[Federal Register: November 3, 2004 (Volume 69, Number 212)]
[Notices]
[Page 64081-64082]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03no04-90]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Toxicology Program; National Institute of Environmental
Health Sciences (NIEHS); National Institutes of Health (NIH) Notice of
an Expert Panel Meeting To Assess the Current Validation Status of In
Vitro Testing Methods for Identifying Potential Ocular Irritants;
Request for Comments
Summary
Notice is hereby given of a meeting sponsored by the NIEHS and the
National Toxicology Program (NTP), and organized by the NTP Interagency
Center for the Evaluation of Alternative Toxicological Methods
(NICEATM) in collaboration with the Interagency Coordinating Committee
on the Validation of Alternative Methods (ICCVAM). At this meeting, an
expert panel (``Panel'') will assess the current validation status and
develop recommendations for further validation of in vitro test methods
proposed for identifying substances that may cause serious eye damage.
The meeting will take place on January 11-12, 2005, from 8:30 a.m. to 5
p.m., at the National Institutes of Health (NIH), Natcher Center,
Bethesda, MD. The meeting is open to the public with attendance limited
only by the space available.
Evaluation of In Vitro Ocular Test Methods Background
In August 2003, the Scientific Advisory Committee on Alternative
Toxicological Methods (SACATM) recommended that ICCVAM review the
validation status of screening test methods that could be used to
identify severe and irreversible ocular effects and carry out
appropriate reviews of these test methods. In October 2003, the U.S.
Environmental Protection Agency nominated several ocular-related
activities to ICCVAM including evaluation of the validation status of
four in vitro ocular toxicity test methods for screening for severe/
irreversible ocular effects: (1) The Bovine Corneal Opacity and
Permeability (BCOP) test; (2) the Hen's Egg Test--Chorion Allantoic
Membrane (HET-CAM); (3) the Isolated Rabbit Eye (IRE) test; and (4) the
Isolated Chicken Eye (ICE) test. ICCVAM endorsed the review of the
methods as a high priority and recommended that Background Review
Documents be developed for each method by NICEATM in collaboration with
the ICCVAM Ocular Toxicity Working Group. ICCVAM also
[[Page 64082]]
recommended that an expert panel be convened to independently review
the validation status of these methods and the proposed, standardized,
test method protocols.
A request for public comment on the nomination of these and other
ocular toxicity test methods and related activities and a request for
data on chemicals evaluated by in vitro or in vivo ocular irritancy
test methods was previously published in the Federal Register (Vol. 69,
No. 57, pp. 13859-13861, March 24, 2004, available at http://iccvam.niehs.nih.gov/
). Additionally, NICEATM solicited the nomination
of scientific experts for independent expert panel evaluations and/or
reviews of in vitro testing methods for identifying potential ocular
irritants through the Federal Register (Vol. 69, No. 77, pg. 21565,
April 21, 2004, available at http://iccvam.niehs.nih.gov/). This notice
also announced that ICCVAM and NICEATM would coordinate an expert panel
meeting to evaluate in vitro ocular test methods for their ability to
detect severe and irreversible ocular irritants. No additional methods
for identifying severe/irreversible ocular effects other than the four
named above were identified in response to the Federal Register
notices.
NICEATM has prepared Background Review Documents (BRDs) on the four
test methods nominated by the EPA (BCOP, HET-CAM, IRE and ICE). Each of
the BRDs contains comprehensive summaries of available data, analyses
of the accuracy and reliability of the available test method protocols,
and related information characterizing the current validation status of
these assays. At this meeting, the Panel will review each of the four
BRDs and develop conclusions and recommendations on the following:
The current usefulness and limitations of the test methods
for identifying severe/irreversible ocular irritants and corrosives.
The adequacy of the specific protocols recommended for
future validation and testing studies.
The adequacy of recommended test method validation
studies.
The adequacy and appropriateness of substances recommended
for future validation studies.
