How Does the CFIA Manage Cases of Non-compliance of Unauthorized Plant Products Derived through Biotechnology?

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This fact sheet describes the current Canadian approach to managing cases of unauthorized presence of plants (and their products) derived through biotechnology in food, livestock feed, and the environment. These occurrences are rare and, in cases to date, the CFIA and Health Canada's assessments have not identified health or environmental safety concerns associated with these incidents.

The fact sheet highlights the basic principles that are followed and the general steps that are taken during risk assessment and risk management of such occurrences.

What regulatory oversight are plant products derived through biotechnology subject to?

In Canada, novel plant products derived through biotechnology must be kept in containment (such as in laboratories or greenhouses) during the research and development stage. They cannot be planted outside of containment unless they are in confined research field trials authorized and inspected by the CFIA.

Before these products are authorized for use as food, livestock feed, or for environmental release (for example, cultivation), they are required to undergo rigorous, pre-market science-based safety assessments. The environmental safety and livestock feed safety assessments are performed by the CFIA, while Health Canada is responsible for assessing food safety. The CFIA also performs the inspection and enforcement activities related to environmental release as well as food and feed use of plant products derived through biotechnology.

Food, feed and environmental safety are assessed using established criteria. A food safety assessment considers:

  • the potential for introducing new toxins into the food supply or causing allergic reactions; and
  • the implications of a food's nutritional characteristics, for the population as a whole and/or for specific subgroups.

A livestock feed safety assessment considers:

  • the potential for introducing new toxins or allergens into the livestock feed supply;
  • the livestock feed's nutritional characteristics;
  • safety of the feed to humans, via worker/bystander exposure and consumption of animal products; and,
  • safety of the feed to the environment.

An environmental safety assessment considers:

  • the potential of the organism to become a weed of agriculture or be invasive of natural habitats;
  • the potential for, and consequences of, gene-flow to wild relatives;
  • the potential for the organism to become a plant pest;
  • the potential impact of the organism or its gene products on non-target species, including humans; and,
  • the potential impact on biodiversity.

What actions are taken by regulators when unauthorized plant products are found in the Canadian food or feed marketplace or in the environment?

In addition to evaluating the safety of plant products that are proposed for use or release in Canada, the CFIA and Health Canada address cases where unauthorized plant products are found in the Canadian food or feed marketplace or in the environment.

Unauthorized plant products derived through biotechnology are those that would normally trigger food, feed or environmental safety assessments if intended for use or release in Canada, but have not received the required authorizations from Health Canada and/or the CFIA.

Unauthorized plant products can originate from:

  • research material (for example, products that should be controlled in laboratories, greenhouses or field trials, but appear unexpectedly in food, feed or the environment), or
  • plant products authorized in other countries but not yet authorized in Canada.

Under Canadian legislation, the presence of an unauthorized plant product in the marketplace or environment constitutes regulatory non-compliance.

In such a case, the CFIA and/or Health Canada evaluate the risk associated with the non-compliance. The CFIA then determines which risk management and compliance actions are required to mitigate the risk. The goal is to maintain food, feed and environmental safety, while using the most appropriate level of intervention that would result in returning the situation back into compliance.

Each occurrence of an unauthorized plant product derived through biotechnology is unique. Nevertheless, it is possible to characterize the general approach taken by the CFIA in dealing with these occurrences. Although the focus of this document is on unauthorized plant products derived through biotechnology, it is important to keep in mind that the CFIA applies the same basic principles in dealing with the presence of all unauthorized products.

The general approach taken when dealing with occurrences of unauthorized plant products, including those derived through biotechnology, is summarized in Figure 1. This can be categorized into risk assessment and risk management steps.

Click on image for a larger view

Flowchart - General risk assessment/risk management framework

Description for: Figure 1 - General risk assessment/risk management framework for unauthorized plant products derived through biotechnology

This flowchart shows the steps for general risk assessment/risk management framework for unauthorized plant products derived through biotechnology.

