Frequently Asked Questions – Revised Draft Policy on the Management of Low-Level Presence of Genetically Modified Crops in Imported Grain, Food and Feed and its Associated Implementation Framework for Grain

Government of Canada Revised Draft Low-Level Presence (LLP) Policy and Framework

1. What is low-level presence?

Low-level presence (LLP) is the unintended presence, at low levels, of unauthorized genetically modified (GM) crops in imported grain, food or feed, where the GM crop is authorized for food use in one or more foreign jurisdictions but is not authorized in Canada.

2. What conditions must be met for GM content of an imported shipment to be considered low-level presence in the revised draft LLP Policy and Framework?

Three conditions must be met for GM content of an imported shipment to be considered LLP under this revised draft LLP policy and framework: (a) the GM crop must be approved for use as food in at least one foreign jurisdiction, (b) Canada must have recognized that the safety assessments conducted by the regulatory authority in that foreign jurisdiction are consistent with Codex Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Plants (ALINORM 03/34 Appendix III), and (c) appropriate test methodologies and reference material must be available and provided to Canadian Food Inspection Agency (CFIA) upon request.

3. How does LLP originate?

LLP situations can occur when there is a time gap in the authorization of GM crops between the importing and exporting jurisdictions, or when developers do not seek authorizations in importing jurisdictions. Sources of LLP can vary, including lingering traces of discontinued varieties present in export streams, or unintentional mixing into export streams of crops intended for domestic use.

4. Is LLP avoidable?

In many jurisdictions, including Canada, grain is handled in bulk with grain storage, treatment facilities and conveyances such as trucks, railcars and ships being used for different loads at different times. This provides many opportunities for crops to commingle during transportation, conditioning and storage.

Although most GM crops entering Canada have been fully authorized prior to commercial use, the risk of LLP exists for imported products. An increasing number of GM crops are being developed around the world for domestic use only. In certain circumstances, it may be too expensive to pursue authorizations in other jurisdictions and developers may choose authorization of their GM products for that jurisdiction only. If these authorizations were not sought in Canada, this will likely result in the occurrence of LLP in imported products into Canada.

5. What is the potential for LLP to enter Canada through imports?

Currently, the potential for LLP to enter Canada through imports is low. The vast majority of GM crops that are likely to be found in international trade have already undergone safety assessments by Health Canada and the Canadian Food Inspection Agency, and have been authorized for use in Canada. However, the likelihood of LLP in Canadian imports is expected to increase as other jurisdictions develop more GM crops intended for domestic use.

In the coming years, the number of GM crops in commercial production globally will increase from about 30 to over 100. Many of these products are intended for domestic use in jurisdictions other than Canada and are not intended for exports, so there may be little incentive to pursue authorizations in other jurisdictions. However, these products could commingle with exports destined for Canada and therefore, the likelihood for LLP to enter the country is expected to increase in the future.

6. What is the difference between adventitious presence and LLP?

For the purpose of this policy and framework, adventitious presence is defined as the unintended presence of research or "pre-commercial", or otherwise unauthorized material which has not been assessed for food or feed use and unconfined environmental release in any jurisdiction. Therefore, and contrary to the situation with LLP, a product found to contain any level of adventitious presence would be subject to immediate actions by the Canadian Food Inspection Agency, including border controls.

7. Why was a review of the current LLP Policy necessary?

With the increasing number of GM products being developed globally for commercial production, appropriate approaches are required to manage the increased likelihood of LLP situations. In light of anticipated increases of LLP in imports and in support of an international LLP strategy that aims to take a practical and trade-facilitating approach to LLP, Canada is working to put in place a rigorous, workable domestic LLP policy.

Many jurisdictions enforce a zero-tolerance policy for unapproved GM crops, including those that have been deemed to be safe through a comprehensive safety assessment in another jurisdiction. Therefore, if trace amounts of such an unapproved GM crop are found in import shipments, in a jurisdiction where that GM crop is not approved, these imports may be rejected. This creates unpredictability and could have negative economic impacts on global trade, including incremental costs associated with the use of segregation systems that can extend into the value chain. Canada's current work on LLP is meant to encourage other jurisdictions to investigate predictable and pragmatic approaches to address LLP occurrences, in order to avoid strict zero-tolerance policies in the absence of safety concerns for food, feed or the environment.

