FSMA Preventive Controls for Animal Food (PCAF) Guidance

FDA Preventive Controls for Animal Food: What Pet Food and Feed Manufacturers Need to Know

Written by Bita Saidi, FSPCA Lead Instructor

June 12, 2026

Animal food safety is not only about keeping animals healthy. It is also about protecting the people who handle animal food, the families who feed pets at home, and, in the case of food-producing animals, the broader food supply connected to meat, milk, and eggs. That is why the FDA’s Preventive Controls for Animal Food rule is such an important part of the Food Safety Modernization Act, commonly known as FSMA.

Under FSMA, FDA moved the food safety system away from simply reacting to contamination after something goes wrong and toward preventing hazards before unsafe food reaches the market. For animal food manufacturers, that preventive approach is found primarily in 21 CFR Part 507, formally titled Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals. This regulation is also referred to as the Preventive Controls for Animal Food rule.

For pet food companies, livestock feed mills, ingredient suppliers, and all facilities that manufacture, process, pack, or hold animal food, the regulation can affect everything from employee training and sanitation to hazard analysis, preventive controls, supplier approval, recall planning, and recordkeeping. It also creates a major role for the Preventive Controls Qualified Individual, or PCQI, who must prepare or oversee the preparation of an animal food safety plan, among other key food safety responsibilities when it comes to animal food production. 

This article breaks down what pet food and feed manufacturers need to know about FDA preventive controls for animal food, why PCQI for Animal Food training matters, and what facilities should be thinking about when building or maintaining an animal food safety system.

Why Animal Food Safety Matters for Both Animals and People

Animal food can create food safety risks in more than one way. An unsafe pet food may make a dog or cat sick, but it may also expose people in the home to pathogens when they handle kibble, treats, bowls, scoops, or contaminated surfaces. This is one reason pet food hazards such as Salmonella and Listeria monocytogenes receive significant attention.

Livestock feed can also affect both animal and human health. A hazard in feed may harm food-producing animals directly, but it may also affect the safety, availability, or quality of animal-derived foods. For example, contaminated or improperly formulated feed may contribute to animal illness, residues, nutrient toxicities, or other food safety concerns.

This is why FDA’s animal food preventive controls framework includes hazards that may affect humans, animals, or both. The rule is not limited to hazards that only affect people, and it is not limited to finished pet food. It applies across a wide range of animal food operations, including pet food, livestock feed, medicated and non-medicated feed, ingredients, and certain by-products, depending on the facility and activity.

What Is the FDA Preventive Controls for Animal Food Rule?

The FDA Preventive Controls for Animal Food rule is part of FSMA and is found in 21 CFR Part 507. The rule applies to many facilities that manufacture, process, pack, or hold animal food for consumption in the United States. This includes many pet food manufacturers, livestock feed manufacturers, animal food ingredient manufacturers, and some facilities handling human food by-products for use as animal food.

The rule is designed to help ensure that animal food is produced under sanitary conditions and that significant hazards are identified, evaluated, and controlled when necessary. In practical terms, the rule has two major layers.

The first layer is Current Good Manufacturing Practice, or CGMPs. These are baseline requirements for producing animal food under sanitary and suitable conditions. They cover areas such as personnel practices, plant and grounds, sanitation, water supply, equipment, plant operations, holding, distribution, and certain human food by-products used as animal food.

The second layer is hazard analysis and risk-based preventive controls. This is where covered facilities must identify known or reasonably foreseeable hazards, evaluate those hazards, determine whether any require a preventive control, and document the system in a written food safety plan.

For many animal food facilities, compliance is not just about having a written binder. It is about having a functional food safety system that connects the facility’s ingredients, equipment, process, employees, suppliers, finished products, records, and corrective actions.

Who Needs to Pay Attention to 21 CFR Part 507?

Many facilities that are required to register with FDA as food facilities and that manufacture, process, pack, or hold animal food for consumption in the United States must evaluate how 21 CFR Part 507 applies to them. This can include domestic facilities and foreign facilities that manufacture animal food for the U.S. market.

Examples may include pet food manufacturers, dry kibble manufacturers, canned pet food manufacturers, treat manufacturers, livestock feed mills, feed ingredient manufacturers, renderers, grain processors, facilities producing medicated or non-medicated feed, and facilities handling certain human food by-products for use as animal food.

However, applicability can vary. Some operations may be exempt from certain requirements, subject to modified requirements, or covered by other specific regulations. For example, some farm activities, raw agricultural commodity holding or transportation activities, certain storage activities, qualified facilities, and facilities subject to other specific regulations may need a closer applicability review.

