EDF Health

EDF has deep concerns over nomination of industry consultant to lead toxics program at EPA

By / Published: July 18, 2017

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

We are deeply concerned over the nomination of Michael Dourson to head the toxics office at EPA.  Unfortunately, this nomination fits the clear pattern of the Trump Administration in appointing individuals to positions for which they have significant conflicts of interest.  Dr. Dourson has extensive, longstanding ties to the chemical industry (as well as earlier ties to the tobacco industry).  He also has a history of failing to appropriately address his conflicts of interest.  For example:   Read More »

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

Of foxes, henhouses and TSCA implementation: The chemical industry burrows into EPA’s toxics office

By / Published: April 19, 2017

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

The lead article in this past Sunday’s New York Times is titled “With Trump Appointees, a Raft of Potential Conflicts and ‘No Transparency’.”  It features several prominent examples of recent political appointments of industry representatives and industry lobbyists to key policy positions where they are now charged with or involved in reviewing or crafting the very same agency regulations and policies that were the focus of their paid private sector work just prior to their appointments.

Add EPA’s implementation of the newly amended Toxic Substances Control Act (TSCA) to the list.

Dr. Nancy Beck has just been appointed Principal Deputy Assistant Administrator in the Office of Chemical Safety and Pollution Prevention (OCSPP) at the Environmental Protection Agency (EPA), and reportedly started in that position on Monday, April 17, 2017.  Dr. Beck is moving into her new position at EPA directly from her job as Senior Director, Regulatory Science Policy, Division of Regulatory & Technical Affairs at the American Chemistry Council (ACC), a position she has held since January, 2012.  ACC is the main trade association for the chemicals industry, with a membership of more than 150 chemical companies, including such behemoths as BASF, Dow, DuPont and ExxonMobil.

In her new job, Dr. Beck is expected to play a key role in implementing the new reforms made to TSCA, including in critical decisions that EPA will be making literally any day now, many of them driven by firm statutory deadlines.  These decisions will directly affect the financial interests of the companies represented by ACC.  And they will involve deciding whether or not the agency should take positions for which Dr. Beck has advocated on behalf of her former employer, as recently as last month.  Any reasonable person would see a conflict here, one sufficient to seriously question whose interests Dr. Beck will be representing in playing such a role in TSCA implementation.  But as the Times article indicates, this Administration appears to have little concern about the fox guarding the henhouse.

Nor does this situation bode well for the prospect of creating a credible federal system capable of restoring public and market confidence in the safety of chemicals – which was the key reason that such strong bipartisan and stakeholder support gelled behind the major reforms made to TSCA just last June.  Placing a key chemical industry player in a position where she will now have direct and major influence over the direction that reform will take raises serious new doubts about the industry’s claims that it supports providing EPA with stronger, independent authority and resources to vigorously establish the safety of chemicals in and entering commerce.   Read More »

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

EDF’s recommendations for IRIS conflicts-of-interest disclosures, and the strong precedents for them

By / Published: November 11, 2014

Richard Denison, Ph.D., is a Lead Senior Scientist.  Lindsay McCormick is a Research Analyst. 

Our last blog post was quite lengthy and some readers may not have gotten to the recommendations we provided to EPA’s Integrated Risk Information System (IRIS) governing disclosures of conflicts of interest.  In that post, we also cited the numerous strong precedents for requiring such disclosures.

So we’re reposting here our recommendations and discussion of precedents.   Read More »

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

Time to come clean: IRIS needs to require stakeholders attending its meetings to disclose their conflicts of interest

By / Published: November 7, 2014

Richard Denison, Ph.D., is a Lead Senior Scientist.  Lindsay McCormick is a Research Analyst.  

EPA’s Integrated Risk Information System (IRIS) has been implementing a number of changes in the last couple of years, in response to criticism and concerns coming at it from all sides.  As stated on its website:  “These enhancements will improve productivity and scientific quality in IRIS assessments and help EPA meet the goal of producing IRIS assessments in a timely and transparent manner.”  IRIS has noted that increasing “stakeholder engagement is an essential part of the enhancements.”

Simultaneously pursuing these lofty goals of increasing throughput, scientific quality, transparency and stakeholder engagement in IRIS assessments is challenging, to say the least.  EDF has and will continue to emphasize the need to strike a balance between these goals, given that overemphasis on one can actually exacerbate the problems aimed to be addressed by another.