8. What impact will the revised draft LLP policy and framework have on food, feed and environmental safety?

None. Protecting food, feed and environmental safety is a high priority for the Government of Canada. The revised draft LLP policy and framework will maintain our high standards for food, feed and environmental safety.

9. What is Canada's current approach to manage LLP?

The presence of an unapproved GM product, including LLP, constitutes non-compliance with current Canadian legislation. This triggers a risk assessment and risk management response to bring the situation back into compliance. The Canadian Food Inspection Agency (CFIA) has the flexibility to select the appropriate response based on the gravity of the non-compliance, considering factors such as the potential or actual harm, the compliance history of the regulated party and the intent.

Please visit the CFIA website for more information on the CFIA's Policy on Managing Cases of Non-compliance of Unauthorized Plant Products Derived through Biotechnology.

10. How did the Government of Canada arrive at the revised draft LLP Policy and Framework?

In 2009, Canadian government officials established a working group to examine how Canada manages the occurrence of LLP and to explore whether alternative approaches should be considered. For any approach to be considered, it would need to continue to protect the health and safety of Canadians, animal health and the environment, while helping to provide greater trade predictability.

The working group is co-chaired by Agriculture and Agri-Food Canada and the Canadian Food Inspection Agency. Members include representatives from the Canadian Grain Commission, Foreign Affairs, Trade and Development Canada, and Health Canada.

To understand the broad nature of this issue and to help ensure that the revised draft LLP policy and framework meet the needs of all stakeholders, the Government of Canada has sought input and views on LLP management through general public and stakeholder consultations. The feedback was used to inform the current revised draft.

11. What considerations are being used to evaluate the current and revised draft LLP Policy and Framework?

The following considerations are being used in the review of the revised draft LLP Policy and Framework:

  1. the safety of food, feed and the environment;
  2. the scientific basis of the approach;
  3. the promotion of and incentive for compliance with Canada's regulatory system for GM products;
  4. minimization of unnecessary trade disruptions;
  5. potential impact of imported LLP on exports from Canada;
  6. administrative efficiency, transparency and predictability;
  7. the facilitation of agricultural innovation; and
  8. consistency with international guidance on LLP, as appropriate, such as the Codex Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Plants, and advice of the working groups of the Food and Agriculture Organization of the United Nations (FAO) and the Organisation for Economic Co-operation and Development (OECD).
12. What is the difference between safety assessment and risk assessment?

Safety assessments are aimed at considering products for full regulatory authorization and commercialization, 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.

13. Why is the Codex Guideline referenced as the basis for the proposed Policy and Framework?

Standards developed by the Codex Alimentarius Commission are based on the best available science assisted by independent international risk assessment bodies or ad-hoc consultations organized by FAO and World Health Organization (WHO). While recommended for voluntary application by member countries (such as Canada), Codex standards serve in many cases as a basis for national legislation and regulations.

In 2003, the Commission adopted the Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Plants (ALINORM 03/34 Appendix III). This guidance provides a robust, science-based and internationally recognized approach to assess the safety of GM foods. Canada, as well as many other jurisdictions, has based its own guidance for GM foods on the Codex Guideline.

As such, for the intent of this revised draft Policy and Framework, Canada will only consider GM crops from jurisdictions which apply the Codex Guideline on a consistent basis in order to be assured that the products covered by this Policy and Framework have been assessed adequately and determined to be safe for use as human food. It should be noted that this Guideline does not address animal or environmental considerations.

14. Are there any international standards governing the LLP of unauthorized GM content?

Codex Alimentarius developed an approach to conduct LLP food safety assessments based on the Codex guidelines to assess the safety of GM foods. The approach can be found in the Annex 3 of the Codex Guideline for the Food Safety Assessment of Foods Derived from Recombinant-DNA Plants. It is currently the only international standard to apply specifically to LLP.

15. Why is seed for propagation excluded from the scope of the revised draft LLP Policy and Framework?

Complexities regarding the management of LLP in seed for propagation were identified in previous consultations resulting in a decision to have the LLP Policy and Framework apply only to food and feed, with a review of LLP approaches for seed done separately.

