[Federal Register Volume 72, Number 109 (Thursday, June 7, 2007)]
[Notices]
[Pages 31582-31583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10966]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP) Interagency Center for the 
Evaluation of Alternative Toxicological Methods (NICEATM); Request for 
Ocular Irritancy Test Data From Human, Rabbit, and In Vitro Studies 
Using Standardized Testing Methods

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

ACTION: Request for submission of relevant data.

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SUMMARY: The Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) and NICEATM are collaborating with the 
European Centre for the Validation of Alternative Methods (ECVAM) to 
evaluate the validation status of in vitro test methods for assessing 
the ocular irritation potential of substances. On behalf of the ICCVAM, 
NICEATM requests data on substances tested for ocular irritancy in 
humans, rabbits, and/or in vitro. These data will be used to: (1) 
Review the state-of-the-science in regard to the availability of 
accurate and reliable in vitro test methods for assessing the range of 
potential ocular irritation activity, including whether ocular damage 
is reversible or not and (2) expand NICEATM's high-quality ocular 
toxicity database. In vitro test methods for which data are sought 
include, but are not limited to: (1) The Bovine Corneal Opacity and 
Permeability (BCOP) test, (2) the Isolated Rabbit Eye (IRE) test, (3) 
the Isolated Chicken Eye (ICE) test, and (4) the Hen's Egg Test--
Chorioallantoic Membrane (HET-CAM).

DATES: Data should be received by July 23, 2007. Data received after 
this date will be considered as feasible.

ADDRESSES: Dr. William S. Stokes, NICEATM Director, NIEHS, P.O. Box 
12233, MD EC-17, Research Triangle Park, NC 27709, (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. Responses can be submitted electronically at the ICCVAM-NICEATM 
Web site: http://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm or by 
e-mail, mail, or fax.

FOR FURTHER INFORMATION CONTACT: Other correspondence should be 
directed to Dr. William S. Stokes (919-541-2384 or 
[email protected]).

SUPPLEMENTARY INFORMATION:

Background

    In October 2003, the U.S. Environmental Protection Agency (EPA) 
submitted to ICCVAM a nomination with several activities related to 
reducing, replacing, and refining the use of rabbits in the current in 
vivo eye irritation test method (Federal Register Vol. 69, No. 57, pp 
13859-13861, March 24, 2004). In response to this nomination, ICCVAM 
completed an evaluation of the validation status of the BCOP, ICE, IRE, 
and HET-CAM test methods for identifying severe (irreversible) ocular 
irritants/corrosives using the United Nations Globally

[[Page 31583]]

Harmonized System of Classification and Labeling of Chemicals (GHS), 
the EPA, and the European Union hazard classification systems. NICEATM 
and ICCVAM prepared a comprehensive background review document (BRD) on 
each of the four in vitro test methods. Each BRD included an analysis 
of test method performance (i.e., reliability and relevance) as 
compared to the in vivo rabbit eye reference test method, based on all 
available data. ICCVAM developed recommendations on the usefulness and 
limitations of these in vitro test methods for identifying ocular 
corrosives/severe irritants after considering the BRDs, comments 
received from the public and the Scientific Advisory Committee on 
Alternative Toxicological Methods (SACATM), and comments and 
recommendations received from an independent expert panel (Federal 
Register Vol. 70, No. 53, pp 13513-13514, March 21, 2005 and Vol. 70, 
No. 211, p 66451, November 2, 2005).
    ICCVAM is now reviewing the validation status of these and other in 
vitro test methods for identifying nonsevere ocular irritants (i.e., 
those that induce reversible ocular damage) and non-irritants.

Request for Data

    As part of the review process, NICEATM requests the submission of 
data from substances tested for ocular irritancy in humans, rabbits, 
and/or in vitro. Data received by July 23, 2007 will be compiled and 
added to the database maintained by NICEATM and utilized where 
appropriate in the evaluation of in vitro ocular irritation test 
methods. Data received after this date will also be considered and used 
where applicable for future evaluation activities. All information 
submitted in response to this notice will be made publicly available 
upon request to NICEATM.
    When submitting substance and protocol information/test data, 
please reference this Federal Register notice and provide appropriate 
contact information (name, affiliation, mailing address, phone, fax, e-
mail, and sponsoring organization, as applicable).
    NICEATM prefers data to be submitted as copies of pages from study 
notebooks and/or study reports, if available. Raw data and analyses 
available in electronic format may also be submitted. Each submission 
for a substance should preferably include the following information, as 
appropriate:
     Common and trade name.
     Chemical Abstracts Service Registry Number (CASRN).
     Chemical and/or product class.
     Commercial source.
     In vitro test protocol used.
     Rabbit eye test protocol used.
     Human eye test protocol used.
     Individual animal/human or in vitro responses at each 
observation time (i.e., raw data).
     The extent to which the study complied with national/
international Good Laboratory Practice (GLP) guidelines.
     Date and testing organization.
    Additional information on the submission of data may be obtained at 
http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox.htm.

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, or replace 
animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3, 
available at http://iccvam.niehs.nih.gov/docs/about_docs/PL106545.pdf) 
established ICCVAM as a permanent interagency committee of the NIEHS 
under 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 federal agencies. Additional information 
about ICCVAM and NICEATM is available on the following Web site: http://iccvam.niehs.nih.gov.

    Dated: May 25, 2007.
Samuel H. Wilson,
Deputy Director,National Institute of Environmental Health Sciences and 
National Toxicology Program.
 [FR Doc. E7-10966 Filed 6-6-07; 8:45 am]
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