Greenwire, June 23, 2008


[Rachel's introduction: Shifting the burden of proof is one of the most important elements of the precautionary principle: Chemicals should be tested for safety before marketing. No data? No market.]

By Sara Goodman, Greenwire reporter

The chemical industry is scrambling to comply with a sweeping new European Union law requiring manufacturers to provide detailed information about their products and their effects on the environment and health.

"You have a very dramatic reform in chemical policy taking place in the seat of the largest proportion of the global chemical market," said Richard Denison, senior scientist at the Environmental Defense Fund, an advocacy group. "That is going to have a huge impact on the global chemical arena."

The law -- Registration, Evaluation and Authorization of Chemicals, or REACH -- was enacted last year, and its requirements are just starting to affect European chemical manufacturers and importers. What happens in Europe is important because the continent's chemical trade accounts for about 40 percent of the global market, with 27 countries and nearly half a billion people.

"REACH has a potential impact outside the E.U. -- it doesn't stop at the borders," said Walter van het Hof, spokesman for Dow Chemical.

REACH requires companies to register chemicals manufactured in or imported into Europe. They must include detailed information about the chemical and whether it accumulates in the environment.

"It's using the concept of 'no data, no market,'" Denison said. "REACH has acknowledged that there are tens of thousands of chemicals in commerce that have never been assessed or tested. It recognized that the legacy of old chemical policy needed to be tackled and addressed."

The registration system stipulates that as a condition for being in the market, there must be at least a minimum amount of data available in the public domain. Companies must preregister between June 1 and Dec. 1, meaning they have to turn in basic information on chemicals. If a company fails to meet this first deadline, it will not be allowed to sell its wares.

Over the next decade, further requirements will be rolled out, giving smaller companies more time than bigger companies to meet the new regulations.

'More modern way'

As a part of the rollout, companies will also be required to provide information on how their chemicals are used throughout the supply chain, including in final products.

"One of the big ideas behind REACH is to force a conversation between those who make chemicals and those who use chemicals," said Daryl Ditz, senior policy adviser at the Center for International Environmental Law. "Chemical users are a lot less aware than chemical [manufacturers]. There are a lot of American companies that don't know a lot about REACH. For starters, they have to understand what chemicals they rely on."

Requiring companies to provide information on the chemicals and prove they are safe before they enter the marketplace is a dramatic shift from the way chemicals were regulated in Europe and continue to be regulated in the United States.

"It's reversing the burden of proof and shifting responsibility," Ditz said. "It's a more modern way of going about regulating companies."

Under the Toxic Substances Control Act (TSCA) -- the 1976 law governing roughly 82,700 chemicals in the United States -- the government must prove a chemical poses a health threat before it can act. However, it needs proof before it can require companies to provide more information about the chemical -- in what both Ditz and Denison called a Catch-22, or a situation in which regulators are given no good choice.

Because the burden of proof is so onerous for the United States' chief regulator, U.S. EPA, the agency relies on companies voluntarily giving information, Ditz said. While some companies have provided information, there is nothing to push them to do so, meaning the flow of information has been very slow.

Since TSCA was enacted 32 years ago, EPA has used it to evaluate the safety of 200 chemicals and banned five.

"It's not unrealistic to say that TSCA doesn't have any teeth," Ditz said. "REACH is the European answer to the same problem. EPA is more or less playing a game of 'pretty please,' asking chemical companies to please give them data. Unlike that, REACH is backed by the law."

Mike Walls, managing director with the American Chemistry Council, a trade group, disputed this evaluation of TSCA, saying he worries that U.S. policymakers are not sufficiently evaluating the positive and the negative aspects of REACH.

"It's unfortunate that there's this perception that REACH is now the gold standard in chemical regulation," Walls said. "EPA has a robust regulatory authority. We can do better in some cases, but that doesn't mean that chemicals are unregulated or that there are significant risks to human health in the environment that have gone unaddressed."

Walls pointed to a new program, the Chemical Assessment and Management Program, or ChAMP, under which EPA made the commitment to get risk- based decisions for all chemicals in commerce by 2012.

"ChAMP will allow U.S. EPA to reach risk-based priority assessments and prioritize EPA's priorities on chemicals in a way that REACH doesn't allow for," he said. "There's a recognition REACH is not the only game plan around."

Deadlines loom

In addition to requiring data on all industrial chemicals, REACH also establishes criteria for identifying "substances of very high concern," which include those known to be carcinogens, cause other health problems or persist in the environment. For these chemicals, companies will be required to apply for authorization, which would then allow them to manufacture the chemicals for specific purposes only.

One of REACH's biggest impacts will be on the amount of information it will make available to the public, Denison said. That should help promote better buying decisions on all levels, he said.

To meet the demands of providing extensive information, Dow has 23 teams gathering the data for the December deadline on as many as 10,000 chemicals, van het Hof said.

"There are definitely challenges for everybody involved in REACH -- companies, the government -- because everything is still really new," van het Hof said. "You have to find the right balance between keeping it a workable system and making sure that all things, like competitiveness and protecting companies' sensitive information, is all handled well."

Companies are venturing into new territory as they figure out how to meet these challenges, van het Hof said. One way is by forming consortiums for common chemicals so that they can be tested and registered just once.

"For us, it is [the] next step," he added. "We don't say it's all great, though, because it brings complexity and effort with it."

There are concerns about compliance at smaller companies, Walls said.

"Clearly, no one's going out of business tomorrow because of REACH," Walls said. "But those impacts are still ones that have to be watched for as REACH's full impact becomes known. Companies are having to make strategic business decisions in planning for REACH's implementation, and it can be harder for smaller companies to do that."

'Potential to drive market innovation'

As companies develop strategies to meet the REACH requirements, many are acknowledging that the far-reaching impact of Europe's law will also offer opportunities.

"We are implementing REACH as a global program across DuPont, and the impact of REACH will be varied and widespread," said Rick Straitman, a DuPont spokesman. "We see it as potential to drive market innovation. There are chemicals that may be restricted under REACH, and it'll provide the opportunity for a science company like DuPont to develop replacement products to satisfy market needs."

REACH's acceptance by major companies -- combined with Europe's push for the law despite resistance from the Bush administration and the U.S. chemical industry -- shows a changing global political climate, some say.

"The fact that Europe did this -- spent 10 years negotiating, passing it and implementing it -- is a powerful political message," Ditz said. "Congress, state governments are saying, 'Europeans did this; maybe we need to face the same problem set and come up with our own solution.'"

Individual U.S. states are considering banning individual chemicals, while several lawmakers have proposed legislation that would halt the sale of specific chemicals.

The "Kid Safe Chemical Act" offered by Sen. Frank Lautenberg (D-N.J.) last month is similar to REACH and would be the first effort to reform TSCA by requiring chemical manufacturers to provide health and safety information on chemicals used in products such as baby bottles and food wrappings instead of presuming a substance is safe until proven dangerous.

Because REACH's regulations are just starting to take effect and will continue to roll out over the next 10 years, observers caution against jumping to conclusions about the wide-reaching effects this law will have.

"Some of the aspects of REACH are still only on paper," said Environmental Defense Fund's Denison. "It's just beginning to be implemented, so it's a little premature to judge entirely what level of impact it will have. But all of [the] pieces are in place to have a very dramatic global impact."