Hazard analysis guidance: General overview Feeds Regulations, 2024

On this page

• Introduction
• Purpose
• What is included
• Roles and responsibilities
• Businesses that need a hazard analysis
• Exemptions
• On-farm feed mills
• Types of hazards
• Conducting a hazard analysis
• Implement your hazard analysis

Introduction

The Feeds Regulations, 2024 were published in the Canada Gazette, Part II (CGII) on July 3, 2024. 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 identify, evaluate, and analyze hazards will come into effect on June 17, 2025, 12 months after CGII publication. Hazard analysis is the first principle of a Hazard Analysis Critical Control Point (HACCP) system.

Under the Feeds Regulations, 2024, most livestock feed (feed) businesses need to conduct a hazard analysis as part of the development of their written preventive control plan (PCP). The regulations require feed businesses to identify the biological, chemical and physical hazards that are present in their feeds and activities they conduct, and determine whether they present a risk of contamination. Any identified hazards must then be prevented, eliminated or reduced to an acceptable level using control measures that have been proven to be effective.

Purpose

This document provides a general overview of the hazard analysis process and is intended to help feed businesses better understand how to conduct a hazard analysis when the hazard analysis and PCP requirements come into effect.

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

What is included

This document provides information on:

• roles and responsibilities
• what hazards are, and where they come from
• how to identify potential hazards
• how to evaluate whether an identified hazard is significant
• how to determine effective control measures for the hazards identified

This document also refers to the use of various documents and tools for the identification and evaluation of hazards and the recording of results from the hazard analysis process, such as product description sheets, list of materials and ingredients, process flow diagrams, etc.. Companies may already have these documents or may need to create new ones to facilitate their hazard analysis.

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 feeds and processes employed at their establishments meet all regulatory requirements.

The 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 hazard analysis

If you manufacture, store, package, label, or sell a feed within Canada, you must prepare a PCP which includes identifying the hazards that are present in that livestock feed, analyzing them to determine if they present a risk of contamination to that feed, and preparing and using control measures to prevent, eliminate or reduce the hazards identified to an acceptable level.

If you are an exporter, you must prepare a PCP, including a hazard analysis, for the 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, including a hazard analysis, for the activities you conduct with the imported 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 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 set out in the Feeds Regulations, 2024. However, it is the responsibility of feed businesses to determine any gaps between such programs and the regulatory requirements, and address them accordingly.

Exemptions

A hazard analysis 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 hazard analysis 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 hazard analysis (and as a consequence, a PCP) will be required for those feeds and those activities.

Types of hazards

A hazard is a biological, chemical or physical agent in feed that, when not controlled, has the potential to cause an adverse effect on animal health, human health or the environment. Feed businesses need to identify hazards that present a potential risk of contamination to feed, and implement control measures for each hazard identified.

Conducting a hazard analysis is important for identifying the hazards associated with feeds and feed-related activities such as manufacturing, storing, packaging, labelling, selling, importing and exporting.

To identify hazards, you need to understand the types of hazards that your feed establishment needs to control:

Biological hazards include microorganisms such as bacteria, viruses, parasites, fungi and prions. Some microorganisms can cause illnesses and other microorganisms produce harmful toxins.

Examples of sources of biological hazards include:

• incoming ingredients, including raw materials
• cross-contamination during processing, storage and transportation
• employees
• contact surfaces
• insects and rodents
• birds

Chemical hazards include contaminants such as heavy metals, processing aids, dioxins, veterinary drug residues, pesticide residues, and natural toxins. Some chemical hazards occur naturally while others are intentionally or unintentionally added during manufacturing and processing.

Examples of chemical hazards include:

• chemicals intentionally used in manufacturing such as processing aids, medicating ingredients
• chemicals that are by-products of processing
• chemical contamination from equipment
• industrial chemicals such as cleaning and disinfecting agents
• naturally occurring toxins such as mycotoxins, histamines, marine biotoxins
• agricultural chemicals such as pesticides and fertilizers
• nutrients such as excess levels of vitamins or minerals

Physical hazards in feed include many types of extraneous materials that may be introduced anywhere along the production chain, from primary production up to and including the farm (livestock producers). Extraneous materials can be introduced by anything or anyone coming in contact with a feed, including during processing, transportation or storage. Extraneous materials are considered to be hazards if they result in risk of harm to the animal who consumes the feed or if there is a risk of contamination of the foods of animal origin (for example, eggs, dairy products and by-products, and meat) consumed by humans.

Examples of physical hazards include:

• stones, rocks and dirt
• metal (commonly associated with processing activities such as grinding or cutting operations, as well as packaging materials or containers)
• glass, plastic or other physical contaminants from packaging materials or containers, or from the processing environment
• wood splinters from broken pallets or packaging materials
• flaking paint from overhead structures or equipment

Conducting a hazard analysis

Hazard analysis, required in section 56(1)(a) of the Feeds Regulations, 2024, is a process by which hazards that present a risk of contaminating a livestock feed are identified, evaluated, and mitigated through control measures.

The first step in the hazard analysis process is hazard identification, which must consider known or potential hazards. These hazards could be present because they occur naturally, are unintentionally introduced, or are intentionally introduced for the purpose of economic gain.

The second step is hazard evaluation. Each known or potential hazard identified must be assessed to determine its type (for example, biological, chemical, physical) and its effect on animal health, human health or the environment. This means that hazards need to be evaluated to determine whether they are significant or not, and if so what additional control measures are needed.

The third step is to determine control measures for preventing or eliminating the hazards identified, or for reducing them to an acceptable level.

