Guidelines for botanical identification methods were finalized by an AOAC expert review panel (ERP) and approved by the Official Methods Board as an official AOAC standard, concluding the scope of work for the AOAC/U.S. Food and Drug Administration/National Institutes of Health, Office of Dietary Supplements (NIH-ODS) contract.

The plan now is to harmonize the guidelines to meet the needs of the OMB, the AOAC Statistics Committee, and other analytical communities who may be working on similar initiatives for identity testing.

Developed under contract with NIH-ODS, the guidelines are designed to provide technical guidance for validating “black box” methods—“ID methods that would be developed by users or stakeholder groups and return yes/no answers (a qualitative, binary answer),” said James Harnly, U.S. Department of Agriculture, and chair of the panel. “It would be up to future ERPs dealing with specific botanicals to determine what methods would be adequate for that botanical.”

The guidelines include sections on Scope, Applicability, Terms and Definitions, and Validation Study Guidelines, and were originally developed by the Working Group for Validation of Identity Methods for Botanical Raw Materials, chaired by Mark Roman, Tampa Bay Analytical Research.

First, the ERP focused on reviewing and revising the Scope, Applicability, and Terms and Definitions, and subsequently focused on basic concepts and statistics. The group agreed to define a botanical ID method as one that establishes identity specifications for a botanical material and determines, within a specified statistical limit, whether the test material is a true example of the target botanical material--the botanical of interest.

Inherent in the definition of a botanical ID method is that it achieves its goal by comparing the test material to a reference material, where the reference material can be any botanical material whose composition and/or characteristics are judged to accurately represent the target material.

Botanical ID methods must also be compatible with the Probability of Identification (POI) statistical model. The POI paper is the basis for the statistical recommendations of the guidelines, and is scheduled for publication in the January/February 2012 issue of the Journal of AOAC INTERNATIONAL.

Overall, inclusivity/exclusivity, SSTM (standard superior test material; the minimum concentration that would be acceptable), SITM (standard inferior test material; the best possible material that would be rejected), and POI studies would be used to determine if a method meets established standard method performance requirements (SMPRs), and if so, the method can be adopted as an AOAC Official Method^SM.

The Guidelines for Validation of Botanical Identification Methods will be published in J. AOAC Int. and available online at www.eoma.aoac.org.

Full coverage is scheduled for the November/December 2011 issue of Inside Laboratory Management.

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