Because these distinctions can become technical, facilities should not assume that they are covered or exempt based only on their product type. A feed mill located on a farm, a pet treat company, a warehouse, and an ingredient supplier may all have different regulatory obligations depending on registration status, activities performed, ownership, product exposure, processing steps, business size, and distribution.

CGMPs: The Foundation of Animal Food Safety

Current Good Manufacturing Practices or CGMPs are the foundation of the animal food safety system. Under 21 CFR Part 507, Subpart B, CGMPs establish baseline conditions and practices to help prevent animal food from becoming contaminated, adulterated, or otherwise unfit for use.

In plain language, CGMPs are the basic operating conditions that should already be in place before a facility can effectively manage higher-risk hazards. If employees are not trained, equipment is not maintained, pests are not controlled, sanitation is inconsistent, or ingredients are not protected during storage, it becomes much harder to rely on a food safety plan.

Animal food CGMPs are intentionally flexible because animal food facilities are extremely diverse. A dry pet food plant, a livestock feed mill, a rendering facility, a grain elevator, and a facility handling human food by-products for animal food do not all have the same design, risks, or controls. That is why the regulation uses terms like “as appropriate” and “as necessary.” Flexibility does not mean optional. It means the facility must apply the requirements in a way that makes sense for its animal food, process, equipment, and hazards.

CGMP topics under Part 507 include personnel, plant and grounds, sanitation, water supply and plumbing, equipment and utensils, plant operations, holding and distribution, and holding and distribution of human food by-products for use as animal food.

The Written Animal Food Safety Plan

A major requirement under the Preventive Controls for Animal Food rule is the written food safety plan. The food safety plan is not a generic document copied from another facility. It should reflect the actual animal food, process, hazards, controls, records, suppliers, and operations at the site.

A complete food safety plan generally includes the written hazard analysis, preventive controls when required, supply-chain program when required, recall plan when required, monitoring procedures, corrective action procedures, verification procedures, validation documentation when required, reanalysis documentation, and implementation records.

Facilities often include additional useful sections, such as a facility overview, product description, intended use, food safety team, process flow diagram, and ingredient or product grouping logic. These sections may not all be required in the same way as the hazard analysis, but they help make the plan easier to understand, implement, maintain, and explain during internal review or regulatory inspection.

Who is Responsible for an Animal Food Safety Plan?

The owner, operator, or agent in charge of the facility must sign and date the animal food safety plan upon initial completion and after subsequent modifications. When it comes to actually developing the plan, one or more Preventive Controls Qualified Individuals, or PCQIs, must prepare or oversee its preparation, among other responsibilities. 

For pet food and feed manufacturers, this is why PCQI training is so important. The role is not just about knowing the regulation. It is about understanding how to apply hazard analysis, preventive controls, monitoring, corrective actions, verification, and records to the facility’s actual animal food products and processes.

Facilities that need formal training can choose FIC’s live-virtual PCQI for Animal Food training or the self-paced Preventive Controls for Animal Food course, depending on whether their team prefers instructor-led discussion or flexible online learning.

Facilities that need formal PCQI training can choose the official 2.5 day live virtual PCQI for animal food training or the self-paced PCQI training for Animal Food options to fit your team's learning preferences and schedule. Both options follow the standardized curriculum recognized by the FDA and included the official PCQI certificate.

Note: PCQI qualification is different from general employee qualification. All employees who manufacture, process, pack, or hold animal food must be qualified individuals, or QIs, for their assigned duties through education, training, experience, or a combination of these. A PCQI is also a qualified individual, but the role is more specific because the PCQI is responsible for key food safety plan activities, such as overseeing the hazard analysis, preventive controls, validation decisions, record review, and reanalysis when required

Hazard Analysis: The Core of the Preventive Controls System

Hazard analysis is the foundation of the food safety plan. It is where the facility identifies and evaluates known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held.

The hazard analysis must consider biological, chemical, including radiological, and physical hazards. These hazards may occur naturally, be unintentionally introduced, or be intentionally introduced for economic gain.

The facility must then evaluate those hazards based on severity and probability, to determine which potential animal foods safety hazards require preventive controls (stricter measures that go beyond basic CGMP practices and requirements). Severity means how serious the illness or injury could be if the hazard occurred. Probability means how likely the hazard is to occur in the absence of preventive controls.

This part requires careful thinking. A hazard may be known or reasonably foreseeable but still not require a preventive control if the evaluation does not support that conclusion. On the other hand, a hazard may require a preventive control because the severity and probability, in the context of the animal food and facility, justify a higher level of control.

