Preventive control plan guidance: General overview Feeds Regulations, 2024

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Introduction

The Feeds Regulations, 2024 were published in the Canada Gazette, Part II (CGII) on July 3, 20254. To provide stakeholders time to adjust to the new and amended regulatory requirements, the Canadian Food Inspection Agency (CFIA) has chosen a staggered coming into force for the Feeds Regulations, 2024 over a period of 18 months.

The new regulatory requirement to prepare, implement, keep, and maintain a preventive control plan (PCP), will come into effect on June 17, 2025, 12 months after CGII publication. Under the Feeds Regulations, 2024, most livestock feed (feed) businesses will require a written PCP that describes how an establishment's hazards are identified and controlled as well as how compliance with other regulatory requirements are met.

Purpose

This document is intended to help feed businesses to better understand how to prepare, implement, keep and maintain a PCP when this requirement comes into effect.

Additional guidance on PCPs will be published closer to when the PCP requirements come into force.

What is included

This document provides information on:

  • roles and responsibilities
  • what types of livestock feed businesses are required to have a PCP
  • how to prepare, keep and maintain a written PCP
  • how to implement a PCP
  • keeping PCP records

Roles and responsibilities

Stakeholders that conduct livestock feed-related activities are responsible for complying with the applicablerequirements in the Feeds Regulations, 2024. They must demonstrate compliance by ensuring that livestock feeds and processes employed at the livestock feed establishments meet all regulatory requirements.

The Canadian Food Inspection Agency (CFIA) verifies the compliance of a feed business by conducting activities that include inspection, and surveillance. When a non-compliance is identified, the CFIA takes appropriate compliance and enforcement actions.

Businesses that need a written PCP

If you manufacture, store, package, label, sell or export a feed, you must prepare, implement, keep and maintain a PCP. The PCP must include a hazard analysis (section 59(1)), preventive controls related to the operations of the livestock feed establishment (section 59(2)), and preventive controls to comply with other relevant regulatory requirements, such as meeting standards and labelling requirements (section 59(3)).

If you are an exporter, you must prepare a PCP for the livestock feed intended to be exported that includes the preventive controls implemented to comply with the regulatory requirements of the importing country.

If you are an importer, you will require a PCP for the activities you conduct with the imported livestock feed once it has arrived in Canada, such as storing, packaging, labelling and selling. In addition, you must be able to demonstrate that the imported livestock feed has been manufactured, stored, packaged or labelled under conditions which provide the same level of protection as if the activities took place in Canada under a PCP. 

Keep in mind

Livestock feed importers who conduct any of the described feed-related activities with a foreign feed, once in Canada, also need to prepare, implement, keep and maintain a PCP.

Many feed businesses have already implemented industry-led programs such as FeedAssure®, a feed safety management program administered by the Animal Nutrition Association of Canada (ANAC), and on-farm food safety programs administered by national livestock producer associations or provincial governments. These programs may address similar feed safety concerns identified by the CFIA and a number of their components would be applicable to the PCP requirements set out in the Feeds Regulations, 2024. However, it is the responsibility of livestock feed businesses to determine any gaps between such programs and the regulatory requirements, and address them accordingly.

Keep in mind

PCP approaches that have been prepared by other feed safety authorities, industry associations, international partners, academia, or privately by an individual company or corporation, may be used in lieu of this suggested guidance.

It is important to ensure that the information in a PCP is tailored for that particular feed establishment, its livestock feeds and processes. The responsibility for ensuring that the written PCP meets the requirements of the Feeds Regulations, 2024 lies with each individual livestock feed business.

Exemptions

A PCP is not required when a feed business is conducting operations with a feed that:

  • is exempt from the Feeds Act and Feeds Regulations, 2024
  • 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" (section 57(2))

On-farm feed mills

A feed that is manufactured by a livestock producer which is not sold and does not have incorporated into it any drug or other substance that presents a risk of harm to human or animal health or the environment is exempt from the Feeds Act and Feeds Regulations, 2024. Therefore, a PCP is not required for any activities associated with that feed. However, if a livestock producer sells a feed off the farm, manufactures a medicated feed on farm or manufactures a feed that contains a substance that presents a risk of harm to human health, animal health or the environment, a PCP will be required for those feeds and those activities.

