dures for the ethical review of toxicant studies, before and after they are conducted.

Chapter 6 recommends a procedural framework for EPA’s implementation of the scientific and ethical principles described in earlier chapters, including the formation of a new review board within EPA. Chapter 7 provides the committee’s discussion of and recommendations for EPA’s use of human study results in risk assessment and in considering possible adjustments in the interspecies uncertainty factor.


Environmental Protection Agency (EPA). 1989. Risk Assessment Guidance for Superfund, Vol. 1: Human Health Evaluation Manual, Interim Final. EPA/540-1-89/002, December. Available at www.epa.gov/cgi-bin/claritgw?op-display&document=clserv:OSWER:1175;&rank=4&template=epa).

EPA. 2003. Human Testing; Advanced Notice of Proposed Rulemaking. Federal Register 68:24410-24416.

Environmental Working Group. 1998. The English Patients: Human Experiments and Pesticide Policy. Washington, D.C.: Environmental Working Group. Available at www.ewg.org/reports/english/English.pdf.

Gorovitz, S., and H. Robertson. 2000. Pesticide toxicity, human subjects, and the Environmental Protection Agency’s dilemma. Journal of Contemporary Health Law Policy 16(2):427-458.

McConnell, E. 2001. The value of human testing of pesticides. Human and Ecological Risk Assessment 7(6):1575-1581.

National Bioethics Advisory Commission (NBAC). 2001. Ethical and Policy Issues in Research Involving Human Participants: Vol. 1. Bethesda, MD: U.S. Government Printing Office.

National Research Council (NRC). 1983. Risk Assessment in the Federal Government: Managing the Process. Washington, D.C.: National Academy Press.

NRC. 1993. Pesticides in the Diets of Infants and Children. Washington, D.C.: National Academy Press.

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