Selected tags: American Chemistry Council (ACC)

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

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

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.

The company selected by WV TAP to convene the Health Effects Expert Panel is named Toxicology Excellence in Risk Assessment (TERA), founded by Dr. Michael Dourson.  TERA has a long history of working with the petrochemical and related industries.  Acknowledged sources of industry funding noted on its website include the American Petroleum Institute, PPG Industries, Eli Lilly, the American Cleaning Institute (formerly called the Soap and Detergent Association), Procter & Gamble, and the Nickel Producers Environmental Research Association.

While TERA was chosen by WV TAP to convene the Health Effects Expert Panel, TERA’s role is far more substantial.  TERA appointed its own founder, Dr. Dourson, as chair of the panel, and Dourson was the only one of the panel’s members to speak at yesterday’s press conference.

At the press conference, a reporter asked Dourson whether he or TERA had worked for Eastman Chemical, Dow Chemical (the maker of the other chemicals that spilled on January 9) or trade associations that represent their interests.  Dourson’s response to this question was apparently the first public disclosure of his affiliations with these companies.  According to the Charleston Daily Mail:

During the event, Dourson acknowledged his nonprofit organization TERA had conducted some work for Dow Chemical, one of the makers of a chemical believed to have been involved in the spill. He said they’ve also done work for Eastman Chemical, the maker of crude MCHM, but not recently. TERA has done work for the state of West Virginia in the past as well, he said.

On its website, TERA says it’s received between 31 and 40 percent of its funding since 2008 from industry and industry related work. The rest comes from “government and other nonprofit work.”

The fact that an individual and company that have done work directly for the companies that make the spilled chemicals were selected not only to convene the expert panel, but to chair it and serve as its spokesperson, points to a clear conflict of interest.  And the fact that the conflict was only revealed because a reporter happened to ask the right question is even more troubling.

A quick search for recent work done by Dourson and TERA funded by Dow turned up the following:

TERA also convenes and manages several other projects that are heavily funded by the chemical industry and promote its agenda.  These include:

Anyone else see a problem here?

 

Posted in Health Science, Industry Influence, States | Also tagged , | Leave a comment

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 , , | 3 Responses, comments now closed

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.

 

Posted in Health Policy, Health Science, Industry Influence | Also tagged , | Comments closed

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 »

Posted in Health Policy, Industry Influence, TSCA Reform | Also tagged , , , , , , , | Comments closed

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 closed

EDF comments at National Academy of Sciences workshop on “weight of evidence” in chemical assessments

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

This week I attended a workshop sponsored by the National Academy of Sciences’ Committee to Review the IRIS Process.  This committee was established in response to a rider attached to an “omnibus” spending bill passed by Congress in late 2011.  The committee’s charge is to “assess the scientific, technical, and process changes being implemented by the U.S. Environmental Protection Agency (EPA) for its Integrated Risk Information System (IRIS).”

EPA describes IRIS as "a human health assessment program that evaluates information on health effects that may result from exposure to environmental contaminants."  The key outputs of IRIS assessments are one or more so-called “risk values,” quantitative measures of an “acceptable” level of exposure to the chemical for each cancer and non-cancer health effect associated with the chemical.  IRIS risk values are in turn used by regulators to set everything from cleanup standards at Superfund sites to limits in industrial facilities’ water discharge permits.

This week’s workshop – a detailed agenda is available herewas intended to provide expert input to the committee to inform its review of IRIS.  It focused on the complex and controversial issue known as “weight of evidence” (WOE) evaluation.  Here WOE refers to how EPA – in conducting an IRIS assessment of a particular chemical – selects studies, evaluates their quality, and assesses and integrates their findings, as well as how it communicates the results.  At issue in particular in a WOE evaluation is how the assessor determines the relative importance – or weight – to be given to each study.

One of the many issues that came up in the discussion of WOE is how to identify and assess the “risk of bias” in individual studies – a concept borrowed from the evaluation of the reliability of clinical trials used in drug evaluations.  (See this Powerpoint presentation by one of the committee’s members, Dr. Lisa Bero, which provides a nice overview of risk of bias in that setting).  Evaluating a study’s risk of bias is critical for assessing its quality and in turn the weight it should be given, because bias in studies can result in significant under- or overestimates of the effects being observed. 

One type of bias is so-called “funder bias.”  Dr. Bero and other researchers have documented through extensive empirical research that there is a significantly increased likelihood that a study paid for by a drug manufacturer will overstate the efficacy or understate the side effects of a drug.  As to studies of environmental chemicals, at the workshop and more generally, the chemical industry has pointed to adherence to Good Laboratory Practice (GLP) standards as a sufficient antidote to bias, including funder bias, a notion that has been heartily disputed by others.

But enough background.  My intent here is not to fully describe the workshop discussions, but rather to provide the comments I presented during the public comment period at the end of the meeting.  My comments addressed the issue of funder bias and also sought to urge the committee not to dive so deeply into the weeds in reviewing and proposing enhancements to EPA’s IRIS process that it loses sight of the need for a workable IRIS process that is able to provide in a timely manner information so critical to ensuring public health protection.

Read More »

Posted in Health Policy, Health Science | Also tagged , , , , | Comments closed

The chemical industry says formaldehyde and styrene don’t cause cancer. Only one of 52 scientists agree.

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

Last week, the National Academy of Sciences (NAS) held a joint meeting of its two panels that are charged with reviewing the listings of formaldehyde and styrene as carcinogens in the 12th Report on Carcinogens, which was released in June 2011.

The 12th Report on Carcinogens (RoC) is the latest edition of a Congressionally mandated report developed by the National Toxicology Program (NTP).  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.”  That put the chemical industry into a real tizzy, what with the threat these listings pose to its profits from the huge volumes of these cash cows sold each year, not to mention the huge potential liability it faces.

