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Operational guideline (OG/OO-18136): Biosecurity for inspection activities

Although the Safe Food for Canadians Regulations (SFCR) came into force on January 15, 2019, certain requirements may apply in 2020 and 2021 based on food commodity, type of activity and business size. For more information, refer to the SFCR timelines.

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1.0 Purpose

This operational guideline outlines the biosecurity principles and describes the biosecurity measures that are required in the delivery of CFIA inspection activities within all 3 business lines (animal health, plant health and food safety). This document is:

2.0 Overview

Biosecurity is a set of practices used to minimize the introduction and spread of hazards. Hazards can be transferred through many means including footwear, clothing, equipment and vehicles. A biosecurity breach can have devastating impacts on health, food safety and the environment which often results in significant financial losses. Everyone has a role to play in biosecurity and it is vital that CFIA inspectors take measures to reduce the risk of being a vector of hazards while conducting inspection activities.

Biosecurity measures are divided into 3 categories (exclusion, management and containment), based on their intent.

  1. exclusion prevents the introduction of hazards into a premises
  2. management minimizes the movement of hazards within a premises
  3. containment prevents the release of hazards outside of a premises

Diagram of the biosecurity categories

Picture - Figure 1: Diagram of the biosecurity categories. Description follows.
Figure 1: Diagram of the biosecurity categories

Exclusion limits the introduction of hazards into a premises. This is illustrated by an arrow that leads to a red X before the premises. Different areas within the premises are illustrated by a green and yellow rectangle. A double ended arrow crosses the coloured sections of the premises rectangle with a red X illustrating management of hazards within the premises. An arrow leads out of the premises rectangle to a red X illustrating the containment of hazards from the outside environment.

Therefore, biosecurity measures are to be taken by CFIA staff:

  1. before entering a premises to prevent the introduction of hazards (exclusion)
  2. while moving from one area to another within a premises to minimize the spread of hazards (management)
  3. when exiting a premises to prevent the spread of hazards to other premises (containment)

3.0 Acronyms

CFIA

Canadian Food Inspection Agency

DIN

Drug Identification Number

HACCP

Hazard Analysis Critical Control Point

iAIM

Integrated Agency Inspection Model

OFFSP

On Farm Food Safety Programs

PMRA

Pest Management Regulatory Agency

SDS

Safety Data Sheets

pH

Power of Hydrogen or Potential Hydrogen

PPE

Personal Protective Equipment

SIP

Standard Inspection Procedure

4.0 Glossary

Antiseptic:

Chemical compounds used on living tissue (for example: skin) to inactivate disease-causing organisms to a level determined to be safe.

Biosecurity:

A set of practices used to minimize the transmission of pests, diseases and contaminants including their introduction (exclusion), spread within populations (management), and release (containment).

Basic biosecurity (Level 1):

Low risk, no contact inspection activities that are limited to areas where there is a low likelihood of the presence of a hazard that may present a potential risk.

Routine biosecurity (Level 2):

Applies to inspection activities where there is moderate risk of contact with potential hazards. This biosecurity level is considered the standard for day to day inspection activities.

Enhanced biosecurity (Level 3):

High risk of transmission of regulated diseases that are not highly transmissible and unregulated diseases that may be highly transmissible. To be employed for situations requiring heightened biosecurity. This may include enhanced bioexclusion for visits to livestock and poultry facilities (specific pathogen-free, breeding facilities, and other sites when necessary), situations requiring heightened biocontainment (suspicion or confirmation of an unregulated disease that may be highly transmissible or regulated disease that are not highly transmissible), or other applicable situations requiring enhanced biosecurity.

Biocontainment:

A set of measures and procedures implemented to prevent the spread and release of pests, diseases and contaminants from a site.

Containment biosecurity (Level 4):

A level of biosecurity that requires the implementation of control functions when a regulated highly transmissible hazard or public health concern is suspected or has been identified.

Compliance verification:

An evaluation of a regulated party's compliance with legislative requirements using a combination of inspection and audit techniques.

