Environmental Factor, August 2007, National Institute of Environmental Health Sciences
NTP Board Calls for Expediting Alternative Testing Methods
By Eddy Ball
August 2007
As the final item on its June 22 meeting agenda, the National Toxicology Program (NTP) Board of Scientific Counselors (BSC) reviewed a draft five-year plan to encourage research, development and validation efforts that will lead to alternative approaches to regulatory testing using animals. William Stokes, D.V.M., director of the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and executive director of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) presented the BSC with an overview of the history and progress of the plan’s development.
The draft NICEATM /ICCVAM five-year plan, which has undergone a period of public comment that included a Town Meeting in early June attended by more than 90 stakeholders, is currently in revision for expected public release in late 2007. "We’re looking forward to considering all of the public input we’ve received and assessing how we can make a more effective plan for the future," Stokes explained.
Several members echoed the points articulated in Stokes’ report and expressed in public comments calling for ICCVAM to work to try to help increase the pace of developing and introducing alternative methods. ICCVAM depends on government and industry labs to develop, validate and submit alternative test methods for ICCVAM consideration. ICCVAM then carries out a careful review of their scientific validity and forwards recommendations on their usefulness and limitations to federal agencies. Federal regulatory agencies have the final say as to whether they accept the test methods.
Operating under a statutory mandate to promote alternative methods that protect human and animal health and the environment, NICEATM and ICCVAM programs have for the past ten years reviewed alternatives to animal testing for regulatory toxicology studies. The Animal Welfare Act and Public Health Service Policy require scientists to consider alternatives prior to the use of animals for research and testing. The legislation established goals referred to as the "3 Rs" — reduce the number of animals, refine procedures to lessen or eliminate pain and distress, and replace animals with non-animal systems or with phylogenetically lower animal species, such as the worm C. elegans and the zebra fish.
The desire to ramp those efforts was underscored by two alternative testing advocates who spoke following Stokes’ report. Catherine Willett, Ph.D., science policy advisor for People for the Ethical Treatment of Animals, and Sue Leary of the Alternatives Research and Development Foundation both voiced concerns that the ICCVAM plan would not quickly implement alternative methods.
Leary balanced her criticism with an appreciation for Stokes’ "very fair job representing the rather strong comments that ICCVAM received at the Town Meeting." She also characterized recent reorganization efforts at NTP as offering "a wonderful opportunity for the new leadership at NTP to have this very exciting, very vital field of alternatives take a stronger role in the research portfolio."
Several BSC members echoed the sentiments of colleague Kenny S. Crump, Ph.D., who said, "Let’s don’t keep the bar too high for accepting new testing approaches." Fellow counselor Jon Mirsalis, Ph.D., added, "Some of these tests are never going to replace animal testing… but go ahead and adopt them for what they can be used for — for early screening, for moving forward."
Stokes summed up the common ground shared by all the stakeholders as the meeting came to a close. "The ultimate goal is to develop predictive systems that very rarely would need to involve animals or perhaps not at all," he said.
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