EDF Health

Selected tag(s): Risk evaluation

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

By Richard Denison / 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.

Posted in Health policy, Health science, Regulation, TSCA reform / Also tagged , , | Comments are closed

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

By Richard Denison / 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 / Also tagged , | Comments are closed

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

By Richard Denison / 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 / Also tagged , , | Comments are closed

More words minced this time, but EPA’s science advisors raise serious concerns with its draft risk evaluation of 1-bromopropane

By Richard Denison / Published: December 16, 2019

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

The peer review report by the Scientific Advisory Committee on Chemicals (SACC) on EPA’s draft risk evaluation of 1-bromopropane (1-BP) has been released.  This carcinogenic solvent is one of the first 10 chemicals undergoing risk evaluation under the amended Toxic Substances Control Act (TSCA), and the new SACC report covers the fourth of EPA’s draft risk evaluations (DREs) to be peer-reviewed.  We’ve blogged earlier about the SACC’s reports on EPA’s draft risk evaluations for 1,4-dioxane and HBCD and Pigment Violet 29.

At first blush, the new report reads less harshly than the last one, and the SACC notes clear improvements in the content and organization of the 1-BP draft over earlier ones.  But even the Executive Summary raises quite scathing criticisms that go to the heart of whether EPA has developed sufficient data to support its risk determinations for this chemical.  Here is a telling excerpt (p. 17, emphases added):

Overall, the Committee concurred that even though data provided in the DRE underestimated risk, these data did support the finding of unreasonable risk to consumers and occupational conditions, including occupational non-users. Conversely, inadequate data were presented for a robust risk characterization for the environmental assessment, and the information provided did not support the conclusion of “no unreasonable risk to the environment.”

These conclusions mirror those drawn by EDF in the comments we submitted to EPA on the 1-BP DRE.

Themes sounded by the SACC in its earlier peer reviews came up again here.  Read More »

Posted in Health policy, Health science, TSCA reform / Also tagged , , | Comments are closed

While harder to discern, another EPA risk evaluation severely understates risk, this time for methylene chloride

By Richard Denison / Published: November 27, 2019

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

When EPA released the draft of its risk evaluation for methylene chloride at the end of last month, some were surprised that EPA had identified numerous unreasonable risks presented under a variety of the chemical’s conditions of use.

In an earlier post, EDF provided some context, noting how dangerous the chemical is and raising initial concerns that EPA was once again excluding known uses and exposures, making unsupported assumptions, and applying inappropriate risk benchmarks that were once again leading it to significantly understate the actual risks posed by methylene chloride.

Four weeks later, EDF has confirmed these concerns in spades.  Last night we filed 84 pages of comments on the draft risk evaluation, for consideration by EPA’s Scientific Advisory Committee on Chemicals (SACC), which will meet next week to peer review the draft.

EDF’s deep dive into the draft demonstrates that EPA has employed a host of unwarranted and unsupported assumptions and methodological approaches that lead it to either avoid identifying unreasonable risk when it should have, or to understate the extent and magnitude of the unreasonable risks it did identify.  Below we summarize some of the major concerns, which are addressed in detail in our comments.  Read More »

Posted in Health policy, Health science, Regulation, TSCA reform, Worker safety / Also tagged , , | Comments are closed

The Court’s TSCA decision is a much bigger win for public health than first meets the eye

By EDF Blogs / Published: November 15, 2019

Robert Stockman is a Senior Attorney.  Richard Denison, Ph.D., is a Lead Senior Scientist.

Yesterday the Ninth Circuit Court of Appeals ruled in a landmark case involving a challenge to EPA’s so-called “framework rules” that lay out how it will implement core provisions of the Toxic Substances Control Act (TSCA) as amended in 2016 by the Lautenberg Act.

An array of health, labor and environmental groups, EDF among them, (see full list of petitioners below) had challenged EPA’s Risk Evaluation Rule and Prioritization Rule on the grounds that they deviated in significant ways from amended TSCA’s requirements.

We clearly won on a major issue in the litigation, but a careful reading of the Court’s opinion shows that we effectively won on another key issue even though the court ruled against us.  And several of the court’s other rulings either suggest it agrees with, or outright affirms, our view of TSCA’s core requirements.  On those remaining issues, the Court specifically did not foreclose any of our arguments, making it clear that they could be presented in legal challenges we bring to EPA decisions in risk evaluations and determinations for individual chemicals.

Read on for our analysis.  Read More »

Posted in Health policy, TSCA reform / Also tagged , | Comments are closed