[Federal Register Volume 69, Number 77 (Wednesday, April 21, 2004)]
[Notices]
[Page 21565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9032]



[[Page 21565]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Institute of Environmental Health Sciences (NIEHS), 
National Institutes of Health (NIH), National Toxicology Program (NTP); 
Request for Nominations of Scientific Experts for Independent Expert 
Panel Evaluations and/or other Reviews of In Vitro Testing Methods for 
Identifying Potential Ocular Irritants

Summary

    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) is seeking nominations of scientific experts to evaluate the 
validation status of in vitro test methods for determining the 
potential ocular irritancy of chemicals and other substances. The 
experts will serve on future independent expert panel(s) or participate 
at other similar meetings and provide input on the usefulness, 
limitations, accuracy, and reliability of test methods proposed for 
identifying whether and to what extent substances may cause reversible 
or irreversible eye damage. The initial review activity will evaluate 
test methods that may be used to identify severe irreversible ocular 
irritation/corrosion. Applicable test methods anticipated for review 
include, but are not limited to: (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. Details about future meetings to 
evaluate the validation status of in vitro ocular toxicity test 
methods, including the date, location and availability of background 
documents, will be announced in the Federal Register and posted on the 
ICCVAM/NICEATM website (http://iccvam.niehs.nih.gov).

Request for Nominations of Experts

    NICEATM invites nominations of scientists with relevant knowledge 
and experience that can serve on independent expert panels or 
participate at other similar meetings to evaluate in vitro ocular 
toxicity test methods. Areas of relevant expertise include, but are not 
limited to: human and animal ophthalmology, with an emphasis on 
evaluation and treatment of chemical injuries; in vivo ocular toxicity 
testing; in vitro ocular toxicology (particularly experience with BCOP, 
IRE, ICE, and/or HET-CAM); test method validation; and biostatistics. 
Each nomination should include the person's name, affiliation, contact 
information (i.e., mailing address, e-mail address, telephone and fax 
numbers), a brief summary of relevant experience and qualifications, 
and curriculum vitae, if possible. Nominations should be sent to 
NICEATM by mail, fax, or e-mail within 45 days of the publication date 
of this notice. Correspondence should be directed to Dr. William 
Stokes, Director, NICEATM, NIEHS, 79 T.W. Alexander Dr., MD EC-17, P.O. 
Box 12233, Research Triangle Park, NC 27709; telephone: 919-541-2384; 
fax: 919-541-0947; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: In August 2003, the Scientific Advisory 
Committee on Alternative Toxicological Methods (SACATM) recommended 
that ICCVAM evaluate certain in vitro test methods for ocular toxicity 
that could be used to identify substances that cause irreversible 
ocular damage. The SACATM recommended that NICEATM and ICCVAM prepare a 
background review document and convene a workshop or other appropriate 
review activity. In October 2003, EPA submitted a nomination to ICCVAM 
that included a request to: (1) Review the validation status of four in 
vitro ocular test methods with the potential to screen chemicals for 
severe eye irritation or corrosion (BCOP, IRE, ICE, HET-CAM); (2) 
review the state of the science for other in vitro methods for 
assessing moderate or mild eye irritation; (3) obtain good quality in 
vivo eye irritation/corrosion reference data; and (4) to review ways to 
alleviate pain and suffering which might arise from current in vivo eye 
irritation testing. ICCVAM endorsed this nomination as a high priority. 
NICEATM published a Federal Register notice on March 24, 2004 (Vol. 69, 
No. 57, pages 13959-13861) inviting public comment on the nomination 
and related activities.
    NICEATM is preparing Background Review Documents on in vitro ocular 
test methods that will contain comprehensive summaries of available 
data, an analysis of the accuracy and reliability of available test 
method protocols, and related information characterizing the current 
validation status of these assays. NICEATM requested data on ocular 
irritancy for chemicals tested using in vivo and in vitro test methods 
in the March 24 Federal Register notice. Applicable data received in 
response to this notice will be included in the Background Review 
Documents and used to assess the performance of in vitro ocular 
toxicity test methods. Conclusions and recommendations from independent 
evaluations will be made publicly available and considered by ICCVAM in 
developing its recommendations on in vitro ocular toxicity test 
methods. ICCVAM recommendations will address the usefulness and 
limitations of the test methods for regulatory testing purposes and may 
include recommended standardized protocols, performance standards, and 
reference chemicals for future validation studies.

Background Information on ICCVAM and NICEATM

    ICCVAM is an interagency committee composed of representatives from 
fifteen 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 test methods 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) 
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: April 9, 2004.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 04-9032 Filed 4-20-04; 8:45 am]
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