EPA Announces Proposed Rules on Human Pesticide Studies

The Environmental Protection Agency on Tuesday announced proposed rules on human pesticide studies, the Washington Post reports. The rules, which will take effect next year after a 90-day public comment period, would prohibit human pesticide studies that involve children and pregnant women (Eilperin, Washington Post, 9/7). In addition, EPA in most cases could not accept data from human pesticide studies that involve pregnant women and children (Cone, Los Angeles Times, 9/7).

The rules also would require EPA to establish an independent Human Studies Review Board to review all studies that involve pesticides (Washington Post, 9/7). The rules would allow human pesticide studies that meet new ethical standards and receive approval from the board, EPA officials said. Under the rules, the Common Rule, which establishes ethical standards for federal agencies that conduct or fund human studies, for the first time would apply to all studies conducted by third parties, such as pesticide manufacturers.

Jim Jones, director of the Office of Pesticide Programs at EPA, said that the rules follow the recommendations of a national committee of scientists, which concluded last year that the agency should allow some human pesticide studies but implement restrictions on the research. "We want to send the message clearly that certain kinds of human research can never be acceptable," Jones said, adding, "We strongly discourage and hope to prevent the conduct of human studies that do not meet rigorous ethical and scientific standards" (Los Angeles Times, 9/7). Jones also said that EPA has decided to accept data from previous human pesticide studies because "an existing study cannot do things to get into compliance with" the proposed rules. EPA discussed the rules at a news conference on Tuesday but did not release them.

Jay Vroom, president of CropLife America, said, "We haven't seen this proposed rule, but we believe it has the potential to establish ethical and scientific safeguards and uniform standards to protect research subjects and improve the risk-assessment process."

However, several lawmakers raised concerns about the proposed rules. Sen. Barbara Boxer (D-Calif.) said, "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" (Washington Post, 9/7). She added, "It will still be a direct attack on our most vulnerable citizens."

Rep. Henry Waxman (D-Calif.) said, "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" (Los Angeles Times, 9/7).