The following 21 CFR 507 Compliance Tool should be viewed only as an informational aid to navigating the complexities of this FDA rule regarding Animal Food. Statements provided should not be considered legal advice and do not replace independent legal counsel.
Jump to Hazard Analysis Guidance.
#1 - Does your firm handle animal feed or feed ingredients intended for consumption in the United States?
#2 - Is your facility required to complete a Food Facility Registration under the federal Bioterrorism Act?
#3 - Is your facility any of the following: Restaurant, Grocery Store, Pet Shelter, Veterinary Facility, or other Retail Food or Animal Feed Establishment selling soley to end users?
#4 - Does your facility meet the FDA definition of a farm?
#5 - Does your farm facility engage in any processing activities (other than blending, harvesting, drying, packaging, etc) that would classify it as a Mixed Type Facility and offer those products for sale to off-farm customers?
#6 - Your facility is required to be registered with the Food Facility Registration as part of the federal Bioterrorism Act and is subject to compliance with all or part of 21 CFR 507, rules regarding Preventive Controls for Animal Food (PCAF).
#7 - Is your facility engaged in the manufacture or processing of animal feed or feed ingredients?
#8 - Is your facility solely engaged with holding and/or transporting Raw Agricultural Commodities?
#9 - Does your facility hold only packaged, unexposed animal feed products?
#10 - Does your facility hold one or more manufactured feed product in bulk?
#11 - Do the packaged animal feed products at your facility require time or temperature to control pathogens?
#12 - Is your facility engaged in any of the following activities: (Check all that apply)
#13 - Are there manufacturing processes other than sorting, drying, and/or packaging that are completed on animal feed products at your facility other than those regulated by rules from the previous question?
#14 - Is your firm a small or very small business that is a Farm Mixed Type Facility engaged in holding animal feed or various low-risk animal food/activity combinations intended for commerce?
#15 - Does your firm meet the following criteria of a Qualified Facility?
Raw Agricultural Commodity as defined by the Federal Food, Drug and Cosmetic Act
(r) The term "raw agricultural commodity" means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.
Farm Mixed Type Facility
(e) For a farm mixed-type facility that is a small or very small business, subparts C and E of this part do not apply to on-farm packing or holding of processed animal food, and §507.7 does not apply to on-farm packing or holding of processed animal food by a very small business, if the only packing or holding activities subject to section 418 of the Federal Food, Drug, and Cosmetic Act that the business conducts are the following low-risk packing or holding activity/animal food combinations—i.e., packing (or repacking) (including weighing or conveying incidental to packing or repacking); sorting, culling, or grading incidental to packing or storing; and storing (ambient, cold and controlled atmosphere) of:
(f) For a farm mixed-type facility that is a small or very small business, subparts C and E of this part do not apply to on-farm manufacturing/processing activities conducted by a small or very small business for distribution into commerce, and §507.7 does not apply to on-farm manufacturing/processing activities conducted by a very small business for distribution into commerce, if the only manufacturing/processing activities subject to section 418 of the Federal Food, Drug, and Cosmetic Act that the business conducts consists of the following low-risk manufacturing/processing activity/animal food combinations:
Based on the information given, your facility is exempt from 21 CFR 507.
Based on the information provided, your facility is exempt from 21 CFR 507 Subparts B, C, and E, but may subject to Subparts A and F. Learn more.
Your answers indicate that your firm is engaged in activities that will require it to be in full compliance with 21 CFR 507. Your facility should pay particular attention to Subpart A (General Provisions), Subpart B (Current Good Manufacturing Practices), Subpart C (Hazard Analysis and Risk-Based Preventive Controls), and Subpart F (Requirements Applying to Records That Must Be Established and Maintained). Learn more.
Based on your answers, your facility is exempt from Subparts C and E of 21 CFR 507. You will still need to be in compliance with Subparts A, B, and F. Learn more.
Based on your answers, your facility is exempt from the full requirements of Subparts C and E of 21 CFR 507. However, your firm maintains time and temperature controls and so must be in compliance with modified requirements for this facility type. Learn more.
Human Food/Low-Acid Canned Food/Produce Safety Rule with Additional Manufacturing
From your answers, it appears that your facility may be subject to both 21 CFR 507 and additional FDA regulations. Those regulations supersede 21 CFR 507 where they are applicable, but you will need to be in compliance with the PCAF Rule if additional processing is done after other regulated processes are complete. Your facility's situation may be outside the scope of this tool's ability to provide guidance regarding regulations beyond 21 CFR 507, but you may answer the questions again omitting any processes regulated by other FDA standards in order to view recommendations on any products or processes that might be regulated specifically by 21 CFR 507.
The above is provided for informational purposes only. It is not intended to be legal advice and does not replace the advice of independent legal counsel.
Human Food/Low-Acid Canned Food/Produce Safety Rule with No Additional Manufacturing
Based on your answers, your manufacturing processes are subject to other FDA standards that supersede 21 CFR 507 and so your facility's compliance requirements are outside the scope of this tool. However, parts of 21 CFR 507 may still apply to certain warehouse or storage areas, especially Subparts A, B, and F, as well as modified requirements for Subparts C and E if animal products being held require time or temparture controls to mitigate pathogens. If you would like to view recommendations specific to compliance with 21 CFR 507, you may consider answering the questions again and omitting any manufacturing processes regulated by other FDA standards.
The above is provided for informational purposes only. It is not intended to be legal advice and does not replace the advice of independent legal counsel.
