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Environmental Factor, December 2012

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Fall NICEATM activities focus on international collaborations

By Debbie McCarley and Cathy Sprankle

NICEATM group shot

The organizing committee for the Leptospira workshop, gathered for a photo after the workshop. From left to right,Marta Guerra, D.V.M., Ph.D., Centers for Disease Control and Prevention; Eric Klaasen, D.V.M, Ph.D., MSD Animal Health, The Netherlands; Jeffrey Galvin, Ph.D., Pfizer Animal Health; Brett Webster, Boehringer Ingelheim Vetmedica, Inc.; David Alt, D.V.M., Ph.D., USDA; Karen Brown, Ph.D., Pair O Docs Consultants; Hans Draayer,Gourdneck View Consulting, LLC; Catrina Stirling, Ph.D., Pfizer; Warren Casey, Ph.D., NICEATM; Geetha Srinivas, D.V.M, Ph.D., USDA; Angela Walker, D.V.M, Ph.D., USDA; Stokes; Kevin Ruby, Ph.D., USDA; Randal Sebring, D.V.M., Colorado Serum Company; Richard McFarland, M.D., Ph.D., FDA (Photo courtesy of James Fosse, Animal and Plant Health Inspection Se)

Scientists in the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) worked with international colleagues this fall to advance innovative new test methods and integrated testing and decision strategies for chemical safety and vaccine testing.

Stokes coordinates test method development activities with Japanese counterparts

Regulatory authorities, worldwide, require testing of  chemicals and products for skin allergy hazard potential. NICEATM Director Rear Adm. William Stokes, D.V.M., joined scientists in Japan for a September workshop on “Adverse Outcome Pathways for Skin Sensitization Testing.” He also participated in a meeting of the management team for a Japanese-led study of a new test method proposed to identify whether substances have the potential to cause skin allergies.

“Our work at NICEATM has shown that it is now possible to accurately identify many allergy hazards without using animals,” explains Stokes. “Any animal testing that is still required can be accomplished using a recently adopted procedure that uses only a small number of mice. Based on recent progress, we expect that most, if not all, chemical skin allergy hazards will soon be identified without using animals.”

The Japan workshop focused on using methods to identify skin allergy hazards, based on key events that occur in the adverse outcome pathway leading to skin allergy reactions. Stokes spoke about the NICEATM development of an integrated testing and decision strategy, and said the testing strategy, presented at the 2012 meeting of the Society of Toxicology, can identify most chemical allergens without animals, and reduces overall animal use by 72 percent.

NICEATM workshop reviews new Leptospira vaccine testing approaches

Later in September, over 80 scientists from around the world gathered in Ames, Iowa, at the NICEATM-sponsored “International Workshop on Alternative Methods for Leptospira Vaccine Potency Testing: State of the Science and the Way Forward.” Workshop participants reviewed available improved methods for Leptospira vaccine potency testing, which currently uses many laboratory animals and causes significant pain and distress to the animals used.

Participants in the workshop, including vaccine manufacturers and regulators, discussed steps that could be taken to achieve wider use of in vitro replacement methods for Leptospira vaccine potency testing developed by the U.S. Department of Agriculture (USDA) Center for Veterinary Biologics. These suggestions included exploration of new approaches to validation, and sharing of data, reagents, and best practices.

Workshop participants also proposed the development and application of serological methods, which measure the levels of specific antibodies in the blood of immunized test animals. These methods use fewer animals, and reduce or eliminate animal pain and distress compared to traditional methods. Participants agreed on specific characteristics that serological methods must have and which regulatory agencies would require these methods.

“Action on the proposals from this workshop can immediately reduce, and eventually replace, animal use for Leptospira vaccine potency testing, while still protecting human and animal health,” said Stokes.

Slides presented by speakers are available on the NICEATM website. A workshop report will be published next year as a special issue of the journal Biologicals.

(Debbie McCarley is a special assistant to Stokes. Cathy Sprankle is a communications specialist with ILS, Inc., support contractor for NICEATM.)

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