Executive summary of the variety registration task team final report – seed regulatory modernization

The Canadian Food Inspection Agency (CFIA) is committed to a full-scale review of the following parts of the Seeds Regulations:

• Part I – Seeds other than Seed Potatoes
• Part II – Seed Potatoes
• Part III – Variety Registration
• Part IV – Registration of Establishments that Prepare Seed and Licensing of Operators

The objective of the variety registration task team was to provide recommendations in a report to the seed regulatory modernization (Seed-RM) working group (WG) on opportunities for improvement with respect to how the Seeds Regulations govern variety registrations in Canada.

The Seeds Act and Seeds Regulations have undergone periodic amendments and modernizations since the first laws were established in 1905. During this current initiative, the CFIA is looking to update the Seeds Regulations to:

• improve responsiveness and consistency
• reduce complexity
• become adaptable and flexible to address future technological advances and scientific innovation
• protect producers and consumers by strengthening existing requirements

Canada's variety registration system is internationally recognized and respected for ensuring varietal identity and varietal purity while providing the tools for seed certification of those varieties and ensuring Canadian varieties are internationally recognized as plant varieties. In Canada, to qualify for variety registration the following must be met:

• meet the regulatory definition of variety (varietal eligibility)
• meet the eligibility requirements for variety registration listed in the Seeds Regulations section 67.1 (1) or (2) or (3)

Since 2009, crops subject to registration can move to one of 3 levels of registration requirements (Part I, Part II, or Part III requirements) and placement in a registration level is a value-chain stakeholder-driven process that the CFIA facilitates via a regulatory amendment process. Part I registration crops are "merit-based"; they must demonstrate merit (defined in the regulations – they must be equal to or superior to designated varieties used as "checks" in the registration test system for that crop kind. It can be as little as one trait in one region of Canada). The test protocols for merit determination and in many cases the actual testing for merit, as well as the evaluation of merit, are conducted by the CFIA-recognized crop-specific regional variety registration recommending committees in Canada (there are 10 at present). These recommending committees are comprised of a balanced group of value-chain crop experts (as laid out in the Seeds Regulations) and are subject to oversight by the CFIA. By regulation, they are expected to behave in a fair, predictable, and transparent manner.

In practical terms, a registration package will require:

• paying a fee (< $1,000)
• to provide an official reference seed sample (breeder seed) that meets the pedigreed seed standard for purity and is representative of the variety
• to provide a standardized variety description suitable for distinguishing the variety from other varieties registered in Canada (it is used for crop inspection and seed certification)
• to undergo a name check (suitability assessment)
• to provide scientific data to back up claims made in the variety description (for example, disease tolerance, herbicide tolerance, end-use characteristics, etc.)
• to provide all the information required on the registration application form (trademark declaration for the variety name, pedigree, breeding history, plant with novel trait(s) (PNT) declaration with proof of genetics/proof of trait and signing to attest to the accuracy of the information provided on the form)

The CFIA has a performance standard of 8 weeks of processing time to complete a submitted and complete registration package. Once registered, a registration number is assigned, a registration certificate is sent to the Registrant, and the variety can then be imported and/or sold in Canada.

Variety registration is the entry point into the seed market for the 53 crop kinds currently subject to registration in Canada and listed in Schedule III, Seeds Regulations. It ensures that data for determining varietal identity and also varietal purity are in place and that the name (denomination) is acceptable in Canada.

Critics of the registration system focus primarily on merit-based variety assessments which, depending on the crop, can take anywhere from one to three summers of field testing and analysis (for example, cereal crops, depending on the grain class they are bred for). Time to market is an issue for variety developers (time is money). Other stakeholders point to a less than desired way of treating innovative varieties which can block or slow down market entry. Still, others reference other geographies where there are no registration systems and point out that they believe Canada can operate without a variety registration system.