Contaminant:

Any biological, physical, chemical agent or other substance that is present in a regulated commodity and that compromises human, animal or plant health or the environment.

Control function:

A specific set of activities and actions undertaken in response to an incident indicating an unacceptable or possibly unacceptable risk to human, plant or animal health or the environment. It is a response function when risk is realized.

Direct contact:

Direct contact transmission requires physical contact between animals or plants or food products and a susceptible animal, plant or person and the transfer of the hazard. Personal Protective Equipment (PPE) minimizes the risk of transmission through direct contact.

Disinfectants:

Chemical compounds applied to inanimate (non-living) objects to destroy or irreversibly inactivate micro-organisms, including disease causing micro-organisms.

Disinfection:

Refers to the application of a physical or chemical process at an application rate effective in inactivating disease-causing organisms and includes but is not limited to chemicals, heat, and radiation/ultraviolet light.

Exclusion:

A set of measures and procedures implemented to minimize or help prevent the introduction of pests, diseases and contaminants onto a site.

Hazard:

As indicated in the Integrated Agency Inspection Model (iAIM), a hazard can be biological, chemical or physical. They are defined in the iAIM as follows:

Biological - Any illness- or disease-causing pathogen, micro-organism, pest or vector that poses a danger to human, animal or plant health or the environment.

Chemical - A chemical substance that poses a danger to human, animal or plant health or the environment.

Physical - Any foreign material that is not normally found in a commodity and that poses a danger to human, animal or plant health or the environment.

Indirect contact:

Indirect contact transmission refers to situations where a susceptible host (animal, plant or person) is exposed from contact with a contaminated surface.

Some examples of surfaces that may become contaminated include:

  • equipment
  • food
  • packaging materials
  • vehicles
  • clothing/footwear
  • soil, water or organic matter
Management:

A set of measures and procedures implemented to minimize or help prevent the spread of pests, diseases and contaminants between individuals within a site.

Monitoring:

The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a control measure is under control.

Pest:

Any species, strain or biotype of organism injurious to or impacting on human, animal or plant health or the environment (including prions).

Pesticide:

Pesticides, as the name implies, are used to control pests. The term generally encompasses both insecticides and fungicides. Insecticides are used directly against chewing and sucking insects and their larvae, while fungicides are directed against fungi, mildew and bacterial infections.

Premises:

A geographically defined place that includes lands, establishments, buildings and facilities (for example: greenhouses, corrals, assembly centre).

Risk:

Includes health, environmental, economic, social and consumer protection concerns. Risk is the product of the probability of an adverse event and the severity of its impacts. Biological, chemical and physical hazards which threaten human, animal or plant health or the environment (including economic and social impacts) are considered in assessing risk.

Sanitizer:

Chemical compounds that reduce but do not completely eliminate the number of organisms on inanimate objects.

Vector:

A carrier, or an agent, capable of transmitting a hazard from an infected source to a host.

5.0 Operational guideline

5.1 Biosecurity principles

Many hazards can be transmitted readily among plant and animal populations or a food processing environment. CFIA inspectors need to keep in mind that they may serve as vectors for hazards and inadvertently transfer these hazards within and to other premises on clothing, footwear, equipment and/or vehicles during their activities.

A routine day may require an inspector to visit one or more premises. Depending on the situation, these premises may be operating under various biosecurity levels which could potentially increase the risk of introducing and spreading hazards to the next inspected premises. Therefore, the inspector must schedule their day to ensure they have adequate resources to implement biosecurity measures between inspection activities. When possible schedule inspections of the same biosecurity level on the same day when multiple inspections are required. When multiple inspection activities are required at premises of varying risk the inspector should plan inspections from the least risk of contact or transmission of a hazard to the highest risk. Similarly, inspectors must also plan their inspection activities in each premises to reduce the risk of spreading a hazard by moving from areas and activities of lower risk of contact or transmission of a hazard to the highest risk.

Note

Be aware that soil, bodily fluids (either directly from live animal contact or indirectly from the slaughter process) and various surfaces may harbour hazards that can inadvertently be transferred. It is important to ensure appropriate measures are effectively implemented to mitigate the potential risk.

