Model Operating Procedures
Overview

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This document provides guidance to the variety registration recommending committees (RCs) in the development of their crop-specific operating procedures. Each RC (also referred to as "committee" in this document) must put in place procedures and processes to ensure fair, transparent, and consistent determination of merit for Schedule III, Part I crop kinds and designs of test protocols for Parts I and II crop kinds as set out in the Seeds Regulations. It is expected that each committee will incorporate the principles and objectives described in this document into their operating procedures.

Roles of the Recommending Committees in Variety Registration in Canada

The RCs are volunteer, crop-specific committees of experts who are also part of the crop sector value chain. Their role is: to define and assess merit for Part I crops, to design the test protocols for Part I and II crops, and to make a registration recommendation to the Registrar, Variety Registration Office (VRO), Canadian Food Inspection Agency (CFIA).

The definition of merit for a given crop kind is determined in terms of the key attributes that, together are beneficial to Canadian agriculture. The members of the committees are to apply their expertise to determine what the merit should be for their crop and how to best determine if a candidate variety has merit. In determining the best test protocols to assess merit, the committee also weighs the commercial impact of the test protocols, balancing the need for adequate data against the burden of costs and delayed time to commercialization of these varieties. The process should be as rapid as possible while meeting the minimum requirements to assess merit within a tolerable level of risk to the industry.

The committee consists of value chain stakeholders (individuals or representatives of an organization) who are experts on a particular crop, and the membership should reflect the interests of the full value chain stakeholder group for that crop kind. Above all, the variety registration recommendation system, by design, is a full spectrum crop value chain stakeholder-driven process. The committees' recommendations to the Registrar carry significant weight and are a requirement for eligibility for registration under the Seeds Regulations (Schedule III, Parts I and II crop kinds). The final decision to register new varieties, however, rests with the Registrar, VRO.

This document was generated to ensure that the following criteria for the RCs are met in accordance with the spirit and the letter of subsections 65.1 (1) to (3) of the Seeds Regulations:

Representative Recommending Committee Membership

  • The committee is composed of a balanced representation reflecting the full value chain of stakeholders for that crop sector (the broad categories being: production, crop specific variety development, processing, marketing, and crop specific seed trade), such that the committee's decisions represent a consensus in that crop sector with respect to current and future variety development and future crop sector value generation.

Membership in the committee is open to all crop sector experts (crop specific variety development, production, processing, marketing and trade) upon expression of interest. The process for becoming a member is open, unbiased and predictable.

Transparency and Predictability

  • There is consistency and predictability in the evaluation and determination of merit across committees in Canada for the same crop kind.
  • The committee governance structure is clear and efficient.
  • There is a clear set of merit criteria based on the discrete values of check varieties or the mean of check varieties. Varieties that demonstrate equal or better values compared to the checks or check mean are eligible for recommendations. All eligible varieties should be voted on for recommendation in a block rather than as individual varieties.
  • There are clear options for varieties that fail to meet one or more of the merit criteria. In cases where there are deficiencies in one or more merit criteria, but where the proponents wish to make their case based on the overall attributes of the variety, they may elect to request a review by the committee: a set aside of the rules by a simple majority (50 per cent plus one) vote. The set aside vote is a procedural vote, made en masse for a group comprised of all varieties fitting the scenario. All variety registration test data for varieties which become registered are published.
  • A summary table of performance data for all the check varieties shall be published annually to ensure developers understand their breeding targets within these criteria (e.g., publishing the performance of the checks for all required merit criteria).
  • A formal appeals process is included in the committee procedures to allow for variety developers to challenge a negative decision from the committee on the basis of procedural errors. Any complaint in this regard will be heard by an independent third-party tribunal with representation from across the value chain (crop specific variety development, production, processing, marketing and trade).

Facilitating Innovation in the Industry (time to market vs. regulatory burden)

  • All committee decisions will be based on efficiency, supporting innovation, minimizing regulatory burden within a tolerable level of risk, and providing value to the crop sector. Risk refers to the balance between having adequate scientific data to fully assess merit versus the impact of delayed time to market and other innovation-related considerations. This should be clearly understood and taken into account for the full crop sector when developing merit test requirements.
  • Committees, at a minimum, meet annually. They are encouraged to meet more frequently (by electronic meetings and/or face-to-face meetings) at any time throughout the year, in accordance with their operating procedures.
  • There is flexibility in the decision-making/recommendation process so that innovative products falling short of the merit criteria are given due consideration for a possible path to market using Interim and/or Contract registration when deemed appropriate by the committee. For crop kinds with multiple potential end uses, a candidate failing to meet the criteria for be variety registration recommendation after having tested in a particular RC "intended end-use based trial" (e.g., the PRCWRT bread wheat trials) will be eligible for RC consideration for any of the other "intended end use" categories set by the committee for which it may be qualified. Once the data is available and this situation is apparent, then the committee would need to be notified of this proposed change of end use eligibility prior to the annual meeting at which varieties are recommended for registration. Note: The Canadian Grain Commission determines Canadian grain class eligibility for varieties, where applicable.
  • There is a process for up to 100 per cent privately generated data to be submitted in support of a variety registration recommendation. The committee may choose to have these trials inspected and approved as part of their quality assurance of this system. All data must meet the committee's test protocol requirements as published in their procedures document. The acceptable data sets for merit assessment and registration recommendation may be all private, all cooperative or any combination of the two. In setting out its yearly testing plans, committees should give equal consideration to all requests for testing. The committee, through the trial coordinator(s) must ensure that resources are allocated equally to all candidate varieties received (entries).
  • Foreign data that is representative of Canadian crop production areas (suitability to be determined by the committee) is accepted in whole or in part, subject to it meeting the committee test protocol standards. Acceptable data will be considered either in part or in its entirety as meeting the data set requirement for RC merit assessment and variety registration recommendation.
  • Restricted Registrations – by default, all committee registration recommendations are National. However, there are forms of restricted registration such as Interim registration and Contract registration. The committee will consider Interim registration recommendation in situations where a variety is deficient in one or more characteristics but still has merit (one of the regulatory requirements for consideration for Interim registration). They will consider Contract registration in situations where the variety has merit but may cause harm to mainstream commodity production of that crop kind. These restricted forms of registration will be considered by the committee where appropriate.
  • The committee's deliberation and decision-making processes will be streamlined, efficient and timely. With the trend towards block voting of pre-determined varieties of merit, it is anticipated that the number of instances requiring formal ballot votes will diminish.
  • Clear and consistent committee conflict of interest guidelines for recommendation voting are in place, as well as a procedure for dealing with appeals based on conflict of interest (p. 13).
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