Final Amendments to EPA’s 2006 Rule Strengthen Protections
On February 8, 2013, EPA Administrator Lisa P. Jackson signed amendments strengthening existing standards for human research involving pesticides submitted by third parties for consideration in EPA decision-making. The amendments apply to the portions of EPA’s 2006 rule, Protections for Subjects in Human Research (40 CFR part 26), that cover third parties, including pesticide companies and other research sponsors, who may want to submit to EPA human research involving pesticides. The new amendments implement the recommendations from a 2004 report from the National Academy of Sciences (NAS) and satisfy EPA’s commitments under a 2010 settlement agreement with the Natural Resources Defense Council and other groups who challenged the 2006 rule.
The amendments broaden the scope and applicability of the rule, further strengthening the standards for research to be considered in EPA decisions; clarifying the approach used in the EPA’s science and ethics reviews of human research involving pesticides; and formally disallowing participation in testing by subjects who cannot consent for themselves.
The amendments do not make any changes to 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 important changes are consistent with EPA’s commitment to relying on scientifically sound research that is ethically conducted and to transparency in its review processes and decision-making.
The Final Rule published in the Federal Register on February 14, 2013.
EPA issued a press release on this topic on February 8, 2013.
Additionally, the EPA issued a memorandum to the Agency’s scientists reaffirming ethical considerations set forth in an agency document, “Scientific and Ethical Approaches for Observational Exposure Studies (SEAOES)” (PDF) (79 pp, 292K, about PDF). All research conducted and supported by the EPA that involves people as research participants must adhere to the principles in SEAOES. The agency also will amend its policy and procedures to ensure that SEAOES is incorporated during the review of study proposals. Additionally, SEAOES will be incorporated into the agency’s exposure assessment guidelines. These actions further strengthen the agency’s commitment to ethical, sound science.
On February 2, 2011, the EPA published a Federal Register notice announcing the proposal and seeking public comment.
EPA’s 2006 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 EPA 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. These final regulations 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.
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;
- requiring submission to EPA of protocols and related information to ensure any future studies meet these high ethical safeguards; and
- 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 on 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; and
- 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.
All Pregnant and Nursing Women and Children are Included in the Ban
EPA’s rules make it clear that all pregnant women, all nursing women, and all children are excluded from all studies for pesticides involving intentional exposure that are intended for submission to EPA.
Human Studies Review Board
In 2006, EPA established a new, independent Human Studies Review Board (HSRB) to provide independent advice and recommendations on issues related to the scientific and ethical review of research involving human subjects. The HSRB meets quarterly (as needed) to review research proposals and reports of completed research with human subjects submitted to the EPA for its review. For more information about the HSRB, visit: http://www.epa.gov/osa/hsrb/about.htm
Decrease in New Human Studies
Since implementing the 2006 rule, the EPA has received no proposals for new research involving pesticide toxicity or metabolism in human subjects. In fact, only two types of research proposals have been received since 2006: research measuring the effectiveness of skin-applied insect repellents, and research monitoring the occupational exposure of pesticide handlers as they mix, load or apply pesticides in agricultural and non-agricultural use scenarios. Close scrutiny by both the EPA and the Human Studies Review Board of proposals for new repellent performance testing and worker exposure studies has led to steady and substantial improvement both in the scientific design of these studies and in their provision for the ethical treatment of subjects.