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Food Safety Objective Approach for Controlling Clostridium botulinum Growth and Toxin Production in Commercially Sterile Foods

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Abstract:

As existing technologies are refined and novel microbial inactivation technologies are developed, there is a growing need for a metric that can be used to judge equivalent levels of hazard control stringency to ensure food safety of commercially sterile foods. A food safety objective (FSO) is an output-oriented metric that designates the maximum level of a hazard (e.g., the pathogenic microorganism or toxin) tolerated in a food at the end of the food supply chain at the moment of consumption without specifying by which measures the hazard level is controlled. Using a risk-based approach, when the total outcome of controlling initial levels (H 0), reducing levels (ΣR), and preventing an increase in levels (ΣI) is less than or equal to the target FSO, the product is considered safe. A cross-disciplinary international consortium of specialists from industry, academia, and government was organized with the objective of developing a document to illustrate the FSO approach for controlling Clostridium botulinum toxin in commercially sterile foods. This article outlines the general principles of an FSO risk management framework for controlling C. botulinum growth and toxin production in commercially sterile foods. Topics include historical approaches to establishing commercial sterility; a perspective on the establishment of an appropriate target FSO; a discussion of control of initial levels, reduction of levels, and prevention of an increase in levels of the hazard; and deterministic and stochastic examples that illustrate the impact that various control measure combinations have on the safety of well-established commercially sterile products and the ways in which variability all levels of control can heavily influence estimates in the FSO risk management framework. This risk-based framework should encourage development of innovative technologies that result in microbial safety levels equivalent to those achieved with traditional processing methods.

Document Type: Research Article

DOI: https://doi.org/10.4315/0362-028X.JFP-11-082

Affiliations: 1: Institute for Food Safety and Health, National Center for Food Safety and Technology, U.S. Food and Drug Administration, 6502 South Archer Road, Bedford Park, Illinois 60501-1957, USA. nathan.anderson@fda.hhs.gov 2: Institute for Food Safety and Health, National Center for Food Safety and Technology, U.S. Food and Drug Administration, 6502 South Archer Road, Bedford Park, Illinois 60501-1957, USA 3: Institute for Food Safety and Health, National Center for Food Safety and Technology, Illinois Institute of Technology, 6502 South Archer Road, Bedford Park, Illinois 60501-1957, USA; CSIRO, 11 Julius Avenue, North Ryde, New South Wales 2133, Australia 4: U.S. Food and Drug Administration, College Park, Maryland 20740, USA, Exponent, Inc., 17000 Science Drive, Suite 200, Bowie, MD 20715, USA 5: Unilever, Safety & Environmental Assurance Centre, Sharnbrook, Bedford MK44 1LQ, UK; Uniliver R&D Shanghai, 4th Floor, 66 Lin Xin Road, Linkong Economic District, Shanghai 200335, People's Republic of China 6: Institute for Food Safety and Health, National Center for Food Safety and Technology, Illinois Institute of Technology, 6502 South Archer Road, Bedford Park, Illinois 60501-1957, USA; PQS Technologies, LLC, P.O. Box 951, Arlington Heights, IL 60006, USA 7: U.S. Food and Drug Administration, College Park, Maryland 20740, USA; Nutrition & Food Science, 0112 Skinner Building, University of Maryland, College Park, MD 20742, USA 8: Institute for Food Safety and Health, National Center for Food Safety and Technology, Illinois Institute of Technology, 6502 South Archer Road, Bedford Park, Illinois 60501-1957, USA; PepsiCo, 3 Skyline Drive, Hawthorne, NY 10532, USA 9: General Mills, Number One General Mills Boulevard, Minneapolis, Minnesota 55426, USA, Kellogg Company, 2 Hamblin Avenue East, Battle Creek, MI 49017, USA 10: International Product Safety Consultants, 4021 West Bertona Street, Seattle, Washington 98199, USA 11: ConAgra Foods Inc., One ConAgra Drive, Omaha, Nebraska 68102, USA, AIV Microbiology & Food Safety Consultants, Inc., 15504 Windsor Street, Overland Park, KS 66224, USA

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