpone the SACC peer review of TCE and reschedule it at a time and in a manner that respects the critical role the SACC plays.

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Reveal News exposes Trump Administration’s disregard for protecting the public from a highly dangerous chemical: 5 key takeaways

By / Published: March 2, 2020

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

This weekend, Elizabeth Shogren at Reveal News published an in-depth investigative report and hour-long radio segment delving into the Trump EPA’s latest abandonment of science and its serious consequences for public health.  The story focuses on the ubiquitous solvent trichloroethylene (TCE), a known human carcinogen and neurotoxicant that is also linked to birth defects at very low levels of exposure.

In reforming the Toxic Substances Control Act (TSCA) in 2016, Congress directed EPA to conduct comprehensive reviews of the risks posed by TCE and other widely used chemicals.  EPA was charged with identifying risks both to the general public and to “vulnerable subpopulations,” including pregnant women, infants, workers, and others.

EPA’s draft risk evaluation of TCE was released on February 21.  It suffers from many of the same gaping flaws as do EPA’s draft risk evaluations for other chemicals.  Once again, EPA has utterly failed to carry out the clear intent of the law, putting our health at greater risk.

  • EPA has ignored all exposures of the general population to TCE that arise from releases of the chemical to air, water and land – amounting to millions of pounds annually.
  • EPA has once again assumed, without any supporting data, that workers will wear personal protective equipment and that it will be effective in eliminating or reducing exposures.
  • EPA has inflated the acceptable level of risk of cancer that will allow workers to be exposed to as much as 100 times more of the chemical.

[pullquote]“This decision is grave. It not only underestimates the lifelong risks of the chemical, especially to the developing fetus, it also presents yet another example of this administration bowing to polluters’ interests over public health.”

— Dr. Jennifer McPartland[/pullquote]But in this new draft EPA has gone even further in abandoning both science and the law.  Reveal’s exposé identifies key changes made at the 11th hour to the draft that were forced on career staff at the agency by the White House.

Here are five key takeaways from the Reveal story:  Read More »

Posted in Health policy, Health science, Industry influence, Public health, Regulation, TSCA reform, Worker safety / Tagged , , | Comments are closed

EPA’s draft risk evaluation of carbon tetrachloride is riddled with unsupported exclusions and assumptions

By / Published: February 21, 2020

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

Next week, the Scientific Advisory Committee on Chemicals (SACC), established under the Toxic Substances Control Act (TSCA) to peer-review EPA’s draft chemical risk evaluations, will meet to review the latest of those drafts, for the likely human carcinogen carbon tetrachloride.

As with other recent draft risk evaluations, EPA has been scheduling the SACC meetings in the middle of rather than following the public comment period.  This means the public has at best a few weeks to digest these huge documents and draft and submit comments in order to have them be part of the record that the SACC is allowed to take into consideration in its peer review.

However, we have learned that EPA is now further constraining the SACC’s schedule, requesting that the panel members come to the peer review meeting with their comments already drafted, and then delivering their final report within 60 days rather than the 90 days previously provided.  These developments further jam both the public and the SACC in their efforts to ensure EPAs work is subject to a robust peer review.

Whatever the reasons for EPA making these changes, EDF decided to expedite our initial comments to seek to ensure they could be considered.  We submitted comments last week, a full week before the February 19 deadline, to ensure the SACC received and had sufficient time to review them in advance of the peer review meeting.

We deemed this critical because of the glaring gaps and flaws in EPA’s draft that lead it yet again to drastically understate the risks of this chemical.  These include the same problems that have plagued the draft risk evaluations for other chemicals, as well as new ones.  Read More »

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