C. Verification Testing of Raw Materials and Ingredients
Raw materials and ingredients are often tested as part of a supplier approval and verification program, as one of the verification activities when a preventive control that is adequate to significantly minimize or prevent the hazard is not applied at the receiving facility. The utility and frequency of raw material and ingredient testing for verification of supplier controls depend on many factors, including:
* The hazard and its association with the raw material or ingredient;
* The likelihood that the animal, or person handling the animal food, would become ill if the hazard were present in the raw material or ingredient;
* How that raw material or ingredient will be used by the receiving facility (e.g., the effect of processing on the hazard); and
* The potential for contamination of the facility's environment with the hazard in the raw material or ingredient.
Further discussion of verification testing of raw materials and ingredients can be found in section I.C of the Appendix of the document for the proposed rule for preventive controls for human food (78 FR 3646).
D. Verification of Sanitation Controls to Significantly Minimize or Prevent the Potential for an Environmental Pathogen To Contaminate Animal Food
1. Environmental Pathogens in Animal Food
Animal food can become contaminated with pathogenic microorganisms at many different steps: on the farm; in packing, manufacturing/processing, or distribution facilities; during storage or transit; at retail establishments; and at the location of the animal. Any time animal food is exposed to the environment during a manufacturing, processing, packing, or holding activity, there is the potential for the food to be contaminated with pathogenic microorganisms. As discussed in section VIII.B of the preamble, proposed SEC 507.3 would define the term "environmental pathogen" to mean a microorganism that is of animal or human health significance and is capable of surviving and persisting within the manufacturing, processing, packing, or holding environment. The environmental pathogens most frequently involved in the contamination of animal food leading to foodborne illness are Salmonella spp.
2. Salmonella spp. as an Environmental Pathogen
The Agency discusses Salmonella spp. in section II.E of the preamble of this document and in section I.D.2 of the Appendix of the document for the proposed rule for preventive controls for human food (78 FR 3646). Salmonella has been isolated from a variety of foods and it can get into food by a variety of mechanisms. The focus here is on Salmonella contamination from the environment, particularly as a hazard associated with low-moisture animal food such as protein meals and dry animal food (Ref. 6). In the first RFR Annual Report, 86 of the primary RFR entries reported for human and animal food were a result of Salmonella contaminations. Almost half of these were from low-moisture foods and 13 of these were animal food (Ref. 7).
3. Environmental Pathogens in the Plant Environment
Environmental pathogens may be introduced into a facility through raw materials or ingredients, people, or objects. Once in the facility, environmental pathogens can be a source of contamination of animal food. Further discussion of "Environmental pathogens in the plant environment" can be found in section I.D.4 of the Appendix of the document for the proposed rule for preventive controls for human food (78 FR 3646).
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