EDF Health

Selected tag(s): American Chemistry Council (ACC)

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

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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Should we be holding our breath waiting for more information on risks of the chemical spilled in West Virginia?

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

A hearing held yesterday by the West Virginia Legislature’s Joint Legislative Oversight Commission on State Water Resources created quite a stir, when a witness – West Virginia Environmental Quality Board vice-chairman Scott Simonton – said that the human carcinogen formaldehyde had been detected in several water samples drawn from a Charleston, WV, restaurant, and that people in the area affected by the January 9 spill could be expected to have inhaled the chemical, which he identified as a likely breakdown product of the spilled material, crude MCHM.  See stories in the Charleston Gazette and USA Today.

State officials and the West Virginia American Water company were quick to call Simonton’s claims “unfounded” and “misleading and irresponsible,” respectively.  The controversy led even the American Chemistry Council – which has laid low ever since the spill – to quickly issue its first statement related to the spill through its Formaldehyde Panel.

While experts are noting that data are insufficient to identify the spill as the source of any formaldehyde detected in the water samples, this new kerfuffle does point to yet another major data gap on crude MCHM.

The one part-per-million (1 ppm) “safe” level state and federal officials set was based on limited data from studies in which rats were exposed to crude or pure MCHM through oral ingestionAbsolutely no data are available on the chemical with respect to exposure through inhalation.  Yet officials did not hesitate to tell residents the 1 ppm level would be safe not only for drinking the water, but also for bathing and showering.

(It’s curious that the Eastman Chemical Company apparently performed no inhalation studies on crude or pure MCHM, given that Eastman said its motivation for the studies it did perform was to understand risks to workers in industrial settings, and its safety data sheet for crude MCHM prominently notes the potential for health concerns for workers from inhalation.)

[UPDATE 1/31/14:  This morning, Eastman posted an updated version of its Q&A document on its website (linked to in the above paragraph), and took down the earlier version.  Here is the original version, the updated version dated 1/31/14, and a redline comparison of the two versions.]

Clearly the material that spilled is volatile – that’s why people can smell it.  Taking a hot shower in such water means that people would clearly be exposed via inhalation of the vapor; how much exposure would occur has not been ascertained.  But in the absence of any data as to toxicity of the chemical via inhalation, there is simply no scientific basis on which to say or imply that showering in water contaminated at 1 ppm level was OK.

Chemicals can be more or less toxic by inhalation than by ingestion, with one study finding inhalation to be the more toxic route for half of the chemicals examined and oral ingestion to be the more toxic route for the other half.  Benzene, for example, is estimated to be several hundred times more toxic by inhalation than by ingestion, while inhalation of chloroform is estimated to be about 25-fold lower in toxicity than it is by ingestion.

What such comparisons indicate is that extrapolating from data on oral toxicity to predict inhalation toxicity – which is effectively what government officials did in this case – is about as accurate as flipping a coin.

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