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NTP Marks Milestones in Alternatives to Animal Testing

By Eddy Ball and Robin Mackar
August 2008

Freeman
Freeman, center, monitored discussion by SACATM members. Seated behind him and to the right is Bucher. (Photo courtesy of Steve McCaw)

Lori D. White, Ph.D.
The meeting was the first for NTP Executive Secretary Lori D. White, Ph.D., left, and NIH Deputy Director for Extramural Research, Norka Ruiz Bravo. (Photo courtesy of Steve McCaw)

Wind and Stokes
Wind, left, and Stokes listened to SACATM comments on their reports about ICCVAM milestones and plans to expand available alternative tests in the next five years. (Photo courtesy of Steve McCaw)

ICCVAM Vice-Chair Jodie Kulpa-Eddy, D.V.M.
ICCVAM Vice-Chair Jodie Kulpa-Eddy, D.V.M., of the Department of Agriculture, center, responded to the one public comment on the ICCVAM report. She is shown with Department of Defense representative Peter Schultheiss, D.V.M., Col. US Army, left, and ECVAM representative Jens Linge, Ph.D., right. (Photo courtesy of Steve McCaw)

When the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) (http://ntp-server.niehs.nih.gov/ntpweb/index.cfm?objectid=720165EC-BDB7-CEBA-F517D1DEE4D7D129), convened its annual meeting June 18 - 19 at the Research Triangle Park Radisson Hotel, there seemed to be a general sense of satisfaction about the accomplishments being made by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) (http://iccvam.niehs.nih.gov/home.htm). The meeting provided an opportunity for federal agencies to discuss the progress each was making in implementing the NICEATM-ICCVAM Five-Year Plan, celebrate accomplishments, enjoy some lively debate and discuss future directions.

After some brief welcoming and introductory remarks by ICCVAM Chair Marilyn Wind, Ph.D., and NTP Associate Director John Bucher, Ph.D., on behalf of NTP Acting Director Samuel Wilson, M.D., the meeting was turned over to the SACATM Chair, James Freeman, Ph.D.

The meeting commenced with two presentations, one by NTP scientist Bill Stokes, D.V.M., the executive director of ICCVAM and director of NICEATM, and one by Kim Boekelheide, Ph.D., of Brown University.

Stokes opened with a progress report on ICCVAM and NICEATM activities during the past year including the tenth anniversary celebration of ICCVAM in February, which coincided with release of the committee's Five-Year Plan (http://iccvam.niehs.nih.gov/docs/5yearplan.htm). The plan outlines strategies for researching, developing, translating, validating and promoting new and revised non-animal and other alternative assays for integration of the three Rs - reduction, refinement, and replacement of animal testing- into Federal agency testing programs through 2012.

As ICCVAM looks forward, Stokes said, the committee also reflected on accomplishments over the past decade. "Seventeen alternative methods have been accepted or endorsed by US federal agencies since 1999... [and] include alternative methods that can be used to reduce and refine animal use for the most commonly conducted product safety tests," he explained. "Twelve of these are non-animal methods, [and] ten of those seventeen are based on ICCVAM technical evaluations and recommendations."

Stokes then discussed the recent acceptance (http://www.niehs.nih.gov/news/releases/2008/ocular.cfm) of two new alternative methods recommended by ICCVAM to reduce live animal use for ocular safety testing. The two alternative test methods, the bovine corneal opacity and permeability (BCOP) assay and the isolated chicken eye (ICE) assay, are the first scientifically valid alternative methods to gain regulatory acceptance for ocular safety testing.

Stokes also emphasized that increasing international cooperation will be instrumental in helping the testing community adopt more alternative methods over the next five years. Stokes was pleased to acknowledge that a representative of the European Centre for Validation of Alternative Methods (ECVAM) and the director of the Japanese Center for Validation of Alternative Methods (JaCVAM) were attending the meeting, and noted the increasing collaborations among the three organizations, as well as ICCVAM participation in several international forums.

Boekelheide finished out the morning with a summary of the National Research Council report, Toxicity Testing in the 21st Century. He discussed why the NRC panel was established, the Panel's charge and its recommendations, as well as some of his own personal views on the need for a paradigm shift for toxicity testing.

"This is not something that anyone expects to happen overnight," Boekelheide said of the implementation. "The Panel was thinking in the 20- to 50-year time frame for this to come about."

He pointed out that one of the most attractive features of the report is its focus on mechanisms of action and toxicity pathways rather than phenotypic responses. "It's the new science, and I think that's an important driver."

The afternoon sessions focused on short individual presentations by agency representatives on the role they are playing related to the implementation of the Five-Year Plan.

Attending her first meeting of SACATM, Norka Ruiz Bravo, Ph.D., NIH deputy director for Extramural Research, highlighted some of the scientific projects NIH is supporting in relation to the NICEATM-ICCVAM Five-Year Plan, including the development of non-mammalian models such as zebra fish. Bravo also talked about the significance of the Memorandum of Understanding signed between NIH and EPA to screen chemicals more rapidly, the value of microarray gene chips in research efforts and the advantages of 3-D tissue models to help accelerate discovery and safety evaluations of therapeutic agents.

(Robin Mackar is News Director in the NIEHS Office of Communications and Public Liaison and a regular contributor to the Environmental Factor.)

"A Very Loaded Mission Statement"

In her opening remarks, Marilyn Wind, Ph.D., chair of ICCVAM and principal ICCVAM representative for the Consumer Product Safety Commission, talked about the importance of the role of SACATM, anchoring her comments with the ICCVAM mission statement:

  • The ICCVAM mission is to facilitate the development, validation and regulatory acceptance of new and revised regulatory test methods that reduce, refine and replace the use of animals in testing, while maintaining and promoting scientific quality and the protection of human health, animal health and the environment.

The mission statement, Wind went on to explain, is "loaded" both because its goals are noble, but difficult to achieve, and because of ICCVAM's role as a facilitator, rather than a test method developer or regulatory agency. ICCVAM can encourage others who have the resources to put forth methods for validation - and give developers guidance during the process - but the ultimate acceptance of methods by regulatory agencies depends on successful completion of a scientifically rigorous process.

The bottom line, Wind reminded SACATM members, is that "we need to do all this while still maintaining, if not improving, the safety in terms of humans, the environment and animals. The role that you play in giving us feedback and helping us maintain good science at the same time that we are encouraging and facilitating the three R's is extremely important."

In recognition of their work on the NICEATM-ICCVAM Five-Year Plan, Wind and eleven other members received an NIH Director's Group Award on July 21:

NIEHS - William Stokes, D.V.M., Sheila Newton, Ph.D., Deborah McCarley, Raymond Tice, Ph.D.

Other ICCVAM Agency Representatives- Suzanne Fitzpatrick, Ph.D., FDA; David Hattan, Ph.D., FDA; Abigail Jacobs, Ph.D., FDA; Jodie Kulpa-Eddy, D.V.M., USDA; Alan Poland, M.D., NCI; Amy Rispin, Ph.D., EPA; Margaret Snyder, Ph.D., NIH, Office of the Director



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