Procedures for the registration of crop varieties in Canada

Section A - General information

1. Legislation

The Seeds Act and the accompanying Seed Regulations is the federal legislation governing the testing, inspection, quality and sale of seeds in Canada.

Section 3(1)(b) of the Seeds Act states that:

"no person shall sell or advertise for sale in Canada or import into Canada seed of a variety that is not registered in the prescribed manner."

This document clarifies and explains the legislation specified in part III of the Seeds Regulations (sections 63 to 77) concerning the application process and the variety registration system. Companion documents include the variety registration application form, and the appropriate objective description form available for most crop kinds.

Copies of the Seeds Act and regulations and accompanying schedules, procedures, etc. are available on the Canadian Food Inspection Agency (CFIA) website.

2. False or misleading statements

It is an offence under the Seeds Act to make a false or misleading statement either verbally or in writing to an official engaged in carrying out his/her duties under this act. In addition, such statements could result in the refusal or suspension of a registration.

3. Registration

• The Seeds Regulations partitions the list of crop types requiring registration of varieties (Schedule III to the Seeds Regulations) into 3 parts with differing requirements for each part:
  • part I requires pre-registration testing and merit assessment (see Glossary section B.7 for a definition of merit), as well as the basic requirements for applications for variety registration
  • part II requires pre-registration testing as well as the basic requirements for applications for variety registration
  • part III requires basic registration requirements only
• Unless otherwise specified in the certificate of registration, the registration is valid for all provinces and territories of Canada, until such time as the registration is cancelled or suspended, and without any restrictions on the production of seed or commodity.

  For part I and II crop kinds, regional tests normally provide the basis for national registration. A variety is to be entered into official tests in the area(s) of anticipated adaptation. If it is supported by a recommending committee (see section A.9) and granted a registration, it may be imported or sold in all of Canada, except where regional restrictions apply.

• When a variety is registered, a registration number is assigned, the registrant is notified, and the Registrar issues a certificate of registration to the applicant. Only 1 certificate is granted per variety.
• The list of varieties which are registered in Canada is updated and posted on our website annually (a regulatory requirement), however, CFIA currently targets quarterly updates. The list includes varieties that have been granted national, interim, regional, and contract registrations and any regional restrictions that may apply to them, based on regional recommending committees' (same crop) input. As part of a commitment to make synonyms publicly available, all CFIA-known synonyms are listed.
• Where a registration is granted that is limited in duration (Interim registration) or geographic scope (regional restrictions on a national registration), or is made subject to a documented quality system (contract registration, see section A.4), the registrant will receive a notice from the Registrar by registered mail, giving the reasons for the restriction(s) to the registration.

4. Restricted registrations

4.1 Interim registration

1. An interim registration is normally granted for any of 3 reasons and at the discretion of the recommending committee for a crop in a region:
   • production of grain or other commodity for market acceptability tests (to allow a variety close to meeting merit requirements to go out onto the market and prove it has merit; this is a judgement call by the recommending committee) or
   • emergency/crisis reasons (for example disease) to expedite critical technology to market in times of high need
   • to foster innovation – in cases where new technology is being introduced, the committee can expedite registration after as little as 1 year of data (this is in the regulations) in situations where the benefit of introducing the technology outweighs the merit of the underlying variety (as determined by the committee)
2. An interim registration gives all the rights/privileges of full registration, but for a specified period of time only.
3. An interim registration may be granted initially for a period of up to 3 years, if requested by the recommending committee, provided the appropriate fees are submitted. Otherwise, a variety will be granted a 1 year registration.
4. An interim registration may be renewed for additional periods, to a maximum total life of 5 years, after which it automatically expires and is removed from the market.
5. An interim registration may have 1 or more regional restrictions for sale of seed assigned to it as a result of other recommending committees, same crop, object to the national registration in their region. This applies to all forms of registration, including contract registration.
6. There is no provision for an interim registration to be granted for undefined periods of time such as from planting date to harvest date. In the case of a winter wheat variety, if the applicant wishes to have the issuance of the registration deferred until fall, this must be indicated on the application. This would prevent the registrant from selling any seed of the variety until the variety is registered.
7. A minimum of 1 year of evaluation in variety registration trials is required for an interim registration (this is a regulatory mandate; a minimum).
8. Interim registration provides an avenue to proceed with registration of varieties on an interim basis for the reasons stated above (section B.4a) while the testing and/or merit of the variety is being confirmed. Since varieties of crop kinds listed in Schedule III, part III do not require testing or merit assessment, varieties of crop kinds listed in part III are not eligible for interim registration.

4.2 Regional restrictions placed on national registrations

1. certain cases, some varieties may be desirable in 1 region, but could cause serious problems in other regions. Regional restrictions (to sale of seed) on a registration may be granted for crop varieties in those instances where the variety poses a potential threat to agriculture, in specific regions for reasons. By regulation, the objection to national registration in a region is made by the recommending committee for that region and by regulation their rationale for that objection is either for seed/grain quality risks or for disease susceptibility risks such that the variety or its progeny may be detrimental to human or animal health and safety, and/or the environment.
2. For regional restrictions on variety registration, adverse effects are defined as harm to the industry (for example feed wheat in milling wheat or Deoxynivalenol (DON) toxin/Fusarium head blight (FHB) in wheat). Characteristics related to regional adaptation such as lack of winter hardiness do not constitute an adverse effect and neither does pending foreign approvals for the variety (for example had export market related approvals).

4.3 CFIA contract registration (variety registration)

1. This category of registration is used for those varieties where the biochemical or biophysical characteristics distinguish it from the majority of registered varieties and where delivery of the resulting commodity into traditional commodity channels may cause an adverse effect on those channels. Thus, a variety must demonstrate the possibility of causing adverse effects in order to be granted an unrestricted contract registration. This is referred to as the "harm trigger". Examples of contract registered crops  include high erucic acid (C22:1) rapeseed (Brassica napus) and canola-quality Brassica juncea, as well as crops modified to produce cosmetic, pharmaceutical or industrial substances. A requirement of Contract Registration is that a comprehensive a quality control system and document must be developed to address any regulatory concerns under the Canada Grain Act (see below)..
2. The applicant must make available, to the Registrar, a comprehensive quality control system document that describes fully how any and all potentially adverse effects of the variety will be managed. Appendix X provides further information. In the case of wheat and barley, the Variety Registration Office will share the quality control system with the Canadian Grain Commission to determine its acceptability. Applicants are advised to consult with The Canada Grain Commission (CGC) on their quality control system, as part of the process of developing their quality assurance manual. This should be done prior to the variety being presented to the registration recommending committee.
3. The applicant must agree in writing to provide information on the distribution, use and disposition of any seed of the variety or any progeny thereof to the Registrar, upon request. This declaration can be found in the application form.
4. In some circumstances, the production of crops from the variety will be required to be conducted using sufficient isolation distances for the species. This will be required in cases where cross pollination to grain of a traditional commodity type would have a negative effect on the latter crop, or for physical separation to avoid inadvertent mixing of crops.
5. Contract registered varieties along with their accompanying quality control systems may be subject to auditing by CFIA and at the discretion of the Registrar.

5. Eligibility requirements for registration

Varieties are only eligible for variety registration if:

1. the variety or its progeny is not detrimental to human or animal health and safety or the environment when grown and used as intended
2. The representative reference sample of the variety does not contain off-types or impurities in excess of the Canadian Seed Growers Association (CSGA) Circular 6 standards for varietal purity for that class of pedigreed seed (typically Breeder seed is submitted but registered and/or Foundation seed can be provided, given a rationale for it.
3. the variety meets the standards for varietal purity established by the Canadian Seed Growers Association Circular 6 Field Crop Regulations or the Seeds Regulations for a variety of that species, kind or type

4. the variety is distinguishable from all other varieties that were or currently are registered in Canada (CFIA determines this via examination/comparison of the following: pedigree, breeding history, variety description, plants with novel traits (PNT) traits (if applicable), generation Breeder seed is declared, and finally a reference seed sample field grow out (10K plants) and supplemental DNA fingerprinting where called for to make a call.

   Note: this is 1 half of the definition of variety used in the regulations: the other half is "stable"; the variety, as described, as evidenced in the reference seed sample submitted, must be stable across generations for all traits claimed and within normal accepted tolerances for varieties of that crop kind.

5. the variety name is not a registered trademark in respect of the variety
6. the variety name is not likely to mislead a purchaser with respect to the composition, genetic origin or utility of the variety
7. the variety name is not likely to be confused with the name of a variety that was or currently is registered in Canada or is likely to be imported into Canada (for example from the US).
8. the variety name is not likely to offend the public
9. no false statement or falsified document and no misleading or incorrect information has been submitted in support of the application for registration, regardless of intent.
10. the information provided to the Registrar is sufficient to enable the variety to be evaluated. Its name could deceive or mislead the purchaser with respect to the composition, genetic origin or utility of the variety.

Where a variety is not eligible for registration, the Registrar will send the applicant a notice by registered mail, stating that the registration has been refused and the reasons for the refusal.

6. Cancellation (deregistration) of registration

The registration of a variety shall be cancelled if requested by the Registrant. Prior to requesting the cancellation of a registration, the registrant is required to check the variety's pedigreed seed stocks in the market and ensure an orderly removal of seed from commercial streams. There is a 3 year notification period prior to the actual cancellation of a variety in order to allow growers to clear any seed out of the system. The Canada Grain Commission and CFIA developed a joint communications policy for dealing with varieties about to be cancelled. Once a request to cancel a registration is received from the registrant, the Variety Registration Office will publish a list of varieties whose registrations are proposed for cancellation, on the CFIA website. This database is updated annually in early September of each year. Cancellations are coordinated to occur on August 1 of each year (for those meeting the 3 year notification requirement).

Another rare form of cancellation is cancellation for cause by the Registrar; an enforcement tool. Where the registration of a variety has been cancelled for cause, the Registrar will send the registrant a notice by registered mail stating that the registration has been cancelled and the reason(s) for taking this action. By regulation, the Registrar a stakeholder expert consultative body established by CFIA annually for the purpose of providing expert guidance on cancelling a variety, should the Registrar choose to consult.

