Model operating procedures

September 21, 2015

Overview

This page 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 page) 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 page 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
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 page 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% 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 (for example, 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" (for example, 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% 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.

Recommending committee procedures

Introduction

This page outlines the pre-registration testing system protocol and evaluation process for a variety registration recommending committee (RC). The RC (also referred to as "committee" in this page) evaluates candidate varieties of designated crop kinds for merit as a part of pre-registration requirements and makes a recommendation for registration, for its region of Canada, to the VRO. The procedures for entering a variety for testing are documented and reviewed annually by the committee, and are available to the public, at a minimum, upon request to the Chair of the committee.

As required by the Seeds Regulations paragraphs 65.1 (1) (e) and (2) (c), each RC shall function transparently and deal with varieties in a fair and consistent manner.

Legislation and authority

The Seeds Act is the legislative authority for the Seeds Regulations. In section 65.1 of the Seeds Regulations (Appendix I) there is a provision for the Minister of Agriculture and Agri-Food to approve crop-specific variety registration recommending committees.

The purpose of each committee is to establish and administer protocols for testing varieties of crop kinds listed in Parts I and II of Schedule III of the Seeds Regulations, to determine the merit of varieties of crop kinds listed in Part I and, subsequently, to make registration recommendations to the Registrar, VRO. In practice, the Minister's authority to approve each RC is delegated to the Registrar (currently the National Manager, Seed Section, CFIA).

These committees are integral to the variety registration system in Canada and serve to provide expertise and guidance to the Registrar.

Role of the Variety Registration Office

The VRO reviews and approves each committee's operating procedures document annually. Any changes to this document require approval by the committee members and subsequent approval by the VRO. The VRO issues an annual approval letter, signed by the Registrar on behalf of the Minister to each variety recommending committee in Canada. This letter recognizes the committee as the sole authority in that region to provide variety registration recommendations to the VRO for the year.

The VRO has regulatory oversight of the recommending committees to ensure that the committees are functioning transparently and that varieties are dealt with in a fair and consistent manner, in accordance with the approved committee operating procedures and in compliance with the Seeds Regulations. The VRO provides guidance on the requirements of the Seeds Act and the Seeds Regulations to all the recommending committees as required. The MOPs document is an example of this. The committees provide their expertise and advice to the VRO, and this is considered by the Registrar in rendering a decision on variety registrations.

The VRO (the Registrar) is also the 'court of last resort' for stakeholders taking issue with the compliance of the recommending committees with the MOPs, or the Seeds Regulations, the first step being to contact the committee itself with the grievance.

See the list of all current, recognized recommending committees.

The committee's core mandate and objectives

Committee's core mandate

To determine merit^Footnote 1 criteria to be used in evaluating candidate varieties (as defined in the Seeds Regulations)
To establish practical and science-based test protocols
To develop a written procedures manual
To evaluate trial data to determine the merit of candidate varieties of crop kinds for which they are recognized

The committee has no registration recommending authority outside of the region of Canada for which it is recognized.

Committee's objectives

To recommend for registration, based on merit and in accordance with the approved committee operating procedures, candidate varieties to the VRO for Schedule III, Part I crop kinds
To recommend for registration, based on completion of variety testing according to approved test protocols, candidate varieties to the VRO for Schedule III, Part II crop kinds

Committee's name

The recommending committee's identification (Title) is clear and based on the region they represent, the crop kind(s) and types (where applicable). For example: the Prairie Wheat, Rye, and Triticale Recommending Committee or the Ontario Cereal Crops Recommending Committee. Each committee's procedures document should be made available to the public, either online or upon request to the chair of the recommending committee.

Committee's roles and responsibilities

As noted in the overview, each RC must put in place procedures and processes to ensure fair, transparent, and consistent determination of merit for varieties of Schedule III, Part I crop kinds, and design of test protocols for Parts I and II listed crop kinds as set out in the Seeds Regulations. Each committee will incorporate the principles and objectives described in this page into its operating procedures.

In addition, the committee's role in determining the merit of a candidate variety is to foster innovation in the crop while mitigating the risk of registering varieties lacking in merit and to provide increased value to the crop sector.

The committee will balance the value of: accelerated time to market, encouraging crop innovation, and the rapid improvement of the crop versus the value of ensuring varieties with clear benefit (based on precision of prediction) are recommended for registration.

