Reinterpreting a code of ethics can lead to a slippery slope, and in January the Environmental Protection Agency became the latest downhill skier. After World War II and its medical “experiments,” signatories to the Nuremberg Code pledged not to conduct studies on those who could be harmed by the research and/or those who could not give consent. The Congress of the United States directed the EPA to follow the Nuremberg Code, which meant that deliberate human studies could not be considered by the agency in setting pesticide toxicity levels.
But consideration of such studies might soon become possible if a new rule by the EPA is allowed to stand. The change, which became law in late January, would allow the EPA to consider studies in which humans are deliberately exposed. Why? So the EPA might change its standards of how much pesticide exposure is too much for human health; the pesticide industry has long fought EPA guidelines for use and exposure, believing the agency’s figures are too conservative.
The EPA emphasizes that the new rule prohibits studies on pregnant women and children and sets up a review board to determine whether future studies meet the new guidelines. But critics say that the law has loopholes that would encourage more testing of non-pregnant adults. “The new rule explains under what circumstances [the EPA] would accept studies on humans. Previously, they didn’t accept such reports at all,” says Brian Hill, staff scientist at Pesticide Action Network North America (PANNA). “We believe this violates what Congress has told them to do, so our only recourse at the federal level is to sue, and we might also seek stronger state protections as well.”
Watchdog groups also protested. “The guidelines do not prohibit [using data from] pesticide experiments with children who are in orphanages, foster care, or have handicaps,” says Michael Susko of Citizens for Responsible Care and Research, “and [they] also appear to allow for third-party data which may be acquired from third-world studies that may not follow ethical practices. The use of such studies can make us complicit in such practices.”
At least 22 studies previously submitted to the EPA that had been barred from consideration during past administrations stand to gain acceptance under the new rule.
In one of these studies, people were instructed to take pesticides with their morning orange juice, according to a recent report by Senator Barbara Boxer (D-CA) and Congressmember Henry Waxman (D-CA), who oppose the new rule. In another such experiment, students and other healthy young adults were enclosed in a room and gassed with a chloropicrin—an active ingredient in tear gas—for an hour at a time over four consecutive days. Several environmental organizations expect to mount legal challenges this March.
Critics of the rule say that part of what’s driving the issue is the use of “the interspecies rule of ten,” which is used to translate the results of animal studies into thresholds for pesticides in humans. A standard routinely used in toxicity calculations, it starts with the level at which animals experience toxic effects then multiplies that level by a “safety factor” of ten to convert animal exposure levels to allowable human exposure levels.
Next, researchers must multiply by another factor of ten (called the “intraspecies factor”) to account for the fact that even among human beings, people differ in how much of a pesticide they can tolerate. For example, asthmatics are often more sensitive to inhaled chemicals than the general population.
Finally, the Food Protection Act of 1996, which only recently has begun affecting the EPA’s decision-making, requires another safety factor of ten to account for the fact that children are often more sensitive to chemical exposures because of their size and continuing development.
“When you’re basing your testing on animals, you’re talking about a safety factor of 1,000. This drives the pesticide companies nuts,” says Jan Hasselman, an attorney at Earthjustice. He adds that by testing pesticides in humans, pesticide manufacturers could argue for exposure levels that are up to ten times less stringent than today’s, because they wouldn’t have to use the interspecies factor in their toxicity calculations.
Critics of the new regulations also worry that chemical companies might rush to start new pesticide studies unfettered even by what they consider loophole-ridden rules, because the current EPA rule holds that any studies begun before April don’t even have to satisfy the new guidelines to be considered admissible.
“Any study started before April 7 is considered an existing study,” says Hasselman. “There’s an incentive for pesticide manufacturers to go out tomorrow and start their studies,” he adds. “And with the EPA clearing up uncertainty with a rule like this that has big loopholes, the pesticide manufacturers will increase their reliance on human testing,” says Hasselman.
The rule’s opponents are also quick to add that they are not against studies that look at incidental pesticide exposure to populations living and working near places that are sprayed, as long as the studies are carried out ethically. PANNA’s communications director Stephenie Hendricks is careful to point out that such studies, carried out properly, could help people regularly exposed to pesticides, such as farm workers and people living in rural areas. But, as Earthjustice’s Hasselman puts it, “That’s a far cry from paying someone to spray pesticide in their eyes.”
MAKING CONTACT:
http://www.epa.gov/oppfead1/guidance/human-test.htm
http://www.panna.org/resources/humanTesting.html