6.1 The Rationale for Variety Cancellation

The Registrar will cancel the registration of a variety where the variety:

1. has been altered in such a manner as to convert it to a variety that is registered under a different name
2. has been found to be indistinguishable from another variety already registered or known to exist
3. if false or misleading information has been provided for the application for registration, regardless of intent
4. is of a crop kind or species no longer subject to the variety registration requirements (for example crop placement to a new registration category) or
5. upon the request of the Registrant, with the written permission of the breeder of the variety and subject to advance notification in the seed industry (as per the joint Canada Grain Commission and Canadian Food Inspection Agency on notification of intent to cancel a variety posted online (see Section B.5.14)

6.2 The Procedure for Variety Cancellation

Cancellation can be requested by the Registrant in the following ways:

• by amending their application through their My CFIA application account and indicating a request for cancellation in the 'summary of changes' section.
•  by contacting the Variety Registration Office (VRO) or The Pre-Market Applications Submissions Office (PASO) by email, phone or mail.

7. Reinstatement of registration

The Registrar may, upon written request and the submission of appropriate fees, reinstate the registration of a variety. However, there must be just cause for any reinstatement. In the case of reinstatement of permanent registrations cancelled at the request of the registrant, where a considerable period of time has elapsed since the cancellation, the Variety Registration Office may require the involvement of a recommending committee(s) to determine if the variety in question still has merit. In the case of reinstatement of interim registrations, a recommendation for registration from a recognized variety registration recommending committee must accompany the request.

Where more than 1 year has elapsed since the cancellation, a new legal reference sample and an application form will be required to be submitted.

8. Review of registration decisions

8.1 Process

Where the Registrar refuses to register a variety, or grants the variety a registration that is restricted regionally or in duration, or where the registration restricts the manner in which seed or commodity crop is produced (contract registration), the applicant may request that the Registrar review the decision. Similar procedures may be used for the review of the suspension or cancellation of registration.

If there is a valid objection to a registration decision, the Registrar may choose to consult with an expert or group of experts knowledgeable in the area of concern who have no interest in the outcome of the review.

The selected expert(s) will recommend a course of action to the Registrar. The recommendations are not binding on the Registrar.

8.2 Procedures for application for appeal of a registration decision

1. The appellant must make a written request to the Registrar within 30 days of receipt of notice that the decision was made
2. The appellant must include the reasons for requesting the review along with substantiating information or documentation

9. Recommending committees

All committees that recommend varieties for variety registration must be officially recognized by the Minister of Agriculture and Agri-Food Canada for this purpose. Appendix XI lists the currently recognized committees. These regional recommending committees receive their authority from CFIA Seed Section (the Registrar) annually in the form of a signed recognition letter and it is contingent on having successfully completed a CFIA review of their latest (current year) written operating procedures. The names and addresses of the contact persons for each recommending committee is available on the CFIA website.

The roles and responsibilities of recommending committees to make recommendations for crop kinds in parts I and II are clearly defined in the Seeds Regulations.

The recommending committees are responsible for:

For crop kinds listed in part I:

• ensuring members of the committee have the knowledge and expertise required to establish and administer testing protocols and determine the merit for varieties of that species, kind or type of crop
• formulating testing procedures that are appropriate for their crop(s)
• making recommendations to the CFIA respecting the merit of the variety
• regularly reviewing the testing procedures to ensure that they reflect acceptable scientific practices
• ensuring that reference varieties are current and fairly represent the requirements of Canadian agriculture and
• establishing operating procedures to ensure that its functioning is transparent and that varieties are dealt with in a fair and consistent manner

For crop kinds listed in part II:

• ensuring members of the committee have the knowledge and expertise required to establish and administer testing protocols for varieties of that species, kind or type of crop
• formulating testing procedures that are appropriate for their crop(s)
• making recommendations to the CFIA respecting whether the variety has been tested according to established testing procedures
• regularly reviewing the testing procedures to ensure that they reflect acceptable scientific practices
• ensuring that reference varieties are current and fairly represent the requirements of Canadian agriculture and
• establishing operating procedures to ensure that its functioning is transparent and that varieties are dealt with in a fair and consistent manner

10. Descriptions of varieties

As of April 1, 1994, the Variety Registration Office ceased publishing descriptions of registered varieties. Requests for information on specific varieties are referred to the Canadian representative or The Breeder of the variety, however, variety descriptions are public domain and can be provided upon request, to any member of the public as a computer file.

Detailed information describing the variety is still required as part of the application for crop inspection and variety verification purposes. CFIA routinely data shares the description of variety (DoV) data with the Canadian Seed Growers Association who in turn incorporates it into their SeedCert™ database for crop inspectors to access in order to conduct their pedigreed seed field crop inspection role.

11. Confidential business information (CBI)

Although pedigree information, breeding history/techniques and any proprietary disease testing, (as an example), is required as part of the registration review process, it is considered confidential business information (CBI) or in CFIA terms: Category B document (Secret). Similarly, for hybrid crops, the inbred line codes used by companies to identify their parental lines are kept secret; the parental lines are simply referred to as female of variety XYZ and male of variety XYZ. Other legitimate forms of CBI may be withheld upon written request of the Registrant, and consent of the Registrar. The dissemination of potential CBI is subject to the Access to Information and Privacy (ATIP) legislation. The withholding of information from dissemination (other than pedigrees of hybrid crops, breeding history/methods, and any proprietary tests for disease/quality/genetics) will require review by Access to Information and Privacy (ATIP) officials. The Registrant may be required to show just cause under ATIP legislation as to how dissemination would breach confidentiality.

Information on variants/off-types, variety name synonyms, or changes in variety name are considered to be public information and will not be considered CBI.

12. Advertising a variety prior to registration

1. Prior to registration: a company may advertise a variety prior to registration provided all of the following conditions are met:

   • the variety has been supported for registration by a recognized recommending committee (not applicable to varieties of crop kinds in part III)
   • an application for registration with the appropriate fee has been received by the Variety Registration Office (meaning the application has cleared the preliminary review stage and the client was notified of such) and
   • the variety advertisement clearly states "registration pending" or "Pending registration"

   Sales shall not occur until registration is granted.

Section B - Application procedures

1. General

1. Applications and supporting documents submitted must be in 1 of Canada's official languages (English or French)

   Translations must accompany all documents that are in a language other than English or French.

2. Appendix I lists the crop kinds for which variety registration applies.
3. All required fees must accompany applications.

2. How to apply

Applications for the registration of varieties are to be submitted in 1 of the following ways.

1. Using the My CFIA application (highly preferred)
   • This application method combines the application form, fee form, and description of variety form, and is optimized to include all additional information as required for each type of registration
   • Legal reference sample will still need to be shipped to the Variety Registration Office.

2. Using the variety registration application form and sending it to us by email or mail:

   Variety Registration Office
   c/o Pre-market Application Submissions Office
   Canadian Food Inspection Agency
   59 Camelot Drive
   Ottawa, Ontario
   K2G 5X4

   Telephone: 1-855-212-7695
   Fax: 613-773-7115
   Email: cfia.paso-bpdpm.acia@inspection.gc.ca

3. applications for variety registration must be submitted separately from applications for Plant Breeders' Rights
4. applications are processed on a first come, first served basis

5. in the event 2 applications are received by the Variety Registration Office that, based on all available information, appear to be identical varieties, preference will be given to registering the variety with the first complete application, and having an acceptable legal reference seed sample submitted (see also section B. 5.1)

   Where the 2 applications (identical varieties) are submitted by the same applicant, the applicant will be given the option to select 1 variety for registration. The registration of the second variety will be held pending resolution of the varietal distinguishability issue.

   In the event that 2 applications are received for 2 different varieties of the same crop kind with the identical or very similar proposed variety name, preference will be given to the variety with the first complete application (including fees and legal reference sample).

6. in order to facilitate the evaluation process, applications should be submitted as far as possible in advance of the desired period of sale or importation for sale.

   The time required to process complete and accurate applications varies depending on the extent of review required, how complete the applications are and the number of applications pending at any 1 time. Please allow 2 weeks for the completion of the preliminary review, when a check is done on the acceptability of the legal reference seed sample and required documentation. (A more rapid response may be possible if a facsimile number and/or email address is provided). Allow up to an additional 4 weeks for the detailed review of applications. (Crop kinds included in part III may have reduced review time.) After receipt of all required information, a registration decision can normally be made and registration documentation completed within 2 weeks.

   For plants with novel traits (PNTs), an assessment of the food, feed and environmental safety of the variety by the Food Directorate of Health Canada and the Feed Section and the plant biosafety office (PBO) of the Canadian Food Inspection Agency may be required. Also, additional reviews by the Pest Management Regulatory Agency (PMRA) may be required to substantiate claims made with respect to pesticidal tolerances or properties. Such reviews may require up to 120 days. Please see Appendix VII for more details. Please note that a PNT detection method must be submitted prior to a variety registration application for a PNT variety with the same trait, to be reviewed and approved by a subject matter expert in CFIA's Science Branch.

3. Incomplete applications

If an application for registration is incomplete with respect to the submission of fees, the application will not be returned. However, the application will not be considered accepted until fees are submitted and no review will be initiated. If the application is not considered to be received due to lack of fee submission, no advertising of the variety may be undertaken. The order of the review of applications will take into account the day the fees are submitted.

If an application for registration is incomplete with respect to other requirements such as a description of variety, recommendation for registration from a recommending committee, acceptable legal reference sample or photographic slides/ digital images, the application for registration will be retained pending this information.

4. Recognized applicants

Applications for registration shall be made by a permanent resident of Canada to whom any notice or correspondence under the Seeds Act and regulations may be sent. This may be a Canadian representative, or in the case of varieties developed in Canada, the plant breeder.

Upon registration, the applicant automatically becomes the Registrant, unless otherwise specified in the application. For restricted registrations, the registrant must ensure that the terms and conditions of the restrictions are met. As such, the registrant need not be the breeder or owner of the variety. They are the sole party CFIA holds accountable for the registration.

5. Required information

Basic registration requirements (for all applications) for variety registration: (for example for crop kinds in parts I, II and III of Schedule III)

A complete application package, which must be supplied and signed by the applicant, contains the following information:

1. a proposed variety name (see section B. 5.2)

   As of January 1, 1996, a Canadian trademark search is not required to be submitted as part of the application for registration. Applicants are required to sign a declaration that they have not applied for or trademarked the name, or any part of the name, of that variety. The declaration is found in the Variety Registration Application Form (page 1) or within the My CFIA application. However, the Trademarks Office of Industry Canada strongly suggests that applicants have a trademark search conducted in order to identify potential trademark infringements.

2. the scientific and/or common names of the species

3. a complete description of pedigree, origin, history and methods of development of the variety including the experimental test number(s) and the name and location of the breeding organization (see section B.5.3)

   The breeding organizations are those parties involved in parental selection, crossing, progeny selection, etc. and may be different from the owner of the variety. If the breeding organization is different from the owner, please provide the name and location of both the owner and breeder.

