Reaching for Control of Carcinogenic Chemicals

PARIS, France, May 5, 2004 (ENS) - At UNESCO Headquarters on Friday, The French Association for Research on Treatments Against Cancer is convening a trans-Atlantic group of leading cancer specialists to present scientific evidence on the role of environmental pollutants as major causes of cancer and other diseases.

Foremost on the agenda is the proposed new chemicals policy for the European Union, known as REACH - Registration, Evaluation and Authorization of Chemicals - an unprecedented complex of regulations for industrial chemicals.

First outlined by the European Commission in 2001, REACH was opposed by the European and U.S. chemical industries, and also by the Bush Administration. A weaker version was offered in 2003, but in view of the drastic rise in deaths from avoidable causes of cancer such as industrial chemicals, the distinguished scientists at this Colloquium will present evidence to show that REACH needs to be strengthened, not weakened.

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BP Chemicals' acetyls complex at Saltend Works, Hull, England. (Photo by Ian Britton courtesy FreeFoto)
As the world's largest chemical market, Europe has the ability to act as a catalyst for reform of global legislative policies on the regulation of industrial chemicals. The U.S. government and chemicals industry is closely watching the progress of REACH on its path through the European legislative process. At this critical moment, the experts meeting at UNESCO are engaged in a life and death struggle with cancer and the chemicals that cause this constellation of diseases.

The Colloquium opens with an address by distinguished French oncologist Lucien Israel, MD, who has spent nearly 60 years in the cancer field. He will share the podium with renowned French virologist Dr. Luc Montagnier, best known for his 1983 discovery of the human immunodeficiency virus (HIV), which has been identified as the cause of AIDS.

From the American side of the Atlantic comes Samuel Epstein, M.D., professor emeritus of environmental and occupational medicine at the University of Illinois at Chicago School of Public Health, and a winner of the Right Livelihood Award who chairs the Cancer Prevention Coalition.

Dr. Epstein will give the introductory morning talk on cancer prevention, which will emphasize the escalating incidence of non-smoking related cancers, such as testicular, brain and childhood cancers.

Boston University Professor of Environmental Health Dr. Richard Clapp will offer his perspective on the epidemiological approach to the links between cancer and the environment. Founder of the Massachusetts Cancer Registry, he now sits on the Governing Council of the International Society for Environmental Epidemiology.

The Colloquium, organized by Dr. Dominique Belpomme of Pesticides Action Network Europe, will hear from representatives of American, Belgian, British, French, and Spanish scientific and citizens' groups such as the Royal Commission on Environmental Pollution, Greenpeace Europe, the WWF, and the European Environmental Bureau, which represents 143 member organizations in 31 countries.

Paul Lannoye of Belgium, a Member of European Parliament representing the Green Group, will address the issues of a Europe facing environmental pollution, and lawyer Corinne LePage of France will advance the idea that polluting is a crime against humanity.

Cancers resulting from occupational exposure, cancer and foods, chemicals in consumer products - a full spectrum of chemical causes of cancer will be considered with the precautionary principle as well as the principle of prevention in mind.

"We have developed a very high dependence on chemicals," European Environment Commissioner Margot Wallstrom told the Second US-EU Chemicals Conference in Charlottesville, Virginia on April 26. "Yet this is not matched by sufficient knowledge about their potential risks and long-term effects, for which we are paying a high price."

"This is not just an issue for European countries," she said. "Chemical safety is a global concern. Countries all over the world are paying a high price for failures to address chemical safety."

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European Environment Commissioner Margot Wallstrom (Photo courtesy European Commission)
Wallstrom has been the point person for the REACH program, which she said is designed to provide the information and safety Europe needs but in a way that is integrated with international efforts. "To facilitate transfer of information, we will be implementing the Globally Harmonised System, which is the UN system for classification and labeling of dangerous substances," she said.

But experts at the Colloquium strongly believe that the current version of REACH is too weak to be effective, and that it has been deliberately weakened at the behest of the chemicals industry on both sides of the Atlantic.

In a detailed 40 page report, "REACH: An Unprecedented European Initiative for Regulating Industrial Chemicals," Dr. Epstein writes, "In striking contrast to EU governments, which have maintained neutral positions, the Bush Administration has encouraged industry to take aggressive opposition to REACH."

Citing articles in the "New York Times," "Environmental Health Perspectives," and other respected publications, Dr. Epstein presents evidence that the Bush Administration is doing its best to undermine the precautionary principle on which REACH is founded, a principle accepted by the European Commission as a "full fledged and general principle of international law."

