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Preventive control plan guidance for the proposed Feeds Regulations, 2022

The information in this document is based on requirements set out in the proposed Feeds Regulations, 2022 (the "regulations"). The information is intended to help regulated parties understand the requirements within the regulations once they come into force. The proposed requirements are subject to change as the regulatory process advances through its various stages. In the interim, current laws applicable to livestock feed in Canada continue to apply.

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Introduction

A preventive control plan (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. Written PCPs demonstrate how hazards and risks associated with feeds are prevented, eliminated, or reduced to an acceptable level. PCPs are recognized internationally, and include elements related to feed safety, general and safety standards, packaging and labelling, export provisions, recalls, investigations, complaints, record-keeping and traceability.

A PCP outlines:

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

Purpose

The proposed Feeds Regulations, 2022 require feed businesses to implement a written PCP that describes how a feed establishment's hazards are identified and controlled as well as how compliance with other regulatory requirements will be met. This guidance is intended to help feed businesses better understand how to implement a PCP and what information the Canadian Food Inspection Agency (CFIA) may require under the proposed Feeds Regulations, 2022.

What is included

This document provides information on:

Exceptions

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

  • is exempt from the Feeds Act and proposed Feeds Regulations, 2022
  • 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".

In addition, livestock producers who manufacture feed on-farm (that is, on-farm feed mills) are exempt from the Feeds Act and proposed Feeds Regulations, 2022 and therefore are not required to have a PCP as long as their feed is not sold off farm and is not medicated.

Roles and responsibilities

Regulated parties that conduct feed-related activities are responsible for complying with the applicable requirements in the proposed Feeds Regulations, 2022.

Any feed business that manufactures, stores, packages, labels, sells, exports or imports a feed in Canada must implement a written PCP in accordance with the proposed Feeds Regulations, 2022 and verify that all control measures are effective.

The PCP must include a hazard analysis (section 60(1) ), preventive controls related to the operations of the feed establishment (section 60(2)), and preventive controls to comply with other relevant regulatory requirements (section 60(3)).

A feed exporter must develop a PCP for the feed intended to be exported that includes the preventive controls implemented to comply with the regulatory requirements of the importing country.

A feed importer must demonstrate that the imported 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.

The CFIA verifies the compliance of a feed establishment by conducting inspection and surveillance activities. When a non-compliance is identified, the feed establishment must initiate corrective actions to bring the feed establishment, feed and/or label into compliance. The CFIA conducts follow-up inspection activities to verify that compliance has been achieved. If not, the CFIA will choose from a number of regulatory response options, including control measures and enforcement actions in accordance with the CFIA's Compliance and Enforcement Continuum.

Overview

Under the proposed Feeds Regulations, 2022, feed businesses that would be required to implement a PCP include:

  • single ingredient feed manufacturers and suppliers
  • mixed feed manufacturers and suppliers (for example, commercial feed mills, specialty feed manufacturers, etc.)
  • rendering facilities manufacturing livestock feed ingredients
  • feed retail outlets
  • livestock producers (on-farm feed mills)
  • feed importers
  • feed exporters

PCPs must be prepared, implemented and maintained by anyone who conducts a feed-related activity such as:

  • manufacturing
  • storing
  • packaging
  • labelling
  • selling
  • exporting

Importers will require a PCP for the activities they conduct with the imported feed such as storing, packaging, labelling and selling. In addition, importers must demonstrate that the imported 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.

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 in the proposed Feeds Regulations, 2022.

Keep in mind

PCP approaches that have been developed 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 preventive control plan is tailored for that particular feed establishment, its feeds and processes. The responsibility for ensuring that the written PCP meets the requirements of the proposed Feeds Regulations, 2022 once they come into force lies with each individual feed business.

Developing a preventive control plan

Depending of the nature of a feed operation, a PCP will cover some or all of the following elements:

  • product and process controls (for example, manufacturing controls, treatment processes)
  • sanitation, biosecurity, pest control and chemical agents
  • hygiene, biosecurity and employee training
  • equipment design and maintenance
  • physical structure, surroundings and maintenance of the feed establishment
  • receiving, transportation and storage of feed
  • traceability, controls and complaints

Feed businesses must address the elements listed above by meeting the following requirements of the proposed Feeds Regulations, 2022:

Related to hazards

  • hazard analysis that describes the biological, chemical, and physical hazards that are known to or have the potential to contaminate the feed (section 60(1)(a))
  • control measures used to prevent, reduce or eliminate the identified hazards (section 60(1)(a))
  • critical control points (CCPs) in the process, including the related control measures and evidence the measures are effective (section 60(1)(b)(i))
  • critical limits (section 60(1)(b)(ii))
  • monitoring procedures for each CCP to verify that hazards are consistently addressed (section 60(1)(b)(iii))
  • corrective action procedures to implement when there is a deviation from the critical limits (section 60(1)(b)(iv))
  • verification procedures to confirm that the PCP fulfills its intended purpose and meets the requirements of the proposed Feeds Regulations, 2022 (section 60(1)(c))

Related to measures to be taken

  • description of the preventive controls in place to meet requirements indicated in section 60(2)

Other requirements

  • description of the preventive controls in place to meet applicable regulatory requirements indicated in section 60(3)
  • if applicable to the feed establishment, its PCP may need to include additional content related to feed for export or import outlined in the proposed Feeds Regulations, 2022.

