[Federal Register Volume 65, Number 100 (Tuesday, May 23, 2000)]
[Notices]
[Pages 33343-33345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12908]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


Meeting: National Toxicology Program; Center for Evaluation of 
Risks to Human Reproduction

    National Toxicology Program (NTP), National Institute of 
Environmental Health Sciences (NIEHS), Center for the Evaluation of 
Risks to Human Reproduction, announces an Expert Panel Meeting to 
complete a review of seven phthalates. The review will take

[[Page 33344]]

place on July 12-13, 2000, at the Sheraton National Hotel 900 S. Orme 
Street (Columbia Pike and Washington Boulevard) Arlington, VA 22204. 
The meeting is open to the public and attendance is limited only by the 
availability of space.

Background

    The NTP and the NIEHS established the NTP Center for the Evaluation 
of Risks to Human Reproduction (CERHR) [Federal Register (FR), December 
14, 1998 (Volume 63, Number 239, page 68782)] 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. An expert panel is established to review the 
scientific evidence on the chemical(s) under review, receive public 
comments, and then prepare a report on the chemical(s) that is publicly 
available and is also published in Environmental Health Perspectives 
(EHP). NTP staff prepares a final NTP Center Report on the evaluated 
chemical(s) that integrates background information on the chemical(s), 
findings of the expert panel, a summary of public comments, and a 
discussion of any additional, recent studies. The final report is made 
publicly available, distributed to interested stakeholders, appropriate 
regulatory and research agencies, and published in EHP. A summary of 
the complete review process can be found on the CERHR website (http://cerhr.niehs.nih.gov), in FR March 20, 2000 (Volume 65, Number 54, page 
14497), or a hardcopy may be requested from Ms. Sheren (see below).
    The Center is completing a review of the following seven phthalate 
esters (Chemical Abstracts Service registry numbers are in 
parentheses):

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

    An independent, expert panel began the phthalate review at the 
first Phthalate Expert Panel Meeting on August 17-19, 1999, in 
Alexandria, VA [FR August 5, 1999 (Volume 64 Number 150, pp. 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. The Expert Panel continued its work at a second meeting 
held on December 15-17 in Research Triangle Park, NC [FR November 19, 
1999 (Volume 64 Number 223, pp. 63327-63329)]. Summaries of the first 
two Phthalate Expert Panel meetings are available on the Center's 
website (http://cerhr.niehs.nih.gov) or can be obtained in hardcopy 
from Ms. Sheren (see below).

Review 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                              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 Final Phthalate Expert Panel meeting.

Preliminary Agenda

    The Expert Panel's primary activities at the third and final 
meeting will be to: (1) Review and approve Integrated Evaluation 
(Section 5.2) language of the five reports (DnHP, DnOP, DINP, DIDP, and 
DBP) proposed at the December meeting and generally agreed through 
review and comment following that meeting and (2) review and discuss 
Data Summary and Integration (Section 5) of the reports for two 
phthalates, BBP and DEHP. Initial discussion will be in plenary 
sessions. All aspects of BBP will be discussed, whereas, the main focus 
of the DEHP discussion will be data relevant to use of medical products 
that contain this phthalate. It is expected that the Expert Panel will 
approve Section 5 language for DEHP and BBP before the end of the July 
meeting.

Wednesday, July 12, 2000

8:30 am--Introductory Remarks and Status of Phthalate Review
9:00 am--Phthalates Expert Panel Opening Comments
Review of BBP (Section 5.0, including 5.1-5.3)
9:10-9:30 am--Public Comments on BBP
9:30-9:40 am--Break
9:40-12 N--Panel Review of BBP
12N-1:00 pm--Lunch
1:00-2:45 pm--Summaries of Previously Reviewed Phthalate Reports, DnHP, 
DnOP, DINP, DIDP, DBP (Section 5.2 of each report) Public Comment
Expert Panel Discussion and Approval of Sections 5.2
2:45-3:00 pm--Break
Review of DEHP (Section 5.0, including 5.1-5.3)
3:00-3:15 pm--Public Comments on DEHP
3:15-4:30 pm--Panel Review of DEHP
4:30-6:00 pm--Panelists Work on Plenary Assignments
6:00 pm--Progress Report on Plenary Assignments
6:30 pm--Adjourn

Thursday, July 13, 2000

8:30-10:00 am--Panel Review of Revised BBP Report
10:00-10:15 am--Break
10:15-11:00 am--Panel Review of Revised DEHP Report
11:00-1:00 pm--Panel Works on Plenary Assignments (working lunch)
1:00-2:30 pm--Expert Panel Discussion and Approval of BBP Report
2:30-2:45 pm--Break
2:45-4:15 pm--Expert Panel Discussion and Approval of DEHP Report

[[Page 33345]]

4:15-4:45 pm--Public Comments
4:45-5:00 pm--Closing Remarks
5:00 pm--Adjourn

Abbreviations:

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

Reports Available for Public Review

    Based on deliberations at the previous meetings. Expert Panel 
Reports are currently being finalized. Each Report is composed of the 
following sections:

1.0  Exposure
2.0  General Toxicological and Biological Parameters
3.0  Developmental Toxicity Data
4.0  Reproductive Toxicity Data
5.0  Data Summary & Integration
5.1  Summary (Sections 1-4)
5.2  Integrated Evaluation
5.3  Critical Data Needs
    All sections of the reports for DIDP, DINP, DnHP and DnOP will be 
available to the public after May 15 and for DBP, BBP and DEHP after 
June 1. They can be obtained electronically on the CERHR website 
(http://cerhr.niehs.nih.gov) or in hardcopy by contacting Ms. Sheren at 
the address given below.

Solicitation of Public Comments

    As shown on the above preliminary agenda, time is allotted at this 
meeting for public comments (seven minutes per speaker). It is expected 
that comments will be directed to the specific portions of the reports 
being discussed by the Expert Panel. In order to facilitate planning of 
this meeting, those wishing to make public comments are asked to submit 
their comments in writing, provide an electronic copy, and notify Ms. 
Sheren, (see below) no later than June 30, 2000. Please reference the 
specific draft phthalate report the comments address. Provide your 
name, affiliation, mailing address, phone, fax, e-mail and sponsoring 
organization (if any) and 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 40 
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 
no later than June 30 in order for them to be considered at the July 
12-13 meeting. Persons sending written comments are asked to provide 
their name, affiliation, mailing address, phone, fax, e-mail and 
sponsoring organization (if any) and provide an electronic copy. Please 
reference the specific draft phthalate report the comments address.
    Following this meeting, there will be another opportunity for 
written comment on each Expert Panel Report. These public comments will 
be considered in the final NTP Center Report prepared by the NTP staff 
and subsequently distributed to Federal and State Agencies, interested 
stakeholders and the public.
    An index of written public comments will be posted on the CERHR 
website (http://cerhr.niehs.nih.gov). This index and copies of specific 
public comments may be obtained by contacting Ms. Sheren.
    For other questions or additional information about the meeting, 
please contact Ms. Peggy Sheren at CERHR, 1800 Diagonal Road, Suite 
500, Alexandria, VA 22314-2808, Phone: (703) 838-9440, 
[email protected].

    Dated: May 12, 2000.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 00-12908 Filed 5-22-00; 8:45 am]
BILLING CODE 4140-01-U