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The status of eye irritancy testing: a regulatory perspective.

Eye irritation testing is a salient public issue and continues to escalate on the public agenda. Issues relevant to this milieu include legislative proposals to ban animal use for cosmetic testing, adequacy of the current standard (viz., the Draize Eye Irritancy Test), availability of non-animal methodologies, validation paradigm for new testing models, international harmonization of testing standards and methods, and the regulatory role in product testing and enforcement. The Food and Drug Administration (FDA) feels that enactment of legislation proposed to ban animal use from testing products for safety would pose serious problems from a public health perspective. FDA encourages the development of alternative test methods and is aware that many such tests are in various stages of evolution. At this time, however, none of these tests has been accepted by the scientific community as total replacement to the Draize test. FDA's basic positions on the use of non-animal alternatives are as follows: 1) The use of animal tests by industry to establish the safety of regulated products is necessary to minimize the risks from such products to humans, 2) The Draize eye irritancy test is currently the most valuable and reliable method for evaluating the hazard or safety of a substance introduced into or around the human eye, and 3) No non-animal tests are presently available to completely replace the Draize. FDA is actively involved with U.S. and international groups to harmonize protocols for product development, evaluate the current status of non-whole animal methodologies, and standardize testing requirements. The Agency has recently participated in several scientific symposia evaluating the status of non-whole animal methods in toxicity testing. Moreover, FDA representatives are currently scheduled to participate in international meetings and workshops planned for the immediate future addressing several issues in product safety determination.