Preventive control plan guidance: On-farm feed mills

On this page

• Introduction
• Purpose
• Exceptions
• What is included
• What is not included
• When is a PCP required
• Biological, chemical and physical hazards
  • Identification and analysis of hazards
  • Factors to consider when conducing a hazard analysis
• What this means for on-farm feed mills
  • Control of hazards
• Preventive control plan
  • Preparing, keeping and maintaining a PCP
  • Implementation
  • Measures to be taken
  • Other requirements
• Record-keeping
  • Keeping records of your PCP
  • Record-keeping procedures
• References

Introduction

Livestock producers who operate on-farm feed mills that manufacture medicated feeds or who sell livestock feed are required to have a written preventive control plan (PCP).

A PCP is a combination of control measures that, when taken as a whole, provide a science-based approach to managing potential risks posed by hazards and contribute to achieving compliance with regulatory requirements. Written PCPs demonstrate how hazards and risks associated with livestock feeds are prevented, eliminated or reduced to an acceptable level. PCPs are recognized internationally and include elements related to feed safety, compositional and safety standards, packaging and labelling, export provisions, recalls, investigations, complaints, record-keeping and traceability.

A PCP outlines:

• the preventive controls employed by a livestock feed establishment
• the potential hazards associated with the establishment, equipment used, incoming materials, livestock feeds, processes and the measures used to control those hazards; and
• the steps taken by a livestock feed establishment to comply with all other applicable regulatory requirements

PCPs for on-farm feed manufacturing help to control the risks related to making medicated feeds. There are risks associated with providing both too little and too much of a medicating ingredient in a livestock feed. Too little may result in animal health concerns as the animal may not receive enough of the medicating ingredients to treat or prevent the condition it is intended for. Too much medicating ingredient could result in animal health issues or may cause violative residues in foods of animal origin (for example, meat, milk or eggs) that result in human food safety concerns. PCPs help to ensure that livestock feeds manufactured on-farm are safe and effective. Many farms already participate in an on-farm food safety program that includes controls around livestock feeds. If an existing program meets all of the PCP requirements of the Feeds Regulations, 2024, then no additional preventive controls or documentation would be required. If a program meets only some of the requirements of the Feeds Regulations, 2024 then the controls and documentation to support that unmet requirement(s) will be needed.

Purpose

The purpose of this guidance document is to aid livestock producers who operate on-farm feed mills with the interpretation and implementation of the PCP requirements presented in sections 55 to 60 of the Feeds Regulations, 2024.

Exceptions

Livestock producers who manufacture feed on-farm are exempt from the Feeds Act and the Feeds Regulations, 2024 and therefore are not required to have a PCP if their livestock feed is not sold off farm and is not medicated.

In addition, a PCP is not required for a livestock feed that:

• is exempt from the Feeds Act and the Feeds Regulations, 2024 (section 3)
• is for research or experimental purposes
• is a cultivated farm crop that is unprocessed and will be further processed and has a label attached indicating "For Further Preparation Only"

What is included

This guidance document includes information concerning:

• the identification, analysis and control of hazards
• the preparation, maintenance and implementation of a PCP
• record-keeping in association with a PCP

What is not included

While this document provides guidance and examples of how to develop a PCP for on-farm feed mills, it is not exhaustive. A PCP for a given on-farm feed mill may vary depending on the extent of the operations being conducted.

When is a PCP required

A PCP is required if the livestock feed is medicated, is manufactured (mixed) on farm and is remaining on the farm.

Any time a livestock producer is selling livestock feed to someone, they are considered to be operating like a commercial feed mill and will need to meet all of the requirements of the Feeds Regulations, 2024.

When determining if a PCP is required for livestock feed that is being used on-farm, there are 2 key considerations:

• if the livestock feed is medicated
• if the livestock feed is being manufactured on the farm

A medicating ingredient is any drug that has been assigned a drug identification number (DIN) by Health Canada, regardless of whether a veterinary prescription is required to obtain the drug. This includes, ionophores (for example, monensin), coccidiostats, antimicrobials, etc. The Compendium of Medicating Ingredient Brochures (CMIB) sets out the medicating ingredients that are approved for use in livestock feed. In addition, veterinarians may prescribe other medicating ingredients for use in livestock feed.

