Finished product testing is more important and useful when there is a reasonable probability that exposure to an identified hazard will result in serious adverse health consequences or death to humans or animals. FDA believes that there are certain situations in which finished product testing is particularly useful as a verification measure, including the following circumstances:
* The outcome of the hazard analysis conducted under proposed SEC 507.33 is that a biological hazard is reasonably likely to occur in an ingredient and the preventive controls established and implemented under proposed SEC 507.36 do not include a process control that will significantly minimize the hazard. An example is a dry blending operation that mixes a variety of ingredients such as seeds, nuts that may be contaminated with Salmonella spp., dried fruit, and algae meal to make bird food.
* The outcome of the hazard analysis conducted under proposed SEC 507.33 is that a biological hazard is reasonably likely to occur in an ingredient that is added during manufacturing after the stage that applies a process control to significantly minimize biological hazards. An example is pet food (such as dry pet food and pet treats) in which untreated flavorings that may contain Salmonella spp. are applied after the pet food has undergone a heat treatment.
* The outcome of the hazard analysis conducted under proposed SEC 507.33 is that a biological hazard is reasonably likely to occur as a result of handling of a product or exposure of a product to the environment after a process control that significantly minimizes a hazard such that a hazard could be introduced or re-introduced into the product. An example is the manufacture of pet treats, such as pig ears, that after heat treating become contaminated with Salmonella spp. from the processing environment.
In addition, the frequency of testing and the number of samples tested must be determined and needs to take into account a variety of hazard/commodity/facility considerations. FDA believes that factors to consider include whether ingredients that may contain a hazard have been tested, the extent of any environmental monitoring program, and whether other programs established by the facility provide added assurance that the potential for hazards has been minimized. The frequency of testing and the number of samples tested should have a scientific basis. Sampling plans and their performance have been described in the literature (Refs. 89, 90, and 91) and are included in several Codex documents (Refs. 92 and 93). The Agency discusses likely considerations that could impact finished product verification testing in more detail in section I.F of the Appendix.
Although the Agency is not including a testing provision in this proposed rule, the Agency estimates that a requirement for a finished product testing program, when implemented appropriately in particular facilities, could impose an incremental annual cost of
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