Protections for Subjects in Human Research with Pesticides
All pesticide research using human subjects must meet our strict protective standards before we would consider using them in evaluating pesticides:
- We have strong standards and high ethical protections for adults who voluntarily participate in intentional exposure studies for pesticides.
- EPA's rules make it clear that all pregnant women, all nursing women, and all children are banned from all studies involving intentional exposure to pesticides.
Our regulation “Protections for Subjects in Human Research” was promulgated in 2006 and amended in 2013. The regulation is consistent with the recommendations of a 2004 National Academy of Sciences report and has been modeled primarily on EPA’s practice under the Federal Policy for the Protection of Human Subjects (the “Common Rule”).
Under EPA’s rule titled Protections for Subjects in Human Research, which was promulgated in February 2006, all third-party intentional dosing research on pesticides involving intentional exposure of pregnant or nursing women and children intended for submission to EPA is banned, and we will neither conduct nor support any intentional dosing studies that involve pregnant or nursing women or children for all substances EPA regulates. EPA’s rule provides high ethical protections to adult subjects who volunteer to participate in intentional exposure studies for pesticides.
EPA’s 2006 rule significantly strengthened and expanded the protections for participants in third-party research by:
- prohibiting new research involving intentional exposure of pregnant or nursing women or children intended for submission to EPA under the pesticide laws;
- extending the ethical protections in the Federal Policy for the Protection of Human Subjects of Research (the "Common Rule") to other human research involving intentional exposure of non-pregnant or non-nursing adults, intended for submission to EPA under the pesticide laws;
- establishing an independent Human Studies Review Board (HSRB) to obtain expert peer review of both third-party proposals for new research and completed intentional dosing research on which EPA may rely under the pesticide laws.
In addition, the rules:
- categorically prohibit any EPA-sponsored research involving intentional exposure of pregnant or nursing women or children to any environmental substance
- adapt regulations of the Department of Health and Human Services providing additional protections beyond those of the Common Rule to pregnant women and children as subjects in EPA observational research--i.e., research that does not involve intentional exposure to any substance
- adopt and implement the recommendations from a 2004 National Academy of Sciences report;
- have benefited from public comments; and
- adhere to the legislation passed by Congress in August 2005.
2013 Amendments to the Regulations
On February 8, 2013, we strengthened the standards for human research involving pesticides submitted by third parties for consideration in EPA decision-making. That is, the standards cover third parties, including pesticide companies and other research sponsors, who may want to submit to EPA human research involving pesticides.
See Protections for Subjects in Human Research Involving Pesticides, also available in docket number EPA-HQ-OPP-2010-0785.
- broaden the scope and applicability of the rule;
- further strengthen the standards for research to be considered in our decisions;
- clarify the approach used in the our science and ethics reviews of human research involving pesticides; and
- formally disallow participation in testing by subjects who cannot consent for themselves.
The amendments do not change the current Federal Policy for the Protection of Human Subjects (the “Common Rule”), which governs research with human subjects conducted or supported by the EPA and many other federal departments and agencies.
These amendments implement the recommendations contained in a 2004 report from the National Academy of Sciences (NAS) and satisfy our commitments under a 2010 settlement agreement with the Natural Resources Defense Council and other groups who challenged the 2006 rule.
These important changes are consistent with our commitment to:
- reliance on scientifically sound research that is ethically conducted; and
- transparency in our review processes and decision-making.