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By Eileen McMahon, Melanie Rowand and Yu Seon Gadsden-Chung
Health Canada has signaled a favourable regulatory environment for foods derived from gene-edited plants in new guidance on novel foods (Guidance on the Novelty Interpretation of Products of Plant Breeding, and Guidance on the Pre-market Assessment of Foods Derived from Retransformants, "new guidance")1. The new guidance was developed to clarify the interpretation of the definition of a "novel food" under the Novel Food Regulations2, and has been attached as two appendices to the 2006 Guidelines for the Safety Assessment of Novel Foods (2006 guidelines)3. In particular, the new guidance was developed to address gaps in the 2006 guidelines regarding newer technologies, such as gene editing.
What you need to know
The new guidance is guidance: it is not law. However, it does provide comfort on how Health Canada interprets and applies the definition of "novel food" under the Novel Food Regulations.
The new guidance signals a lighter regulatory touch for certain gene-edited plants.
According to the new guidance, foods derived from genetically modified plants (including gene-edited plants) do not meet the definition of a "novel food" and will not require a pre-market notification and assessment unless the genetic modification results in the presence of foreign DNA in the final plant product or alters specified characteristics in the final plant product—such as introducing a known allergen or toxin, changes to key nutritional composition, or changes in the food use of the plant.
Of specific importance for gene-edited plants, DNA encoding machinery (e.g., CRISPR Cas protein and associated guide RNAs) is considered foreign DNA but will only trigger the Novel Food Regulations when it is not bred out of the final product. As a result, it is expected that many foods derived from gene-edited plants will not require pre-market notification and assessment under the novel food regime.
Under Health Canada's Transparency Initiative, plant developers are encouraged to voluntarily notify Health Canada of gene-edited plants developed for food use that do not meet the definition of a "novel food", for publication on Health Canada's website. This is a voluntary, not mandatory, initiative.
An expedited review process will be available for pre-market assessment of novel foods derived from genetically modified plants that have been transformed with the identical DNA sequence as a previously assessed genetically modified plant (i.e., "retransformants"), even if the specific genetic changes are not identical.
While the new guidance is limited to foods derived from plants, Health Canada has signaled an intent to develop similar guidance for novel foods derived from genetically modified animals and microorganisms.
Health Canada has published a notice of intent to propose amendments to the Novel Food Regulations that are consistent with the interpretation of a "novel food" provided in the new guidance. Such amendments, if promulgated, would be law, rather than guidance. There would be an opportunity for stakeholders to comment on proposed amendments to the law.
The details
Novelty interpretation of products of plant breeding
Since the 2006 guidelines were finalized, technological advancements have created new tools of genetic modification by which new plant varieties can be developed (e.g., gene editing technologies). In the new guidance, Health Canada has identified five categories of foods derived from plants that do not meet the definition of "novel food"4, where the genetic modifications:
do not alter an endogenous protein in a way that introduces or increases similarity with a known allergen or toxin relevant to human health;
do not increase levels of a known endogenous allergen, a known endogenous toxin, or a known endogenous anti-nutrient beyond the documented ranges observed for these analytes in the plant species;
do not have an impact on key nutritional composition and/or metabolism;
do not intentionally change the food use of the plant; and
do not result in the presence of foreign DNA5 in the final plant product.
Foods derived from plants which satisfy these five criteria do not meet the novelty threshold of a "novel food" and therefore do not require pre-market notification and assessment. Foods which do not satisfy these five criteria and pose a potential safety concern (e.g., introduction/increase of allergens, toxins and anti-nutrients, changes to key nutritional composition and metabolism, intentional changes in the food use of the plant, and where the final plant product contains foreign DNA) would be considered a "novel food" and require a pre-market notification and assessment. Of specific importance for gene-edited plants, Health Canada notes that the DNA encoding machinery (e.g., CRISPR Cas protein(s) and associated guide RNAs) is considered to be foreign DNA if present in the final product. Health Canada notes that "[m]ost plant developers will remove this DNA through subsequent plant breeding; however, in the event that a gene-edited plant still contains the DNA encoding machinery within its genome, foods derived from such a gene-edited plant require pre-market notification and assessment as novel foods"6.
Pre-market assessment of foods derived from retransformants
Health Canada has introduced an expedited review process for pre-market assessment of novel foods derived from genetically modified plants that have been transformed with the identical DNA sequence as a previously assessed genetically modified plant, referred to as a retransformant. This is based on Health Canada's evaluation of over 140 genetically modified plant varieties since the enactment of the Novel Food Regulations in 1999, where foods derived from these genetically modified plant varieties were found to be safe for food use in all cases. The new guidance provides that "while the specific genetic changes in the genome of the retransformant do not need to be identical to the genetic changes in the previously assessed genetically modified plant, they must result in the same mechanism of action and characteristics as that plant in order to be considered a retransformant".
The new guidance sets out the information required for pre-market assessments for foods derived from retransformants. Further, the new guidance indicates that the expedited pre-market assessment for foods derived from retransformants will be completed within 120 calendar days of the submission (compared to 410 calendar days for other products that are novel).
Health Canada's transparency initiative
In addition to the publication of the new guidance, Health Canada has introduced a Transparency Initiative process7, where developers can voluntarily submit information to Health Canada about food products derived from gene-edited plants which do not meet the definition of a "novel food" (i.e., which do not require pre-market notification and assessment), for publication on the Health Canada website. This Transparency Initiative is intended to provide information on all products developed using gene editing technologies that are present in the Canadian food supply.
Once Health Canada receives information on a food product through the Transparency Initiative, it will review the product information and publish the information on the List of Non-Novel Products of Plant Breeding for Food Use8 within 60 calendar days of receiving the information. Health Canada reserves the right to request additional information and require a pre-market assessment if it believes that such foods meet the "novel food" definition.
Health Canada's scientific opinion on the regulation of gene-edited plant products
Health Canada has also published "Scientific Opinion on the Regulation of Gene-Edited Plant Products within the Context of Division 28 of the Food and Drug Regulations (Novel Foods)"9, which points to a favorable regulatory environment for plant products developed through genetic editing10. Notably, the publication states that "it is Health Canada's scientific opinion that gene-edited plant products should be regulated like all other products of plant breeding, by focusing on their final characteristics and not the method of product development"11. The publication affirms Canada's product-based approach to food regulation and notes that gene-edited plant products which do not meet certain risk-based criteria will not require pre-market notification and assessment under Canada's novel food regime. Health Canada has also published a summary of feedback received during the consultation period for the new guidance12.
What's next
Health Canada has published a notice of intent to propose amendments to the Novel Food Regulations that are consistent with the interpretation of a "novel food" provided in the new guidance and to improve clarity, predictability and transparency for stakeholders13. Once the amendments are published, stakeholders will be given an opportunity to comment on the proposed amendments before they become law. There is currently no projected timing of publication of the proposed amendments. In the meantime, the new guidance is now in effect.
Although the new guidance is limited to foods derived from plants, the notice of intent indicates that Health Canada will develop similar guidance for genetically modified animals and microorganisms14.
Footnotes
1. Appendix 1: Health Canada Guidance on the Novelty Interpretation of Products of Plant Breeding. Appendix 2: Health Canada Guidance on the Pre-market Assessment of Foods Derived from Retransformants.
2. Division 28, part B of the Food and Drug Regulations.
3. Guidelines for the Safety Assessment of Novel Foods Derived from Plants and Microorganisms.
4. As set out in section B.28.001 of the Food and Drug Regulations.
5. "Foreign DNA" refers to DNA that is originally sourced from genetic sources outside the plant species and cannot be introduced into that plant species using conventional methods of plant breeding as provided under section 5. List of conventional methods of plant breeding, Appendix 1 of the 2006 guidelines.
6. Ibid, at section 4.4.
7. Novel Foods: Transparency Initiative.
8. List of Non-Novel Products of Plant Breeding for Food Use. There are currently three products listed.
10. According to Health Canada, "gene editing technologies refer to biotechnology tools that can be used to generate specific modifications to the genome of living organisms by adding, removing, or altering genetic sequences at precise locations...At present, it is mainly used to describe CRISPR-Cas, but it also refers to Oligonucleotide Directed Mutagenesis (ODM), Transcription Activator-like Effector Nucleases (TALENS), Zinc-Finger Nucleases (ZFNs) and meganucleases, as well as variations of these technologies." (see Ibidat section 5.0).
11. Ibidat section 2.0.
12. Consultation summary: Proposed guidance for Novel Food Regulations Focused on Plant Breeding.
13. Notice of Intent to Propose Amendments to Division 28 of the Food and Drug Regulations (Novel Foods).
14. Ibid.
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