As the New York Times reported last week, the EPA has denied a petition from the Natural Resources Defense Council (NRDC) to revoke approval of the herbicide 2,4-D.  http://www.nytimes.com/2012/04/10/business/energy-environment/epa-denies-request-to-ban-24-d-a-popular-weed-killer.html.  A story about an environmental advocacy group coming up short – - unfortunately, we have heard that tale before.

Further down in the Times’ article, however, comes the real story that explains what happened here and also why efforts to limit environmental and human exposures to toxic substances is such a enormous challenge.

See, the weed-killer in question, known better by its shortened name than by its full chemical name, 2,4-Dichlorophenoxyacetic acid, is one of the most widely used herbicides in the world.  And, the Times reports, Dow Chemical is one of the product’s major manufacturers.

Turns out that Dow (along with Monsanto) is also applying for federal approval for a genetically-modified corn.  What is this particular corn seed genetically modified to do?  Dow’s corn is specially designed to resist the toxic effects of 2,4-D  The advantages of Dow’s corn?  Farmers can use more 2,4-D to treat crops for weeds.

So, Dow wants to sell its genetically modified corn and in so doing sell more weed killer.  It’s a win-win for Dow.

The NRDC petition asked EPA to revisit the question of whether Dow’s weed killer is safe.  This seems like a perfectly fair question, especially considering that there is likely to be a lot more 2,4-D introduced into the environment if Dow’s genetically-engineered corn gains acceptance.  The NRDC, according to the TImes, cited various scientific studies that suggested links between exposure to 2,4-D and serious health consequences, including hormone disruption and other genotoxic and neurotoxic effects.  The International Agency for Research on Cancer (IARC) has given 2,4-D a classification of 2B, which is for substances possibly carcinogenic to humans.

One study showed increased incidence of lymphoma among farmers exposed to 2,4-D.  EPA viewed the study as inconclusive because the farmers could have been exposed to many things so it would be difficult to pin the cancers specifically on the 2,4-D.  2,4-D is also well known as one of the components of Agent Orange, controversial defoliant used widely during the Vietnam War.  But studies have showed that health problems from exposure to Agent Orange were attributable to exposure to other ingredients, not the 2,4-D.

In rejecting NRDC’s claims that there is scientific basis for concern about exposure to 2,4-D, the EPA cited, among others, a study that failed to establish evidence of reproductive problems in rodents fed a diet of high-dose 2,4-D.  The study EPA relied on, that’s right, was a study conducted by industry and by Dow Chemical.

If the EPA is to have any credibility in these sorts of determinations, then there should be more separation.  Dow has a powerful interest here.  Dow’s science should not be any basis for permitting Dow’s products to pass muster at the agency charged with protecting our safety, not Dow’s.

In an April 10, 2012 decision, the Supreme Court declined to hear the appeal of Rohm and Haas, now a subsidiary of Dow, which means the opinion of the Superior Court (Pennsylvania’s intermediate appellate court) stands.

And that means Dow and Rohm and Haas have lost their challenge to a court order compelling Dow to make available certain witnesses to answer questions about whether Dow concealed from epidemiology researchers evidence of workers who had been exposed to vinyl chloride and who later were diagnosed with brain cancer.  The reason Dow allegedly concealed such evidence: To weaken the scientific links between vinyl chloride, a key ingredient in the making of plastic, and brain cancer.

Case Background

The dispute over Dow witnesses arises from litigation involving a group of cases involving almost three dozen individuals who developed brain tumors and who lived not far from a Rohm and Haas chemicals factory inMcHenry County,Illinois.  Joanne Branham, on behalf of her late husband, Franklin Delano Branham, filed the first case.  The Branhams were longtime residents ofMcCullomLake, a small community about one mile south of the Rohm and Haas (former Morton Chemical) plant.

TheMcCullomLakecases began after Mr. Branham and two former side-by-side neighbors were diagnosed with malignant brain cancer within the same 12-month time period.  After all three filed civil actions in Philadelphia, where Rohm and Haas has its worldwide headquarters, other current and former residents who had developed brain tumors as well, came forward to join the litigation. In 2006, fourMcCullomLakeresidents were diagnosed with glioblastoma multiforme.  All but one has since died.

