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
"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
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
"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
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
"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
"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
"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
"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
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