Small or Very Small Farm Mixed Type Facility
According to your answers, your small or very small farm mixed type facility is exempt from Subparts C and E of 21 CFR 507. You will still need to be in compliance with Subparts A, B, and F. Learn more.
Qualified Facilities
Your facility may meet the requirements of a qualified facility. You are required to complete a qualified facility attestation by July 31 of the applicable year and then every two years afterward to maintain this status. You will be exempt from Subparts C and E, but will need to remain in compliance with 21 CFR 507.7 and other modified requirements. Learn more.
Feed Manufacturers
Your answers indicate that your firm is engaged in activities that will require it to be in full compliance with 21 CFR 507. Your facility should pay particular attention to Subpart A (General Provisions), Subpart B (Current Good Manufacturing Practices), Subpart C (Hazard Analysis and Risk-Based Preventive Controls), and Subpart F (Requirements Applying to Records That Must Be Established and Maintained). Learn more.
Determine Hazard Analysis Guidance (below).
#16 - Ingredients used in animal feed or feed ingredient manufacture: (check all that apply)
#17 - Processes completed at your facility to manufacture feed or feed ingredients: (check all that apply)
#18 - Processes completed at your facility to manufacture feed or feed ingredients: (check all that apply)
#19 - Identify the species for which feed is handled at your facility: (check all that apply)
#20 - Does your firm have a recent history of violations or actions taken by a regulatory body?
| Hazard | Hazard Type | Considerations |
| BSE | Biological | Firms manufacturing and handling feeds or feed ingredients, especially those with products being fed to ruminants, should be aware of the BSE Rule, 21 CFR 589.2000 and 21 CFR 589.2001. Firms should consider how grains and grain by-products may become adulterated with Prohibited Mammalian Tissue via shared transportation or equipment. |
| Mycotoxin(s) | Chemical | Mycotoxins are toxins produced by one or more of a variety type of fungi that are found in grains and grain products. These can include aflatoxin, fumonisin, vomitoxin, among others. The type of mycotoxin that your facility should consider depends on type of grain, geographic area, harvest conditions, storage conditions and species for which the feed is intended. When determing which mycotoxins might be a hazard for your facility and how to mitigate the hazard, FDA guidance and University Extension can provide more information. |
| Nutrient Deficiency | Chemical | Certain RACs, grains, or by-products may be a significant source of particular nutrients in the diets of animals for which the final feed is intended. Consider whether or not any feeds or feed ingredients handled by your facility are the primary source of essential nutrients to the intended animals. If a risk exists, a program should be developed to mitigate it. |
| Nutrient Toxicity | Chemical | Depending on the species for which feed or feed ingredients handled by your facility are intended, you and your colleagues may need to be aware of potential nutrient toxicities. Some species are very sensitive to particular nutrients. Be aware of any species and nutrient combinations that may result in a potential animal health risk and then consider if there may be a ways that feed or feed ingredients at your facility may be processed or contaminated in a way that might pose a hazard. |
| Debris | Physical | Physical debris such as metal, plastic, and other foreign material can create a choking hazard for some animals or create other physiological problems if ingested. Bulk loads of feed or feed ingredients should be screened for potential physical hazards, but physical debris could also be introduced to animal feeds with in your facility if there is damage to processing equipment or conveyances. Consider the role of maintenance in mitigating the hazard of physical debris - processing equipment and conveyances should be well maintained to prevent the introduction of debris, as well as monitoring and maintaining devices such as screens, scalpers, and magnets meant to remove debris from feed and ingredients. |
| Hazard | Hazard Type | Considerations |
| BSE | Biological | Firms manufacturing and handling feeds or feed ingredients, especially those with products being fed to ruminants, should be aware of the BSE Rule, 21 CFR 589.2000 and 21 CFR 589.2001. Firms should consider how feed ingredients containing plant-derived fats may become adulterated with Prohibited Mammalian Tissue via shared transportation or equipment. |
| Mycotoxin(s) | Chemical | Mycotoxins are toxins produced by one or more of a variety type of fungi that are found in grains and grain products. These can include aflatoxin, fumonisin, vomitoxin, among others. The type of mycotoxin that your facility should consider depends on type of grain, geographic area, harvest conditions, storage conditions and species for which the feed is intended. When determing which mycotoxins might be a hazard for your facility and how to mitigate the hazard, FDA guidance and University Extension can provide more information. |
| Nutrient Toxicity | Chemical | Depending on the species for which feed or feed ingredients handled by your facility are intended, you and your colleagues may need to be aware of potential nutrient toxicities. Some species are very sensitive to particular nutrients. Be aware of any species and nutrient combinations that may result in a potential animal health risk and then consider if there may be a ways that feed or feed ingredients at your facility may be processed or contaminated in a way that might pose a hazard. |
| Debris | Physical | Physical debris such as metal, plastic, and other foreign material can create a choking hazard for some animals or create other physiological problems if ingested. Bulk loads of feed or feed ingredients should be screened for potential physical hazards, but physical debris could also be introduced to animal feeds with in your facility if there is damage to processing equipment or conveyances. Consider the role of maintenance in mitigating the hazard of physical debris - processing equipment and conveyances should be well maintained to prevent the introduction of debris, as well as monitoring and maintaining devices such as screens, scalpers, and magnets meant to remove debris from feed and ingredients. |
| Hazard | Hazard Type | Considerations |