4. a detailed description of the variety respecting morphological, pathologic, agronomic, physiologic, and biochemical characteristics (where applicable)
5. a statement as to whether the variety is sold in other countries and if so, by what name(s)

6. particulars of the provisions for the maintenance of seed stocks

   Authorization is required from the breeder of a foreign variety for the Canadian representative to maintain breeder seed in Canada. If there is intent to maintain breeder seed in Canada, this must be done under the supervision of a plant breeder recognized by the CSGA.

7. the name and address of the Canadian representative as well as the names and addresses of the breeder and owner, if different from the Canadian representative

   Telephone and facsimile numbers facilitate rapid communication, as do electronic mail addresses. Unless otherwise indicated by the applicant, all correspondence with respect to the registration or cancellation of a variety will be addressed to the Canadian representative listed on the application form.

8. where the applicant is a person, company or organization other than the breeder or owner of the variety, the application must be accompanied by a signed statement from the breeder or owner of the variety indicating that the applicant has been authorized to apply for registration in Canada (letter of authority)

   If, at any time, there is a change in the Canadian representative of a variety, it is the responsibility of the current Registrant of the variety to inform the Variety Registration Office of the change.

9. for all species except potatoes, a representative legal reference sample of seed (see Appendix II) must be submitted

   In the case of hybrid/composite canola, hybrid alfalfa and hybrid tobacco variety, a sample of each parental line is also required. In the case of hybrid rye, a sample of the technical mix planted in Canada for Certified hybrid rye seed production must be submitted. Unacceptable samples may only be returned upon submission of an acceptable legal reference sample or upon withdrawal of the application. Unacceptable samples however, are typically returned or(less often) destroyed, after registration of the variety (this is a Registrant's decision to make).

10. for hybrid/composite canola, hybrid rye, hybrid alfalfa and hybrid tobacco varieties, descriptions of each inbred parental line and a reproducible hybridity test methodology (see Appendix IV) are required for the purposes of variety verification and seed certification (see Appendix III)

11. for potato varieties, a set of photographic slides or digital images detailing plant morphology, the results of total glycoalkaloids (TGA) testing for cyanogenic compounds in potato, and a description of the TGA test methodology employed are required (see Appendix V)

    It is also recommended that the application package include molecular data identifying the variety and a sample consisting of 2 potato leaf triplet samples (for DNA extraction).

12. the Applicant will be asked if the variety is to be added to the Organisation for Economic Co-operation and Development (OECD) List of Cultivars Eligible for Certification.

    This information is not required for variety registration, nor is there any obligation to add a variety to the list. In most cases, CFIA will not add to the list varieties for which breeder seed is maintained outside of Canada. These varieties should be added by the National Designated Authority of the country in which breeder seed is maintained. Exceptions may be made for varieties from countries not participating in the OECD Seed Schemes. For addition of hybrid canola and sunflower varieties, the applicant must supply a statement confirming that the variety consistently meets the OECD minimum hybridity standard of 90%. Applicants should note that only seed lots of the variety that actually meet the standard can be certified under the OECD Seed Schemes. Transgenic varieties (PNT-GMOs) may be added to the list, but must meet the regulatory requirements of each importing country. Varieties with interim registrations are eligible for addition to the OECD List of Cultivars. Note that "composite" canola and potato varieties will not be added to the OECD list of cultivars.

13. the appropriate fees must be submitted

    This can occur through the My CFIA account application process specific for variety registration or with a "Fee Submission Form" from our website. Review of an application package does not start until there is proof of applicable feeds having been received by CFIA

14. the Registrar may require that the applicant supply further information that will enable the determination of the merit and identity of the variety in question (see section B. 5.1).

Additional requirements for crop kinds in part I

1. The results of valid experimental trials comparing the agronomic and/or quality characteristics of the variety to the performance of the appropriate reference varieties designated by the recommending committees (see section B.5.5)

   The VRO requires the exact same data which the recommending committee used to determine merit of the variety (summary data sets are acceptable).

2. A recommendation that is not more than 2 years old or, in the case of a forage variety, not more than 4 years old, from a recommending committee stating whether the variety has been tested according to recommending committee protocols and whether the variety has merit

   Where support for registration is conditional upon submission of additional information, please ensure that the latter information is supplied in your application.

Additional requirements for crop kinds in part II

1. results of valid experimental trials comparing the agronomic and/or quality characteristics of the variety to the performance of the appropriate reference varieties designated by the recommending committees (see section B.5.5)

2. a recommendation that is not more than 2 years old or, in the case of a forage variety, not more than 4 years old, from a recommending committee stating whether the variety has been tested according to recommending committee protocols

   Where support for registration is conditional upon submission of additional information, please ensure that the latter information is supplied.

5.1 Definition of a variety

A variety is considered to be a cultivar (cultivated variety), and denotes an assemblage of cultivated plants, including hybrids constituted by controlled cross-pollination, that:

1. are distinguished by common morphological, physiological, cytological, chemical or other characteristics and
2. retain their distinguishing characteristics when reproduced

Where a variety has a similar genetic background to a previously registered variety, it may be eligible for registration provided it has merit and is distinguishable from the previously registered variety. The Registrar must be assured that he/she is not registering a previously registered variety under another name. There is also an obligation on the part of the Variety Registration Office to ensure that the registration of a variety will not compromise the varietal eligibility principles upon which seed and crop certification is based (a variety is distinguishable from all others of its kind in Canada and the variety is stable across generations of seed production). The onus is on the applicant to show distinguishability for non-hybrid crops and for hybrid crops where the 2 varieties in question are developed by the same breeding organization. In determining the distinguishability of 2 varieties, the applicant should consider the magnitude and consistency of the differences as well as the heritability of the traits involved.

Currently, varieties will not be registered if distinguished solely on the basis of DNA analyses. By way of explanation, the variety registration system and the seed certification system in Canada are based on phenotypic or visual data. While some varieties may be very similar in their visual appearance, they can often be characterized by chemical properties, functional grain properties, and/or differential reactions to changes in their environment (observable traits). In some cases, these traits may only be observable under certain environmental conditions but they are differential in nature (for example iron chlorosis in soy on iron-deficient soils in the West or near-identical potato varieties which differ in 1 anti-oxidizing gene; a trait visually distinguishable in the processing end of the business but also identifiable via a post-harvest chemical test method).

5.2 Variety name guidelines

1. The proposed variety name indicated on the Variety Registration Application Form will be the name used for all official records including the certificate of registration

   This includes spaces, hyphens and capitalization. Any proposed changes to variety names prior to registration must be submitted in writing.

2. A variety shall be known by only 1 name in Canada

   The name used in the country of origin is the name that should be applied for in Canada. If this name is not acceptable to the Registrar, the Registrar may request that a synonym be used in Canada. An applicant may also choose a synonym for a variety bred outside of Canada.

3. A variety may not bear the identical name to a different variety of the same crop kind marketed outside Canada
4. If a synonym is used the following conditions would apply:
   • only 1 name will be used for the variety in Canada
   • the owner of the variety agrees to the use of the synonym
   • all known names and synonyms must be indicated on the application form
   • all synonyms will be made publicly available by CFIA and
   • it is understood that the use of a synonym in Canada may make the variety name unacceptable for Plant Breeders' Rights in Canada
5. Names with similar spelling must be phonetically different
6. A variety name that is acceptable for variety registration may not be acceptable for Plant Breeders' Rights purposes if the rights have not been granted when the variety is registered
7. The name under which a variety is registered must be identical to the name under which a variety is granted Plant Breeders' Rights. Plant Breeders' Rights legislation is more restrictive as to the conditions under which a variety name may be changed

8. Classes:

   variety names shall be unique, for example not the same as, or very similar to the name of other varieties of the same genus. If they fall within 1 of the following International Union for the Protection of New Varieties of Plants (UPOV) classes, they must be different from all the genera or species in the Class.

   Class 201: Secale, Triticale, Triticum
   Class 203: Agrostis, Dactylis, Festuca, Festulolium, Lolium, Phalaris, Phleum and Poa
   Class 204: Lotus, Medicago, Ornithopus, Onobrychis, Trifolium

   For all crop genera/species subject to registration and not listed in the above classes, each species is considered to be an individual class.

9. A variety name is a generic term and neither the name nor any part of the name shall be trademarked in Canada for use on seed of the variety

   Once a variety is registered, trademarking the variety name will result in the suspension or cancellation of registration.

10. The name of a variety that has been deregistered may not be reused for another variety of the same or similar genus or class
11. Species names, common crop names or names of botanical types shall not be used as variety names

12. Variety names which vary from another variety by the addition of number(s), letter(s), word(s) or symbol(s), are acceptable providing their pedigree indicates direct derivation from the variety to which the suffix or prefix is added

    The proportion of germplasm contributed by another variety should be at least 50% when giving the new variety a name very similar to that of another variety (for example cv. Binbuster and then registration of "Binbuster II" – this means the latter variety must have at least 50% common genetics with the original Binbuster in order to claim use of the word Binbuster in the variety name).

13. Any explicit or implicit claims incorporated as part of a variety name may only be used if they are accurate and verifiable
14. A variety name shall not be such as to be considered offensive

15. When selecting a variety name, consideration should be given to the limitations of seed tags and the equipment used to generate them

    Seed tags must bear the variety name exactly as registered.

16. The Variety Registration Office will not approve variety names prior to the receipt of appropriate fees and an application for registration, or an application for variety name amendment

17. In order to avoid disappointments over variety name acceptability, applicants may wish to review the OECD List of varieties eligible for certification

    Other sources include the Crop Science Registrations in Germplasm Resources Information Network (GRIN), Plant Variety Protection registration and the Union for the Protection of New Varieties of Plants (UPOV) list of varieties. While these sources will not provide a definitive answer on variety name acceptability, they are a good source of information to determine if the proposed name is already in use.

18. Variety name check process

    The VRO and PASO offices conduct name checks on all varieties before they are registered. This name check consists of:

    • a review of the names of all registered varieties (both with and without PBR) in Canada to ensure that there are no varieties in the Canadian market, in that crop class, that have a name that could be confused in the marketplace.
    • a review of international databases (PVPO, CVPO, CGRIN,UGRIN, UPOV, OECD) to ensure that there are no varieties in the world market in that crop class that have a name that could make it's way to the Canadian market and be confused in the marketplace.
    • a generic search to assess if there are other considerations that might affect the performance of the variety in the Canadian marketplace.

