FDA requests comment on when and how product testing programs are 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. Should a product testing program be limited to finished product testing or include raw material testing? What is the appropriate level of specificity for a product testing program? For example, should the Agency simply require that the owner, operator, or agent in charge conduct, as appropriate to the facility and the animal food, finished product testing, when appropriate based on risk, to assess whether the preventive controls significantly minimize or prevent the hazards that are reasonably likely to occur? This would provide flexibility to account for the wide diversity of animal food and animal food manufacturing, processing, packing, and holding systems subject to this rule and be consistent with the discussions within this proposed rule.
FDA also requests comment on whether more detail would be appropriate, by, for example:
* Specifying particular hazards, situations or product types for which finished product testing would be required;
* Specifying the frequency of testing and, if so, whether this frequency should depend on the type of product;
* Identifying appropriate sampling plans for finished product testing;
* Requiring periodic testing for trend analysis and statistical process control; and
* Requiring written procedures for conducting finished product testing and, if so, also require that procedures for finished product testing be scientifically valid and include the procedures for sampling and the sampling frequency.
FDA also requests comment on the impact of product testing requirements on small businesses and on whether any product testing verification requirements should differ based on the size of the operation.
3. Environmental Monitoring
As discussed in section X.G.1 of this document, section 418(f)(4) of the FD&C Act states that the owner, operator, or agent in charge of a facility shall verify that "the preventive controls implemented under [section 418(c) of the FD&C Act] are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means." In addition, section 418(o)(3) indicates that preventive controls may include environmental monitoring to verify the effectiveness of pathogen controls is an example of preventive controls. The statute does not indicate the specific circumstances where environmental testing would be required or the specific manner in which such testing should be performed. Nevertheless, FDA believes that this testing can form an important component of a modern animal food safety system. FDA believes that the role and need for these measures varies depending on the type of products and activities of a facility. FDA further believes that the performance of environmental monitoring, for an appropriate microorganism of public health significance or for an appropriate indicator organism, is particularly useful as a verification measure for preventive controls (i.e., sanitation controls) when contamination of animal food with an environmental pathogen is a hazard reasonably likely to occur.
As discussed in section X.B.3, proposed SEC 507.33(b) would require a hazard identification that must consider hazards that may occur naturally or may be unintentionally introduced. The data from recalls and the RFR support a conclusion that Salmonella spp. is a hazard in animal pet treats and pet food products. When certain animal food, such as dry pet food, is exposed to the environment prior to packaging, FDA believes that most facilities producing such animal foods would identify Salmonella spp. as a known or reasonably foreseeable hazard under proposed SEC 507.33(b). A robust environmental monitoring program for Salmonella spp. can verify the effectiveness of sanitation controls designed to prevent Salmonella spp. from contaminating animal food-contact surfaces and animal food (Ref. 94).
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