[Federal Register Volume 63, Number 225 (Monday, November 23, 1998)]
[Notices]
[Pages 64714-64715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31247]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-6192-3]


Science Advisory Board/Scientific Advisory Panel; Notification of 
Public Advisory Committee Meeting; Open Meeting

    Pursuant to the Federal Advisory Committee Act, Public Law 92-463, 
notice is hereby given that a Joint Subcommittee of the Science 
Advisory Board (SAB) and the Scientific Advisory Panel (SAP) will meet 
on the dates and times described below. All times noted are Eastern 
Standard Time. The meeting is open to the public; however, due to 
limited space, seating will be on a first-come basis.
    The Joint SAB/SAP Data from Testing on Human Subjects (DTHS) 
Subcommittee will meet on Thursday and Friday, December 10/11, 1998 at 
the Sheraton Crystal Hotel, 1800 Jefferson Davis Highway, Arlington VA 
22202. The hotel telephone number is 703-486-1111. The meeting will 
begin at 8:30 am and end no later than 5:00 pm. This is the first 
meeting of this Subcommittee.
    Purpose of the Meeting: This Joint Subcommittee was established to 
provide advice and comment to EPA on issues related to data derived 
from testing on human subjects and its use in pesticides decision 
making. In the midst of this effort, some specific issues have arisen 
regarding the testing of human subjects in support of pesticide 
registrations. Both scientific and (primarily) ethical questions have 
been raised about the data, the manner in which they were developed, 
and the purpose to which they can or should be put. The Agency thus 
seeks advice from the SAB/SAP Joint Committee on a range of issues, 
especially focusing on the practical questions confronting the 
Pesticide Program as it seeks to implement the Food Quality Protection 
Act. During this public meeting, the Subcommittee will address these 
scientific and ethical issues, including: (a) the value of human 
studies; (b) how to determine what constitutes an appropriate 
(scientifically and ethically) human study; (c) the risks and benefits 
to subjects and society; (d) applying principles to specific 
situations; (e) identifying clearly out-of-bounds studies; and (f) 
assessing and assuring compliance with appropriate standards. A copy of 
the formal Charge to the Subcommittee will be posted on the SAB Website 
(http://www.epa.gov/sab) on or about November 16.
    At the public meeting, Agency staff will brief the Subcommittee on 
current activities involving human studies, as well as on issues/
problems raised by these activities. In concert with these 
presentations, EPA will present background materials for the 
Subcommittee's information and consideration.
    Availability of Review Materials: Hard copies of EPA primary 
background documents for the meeting may be obtained by contacting: 
Public Information and Records Integrity Branch, Information Resources 
and Services Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; 
Office location: Room 119, Crystal Mall #2, 1921 Jefferson Davis 
Highway, Arlington, VA 22202; telephone: (703) 305-5805.

FOR FURTHER INFORMATION: Members of the public desiring additional 
information about the conduct of the public meeting itself should 
contact Mr. Samuel Rondberg, Co-Designated Federal Officer, DTHS 
Subcommittee, Science Advisory Board (1400), Room M3706, U.S. EPA, 401 
M Street, SW, Washington, DC 20460; telephone/voice mail at (301) 812-
2560; fax at (202) 260-7118; or via E-mail at: [email protected]. A 
copy of the draft agenda will be available on the SAB Website (http://
www.epa.gov/sab) or the SAP Website (http://www.epa.gov/pesticides/SAP/
), or upon request from Ms. Wanda Fields, Management Assistant, Science 
Advisory Board at (202) 260-5510 or by FAX at (202) 260-7118 or via E-
Mail at: [email protected]. Anyone desiring additional information 
on the substantive issues to be addressed at this meeting should 
contact Mr. Larry C. Dorsey, Co-Designated Federal Officer for the 
Subcommittee, Environmental Protection Agency (7509C), 401 M St., SW, 
Washington, DC 20460. Mr. Dorsey may be contacted via telephone/voice 
mail at (703) 305-5369, or by E-Mail at: [email protected].
    Members of the public who wish to make a brief oral presentation to 
the Subcommittee must contact Mr. Rondberg in writing (by letter, fax, 
or by E-Mail--see previously stated information) no later than 12 noon 
Eastern Time, Friday, November 27, 1998 in order to be included on the 
Agenda. These oral comments will be limited to five minutes per speaker 
or organization. The request should identify the name of the individual 
making the presentation, the organization (if any) they will represent, 
any requirements for audio visual equipment (e.g., overhead projector, 
35 mm projector, chalkboard, etc), and include at least 35 copies of an 
outline of the issues to be addressed or of the presentation itself. By 
mail, submit written comments to: The Public Information and Records 
Integrity Branch (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person or 
by delivery service, bring comments to: Room 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, Virginia 22202.
    Comments and data also may be submitted electronically by sending 
electronic mail (E-Mail) to: [email protected]. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data also will be 
accepted on disks in WordPerfect 8.0 file format or ASCII file format. 
All comments and data in electronic form must be identified by the 
docket number ``OPP- ''. No Confidential Business Information (CBI) 
should be submitted through E-Mail. Electronic comments may be filed 
online at many Federal Depository Libraries. Additional information on 
electronic submissions can be found under Supplementary Information 
below.

SUPPLEMENTARY INFORMATION: The Agency encourages that written 
statements be submitted before the meeting to provide Panel Members 
time to consider and review the comments.
    Information submitted as a comment in response to this notice may 
be

[[Page 64715]]

claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). Information marked CBI 
will not be disclosed except in accordance with procedures set forth in 
40 CFR Part 2. An edited copy of the comment that does not contain the 
CBI material must be submitted for inclusion in the public docket. 
Information not marked confidential will be included in the public 
docket. All comments and materials received will be made part of the 
public record and will be considered by the Panel.
    A public record has been established for this notice (including 
comments and data submitted electronically) under docket number ``OPP- 
''. A public version of this record, including printed versions of 
electronic comments, which does not include information claimed as CBI, 
will be available for inspection from 8:30 am to 4:00 pm, Monday 
through Friday, excluding legal holidays. The public record is located 
in Room 119 of the Public Information and Records Integrity Branch, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 
1921 Jefferson Davis Highway, Arlington, Virginia 22202.
    The official record for this notice, as well as the public version, 
as described above will be kept in paper form. Accordingly, EPA will 
transfer all comments received electronically into printed, paper form 
as they are received and will place the paper copies in the official 
record which will also include all comments submitted directly in 
writing. The official record is the paper record maintained at the 
address in Availability of Review Materials earlier in this Notice.

    Dated: November 13, 1998.
Donald G. Barnes,
Staff Director, Science Advisory Board.
[FR Doc. 98-31247 Filed 11-20-98; 8:45 am]
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