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December 10 - 11, 1998

Sheraton Crystal Hotel
1800 Jefferson Davis Highway
Arlington, VA 22202
OPP Docket Telephone: (703)305-5805

Thursday, December 10, 1998

  • 8:30  AM
Introductions - Drs. Ernest E. McConnell and Mark Utell (Co-Chairs)
  • 8:40  AM
Administrative Procedures - Designated Federal Officials - Mr. Larry Dorsey and Mr. Samuel Rondberg
  • 8:45  AM
Opening Remarks - Dr. Lynn Goldman, Assistant Administrator, EPA Office of Pollution Prevention and Toxics
  • 9:00  AM
Presentation of the Common Rule - Dr. Gary Ellis, Director of the Office of Protection from Research Risks, National Institutes of Health
  • 9:30  AM
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
  • 10:00 AM
Identification of major issues - Mr. John Carley, Office of Pesticide Programs, Office of Prevention, Pesticides, and Toxic Substances
  • 10:30 AM
  • 10:45 AM
Public Comment
  • 11:45 AM
  • 1:00  PM
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?
Dr. Weiss, Lead Discussant; Dr. Needleman, Associate Discussant

  • 2:00  PM
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.

a. What factors are relevant to consider when reaching a judgment on what constitutes an ethically appropriate human study?

b. How can these factors be used to make decisions in such cases? Please give some examples.

c. In using these factors, are there "benchmarks" that emerge that would clearly make a study appropriate (or inappropriate) for use? Please give some examples.

Dr. Meslin, Lead Discussant; Drs. Ellis, Gorovitz and Goebel, Associate Discussants

  • 3:00  PM
  • 3:15  PM
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.

a. What are the benefits to subjects and to society from human participation in research studies; e.g., those supporting pesticide registration?
Dr. Kahn, Lead Discussant
; Dr. Kendall, Associate Discussant

b. What is the impact of remuneration on this question of benefits to subjects and society?
Dr. Caplan, Lead Discussant; Dr. Andre Knottnerus, Associate Discussant

c. Are there differences or distinctions that should be made for studies involving pesticides versus those involving other environmental chemicals?
Dr. Fiedler, Lead Discussant; Dr. Portier, Associate Discussant

  • 5:00  PM

      Friday, December 11, 1998

  • 8:30  AM
Administrative Issues - Co-Chairs and DFOs
  • 8:45  AM
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:

a. How can/should this guidance be applied to

1) Studies conducted in the past, prior to the adoption of the Common Rule (1991), but may (or may not) have adhered to another ethical standard of another day?

2) Studies gathered from the open literature for use by the Agency?

Dr. Gorovitz, Lead Discussant; Drs. and Weiss, Associate Discussants

b. Is it ethical to engage in the oral dosing of human volunteers with environmental toxicants (e.g., cryptosporidium, SOx, or organophosphates (OPs)) in order to establish a NOAEL?

Dr. Payton, Lead Discussant; Drs. Goebel and Thrall, Associate Discussants

  • 10:15 AM
  • 10:30 AM
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:

a. Informed consent

b. Voluntary participation

c. Institutional Review Board (IRB)

Dr. Ellis, Lead Discussant; Drs. Kahn and Meslin, Associate Discussants

  • 12:00 PM
  • 1:00  PM
Additional Public Comment (if Required)
  • 2:00  PM
General Discussion, focusing on arriving at a Subcommittee Consensus for the various Issues.
Co-Chairs and Panel
  • 3:00  PM
  • 3:15  PM
Writing Session for Subcommittee Report
  • 5:00  PM

Joint Science Advisory Board (SAB) and FIFRA Scientific Advisory Panel (SAP)
Open Meeting December 10-11, 1998

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