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WHAT IS TO COME?
Validation, verification and fitness-for-purpose are
important elements in assuring method performance, with
clear guidance on how they apply in certain circumstances:
* Developers of diagnostic test kits can submit for validation through a formal scheme.
* Regulatory labs (e.g., US FDA, Health Canada, Public
Health England) have internal validation guidelines
to follow.
Unfortunately, the guidance for food companies and
independent laboratories is less clear. In this article we have
aimed to briefly review the complexity of this topic and

raise a number of questions that we have found are generally
recognized as difficult. We intend this to be the first in a
series of articles in which we will address these questions
and offer some sound approaches that can be readily adopted
to simplify some of the difficult questions addressed in
laboratories every day.
ACKNOWLEDGMENTS
The authors acknowledge the IAFP Applied Lab Methods
Professional Development Group, as well as the Method
Validation & Verification Interest Group, in particular Josephine Greve-Peterson and Sharon Brunelle, who provided
helpful viewpoints and discussions on many of the topics
discussed here.

REFERENCES
1. AOAC International. 2012. Appendix J:
AOAC International methods committee
guidelines for validation of microbiological
methods for food and environmental
surfaces. Official Methods of Analysis, 19th
ed. AOAC International, Gaithersburg, MD.
2. AOAC International. Presidential Task
Force on Best Practices for Microbiological
Methodology. Executive Summary Method/
Matrix Extension Working Group. https://
www.fda.gov/media/73299/download .
Accessed 15 May 2019.
3. Brackett, R., W. Ocasio, K. Waters, J. Barach,
and J. Wan. 2014. Validation and Verification:
A practical industry-driven framework developed to support the requirements of the Food
Safety Modernization Act (FSMA) of 2011.
Food Prot. Trends 34:410-425.
4. Fuller, G. W. 2011. What is new food product
development? p. 1-33. In G. W. Fuller (ed.),
New Food Product Development: From
Concept to Marketplace, 3rd Ed. CRC Press,
Boca Raton, FL.
5. International Commission on Microbiological Specification for Foods. 2004. Microbiological sampling plans - Statistical aspects.

Available at: http://www.icmsf.org/wp-content/uploads/2018/02/032-044_Dahms.
pdf. Accessed 15 May 2019.
6. ISO/TC/34/SC9. 2016. ISO 16140:
Microbiology of the food chain -
Method validation - Part 1: Vocabulary.
International Organization for
Standardization. Geneva, Switzerland.
7. ISO/CASCO. 2017. ISO 17025: General
requirements for the competence of testing
and calibration laboratories. International
Organization for Standardization. Geneva,
Switzerland.
8. Shelomi, M. 2015. Why we still don't eat
insects: Assessing entomophagy promotion
through a diffusion of innovations
framework. Trends Food Sci. Technol.
45:311-318.
9. The United States Pharmacopeia Convention.
2018. USP 41-NF36, <<61>> Microbiological
examination of nonsterile products: tests for
specified microorganisms, United States Pharmacopeia 41:5971-5978. In The United States
Pharmacopeia Convention. Rockville, MD.

10. Tuder, S. 21 January, 2015. ABC News.
Available at: https://abcnews.go.com/blogs/
lifestyle/2014/01/charting-greek-yogurtsamazing-rise/. Accessed 15 May 2019.
11. U.S. Department of Agriculture. 2018. Trends
in Food Recalls: 2004-2013. Available
at: https://www.ers.usda.gov/webdocs/
publications/88497/eib-191.pdf?v=0.
Accessed 15 May 2019.
12. U.S. Department of Agriculture, Economic
Research Service. 2017. New Products.
Available at: https://www.ers.usda.gov/
topics/food-markets-prices/processingmarketing/new-products.aspx. Accessed 15
May 2019.
13. U.S. Food and Drug Administration Office
of Foods and Veterinary Medicine. 2015.
Guidelines for the Validation of Analytical
Methods for the Detection of Microbial
Pathogens in Foods and Feeds 2nd Edition.
Available at: https://www.fda.gov/
downloads/ ScienceResearch/FieldScience/
UCM298730.pdf. Accessed 16 May 2019.

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http://www.icmsf.org/wp-content/uploads/2018/02/032-044_Dahms https://abcnews.go.com/blogs/lifestyle/2014/01/charting-greek-yogurts-amazing-rise/ http://www.icmsf.org/wp-content/uploads/2018/02/032-044_Dahms https://abcnews.go.com/blogs/lifestyle/2014/01/charting-greek-yogurts-amazing-rise/ https://abcnews.go.com/blogs/lifestyle/2014/01/charting-greek-yogurts-amazing-rise/ https://www.ers.usda.gov/webdocs/publications/88497/eib-191.pdf?v=0 https://www.ers.usda.gov/webdocs/publications/88497/eib-191.pdf?v=0 https://www.fda.gov/media/73299/download https://www.fda.gov/media/73299/download https://www.ers.usda.gov/topics/food-markets-prices/processing-marketing/new-products.aspx https://www.ers.usda.gov/topics/food-markets-prices/processing-marketing/new-products.aspx https://www.ers.usda.gov/topics/food-markets-prices/processing-marketing/new-products.aspx https://www.fda.gov/downloads/ScienceResearch/FieldScience/UCM298730.pdf https://www.fda.gov/downloads/ScienceResearch/FieldScience/UCM298730.pdf https://www.fda.gov/downloads/ScienceResearch/FieldScience/UCM298730.pdf

Food Protection Trends - September/October 2019

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