Lawmakers agreed late Tuesday to bar the Environmental Protection Agency from using data from experiments that expose human subjects to toxic chemicals until the agency establishes a new standard for evaluating pesticides based on such tests.
Environmentalists and industry officials both declared victory yesterday, saying the provision added to next year's Interior Department spending bill would encourage the Bush administration to devise a better policy for handling information culled from human testing.
The House and Senate earlier adopted language imposing a one-year moratorium on the use of human testing data, though the Senate also passed language allowing EPA to use the data as long as the studies met certain ethical standards and their benefits outweigh the risks to volunteers.
As a compromise, negotiators agreed to bar the agency from using the data until it establishes a comprehensive scientific and ethical standard for human pesticide testing. The provision directs EPA to finish the rule within 180 days and prohibits the use of pregnant women, infants or children as subjects. The agency will have to establish an independent scientific board to review the experiments, and the tests will have to conform with international standards.
Rep. Hilda L. Solis (D-Calif.), who had pushed for a one-year ban, said in an interview that the agreement represents "a small victory for us" and that "we'll certainly be watching to see what the EPA does." As for testing on pregnant women and infants, she added: "The moral of the story is that it's not acceptable."
Pesticide manufacturers said the provision would allow them to collect data they need when submitting federal applications to market their products.
"CropLife America believes the final agreement in the bill is a clear rejection of outright bans on using pesticide data from volunteer subjects," said Jay Vroom, president of the pesticide trade association. "Our industry is ethically bound to provide regulators the information they need to determine that our products are safe and beneficial."
For years, federal officials allowed manufacturers to conduct human experiments on the grounds they provided a clearer assessment of how pesticides could affect the environment and public health. Concerned that these tests were harming volunteers, President Bill Clinton imposed a moratorium in 1998, but President Bush lifted it in his first term. EPA officials now judge human pesticide studies on a case-by-case basis.
Last month, congressional Democrats released a report showing EPA was using data from tests that exposed volunteers to several poisons, including an insecticide used for chemical warfare in World War I and a pesticide closely related to the chemical that killed thousands in Bhopal, India.
Administration officials have resisted the idea of a one-year moratorium but said they could accept the new testing provision.
"This language makes it clear that Congress shares our commitment to good science and supports our efforts to expedite the first-ever EPA rule addressing the scientific and ethical issues in considering third-party human studies," agency spokeswoman Eryn Witcher said.