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New eye safety test methods proposed by interagency group

By Debbie McCarley
October 2010

Over the next six months, federal regulatory agencies will consider adopting new test methods and strategies applicable to safety testing required to identify chemicals and products that may cause eye injuries. The recommendations (http://iccvam.niehs.nih.gov/methods/ocutox/Transmit-2010.htm), including several in vitro safety testing methods and a testing strategy that does not require the use of animals, were developed by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) (http://iccvam.niehs.nih.gov/), which is administered by a center that is part of the National Toxicology Program at NIEHS.

NIEHS/NTP Director Linda Birnbaum, Ph.D., forwarded the ICCVM recommendations Sept 7 on behalf of U.S. Secretary of Health and Human Services Kathleen Sebelius. ICCVAM, an interagency committee of the U.S. Federal government, is administered by the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), directed by Rear Admiral William Stokes, D.V.M., who also serves as executive director of ICCVAM. The recommendations appear in an announcement (http://iccvam.niehs.nih.gov/SuppDocs/FedDocs/FR/FR-2010-23262.pdf)  Download Adobe Reader (58 KB) published Sept. 17 in the Federal Register.

"Routine use of the recommended pain management procedures for eye safety testing will ensure that animals are used in the most humane way possible, while providing information necessary to help protect the public from eye injuries that might result from chemicals and products," Stokes explained. "Routine consideration and use of the in vitro methods where appropriate will also reduce animal use required for such testing."

To protect workers and consumers, regulatory agencies require testing to determine if chemicals and products may cause temporary or permanent eye injuries such as blindness. Each year, approximately two million eye injuries occur in the U.S., of which more than 40,000 result in permanent visual impairment. Household cleaning chemicals and other chemical products are the leading cause of consumer product-related eye injuries in children under age 10. Adoption and implementation of the ICCVAM recommendations are expected to support continued protection of public health, while contributing to more humane and reduced animal use for required product safety testing.

ICCVAM recommended that pain management procedures should always be used whenever it is necessary to use rabbits for eye safety testing required by federal regulatory agencies. The ICCVAM evaluation report includes a test method protocol that describes how to use topical anesthetics, similar to those used in human eye surgeries, and systemic analgesics prior to and after test substance administration in order to avoid or minimize animal pain and distress. The report also identifies specific clinical signs and lesions that, if observed during animal testing, can be used as humane endpoints to allow the investigator to end a study early in order to reduce or avoid potential animal pain and distress.

The current recommendations are the latest from a series of NICEATM and ICCVAM evaluations of non-animal test methods for identifying potential eye injury hazards. In 2008, federal agencies accepted the first two in vitro test methods recommended by ICCVAM that can be used to identify substances that cause the most severe eye injuries without the use of animals. All federal agencies also accepted or endorsed the ICCVAM recommendations. These recommendations were used to develop international test guidelines that were adopted last year by the 32 member countries of the Organisation for Economic Co-operation and Development.

Federal agencies must respond regarding their acceptance of the current ICCVAM test method recommendations within 180 days.

(Debbie McCarley is the special assistant to Rear Admiral William Stokes, D.V.M., D.A.C.L.A.M., director of the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods.)

Members of the ICCVAM Ocular Toxicity Working Group
Members of the ICCVAM Ocular Toxicity Working Group are shown during a recent meeting. Shown in the front, left to right, are Donnie Lowther, U.S. Food and Drug Administration (FDA); Working Group Chair Jill Merrill, Ph.D., FDA; Marilyn Wind, Ph.D., former ICCVAM chair; and Jodie Kulpa-Eddy, D.V.M., U.S. Department of Agriculture, ICCVAM vice chair and acting chair. Shown in the back, left to right, are Masih Hashim, D.V.M., Ph.D., U.S. Environmental Protection Agency (EPA); Debbie McCall, EPA; John Redden, EPA; Meta Bonner, Ph.D., EPA; William Stokes, D.V.M., NICEATM director. (Photo courtesy of William Stokes)

ICCVAM recommendations

The ICCVAM and the Ocular Toxicity Working Group (OTWG) developed the recommendations with scientific support from NICEATM. The OTWG is chaired by Jill Merrill, Ph.D., of the Food and Drug Administration (FDA) and includes scientists from the U.S. Consumer Product Safety Commission, the U.S. Department of Defense, the U.S. Department of Transportation, the U.S. Environmental Protection Agency, FDA, NIEHS, and the Occupational Safety and Health Administration.

Several NIEHS scientists serve on the working group and contributed to the ICCVAM evaluations and recommendations, including Warren Casey, Ph.D., Mark Cesta, D.V.M., Buck Grissom, Ph.D., and William Stokes, D.V.M.

The ICCVAM test method evaluation reports, which contain the complete ICCVAM recommendations, are available on the NICEATM-ICCVAM Website. Along with an overview(http://iccvam.niehs.nih.gov/methods/ocutox/ocutox.htm) of the ICCVAM evaluation of ocular safety testing methods, this site contains links to pages with more detailed information on each of the ICCVAM evaluations of ocular toxicity test methods, including test method evaluation reports.



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