"Secretary of State Colin Powell, in a March 2002 U.S. "Nonpaper on EU Chemical Policy," warned that the Precautionary Principle would result in "politically motivated bans" of U.S. chemical products, which account for over 20 percent of all U.S. exports.

Dr. John Graham, administrator of the U.S. Office of Information and Regulatory Affairs, and former director of the industry-funded Harvard University Center for Risk Analysis, in a May 18, 2003 speech to EU regulators, stated that the Administration considers the Precautionary Principle "to be a mythical concept, perhaps like a unicorn."

Confidential documents obtained under the U.S. Freedom of Information Act, have revealed that the U.S. State and Commerce Department, the Environmental Protection Agency, and Office of the U.S. Trade Representative, have formed an alliance with Dow Chemical to fight REACH, as reported in the "Wall Street Journal" on September 9, 2003.

"These tactics, however, may backfire," Dr. Epstein writes. "Senator Frank Lautenberg (D-NJ), with other influential Congressional Democrats, is drafting a proposal to overhaul U.S. regulations to resemble the EU's proposed reforms."

The mainstream industry opposition has been mobilized by the American Chemistry Council and the European Chemical Industry Council, each accounting for approximately 30 percent of the world's chemical production. The Trans-Atlantic Business Dialogue has been established to coordinate industry opposition to REACH, Dr. Epstein notes.

A leaked American Chemistry Council memo made public by the Washington, DC based Environmental Working Group in November 2003 revealed aggressive and well-funded plans to fight laws and regulations based on the precautionary principle, observes Dr. Epstein.

The Council's public relations campaign is being handled by the firm of Nichols-Dezenhall, which, Dr. Epstein writes, "has hired former FBI and CIA agents to create phony front groups, and spy on environmental activists, including digging through their trash in efforts to smear them."

The industry is fighting against regulation of highly toxic industrial chemicals that REACH would impose.

Under REACH, certain classes of industrial chemicals are regarded as of Very High Concern. They are:

Many of these chemicals are ingredients or contaminants in pesticides, and in consumer products, including food, cosmetics and household products.

Under REACH, when a company intends to produce or import new and existing chemicals it would be required to prepare a Chemical Safety Report to notify the European Chemicals Bureau, a new body which would be responsible for the classification and labeling of dangerous substances.

The report would include - data on the identity of each chemical; toxicological, and ecotoxicological properties of intended uses; estimated human and environmental exposures; production quantity; proposed classification and labeling; safety data sheet; preliminary risk assessment; and proposed risk management.

This information would be entered into a publicly available database to be managed by the European Chemicals Bureau.

The chemicals notified would be evaluated by testing, and authorization will be granted for a limited number of chemicals of very high concern.

Chemical companies would be required to pay fees for each submission. Overall costs are estimated at: registration: 300 million; testing of 30,000 high production volume chemicals: 2.1B for a total of: 2.4 billion. Administrative costs of approximately 0.4 billion would be recovered on a fee based system.

The first formalized critique of REACH was detailed by the American Chemistry Council in July 10, 2003. "REACH is impractical and too costly," the Council said, and should be replaced by a "risk-based approach." The high costs of REACH would impose a negative impact on innovation and competitiveness of EU industry, the Council warned.

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Dr. Samuel Epstein chairs the Cancer Prevention Coalition. (Photo courtesy foxBGHsuit.com)
Dr. Epstein says the chemical industry is making exaggerated claims about the costs of REACH, which he says are only 0.05 percent of the chemical industry's 417 billion turnover in 2000. He maintains that these costs are "likely to be dwarfed by costs of poorly recognized public health and environmental impacts to which REACH makes the briefest reference. "

The latest REACH proposal "fails to recognize the much higher public health and environmental costs of its drastically weakened regulations," Dr. Epstein warns. He points to "significantly increased incidence of testicular cancer in young men, and allergies over the last decades, for which the underlying reasons have not yet been identified."

The American Chemistry Council objects that REACH is trade restrictive and incompatible with World Trade Organization objectives and international chemical regulations. The Council and its European counterpart say the EU should rely on existing registration and risk management, rather than on REACH.

The opposition to REACH by European and U.S. industry was so strong that the EU was forced to make substantial concessions, which were formalized in its October 2003 legislative proposals. These were jointly developed by Wallstrom and EU Enterprise Commissioner Erkki Liikanen.

Key among these concessions was the reduction of the number of high production volume chemicals for which comprehensive safety testing would be required from 30,000 to 10,000, in spite of what Dr. Epstein calls "minimal available test data on most of them."

Chemicals produced in smaller amounts, from one to 10 metric tons, were exempted from the requirements to produce data on reproductive toxicity and environmental persistence.

