The EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following:
In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studies–both at the beginning and upon completion of the experiments–if they are carried out with the intent of affecting the agency's policy-making.
Table of Contents
|Executive Summary and Recommendations||1-20|
|1 Introduction and Background||21-45|
|2 The Regulatory Framework for Protecting Humans in Research||46-65|
|3 Scientific Justification for and Conduct of Intentional Human Dosing Studies||66-83|
|4 A Risk-Benefit Framework for Assessing Intentional Human Dosing Studies||84-109|
|5 Ethical Considerations in the Review of Intentional Human Dosing Studies||110-131|
|6 Procedures for EPA Review of Intentional Human Dosing Studies||132-143|
|7 EPA's Use of Data from Intentional Human Dosing Studies in Risk Assessment||144-158|
|Appendix A: Values and Limitations of Animal Toxicity Data||159-167|
|Appendix B: Pharmacokinetics and Metabolism of Pesticides||168-172|
|Appendix C: Biographical Sketches of the Members and Staff of the Committee on the Use of Third Party Toxicity Research with Human Research Participants||173-184|
|Appendix D: Biographical Sketches of the Members of the Science, Technology, and Law Panel||185-191|
|Appendix E: Meeting Agendas||192-200|
|Appendix F: Combined Registrants List for All Meetings||201-208|
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