[Federal Register Volume 64, Number 223 (Friday, November 19, 1999)]
[Notices]
[Pages 63327-63329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30199]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


Review Phthalates Meeting Notice

    National Toxicology Program (NTP), National Institute of 
Environmental Health Sciences (NIEHS), Center for the Evaluation of 
Risks to Human Reproduction, announces the second meeting of an expert 
panel to review phthalates, December 15-17, 1999. The meeting will be 
held at Hawthorn Suites Hotel, 300 Meredith Drive, Durham, NC (near the 
intersection of highways 54 and 55 in Research Triangle Park) and will 
begin at 8:30 a.m. each day.

Background

    The NTP and the NIEHS established the NTP Center for the Evaluation 
of Risks to Human Reproduction (CERHR) (63 FR 68782, No 239) in June 
1998. 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, which may be 
caused by agents to which humans are exposed. The evaluations produced 
through the Center will be published as monographs in Environmental 
Health Perspectives (EHP); a special effort will be made to summarize 
the reports in non-scientific terms for use by the general public. 
These documents will be available on the CERHR website (http://
cerhr.niehs.nih.gov) or in hardcopy by contacting Ms. Peggy Sheren 
(contact

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information given below), and will also be transmitted to appropriate 
Federal and State Agencies. Public comments on the final documents will 
be welcome. The Center's first review is underway and covers the 
evaluation of the following seven phthalate esters (Chemical Abstracts 
Service registry numbers are in parentheses).

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)

First Meeting of the Expert Panel to Review Phthalates, August 17-
19, 1999

    An independent, expert panel began the phthalate review at the 
first Phthalate Expert Panel Meeting on August 17-19 in Alexandria, 
Virginia (64 FR 42707-42708). Prior to this meeting, panelists reviewed 
existing literature in their areas of expertise and provided other 
panel members with their summary evaluations. This effort involved the 
review of nearly 1,000 reports or publications covering general 
toxicity in animals and humans, developmental and reproductive 
toxicity, and information on human exposure. Integrated evaluation 
documents drafted at the Panel's meeting addressed the nature and 
consistency of the reviewed data, relevancy of experimental models to 
humans, and important papers in the areas of toxicity and human 
exposure.
    Draft integrated evaluation documents were reviewed and discussed 
in plenary session by the Panel for the following phthalates: butyl 
benzyl phthalate, di(2-ethylhexyl)phthalate, and di-n-octyl phthalate. 
Further discussion of these draft documents and formulation of summary 
statements will take place at the second Phthalate Expert Panel Review. 
A summary of the first Phthalate Expert Panel meeting is available on 
the Center's website (http://cerhr.niehs.nih.gov) or can be obtained in 
hardcopy from Ms. Sheren (see below).

December 15-17, 1999 Phthalate Expert Panel Review

    The integrated evaluations on the four remaining chemicals (di-
isodecyl phthalate, di-isononyl phthalate, di-n-butyl phthalate, and 
di-n-hexyl phthalate) are being written and will be discussed at the 
Expert Panel meeting to be held December 15-17. The draft integrated 
evaluations will be publicly available after December 1, 1999 at the 
Center's website (see above) or can be obtained in hardcopy by 
contacting Ms. Peggy Sheren, (see below). Following review and 
agreement by the Panel on the integrated evaluations, the members will 
develop consensus summary statements for each of the seven phthalates. 
These narrative statements will reflect a consensus opinion of the 
Panel as to the developmental and reproductive toxicity of these 
chemicals in experimental models and will address the potential 
significance of these results to human reproduction and development. 
Following this meeting, integrated evaluations and the summary 
statements will be incorporated into a monograph on phthalates that is 
published in EHP and available for public comment.

Review Panel and Charge to Panel

    A panel of 16 independent scientists selected for their expertise 
in various aspects of reproductive toxicology and other relevant areas 
are conducting this review. The roster of 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 (chair), EPA/ORD, Research Triangle Park, NC
Ruth Little, Sc.D*, NIEHS, Research Triangle Park, NC
Jennifer Seed, PhD, EPA/OPPT, Washington, DC
Katherine Shea, MD, North Carolina State University, Raleigh, NC
Sonia Tabacova, MD, PhD**, FDA, Rockville, MD
Shelley 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

    * Unable to attend the second Phthalate Expert Panel meeting.
    ** Added to the Panel to assist in the evaluation of literature and 
identification of research and testing needs in epidemiology.

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 meeting is open to the public and attendance is limited only by 
the availability of space. This review will take place from December 
15-17 at Hawthorn Suites Hotel, 300 Meredith Drive, Durham, NC (near 
the intersection of highways 54 and 55 in Research Triangle Park). The 
meeting commences each day at 8:30 a.m. .

Preliminary Agenda

December 15 (8:30 a.m.)

    Opening remarks by Dr. George Lucier, Director, ETP, NIEHS; Dr. 
Michael Shelby, NIEHS and Director of

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the Center; Dr. John Moore, Sciences, International and CERHR; and Dr. 
Robert Kavlock, EPA and Chair of the Expert Panel on Phthalates.
    Following opening remarks, the Panel will receive public comments 
(time seven minutes per speaker). Information for those wishing to 
register to give oral comments or to submit written comments is 
provided below. Following the comment period, draft integrated 
evaluations for each of the seven phthalates will be discussed in 
plenary session with the purpose of reaching consensus on each 
chemical. These draft documents will be available to the public 
electronically on the CERHR website (http://cerhr.niehs.nih.gov) after 
December 1 or in hardcopy by contacting Ms. Sheren at the address given 
below.

December 16 (8:30 a.m.)

    Complete discussions of the integrated evaluations. Begin drafting 
summary statements for each of the chemicals. This will be accomplished 
through an iterative series of workgroup discussions and plenary 
sessions.

December 17 (8:30 a.m.)

    Summary statements reflecting significant conclusions and 
judgements reached by the Panel Workgroups for each of the phthalates 
will be presented, discussed, and agreed upon by the entire expert 
panel in the final plenary session. Closing comments by Dr. Michael 
Shelby, NIEHS, and Dr. Lynn Goldman, Johns Hopkins University and 
NIEHS.

Solicitation of Oral and Written Public Comments

    Following opening remarks on December 15, time is allotted for 
public comments (seven minutes per speaker on the chemicals being 
reviewed). In order to facilitate planning of this meeting, those 
wishing to make public comments are asked to notify Ms. Sheren, (CERHR, 
1800 Diagonal Road, Suite 500, Alexandria, VA 22314-2808, Phone: (703) 
838-9440) no later than December 10, 1999. When registering to comment 
orally, please provide your name, affiliation, mailing address, phone, 
fax, e-mail and sponsoring organization (if any). If possible, also 
send a copy of the statement or talking points to Ms. Sheren; this 
information will be provided to the Panel and will assist the Chair and 
Panel Members in identifying issues for discussion. Registration for 
public comments will also be available on-site (7:30-8:30 a.m.). Those 
registering on site are asked to bring 20 copies of their statement or 
talking points.
    A written statement may be submitted in lieu of making an oral 
presentation. These written comments should be received by Ms. Sheren 
(address given above) no later than December 10 in order for them to be 
considered at the December 15-17 meeting. Persons sending written 
comments are asked to provide their name, affiliation, mailing address, 
phone, fax, e-mail and sponsoring organization (if any). .
    For other questions or additional information about the meeting, 
please contact Ms. Sheren.

    Dated: November 10, 1999.
Samuel H. Wilson,
Deputy Director, NIEHS and NTP.
[FR Doc. 99-30199 Filed 11-18-99; 8:45 am]
BILLING CODE 4140-01-P