The variety registration task team, with support provided by government representatives, was composed of 21 members:

• 6 from seed industry
• 5 from producer groups
• 5 from commodity/value chain associations
• 2 variety developers
• 2 non-governmental organizations
• 1 other government

Starting with the initial topics suggested by the Seed-RM WG (refer to appendix 2, document 4 of final report) and adding a few of their own, the variety registration task team presented a work plan for the analysis and discussion of the following 13 topics:

• The big picture question: should Canada have a national variety registration system
  • Follow-up question: If yes, who should be running it
• Varietal eligibility (meeting the definition of variety)
• Crop placement in the variety registration system
• Varietal purity in the registration system
• One variety, one name policy in variety registration
• Cancelation of variety registration
• Parsing subsets of species in Schedule III, Seeds Regulations
• Regional restrictions on national registrations
• The use(s) of incorporation by reference (IbR) for variety registration
  • Who should administer the IbR document
• Heritage, heirloom, heterogeneous varieties, and alternatively bred varieties
• Regionalized crop placements in Schedule III, Seeds Regulations (crop placements within regions of Canada is not currently done)
• Phenotype, genotype, and the variety registration system (looking to the future)
• Recognition of and acceptance of foreign equivalent to variety registration for the Canadian variety registration process, Part III crops only (currently this comprises of 23 forage species, oilseed soybean, non-ornamental sunflower, and potatoes)

In addition, the following overarching topics, provided by the Seed-RM WG, were to be considered during the discussion of specific topics:

• Future trends
• Government versus industry role
• Linkages and unintended consequences (for example, variety cancellation and common seed)
• Incorporation by reference – opportunities for use thereof
• International obligations (for example, Organisation for Economic Co-operation and Development (OECD) and Association of Official Seed Certifying Agencies (AOSCA) seed schemes)
• Alternative service delivery including licensing and accreditation

The task team focused on 4 major opportunities for improvement:

• Ability to adapt the requirements to changes occurring within the seed sector (modernize; facilitate growth)
• Simplifying or eliminating the registration requirements, where possible (streamlining regulations)
• Strengthening existing requirements, if needed (addressing shortcomings)
• Creating a commercial path for innovative products not currently addressed in the regulations (building more flexibility into the system)

For each of the topics addressed the variety registration task team developed multiple options (ideally 3 or more), each with a rationale along with pros/benefits and cons/risks of each possible option prior to providing recommendations on each topic. Each task team topic report submitted to the Seed-RM WG is available in the variety registration task team final report. The task team held 27 meetings from April 29, 2021 through to August 5, 2022. A total of 42 options across the 13 topics were proposed, discussed, and rationale developed. Pros and cons were identified for each option. The variety registration task team generated 42 recommendations for presentation to the Seed-RM WG.

In expressing the final recommendation results, the concept of a qualified consensus represents the threshold for agreement by the group. Here is the definition of qualified consensus used by the CFIA throughout the whole co-development process:

Topic 1 – Should there be a variety registration system in Canada

2 options were developed:

• Yes
• No

If yes, then a second question was to be answered (who should run the variety registration (VR) system).

Final recommendations/comments

• A majority, 16/20 favored yes (option 1)
  • This was not a qualified consensus, however, because a majority of the seed industry stakeholders indicated they can do without a VR system
  • The seed associations, our national field crop certification organization along with producers favored having a registration system
• This raised the second item, given a majority supported having a registration system, we had a qualified consensus (unanimity) on the task team for the position that government should run the national variety registration system.

Reference for this topic: Topic report 1; appendix 2, documents 1, 2, and 3 in the final report.

Topic 2 – Varietal eligibility

This addresses the current system of varietal eligibility determination as part of variety registration. The CFIA conducts an assessment (paper based at the point of registration application) of whether or not a variety meets the definition of variety in Canada (from the Seeds Regulations). Unlike the European Union (EU), we do not apply a distinct, uniform, stable (DUS) requirement for registration. In Canada we look for distinguishable (from other varieties within Canada) and stable; uniform is not one of our requirements.