In this somewhat lengthy post, we’ll examine one such serious problem – skewed participation in IRIS’ bimonthly meetings.  We’ll look at steps EPA has taken to partially address the problem, and argue that the lack of adequate disclosure by participants of conflicts of interest remains a major unaddressed contributing factor.  We’ll discuss our recommendations for full disclosure and point to the strong precedents for such disclosures in other venues.   Read More »

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

Conflicted West Virginia chemical spill panel is repeating many of CDC’s mistakes

By / Published: April 2, 2014

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

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

Yesterday, the chair of a “Health Effects Expert Panel” convened by the West Virginia Testing Assessment Project (WV TAP) held a press conference to present the panel’s preliminary findings from its review of the “safe” level set by the Centers for Disease Control (CDC) for MCHM and other chemicals that spilled into the Elk River in early January and contaminated the drinking water of 300,000 West Virginia residents.

A final report from the panel apparently won’t be released until May, but a press release issued yesterday sounds far from preliminary in saying the panel supports CDC’s methods, assumptions, toxicity data and “safety factors.”  While providing no details, the release indicates the panel is using the same flawed and incomplete summary of a toxicity study used by CDC in its rush to set a safe level for MCHM.  And it parrots CDC’s erroneous use of the term “safety factors,” which is at odds with the National Academy of Sciences’ strong recommendation that such term should be avoided as it is highly misleading.

In addition to choosing to rely on the same summary CDC used of a 1990 study conducted by MCHM’s manufacturer, Eastman Chemical, the panel accepted at face value Eastman’s interpretation that the study identified a no-effect level.  That conclusion has been questioned and cannot be independently assessed because Eastman has not provided the actual quantitative data from the study.  Moreover, the study used a protocol dating from 1981 that has been extensively revised at least twice since then.  These are among the many problems identified with this study.

It appears the panel’s main departure from CDC was to assume the most highly exposed population would have been formula-fed infants instead of older children.  The panel’s “safe” level is 120 parts per billion (ppb), a value about 8-fold lower than CDC’s level of 1 part per million (ppm).  That seems an improvement over the CDC’s methodology.

The panel’s conflict of interest

However, the process by which the panel itself was formed and the clear conflict of interest (COI) involved – a conflict that only came to light in response to a reporter’s questions at yesterday’s press conference – are deeply concerning.   Read More »

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Avoiding conflict and delay: EDF comments to yet another IRIS review panel

By / Published: April 5, 2013

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

Chemical industry representatives and their consultants often argue that they should be on panels reviewing government assessments of their chemicals because “they know their chemicals best.”  Well, the mother of a young man accused of a crime may well know her son better than anyone – but that doesn’t mean we should seat mom on the jury.

I made that comment as part of my public comments delivered at this week’s meeting of a new committee formed by EPA’s Science Advisory Board, which has a charge of peer reviewing chemical assessments developed by EPA’s Integrated Risk Information System (IRIS) program.  (If you’re a regular reader of this blog and you feel like you’re having a déjà vu, yes, this is yet another panel set up to oversee or assess IRIS; see this earlier post.)  I felt compelled to make that comment in part because in the preceding day and a half of the meeting, well over half of the comments offered by the 26-member committee came from just four of those members, all of them industry consultants.

It turns out that the assigned members of the committee, named the Chemical Assessment Advisory Committee, or CAAC (I recommend just saying C-A-A-C, rather than trying to pronounce the acronym), have not yet been screened for potential conflicts of interest (COI) or lack of impartiality.  This step won’t happen until later, when a subset of committee members are tapped to serve on a review panel for a specific IRIS assessment.  But this process made for an awkward meeting, which was supposed to be limited to a “fact-finding” briefing by the IRIS program, but constantly veered into territory verging on providing advice to EPA (again dominated by the industry consultants).  Federal law requires that any committee offering such advice be free of conflicts of interest in all but the most exceptional of circumstances.

In my comments, I raised concerns about the high potential for conflicts of interest to arise, given the composition of the committee.  I also reiterated the points I have made to other similar panels that getting the science right in IRIS needs to be balanced with ensuring that IRIS assessments are completed in a timely manner — because there are real-world adverse public health consequences to the delays that have plagued the IRIS program.

Read on for my full comments. Read More »

Posted in Health policy, Health science / Tagged , | Comments are closed