The overall effect of the committee's requirements and processes on Canada's international competitiveness in that crop also will be considered. A balance will be struck between fostering innovation, determining the merit of a variety (for Part I), and keeping the market risk tolerable. The categories of and number of merit criteria should be reviewed on a regular basis with these considerations in mind.

Historical background of the committee (Optional)

(Appendix: History and background of the RC)
This section can include historical context regarding the committee (for example, previous names of the committee and any other previous changes).

Membership

The officially recognized recommending committee consists solely of members who vote to make variety registration recommendations to the VRO. In accordance with paragraphs 65.1 (1) (a) and (b) of the Seeds Regulations, the committee will have the knowledge and expertise required to establish and administer testing protocols and to determine the merit of varieties of that species, kind or type of crop for the specific region(s). The recommending committee members are often selected from a larger crop expert advisory group which constitutes a pool of expertise for the recommending committee to draw on, as required.

The committee will reflect the full value chain of crop-specific stakeholders: individuals actively engaged in the crop specific variety development, production, processing, marketing, and seed trade of varieties and are residents of Canada. The committee will include equal representation from three broad-based value chain stakeholder groups (keeping in mind that a smaller committee is favoured over a larger one in order to optimize efficiency):

variety/trait developer and assessor representation, including:
- plant breeders
- agronomists
- pathologists
- entomologists
- molecular geneticists
- business leaders with expertise in one or more aspects of the specific crop
producer representation (representatives chosen by crop specific producer and seed grower organizations)
end user representation (includes the seed trade, representatives chosen by, for example, a miller's organization, grain traders' organization representing domestic and export markets (marketers) for the specific crop, processors)

Equal representation is by broad-based grouping, and designated by stakeholder value chain organizations within those groups as opposed to individuals (for example, the Variety/Trait Developer group may, in order to meet the requirements of the MOPs, have designated organizations represented on the committee such as a breeder from the Canadian Seed Trade Association (CSTA) Plant Breeders' committee or a domestic miller chosen by the Canadian Millers Association, etc.). In this circumstance it is these organizations that will nominate their own representatives for this designated position on the committee.

In the event that a representative from a member organization is unable to attend, an alternative representative chosen by their member organization may fill in for them as a voting member. In addition to these voting members, the Canadian Grain Commission (CGC), the Canadian Seed Growers' Association (CSGA), the Canadian Seed Trade Association (CSTA), and the VRO will all be eligible to have an ex officio (non-voting) seat on the committee available to them. The CFIA and the CGC being federal regulatory agencies will not have a voting representative on recommending committees.

As an example, a committee might have 25 members, of which 21 are voting (7 each from the three broad based groups) and up to 4 non-voting. The committee may elect to have subject matter experts (from outside the committee) present, by request as required, to provide detailed expert input related to the merit assessment of varieties being considered. Each recommending committee in each crop sector is unique and it is recognized that one size does not fit all but the principle of a smaller rather than larger voting body that captures the full crop sector value chain holds true. The smaller voting body draws expertise from a wider pool of expertise in many situations. This should not bias the voting as members represent the consensus in their constituency, not their personal viewpoint.

The identification, affiliation and area of expertise of the committee members will be provided to the VRO and to the committee membership:

the name of the person
title on the committee
expertise criteria (for example, agronomy, pathology, quality, milling, processing, exporting/marketing, etc.)
title in organization
identification of their organization
contact information

It is expected that the committee members will discuss changes to the operating procedures, including governance and the setting of future goals for merit in the crop, with the entire crop expert advisory group present at the meeting to obtain consensus. Committee members will then vote on any subsequent changes.

Committee members will serve on the committee for a maximum term of three years; however, they can let their name stand to be voted in for subsequent terms. This will be clearly stated in the procedures document. The existing committee votes on the upcoming changes to its membership via a simple majority (if representation by organization is part of the committee structure then this is simply a procedural function to ratify already appointed new members).

Committee structure

Each recommending committee will have a Chair, a Vice-Chair (who can step into the Chair role in the absence of the Chair) and a Secretary, which will be approved by a simple majority vote (50% plus one) of the voting members. If the Chair is unavailable to act in their position, the Vice-Chair will assume that role.

