Issue Date: March 12, 2012
Learning From Europe
Chemical industry groups have repeatedly told Congress they don’t want the European Union’s chemical regulation law used as a model for updating the U.S. Toxic Substances Control Act (TSCA). That EU law—the Registration, Evaluation, Authorization & Restriction of Chemical substances (REACH) program—took effect in 2006.
Now, researchers at Indiana University are suggesting what might make the chemical industry cringe: The U.S. could modernize TSCA, which dates to 1976, by adopting a modified version of REACH. “It is unlikely that the REACH program will be adopted wholesale in the U.S.,” a recent report by those researchers acknowledges up front. But, they say, a simplified version of REACH could work well in the U.S.
“Our interest is in the extent to which the European experience implementing this complicated and innovative piece of legislation can inform efforts to revise TSCA,” says Lois R. Wise, coauthor of the report and director of the university’s European Union Center and West European Studies Center.
“Some aspects of REACH are innovative and promising, while others are overly burdensome and complicated,” says John D. Graham, dean of the university’s School of Public & Environmental Affairs and a coauthor of the report. Graham served as the White House’s regulatory gatekeeper under President George W. Bush.
The report suggests that Congress consider a streamlined version of REACH to replace TSCA. An example of this sort of simplification, the report says, is constraining the number commercial chemicals subject to formal registration. REACH focuses strongly on the production volume of each manufacturer as well as a chemical’s hazards. But instead of these criteria, the report says, “industry-wide production volume is more relevant to overall risk than volume manufactured or imported by any specific company.”
One problem with REACH, the report notes, is that it lacks a coherent and consistent definition of safety, which has created many implementation problems. As Congress rewrites TSCA, lawmakers may find it easier to reach consensus by remaining silent on this issue. But to avoid the problems the EU is facing, the report says it is critical that legislators clearly establish what “safe” means.
The report also cautions against adoption of REACH’s proprietary treatment for important safety data about chemicals. More data on a substance’s safety need to be public than is allowed under the EU system, the report states, citing the public’s right to know about chemicals in the marketplace. Widespread availability of hazard and exposure information could prompt the private sector to adopt safety measures and substitution of safer substances, lessening the need for the government to regulate chemicals, it says.
In response, the American Chemistry Council, a chemical industry organization, said in a statement that “while there are very valuable lessons to be learned from Europe, the Indiana University report is clear that simply adopting REACH in the United States is not the answer for modifications to TSCA.”
In conjunction with release of the report, Indiana University held a briefing in Washington, D.C., on March 2 about TSCA and the EU’s experiences thus far with REACH.
At that briefing, Richard A. Denison, senior scientist with the Environmental Defense Fund, noted that the U.S. Environmental Protection Agency’s regulatory program on chemicals will benefit from REACH regardless of the status of TSCA reform. The information that the EU is requiring companies to provide about their chemicals’ hazards and use is being distributed around the world by chemical companies or via the European Chemical Agency (ECHA).
In fact, Wendy Cleland-Hamnett, director of EPA’s Office of Pollution, Prevention & Toxics, told those attending the briefing that the agency has approached ECHA about sharing chemical information not covered by confidentiality claims. She said that the U.S. agency may also ask companies doing business both in the U.S. and the EU to share with EPA some of the information they provided under REACH. Additionally, she noted, EPA may seek such information from businesses as it conducts risk assessments of specific chemicals. The agency may ask companies to provide this information voluntarily or may issue regulations requiring chemical manufacturers to provide it, she added.
But businesses may not be free to share the information they provided under REACH, said Anna Gergely, the Brussels-based director of European environment, health, and safety at the law firm Steptoe & Johnson. Under REACH, many companies manufacturing the same chemicals formed coalitions called Substance Information Exchange Forums to share the cost of generating data needed to register their products in the EU. Many legal contracts governing these coalitions specify that the participating companies will share the data only for REACH registration, Gergely said at the briefing.
ECHA’s ability to share data claimed as confidential business information is complicated, Eva Sandberg, senior scientific officer for the EU agency, told C&EN. Even if ECHA and EPA struck an agreement on protection of propriety data, the European agency would need further approval from the EU before it could actually provide the U.S. agency access to the information, she said.
Meanwhile, companies’ generation and compilation of data for REACH registration is leading the private sector to make better business decisions, Denison asserted. For example, companies are forgoing the use of some risky substances or putting in place better protective measures for others, just as the Indiana University report suggests, Denison said. However, it is too early to tell whether implementation of REACH will boost the public’s confidence in commercial chemicals or improve human health and the environment, he added.
Nonetheless, the idea of using REACH as a model for TSCA reform is a stretch, said Mark A. Greenwood, partner at the Ropes & Gray law firm, at the briefing. Foremost, it is inconceivable that today’s partisan, polarized Congress would consider REACH as a model for TSCA reform, said Greenwood, who directed EPA’s Office of Pollution Prevention & Toxics, which implements TSCA, from 1990 to 1994.
In addition to politics, REACH couldn’t work in the U.S. for practical reasons, Greenwood said. EPA’s already small TSCA program lacks the resources to handle an avalanche of chemical data like those required from companies under REACH, he said. As the U.S. government tightens its budget, it’s unlikely that Congress would expand this program, he pointed out.
The Indiana University report is available at indiana.edu/~spea/faculty/pdf/REACH_report.pdf.
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