Risk-based approach on the movement of live fish under section 56 of the Fishery (General) Regulations

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Ensuring the sustainable management of Canada’s aquatic resources requires a robust regulatory structure and a suite of policies that guide decision-making. On December 10, 2018, the Minister of Fisheries and Oceans, and the Canadian Coast Guard (DFO) presented a new vision for aquaculture in Canada and announced the implementation of an area-based management approach which would complement a risk-based decision-making framework for aquaculture. Together, these tools help ensure that the precautionary approach guides DFO’s decision-making and the industry continues to be environmentally sustainable.

It is within this context that DFO has developed an enhanced decision-making process to guide licensing decisions for the movement of live fish under section 56 of the Fishery (General) Regulations (FGR). This new approach, as outlined in this document, will nest under the Department’s draft framework for aquaculture risk management (FARM). The FARM relies on the best available science-based risk assessments and analyses, and incorporates risk management approaches to avoid and/or mitigate risks to the environment.

DFO applies precaution at multiple steps of the risk management approach in its decision-making. When assessing risk, it is important to understand the extent of the effect of the activity on fish and fish habitat and the uncertainties associated with the assessment of these effects. Characterizing how the uncertainty in the data affects the overall assessment, and particularly if it is anticipated to result in an overestimate or underestimate of the assessment, is key; the more uncertainty, the more risk-adverse measures are implemented and efforts made to increase the level of certainty. It is also important to consider local environmental conditions, the status of local wild fish populations and their habitats, and how both interact with aquaculture operations. In this way, an area-based approach recognizes that appropriate risk management may require additional mitigation measures in locations where specific geographic or population-level conditions warrant extra consideration.

DFO’s new approach to aquaculture means we are continuously seeking the best scientific knowledge and aquaculture management practices available to make significant improvements in the way we regulate the industry to meet the global demand for our farmed seafood products, while making sure our aquatic ecosystems are healthy and wild fish populations are protected. Achieving these goals requires engagement with Canadians across a broad range of interests; we work with provinces, territories, federal partners, Indigenous Peoples, environmental groups, industry, and members of the public to arrive at informed decisions.

1 Introduction

This document is an overview of the interim Departmental approach regarding the issuance of licences pursuant to section 56 of the Fishery (General) Regulations (FGR). The approach is presented as a directional and overarching description of how recommendations will be developed for Ministerial authorizations for the transfer or release of live fish (as defined under the Fisheries Act) under FGR s.56.The process is consistent with the draft Framework for Aquaculture Risk Management (FARM), which outlines how and when the precautionary approach is used. This process is also designed to be consistent with the Sustainable Fisheries Framework, and “Canada's Policy for Conservation of Wild Pacific Salmon” (Wild Salmon Policy), and legislative responsibilities in the management of aquatic ecosystems and fisheries, including aquaculture.

Prior to issuing a licence to release or transfer live fish, the Minister must be satisfied that the three preconditions outlined in FGR s.56 are met. If the proposed release or transfer (i.e., movement) fails to meet any one of subsection 56(a), (b), or (c) of the FGR, the Minister cannot issue the licence.

Section 56 of the FGR states that the Minister may issue licences authorizing the transfer of live fish if:

  1. the release or transfer of the fish would be in keeping with the proper management and control of fisheries
  2. the fish do not have any disease or disease agent that may be harmful to the protection and conservation of fish
  3. the release or transfer of the fish will not have an adverse effect on the stock size of fish or the genetic characteristics of fish or fish stocks

In making specific live fish movement decisions under FGR s.56, the management objective is to avoid minimize and/or mitigate effects on fish and fish habitat.

When making decisions, it is important to consider local environmental conditions, status of local populations, the scale and intensity of fish movements, and predicted effects on habitats, particularly those that have specific functions for fish populations (i.e., nursery grounds, spawning grounds, forage grounds, etc.). The specific management objectives for a local area may reflect the biological, environmental, economic, cultural and social considerations for that area. 

The Department will manage decisions surrounding the authorization to move fish under FGR s.56 following the process laid out in the FARM, which outlines a structured process the Department will follow in making recommendations and decisions related to the management of aquaculture. It is consistent with the Sustainable Fisheries Framework (SFF). The FARM is the overarching framework for future policies and tools related to the science-based management of aquaculture, according to the DFO legislative mandate. The SFF provides the foundation for an ecosystem-based and precautionary approach to fisheries management in Canada, and provides the basis for ensuring Canadian fisheries are managed in a manner which supports conservation and sustainable use of fisheries resourcesFootnote 1. The FARM and associated policies will consider and include similar language, approaches, and principles as the SFF, to the extent possible, considering conservation and sustainable use of the ecosystems.