Malignant brain cancer originating in the brain – as opposed a brain tumor that is the result of metastasis from cancer in some other part of the body – is an especially rare form of cancer.  In the general population, there are only a few cases per 100,000 people per year.  The population ofMcCullomLakeis about 1,000 residents.

Rohm and Haas had bought Morton Chemical, and along with it theMcHenryCountychemicals plant, in 1999.  Dow Chemical in turn bought Rohm and Haas, paying about $15 billion, in 2009.  Because Dow acquired Rohm and Haas after the Branham case was filed, Dow was not directly a party to the lawsuit.

The thrust of the Branham case, and the otherMcCullomLakebrain cancer cases as well, is the claim that Rohm and Haas maintained an open, unlined chemical waste lagoon that was used to store millions and millions of gallons of liquid and solid waste during the 1960s and 1970s.  That lagoon leaked its contents, which then migrated through the groundwater moving in the direction ofMcCullomLake.  The contamination also percolated up through the shallow groundwater and into the air.

Among the contaminants in the groundwater, the company has acknowledged, was vinyl chloride.  Vinyl chloride is a known human carcinogen.

Epidemiology studies

One of the issues in theMcCullomLakecases was whether vinyl chloride could cause brain cancers.  Scientists widely agree that vinyl chloride causes a rare form of liver cancer and studies of vinyl chloride workers have strongly affirmed that conclusion.  But the chemical industry, led by Dow Chemical, has long resisted and actively fought against linking vinyl chloride to brain cancer, even though a great deal of science, including animal studies and worker epidemiology studies demonstrate that vinyl chloride does cause brain cancer.

Starting in the 1970s, the chemical industry, through the Chemical Manufacturers’ Association (now called the American Chemistry Council), commissioned epidemiology studies of vinyl chloride workers to try to disprove any association between vinyl chloride and brain cancer. The idea was to create an industry-wide cohort of workers, that is, to include in one study a large group of workers potentially exposed to vinyl chloride from many different facilities owned by a variety of vinyl manufacturers.

Dow was one of the manufacturers that contributed workers from several plants to this industry-wide cohort.  So was Union Carbide, a company later acquired by Dow.

The companies did what they could to control the outcome.  For example, the company managers, rather than the researchers brought in to do the scientific investigation, controlled which plants were included and determined which workers should be included.  In spite of these efforts, the initial versions of the industry-wide epidemiology studies gave the chemical manufacturers the unexpected and unwelcome news: the vinyl chloride workers did see a statistically significant increase in brain cancers.

In the late-1990s, the chemical companies revisited these earlier studies, engaging a new researcher, Kenneth Mundt, an epidemiologist fromBoston.   Mundt took all the worker data previously examined by different researchers and “updated” the information.  For example, one of the brain cancer cases counted in the earlier works was “un-counted” in the Mundt study.

The Mundt study, published in 2000, still found an association between vinyl chloride exposure and brain cancer, but characterized that association as “weak” from a statistical perspective.  In a cohort of some 10,000 workers, there were 36 brain cancers identified.  The fact that the study identified 36 cases meant that the increase in brain cancers over the expected number of cases was right on the line, just a hair shy of being statistically significant.

In other words, if Mundt had identified just one more case of brain cancer, then he would have had to acknowledge, as his predecessors had, that there was indeed a statistically significant association between vinyl chloride and brain cancer.  Just one more case would have changed the outcome of his study.

In response, the chemical companies waved the Mundt paper triumphantly, as if to say, You see!  That’s what we’ve been saying all along!  Experts for chemical companies used Mundt’s work in defending legal claims brought on behalf of workers and others claiming that their brain cancer resulted from exposure to vinyl chloride.

The Dow Subpoena

During the investigation of theMcCullomLakebrain cancer cases, we were able to develop evidence that there were certain cases of brain cancer among workers in the industry-wide cohort that Mundt may not have counted.  We developed evidence, supported by Affidavits and Death Certificates and other documentation, evidence that could show that not one but several chemical company workers who died of brain cancer should have been counted but were not counted.

On March 3, 2010, therefore, a subpoena was served on Dow in the Branham case to produce witnesses to testify about its participation in the industry-wide epidemiology studies.  Dow brought in its own legal team to file a motion to quash the subpoena, meaning they asked the trial court to throw out the subpoena and prevent the Plaintiff from taking the testimony.  As if they were separate companies and had not gone through a high-profile, multi-billion dollar acquisition just months before, Rohm and Haas filed its own motion, joining Dow’s request to quash the subpoena.

