Food Protection Trends -May/June 2015 - (Page 228)

SPECIAL INTEREST PAPER FSMA: Testing as a Tool for Verifying Preventive Controls Robert L. Buchanan 1*and Donald Schaffner 2 Center for Food Safety and Security Systems, College of Agriculture and Natural Resources, University of Maryland, Symons Hall, Room 0119, College Park, MD 20742, USA; 1 2 Dept. of Food Science, Rutgers University, New Brunswick, NJ 08901, USA ABSTRACT In 2013, we were approached by the PEW Charitable Trusts (PEW) to develop a scientific "white paper" describing the principles, concepts, and potential applications of microbiological testing to verify preventive controls implemented as part of food safety system that combined both HACCP and Good Hygienic Practices. This was undertaken with the knowledge that it would be included as an independently developed appendix to Pew's comments to FDA regarding microbiological testing aspects of the FSMA preventive controls proposal. [For the sake of full disclosure, both of the authors received an honorarium from PEW for undertaking this project.] On Feb 26, 2014, the Pew submitted its comments to the open FSMA docket (FDA-2011-N-0920-1257), including our document, Appendix B. The appendix reviewed some of the key aspects of verification testing, laying out how it differs from traditional "batch testing" of food products. This included describing the key characteristics needed in implementing verification testing as part of an integrated food safety system. This included a series of recommendations to FDA regarding inclusion of verification testing in FSMA. Since its initial posting, we have been encouraged by multiple individuals to publish our comments so that they could be more widely shared among food safety professionals. While Federal dockets are accessible by the public, it is not the easiest way of sharing information. We also wanted to use this as an opportunity to encourage other scientists to consider submitting scientific comments to future regulatory proposals, thereby helping ensure an active debate of the scientific foundation upon which sound food safety policies must be built. We are presenting the document as originally presented when placed in the "preventative controls docket" for the proposed regulation. The only changes that were made to the original document were to correct a few typos that were discovered after transmission to the FDA. INTRODUCTION At the request of The Pew Charitable Trusts, we were asked to summarize scientific concepts and practices related to the testing of food to verify preventive food safety controls that are pertinent to the finalization of FDA regulations associated with the FDA Food Safety Modernization Act. The comments that follow are focused on the role of microbiological testing for verification; however, many of the principles and parameters discussed are also pertinent to other physical and chemical hazards. It is important to note that while we were requested to prepare this report by Pew, the comments, interpretations, and recommendations in this report are based on our personal experiences and evaluations of the scientific underpinnings of microbiological testing of foods and practices associated with its utilization by both industry and governments. In considering the role of microbiological testing in food safety systems it is important to note that there are multiple forms of microbiological testing (e.g., process *Corresponding Author: Phone: +1 301.405.1209; E-mail: 228 Food Protection Trends May/June verification, lot release, investigational), each with its own protocols and underlying mathematics. Most food safety systems generally include some form of microbiological testing, but it is critical that the right form of testing is used for the application being considered. It is also important to emphasize that it is highly unlikely that a single microbiological test will be adequate for all foods and all applications. As will be discussed later in this document, while a general framework can be articulated, flexibility in specific applications and targets will be needed for broad application of microbiological verification testing programs. Testing within a food safety systems based on preventive controls It is important to clearly define verification and distinguish it from "monitoring" before getting into specific issues and recommendations related to microbiological verification. Monitoring can be defined as the measurements and observations that are taken in real-time that reflect the

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Food Protection Trends -May/June 2015