Never one to go down lightly, the American Chemistry Council (ACC) has launched an all-out assault on the NTP and the RoC.  It is waging battle not only with the executive branch, but also in the courts and in Congress.  In late 2011, it managed to get its allies in Congress to slip into the Consolidated Appropriations Act of 2012, without any debate, a rider that mandated the NAS reviews of the formaldehyde and styrene listings in the 12th RoC that are now underway.

ACC also pushed legislation in the last Congress to shut down all funding for the RoC until the reviews are completed; failing on that front, earlier this month it demanded that NTP cease all work on the next (13th) edition of the RoC.  (For more background, see previous blog posts by EDF and NRDC.)

Lost in all this kerfluffle, however, are these salient facts:

  • The formaldehyde and styrene listings are the outcome of one of the most extensive scientific assessment processes on the planet, entailing reviews by four separate groups of expert scientists for each chemical.
  • ACC as well as the public had at least three separate formal opportunities for providing input to these expert bodies.
  • Of a total of 52 votes cast by these scientific panels on the NTP’s recommended listings, 51 of those votes supported the recommendations and only one opposed them. Read More »

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

“Toxic Clout” shines a much-needed light on the chemical industry’s undue influence over toxic chemical decisions

Rachel Shaffer is a research assistant.

Remember the 2000 hit film, Erin Brockovich?  It was the Hollywood version of a real-life investigation into the contamination of groundwater in Hinkley, California with a known human carcinogen called hexavalent chromium (or hexchrome for short).  

Well, hexchrome is back on (a slightly smaller) screen, this time featured in a two-part series by the Center for Public Integrity (CPI) and PBS NewsHour.

The series, which aired on public TV stations earlier this month, highlights the continuing problem of hexchrome contamination around the country, including the still-unresolved situation in Hinkley.  Some 70 million Americans are exposed to this carcinogen through the water they drink. 

But the program also dives into another, even more concerning problem:  Years of delay in finalizing EPA’s risk assessment for the toxic metal, a prerequisite to any effective regulation.  Why the delay? Unfortunately, it’s an all-too-familiar story:  the chemical industry is stalling the process.  

And what are the consequences?  As EDF’s Senior Scientist Dr. Richard Denison says in the series:  “Decisions delayed are health protections denied.”  The chromium standard for drinking water has not been updated since 1991 and does not reflect recent scientific findings indicating that the standard needs to be significantly lowered to protect public health.

Check out the CPI/PBS segments (links below) and the related articles in CPI’s Toxic Clout series, which is part of an ongoing investigation of excessive industry influence in science and policy.

                Part 1: Science for Sale

                Part 2: Decision Delayed on Dangerous Chemical in Drinking Water

Posted in Health Policy, Health Science, Industry Influence | Also tagged , , , | Comments closed

A mission corrupted: Your tax dollars pay for ACC to coach big industry on how to undercut EPA’s IRIS program

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

On February 22, the Advocacy Office of the Small Business Administration, an agency of the Federal Government, held a meeting without any public notice and from which the press was barred.  And while the office’s mission is supposed to be to provide “an independent voice for small business within the federal government,” many if not most of the attendees were from large companies and the trade associations and Washington lobbyists that represent their interests.

This meeting was the latest in a long and continuing series of so-called “environmental roundtables” that serve as a basis for the SBA’s Advocacy Office to weigh in against environmental or workplace regulations that big business opposes.   

There are no records from these meetings that are made publicly available.  Agendas and attendee lists are not disclosed, though I was able to obtain an agenda for this particular meeting at the last minute.  I noted with interest that the first half of the meeting focused on the US Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) program, which provides health assessments of chemicals used by public health and environmental officials around the world. 

The key draw in this meeting:  a senior official from the American Chemistry Council (ACC), whose dominant members are huge global chemical companies like ExxonMobil, BASF, Dow and DuPont – in short, Big Chem.   The ACC official spent a full hour coaching representatives of Big Chem and other global mining companies and automobile corporations like GM in how to pick apart and challenge recent documents developed by the IRIS program.  IRIS has become a focal point of the chemical industry’s multi-front attack on independent government science.  Here is the deck of Powerpoint slides used by the ACC representative and the other industry speaker.  Read More »

Posted in EPA, Health Policy, Health Science, Industry Influence | Also tagged , , , | Comments closed

TERA’s Kids+Chemical Safety website: On non-profits, objectivity and independence

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

My recent post about the new American Chemistry Council (ACC)-sponsored website, Kids + Chemical Safety, engendered some comments that go directly to the issues of scientific objectivity and independence.

The website says “TERA [Toxicology Excellence in Risk Assessment, manager of the site] was founded on the belief that an independent non-profit organization can provide a unique function to protect human health by conducting scientific research and development on risk issues in a transparent and collaborative fashion and communicating the results widely.”  The “non-profit” descriptor – which TERA uses to describe itself no fewer than eight times on the site, including four times on this one page alone – seems intended to convey that TERA provides information that is purely objective and that it operates in a manner that is independent of who pays it to do its work.

It’s critical to recognize that being a non-profit does not conflate to, or somehow confer the right to claim, objectivity or independence.  The National Rifle Association is a non-profit that clearly has strongly held and expressed opinions.  EDF is also a non-profit, but I don’t pretend, as does TERA, that we don’t have a particular perspective and position.

So putting the issue of non-profit status entirely aside, we should judge TERA’s claim that its website provides information that is objective and independent based on its content, and that’s where it becomes quite clear that the information is neither.  Read More »

Posted in Health Policy, Health Science, Industry Influence | Also tagged , , , , | Comments closed
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