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NCCOS-developed Method for Toxins Detection Approved for Regulatory Testing of Shellfish in the U.S

Published on: 02/21/2014

Earlier this year, the Interstate Shellfish Sanitation Conference (ISSC) approved a new assay developed by the National Centers for Coastal Ocean Science (NCCOS)as an official method for identifying toxicity that could result in paralytic shellfish poisoning. This approval is the culmination of more than a decade of effort to find an alternative to live animal testing for paralytic shellfish toxins. Paralytic shellfish poisoning is a world-wide, sometimes fatal seafood poisoning caused by potent algal neurotoxins that accumulate in shellfish. Both U.S. and international shellfish commerce regulations require testing for paralytic shellfish toxins, and, until recently, the only approved toxins testing method in the U.S. had been the mouse bioassay.

The NCCOS-led effort to see this method through to fruition began in the 1990s when NCCOS scientists were charged with developing reliable testing methods for algal toxins. NCCOS then partnered with the U.N. International Atomic Energy Agency to make this technology available to developing countries with growing incidence of paralytic shellfish poisoning. However, to be accepted for regulatory use, extensive collaborative testing of methods is required. Several years of international collaborative study were therefore conducted through the auspices of the Association of Official Analytical Chemists (AOAC), and the method received ‘AOAC Official Method’ status in 2012 . This status provided sufficient recognition of the method for the U.S. Food and Drug Administration to partner with NCCOS to submit the receptor binding assay to the ISSC for shellfish commerce in the U.S. This is the first method for detectingparalytic shellfish toxinsto be accepted by the ISSC as a full regulatory method since the mouse bioassay was accepted over 30 years ago.

For more information, contact Fran.VanDolah@noaa.gov.

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