Listeria spp. is an appropriate indicator organism for L. monocytogenes. The Agency is aware that listeriosis occurs in a number of animal species, especially ruminant animals, and is asking for comment on whether L. monocytogenes is an environmental pathogen of concern for animal food facilities. FDA's current thinking is that there is no currently available indicator organism for Salmonella spp. The Agency requests data, information, and other comment bearing on whether there is a currently available indicator organism for Salmonella spp. that could be used for environmental monitoring.
For additional discussion on indicator organisms, monitoring procedures, and corrective actions, see section I.E.2 through 5 of the Appendix for the proposed rule for preventive controls for human food (78 FR 3646).
F. The Role of Finished Product Testing in Verifying the Implementation and Effectiveness of Preventive Controls
Although FDA is not including a provision for finished product testing in this proposed rule, here the Agency sets out some considerations regarding the appropriate use of such testing. The utility of finished product testing for verification depends on many factors that industry currently considers in determining whether finished product testing is an appropriate approach to reducing the risk of: animals consuming contaminated food, humans handling contaminated food, and humans consuming food derived from animals that consumed contaminated food. The first such consideration is the nature of the hazard and whether there is evidence of adverse health consequences from that hazard in the animal food being produced or in a similar animal food. If the hazard were to be present in the animal food, how likely is it that illness will occur and how serious would the consequences be? The more likely and severe the illness, the greater the frequency of conducting verification testing should be. For example, Salmonella spp. is a hazard that could cause serious illness, particularly in children and the elderly who might get exposed to it through handling pet food products contaminated with the organism. In contrast, in situations where unlawful pesticide residues are considered reasonably likely to occur, the presence of a pesticide residue that is not approved for a specific commodity, but that is within the tolerance approved for other commodities, while deemed unsafe as a matter of law, may not actually result in illness. Thus, a firm is more likely to conduct finished product testing to verify Salmonella spp. control than to verify control of pesticides.
Another consideration in determining whether finished product testing is appropriate is the intended "consumer" of the animal food and whether indirect exposure of a susceptible population may occur. The greater the sensitivity of the intended "consumer" (as would be the case, for example, for dioxin contamination), the greater the likelihood that finished product testing would be used as a verification activity.
Another consideration in determining whether finished product testing is appropriate is the impact of the animal food on the contaminant. For example, depending on the animal food, pathogens may survive in the food, increase in number, or die off. Finished product testing generally is not conducted if pathogens that may be in an animal food would die off in a relatively short period of time (e.g., before the food reaches the "consumer").
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