(a) Management of the establishment must ensure that:

1. (1) All operations in the manufacturing, processing, packing, and holding of animal food (including operations directed to receiving, inspecting, transporting, and segregating) are conducted in accordance with the current good manufacturing practice requirements of this subpart;
2. (2) Animal food, including raw materials, other ingredients, or rework is accurately identified;
3. (3) Animal food-packaging materials are safe and suitable;
4. (4) The overall cleanliness of the plant is under the supervision of one or more competent individuals assigned responsibility for this function;
5. (5) Adequate precautions are taken so that plant operations do not contribute to contamination of animal food, animal food-contact surfaces, and animal food-packaging materials;
6. (6) Chemical, microbial, or extraneous-material testing procedures are used where necessary to identify sanitation failures or possible animal food contamination;
7. (7) Animal food that has become adulterated is rejected, disposed of, or if appropriate, treated or processed to eliminate the adulteration. If disposed of, it must be done in a manner that protects against the contamination of other animal food; and
8. (8) All animal food manufacturing, processing, packing, and holding is conducted under such conditions and controls as are necessary to minimize the potential for the growth of undesirable microorganisms to protect against the contamination of animal food.

(b) Raw materials and other ingredients:

1. (1) Must be examined to ensure that they are suitable for manufacturing and processing into animal food and must be handled under conditions that will protect against contamination and minimize deterioration. In addition:

   1. (i) Shipping containers (e.g., totes, drums, and tubs) and bulk vehicles holding raw materials and other ingredients must be examined upon receipt to determine whether contamination or deterioration of animal food has occurred;
   2. (ii) Raw materials must be cleaned as necessary to minimize contamination; and
   3. (iii) Raw materials and other ingredients, including rework, must be stored in containers designed and constructed in a way that protects against contamination and deterioration, and held under conditions, e.g., appropriate temperature and relative humidity, that will minimize the potential for growth of undesirable microorganisms and prevent the animal food from becoming adulterated;
2. (2) Susceptible to contamination with mycotoxins or other natural toxins must be evaluated and used in a manner that does not result in animal food that can cause injury or illness to animals or humans; and
3. (3) If frozen, must be kept frozen. If thawing is required prior to use, it must be done in a manner that minimizes the potential for the growth of undesirable microorganisms.

(c) For the purposes of manufacturing, processing, packing, and holding operations, the following apply:

1. (1) Animal food must be maintained under conditions, e.g., appropriate temperature and relative humidity, that will minimize the potential for growth of undesirable microorganisms and prevent the animal food from becoming adulterated during manufacturing, processing, packing, and holding;
2. (2) Measures taken during manufacturing, processing, packing, and holding of animal food to significantly minimize or prevent the growth of undesirable microorganisms (e.g., heat treating, freezing, refrigerating, irradiating, controlling pH, or controlling aw) must be adequate to prevent adulteration of animal food;
3. (3) Work-in-process and rework must be handled in such a way that it is protected against contamination and the growth of undesirable microorganisms;
4. (4) Steps such as cutting, drying, defatting, grinding, mixing, extruding, pelleting, and cooling, must be performed in a way that protects against the contamination of animal food;
5. (5) Filling, assembling, packaging, and other operations must be performed in such a way that protects against the contamination of animal food and the growth of undesirable microorganisms;
6. (6) Animal food that relies principally on the control of water activity (aw) for preventing the growth of undesirable microorganisms must be processed to and maintained at a safe aw level;
7. (7) Animal food that relies principally on the control of pH for preventing the growth of undesirable microorganisms must be monitored and maintained at the appropriate pH; and
8. (8) When ice is used in contact with animal food, it must be made from water that is safe and must be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in this subpart.