1. The CFIA is informed of occurrence, or potential occurrences, of an unauthorized product1

2. Appropriate group(s) within the CFIA contacted Plant Biosafety Office (PBO) Animal Feed Division, and Domestic Food Safety Systems Division. - information gathering.2

3. Risk assessments (RA) commissioned as necessary. In the case of food safety, the CFIA Food Safety Division will request the Health Canada carry out a health risk assessment. In the case of environmental safety, the CFIA's PBO asks the CFIA Plant and Biotechnology Risk Assessment (PBRA) Unit for an assessment. In the case of feed safety, the CFIA Animal Feed Division does the assessment - information gathering.3

4. RA: Identification and characterization of potential hazards (to the environment, food or feed) - Additional information gathered or made available as appropriate

5. RA: Characterization of potential exposure (potential routes, likelihood of exposure and amounts) - Additional information gathered or made available as appropriate

6. RA: Determination of potential risk (hazard x exposure) - Additional information gathered or made available as appropriate

7. Risk management (decision making and implementation) - Evaluation of effectiveness of risk management decisions

8. The situation is brought to compliance - Evaluation of effectiveness of risk management decision

1 The originator of the information may vary:  the CFIA, provincial governments, Health Canada, governments of other countries, developers, or other stakeholders.

2 Other relevant government departments may also be contacted depending on the case.

3 If appropriate, the Consumer Protection Division will evaluate the risk of economic fraud.

Step 1: Risk Assessment

When unauthorized plant products derived through biotechnology are identified in the Canadian environment or the food and/or feed supply, or have the potential to be so, the CFIA conducts risk assessments for livestock feed and environmental safety, while Health Canada conducts a food safety risk assessment.

These assessments are intended to determine the risk to the Canadian public, environment, and livestock. The process of risk assessment is rigorous, yet flexible enough to adapt to the particulars of each case.

What is the scope of a risk assessment?

The general risk assessment framework applied to unauthorized plant products, including those derived through biotechnology, involves identifying potential hazards and potential routes of exposure.

The hazard component considers the following questions:

  • Is there any characteristic of the product that could cause harm to human health due to consumption?
  • Is there any characteristic of the product that could cause harm to livestock health, or to workers or bystanders?
  • Is there any characteristic of the product that could cause harm to the environment?

The exposure component considers the following questions:

  • Is there a potential exposure route for food, feed or the environment?
  • What is the likelihood of each exposure pathway?
  • How much of the product may enter the food or feed marketplace or the environment?

These two components determine the level of risk that the presence of an unauthorized product represents (that is, risk = hazard x exposure). If there is no route or limited routes for exposure, the risk level is reduced. Similarly, if no hazards have been identified, the risk will be low regardless of the level of exposure.

The scope of regulatory action taken in response to an instance of non-compliance is based on the conclusions of the risk assessment(s) and is influenced by other legitimate factors (see Step 2 below, "Risk Management").

What information is gathered and how is it used?

If an unauthorized plant product is found, all available information regarding the nature of the product, and the scale and scope of the unauthorized occurrence, is gathered.

Things that are particularly important are:

  • data regarding any novel proteins expressed;
  • their level of expression in various tissues; and
  • potential toxicity or allergenicity.

For species with known endogenous toxins and/or allergens, data regarding these compounds in the unauthorized product may also be required.

Basic biological information about the plant species in Canada is important when considering environmental risks. Examples include:

  • information on the plant's reproductive biology;
  • the presence of wild relatives; and
  • its ability to persist in the Canadian environment.

In addition, information on the scale and scope of the release is key to evaluating exposure pathways.

Sources of information that may be considered in the risk assessments conducted by the CFIA and Health Canada include:

  • product information from the developer;
  • previous assessments of similar products (in Canada or elsewhere);
  • other governments and internationally recognized authorities;
  • published literature, including publications or databases from international organizations such as the Codex Alimentarius Commission and the Organization for Economic Co-operation and Development; and
  • other relevant sources, including data generated by regulatory authorities.