How to develop a PCP

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

Preparing a PCP

The following steps will assist you in preparing a written PCP and as a result comply with section 57(1) of the Feeds Regulations, 2024:

Step 1: assemble the PCP team

Preparing, implementing, keeping, and maintaining an effective PCP depends on knowledgeable and experienced staff (management and employees) working together to identify hazards and how to control them.

Assemble a team to lead the preparation of the PCP, making sure to include key personnel to cover all aspects of the operations of the livestock feed establishment and feed-related activities.

Consider including team members who:

  • understand the practical aspects of feed manufacturing such as the process flow, and the technology and equipment used, and
  • are knowledgeable in the area of feed safety, including biological, chemical and physical hazards, related to the feed being manufactured

Some effective ways of enabling the team in preparing the PCP may include:

  • providing the team with the necessary resources and time, and
  • training staff to ensure they are qualified to carry out the tasks
Keep in mind

The size of the team is not a determining factor in preparing a comprehensive PCP. In some instances, the team may consist of 1 individual. When a feed establishment does not have personnel with appropriate knowledge or expertise necessary to assemble an appropriate team, consider including personnel from other local feed establishments or representatives from local universities or colleges, or obtain assistance from industry associations to assist in preparing an effective PCP.

Step 2: developing good manufacturing practices

The measures presented in section 59(2) of the Feeds Regulations, 2024 are a set of basic control measures that a feed establishment must follow to reduce the risk of introducing hazards to the feed through the processing environment. They address key elements related to good manufacturing practices (sometimes also referred to as "pre-requisite programs") such as: sanitation, biosecurity, hygiene and employee training; equipment design and maintenance; building, surroundings and maintenance; and receiving, transportation and storage of the feed.

Feed establishments must develop specific measures to address each of the requirements in section 59(2).

Step 3: conducting a hazard analysis

The next step in the preparation of a PCP is to identify and evaluate all applicable hazards with respect to the feed and feed-related activities that the establishment conducts. In addition, control measures must be determined to prevent or eliminate each hazard or reduce it to an acceptable level (section 59(1)(a)).

Conducting a hazard analysis is the first principle of the Hazard Analysis Critical Control Points (HACCP) system.

The good manufacturing practices implemented as per section 59(2) can serve as control measures for some of the hazards identified. However, establishments will have to develop additional control measures if those basic practices are not enough to control any of the hazards.

The guidance document Hazard analysis guidance: General Overview provides details on how to conduct a hazard analysis and its process.

Keep in mind

It may be beneficial to seek the expertise of a professional association or a consultant to help analyze relevant biological, chemical and physical hazards when conducting a hazard analysis.

Step 4: determining critical control points and critical limits

Determining critical control points (CCPs) in your process and establishing critical limits for them are essential steps in the development of a PCP that will effectively control the hazards identified as significant for a livestock feed or processes conducted. Determining CCPs (section 59(1)(b)) and critical limits (section 59(1)(b)(ii)) are the second and third principles of a HACCP system, respectively.

A CCP is a process step at which the application of a control measure(s) is essential to prevent or eliminate a significant hazard that presents a risk of contamination of a feed or to reduce it to an acceptable level. The control measures applied at a CCP (section 59(1)(b)(i)) can be measures developed in step 2, additional control measures implemented by the livestock feed establishment, or a combination of both.

Critical limits are pre-set values or criteria that are measurable or observable, and separate what is acceptable from what is not acceptable to achieve safety of feeds.

The control measures must be validated to ensure that they are effective. Validation of control measures is defined in the Codex Alimentarius as the action of obtaining evidence that a control measure, when properly implemented, is capable of controlling the hazards to a specified outcome.

The requirement to validate control measures is indicated throughout the PCP provisions in the Feeds Regulations, 2024 with statements such as "…the evidence that control measures are effective…", or "…effective means of…".

Step 5: developing monitoring procedures for critical control points

Developing monitoring procedures for CCPs (section 59(1)(b)(iii)) is an integral part of preparing an effective PCP. It is also the fourth principle of a HACCP system.

Monitoring is defined by the Codex Alimentarius as the act of conducting a planned sequence of observations or measurements of control parameters to assess whether a control measure is working as intended.

