4. Contamination of Animal Food With Salmonella spp. From the Plant Environment
The available data and information associate insanitary conditions in animal and human food facilities with contamination of a number of foods with the environmental pathogen Salmonella spp. Such contamination has led to recalls and to outbreaks of foodborne illness.
In 2007, FDA identified S. Schwarzengrund, a rare serotype of Salmonella associated with human illness, in a pet food.
In 2008-2009, an outbreak was linked to Salmonella Typhimurium in peanut butter and peanut paste (Ref. 9) (Ref. 10). This outbreak resulted in an estimated 714 illnesses, 166 hospitalizations, and 9 deaths (Ref. 10). Inspections conducted by FDA at the two implicated ingredient manufacturing facilities (which shared ingredients) revealed lack of controls to prevent product contamination from pests, from an insanitary air-circulation system, from insanitary food-contact surfaces, and from the processing environment (Ref. 11) (Ref. 12). Several strains of Salmonella spp. were found in multiple products and in the plant environment (Ref. 12). This outbreak led to the recall of more than 3900 animal (including pet food) and human food products containing peanut-derived ingredients (Ref. 11).
E. Role of Environmental Monitoring in Verifying the Implementation and Effectiveness of Sanitation Controls in Significantly Minimizing or Preventing the Potential for an Environmental Pathogen To Contaminate Animal Food
1. Purpose of Environmental Monitoring
The purpose of monitoring for environmental pathogens in facilities where animal food is manufactured, processed, packed, or held is to verify the implementation and effectiveness of sanitation controls intended to significantly minimize or prevent the potential for an environmental pathogen to contaminate animal food. In so doing, environmental monitoring can find sources of environmental pathogens that remain in the facility after routine cleaning and sanitizing so that the environmental pathogens can be eliminated by appropriate corrective actions (e.g., intensified cleaning and sanitizing, sometimes involving equipment disassembly). For further discussion, see section I.E. of the Appendix of the document for the proposed rule for preventive controls for human food (78 FR 3646).
2. Indicator Organisms
The term "indicator organism" can have different meanings, depending on the purpose of using an indicator organism. As discussed in the scientific literature, the term "indicator organism" means a microorganism or group of microorganisms that is indicative that (1) a food has been exposed to conditions that pose an increased risk for contamination of the food with a pathogen or (2) a food has been exposed to conditions under which a pathogen can increase in numbers (Ref. 13). This definition in the scientific literature is consistent with a definition of indicator organism established by NACMCF as one that indicates a state or condition and an index organism as one for which the concentration or frequency correlates with the concentration or frequency of another microorganism of concern (Ref. 14). FDA considers the NACMCF definition of an indicator organism to be an appropriate working definition for the purpose of this document.
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