Decision-analysis tool for the characterization of CFIA involvement and role in animal health and zoonotic events

October, 2020
Version 3

On this page

• 1.0 Introduction
  • 1.1 Purpose
  • 1.2 Design principles
• 2.0 How to use the decision-analysis tool
• 3.0 Level 1 – Determination of CFIA involvement
  • 3.1 Level 1 – Decision-analysis flow chart
  • 3.2 Level 1 – Guide to applying decision-analysis tool
• 4.0 Level 2 – Determination of CFIA and CVO roles
  • 4.1 Level 2a – Initial involvement
  • 4.2 Level 2a – Initial involvement – Guide
  • 4.3 Level 2b – Decision-analysis flow chart
  • 4.4 Role of the CVO
  • 4.5 Role of the CFIA
  • 4.6 Level 2 – Guide to applying decision-analysis tool

Introduction

1.1 Purpose

In the face of the increasingly complex challenges posed by emerging and re-emerging diseases^{Footnote 1}, zoonotic pathogens and other animal health-related events that occur in Canada, the Canadian Food Inspection Agency (CFIA) has expressed the need for new decision-making tools to support the rapid assumption, clarification and communication of roles and responsibilities for management of an animal health event.

The unpredictability and increasing prevalence of novel threats and the emergence of new variants on existing hazards have rendered it difficult to employ the traditional approach of establishing definitive lists and categories of risks as the means to distribute resources and responsibilities. Furthermore, these animal health events are rarely static in orientation, requiring re-assessment of current conditions and characteristics of the threat and the means to alter mitigation strategies as circumstances change and new information is made available.

A tool is required to help CFIA decision-makers employ a consistent approach towards the application of limited resources in a timely fashion to reduce risks associated with animal health events. The tool should assist collaboration with partners by providing an accessible and transparent rationale for defining roles and responsibilities and establishing pre-defined triggers for review and possible reallocation. Finally, the tool should support quality management by providing a standardized process for decision-making that promotes the documentation of evidence in support of those decisions, allowing for retroactive assessment and supporting continuous improvement.

1.2 Design principles

Development of the decision-making tool was aligned with a number of key design principles that defined the end product. Incorporation of these key principles into the design process was critical to ensure that the tool would meet the needs of the CFIA.

1. All-hazards approach

The new paradigm for animal health, characterized by an increasing focus on emerging issues and a diminished reliance upon existing lists of named diseases, requires an approach that guides decision-making based on common risk characteristics that can be applied to any potential threat.

This movement towards an all-hazards approach to risk mitigation is consistent with similar initiatives already underway around the world. For example, the World Health Organization's International Health Regulations (IHRs) include a tool that employs an all-hazards approach for the reporting of threats to public health.

2. Collaboratively-focused

Successful interventions on animal health issues require effective collaboration by all relevant partners and stakeholders, including the CFIA and other federal departments and agencies, provincial and municipal organizations, industry, academia and private practitioners.

In that vein, the decision-making tool was designed to provide a clear and transparent rationale for assumption of roles and responsibilities that can be easily communicated to animal health partners. In keeping with One Health principles and the CFIA's membership within the Canadian federal health portfolio, the tool also includes key inputs from the Public Health Agency for determination of the public health significance of animal health events.

3. Incorporation of the role of the Chief Veterinary Officer of Canada (CVO)

Key to the management of emerging issues will be the role of the Chief Veterinary Officer of Canada (CVO). As the figurehead and chief spokesperson for the Canadian animal health community, the CVO is charged with representing the interests of the entire community both nationally and internationally and coordinating collaborative action in response to novel animal health issues.

In order to take into account the increasing importance of the CVO as a significant actor within the animal health community, the tool defines and assigns roles for both the CFIA and the CVO.

4. Employment of triggers for reassessment of involvement and role

Responding to the need for a more flexible and resource-efficient approach to risk mitigation, the decision-tool requires the use of triggers to allow for potential change in the level of involvement and role of the CFIA with regard to a particular animal health event as conditions change and new information emerges.

Triggers have been incorporated into the design of the tool in the form of the key questions that serve as the building blocks of the flow charts. Changes in circumstances that alter the response to a key question serve as a trigger for reassessment of the issue and a potential reallocation of role and resources.

