EPA Criticized for Pesticide Testing Rules

Three California lawmakers have sharply criticized as inadequate a proposed regulation by the U.S. Environmental Protection Agency governing the use of human volunteers in pesticide experiments.

Democratic Reps. Hilda L. Solis of El Monte and Henry A. Waxman of Los Angeles and Democratic Sen. Barbara Boxer issued statements after jointly releasing a working draft of the EPA regulation. They said it would legitimize unethical and unsafe experiments that intentionally dosed humans, possibly including children, with pesticides, and that it contained “loopholes that would invite abuse” by pesticide manufacturers.

Boxer called the draft policy “quite troubling,” saying it lacked several safeguards recommended by a national panel of scientists and was “rife with industry-friendly loopholes, ethical lapses and questionable scientific method.”

EPA officials had expected to unveil the rule in August, and said the draft released Monday was not a final proposal and had not been reviewed by EPA Administrator Stephen L. Johnson or his top aides.

“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,” the agency said in a statement Monday.

The release of the draft comes as the Senate prepares to vote today on an amendment, written by Boxer, that would impose a one-year moratorium on the EPA accepting, considering or conducting tests in which people were intentionally dosed with pesticides. The same amendment, written by Solis and included in an appropriations bill, has already been approved by the House. It is opposed by the pesticide industry and the American Farm Bureau Federation.

Pesticide manufacturers say human studies are rare but can provide information critical to safety decisions and insights not available through animal testing, such as whether a chemical produces allergic skin reactions in people or what protective devices farmworkers should wear. Without human data, some standards for pesticides would be more lax than they are, said Patrick Donnelly, a vice president of CropLife America, a group representing pesticide companies.

Results of two dozen human experiments involving pesticides are being reviewed by the EPA -- most of them conducted outside of the United States. In contrast, thousands of tests have been conducted on laboratory animals.

The EPA, according to the draft of the regulation, would extend a protection called the Common Rule to all human experiments intended for EPA review, not just those conducted by the agency. The Common Rule sets ethical standards for federal agencies, requiring that the benefits of human testing outweigh the risks to the subjects and that all volunteers must be informed of the risks.

At issue is whether the EPA will adhere to recommendations made last year by a panel of the National Academy of Sciences, created at the behest of the agency. The panel said experiments in which people were dosed intentionally were valid if they addressed important regulatory questions and met stringent ethical considerations.

James F. Childress, co-chairman of the panel and director of the Institute for Practical Ethics at the University of Virginia in Charlottesville, said at the time that the “EPA should subject these studies to the highest level of scientific and ethical scrutiny.”

In the draft released Monday, the EPA proposed to reject a recommendation from the National Academy of Sciences to create a review board to consider each study before it was conducted. The EPA called the board unnecessary, saying the scientific institutions had their own ethics review boards and the agency had an official designated to review their work.

Solis, Waxman and Boxer were particularly critical that the EPA in its draft plan did not prohibit all testing of children.

“Its draft rule fails to meet the National Academy of Sciences’ most basic recommendations and further legitimizes the testing of pesticides on children and other vulnerable communities. Human testing is immoral and unethical, and it is our job to hold the Bush administration accountable for public health and safety,” said Solis, ranking member of the House Commerce subcommittee on environment and hazardous materials.

Under its proposal, the EPA would ban experiments on children when performed “for the purpose of identifying or quantifying a toxic effect.” In other cases, such as measuring children’s exposure during normal activities, the EPA could allow experiments.

For example, the EPA had planned this year to monitor children in Jacksonville, Fla., who lived in homes where pesticides were sprayed by licensed exterminators. EPA officials thought the project was ethical and safe because the pesticides were routinely used in millions of homes and because the testing would help determine the levels that children were exposed to. But the project was abandoned when environmental groups and some members of Congress protested.

Donnelly of the pesticide industry said it was “ludicrous” to ban experiments that simply monitored children during normal activities, and that politicians were mentioning children when criticizing the EPA’s proposed rule “for political gain only.”

The EPA typically doesn’t conduct pesticide tests, but uses information collected by others. Pesticide companies generally pay for tests and researchers at academic institutions conduct them.

The EPA said it “sometimes” encouraged research with human subjects, particularly in cases when a pesticide can irritate skin, to determine what level of exposure caused the irritation.

At UC San Diego from March 2002 to June 2004, 127 adult volunteers -- mostly students -- were exposed to a low-dose vapor of chloropicrin, a soil fumigant that is a strong irritant and which was used as tear gas during World War I. The experiment sought to determine at what levels the chemical was an irritant, which would help the EPA decide whether it should be allowed in agricultural fields near homes and businesses.