| BSE | Biological | Firms manufacturing and handling feeds or feed ingredients, especially those with products being fed to ruminants, should be aware of the BSE Rule, 21 CFR 589.2000 and 21 CFR 589.2001. Firms that use animal derived fats and/or proteins should make certain of the source and quality of these products. Proteins derived from ruminants may not be fed to other ruminants. Ruminant derived fats may be used in formulations for other ruminants provided they are free from impurities. Additionally, firms handling feed feed or ingredients intended for ruminants should consider ways that those products may become adulterated with Prohibited Mammalian Tissue via shared transportation or equipment. |
| Salmonella | Biological | Animal derived products that have not undergone a sufficient kill step can be a carrier of the bacteria, Salmonella. Salmonella may cause serious adverse health effects in animals and humans, including severe illness and death. Young animals can be especially susceptible to food poisoning from Salmonella. Depending on the strain of Salmonella, animals and/or humans may contract the bacteria through consumption or handling of animal food or feces from infected animals. Section 402(a)(1) of the Food, Drug and Cosmetic Act details FDA's stance regarding the adulterated status of pet food contaminated with Salmonella. |
| Nutrient Toxicity | Chemical | Depending on the species for which feed or feed ingredients handled by your facility are intended, you and your colleagues may need to be aware of potential nutrient toxicities. Some species are very sensitive to particular nutrients. Be aware of any species and nutrient combinations that may result in a potential animal health risk and then consider if there may be a ways that feed or feed ingredients at your facility may be processed or contaminated in a way that might pose a hazard. |
| Debris | Physical | Physical debris such as metal, plastic, and other foreign material can create a choking hazard for some animals or create other physiological problems if ingested. Bulk loads of feed or feed ingredients should be screened for potential physical hazards, but physical debris could also be introduced to animal feeds with in your facility if there is damage to processing equipment or conveyances. Consider the role of maintenance in mitigating the hazard of physical debris - processing equipment and conveyances should be well maintained to prevent the introduction of debris, as well as monitoring and maintaining devices such as screens, scalpers, and magnets meant to remove debris from feed and ingredients. |
| Hazard | Hazard Type | Considerations |
| BSE | Biological | Firms manufacturing and handling feeds or feed ingredients that contain ruminant meat or bone meal (Prohibited Mammalian Tissue) must be aware of the BSE Rule, 21 CFR 589.2000 and 21 CFR 589.2001. Any items containing Prohibited Mammalian Tissue must be marked "Do not feed to cattle or other ruminants" unless intended as retail pet food. If a firm produces feed products that are sourced from both ruminants and nonruminants efforts must be taken to ensure that there is no cross contamination. |
| Salmonella | Biological | Animal derived products that have not undergone a sufficient kill step can be a carrier of the bacteria, Salmonella. Salmonella may cause serious adverse health effects in animals and humans, including severe illness and death. Young animals can be especially susceptible to food poisoning from Salmonella. Depending on the strain of Salmonella, animals and/or humans may contract the bacteria through consumption or handling of animal food or feces from infected animals. Section 402(a)(1) of the Food, Drug and Cosmetic Act details FDA's stance regarding the adulterated status of pet food contaminated with Salmonella. |
| Nutrient Toxicity | Chemical | Depending on the species for which feed or feed ingredients handled by your facility are intended, you and your colleagues may need to be aware of potential nutrient toxicities. Some species are very sensitive to particular nutrients. Be aware of any species and nutrient combinations that may result in a potential animal health risk and then consider if there may be a ways that feed or feed ingredients at your facility may be processed or contaminated in a way that might pose a hazard. |
| Debris | Physical | Physical debris such as metal, plastic, and other foreign material can create a choking hazard for some animals or create other physiological problems if ingested. Bulk loads of feed or feed ingredients should be screened for potential physical hazards, but physical debris could also be introduced to animal feeds with in your facility if there is damage to processing equipment or conveyances. Consider the role of maintenance in mitigating the hazard of physical debris - processing equipment and conveyances should be well maintained to prevent the introduction of debris, as well as monitoring and maintaining devices such as screens, scalpers, and magnets meant to remove debris from feed and ingredients. |
| Hazard | Hazard Type | Considerations |
| Salmonella | Biological | Animal derived products that have not undergone a sufficient kill step can be a carrier of the bacteria, Salmonella. Salmonella may cause serious adverse health effects in animals and humans, including severe illness and death. Young animals can be especially susceptible to food poisoning from Salmonella. Depending on the strain of Salmonella, animals and/or humans may contract the bacteria through consumption or handling of animal food or feces from infected animals. Section 402(a)(1) of the Food, Drug and Cosmetic Act details FDA's stance regarding the adulterated status of pet food contaminated with Salmonella. |
| Animal Drugs | Chemical | Some animal milk products or supplements derived from milk contain drugs approved for animals. Animals in early life stages can be susceptible to a variety of conditions that can be mitigated by medicated feeds. However, they are also especially susceptible to complications if medicated feeds are improperly formulated. Firms handling medicated animal milk products should take care that the appropriate medications are used and formulations are followed accurately. Additionally, firms working with medicated and nonmedicated products should consider hazards resulting from drug carryover that can occur if clean out or flushing is insufficient. Further information about compliance with handling medicated feeds can be found in 21 CFR 225.120-225.202. |
| Nutrient Deficiency | Chemical | Animal Milk or Milk Derived Ingredients may be the only source of nutrients in the diets of young and growing animals. At this stage of life, proper nutrients are critical to animal health and development. Consider whether or not any feeds or feed ingredients handled by your facility are the primary source of essential nutrients to the intended animals. If a risk exists, a program should be developed to mitigate it. |
