EPA and EU Collaborate on Chemicals Regulations

24 June 2002 00:00  [Source: ICB Americas]

European Chemicals regulations are poised for change, causing anxiety among European multinational chemical companies.

In its quest for greater harmonization of regulations on the transatlantic and global levels, the European chemical industry is gaining strong support from the En-vironmental Protection Agency (EPA).

"Europe and the US account for the overwhelming majority of chemicals production worldwide," Stephen Johnson, assistant administrator at the EPA's Office of Prevention, Pesticides and Toxic Substances, told the general assembly of the European Chemical Industry Council (Cefic).

"Our working together and making our two regulatory systems as compatible as possible, would have tremendous payoffs globally, both in strengthening security against terrorism and in our usual business of protecting the environment and health of citizens worldwide and in providing goods and services consumers want," he noted.

Europe and the US have already been involved in drawing up international agreements for a chemical classification system, uniform chemical testing guidelines and screening data, in addition to global treaties governing persistent organic chemicals and trade in listed chemicals.

These agreements "are being achieved without creating unnecessary trade barriers," Mr. Johnson told the meeting at Versailles, near Paris. "We should continue them and build on them. And as we move forward, we should encourage making our two regulatory systems compatible where possible."

He urges Europe to adopt the EPA's policy of building partnerships between government and industry, centered on cooperative and voluntary programs.

"We believe in the power of partnerships," he explains. "We believe that those familiar with a problem can often solve it most effectively. One of our goals is to strengthen the partnership between industry and government, both in America and worldwide."

For Cefic, the EPA's drive for greater compatibility in the way chemicals are controlled raises hopes that the European Union (EU) can be persuaded to adopt a more conciliatory approach to chemical regulations. EU governments and politicians have been criticized by the industry for wanting to impose unnecessary restrictions on the chemicals sector.

"We have to work together not only on a transatlantic level, but also with Japan," Eggert Voscherau, newly elected president of Cefic and an executive board member of BASF, told the meeting. "It's a global matter and we cannot work with different interpretations of regulations.

"The EPA tries to achieve a balance between the need to prevent pollution and the needs of the chemical industry. We can learn from each other and we can learn from the pragmatic approach of the EPA in the regulation of chemical products. We cannot have on either side of the Atlantic different regulations for the same product made by the same company."

Cefic is particularly concerned about proposals by the European Commission, the EU executive, for the registration, evaluation and authorization of 30,000 chemicals having outputs of more than a one metric ton per year. The proposals were outlined in a White Paper discussion document last year.

Cefic wants the Commission to make its proposals more workable and to take into account the costs of collecting safety data on so many products. It has suggested that the Commission reconsider the need for including intermediates and degradable products in the project.

"The proposed chemicals policy [of the EU] will have far-reaching implications for the competitiveness of the European chemical industry and downstream users and their ability to innovate," Mr. Voscherau says. "The objective is to enhance the level of protection, while minimizing the adverse impact of the policy on the competiveness of the industry."

Mr. Johnson says that the EU's planned regulatory system amounts to a new regulatory approach that is both a great opportunity and responsibility.

"The ideal, in our opinion, is to balance the simultaneous demands of an innovative and viable chemical industry and a high degree of public health and environmental protection," he continues.

"We want your new White Paper program to work. We have a strong interest in cooperating with the EU on future chemical issues. To the extent we can make our two programs more compatible, the better we'll be able to realize the ideal of safety and prosperity."

He urges the European Commission to ensure that its plans remain consistent with the testing capabilities within the EU and not create backlogs of products requiring risk assessments.

"It's important for us all to think about prioritization in the context of reviewing as well as requiring testing for chemicals," he says. "For example, when there are site-limited intermediates and/or a chemical has physical characteristics, such as rapid degradation, these should be considered lower priority."

Mr. Voscherau also complains about obstacles to the introduction of new chemicals in Europe under EU legislation approved 20 years ago. Since then, only 3,000 substances having an output of more than one ton per year have been launched on the market, against a predicted 20,000.

"Extensive testing requirements mean that bringing a new substance to market in amounts one to 10 metric tons a year costs ten times more in the EU than it does in the US," he says. "It also takes three times longer. Despite this, no one can seriously maintain that the US has a worse safety record or pays less attention to protecting humans and the environment."

Most new chemicals now marketed in Europe come from non-EU countries with conditions more conducive to innovation. In some product areas, European companies have stopped developing new substances, while small and medium-sized businesses cannot afford to bring them to market, Mr. Voscherau says.

Since the US Toxic Substances Con-trol Act of 1976, the EPA has reviewed more than 30,000 chemicals, of which 1,500 have been restricted or banned, according to Mr. Johnson.

Unlike in the EU, the EPA does not require companies with new chemicals to submit minimum pre-market data. Instead, it relies on projects such as Structure Activity Relationships (SAR) analysis, based on modeling and assessment techniques, to identify potentially risky chemicals.

"Using the SAR diagnostics, R&D firms can quickly and inexpensively compare and contrast new chemical product alternatives for risk concerns-something they have been unable to do previously," Mr. Johnson says. "Risk screening early on in R&D is the most pure form of pollution prevention."

The EPA wants to work with Europe in using new health and environmental data to improve the agency's modeling, assessment and screening techniques, such as SAR.

"Our hope is that building and sharing these techniques could make our approaches to chemical regulation more compatible," Mr. Johnson says.

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