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Scientists Critical of EU’s Draft Chemical Regulation Policy Have Industry Ties

This special report by Stéphane Horel and Brian Bienkowski was originally published Sept. 23 by Environmental Health News.

Seventeen scientists who have criticized plans in Europe to regulate endocrine-disrupting chemicals have past or current ties to regulated industries.

An investigation by Environmental Health News reveals that of 18 toxicology journal editors who signed a controversial editorial, 17 have collaborated with the chemical, pharmaceutical, cosmetic, tobacco, pesticide or biotechnology industries. Some have received research funds from industry associations, while some have served as industry consultants or advisors. [Read about the scientists here.]

The editorial – published in 14 scientific journals from July to September – has created a firestorm in Europe among many scientists and regulators. It criticized a leaked draft proposal by Europe’s Environment Directorate-General that recommends a precautionary approach, which could lead to the ban of some commonly used chemicals. The stakes are high in the controversy because it involves the European Union’s strategy to regulate hormone-altering chemicals – the first attempt in the world to do so. The new rules would have sweeping, global ramifications because all companies that sell a variety of products in Europe would have to comply.

The signees, including many toxicology professors at universities in Europe, wrote that the European Commission plan is “scientifically unfounded” and is “defying common sense, well-established science and risk assessment principles.”

The proposed rules have “worrisome ramifications” for “science, the economy, and human welfare the world over” and “lack the required scientific robustness needed for such an important piece of legislation,” they wrote.

All of the scientists who responded to questions from Environmental Health News denied they were influenced by industry.

Daniel Dietrich, a toxicologist who was the editorial’s lead author, is a former advisor for an industry organization funded by chemical, pesticide and oil companies that lobbies the European Commission on endocrine disruptors.

“We do not believe the discussion on the conflicts of interests will serve anybody because it takes away the focus from the real issue,” Dietrich said in an interview.

‘Worrying’ conflicts of interest

But other scientists question the writers’ motives and undisclosed ties to industry, calling the editorial criticizing a policy proposal an “unusual initiative” for science journal editors.

“I was very surprised by the editorial. I thought it was emotional and non-specific, a mixture of science and policy, and with too many errors,” said Åke Bergman, an environmental chemistry researcher at Stockholm University.

When Bergman learned of the conflicts of interest of the editors, he called it “worrying.”

rebuttal, published in the journal Environmental Health, was signed by Bergman and 40 other scientists with no declared conflicts of interest. They wrote that they were “concerned that the Dietrich editorial appears to be intended as an intervention designed to impact imminent decisions by the European Commission.” The editorial “ignores scientific evidence and well-established principles of chemical risk assessment” related to endocrine-disrupting chemicals, they wrote.

Another rebuttal signed by 104 scientists and editors of journals was published last week. “The letter by Dietrich, et al does the European Commission, science – including the field of toxicology – and most importantly, public health – a profound disservice,” they wrote in the journal Endocrinology. One of the signees was Pete Myers, founder of EHN, chief scientist of Environmental Health Sciences and associate editor of the journal Endocrine Disruptors.

Some authors of the first rebuttal, including Bergman, are widely considered leading scientific experts in endocrine disruption; 14 of them wrote a recent report by the World Health Organization and the United Nations Environment Programme that called endocrine disruptors a “a global threat that needs to be resolved.”

Endocrine disruptors are chemicals that can interfere with hormones, including estrogen, testosterone and thyroid hormones. They are found in everyday consumer products such as food, cosmetics, pesticides and plastics. Included are bisphenol A, found in hard plastics, some receipts and food can liners; phthalates used in fragrances and vinyl; and some pesticides and flame retardants.

Their effects on human health are uncertain, but many lab animal studies and some human studies have linked them to reproductive problems, cancers and other diseases.

The European Commission’s strategy

The European Commission is planning to regulate the chemicals by updating three of its existing regulations. Two controversial issues are critical to the efforts.

First, the commission is trying to decide whether these chemicals are safe under certain threshold concentrations. If no safe threshold can be determined, industry would then have to demonstrate that the economic benefits outweigh human health risks or that there are no alternatives. Otherwise, they would be banned under Europe’s REACH, a sweeping regulation adopted in 2006 that controls industrial chemicals.

Second, pesticides and biocides are regulated under new regulations that already require that endocrine disruptors must be removed from the market. The commission still needs to formulate precise identification criteria for those.

The commission’s final proposal was expected this year. But now the commission is considering launching an “impact assessment,” a procedure that is likely to postpone the decisions until the end of next year.

The chemical, pesticides, cosmetics and plastics industries have been lobbying the commission against any regulation. They claim that thresholds do exist for endocrine disruptors, and they contest the precautionary approach in setting the identification criteria.

The journal editors admonished the commission for a framework “based on virtually complete ignorance of all well-established and taught principles of pharmacology and toxicology.” They said that a threshold can be set for endocrine disruptors, and that toxicologists should distinguish between the effects the hormonal system can adapt to and actual adverse effects.

But other scientists disagree.

