WASHINGTON – The Environmental Protection Agency for the first time is establishing criteria for tests by pesticide makers on human subjects.
Susan Hazen, the EPA's principal deputy assistant administrator for the Office of Prevention, Pesticides and Toxic Substances, said Monday the new rule for accepting tests won't allow "intentional pesticide dosing studies of children and pregnant women."
Last year, President Bush signed a ban on the use of human pesticide test data until the EPA created regulations for accepting them. The agency also was required to ban the use of pregnant women and children as subjects, and to incorporate ethical guidelines from the National Academy of Sciences and the post-World War II Nuremberg Code.
"We have met and exceeded Congress' direction," Hazen said Monday.
A copy of the EPA's final draft, prepared within the past two weeks, was reviewed by The Associated Press.
Three California Democrats, Sen. Barbara Boxer and Reps. Henry Waxman and Hilda Solis, denounced the new rule after obtaining a copy of the final draft. They had led the effort in Congress to require that the EPA outlaw the use of pregnant women and children as subjects and that it meet high ethical standards.
"The fact that EPA allows pesticide testing of any kind on the most vulnerable, including abused and neglected children, is simply astonishing," Boxer said.
She said the EPA rule is inconsistent with what Congress ordered. She said manufacturers could still conduct testing on pregnant women and children as long as they could convince the EPA that the researchers didn't intend to submit the results to the agency at the outset of the study.
Hazen said, however, that the only exception to the ban on accepting data, including that from pregnant women and children, involves cases in which the EPA becomes aware that it might need to take additional measures to protect public health.
However, she noted, "No pesticide company in the U.S. or in most countries would invest money in developing data to try and prove that EPA should regulate them more stringently."
The EPA expects a substantial increase in the number of tests it receives involving intentional exposure of humans to pesticides. The draft final rule said the agency anticipates receiving 33 such reports a year.
In the last 10 years, only about 20 such studies have been submitted to the EPA, the agency says. Hazen, however, said those studies include ones from the 1940s to recent years.
The new criteria for accepting the tests come after a long fight.
Toward the end of the Clinton administration, the EPA briefly stopped accepting industry data from pesticide experiments on humans. But the agency resumed considering that data after Bush took office in January 2001.
Then, in a lawsuit brought by the pesticide industry, the U.S. Court of Appeals for the District of Columbia ruled in 2003 that the EPA cannot refuse to consider data from manufacturer-sponsored human exposure tests until it develops regulations on them.
Agency officials said last November that in the meantime it would consider each study on a case-by-case basis. But Congress stepped in last year to impose a moratorium after Boxer and Sen. Bill Nelson, D-Fla., demanded that the EPA cancel an industry-backed pesticide study in which the families of 60 children in Duval County, Fla., would receive children's clothes, a camcorder and $970 for participating.