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February 20, 2013
Amendments address human testing complaint

As a result of a June 2010 settlement with environmental and agricultural worker groups, the EPA has issued new requirements governing the use of human subjects in pesticide testing.  The action revises a 2006 Agency action that generally prohibited the EPA from relying on third-party research on pesticides wherein children or pregnant or nursing women were exposed. 

But the 2006 rule allowed the Agency to use such research if it produced data crucial to a decision that “would impose a more stringent regulatory restriction that would improve protection of public health than could be justified without relying on the data.”  In the context of the rulemaking, the EPA defines third-party research as research neither conducted (first-party) nor supported (second-party) by the EPA or another federal agency.

‘Riddled with loopholes’

“Although the rule prohibits some kinds of testing and limits others, it is riddled with loopholes that undermine its effectiveness and ultimately encourage more human testing,” said the Natural Resources Defense Council (NRDC) in 2006.  “The rule also fails to ensure that pesticide testing on human subjects meets the strictest scientific and ethical standards recommended by a 2004 National Academy of Sciences (NAS) report and outlined in the Nuremberg Code after World War II.”  The NRDC was joined in the complaint by the Farm Labor Organizing Committee and the AFL-CIO, among other organizations. 

All environmental statutes

The final action is made up of  four amendments:

  • Broadens the applicability of 40 CFR Part 26 (Protection of Human Subjects), Subparts K, L, M, and Q, so these subparts would apply not only to research submitted to or considered by the EPA under the pesticide laws but also to research involving a pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)), which is submitted to or considered by the EPA under any other regulatory statute it administers.
  • By incorporating the definition of pesticide from FIFRA, as a substance or mixture of substances intended for pesticidal effect.
  • By deleting from 40 CFR Part 26, Subpart K, all references to consent on behalf of a subject in research involving intentional exposure to a pesticide by a subject’s “legally authorized representative.”
  • By incorporating into 40 CFR Part 26, Subparts K, L, M, and Q, factors to be considered by the EPA and the Human Studies Review Board (HSRB) in their review of proposed and completed human research, derived from the recommendations by the National Research Council of NAS in its 2004 report, titled Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues, to the EPA.

The proposed amendments were substantially consistent with the regulatory language negotiated with the petitioners, states the EPA.

“While the new standards do not completely ban human testing, they prohibit the EPA from considering pesticide tests conducted on pregnant women and children,” said the NRDC in a statement.  “They also protect people by ensuring that the EPA puts sound science first when determining whether a human study can be relied upon for setting human health standards.”

EPA’s final amendments were in the February 14, 2013 Federal Register.

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