Agenda
The public meeting will take place January 11-12, 2005, at the NIH
Campus, Natcher Center, Bethesda, MD (a map of the NIH Campus and other
visitor information are available at http://www.nih.gov/about/visitor/index.htm
). The meeting will begin at 8:30 a.m. each day and conclude
at approximately 5 p.m. A preliminary agenda is given below. A detailed
agenda and roster of the expert panel members will be available two
weeks prior to the meeting on the ICCVAM/NICETATM Web site (http://iccvam.niehs.nih.gov
) or by contacting NICEATM (contact information
below). Persons needing special assistance, such as sign language
interpretation or other special accommodations, should contact NICEATM
at least seven business days in advance of the meeting.
On the morning of January 11th, there will be a brief orientation
on ICCVAM and the ICCVAM test method review process, followed by the
Panel's evaluation of the BRDs for the ICE and BCOP assays. It is
anticipated that review of the HET-CAM assay will continue on the
morning of January 12th after which the review of the BRD for the IRE
assay will take place. The Panel will evaluate the current status of
each of the four different types of in vitro assays and develop
recommendations regarding their future validation and use.
Availability of Background Review Documents
NICEATM has prepared four BRDs, one for each of the assays being
evaluated. Copies of each BRD can be obtained on the ICCVAM/NICEATM Web
site at http://iccvam.niehs.nih.gov, or by contacting NICEATM, NIEHS,
PO Box 12233, MD EC-17, Research Triangle Park, NC, 27709, (phone) 919-
541-3398, (fax) 919-541-0947, (email) iccvam@niehs.nih.gov.
Request for Comments
NICEATM invites the submission of written comments on each of the
BRDs. When submitting written comments please include appropriate
contact information (name, affiliation, mailing address, phone, fax,
email and sponsoring organization, if applicable). Written comments and
additional information should be sent by mail, fax, or email to Dr.
William Stokes, Director of NICEATM, at the address listed above not
later than December 30, 2004. Written comments will be placed on the
ICCVAM/NICEATM website and made available to the Panel, ICCVAM agency
representatives and experts, and attendees at the meeting.
The meeting is open to the public and time will be provided for the
presentation of public oral comments at designated times during the
peer review. Members of the public who wish to present oral statements
at the meeting (one speaker per organization) should contact NICEATM
(at the address above) no later than noon on January 5, 2005. Speakers
will be assigned on a consecutive basis and up to seven minutes will be
allotted per speaker. Persons registering to make comments are asked to
provide a written copy of their statement by January 5th, so that
copies can be distributed to the Panel prior to the meeting or if this
is not possible to bring 40 copies to the meeting. Written statements
can supplement and expand the oral presentation. Each speaker is asked
to provide contact information (name, affiliation, mailing address,
phone, fax, email and sponsoring organization, if applicable) when
registering to make oral comments.
Summary minutes and a final report of the Panel will be available
following the meeting at the ICCVAM/NICEATM Web site (http://iccvam.niehs.nih.gov
).
Background Information on ICCVAM and NICEATM
ICCVAM is an interagency committee charged with the technical
review and evaluation of new, revised, and alternative test methods
applicable for specific regulatory uses. The committee is composed of
representatives from 15 Federal regulatory and research agencies that
use or generate toxicological information. ICCVAM promotes the
development, validation, regulatory acceptance, and national and
international harmonization of toxicological test methods that more
accurately assess the safety or hazards of chemicals and products and
that refine, reduce, or replace animal use. The ICCVAM Authorization
Act of 2000 (Pub. L. 106-545, available at http://iccvam.niehs.nih.gov/about/PL106545.htm
) established ICCVAM as a permanent interagency
committee of the NIEHS under the NICEATM. NICEATM administers the
ICCVAM and provides scientific support for ICCVAM and ICCVAM-related
activities. NICEATM and ICCVAM work collaboratively to evaluate new and
improved test methods applicable to the needs of Federal agencies.
Additional information about ICCVAM and NICEATM can be found at the
following Web site: http://iccvam.niehs.nih.gov.
Dated: October 21, 2004.
Samuel Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 04-24481 Filed 11-2-04; 8:45 am]
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