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Expanded Protections for Subjects in Human Research Involving Pesticides

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Proposed Amendments to the 2006 Rule

On January 19, 2011, the EPA announced proposed amendments to its 2006 human research protections rule. The proposed amendments reflect the EPA’s commitment to scientifically sound and ethically conducted research. The amendments, if finalized, would strengthen the protections provided by the 2006 rule by broadening the scope of the rule, disallowing participation by subjects who cannot consent for themselves, and identifying specific considerations to be addressed in EPA science and ethics reviews of proposed and completed human research with pesticides.

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.

2006 Rule for Human Research Involving Pesticides

Under the current rule (implemented in 2006), all third-party intentional dosing research on pesticides involving pregnant or nursing women and children intended for submission to the EPA is banned, and the EPA will neither conduct nor support any intentional dosing studies that involve pregnant or nursing women or children. The 2006 rule also extended high ethical protections to adult (non-pregnant, non-nursing) subjects involved in intentional dosing human studies for pesticides. These regulations are consistent with the recommendations from the National Academy of Sciences, have benefited from public comments, and adhere to the legislation passed by Congress in August 2005. In its final rule, the EPA 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 the 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 the EPA under the pesticide laws;
  3. requiring submission to the EPA of protocols and related information to ensure any future studies meet these highest ethical safeguards; and
  4. establishing an independent Human Studies Review Board (HSRB) to obtain expert peer review of both proposals for new research and completed third-party intentional dosing research on which the EPA may rely on under the pesticide laws.

In addition, the rules:

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Ban Protects Children and Pregnant and Nursing Women

The EPA's rule makes it clear that all children, all pregnant women, and all nursing women are excluded from all studies involving intentional exposure to a pesticide.

Human Studies Review Board

To inform its decisions on whether to rely on or reject a human study, the agency has established a Human Studies Review Board (HSRB) to provide independent advice and recommendations to the EPA on issues related to the scientific and ethical review of research involving human subjects. The HSRB reviews research proposals and reports of completed research with human subjects submitted to the EPA for its review in connection with pending pesticide reregistration, tolerance reassessment, and new registration decisions. Only after an external, rigorous review, including opportunities for public involvement, will the EPA reach decisions on whether to rely or not rely on a human study.

Decrease in New Human Studies Expected

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

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

June 16, 2010 – The EPA settled litigation over its 2006 regulation that established protections for subjects of human research. Under the settlement, the EPA agreed to propose amendments to the final human studies rule by January 18, 2011.

August 22, 2006 -- The direct final rule that banned nursing women from participating as subjects in intentional dosing research for pesticides became effective. The parallel notice of proposed rulemaking solicited public comments through July 24, 2006. Since no adverse comments were received, the direct final rule became effective August 22, 2006.

June 23, 2006 – The 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. The 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 the EPA in February 2006.

February 6, 2006 -- All third-party intentional dosing research on pesticides involving children and pregnant women intended for submission to the EPA is banned. The 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 – The 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 the 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 the 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 the 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 became effective. Section 201 stated:

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.

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 the EPA over the policy articulated in the December 2001 press release, and the U.S. Court of Appeals for the District of Columbia Circuit ruled that the EPA's interim approach was not established through required notice and comment rulemaking and should be vacated. In a June 2003 decision, 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."

December 2001 – The 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 – The 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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