Crop expert advisory group and visitors

Crop-specific experts and stakeholders who are not RC members (those who vote on variety recommendations) will be eligible to attend and participate in general meetings. It is recommended that recommending committee members and non-voting subcommittee members wear some form of identification at the meetings (for example, name tags). There will be a provision for other visitors with an interest and/or expertise in the crop sector to attend the meetings (for example, students, educators and researchers, members of the press, interested parties). This will obviously be subject to the logistics of the venue chosen.

Non-recommending committee members will have an opportunity to be recognized by the Chair and provide constructive input to the voting committee. At the discretion of the RC, ad hoc working sub-committees can be struck (for example, agronomy, pathology, quality evaluation subcommittees). These sub-committees may be made up of either committee members and/or non-voting crop specific value chain stakeholder experts attending the meeting. Subcommittees may, at the discretion of the RC, be established for specific purposes (for example, selection of new check varieties, recommendations on quality, pathology, agronomy of candidate varieties) culminating in a report to the RC with recommendations to be voted on.

Process for becoming a member of the VR recommending committee

With the exception of ex officio members, the variety registration recommending committee is comprised solely of those members authorized to vote on the variety registration recommendation of a candidate variety. The variety registration recommending committee is a standalone group of crop experts recognized by the Minister for the purpose of making variety registration recommendations to the VRO.

Although it is anticipated that the RC representation will be by organizations representing key stakeholder value chain groups, some of the RC membership may be drawn from a larger pool of crop experts and interested parties attending the annual meeting. Members, authorized to vote on VR recommendations may be selected from this larger pool. Where this is the case, the process must be clearly explained in the procedures document. Anyone wishing to be considered for RC appointment can apply directly to the committee during the membership business section of a meeting. Member-stakeholder organizations holding a voting position on the RC can also replace their member prior to expiry of their current term at their discretion. In their function as a variety registration recommending body to the CFIA-VRO, the RC must be a completely independent stakeholder group.

Voting procedure

Voting for changes to the committee operating procedures and for variety registration recommendation are by a simple majority vote: 50% plus one person. The Vice Chair votes, the Chair only votes in the case of a tie and the Secretary votes if they are a bona fide voting member. A committee in their wisdom may see value in having a non-voting Secretary, for example, a hired professional, instead of having that position being taken on by a value-chain stakeholder with a vote.

For all varieties meeting all the minimum criteria for merit (for example, protein = check mean), a single vote should be conducted to recommend them all for registration as a block or group. A variety not meeting the merit criteria, but for which the proponent wants its strengths to be taken into account, may be brought before the committee with a request to "set aside the rules" and have its overall merit re-examined, taking into account strengths and weaknesses of the variety on an individual basis.

Set aside rule

As noted above, the applicant can request that the committee set aside the rules to consider the merit of a variety that otherwise has failed to meet the standard in one or more required characteristics.

The committee may take the vote on a variety by variety basis or they may choose to lump all such varieties together and take a single vote for the group. It is up to the committee. For this to proceed, a simple majority vote must be held to set aside the rules.

The committee would then hear the applicant's request (a presentation of the attributes of the variety and why it should be considered) followed by a registration recommendation vote based on a simple majority. For example, a new and valuable technology has been introduced in an otherwise partially deficient variety and the committee is being asked to make a decision on the new, valuable attributes not yet captured in the definition of merit for that crop kind. In this example, the proponent may be requesting interim registration or a full registration.

As another example, if the minimum data set or minimum merit performance are lacking due to extenuating circumstances, the committee may choose to take this into account.

Voting options

There are only three possible voting options for committee members:

to support (the motion)
to object to (the motion), or rarely
to abstain from voting

In the past, some committees have allowed a "do not object" vote (which, by default, counted in favour of a registration recommendation in that it was not an objection). This is no longer acceptable for variety registration recommendation voting. Whereas in the past this voter choice was often associated with uncertainty as to the overall merit of the variety (due to many and varied factors, each situation being unique) this will no longer be an option. The variety either demonstrates merit with the information provided or it fails to do so and the vote should be cast accordingly. Abstaining is only appropriate if there is a real or perceived conflict of interest (see below). A lack of suitable data is not a valid reason for abstaining from voting on variety recommendations.

Conflict of interest (With respect to voting on the committee)

In general, a conflict of interest may arise if the impartiality of a member could be undermined due to a conflict between their self or professional interest and the public interest.

