December 10 - 11, 1998
Sheraton Crystal Hotel
1800 Jefferson Davis Highway
Arlington, VA 22202
OPP Docket Telephone: (703)305-5805
Thursday, December 10, 1998
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Introductions - Drs. Ernest E. McConnell and Mark Utell (Co-Chairs) |
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Administrative Procedures - Designated Federal Officials - Mr. Larry Dorsey and Mr. Samuel Rondberg |
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Opening Remarks - Dr. Lynn Goldman, Assistant Administrator, EPA Office of Pollution Prevention and Toxics |
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Presentation of the Common Rule - Dr. Gary Ellis, Director of the Office of Protection from Research Risks, National Institutes of Health |
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Discussion of the use of human data for risk assessment in a regulatory context - Dr. William Farland, Director, National Center for Environmental Assessment, Office of Research and Development, U.S. EPA |
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Identification of major issues - Mr. John Carley, Office of Pesticide Programs, Office of Prevention, Pesticides, and Toxic Substances |
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BREAK |
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Public Comment |
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LUNCH |
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Issue 1 - The Value of Human
Studies
What are the general arguments for the proper role
of human studies in supplementing animal studies in making
regulatory decisions about various environmental agents; e.g.,
water pollutants, air emissions, and pesticides? |
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Issue 2 - Factors for Consideration
The Agency is confronted with the question of how to determine what constitutes an appropriate human study for use in environmental decisionmaking. There are similarities and differences between the use of such studies in reaching decisions in other areas; e.g., drug licensing. In all cases, the Agency recognizes that the scientific benefits must at least be commensurate with the risks involved.
Dr. Meslin, Lead Discussant; Drs. Ellis, Gorovitz and Goebel, Associate Discussants |
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BREAK |
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Issue 3 - The Risks and Benefits
to Subjects and Society
The Agency is concerned that the best scientific information be brought to bear in making its decisions. At the same time, the Agency is concerned that the studies they require/rely on to make those decisions should meet rigorous ethical standards. Specifically, the risks to the study subjects should be commensurate to the benefits for them personally and for society as a whole.
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ADJOURN |
Friday, December 11, 1998
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Administrative Issues
- Co-Chairs and DFOs |
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Issue 4 - Application to
specific situations
The Agency must make judgments on a wide variety of studies involving humans. It would be helpful to have advice on how the guiding principles on human subject research and testing (i.e., the Common Rule and Declaration of Helsinki) might be applied to a given study in light of each of the following aspects of the study, particularly as they might apply in the case of studies submitted in support of a pesticide registration. Specific cases are:
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BREAK |
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Issue 5 - Compliance
Even if the Agency has appropriate ethical standards in place, there is the question of determining compliance with those standards. How can the Agency determine whether and to what extent its ethical standards have been met in a particular test with respect to the following aspects:
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LUNCH |
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Additional Public Comment (if Required) |
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General Discussion, focusing
on arriving at a Subcommittee Consensus for the various Issues.
Co-Chairs and Panel |
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BREAK |
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Writing Session for Subcommittee
Report Subcommittee |
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ADJOURN |