Risk Policy Report, April 24, 2007

NATIONAL ACADEMY PANEL IS URGED TO EMBRACE PRECAUTION

[Rachel's introduction: Last week, Nicholas Ashford of MIT and Amy Kyle of University of California, Berkeley, urged a panel of the National Academy of Sciences to recommend adoption of the precautionary principle.]

By Adam Sarvana

A National Academy of Sciences (NAS) panel charged with improving EPA's [U.S. Environmental Protection Agency's] risk assessment methodology is being encouraged to consider using the so-called precautionary principle in directing the agency's future risk assessments, which could be significant if it leads to NAS recommending that EPA develop European-style safeguards on bringing substances to market only after extensive information has been provided to regulators about their potential health risks.

The panel heard from several academic experts on risk assessment and toxicology at an April 17 meeting in Washington, DC. The experts also broadly backed a risk assessment approach that would involve more public input on assessing the risks to communities, rather than just individuals, of such things as the location of power plants and manufacturing facilities.

Nicholas Ashford, a professor at the Massachusetts Institute of Technology and a former chairman of the National Advisory Committee on Occupational Safety & Health, told the committee that regulators should not be afraid to follow the precautionary principle -- which says substances should not be allowed on the market until they are proved safe, shifting the burden from the regulator to industry.

Ashford also said officials should be willing to set stricter standards to control chemical, pesticide and other substances' risks to humans. Basing risk assessment and potential regulations on existing technologies, for instance, stifles innovation and ultimately harms the United States' economic competitiveness, he said.

"Thinking solutions are based on static technology is a mistake," especially when doing cost-benefit analysis of potential risk mitigation measures, he said at the meeting. "If you regulate beyond the capability of current technologies you get more innovation.... You can't separate scientists and engineers when you're regulating chemicals." Ashford encouraged the panel to consider advancements that have already occurred, such as when Dow silicone widely replaced polychlorinated biphenyls after the latter were found to be more harmful to human health than previously thought.

Setting sufficiently protective standards has become more difficult because of the need to justify every proposal economically, he argued, which can be difficult when innovations that would be spurred by a regulation cannot be accounted for. "We have lost so much courage because of cost-benefit analysis just because you can't guarantee you'll come up with a new and better technology, even though we always have in the past," he said.

Ultimately he urged the panel to prod the United States in the direction of the European Union, where strict new testing methods and the precautionary principle are the prevailing risk assessment and mitigation model. "Don't truncate analysis of risk to what's possible with current technologies," he said. "Look at Europe and find out what's happening."

Some experts at the meeting also stressed the need for EPA to expand its definition of risk assessment beyond measuring an individual's response to a given dose of a potentially harmful substance -- the currently prevailing risk assessment model at the agency. Instead, the experts said EPA's definition of risk assessment should encompass potential risks to whole communities.

"Risk assessment needs to be informed by a public problem paradigm, not just using the same [study] model every time," Amy Kyle, a professor at the University of California (UC) at Berkeley, said at the meeting. "The audience isn't just agencies" but includes the public being protected by regulations, she said, adding that such work could, for instance, "support decisions on safer, less toxic products" by communities as well as individuals.

She argued that "at the heart of this is the 'My way or the highway' attitude from the risk assessment community, the idea that if you don't do it my way nothing else you do is scientific. People in California communities have been told their concerns are unscientific because risk assessment doesn't show them. We need to reach a more accommodating way to address that."

NAS panel member Thomas McKone, also of UC Berkeley, asked Kyle whether EPA would be the right agency to do the kind of work she proposed. "I'm not saying EPA can do all of this," she responded, "but thinking about how to do it could be beneficial."

Ashford agreed with Kyle's assessment, saying, "When you talk to a community you tell them about risk assessment and uncertainty and so on and then someone [from the community] says, 'Does that plant need to be there? Does it need to do what it's doing the way it's doing it?' Well, that's an embarrassing question, and the answer is usually 'I don't know, I'm just a toxicologist.'"

More broadly, Ashford touted some state laws, such as in Massachusetts and New Jersey, as attractive alternative models to the federal Toxics Release Inventory, which mandates disclosure of emissions and discharges but does not set caps on permitted levels of harmful substances. "Under [those state] laws industry is asked the question, 'How can you do things differently?' Risk assessment is important but it's only part of the picture."

The panel is conducting an ongoing scientific and technical review of EPA's current risk analysis concepts and practices, and is expected to release a final report to the agency late next year. Kyle and Ashford addressed their remarks mainly to the panel's charge question from EPA of how to "identify priorities and approaches for research to obtain relevant data to increase the utility of risk analyses."