EDF Health

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

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 »

Posted in Health Policy, Health Science, Industry Influence / Also tagged , , | Read 2 Responses

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 »

Posted in Health Science, Industry Influence, States / Also tagged , , | Comments are closed

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.

Posted in Environment, Health Policy, Health Science / Also tagged , , | Read 3 Responses

Doublespeak is alive and well in the ACC-backed “SAB Reform Act”

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

George Orwell would be proud

Yesterday a Senate copycat of a House bill called the “EPA Science Advisory Board Reform Act of 2013” was introduced.  The Senate bill has yet to be made publicly available, but that didn’t stop the American Chemistry Council (ACC) from sending out its own release strongly supporting the bill, literally within minutes of the issuance of a press release by the bill’s main sponsors.

Assuming (as stated in the release) that the Senate bill is the same as the House bill, H.R. 1422, no wonder ACC loves this bill: 

  • Tired of having your companies’ scientists and hired consultants excluded from SAB panels because of conflicts of interest?  Write a bill that eliminates such a pesky rule, and then say the bill “eliminates conflicts of interest.”
  • Frustrated by the time limit placed on comments from the army of industry commenters that typically show up at SAB panel meetings?  Bar the setting of any time limit so you can stack the deck, and then say the bill “promotes fairness” and “strengthens public participation.”
  • Unhappy with how many independent academic scientists are seated on SAB panels?  Require not only that panel members be willing to devote their time to review lengthy EPA documents, but that they respond in writing to every public comment received – a massive expansion in the workload placed on panel members, given the flood of industry comments typically provided – and then say the bill “promotes transparency.”
  • Upset with academic scientists on SAB panels that receive government grants not always supporting the industry position?  Claim that they are the ones who have conflicts of interest, single them out for disclosure of their grants and contracts – with no mention of industry consultants – and then say the bill “increases disclosures” related to potential conflicts.  (An earlier version of the bill would actually have set a 10% quota for government-funded scientists on SAB panels; happily that was removed after an outcry.)
  • Want to slow down the pace of EPA risk and hazard assessments?  Require that every single such assessment be sent to SAB for review, exponentially expanding the SAB’s workload and adding months or years to the process of finalizing assessments, and then say the bill merely “enables SAB reviews” of such documents.

Despite its grand claims, the EPA SAB Reform Act is nothing more than a thinly veiled attempt by ACC and its Hill allies to heavily stack the deck in its favor when it comes to independent scientific reviews of EPA work products.

When the House bill was introduced earlier this year, more than a dozen of the country’s premier public health scientists weighed in strongly opposing the bill, as did a group of prominent environmental NGOs.  See those letters for more details.

While the bill clearly parrots the talking points of the chemical industry when it comes to peer review of government chemical assessments, it should be noted that the bill would apply to any and all aspects of SAB’s work, not just that on chemicals.  So scientists in all fields of endeavor relating to protection of health and the environment ought to be concerned.

 

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Why can’t ACC tell the truth about the Safe Chemicals Act?

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

It’s very disheartening to see just how far the American Chemistry Council (ACC) has moved away from anything resembling a good-faith effort to debate and advance meaningful reform of the Toxic Substances Control Act (TSCA).  There’s more than enough in TSCA reform for stakeholders to debate and disagree about without adding distortions and outright falsehoods to the mix, yet ACC seems intent on doing just that.

The latest indication?  An April 16, 2013 post to ACC’s blog titled “A new year, but the same unworkable Safe Chemicals Act.”  The post purports to identify four fatal flaws in the Safe Chemicals Act of 2013, which was introduced on April 10 and is cosponsored by 29 Senators.  The first two utterly ignore or fault the legislation for major changes made to it to address industry concerns, while the latter two once again restate outright falsehoods ACC has made about the Act – claims that ACC knows are false.  Read More »

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Might we soon be facing an effort to roll back the Toxic Substances Control Act?

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

It seems like only yesterday there was broad consensus on the need to strengthen the Toxic Substances Control Act (TSCA), a consensus that included the chemical industry.

But that was then.  Now there are growing indications that legislation will soon be introduced in the U.S. Senate that would not only not fix the fundamental flaws of TSCA, but would actually make the law even weaker.  Read More »

Posted in Health Policy, TSCA Reform / Tagged | Comments are closed