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Parameters for Determining Inoculated Pack/Challenge Study Protocols

ADOPTED 20 MARCH 2009, WASHINGTON, D.C. NATIONAL ADVISORY COMMITTEE ON MICROBIOLOGICAL CRITERIA FOR FOODS

NACMCF Executive Secretariat, * U. S. Department of Agriculture, Food Safety and Inspection Service, Office of Public Health Science, Room 333 Aerospace Center, 1400 Independence Avenue S. W., Washington, D. C.20250-3700, USA

*Author for correspondence: NACMCF Executive Secretariat. Tel: 202-690-6600; Fax: 202-690-6364; Email: gerri.ransom@fsis.usda.gov Sponsored by the U. S. Department of Agriculture, Food Safety and Inspection Service; U.S. Department of Health and Human Services, Food and Drug Administration, and Centers for Disease Control and Prevention; U.S. Department of Commerce, National MarineFisheries Service; and U.S. Department of Defense, Veterinary Service Activity. This article may be reproduced without prior permission.

Disclaimer: Mention of trade names or commercial products in this publication is solely for the purpose of providing specific information and does not imply recommendation or endorsement by the U.S. Department of Agriculture and other NACMCF sponsoring Agencies.1

ABSTRACT

The National Advisory Committee on Microbiological Criteria for Foods (NACMCF or Committee) developed guidelines for conducting challenge studies on pathogen inhibition and inactivation studies in a variety of foods. The document is intended for use by the food industry, including food processors, food service operators, and food retailers; federal, state and local food safetyregulators; public health officials; food testing laboratories; and process authorities. The document is focused on and limited to bacterial inactivation and growth inhibition and does not make specific recommendations with respect to public health. The Committee concluded that challenge studies should be designed considering the most current advances in methodologies, current thinking onpathogens of concern, and an understanding of the product preparation, variability, and storage conditions. Studies should be completed and evaluated under the guidance of an expert microbiologist in a qualified laboratory and should include appropriate statistical design and data analyses. This document provides guidelines for choice of microorganisms for studies, inoculum preparation, inoculum level,methods of inoculation, incubation temperatures and times, sampling considerations, and interpreting test results. Examples of appropriately designed growth inhibition and inactivation studies are provided.

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SCOPE OF DOCUMENT

This document was prepared at the request of the sponsoring agencies of the National Advisory Committee on Microbiological Criteria for Foods. The document isintended for use by the food industry, including food processors, food service operators, and food retailers; federal, state and local food safety regulators; public health officials; food testing laboratories; and process authorities. The document is focused on and limited to bacterial inactivation and growth inhibition. The document does not consider toxigenic fungi or the inactivation of viruses.INTRODUCTION AND STATEMENT OF CHARGE

Statement of Charge

Because of the many questions raised by regulatory and industry users on the definition of potentially hazardous food (PHF) or time/temperature control for safety food (TCS food), the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) is asked for its guidance to clarify these issues.

1. What are theappropriate criteria that must be considered for an inoculated pack/challenge study to determine if a food requires time/temperature control for safety (TCS)? For example, pathogen species/strain selection, use of surrogate organism, number of

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pathogen strains, inoculation level(s), incubation temperature(s), length of incubation/duration of study, food product physical properties, etc.

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