LLP in seed is a challenge to the seed trade. There is international agreement on the need to work collaboratively to address this issue in order to determine how a risk assessment would be conducted for LLP in seed for propagation. The Government of Canada is committed to actively work with stakeholders and other countries to find a workable solution to manage LLP in seed.

If LLP of a GM crop is detected in imported seed, the current approach will continue to apply.

16. What considerations were used to arrive at a 0.2% level to address trace amounts of LLP?

The considerations for selecting the 0.2% concentration value to address trace amounts of LLP include: minimizing to the extent possible the safety risks posed by LLP in grain; current detection technologies and internationally accepted methodologies to detect GM material in crops; and the practical challenges of quantifying the level of a GM crop present in monitoring samples.

Given that the GM crop has been approved for human consumption in another jurisdiction that follows the same Codex safety assessment guidelines as Canada, a 0.2% LLP concentration value is considered unlikely to pose a risk. In addition, the detection of 0.2% GM material in grain aligns with the capabilities of detection technologies, and takes into consideration the practical ability to detect and quantify LLP concentration in monitoring samples.

The principles of measurement uncertainty will be applied to the raw test result when they are interpreted to determine the level to address trace amounts of LLP.

17. Why is the Threshold Level the same for all grain types in the revised draft LLP Policy and Framework?

The Threshold Level component of the LLP Policy and Framework addresses unavoidable commingling that can occur during agricultural production and commodity trade. Given that small amounts of unintentional and unavoidable commingling can occur during crop transportation, bulk handling, conditioning, and storage, even when best management handling practices are followed, a risk management measure that recognizes LLP at up to this level would minimize trade disruptions. The Threshold Level has not been set. Health Canada and the Canadian Food Inspection Agency will set the Threshold Level, taking into consideration advice from appropriate experts as well as the overarching objectives and guiding principles to be stipulated in the LLP Policy and Framework.

Canadian risk assessments for GM crops will have to be completed for the Threshold Level value to apply. In other words, a GM crop would be allowed to be present in imported grain up to the crop Threshold Level only after a Canadian risk assessment has been completed for the GM crop and determined that it does not pose a risk. When combined with risk assessments, the Threshold Level will provide a stable, predictable LLP level for importers, while protecting the safety of humans, animals and the environment in Canada.

18. What impact will the revised draft LLP Policy and Framework have on the current authorization process for GM crops in Canada?

The revised draft LLP Policy and Framework will not change the Canadian authorization process for GM products. Regulatory submissions will continue to be assessed under the current authorization process for GM products.

Developers of GM products will continue to be encouraged to submit a regulatory package to all major markets, including Canada, even when the product is not intended for full commercial release in those markets. This will reduce the occurrence of LLP because the products will have been assessed and decisions regarding authorization will have been made.

19. Will the revised draft LLP Policy and Framework affect the rules for certification of organic products in Canada?

The revised draft LLP Policy and Framework is not intended to supersede organic practices or to alter the requirements for organic certification. The Canadian Organic Products Regulations and Standards, which came into force on June 1, 2009, prohibit the use of GM ingredients in organic products, regardless of whether those GM ingredients are authorized.

Canadian organic farmers and food producers use a range of management practices to avoid the use of prohibited ingredients, including those which are genetically modified. Importers of organic products produced in Canada can continue to be confident that these management practices will continue to prevent the use of prohibited ingredients in these products.

20. What policies do our key trading partners have in place to deal with LLP?

Canada's trading partners have differing levels of acceptance of products of agricultural biotechnology and, as a result, react differently to the occurrence of LLP. Some markets have strict zero tolerance policies, others employ tolerance thresholds with varying conditions and still others have no established policy or are in the process of developing one.

21. What will the impact of this policy be on Canadian agricultural exports?

Canada's LLP policy is expected to facilitate trade. Considering that Canada is mostly a grain exporting country and that seed is excluded from the scope of the revised draft policy, unapproved grains are unlikely to be present in exports of Canadian grains.

22. How is Canada engaging the international community in resolving the issue of low-level presence?

Canada continues to advocate for further international guidance on the management of LLP and encourages jurisdictions to develop domestic trade facilitating LLP approaches. Canada is also leading the international process on LLP where a group of countries with interest in the issue are working together to develop international approaches designed to facilitate the global management of LLP.

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