EDF Health

“Illegal, unscientific, and un-health protective”: Summing up EPA’s final methylene chloride risk evaluation

By / Published: June 19, 2020

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

Today, the Trump EPA released its first final risk evaluation and determination under the reformed Toxic Substances Control Act (TSCA), for the carcinogenic and acutely lethal chemical methylene chloride.

Sadly, despite EPA’s rush to issue this document as the 4th anniversary of TSCA reform on June 22 approaches, EPA doubled down on the illegal, unscientific, and un-health protective approach it has taken in all of its draft risk evaluations for the first 10 chemicals reviewed under TSCA.

EDF will be closely examining this final document, but it is already apparent that EPA has grossly and systematically underestimated the exposures to and risks of methylene chloride.  Read More »

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EPA’s own words reveal what its new chemicals program has become – a captive of industry

By / Published: May 29, 2020

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

[pullquote]“The agency’s goal is to allow the commercialization of products,” said EPA associate deputy assistant administrator for new chemicals Lynn Dekleva.[/pullquote]Readers of this blog know that EDF is no fan of how the Trump EPA has implemented – in our view, twisted – the 2016 reforms made to the review process for new chemicals under the Toxic Substances Control Act (TSCA).  Decision after decision over the last 3.5 years under this administration has undercut public health and benefitted industry interests, despite some noble efforts by career staff to chart a better course.  In recent weeks the Trump EPA’s intentions have been even more clearly revealed, thanks to the trade press’s reporting of EPA political appointees’ comments delivered to industry audiences.  That’s what this post is about.  Read More »

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Former chemical industry official Beck, now at Trump White House, again interferes to weaken EPA action on dangerous chemicals: This time it’s PFAS

By / Published: April 20, 2020

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

It was only in February that Reveal News’ Elizabeth Shogren exposed the Trump White House’s role in dramatically weakening the Environmental Protection Agency’s (EPA) draft risk evaluation for the solvent trichloroethylene (TCE), which is linked to fetal heart defects at low doses.  The White House’s 11th-hour intervention, led by former chemical industry official Dr. Nancy Beck, forced EPA to rely on a different health effect that would allow 500 times greater exposures to the ubiquitous toxic chemical.

There was every reason to expect this episode was not a one-off, given Beck’s other actions both while at EPA and once arriving at the White House.  Sure enough, last week Ellen Knickmeyer of the Associated Press exposed another such incident, this time involving a group of chemicals collectively known as “perfluoroalkyl and polyfluoroalkyl substances” or PFAS that are showing up as environmental contaminants all over the country.[pullquote]Beck’s first order of business was to compel her former colleagues at EPA to submit the proposed PFAS rule for White House review, which neither the Obama administration nor the Trump administration up to that point had deemed necessary.[/pullquote]

Knickmeyer reported on documents obtained by Senator Tom Carper of Delaware, ranking member of the Senate’s Environment and Public Works Committee, that detail Beck’s largely successful effort to scale back a rule EPA first proposed in 2015.  Called a Significant New Use Rule, or SNUR, it would require companies seeking to import products containing certain PFAS to notify EPA in advance, thereby allowing EPA to determine whether to allow the import and impose needed restrictions.  Sen. Carper made the documents public via a letter he sent to EPA Administrator Andrew Wheeler calling on EPA to finalize the original rule instead of the watered-down re-proposed rule EPA released for public comment in February.  Read More »

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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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