lic health or environmental benefits, the committee concludes that such studies that pose no identifiable risk to study participants or that present a reasonable certainty of no harm, based on a careful review of an adequate body of scientific evidence, can be justified under restricted conditions and with appropriate oversight and review regardless of whether the information obtained from the study results in a less stringent or more stringent regulatory outcome.

The committee determined that the analysis and conclusions presented in this chapter could clarify some issues regarding the use of studies that deliberately expose participants to toxicants for EPA regulatory decision making purposes, but it does not pretend to resolve here all of the nettlesome issues that arise from intentional human dosing studies. These ultimately must be resolved through EPA’s publicly transparent policy deliberations and through the case-by-case decisions of duly constituted review bodies charged with protecting the interests of participants in particular studies.

REFERENCES

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

EPA. 1991. Strategic Direction for the U.S. Environmental Protection Agency.

EPA. 1992. Safeguarding the Future: Credible Science, Credible Decisions. EPA/600-9-91-050.

EPA. 1993. Reference Dose (RfD): Description and Use in Health Risk Assessments, § 1.3.2.2.1. Background document. Available at www.epa.gov/IRIS/rfd.htm.

EPA. 1994. Peer Review and Peer Involvement at the U.S. Environmental Protection Agency. Available at www.epa.gov/osp/spc/perevmem.htm.

EPA. 1996. Proposed Guidelines for Carcinogen Risk Assessment. Federal Register 61:17960, 17964.

EPA. 1998a. Draft Water Quality Criteria Methodology Revisions: Human Health; Notice. Federal Register 63(157):43755-43828.

EPA. 1998b. Guidelines for Neurotoxicity Risk Assessment. Federal Register 63(93):26926-26954.

EPA. 2000. Comments on the Use of Data from the Testing of Human Subjects: A Report by the Science Advisory Board and the FIFRA Scientific Advisory Panel. EPA-SAB-EC-00-017. Washington, D.C.: EPA. Available at HtmlResAnchor www.epa.gov/science1/pdf/ec0017.pdf.


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 Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission). 1979. Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, D.C.: 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. 1994. Science and Judgment in Risk Assessment. Washington, D.C.: National Academy Press.



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