[Federal Register Volume 69, Number 212 (Wednesday, November 3, 2004)]
[Notices]
[Pages 64081-64082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24481]


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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:
    <bullet> The current usefulness and limitations of the test methods 
for identifying severe/irreversible ocular irritants and corrosives.
    <bullet> The adequacy of the specific protocols recommended for 
future validation and testing studies.
    <bullet> The adequacy of recommended test method validation 
studies.
    <bullet> 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) <a href="/cdn-cgi/l/email-protection#d3bab0b0a5b2be93bdbab6bba0fdbdbabbfdb4bca5"><span class="__cf_email__" data-cfemail="e28b818194838fa28c8b878a91cc8c8b8acc858d94">[email protected]</span></a>.

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]
BILLING CODE 4140-01-P


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