Managing the risks associated with inspection activities is very challenging as hazards are not always easily identifiable, often are not visible and many can only be confirmed with testing. Given this reality, CFIA inspectors visiting premises must use a precautionary principle and assume hazards are present, be aware of the risk they pose for spreading them and must take appropriate precautions.

Many producers will have biosecurity plans in place, particularly those in sectors and commodities that have adopted a set of standardized food safety practices, for example: On Farm Food Safety Programs (OFFSP), to meet domestic and international commerce requirements. In the case of food processing, many facilities have Hazard Analysis Critical Control Point (HACCP) programs in place. Many of these programs will have biosecurity requirements. It is important that CFIA inspectors are aware of and comply with the specific biosecurity requirements of a premises. In some cases, a premises may have biosecurity protocols that are more stringent than the applicable CFIA biosecurity level and CFIA staff must comply with the higher level of biosecurity.

The CFIA has developed commodity specific guidance documents for producers to assist them in the development of their biosecurity plans, for example, for terrestrial animals (National Biosecurity Standards and Biosecurity Principles - Animals - Canadian Food Inspection Agency) and for plants (Crop Biosecurity - Plants - Canadian Food Inspection Agency). Commodity specific biosecurity information can be accessed through Merlin under its business line information.

5.2 Determining the required level of biosecurity

The level of biosecurity required for inspection activities is determined by the level of potential risk. As CFIA inspectors, it is necessary to be proactive and provide leadership in the prevention of transmission of hazards. The difficulty is that many hazards are not visible until the signs or symptoms are apparent and test confirmation of the hazard is acquired, which could take hours, days or weeks. Therefore, proactive biosecurity is based on the assumption that a hazard could be present.

The continuum of biosecurity includes proactive measures to minimize the risk of introducing a hazard, monitoring for hazards and containing hazards once they have been identified. The biosecurity effort required is directly related to the risk of the inspection activities and classified as levels, for example level 1 for low risk.

It is vital that inspectors are aware of the potential risks involved with day to day inspections and plan accordingly to mitigate the risks. The biosecurity measures required greatly depends on:

Considering this, the following questions need to be answered when preparing and scheduling inspection activities.

Always validate the status (the degree of risk or hazards present) of a premises and surrounding area prior to conducting an inspection activity and review the history of concerns reported from previous inspection activities. Validation will require communication with the premises management prior to the visit to ensure new information is considered as it may change the biosecurity level required or postpone the visit.

This communication will also identify if additional biosecurity measures are required as part of the premises or facility biosecurity requirements. Some specific biosecurity requirements of a premises may include: sign in procedures, footwear covers, foot baths, over coats, hairnets that may be required to transit through an area to reach an office, a designated parking area, etc. Finally, the communication will help establish any protective personal equipment (PPE) that is supplied by the operator which assists the inspector to identify supplies that need to be brought to the site. Some examples of PPE include boots, boot covers, coveralls, over coats, gloves, masks, hairnets, etc.

Importance of PPE

PPE provides a barrier that protects people from direct and indirect contact with hazards. It also provides an effective mechanism to contain a hazard when PPE is removed properly and placed in sealable containers or disposed of on a contaminated site. The extent of PPE required is directly linked to the risk probability, that is, the nature of the hazard and the severity of its impact, and the level of biosecurity effort required for the inspection activity.

5.3 Biosecurity levels

Biosecurity measures are divided into 4 levels.

Each level represents a collection of biosecurity measures. Some specific inspection activities already require CFIA biosecurity protocols, therefore, CFIA inspectors must identify if official biosecurity requirements exist while planning their inspection activities.

It is recognized that not all inspection activities delivered by CFIA inspectors will be a "perfect" fit into one of the 4 levels, therefore, some risk determination and judgement may be necessary for an inspector to determine the most appropriate combination of precautionary measures.