Briefly, the FARM outlines the following steps that are followed in making science-based management decisions, allowing for more transparent and robust decisions:

  1. defining the objectives for activities
  2. issue identification
  3. scientific advice and scientific risk assessments. Includes the characterization of uncertainties
  4. risk analysis. Considers scientific, social, economic, as outlined in regulations, legislation, and other Departmental objectives
  5. risk management. Includes the consideration and assessment of risk mitigation measures, precautionary approach, and the final risk determination after the application of riskmitigation
  6. monitoring and evaluation. Includes environmental and compliance monitoring, auditing and regulatory reporting. The information obtained through these activities will be used to help inform future decisions, evaluating the effectiveness of risk-mitigation activities, and supports adaptive management.

Given the complexity of ecosystems, there will always be some uncertainty associated with predicting the likelihood and impact of activities. Characterization of the type and degree of uncertainties and how these will influence the assessment is critical to evaluating when and where to apply precautionary measures. Some uncertainties can be reduced through additional data collection or research; however, other uncertainties in the assessment are because of natural variability.  The anticipated impact of the uncertainties and any associated assumptions on the risk estimation is considered as part of overall risk analysis and risk management activities.

The Department incorporates the Precautionary Approach within it’s management approach to fisheries and aquaculture decision-making, by supporting the economic use of resources while at the same time ensuring that potential risks to aquatic environments are managed to protect to fish and fish habitat. Management decisions are more cautious when scientific information is uncertain, unreliable or incomplete. The decision-making process outlined in this document, including the use of structured scientific risk assessments, ensures that any live fish movement decisions under FGR s.56 reflect this approach. Precautionary measures are applied during the risk management step, as described in the FARM, once the characterization of the overall risk has been completed. To be effective, the precautionary measures selected must be reasonably expected to reduce the likelihood and/or consequence of the expected effect.

Alternatively, precautionary measures may also be applied if they are reasonably expected to reduce the uncertainty associated with the estimated likelihood or consequence of the expected effect.

Additionally, precautionary measures must be appropriately scaled to the risk and the significance of uncertainty in potentially underestimating or overestimating the risk. Therefore, the lower the risk, regardless of the uncertainty, the extent of precautionary measures required will be reduced compared to the measures required if the risk was higher. Additionally, the most effective precautionary measures would be expected to result in a decrease in the overall estimated risk to the target population or environment. Further details on the DFO’s application of the precautionary approach can be found in the document Fisheries and Oceans’ Management of Aquaculture and the Application of the Precautionary Approach. Recommendations and resulting decisions will incorporate new information, in support of an adaptive management approach. This information may include results from environmental monitoring, audits, peer reviewed science advice, status updates on aggregates of concern, and local and/or Indigenous knowledge.

Throughout Canada, where DFO makes decisions regarding the issuance of licences for the movement of fish, related to aquaculture activities and the release of fish to the wild, numerous policy considerations and elements of scientific advice are considered. Discussions with other federal and provincial departments and agencies as well as engagement and consultation with Indigenous Peoples and interactions with industry and stakeholders inform decision-making on an ongoing basis.

2 Application

This interim approach will apply in all cases and jurisdictions where s.56 licences are issued pursuant to the FGR. This includes releases or transfers (movements) of live fish as defined in the Fisheries Act, regardless of purposes.

3 Assessing and managing risk related to Fishery (General) Regulations s.56

To ensure that FGR s.56 is fully assessed, movement decisions will explicitly consider the potential introduction or transmission of infectious disease, the likelihood of exposing fish in the receiving environment to an infectious disease agent, and any potential for genetic interactions.

The advice to the Minister to issue a licence under s.56 to release or transfer fish will be supported by scientific risk assessments that follows the structured process outlined in the Aquaculture Science Environmental Risk Assessment Framework. This framework is aligned with international and national risk assessment standards, and has been scientifically peer-reviewed through DFO’s Canadian Science Advisory process (2007; 2019a,b,c,d,e) specifically for assessing the risks associated with disease agent spillover from Atlantic salmon farms into the marine environment. These peer-reviews contribute to the scientific robustness of the stepwise process for assessing the likelihood and consequence (or impact) associated with the potential release of endemic disease agents as they are related to aquaculture.

The risk assessment process systematically evaluates the likelihood that susceptible wild fish in the receiving environment will be exposed, and evaluates the potential impact if the event occurs. This process takes into account the application of any mitigation measures that are common practice prior to the release or transfer.