5. Evergreen format

It is recognized that the tool in its current format cannot account for all future possibilities and developments. Thus, it is important that the tool can be easily altered and updated as required.

The tool has been designed in 2 parts (a flow chart and a guide) partly in order to allow for changes to be made to the tool in a manner that does not undermine the consistency and of the tool. Revisions can be made to the questions within the Guide that underpin the tool while retaining the more general key questions that provide structure to the flow chart.

6. Previous consultation and approvals process

Following development of this tool, it underwent limited circulation within the CFIA. After having taken initial comments into consideration, the tool was presented at the annual forum of the National Farmed Animal Health and Welfare (NFAHW) Council. The emerging disease committee of the NFAHW Council were given an opportunity to apply the tool to 2 example diseases. CFIA Animal Health program staff also applied the tool in day to day work settings as appropriate circumstances presented themselves (terrestrial and aquatic diseases). Feedback from all of these presentations, discussions and pilots were collected an applied to the document in order to produce the second version.

CFIA Animal Health program staff also applied the tool in day to day work settings as appropriate circumstances presented themselves (terrestrial and aquatic diseases). Feedback from all of these presentations, discussions and pilots were collected an applied to the document in order to produce the second version.

For a description of further consultation and approvals please refer to Section 5: Next steps of this document.

2.0 How to use the decision-analysis tool

The decision-analysis tool has been designed around two key questions facing the CFIA with respect to an existing, emerging or re-emerging animal health event. For the purpose of this document an emerging animal health event is used to refer to a situation in which a novel threat is causing the event. A re-emerging animal health event is used to refer to a situation in which:

• a threat that has been present in Canada before but was eliminated;
• a threat which has become resistant to current control tools; or,
• a threat has changed its characteristics such as strain, species range or virulence is the causing the event.

2 flow charts comprised of 5 key questions have been developed to help generate answers to each of those questions. An additional flow chart / question has been developed as a preface to the second chart based on comments that were submitted and situations that were encountered. A key question can only be answered with a Yes or No response^{Footnote 2}. To help answer each key question, an accompanying Guide comprised of supporting questions has been developed. Proceeding through the Guide allows the user of the tool to navigate the flow chart in order to determine possible involvement and role for the CFIA.

Level 1: Should the CFIA be involved in addressing an animal health event?

Level 1 of the decision-analysis tool will generate 1 of 2 outcomes – further consideration of CFIA involvement or non-involvement.

Level 1 of the tool is intended to be employed by a wide variety of staff and stakeholders in order to ascertain if and when the CFIA should be involved. Generally PPB staff in AHD would lead the application of this tool.

The tool is deliberately skewed towards CFIA involvement in the case of emerging or novel threats or in situations in which substantial evidence is lacking, in other words, when there is a large degree of uncertainty.

In the case of potential CFIA involvement, subsequent usage of Level 2 of the decision-analysis tool will serve to determine potential roles and responsibilities for the Agency.

Level 2: What role should the CFIA assume with respect to the animal health event?

Level 2 of the decision-analysis tool ends in the assignment of 1 of 4 roles to the CFIA and 1 of 2 roles to the CVO with respect to a given animal health event.

Revisiting the key questions as changes in conditions occur or available information or tools become available for the particular disease agent / hazard allows for transition for the CFIA and the CVO from 1 role and another.

Level 2 of the tool is intended to be employed by key CFIA policy decision-makers and technical staff and requires specific experts including those from outside the CFIA, to provide evidence and facilitate a more in-depth analysis.

Note: Foot note 2 explains how to answer the questions in face of uncertainty and change in knowledge / situation.

3.0 Level 1 – Determination of CFIA involvement

3.1 Level 1 – Decision-analysis flow chart

Description of Figure 1: Decision Analysis Tool for Determination of CFIA Involvement

The Level 1 – Decision-analysis flow chart is a decision tree chart. The top box of the flow chart describes the initiation of the process by identification of events detected by:

• Foresight
• Intelligence gathering
• The national surveillance system

Below is a choice of 4 boxes:

1. A case of a threat currently regulated under the Health of Animal Act
2. A case of a known threat with a demonstrated impact on animal health and ability to spread
3. Any event of potential international animal health concern including those of unknown cause or sources
4. An event involving a known public health threat that does not cause significant harm in animals but exists in an animal reservoir

If selecting choice 1, then, "CFIA will consider further involvement (proceed to Level 2: Determination of CFIA Role)."