Dow argued that it was aMichigancorporation and that Plaintiff could only serve a subpoena on Dow there.  In other words, Dow argued that it was not subject to aPennsylvaniacourt’s jurisdiction.

This was a curious argument and perhaps a poorly timed argument as well.  After all, Dow had not only acquired Rohm and Haas, but, at the very time that these motions were being filed, Dow was erecting a large Dow red-diamond logo sign high above the Rohm and Haas headquarters at 5^th and Market Streets, just a few blocks from the court house.

The trial court rejected Dow’s arguments and ordered Dow to produce the company witnesses.  Dow appealed.

One year later, the Pennsylvania Superior Court published its decision affirming the trial court.  The appeals court ruled that Dow’s “argument that as a non-resident Dow is per se immune from subpoena is misguided and does not merit relief.”

The court found, “The installation of a high corporate executive, the erection of prominent signage, and the establishment of ongoing marketing efforts under the Dow brand are not isolated, sporadic acts.  The trial court did not abuse its discretion in concluding that they constituted the carrying on of a continuous and systematic part of Dow’s general business within this Commonwealth.”

There are many other interesting details in the Superior Court’s analysis of Dow’s arguments.  At one point, the Court refers to one of Dow’s arguments as “unsupported, speculative, and in substantial variance with Dow’s original argument on appeal.”  At another point, the Court pointed out that Dow was a point about “settledPennsylvanialaw” by citing to cases fromMississippi,Louisiana,OklahomaandNorth Carolina.  At another point, the Court noted that Dow had quoted the trial court out of context.

In the end, the Superior Court’s ruling stands, by virtue of the Supreme Court’s decision not to hear any further appeal from Dow or Rohm and Haas.  That means that businesses, like Dow, that do actual business inPhiladelphiaor elsewhere inPennsylvaniawill not be able to avoid the reach of our courts merely because they happen to be incorporated in some other state.

It also means we have forced the largest chemical company in the world to face some important questions about its role in influencing the science of vinyl chloride.  This could well have a major impact on the families of those who have been exposed to vinyl chloride and have then developed brain tumors.

The link to the opinion on the Pennsylvania Superior Court website is no longer available.  But this link should get you to the Court’s 32-page opinion: druganddevicelaw.net/Opinions%20in%20blog/Branham_Rohm%20&%20Haas.pdf.

BPA (found in plastics).  Dioxin (highly toxic byproduct of various industrial processes).  Atrazine (a widely used herbicide).

Dangerous chemicals, right?  One would think that it would be easy and obvious to associate these well-known chemicals with harmful consequences to human health and also to wildlife.  When there is a well-funded, highly motivated lobby resisting the weight of scientific findings, then that lobby can create a scientific debate.

Who could possibly be interested in resisting that highly toxic chemicals, even at lower doses, can have adverse health effects?  Why, the chemical industry, of course.

In the forthcoming (June 2012) issue of Endocrine Review, a team of researchers, led by Laura N. Vandenberg, of the Center for Regenerative Biology at Tufts University, has published a review of the medical and scientific literature on endocrine-disrupting chemicals (EDCs) and their impact, even at relatively low doses, on human and environmental health.  A copy of the journal article can be found at:  http://edrv.endojournals.org/content/early/2102/03/14/er.2011-1050.full.pdf.

The 79-page article, including nearly 1,000 citations to the literature, examines the links between exposure to relatively low doses of EDCs and hormone-altering health effects.  The significance of this elaborate review, as the authors state up front, is that these findings challenge the traditional notion of cause and effect in cases of chemical exposure, namely that “the dose makes the poison.”

The industry doubters and deniers, especially those who are paid and supported by the chemical industry to question the science linking exposure and adverse health effects, for decades have argued that more exposure and higher doses are needed to establish a scientific link to cancer or some other health impact.   If dangerous exposure occurs only at higher levels of dose, once can see how this would be very appealing for industry.

If there are safe levels of exposure to known dangerous chemicals, then there can be “protections” for workers.  Regulators can set standards for cleaning up contamination that spares polluters from addressing anything but the most serious environmental problems.  And companies can claim their products or their industrial waste are not responsible for an individual’s unfortunate illness or death.

