2. Proposed SEC 507.33(a)--Hazard Analysis
a. Proposed SEC 507.33(a)--Requirement to identify and evaluate hazards. Proposed SEC 507.33(a) would require that the owner, operator, or agent in charge of a facility must identify and evaluate known or reasonably foreseeable hazards, for each type of animal food manufactured, processed, packed, or held at the facility to determine whether there are hazards that are reasonably likely to occur. As discussed more fully in the remainder of this section, proposed SEC 507.33(a) would implement section 418(b)(1) of the FD&C Act.
In developing the proposed requirement for a hazard analysis, the Agency considered the language of section 418(b)(1) of the FD&C Act describing the hazards that a facility would be required to identify and evaluate, i.e., "known or reasonably foreseeable hazards that may be associated with the facility." The Agency considers the "known or reasonably foreseeable hazards" in section 418(b) of the FD&C Act to be analogous to the "potential hazards" discussed in the NACMCF HACCP guidelines, and the hazards that are required to be identified to determine if they are "hazards that may be reasonably expected to occur at each step" in the Codex HACCP Annex, or "reasonably likely to occur" in Federal HACCP regulations for seafood, juice, and meat and poultry (Refs. 29 and 36).
Proposed SEC 507.33(a) would establish the requirement to identify and evaluate hazards by conducting a hazard analysis. The specific requirements for the hazard identification are in proposed SEC 507.33(b) (see section X.B.3) and specific requirements for the hazard evaluation in proposed SEC 507.33(c) and (d) (see sections X.B.4 and X.B.5.)
Proposed SEC 507.33(a) would require that the identification and evaluation of hazards be done "for each type of animal food manufactured, processed, packed, or held at the facility." In developing the proposed requirement for a hazard analysis, the Agency considered the language of section 418(b)(1) of the FD&C Act. The purpose of sections 418(b)(1) appears clear, i.e., that the owner, operator, or agent in charge of a facility identify and evaluate known or reasonably foreseeable hazards that may be associated with the food produced by the facility. The known or reasonably foreseeable hazards associated with the facility's food may differ based on the type of food.
The process of identifying and evaluating the hazards that may occur for specific types of animal food handled in a facility provides an efficient means for keeping track of multiple hazards that may occur in a facility that handles several types of animal food. Such a process also provides an efficient means for ensuring that preventive controls are applied to specific animal food products when required. Thus, a facility may need to conduct multiple hazard analyses. For example, a facility that uses an animal protein blend (by-products derived from meat and animal production industries) as an ingredient in the manufacture of food intended for swine, poultry, dogs and cats, would be required by proposed SEC 507.33 to identify the Salmonella serotypes to which swine, poultry, dogs, and cats are each susceptible (e.g., Salmonella Choleraesuis in food for swine; Salmonella Pullorum, Salmonella Gallinarum, or Salmonella Enteritidis in food for poultry) along with an evaluation of the adverse health effects each Salmonella serotype would cause in each of the animal species for which the food is intended (e.g., diarrhea, fever, or pneumonia in pigs caused by Salmonella Choleraesuis; diarrhea, gasping, or depression in poultry caused by Salmonella Pullorum) (Ref. 14). In addition, for the animal protein blend used in the manufacture of food for dogs and cats, a hazard analysis would need to include the hazards reasonably likely to occur related to the health of human handlers (e.g., pet owners) who are likely to come in contact with the finished food. In other words, if a facility manufactures food for multiple animal species, the Agency would consider the animal food intended for each animal species to be a type of animal food under proposed SEC 507.33(a), each requiring its own hazard identification and evaluation, even if the animal food the facility produces for each animal species consists of the same primary ingredients. As with the example above, the same biological, chemical, physical, or radiological agent in different types of food intended for different animal species may lead to varied adverse health effects in each of the animal species consuming the food.
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