19. Naming guidelines for those applying for VR and PBR:

    • Canada has a 1 variety – 1 name policy, meaning that a variety subject to registration under the Seeds Act can only have one name in Canada. Variety name checks are conducted at the time of application to determine their acceptability. A name change can be requested for varieties that have already been registered by the VRO. The denomination used to register a variety must be the same as that used to apply for PBR Protection.
    • The PBRO also applies a 1 variety – 1 name rule, both domestically and internationally, and across all plant species (not just those subject to registration under the Seeds Act). For plant breeders' rights naming guidelines visit Variety naming guidelines

5.3 Description of pedigree/breeding

1. The origin of the variety should include the name and location of the institution(s) involved in the variety's development, the pedigree of the variety, breeding methodology and history, including dates, selection criteria and experimental designations

   The derivation and maintenance of breeder seed stocks should be fully described.

2. In the case of hybrid or composite varieties, an uncoded pedigree and derivation of the inbred (parental) lines must be submitted

   This information is considered confidential and will be treated as such.

3. Pedigree:

   the genetic background of at least the 2 previous generations should be provided. Where the parentage of a variety includes experimental lines, please give the genetic background of these lines. This information is valuable in distinguishing variants and off-types found in seed fields subsequent to variety registration as well as determining the uniqueness of the variety. The pedigree of PNT varieties must trace back to the approved event.

   The use of common pedigree notation to describe the origins of the variety is encouraged. (See Appendix XII: Guide to commonly used pedigree nomenclature systems.)

4. Varieties will only be considered for registration if:
   • they are developed or maintained by a plant breeder recognized by the Canadian Seed Growers' Association, or
   • the seed of the variety has been accepted for certification in the country of origin by an official certifying agency

5. In the case of varieties resulting from recombinant gene technology (transformation), information on the gene(s) inserted, its source and gene products must be provided

   Exact DNA sequence information must be provided to facilitate the generation of genetic markers used for variety verification purposes.

6. If the applicant has previously supplied this information as part of an application for environmental release through the Plant Biosafety Office (PBO), this information will be accessed directly and supplied to the CFIA Variety Verification Unit at the time of registration

   If the applicant is using genetic constructs for which another organization has been granted environmental release, the applicant must submit a letter of permission from this organization to allow access to the DNA sequence information (Confidential Business Information).

5.4 Varietal characteristics

1. The description of a variety (DoV) should include as much relevant morphological information as possible to ensure that seed and crop inspections, as well as variety verification, can be properly conducted

   For certain crops (alfalfa, barley, beans (field), bird's foot trefoil, bromegrass, buckwheat, canola/rape, clover (red), faba bean, fescue, flax, lentils, lupin, mustard, oat, orchardgrass, pea, potato, safflower, soybeans, timothy and wheat), objective description forms have been developed and are available from the Variety Registration Office. These forms list the traits that must be provided for variety registration as well as supplemental traits. For other crops, standard forms are not available but information on relevant characteristics may be obtained from the Variety Registration Office. Where a variety description is supplied in 2 formats: for example on an old CFIA Objective Description Form (ODF) and as a Breeder generated summary page, the onus is on the applicant to ensure that the 2 descriptions are consistent and at a minimum, cover off on all the mandatory descriptors for that crop kind as specified in the current Description of Variety (DoV) forms used by CFIA.

2. Where the description of variety is developed outside of Canada, the onus is on the applicant to ensure that the description is representative of the variety under Canadian growing conditions

   Copies of official variety descriptions, including accepted variants as provided to foreign seed certification agencies should be included with the application.

3. If there is known variability in the variety, details of this must be provided

   If information is available on variants that are considered acceptable this information should be included, as well as the maximum acceptable frequency of occurrence in each class of pedigreed seed. In cases where doubt exists, the applicant may also be asked to provide genetic information on the origin of these variants.

4. Disease reaction information should include resistance and susceptibility to the diseases that are economically important to the specific crop in Canada

   Disease information should be supplied directly by the recommending committee where possible. Data must be submitted to substantiate any claims of insect or disease resistance.

   As of July 1, 1990, alfalfa varieties must be resistant to bacterial wilt (Corynebacterium insidiosum) in order to qualify for registration.

   In order to receive registration in Eastern Canada (meaning Ontario, Quebec, or Atlantic Canada), a wheat variety must have a minimum level of resistance to fusarium head blight or FHB (see Appendix IX). Provincial guidelines within Eastern Canada vary as to the exact requirements.

5. Claims that are made by the applicant, such as quality, insect tolerance, herbicide tolerance, maturity, seedling vigour, etc., of a variety should be substantiated by Canadian scientific data

   It may be appropriate, in certain cases, to include US data. See Appendix VIII for more information regarding herbicide tolerance trial data requirements.

6. If a variety possesses characteristics that would indicate it has a particular use or market, the variety description should include a statement as to its potential utilization

   Claims of specific strengths for example tolerance to herbicides, must be supported by valid scientific data. This information may also be required by Industry Canada under the authority of the Competition Act. All claims to be used in advertising must be submitted at the time of application for registration.

7. Photocopies of objective description forms completed for the variety for Plant Breeders' Rights purposes may be submitted if:

   • it is clearly marked on the photocopy that the submission is for Variety Registration Office use, and
   • information has been provided for the traits required for variety registration purposes

   The submission of information for "non-mandatory" traits is useful to the Variety Registration Office in determining rapidly if the variety can be distinguished from a previously registered variety or if a subsequent candidate variety is distinguishable.

8. If an application is made for both Plant Breeders' Rights and variety registration, the onus is on the applicant to ensure that descriptive information submitted for variety registration purposes does not contradict descriptive information submitted for Plant Breeders' Rights purposes

   The applicant must also ensure that both offices are individually informed of changes to the applications or to descriptions of variety.

9. Other than the addition of supplementary information, variety descriptions will not be amended more than 2 weeks after the CSGA deadline for applications for crop inspection for the crop kind in question

   After crop inspections are completed, variety descriptions may be amended as required.

10. The breeder may require additional certification standards for a variety provided that the additional standards are defined in the variety description and the following CSGA requirements are met:

    • the additional certification standards have been communicated by the responsible Plant Breeder or agent to all parties involved with regulation and production of the variety and
    • when required to verify varietal identity, the CSGA has been authorized by the responsible Plant Breeder or agent to require varietal purity verification testing before a Crop Certificate is issued by the CSGA

    Examples of additional certification standards include previous land use or isolation distance requirements that exceed the standards in Circular 6, border row removals or requirements for laboratory tests for varietal identity verification.

5.5 Experimental data

1. The applicant must submit the experimental data used by the recommending committee in supporting the variety for registration directly to the Variety Registration Office

2. Unless recommending committee protocols indicate otherwise, only data considered by the recommending committee in supporting the variety for registration should be included in the application

   The complete package of information (data, notes, etc.) that the committee used to make the recommendation decision should be submitted to the Variety Registration Office. This would include decisions to object to, or to not support the registration of a variety. Other data to support claims of variety performance (see section B.5.4 (e), (f) and (g)) should also be submitted.

3. Data used by a recognized recommending committee in making a recommendation decision, when quoted to support a variety for registration must be used in its entirety without "selection" and are subject to approval by the appropriate recommending committee
4. Actual experimental data including a summary of the agronomic performance must be included. Summarized merit scores are not acceptable in lieu of actual data

5.6 Signed and dated declaration for plants with novel traits (PNTs) and for varieties derived from PNTs

For plants with novel traits developed by genetic engineering or by traditional plant breeding using transgenic parents, the applicant must:

1. submit a signed, dated declaration on the letterhead of the applicant organization with the variety registration application (1 declaration per variety), indicating that molecular tests conducted on seed of the variety entered in variety registration trials, and also the seed contained in the legal reference sample submitted for registration, confirm the specific genetic makeup of the variety (for example that they contain the appropriate construct and insertion or mutation event and only that event) and

2. provide the detailed CFIA reviewed and approved* laboratory detection protocols used to conduct these trait detection tests

   If the protocols have been previously submitted to the CFIA-Variety Registration Office (VRO), it is acceptable to indicate that the samples were analysed using the specific approved protocol. The protocol reference number (including version number) must be cited in the declaration

In the case of potatoes, the declaration should indicate that tests were conducted on seed potatoes entering the variety registration trials and the seed certification system.

Applicants are encouraged to submit new PNT detection protocols (see Appendix VI) well in advance of variety registration application, to allow time for CFIA to review and approval the protocol prior to a variety registration application. Any revisions to an approved protocol should be sent in to the CFIA-VRO for review and approval as soon as possible to avoid delays in a variety registration application.

5.7 Support for registration

Variety Registration Regional Recommending Committee recommendations for varieties of crop kinds in part I are based on pre-registration testing and determination of merit.

Recommending committee recommendations for varieties of crop kinds in part II are based on pre-registration testing only.

To speed the processing of all registration applications, a copy of a letter or motion of support from the registration recommending committee must be submitted directly by the applicant. The recommendation may not be more than 2 years old, or in the case of a forage crop variety, not more than 4 years old.

Please note that no recommendation support is required for varieties of crop kinds in part III (the non-merit based minimum requirements tier for registration).

5.8 Fees

As of December 1, 1997, fees came into effect for the evaluation of variety registration applications, and related services. While fees were frozen for decades, fees are now being adjusted for inflation (see below). If applying through My CFIA, the appropriate fee will be invoiced to you after you submit your application electronically. If applying using email or mail, please ensure that a separate Fee Submission Form is included in each application package along with the appropriate fee (see Appendix XIII). Once an application review has been initiated, no refund will be issued.

The CFIA Fees notice sets out the fees for each activity within the Variety Registration Office (part 14, table 2, and section 6). These fees are updated annually on March 31 based on the Consumer Price Index. If applying using email or mail, please check the Fees Notice prior to your submission to ensure you are including the correct amount on your Fee Submission Form. If applying through My CFIA, no additional action needs to be taken as the system will update the fees internally.

5.9 Legal reference samples

1. The reference samples submitted for variety registration are legal samples for use in monitoring varietal purity of seed lots offered for sale in Canada and may be used as evidence in a court of law

   The submission of an improper or non-representative sample for a variety could result in a variety not being registered, seed lots being rejected for pedigreed status and/or the cancellation of a registration.

2. Requirements for the Breeder seed reference seed sample (see checklist in Appendix II)

   Seed sample bags must bear an outer tag as a minimum.

