As discussed in section I.E.2 of the Appendix to this document, the Agency is also 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 Listeria spp. may be an appropriate indicator organism for L. monocytogenes, because tests for Listeria spp. will detect multiple species of Listeria, including L. monocytogenes. However, FDA's current thinking is that there are no currently available indicator organisms for Salmonella spp. The Agency requests comment on these findings and conclusions.
Although the Agency is not including an environmental testing provision in this proposed rule, the Agency estimates that an environmental monitoring program for Salmonella spp., when implemented appropriately in certain animal food facilities, could impose an annual cost of about
The facilities that could adopt environmental monitoring programs are facilities producing animal food products, such as dry pet food, exposed to the environment prior to packaging, whereby they may become contaminated and for which such testing would be particularly useful as a verification measure for sanitation controls.
FDA requests comment on when and how environmental testing is an appropriate means of implementing the statutory directives set out above. Although the Agency has not included these provisions in the proposed rule, the Agency requests comment on their inclusion in a final rule. If they are included, what is the appropriate level of specificity? For example, should the Agency simply require the performance of environmental monitoring, for an appropriate microorganism of public health significance or for an appropriate indicator organism, if contamination of animal food with an environmental pathogen is a hazard reasonably likely to occur? FDA also requests comment on whether more detail would be appropriate, by, for example:
* Specifying the environmental pathogen or the indicator organism for which the samples must be tested;
* Specifying the corrective actions that should be taken if environmental testing identifies the presence of an environmental pathogen, such as;
* Conducting microbial sampling and testing of surrounding surfaces and areas to determine the extent of the contamination and the potential source of the contamination;
* Cleaning and sanitizing the contaminated surfaces and surrounding areas to eliminate the test organism;
* Conducting additional microbial sampling and testing to determine whether the contamination has been eliminated; and
* Conducting finished product testing.
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