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From September 13, 2005                                                                                                           

EPA Rule Would Allow Human Pesticide Testing, Public Comments Requested
(Beyond Pesticides, September 13, 2005) On September 12, 2005, the Environmental Protection Agency (EPA) published in the Federal Register (70 FR 53838) its proposed rule for “Protections for Subjects in Human Research,” which will allow human testing of pesticides undergoing registration review. The rule, which amends 40 CFR Part 26, sets some restrictions on human pesticide testing, but still falls short of providing adequate protection, according to public health advocates, who point to a long list of loopholes in the rule.

“It has so many exceptions, it’s not an unvarnished advance,” said Jeff Ruch, executive director of Public Employees for Environmental Responsibility (PEER). “There are far more safeguards for similar studies for drugs and medicines to help people.”

Weighing in on the issue, a June 2005 congressional review of 22 human studies previously submitted to EPA show that human experiments violate ethical standards by deliberately exposing subjects to dangerous pesticides, many of which are suspected carcinogens and neurotoxicants. Additionally, the report found the studies also fail to obtain informed consent, used unethical liability waivers, lack scientific validity, dismiss adverse outcomes, and fail to conduct long-term medical monitoring. EPA’s proposed rule change is open for public comment until December 12, 2005.

EPA states the purpose of the rule is to “ban intentional dosing human testing for pesticides when the subjects are pregnant women or children, to formalize and further strengthen existing protections for subjects in human research conducted or supported by EPA, and to extend new protections to adult subjects in intentional dosing human studies for pesticides conducted by others who intend to submit the research to EPA.”

Upon preliminary review of the rule, Beyond Pesticides finds several weaknesses. Although pregnant women and children are provided additional protections under this rule, populations vulnerable to coercion or undue influence are not. For example, EPA has chosen to defer the proposal of additional protections for prisoners. The rule establishes an Independent Review Board to review proposed studies. The Board will approve a study “only if risks to subjects have been minimized and are reasonable in relation to anticipated benefits.” However, EPA does not evaluate pesticide benefits to determine whether there is a less toxic approach to managing a defined pest. According to ethicists, there must be a highly significant societal benefit to justify jeopardizing the health of individuals. Chemical companies carry out pesticide testing in order to provide data for EPA registration that justifies widespread human and environmental exposure. However, according to advocates, human testing of pesticides, which frequently have less-toxic equivalents, has no societal benefit.

Several legal maneuvers and committees have led up to the drafting of this rule, drawing wide criticism over the rulemaking process during the last several years. A moratorium had been put in place during the Clinton-era, but it was reversed in 2003 after a lawsuit brought by the pesticide industry. The Bush Administration flip-flopped on the issue, eventually deferring to the National Academy of Sciences (NAS). In 2004, an NAS panel concluded that human testing is ethical under certain conditions. Previous rulemaking attempts disregard NAS recommendations; did not meet international norms for human studies, such as the Nuremberg Code or the Helsinki Declaration; and prompted an internal EPA memo from toxicologists, physicians, and lawyers denouncing the established guidelines.

The Interior Appropriations Bill of 2006 requires EPA to submit a final version of the proposed rule that adheres to international ethical standards and NAS recommendations. A recent internal draft of the proposed rule fails to fulfill the congressional requirements, and drew the criticism of medical experts, Congress, environmental groups and EPA staff. The published draft of the rule continues to be criticized.

TAKE ACTION: Beyond Pesticides is working on materials to facilitate informed comments. Comments must be submitted by December 12, 2005 to the EPA (online or via email, Docket ID Number OPP-2003-0132) or to the Federal eRulemaking Portal (for more options see the proposed rule).