I. The Role of Testing as a Verification Measure in a Modern Food Safety System
A. Verification of Preventive Controls
In some respects, animal food safety is a more complex subject than human food safety in that the feeding of multiple and diverse animal species is involved, many of which are associated with human food in the form of meat, milk and eggs. However, the core principles and approaches used to assess and prevent hazards that are reasonably likely to occur in animal food are similar to those used during the manufacture of food for humans, despite differences in production practices and levels of sanitation involved (Ref. 1).
The safety of food is principally ensured by the effective implementation of scientifically valid preventive control measures throughout the food chain (Ref. 2) (Ref. 3). Prevention of hazards in animal food is much more effective than trying to differentiate safe from unsafe animal food using testing. Although testing is rarely considered a control measure, it plays a very important role in ensuring the safety of animal food. An important purpose of testing is to verify that control measures, including those related to suppliers and those verified through environmental monitoring, are controlling the hazard (Ref. 4) (Ref. 5). Testing is used in conjunction with other verification measures in the 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. Although testing may be conducted for biological, chemical, physical, or radiological hazards, the most common testing is for microbiological hazards. Thus, much of the testing described below focuses on microbial testing, but many of the issues discussed apply to testing for other hazards as well. The Agency focuses more of its discussion below on verification testing of the environment because of the increasing recognition of the benefits of such testing in identifying conditions that could result in environmental pathogens contaminating animal food; thus such verification testing is important in preventing contamination in animal food, whereas verification testing of raw materials, ingredients, and finished products is used to detect contamination that has already occurred.
As discussed in sections I.C, I.E, and I.F of this Appendix, microbial testing may include:
* Testing raw materials and ingredients to verify that suppliers have significantly minimized or prevented hazards reasonably likely to occur in the raw materials and ingredients;
* Testing the environment to verify that sanitation controls have significantly minimized or prevented the potential for environmental pathogens to contaminate animal food; and
* Testing finished product to verify that preventive controls have significantly minimized or prevented hazards reasonably likely to occur in the animal food.
Further discussion of verification of preventive controls can be found in section I.A of the Appendix of the document for the proposed rule for preventive controls for human food (78 FR 3646).
B. Scientifically Valid Sampling and Testing
Consistent with the Agency's discussion of the term "scientifically valid" in the proposed rule to establish CGMP requirements for dietary ingredients and dietary supplements for humans (68 FR 12158 at 12198), the Agency uses the term "scientifically valid" with respect to testing to mean using an approach to both sampling and testing that is based on scientific information, data, or results published in, for example, scientific journals, references, text books, or proprietary research. A scientifically valid analytical method is one that is based on scientific data or results published in, for example, scientific journals, references, text books, or proprietary research (68 FR 12158 at 12198). Sampling and testing used for verification in a food safety system must be scientifically valid if they are to provide assurance that preventive controls are effective.
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