In the CORE table the FDA reported closing its investigation of an outbreak of Salmonella Typhimurium that sickened 274 people. No source for the outbreak was identified. The FDA conducted a trace back analysis and onsite inspection during the outbreak. No food was identified as the source of the outbreak. The FDA did not report the name of the company involved in the onsite inspection. @ https://www.fda.gov/food/outbreaks-foodborne-illness/investigations-foodborne-illness-outbreaks
The following is a list of outbreak and adverse event investigations primarily being managed by FDA’s CORE Response Teams.
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On January 10, 2023, the FDA published guidance for industry on the requirements for a foreign supplier verification program (FSVP). in 21 CFR part 1, subpart L, requiring that importers of human or animal food must establish and follow to ensure that each food they import into the United States meets applicable U.S. requirements and is not adulterated or (for human food) misbranded concerning allergen labeling. FDA’s guidance documents do not establish legally enforceable responsibilities. The document describes the FDA’s current thinking. The guidance provides questions and answers to facilitate importers’ understanding of the FSVP requirements. The FSVP rule requires importers to perform risk-based FSVP activities that verify that the food is produced in a way that provides the same level of public health protection as section 418 (concerning hazard analysis and risk-based preventive controls) or 419 (concerning standards for the safe production and harvesting of certain fruits and vegetables that are raw agricultural commodities (RACs) of the FD&C Act); The food is not adulterated; and The human food is not misbranded. @ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-foreign-supplier-verification-programs-importers-food-humans-and-animals?utm_medium=email&utm_source=govdelivery
The purpose of this document is to provide guidance for industry on the requirements for a foreign supplier verification program (FSVP).
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A study published in the ASM journal “Microbiology Spectrum” used WGS to provide insights into two species of presumed nonpathogenic Listeria innocua and L. welshimeri and found that they are developing a surprising number of characteristics that are potentially harmful to humans. The study used a comparative genome approach to analyze 41 genome sequences belonging to L. innocua and L. welshimeri isolated from food and food processing facilities. Genetic determinants responsible for disinfectant and stress tolerance were identified, including the efflux cassette bcrABC and Tn6188_qac_1 disinfectant resistance determinant and stress survival islets. These disinfectant-resistant genes were more frequently found in L. innocua (12%) than in L. welshimeri (2%). Several isolates representing the presumed nonpathogenic L. innocua still carried virulence-associated genes absent in all L. welshimeri isolates. The results suggest that the presumed nonpathogenic isolates, especially L. innocua can carry genes relevant to the strain’s virulence and stress tolerance in food processing facilities. The presence of genetic loci previously associated with adaption/survival in stressful conditions was higher in L. innocua, especially L. innocua ST132, than in any of the L. welshimeri strains. Some strains of L. innocua and L. welshimeri examined in the study show three genes for resistance to a widely-used disinfectant from the quaternary ammonium compounds. The study highlights that the low occurrence of important core genes could result from a functional CRISPR-cas system in the Listeria genomes. @ https://journals.asm.org/doi/10.1128/spectrum.01189-22
