EPA pesticide-testing rules don't protect the vulnerable, critics say.

After years of controversy over the ethics of exposing vulnerable populations to chemicals to assess their toxicity, the EPA has finalized rules establishing criteria for pesticide testing involving human subjects.

Published in January, the new rules say the agency will not consider data from studies that intentionally expose children or pregnant women to toxic chemicals. The rules establish an independent review board to assess all other studies on humans submitted with manufacturers' applications to market new pesticides.

Critics, including Sen. Barbara Boxer (D-Cal.), say the rules don't go far enough. For example, Boxer noted, results of tests on children and pregnant women could still be used if a pesticide maker could show that at the start of a study it had not planned to submit the results to the EPA.

"The fact that the EPA allows pesticide testing of any kind on the most vulnerable, including abused and neglected children, is simply astonishing," Boxer said in a news release.

Under the Clinton administration, the agency had a moratorium on using data from studies that involved human exposure. The Bush administration renewed that policy in 2001 and asked the National Academy of Sciences (NAS) to review the issue.

In February 2004, the NAS recommended ethical guidelines for what human-subject testing the EPA should consider and advised the agency to create an independent review board to evaluate all proposed chemical toxicity studies to ensure that they comply with the guidelines.

In the meantime, pesticide makers challenged the moratorium in court, and in June 2003, the District of Columbia Circuit Court invalidated the policy because it had not been implemented with the required notice and public comment period. (CropLife Am. v. EPA, 329 E3d 876 (D.C. Cir. 2003).) The agency said it would consider such data on a case-by-case basis until it finalized new rules.

Last summer, Boxer and Rep. Henry Waxman (D-Cal.) released a report showing that the EPA was reviewing data from at least two dozen tests conducted between 1967 and 2004 (most within the last decade) that intentionally exposed humans to toxic chemicals. They found that one-third of the tests were designed "specifically to cause harm to human test subjects" and that in many the informed consent was insufficient. Boxer said she was considering introducing a bill in the Senate to ban use of such data.

A few weeks later, reports of draft rules emerged, and many who obtained a copy criticized the rules for not following all the NAS recommendations: The rules did not establish an independent review board, and they allowed the agency to continue to accept some studies involving children and pregnant women as well as intentional testing on prisoners. Boxer called the rules "rife with industry-friendly loopholes, ethical lapses, and questionable scientific methods."

In late July, Congress passed the EPA appropriations bill, including an injunction against using data culled from experiments that expose humans to pesticides. President Bush signed the bill, which required the agency to adopt regulations that incorporated the NAS guidelines and the international Nuremberg Code and that banned using children and pregnant women as subjects.

A few weeks later, new draft rules surfaced that largely complied with Congress's mandate, including creation of a review board, but did not completely close the door on data from exposing children and pregnant women. Boxer again criticized the draft rules in a letter to the agency, saying they didn't go far enough. Other critics noted that loopholes could allow pesticide makers to conduct questionable tests if they were not trying to gauge toxicity.

In early September, yet another draft of the rules was announced, but no early copy was released before they were published for public comment on September 12. The agency said it had removed the weaknesses identified in the previous draft and strengthened protection for children and pregnant women, and that the rules would apply to several such studies already before the agency for review.

The September draft was published as the final version in January 2006. Boxer, Waxman, and Rep. Hilda Solis (D-Cal.) said the EPA still had not gone as far as Congress had ordered. The appropriations act instructed the agency to formulate a rule that would "not permit the use of pregnant women, infants, or children as subjects," but the final rule restricts only intentional exposure, they noted.

Susan Hazen of the EPA's Office of Prevention, Pesticides, and Toxic Substances called the new rules "groundbreaking," saying they will protect vulnerable populations from unnecessary exposure. The agency needs adequate data to evaluate new pesticides, particularly their potential health effects on children and infants, she said.

The National Institute for Occupational Safety and Health reported last summer that from 1998 to 2002, pesticides in or near schools sickened more than 2,500 children and school employees. The Environmental Working Group also released a study in July showing that hundreds of chemicals--including mercury, gasoline byproducts, and pesticides--pass to fetuses through the placenta. The researchers tested umbilical cord blood from 10 randomly selected babies born in U.S. hospitals in August and September 2004.

The new rule does not ban intentional-exposure studies on most adults who are willing volunteers, as long as those studies pass muster with the independent review board. The EPA said it expects to receive more such studies in the future. The final rule said the agency anticipates receiving at least 33 a year, even though it received only 20 such studies over the last 10 years.

A copy of the final rule is available at www.epa.gov/oppfeadl/guidance/ human-test.htm.