Integrated Agency Inspection Model – Consultation Draft (December 4, 2013)
4.0 CFIA Oversight
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Introduction
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 are considered in assessing risk. The likelihood of a hazardous event (e.g., the food-borne organism, invasive plant pest, or animal disease in question) and the magnitude or severity of its impacts following exposure are key components of risk assessment. Additional risk factors may also include impact on consumer protection and market fairness (e.g. product misrepresentation and substitution).
Risks must be managed or eliminated during production, processing, importing and distribution. It is the responsibility of regulated parties to:
- Produce or import commodities that meet Canadian regulatory requirements;
- Mitigate identified risks associated with those commodities; and,
- Demonstrate a commitment to reducing risks associated with regulated commodities to an acceptable level through responsible practices such as:
- surveillance and control measures,
- processing controls (e.g., heat treatment, seed cleaning, bark removal, composting),
- cross-contamination controls (e.g., sanitation and hygiene, establishment of buffer zones or controlled access areas), or by
- limiting exposure (e.g., containment prior to processing).
The CFIA currently follows a variety of risk management approaches which reflect differences in the international foundations, legal frameworks and industry practices that influence the CFIA's risk oversight activities.
Other inspection systems around the world, such as those implemented in the United States, Australia, and New Zealand are adopting risk-based approaches that compare risk across regulated commodities. Science knowledge and tools available for analysing the risks associated with a variety of regulated commodities are constantly evolving. Canada is committed to using the most modern tools and systems available for risk management and delivery of its oversight activities.
As part of its modernization efforts, the CFIA will enhance its risk-based approach to its oversight activities, and will adopt a more structured and transparent approach to allocating resources. This will utilize more modern methods and tools, thus ensuring a standard and consistent approach to oversight (e.g., inspection, audits, directed sampling and testing, etc.) without compromising human, animal or plant health, the economy or the environment.
4.1 Risk-based oversight in the model
The CFIA will take a:
- consistent and structured approach to analysing risks related to different regulated commodities by:
- updating risk information on a regular basis to take into consideration any developments in science, experiences in Canada or other countries, or other new information;
- making the risk information accessible and transparent; and
- applying this approach across all commodities (food, animal, plant, seed, feed and fertilizer); and,
- common systematic approach to determining appropriate levels for oversight activities by assessing and re-assessing preventive control plans or relevant equivalents, and the track record of regulated parties (including associated surveillance and recall data, certification to a relevant standard that is recognized by the CFIA, and the regulated party's compliance history). For example, once a regulated party has established a history of compliance with regulatory requirements, the intensity of inspection and/or methods of inspection may be adjusted to correspond with how effectively the regulated party has demonstrated its commitment to effectively mitigate identified risks.
Based on the results of this process, the CFIA will determine the frequency, intensity and type of oversight activities required, and allocate its resources to those areas and regulated parties that present the highest risk to Canadians and Canadian animal and plant populations and the environment. The CFIA will also continue to take into account specific requirements of other countries to facilitate access to export markets.
There are a number of other triggers that could also impact CFIA oversight activities which can be included as elements of a risk management strategy. These include:
- response to complaints, investigations, recalls or outbreaks/incursions in Canada;
- results of concern arising from an oversight activity, such as inspection or sampling
- information about a potential issue received from a third party (including, another government department, or an international trading partner);
- a request for inspection by a regulated party (e.g., for export marketing purposes); or,
- a request by a foreign trading partner or foreign delegation for a site visit.
4.2 How does a risk-based approach work?
This systematic and structured risk-based approach would help the CFIA enhance its determination of:
- whether licensing is an appropriate mechanism for addressing risks associated with a particular party or activity;
- whether an inspection is required before licensing;
- the frequency, extent or type to which the CFIA would inspect, audit or monitor specific products, establishments and importers; and,
- how the CFIA will conduct other oversight activities such as marketplace monitoring and border blitzes.
Figure 3 illustrates the risk oversight process, highlighting the information and intelligence sources as well as the analyses used by the CFIA to determine the frequency, extent or type of oversight activities appropriate in a given circumstance.
