(a) The milk plant shall operate in a manner to facilitate maintenance and sanitary operations for food-production purposes (i.e., manufacturing, processing, packing, and holding). The milk plant shall:

1. (1) provide adequate space for placement of equipment and storage of materials as is necessary for maintenance, sanitary operations, and the production of safe food;
2. (2) take adequate precautions to reduce the potential for allergen cross-contact and for contamination of food, food-contact surfaces, or food-packaging materials with microorganisms, chemicals, filth, and other extraneous material. The potential for allergen cross-contact and for contamination shall be reduced by adequate food safety control, operating practices, or effective design, including the separation of operations in which allergen cross-contact and contamination are likely to occur, or by any affective means including but not limited to: location, time, partition, air flow systems, dust control systems, and/or enclosed systems;

3. (3) take adequate precautions to protect food in installed outdoor bulk vessels by any effective means, including but not limited to:

   1. (i) using protective coverings;
   2. (ii) controlling areas over and around the vessels to eliminate harborages for pests;
   3. (iii) checking on a regular basis for pests and pest infestation.
4. (4) Be operated in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food, food-contact surfaces, or food-packaging materials with clothing or personal contact.
5. (5) Provide shatter-resistant light bulbs, fixtures, skylights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage.

(d) All product-contact surfaces of containers, equipment and utensils are covered or otherwise protected to prevent the access of insects, dust, condensation and other contamination. All openings, including valves and piping attached to milk storage and milk tank trucks, pumps or vats, etc., shall be capped or otherwise properly protected. While unloading at a receiving station, transfer station or pasteurization plant, one of the following conditions shall be met:

1. (1) If the area is completely enclosed (walls and ceiling, with doors closed) during the unloading process and the dustcover or dome and the manhole cover is opened slightly and held in this position by the metal clamps used to close the cover, then a filter is not required. However, if the dustcover and/or manhole cover(s) are opened in excess of that provided by the metal clamps or the covers have been removed, then a suitable filter is required for the manhole.
2. (2) If the area is not completely enclosed or doors of the unloading area are open during unloading, a suitable filter is required for the manhole or air inlet vent and suitable protection must be provided over the filter material either by design of the filter holding apparatus or a roof or ceiling over the area. Direct connections from milk tank truck to milk truck must be made from valve to valve and not through the manhole and the manhole and the dustcover (dome) of the milk tank truck being filled must be closed.
3. (3) Receiving and dump vats shall be completely covered, except during washing and sanitizing, and when milk is being dumped. Where strainers are used, the cover for the vat opening shall be designed to cover the opening with the strainer in place.

(i) All ingredients and nonproduct-contact materials used in the preparation or packaging of milk and milk products shall be stored in a clean place and so handled as to prevent their contamination.

1. (1) Raw materials and other ingredients shall be inspected and segregated or otherwise adequately handled to ensure that they are clean and suitable for processing into food and stored be stored under conditions that will protect against allergen cross-contact and against contamination and minimize deterioration. Raw materials shall be washed or cleaned as necessary to remove soil or other contamination.
2. (2) Raw materials and other ingredients must either not contain levels of microorganisms that may render the food injurious to the health of humans, or shall be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated.
3. (3) Raw materials and other ingredients susceptible to contamination with aflatoxin or other natural toxins shall comply with 21 CFR part 109 for poisonous or deleterious substances before being incorporated into finished food.
4. (4) Raw materials, other ingredients, and rework that contain an added poisonous or deleterious substance shall not contain an amount any such substance in excess of the applicable defect action level.
5. (5) Raw materials, other ingredients, and rework shall be held in bulk, or in containers designed and constructed so as to protect against allergen cross-contact and against contamination, and must be held at such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated. Material scheduled for rework must be identified as such.
6. (6) Frozen raw materials and other ingredients shall be kept frozen. If thawing is required prior to use, it must be done in a manner that prevents the raw materials and other ingredients from becoming adulterated.
7. (7) Liquid or dry raw materials and other ingredients received and stored in bulk form shall be held in a manner that protects against allergen cross-contact and against contamination.
8. (8) Raw materials and other ingredients that are food allergens, and rework that contains food allergens, shall be identified and held in a manner that prevents allergen cross-contact.

(k) Only the following toxic materials may be used or stored in a plant where food is processed or exposed:

1. (1) those required to maintain clean and sanitary conditions;
2. (2) those necessary for use in laboratory testing procedures;
3. (3) those necessary for plant and equipment maintenance and operation; and
4. (4) those necessary for use in the plant's operations.

(l) Those poisonous or toxic materials that are necessary:

1. (1) shall not be stored in a room where milk or milk products are received, processed, pasteurized or stored, or where equipment, containers, or utensils are washed or where single-service containers, closures or caps are stored; and
2. (2) shall be stored in a manner that protects against contamination of food, food-contact surfaces, and food packaging materials.

(w) Human food by-products held for distribution as animal food without additional manufacturing or processing by the human food processor shall be held under conditions that will protect against contamination, including the following:

1. (1) containers and equipment used to convey or hold human food by-products for use as animal food before distribution shall be designed, constructed of appropriate material, cleaned as necessary, and maintained to protect against the contamination of human food by-products for use as animal food;
2. (2) Hhuman food by-products for use as animal food held for distribution must be held in a way to protect against contamination from sources such as trash;
3. (3) during holding, human food by-products for use as animal food shall be accurately identified;
4. (4) labeling that identifies the by-product by the common or usual name shall be affixed to or accompany human food by-products for use as animal food when distributed;
5. (5) shipping containers (e.g., totes, drums, and tubs) and bulk vehicles used to distribute human food by-products for use as animal food shall be examined prior to use to protect against contamination of the human food by-products for use as animal food from the container or vehicle when the facility is responsible for transporting the human food by-products for use as animal food itself or arranges with a third party to transport the human food by-products for use as animal food.