Conflict of interest is minimized by instituting automated procedures for variety evaluation (a pre-set, clearly written set of specific merit criteria that, if met in its entirety, will result in the variety being added to a list of similarly qualified varieties to be recommended automatically by a single procedural vote of the committee).

There is the potential for a conflict of interest to occur within the committees if a voting member derives direct benefit from the outcome of the vote and determines that he or she is in a position of undue influence with regard to the variety. The choice of abstaining from the vote is left up to the individual voting member, in accordance with the code of ethics of the committee. It is recognized that a voting member may derive benefit from the outcome of a vote but that he or she is capable of acting impartially and professionally on behalf of their constituency when it comes to voting. It is also recognized that having a committee of crop-sector experts voting on variety recommendations means that voting members will occasionally have a vested interest in one or more of the varieties coming up for the vote. This is a feature of all variety registration recommending committees in Canada where voting on an individual variety occurs.

If a variety proponent believes that a conflict of interest is responsible for their variety not being recommended by the committee, their recourse is to file an appeal with the committee and present their case. Once completed, should this process and/or its outcome prove unsatisfactory to the variety proponent based on the guidance and principles outlined in the MOPs, they have recourse to present their grievance to the Registrar (the VRO). The rationale for the grievance along with any available factual evidence should be submitted. The final decision on the eligibility of the variety for registration under the Seeds Regulations will rest with the Registrar. It should be noted that this is anticipated to be a rare occurrence as it has been in the past.

Committee meetings requirements

The current RC membership should meet in person at least once a year for registration recommendation voting and for general committee business, including annual review and revision (if any) of their procedures document. In order to be efficient and responsive to variety developers, the committee may have additional meetings (virtual or in person) to conduct their business as they deem necessary. This may include registration recommendation voting. These meetings will be in accordance with the governance requirements outlined in the procedures document.

Trial procedures

Site information

Information about the site crop rotation (history of the land use), soil condition, seeding rate, fertilizer application, disease control, pesticide application, and harvesting date should be provided to all RC members and variety proponents.

Location

For field trials, a list of crop production regions should be outlined in the procedures document. Locations for trials should be chosen on the basis of them being representative of the crop production region where the variety is intended to be grown after commercialization. The trial coordinator(s) should select trial sites each year and present their choices to the committee for approval prior to testing entries in the next crop year.

An appendix to the procedures document must be included, consisting of a list of locations, name of the trial coordinator(s), and contact information. This will be made available to interested parties.

Data set requirement: Station-years

The minimum required number of station-years of field trialing (sum total of the number of trials conducted across years and locations) will be included in the procedures document. This is one of the data set requirements for merit assessment by the committee.

Check varieties

The choice of check varieties should be reviewed annually by the RC. Changes to any check varieties are by majority vote of the recommending committee. As a general principle, any candidate variety entering into the test system should be judged for merit against the set of check varieties in use at the time of entry into the system.

A list of check varieties and their appropriate application (for example, pathology checks, quality checks, agronomy checks) must be included. Generally, check varieties shouldn't change for at least three years, but it is at the discretion of the committee to make these decisions based on their crop sector's needs. Check varieties are typically commercially grown varieties whose attributes are such that they provide a stable measurement of one or more merit criteria at a commercially desirable level and can act as an appropriate minimum standard for that trait or set of traits.

Confidentiality of RC test data

Variety merit assessment test data either provided to the RC or generated via a co-operative test system is to be treated as confidential data of the variety developer to be used for the sole purpose of determining merit of the variety and making a recommendation to the VRO. Its use is restricted to this function only. Any other use requires that express permission is obtained from the variety developer prior to registration. If the candidate variety is recommended and if it becomes registered, the test data that accompanies the registration will become public domain. Data on check varieties or registered varieties in any of the registration trials will be considered public domain.

Merit assessment criteria

Under the Seeds Regulations, merit can be one or more characteristics of a variety that provides value in any one region of Canada. The attributes or traits that constitute merit for a given crop kind will be clearly defined by the RC, made publicly available, and may be published by the VRO.

All merit assessment is based on the principle of being equal or superior to the appropriate check or checks within the same experimental trial. By default, unless otherwise specified, the standard for merit (for those traits that the committee defines as part of merit) is equal to the checks. Equal means arithmetically equal to the appropriate check(s) based on valid trial data (that is, trials meeting the minimum statistical and agronomic requirements). Alternatively, the merit minimum standard may, as designated by the committee, be a number relative to the designated check(s) (for example, check mean plus 1%). In either case the check variety is the baseline for the merit standard.