2 options were developed:

• Keep the current definition
• Move to the DUS standard

Final recommendations/comments

• There was qualified consensus (unanimous) for keeping Canada's varietal eligibility requirement (distinguishability and stability) versus EU's DUS; we have flexibility with our system, for more heterogeneous varieties.
  • This goes to meeting the international definition of "variety"
    • Note: this was helpful in dealing with topic 10 (heritage/heirloom, heterogeneous materials, and alternatively bred cultivars)

Reference for this topic: Topic report 2; appendix 2, document 1 in the final report.

Topic 3 – Crop placement in the variety registration system

This refers to the current stakeholder-driven process of moving crop kinds from one part of Schedule III to another part (there are 3 parts/3 registration streams from highest (1) to lowest (3) regulatory requirements). Crop sectors can "move" a crop kind from one level of requirement to another following a process involving the submission of a rationale and evidence of the level value across the value-chain for that crop.

4 questions were raised and 2 options for each question were developed.

Question: should Part II of Schedule III be kept or removed

• Options:
  • Part II of Schedule III should be removed
  • Part II of Schedule III should be maintained

Question: who should be able to determine where in Schedule III a crop is placed

• Options:
  • The value chain should continue to be the group responsible for moving a crop from one part of Schedule III to another
  • The CFIA should be responsible for moving a crop from e one part of Schedule III to another, without input or direction from the value chain

Question: should there be a process developed to add crop kinds to Schedule III

• Options:
  • A process needs to be developed by the CFIA to be able to add crop kinds to Schedule III
  • There is no need to add crop kinds to Schedule III; no process should be developed

Question: should there be a process developed to remove crop kinds from Schedule III

• Options:
  • A process needs to be developed by the CFIA to be able to remove crop kinds from Schedule III
  • There is no need to add or remove crop kinds from Schedule III; no process should be developed

Final recommendations/comments

• A qualified consensus  supported removal of Part II Registration from Schedule III, otherwise no other changes
• A qualified consensus (unanimous) supported crop placements needing to be a stakeholder-driven process
• A qualified consensus (unanimous) supported a process to be developed by the CFIA for both adding new crops into Schedule III (making them subject to registration)
• A qualified consensus (unanimous) also supported the CFIA developing a process for removing a crop from Schedule III (removing a crop from variety registration)

Reference for this topic: Topic report 3; appendix 2, document 1 in the final report.

Topic 4 – Varietal purity (variety registration)

This refers to a specific situation with oilseed soybean varieties in Canada (some but not all) that the CFIA presented to the team. A lot of time and effort (a disproportional amount relative to the crop and its acreage versus the other 52 crop kinds under variety registration. The CFIA spends a lot of time dealing with variants versus off-types due to the high number and frequency of seed hilum colour variants, in particular. One suggestion was to lower the variety purity requirement (field visually based) from 99.7%, dropping it a few percentage points and then removing any allowance for variants and simply including them in the other category (with off-types and everything else). This would solve the variant issue in soybeans and the CFIA would not consume time/effort in discussions with breeders nor would they have to resort to the level of DNA fingerprinting they do to sort out what is of the variety and what is not of the variety.

There was only 1 option developed from discussions:

• Should the purity standard for oilseed soybeans be adjusted

Final recommendations/comments

• It was noted that a regulatory amendment would not be needed to enable this recommendation and that CSGA is the one with the authority to set field crop purity standards within the seed certification system, including variety purity
• Further, Canada is a member of AOSCA and any proposed change to varietal purity in soybeans would have to go through AOSCA as well
• The task team developed qualified consensus (unanimous) recommending that CSGA work with AOSCA to review varietal purity standards not only for oilseed soybeans but also for other crops

Reference for this topic: Topic report 4; appendix 2, document 1 in the final report.

