CFIA's Seed Program Modernization Initiative: 2010 Update Bulletin

Background on the Seed Program Modernization Initiative

The Seed Program Modernization Initiative (SPMI) was launched four years ago by the Canadian Food Inspection Agency (CFIA) to formalize a forward-thinking approach to re-evaluating and updating the Seed Program to make it more responsive to the evolving needs of seed sector stakeholders.

This Initiative consists of focussed efforts to improve the Canadian seed policy, regulatory and institutional frameworks - to remove or reduce barriers to diversification, innovation, competitiveness, profitability and sustainability; to maintain and enhance consumer confidence, protect the environment, and contribute to food safety; and to be inclusive, transparent and responsive as new challenges emerge. The means of achieving SPMI objectives have been documented in a strategic action plan (SAP) that was validated by stakeholders at a national workshop in 2008.

The SAP was created based on extensive stakeholder feedback from an online survey and regional workshops as well as from CFIA input. It details the Seed Program's goals and project-based strategies aimed at modernizing and enhancing the existing Program, with emphasis on changes to regulatory and policy areas in particular. It is subject to ongoing review and revision as priorities continue to evolve.

This bulletin has been sent out in lieu of a national workshop this year to keep stakeholders informed of recent progress and accomplishments as well as developing issues in the seed sector. It is also an important means of inviting input and feedback from all stakeholders on seed-related subjects, which will be used to focus CFIA's efforts.

Flexible Variety Registration System Established, Crop Placement Discussions

In July 2009 the Government of Canada introduced a flexible variety registration system, intended to reduce regulatory burden and maintain competitiveness in the seed sector. A regulatory framework consisting of three categories with varying degrees of registration requirements has been established. This created options in regulatory category for any given crop subject to registration in Canada. Future crop placements into these categories will depend on the strength of rationale for change, as well as the degree of consensus among stakeholders.

The Variety Registration Office (VRO) has received feedback from stakeholders regarding the potential placement of oilseed soybean and forage crops within this new variety registration system, as these were initially deemed most likely to have strong rationales for change. Once all feedback received has been considered, the CFIA will work towards a regulatory change proposal.

Forage Crop Placement:

• To explore options for change for forage crops, the CFIA sought feedback through a discussion document on the crop placement of forages distributed on March 25, 2010. The National Forum on Seed also hosted a working group meeting on March 30, 2010 to discuss forage crop placement.
• To date, these consultations demonstrated that there is clear consensus among stakeholders that it would be beneficial to move all the minor forage crops to Part III of the flexible registration system (the most basic requirement) because there is not sufficient variety development in Canada to maintain the current system. More diverse opinions have been received regarding appropriate crop placement for the major forage crops, such as alfalfa (Part II or Part III).
• Also, a great deal of feedback was received on topics associated with variety registration, such as issues surrounding the post-registration performance testing system and the regulatory system for plants with novel traits, including genetically modified plants. These topics are outside the mandate of the variety registration system.

Oilseed Soybean Crop Placement:

• To explore options for change for oilseed soybean, the CFIA recently sought feedback through a discussion document on the crop placement of oilseed soybean. The National Forum on Seed also hosted a conference call working group meeting on November 4, 2010 to discuss oilseed soybean crop placement, during which the CFIA heard feedback on the potential impacts of the movement of oilseed soybean to Part III. Responses to the CFIA's discussion document were requested by December 6, 2010 but feedback will still be welcomed (for a copy of the discussion document, please contact us by email at SeedSemence@inspection.gc.ca).
• To date these consultations demonstrated that there is clear consensus among stakeholders that it would be beneficial to move oilseed soybean to Part III of the flexible registration system (the most basic requirements) to reduce time to market, increase speed of delivery of varieties to growers, and reduce varietal commercialization time for variety developers.

Canola Interim Registration Requirements:

The VRO is implementing a change in canola variety registration policy to allow producers quicker access to new innovative canola varieties. New canola varieties are now eligible for an optional initial temporary registration (known as interim registration) based on an initial data set. Permanent registration is available after additional data is collected.