Agronomic characteristics where a component of merit

A list of all required agronomic traits and their number of trials requirement (station-years, number of years) with a unit of measurement must be provided.

The unit of measurement should be consistent with the objective description form (ODF) designed by the VRO (for example, relative maturity units for soybean). It is recommended that this information also be summarized in a tabular format and added as an appendix. As with all merit criteria, the merit level performance for required traits is either equal to the designated check or checks mean for that trait and from that same trial, same location or it is a calculation relative to the checks (for example, checks +1%).

The mathematical calculation procedure used for determining merit (for example, the rounding off of figures procedure, significant figures) and the method of measurement (for example, any official test protocol(s)) must be provided in the procedures document.

Pathology characteristics where a component of merit

A list of all required pathology traits and their number of trials requirement (station-years, number of years) with a unit of measurement must be provided.

The unit of measurement should be consistent with the objective description form from the VRO. It is recommended that this information is also summarized in a tabular format and added as an appendix. Disease rating systems will be clearly referenced and the method of calculation clearly identified.

The rating system used must be recorded in the RC procedures document (for example, S, MS, MR, R or 0-9 scales). The designated check varieties for each disease assessment must be clearly identified ahead of time. Protocols for pathology (tolerance) tests used will be clearly explained in the procedures document. The protocols will be highly reproducible and follow scientifically valid experimental designs. As a minimum, tests will utilize a susceptible and a disease-tolerant check variety (controls) and will be scientific and replicated test designs.

Quality where a component of merit

A list of all required quality traits and their number of trials requirement (minimum station-years and minimum number of years tested) with a unit of measurement must be provided.

The unit of measurement should be consistent with the ODF designed by the VRO. Each quality attribute will have a set minimum value relative to the designated check or checks mean that is acceptable and which must be met in order to exhibit merit (for example, a discrete number or equal to the mean of the appropriate checks of the trial). Further, it is recognized that in some crops where functional end use characteristics are being assessed, the overall merit for quality is a balance of the sum total for the various quality criteria (a variety may fall short on some but hit the mark on others). For these varieties, an expert summary assessment for intended end-use is required based on knowledge and experience in the end-use characteristics and the end-use industry. It is recommended that this information is also summarized in a tabular format and added as an appendix (examples of mixed quality parameters with overall merit).

Experimental design

A clear description of the scientific experimental designs (for example, RCBD, split plot, square and rectangular lattice designs) must be provided, and these designs will allow valid statistical analysis (ANOVA, F-statistic, and error term).

Trial design and size limitations are determined by the committee for the crop and variability (year, location, soil variation) they deal with in their region.

Site examinations

The committee must establish a procedure and set a standard for the field trial inspection and reporting process to ensure that its requirements are met. This would apply equally to all trials intended to generate data to be provided to the RC.

Criteria for trial inspection must be included in the procedures document. The trial operator should inspect on a regular basis to ensure the uniformity of the trial and to note any conditions that would affect uniformity. Trial sites should be designated acceptable or not acceptable by the trial coordinator once yield data is in and a coefficient of variation (CV) for yield is calculated.

In summary, all trials whose data is intended to be submitted to the RC should be inspected beforehand and held to a set of standards determined by the committee and captured in the procedures document. They must be monitored by the trial coordinator.

Note: Visits to trial sites on privately owned and contracted land require prior notice of intent to visit to be made to the entity contracting the trial so that supervision of the visit may be provided if necessary. This aspect is to be incorporated in the procedures document.

Analysis and data summary

The acceptability of a data set for a trial will be determined after harvest and analysis for yield and the determination of the coefficient of variation (CV) for yield for that trial. The acceptable level of the CV will be determined by the committee and stated in the procedures document (it varies by crop kind but is always less than or at most equal to 20%). Requirements for data handling, data validation, and data analysis processes must be accurately described and must be followed (for example, rounding off numbers, format of calculation of check means, handling of missing data). The full data set for all traits measured must be available to the trial entry proponent prior to the annual meeting in order to prepare for submission to the RC.

