Newly approved ocular safety methods reduce anim...( Federal regulatory agencies have ac...),Health

Federal regulatory agencies have accepted recommendations of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) for two methods that can reduce live animal use for ocular safety testing, the committee announced today. ICCVAM is a permanent interagency committee composed of representatives from 15 federal regulatory and research agencies, including the National Institutes of Health (NIH) that use, generate or disseminate toxicology testing information.

The two alternative test methods, the bovine corneal opacity and permeability (BCOP) assay and the isolated chicken eye (ICE) assay, do not involve the use of live animals. These are the first scientifically valid alternative methods to gain regulatory acceptance for ocular safety testing.

The Consumer Product Safety Commission (CPSC), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA) concurred with the ICCVAM recommendations for the BCOP and ICE tests. CPSC will now accept these tests instead of the conventional ocular toxicity test for the purpose of classification for labeling under the Federal Hazardous Substance Act (15 U.S.C. 1261-1278).

"Based on an extensive database of product test results, the use of these two alternative test methods will likely reduce the use of live animals for eye safety testing by 10 percent or more," stated William Stokes, D.V.M., the executive director of ICCVAM and director of the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods NICEATM). "More importantly, the use of these tests will eliminate the testing in animals of most substances likely to cause the most severe pain and discomfort."

If a positive response is obtained using either of the two new approved alternative methods, the product can be labeled as causing irreversible or severe eye damage and no live animal testing will be required. If the response is negative, the product is
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