(5) The corrective action procedures as required by SEC 507.42; and
(6) The verification procedures and the frequency with which they will be performed as required by SEC 507.45.
SEC 507.33 Hazard analysis.
(a) 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 and develop a written hazard analysis.
(b) The hazard analysis must consider hazards that may occur naturally or may be unintentionally introduced including:
(1) Biological hazards, including microbiological hazards such as parasites, environmental pathogens, and other microorganisms of animal or human health significance;
(2) Chemical hazards, including substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and nutrient imbalances;
(3) Physical hazards; and
(4) Radiological hazards.
(c) The hazard analysis must contain an evaluation of the hazards identified in paragraph (b) of this section to determine whether the hazards are reasonably likely to occur, including an assessment of the severity of the illness or injury if the hazard were to occur.
(d) The hazard analysis must consider the effect of the following on the safety of the finished animal food:
(1) The formulation of the animal food;
(2) The condition, function, and design of the facility and equipment;
(3) Raw materials and ingredients;
(4) Transportation practices;
(5) Manufacturing/processing procedures;
(6) Packaging activities and labeling activities;
(7) Storage and distribution;
(8) Intended or reasonably foreseeable use;
(9) Sanitation, including employee hygiene; and
(10) Any other relevant factors.
SEC 507.36 Preventive controls for hazards that are reasonably likely to occur.
For hazards identified in the hazard analysis as reasonably likely to occur:
(a) The owner, operator, or agent in charge of a facility must identify and implement preventive controls, including at critical control points, if any, to provide assurances that hazards identified in the hazard analysis as reasonably likely to occur will be significantly minimized or prevented and the animal food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act.
(b) Preventive controls must be written.
(c) Preventive controls must include, as appropriate to the facility and animal food:
(1) Parameters associated with the control of the hazard, such as parameters associated with heat processing, irradiating, and refrigerating animal foods; and
(2) The maximum or minimum value, or combination of values, to which any biological, chemical, physical, or radiological parameter must be controlled to significantly minimize or prevent a hazard that is reasonably likely to occur.
(d) Preventive controls must include, as appropriate:
(1) Process controls that include those procedures, practices, and processes performed on an animal food during manufacturing/processing that are employed to significantly minimize or prevent hazards that are reasonably likely to occur;
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