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March/April 1999 SAP Meeting Agenda
March 30 - April 1, 1999
Sheraton Crystal Hotel
1800 Jefferson Davis Highway
Arlington, VA 22202
OPP Docket Telephone: (703)305-5805
Tuesday, March 30, 1999
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Introductions - Drs. Joan Daisey and Gene McConnell (Co-chairs) |
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Administrative Issues and Conflict of Interest Statements - Designated Federal Officials - Mr. Larry Dorsey and Mr. Samuel Rondberg |
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Opening Remarks - James Aidala, Associate Assistant Administrator for EPA Office of Prevention, Pesticides and Toxic Substances and Charles Fox, Acting Assistant Administrator for EPA Office of Water |
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Background and Orientation to Framework for Agency Presentations - Dr. Penelope Fenner-Crisp, Gary Timm, and Anthony Maciorowski |
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Public Comments |
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BREAK |
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Public Comments (continued) |
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LUNCH |
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Public Comments (continued) |
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Session 1: Scope of the Program - Background briefing on the Endocrine Disruptor Screening Program, and discussion of major issues by an EPA Panel, moderated by Dr. Jeanette Wiltse, Office of Water. Also participating are Dr. Bernard Schwetz (FDA), Charlie Auer (OPPT-EPA) and Susan Hazen (OPP-EPA) |
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Specific Questions Overall Lead Discussant for Section 1 – Dr. Richard Bull; Associate Discussants, Drs. Genevieve Matanoski and Kenneth Davis 1) Does the SAB/SAP agree that this expanded scope is appropriate
to serve as the starting point for the Endocrine Disruptor
Screening Program (EDSP), given the understanding that the
framework for the Program can support further expansion at
a later date? 2) Does the Subcommittee agree that this expanded set of
substances should be included in the EDSP process, at a minimum
in the priority-setting phase, and continuing on if a potential
for concern is identified? |
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BREAK |
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3) Does the Subcommittee agree that
there are categories of pesticides and other substances that
should be exempt from the EDSP? In addition to the examples
noted here, are there additional categories that should be considered
for exemption? Lead Discussant, Dr. Diane Henschel 4) Mixtures Lead Discussants, Drs. Kenneth Davis, Genevieve Matanoski and John Doull
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ADJOURNMENT |
Wednesday, March 31, 1999
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Introductions - Drs. Joan Daisey and Gene McConnell (Co-chairs) |
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Administrative Issues and Conflict of Interest Statements - Designated Federal Officials - Mr. Larry Dorsey and Mr. Samuel Rondberg |
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Session 2: Priority-setting Background briefing on setting priorities, and discussion of major issues by an EPA Panel, moderated by Anthony Maciorowski assisted by Pat Kennedy, James Darr, Dr. John Walker, and Terry O'Brien. |
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Specific Questions. Dr. Alan Maki, Overall Lead Discussant for this Section; Associate Discussant Dr. Mary Anna Thrall 5) Are these principles and the compartment-based approach
to priority setting reasonable? Are there other approaches
that would be more useful? 6) Would the Joint Subcommittee comment on the approach and
provide additional insights to improve the content of the
relational database or its implementation? |
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BREAK |
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Session 3: High Throughput Pre-screening Approach. Background briefing on the pre-screening approach, and discussion of major issues by an EPA Panel, moderated by Gary Timm and assisted by Drs. William Kelce, Earl Gray and John Haley. |
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LUNCH |
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Specific Questions Dr.
Timothy Zacharewski Overall Lead for session; Associate Discussants
Drs. Charles Capen, Tim Gross, Philippe Grandjean, Margaret
McCarthy, and Michael McClain
7) High throughput Technology
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BREAK |
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Session 4: The Proposed Endocrine Disruptor Screening Program. Background briefing on the screening approach, and discussion of major issues by an EPA Panel, moderated by Dr. Penelope Fenner-Crisp and assisted by Drs. Earl Gray, Joseph Tietge, William Stokes, William Kelce, Daniel Sheehan and Theo Colborn |
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Specific Questions. Lead
Discussant Dr. John Vandenbergh; Associate Discussants Drs.
Geoff Scott, Charles Capen, Michael McClain and F.M. Anne McNabb
8) Is it reasonable and appropriate to develop and implement
a two-phase program, the first phase focused on identifying
a substance’s potential to interact with one or more
of the three hormone systems, the second phase to characterize
the effects of concern that interaction with these hormone
systems might elicit? 9) Does the SAB/SAP agree with this assessment? If not, what
changes should be made in the battery to assure the identification
of substances of potential concern? |
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Reprise of days’ discussion and findings – Co-chairs, Subcommittee |
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Adjournment of Meeting (Informal Drafting of Report Session by Panel Members) |
Thursday, April 1, 1999
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Introductions - Drs. Joan Daisey and Gene McConnell (Co-chairs) |
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Administrative Issues and Conflict of Interest Statements - Designated Federal Officials - Mr. Larry Dorsey and Mr. Samuel Rondberg |
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Opening Remarks - Marcia Mulkey, Director, Office of Pesticide Programs |
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Re-cap of Previous Days Discussion of Proposed Endocrine Disruptor Screening Program - Dr. Penelope Fenner-Crisp |
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Resume Responding to Agency
Questions:
10) Does the Joint Subcommittee believe that there
is adequate coverage of the thyroid provided in the proposed
screening battery? If not, what modifications should/could
be made? |
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11) At the time the proposed
screening battery was being assembled, EPA was not aware of
the existence of any such screens (containing an in utero
or in ovo component). Is the Joint Subcommittee
aware of any such assays that may exist or are under development
that could supplant or complement one or more components of
the proposed screening battery? Lead Discussant, Dr. Robert Chapin 12) does the Joint Subcommittee agree with the [EDSTAC]
recommendation, and if not, what suggestions would it have
to modify the approach, keeping pace, volume, cost, and efficiency
in mind? (Note: At the May consultation, some members
raised concern about relying on a single dose and suggested
that a minimum of two doses, and perhaps even three, could
be used to ensure that the screens do not yield false negative
results.) What would be the public health consequences
of these false negatives? |
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BREAK |
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13) Does the Subcommittee believe
that these test protocol designs will provide sufficient rigor
to identify effects of concern and establish their dose responses
for disruption in the estrogen-, androgen- and/or thyroid-hormone
systems? Lead Discussant, Dr. John Ashby 14) Does the Joint Subcommittee believe that
the tests in the testing phase will be adequate to detect
all known critical endpoints in the estrogen-, androgen- and
thyroid hormone systems? If not, what modifications should
be made? |
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LUNCH |
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15) If the results of any of the
testing phase tests are negative, what, if any, additional screening
or testing should be conducted to assure that the chemical is
not an endocrine disruptor in the estrogen-, androgen- or thyroid
hormone systems of that sector of the animal kingdom? Lead Discussant, Dr. John Ashby |
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16) Is it important to be able to
identify substances as endocrine disruptors from the standpoint
of conducting a hazard assessment? If so, why? If not,
why not? Lead Discussant, Dr. Robert Chapin |
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17) The mammalian two-generation
test will require limited testing in one laboratory to validate
the new endpoints since the basic protocol is already considered
to be valid. All of the non-mammalian assays will require the
full validation regime and some will require further pre-validation
development. Does the Joint Subcommittee agree with this assessment?
Lead Discussant, Dr. John Ashby |
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18) Does the Joint Subcommittee have any other
suggestions or recommendations that would help EPA meet its
charge? |
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Review Subcommittee findings and discuss report preparation. Co-chairs, Subcommittee, and DFOs |
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ADJOURN |