Issue Date: October 1, 2007
Banding Together To Manage Chemicals
Summits among national leaders often involve discussions on the economy, trade, wars, scientific cooperation, or, increasingly, climate change. Commercial chemicals generally don't make the agenda.
But at the recent Security & Prosperity Partnership of North America Summit in Montebello, Quebec, the leaders of the U.S., Canada, and Mexico set a new precedent: They agreed to cooperate on the management of chemicals (C&EN, Aug. 27, page 29).
This endorsement by U.S. President George W. Bush, Canadian Prime Minister Stephen Harper, and Mexican President Felipe Calderón signals that chemicals management programs are starting to get attention at the highest level of government, says Michael P. Wilson, a researcher at the University of California, Berkeley, Center for Occupational & Environmental Health.
"It's quite a remarkable development," says Charles M. Auer, director of the U.S. Environmental Protection Agency's Office of Pollution Prevention & Toxics. The new partnership, he adds, sets in motion "a more common approach to data collection and assessment, sharing information where we can, and collaborating on assessments and actions where we can."
Under the agreement announced at the Aug. 21 summit, EPA will, by 2012, assess the hazards and risks and take any necessary action on more than 9,000 chemicals with U.S. production volumes of at least 25,000 lb per year. Mexico pledged to develop an information system for dangerous materials by 2012 and an inventory of chemicals in its domestic commerce by 2020. Canada, meanwhile, committed to completely assessing and taking regulatory action by 2012 on substances it has deemed pose the highest potential harm to health or the environment.
EPA is already working on toxicity assessments for more than 2,000 high-production-volume (HPV) chemicals, which are those substances produced in amounts of 1 million lb or more per year (C&EN, Sept. 17, page 10). The assessments use the basic data provided voluntarily by chemical manufacturers through the nine-year-old HPV Challenge Program launched by EPA, industry, and Environmental Defense.
For the 6,500-7,000 substances made in volumes between 25,000 and 1 million lb annually, EPA will use available toxicity information and structure-activity relationships in its assessments, Auer says. As its starting point for reviewing these so-called moderate-production-volume substances, EPA will use results from Canada's effort to categorize commercial chemicals for review, assessment, and control, he adds.
The government agencies Environment Canada and Health Canada recently completed a systematic review of the hazards of 23,000 commercial substances. The agencies selected 4,300 for further review due to human exposure concerns or because the chemicals are persistent, bioaccumulative, or inherently toxic (C&EN, Dec. 18, 2006, page 13). Canadian regulators are focusing initially on 470 of these substances that have the greatest potential for harm to health or the environment.
EPA has worked closely with Canadian regulators during this assessment, Auer says. The U.S. agency provided them with tools that use structure-activity relationships to predict a chemical's toxicity. EPA uses such tools when it reviews new commercial chemicals. In addition, the agency also provided the Canadian government with results of any toxicity studies it has on these compounds. Thus, EPA is "comfortable" using the Canadian results as starting points for assessment of moderate-volume chemicals, Auer tells C&EN.
For moderate-production-volume substances not covered by the Canadian effort, EPA will employ its tools to predict toxicity on the basis of structure-activity relationships. Auer acknowledges, however, that EPA doesn't expect to have much data on exposure to many moderate-production-volume chemicals, although exposure information is essential for characterizing risk from these compounds. For many of these substances, companies are not required to submit use and exposure data to the agency.
Canada and the U.S. may coordinate future efforts to obtain exposure and other information on some of these chemicals, Auer says. Gathering these data could involve new regulations as well as voluntary calls for information. EPA plans to develop more details about implementing the assessment program after meetings this fall with industry and other stakeholders, he adds.
The new chemicals management partnership is among Canada, Mexico, and the U.S., but it could foster data sharing with the European Union, Auer says.
EPA's assessments based on structure-activity relationships, Auer says, may be of value to companies preparing submissions to register their substances in the European Union under the new Registration, Evaluation & Authorization of Chemicals program. In turn, the results of toxicity tests that companies conduct to comply with REACH—and made public by the EU—may also supply information that EPA will use in its assessments.
Chemical industry trade group representatives, environmental advocates, and academicians agree on one point about the new trilateral partnership: It isn't North America's answer to REACH. If anything, they say, it is a response to Canada's success in assessing thousands of commercial chemicals.
More important, says Ernie Rosenberg, president of the Soap & Detergent Association, "it's a response to the need to have a North American chemicals program that is harmonized to the degree possible among the three countries and that produces results that will be evident to the critics of current regulation."
By cooperating, says William E. Allmond IV, director of government relations for the Synthetic Organic Chemical Manufacturers Association, the U.S. and Canada are demonstrating to Mexico how successful their regulatory approaches on chemicals are.
The American Chemistry Council (ACC), meanwhile, sees the North American partnership as laying out an effective chemicals management policy that contrasts with the EU approach, says Michael P. Walls, the trade group's managing director of regulatory and technical affairs. The chemical industry trade group has been a stern critic of REACH.
The North American effort "gets to a result similar to that of REACH but far faster," Walls says.
The EU policy, he argues, denies market access to chemicals unless their producer or importer provides toxicity data on the substances. The North American partnership, on the other hand, underscores the need for scientific information before regulators determine whether or how to control a chemical, he says.
ACC hopes the new collaboration among the North American governments on chemicals will spur similar partnerships around the world, Walls says, including the Pacific Rim nations. The joint statement on chemicals management from Bush, Calderón, and Harper says: "While our focus today is on our region, our cooperation can also help us convey more coordinated views on practical approaches to the development and promotion of chemical assessment and management efforts consistent with ours."
The trilateral cooperation could also influence California's Green Chemistry Initiative, Walls says. Launched by California EPA Secretary Linda S. Adams in May, the initiative is tasked to produce recommendations for the state to evaluate the risk of and reduce exposure to chemicals, to encourage use of less toxic industrial processes, and to identify safer alternatives to hazardous substances.
California recognizes Canada's effort on categorizing chemicals for review, assessment, and management as "innovative," says Susie Wong, spokeswoman for the initiative. "We look forward to drawing on their experience as well as on other examples in developing green chemical policy in California," she tells C&EN.
Some who are calling for reform of the U.S. regulatory system for commercial chemicals rate the EPA goals set out in the North American leaders' announcement as a good first step, but a small one. Joel A. Tickner, assistant professor at the University of Massachusetts, Lowell, Center for Sustainable Production, says it is "not a very innovative initiative." EPA could have applied its toxicity-predicting tools based on structure-activity relationship to chemicals in commerce years ago, he says.
Richard Denison, senior scientist with Environmental Defense, says the announcement by the North American leaders does not spell out whether or how regulators would require further testing of chemicals or regulate any health or environmental risks they find through their assessments. Under current law, EPA must amass significant scientific information, conduct extensive cost-benefit studies, and build a tight legal case before it can regulate chemicals, Denison notes.
UC Berkeley's Wilson contends that "the market isn't working right because companies aren't motivated to generate hazard information and provide it to buyers." Providing this kind of data is, under the current U.S. system, seen as a liability in the marketplace, he points out. Yet many companies that use chemicals—notably those that promote green chemistries—need and want governments to help them decide which substances to purchase, he says.
Government, Tickner says, should provide indicators—such as comparable data on the aquatic toxicity of substances—that companies can weigh in their chemical and product purchasing decisions. According to Wilson, this would help buyers of chemicals evaluate the hazardous properties of chemicals along with function, price, and performance of substances.
The new North American initiative represents one of many steps needed for modernizing policies on chemicals, Wilson notes, adding that "I hope it's the beginning of something substantial."
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