   It is recommended that a CSGA Breeder seed tag is used, however, a plant breeder generated tag is still accepted. These tags can be obtained from the CSGA at no cost. For breeders using tags other than those provided by the CSGA, the following information must be included on the tag:

   • variety name (experimental number is acceptable if the name is not finalized)
   • crop kind
   • lot number (if applicable)
   • crop certificate number
   • pedigreed status and
   • signature of the CSGA recognized plant breeder (this is the plant breeder attesting as to the contents of the reference seed sample bag containing seed representative of their variety)

   Although the CSGA breeder tag indicates it may be signed by a Canadian agent, this is not acceptable for variety registration purposes.

   Foreign produced samples

   The sample must bear a tag that states the year of production and:

   • is from an official seed certification agency or
   • that contains the equivalent information required for a CSGA breeder seed tag (see above) including the signature of the plant breeder who developed the variety

   Where samples are submitted with tags from a European seed certification agency, information must be provided on:

   • the generation of the seed expressed as the number of generations prior to certified seed and
   • the number of generations from breeder seed that are allowed in total

   Failure to provide all of the above information will result in a sample being rejected.

3. Where Breeder seed is not available, Select or Foundation seed may be acceptable provided that it is:
   • tagged with an official tag issued by a seed certification agency and
   • accompanied by a letter from the breeder explaining why breeder seed is not provided

4. Requirements for hybrid or composite seed samples

   Seed samples of all hybrid or "composite" varieties of Brassica spp, hybrid alfalfa, hybrid tobacco or hybrid sunflower varieties shall be of the first generation of pedigreed seed to be offered for sale (for example certified seed.) Samples must be tagged with tags issued by an official seed certification authority.

   If such seed is not available, hand-pollinated seed or seed produced in isolation cages under the breeder's supervision may be submitted as a legal reference sample provided the following conditions are met:

   • the seed is produced under the direct supervision of a plant breeder recognized by the CSGA
   • the sample is accompanied by a declaration signed by the breeder indicating the manner in which the seed was produced and indicating that the seed is representative of the variety
   • the seed is properly sealed and tagged with the variety name/experimental number, lot number and signature of the plant breeder and
   • the breeder commits in writing to provide a certified seed sample within 1 year of registration

   Seed produced by hand pollination or in isolation cages is not eligible for sale by variety name.

5. Inbred or composite parental line

   For varieties of hybrid or composite canola, hybrid alfalfa and hybrid tobacco, the inbred or composite parental lines must be submitted in a seed envelope which has been well taped shut and labelled with the following information:

   • variety name
   • lot number
   • crop certificate number (where applicable)
   • name of parental line and
   • indication of whether it is the female or male parent of the variety

6. Samples and tags must either be sewn or tied and fastened with a tamper-proof seal. When samples are submitted in seed envelopes, they should be well taped shut and the tag well taped to the outside.

   The container should be of 1 of the following types of material:

   • cotton or woven poly bags (most desirable)
   • Manilla cardboard sealable seed envelopes (large sample size)
   • heavy paper bags (double bagged, sealed)

   Samples submitted in sealed plastic bags (for example zip loc™ plastic bags) will not be accepted as this packaging is detrimental to the longevity of the seed. Seed must be submitted in new containers and must be shipped in a manner to ensure the intact arrival.

7. Sample sizes must conform to the requirements listed in Appendix II

8. The sample should not be treated with any pesticide, as seed treatments may cause problems with certain types of laboratory analysis

   In addition, some delivery agents will not transport seed treated with pesticides unless specially packaged.

9. Samples submitted from a crop harvested more than 1 year prior to application must be accompanied by a germination analysis conducted by a recognized laboratory no more than 6 months prior to sample submission conducted
10. Legal reference samples must be at least Foundation No. 1 grade for purity and minimum Foundation No. 2 for germination
11. All legal reference samples originating from outside of Canada must be sent via the Canadian representative
12. The VRO in conjunction with the SSU at OPL-Fallowfield will determine if a submitted sample is acceptable. If a sample is deemed unacceptable, a new reference sample must be provided as soon as possible (subject to time of year/growing season).

    Samples submitted may be deemed unacceptable in the following circumstances (not exhaustive):

    • Packaging failure
    • Inappropriate amount provided (too much or too little)
    • Unlabeled, or illegible label
    • Poor germination at time of planting variety verification samples
    • Treated seed
    • Poor seed quality/high moisture
13. Unacceptable samples may only be returned upon submission of an acceptable legal reference sample or upon withdrawal of the application

5.10 Interim registration renewals/reinstatements

When applying by My CFIA, request your renewal/reinstatement via the 'Amendment' application type. Complete the application, and indicate in the 'Summary of Changes' section that you are requesting a renewal/reinstatement.

When applying by email or mail, the registrant must submit:

1. a letter requesting the renewal/reinstatement of registration
2. a recommendation from a recommending committee supporting renewal/reinstatement for the variety and
3. a current CFIA description of variety form (DoV) for the renewal or for a new national registration
4. the appropriate fees along with the fee submission form

The onus is on the registrant to ensure interim registrations are not allowed to expire. If the interim registration of a variety has been allowed to lapse for a period greater than 1 year, for crops other than potatoes, a new legal reference sample must be submitted.

If an application for renewal (with applicable fees) is received prior to the expiry date, the application will be considered to be a renewal. If the application is received after the expiry date, the application will be considered to be a reinstatement and appropriate fees will apply.

5.11 Extension of regions of registration

All registrations (part 1 and part 2 crop kinds) involve a recommending committee. Some crop kinds in Canada have more than 1 of these regional recommending committees. When a variety is reviewed and recommended by a registration recommending committee, it starts off as a national registration for that region. If it is the intent of the Registrant to extend the registration geographically beyond the original committee that recommended it, the other committees are approached by CFIA to see if they object to the national registration of that variety (if they object on the basis of disease or quality issues that present a threat to crop production in their region, then a regional restriction for that region is applied to the registration.

If the Registrant wishes to pursue a country-wide registration (no restrictions) then:

1. a letter requesting the extension of regions of registration and
2. a letter from the appropriate registration recommending committee indicating they do not object to the registration of the variety in the region of its jurisdiction

5.12 Changing a variety name after registration

A variety name may be changed following registration.

When applying by My CFIA, request your name change via the 'Amendment' application type. Complete the application, and indicate in the 'Summary of Changes' section that you are requesting a name change.

When requesting a name change via email or mail:

1. a written request by the Canadian representative indicating an acceptable alternative name
2. written permission by the breeder or owner of the variety (where applicable)
3. a completed page 1 of the Application Form indicating if Plant Breeders' Rights have been applied for or granted and whether the variety is sold by any other name(s) in other countries, as well as an original signed declaration that a Canadian trademark has not been applied for or received for use of the name or any part of the name on seed
4. the applicable fee along with a Fee Submission form for variety registration and
5. the original certificate of registration, so that an amended certificate can be issued

The name under which a variety is granted plant breeders' rights must be identical to that under which the variety is registered. A separate application and appropriate fees must be submitted to the plant breeders' rights office. Under Plant Breeders' Rights legislation, there are limited circumstances under which a name change may be accepted.

5.13 Inactive applications

Applications are considered inactive when no correspondence has been received from the applicant within 1 year of written notification that an application is incomplete. Inactive applications will be closed.

An application may be withdrawn or cancelled at any time, upon the written request of the applicant.

Prior to closing an inactive application, the Variety Registration Office will contact the applicant, in writing, to notify them that their application is inactive and will be closed if no response is received within 60 days. Applicants may request, within the 60 days, to re-activate the application and gather the required information. Re-activation of an application may require the submission of a new legal reference sample.

The Variety Registration Office will notify the applicant in writing once an application is closed. Submitted reference samples will then be returned to the applicant.

Note: Once an application is withdrawn or closed, a new evaluation fee must be paid if the applicant wishes to re-apply for registration (see Appendix XIII).

5.14 Deregistration/cancellation of registration

A variety may be cancelled (syn. deregistered) at any time upon the written request of the registrant with written permission of the breeder or owner of the variety (where applicable). Prior to requesting cancellation of a variety, the Registrant is required to check the availability of pedigreed seed and/or develop a disposal plan acceptable to seed growers in possession of pedigreed seed of the variety.

6. Obligations of the registrant following registration

1. Publicly generated co-operative tests or other data quoted in advertising a registered variety for sale must be used in its entirety and are subject to approval by the appropriate recommending committee

2. The registrant must notify the Variety Registration Office of any proposed changes to the descriptive information of a variety including the designation of variants and off-types, as well as changes of Canadian representative and distributor

   This information must be provided separately from information submitted to the Plant Breeders' Rights Office. Any changes to descriptions of variety submitted to the Variety Registration Office will only be made after consultation with area CFIA inspection staff, variety verification personnel and other affected parties. Changes to official descriptions will not be made during the growing season (see section B.5.4 (j)).

3. For those varieties added to OECD Seed Schemes List of Varieties Eligible for Certification, the registrant must provide the description of the variety and legal reference samples to OECD seed certification authorities upon request
4. The Registrant must not trademark the variety name, or any part of the name, following registration
5. Registrants are responsible for ensuring that all terms and conditions of restricted registration are complied with
6. Registrants are responsible for submitting legal reference samples that are properly tagged and sealed, to the Variety Verification Unit, upon request
7. The Registrant must notify the Variety Registration Office if a variety registered for sale in Canada is granted a synonym in another country after its Canadian registration is granted
8. For varieties with novel traits, Registrants are responsible for providing updated molecular testing protocols (see Appendix VI) for the detection of transgenes when updated by the laboratory conducting the analysis

9. For varieties with a contract registration, Registrants are responsible for providing updated quality control system manuals (QSMs)

   Where the Canadian Representative or Registrant of a variety with contract registration changes, a new quality management system manual will be required to reflect any relevant variation in handling along with the commitment of the new representative to the quality management system. (See appendix X)

10. For hybrid and composite canola varieties, registrants are responsible for providing updates to hybridity testing protocols (see Appendix IV)

    Crop certificates may not be issued for crops tested using unapproved protocols.

11. Brand names may be used in advertising in association with registered variety name if the brand name is conspicuous and legible, for example: if a company has a brand called "DMX" and a variety registered as "1234", then the company can advertise the variety using 1 of the following methods:

    DMX^TM 1234 or DMX® 1234 or DMX Brand 1234
    It is not acceptable to advertise the variety as: DMX1234 or DMX 1234.