If selecting choices 2, 3 or 4, then Q: "Is the public health impact of the event serious?"

• If "Yes", then "CFIA will consider further involvement (proceed to Level 2: Determination of CFIA Role)."

If "No", then "Is the animal health impact of the event serious?"

• If "Yes", then "Is the event unusual or unexpected?"
• If "Yes", then "CFIA will consider further involvement (proceed to Level 2: Determination of CFIA Role)."

If "No", then Q: "Is there significant risk of spread (inter-provincial/international)?"

• If "Yes", then "CFIA will consider further involvement (proceed to Level 2: Determination of CFIA Role)."
• If "No", then Q: "Is there significant risk of international travel or trade restrictions?"
  • If "Yes", then "CFIA will consider further involvement (proceed to Level 2: Determination of CFIA Role)."
  • If "No", then "Lead by other partners (such as provinces and industry)."

If "No" to Q: "Is the animal health impact of the event serious?" then Q: "Is the event unusual or unexpected?"

• If "Yes", then Q: "Is there significant risk of spread (inter-provincial/international)?"
• If "Yes", then "CFIA will consider further involvement (proceed to Level 2: Determination of CFIA Role)."
• If "No", then Q: "Is there a significant risk of international travel or trade restrictions?"
• If "Yes", then "CFIA will consider further involvement (proceed to Level 2: Determination of CFIA Role)."
• If "No", then "Lead by other partners (such as provinces and industry)."

If "No" to Q: "Is the event unusual or unexpected?" then "Is there significant risk of spread (inter-provincial/international)?"

• If No", then "Lead by other partners (such as provinces and industry)."
• If "Yes", then Q: "Is there a significant risk of international travel or trade restrictions?"
  • If "Yes", then "CFIA will consider further involvement (proceed to Level 2: Determination of CFIA Role)."
  • If "No", then "Lead by other partners (such as provinces and industry)."

3.2 Level 1 – Guide to applying decision-analysis tool

The examples appearing in this guide are not binding and are for indicative guidance purposes to assist in the interpretation of the decision instrument criteria.

I. Is the public health impact of the event serious?

1. Is the public health impact of the event currently unknown or officially unassessed?
   • Does the cause of the event have the potential to affect humans?
   • Is the cause of the event similar to an agent that does affect humans?
2. Has the Public Health Agency of Canada, an international health authority or other public health organization categorized the event as serious from a public health perspective?

As taken from the WHO International Health Regulations (2005), the following are examples of circumstances or characteristics of the event that may contribute to a serious public health impact:

• Event caused by a pathogen with high potential to cause epidemic (infectiousness of the agent, high case fatality, multiple transmission routes or healthy carrier)
• Event represents a significant public health risk even if no or very few human cases have yet been identified
• No known effective treatment available
• Indication of treatment failure (new or emerging antibiotic resistance, vaccine failure, antidote resistance or failure)
• Cases reported among animal industry workers, veterinarians or close contacts on farms
• The population at risk is especially vulnerable (refugees, low level of immunization, children, elderly, low immunity, undernourished, etc.)
• Concomitant factors that may hinder or delay the public health response (natural catastrophes, isolated location, unfavourable weather conditions)
• Spread of toxic, infectious or otherwise hazardous materials that may be occurring naturally or otherwise that has contaminated or has the potential to contaminate a population and/or a large geographical area
  

II. Is the animal health impact of the event serious?

1. Has the event the potential to have a high animal health impact?

The following are examples of circumstances or characteristics of the event that may contribute to a serious animal health impact:

• High (>50%) morbidity among owned animal and / or wild aquatic animal population(s)
• High (>50%) mortality rate among owned animal population(s)
• High (rapid / easy) transmissibility among owned animal population(s)
• Multiple transmission routes or unusual/unknown transmission routes
• Affects multiple species
• No known effective treatment available
• Indication of treatment failure (new or emerging antibiotic resistance, vaccine failure, antidote resistance or failure)
• Spread of toxic, chemical or otherwise hazardous materials that may be occurring naturally or otherwise that has contaminated or has the potential to contaminate an owned animal population and/or a large geographical area.

