EDF Health

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

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 »

Posted in EPA, Health Policy, Health Science, Industry Influence, Public Health, Regulation, TSCA Reform, Worker Safety / Tagged , , | Comments are closed

The Trump Administration’s got a problem with testing (TSCA edition)

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

A constant criticism of EPA’s draft risk evaluations for the first 10 chemicals has been the dearth of information on which EPA has relied to draw sweeping, unqualified risk conclusions.  EDF and other stakeholders, as well as EPA’s own Science Advisory Committee on Chemicals (SACC), have repeatedly pointed to the lack of sufficient, reliable information on:

The Trump EPA appears intent on continuing to conduct risk evaluations that are ill-informed by actual data.

  • the chemicals’ presence in and releases into various environmental media;
  • their presence in and releases from industrial, commercial, and consumer products and materials;
  • the extent and magnitude of workplace exposure levels;
  • key human hazard endpoints; and
  • ecological hazards to and exposures of sediment- and soil-dwelling and terrestrial, as well as aquatic, organisms.

Concerns have also been repeatedly raised about EPA’s over-reliance on models in the absence of measured data and on physical-chemical and environment fate data to rule out exposure pathways, especially in the absence of rigorous uncertainty analyses and incorporation of uncertainty into EPA’s risk conclusions.

It’s not as if there isn’t a solution to the dearth-of-data problem.  Yet the Trump EPA has steadfastly refused to use it.  Read More »

Posted in EPA, Health Policy, Health Science, TSCA Reform / Comments are closed

EPA refuses to extend TCE comment deadline, ignoring requests from Congress, health groups

Joanna Slaney, Legislative Director and Lindsay McCormick, Program Manager. 

Yesterday, in the midst of the COVID-19 national emergency, the Environmental Protection Agency (EPA) closed the comment period on an extremely flawed draft risk evaluation on the toxic chemical, trichloroethylene (TCE).

Due to the many scientific and legal concerns raised by the draft risk evaluation, and its significance for any future regulation of TCE, the draft needs thorough and careful review from experts, the public, and other affected stakeholders. However, EPA refused to delay the deadline for the draft risk evaluation’s comment period, despite the growing hardships and major disruptions resulting from the current COVID-19 crisis.  EPA now seems intent on racing to the finish line with its flawed evaluation, ignoring multiple requests to ensure the document is fully vetted:

  • Congress: In two separate letters from the House and Senate, Members of Congress raised concerns with EPA moving forward with various rulemakings and scientific reviews without sufficient opportunity for expert and public input in light of the pandemic – explicitly referencing the TCE draft risk evaluation as a prime example.
  • Health groups: Health organizations whose staff and members are on the front lines of the pandemic requested that EPA extend the public comment period until after the national emergency is lifted due to severe capacity constraints. EPA did not respond.
  • Impacted communities: In early March, nearly 300 people from communities grappling with TCE contamination asked EPA to hold a public meeting to allow them “to ask questions of the agency and engage in critical dialogue.” EPA denied the request.

Read More »

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

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 »

Posted in EPA, Health Policy, Health Science, Industry Influence, Regulation, TSCA Reform / Tagged , | Comments are closed

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

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 commentsRead More »

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

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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