But people are getting sick and dying in increasing numbers from exposure to the very chemicals REACH is designed to regulate, chemicals that they are exposed to not just one at a time, but in combination.

This is one of the most serious weaknesses of the latest REACH proposal writes Dr. Epstein. "REACH focuses on the carcinogenic and other toxic effects of individual chemicals," particularly chemicals classified as of Very High Concern, "to the exclusion of well-documented evidence on additive and unpredictable synergistic interactions between individual carcinogens."

Formaldehyde, styrene, and atrazine each is toxic alone, for instance, but when a person is exposed to them at once, their combined toxicity is even greater.

REACH should be strengthened by emphasis that the right-to-know "is an inalienable democratic principle, with the exception of sensitive national security concerns," writes Dr. Epstein. "This right clearly extends to information on avoidable risks of disease and death, and environmental contamination, due to industry practices."

"These rights override claims of trade secrecy and confidentiality," he writes. "It should, however, be recognized that the right-to-know in the EU, besides other nations, is more honored in the breach than the observance. REACH should explicitly acknowledge this right, and detail the mechanism for its widest implementation."

Workers are at greatest risk of high level exposure to industrial chemicals of Very High Concern, and Dr. Epstein is calling on industry to recognize workers' right-to-know information on all such life threatening dangers. Workers must have specific information on the chemical and common name of each carcinogen, and carcinogenic process, he says, and specific information on precautions that can be taken to avoid inhalation and skin exposures.

Among many other recommendations for strengthening the REACH legislation, Dr. Epstein is calling for "independent audits of industry chemical safety dossiers prior to registration under REACH, and independent auditing of industry claims for waiving authorization of chemicals classed as of Very High Concern, based on no "right to concern," or that risks can be "adequately controlled."

"All advisory committees should include representatives of independent expert stakeholders, and meetings should be open to the public," he advises, and "all committee members should fully disclose their conflicts of interest."

He challenges the existing estimated health benefits, of 50 billion over 30 years, saying they do not reflect the escalating incidence of cancer, nor early life exposures due to industrial chemicals.

The environmental benefits should be estimated and recognized, and industry benefits from technological innovation stimulated by REACH also should be estimated and recognized, Dr. Epstein says.

The very existence of the REACH proposal has emphasized the inadequacies of the 1976 U.S. Toxic Substances Act, Dr. Epstein will tell the Colloquium. These U.S. regulations still require testing of only about five percent of chemicals in commerce. "Reflecting such concerns, exacerbated by the deregulation policies of the Bush Administration, progressive Congressional Democrats are now drafting a proposal to overhaul U.S. regulations to conform with those of REACH," he says. These initiatives may extend to state level, and the city of San Francisco is already moving in this direction.

Considering the wide range of exposure of the public to high production volume chemicals, Dr. Epstein is not surprised that many have been identified, particularly in the United States as body burden contaminants in fat and blood of the general population.

These chemicals are in the fat and blood of Europeans too, and European Environment Commissioner Wallstrom is no exception. The results of her personal blood test are now public knowledge and she shared them with participants in the Second US-EU Chemicals Conference.

"Among all the talk of costs, trade barriers, bureaucracy," she said, "the results of the test underline the urgency of cleaning out the chemicals stable."

"A couple of years ago, a British doctor told me that each of us have roughly 300-400 synthetic substances in our bodies, and that these were not present in our grandparents' generation. This got me curious," Wallstrom said.

"Last summer I participated in a limited screening involving three groups of man-made substances brominated flame retardants, PCBs and organo chlorine pesticides," she said. "Of the 77 looked for in this screening, I had 28 in my body, including PCB and DDT, which have been banned in Europe for several decades."

"I was told that my result was below the average of the group tested," Wallstrom said. "The result certainly made me concerned, particularly since I also was told that some of the chemical burden in my body was transferred to my children when I was breast feeding them. And, synthetic chemicals are certainly not something that I want to leave as a legacy with them!"

Dr. Epstein puts it even more strongly. "Reckless industry practices are violations of human rights, and white collar crime," he says, and under REACH authorization of chemicals of Very High Concern should be denied if safe alternatives are available.

If public support for REACH is forthcoming when it is introduced to the new European Parliament of 25 member states after the May elections, it will be none too soon for the scientists and nongovernmental organizations at the Paris Colloquium. Cancer is now a leading cause of disease and death in France and the United States, striking nearly one in two men and more than one in three women in their lifetimes.

Dr. Epstein's full report on REACH is available on the Cancer Prevention Coalition site: http://www.preventcancer.com.