(Beyond Pesticides, October 21, 2010) Last week, the U.S. Environmental Protection Agency (EPA) announced that it has forwarded to the Secretary of Agriculture a draft proposed rule to amend EPAâ€™s protocol for the testing of pesticides on humans. This draft proposed rule is a result of a settlement agreement reached on June 2010 in a lawsuit over its 2006 final rule.
The 2006 final rule lifted a ban on human testing put in place by Congress. It allows experiments in which people are intentionally dosed with pesticides to assess the chemicalsâ€™ toxicity and allows EPA to use such experiment to set allowable exposure standards. In such experiments, people have been paid to eat or drink pesticides, to enter pesticide vapor â€śchambers,â€ť and to have pesticides sprayed into their eyes or rubbed onto their skin. The pesticide industry has used such experiments to argue for weaker regulation of harmful chemicals.
The coalition that challenged the regulation argued in the U.S. Court of Appeals for the Second Circuit that the rule ignores scientific criteria proposed by the National Academy of Sciences, did not prohibit testing on pregnant women and children, and even violated the most basic elements of the Nuremberg Code, including fully informed consent. The Nuremberg Code, a set of standards governing medical experiments on humans, was put in place after World War II following criminal medical experiments performed by Nazi doctors.
According to Bergeson & Campbell, P.C., the proposed rule is expected to closely follow the text that was included in the court settlement. It is unknown whether comments submitted on the proposed rule will lead to any significant revisions. EPA states in its Federal Register notice that the draft proposed amendments would â€śclarify the applicability of the rules to human testing for pesticides submitted to EPA under any statute, would disallow consent by a legally authorized representative of participants in pesticide studies who cannot consent for themselves, and would identify specific considerations to be addressed in EPA science and ethics reviews of proposed and completed human research for pesticides, based on the recommendations of the National Academy of Sciences and on the Nuremberg Code.â€ť
Human testing, which was stopped by a moratorium in 1998, was reintroduced in 2003 by a court ruling in a pesticide industry suit. Following the reintroduction of human studies, EPA began to develop a rule for such testing. This came despite flaws found in such studies, and took into account industry pressure to approve testing in children, among other allowances. EPA released its final rule in 2006, despite the Congressional report decrying human testing in 2005. At the time, committee member Rep. Henry Waxman stated, â€śWhat weâ€™ve found is that the human pesticide experiments that the Bush Administration intends to use to set federal pesticide policies are rife with ethical and scientific defects.â€ť
This draft proposed rule is required to be submitted to the Secretary of Agriculture at least 60 days before signing it for publication in the Federal Register under section 24(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The draft will not be available to the public until after EPA has signed it. The Secretary has 30 days to submit comments in writing which will be included on the public proposed rule along with any responses by EPA. Under this agreement, a proposed rule must be issued for public comment by January 2011.
Beyond Pesticides rejects human testing as unethical and dangerous to both test participants and agricultural workers exposed to toxic, approved pesticides. For more information on the timeline of human testing regulation, click here.