1. Evaluate all reproductive and developmental toxicity
studies--in humans and animals--for quality, completeness, and sufficiency. Determine
consistency of reported effects within and among species. Briefly summarize relevant
2. Review and summarize related studies paying particular attention to studies of general toxicity, pharmacokinetics, genetic toxicity, and mechanisms of toxicity, within and across species. Both in vivo and in vitro studies will be included.
3. Determine, to the extent possible, patterns of use (such as timing, duration) and exposure (such as dose, route) to humans.
4. Integrate this information, using a weight of evidence approach. Determine how human, animal and other data can reasonably be used to predict reproductive or developmental effects in humans under particular exposure conditions.
5. Provide judgments, including qualitative statements of the certainty of the judgments, that an agent presents a potential risk to human reproduction and/or development.Describe the major factors that contributed to these judgments. State the exposure circumstances under which such risk might be expected to exist.
6. Identify specific areas of uncertainty (such as inadequate pharmacokinetic data in a given species) that would prevent a more definitive assessment of human risk.
7. Identify research and testing needs that, if met, would significantly reduce the uncertainty inherent in the stated judgments of risk.
Meeting Open to the Public
The preliminary agenda for the panel meeting follows:
August 17 (Beginning at 8:30 a.m.)
Opening remarks by Dr. Michael Shelby, NIEHS and Director of the Center, Dr. George Lucier, Director of the NIEHS ' Environmental Toxicology Program, and Dr. Robert Kavlock, EPA, and Chair of the Expert Panel.Panel members will present summaries of the literature they will have individually reviewed in advance of the meeting.The Phthalate Esters Panel of the Chemical Manufacturers Association, Health Care Without Harm, and the American Council on Science and Health will summarize the deliberations of their recent literature reviews of the possible reproductive and developmental health risks of phthalate exposures.Panel discussion will follow to identify areas where there is broad panel agreement as well as issues requiring further discussion by workgroups of the panel. Time will be available to members of the public for comment.
August 17 (PM)--18-19
The remainder of the meeting will be an iterative series of workgroup discussions and plenary sessions. Significant conclusions and judgments reached by the panel workgroups will be presented, discussed, and agreed to by the entire expert panel in plenary sessions. Definitive judgments will be made for each of the seven phthalates.
August 19, 11:00 a.m. (Tentatively)
Closing plenary session, review of panel conclusions.
The review will take place from August 17-19 at the Embassy Suites Hotel, 1900 Diagonal
Road, Alexandria, VA with some workgroup sessions at Sciences, International, Inc., 1800
Diagonal Road, Suite 500, Alexandria, VA (limited seating availability). The meeting will
commence at 8:30 AM on August 17 in the Virginia Ballroom of the Embassy Suites Hotel. The
review will be open to the public with an opportunity scheduled for oral public comment.
Attendance will be limited only by the availability of space. For registration information
please contact: Ms. Harriet McCollum, CERHR, 1800 Diagonal Road, Suite 500, Alexandria, VA
22314-2808, Phone: (703) 838-9440, e-mail: email@example.com.
Dated: July 28, 1999.
Samuel H. Wilson,
Deputy Director, NIEHS.
[FR Doc. 99-20076 Filed 8-4-99; 8:45 am]
BILLING CODE 4140-01-P