Notes

5.3.1 Basic biosecurity (Level 1)

Basic biosecurity applies to low risk, no contact inspection activities, that are limited to areas where there is a low likelihood of the presence of a hazard that may present a potential risk. No contact is anticipated with potentially hazardous material that could result in a contamination of the person, their clothing, footwear, equipment, and/or vehicles. Arriving clean and leaving clean reflects the very minimal biosecurity measures required and illustrates respect and professionalism.

Examples of work/inspection activities that may require Basic Biosecurity measures include but are not limited to:

Notes
Basic level biosecurity measures
Planning
Inspection
Post Inspection
To disinfect or not to disinfect - that is the question

Whether it is your footwear, the vehicle's tires, wheel wells or under carriage, below are few examples of situations that may require disinfection when performing a basic or routine level inspection activity.

  • During preparation for the inspection you become aware that the area has a previous history of hazards. As a result, there is heightened awareness of the vulnerability of the commodity sector to hazards.
  • The regulated party requires disinfection prior to arrival and upon exiting the premises. The regulated party may have the perception that government inspectors are responsible for spreading hazards. Implementing additional precautions may mitigate these concerns and improve working relationships.
  • There is an emerging hazard of concern for Canada that may impact the capacity of the regulated party to maintain current markets and access new ones.
  • You have inadvertently walked or driven through organic material, waste water, secretions, fluid and/or manure.

Lead by example to encourage the regulated party to implement best biosecurity practices.

5.3.2 Routine biosecurity (Level 2)

Routine biosecurity applies to inspection activities where there is moderate risk of contact with potential hazards. This biosecurity level is considered the standard for day to day inspection activities. Routine biosecurity precautionary measures are in addition to the minimum Basic Biosecurity measures described previously.

Implementation of precautionary biosecurity measures can mitigate the risks associated with these potential hazards. Biosecurity relies on the consistent application of routine measures. It begins prior to leaving home and continues after returning home from work. Staff who come into contact with hazards during their personal activities must ensure that these are not inadvertently transmitted during their work duties. Personal clothing and vehicles can become contaminated and transmit hazards.

The majority of CFIA inspection activities will require routine biosecurity precautions and will involve compliance verification and monitoring. The information provided by these activities may elevate the level of biosecurity required when conducting inspection activities at a premises. If the presence of a non-regulated or regulated hazard is suspected or identified, the biosecurity level may be elevated to Enhanced Biosecurity (Level 3) or containment (Level 4).

Examples of inspection activities that may require Routine Biosecurity measures include but are not limited to:

Routine level biosecurity measures

Adequate preparation and planning of the site visit are necessary to ensure that communication between CFIA staff and the owner/manager/producer occurs in order to minimize the risk of biosecurity lapses and the spread of hazards.

Planning
Inspection
Note

If an ideal logistical flow as identified above is not possible, then additional biosecurity efforts would be required to minimize the potential transmission of hazards.

Leaving a premises
Note

Many of the measures listed in the following sections begin with "If applicable…" or "Where possible…" These mentions are intended to allow for protocol differences for Routine Biosecurity within business lines or commodities.

Vehicle processes

A detailed description of the vehicle cleaning and disinfection process can be found in Appendix 1.

Post inspection

5.3.3 Enhanced biosecurity (Level 3)

The biosecurity level is elevated from basic and routine to enhanced biosecurity when:

Generally, the situations that could be encountered are:

Examples of inspection activities that may require Enhanced Biosecurity measures include but are not limited to:

What is high risk population?

A high risk population is a population of animals, plants or people that are significantly more susceptible to hazards. Examples of these include:

  • animals that are susceptible to certain pathogens
  • animal collection hubs or auctions
  • vulnerable animals or plants (propagative material)
  • plants (such as nuclear stock) that have been bred and tested to be free of viruses or other disease agents
  • people with sensitivities or allergies to food and/or food ingredients (for example: peanuts, eggs, or gluten)
  • children, elderly, pregnant women and immunosuppressed individuals
  • people with special dietary considerations
Enhanced biosecurity level measures

Note: Employ all measures in the Routine Biosecurity section, including additional measures as follows:

High risk populations
Planning
Inspection
Post inspection
Non regulated hazards – highly transmissible
Planning
Inspection

If required by a CFIA program:

To minimize disease carriage off-site, advise the producer to:

Note

The primary responsibility for controlling and responding to unregulated disease occurrences resides with industry (producers and their associations) and the information is provided to producers as advice. Producers are not required to implement the recommendations provided by CFIA.