The following steps will assist in developing a written PCP:

Step 1: Assemble the team

Developing, implementing 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 development of the PCP, making sure to include key personnel to cover all aspects of the operations of the 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 in the feed establishment, 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 developing 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 developing a comprehensive PCP. In some instances, the team may consist of one 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: Preventive control requirements

Preventive controls (PCs) covered in section 60(2) of the proposed Feeds Regulations, 2022 are the basic practices that a feed establishment must follow to reduce the risk of introducing hazards to the feed through the processing environment. These PCs address key elements related to good manufacturing practices, such as: sanitation, biosecurity, hygiene and employee training, equipment design and maintenance, building, surroundings and maintenance, receiving, transportation and storage.

Step 3: Performing a hazard analysis

The next step in the development of a PCP is to identify and evaluate all applicable hazards with respect to the feed and feed-related activities that the establishment conducts. This includes control measures, critical control points, critical limits, monitoring, corrective action and verification procedures, and to document the steps taken. It is important to list all feed-related activities being conducted at the establishment for each type of feed being manufactured, including their distribution, intended use, intended livestock species and class of livestock, as well as a description of the manufacturing process (along with a process flow diagram) for each feed type manufactured.

The following processes may assist in performing a hazard analysis.

Step 3.1 – Hazard identification and evaluation

Most feed establishments performing a feed-related activity, such as manufacturing, storing, packaging, labelling or selling, must conduct a hazard analysis to identify and evaluate hazards that are known to be or have the potential to be associated with a feed or with a feed establishment. Those hazards identified during the analysis which are not addressed by any of the requirements in section 60(2) of the proposed Feeds Regulations, 2022, must be further managed using additional control measures that are shown by evidence to be effective.

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 3.2 – Control measures, CCPs, critical limits, monitoring, corrective actions, and verification procedures

After you have identified all potential hazards that will occur, you need to determine their control measures, their significance, and the critical control points (CCPs) that you will use to control significant hazards. A CCP is the step at which the application of a control measure is essential to prevent or eliminate an identified hazard, or reduce it to an acceptable level.

When establishing your CCPs, you also need to determine:

  • critical limits for each CCP
  • monitoring procedures of each CCP in relation to its critical limit
  • corrective action procedures
  • verification procedures

The Hazard analysis guidance for the proposed Feeds Regulations, 2022 provides more details regarding the steps to follow when conducting hazard analysis.

Step 4: Other relevant regulatory requirements

Regulated parties must describe the measures in place to meet other relevant regulatory requirements referred to in section 60(3) of the proposed Feeds Regulations, 2022, such as general and safety standards, packaging, labelling, complaints, recalls, and traceability.

If applicable to the feed establishment, its PCP may need to include additional content related to feed for export or import outlined in the proposed Feeds Regulations, 2022.

Step 5: Documents

Assemble the following documents to be included in the written PCP:

  • preventive controls, identification and description
  • hazard analysis, identification and evaluation
  • control measures implemented and the evidence that they are effective
  • 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 preventive control plan

Once the PCP has been developed, it is important to fully implement it as written into the feed establishment's day-to-day operations. 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 3 years
  • verifying the PCP's effectiveness in preventing animal health, human health or environmental concerns, resulting in compliance with the proposed Feeds Regulations, 2022

The CFIA will conduct inspection activities to assess if the PCP is complete, implemented and effective.

Maintaining the preventive control plan

Once the PCP has been developed and implemented, it is important to review it at a frequency appropriate to the feed establishment and revise it as necessary.

The PCP also needs to be reassessed and updated when:

  • something is new or has changed (for example, type of feeds manufactured, feed ingredients or incoming materials, feed 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, feed recalls, unsatisfactory laboratory results, etc.)

Keeping the preventive control plan records

The written PCP must be kept for 3 years after the day on which it ceases to be implemented.

In addition, supporting documents used and produced during the development of the PCP (for example, information used to identify hazards, the rationale used to determine the critical control points, and other data), and documents that demonstrate that the PCP has been implemented (for example, operational procedures, records, service contracts) must be kept for 3 years after the day on which they were prepared (section 61).