As discussed (see section I of this document), animal food safety is best assured if each facility understands the hazards that are reasonably likely to occur in its particular product and operation and puts in place scientifically sound preventive controls to significantly minimize or eliminate those hazards. From a regulatory perspective, specifying the circumstances and manner in which these controls and practices are to be applied must take into account the wide array of factors, including the diversity among animal food products, the wide variety of manufacturing and processing methods used to produce the animal food, the variety of sources for raw materials and ingredients, variations in the nature and types of hazards associated with manufacturing, processing, packing, and holding animal food, and the possibility that different mitigation methods may achieve the same end. Further, regulatory requirements should make clear when one of these preventive controls or verification measures is necessary yet also be sufficiently flexible to account for a vast number of animal food and facility combinations and circumstances.
Although the Agency is not including provisions for environmental and product testing programs or a supplier approval and verification program in this proposed rule, the Agency recognizes that these preventive controls and verification measures, when implemented appropriately in particular facilities, can play important roles in effective animal food safety programs. The role and need for these measures varies depending on the type of products and activities of the facility. To facilitate comment and share the Agency's current thinking, the Agency discusses the topics of environmental and product testing programs and a supplier approval and verification program immediately below. See the Appendix to this document for additional background information relevant to these topics.
2. Product Testing
As discussed in section X.G.1, 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" The statute does not indicate the specific circumstances where product testing would be required or the specific manner in which such testing should be performed. 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 owner, operator, or agent in charge of a facility could consider a number of factors to establish a product testing program.
Although finished product testing is rarely considered a preventive control, it plays a very important role as a verification measure in ensuring the safety of animal food, when implemented appropriately in particular facilities. Similarly, testing of raw materials or ingredients by a facility that is receiving the product often plays an important role in verification of hazard control that is performed by its supplier. Thus, an important purpose of testing is to verify that preventive controls, including those related to suppliers and those related to environmental monitoring, are controlling the hazard (Refs. 31 and 32). Testing is used in conjunction with other verification measures in the animal food safety system, such as audits of suppliers, observations of whether activities are being conducted according to the food safety plan, and reviewing records to determine whether process controls are meeting specified limits for parameters established in the food safety plan.
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