Topic 5 – One variety, one name policy in variety registration

The CFIA, Variety Registration Office has always operated under the policy of one variety/one name. This is to avoid confusion in the seed market and addresses the principle of fair and accurate representation of a variety in the marketplace (part of the regulations). The seed trade would like more flexibility in variety naming and the question of multiple names for the same variety (to support flexible licencing arrangements by seed companies) was raised.

2 options were developed:

• Keep the policy as-is
• Remove the policy

Final recommendations/comments

• The task team developed a qualified consensus (unanimous) to maintain the current policy of "one variety, one name" for variety registration in Canada.

Reference for this topic: Topic report 5; appendix 2, document 1 in the final report.

Topic 6 – Variety cancellation

3 options were developed:

• Keep the current system whereby the Registrant can cancel their registration by request
• Change the system to allow for parties other than the Registrant to influence cancellation
• To allow cancellation only when the variety is deemed to cause harm (cancellation for cause by the Registrar)

Also, when the topic of "unintended consequences" came up, the impact of variety cancellation on off-patent and off-plant breeders' rights varieties was raised. The impact on the common seed market was also raised and the task team unanimously chose to share this report with the common seed task team and ask for their input on the common seed angle.

The common seed task team came up with 5 options on this topic:

• Maintain the current system
• Make all registrations for life
• Allow for an interested party to become the variety maintainer, prior to cancelation
• Have an application process for canceling a variety with an appeal period for cancelation (to be made to the Registrar)
• That seed harvested from a certified hybrid (for example, hybrid canola, hybrid corn, hybrid cereals, etc.) should not be sold as common seed in Canada

Final recommendations/comments

• The task team did not reach a qualified consensus on any of the 3 options that were developed
• Option 1 (keep the current system) had the majority support but did not reach the threshold for consensus by the task team
  • The input received from the common seed task team did not change the recommendations in this report, after a re-vote
• Producer stakeholders on the VR task team chose option 2 (bring other stakeholder (producer) parties into the cancellation process)
• There is no single option to recommend to the SEED-RM WG, therefor, the 2 options (1 and 2) with the most support, along with an explanation of level of support, was forwarded to the SEED-RM WG

Reference for this topic: Topic report 6; appendix 2, document 1 in the final report.

Topic 7 – Parsing subsets of species in Schedule III, Seeds Regulations

This refers to the numerous crop kinds in Schedule III of the Seeds Regulations which are parsed or have qualifying text, in brackets, associated with them (for example, flax (oilseed type) or triticale (grain type)) which can be problematic for the regulator as it often requires interpretation.

2 options were developed:

• Parsing is permitted for subsets of species which allows them to be treated differently (the current situation for a number of species)
• No parsing would be permitted and all subsets of species would be treated the same

In addition, there was an amendment to option 2 made whereby all crops would be moved to Part III registration.

Final recommendations/comments

• The team developed a qualified consensus for option 1 (keep the current parsing of crop kinds in Schedule III) with a note that this will be easier to implement once incorporation by reference (for Schedule III) happens (they are assuming)
  • Of note: the majority of seed industry stakeholders support option 2 (no parsing and move all to Part III registration)

Reference for this topic: Topic report 7; appendix 2, document 1 in the final report.

Topic 8 – Regional restrictions on registrations

Currently, some crops (notably wheat) when recommended by a regional committee (for example, the Prairie Recommending Committee for wheat, rye, and triticale (PRCWRT)) have the CFIA contacting other recommending committees in Canada for the same crop and asking the question: do you have any objection to the national registration of this variety? There are only 2 grounds for this: disease issues or seed/grain quality issues such that it might provide confusion in the market. If they do object, a regional restriction for the sale of seed for that variety is put on the registration. This is time-consuming (slows down the final registration) and problematic for the CFIA.