Numerous sources of information are used as inputs into the determination of commodity risk (e.g., surveillance, research, country evaluations and knowledge of processes and interventions). The analysis of surveillance data generated by the CFIA or recognized external partners provides a useful body of information to support the risk oversight process. In general, surveillance is aimed at demonstrating the absence of a hazard, determining the presence or distribution of a hazard or detecting as early as possible exotic or emerging hazards. The type of surveillance applied depends on the outputs needed to support decision-making. Surveillance information may be derived from active surveillance programs designed to meet specific needs and/or gathered from structured non-random sources as supporting evidence.
Surveillance information is used to support all aspects of CFIA regulatory programs such as, program design, import requirements, export trade, domestic movement as well as pest or disease control and eradication programs.
The determination of commodity risk differs in format and delivery across food, animal and plant programs. It can include both risk assessment and risk ranking. For example, food safety risk assessments are conducted by Health Canada. Animal health, plant health, feed and fertilizer risks are assessed by the CFIA. Risk assessments are conducted according to international standards for risk analysis, as established by the relevant international organizations.
Allocation of CFIA resources related to export certification is also influenced by international requirements for market access. Some regulated commodities are subject to specific oversight requirements for eligibility to export to certain countries. Generally, these considerations flow from foreign country-specific standards for specified commodities.
The CFIA takes the overall risk and market access requirements into consideration to select appropriate frequency, extent or types of oversight activities to achieve desired risk management objectives.
Using this approach, if a trend in non-compliance is observed at a specific regulated party's operation (such as a recurring microbiological issues or imported nursery plants consistently failing to meet import requirements for freedom from pests and diseases), the CFIA could:
- enhance its oversight activities by adjusting the frequency, extent or type of oversight activities, such as enhanced directed sampling and testing and/or,
- apply other compliance and enforcement tools to support compliance.
The frequency, extent or type of CFIA oversight activities may also be adjusted when:
- a regulated party implements and maintains a preventive control plan that exceeds minimum requirements; or
- the effectiveness of a regulated party's preventive control plan, in preventing and mitigating risks and achieving regulatory compliance, is consistently demonstrated through the regulated party's compliance history.
Practical application of the risk oversight process: The following example illustrates how the risk-based oversight process could be applied to food commodities. The CFIA would group food commodities and preparation processes with similar levels of risk, such as regulated parties who prepare or import ready-to-eat foods for trade (e.g., cheese and chopped salads) that support the growth of pathogens versus regulated parties who prepare or import ready-to-eat foods that are shelf-stable (e.g., honey products and bakery products) and do not support the growth of pathogens.
Other sources of information (as listed in Figure 3) would then be considered jointly with the identified commodity risk to determine overall risk and hence the level of oversight activities appropriate for each regulated party.
Figure 3 – Risk-based oversight process
Figure 3 illustrates the factors and criteria that the CFIA considers when conducting commodity risk analysis and the assessment of regulated parties in order to determine the frequency, intensity and type of Agency oversight activities.
The graph flows from top to bottom starting with
- sources of information for determining risk, with an arrow pointing to
- determination of risk, with an arrow pointing to
- information determining overall risk (examples), with an arrow pointing to
- overall risk
- Selection of frequency, extent or type of oversight activities (inspection, monitoring, surveillance, etc.)
The market access requirements would also need to be considered after the overall risk, but prior to determining frequency, intensity and type of oversight activities.
The sources of information for determining risk include
- Commodity/ commodity type
- Volume of production/shipment, intended end-use, consumer target groups
- environmental scanning, forseight and intelligence
- Knowledge of the process/system/other interventions used to produce, process or market the commodity
- Hazard identification
- Monitoring and surveillance data
- Research
- Country evaluations
- Risk assessments by the CFIA, other agencies and countries
Determination of risk include
- Likelihood of occurrence of biological, chemical and physical hazards in/on/with regulated commodities or travel in/on/with a defined pathway
- Magnitude of human, animal, plant or environmental health impacts, including economic and social impacts
Information determining overall risk (examples) are
- Government of Canada Outcome Areas and CFIA Key Priorities
- Other Risk intelligence (e.g., third party certification / audit, recognition by external standards associations
- Track records and performance history of regulated party and /or sector (data from oversight activities)
- Preventive Control Plan (PCP) or equivalent
These would then lead, along with the consideration of market access requirements, to the Selection of frequency, extent or type of oversight activities (inspection, monitoring, surveillance, etc.).
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