Prior to coming to this decision, the CFIA sought feedback from stakeholders on this proposal through a discussion paper. While many companies support the proposed changes, several concerns were raised by farmers and seed growers regarding the potential for rapid introduction of new varieties that do not meet all quality standards. To address these concerns, it will be important for canola variety developers to continue to apply for permanent registration of varieties, and not rely solely on the interim registration option.

Variety Registration - Reminders to Applicants

• For hybrid crops such as canola, applicants are reminded to submit hybridity test methods to the CFIA well in advance of applications for variety registration, in order to allow for timely processing of applications.
• For variety applications requiring a plant with novel trait (PNT) affidavit (e.g. for genetically modified (GM) crops), applicants are reminded to submit their trait detection protocol(s) well in advance of applications for variety registration as these protocols must be reviewed and approved by the CFIA before they can be referenced in their variety applications.
• Microsoft Word versions of the application form and objective description form are now available, and will be distributed through recommending committees this winter.

CFIA and Industry to Explore Options for Seed Certification

The CFIA has begun to implement a plan to explore options for a more efficient and effective seed certification system for Canada. The Canadian Seed Growers' Association (CSGA) and the Canadian Seed Institute (CSI) have been co-managers of the seed certification system for many years, and are working with the CFIA to examine opportunities for improvement.

A pilot project is proposed for 2011 for the inspection of Certified soybean seed in the London and Chatham districts of Ontario. This project will be limited to two companies that are already authorized to conduct seed crop inspections in other crop kinds. Evaluation criteria are being developed to assess the project's merits. The CFIA, CSGA, CSI and Canadian Seed Trade Association (CSTA) will review the results of the pilot project and work together to determine next steps.

The CFIA remains committed to ensuring that Canada's seed certification system continues to be among the best in the world.

Seed Program Plays Role in Resuming Exports to the EU After GM Flax Found

In 2009, low-level presence of GM material was detected in Canadian flax exports by the EU. Low level presence has been attributed to the variety CDC Triffid (experimental code FP967), which was deregistered in 2001 and was never to have entered into commercial production. All safety-related authorizations for FP967 remain in place today.

The CFIA's Seed Section, Ottawa Plant Laboratory and inspection staff were engaged in addressing this issue through the fall and winter of 2009-2010. The CFIA assisted in decision-making, development of related strategies and engagement with flax stakeholders.

The flax industry developed a 2010 Farmer Stewardship Procedures for Farm Saved Planting Seed. For more information, visit Flax Council of Canada and click on "Farm Saved Planting Seed Testing Program (rev.5)".

Interdepartmental Committee on Market Access Issues / Low Level Presence

Low level presence (LLP) refers to a specific genetically modified event which has been authorized for food use in at least one country, but has not been authorized in the importing country. LLP can arise in the trade of agricultural commodities, particularly grain and seed, and is both an import and export issue for Canada.

An Assistant Deputy Minister (ADM) Steering Committee on Market Access Issues related to GM Crops was struck in 2009 to review current issues including LLP. The ADM Committee, co-led by Agriculture and Agri-Food Canada (AAFC) and CFIA with members from Health Canada, Foreign Affairs and International Trade Canada (DFAIT) and the Canadian Grain Commission (CGC), will consider a variety of options to address market access. More information on stakeholder engagement and consultation will become available as this process evolves.

The CFIA gave a presentation on Canada's approach to LLP and using the international seed certification system as a tool for addressing LLP at a meeting of the Seed Association of the Americas in Buenos Aires in May 2010. Canada's LLP policy was also presented at an International Seed Federation workshop on LLP in Calgary in early June 2010.

CFIA's PBRO Hosts UPOV Meeting in Spring 2010

CFIA hosted the 12th Session of the International Union for the Protection of New Varieties of Plants (UPOV) Working Group on Biochemical and Molecular Techniques and DNA-Profiling in Particular (BMT) in Ottawa, May 10-13, 2010. The focus of this working group is to investigate the potential for molecular techniques, including DNA profiling, in the determination of distinctness and identification of new plant varieties and in the enforcement of intellectual property (IP) rights. There were 80 participants from 16 countries at this session, and it included four presentations by Canadian participants.