The risk estimation is the product of the likelihood of the event occurring against the impact or consequence of the event and is illustrated in a two-dimensional risk matrix. The risk matrices reflect the Department’s risk tolerance. The scientific analysis is then linked to a classification of these potential impacts as low, medium, or high risk, reflecting the Department’s risk tolerance, and for FGR s.56 assessments. Different areas may have more resilience to potential impacts, which will be in part, linked to the state of the wild fish aggregate that is being assessed.

The level of impact is assessed as it relates to the spawning population of the fish species aggregate under consideration. The level of impact or consequence is consistent with what has been used in previous science peer-reviewed assessments is categorized as follows:

The terminology is relative rather than absolute. These categories are more conservative incomparison to other risk tolerances for the management of fisheries that the Department considers (A fishery decision-making framework incorporating the precautionary approach — Annex 2B).

Where there are uncertainties and assumptions are required, the assessment will assume that the event has occurred. Scenarios to evaluate the sensitivity of the assessment to different assumptions are also presented. Where sufficient historical data exists, this will be used. For example, there is significant natural variability in the specific migration routes that Fraser River Sockeye Salmon can take through the Discovery Islands area, including passages where there are no aquaculture sites located. However, since determining what proportion of the population will actually be exposed to one or more farms in any given year is uncertain, the assumption will be that 100% of the population is exposed, even though this will overestimate the overall likelihood or consequence.

The assessment will be conducted on aggregates of susceptible species that are known to be present in the receiving environment, and considers the biological status of these wild fish aggregates. The biological status will be determined in a manners outlined in the Fishery Decision-Making Framework Incorporating the Precautionary Approach and the SFF. Where formal biological status assessments have been completed, they will be applied: for example, the biological status of these aggregates as determined through the Wild Salmon Policy integrated status assessment or through established DFO fisheries management processes in accordance with the SFF, which defines stock status as being Critical (conservation considerations prevail), Cautious (socio-economic and conservation considerations to be balanced), and Healthy (socio-economic considerations prevail). Additional information is also available through processes undertaken in accordance with the Species at Risk Act and by the Committee on the Status of Endangered Wildlife in Canada (COSEWIC).

3.1 Fishery (General) Regulations s.56(b) risk assessment

The FGR s.56 (b) assessment focuses on the detection and mitigation of infectious disease and disease agents in the source population of fish to be released or transferred. The presence or absence of a given infectious disease agent is only one aspect of fish health considered by the Department. As part of the assessment process, the Department also considers biosecurity practices, the mortality records of the source facility, the vaccination history of the fish, information on clinical signs of disease, and the health history at the source facility and at the receiving environment. Where jurisdiction is shared with Provincial or Territorial governments, this information will be sought from the provincial veterinarians.

All organisms carry a community of living organisms, including infectious and non-infectious microbes, but whether or not a disease occurs depends on an interaction of factors related to the host, environment, and the microbe. Therefore, tools and thresholds that reduce the potential for the development of a disease within the group of fish to be moved should also reduce the likelihood of fish aggregates of concern in the receiving environment being exposed to the infectious disease agent the result of the transfer.

The assessment process is structured to allow for movements of live fish that do not pose a risk of propagating a given infectious disease agent in the receiving environment. If the infectious disease agent is already present in the receiving environment, the infectious properties of the disease agent, the nature (environmental conditions) of the receiving environment, and the density, proximity, and exposure time of susceptible hosts are all considered in predicting the likelihood of disease propagation (i.e., an outbreak) that would result from the release or transfer of fish.

If the prevalence of an infectious disease or disease agent in a population of fish to be released or transferred is not anticipated to spread within the population to be moved, than it is also not anticipated to spread to any significant degree to susceptible species in the receiving environment. If aggregates of concern are identified in the receiving environment, evaluation of the impact of this on the aggregates of concern will be conducted.

The assessment of the likelihood of infection is informed by when, where, and for how long the aggregate of the susceptible wild fish is expected to be present in the receiving environment where the fish proposed for release or transfer will be located. 

Additionally, environmental conditions as well as the incubation period of the infectious disease agent, and the disease dynamics in the susceptible fish will all influence the likelihood of infection. The consequence or impact assessment examines the scientific knowledge of the effect of infection in the susceptible wild fish species, the proportion of the susceptible aggregate of fish that is estimated to become infected and develop clinical disease, the outcome of the infectious disease in the susceptible fish, the infection dynamics of the infectious disease agent, the life stage of exposure, and examines the potential for any negative population-level effects.

