title: Food safety objective approach for controlling Clostridium botulinum growth and toxin production in commercially sterile foods.
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.
authors: Institute for Food Safety and Health, National Center for Food Safety and Technology, U.S. Food and Drug Administration, Bedford Park, Illinois 60501-1957, USA. nathan.anderson@fda.hhs.gov
authors: N M
authors: NM
authors: Anderson
authors: J W
authors: JW
authors: Larkin
authors: M B
authors: MB
authors: Cole
authors: G E
authors: GE
authors: Skinner
authors: R C
authors: RC
authors: Whiting
authors: L G M
authors: LG
authors: Gorris
authors: A
authors: A
authors: Rodriguez
authors: R
authors: R
authors: Buchanan
authors: C M
authors: CM
authors: Stewart
authors: J H
authors: JH
authors: Hanlin
authors: L
authors: L
authors: Keener
authors: P A
authors: PA
authors: Hall
mesh_terms: D000818:Animals; D001905:Botulinum Toxins / Q000096:biosynthesis*; D003014:Clostridium botulinum / Q000254:growth & development* / Q000378:metabolism*; D015169:Colony Count, Microbial; D003132:Commerce; D003257:Consumer Product Safety; D005506:Food Contamination / Q000517:prevention & control*; D005511:Food Handling / Q000379:methods / Q000592:standards; D005516:Food Microbiology; D005519:Food Preservation / Q000379:methods* / Q000592:standards; D059022:Food Safety; D006358:Hot Temperature; D006801:Humans; D012308:Risk Management; D013242:Sterilization
chemical_list: D001905:Botulinum Toxins