The hazard analysis must be written regardless of the outcome. Even if a facility determines that no hazards require preventive controls, the rationale must still be documented.

Common Hazards in Pet Food

Pet food manufacturers need to think carefully about hazards that affect both animals and humans. Because pet food enters homes, pathogens can become a human exposure concern through direct handling, contaminated bowls, scoops, surfaces, or contact with pets.

For dry or ready-to-eat pet food, Salmonella is often a major concern because of its potential impact on both pets and people. Listeria monocytogenes may also be relevant depending on the product and process. For raw, frozen, freeze-dried, or minimally processed pet food, biological hazards may require even closer evaluation, especially when animal-derived ingredients do not receive a validated kill step.

Chemical hazards in pet food may include nutrient deficiencies or toxicities, elevated vitamin or mineral levels, mycotoxins, residues, cleaning chemical contamination, unapproved ingredients, or formulation errors. Physical hazards may include metal, glass, hard plastic, bone fragments, or other foreign material.

Pet food manufacturers also need to watch emerging hazards. In 2025, FDA announced that certain cat and dog food manufacturers covered by the PCAF rule and using uncooked or unpasteurized poultry or cattle-derived materials, such as uncooked meat, unpasteurized milk, or unpasteurized eggs, need to reanalyze their food safety plans to include H5N1 as a known or reasonably foreseeable hazard. This is a strong example of how food safety plans are not static documents. They must be reanalyzed when new hazards, new scientific information, or significant changes affect the facility’s hazard analysis.

Common Hazards in Livestock Feed

Livestock feed manufacturers may face a different hazard profile. Biological hazards can still be relevant, especially depending on ingredients, storage, moisture, processing, and intended use, but many feed-related concerns involve chemical hazards.

Examples may include mycotoxins such as aflatoxin, nutrient deficiencies or toxicities, elevated copper, elevated non-protein nitrogen, drug carryover, unapproved drug contamination, incorrect medication levels, mineral imbalances, formulation errors, sequencing failures, and mislabeling. These hazards may affect animal health and, in some cases, the safety of human food derived from food-producing animals.

Physical hazards can also matter in livestock feed, but their severity may vary based on the animal species, eating behavior, particle size, and likelihood of consumption. For example, the same size metal fragment may create a different level of concern in a small companion animal than in a large livestock species. This is why hazard analysis must be specific to the product, process, facility, and intended animal species.

Preventive Controls: When CGMPs Are Not

Not every hazard requires a preventive control. Some hazards may be adequately managed through CGMPs or other prerequisite programs. However, when the hazard analysis identifies a hazard requiring a preventive control, the facility must implement risk-based preventive controls to significantly minimize or prevent that hazard.

Preventive controls for animal food may include process controls, sanitation controls, supply-chain-applied controls, and other controls as appropriate.

Process controls may include steps such as heat treatment, pelleting, extrusion, drying, cooling, formulation controls, sequencing, cleanout, or other process-based measures when those controls are needed to manage a hazard. For example, a pet food facility may rely on a validated heat treatment step to control Salmonella, while a feed mill may use formulation and mixing controls to prevent nutrient toxicity or deficiency.

Sanitation controls are used when sanitation activities are needed to significantly minimize or prevent hazards such as environmental pathogens or biological hazards related to handling. These are different from general sanitation CGMPs. General sanitation supports the facility’s overall hygienic condition, while sanitation preventive controls are tied to a hazard requiring a preventive control.

Supply-chain-applied controls may be needed when a hazard in a raw material or ingredient is controlled before the ingredient reaches the receiving facility. These controls can include supplier approval, supplier verification, onsite audits, sampling and testing, review of supplier food safety records, or other appropriate verification activities depending on the hazard and supplier relationship.

Other controls may also be appropriate when the facility identifies a hazard requiring a preventive control that does not fit neatly into the process, sanitation, or supply-chain categories.

Supply-Chain Controls for Animal Food

Supply-chain controls are especially important when a facility receives ingredients that may carry hazards requiring control before they are used. In animal food, supply-chain controls may be particularly relevant for chemical hazards, although they can apply to other hazard types depending on the situation.

A facility must understand whether it is a receiving facility under the rule, whether the hazard is controlled by the supplier or another entity in the supply chain, and what verification activities are appropriate. Supplier approval and supplier verification should not be treated as a generic purchasing exercise. They should be connected to the hazard analysis and the specific hazard being controlled.