| Nutrient Toxicity | Chemical | Depending on the species or growing stage for which feed or feed ingredients handled by your facility are intended, you and your colleagues may need to be aware of potential nutrient toxicities. Some species are very sensitive to particular nutrients. Additionally, animals in early life stages may be sensitive to some nutrients as well. Be aware of any combination of nutrients and species and/or life stages that may result in a potential animal health risk and then consider if there may be a ways that feed or feed ingredients at your facility may be processed or contaminated in a way that might pose a hazard. |
| Debris | Physical | Physical debris such as metal, plastic, and other foreign material can create a choking hazard for some animals or create other physiological problems if ingested. Bulk loads of feed or feed ingredients should be screened for potential physical hazards, but physical debris could also be introduced to animal feeds with in your facility if there is damage to processing equipment or conveyances. Consider the role of maintenance in mitigating the hazard of physical debris - processing equipment and conveyances should be well maintained to prevent the introduction of debris, as well as monitoring and maintaining devices such as screens, scalpers, and magnets meant to remove debris from feed and ingredients. |
| Hazard | Hazard Type | Considerations |
| Animal Drugs | Chemical | Liquid feed supplements may be used to provide animal drugs in feed formulations. Firms handling medicated liquid feed supplements should take care that the appropriate medications are used and formulations are followed accurately. Some medicated liquid supplements will require regular agitation to ensure that there is no settling. If this is the case, it should be indicated on product labeling. Additionally, firms working with medicated and nonmedicated products should consider hazards resulting from drug carryover that can occur if clean out or flushing is insufficient. Further information about compliance with handling medicated feeds can be found in 21 CFR 225.120-225.202. |
| Nutrient Deficiency | Chemical | In some cases, Liquid Feed Supplements may be a significant source of particular nutrients in the diets of animals for which the final feed is intended. Consider whether or not any feeds or feed ingredients handled by your facility are the primary sources of essential nutrients to the intended animals. If a risk exists, a program should be developed to mitigate it. |
| Nutrient Toxicity | Chemical | Depending on the species for which feed or feed ingredients handled by your facility are intended, you and your colleagues may need to be aware of potential nutrient toxicities. Some species are very sensitive to particular nutrients. Be aware of any species and nutrient combinations that may result in a potential animal health risk and then consider if there may be ways that feed or feed ingredients at your facility may be processed or contaminated in a way that might pose a hazard. |
| Debris | Physical | Physical debris such as metal, plastic, and other foreign material can create a choking hazard for some animals or create other physiological problems if ingested. Bulk loads of feed or feed ingredients should be screened for potential physical hazards, but physical debris could also be introduced to animal feeds within your facility if there is damage to processing equipment or conveyances. Consider the role of maintenance in mitigating the hazard of physical debris - processing equipment and conveyances should be well maintained to prevent the introduction of debris, as well as monitoring and maintaining devices such as screens, scalpers, and magnets meant to remove debris from feed and ingredients. |
| Hazard | Hazard Type | Considerations |
| Heavy Metals | Chemical | Heavy metals, such as lead, arsenic, and mercury, may be present in mineral sources. Facilities involved in the manufacture of mineral-containing supplements should take care to reduce the presence of heavy metals as much as possible because there are no known safe levels for these materials. |
| Dioxins | Chemical | Dioxins are toxic environmental pollutants. They are sometimes found in mineral products that have been dried in temperatures above 500 degrees Fahrenheit. Mineral manufacturers should consider their processes and strive to reduce the dioxins being present in feed products. |
| Nutrient Deficiency | Chemical | Vitamins, Minerals, and Premixes are often a significant source of one or more nutrients in the diets of animals for which the final feed is intended. Firms that manufacture sources of vitamins, minerals, and/or premixes or use those products as ingredients in feed production should take particular care that essential nutrients are provided at appropriate levels for the intended species. Some potential hazards related to vitamin and mineral products might be confirming that the potency of products used, ensuring correct batching and labeling, and taking care not to use expired vitamin supplements that may have degraded. |
| Nutrient Toxicity | Chemical | Vitamins, Minerals, and Premixes often provide one or more nutrients at relatively high concentrations compared to the levels that should be provided in an animal's final diet. Firms that manufacture sources of vitamins, minerals, and/or premixes or use those products as ingredients in feed production should take particular care that essential nutrients are provided at appropriate levels for the intended species. Some potential hazards related to vitamin and mineral products might be confirming that the potency of products used and ensuring correct batching and labeling. Additionally, some species are particularly sensitive to certain nutrients. Care should be taken to be aware of such combinations of species and nutrient sensitivity and steps taken to avoid cross-contamination. |
| Debris | Physical | Physical debris such as metal, plastic, and other foreign material can create a choking hazard for some animals or create other physiological problems if ingested. Bulk loads of feed or feed ingredients should be screened for potential physical hazards, but physical debris could also be introduced to animal feeds within your facility if there is damage to processing equipment or conveyances. Consider the role of maintenance in mitigating the hazard of physical debris - processing equipment and conveyances should be well maintained to prevent the introduction of debris, as well as monitoring and maintaining devices such as screens, scalpers, and magnets meant to remove debris from feed and ingredients. |
| Hazard | Hazard Type | Considerations |
