[Federal Register: November 26, 2007 (Volume 72, Number 226)]
[Notices]
[Page 65964-65965]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26no07-44]
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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 the Interagency Coordinating Committee on the Validation of
Alternative Methods (ICCVAM) Test Method Evaluation Report on In Vitro
Ocular Toxicity Test Methods for Identifying Severe Irritants and
Corrosives and Final In Vitro Ocular Test Method Background Review
Documents; Notice of Transmittal of ICCVAM Test Method Recommendations
to Federal Agencies
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH).
ACTION: Availability of ICCVAM Test Method Evaluation Report and Final
Background Review Documents.
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SUMMARY: NICEATM announces availability of the ICCVAM Test Method
Evaluation Report: In Vitro Ocular Toxicity Test Methods for
Identifying Severe Irritants and Corrosives (NIH Publication 07-4517).
The report describes four ocular toxicity test methods evaluated by
ICCVAM: (1) The Bovine Corneal Opacity and Permeability [BCOP] test,
(2) the Isolated Chicken Eye [ICE] test, (3) the Isolated Rabbit Eye
[IRE] test, and (4) the Hen's Egg Test--Chorioallantoic Membrane [HET-
CAM]. The report includes ICCVAM's (a) final test method
recommendations on the use of these four in vitro test methods, (b)
recommended test method protocols for future testing, (c)
recommendations for further optimization and validation studies for
these test methods, and (d) recommended reference substances for
validation studies. The report recommends that the BCOP and ICE
methods, with specific limitations for certain chemical classes and/or
physical properties, can be used in a tiered testing strategy to
determine ocular hazards, and substances that test positive can be
classified as ocular corrosives or severe irritants without further
testing in animals. The report also recommends that these in vitro test
methods should be considered before using animals for ocular testing
and used when determined appropriate.
NICEATM also announces availability of the final Background Review
Documents (BRDs) for the BCOP, ICE, IRE, and HET-CAM test methods (NIH
Publications 06-4512, 06-4513, 06-4514, and 06-4515, respectively).
These BRDs provide the data and analyses used to assess the current
validation status of these four test methods for identifying ocular
corrosives and severe irritants.
Electronic copies of the ICCVAM Test Method Evaluation Report and
the four BRDs are available from the NICEATM/ICCVAM Web site at http://iccvam.niehs.nih.gov
or by contacting NICEATM (see FOR FURTHER
INFORMATION CONTACT). The ICCVAM Test Method Evaluation Report and the
final BRDs have been forwarded to U.S. Federal agencies for regulatory
and other acceptance considerations where applicable. Responses will be
posted on the ICCVAM/NICEATM Web site as they are received.
FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, Director,
NICEATM,
[[Page 65965]]
NIEHS, P.O. Box 12233, MD EC-17, Research Triangle Park, NC 27709,
(phone) 919-541-2384, (fax) 919-541-0947, (e-mail)
niceatm@niehs.nih.gov. Courier address: NICEATM, NIEHS, 79 T.W.
Alexander Drive, Building 4401, Room 3128, Research Triangle Park, NC
27709.
SUPPLEMENTARY INFORMATION:
Background
In 2003, the Scientific Advisory Committee on Alternative
Toxicological Methods (SACATM) and U.S. Environmental Protection Agency
(EPA) recommended that ICCVAM review the validation status of screening
test methods that could be used to identify severe and irreversible
ocular effects. ICCVAM unanimously agreed that the four in vitro test
methods (IRE, ICE, BCOP, and HET-CAM) nominated by EPA should have high
priority for evaluation. On March 24, 2004, NICEATM published a Federal
Register notice (Vol. 69, No. 57, pp. 13859-13861) requesting all
available data on these four in vitro ocular irritancy test methods and
corresponding data from in vivo rabbit eye test methods, as well as any
human exposure data (obtained either from ethical human studies or by
accidental exposure). NICEATM subsequently compiled data and
information on each test method and released four draft BRDs for public
comment on November 3, 2004 (Federal Register, Vol. 69, No. 212, pp.
64081-64082).
On January 11-12, 2005, NICEATM, on behalf of ICCVAM, convened an
expert panel meeting to independently assess the validation status of
these four test methods. The panel's report was released in March 2005
(Federal Register, Vol. 70, No. 53, pp 13513). Public comments at this
meeting indicated that additional data on these in vitro test methods
could be made available; therefore, the panel recommended that NICEATM
obtain the additional data and reanalyze the accuracy and reliability
of each test method. On February 28, 2005, NICEATM again solicited in
vitro data on these four test methods and corresponding in vivo data
(Federal Register, Vol. 70, No. 38, pp. 9661-9662). The revised
analyses were published on July 26, 2005, as an addendum to the draft
BRDs (Federal Register, Vol. 70, No. 142, pp. 43149).
NICEATM, on behalf of ICCVAM, reconvened the panel on September 19,
2005, to discuss the addendum to the draft BRDs (Federal Register, Vol.
70, No. 174, pp. 53676-53677). An addendum to the panel report was
published in November 2005 (Federal Register, Vol. 70, No. 211, pp.
66451). At its December 2005 meeting, the SACATM discussed and provided
comments on the panel report and addendum (Federal Register, Vol. 70,
No. 216, pp. 68069-68070) (minutes from that meeting are available at
http://ntp.niehs.nih.gov/go/8202).
ICCVAM considered the expert panel report and its addendum, public
comments, SACATM comments, and the draft BRDs and their addendums in
finalizing its recommendations on the validation status of these four
test methods. The ICCVAM Test Method Evaluation Report includes the
ICCVAM recommendations on the use of each test method, as well as
recommended test method protocols, recommendations for further
optimization and validation studies, recommended reference substances
for future validation studies, the panel report and its addendum, and
Federal Register notices. The four final BRDs, which provide the
supporting documentation for this report, are available as separate
documents. The ICCVAM Test Method Evaluation Report and the supporting
final BRDs were forwarded to U.S. Federal agencies for their
consideration for regulatory acceptance as required by the ICCVAM
Authorization Act of 2000 (42 U.S.C. 285l-3). Agencies' responses to
the test method recommendations will be posted on the ICCVAM/NICEATM
Web site as they are received.
Background Information on ICCVAM, NICEATM, and SACATM
ICCVAM is an interagency committee composed of representatives from
15 Federal regulatory and research agencies that use, generate, or
disseminate 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
established ICCVAM as a permanent interagency committee of the NIEHS
under NICEATM. NICEATM administers 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 U.S. Federal agencies. Additional
information about ICCVAM and NICEATM can be found on their Web site
(http://iccvam.niehs.nih.gov).
SACATM was established January 9, 2002, and is composed of
scientists from the public and private sectors (Federal Register, Vol.
67, No. 49, page 11358). SACATM provides advice to the Director of the
NIEHS, to ICCVAM, and to NICEATM regarding the statutorily mandated
duties of ICCVAM and activities of NICEATM. Additional information
about SACATM, including the charter, roster, and records of past
meetings, can be found at http://ntp.niehs.nih.gov/ see ``Advisory Board & Committees'' (or directly at http://ntp.niehs.nih.gov/go/167).
Dated: November 13, 2007.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences
and National Toxicology Program.
[FR Doc. E7-22906 Filed 11-23-07; 8:45 am]
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