[Federal Register Volume 70, Number 53 (Monday, March 21, 2005)]
[Notices]
[Pages 13513-13514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5473]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Toxicology Program; National Toxicology Program (NTP) 
Interagency Center for the Evaluation of Alternative Toxicological 
Methods (NICEATM); Availability of Expert Panel Report on the 
Evaluation of the Current Validation Status of In Vitro Test Methods 
for Identifying Ocular Corrosives and Severe Irritants

AGENCY: National Institute of Environmental Health Sciences (NIEHS), 
National Institutes of Health (NIH).

ACTION: Availability of report and request for comments.

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SUMMARY: The National Toxicology Program (NTP) Interagency Center for 
the Evaluation of Alternative Toxicological Methods (NICEATM) announces 
the availability of a report entitled, ``The Interagency Coordinating 
Committee on the Validation of Alternative Methods (ICCVAM) Expert 
Panel Evaluation of the Current Validation Status of In Vitro Test 
Methods for Identifying Ocular Corrosives and Severe Irritants.'' The 
NICEATM invites public comment on the expert panel report. Copies of 
the expert panel report may be obtained on the ICCVAM/NICEATM Web site 
at http://iccvam.niehs.nih.gov, or by contacting NICEATM at the address 
given below.

DATES: Written comments and additional information should be received 
by noon on May 5, 2005.

ADDRESSES: Comments and additional information should be sent by mail, 
fax, or e-mail to Dr. William S. Stokes, Director of NICEATM, at 
NICEATM, NIEHS, P. O. Box 12233, MD EC-17, Research Triangle Park, NC 
27709, (phone) 919-541-2384, (fax) 919-541-0947, (e-mail) 
[email protected]. Courier address: NICEATM, 79 T.W. Alexander 
Drive, Building 4401, Room 3128, Research Triangle Park, NC 27709.

FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, Director of 
NICEATM, (phone) 919-541-2384, (e-mail) [email protected].

SUPPLEMENTARY INFORMATION:

Background

    On January 11 and 12, 2005, NICEATM and ICCVAM held an expert panel 
meeting to evaluate the validation status for four in vitro ocular test 
methods nominated by the EPA: (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. At this meeting, the expert panel 
reviewed the Background Review Document (BRD) for each method and was 
asked to:
     Evaluate the extent and adequacy that each method's BRD 
addresses the applicable ICCVAM validation and acceptance criteria 
based on available information and data, or will address the criteria 
in proposed studies, focused on identifying ocular corrosives and 
severe irritants in a tiered testing strategy.
     Develop conclusions and recommendations on:
--The current usefulness and limitations of each of the four test 
methods for identifying ocular corrosives and severe/irreversible 
irritants.
--The test method protocol that should be used for future testing and 
validation studies.
--The adequacy of proposed optimization and/or validation studies.
--The adequacy of reference substances proposed for future validation 
studies.
    The expert panel's conclusions and recommendations on the four test 
methods are described in ``The ICCVAM Expert Panel Evaluation of the 
Current Validation Status of In Vitro Test Methods for Identifying 
Ocular Corrosives and Severe Irritants''.
    Prior to the expert panel meeting, NICEATM issued several Federal 
Register notices to (1) request public comment on the EPA nomination of 
ocular toxicity test methods and related activities and request data on 
chemicals evaluated by in vitro or in vivo ocular irritancy test 
methods (Federal Register, Vol. 69, No. 57, pp. 13859-13861, March 24, 
2004, available at http://iccvam.niehs.nih.gov/); (2) request the 
nomination of scientific experts to serve on the expert panel (Federal 
Register, Vol. 69, No. 77, pg. 21565, April 21, 2004, available at 
http://iccvam.niehs.nih.gov/); and (3) request public comments on the 
BRDs prepared by NICEATM for each of the four test methods (Federal 
Register, Vol. 69, No. 212, pp. 64081-64082, November 3, 2004, and 
public comments are available at http://iccvam.niehs.nih.gov/).

Request for Comments

    NICEATM invites the submission of written comments on the expert 
panel report. When submitting written comments please include 
appropriate contact information (name, affiliation, mailing address, 
phone, fax, email and sponsoring organization, if applicable). All 
written comments received by the deadline listed above will be posted 
on the ICCVAM/NICEATM Web site and made available to ICCVAM.
    ICCVAM will consider the expert panel report and any written public 
comments received on that report as it prepares final ICCVAM test 
method recommendations for the four in vitro ocular test methods. An 
ICCVAM test method evaluation report, which includes the ICCVAM 
recommendations, will be forwarded to appropriate Federal agencies for 
their consideration. This report also will be available to the public 
on the ICCVAM/NICEATM Web site and by request to NICEATM.

Background Information on ICCVAM and NICEATM

    ICCVAM is an interagency committee composed of representatives from 
15 Federal regulatory and research agencies that use or generate 
toxicological information. ICCVAM conducts technical evaluations of 
new, revised, and alternative methods with regulatory applicability, 
and promotes the scientific validation and regulatory acceptance of 
toxicological test methods that more accurately assess the safety and 
hazards of chemicals and products and that refine, reduce, and replace 
animal use. The ICCVAM Authorization Act of 2000 (Pub. L. 106-545, 
available at http://iccvam.niehs.nih.gov/about/PL106545.htm) 
establishes ICCVAM as a permanent interagency committee of the NIEHS 
under the NICEATM. NICEATM administers the ICCVAM and provides 
scientific and operational support for ICCVAM-related activities. 
NICEATM and ICCVAM work collaboratively to evaluate new and improved 
test methods applicable to the needs of

[[Page 13514]]

Federal agencies. Additional information about ICCVAM and NICEATM can 
be found at the following Web site: http://iccvam.niehs.nih.gov.

    Dated: March 9, 2005.
Samuel Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 05-5473 Filed 3-18-05; 8:45 am]
BILLING CODE 4140-01-P