Proposed SEC 507.3 defines "food" to mean food as defined in section 201(f) of the FD&C Act and includes raw materials and ingredients.
Proposed SEC 507.3 defines "food-contact surfaces" as those surfaces that contact food and those surfaces from which drainage, or other transfer, onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. "Food-contact surfaces" includes food-contact surfaces of utensils and equipment. The Agency is proposing this definition to clarify the meaning of the phrase "food-contact surfaces" when used in this proposed part.
The Agency is proposing to define the term "harvesting" as follows: Harvesting applies to farms and farm mixed-type facilities and means activities that are traditionally performed by farms for the purpose of removing raw agricultural commodities from the place they were grown or raised and preparing them for use as food. Harvesting is limited to activities performed on raw agricultural commodities on the farm on which they were grown or raised, or another farm under the same ownership. Harvesting does not include activities that transform a raw agricultural commodity, as defined in section 201(r) of the FD&C Act, into a processed food as defined in section 201(gg) of the FD&C Act. Gathering, washing, trimming of outer leaves of, removing stems and husks from, sifting, filtering, threshing, shelling, and cooling raw agricultural commodities grown on a farm or another farm under the same ownership are examples of harvesting. The Agency is proposing the same definition of "harvesting" here as in proposed
The Agency is proposing to define "hazard" to mean any biological, chemical, physical, or radiological agent that is reasonably likely to cause illness or injury in animals or humans in the absence of its control. The phrase "in animals or humans" is included in this definition because a biological, chemical, physical, or radiological agent in animal food could cause injury and illness to not only animals, but to humans that handle the animal food, or eat products (such as milk, meat, or eggs) derived from animals that ingested the food. The Agency is proposing to include radiological agents to implement section 418(b)(1)(A) of the FD&C Act, which includes radiological hazards as an example of known or reasonably foreseeable hazards that may be associated with a facility. For further discussion on the definition of "hazard" and its consistency with HACCP, see section X.B of the document for the proposed rule for preventive controls for human food (78 FR 3646).
The Agency is proposing to define the phrase "hazard reasonably likely to occur" to mean a hazard for which a prudent person who manufactures, processes, packs, or holds food would establish controls because experience, illness data, scientific reports, or other information provides a basis to conclude that there is a reasonable possibility that the hazard will occur in the type of food being manufactured, processed, packed, or held in the absence of those controls. For further discussion on the definition of "hazard reasonably likely to occur" and its consistency with HACCP, see section X.B of the document for the proposed rule for preventive controls for human food (78 FR 3646). This concept is used in
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