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Protections for Subjects in Human Subjects Research with Pesticides

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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.

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:

  1. prohibiting new research involving intentional exposure of pregnant or nursing women or children, intended for submission to EPA under the pesticide laws;
  2. 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;
  3. requiring submission to EPA of protocols and related information to ensure any future studies meet these high ethical safeguards; and
  4. 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:

  1. categorically prohibit any EPA-sponsored research involving intentional exposure of pregnant or nursing women or children to any environmental substance; and
  2. 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.

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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.

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Timeline

February 8, 2013 – EPA Administrator Lisa Jackson signed final rule for amendments to the 2006 rule.

February 2, 2011 - EPA published notice of proposed rulemaking in the Federal Register and opened a 60-day comment period.

January 18, 2011 - EPA Administrator Lisa Jackson signed a notice of proposed rulemaking for amendments to the 2006 rule.

June 16, 2010 - EPA settled litigation over its 2006 regulation that established protections for subjects of human research. Under the settlement, EPA agreed to propose amendments to the final human studies rule by January 2011.

August 22, 2006 - The direct final rule that bans nursing women from participating as subjects in intentional dosing research for pesticides became effective.

June 23, 2006 - EPA published a direct final rule and parallel notice of rulemaking to solicit public comment on banning nursing women from participating as subjects in intentional dosing research for pesticides. This action guarantees nursing women are not involved in human studies and provides protection to nursing infants who may also be exposed. EPA will not rely on data from previous studies that included nursing women. The new restrictions mirror the protections explicitly provided for studies involving pregnant women and children in the final rule issued by EPA in February 2006.

February 6, 2006 - All third-party intentional dosing research on pesticides involving children and pregnant women intended for submission to EPA is banned. EPA will neither conduct nor support any intentional dosing studies that involve pregnant women or children for all substances EPA regulates. These final rules also establish stringent enforceable ethical safeguards to protect individuals who volunteer to participate in third-party intentional dosing research.

September 2005 - EPA proposed and invited public comment on a rulemaking to ban intentional dosing human testing for pesticides when the subjects are pregnant women or children, 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.

August 2005 -The President signed into law the Department of Interior, Environment, and Related Agencies Appropriations Act, 2006, Pub. L. No. 109-54 (Appropriations Act), which provides appropriated funds for the Environmental Protection Agency and other Federal departments and agencies. Section 201 of the Appropriations Act addressed EPA activities regarding intentional dosing human toxicity studies for pesticides and discontinued reliance on third-party, intentional human dosing toxicity studies in its decision-making under the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Food, Drug, and Cosmetics Act until a final rule becomes effective. Section 201 states:

None of the funds made available by this Act may be used by the Administrator of the Environmental Protection Agency to accept, consider or rely on third-party intentional dosing human toxicity studies for pesticides, or to conduct intentional dosing human toxicity studies for pesticides until the Administrator issues a final rulemaking on this subject. The Administrator shall allow for a period of not less than 90 days for public comment on the Agency's proposed rule before issuing a final rule. Such rule shall not permit the use of pregnant women, infants or children as subjects; shall be consistent with the principles proposed in the 2004 report of the National Academy of Sciences on intentional human dosing and the principles of the Nuremberg Code with respect to human experimentation; and shall establish an independent Human Subjects Review Board. The final rule shall be issued no later than 180 days after enactment of this Act.

2004 - National Academy of Sciences publishes report titled, Intentional Human Dosing Studies for EPA Regulatory Purposes. EPA commissioned the study in 2001 to provide recommendations on whether and under what circumstances EPA should accept from third parties, and consider in its regulatory decision making, studies that involve the intentional dosing of human subjects.

June 2003 - The U.S. Court of Appeals for the District of Columbia Circuit ruled that EPA's interim approach announced in the December 2001 press release was not established through required notice and comment rulemaking and should be vacated. The court stated that, as a consequence, "the agency's previous practice of considering third-party human studies on a case-by-case basis, applying statutory requirements, the Common Rule, and high ethical standards as a guide, is reinstated and remains in effect unless and until it is replaced by a lawfully promulgated regulation."

May 2003 - EPA issued Human Studies: Advance Notice of Proposed Rulemaking (ANPR) to solicit comments. The ANPR proposed an approach to developing criteria and standards for deciding on whether to consider various types of human subject research.

March 2002 - The pesticide industry sued EPA over the approach described in the December 2001 press release.

December 2001 - EPA asked the National Academy of Sciences to advise the Agency on the many difficult scientific and ethical issues associated with the consideration of such human studies.

December 2001 - EPA issued a press release stating that, among other things, while the NAS studied the issue, third-party intentional dosing studies conducted for the purpose of identifying or quantifying toxic effects would not be considered or relied on by the Agency in its regulatory actions, unless consideration of such data were legally required or necessary to protect public health.

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