As discussed in section X.C.4 of this document, proposed SEC 507.36(c)(2) would require that preventive controls for hazards identified in the hazard analysis as reasonably likely to occur include, when applicable, the maximum or minimum value, or combination of values, to which any biological, chemical, physical, or radiological parameter must be controlled. (For process controls in particular, the term "parameter" used in proposed SEC 507.36(c)(1), and the value associated with the parameter in proposed SEC 507.36(c)(2), are associated with the term "critical limit" used in HACCP systems.)
For example, a facility that holds shelled corn in bulk storage units for an extended time period until it is sold or mixed into an animal food may identify the potential for growth of aflatoxin-producing molds on the corn as a hazard reasonably likely to occur. As a process control to prevent such molds from growing on the corn during storage, the facility may elect to dry the corn to a specific moisture content (e.g., no more than 15 percent) prior to placing the corn in storage. The process control would be "drying" and the associated parameter would be moisture level, with its maximum value, or limit, being 15 percent.
6. Proposed SEC 507.36(d)(2)--Sanitation Controls
Proposed SEC 507.36(d)(2)(i)(A) and (B) would establish two requirements for sanitation controls where necessary to significantly minimize or prevent hazards that are reasonably likely to occur. Proposed SEC 507.36(d)(2)(i)(A) would require that the owner, operator or agent in charge of the facility implement, where relevant to hazards that are reasonably likely to occur, sanitation controls that would include procedures for the cleanliness of animal food-contact surfaces, including animal food-contact surfaces of utensils and equipment. Examples of such sanitation controls include cleaning and sanitizing procedures (including appropriate frequencies for these procedures, concentrations of cleaning and sanitizing compounds, method of application, and contact time). Such controls can prevent contamination of animal food with microorganisms of animal or human health significance, including environmental pathogens that result from inadequate cleaning of animal food-contact surfaces.
Proposed SEC 507.36(d)(2)(i)(B) would require that the owner, operator or agent in charge of a facility implement, where relevant to hazards that are reasonably likely to occur, sanitation controls that include procedures for the prevention of cross-contamination from insanitary objects to animal food, animal food packaging material, and other animal food-contact surfaces and from raw product to processed product. Examples of such controls to prevent cross-contamination include procedures for ensuring that personnel do not touch insanitary objects such as waste and waste bins and then animal food, animal food contact surfaces, or animal food packaging material; procedures for protecting animal food packaging material from environmental contamination; procedures for protecting exposed animal food products from contamination from the environment; and procedures for controlling traffic (including traffic of people and traffic of equipment such as forklifts) between the raw and finished sides of the operation. Any time an animal food is exposed to the environment during a manufacturing, processing, packing, or holding activity, there is the potential for the animal food to be contaminated. Appropriate sanitation controls can minimize the presence and transfer of contaminants, including environmental pathogens, to animal food. (See section I.D and I.E of the Appendix to this document for a discussion on the importance of controlling environmental pathogens.) Proposed SEC 507.36(d)(2)(i)(A) and (B) would implement section 418(c) of the FD&C Act. For a discussion on sanitation controls under HACCP, see section XII.C.7 for the proposed rule for preventive controls for human food (78 FR 3646).
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