The purpose of monitoring CCPs is to ensure that control measures are working as intended (that is, the significant hazards are effectively controlled) and that deviations from the critical limits (that is, unacceptable monitoring results) are detected in time to regain control of the process and prevent the production of unsafe livestock feed.

Step 6: developing corrective action procedures for critical control points

Developing corrective action procedures (section 59(1)(b)(iv)) is the fifth principle of the HACCP system and is an essential part of a PCP. A corrective action is defined by the Codex Alimentarius as any action taken when a deviation occurs in order to re-establish control, segregate and determine the disposition of an affected product, if any, and prevent or minimize reoccurrence of the deviation.

Corrective action procedures outline the steps to be taken when a deviation from established critical limits occurs. These procedures must be implemented for each CCP identified in the process and in advance of any possible deviation so that the feed establishment is ready to re-establish control promptly when a deviation occurs.

Keep in mind

Although this step describes the requirement for corrective action procedures for CCPs, you still need to take corrective action for any deviation from other preventive controls implemented throughout your PCP.

Step 7: implementing other relevant regulatory requirements

Feed businesses must describe the measures in place to meet other relevant regulatory requirements referred to in section 59(3) of the Feeds Regulations, 2024, such as compositional and safety standards, packaging, labelling, investigations, complaints, recalls, and traceability.

If applicable to the livestock feed establishment, the PCP may need to include additional content related to feed for export or import as outlined in the Feeds Regulations, 2024.

Step 8: developing verification procedures for the PCP

According to the Codex Alimentarius, verification is the application of methods, procedures, tests, and other evaluations, in addition to monitoring, to determine whether a control measure is or has been operating as intended. Verification is an integral component of an effective PCP that, in addition to monitoring procedures, ensures ongoing control. It is the sixth principle of the HACCP system.

Verification procedures (section 59(1)(c)) are required to demonstrate that all control measures and operational procedures outlined in your PCP are implemented and effective in obtaining the intended outcomes, hence, achieve compliance with the Feeds Act and Feed Regulations, 2024. Verification activities include validation, verification of monitoring activities being conducted, verification of corrective actions being made, verification of implementation and effectiveness of preventive controls, and reassessment of the entire PCP. Verification procedures are part of maintaining the PCP.

Step 9: assemble your documents

In order to demonstrate that a written PCP has been prepared as per section 57(1), the following documents must be assembled:

  • hazard analysis, which includes hazard identification and evaluation
  • description of good manufacturing practices
  • implementation and evidence of the effectiveness of control measures
  • CCP documentation, including critical limits
  • monitoring and corrective action procedures
  • verification procedures
  • supporting documents, operational procedures and records used to implement the PCP
  • measures describing how other relevant regulatory requirements are being met

Implementing the PCP

Once the PCP has been prepared, it is important to fully implement it as written into the feed establishment's day-to-day operations (section 58). This will include:

  • training staff on PCP concepts and the newly developed procedures
  • generating records that show the PCP has been implemented, and retaining those records for at least 2 years
  • verifying the PCP's effectiveness in preventing animal health, human health or environmental safety concerns, resulting in compliance with the Feeds Regulations, 2024

Keeping and maintaining the PCP

Once the PCP has been prepared and implemented, it must be maintained (section 57(1)). Verification activities presented in step 8: Developing verification procedures for the PCP, are a good resource to keep and maintain a PCP.

The PCP must be reviewed at a frequency appropriate to the feed establishment and revised as necessary.

The PCP also needs to be reassessed and updated when:

  • something is new or has changed (for example, type of feeds manufactured, ingredients or incoming materials, formulations, equipment, processing steps, etc.)
  • a problem has been identified (for example, deficiency or deviation observed during monitoring or verification procedures, non-compliance identified by the CFIA or third party auditors, customer complaints that reveal a problem with the PCP, recalls, unsatisfactory laboratory results, etc.)

Reassessing your plan includes reviewing records and conducting on-site assessments of all preventive controls.

Retaining the PCP documents

The written PCP must be kept for 2 years after the day on which it ceases to be implemented (section 60(a)).

In addition, supporting documents used and produced during the preparation of the PCP (for example, information used to identify hazards, the rationale used to determine the CCPs, and other data), and documents that demonstrate that the PCP has been implemented (for example, operational procedures, records, service contracts) must be kept for 2 years after the day on which they were prepared (section 60(b)).

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