| Animal Drugs | Chemical | Many animal feeds provide animal drugs to promote or maintain animal health. Firms handling medicated feeds should take care that the appropriate medications are used and formulations are followed accurately. Correct labeling should accompany any medicated feed product. Labels will provide mixing and/or feeding directions as well as any precautions associated with use. Additionally, firms working with medicated and nonmedicated products should consider hazards resulting from drug carryover that can occur if cleanout or flushing is insufficient. Further information about compliance with handling medicated feeds can be found in 21 CFR 225.120-225.202. |
| Debris | Physical | Physical debris such as metal, plastic, and other foreign material can create a choking hazard for some animals or create other physiological problems if ingested. Bulk loads of feed or feed ingredients should be screened for potential physical hazards, but physical debris could also be introduced to animal feeds within your facility if there is damage to processing equipment or conveyances. Consider the role of maintenance in mitigating the hazard of physical debris - processing equipment and conveyances should be well maintained to prevent the introduction of debris, as well as monitoring and maintaining devices such as screens, scalpers, and magnets meant to remove debris from feed and ingredients. |
| Hazard | Hazard Type | Considerations |
| Listeria Monocyto-genes | Biological | Listeria is a bacteria that can cause food poisoning and miscarriage. It is found in the environment and can tolerate a wide range of conditions including refrigeration. Health risks associated with Listeria may not develop readily in many animals, but it can be a risk to humans who handle raw meat, unproperly cleaned surfaces, or have close contact with companion animals that shed the bacteria. Firms handling meat products and/or feed for companion animals should consider how the hazard to human health might be mitigated. |
| Salmonella | Biological | Animal-derived products that have not undergone a sufficient kill step can be a carrier of the bacteria, Salmonella. Salmonella may cause serious adverse health effects in animals and humans, including severe illness and death. Young animals can be especially susceptible to food poisoning from Salmonella. Depending on the strain of Salmonella, animals and/or humans may contract the bacteria through consumption or handling of animal food or feces from infected animals. Section 402(a)(1) of the Food, Drug and Cosmetic Act details FDA's stance regarding the adulterated status of pet food contaminated with Salmonella. |
| BSE | Biological | Firms manufacturing and handling feeds or feed ingredients that contain ruminant meat or bone meal (Prohibited Mammalian Tissue) must be aware of the BSE Rule, 21 CFR 589.2000 and 21 CFR 589.2001. Any items containing Prohibited Mammalian Tissue must be marked "Do not feed to cattle or other ruminants" unless intended as retail pet food. If a firm produces feed products that are sourced from both ruminants and nonruminants efforts must be taken to ensure that there is no cross-contamination. |
| Animal Drug Residue | Chemical | Animal feed derived from animal carcasses has the potential to be contaminated with animal drug residues. Certain organs, such as the liver and kidneys, may have higher concentrations of residues, as well as skeletal meat. Some antibiotics and pentobarbital, which is used for euthanasia, could be a hazard in feed for other animals. The risk is potentially exasperated by large portions of meat that have not been co-mingled with other animal carcasses. |
| Persistent Organic Pollutants (POP) | Chemical | Firms processing animal carcasses into animal feed and/or feed ingredients should be aware of Persistent Organic Pollutants (POP). POP may be found in animals who have consumed contaminated feed or water or have been exposed to the application of certain pesticides. The United States has banned the use of many pesticides that contribute to POP contamination, but the pollutants themselves are persistent and remain in the environment for a significant time. POP are most likely to be dissolved in fats and oils, so they may be found concentrated in those products. Firms working with and processing animal carcasses may consider testing for POP. |
| Debris | Physical | Physical debris such as metal, plastic, and other foreign material can create a choking hazard for some animals or create other physiological problems if ingested. Bulk loads of feed or feed ingredients should be screened for potential physical hazards, but physical debris could also be introduced to animal feeds within your facility if there is damage to processing equipment or conveyances. Consider the role of maintenance in mitigating the hazard of physical debris - processing equipment and conveyances should be well maintained to prevent the introduction of debris, as well as monitoring and maintaining devices such as screens, scalpers, and magnets meant to remove debris from feed and ingredients. |
| Hazard | Hazard Type | Considerations |
| Debris | Physical | Physical debris such as metal, plastic, and other foreign material can create a choking hazard for some animals or create other physiological problems if ingested. Bulk loads of feed or feed ingredients should be screened for potential physical hazards, but physical debris could also be introduced to animal feeds within your facility if there is damage to processing equipment or conveyances. Consider the role of maintenance in mitigating the hazard of physical debris - processing equipment and conveyances should be well maintained to prevent the introduction of debris, as well as monitoring and maintaining devices such as screens, scalpers, and magnets meant to remove debris from feed and ingredients. |
| Hazard | Hazard Type | Considerations |
| Animal Drugs | Chemical | Many animal feeds provide animal drugs to promote or maintain animal health. Firms handling medicated feeds should take care that the appropriate medications are used and formulations are followed accurately. Equipment and procedures should be assessed to ensure that medicated feeds thoroughly mixed. Correct labeling should accompany any medicated feed product. Labels will provide mixing and/or feeding directions as well as any precautions associated with use. Additionally, firms working with medicated and nonmedicated products should consider hazards resulting from drug carryover that can occur if cleanout or flushing is insufficient. Further information about compliance with handling medicated feeds can be found in 21 CFR 225.120-225.202. |
| Nutrient Deficiency | Chemical | Firms manufacturing animal feeds should be aware of which nutrients are essential to animal health. It is important that essential nutrients are provided at adequate levels to prevent deficiency. To aid in this process, firms should ensure nutrient sources of the appropriate kinda and concentration are used and that formulations are followed accurately. Equipment and procedures should be assessed to ensure that all feeds are thoroughly mixed. If further mixing is required, labeling should accompany the feed product to provide mixing directions as well as any precautions associated with use. |