3.2 Fishery (General) Regulations s.56(c) risk assessment

3.2.1 Disease agent amplification and spillover risk assessment (or disease agent transfer risk assessments)

Under FGR s.56(c), the incremental impact from the amplification and spillover of endemic pathogens will be assessed. The information and analysis process for these risk assessments will build on the completed disease agent transfer risk assessments (Mimeault et al. 2017, 2019 a-e), but will incorporate movement-specific information, such as infection prevalence of the stock to be moved, and historical information about the occurrence of infectious diseases in the receiving environment.

3.2.2 Genetic interactions risk assessment

Genetic interactions risk assessments predict the likelihood and effects of interbreeding between introduced and wild fish of the same species (conspecifics). The likelihood assessment focuses on the likelihood that the cultured fish will not be contained and the likelihood that these released cultured fish will be present to reproduce with wild fish of the same species. The consequence or impact assessment predicts the effects of interbreeding on the protection and conservation of aggregates of conspecific wild fish.

For example, hatchery fish introduced in a controlled manner for wild population restoration purposes (i.e., stocking or enhancement) may provide benefits to wild aggregate abundance by interbreeding with wild conspecifics, whereas the interbreeding of fish from harvest-oriented production hatcheries and wild conspecifics is considered detrimental to wild conspecifics. Similarly, the breeding of escaped farm fish in natural environments and their interbreeding with wild conspecifics is generally detrimental to wild population maintenance and restoration. Genetic interactions risk assessment for escaped farm fish or hatchery fish that may interact with wild conspecific aggregates, involves examination of the historical and current rate of farm escapes or hatchery strays from the site and in the vicinity, as well as the current production level of farmed or hatchery fish in the vicinity, the proximity of introduction sites to natal streams of wild conspecifics, and the status of the wild conspecifics. In addition, particular life history traits of the stocked and wild species can help to further refine estimates of risk.

3.3 Risk tolerances related to Fishery (General) Regulations s.56

Risk tolerances are categorized into low, medium, and high risk. The delineation between them follows the principles of risk matrices, in that there is a progression of risk levels from low through medium to high. It also incorporates wild aggregate stock status information and the application of precaution.

The magnitude and severity of any potential impacts (consequences) and the likelihood of those impacts are plotted on risk matrices, which allows for direct nominal scoring of risk as low (green), medium (yellow), or high (red).

Different risk matrices have been developed to assess requests for fish movements under FGR s.56 to specifically consider the biological state of the aggregate in the receiving environment. A data-rich example would be, for aggregates that can be formally assessed a biological status and are within the Critical zone (which would include At Risk populations), the risk tolerance is illustrated such that the low risk areas within the risk matrix are designated only for impacts of negligible consequence or those that are extremely unlikely. For aggregates that have formal biological status assessments within the Cautious zone, the low risk areas include additional combinations of likelihoods and consequences. For aggregates where data is only sufficient to produce an assessment of state, the assessment will indicate whether current abundance is above, below, or average; and whether the trend is increasing, decreasing, or stable.

The resilience of the aggregate is linked to the status, and therefore the informs the risk tolerances. The risk tolerance decreases as the status of the aggregate changes from Healthy to Critical; the area in the matrix representing high risk (red) increases and the area representing low risk (green) decreases. Inversely, as the status of the aggregate changes from Critical to Healthy, the area representing high risk (red) decreases and the area representing low risk (green) increases. This is illustrated in the following risk matrices that will be applied to fish movements, and that specifically account for the status of the aggregates.

Figure 1. Differential risk matrices:

  1. represents the risk tolerance levels for aggregates that are at risk or, under the Sustainable Fisheries Framework (SFF), identified as “Critical”
  2. represents the risk tolerance for aggregates that are identified as “Cautious” under the SFF
  3. is the risk tolerance levels for aggregates identified as “Healthy” under the SFF

(a) Risk matrix for “Critical zone” aggregates

(a) Risk matrix for “Critical zone” aggregates. Consequence to aggregate
Likelihood Negligible Minor Moderate Major Severe Extreme
Extremely likely Low Medium High High High High
Very likely Low Medium High High High High
Likely Low Medium High High High High
Unlikely Low Medium High High High High
Very unlikely Low Medium Medium Medium Medium Medium
Extremely unlikely Low Low Low Low Low Low

(b) Risk matrix for “Cautious zone” aggregates

(b) Risk matrix for “Cautious zone” aggregates. Consequence to aggregate
Likelihood Negligible Minor Moderate Major Severe Extreme
Extremely likely Low Medium Medium High High High
Very likely Low Medium Medium High High High
Likely Low Low Medium Medium High High
Unlikely Low Low Medium Medium Medium Medium
Very unlikely Low Low Low Low Medium Medium
Extremely unlikely Low Low Low Low Low Low