For example, if a facility relies on a supplier to control aflatoxin, nutrient levels, drug residues, or another significant hazard, the facility needs documentation and verification activities that support that reliance. The level of verification should match the risk, supplier performance, ingredient history, and nature of the hazard.

Recall Plan Requirements

A recall plan is required when a facility identifies a hazard requiring a preventive control. The recall plan must be written and must describe procedures for carrying out a recall of animal food associated with that hazard.

A strong recall plan should address how the facility will directly notify consignees, how it will notify the public when appropriate, how it will conduct effectiveness checks, and how it will determine the disposition of recalled animal food. Disposition may include reprocessing, reworking, diverting to a safe use, or destruction, depending on the situation and whether the product can be safely handled.

A recall plan should not sit untouched after it is written. It should be understood by the people responsible for using it, tested or reviewed periodically, and connected to traceability, complaint handling, distribution records, and internal decision-making.

Monitoring, Corrective Actions, Verification, and Validation

Preventive controls do not work just because they are listed in a food safety plan. They need management components.

Monitoring is how the facility checks whether the preventive control is being performed as intended. Corrective actions and corrections describe what happens when something goes wrong. Verification confirms that monitoring, corrective actions, and the food safety system are being implemented properly. Validation, when required, provides evidence that the control is capable of controlling the hazard.

For example, if a facility relies on a heat treatment step to control Salmonella in pet food, it may need validation to demonstrate that the process achieves the intended reduction. If a feed mill relies on formulation and sequencing controls to prevent drug carryover or nutrient toxicity, the facility needs records and procedures that show those controls are being followed and verified.

Record review is also a major PCQI responsibility. Records should be reviewed within required timeframes unless a justified alternate timeframe is documented. These records are not just paperwork; they are evidence that the facility’s preventive controls were implemented and that deviations were handled appropriately.

Reanalysis: Why Food Safety Plans Must Stay Current

Animal food safety plans must be reanalyzed at required intervals and when certain triggers occur. Reanalysis may be needed when there is a significant change in activities, ingredients, equipment, product formulation, supplier performance, process flow, hazards, scientific understanding, or when a preventive control is found to be ineffective.

FDA’s H5N1 update for certain cat and dog food manufacturers is a useful reminder of why reanalysis matters. New scientific information can change what a facility must consider in its hazard analysis. A hazard that was not previously considered reasonably foreseeable may become relevant because of new illness data, outbreak information, ingredient risk, or FDA determination.

Reanalysis should not be treated as a quick signature exercise. It should involve reviewing whether the food safety plan still reflects the facility’s actual operation and current hazard information.

Pet Food vs. Livestock Feed: Why One Plan Does Not Fit All

One of the biggest mistakes animal food facilities can make is treating all animal food hazards the same. Pet food and livestock feed are both animal food, but they are not always evaluated the same way.

Pet food is often handled directly by consumers in homes. That increases the importance of human exposure hazards, especially pathogens in products that may be handled frequently or stored in kitchens. The intended animal may also be small, elderly, young, immunocompromised, or otherwise more vulnerable.

Livestock feed may involve different concerns, including nutrient balance, medicated feed controls, species-specific toxicity, mixing uniformity, sequencing, carryover, and feed intended for food-producing animals. The impact of a hazard may depend on species, life stage, production class, feeding rate, intended use, and whether the animal contributes to the human food supply.

This is why FDA preventive controls for animal food require facility-specific thinking. A food safety plan should not simply copy another company’s hazard analysis. Even two facilities making similar animal food may reach different conclusions based on their ingredients, process, equipment, environment, supplier controls, historical data, and intended species.

Practical Steps for Pet Food and Feed Manufacturers

For pet food and feed manufacturers, the key question is not only whether 21 CFR Part 507 applies. The bigger question is whether the facility understands how the rule applies to its own products, ingredients, processes, animal species, suppliers, and hazards. That is where many facilities need structured PCQI training.

PCQI training helps animal food professionals understand how to think through the major requirements, including CGMPs, hazard analysis, preventive controls, supporting records, recall plans, validation decisions, record review, and reanalysis when required. The goal is not just to know that these requirements exist, but to understand how they connect to real food safety decisions in a pet food or feed manufacturing operation.

FIC offers two training options for animal food professionals. The live-virtual PCQI for Animal Food training is a strong option for participants who want instructor-led discussion, real-time questions, and structured interaction. The self-paced FSPCA Preventive Controls for Animal Food course is designed for participants who need flexibility and want to complete the training online on their own schedule.

Both options support professionals working in pet food, livestock feed, animal food ingredients, and related operations who need to understand FDA preventive controls for animal food and the role of the PCQI.

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