Trial source consideration

Where RC run or RC overseen co-operative trials are part of the registration testing system, the committee must also have a provision to alternatively accept non-RC generated trial data in part or in whole to provide a complete data set as required for merit assessment. The data must be conducted using the same testing protocols (for example, test design, check varieties) as co-operative (public) trials and follow the same test protocol guidelines. All valid data generated will be submitted. All trials will use the same source seed of the check variety for all the designated checks. Data generated from trials meeting the committee's requirements will all to be treated equally.

The following guidelines have been established:

The committee must be informed that a variety developer or associated party wishes to conduct a recognized trial so that:

the appropriate seed lots of the check variety(s) can be sent to the variety developer for testing, or appropriate arrangements can be made with the private company to locate seed of the check variety that has been adequately tested for quality
the trial can be visited for evaluation by the committee (trial has to be accessible to RC members and trial coordinators)
- given that these trials are often on privately owned, contracted land, any visits of the trials must be after reasonable advance notice has been given to the party contracting the trial such that, if deemed necessary, the visit can be supervised and the land owner notified ahead of time
- contact information for visiting trials must be submitted to the committee well in advance of the field trial season
the evaluation committee (part of the recommending committee) will know prior to the annual meeting that private data is forthcoming on certain entries
- data will be submitted to, and in a format specified by, the recommending committee
full dataset(s) from private tests conducted by a variety developer will be provided to the cooperative trial coordinator at least 14 days prior to the annual meeting of the committee

Designated trial coordinators

Trial co-ordinators are appointed by the committee. Co-ordinators can be from public or private organizations and possess the necessary technical skill and expertise in running agronomic assessment field trials for crop kinds.

Responsibilities of the trial co-ordinators include:

co-ordinating and organizing regional screening (for example, disease) and registration recommendation tests
working with the committee in determining appropriate number of sites, their locations and co-operators
supplying seed for planting to co-operators with adequate instructions for packaging and seeding. This usually includes a planting plan and list of data to be collected
ensuring that data are collected, summarized, and made available for distribution to developers and committee members in accordance with deadlines for entry decisions and variety registration recommendations
in accordance with the committee procedures, ensuring that official RC check varieties (including agronomic and disease check, as recommended by experts) are included in the test
ensuring that all the replicated data for all traits measured is available to the committee upon request

Eligibility for trial entry

Varieties with potential for merit are eligible for entry into RC coordinated co-operative registration trials, where they exist. The entries should meet minimum performance level criteria as pre-determined by the RC. These eligibility criteria will not exceed the RC merit criteria for recommending varieties of that crop for registration.

There may be situations where bona fide eligible entries cannot enter the co-operative trial due to resource constraints. In these instances, the trial co-ordinator will provide the proponent a list of eligibility criteria in order to conduct private trialing (either contracted, in-house, private co-operative trials, or a combination of these) that will be acceptable to the RC.

Basic testing requirements

Eligibility

The deadline for submission of seed and for fee payment for testing must be stated, if applicable. Eligibility for entry into co-operative trials may require preliminary (private) data to support the potential merit of the variety prior to entering RC coordinated cooperative registration trials. Any such requirements will be clearly identified in the procedures document as well as the method of selecting entries for incorporation into these trials.

Fees

Fees for RC coordinated cooperative trial testing as well as for inspection of private trials (if applicable) will be specified.

Seed

It is the responsibility of the variety developer to submit a distinguishable, uniform and stable variety into the test system. The standard of varietal purity of the sample submitted for registration testing should be the same as or better than that stated for certified class seed of that crop kind. Varieties failing to meet this standard may either be withdrawn from the test by the developer or removed from the test by the committee.

Trial data

All raw and summary trial data must be submitted to the RC in a timely manner (specified by the RC) and in the format specified by the committee.

Special requirements

Phytosanitary

The committee may impose additional registration test requirements as necessary: for example, seed-borne disease testing prior to entering the public trial as a phytosanitary measure to protect a given geographical area, a province, or Canada as a whole. This may or may not also be the result of a specific provincial requirement.

Plant with novel trait(s) (PNTs)

Proponents must inform the committee where a variety is deemed to be derived from a PNT. The proponent must confirm to the RC that Food, Feed and Environmental Safety approvals are in place and that the PNT has "unconfined release status" or the equivalent (for example, an exemption letter from the CFIA Plant Biosafety Office). The committee cannot refuse entries into the registration test system where the necessary domestic approvals are all in place (for example, they cannot refuse entry on the basis of a lack of major foreign market approvals).

