[Federal Register Volume 64, Number 150 (Thursday, August 5, 1999)]
[Notices]
[Pages 42707-42708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20076]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program, National Institute of Environmental 
Health Sciences, Center for the Evaluation of Risks to Human 
Reproduction; Announces an Expert Panel Review of Phthalates, August 
17-19, 1999 in Alexandria, VA

Background

    The National Toxicology Program (NTP) and the National Institute of 
Environmental Health Sciences have established the NTP Center for the 
Evaluation of Risks to Human Reproduction (63 FR 68782, No 239). The 
purpose of the Center is to provide timely and unbiased, scientifically 
sound evaluations of human and experimental evidence for adverse 
effects on reproduction, including development, caused by agents to 
which humans may be exposed. The evaluations produced through the 
Center will be published as monographs in Environmental Health 
Perspectives; a special effort will be made to summarize the reports in 
terms that can be understood by those who are not scientifically 
trained.

Expert Panel Review of Phthalates

    Seven phthalate esters will be evaluated by an expert panel under 
the auspices of the NTP Center (64 FR 18921-18922, No 73). These were 
selected based on their high production volume, extent of human 
exposures, use in children's products, or published evidence of 
reproductive or developmental toxicity. The chemicals to be evaluated 
are listed below with their Chemical Abstract Service registry numbers.

butyl benzyl phthalate (85-68-7)
di(2-ethylhexyl) phthalate (117-81-7)
di-isodecyl phthalate (26761-40-0, 68515-49-1)
di-isononyl phthalate (28553-12-0, 68515-48-0)
di-n-butyl phthalate (84-74-2)
di-n-hexyl phthalate (84-75-3)
di-n-octyl phthalate (117-84-0)

Review Panel and Charge to Panel

    To date, a panel of 14 scientists have been selected for their 
expertise in various aspects of reproductive toxicology and other 
relevant areas to conduct the review. The roster of these experts 
follows:

Phthalates Expert Panel

Name and Affiliation

Kim Boekelheide, MD, PhD--Brown University, Providence, RI
Bob Chapin, PhD--NIEHS, Research Triangle Park, NC
Mike Cunningham, PhD--NIEHS, Research Triangle Park, NC
Elaine Faustman, PhD--University of Washington, Seattle, WA
Paul Foster, PhD--Chemical Industry Institute of Toxicology, Research 
Triangle Park, NC
Mari Golub, PhD--Cal/EPA, Davis, CA
Rogene Henderson, PhD--Inhalation Toxicology Research Institute, 
Albuquerque, NM
Irwin Hinberg, PhD--Health Canada, Ottawa, Ontario, Canada
Bob Kavlock, PhD--EPA/ORD, Research Triangle Park, NC
Jennifer Seed, PhD--EPA/OPPT, Washington, DC
Katherine Shea, MD--North Carolina State University, Raleigh, NC
Shelly Tyl, PhD--Research Triangle Institute, Research Triangle Park, 
NC
Paige Williams, PhD--Harvard University, Cambridge, MA
Tim Zacharewski, PhD--Michigan State University, East Lansing, MI

Charge to Expert Panel

    Rigorously evaluate all relevant data and reach a conclusion 
regarding the strength of scientific evidence that exposure to a 
chemical may or may not present a risk to human reproduction or 
development.
    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 individual studies.
    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,

[[Page 42708]]

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. 
Peggy Sheren, CERHR, 1800 Diagonal Road, Suite 500, Alexandria, VA 
22314-2808, Phone: (703) 838-9440.

    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