Category: cGMP

a) Management of the establishment must ensure that:

(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) Animal food, including raw materials, other ingredients, or rework is accurately identified;

(3) Animal food-packaging materials are safe and suitable;

(4) The overall cleanliness of the plant is under the supervision of one or more competent individuals assigned responsibility for this function;

(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) Chemical, microbial, or extraneous-material testing procedures are used where necessary to identify sanitation failures or possible animal food contamination;

(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) 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) 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:

(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;

(ii) Raw materials must be cleaned as necessary to minimize contamination; and

(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) 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) 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) 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) 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) 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) 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) 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) 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) 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) 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.

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(a) The following apply to plant equipment and utensils used in manufacturing, processing, packing, and holding animal food:

(1) All plant equipment and utensils, including equipment and utensils that do not come in contact with animal food, must be designed and constructed of such material and workmanship to be adequately cleanable, and must be properly maintained;

(2) Equipment and utensils must be designed, constructed, and used appropriately to avoid the adulteration of animal food with non-food grade lubricants, fuel, metal fragments, contaminated water, or any other contaminants;

(3) Equipment must be installed so as to facilitate the cleaning and maintenance of the equipment and adjacent spaces;

(4) Animal food-contact surfaces must be:

(i) Made of materials that withstand the environment of their use and the action of animal food, and, if applicable, the action of cleaning compounds, cleaning procedures, and sanitizing agents;

(ii) Made of nontoxic materials; and

(iii) Maintained to protect animal food from being contaminated.

(b) Holding, conveying, manufacturing, and processing systems, including gravimetric, pneumatic, closed, and automated systems, must be designed, constructed, and maintained in a way to protect against the contamination of animal food.

(c) Each freezer and cold storage compartment used to hold animal food must be fitted with an accurate temperature-measuring device.

(d) Instruments and controls used for measuring, regulating, or recording temperatures, pH, aw, or other conditions that control or prevent the growth of undesirable microorganisms in animal food must be accurate, precise, adequately maintained, and adequate in number for their designated uses.

(e) Compressed air or other gases mechanically introduced into animal food or used to clean animal food-contact surfaces or equipment must be used in such a way to protect against the contamination of animal food.

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a) The following apply to the water supply:

(1) Water must be adequate for the operations and must be derived from an adequate source;

(2) Running water at a suitable temperature, and under suitable pressure as needed, must be provided in all areas where required for the manufacturing, processing, packing, or holding of animal food, for the cleaning of equipment, utensils, and animal food-packaging materials, or for employee hand-washing facilities;

(3) Water that contacts animal food, animal food-contact surfaces, or animal food-packaging materials must be safe for its intended use; and

(4) Water may be reused for washing, rinsing, or conveying animal food if it does not increase the level of contamination of the animal food.

(b) Plumbing must be designed, installed, and maintained to:

(1) Carry adequate quantities of water to required locations throughout the plant;

(2) Properly convey sewage and liquid disposable waste from the plant;

(3) Avoid being a source of contamination to animal food, water supplies, equipment, or utensils, or creating an unsanitary condition;

(4) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor; and

(5) Ensure that there is no backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for animal food or animal food manufacturing.

(c) Sewage and liquid disposal waste must be disposed of through an adequate sewerage system or through other adequate means.

(d) Each plant must provide employees with adequate, readily accessible toilet facilities. Toilet facilities must be kept clean and must not be a potential source of contamination of animal food, animal food-contact surfaces, or animal food-packaging materials.

(e) Each plant must provide hand-washing facilities designed to ensure that an employee’s hands are not a potential source of contamination of animal food, animal food-contact surfaces, or animal food-packaging materials.

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(a) Buildings, structures, fixtures, and other physical facilities of the plant must be kept clean and in good repair to prevent animal food from becoming adulterated.

(b) Animal food-contact and non-contact surfaces of utensils and equipment must be cleaned and maintained and utensils and equipment stored as necessary to protect against the contamination of animal food, animal food-contact surfaces, or animal food-packaging materials. When necessary, equipment must be disassembled for thorough cleaning. In addition:

(1) When animal food-contact surfaces used for manufacturing, processing, packing, or holding animal food are wet-cleaned, the surfaces must, when necessary, be thoroughly dried before subsequent use; and

(2) In wet processing of animal food, when cleaning and sanitizing are necessary to protect against the introduction of undesirable microorganisms into animal food, all animal food-contact surfaces must be cleaned and sanitized before use and after any interruption during which the animal food-contact surfaces may have become contaminated.

(c) Cleaning compounds and sanitizing agents must be safe and adequate under the conditions of use.

(d) The following applies to toxic materials:

(1) Only the following toxic materials may be used or stored in the plant area where animal food is manufactured, processed, or exposed:

(i) Those required to maintain clean and sanitary conditions;

(ii) Those necessary for use in laboratory testing procedures;

(iii) Those necessary for plant and equipment maintenance and operation; and

(iv) Those necessary for use in the plant’s operations.