Hormone disruption during development can have irreversible impacts, Bergman and the other scientists replied in their rebuttal. The “existence of a threshold for endocrine disruptors,” they wrote, “cannot be demonstrated experimentally.” Some scientists maintain that animal experiments indicate that low doses of BPA and other hormone-like compounds can harm fetuses as they develop, while high doses have no effect or different effects.

“The most worrying aspect of the editorial by Dietrich et al. is the blurring of the border between what constitutes science and what belongs to the realm of political, societal and democratic choice,” the 41 scientists wrote.

In addition to the editorial, a letter was signed by 71 scientists – including some who signed the original editorial – urging the Chief Scientific Advisor of the President of the European Commission to step into the debate. At least 40 of the 71 have ties to various industries. The European Crop Protection Association, the lobby organization for the pesticides industry, recently backed the letter.

Scientist Philippe Grandjean, editor-in-chief of the journal Environmental Healthurged Dietrich and colleagues to correct their “lapse” of disclosure of competing interests in their editorial.

“It is important that academics share their information with stakeholders. But when there is a financial interest, it is also important that this information is made available,” Grandjean said in an interview. He is a professor and chair of environmental medicine at the University of Southern Denmark and an adjunct professor of environmental health at the Harvard School of Public Health.

Dietrich, however, said there was no disclosure because it was an editorial, “not a dataset that would influence any particular chemical.” He dismissed as irrelevant industry’s support of the letter to the Chief Scientific Advisor.

“There are things you cannot control. If someone comes – whether it is the chemical industry or the European Commission or who else – and says ‘that’s a good idea,’ that does not necessarily mean that I have an affiliation with them,” said Dietrich, who is editor-in-chief of the journal Chemico-Biological Interactions and head of the Environmental Toxicology Research Group at the University of Konstanz in Germany.

Dietrich is a former advisor for the European Centre for Ecotoxicology and Toxicology of Chemicals, or ECETOC, funded by chemical, pesticide and oil companies. He also has co-authored research with Dow Europe and some pharmaceutical companies.

When asked if his industry involvement influenced his opinion about the proposed regulations, Bas Blaauboer, editor of the Toxicology in Vitro journal, said, “This is a very stupid question.”

“Working in a university, we have collaborations with people all over the world, including people who work in the industry, but we always have the freedom to say whatever we want,” Blaauboer said. “If you can trace any comment made by me back to the fact that it is influenced by this type of conflict of interest, just let me know, but you cannot find it.”

Blaauboer, a toxicology professor at Utrecht University in the Netherlands, received $529,370 in research funding from the European Chemical Industry Council, or CEFIC, between April 2008 and March 2010. He also is a member of a technical committee on risk assessment within the International Life Sciences Institute, or ILSI, an industry-funded institute.

Getting money from a mix of sources – including industry – is “the normal way” to do research nowadays, said Wolfgang Dekant, editor-in-chief of the Toxicology Letters journal and a toxicology professor at University of Würzburg in Germany. “You can’t do research anymore if you don’t go for money from all sources,” he said.

Dekant received chemical industry funds for a 2008 study of BPA and has signed 18 consultancy contracts in the past five years. He denied any industry influence.

Jan Hengstler, editor-in-chief of the Archives of Toxicology journal, wrote a 2011 review on BPA with an employee of a division of Bayer AG, the leading BPA producer, and a scientist who had been commissioned by the American Chemistry Council for another BPA review. The review concluded that “exposure represents no noteworthy risk to the health of the human population, including newborns and babies.”

Hengstler said in an interview that he has no current ties to industry. “I am only interested in scientific things,” he said. Hengslter is director of the Leibniz Research Centre for Working Environment and Human Factors at the Technical University of Dortmund in Germany.

Nigel Gooderham, editor-in-chief of the Toxicology Research journal, has current or past collaborations with the food, pesticide and pharmaceutical industries.

“I have nothing to gain from any company by signing that document. It was purely based on my scientific thinking and analysis,” said Gooderham, who is a professor of molecular toxicology at Imperial College London.

Sonja von Aulock, editor-in-chief of the ALTEX journal, has no known ties to industry. But she said that collaborating with industry “does not mean that the scientists are biased to the industry’s possible financial interests or that they are not making a statement they believe is in the best interest of public health.”

Olavi Pelkonen, Kerstin Stemmer, Hans Marquardt and Albert Li also acknowledged past or current collaborations but denied having any conflicts of interest. Abby Collier, Gio Batta Gori, Alan Harvey, A. Wallace Hayes, James Kehrer, Florian Lang, Frans Nijkamp and Kai Savolainen did not respond to requests for comment.

Officials from the European Commission stressed that the best available science will guide their endocrine-disruptor regulations.

“We all want our decisions to be based on science,” wrote Joseph Hennon, European Commission spokesperson for the environment, in an email response. “And we count on the scientific community to play its role and inform policy and decision-makers with facts and figures.

“The relationship between science and politics should be based on trust,” he added. “And we trust scientists to act independently for the benefit of all.”

Stéphane Horel, based in Paris, France, is a freelance journalist and documentarian who investigates conflicts of interest and influence on public health issues. She is working on a documentary about the regulation of endocrine disruptors in Europe.

Brian Bienkowski is senior editor and staff writer at Environmental Health News.

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