    Note: only the name by which variety is registered can be used on an official label (for example the seed tag), for example "1234".

7. Glossary

Canadian Representative

Unless otherwise stated, the Canadian Representative is the official Registrant of a variety and is responsible for ensuring compliance with the Seeds Regulations and for all other obligations of the Registrant following registration. The Canadian Representative will receive all correspondence regarding the variety and may authorize the voluntary deregistration of the variety (with permission from the breeder). Any correspondence regarding any legal action taken with respect to the variety is directed to the Canadian Representative.

Composite Canola variety

A plant population in which a specified minimum percentage of the progeny result from the crossing of parental lines (are hybrid). For Brassica napus composite varieties at least 70% of the progeny must be hybrid and for Brassica rapa at least 50% of the progeny must be hybrid. For both species the rest of the progeny are from sib mating and/or selfing of the parental lines. The seed sown to produce a composite canola is an interim seed class (Select Synthetic class) and is the result of a controlled, specific blending of either Breeder Seed class and/or Foundation Seed class seed of the parental lines of the variety.

Note: At this time only 2 component (2 parental line) composite varieties will be considered for variety registration.

Distributor

A distributor generally handles the marketing and sale of seed of a variety.

Forage type oats, triticale and peas

Varieties that are sold as being for herbage or whole plant harvest for livestock feed. Does not include varieties marketed for production of grain for livestock feed.

Home garden potato variety

A potato variety that is not being sold for the table stock or processing market; seed acreage is restricted to a maximum of 1 hectare.

Merit

Equal or superior to appropriate reference varieties with regard to any single characteristic or combination of characteristics that renders the variety beneficial for a particular use in a specific area of Canada.

Off-type

A plant that deviates in 1 or more characteristics from the official description of the variety and is not in any way part of that variety; it does not belong.

Official certifying agency

An organization in a foreign state that is empowered by the government of that state to certify seed crops and seed as to the varietal purity thereof where that state is

1. a participating member of the Organisation for Economic Co-operation and Development's schemes for the varietal certification of seed moving in international trade for that kind or species, or
2. a member of the Association of Official Seed Certifying Agencies.

Plants with novel traits (PNTs)

A plant variety possessing a characteristic that is intentionally selected or created through a specific genetic change and is either not previously associated with a distinct and stable population of the plant species in Canada or expressed outside the normal range of a similar existing characteristic in the plant species.

Plants derived from PNTs

A variety that results from traditional plant breeding using a PNT as a parental line.

Registrant

The party who receives the certificate of registration and to whom correspondence is directed regarding any legal action taken with respect to the variety.

Variant

Any seed or plant which:

1. is distinct within the variety but occurs naturally within the variety
2. is stable and predictable with a degree of reliability compared to other varieties of the same kind, within known tolerances
3. was originally part of the variety as released and
4. is not an off-type

Appendices

Appendix I: Crops kinds subject to variety registration

Appendix II: Legal reference sample size requirements and checklist

2 kilograms

• Barley
• Faba bean
• Field bean
• Oat
• Pea
• Rye
• Soybean
• Triticale
• Wheat

500 grams

• Alfalfa
• Bird's-foot trefoil
• Bromegrass
• Buckwheat
• Canarygrass
• Canola
• Clover
• Fescues
• Flax
• Lentil
• Lupin
• Orchardgrass
• Rapeseed
• Ryegrass
• Safflower
• Sunflower
• Mustard
• Timothy
• Wheatgrass
• Wild Rye

5 grams

• Flue cured tobacco, hybrid tobacco
• Parental lines of hybrid and composite canola
• Parental lines of hybrid alfalfa

1 gram

• Parental lines of hybrid tobacco

Germplasm preservation

To support the preservation of varieties adapted to production in Canada, Plant Breeders are encouraged to deposit a representative Breeder seed sample of each non-hybrid crop variety developed in Canada in the national plant germplasm bank in Saskatoon, as part of the permanent national collection. A copy of the variety description and a representative sample of the variety (minimum 12,000 seeds) are usually sent at the time of applying for variety registration or certification eligibility recognition to:

Plant Gene Resources of Canada
Agriculture and Agri-Food Canada, Saskatoon Research Centre
107 Science Place
Saskatoon SK S7N 0X2
Telephone: 306-385-9465
Fax: 306-385-9489
Email: aafc.pgrc-rpc.aac@agr.gc.ca

(See "Canadian Regulations and Procedures for Production of Breeder Seed Crops" available on the CSGA website)

The gene bank sample (different from the mandatory legal reference sample required for variety registration) will be available to the scientific community for research and breeding purposes only.

Checklist for reference samples

It is recommended that a CSGA seed tag is used unless the sample is coming from a foreign country. It is also beneficial, at your own discretion, to scan or digitally capture an image of the seed tag and email to the Variety Registration Office for verification before sending in the sample. Our email address is: vro-bev@inspection.gc.ca

Breeder seed samples

For all breeder seed tags, ensure the following are clearly labelled on the tag:

• variety name (experimental number is acceptable if the name is not finalized)
• crop kind
• crop certificate number
• pedigreed status
• signature of the CSGA recognized plant breeder
• lot number (if applicable) and
• name of company (optional)

Foreign produced samples

• year of production is on the tag
• tag is from an official seed certification agency or
• contains the equivalent information required for a CSGA breeder seed tag (see above) including the signature of the plant breeder of record for the variety

Where Breeder seed is not available, Select or Foundation seed may be acceptable provided that it is:

• tagged with an official tag issued by a seed certification agency and
• accompanied by a letter from the breeder explaining why breeder seed is not provided

Please note the additional requirements for reference samples:

• samples must be properly sealed and not enclosed in plastic
• no pesticide treatments are permitted
• samples must meet Foundation No. 1 grade for purity and Foundation No. 2 for germination

Germination analysis is required for samples that are produced more than 1 year prior to the time of application for registration.

Appendix III: Registration policy for canola/rapeseed varieties

1. A canola/rapeseed variety is to be entered into official tests in the area(s) of anticipated adaptation

   If a variety is intended to be sold in Ontario or other provinces in Eastern Canada, as a minimum, it must be entered into trials conducted by the Ontario Soybean and Canola Committee (OSCC). If a variety is intended for sale in Western Canada, it must be entered into trials sponsored or conducted under the auspices of the Western Canada Canola/Rapeseed Recommending Committee (WCC/RRC).

2. If a canola/rapeseed variety is tested and supported in the Prairie region, Ontario, and Atlantic Canada then it will automatically be granted a national registration

   In view of the major difference in acreage of canola between Eastern and Western Canada, it is not acceptable to test a spring variety and receive support from 1 of the committees east of Manitoba, then request a national registration for it. If a spring canola/rapeseed variety is tested and supported in Eastern Canada but is not considered and/or supported by the WCC/RRC, then it will be granted a regional registration for Eastern Canada only.

3. If a spring canola variety of Brassica napus is supported for registration in Western Canada, the Variety Registration Office will contact the Ontario committee to determine if they object to the variety being granted a national registration

   There may be objection to the registration in Ontario due to excessive levels of free fatty acids and this may result in a regional registration.

4. Maximum allowable levels of erucic acid (C22;1 fat) allowed in Foundation seed of canola must be submitted with the application

   For hybrid canola varieties, these levels must be provided for the certified hybrid seed. For composite canola varieties, these levels must be provided for the Select Synthetic seed class. Standards for maximum levels of erucic acid should be set at levels consistent with the new definition of canola were implemented on August 1, 2001. For further information please contact the Canola Council of Canada at 204-982-2100.

5. Composite and hybrid varieties:

   it is a requirement for the registration of hybrid canola varieties that the methods and procedures used to test the hybridity of the variety (see Appendix IV) must be submitted with the variety registration application package. These must be of acceptable accuracy and sufficiently detailed to allow the replication of testing by Canadian Food Inspection Agency staff.

Once a variety is registered, no changes may be made to the source of male sterility used for the inbred lines or to the seed production methodology. Such changes may result in agronomic changes to the variety and/or may change the variety such that it becomes identical to a variety registered under another name. Changes to sterility source and seed production methodology may also alter the variety so that it no longer conforms to the legal reference sample of the variety.

The progeny of the "composite" method may differ from the progeny of identical parents produced using the traditional hybrid method. The progeny of 1 composite variety could differ from the progeny of another composite variety using the identical parents if the proportions of parents used to produce composite select seed differ. The applicant will be required, where appropriate, to demonstrate the differences between the varieties for seed and crop inspection purposes.

In describing varieties developed using "composite" canola production practices, the applicant must state the proportion of each component (hybrid and self/sib) within the progeny, each component must be described, and a testing methodology that can be used to verify the identity and purity of the variety must be submitted. The exact proportion of each component must be stated along with suggested appropriate tolerance levels for inherent biological variation.

At this time, composite varieties developed using more than 2 parental lines will not be considered for variety registration. Also, composite varieties are not being entered onto the Organisation for Economic Co-operation and Development (OECD) Seed Scheme List of Cultivars. For both hybrid and composite canola varieties, the applicant must supply descriptions of each inbred parent or parental line of a composite as well as the hybrid or composite variety.

For addition of hybrid canola and sunflower varieties, to the OECD List of cultivars, the applicant must supply a statement confirming that the variety consistently meets the OECD minimum hybridity standard of 90%. Applicants should note that only seed lots of the variety that actually meet the standard can be certified under the OECD Seed Schemes.

Appendix IV: Guidelines for submission of molecular hybridity test methods (Canola as a case model)

Purpose

Section 5.5.5 (e) (Certified Production of Hybrid Canola) of the Canadian Seed Growers' Association's (CSGA) Circular 6 document (Canadian Regulations and Procedures for Pedigreed Seed Crop Production) specifies that: "Percent hybrid seed shall be determined by a method approved by the CFIA". The 'Guidelines for Submission of Molecular Hybridity Test Methods for Approval by CFIA' (this document) is intended to outline content requirements for acceptance of these methods by CFIA.

Background

Section 5.5.5 (g) of CSGA Circular 6 requires that the hybridity test method name or number, number of seeds tested and confidence level of the test be reported on the Declaration of Per Cent Hybrid Seed (CSGA Form 180). The majority of methods currently used include morphological evaluation using grow-out in field and/or growth chamber. However, increasingly, genetic evaluation procedures (DNA or protein based) are being submitted.

