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Tuesday, February 5, 2008, 12:00 p.m. EDT
A new plan to further reduce, refine and replace the use of animals in research and regulatory testing commonly referred to as the 3Rs was unveiled today at a symposium marking the 10-year anniversary of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). The plan identifies priority areas for research, development, translation, and validation activities necessary to achieve regulatory acceptance of alternative test methods. A cornerstone of the federal government's five-year plan is the formation of partnerships with industry and other national and international stakeholders to achieve measurable progress.
"ICCVAM has a proven track record of thoroughly reviewing test methods and has established an excellent blueprint for advancing the 3Rs, and for advancing the health and safety of our nation as well," said Marilyn Wind, Ph.D., deputy associate executive director of the Consumer Product Safety Commission (CPSC) and the chair, ICCVAM. Wind was one of many scientists, public attendees, advocates, media and invited guests participating in a scientific symposium celebrating the 10-year anniversary of ICCVAM in Bethesda, Md., where the plan was released. 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 toxicological information. ICCVAM promotes the development, validation, and regulatory acceptance of scientifically sound new, revised, and alternative testing methods that protect human and animal health and the environment.
Traditionally, chemicals, consumer products, medical devices and new drugs are tested on animals to predict toxicity on humans, but scientists, like those involved in ICCVAM, are working to promote the development and validation of alternative test methods. Alternative test methods are those that accomplish one or more of the 3Rs of reducing the number of animals used in testing, or refining procedures so animals experience less pain and distress, or replacing animals with non-animal systems.
William Stokes, D.V.M., director of NICEATM, the NTP office at the National Institute of Environmental Health Sciences (NIEHS) that administers ICCVAM, highlighted some of the progress made since ICCVAM was formed, including the fact that ICCVAM has evaluated more than185 test methods http://ntp.niehs.nih.gov/iccvam/docs/ocutox_docs/ste-srd-niceatm-rev-508.pdf since its inception in 1997. Many of these methods need further development and validation before they are ready for regulatory consideration. However, several are now in widespread use around the world for routine safety testing, resulting in notable reduction and refinement of animal use. "We've made great progress in the past decade, and with the help of our partners we can do even more to increase the pace of developing and introducing alternative methods." Stokes, who is also an Assistant Surgeon General in the U.S. Public Health Service Commissioned Corps explained that ICCVAM itself does not conduct research but carefully evaluates alternative test methods brought forth by government and industry labs and makes recommendations about their usefulness to federal regulatory agencies.
"We appreciate all of the public input we've received to develop this plan and look forward to working closely with our government and non-government stakeholders to promote good science and validation studies that will support the regulatory use of alternative methods," said Stokes. "By incorporating recent advances in science and technology, new alternative test methods can be developed that will benefit animal welfare by reducing, refining, and replacing animal use, and that will benefit public health by ensuring continued or improved protection of human and animal health and the environment."
Stokes said ICCVAM will emphasize the use of new technologies to develop predictive systems that would be less reliant or not at all reliant on animals. Technologies touted by the National Research Council and the NTP, including high throughput screening techniques that can screen large numbers of potentially hazardous chemicals at one time and toxicogenomics, for example, will be studied and incorporated where they can to provide more accurate and timely public health decisions.
Stokes said a high priority for ICCVAM will be to focus on evaluating alternatives to test methods that use a large number of animals or that can involve significant pain and stress, including safety tests for ocular (eye) injuries, dermal (skin) damage, acute poisoning and tests for biologics such as vaccines. Additional priorities include safety tests to determine if products and chemicals may cause other adverse health effects such as cancer, birth defects, infertility and allergic responses.
The five-year plan was developed over a 12-month period with multiple opportunities for input, including a public Town Meeting held in June 2006. The NICEATM–ICCVAM Five-Year Plan is available electronically at http://iccvam.niehs.nih.gov/docs/5yearplan.htm (If you have problems accessing this document, please contact Cheryl Thompson, 919-541-3345).
About the National Institute of Environmental Health Sciences (NIEHS): NIEHS supports research to understand the effects of the environment on human health and is part of the National Institutes of Health. For more information on NIEHS or environmental health topics, visit www.niehs.nih.gov or subscribe to a news list.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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