Chemical companies and scientific researchers would be prohibited from intentionally dosing children and pregnant women with pesticides under a new human testing regulation to be proposed today by the U.S. Environmental Protection Agency.
Limited tests using human subjects would be allowed, but only after they are subjected to new ethical standards and review by a panel of experts, EPA officials said.
The federal agency has struggled for years over how to regulate scientific tests that involve human beings exposed to pesticides, and earlier drafts of its proposal have come under fire from some influential members of Congress.
Human tests are often the most definitive way to determine the hazards of a substance, but they raise a host of ethical issues.
Jim Jones, director of the EPA’s Office of Pesticide Programs, said the agency is following the recommendations of a national panel of scientists, which concluded last year that some human testing is warranted, but only under close scrutiny. It is the first time any federal agency has set ethical standards for accepting or rejecting human data in scientific testing.
“We want to send the message clearly that certain kinds of human research can never be acceptable,” Jones said in an interview with four reporters on Tuesday. “We strongly discourage and hope to prevent the conduct of human studies that do not meet rigorous ethical and scientific standards.”
But the proposal, to be available for public comment for 90 days, is unlikely to satisfy critics in Congress, including Sen. Barbara Boxer, D-Calif., who lambasted a draft released a month ago as allowing too many loopholes. Last month, President Bush signed legislation adopted by Congress that bans the EPA from accepting pesticide data from human tests until a final rule is adopted.
Aides of Boxer and Rep. Henry A. Waxman, D-Calif., said Tuesday that the EPA refused to give a copy of the proposal to Congress, and they were dismayed that the agency briefed some reporters without revealing the written provisions so they could be scrutinized by congressional aides or the public.
“One thing is clear, it must be changed dramatically from the version EPA forwarded to (the Office of Management and Budget) just a few weeks ago. If not, it will still be a direct attack on our most vulnerable citizens,” Boxer said Tuesday. “A proposed rule on human pesticide testing that fails to protect children and families should be shelved immediately. A protective rule must be issued in its place.”
Said Waxman: “Without seeing the specifics, it is impossible to know whether this provides real protections to families or is simply their old policy with a new cover.”
Pesticide companies say that human tests are rare but sometimes are needed, such as when determining what amount of a chemical may irritate farm workers’ skin.
“We haven’t seen this proposed rule, but we believe it has the potential to establish ethical and scientific safeguards and uniform standards … ,” said Jay Vroom, president of CropLife America, which represents pesticide manufacturers. He said the companies support “protecting research volunteers and excluding vulnerable populations such as pregnant women and children.”
Under its proposal, the EPA would create a review board to analyze each study that involves intentional dosing of humans before it is conducted. Also, for the first time, the Common Rule – which sets ethical standards for federal agencies that conduct or fund human studies – would extend to all studies conducted by third parties, such as pesticide companies.
“This action will help ensure that people who volunteer … are treated ethically, with full disclosure as to potential risks, and with no harm to participants,” the EPA’s Jones said. “At present, third-party human research with pesticides is not required to undergo any external review. We don’t think that is wise.”
Scientists would be prohibited from intentionally dosing pregnant women and children and the EPA would be banned from accepting data from any such existing studies for review.
There is one exception, Jones said: EPA officials can use the data if it would lead to a stronger standard for a pesticide.
The EPA expects the new rule to be adopted in January.