Step 1. Hazard identification

To properly identify a hazard that is known to be or has the potential to be associated with a feed or with a feed establishment, you need to be very familiar with the types of mixed feeds and single ingredient feeds (SIFs) manufactured, packaged, labelled and stored at the establishment, as well as the processing steps conducted (including the movement of feed and the movement of employees within the  establishment). An approach to identify potential hazards is to use a multidisciplinary team of people from within or outside the company. In some cases, you may want to hire an outside consultant for this step.

When conducting a hazard analysis, you must consider the effect of any factor relevant to the safety of the feed, including but not limited to:

• formulation of the feed
• all incoming ingredients and materials (such as packaging materials and processing aids) of the feed
• concentration of any inherent contaminant in the feed
• manufacturing, processing, packaging and labelling procedures
• storage and distribution of the feed
• transportation practices
• intended use of the feed
• condition, function, design and sanitation of the establishment and equipment
• employee hygiene
• meteorological conditions (such as hot weather that may accelerate spoilage)

In addition, external information from regulatory government agencies related to human food and livestock feed safety, industry associations, scientific literature, recalls and investigations, complaints, advisories and notices, may be useful information to consider.

If you are an importer of feed, your hazard analysis will consist of the hazards associated with the shipping, handling, transporting, and storage conditions of the imported feed once it arrives in Canada.

• Preparing a list of hazards
• Gathering information of the listed hazards

Preparing a list of hazards

To identify all potential hazards for a feed, you must prepare a list of biological, chemical and physical hazards that may be likely to occur from:

• all inputs (for example, the incoming materials, ingredients, packaging materials, etc.) and the intended end use of the feed
  • keep in mind special uses of the feed; for instance, restrictions for species and caution and warning statements
  • a product description template and a list of ingredients and materials can help you with this
• each step in the production of a feed as part of the operation of the establishment, from receiving to storage and shipping
  • to help with this stage, you can refer to production documents such as a process flow diagram, traffic flow diagram and the blueprint of the building to identify potential cross-contamination points

Gathering information of the listed hazards

For each hazard identified in your list above, include as much information as possible. This could include:

• the name of the potential hazard (for example, Salmonella, lead, medicating ingredient)
• the type (for example, biological, chemical, physical)
• the cause or source of the hazard
• any known conditions that could impact the hazard's likelihood or severity (for example, survival, presence, growth)

Step 2. Hazard evaluation

For each potential hazard identified in step 1 you must evaluate it in order to determine its significance. A potential hazard is considered significant if it is likely to occur and would severely affect animal health, human health or the environment if it was not controlled.

In evaluating the likelihood that a hazard will occur use a combination of experience, data from past outbreaks, scientific literature, and corporate historical information on recalls and customer complaints

In evaluating the severity of a hazard:

• consider the impact on animal health, human health or the environment, including the duration and magnitude of the impact that the hazard may cause
• consider the susceptibility of certain livestock species or classes of livestock species to  particular hazards in feed (for example, high levels of copper in sheep feed, monensin residues in horse feed, etc.) 

It is important to determining whether a hazard is significant

Significant hazards help with the identification of critical control points (CCPs).

If you miss a significant hazard, it will not be appropriately controlled. On the other hand, if you put unnecessary control measures in place for an insignificant hazard, you are diverting your business's efforts from activities that may have a real impact on feed safety.

Each feed business is responsible for effectively evaluating the hazards they have identified. There are different tools you can use to evaluate the likelihood and significance of a hazard, one being a risk matrix. A risk matrix compares the severity of the risk against the likelihood of it occurring to provide a risk ranking.  As an example, a 5 x 5 risk matrix is shown in figure 1 below.

Figure 1: Example of Risk Matrix

Figure 1: the horizontal axis represents the severity of consequences and is divided into very low, low, moderate, major, and severe. The vertical axis represents the likelihood of occurrence and is divided into rare, unlikely, moderate, likely and almost certain.

As you move across the table the significance of the risk progresses from very low when the likliehood is rare and the severity is very low, to extreme when the likelihood is almost certain and the severity is severe. 

Feed businesses must be able to justify the outcome of their hazard evaluation step and explain decisions such as why a hazard is not reasonably likely to occur, why a hazard reasonably likely to occur is not significant, etc.

Step 3. Developing control measures

A control measure is a measure that is applied to prevent or eliminate any biological, chemical or physical hazard, significant or not, that presents a risk of contamination of a feed, or to reduce the hazard to an acceptable level. Acceptable level means a level of a biological, chemical or physical hazard that does not present a risk to animals, humans or the environment.

Feed establishments must describe the control measures implemented to manage all the hazards identified in their hazard analysis that are relevant to their facility, regardless of their significance. Each control measure requires a written description consisting of the following details:

• what – a description of the task(s) included in the control measure
• how – details of how the task(s) are carried out
  • note: this can include verification of the control measure
• when – the frequency of the task(s)
• who – the person responsible for carrying out the task(s)
• records - any forms used for the day-to-day collection of information to record delivery of the control measure.

Existing procedures and controls that you have in place to meet the control measure requirements of section 59(2) of the Feeds Regulations, 2024 can be used to indicate how a hazard is being controlled.

Evidence that shows that the implemented control measures are capable of controlling the hazards identified must be collected and documented.

When there is no control measure for a significant hazard

When you identify a significant hazard, a control measure is necessary to keep livestock feed safe. If you do not have a control measure for a hazard at the step where it was identified or at a later step, you will need to modify the product or process in order to include a control measure.

Implement your hazard analysis

As per section 58 of the Feeds Regulations, 2024, a complete hazard analysis must be implemented as part of the implementation of a PCP. For details on how to achieve this, refer to Preventive control plan guidance: General overview.

If after completing the hazard analysis you do not identify any hazards in your processes or products, you must provide evidence of your hazard analysis outcome and retain all related documents produced in order to comply with section 56(1) - Identification and analysis of hazards, section 56(3) - Factors, and section 60 - Retention period – documents.