The Vandenberg team’s review sets out the data to support the conclusion that there are indeed biological effects in animals, on other wildlife and in humans from even low doses of certain chemical exposures.  “As discussed several times throughout this review,” the authors note, “there is now substantial evidence that low doses of EDCs have adverse effects on human health. . .The weight of the available evidence suggests that EDCs affect a wide range of human health endpoints that manifest at different stages of life, from neonatal and infant periods to the aging adult.”

The practical implications of the study’s findings are clear:  “Thus, it is logical to conclude that low-dose testing, followed by regulatory action to minimize or eliminate human exposures to EDCs, could significantly benefit human health.”

For example, the Vandenberg team explores the literature regarding BPA, an EDC found in plastic products like water bottles.   Concerns mounted over BPA when it became apparent that quantities of this chemical leached out – say, into the water in a plastic bottle – even under normal conditions

According to the study authors, BPA has been the focus of more than 200 published animal studies, many of them examining the effects from even small doses of BPA.  Many studies, using different designs and approaches have identified impact on the prostate and mammary glands.

The authors are candid in disclosing that some studies looking at potential impact from lower dose exposures have showed no adverse effects.  But the authors point out, “Essentially, all scientists know that it is very easy for an experiment to find no significant effects due to a myriad of reasons; it is more difficult to actually find effects, particularly when using highly sophisticated techniques.”

As for BPA, the authors assess all the scientific evidence, taken together, and evaluate the weight of the evidence for or against the proposition that low-dose exposures of EDCs like BPA can produce adverse effects.  The weight of evidence on BPA, the authors conclude, “clearly shows that low-dose BPA exposure affects development of the mammary gland, mammary histogenesis, gene and protein expression in the land, and the development of mammary cancers.”

The authors analyze the data, the body of published scientific studies, as to several other EDCs as well, including atrazine (a widely used herbicide), dioxin (a byproduct of industrial waste incineration), and perchlorate (a commonly-found industrial waste contaminant).  The findings as to these EDCs are similar to the findings as to BPA.  Low-dose exposures, looking at the weight of the evidence, do produce adverse health effects.

Not all scientists agree with these conclusions.  In itself, this should come as no surprise.  That is why medical and scientific journals increasingly have required that authors disclose when they received funding or support for a particular article.  Bias is always relevant to assess a witness’ credibility in a courtroom and the same is no less so when weighing the views of those engaged in a scientific or policy dispute.

In an article about the EDC study that was published recently in “environment360,” a Yale University on-line publication, it was noted that the American Chemistry Council (ACC) had issued a statement saying that the chemical manufacturers were committing “substantial resources” to better understanding the potential connections between chemical exposure and the endocrine system.  The ACC specifically referred to the work of Michael Kamrin, a toxicologist from Michigan State.

Dr. Kamrin, who has written on the “hypothesis” about low-dose exposures, has proclaimed that such theories are “controversial.”  But who is creating the controversy?

Perhaps the American Council on Science and Health, an industry-funded group whose financial backers include Dow Chemical and other large chemical companies.  Dr. Kamrin is on the Board of Scientific and Policy advisors for that organization.   And, of course, Dow is a major player in the ACC.  For more on Dr. Kamrin’s ties to Dow, see CorpWatch’s paper, “Dow’s Knowledge Factory,” at www.corpwatch.org/article.php?id=10008.

Another critic of Dr. Vandenberg’s study, also quoted in the Yale on-line article, is Lorenz Rhomberg of the Gradient Corporation.  Gradient, based inCambridge,MA, is an environmental consulting company that almost exclusively works for large companies in litigation, including Dow Chemical.  (Gradient does do some government consulting as well.)

What is the take-away?  The ACC and the chemical manufacturers and other industry groups have the ability to devote substantial resources to these issues.    While the public health is an obviously vital interest to protect, Industry also has its interests.  Naturally, industry must protect itself, but from a different kind of exposure.

Industry must protect itself from exposure to avoidable financial costs.  Industry must protect itself against exposure to that which cuts into profits.  Industry must protect itself against exposure to liability.

Recognizing that lower exposures to unnatural chemicals like BPA and atrazine and perchlorate can produce adverse health effects means that federal and state regulatory authorities must act more responsibly in the public’s interest.  This means doing a better job of balancing the needs of companies to make money and the needs of the public to be protected against harmful exposures.