| Nutrient Toxicity | Chemical | Firms manufacturing animal feeds should be aware of which nutrients are essential to animal health and which can be detrimental at toxic levels. It is important that essential nutrients are provided below tolerance levels to prevent toxicity. To aid in this process, firms should ensure nutrient sources of the appropriate kinda and concentration are used and that formulations are followed accurately. Equipment and procedures should be assessed to ensure that all feeds are thoroughly mixed. If further mixing is required, labeling should accompany the feed product to provide mixing directions as well as any precautions associated with use. Additionally, firms manufacturing feeds for multiple species should consider if carryover of certain nutrients is a hazard that can occur if cleanout or flushing is insufficient. |
| Debris | Physical | Physical debris such as metal, plastic, and other foreign material can create a choking hazard for some animals or create other physiological problems if ingested. Bulk loads of feed or feed ingredients should be screened for potential physical hazards, but physical debris could also be introduced to animal feeds within your facility if there is damage to processing equipment or conveyances. Consider the role of maintenance in mitigating the hazard of physical debris - processing equipment and conveyances should be well maintained to prevent the introduction of debris, as well as monitoring and maintaining devices such as screens, scalpers, and magnets meant to remove debris from feed and ingredients. |
| Hazard | Hazard Type | Considerations |
| Nutrient Deficiency | Chemical | The application of heat and pressure can affect the nutrients within animal feed by adjusting their bioavailability. Additionally, processing equipment that is shared with other types of feed, medicated or nonmedicated, or used for feed intended for different species may become a point where cross-contamination can occur. Firms engaged in pelleting, steam flaking, or extrusion should evaluate their processes to ensure that nutrient deficiency will not be a hazard. |
| Nutrient Toxicity | Chemical | The application of heat and pressure can affect the nutrients within animal feed by adjusting their bioavailability. Additionally, processing equipment that is shared with other types of feed, medicated or nonmedicated, or used for feed intended for different species may become a point where cross-contamination can occur. Firms engaged in pelleting, steam flaking, or extrusion should evaluate their processes to ensure that nutrient toxicity will not be a hazard. |
| Debris | Physical | Physical debris such as metal, plastic, and other foreign material can create a choking hazard for some animals or create other physiological problems if ingested. Bulk loads of feed or feed ingredients should be screened for potential physical hazards, but physical debris could also be introduced to animal feeds within your facility if there is damage to processing equipment or conveyances. Consider the role of maintenance in mitigating the hazard of physical debris - processing equipment and conveyances should be well maintained to prevent the introduction of debris, as well as monitoring and maintaining devices such as screens, scalpers, and magnets meant to remove debris from feed and ingredients. |
| Hazard | Hazard Type | Considerations |
| Solvent Suitability | Chemical | Some animal feed ingredients use solvents to extract nutrients from raw ingredients. Firms engaged in solvent extraction to produce animal feed ingredients should consider the effect solvents may have on animal health and how solvents may be effectively separated from animal feed ingredients to ensure a safe product. |
| Hazard | Hazard Type | Considerations |
| Salmonella | Biological | Animal-derived products that have not undergone a sufficient kill step can be a carrier of the bacteria, Salmonella. Salmonella may cause serious adverse health effects in animals and humans, including severe illness and death. Young animals can be especially susceptible to food poisoning from Salmonella. Depending on the strain of Salmonella, animals and/or humans may contract the bacteria through consumption or handling of animal food or feces from infected animals. Section 402(a)(1) of the Food, Drug and Cosmetic Act details FDA's stance regarding the adulterated status of pet food contaminated with Salmonella. |
| Clostridium botulinum | Biological | Clostridium botulinum is a group of seven bacteria that produce dangerous toxins. They thrive in low oxygen conditions such as the intestinal tracts of some animal carcasses. C. botulinum can affect domestic animals differently, but some species are particularly susceptible. Develop of the bacteria can be mitigated with treatment via heat, acidification, refrigeration or freezing. |
| Listeria Monocyto-genes | Biological | Listeria is a bacteria that can cause food poisoning and miscarriage. It is found in the environment and can tolerate a wide range of conditions including refrigeration. Health risks associated with Listeria may not develop readily in many animals, but it can be a risk to humans who handle raw meat, unproperly cleaned surfaces, or have close contact with companion animals that shed the bacteria. Firms handling meat products and/or feed for companion animals should consider how the hazard to human health might be mitigated. |
| Other Microbiological Pathogens | Biological | Often the application of heat, pressure, refrigeration or freezing to animal feed or feed ingredients is done to control microbial pathogens that may adulterate the feed product. Firms using these methods should be sure that the process is adequate to control the pathogens, is monitored for consistency, monitoring is verified, and that pathogens are not reintroduced to feed products after the process is applied. |
| Hazard | Hazard Type | Considerations |
| BSE | Biological | Firms manufacturing and handling livestock feeds or feed ingredients, especially those with products being fed to ruminants, should be aware of the BSE Rule, 21 CFR 589.2000 and 21 CFR 589.2001. Firms should consider how distiller products may become adulterated with Prohibited Mammalian Tissue via shared transportation. |
| Solvents/ Chemicals Suitability | Chemical | The manufacture of distillers grains and oils may use solvents, enzymes, and other chemicals to extract nutrients from raw ingredients. Firms engaged in distillation to produce animal feed ingredients should consider the effect these chemicals may have on animal health and how to ensure feed products are safe. |
