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Regulatory Toxicology and Pharmacology
Vol. 73 (1), 2015, Pages: 164–171

Determining the safety of microbial cultures for consumption by humans and animals

Michael W. Pariza, Kevin O. Gillies, Sarah F. Kraak-Ripple, Gregory Leyer, Amy B. Smith

Department of Food Science, University of Wisconsin–Madison, Madison, WI, USA.


Fermented foods and feeds have been consumed for millennia, and microorganisms isolated from traditional fermentations have been used as probiotics. There is interest in developing new microbial cultures for these uses, but to date safety evaluation procedures have only been discussed in general terms. We propose a comprehensive approach for determining the safety of microbial cultures that lack an established history of safe use for their intended new applications. Three scenarios are considered: (1) substantially increased exposure to a culture that has an established record of safety in a more limited application; (2) a new strain without a history of safe use that was isolated from a food or feed that has a history of safe use; and (3) a new strain isolated from a non-food or non-feed source. Our safety evaluation process is based on scientific procedures and is in the form of a decision tree composed of 13 questions. Our decision tree for determining the safety of microbial cultures for consumption by humans or animals is modeled on previous decision trees that are used worldwide to evaluate the safety of microbial enzymes for use in human food or animal feed.

Keywords: Microbial culture safety; Probiotic safety; Safety evaluation; Safety decision tree; Fermented food; Fermented feed; Food safety.

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