Any mixing of a livestock feed on-farm is considered to be manufacturing. This includes when a premix or supplement is mixed with grains and other ingredients to make a complete feed, blending grains together or making a total mixed ration (TMR). Any type of mixing, such as simple hand mixing to sophisticated automated systems or mixers on trucks, are considered to be manufacturing a livestock feed on-farm.

A PCP is not required if a livestock producer is purchasing a medicated feed and feeding it directly to their animals. This could be a medicated complete feed, a medicated supplement that is top-dressed, or medicated block or tub that is fed directly. If the medicated feed is not further mixed, a PCP is not required. A PCP is also not needed if the livestock feed that is manufactured on farm does not contain any medicating ingredients.

Biological, chemical and physical hazards

Identification and analysis of hazards

On-farm feed mills must identify and document all the biological, chemical and physical hazards that present a risk of contamination of their livestock feed, from receiving to storage and use. These hazards must then be evaluated by determining their likelihood of occurrence and severity.

The document Hazard analysis guidance: General overview Feeds Regulations, 2024 presents information regarding the type of hazards that could potentially affect livestock feeds as well as the general steps to conduct a hazard analysis. To achieve compliance with the regulations, on-farm feed mills must follow the hazard analysis process steps that are applicable to their operations.

A hazard identification and analysis must be performed and documented even if an operator has determined that no hazards would affect their operations. Such documentation must be kept ready to present as justification of non-implementation when required.

Factors to consider when conducing a hazard analysis

Factors impacting the safety of a livestock feed manufactured at an on-farm feed mill must be considered when conducting a hazard analysis. All inputs, processing steps and conditions and the intended end use of the final livestock feed must be considered.

Documents such as a process flow diagram, a traffic flow diagram, a list of ingredients and livestock feed products and a blueprint of the building(s) may be used to help better identify how these factors could become cross-contamination points within the processing environment.

Some examples of factors that on-farm feed mills may identify are:

1. the formulation of the livestock feed:

   The formulation of a livestock feed should ensure the livestock feed meets applicable standards, such as maximum nutrient values and maximum levels for contaminants

2. ingredients used in the livestock feed, including raw materials:

   Ingredients should be considered with respect to any restrictions in their approved purpose, inclusion rates, intended livestock species, etc. as well as any caution and/or warning statements, storage conditions, shelf life, etc.

3. the level of any inherent contaminant(s) in the livestock feed:

   Examples of possible inherent contaminants are: Salmonella in grains, protein meals and rendered products; mycotoxins in grains; pesticide residues in cereals, grains and by-products, oilseeds and by-products; dioxins, furans and dioxin-like polychlorinated biphenyls (DL-PCBs) in fish-based and marine-based ingredients, mineral-based ingredients, anticaking agents and by-products of vegetable oil manufacturing

4. procedures for manufacturing, processing, packaging and labelling the livestock feed:

   Procedures for receiving, handling and storage of ingredients and materials (raw materials, packaging materials, etc.), for mixing ingredients, for cleaning and sanitation activities, etc. need to be considered to identify how hazards could be introduced in livestock feeds

5. storage and distribution of the feed:

   Storage and distribution activities such as segregation of medicated feeds, avoiding cross contamination with other chemicals and safe storage conditions must be considered to identify how hazards could be introduced in livestock feeds

6. transportation practices:

   Loading and unloading ingredients, materials (raw materials, packaging materials, etc.) and livestock feeds, the use of conveyances and all transport-related activities could introduce hazards and affect the safety of the livestock feed through things like cross-contamination if conveyances are used for other purposes

7. intended use or foreseeable use of the livestock feed:

   Keep in mind any special use of a livestock feed. For example, the approved purpose of the livestock feed, any claims on the label, any restrictions in its use for certain species or class of livestock

8. condition, function, design and sanitation of a facility and equipment:

   Situations like crumbling infrastructure, deficient flow of operations, performance of equipment and scope and effectiveness of sanitation procedures may affect the safety of a livestock feed

9. employee hygiene:

   Hazards could be introduced in a livestock feed if people responsible for conducting operations do not maintain a level of personal hygiene as well as of hygiene of personal protective equipment

10. meteorological conditions:

    Rain, heat, strong winds, etc. may directly or indirectly introduce contaminants into livestock feeds

What this means for on-farm feed mills

Livestock producers should take these various factors into consideration when identifying potential sources of hazards. A simple process-flow diagram or product/people pathway diagram may be helpful to identify potential sources of hazards.

Control of hazards

Identified hazards must be prevented, eliminated or reduced to an acceptable level through the development of control measures. The document Hazard analysis guidance: General overview Feeds Regulations, 2024 provides information regarding the implementation of control measures. To achieve compliance with the Feeds Regulations, 2024, on-farm feed mills must follow the steps to determine control measures that are applicable to their operations.

If an operator determines that a hazard does not need preventive controls, the analysis conducted should serve as the support for such decision and therefore must be documented, kept and ready to present when required.

The written PCP for the on-farm feed mill must contain:

1. a description of the biological, chemical and physical hazards identified and analyzed as per subsection 56(1), the control measures required in subsection 56(2) to prevent, eliminate or reduce those hazards and evidence that such control measures are effective
2. a description of critical control points, including control measures, critical limits, monitoring procedures and corrective action procedures
3. verification procedures which ensure that the on-farm operational procedures result in compliance with the PCP provisions in the Feeds Regulations, 2024.

Control measures will likely focus on processes that occur on farm such as incoming materials, proper weighing or measuring and storage.

Preventive control plan

Preparing, keeping and maintaining a PCP

On-farm feed mills that manufacture medicated feeds must prepare, keep and maintain a written PCP. A written PCP consists of documents that demonstrate the preparation (for example, list of materials and ingredients, flow charts, meeting minutes), implementation (for example, standard operating procedures and corresponding records) and maintenance of procedures (for example, verification procedures, review of the PCP) aimed to comply with the requirements laid out in subsections 59(1), (2) and (3) of the Feeds Regulations, 2024. The scope of a PCP of an on-farm feed mill will depend on the extent of their operations, feed safety factors and types of livestock feeds that are manufactured.

Implementation

The PCP which has been prepared, kept and maintained as per subsection 57(1) must be implemented as written. This means that the written information in your documents and procedures must match the actions conducted onsite.

The PCP must be reviewed at a frequency appropriate to the on-farm feed mill, whenever changes are introduced to the livestock feed operations (for example, changes in the formulation, new livestock feeds being manufactured, changes in equipment, new building layout or process flow, etc.) and when a problem is identified (for example, deficiencies in monitoring or verification procedures, non-compliance(s) identified by us or third party auditors, etc.).

Measures to be taken

The on-farm written PCP must also contain measures to address the requirements laid out in subsections 59(2)(a) to (z.2) of the Feeds Regulations, 2024.

It is your responsibility to identify all the elements that are applicable to your operations. In most cases, the requirements in section 59(2) refer to ensuring that there is not a risk of contamination of the livestock feed. If there is no risk of contamination, no measures need to be described. For example, if water is never used to make livestock feed, then the source of the water will not matter as there is no risk that water could contaminate the livestock feed. If water is used to manufacture livestock feed on the farm, but you are using the same water that is used for drinking water for people then no additional measures would be required.