III. Is the event unusual or unexpected?

1. Is the event unusual or unexpected?

The following are examples of unusual or unexpected events:

• The event is caused by an unknown agent or the source, vehicle, route of transmission is unusual or unknown
• Evolution of cases more severe than expected (including morbidity or case-fatality) or with unusual clinical signs
• Occurrence of the event itself unusual for the area, season or species
• The event is caused by a disease/agent that had already been eliminated or eradicated from the region or not previously reported
• The initial presentation of the event is consistent with or indistinguishable from an event which had not previously been reported or had been previously eliminated or eradicated from the region
  • Note: In this case continue to complete level 1 using the cause of the event as the one that would be unusual or unexpected

IV. Is there a significant risk of inter-provincial / international spread?

1. Is there evidence of an epidemiological link to similar events in other provinces / countries?
2. Is there any factor that should alert us to the potential for cross border movement of the cause of the event (threat agent, vector or host)?

Where there is evidence of local spread, an index case (or other linked cases) with a recent history of:

• international or inter-provincial travel
• intentional movements or introductions of animals or associated things
• close contact with an international traveller from an area where the disease is endemic
  • presence at animal gatherings (sales barns, agricultural fairs, animal shows etc.)
• presence in an area of intense international traffic with limited capacity for sanitary control or environmental detection or decontamination.

V. Is there a significant risk of international travel of trade restrictions?

1. Have similar events in the past resulted in new international restriction on trade and/or travel in Canada or in another country experiencing this event?
2. Is the source suspected or known to be an animal product or animal input that might be contaminated and has been exported/imported to/from other countries?
3. Has the event occurred in association with a large international gathering of animals (for example, equestrian events)?
4. Has the event caused requests for more information by foreign officials or international media?

4.0 Level 2 – Determination of CFIA and CVO roles

4.1 Level 2a – Initial involvement

Description of Figure 2: Level 2A: Determination of CFIA role

The chart starts with an overarching top yellow coloured box which contains the following question "Is CFIA immediate action required international reasons?" If the response is no, then an arrow directs to a green box containing the instruction "proceed to level 2b."

If the response is yes, then an arrow directs to two green boxes one stacked on top of each other. The highest green box contains the statement: "CVO leads." The lower green box contains the statement "CFIA leads initial reporting / investigation. Confirms cause of event if required."

There is an arrow that leads from these 2 boxes to a final green box containing the instruction "Proceed to level 2b flow chart using the cause of the event determined in the initial investigation."

4.2 Level 2a – Initial involvement – Guide

I. Is immediate action by the CFIA required for international reasons?

1. Does the CFIA have to differentiate the event from an event that would be led by the CFIA? For example, animals present with vesicular disease. CFIA would lead until it was determined not to be a foreign animal disease of significance.
2. Does Canada have an international reporting responsibility for this event?

4.3 Level 2b – Decision-analysis flow chart

Description of Figure 3: Level 2b – Decision-analysis flow chart

The Level 2b decision-analysis flow chart starts with the following question "Can the cause of the event be detected in animals / products?"

• If "Yes" then Q: "Is the event of serious national and / or international significance?"
• If "Yes" then Q: "Are measures required at a national level to eradicate or control the event? For example, feed ban, import controls (HC asks for control)."
• If "Yes" then an arrow points to 2 boxes.

The highest box contains the statement: "CVO leads." The lower box contains the statement: "CFIA leads." Following there are 3 questions:

• Can the cause of the event be detected in animals / products?
• Is the event of serious national and / or international significance?
• Are measures required at a national level to eradicate or control the event?

If the response to any of these 3 questions is "No", then Q: "Is CFIA's unique expertise required to control the event? For example, zoning, national standards for compartments, laboratory expertise."

If "Yes", an arrow points to 2 boxes stacked one on top of the other. The top box contains the statement "CVO facilitator" and the lower box contains the statement "CFIA collaborator." If "No" to the question about CFIA's expertise being needed, then Q: "Should CFIA monitor?"