Regulated hazards – not highly transmissible

5.3.4 Containment biosecurity (Level 4) – suspected or identified risk – regulated highly transmissible hazards

Containment biosecurity is the level of biosecurity that requires the implementation of control functions when a regulated highly transmissible hazard or public health concern is suspected or has been identified (for example: food recall, water advisory warning). Containment (level 4) biosecurity measures are well defined (for commodity specific information on biosecurity, inspectors consult with their respective subject matter experts using established communication channels) and are supported by a control function that provides for compliance and enforcement activities.

The CFIA has many types of control functions that are designed to mitigate the impact of a hazard. Some control functions that can be implemented are recall, disposition, quarantine, order to treat, prohibition of movement, declaration of a controlled area, confiscation, declaration of an infested or infected place, refused entry, refused certification for export, removal and public warning (a Range of Regulatory Actions can be found in the iAIM Annex D). The biosecurity activities to ensure containment of the hazard are determined by the risk posed to the inspector, as well as the nature of the hazard, the severity of its impact and the risk of spread.

Examples of inspection activities that may require containment biosecurity measures include but are not limited to:

Note

If the presence of a highly transmissible regulated hazard is suspected or confirmed at a premises, strict controls will be implemented by the CFIA Incident Command Structure. Specific biocontainment, hazard response and surveillance measures will be in place. In this situation, routine inspection duties will be halted and access to the premises highly restricted and controlled.

Containment level biosecurity measures

If, while on a premises, staff suspect a highly transmissible regulated hazard, additional measures must be taken to prevent hazard carriage off-site and to ensure proper notification to CFIA staff.

Figure 2: General biosecurity level decision tree

Picture - Figure 2: General biosecurity level decision tree. Description follows.
Figure 2: General biosecurity level decision tree

If there is a suspected or confirmed regulated hazard that is highly transmissible on the premises the inspector should use containment biosecurity measures. If not but the inspector will come into contact (either direct or indirect) with a regulated hazard that is not highly transmissible or a non-regulated hazard that is highly transmissible then enhanced biosecurity measures are to be used. If not but the inspector will come into contact (either direct or indirect) with a high risk population then enhanced biosecurity measures are still to be used. If not but the inspector will come into contact (direct or indirect) with a population where there is a risk of transmitting an unknown hazard then routine biosecurity measures are to be used. If not then basic biosecurity measure are to be followed.

6.0 References

For any questions or additional guidance on this document, follow the normal communication channels in the Area.

Appendix 1: Vehicle biosecurity

Note

The occupant area of any vehicle cannot contain loose objects. Any equipment or storage items in this area must be secured. If this is not possible the trunk or box of the vehicle must be used.

Remember never to enter the clean compartment with soiled footwear and/or clothing.

Note

The above procedures are intended for routine inspection duties. If the presence of a hazard is detected on the premises, intensive procedures specific to the situation must be followed.

Day-to-day procedures

Vehicles should be cleaned after premises visits. The degree of cleaning depends on the degree of contamination and degree of risk posed by the inspection activities. However, staff must assume a level of risk for all site premises visits according to the minimum cleaning described below.

Exterior of vehicle

The vehicle should be visibly clean with no accumulation of organic debris. Pay particular attention to the chassis, wheel wells and tires. If there are small accumulations of debris, cleaning with a stiff-handled brush and disinfection with a hand sprayer may be sufficient. If visibly dirty, or if staff has attended a site with suspect hazard, the vehicle should be thoroughly cleaned. (See below).

Inside of vehicle

Floor mats should be visibly clean. Using a disinfectant, spray or wipe down floor mats and steering wheels.