Security of entries

All persons and institutions involved in conducting trials on behalf of the committee will agree to abide by a written "Code of ethics" (including the Code of Ethics for Plants Breeders and Co-operators Conducting Variety Evaluation Trials in Canada and also including trial inspectors). The RC will develop and include this/these code of ethics in the procedures document.

The seed of candidate entries is proprietary property and should be handled with this in mind. Under no circumstances will seed submitted for these trials be redistributed in any manner other than for the purpose of conducting the registration trials, both cooperative and private.

Withdrawal of entries

A procedure shall be in place to accommodate a request for the withdrawal of entries either from trials or from the recommending committee assessment process. Typically such requests are made to the trial coordinator who passes them along to the Chair of the committee. Under this circumstance, data summaries and performance information are not included in any formal documents generated after the request has been accepted and approved by the RC.

Registration recommendation

The committee has three primary registration options to consider when recommending a variety:

national registration
interim registration
contract registration

Based on the result of the trials, the committee will provide recommendations to the CFIA as follows:

that they 'support' or 'do not support' candidate varieties for registration
that they 'object' or 'do not object' to the national registration of a variety

Some varieties of certain crop kinds (for example, wheat) may be desirable in one region but could be deemed to be a threat to crop production in other regions. In this case, the VRO consults recommending committees other than the committee that supported the variety to see if they object or do not object to the national registration of the variety being recommended.

National registration

Candidate varieties which have merit, as determined by the committee, will be recommended for registration. By default, all variety recommendations from a recommending committee are for national registration. After the committee's recommendation and during the variety registration process, other regional committees that exist for that same crop kind will be contacted to see if they have any objection to the national registration of the variety. An objection by another RC (same crop, different region) can only be based on the candidate variety being assessed as a potential harm to a given crop sector in a given region of Canada (for example, due to disease susceptibility or to significantly inferior end use characteristics). As a result, a restricted national registration (a regionally restricted registration) may be applied by the Registrar (for example, a PRCWRT recommended wheat variety being restricted from being grown in Quebec by the Atelier des Céréals, Quebec's cereal RC, on the basis of Fusarium susceptibility).

Interim registration

The committee may consider a recommendation for interim registration in situations where, after a minimum of one year of testing, the data indicates that a candidate has sufficient merit that it may be eligible for registration. This provision is intended to be used in situations such as:

where a variety proponent brings forward an innovative variety with (a) valuable characteristic(s) not necessarily captured in the merit assessment, viewed as being of benefit to the crop sector and worth bringing to the market quickly. It may be slightly deficient in one or more merit characteristics but its attributes outweigh its deficiencies. Normally such a variety would be considered for interim registration and concurrent (continued) testing for the purposes of full registration;
where a variety demonstrates outstanding merit after the one year of testing. The committee has the option, if they deem it appropriate, of considering the variety for interim registration and further, concurrent testing for the purposes of full registration; and
where a variety is brought forward that is deficient in one or more merit criteria, but the proponent has evidence (presented to the committee) of commercial interest in an identity preserved (IP) production program between the developer and an end user (this can be a tool to allow a variety to establish a niche market in a closed loop system).

Interim registrations are typically recommended for three years initially and would normally involve a condition of generating new data to be brought back to the committee during that time frame in order to support either a request for recommendation of national registration or a request for extension of the interim registration up to a total maximum of five years.

The registrant has the option of coming back to the committee and making a request for an extension of Interim registration for an additional one or two years but the total cannot not exceed five years. They do this by submitting the full data package to the committee including data collected since registration. Interim registrations expire after their designated term.

Reference: 68. (2) (a), Seeds Regulations

Contract registration

Contract registration is available for candidate varieties where biochemical or biophysical characteristics distinguish them from the majority of registered varieties of the same kind or species. Further, it must be shown that these characteristics may cause harm toward varieties registered for traditional commodity markets. For example, high erucic acid rapeseed although valuable, is a threat to the integrity of canola production.

Another example is canola quality mustard as a threat to the integrity of mustard production. To qualify for contract registration, the owner/sponsor of the variety must demonstrate the possibility of industry harm if granted an unrestricted registration.

