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ICCVAM Biennial Report 2018-2019

Biennial Progress Report 2018-2019 Interagency Coordinating Committee on the Validation of Alternative Methods

Request for Information on Botulinum Neurotoxin Assays

Tests to detect and measure botulinum neurotoxin are required by multiple federal agencies for regulatory and other decision contexts. Currently, the standard test for these endpoints is a mouse lethality assay that can use large numbers of animals. In a June 2018 Federal Register notice (83 FR 27622), NICEATM requested available data and information on approaches and/or technologies currently used to detect and measure botulinum neurotoxin. The scope of the request included information on any activities relevant to the development or validation of alternatives to in vivo test methods currently used by federal agencies for regulatory and other decision contexts. The announcement also requested available data from in vivo botulinum neurotoxin tests used for similar applications as the proposed alternative, such as distinguishing between botulinum neurotoxin serotypes in biological matrix samples or measuring the potency of therapeutic botulinum neurotoxin preparations. Submitted information is being used to assess the state of the science and determine technical needs for non-animal test methods that are used to detect the presence of botulinum neurotoxin and measure potency of botulinum neurotoxin preparations.