Expanded Protections for Subjects in Human Studies Research

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Under the new rules all third-party intentional dosing research on pesticides involving 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 is also extending new ethical protections to adult (non-pregnant, non-nursing) subjects involved in intentional dosing human studies for pesticides. Now such adult volunteers who choose to participate in this research will be protected by EPA's new, high ethical standards. These final regulations adopt and implement many of 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 rules, EPA 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 highest ethical safeguards; and
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 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 involving intentional exposure that are intended for submission under the pesticide laws.

Human Studies Review Board

In order to reach decisions on whether to rely on or reject a human study, the Agency is establishing a Human Studies Review Board (HSRB) to provide independent advice and recommendations to EPA on issues related to the scientific and ethical review of research involving human subjects. The HSRB will review completed human research relevant to pending pesticide reregistration, tolerance reassessment, and new registration decisions in accordance with the provisions in EPA's rules. Only after an external, rigorous review, including opportunities for public involvement, will EPA reach decisions on whether to rely or not rely on a human study.

Decrease in New Human Studies Expected

EPA expects its tougher new rules will decrease the number of systemic intentional dosing toxicity studies conducted for pesticides. Historically, EPA has received approximately 33 intentional dosing studies of ALL types annually. These include studies measuring worker exposure, studies of the efficacy of insect repellents, other studies designed to help assess exposure, and intentional dosing systemic toxicity studies. Of these 33 studies, only 4 a year on average involve intentional exposure of human subjects to measure minor, reversible systemic toxic effects. (Systemic effects are those that occur to organs within the body, such as effects on the nervous system that might cause, for example, tremors.) We expect the number of systemic toxicity studies to drop to as few as zero or one per year.

The sweeping requirements of EPA's rules will lay the groundwork and provide an important foundation for the Agency to build upon in future actions that may be determined necessary to provide further protections to public health.

Background on Human Testing

Over the years, scientific research with human subjects has provided much valuable information to help characterize and control risks to public health, but its use has also raised particular ethical concerns for the welfare of the human participants in such research, as well as scientific issues related to the role of such research in assessing risks.

Studies conducted by or supported by the Federal Government since 1991 must meet the ethical guidelines in the government-wide Common Rule (see EPA's 40 CFR 26 - Protection of Human Subjects). Studies conducted by third parties, including other governments or private industry/organizations, were not required to meet the Common Rule (although many do or adhere to other international ethical standards). In the final rule EPA has extended the Common Rule requirements to third-party research involving intentional exposure of non-pregnant, non-nursing adult human subjects, when the research is intended for submission to EPA under the pesticide laws. In addition, the rules forbid either EPA or covered third parties to conduct new research involving intentional exposure of children or pregnant women, and forbid EPA to consider any such research in its actions taken under the pesticide laws. More information about human studies. Various types of human studies have often been considered by program offices in their decisions (e.g., National Ambient Air Quality Standards, water quality criteria and drinking water standards, cleanup levels, and pesticide registration).

Timeline

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

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.

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 this approach, and the U.S. Court of Appeals for the District of Columbia Circuit ruled that 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 -- 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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