• If "Yes" then "CFIA observer."
• If "No" then "No role for CFIA."

4.4 Role of the CVO

CVO lead:

• Provides national leadership
• National / international spokesperson on event
• Oversight of national preparedness
• Facilitates coordination of response

CVO facilitator:

• Provides national coordination
• Facilitates development of collaborative strategy
• Negotiates CFIA participation / resources
• Provides national foresight and advice
• Facilitates CFIA response

4.5 Role of the CFIA

CFIA lead:

• Lead in development / executing national strategy and engagement with international bodies (such as World Organisation for Animal Health (WOAH; founded as Office International des Épizooties (OIE)))
• Can apply full range of mandates control measures
• May order destruction and compensation
• Examples: FMD, BSE

CFIA collaborator:

• Collaborates in developing national approach
• Provides negotiated specific services as required (for example, inspection, laboratory services, surveillance, risk assessment, research, NEOC)
• Does not order destruction and compensation
• Coordinates lessons learned / effectiveness reviews
• Examples: PED

CFIA observer:

• Conducts foresight
• Monitors international events
• Monitors collaborative efforts by partners
• Examples: IBR

No role for CFIA:

• No active role for CFIA at this time
• Re-evaluate if conditions change
• Examples: sea lice

4.6 Level 2 – Guide to applying decision-analysis tool

The examples appearing in this guide are not binding and are for indicative guidance purposes to assist in the interpretation of the decision instrument criteria.

I. Can the cause of the event be detected or diagnosed in animals or animal products?

1. Successful detection or diagnosis requires 1 of the following:

• Existence and availability of a diagnostic test (pre or post-mortem)
• Clinical signature that is unique for the illness
• Criteria for declaration of freedom
  

II. Is the event of critical national and/or international significance?

1. Has the event the potential to result in the loss of major export markets for any specific sector for an extended period of time?

The following are examples of past or existing threats to major export markets:

• Foot-and-mouth disease (FMD)
• Bovine Spongiform Encephalopathy (BSE)
• African Swine Fever (ASF)
  

2. Has the Public Health Agency of Canada determined that the event has the potential to cause serious morbidity / mortality in humans from direct contact with owned animals?

The following are examples of past or existing threats to public health resulting from direct contact with owned animals:

• Rabies
• Nipah virus
• Hendra virus
  

3. Is the event the result of a suspected terrorist attack or deliberate release?

The following are examples of past or existing threats associated with terrorist attacks or deliberate release on owned animal populations:

• Deliberate distribution of anthrax spores
• Intentional release of FMD virus
• Delivery of a chemical weapon
  

III. Are measures required at a national level to effectively eradicate or control the event?

1. Does mitigation of the event require a national approach and is it desired by government and industry?

The following are examples of situations that could necessitate a national approach:

• Individual mitigation tools such as treatments or vaccines do not exist
• Mitigation requires controls at international borders
• Mitigation measure must cross provincial / territorial boundaries or industry sectors

The chosen mitigation strategy has to produce acceptable outcomes that:

• Are ethically and socially-supported to a level that allows implementation
• Will lead to international recognition of containment / eradication
  

2. Is there a high likelihood that the strategy will be effective?

IV. Is the CFIA's unique expertise required to control the event?

1. Is there a requirement for the application of CFIA's expertise and capacity?

The following represents a partial list of potential CFIA services:

• Reference laboratory / initial confirmation / biocontainment
• Development and tech transfer of diagnostic tests / bioassays
• Testing and diagnostics
• Epidemiology / risk assessment
• Modelling
• Surveillance
• Biosecurity standards
• Communications and information-sharing platforms (NEOC) (CAHSN)
• Border controls
• International engagement (International reporting, WOAH, bilateral agreements)
• Export certification / imports
• Research

V. Should the CFIA be monitoring the threat?

1. Does the event have the potential to significantly change its risk profile resulting in the requirement for CFIA expertise?

The following are examples of potential drivers to change in risk profile:

• Affects a different species of owned animal or wild aquatic animal
• Change in morbidity / mortality
• Development of anti-microbial or vaccine resistance
• Emergence of a new variant of the threat

2. Does the event have an international requirement (for example, to WOAH) for monitoring?