The CFIA is accredited by the Standards Council of Canada to ISO/IEC (International Electrotechnical Commission) 17025 (the International Organization for Standardization's 'General requirements for the competence of testing and calibration laboratories'). This accreditation requires that each test method used be validated to determine "fitness for purpose" and measurement of uncertainty prior to use. Submitted methods may be used for monitoring and enforcement by the CFIA, therefore, it is important to ensure that these methods are fit for purpose, and will meet the ISO 17025 requirement.

Molecular test methods submitted for approval as part of the variety registration process must be presented in a step wise fashion with sufficient detail to allow replication within a CFIA laboratory. Information on sample size, replicates, extraction procedures, expected result, data interpretation and acceptance criteria along with supporting validation data and appropriate references must be included. Factors that will be examined during the course of the review:

• is the method applicable to seeds
• is it a method that can be used to determine % hybridity
• is it scientifically logical
• is the protocol clear and complete
• does the protocol require the reviewer to make any assumptions
• is there potential for cross reactivity
• is there a limit of detection and does this influence the results
• can it determine % hybridity with the appropriate confidence
• has data been provided to support the claims and illustrate the method performs as stated

The additional information below describes in more detail, the content that will be examined during the course of a method review. Currently, method reviews are paper based evaluations only. Because of this, the reviewer does not guarantee a method will perform as expected on the bench. The reviews are advisory only and no endorsement for use of the method in any way other than that required by the Seed Section for variety registration purposes is given. Over time, different reviewers may be consulted by Seed Section, and thus each review is carried out as a completely independent process. Only the information contained within the package submitted to the reviewer is evaluated during an assessment and so each package must be complete and make no reference to previously submitted documents.

The length of time required to determine that a method is reproducible and of acceptable accuracy is dependent on the complexity and completeness of the submission.

The time to complete a CFIA review of a Hybridity determination protocol will depend on the workload of the reviewer at any given time, and on the accuracy of the protocol in addressing all the aforementioned aspects of the protocol. In general, it is reasonable to assume that an accurate, complete protocol will complete a review in 30 days or less but this may extend during labour intensive periods within the CFIA. For this reason, applicants are encouraged to send their protocols in prior to an actual variety registration application.

Additional information

The following is a more detailed description of the content examined during a method review. Any format for submission is considered acceptable, as long as all relevant information is included within the documentation provided to the reviewer.

1. Title: the applicable crop and varieties are specified, and general method employed: test number, version number, date, and number of pages should appear on each page of document

2. Scope: outlines the how the method would be used

   It must be clearly stated that the method is applicable to seed or plants grown from individual seeds. It must be clearly explained how it can determine % hybridity.

3. Definitions: abbreviations or unique terminology should be defined

4. References: all documents/software/statistical analysis packages/publications etc. should be included

   Sufficient detail should be provided to facilitate retrieval by the CFIA if required.

5. Reagents and solutions: all required chemicals, kits, reagents, etc. must be disclosed

   Recipes for all solutions used must be disclosed.
   Primer/probe sequences must be disclosed.

6. Equipment: all equipment used must be listed
7. Software: all required software used for the data analysis and interpretation must be referenced

8. Critical points: any reagent/solution/equipment/or software that cannot be substituted should be identified

   Examples would include specific primer sequences or internally developed software applications. As well, any specific aspects of the protocol that are considered critical should be noted as well.

9. Controls: all controls required must be described – positive and negatives for male/female/hybrids, variety (ies) for x-reactivity, etc., legal reference material, etc.

10. Procedures the individual steps an analyst must follow a logical progression

    These usually include, but are not limited to:

    1. sub sampling\working sample collection and prep:
       How are the samples collected/counted? What environmental conditions must be considered, storage, etc.?

    2. extraction/sample processing:
       does the sample require processing prior to extraction and how

       How to extract the DNA/protein? If a kit is used, are any steps modified?, etc.

    3. Polymerase Chain Reaction (PCR):
       components of the master mix and cycling conditions, controls, etc.
    4. visualization:
       Procedure for visualization of the results – ELISA plate reader, gel-based, etc.

    5. data recording:
       What raw data is recorded and how is it captured

       For hybridity testing, the data should also summarize: total number of seeds analyzed, the number of failed reactions, number of males/females/hybrids and number of variants or off types identified.

    6. Computations:
       an example of the computation(s) performed
    7. Interpretation:
       an explanation of how to interpret the raw data produced, as well as the final computed data
    8. Acceptance criteria:
       a description of the conditions that must be met in order for the data set to be acceptable (for example results of positives, negatives, correct, etc.)
11. Supporting data: molecular sequence information (targeted regions) should be provided
    Examples of visualized data showing the expected performance of all controls, lack of cross-reactivity, etc.

Appendix V: Registration policy for potato varieties

1) Description of Variety (DoV) form

If applying via My CFIA, the DoV is included in the application process.

If applying via email or mail, a completed Potato Description of Variety Form (DoV) must be submitted along with the application for variety registration. If the applicant has applied for Plant Breeders' Rights (PBR), the ODF or Objective Descriptive form completed for PBR purposes may be submitted along with the supplemental potato objective description form (ODF/S) describing traits in Appendix I of the Variety Registration Potato DoV. In the DoV for potato varieties, the registrant shall provide 3 definitive identifying plant morphological characteristics that differentiate this variety from another.

2) Colour slides

Applications for registration of potatoes must include 1 digital colour image of each of the following characteristics of the candidate variety. The recommended background colours for each slide are indicated in brackets.

1. a typical tuber, (black, blue or tan)
2. the apical end of the tuber, (black, blue or tan)
3. a tuber cut lengthwise, (black, blue or tan)
4. a typical sprout, (black)
5. a typical complete inflorescence, (dark background or black)
6. a typical flowering plant in the field, (black, blue or tan)
7. a typical compound leaf, (black, blue or tan)

The digital images must be taken in such a manner that the subject makes up at least 60% of the photograph. Each slide must be labelled with the variety name. A complete set of images is required for permanent and new Interim registrations.

If the quality of the digital images is not satisfactory, the Variety Registration Office and/or the Potato Section reserve the right to request that a new set of images be submitted.

If applying via mail, the digital photos must be submitted on Compact Disk (CD) media along with a signed and dated, hard copy of the colour photos and a signed Digital Photo Declaration Form (below). If applying via email, the digital photos can be included electronically in jpg format. If applying via My CFIA, please upload your pictures directly into the application.

The CD must be labelled with the following information using a permanent marker

• Proposed variety name
• Experimental designation
• File names

Image specifications

• The original unmodified image file must be sent for the purpose of variety registration
• jpeg file format (or Tiff or RAW format if available)
• Highest quality, highest resolution, lowest compression available on the camera (not less than 3 megapixels)
• Largest image size available on the camera (for example: 2272 X 1704, large)

Note: The jpeg file format will compress the photo/image. Compression results in diminished quality of the pictures, as such, please keep the use of compression to a minimum. If using jpeg format, the highest quality must be selected.

To facilitate posting on our website, variety names should be confined to the outer frame of the digital image while dates should not appear on the digital image at all.

All photo image files must be named in accordance with the following guidelines

The following declaration form must be submitted with the application package when digital photographs are supplied as reference material.

Digital photo declaration form

Notes:

Only the PDF version of the "Digital photo declaration form PDF (18 kb)" will be accepted

This is to certify that the digital photographs submitted are representative of the variety and the photographs have not been altered or modified in any manner:

• Variety name
• Experimental number
• Name of Canadian Representative
• Signature
• Date

The Canadian Representative is typically the applicant for variety registration and must be a permanent resident of Canada

3) Total Glycoalkaloid (TGA) values in Potato Varieties

Results for the analysis of TGA (a catch-all term for cyanogenic glucosides found in the green skin of potatoes) must be submitted for national and new interim registrations of potato varieties, for human health and safety reasons. The TGA test methodology employed, as well as the name of the testing lab, must be clearly stated. The following methodologies are recommended:

1. High Performance Liquid Chromatography (HPLC) analysis (Carman, S.A.; Kuan, S.S.; Francis, O.J.; Kirschenheuter, G.P. 1986. Rapid HPLC determination of the potato glycoalkaloids alpha-solanine and alpha-chaconine. J. Agric. Food Chem. 34:277-279) or
2. colourimetric analysis (Smittle, D.A. 1971. A comparison and modification of methods of total glycoalkaloid analysis. Am. Potato J. 48:410-413)

Potato varieties will be assessed against Health Canada's Health and Safety guideline for maximum allowable TGA content in potatoes sold for human consumption of 20 mg per 100 grams fresh weight, unpeeled.

4) Plants with novel traits (PNTs) or varieties derived from PNTs

In addition to the requirements of section 5.3 Description of Pedigree/Breeding (Procedures for the Registration of Crop Varieties in Canada), for PNT varieties, information required for confirmation of the specific genetic makeup of the variety must also be included with the registration package, including detailed laboratory protocols (see Appendix VI) used to conduct molecular tests.

5) The following are recommended, but not required, for the registration of potato varieties

a) Reference material for molecular characterization

Reference samples of potato tissue may be used to assist in monitoring varietal purity of seed potatoes in Canada under the Seed Potato Certification Program. The potato reference sample will consist of 2 potato leaf triplets (1 terminal leaflet with the first pair of primary leaflets).

• Each sample is taken from a different plant, at or close to flowering-time
• Each triplet is placed in separate plastic sample bags, either twist tie or zip-type
• The bag must be sealed to prevent leaf sample from drying out; and labelled with:
  • the variety name
  • indicate reference sample for Variety Registration
  • lot number (if applicable)
  • crop certificate number
  • pedigree status and
  • the signature of the applicant
• Submit a duplicate of the Variety Registration Application Form to the laboratory along with the sample

Leaf samples must be sent by courier to:

Canadian Food Inspection Agency
Ontario Plant Lab, Genotyping Unit
3851 Fallowfield Road
Ottawa, Ontario, K2J 4S1

Samples must be sent separately to the Ontario Plant Lab and not to the Variety Registration Office with the application package. Leaf samples included in the application package to the Variety Registration Office will be destroyed.

b) Molecular data

It is recommended that the application package include any information regarding molecular data identifying the variety. If the applicant is aware of specific molecular data that may assist the CFIA in variety identification this may be submitted along with the protocols with the registration package and will be retained for evaluation. The CFIA will make the determination as to how the information may be used in the variety registration program (for example may be used for confirmatory testing as a back-up to CFIA established methodology).

c) Leaf outline

A photocopy of a leaf of the candidate variety and reference variety (ies) that best represent the leaf characteristics described in the Objective Description Form is recommended to be included with the description of the variety.

