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.
J Food Prot. 2010 Jan;73(1):140-202. doi: 10.4315/0362-028x-73.1.140.
The National Advisory Committee on Microbiological Criteria for Foods 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 safety regulators; 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 on pathogens 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.
国家食品微生物学标准顾问委员会为在各种食品中进行病原体抑制和灭活研究制定了指导方针。本文件旨在供食品行业使用，包括食品加工商、食品服务经营者和食品零售商；联邦、州和地方食品安全监管机构；公共卫生官员；食品检测实验室；和流程管理部门。本文件侧重于并仅限于细菌失活和生长抑制，并不针对公共卫生提出具体建议。委员会得出结论，应考虑到方法学的最新进展、对相关病原体的当前思考以及对产品准备、变异性和储存条件的理解来设计挑战研究。研究应在合格实验室中具有专业微生物学家的指导下完成并进行评估，并且应包括适当的统计设计和数据分析。本文提供了选择用于研究的微生物、接种物制备、接种物水平、接种方法、孵育温度和时间、采样注意事项以及解释测试结果的指南。还提供了适当设计的生长抑制和灭活研究的示例。
