To give another example, a facility that uses corn as a raw material in the manufacture of animal food intended for lactating dairy cows, beef cattle, swine, and poultry, would determine if aflatoxin is a reasonably foreseeable hazard that is reasonably likely to occur in the corn. An evaluation of the hazard would include the adverse health consequences to humans consuming milk and milk products from the dairy cows (See FDA Compliance Policy Guide (CPG) 683.100, Action Levels for Aflatoxins in Animal Feeds) (Ref. 15). This evaluation is likely to differ from the evaluation of aflatoxin in corn used to manufacture food for beef cattle, swine, and poultry, where higher levels of aflatoxin, to a point, would not be likely to cause illness or injury to the animals that consume the food or to humans consuming food products derived from those animals (Ref. 15). As a result, in evaluating the same hazard, the hazard analysis for the food for dairy cattle would lead to a different conclusion than the hazard analysis for the food for beef cattle, swine, and poultry.
Proposed SEC 507.33(a) would identify the purpose of the hazard analysis, i.e., to determine whether there are hazards that are reasonably likely to occur in animal food. Although section 418(b)(1) of the FD&C Act does not explicitly identify the purpose of the hazard analysis, the Agency interprets the combined requirements of sections 418(b), (c)(1) and (c)(3) of the FD&C Act to reflect a purpose, i.e., to enable the facility to identify and, where necessary, implement preventive controls to provide assurances that hazards identified in the hazard analysis will be significantly minimized or prevented and the animal food manufactured, processed, packed or held by the facility will not be adulterated under section 402 of the FD&C Act. If, for example, a facility concludes during the hazard analysis that one or more (or even all) reasonably foreseeable hazards are not reasonably likely to occur in the facility, the facility could conclude that there is no need to implement preventive controls for those hazards. The purpose of the hazard analysis identified in proposed SEC 507.33 is consistent with the purpose identified in the NACMCF HACCP guidelines, the Codex HACCP Annex, and Federal HACCP regulations for seafood, juice, and meat and poultry.
b. Requirement for the hazard analysis to be written. Proposed SEC 507.33(a) would require that the hazard analysis "be written" as required by section 418(b)(3) of the FD&C Act. A written hazard analysis can help the facility organize the scientific basis for the hazard analysis and would be essential to the facility's food safety team, auditors, and inspectors during review and evaluation of the hazard analysis. The facility's food safety team would need to fully understand the nature of the hazards in order to produce safe animal food. For example, although the facility's food safety plan would include corrective action procedures that address problems that can be anticipated, the food safety team would need to identify appropriate corrective actions when there is an unanticipated problem (see, e.g., the discussion of a proposed requirement (proposed SEC 507.42) for corrective actions when there is an unanticipated problem in section X.F.3). The written hazard analysis would be useful at these times. Having a written hazard analysis available for auditors and for inspectors is essential for assessing the adequacy of the hazard analysis. A written hazard analysis would also be essential during reanalysis and updates of the hazard analysis, as would be required by proposed SEC 507.45(e) so that the person doing the reanalysis or update has a baseline from which to start. A written hazard analysis would also be useful for training purposes as a tool to make employees aware of food safety hazards that are reasonably likely to occur.
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