| Solvent/Chemical/Alcohol Extraction | Chemical | The manufacture of distillers grains and oils may use solvents, enzymes, and other chemicals to extract nutrients from raw ingredients. Firms engaged in distillation to produce animal feed ingredients should consider how they may be effectively separated from animal feed ingredients to ensure a safe product. |
| Mycotoxin(s) | Chemical | Mycotoxins are toxins produced by one or more of a variety type of fungi that are found in grains and grain products. These can include aflatoxin, fumonisin, vomitoxin, among others. The type of mycotoxin that your facility should consider depends on the type of grain, geographic area, harvest conditions, storage conditions and species for which the feed is intended. When determining which mycotoxins might be a hazard for your facility and how to mitigate the hazard, FDA guidance and University Extension can provide more information. |
| Sulfur | Chemical | Sulfur is in a number of processing aids and cleaning agents used in facilities that produced distillers products. If sulfur-containing chemicals are not properly flushed or separated from distillers grains and oil products, elevated levels of sulfur may be introduced into animal feed ingredients. Animals have been known to experience poor health ranging from weight loss to fatalities from consuming excess sulfur. Firms engaged in handling distillers products should consider ways to reduce sulfur content in animal feeds. |
| Debris | Physical | Physical debris such as metal, plastic, and other foreign material can create a choking hazard for some animals or create other physiological problems if ingested. Bulk loads of feed or feed ingredients should be screened for potential physical hazards, but physical debris could also be introduced to animal feeds within your facility if there is damage to processing equipment or conveyances. Consider the role of maintenance in mitigating the hazard of physical debris - processing equipment and conveyances should be well maintained to prevent the introduction of debris, as well as monitoring and maintaining devices such as screens, scalpers, and magnets meant to remove debris from feed and ingredients. |
| Hazard | Hazard Type | Considerations |
| Salmonella | Biological | Animal-derived products that have not undergone a sufficient kill step can be a carrier of the bacteria, Salmonella. Salmonella may cause serious adverse health effects in animals and humans, including severe illness and death. Young animals can be especially susceptible to food poisoning from Salmonella. Depending on the strain of Salmonella, animals and/or humans may contract the bacteria through consumption or handling of animal food or feces from infected animals. Section 402(a)(1) of the Food, Drug and Cosmetic Act details FDA's stance regarding the adulterated status of pet food contaminated with Salmonella. |
| Other Potential Biological Agents | Biological | A wide variety of potential hazards may be associated with By-Products from Human Food. Firms engaged in handling human food by-products should consider the source and purpose of these feed products. It is possible that by-products carry drug residue, nutrients, toxins, pathogens or other agents that could be a hazard to animals for which the feed product is intended. Firms should consider ways to mitigate any identified hazard. |
| Mycotoxin(s) | Chemical | Mycotoxins are toxins produced by one or more of a variety type of fungi that are found in grains and grain products. These can include aflatoxin, fumonisin, vomitoxin, among others. The type of mycotoxin that your facility should consider depends on the type of grain, geographic area, harvest conditions, storage conditions and species for which the feed is intended. When determining which mycotoxins might be a hazard for your facility and how to mitigate the hazard, FDA guidance and University Extension can provide more information. |
| Nutrient Deficiency | Chemical | By-products derived from Human Foods can come from various sources and be intended for many different purposes. It may be that such products are a significant source of particular nutrients in the diets of animals for which the final feed is intended. Consider whether or not any feeds or feed ingredients handled by your facility are the primary sources of essential nutrients to the intended animals. If a risk exists, a program should be developed to mitigate it. |
| Nutrient Toxicity | Chemical | Depending on the species for which feed or feed ingredients handled by your facility are intended, you and your colleagues may need to be aware of potential nutrient toxicities. Some species are very sensitive to particular nutrients. Be aware of any species and nutrient combinations that may result in a potential animal health risk and then consider if there may be ways that feed or feed ingredients at your facility may be processed or contaminated in a way that might pose a hazard. |
| Debris | Physical | Physical debris such as metal, plastic, and other foreign material can create a choking hazard for some animals or create other physiological problems if ingested. Bulk loads of feed or feed ingredients should be screened for potential physical hazards, but physical debris could also be introduced to animal feeds within your facility if there is damage to processing equipment or conveyances. Consider the role of maintenance in mitigating the hazard of physical debris - processing equipment and conveyances should be well maintained to prevent the introduction of debris, as well as monitoring and maintaining devices such as screens, scalpers, and magnets meant to remove debris from feed and ingredients. |
| Hazard | Hazard Type | Considerations |
| Salmonella | Biological | Animal-derived products that have not undergone a sufficient kill step can be a carrier of the bacteria, Salmonella. Salmonella may cause serious adverse health effects in animals and humans, including severe illness and death. Young animals can be especially susceptible to food poisoning from Salmonella. Depending on the strain of Salmonella, animals and/or humans may contract the bacteria through consumption or handling of animal food or feces from infected animals. Section 402(a)(1) of the Food, Drug and Cosmetic Act details FDA's stance regarding the adulterated status of pet food contaminated with Salmonella. |
| Other Potential Biological Agents | Biological | A wide variety of potential hazards may be associated with Salvaged Animal Feeds. Firms engaged in salvaging feed should consider the source and purpose of salvaged feeds. It is possible that salvaged animal feeds carry drug residue, nutrients, toxins, pathogens or other agents that could be a hazard to animals for which the salvaged product is intended. Firms should consider ways to mitigate any identified hazard. |