Proposed Changes to Weed Seeds Order Take into Account Consultation Feedback Received

The Seed Section continues to consult on proposed changes to the Weed Seeds Order. The Seed Program contributes to the CFIA's Invasive Plants policy through regulation of weeds via the seed pathway. Proposed changes to the Weed Seeds Order reflect current species' distributions, new species of concern, and reviewed classifications of species currently listed.

A broad-based consultation was held between October 2009 and February 2010, during which a total of 55 responses were received. Of these, six responses represented the joint submission of a stakeholder group expressing the opinions of their constituencies. A summary document entitled Weed Seeds Order Review: Responses Received was distributed on April 30, 2010 to all interested persons. To date, there has been general support for the majority of the proposed Prohibited Noxious species and for having Class 2 Primary Noxious apply to all Grade Tables.

A secondary consultation document, including CFIA's response to comments received to date will be distributed to stakeholders prior to a Canada Gazette, Part I pre-publication.

Proposed Amendments to Seeds Regulations Clarify Requirements for Sale of Plant Pest Tolerance Management Varietal Blends

Proposed amendments to the Seeds Regulations that would clarify the grading, labelling and advertising requirements for seed of varietal blends intended for the management of plant pest tolerance characteristics (PPTM varietal blends) were pre-published in Canada Gazette, Part I on November 6, 2010 for a 30-day comment period. The Government of Canada proposed these amendments to respond to the evolving needs of the seed and crop sectors.

The proposed amendments would clarify that seed of PPTM varietal blends may be graded with Canada pedigreed grade names in the same way as seed of a single variety if the components meet the varietal purity and seed quality standards for that crop kind. The proposed amendments would be applicable to the management of plant pest tolerance characteristics in major crop kinds grown in Canada listed in Tables I to II.1 or IV to VII of Schedule I to the Seeds Regulations.

For more information on the proposed amendments to the Seeds Regulations as pre-published in the Canada Gazette, Part I, visit the CFIA's website.

Licence Agreement to Print Official Seed Tags Modified to Offer Greater Flexibility

In July 2009 the CFIA launched the official seed tags licensing agreement, enabling registered seed establishments (RSEs) registered under Part IV of the Seeds Regulations to apply to print official seed tags. RSEs that have met the stipulated terms and conditions are issued a licence allowing them to print official seed tags, on-site or by a third party, under CFIA oversight. This initiative is proving beneficial by enhancing the efficiency of both industry and the CFIA, as licensed RSEs gain more flexibility in the printing, availability and inventory of their own official seed tags.

Subsequent to the July 2009 launch, the licence agreement has been modified to include:

• The ability to add multiple printers (third party) to the licence agreement
• The option to print official seed tags outside of Canada under the licence agreement
• The ability to distribute the printed tags to other RSEs under the licence agreement

The Request Form for the Grant of a License to Print Official Seed Tags and Resulting Licence Agreement Terms and Conditions is available for stakeholders on the CFIA's website, along with responses to frequently asked questions about it. Alternatively, the Request Form can be obtained by contacting us by email at SeedSemence@inspection.gc.ca.

Authorized Exporter Program Offers Industry Greater Control of Sampling and Testing

The CFIA's voluntary Authorized Exporter Program (AEP) enables authorized industry personnel to sample and test seed for the purposes of certification of seed lots in accordance with requirements of the Organisation for Economic Co-operation and Development (OECD) Seed Schemes. This program provides Canadian seed exporters with an opportunity for timely sampling, testing, and certification of export seed lots and diverts the sampling and testing of these lots from the CFIA.

There are currently six RSEs and three seed testing laboratories participating in the AEP. In the 2008-2009 and 2009-2010 export seasons respectively, AEP participants collectively exported 484 and 298 OECD Certified seed lots from Canada to other OECD member countries. Most AEP participants are located in western Canada, and no corn companies are currently participating in the AEP. This program has a three-fold benefit - to the CFIA (fewer samples to handle and test), to Authorized Exporters (greater control of sampling and testing, with no delays due to CFIA backlog), and to non-authorized exporters (fewer samples awaiting CFIA testing means faster turnaround time).

