Safety assessments at a snail’s pace

After six years of deliberations, the US Environmental Protection Agency (EPA) today ended the public comment period on a longawaited cumulative risk assessment methodology for the organophosphate class of pesticides. But six years is far too long, and the whole process highlights inadequacies in the way the agency seeks and utilizes scientific counsel, contend some experts.

“The input sought and received from the scientific community has been far too narrow,” pesticide risk expert Charles Benbrook told BioMedNet News. “Only a handful of scientists have paid attention to this risk assessment.”

Benbrook, who submitted comments on Friday, directed a National Academy of Sciences committee to review stronger pesticide tolerances for food, in the late 1980s. Based partly on work by Benbrook’s committee, the 1996 Food Quality Protection Act (FPQA) requires the EPA to calculate the combined, or “cumulative,” effects of exposure to chemicals that have a common mechanism of toxicity, before it can set regulatory tolerances for those chemicals.

To assess risk, the EPA forms scientific advisory committees and invites a broad spectrum of experts from the academic, public interest, and industry communities to join them. All committee members are subject to federal laws regarding conflict of interest. The agency also tries to avoid people who have taken any public positions on an issue, says William Jordan, of the EPA’s Office of Pesticide Programs.

In the case of the widely-used organophosphates, known to interfere with the neurotransmitter acetylcholine, the methodology took six years to compile, totals nearly 3,000 pages, and is only the first of many the EPA will have to develop.

For most academic scientists, the “return on investment” on the work required by committees is simply inadequate, notes Routt Reigart, who has chaired the EPA’s Children’s Health Advisory Protection Committee for the last four years.

Being on a committee is time -intensive, says Reigart, a pediatrics professor at the Medical University of South Carolina. “If you take the time to advise EPA, you’re not doing what you are paid to do by your institution, which is to teach, write grants, conduct research.” A staff scientist for an industry group, in contrast, is “paid to sit on these panels and advise and lobby.”

The most frustrating aspect of the experience, Reigart told BioMedNet News, is that participants are often not informed of the outcomes, if any, of their advice. Being an advisory member is generally not highly valued in academic circles, he says, and many scientists feel they could spend their time in more rewarding ways.

The process is also “highly contentious and highly politicized,” said Benbrook, and it turns off many well-meaning scientists. “This is the wild, wild west of scientific dialogue,” he said. As a result, he adds, many advisory groups tend to be dominated by industry participants, because they have the most time to study the issues and prepare their expert commentary.

At the same time, the regulatory system must be based on sound science, points out Angelina Duggan of the American Crop Protection Association, an industry group that also submitted comments on the organophosphate risk assessment. If scientists “really believe that something is worth saying, or feel the need to set the record straight, then you owe it to the scientific community to participate,” just as if they would in an annual scientific meeting, she said.

“I wouldn’t disagree that the process can be political,” Duggan said. But while the process is not perfect, it’s “the best we have and need to work within it.”

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