Pest refers to any objectionable animals or insects including birds, rodents, flies, and larvae.
Plant means the building or establishment, or parts thereof, used for or in connection with the manufacturing, processing, packing, or holding of animal food.
Preventive controls means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.
Qualified end-user, with respect to an animal food, means the consumer of the food (where the term does not include a business); or a restaurant or retail food establishment (as those terms are defined in SEC 1.227(b) of this chapter) that:
(1) Is located:
(i) In the same State as the qualified facility that sold the food to such restaurant or retail food establishment; or
(ii) Not more than 275 miles from such facility; and
(2) Is purchasing the food for sale directly to consumers at such restaurant or retail food establishment.
Qualified facility means (when including the sales by any subsidiary; affiliate; or subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate) a facility that is a very small business as defined in this part, or a facility to which both of the following apply:
(1) During the 3-year period preceding the applicable calendar year, the average annual monetary value of the animal food manufactured, processed, packed, or held at such facility that is sold directly to qualified end-users (as defined in this part) during such period exceeded the average annual monetary value of the animal food sold by such facility to all other purchasers; and
(2) The average annual monetary value of all animal food sold during the 3-year period preceding the applicable calendar year was less than
Qualified individual means a person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA, or is otherwise qualified through job experience to develop and apply a food safety system.
Quality control operation means a planned and systematic procedure for taking all actions necessary to prevent food from being adulterated.
Reasonably foreseeable hazard means a potential biological, chemical, physical, or radiological hazard that may be associated with the facility, or the food.
Rework means clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use as food.
Safe moisture level is a level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the intended conditions of manufacturing, processing, packing, and holding. The safe moisture level for a food is related to its water activity (aw). An aw will be considered safe for a food if adequate data are available that demonstrate that the food at or below the given aw will not support the growth of undesirable microorganisms.
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