A new version of the AEP Industry Manual (Version 2, Sept 27, 2010) was distributed to AEP participants in late September 2010.

Seed Importation Procedures Reviewed, Authorized Importers Offered Training

The CFIA's Seed Program is reviewing seed importation documents and procedures in order to address the increased volume of seed imports, the risk of introduction of weeds via the seed pathway, and issues raised in the 2008 Office of the Auditor General (OAG) report. This review includes improvements to the information within the Automated Import Reference System (AIRS), as well as increased marketplace monitoring of imported seed.

Authorized Importers (AIs) are RSEs licensed under Part IV of the Seeds Regulations to make release decisions on imported seed. At the time of importation they need only provide their AI number and a Request for Documentation Review Form. The CFIA and the CSI conducted technical training session for AIs in December 2010. These web-based meetings provided an overview of the seed program import requirements (specifically for the AI program).

In an effort to ensure that all seed import requirements are met, the following two reminders to all seed importers bear repeating:

• Unregistered varieties of Schedule III crop types (subject to variety registration) cannot be imported as common seed for sale; and
• Imported seed that meets minimum requirements, but is later cleaned to improve the grade, may require an import permit.

CFIA Finalizes Policy Document on Service Standards and Associated User Fees

On October 20, 2010, the CFIA published a finalized policy on cost recovery. The policy is available on the CFIA's website. The policy sets out the CFIA's approach to cost recovery and includes a framework that outlines a costing methodology and criteria for developing service standards and user fees. It will be applied when cost recovery is being reviewed or considered in any CFIA program area.

Monitoring of Implementation of Insect Resistance Management Plans

Since 2004, the CFIA has carried out an inspection program to verify that insect resistance management (IRM) plans for Bt corn are being properly implemented. These inspections have traditionally been conducted on farm, however in 2010 the CFIA interviewed seed retailers in order to verify that the appropriate IRM information is provided by technology developers and is effectively being passed on by seed retailers to growers. Approximately 160 seed retailers were surveyed across Canada, the majority of which were in Ontario and Quebec. The survey consisted of a questionnaire to determine the level of training and communication received by the seed retailers from the technology developers, as well as the content they were transferring to growers. The PBO of the CFIA is now analysing the information received from this survey. A summary of the results is available from the PBO and will be published on the CFIA website.

Clarification of the Stacked Policy

In Canada, the PBO must be notified of stacks derived from previously authorized PNTs prior to their environmental release. These notifications are required so that regulators may determine if (1) any conditions of authorization placed on the parental PNTs are compatible and appropriate for the stacked plant product, and (2) additional information is required to assess the safety of the stacked plant product. The PBO posts a list of authorized stacks on its website.

Canada-China Bilateral Meeting on the Regulation of Agricultural Biotechnology Products

The latest bilateral meeting on China-Canada regulatory cooperation for agricultural products of biotechnology took place in Suzhou, China on October 18-19, 2010. The aim of these annual meetings is to facilitate cooperation on technical issues to avoid future potential trade irritants such as LLP. At the latest meeting, both countries agreed that the Canada-China relationship with respect to agricultural biotechnology has been productive, and, in principle, that bilateral work should continue.

Feedback and Contact Information

The CFIA is committed to continued engagement with stakeholders and Canadians, and is looking forward to future opportunities for interaction. Your feedback is always welcome, and any questions or comments may be directed to us via email at SeedSemence@inspection.gc.ca, or by visiting the CFIA's website at www.inspection.gc.ca. You may also reach us by facsimile at our new fax number 613-773-7144, or by mail to the following address:

Seed Section
Canadian Food Inspection Agency
59 Camelot Drive, Ottawa, ON
K1A 0Y9

Sincerely,

Seed Section, Variety Registration Office, Plant Biosafety Office, Plant Breeders' Rights Office
Field Crops Division
Plant Health and Biosecurity Directorate
Canadian Food Inspection Agency