Manufacturers would be allowed to test some pesticides on human volunteers when seeking government approval without applying all the ethical safeguards recommended last year by an expert panel, under proposed rules soon to be issued by the Environmental Protection Agency.
The regulations, a copy of which was obtained yesterday by The Washington Post, represent the latest step in an ongoing battle over whether the EPA should use data from human tests of toxic chemicals when deciding whether to approve new pesticide products. The rules would omit some provisions urged by the National Academy of Sciences last year that would have imposed more stringent limits on such studies.
Policymakers have grappled for nearly a decade over whether to rely on human testing when considering pesticide applications. Manufacturers say these studies help gauge how their products affect consumers and the environment, while critics counter they unnecessarily expose vulnerable subjects to dangerous chemicals.
President Bill Clinton issued a moratorium on using such tests in 1998, but the Bush administration has revived the practice on a case-by-case basis while crafting the new standards.
By regulating third-party human pesticide testing for the first time, Bush officials are establishing new ground rules for one of the most contentious areas of federal regulation. Critics say the administration's proposal could prompt a flurry of new human studies, though industry officials say it won't.
Under the draft rule, the EPA could still accept some studies involving children, pregnant women and newborns, and it would not establish an independent ethics review board to scrutinize human studies on the grounds that this would "unnecessarily confine EPA's discretion." The agency would allow testing pesticides on humans to determine at what level they become toxic. This could include tests on prisoners even though they might be "vulnerable to coercion or undue influence," the draft rule states.
The National Academy had urged creation of a "Human Studies Review Board to address in an integrated way the scientific and ethical issues raised by such studies." It identified children as "a special case" because they can be swayed by adults and are often more vulnerable to toxic exposures, and proposed a national panel of scientists to judge whether they could be included in the tests. The Academy's report said prisoners should not be used as subjects if alternative volunteers could be found because inmates are less free to offer informed consent.
Philip J. Landrigan, a pediatrician who chairs the Community and Preventive Medicine Department at the Mount Sinai School of Medicine, said the EPA proposal marks "a step in the right direction" but falls short of fully protecting public health.
"I'm concerned that what EPA is proposing is basically a fig leaf," Landrigan said, noting that some rodent studies suggest that exposing young animals -- and by extension, children -- can harm their long-term behavior and intellectual development. "I don't know how you could possibly justify administering chemicals to a young child that could produce lifelong learning deficits."
EPA spokeswoman Eryn Witcher said the rule, which will be offered for public comment before it is finalized, marked significant progress.
"This EPA is taking the historic step of regulating, for the first time, scientific and ethical standards for accepting third-party human studies, and it's unfortunate that members of Congress have chosen to politicize this important issue and compromise an effective rule-making process," Witcher said.
CropLife America executive vice president Patrick Donnelly, an endocrinologist whose organization represents the biggest pesticide manufacturers, said the draft "is consistent with or more conservative than the National Academy of Sciences proposal."
Occasional human testing, Donnelly said, helps inform policymakers about the impact of pesticides. "When has less data been more beneficial to protect public health?" he asked.
The draft rules come at a time when lawmakers are preparing to vote on whether to bar the EPA from considering such tests altogether. The House approved a ban last month, and Sen. Barbara Boxer (D-Calif.) plans to offer a similar amendment today to EPA's annual spending bill.
Boxer said the draft rules were "quite troubling" because they would grandfather in studies that have already been submitted and only applied to tests that were conducted specifically in conjunction with pesticide applications. The National Academy suggested the independent review board scrutinize studies "regardless of the sponsor site or site of performance."
"EPA's plan is rife with industry-friendly loopholes, ethical lapses and questionable scientific methods," Boxer said yesterday.
EPA officials have been struggling with how to deal with data from human testing in the absence of an overall federal standard, though in some instances the studies may have resulted in more stringent rules on pesticide use.
In a Jan. 23, 2004, memo, an agency official wrote that tests conducted on the wood preservative methyl isothiocyanate, which was sprayed into some volunteers' eyes, showed "little concern for the safety or welfare of the research subjects. . . . Nonetheless I am aware of no barrier in current law or agency policy to your giving this study full consideration in your risk assessment."
The agency did rely on the study in the end, and it decided in August to make exposure limits for methyl isothiocyanate several times stricter than they had been.