Trunks or truck beds

Ensure they are visibly clean and wipe down with disinfectant any areas where dirty equipment was placed. If visibly dirty, or if staff has attended a site with suspect hazard, the vehicle should be thoroughly cleaned. (see below).

Where a hazard is suspected and/or when vehicles are heavily contaminated:

Exterior of vehicle

Interior of vehicle

Appendix 2: Chemical disinfection

Product regulation

Health Canada regulates the registration of disinfectants and pesticides under the Pest Management Regulatory Agency PMRA) in Canada and provides a Drug Identification Number (DIN) for disinfectants and a registration number for pesticides prior to their marketing. This DIN and registration number is listed on the disinfectant container.

Selecting a disinfectant or a pesticide

Disinfectants and pesticides are evaluated by Health Canada using strict criteria. However, efficacy is determined under controlled laboratory conditions and if using disinfectants on a premises, they must be used according to the manufacturer's recommendations. Disinfectants and pesticides selection is based on a variety of factors, including the:

These factors (in addition to others) will affect the ability of a disinfectant to perform as indicated by the manufacturer. Choose broad-spectrum registered disinfectants (those with a DIN) with minimal toxicity, that are easy to apply and effective under a variety of environmental conditions.

Chemical disinfectants

The following information is provided as a guide for staff when selecting disinfectants. Staff should refer to the Safety Data Sheets (SDS) and manufacturers' labels when selecting and applying disinfectants.

Chemical disinfectants are classified into broad categories based on their chemical structure. Each class of disinfectant confers different disinfectant properties and selection should be based on the criteria outlined above.

Summary table describing disinfectant class, efficacy and limitations (English internal access only).

Disinfectant storage

Chemical composition, physical state (dry, aqueous), method of packaging, and conditions of storage—these all affect the shelf life of a disinfectant. A few disinfectant classes (phenols and quaternary ammonia compounds) are very stable products and may be useful for offices where disinfectant turnover is minimal.

Many disinfectant have a "best-before date" which is based on proper storage and handling of the product. Chemicals degrade over time, reducing the effectiveness of the product; degradation often increases significantly after a product has been opened. Use unexpired disinfectants and ensure lids/tops/bags are securely fastened for storage. If there are manufacturer's recommendations on storage, follow them. If there are no recommendations, store in a cool, dry, dark place.

Disinfectant application

Disinfectants are most effective when applied to clean dry surfaces. Organic material (litter, soil, manure, etc.) on equipment, boots, and structures significantly reduce the activity of disinfectants. These surfaces must be cleaned (dry and wet cleaning) prior to disinfectant application. The following application steps will help improve the efficacy of disinfectants:

  1. physically remove all visible debris from the surface of the area to be disinfected
  2. wash and scrub all surfaces with hot soapy (when possible)
  3. rinse
  4. apply the disinfectant as per manufacture's recommendations
  5. allow for the required contact time

Follow the manufacturer's recommendations for application paying strict attention to the concentration required and contact time. Use warm to hot water when mixing and applying disinfectants (most disinfectants, detergents and soaps have increased activity in warm water). Some disinfectants require rinsing as their final step. The final step of the disinfection process is to allow all surfaces to dry.

Follow local government regulations regarding the application of disinfectants to ensure compliance with environmental legislation.

Once disinfectants are mixed with water or other chemicals, their shelf life decreases dramatically and disinfectant must be replenished regularly. This may be daily for some products and weekly for others.

Disinfectants used for cleaning boots and other heavily contaminated equipment must be replenished frequently and are only effective if properly applied; boot baths/dips when heavily used may be ineffective, and must be used with caution.

Appendix 3: Biosecurity equipment and supplies

The following list is a guideline for common biosecurity equipment and supplies. It is not comprehensive. Different situations will require specific equipment and supplies. For example a tote for storing contaminated equipment may not be necessary for a Level 1 Basic Biosecurity visit but disinfectant and a method of application should be part of a biosecurity kit for all inspection activities.

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