[Federal Register Volume 77, Number 196 (Wednesday, October 10, 2012)]
[Notices]
[Pages 61610-61611]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24868]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Interagency Coordinating Committee on the Validation of 
Alternative Methods Evaluation Report and Recommendations for 
Identifying Chemical Eye Hazards With Fewer Animals; Availability of 
Report; Notice of Transmittal to Federal Agencies

SUMMARY: The NTP Interagency Center for the Evaluation of Alternative 
Toxicological Methods (NICEATM) announces availability of an 
Interagency Coordinating Committee on the Validation of Alternative 
Methods (ICCVAM) test method evaluation report (TMER) that provides 
recommendations for identifying chemical eye hazards with fewer 
animals.
    ICCVAM concludes that using a classification criterion of one or 
more positive animals in a three-animal test to identify chemicals and 
products that are eye hazards will maintain hazard classification 
equivalent to that provided by current testing procedures, while using 
up to 50% to 83% fewer animals. ICCVAM recommends consideration of this 
classification criterion together with eye safety testing procedures 
that use a maximum of three animals per test substance. This 
recommendation also harmonizes the number of animals used for eye 
safety testing across U.S. regulatory agencies and international test 
guidelines.
    The report and recommendations have been transmitted to Federal 
agencies for their review and response to ICCVAM.

FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, Director, 
NICEATM, National Institute of Environmental Health Sciences (NIEHS), 
P.O. Box 12233, Mail Stop: K2-16, Research Triangle Park, NC 27709. 
Phone: 919-541-2384, Fax: 919-541-0947, Email: niceatm@niehs.nih.gov. 
Hand Deliver/Courier address: NICEATM, NIEHS, Room 2034, 530 Davis 
Drive, Morrisville, NC 27560.

SUPPLEMENTARY INFORMATION:
    Background: Eye safety testing procedures vary among U.S. agencies. 
Current testing procedures specified in the U.S. Code of Federal 
Regulations (16 CFR 1500.42) provide criteria and procedures for 
identifying eye hazards based on rabbit eye test results (CPSC,

[[Page 61611]]

2010); however, current testing procedures (16 CFR 1500.42) do not 
provide criteria to classify results obtained from a three-animal test. 
NICEATM, in collaboration with ICCVAM, conducted an analysis to 
determine classification criteria based on results from a three-animal 
test that would maintain hazard classification equivalent to that 
provided by current testing procedures (16 CFR 1500.42).
    The process for developing the ICCVAM recommendations began with a 
critical review of the analysis (Haseman et al., 2011) and existing 
data by the ICCVAM Interagency Ocular Toxicity Working Group (OTWG). As 
part of ICCVAM's ongoing international collaborations, scientists from 
the European Union Reference Laboratory for Alternatives to Animal 
Testing and the Japanese Center for the Validation of Alternative 
Methods served as liaisons to the OTWG. The analysis (Haseman et al., 
2011) was provided to the Scientific Advisory Committee on Alternative 
Toxicological Methods (SACATM) at the June 17-18, 2010 meeting (75 FR 
26758, May 12, 2010) for comment. The public was also given an 
opportunity to comment at that meeting. The OTWG then developed draft 
ICCVAM recommendations regarding classification criteria based on 
results from a three-animal test that would maintain hazard 
classification equivalent to that provided by current testing 
procedures (16 CFR 1500.42). The draft ICCVAM recommendations and 
supporting analysis (Haseman et al., 2011) were made available on the 
NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov/methods/ocutox/reducenum.htm) for comment by the broad stakeholder community (76 FR 
50220, August 12, 2011).
    ICCVAM considered the analysis (Haseman et al., 2011), all public 
comments, and the SACATM comments in preparing the final ICCVAM test 
method recommendations. The recommendations are provided in the ICCVAM 
Test Method Evaluation Report: Identifying Chemical Eye Hazards with 
Fewer Animals (NIH Publication No. 12-7930), which is available on the 
NICEATM-ICCVAM Web site (http://iccvam.niehs.nih.gov/methods/ocutox/reducenum-TMER.htm). ICCVAM concludes that using a classification 
criterion of one or more positive animals in a three-animal test to 
identify chemicals and products that are eye hazards will maintain 
hazard classification equivalent to that provided by current testing 
procedures (16 CFR 1500.42 [CPSC, 2010]), while using up to 50% to 83% 
fewer animals. ICCVAM, therefore, recommends consideration of this 
classification together with eye safety testing procedures that use a 
maximum of three animals per test substance. Consistent with ICCVAM's 
duty to foster interagency and international harmonization (42 U.S.C. 
285l-3), this recommendation harmonizes the number of animals used for 
eye safety testing across U.S. regulatory agencies and international 
test guidelines. The ICCVAM TMER includes relevant ocular toxicity 
regulations and guidelines, applicable Federal Register notices, public 
comments, and SACATM meeting minutes.

Background Information on ICCVAM, NICEATM, and SACATM

    ICCVAM is an interagency committee composed of representatives from 
15 Federal regulatory and research agencies that require, use, 
generate, or disseminate toxicological and safety testing information. 
ICCVAM conducts technical evaluations of new, revised, and alternative 
safety testing methods and integrated testing strategies with 
regulatory applicability and promotes the scientific validation and 
regulatory acceptance of testing methods that more accurately assess 
the safety and hazards of chemicals and products and that reduce, 
refine (enhance animal well-being and lessen or avoid pain and 
distress), or replace animal use. The ICCVAM Authorization Act of 2000 
(42 U.S.C. 285l-3) established ICCVAM as a permanent interagency 
committee of the NIEHS under NICEATM. NICEATM administers ICCVAM, 
provides scientific and operational support for ICCVAM-related 
activities, and conducts independent validation studies to assess the 
usefulness and limitations of new, revised, and alternative test 
methods and strategies. NICEATM and ICCVAM welcome the public 
nomination of new, revised, and alternative test methods and strategies 
for validation studies and technical evaluations. Additional 
information about NICEATM and ICCVAM can be found on the NICEATM-ICCVAM 
Web site (http://iccvam.niehs.nih.gov).
    SACATM was established in response to the ICCVAM Authorization Act 
(Section 285l-3[d]) and is composed of scientists from the public and 
private sectors. SACATM advises ICCVAM, NICEATM, and the Director of 
the NIEHS and NTP regarding statutorily mandated duties of ICCVAM and 
activities of NICEATM. SACATM provides advice on priorities and 
activities related to the development, validation, scientific review, 
regulatory acceptance, implementation, and national and international 
harmonization of new, revised, and alternative toxicological test 
methods. Additional information about SACATM, including the charter, 
roster, and records of past meetings, can be found at http://ntp.niehs.nih.gov/go/167.

References

    CPSC. 2010. Federal Hazardous Substances Act Regulations. 16 CFR 
1500. Available: http://www.gpo.gov/fdsys/pkg/CFR-2011-title16-vol2/pdf/CFR-2011-title16-vol2-chapII-subchapC.pdf.
    Haseman J.K., Allen D.G., Lipscomb E.A., Truax J.F., Stokes WS. 
2011. Using fewer animals to identify chemical eye hazards: revised 
criteria necessary to maintain equivalent hazard classification. Regul 
Toxicol Pharmacol 61: 98-104.

    Dated: October 3, 2012.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2012-24868 Filed 10-9-12; 8:45 am]
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