| Mycotoxin(s) | Chemical | Mycotoxins are toxins produced by one or more of a variety type of fungi that are found in grains and grain products. These can include aflatoxin, fumonisin, vomitoxin, among others. The type of mycotoxin that your facility should consider depends on the type of grain, geographic area, harvest conditions, storage conditions and species for which the feed is intended. When determining which mycotoxins might be a hazard for your facility and how to mitigate the hazard, FDA guidance and University Extension can provide more information. |
| Nutrient Deficiency | Chemical | Salvaged Animal Feeds can come from various sources and be intended for many different purposes. It may be that such products are a significant source of particular nutrients in the diets of animals for which the final feed is intended. Consider whether or not any feeds or feed ingredients handled by your facility are the primary sources of essential nutrients to the intended animals. If a risk exists, a program should be developed to mitigate it. |
| Nutrient Toxicity | Chemical | Depending on the species for which feed or feed ingredients handled by your facility are intended, you and your colleagues may need to be aware of potential nutrient toxicities. Some species are very sensitive to particular nutrients. Be aware of any species and nutrient combinations that may result in a potential animal health risk and then consider if there may be ways that feed or feed ingredients at your facility may be processed or contaminated in a way that might pose a hazard. |
| Debris | Physical | Physical debris such as metal, plastic, and other foreign material can create a choking hazard for some animals or create other physiological problems if ingested. Bulk loads of feed or feed ingredients should be screened for potential physical hazards, but physical debris could also be introduced to animal feeds within your facility if there is damage to processing equipment or conveyances. Consider the role of maintenance in mitigating the hazard of physical debris - processing equipment and conveyances should be well maintained to prevent the introduction of debris, as well as monitoring and maintaining devices such as screens, scalpers, and magnets meant to remove debris from feed and ingredients. |
Your answers reveal that there is a combination of ingredients used or species for which feed is manufactured that could result in cross contamination that may result in risks to the health of animals or humans.
| Hazard | Hazard Type | Considerations |
| BSE | Biological | If your facility handles Prohibited Mammalian Tissue (meat, meal, or other feed products sourced from ruminant carcasses), you will need to be compliant with 21 CFR 589.2000 and 21 CFR 589.2001. Any feeds intended for ruminants cannot contain Prohibited Mammalian Tissue. Additionally, feeds containing Prohibited Mammalian Tissue must be clearly marked "Do not feed to cattle or other ruminants" unless distributed as retail pet food. Firms handling both Prohibited Mammalian Tissue and feed for ruminants must ensure that procedures are in place to mitigate cross-contamination. |
| Animal Drugs | Chemical | If your facility manufactures medicated feeds for multiple species, you may need to consider that some medications may be a hazard to or not approved for use with specific species. Examples of this can include monensin in horse feeds or various ionophores in swine feed. Firms manufacturing medicated feed for multiple species should be certain that sufficient flushing and clean-out procedures are in place to mitigate cross-contamination. |
| Nutrient Toxicity | Chemical | If your facility manufactures feeds for multiple species, you may need to consider nutrients that can create a hazard to specific species. Examples of this can include copper in sheep feeds, urea in cattle feeds, salt in poultry feed, among others. Firms manufacturing feed for multiple species should be certain that sufficient flushing and clean-out procedures are in place to mitigate hazards. |
Your answers indicate that your facility's operations may include circumstances that would require a Preventive Control. There's a variety of factors to consider. They may include one or more of the following: ingredients that might pose a significant risk to human or animal health, products that might pose a significant risk to public health, a combination of ingredients or species that could lead to health risks, or a history or regulatory action. The decision to implement a Preventive Control should be done at the discretion of you and your facility's management and is outside the scope of this tool. However, your Commercial Feed Inspector or other Commercial Feed Staff may be able discuss these matters with you further. Contact the Commercial Feed Program at 402-471-2351 or agr.webmaster@nebraska.gov for more guidance.
Your answers indicate that your facility's operations may ingredients and/or products that are either regulated by rules that supersede 21 CFR 507 or fall outside of the scope of this tool to provide adequate guidance. However, your Commercial Feed Inspector or other Commercial Feed Staff may be able discuss these matters with you further. Contact the Commercial Feed Program at 402-471-2351 or agr.webmaster@nebraska.gov for more guidance.
Based on the data you have provided this tool has identified the above hazards that you may need to consider including in your Hazard Analysis. This list identifies a few common hazards, their type, and associated considerations. It is not a comprehensive list of all possible hazards and each facility will have it’s own unique challenges.
This guidance and the associated informational tool should only be considered a starting point. Now it is up to you and your colleagues to determine which hazards are known and foreseeable hazards for your facility and what actions are appropriate to mitigate those hazards.
There are a number of resources available that can help you navigate the development of a full Food Safety Plan. One of those is FDA’s Draft Guidance #245 Hazard Analysis and Risk-Based Preventive Controls. It can be found here. Additionally, the Food Safety Preventive Control Alliance (FSPCA) with help from FDA and other stakeholders has created a guide for developing a Food Safety Plan for livestock feed which can be found here. If you have further questions, you may reach out to your local Commercial Feed Inspector or contact the Commercial Feed Program at 402-471-2351 or agr.webmaster@nebraska.gov.
The above is provided for informational purposes only. It is not intended to be legal advice and does not replace the advice of independent legal counsel.