(c) Risk matrix for “Healthy zone” aggregates

(c) Risk matrix for “Healthy zone” Low. Consequence to aggregate
Likelihood Negligible Minor Moderate Major Severe Extreme
Extremely likely Low Medium Medium Medium High High
Very likely Low Medium Medium Medium Medium High
Likely Low Low Low Medium Medium Medium
Unlikely Low Low Low Low Medium Medium
Very unlikely Low Low Low Low Low Low
Extremely unlikely Low Low Low Low Low Low

3.4 Risk management

Following the scientific estimate of risk, an overall risk analysis considers the estimated risks to the conservation and protection of susceptible species found in the receiving environment of a proposed movement with any other considerations under FGR s.56(a).

Risk management then considers whether mitigation measures will effectively lower the risk. It also considers the scale and effect of scientific uncertainty on the final determination of risk (or residual risk) and the application of precautionary measures. In addition to mitigation measures, risk management decisions may include enhanced monitoring, identification of research priorities, or enhanced auditing to provide additional data to inform future decisions, as part of an adaptive approach to management.

Considering all of these factors, where the residual risk is assessed as:

  1. “low”, the advice to the Minister or their designate on whether to authorize the movement will be that the preconditions outlined in FGR s.56(b) and (c) are met
  2. “medium”, the advice will be that, depending on an analysis of the overall evidence regarding the specific decision, any available adaptive management measures, and any uncertainty regarding the evidence, the preconditions outlined in FGR s.56(b) and (c) may or may not be met. This determination should also be guided by DFO’s “Guidelines on the Interpretation and Application of Section 56 of the Fishery General Regulations”, and the Department should seek advice from the Department of Justice, as necessary
  3. “high”, the advice will be that the preconditions outlined in FGR s.56(b) and (c) are not met

4 Overall risk assessment and management for Fishery (General) Regulations s.56

Regulations and related policies governing the movement of wild fish are in place to control and manage risks associated with any potential impacts on wild fish populations. The science advice related to FGR s.56(b) and (c) is integrated into risk analysis, which also includes information on wild stock population status.

With respect to FGR s.56(a), the Minister must be satisfied that the proposed movement would be consistent with the proper management and control of the fisheries. This could require consideration of the social and economic impacts that would result from the proposed movement. However, FGR s.56(a) does not require the Minister to re-assess matters that DFO has already considered, including those that the Department considered when issuing the aquaculture licences. Further, the “management and control of fisheries” may also include any conservation concerns not specifically addressed in s.56(b) and (c) of the FGR. Therefore, the recommendation should take into account whether a proposed movement poses any risks to the conservation of fish beyond those captured by s.56(b) and (c), such as impacts on fish habitat.

Other sources of information, such as Indigenous and local ecological knowledge, may also be used to inform recommendations to the decision-maker (i.e., Minister or their designate).

Risk management measures, particularly those that can provide information for future decisions, such as ongoing monitoring, targeted research, or enhanced reporting, support adaptive management approaches, and may also be included in the overall recommendations to the Minister or their designate.

Overall, the development of FGR s.56 recommendations, embodies the assessment of risk, comparison of risks to tolerances, and application of risk management; all aligned with the precautionary approach.

Annex 1: Definitions

is a population-level grouping of a single fish species, across a defined geographic area at a scale most appropriate for decision-making. The resolution of aggregate groups will vary, based on the available data.
Clinical sign
is a stage of the disease continuum that reflects anatomic, physiologic or behavioral changes that are sufficient to produce gross signs of disease. (adapted from PAR marine finfish licence conditions)
is an abnormality of structure or function that results in a measureable and characteristic compromise in physiological, structural, or behavioral performance, which is not the result of physical injury. (adapted from Oxford dictionary)
Disease agent
is an infectious agent that causes or contributes to the development of a disease.
Infectious agent
is a microbe capable of establishment and subsequent multiplication or development in or on a host.
is a microscopic organism. The most common microbes are bacteria, fungi, protozoa, and viruses.
is the proportion of a population or aggregate found to be infected with a disease agent.
Propagation threshold
is the prevalence of an infectious disease agent such that exceeding this threshold enables the agent to successfully spread widely through a population-level aggregate (adapted from the Oxford Dictionary and CDC Principles of Epidemiology).
Receiving environment
is the geographic location where the fish considered for movement are destined. For aquaculture, this is the vicinity around the aquaculture facility to be stocked. For stocking or enhancement purposes, this is the lake, river, coastal or open ocean area where the fish stock will migrate or inhabit.
Susceptible species
is a species that can become infected with a specific infectious agent at some life history stage.
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