Archive for the ‘Human Subject Testing’ Category

The EPA’s Rules for Intentionally Dosing Human Test Subjects with Pesticides

On January 19th, 2011, the EPA published a proposed rule intended to strengthen protections for human test subjects in third-party studies. The proposed rule updates and “tightens” the existing regulations that govern the protection of human subjects, which are codified at 40 CFR Part 26.

Photo from af.mil. Some rights reserved.

This particular set of proposed changes was required under the terms of a 2006 settlement with the NRDC and other health advocates. The initial lawsuit was filed in response to the EPA final rule – published earlier that year – that makes up the current set of protections.

While the EPA had previously accepted such studies, in 2001 the EPA issued a press release stating that they would not consider or rely on “third-party intentional dosing human toxicity studies for pesticides” until the National Academy of Sciences provided them with ethical guidance on the topic.

However, shortly thereafter, the pesticide industry sued the EPA over the press release, arguing that its seemingly casual “interim policy” constituted a “binding regulation, […] which should not have been issued without notice of proposed rulemaking and opportunity for public comment.” The court agreed, and reinstated the EPA’s practice of considering, on a case-by-case basis, some third-party human studies.

Between 2002 and 2006 the EPA drafted, solicited comments on, and eventually finalized a rule that attempted 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.”

But this rule still left something to be desired, and NRDC et al. stepped in with their aforementioned lawsuit. According to the NRDC, the human testing rule, which generally prohibits pesticide testing on pregnant women and children, still “allows parents or other authority figures to allow pesticide testing on their children in some circumstances.” These “circumstantial” exceptions, NRDC argued, violated the 2006 Appropriations Act because they “did not bar all pesticide research with pregnant women and children.” Luckily the EPA’s recent proposed rule eliminates this “loophole.”

You may submit comments on the proposed rule within 60 days of its publication in the Federal Register, which is expected soon.

 

Pop Culture Trivia: The EPA, noticeably sensitive about the human subject testing regulations after so many lawsuits, found it necessary to post a response on their website after an episode of Law and Order: Special Victims Unit aired that depicted research involving pesticide testing and was “filled with factual inaccuracies.”

%d bloggers like this: