Chair’s Report to the Minister on the Industry-Government Technical Committee on Plant Breeding Innovation Transparency

Introduction

The potential introduction of gene-edited seed varieties into Canadian agriculture has highlighted the need for continued marketplace transparency in the seed sector to support value chain stakeholders, including the organic sector. Organic associations in Canada have raised concerns regarding the potential impact of updated Plants with Novel Traits guidance from the Canadian Food Inspection Agency. This update clarifies how CFIA's product-based novelty approach extends to gene editing (for example: that edited crops are not novel if they do not include DNA from another species (foreign DNA) and do not have the capacity to negatively impact the environment).

While certified organic seed is the preferred starting material for organic agriculture, the Canadian Organic Standards allows for the use of conventional seed when organic seed is not available. Since some gene-edited varieties cannot be distinguished from conventional varieties, there is a concern that organic farmers may inadvertently purchase and plant gene-edited seed.

This industry-government technical committee was struck to discuss improving transparency in the sale of seed to mitigate the risk of producers inadvertently purchasing and planting seed varieties that would not meet the requirements of the Canadian Organic Standards.

The Technical Committee, chaired by Agriculture and Agri-food Canada, included member associations representing organic production and export, and the seed value chain from research and development through plant breeding and retail (see membership list in Annex A). The committee met six times between January 16, 2023 and March 7, 2023.

As detailed in the scope of the Technical Committee's Terms of Reference, the work of the Technical Committee focused on the three following objectives:

• Explore ways to achieve the transparency goals of the agricultural sector, including those of the organic sector, beginning with a focus on currently available mechanisms such as the Seeds Canada Canadian Variety Transparency Database^{Footnote 1}.

• Establish a governance structure and process to review the effectiveness of transparency and government oversight components that are adopted to complement the guidance, and consider additional improvements, as appropriate; and

• Discuss options for appropriate oversight of the Canadian Variety Transparency Database or other transparency mechanisms, including a review of completeness of the database or other transparency mechanism (that is, government or third party verification).

While the organic sector has raised several other issues linked to transparency, including sector co- existence, varietal purity, and co-mingling of varieties, among others, this technical committee focused on the above three objectives. AAFC will work with the organic sector to develop an appropriate separate engagement mechanism to address and advance those other issues.

Summary of key topics discussed by the committee

Purchasing of seed

When considering new varieties to grow, producers take many factors into account, including potential yield; quality characteristics; agronomics and regional performance; disease and pest resistance traits; and the method used to develop the variety. Producers will gather this information from several sources, including online or printed seed guides, agronomists, and other producers who grow varieties of interest. Producers may also consult their customers about the acceptability of the seed varieties they choose, or may enter into producer contracts that specify the seed varieties that may be grown.

Through contractual purchase agreements signed throughout the value chain (for example, plant breeders, seed developers, seed marketers, etc.), seed dealers will have access to information to provide appropriate advice on the needs of individual producers, regardless of production system (for example, conventional or organic production).

Organic sector concerns

Transparency is of the utmost importance for the organic sector. When producing, and ultimately marketing, organic products, organic sector stakeholders must be able to adequately demonstrate their products have been produced using organic-compliant inputs and methods. As outlined in the Canadian Organic Standards, producers are strictly prohibited from using gene-edited varieties in organic production systems.

Organic sector stakeholders have raised concerns regarding the CFIA's proposed updated guidance, specifically regarding how some products of gene editing will not be subject to Part V of the Seed Regulations (additional information about Part V is available in Annex B). With no requirement to officially indicate a variety's method of development for some products of gene editing, the sector is concerned some organic producers may unknowingly purchase and grow gene-edited varieties. Should this happen, organic producers who grow gene-edited seed would lose their organic certification for a period of three years. Further, the potential for contamination of organic products with gene-edited plants could lead to loss of international market access. The organic sector has stated a resource must be developed that would capture all gene-edited varieties, thus ensuring varietal transparency. They have stated their position that the resource must be government mandated and managed.

Enhancing industry-led transparency

The regulatory status of a plant trait and/or variety does not provide varietal transparency in the marketplace. In response to value-chain requests for additional and enhanced transparency tools, Seeds Canada launched its Canadian Variety Transparency Database in October 2022. The database was developed as an additional level of transparency for gene-edited varieties which can be used by the value chain to verify which commercially available varieties are gene-edited. The database references Health Canada's Non-Novel Foods Transparency Initiative, which was designed to indicate if a non-novel, gene-edited plant has been developed for food use. These non-novel traits can be integrated into multiple new varieties that are ultimately made commercially available for sale in Canada. The Canadian Variety Transparency Database is designed to provide a link to Health Canada's TI notifications, or decision documents if the product was novel, to indicate when a variety has been developed using gene editing.

Despite the Canadian Variety Transparency Database not being part of a regulatory scheme, CropLife Canada and Seeds Canada, on behalf of their members, have indicated their intent to participate in both the Canadian Variety Transparency Database and the Health Canada Transparency Initiative. Members of the seed sector, which include plant developers, see this as a mandatory practice should they choose to be an active participant in the Canadian seed industry.

Technical Committee recommendations

When considering only the scope of the terms of reference, the Committee was able to reach consensus on the recommendations presented below. Where consensus was not reached or recommendations were out of scope, they have been included in Annex C.

Technical Committee objective 1

Explore ways to achieve the transparency goals of the agricultural sector, including those of the organic sector, beginning with a focus on currently available mechanisms such as the Seeds Canada Canadian Variety Transparency Database.

The goal of the Canadian Variety Transparency Database is to facilitate a clear distinction between commercial seed varieties that have undergone gene editing from those that have not. The database should be comprehensive and clearly identify any commercial gene-edited varieties sold in Canada, including but not limited to seed and vegetative material used to produce: grains, oilseeds, pulses, fruits, vegetables, sprouts, nuts, medicinal and pharmaceutical plant materials.

• 1. The Technical Committee recommends that:
  • 1.1. The Canadian Variety Transparency Database, be established as a publicly accessible resource that is free for public use, and that it:
    • 1.1.1. can expand to be able to include gene-edited crops of all types;
    • 1.1.2. be updated accordingly as new gene-edited varieties are introduced in the marketplace;
    • 1.1.3. be complete, reliable, and user-friendly.
  • 1.2. Improvements to the Canadian Variety Transparency Database be explored, including:
  • 1.2.1. adding functionality to the database to send notification emails when new gene-edited varieties are added;
    • 1.2.2. adding text to the database stating the database may not include all gene-edited varieties available for purchase in Canada, and that producers should contact seed sellers to discuss their growing needs;
    • 1.2.3. adding conventional varieties to the database where there is support from users to do so; and
    • 1.2.4. incorporating user-friendly ways to combine existing databases and information on varieties that have been developed through gene editing or other forms of genetic modification.
  • 1.3. Seeds Canada and CropLife Canada send a letter to the Minister of Agriculture and Agri-Food stating their commitment to participate in the Canadian Variety Transparency Database and transparency initiatives. The letter(s) should also be publicly available (that is, posted on their website);
  • 1.4. CropLife Canada, Seeds Canada and national commodity associations advocate for members and non-members participation in transparency initiatives, including use of the Canadian Variety Transparency Database;
  • 1.5. Government of Canada/CFIA include text on their website promoting the use of the industry- led transparency initiative, similar to the text included on Health Canada's Transparency Initiative. Transparency outcomes of this Technical Committee should be reflected in CFIA's guidance;
  • 1.6. Seeds Canada/Seed sector develop a plan for the rollout of the first gene-edited varieties entering the marketplace, outlining how varieties will be listed in the Canadian Variety Transparency Database and how gene-edited status will be indicated;

Technical Committee objective 2

Establish a governance structure and process to review the effectiveness of transparency and government oversight components that are adopted to complement the guidance, and consider additional improvements, as appropriate.

• 2. The Technical Committee Recommends that:
  • 2.1. Seeds Canada continue to be responsible for managing the Canadian Variety Transparency Database, its operation, and be responsible for recommending and implementing improvements;
  • 2.2. Upon release of the CFIA guidance, AAFC establish a Government-Industry Steering Committee on PBI Transparency in relation to CFIA's guidance that would:
    • 2.2.1. Establish transparency objectives and subsequently review and provide recommendations on the content-related procedures for the Canadian Variety Transparency Database as it pertains to gene-edited seeds to ensure transparency and credibility of the database;
    • 2.2.2. include representatives of the organic, conventional, and seed sectors, as well as representatives from AAFC, and CFIA;
    • 2.2.3. be chaired by a senior AAFC official;
    • 2.2.4. report to the Minister of Agriculture and Agri-Food regarding the implementation of the recommendations outlined in this report; and
    • 2.2.5. make further recommendations to the Minister regarding transparency as it deems appropriate.
  • 2.3. AAFC to provide secretariat services for the committee, and undertake to organize meetings at least annually, or more frequently as decided by the Chair;
  • 2.4. Industry and government to regularly and widely promote the Canadian Variety Transparency Database to all affected stakeholders.

Technical Committee objective 3

Discuss options for appropriate oversight of the Canadian Variety Transparency Database or other transparency mechanisms, including a review of completeness of the database or other transparency mechanism (that is, government or third-party verification)

• 3. The Technical Committee recommends that:
  • 3.1. AAFC commit to provide resources (staff or funding to contract a third-party) to: 3.1.1.conduct regular audits to examine producer seed resources (that is, seed guides, CFIA's
    varieties of crop kinds registered in Canada, Health Canada non-novel list, etc.) to confirm varieties are included in the Canadian Variety Transparency Database; and
    • 3.1.2. conduct surveys (based on input from the Steering Committee) of seed developers to confirm they are using the Canadian Variety Transparency Database.
  • 3.2. The Steering Committee have the following roles as it pertains to audits:
    • 3.2.1. Define the scope of the audits to ensure that agreed upon objectives are achieved;
    • 3.2.2. Determine the frequency of audits (for example, audits held annually, with possibility for increased
      frequency in the first few years after CFIA's guidance is released);
    • 3.2.3. Advise on various information sources to be included in the audit to ensure
      comprehensive representation of seed varieties; and 3.2.4. Consider the audit results.
  • 3.3. The Steering Committee be consulted on all aspects of the survey (for example, frequency, who is surveyed, target and consequences if developers are found to be using/not using the Canadian Variety Transparency Database);
  • 3.4. Seeds Canada and CropLife Canada develop a process to address errors/omissions identified in the Canadian Variety Transparency Database (The Steering Committee would review and provide recommendations about the process);
  • 3.5. Seed sector update their Best Management Practices for Launching Products of Plant Breeding Innovation in Canada document to reflect a commitment to the Minister of Agriculture and Agri-Food to participate in transparency initiatives; and
  • 3.6. AAFC create a publicly-available e-mail inbox for sector stakeholders to contact to provide input/share concerns regarding transparency initiatives.

Should it be determined that seed developers are not disclosing information about gene-edited varieties in the Canadian Variety Transparency Database, additional measures up to and including an appropriate regulatory regime may need to be explored.

Organic sector stakeholders proposed two potential recommendations, which are outlined in Annex C, both of which would be inconsistent with current regulations. Regulatory changes are out of scope for this committee, and as such, are being included in Annex C to ensure it is documented that they were raised.

Conclusions

The Chair would like to thank the members for their time and effort in contributing to the work of this technical committee over the last several weeks and for their on-going commitment to varietal transparency. If accepted, these recommendations would reenforce industry-led transparency efforts for gene-edited seed varieties.

The chair also recognizes the importance of the Seeds Canada/CropLife Canada commitment to develop a pilot project to further demonstrate the process of listing a non-novel gene-edited variety on the Canadian Variety Transparency Database and how it will be linked back to the Health Canada Non-Novel Food Transparency Initiative.

Organic sector stakeholders stated their concern that by limiting the scope of work to just transparency measures, many of the recommendations put forward by the Technical Committee did not go far enough, and fall short of the public commitment made by the Minister of Agriculture and Agri-Food to protect organic certification (see Annex C for organic sector's full comments)

With the organic and seed sectors actively engaged in the proposed governance and oversight activities and with the active participation of plant breeders, the Canadian Variety Transparency Database would provide an improved level of transparency.

Respectfully submitted on April 3, 2023

Donald Boucher
Chair, Industry-Government technical Committee on PBI Transparency
Director General, Sector Development and Analysis Directorate
Agriculture and Agri-Food Canada

Annex A: Committee members

Member	Organization
Ian Affleck	CropLife Canada
Jennifer Hubert	CropLife Canada
Lorne Hadley	Seeds Canada
Lauren Comin	Seeds Canada
Krista Thomas	Canada Grains Council
Emma Coffin	Soy Canada
Brodie Berrigan	Canadian Federation of Agriculture
Allison Squires	Canadian Organic Growers
Deirdre Laframboise	Canadian Organic Growers
My-Lien Bosch	Canada Organic Trade Association
Tia Loftsgard	Canada Organic Trade Association
Nicole Boudreau	Organic Federation of Canada
Christian Legault	Filière biologique du Québec
Jérôme-Antoine Brunelle	L'Union des producteurs agricoles

Government of Canada Members

Member	Organization
Donald Boucher (Chair)	AAFC
Jason Flint	AAFC
Adriana Zeleney	AAFC
Brett Maxwell	AAFC
Linda Webster	CFIA
Cindy Pearson	CFIA
Heather Shearer	CFIA
Neil Strand	HC
Secretariat support
Brett Norton	AAFC
John Sawicz	AAFC

Annex B: Background

Transparency mechanisms for plants with novel traits following safety assessments

Since 1995, when the first genetically modified seeds (canola) were approved in Canada, transparency has always been important. CFIA provides access to all regulatory decisions (for example, safety determinations for the unconfined release or for use as livestock feed) of plants with novel traits (for example, the first time that a new trait is added to a plant species). Similarly, Heath Canada provides access to all regulatory decisions (for example, safety assessments for novel foods) for novel foods derived from plants or microorganisms. For those plant species subject to variety registration (that is, some grains, oilseeds, pulses, potatoes), CFIA maintains a variety registration database that provides information about specific characteristics of the included varieties. For other plant species not subject to registration, a variety database may be maintained by the private sector (that is, Seeds Canada corn hybrid database), or it may be up to the vendor to communicate that the plant variety contains a trait that had been assessed as novel and listed by CFIA and/or Health Canada.

CFIA's proposed updated guidance regarding Part V of the Seeds Regulations

Broadly speaking within the agricultural sector, gene editing is seen as a way to develop new varieties with beneficial traits for producers in less time than conventional breeding methods. With the increased interest in using this new technology, the CFIA recognized the need to develop updated guidance in order to clarify to regulated parties which products of plant breeding innovation would be subject to Part V of the Seeds Regulations. Part V of the Seeds Regulations provides a mechanism to verify that the release of new plants do not have a negative impact on the Canadian environment or human health.

Additionally, plants that are subject to Part V are also listed on a CFIA-managed database.

Having conducted a thorough review of available literature, the CFIA found that gene editing technologies are not expected to pose different risks to environmental health than products of conventional breeding methods. As such, the CFIA has proposed several updates to its guidance to clarify which plants are subject to Part V, one of which is that plants developed through conventional breeding, or resembling conventional breeding, including many products of gene editing, are not expected to require assessment by the CFIA. Because they are not subject to Part V, there is no requirement to indicate method of development for products of gene editing resembling conventional breeding, nor will they be captured in a CFIA-managed database.

Annex C: Organic sector final comments

Note: The content of this section is taken from input received from organic stakeholders and does not represent the views of the chair nor should it be construed as a consensus position from the technical committee.

Throughout the course of Technical Committee meetings, organic sector stakeholders expressed their concern that a voluntary approach where seed developers would share information about products of plant breeding innovation, including gene-edited products, would be insufficient to meet the needs of the organic sector. They regularly stated their opinion that the only approach that would provide the transparency and traceability necessary to ensure producers are able to select seed appropriate for organic agricultural systems is one that is mandatory, government-led, and includes all products of gene-editing. In their view, anything less would leave organic producers vulnerable to inadvertent use of gene-edited seed, which would have consequences regarding their organic certification, and could also lead to potential effects on market access.

During the last Technical Committee meeting, held on March 7, 2023, organic sector stakeholders shared a document they had collectively prepared to present their final comments regarding proceedings of the committee. In it, they expressed their appreciation for the creation of the committee as a way to find a solution to their concerns regarding transparency and traceability. However, they also expressed their belief that the Technical Committee's proceedings were not as promising as they had hoped. They expressed their belief that the timelines for the committee to complete its work were too aggressive, the focus on enhancing a voluntary transparency initiative limited the effectiveness of the committees final recommended solutions, and ultimately will not achieve the organic sector's transparency and traceability objectives. Ultimately, they stated their belief that the recommendations fall short of the government's commitment to protect the organic sector.

In addition to expressing the above-mentioned concerns, organic sector stakeholders also introduced two new recommendations they believe will achieve their sector's transparency and traceability goals. The two suggestions would entail:

• revising Health Canada's novel food guidance to include wording that would mandate pre-market notification of all products of gene-editing, including those deemed to be non-novel; and
• introducing the Canadian Food Inspection Agency's updated guidance for a one-year pilot period to determine how well it functions alongside the Canadian Variety Transparency Database and other transparency mechanisms. This would be coupled with a requirement for seed developers to declare any exemptions to Part V of the Seeds Regulations, the reason for the exemption, and the trait that has been modified.

As the scope of the Technical Committee was to work within existing regulations and determine additional supports which would enhance transparency surrounding products of plant breeding innovation, and that the two recommendations put forward by the organic sector were premised on regulatory amendment, the proposals were deemed to be out of scope for the work of the Technical Committee, but would be noted in the Chair's report.

The full wording of the organic sector's proposed solutions to require full disclosure of gene-edited seeds are as follows:

• Revise Health Canada Novel Foods Guidance to add requirement for pre-market notification for gene-edited foods not considered novel (currently this is voluntary).
  The work of the Technical Committee was based on developing a transparency mechanism that would not necessitate regulatory change and based on strong controls around a voluntary transparency initiative. Although transparency is improved with the recommended mechanism, there are still significant gaps and risks for stakeholders who choose not to use gene-edited seed. Co-existence of conventional and organic seed depends on a stronger traceability and transparency mechanism than has been proposed.
  
  Transparency and traceability can be improved by making it a requirement for gene-edited plants developed for food use that are not novel to be disclosed so that traceability can be guaranteed throughout the organic supply chain. In the absence of regulatory change, this could be achieved relatively simply by revising the Health Canada Novel Foods Guidance to simply maintain the requirement for a pre-market notification for products in the five categories defined as not being novel foods. This could be achieved by:
  • adding a sentence in Schedule 1 to the effect that foods derived from a product genetically manipulated with so-called genome editing methods are not considered novel foods, and that, however, they are still subject to notification as a novel food.

  In this case, the only additional requirement is that the manufacturer or importer must notify the Food Directorate in writing of their intention to sell or advertise for sale the genome-edited food (ref. B.28.001, 02, and 03).

• Publish CFIA guidance as a pilot along with the transparency mechanism.
  To address the ongoing concerns of the organic sector related to voluntary disclosure of gene-edited seeds and considering the needs of the seed sector, it is recommended that the CFIA guidance be released as a pilot for one year. During the pilot stage, all conditions of the guidance would be applicable with the exception that seed developers would need to, if applicable, declare:
  1. exemption from Part V of the Seeds Regulations
  2. reason for their exemption
  3. trait that has been modified. The pilot would not impact the ability of the seed to be developed or commercialized.