Contract registration is only a possibility for varieties that may cause harm based on agronomic performance, disease reaction or end-use quality, not based on socio-economic factors. The determination of whether a variety has the potential to cause harm is a scientific process where it is determined whether the variety has the potential to have an adverse effect on the identity of other registered varieties of that crop kind or if the variety or progeny thereof may be detrimental to human or animal health and safety of the environment.

As a general rule, contract registration is not to be used as a substitute for traditional forms of registration (national or interim) in situations where the committee has objected to the registration of the candidate variety based on deficiency in merit. However, the committee may suggest that the candidate be considered for contract registration where there is rationale to do so.

Reference: 68. (2) (c) (i to iv) of the Seeds Regulations

Appeals

Candidate variety proponents are eligible to object to the committee's decision on the basis of:

procedural errors by the committee (including conflict of interest)
erroneous data having been used by the committee
a personal bias on the part of one or more committee members having resulted in a negative outcome

The committee must have a written appeals procedure. The variety proponent will notify the committee quickly with its intent to appeal, and the appeals procedure should be handled in a timely manner so that registration could occur before the next crop season. The appeal should be heard and decided on by an ad hoc independent third-party tribunal with representation from across the value chain (producers, developers and end users) such that none of the members has a vested interest in the variety in question. The result of the appeal along with the rationale should be conveyed in writing to the variety sponsor, the RC, and the VRO.

Conflict resolution

In the event that a stakeholder identifies a situation where the RC has failed to live up to the spirit or the letter of the MOPs guidance document, they have recourse to present the issue with a detailed explanation to the Chief, VRO or the Registrar. The VRO has oversight in this area and the Registrar with delegated authority from the Minister of Agriculture and Agri-Food will address any shortcomings, oversight or failure to act in accordance with the MOPs directly with the RC in question. The purpose will be to bring the committee into compliance as soon as possible and to correct any wrongs that may have been committed.

One of the roles of the VRO is to monitor RC meetings and avoid this type of situation from the beginning. If the VRO observes actions or governance out of compliance with the letter and spirit of the MOPs, the office will work directly with the committee to find a solution to bring the committee back into compliance in a timely manner. This is part of the oversight role of the CFIA in the variety registration system.

Glossary of terms

Proponent

A proponent is the person responsible for coordinating all of the pre-registration activity required (including providing recommending committees with all that they require) to meet the requirements of variety registration. This term is used pre-registration at the recommending committee level. It refers to the entities the committees deal with (for example, typically public breeding or private breeding entities or their agents submitting varieties or test data of varieties to the committee(s) seeking evaluation and recommendation for registration).

Applicant

An applicant is clearly defined in the Seeds Regulations (Part III, section 63) and is synonymous with what we refer to as the "Canadian Representative" in our application forms. The applicant may be the same person the committee dealt with as the "proponent" but it is not a requirement. It is the designated Canadian Representative who upon registration becomes the registrant that is important to the VRO. The applicant (syn Canadian Representative) must be a resident of Canada. They are the party held accountable by the CFIA for the registration of a given variety in Canada and they are the sole point of contact except where the Breeder and the Canadian Representative are not the same. In this instance, the VRO deals with both parties on issues of registration and cancellation of registration.

Variety registration

Variety registration is a condition for import and/or sale of seed of a variety in Canada under the Seeds Act (for crop kinds listed in Schedule III of the Seeds Regulations). The eligibility requirements for variety registration are clearly identified in the Seeds Regulations 67.1 (a) to (m) and the actual process of registration is defined in 68. (1), (2), (3). In short, the act of registration is the entering of the variety into the Register of Varieties by the Registrar and the issuance of a registration certificate with a registration number to the registrant. To get to this stage, the VRO verifies the variety meets the definition of a variety (distinguishable, uniform, stable), that the variety name is suitable, that the variety exhibits merit (where this applies), that all of the information required for eligibility is met and provided, that there is a reference seed sample of the variety that will define it for its commercial life, and that there is a recommending committee recommendation (where applicable). In practice, registration occurs at the point at which VRO issues a registration number for a given variety, notifying the Canadian Representative the same day. The registration certificate, signed by the Registrar follows at a later date.

Appendix I: Authority provided under section 65.1 in the Seeds Regulations
(To be included in all operating procedures documents)

Recommending Committees

Reference: 65.1 of the Seeds Regulations

Appendix II: Eligibility requirements for variety registration
(To be included in all operating procedures documents)

Reference: 67.1 of the Seeds Regulations