ISPAM September 6 2014 Meeting

Pre-decisional draft, do not distribute

AOAC Standard Method Performance Requirements 2014.XX, Version 14.1; August 28, 2014 1 2 Method Name: Detection of Salmonella species in romaine lettuce and baby spinach. 5 suggested inclusivity/exclusivity organisms to be used during the evaluation of a method. The 6 evaluation may be an on-site verification, a single-laboratory validation, or a multi-site collaborative 7 study. SMPRs are written and adopted by AOAC Stakeholder Panels composed of representatives from 8 the industry, regulatory organizations, contract laboratories, test kit manufacturers, and academic 9 institutions. AOAC SMPRs are used by AOAC Expert Review Panels in their evaluation of validation study 10 data for method being considered for Performance Tested Methods or AOAC Official Methods of 11 Analysis , and can be used as acceptance criteria for verification at user laboratories. 1 3 4 Purpose: AOAC SMPRs describe the minimum recommended performance characteristics and

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Approved Body: Approval Date: Final version date:

AOAC International Stakeholder Panel on Alternative Methods (ISPAM)

16 17 Intended Use : Routine surveillance and monitoring by a trained technician.

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Alternative methods used to detect Salmonella species and their serovars in

1. Applicability:

pre-harvest field samples of romaine lettuce and baby spinach. 21 22 2. Analytical Technique : Any analytical technique that can meet the requirements.

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3. Definitions :

Alternative Method

Method of analysis that demonstrates or estimates, for a given category of products, the same analyte as is measured using the corresponding reference method. The method can be a proprietary or non-commercial, and does not need to cover an entire analysis procedure, that is

from the preparation of samples to the test report. 2

An ISO term used to denote the method to be evaluated against a “reference” method. AOAC uses the term “candidate” method for the same purpose in its guidelines. The terms “alternative” and

“candidate” methods are interchangeable for the purposes of this SMPR.

Acceptable Minimum Detection Level (AMDL)

The predetermined minimum level of an analyte, as specified by an expert committee which must be detected by the alternative method with an estimated 5% lower confidence limit on the probability of detection (POD) of 0.95 or higher. The AMDL is dependent on the intended use. 3

1 Appendix F: Guidelines for Standard Method Performance Requirements of the 19 th edition of the AOAC INTERNATIONAL Official Methods of Analysis . Available at http://www.eoma.aoac.org/app_n.pdf 2 International Standard ISO 16140: 2003(E) - Mircrobiology of food and animal feeding stuffs - Protocol for the validation of alternative methods, 2003. 3 Draft EN ISO/CD 16140-1: Microbiology of food and animal feeding stuffs - Method validation - Part 1: Terminology of method validation, vs 17-03-2011. 1 Draft Salmonella SMPR v12