Risk assessments, in cases of occurrences of unauthorized products, are generally dynamic. This means that the conclusions are often re-visited based on new information that helps to reduce uncertainty about exposure levels and potential hazards.

The pertinent government departments responsible for risk assessment collaborate and share information.

What is the difference between safety assessment and risk assessment?

A key difference between "safety assessments" and "risk assessments" is determined by the situations where these processes are used. Safety assessments are aimed at considering products for regulatory authorization, while risk assessments address specific instances when unauthorized products are found in the Canadian environment or marketplace.

The outcome of a safety assessment influences a decision to authorize the product. An authorization typically indicates that the novel product, including those derived through biotechnology, is as safe and nutritious as its conventional counterpart and therefore can be similarly released and handled.

A risk assessment does not result in the authorization of a product. It aims to determine the level of risk a non-compliant situation may pose. In addition, its outcomes are considered when determining what risk management options are appropriate.

Because the questions asked in risk and safety assessments are different, the types of information required may be different. For example, a food safety assessment considers the potential for a novel food to replace traditional counterparts and, therefore, requires nutritional data for a novel food to be authorized. A risk assessment would not typically consider nutritional content if the presence of an unauthorized product in the marketplace is deemed to be at a low level. However, it may use available nutritional content data to characterize the product.

Note: In this document the term "safety assessment" is used to refer to assessments aimed at considering products for regulatory approval. In contrast, "risk assessment" is the term used for assessments of occurrences of unauthorized products. It should be noted that the term "risk assessment" may be used by Canadian agencies in other contexts beyond the scope of this document - for example, "risk assessment" may be applied to organisms that are not unauthorized products, and "risk assessment" may cover types of risks beyond health and safety risks (for example, trade risks). It should also be noted that risk assessment, risk management and sometimes risk communication are often considered to be part of a broader overall framework called "risk analysis". The components of risk analysis may occur simultaneously and are interlinked.

STEP 2: RISK MANAGEMENT

Risk management involves developing and implementing strategies to manage any potential risks identified.

It is important to note that risk assessment and management may occur simultaneously or one after another. For example, immediate control measures may be implemented before a risk assessment is completed. Such control measures would be taken to mitigate the potential impact of the product on the environment or food or feed supply. The risk management actions used can be revisited and altered on the basis of new information.

Risk management decisions reflect the conclusions reached in the risk assessment and consideration of other factors such as:

  • legislative and regulatory requirements;
  • policy, international obligations;
  • economic impacts; and
  • priorities in resource allocation.

The CFIA also has the flexibility to select the appropriate response, considering factors such as:

  • the potential or actual harm;
  • the compliance history of the regulated party (for example, existence of previous instances and severity of non-compliance); and
  • the intent (for example, evidence that the regulated party knowingly contravened the legislative requirements).

Specific responses can be directed at the product and/or the regulated party. The CFIA has a range of tools available to deal with non-compliance of unauthorized plant products. Examples include:

  • agreements on corrective action plans with the regulated parties;
  • issuing mandatory product recalls;
  • taking legal actions against the offending parties; and,
  • other measures.

Risk management also includes follow-up activities confirming that the situation is returning to compliance. In addition, it includes the review and evaluation of the corrective actions to reduce the likelihood of reoccurring.

Conclusion

The ultimate goal of the risk management steps taken by the CFIA is to address the risk to the environment and food or feed supply, while using the most appropriate level of regulatory intervention, so the situation is returned to compliance.

The CFIA develops the most appropriate risk management strategy to deal with the presence of unauthorized plant products of biotechnology, taking into consideration relevant information from other agencies and departments as deemed appropriate for the issue. The decisions made by the CFIA are based on conclusions of risk assessments as well as on considerations of other legitimate factors, with the primary objective of protecting the safety of the Canadian food and feed supply and the environment.

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