Remember the precautionary principle? It’s the approach that says that even when the science is uncertain about the harm a product or technology may cause, we should take steps to prevent the public and the environment from being exposed to that harm, until its safety can be demonstrated. It is the job of the business that wants to use or sell the product to prove that it is not harmful.
A decade ago, the European Union thought so much of the precautionary principle that the EU made it a cornerstone of its approach to chemicals in commerce.
At the time, the Bush Administration had no use for the precautionary principle. “We consider it to be a mythical concept, perhaps like a unicorn,” John Graham, then head of the Office of Information and Regulatory Affairs at the Office of Management and Budget, told EU regulators in 2003.
Certainly, the precautionary principle has not been at work in the way that U.S. law regulates chemicals. The Toxic Substances Control Act (TSCA), passed in 1976, essentially assumes all chemicals in commerce are innocent until proven guilty. And it’s up to the Environmental Protection Agency, not chemical manufacturers, to provide the proof.
Safety isn’t a reach
Europe, however, in 2007, stuck to its faith in unicorns. In 2007, the EU launched its REACH regimen, Registration, Evaluation, Authorization and Restriction of Chemicals. REACH requires that all chemicals that are produced in volumes that exceed one ton a year must be registered and include safety information. New chemicals must register and provide safety data right away. Existing chemicals produced at more than one ton also must register and provide information, but their deadlines are phased in over 11 years, and vary by their volume and how potentially harmful they may be. Chemicals produced in higher quantities, more than 10 tons annually, will have to meet even more stringent reporting requirements.
Through REACH, the European Union has shown the world how to balance sensible safeguards with economic interests. Photo: European Union
Chemicals of “very high concern” require authorization from the European Commission to be sold. To be authorized, the chemical manufacturer must demonstrate, to the satisfaction of the EU, that its risk management plan can control the potential harms to human health. Even if some risk persists, the EU may authorize if it determines that the chemical’s socio-economic benefits outweigh the risks, or if no suitable safer substitute exists. Phthalates, used in a wide range of plastic goods, cosmetics, cleaning, and other consumer products, have raised serious concerns among scientists about their effect on hormone levels in the body, and their potential harm to our reproductive systems. EPA hasn’t been able to restrict their use, but EU regulators have recommended that three phthalates be designated as chemicals of “very high concern” and require specific authorization to be used.
The opposite of TSCA
REACH is virtually the antithesis of TSCA. REACH requires companies to demonstrate safety, and places most of the burden of proof on them. TSCA requires the Environmental Protection Agency to have some proof that a chemical is unsafe before it can even begin to develop a regulation that requires a company to provide more information about a specific chemical, with the entire process taking two to 10 years. New chemicals only have to submit to the EPA the data they have on hand. As a result, tens of thousands of chemicals are sold and used in the U.S. with scant information about their safety or potential hazards.
REACH was the target of an intense lobbying campaign by the chemical industry, both in the U.S. and Europe. The German chemical industry asked the consulting firm Arthur D. Little to estimate the economic impacts of REACH. Its study predicted the loss of more than 2 million jobs in Germany. The study later was faulted for errors by German economists, in part because it failed to include any economic benefits from the new regulations. One of REACH’s original goals– to ensure that safer substitutes must be found for very hazardous chemicals – was diluted in the final REACH legislation. Nevertheless, with the help of an active grassroots campaign of environmentalists and public health advocates, REACH was not killed outright, and it has begun to make a difference.
REACH is still being implemented, but this year, the European Commission found that the stricter regulations have made chemicals in Europe “considerably safer.” The EU has collected safety and other data on nearly 8,000 chemical substances marketed in Europe. And the European chemical industry has rebounded from recession, proving that regulation can co-exist with economic viability.