Environmental Factor

July 2011


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Steady progress reported at SACATM

By Ernie Hood
July 2011

Rear Adm. William Stokes, D.V.M., Associate Director John Bucher, Ph.D., and Steven Niemi, D.V.M.

Stokes, flanked by NTP Associate Director John Bucher, Ph.D., left, and Niemi, right, discussed the impact of newly developed alternative testing methods of regulatory agencies safety testing. (Photo courtesy of Ernie Branson and NIH)

Linda Birnbaum, Ph.D.

Birnbaum, at microphone, expressed her appreciation for SACATM's steady progress in developing testing to reduce, refine, or replace animal use in chemical and product safety testing. (Photo courtesy of Ernie Branson and NIH)

Rear Adm. William Stokes, D.V.M., Soojung Sohn, and Rajendra Chhabra, Ph.D.

During a break in the proceedings, Stokes, left, joined KoCVAM Vice Director Soojung Sohn, center, and NTP Toxicology Branch Group Leader Rajendra Chhabra, Ph.D. (Photo courtesy of Ernie Branson and NIH)

The Scientific Advisory Committee on Alternative Toxicological Methods (SACATM(http://ntp.niehs.nih.gov/INDEX19B8_2.HTM?objectid=720165EC-BDB7-CEBA-F517D1DEE4D7D129)) meets only once a year, but with considerable progress during the past year in efforts to reduce, refine, or replace animal use in chemical and product safety testing, there was much to discuss and digest at this year's SACATM meeting June 16-17 in Arlington, Va.

In its advisory role to the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM(http://iccvam.niehs.nih.gov/)) and the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), SACATM provides advice on priorities and activities related to the development, validation, scientific review, regulatory acceptance, implementation, and national and international harmonization of new, revised, and alternative toxicological test methods.

NIEHS/NTP Director Linda Birnbaum, Ph.D., in her welcoming remarks to the SACATM members; ICCVAM members, representing the 15 participating Federal agencies; and NICEATM staff in attendance, noted the organizations' successes. "ICCVAM and NICEATM continue to provide an effective process for achieving the regulatory acceptance of new safety testing methods," she said.

"The center and the committee have now contributed to the endorsement or adoption of 42 new alternative methods. 28 of these are in vitro, and over half of those in vitro methods involve human cells," Birnbaum explained. "Thanks to ICCVAM's continued, focused efforts, there are now approved alternatives for many different types of testing, including five of the six most commonly conducted safety tests." Nine of the 42 new alternative methods were put forward in just the past year, she noted.

Two new nominations to NICEATM and ICCVAM, both of which were unanimously supported by the committee, were also prominent in SACATM's agenda. The first, an in vitro pyrogen test method for assessing non-endotoxin pyrogens, is an extension of an existing method to screen for substances that induce fever, which is currently used only to detect gram-negative endotoxin. Validation and adoption of the in vitro method for non-endotoxin pyrogens would further reduce the use of rabbits, the current model for detecting fever reactions in various drugs and products prior to their commercial release.

The second nomination involves three types of in vitro diagnostic and potency assays for botulinum neurotoxins (BoNTs). The new tests are proposed to detect BoNT in suspected botulism poisonings in people and wildlife, and for testing therapeutic and cosmetic BoNT products, which were used in an estimated five million off-label cosmetic treatments in the U.S. in 2008. Rear Adm. William Stokes, D.V.M. (http://iccvam.niehs.nih.gov/contact/staff/Stokes.htm), director of NICEATM and executive director of ICCVAM noted, "these methods have the potential for more rapid and accurate public health and product testing, and could significantly reduce the number of mice used for BoNT testing throughout the world."

SACATM chair Steven Niemi, D.V.M., from Massachusetts General Hospital, said it was very appropriate for the nominations to be front and center for the committee's business at the meeting. "They were both obviously very high priority, and will have a big impact on animal welfare as soon as they're adopted."

Meeting participants were also updated by representatives of ICCVAM's international partners. In-person presentations were made by collaborators from the Korean Center for the Validation of Alternative Methods (KoCVAM) and the Japanese Center for the Validation of Alternative Methods, and the panel was briefed by telephone by officials from Health Canada and the European Centre for the Validation of Alternative Methods, both of whom had taken in the meeting's proceedings by webcast.

Stokes praised the international cooperation ICCVAM and NICEATM have received. "It allows us to leverage resources, so we can share the cost and time that it takes to carry out expensive validation studies, and we can also work together so that we're more likely to be in agreement and can achieve faster acceptance of those methods internationally," he said.

(Ernie Hood is a contract writer with the NIEHS Office of Communications and Public Liaison.)

SACATM paricipants pose for a group photo
SACATM participants gathered to celebrate the increasing acceptance of alternative testing methods. Standing, left to right, are Joy Cavagnaro, Ph.D., Access BIO, L.C.; Steven Hansen, D.V.M., American Society for the Prevention of Cruelty to Animals; Michael Olson, Ph.D., GlaxoSmithKline; Eugene Elmore, Ph.D., University of California Irvine; George Corcoran, Ph.D., Wayne State University; Sharon Meyer, Ph.D., The University of Louisiana at Monroe; Gary Wnorowski, Eurofins/Product Safety Laboratories; Linda Toth, D.V.M., Ph.D., Southern Illinois University School of Medicine; Daniel Wilson, Ph.D., The Dow Chemical Company; and Lori White, Ph.D., NTP. Sitting, left to right, are Birnbaum; Bucher; Stokes; Niemi; ICCVAM Chair Jodie Kulpa-Eddy, D.V.M., U.S. Department of Agriculture; Gwendolyn McCormick, D.V.M., Boehringer Ingelheim Pharmaceuticals, Inc.; and Karen Brown, Ph.D., Pair O' Docs Enterprises. (Photo courtesy of Ernie Branson and NIH)

Putting alternative test methods into practice

During the meeting, Stokes updated SACATM members on the groups' recent activities and priorities, as well as what he said was "a lot of progress" in domestic and international regulatory acceptance and adoption of ICCVAM-recommended alternative test methods. Among the past year's significant activities were:

  • An international workshop (http://iccvam.niehs.nih.gov/meetings/BiologicsWksp-2010/BiologicsWksp.htm) on the state of the science and future directions in vaccine potency and safety testing, where there is enormous potential for reducing, refining or replacing the use of animals
  • Two workshops on best practices (http://iccvam.niehs.nih.gov/meetings/Implement-2011/ImplmtnWksp.htm) for regulatory safety testing, covering ocular safety testing and allergic contact dermatitis hazard testing
  • An ICCVAM Peer Review Panel meeting (http://iccvam.niehs.nih.gov/methods/endocrine/PeerPanel11.htm) to evaluate an in vitro endocrine disruptor screening method, the LUMI-CELL ER® (BG1Luc ER TA) test method to identify substances with estrogen agonist and/or antagonist activity

Regarding the endocrine disruptor screening test, Stokes said that "it looks like a very promising method, and recommendations will be forwarded to both the U.S. agencies and to the international agency, OECD [Organisation for Economic Co-operation and Development], in the near future."



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