Hazard analysis 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.

Introduction

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 establishments 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.

Unless a feed establishment is exempt under the Feeds Act and proposed Feeds Regulations, 2022 from having a written preventive control plan (PCP), they need to conduct and document a hazard analysis as part of their PCP. Feeds that are made on-farm by livestock producers, and are not sold off the farm or medicated are exempt from the Feeds Act and proposed Feeds Regulations, 2022.

Purpose

The proposed Feeds Regulations, 2022 require feed businesses to identify the biological, chemical and physical hazards that are present in their feeds and activities, and determine whether they present a risk of contamination of that feed. Any identified hazards must then be prevented, eliminated or reduced to an acceptable level using control measures. This guidance is intended to help feed businesses better understand how to conduct a hazard analysis and what information the Canadian Food Inspection Agency (CFIA) may require in the future.

What is included

This document provides information on:

what hazards are, and where they come from
how to identify potential hazards
how to evaluate whether an identified hazard is significant
how to identify critical control points (CCPs), and establish critical limits
how to develop and implement monitoring, corrective actions and verification procedures

This document also refers to various templates and tools for documenting the identification and evaluation of hazards, and recording results of the hazard analysis.

Exceptions

A hazard analysis 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 perform a hazard analysis 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 acts and regulations. They must demonstrate compliance by ensuring that the feed and processes employed at the feed establishment meet all regulatory requirements. When required, a feed establishment must prepare, implement and maintain a written PCP, and verify that all control measures are effective.

If you manufacture, store, package, label, sell or export a feed, you must identify the hazards that are present in that feed, analyze them to determine if they present a risk of contamination of that feed, and use control measures to prevent, eliminate or reduce the hazards identified to an acceptable level.

In addition to the hazard identification and analysis and the measures to control them, when you export feed your PCP should include preventive controls implemented to comply with the regulatory requirements of the importing country.

If you import a feed, you must demonstrate that the imported feed has been manufactured, stored, packaged or labelled under conditions which provide the same level protection as if the activities took place in Canada under a PCP.

The CFIA verifies the compliance of a feed establishment by conducting activities that include inspection and surveillance. When a non-compliance is identified, the CFIA takes appropriate compliance and enforcement actions.

Types of hazards

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

biological hazards
chemical hazards
physical hazards

Biological hazards

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
feed contact surfaces
insects and rodents

Chemical hazards

Chemical hazards include contaminants (metals and elements, processing aids, dioxins), veterinary drugs, 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 feed manufacturing such as processing aids, feed additives, medicated ingredients
chemicals that are by-products of processing
chemical contamination from equipment
industrial chemicals such as cleaning and disinfection agents
naturally occurring toxins such as mycotoxins, histamines, marine biotoxins
agricultural chemicals such as pesticides and fertilizers
nutrients such as over-addition of vitamins or minerals

Physical hazards

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 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 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 contaminants from packaging materials or containers, or from the processing environment
wood splinters from broken pallets or packaging material
flaking paint from overhead structures or equipment

Conducting a hazard analysis

Hazard analysis is a 2-step process. The first step 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. In addition, regulated parties will need to determine if the hazard identified is significant or not, and if so what additional control measures are needed.

If the hazard analysis reveals that one or more hazards require a control measure, you must have and implement control measures for those hazards.

Keep in mind

Hazard analysis includes 2 steps!

First, you identify a hazard, and then you evaluate it.

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 manufactured, packaged, labelled and stored at the feed establishment, as well as the processing steps conducted (including the movement of feed and the movement of employees within the feed establishment). One 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 hazard analysis, you must consider the effect of any factor relevant to the safety of the feed, including:

formulation of the feed
ingredients of the feed, including incoming materials
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 facility and equipment
employee hygiene
meteorological conditions

In addition, external information from regulatory government agencies related to food and 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 must include the hazards associated with your foreign company's manufacturing processes and the hazards associated with the shipping, handling, transporting, and storage conditions of the imported feeds.

Preparing a list of hazards
Gathering information of the listed hazards

Preparing a list of hazards

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

all inputs (for example, the incoming materials, ingredients, additives, packaging materials, etc.) and the intended end use of the feed
- Keep in mind special uses of the feed; for instance, claims for certain livestock species or class of livestock. A product description template and a list of ingredients and materials can help you with this
each step in the production of 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 (for example, survival, presence, growth)

Step 2. Hazard evaluation

Each potential hazard identified in step 1 must be evaluated 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:

consider existing procedures and controls that you have in place to meet the preventive control requirements of section 60(2) of the proposed Feeds Regulations, 2022
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 class of livestock species to particular hazards in feed (for example, high levels of copper in sheep feed, monensin residues in horse feed, etc.)

Determining whether a hazard is significant is important

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're diverting your business's efforts from activities that have a real impact on feed safety.

Control measures

Determine the control measures
Critical control points and critical limits
Monitoring procedures
Corrective action procedures
Verification procedures

Determine the control measures

A control measure is a measure that can be applied to prevent or eliminate any biological, chemical or physical hazard 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 of harm to animal health, human health, or the environment. Feed establishments must describe the control measures implemented to manage those hazards identified in the hazard analysis. Each control measure will require 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
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.

Evidence that shows that the control measures are capable of controlling the hazard must be documented.

When there is no control measure for a significant hazard

When you identify a significant hazard, a control measure is necessary for feed safety. If you do not have a control measure for a hazard at the step it was identified or any other step, you need to modify the product or process at that step or at an earlier or later stage, to include a control measure.

Critical control points and critical limits

Feed establishments must determine the critical control points (CCPs) required in their processes to effectively control significant hazards. A CCP is a step in a process where a control measure is applied and is essential to prevent or eliminate the identified hazard, or reduce it to an acceptable level.

Critical control points are determined by responding to a sequence of questions for each significant hazard:

Do control measures for the hazard exist at this process step?
Is the process step specifically designed to prevent or eliminate the hazard or reduce it to an acceptable level?
Will a subsequent process step eliminate the hazard or reduce it to an acceptable level?

For each CCP identified, feed establishments must also establish the critical limits to be used to control the hazard. Critical limits are the maximum or minimum set values that control a hazard at a critical control point.

Monitoring procedures

For each CCP, it is necessary to develop and document monitoring procedures to ensure that the feed establishment's measures are functioning as intended and that deviations from the critical limits are detected in time to regain control of the process and prevent the production of unsafe feed.

Monitoring procedures could be presented in the same table as the critical control points and critical limits or in a separate document.

Corrective action procedures

Equally important is to develop and document corrective action procedures for those instances when critical limits are not being met. Corrective action procedures contain the steps to be taken when a deviation from critical limits of a CCP occurs, and can help to regain control of the processes.

Corrective action procedures could be presented in the same table as the critical control points and critical limits or in a separate document.

Verification procedures

Verification procedures are necessary to demonstrate that the control measures and related procedures are implemented as written and are effective, resulting in compliance with the proposed Feeds Regulations, 2022. Feed establishments must develop and document verification procedures to ensure ongoing control of their processes.