(2) Toxic materials described in paragraph (d)(1) of this section (e.g., cleaning compounds, sanitizing agents, and pesticide chemicals) must be identified, used, and stored in a manner that protects against the contamination of animal food, animal food-contact surfaces, or animal food-packaging materials; and

(3) Other toxic materials (such as fertilizers and pesticides not included in paragraph (d)(1) of this section) must be stored in an area of the plant where animal food is not manufactured, processed, or exposed.

(e) Effective measures must be taken to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of animal food by pests. The use of pesticides in the plant is permitted only under precautions and restrictions that will protect against the contamination of animal food, animal food-contact surfaces, and animal food-packaging materials.

(f) Trash must be conveyed, stored, and disposed of in a way that protects against the contamination of animal food, animal food-contact surfaces, animal food-packaging materials, water supplies, and ground surfaces, and minimizes the potential for the trash to become an attractant and harborage or breeding place for pests.

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(a) The grounds around an animal food plant under the control of the management of the establishment must be kept in a condition that will protect against the contamination of animal food. Maintenance of grounds must include:

(1) Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant that may constitute an attractant, breeding place, or harborage for pests;

(2) Maintaining driveways, yards, and parking areas so that they do not constitute a source of contamination in areas where animal food is exposed;

(3) Adequately draining areas that may contribute to contamination of animal food; and

(4) Treating and disposing of waste so that it does not constitute a source of contamination in areas where animal food is exposed.

(b) The plant must be suitable in size, construction, and design to facilitate cleaning, maintenance, and pest control to reduce the potential for contamination of animal food, animal food-contact surfaces, and animal food-packaging materials, including that the plant must:

(1) Provide adequate space between equipment, walls, and stored materials to permit employees to perform their duties and to allow cleaning and maintenance of equipment;

(2) Be constructed in a manner such that drip or condensate from fixtures, ducts, and pipes does not serve as a source of contamination;

(3) Provide adequate ventilation (mechanical or natural) where necessary and appropriate to minimize vapors (e.g., steam) and fumes in areas where they may contaminate animal food and in a manner that minimizes the potential for contaminating animal food;

(4) Provide adequate lighting in hand-washing areas, toilet rooms, areas where animal food is received, manufactured, processed, packed, or held, and areas where equipment or utensils are cleaned; and (5) Provide shatter-resistant light bulbs, fix

fixtures, and skylights, or other glass items suspended over exposed animal food in any step of preparation, to protect against the contamination of animal food in case of glass breakage.

(c) The plant must protect animal food stored outdoors in bulk from contamination by any effective means, including:

(1) Using protective coverings where necessary and appropriate;

(2) Controlling areas over and around the bulk animal food to eliminate harborages for pests; and

(3) Checking on a regular basis for pests, pest infestation, and product condition related to safety of the animal food.

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In my last post I talked about two different inspections. I hope these “tales” encouraged you (neither was as “bad” as the mills expected); I hope these “tales” inspired you (to be “ready” for your inspection). Are you ready? What have you done?  Over the next few months, I will recap the requirements of the FSMA rule. I hope I can encourage and inspire you to get ready for your inspection. Instead of me telling you what you need to do, I want you to tell me what you have done…

The original CFD FSMA project helped you to “say what you do”, by writing Standard Operating Procedures, the focus was on Current Good Manufacturing Practice. In my training classes I highlighted some of the best practices I have seen various mills do to comply with CGMP’s. Over the past few years, I am confident you have come up with some great ideas.

Every two weeks, I will post the text of one CGMP. I hope you will use each 2-week period to focus on your compliance with this part of the rule. Read it and think about your compliance. What have you done, what do you need to do better than briefly share one or two ideas of ways you comply with this CGMP. Here is the schedule:

I will summarize responses (anomalously of course) in an update to each post.

• 2/28 507.14 Personnel
• 3/14 507.17 Plant and Grounds
• 3/28 507.19 Sanitation
• 4/11 507.20 Water Supply and Plumbing
• 4/25 507.22 Equipment and Utensils
• 5/09 507.25 Plant Operations
• 5/23 507.27 Holding and Distribution

507.14 Personnel – Management of the establishment must take reasonable measures and precautions to ensure that all persons working in direct contact with animal food, animal food-contact surfaces, and animal food-packaging materials conform to hygienic practices as necessary to protect against the contamination of animal food (21 CFR 507.14(a)).

Persons working in direct contact with animal food may include employees, contractors, and visitors. Methods for conforming to hygienic practices and maintaining cleanliness include: maintaining adequate personal cleanliness; washing hands thoroughly in an adequate hand-washing facility as necessary and appropriate to protect against contamination; removing or securing jewelry and other objects that could fall into animal food, equipment, or containers; storing clothing and personal belongings in areas other than where animal food is exposed or where equipment or utensils are cleaned; and taking any other precautions necessary to protect against contamination of animal food, animal food contact surfaces, or animal food-packaging materials (21 CFR 507.14(b)).  

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