As a reference, some key points to consider are provided for each of the following requirements:

1. cleaning and sanitation of the buildings and equipment and cross-contamination
   • procedures to clean and sanitize equipment, utensils and tools does not present a risk of contamination of a livestock feed
   • this can include measures taken to prevent cross-contamination during cleaning and sanitation activities (for example, cleaning and sanitation of equipment in a room specific for that purpose, avoiding spillage or splashing of water and residues from cleaning chemicals on materials, ingredients, livestock feeds, equipment, etc.)
2. pest control and cross-contamination
   • the buildings are protected against the entry of any animal that presents a risk of contamination of a livestock feed
   • this may include storing livestock feed in a manner that prevents pests from entering or having a pest control program
3. use of sanitizers, non-feed chemicals and agronomic inputs
   • this may include pesticides, veterinary drugs, chemical agents, cleaners or other chemical materials
   • procedures for the procurement, receiving, storage, use and disposal of these substances to prevent a risk of contamination of a livestock feed
   • identification and segregation of sanitizers, non-feed chemicals or biological agents
   • management of spillages of sanitizers, non-feed chemicals or biological agents
4. movement of persons and things in and out of the buildings
   • security and visitors procedure to prevent contamination of a livestock feed
   • this may be specific to situations where a biological contaminant may be carried by people and transferred to livestock feed
5. storage conditions of a livestock feed
   • procedures for receiving and storage of ingredients, materials and finished products to prevent contamination of the livestock feed
   • segregation procedures

Other requirements

On-farm feed mills must include in their written PCP some of the requirements laid out in sections 34 to 54, 61 to 64, 69 and 71 of the Feeds Regulations, 2024. Follow the reference subsequent table to determine whether the requirements are applicable to your on-farm feed mill.

Record-keeping

On-farm feed mills must keep copies of records associated with their PCP:

• a copy of each version of a PCP must be kept for 2 years after the day in which it was no longer implemented
• documents used in the development and implementation of requirements in subsections 59(1), (2) and (3) must be kept for 2 years after the day they were prepared

While livestock producers are not required to keep the same traceability records that commercial feed mills are, there are still some required records. A copy of the mix formula and mix sheet must be kept for 2 years for each medicated feed that is made on-farm to meet the requirements of the Feeds Regulations, 2024.

In addition, there are record-keeping requirements under section 171 of the Health of Animals Regulations with respect to prohibited material and animal food. This applies to any animal food, whether it contains a medicating ingredient or not.

Every person who manufactures animal food for ruminants, equines, porcines, chickens, turkeys, ducks, geese, ratites or game birds shall keep, for 10 years, records that contain:

• the formula for the animal food, including the name and weight of each ingredient used for each lot of the animal food
• a mixing sheet that shows that each lot of the animal food has been produced in accordance with the formula referred to in the previous bullet
• information as to whether the animal food contains any prohibited material
• the date of preparation of the animal food
• the lot number and any other information used to identify each lot of animal food; and
• the name and address of any person to whom any animal food is distributed or sold and a description of the food, including the name and quantity

Keeping records of your PCP

A record is a type of document that permanently captures information demonstrating that an action was taken. It can be in either hard copy (printed) or electronic (digital) format. The information can take various forms such as text, figures, graphics, data, pictures and videos.

Accurate record-keeping is essential to the application of a PCP. Records enable you to confirm easily and with confidence that your PCP is implemented and working effectively. Records can also help you improve your PCP by providing a means for you to, for example:

• identify the root cause of an issue
• analyze and improve a process or procedure
• identify gaps in training and training needs

The records you keep will be unique to your on-farm feed mill depending on the size of your operation, the types of livestock feed that you manufacture or import and the design of your PCP.

Some examples of records are:

• observations or measurements taken to monitor a critical control point in relation to its critical limit (such as time and temperature readings) and other processing-related records
• ingredient and finished product test results
• equipment calibration logs
• staff training records
• incident reports (such as for broken glass, chemical spills)
• deviation and associated corrective action records
• verification procedure records
• an invoice, a bill of lading
• a letter of guarantee

Record-keeping procedures

Record-keeping procedures are considered a best practice to help manage your records.

Some of the activities included in record-keeping procedures are:

• to identify the current record version to be used and its location
• to provide instructions on how to fill out the record (who, what, how and when)
• to identify where completed records are kept
• to specify how long records must be kept
• to include measures to protect the integrity and authenticity of records during the retention period

References

• Quick reference guide – On-farm feed mills
• Preventive control plan guidance: General overview Feeds Regulations, 2024
• Hazard analysis guidance: General overview Feeds Regulations, 2024