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

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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 Start Printed Page 33344place 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

NameAffiliation
Kim Boekelheide, MD, PhD.*Brown University, Providence, RI
Bob Chapin, PhDNIEHS, Research Triangle Park, NC
Mike Cunningham, PhD.*NIEHS, Research Triangle Park, NC
Elaine Faustman, PhDUniversity of Washington, Seattle, WA
Paul Foster, PhDChemical Industry Institute of Toxicology, Research Triangle Park, NC
Mari Golub, PhDCal/EPA, Davis, CA
Rogene Henderson, PhDInhalation Toxicology Research Institute, Albuquerque, NM
Irwin Hinberg, PhDHealth Canada, Ottawa, Ontario, Canada
Bob Kavlock, PhD (chair)EPA/ORD, Research Triangle Park, NC
Ruth Little, Sc.DNIEHS, Research Triangle Park, NC
Jennifer Seed, PhDEPA/OPPT, Washington, DC
Katherine Shea, MDNorth Carolina State University, Raleigh, NC
Sonia Tabacova, MD, PhDFDA, Rockville, MD
Shelley Tyl, PhDResearch Triangle Institute, Research Triangle Park, NC
Paige Williams, PhDHarvard University, Cambridge, MA
Tim Zacharewski, PhDMichigan 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 Start Printed 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, psheren@sciences.com.

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Dated: May 12, 2000.

Samuel H. Wilson,

Deputy Director, National Institute of Environmental Health Sciences.

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[FR Doc. 00-12908 Filed 5-22-00; 8:45 am]

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