3 options were developed:

• To continue to allow regional restrictions on variety registrations
• To make all registrations National and not allow regional restrictions
• To allow regional restrictions on National registrations in select species and develop a process to ascertain the status of each of the species subject to registration

Final recommendations/comments

• There was a qualified consensus for option 3: to allow regional restrictions and develop a process to ascertain how it is applied and to what species in Schedule III it should apply to
  • This would provide clarity to the CFIA (and the recommending committees, variety developers) that is currently lacking
• Further, there was also a qualified consensus for the following statement: the CFIA is encouraged to have recommending bodies in Eastern Canada (Ontario, Québec, Atlantic Region) be consolidated to one recommending body for the Eastern Canada Region

Reference for this topic: Topic report 8; appendix 2, document 1 in the final report.

Topic 9 – The use of incorporation by reference (IbR) in variety registration

The Variety Registration section of the Seeds Regulations (Part III, Seeds Regulations) was examined to take advantage of the use of incorporation by reference to remove parts of the regulations and move them to an administrative document that can be altered without the need for the lengthy regulatory amendment process. The only part of the regulations related to variety registration that would make sense for this tool is Schedule III at the back of the regulations. It is the table that defines the 53 crop kinds subject to registration in Canada and defines which type of registration (Part I, II, or III) the crop kind is subject to. Using IbR on this document would allow for timely entry, exit and changes within the registration system for any given crop kind.

2 options were developed:

• No changes to the current system
• Use incorporation by reference to incorporate Schedule III of the Seeds Regulations and remove it from the regulations, make it an administrative document

Final recommendations/comments

• A qualified consensus of task team members recommended the CFIA use incorporation by reference to remove Schedule III from the Seeds Regulations and reference it in the regulations
  • There was also qualified consensus that the CFIA should hold the pen on this document
  • This will facilitate much more rapid stakeholder driven additions of new crops, removal of crops, parsing of crop kinds and crop placements in the flexible variety registration system
  • It removes the need for a regulatory amendment to make changes in this area
  • We could not find any other items in Part III-Variety Registration of the Seeds Regulations that could be incorporated by reference

Reference for this topic: Topic report 9 ; appendix 2, document 1, 5, 6 in the final report.

Topic 10 – Heritage, heirloom, heterogeneous and alternatively bred varieties

The goal was to establish a regulatory path if needed for the commercialization of heritage and heirloom varieties as well as farmer-bred (one form of alternatively-bred) varieties. The issue of heterogeneous varieties was discussed as well and there was consensus within the group that no change was necessary for heterogeneous varieties as our system is not DUS-based like the EU, meaning we allow for much more diversity in our varieties than other geographies. With regard to heritage and heirloom varieties, the task team/sub-group started with establishing a definition for heritage and heirloom:

A heritage variety: is a cancelled or "to-be-cancelled" variety of a crop kind subject to registration (Schedule III) which is 50 years or older.

An heirloom variety is a non-hybrid variety of a crop kind subject to variety registration (Schedule III) that was never registered but grown in Canada prior to 1970.

4 options were developed:

• No change to the current system- heritage/heirloom varieties can be accommodated by the current system
• Heritage and heirloom varieties can be managed to utilize Schedule III Part II
• A special registration category should be available for registering heritage and heirloom varieties similar to the garden variety potato registration
• Regulatory exemption for Schedule III heritage/heirloom varieties

Final recommendations/comments

• There was qualified consensus on the issue of  heterogeneous materials and populations: that Canada's system of registration based on distinguishability and stability but not uniformity (as in the EU) can accommodate these heterogeneous materials
• There was qualified consensus that Canada's current variety registration system can accommodate alternatively bred (for example, organic, low carbon, farmer-selected material, etc.) varieties and that no change to the regulations is required
• Further, the CFIA is recommended to work with AAFC and create a guide for farmers/new breeders on how to navigate the VR system with these types of materials
• The task team could not reach qualified consensus regarding heritage and heirloom varieties
• 4 options were considered to commercially enable these types of varieties and in the end 2 options were almost equally supported:
  • heritage and heirloom varieties could be managed in the current system as a Part II registration crop in Schedule III^{Footnote 1} (so no regulatory changes)
  • there should be a regulatory exemption from Schedule III for heritage/heirloom varieties (this would require a regulatory amendment)
  • The 2 equally supported options for heritage and heirloom varieties had enough support to move them both forward as options for the Seed-RM WG to consider

Reference for this topic: Topic report 10 ; appendix 2, document 1 in the final report.

