Category Archives: Industry Influence

EPA IRIS program requests conflict-of-interest disclosures by commenters

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

EPA’s Integrated Risk Information System (IRIS) is now requesting that persons who make oral comments at its bimonthly meetings or submit written comments on its documents disclose whether they have “financial relationships … with any organization(s) or entities having an interest in the assessments or issues under discussion,” and, if so, to identify the nature of that relationship, (e.g., consulting agreements, expert witness support, or research funding).   Read More »

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

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 »

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

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 »

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Twice in 2 weeks: National Academy of Sciences again strongly affirms federal government’s science, agrees formaldehyde is a known human carcinogen

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

Just last week I blogged that a panel of the National Academy of Sciences (NAS) had fully backed the National Toxicology Program’s (NTP) listing of styrene as “reasonably anticipated to be a human carcinogen.”

Today a separate NAS panel strongly endorsed NTP’s listing of formaldehyde as a “known human carcinogen” in its 12th Report on Carcinogens (RoC).  As with styrene, this second NAS panel both peer-reviewed the RoC listing and conducted its own independent review of the formaldehyde literature – and in both cases found strong evidence to support NTP’s listing.  See the NAS press release here, which links to the full report.  Read More »

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National Academy of Sciences strongly affirms science showing styrene is a human carcinogen

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

It’s been a ridiculously long road to get here, because of the delay tactics of the chemical industry.  But yesterday a panel of the National Academy of Sciences (NAS) fully backed the National Toxicology Program’s (NTP) listing of styrene as “reasonably anticipated to be a human carcinogen.”

We have blogged earlier about this saga.  In June 2011, after years of delay, the NTP released its Congressionally mandated 12th Report on Carcinogens (RoC), in which it upgraded formaldehyde to the status of “known to be a human carcinogen,” and for the first time listed styrene as “reasonably anticipated to be a human carcinogen.”  The chemical industry launched an all-out war to defend two of its biggest cash cows, filing a lawsuit to try to reverse the styrene listing (which it lost), and seeking to cut off funding for the RoC.  

In late 2011, the industry managed to get its allies in Congress to slip into the Consolidated Appropriations Act of 2012, without any debate, a rider that mandated NAS to review the styrene and formaldehyde listings in the 12th RoC.  Yesterday’s NAS report on styrene is the first installment, with the second one on formaldehyde expected shortly.

The NAS report could not be more supportive of the NTP’s listing of styrene, finding “that ‘compelling evidence’ exists in human, animal, and mechanistic studies to support listing styrene, at a minimum, as reasonably anticipated to be a human carcinogen.” (emphasis added)  Read More »

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Imbalanced act: An EPA IRIS agenda that speaks 1000 words

Richard Denison, Ph.D., is a Lead Senior Scientist.  Rachel Shaffer is a research assistant.

[UPDATE 6/24/14:  Perhaps in response to this post of last week, an updated agenda for this week's IRIS meeting was posted by EPA today that reflects a somewhat more balanced set of speakers.  Industry interests appear to have consolidated their number of slots, down from a high of 8 to a high of 6 per issue, and down from a high of 6 to a high of 4 individuals per issue from the same consulting firm.  In addition, several additional slots are assigned to non-industry speakers.  If you wish to see the changes, here is the agenda we linked to that was current as of last week, and here's the updated agenda posted today.]

In comments EDF made at a November 2012 stakeholder meeting held by EPA’s Integrated Risk Information System (IRIS) program, we warned that the tendency of the IRIS program to respond to criticism by expanding opportunities for “public” input would serve to increase rather than decrease the imbalance in stakeholder input.

We noted that providing more opportunities for participation not only lengthens the timeline for completing assessments; it also virtually ensures the input received by EPA is imbalanced and badly skewed toward the regulated community. That’s because companies that produce and use each chemical to be assessed – and the trade associations and myriad hired consultants that represent them – have a clear vested financial interest in the outcome of the assessment.  They can and will take advantage of each and every opportunity for input, and they will be better represented than other stakeholders each and every time.

IRIS recently began holding bimonthly meetings focused on “key science issues” relating to upcoming assessments.  And guess what?  An army of industry representatives, including staff for trade associations and paid consultants, are overwhelming the agendas.

Exhibit A:  Have a quick look at the list of speakers in the agenda for this month’s bimonthly meeting.  A striking imbalance, no?  As many as 8 industry representatives are set to speak on a given issue, including 6 from the same consulting firm!  [UPDATE 6/24/14:  See the top of this post for a description of the updated, slightly more balanced agenda; here is the agenda we had linked to that was current as of last week, and here's the updated agenda posted today.] Read More »

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