[Federal Register Volume 70, Number 142 (Tuesday, July 26, 2005)]
[Notices]
[Page 43149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14707]



[[Page 43149]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP); NTP Interagency Center for the 
Evaluation of Alternative Toxicological Methods (NICEATM); Availability 
of Revised Analyses and Proposed Reference Substances for 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 analyses and proposed reference substances and 
request for comments.

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SUMMARY: NICEATM announces the availability of revised analyses for 
four in vitro test methods proposed for detecting ocular corrosives and 
severe irritants [the Bovine Corneal Opacity and Permeability (BCOP) 
assay, the Hen's Egg Test--Chorion Allantoic Membrane (HET-CAM), the 
Isolated Rabbit Eye (IRE) assay, and the Isolated Chicken Eye (ICE) 
assay]. A revised list of proposed reference substances for validation 
studies on in vitro test methods for identifying ocular corrosives and 
severe irritants is also available. The revised analyses and list of 
proposed reference substances are provided in an addendum that is 
applicable to each of four draft Background Review Documents (BRDs) 
that were released to the public on November 3, 2004. The NICEATM 
invites public comment on the information provided in this addendum. 
Copies of the draft BRDs and addendum may be obtained on the ICCVAM/
NICEATM Web site (http://iccvam.niehs.nih.gov see ``Reports & 
Background Documents''), or by contacting NICEATM at the address given 
below.

DATES: Written comments and additional information should be received 
by August 25, 2005.

ADDRESSES: Comments and additional information should be sent by mail, 
fax, or e-mail to Dr. Raymond Tice, at NICEATM, NIEHS, P. O. Box 12233, 
MD EC-17, Research Triangle Park, NC 27709, (phone) 919-541-4482, (fax) 
919-541-0947, (e-mail) [email protected]. Courier address: 
NICEATM, 79 T.W. Alexander Drive, Building 4401, Room 3113, Research 
Triangle Park, NC 27709

SUPPLEMENTARY INFORMATION:

Background

    On November 3, 2004, NICEATM released draft BRDs that provided 
information about the current validation status of four in vitro test 
methods for detecting ocular corrosives and severe irritants (Federal 
Register, Vol. 69, No. 212, pp. 64081-64082, November 3, 2004, 
available at http://iccvam.niehs.nih.gov/ see ``Reports & Background 
Documents''). The test methods are the BCOP assay, the HET-CAM assay, 
the IRE assay, and the ICE assay. NICEATM in conjunction with ICCVAM 
convened an expert panel meeting on January 11-12, 2005, to 
independently assess the validation status of the four in vitro test 
methods. The expert panel report is available electronically at http://iccvam.niehs.nih.gov/methods/eyeirrit.htm. Public comments at the 
meeting indicated that additional data could be made available that had 
not been provided in response to earlier requests for data announced in 
the Federal Register in March and November 2004 (Vol. 69, No. 212, pp. 
64081-64082, November 3, 2004; Vol. 69, No. 57, pp. 13859-13861, March 
24, 2004). The expert panel recommended that NICEATM conduct a 
reanalysis of the accuracy and reliability of each test method that 
would include these data. In response to this recommendation, NICEATM 
published a notice in the Federal Register (Vol. 70, No. 38, pp. 9661-
9662, February 28, 2005) requesting additional in vitro data on these 
four in vitro ocular irritancy test methods, corresponding in vivo 
rabbit eye test method data, as well as any human ocular exposure/
injury data (either from ethical human studies or accidental exposure). 
In response to this request, NICEATM received additional in vitro and 
in vivo data that were used for the revised analyses and considered in 
revising the list of proposed reference substances.
    The revised analyses and list of proposed reference substances are 
provided in an addendum that is applicable to each of four draft BRDs 
that were released to the public on November 3, 2004 (available at 
http://iccvam.niehs.nih.gov/ see ``Reports & Background Documents''). 
Following the public comment period, NICEATM in coordination with 
ICCVAM plans to reconvene the expert panel during a public 
teleconference to comment on the proposed reference substances and 
finalize their conclusions regarding the current validation status of 
the four methods for detecting ocular corrosives and severe irritants. 
The date and time for this teleconference will be announced in a future 
Federal Register announcement.

Request for Comments

    NICEATM invites the submission of written comments on the revised 
analyses and the proposed list of reference substances. 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 website and 
made available to the expert panel and ICCVAM.

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

    Dated: July 13, 2005.
David A. Schwartz,
Director, National Institute of Environmental Health Sciences and 
National Toxicology Program.
[FR Doc. 05-14707 Filed 7-25-05; 8:45 am]
BILLING CODE 4140-01-P