Topic 11 – Regionalized crop placements in Schedule III, Seeds Regulations (unique crop placements within different regions of Canada)

3 options were considered:

• To allow crop placements within regions of Canada such that, by region, a crop kind could be either a Part 1 or a Part 3 registration crop
• To allow regional placement of Part I crops into Part II or Part III of Schedule III
• No Change to the current system but initiate change at the Recommending Committee level to encourage an expedited pathway to market even though it is a Part I crop (for example,  pulses – create a special provision for colored beans whereby the committee trialing system is by-passed in favor of a developer/end-user documented agreement to work with the variety in the market)

Final recommendations/comments

• No qualified consensus for any of the three options developed
• There are 2 options forwarded onto the Seed-RM WG for consideration from the variety registration task team:
  • To allow regional crop placement such that, by region, a crop kind can be either Part I or Part III registration
  • No change to the system as it is felt that it meets the needs of the stakeholders

Reference for this topic: Topic report 11; appendix 2, document 1 in the final report.

Topic 12 – Phenotype, genotype, and the variety registration system

3 options were developed:

• No change to the current system
• Encourage the CFIA to pursue a vision of increasing use of bio-molecular techniques (BMTs) on the variety registration program and to change the Seeds Regulations to incorporate molecular characterization as a recognized tool for existing work; to make a clear vision of increasing use of BMT based assessment of varietal identity and varietal purity, recognizing that industry is out in front of this technology and has been using BMT extensively for a long time
• Transition to an all-genotype based system for variety registration (exclusive use of BMTs)

Final recommendations/comments

• The task team developed a qualified consensus for option 2
  • For the CFIA to change the regulations to empower the use of BMTs or biomolecular tools, for variety identification and purity determinations in the variety registration space
  • Specifically, it is recommended that the CFIA change the following part of the Seeds Regulations as follows: Part III: Variety Registration, 67 Applications for Registration (1) (iv)… to include a reference to "bio-molecular techniques (BMTs)"

Reference for this topic: Topic report 12 (includes a primer on the topic); appendix 2, document 7 (a primer on the topic), document 8 (a copy of the presentation on markers) in the final report.

Topic 13 – The CFIA recognition of foreign variety registrations and their equivalent (harmonization on registration requirements)

3 options were developed:

• No change
• Modify the list of registration requirements in Part III, Seeds Regulations (Variety Registration section), for Part III registration crops (as listed in Part III, Schedule III) to allow for recognition of foreign registration equivalence such that foreign data packages could be used by the CFIA to meet Canada's registration requirements
  • Canada would still perform their own variety eligibility determination (distinguishability and stability) based on this data
• complete acceptance of foreign registration packages or their equivalent in lieu of Canadian Part III registration (acceptance as equivalent)
  • Acceptance as equivalent would be on the basis of meeting the core information requirements:
    • Varietal eligibility determination
    • Data to support claims in variety description
    • Seed sample
    • Variety description
    • "Tombstone information" on the principals involved in the registration (breeder, Canadian representative/registrant, variety maintainer, owner, etc.)
  • A streamlined Part III registration process would be put in place (shorter processing time – less than 8 weeks)

Final recommendations/comments

• After a re-vote on June 29, 2022 where we had 12 voting members present (versus 8 on the original vote), there was a qualified consensus (unanimous) for option 2: to have the CFIA modify the Seeds Regulations Part III (the list of registration requirements) to allow for the acceptance of foreign registration data (or its equivalent) to allow those same data packages to be submitted for Canadian Part III registrations
  • Canada would still perform their assessment of varietal eligibility but on the foreign data

Reference for this topic: Topic report 13 in the final report.