Overview and Nomination
Workshop Report Now Available [PDF]
In October 2005, the Humane Society of the United States (HSUS) submitted a
test method nomination entitled Alternative Methods to Replace the Mouse LD50
Assay for Botulinum Toxin Potency Testing. In the nomination, the
HSUS proposed a review of the validation status of available in vitro, ex vivo,
and non-lethal in vivo test methods as potential replacements for
the current botulinum toxin potency test method. The nomination also
requested that ICCVAM work with partners and stakeholders to validate
one or more of the alternative test methods available.
The HSUS nomination was reviewed by both ICCVAM and SACATM in
November to December 2005. Both committees endorsed the sponsorship
of a workshop on alternative botulinum toxin test methods with high priority.
Accordingly, ICCVAM established a Biologics Working Group (BWG) to
organize the workshop.
ICCVAM, in collaboration with NICEATM and ECVAM, co-sponsored a
workshop entitled Scientific Workshop on Alternative Methods to Refine,
Reduce, and Replace the Mouse LD50 Assay for Botulinum Toxin Testing
held on November 13-14, 2006. The goals of the workshop were:
- To review the state-of-the-science and current knowledge of
alternatives that may reduce, replace, and refine (less pain and distress)
the use of mice for botulinum toxin testing;
- To identify priorities for research, development, and validation
efforts needed to advance the use of alternative methods.
Specific objectives of the workshop included:
- Review the public health needs for botulinum toxin testing,
including the necessity to determine the safety and efficacy of products
containing botulinum toxin;
- Review the current state-of-the-science and identify knowledge
gaps regarding botulinum toxin structural aspects, mechanisms, and
modes of action that are important to the development of alternative
methods for in vivo botulinum toxin tests, and prioritize future
research initiatives that would address these knowledge gaps;
- Review current development and/or validation status of alternative
test methods for in vivo botulinum toxin tests and their potential to reduce,
refine (less pain and distress), or replace the use of the mouse LD50 assay;
- Identify alternative methods that should have the highest
priority for future development and validation studies to assess
potency/toxicity of botulinum toxin.
Proceedings of the workshop have been released and can be viewed here.
Nomination
USDA Policy Concerning the Use of Humane Endpoints in Biologics Testing
The USDA Center for Veterinary Biologics (CVB) issued a notice (April 1, 2004) clarifying policy on the use
of humane endpoints for animal challenge potency tests on biologics. The notice covers potency tests that
involve administration of viable virus, bacteria, or bacterial toxin to animals in doses expected to be
lethal.
View CVB notice (April 1, 2004) [PDF]
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