Appendix VI: Guidelines for submission of molecular trait detection methods

Purpose

The CFIA Variety Registration Office requires, on their variety registration application forms, identification of whether or not a variety is a PNTs in Canada, identification of the PNTs trait and declaration that the trait is an approved PNTs trait in Canada and that it is the result of the expression of a specified genetic source. Identification of the source and the protocols used to determine the source of the trait are mandatory requirements for registration. The trait protocol(s) used in the declaration must be CFIA reviewed and approved prior to registration. Trait detection protocols can be submitted for review by the CFIA prior to a registration application to expedite the registration process. The 'Guidelines for Submission of Molecular Trait Detection Test Methods for Approval by CFIA' (this document) is intended to outline content requirements for acceptance of these methods by CFIA.

Background

The CFIA – Variety Registration Office (VRO) requires the trait detection method name or number, number of seeds tested and confidence level of the test. Increasingly, genetic evaluation procedures (DNA or protein based) are being submitted.

The CFIA is accredited by the Standards Council of Canada to ISO/IEC 17025 (the International Organization for Standardization's 'General requirements for the competence of testing and calibration laboratories'). This accreditation requires that each test method used be validated to determine "fitness for purpose" and measurement of uncertainty prior to use. Submitted methods may be used for monitoring and enforcement by the CFIA, therefore, it is important to ensure that these methods are fit for purpose, and will meet the ISO 17025 requirement.

Molecular test methods submitted for approval as part of the variety registration process must be presented in a step wise fashion with sufficient detail to allow replication within a CFIA laboratory. Information on sample size, replicates, extraction procedures, expected result, data interpretation and acceptance criteria along with supporting validation data and appropriate references must be included. Factors that will be examined during the course of the review:

• is the method applicable to seeds
• is it a method that can be used to determine the identity of the trait
• is it scientifically logical
• is the protocol clear and complete
• does the protocol require the reviewer to make any assumptions
• is there potential for cross reactivity
• is there a limit of detection and does this influence the results
• can it determine the trait with the appropriate confidence
• has data been provided to support the claims and illustrate the method performs as stated

The additional information below describes in more detail, the content that will be examined during the course of a method review. Currently, method reviews are paper based evaluations only. Because of this, the reviewer does not guarantee a method will perform as expected on the bench. The reviews are advisory only and no endorsement for use of the method in any way other than that required by the Seed Section for variety registration purposes is given. Over time, different reviewers may be consulted by Seed Section, and thus each review is carried out as a completely independent process. Only the information contained within the package submitted to the reviewer is evaluated during an assessment and so each package must be complete and make no reference to previously submitted documents.

The length of time required to determine that a method is reproducible and of acceptable accuracy is dependent on the complexity and completeness of the submission.

The time to complete a CFIA review of a PNTs Trait Detection Protocol will depend on the workload of the reviewer at any given time, and on the accuracy of the protocol in addressing all the aforementioned aspects of the protocol. In general, it is reasonable to assume that an accurate, complete protocol will complete a review in 30 days or less but this may extend during labour intensive periods within the CFIA. For this reason, applicants are encouraged to send their protocols in prior to an actual variety registration application.

Additional information

The following is a more detailed description of the content examined during a method review. Any format for submission is considered acceptable, as long as all relevant information is included within the documentation provided to the reviewer.

1. Title: the applicable crop and varieties are specified, and general method employed: test number, version number, date, and number of pages should appear on each page of document

2. Scope: outlines the how the method would be used

   It must be clearly stated that the method is applicable to seed or plants grown from individual seeds. It must be clearly explained how it can determine trait identity.

3. Definitions: abbreviations or unique terminology should be defined

4. References: all documents/software/statistical analysis packages/publications etc. should be included

   Sufficient detail should be provided to facilitate retrieval by the CFIA if required.

5. Reagents and solutions: All required chemicals, kits, reagents, etc. must be disclosed

   Recipes for all solutions used must be disclosed.
   Primer/probe sequences must be disclosed.

6. Equipment: all equipment used must be listed
7. Software: all required software used for the data analysis and interpretation must be referenced

8. Critical points: any reagent/solution/equipment/or software that cannot be substituted should be identified

   Examples would include specific primer sequences or internally developed software applications. As well, any specific aspects of the protocol that are considered critical should be noted as well.

9. Controls: all controls required must be described – positive and negatives for Event(s), for x-reactivity check, etc., legal reference material, etc.

10. Procedures the individual steps an analyst must follow a logical progression

    These usually include, but are not limited to:

    1. sub sampling\working sample collection and prep:
       How are the samples collected/counted? What environmental conditions must be considered, storage, etc.?

    2. extraction/sample processing:
       Does the sample require processing prior to extraction and how

       How to extract the DNA/protein? If a kit is used, are any steps modified?, etc.

    3. PCR:
       Components of the master mix and cycling conditions, controls, etc.
    4. visualization:
       Procedure for visualization of the results – ELISA plate reader, gel-based, RT-PCR machine, etc.

    5. data recording:
       What raw data is recorded and how is it captured

       For trait testing, the data should also summarize: total number of seeds analyzed.

    6. computations:
       An example of the computation(s) performed
    7. interpretation:
       An explanation of how to interpret the raw data produced, as well as the final computed data
    8. acceptance criteria:
       A description of the conditions that must be met in order for the data set to be acceptable (for example results of positives, negatives, correct, etc.)
11. Supporting data: molecular sequence information (targeted regions) should be provided
    Examples of visualized data showing the expected performance of all controls, lack of cross-reactivity, etc.

Appendix VII: Registration policy for varieties with novel traits

1) Varieties with novel traits requiring unconfined release

Under part V of the Seeds Regulations, varieties with novel traits must receive authorization for unconfined release from the Plant Biosafety Office prior to variety registration.

Similarly, livestock feed safety authorizations by Feed Section, CFIA (where appropriate) must be completed prior to variety registration.

Where a plant with a novel trait (PNT) has been granted a conditional unconfined release that is limited in duration, the variety shall be granted an interim registration with an expiry date no later than that of the conditional unconfined release authorization.

2) Health considerations

Where a variety has a novel trait that may result in a new use (for example a new edible oil) or that may have a new impact on human/animal health, (for example allergenicity) prior to registration, an assessment of the safety of the trait is required to ensure the acceptability for human/animal consumption.

Such evaluations are conducted by the Office of Food Biotechnology, Health Canada and must be completed prior to being registered by the CFIA.

For varieties producing products that do not conform to the legal definition of the traditional product, assessment may be required by Health Canada prior to the sale of the product in Canada, for example, high oleic acid sunflower oil varieties.

3) Pesticide tolerance

Where a candidate variety is claimed to be tolerant to a pesticide and the tolerance to the pesticide is both new to the species and is the primary merit of the variety, the registration of the variety will be deferred pending a decision on the registration of the pesticide for that particular use by the Pest Management Regulatory Agency (PMRA) of Health Canada. Claims of pesticide tolerance must be supported by valid scientific data.

Exemptions from this policy may be given for varieties tolerant to persistent herbicides where there is no intent to register the herbicide for application to the variety in question.

Where a variety's tolerance to a pesticide is the primary merit of the variety and where the pesticide has been granted a temporary registration, the variety shall be granted interim registration with an expiry date no later than that of the pesticide.

Tolerance to a single pesticide should not be considered to provide tolerance to a class of pesticides.

Data on pesticide tolerance of a plant variety may be sufficient for the purposes of variety registration but may be insufficient for the review of pesticidal tolerance by PMRA officials. Please contact the PMRA for data requirements under the Pest Control Products Regulations.

4) Crop plants with novel pesticidal properties

They are regulated under the Seeds Act and regulations, and not the Pest Control Products Act since the primary use of the plant is to produce a crop. Non-crop plants used primarily for pest repellent or pesticidal purposes are subject to the Pest Control Products Act and regulations.

The PMRA will act as advisors to the Variety Registration Office on issues of efficacy, and the Variety Registration Office will act as liaison between applicants and the PMRA. Reviews by the PMRA may take up to 120 days.

The applicant must provide information on the nature, source and characteristics of the genes and proteins that have been introduced. The information would include tissue sites and expression levels of the pesticidal protein. This information is required to assess efficacy as well as varietal characterization.

Data will be required from a minimum of 3 statistically valid efficacy trials with replicates and appropriate controls. Trials must be conducted in a manner consistent with the proposed use of the variety parameters to be measured and would potentially include insect mortality, foliage protection and crop yield as compared to the controls. Appropriate experimental design and statistical analysis are required.

Appendix VIII: Guidelines for generating data to support herbicide tolerance claims

Scope

The guidance contained in this document applies to:

• varieties for which tolerance to a herbicide is claimed where that tolerance is novel to the species (for example glyphosate tolerant soybeans or imidazolinone tolerant wheat); and
• where the data are not generated under the oversight of a registration recommending committee

For tolerance to herbicides for which the variability in tolerance is an inherent genetic component of the species (for example metribuzin tolerance in soybeans), this guidance document does not apply. Traditional screening trials will continue to be accepted. Crop tolerance data are not required where there is no known variation among varieties as to tolerance (for example data for dicamba use on winter wheat).

Requirements

Crop tolerance data requirements for variety registration purposes differ in quantity from those for pest control products registration purposes.

Data must be generated in a manner that is statistically valid and based on established scientific principles:

• minimum 3 replicates, per site
• minimum 3 station-years of field data (for example 3 locations in 1 year)
• appropriate sample sizes/experimental units
• appropriate experimental design (for example randomized complete block design)
• where yield is assessed, the Coefficient of Variation (C.V.) for yield should not exceed 15% for spring crops and 20% for winter crops, and
• use of appropriate controls/check varieties

Based on the widespread use of glyphosate tolerant soybeans (both from GTS-40-3-2 and from MON89788) and the consistent performance of a number of different genetic backgrounds, glyphosate tolerance on these 2 sources in soybean is no longer tested as a condition of variety registration. All other traits and constructs default to the 3 trial/3 reps per trial minimum HT (herbicide treatment) test requirement and must clearly demonstrate tolerance to the herbicide in question at the commercial application rate(s). In the absence of the availability of a registered commercial variety for use as a check in that HT class, sprayed versus unsprayed data must be submitted.

Providing data generated only with the 2x the application rate is acceptable, however, it is strongly recommended that data from both 1x and 2x application rates be provided, as environmental stress in conjunction with intense herbicide application may confound herbicide tolerance results.

For canola:

1. the data generated with the 1x or 2x rate, according to label directions is acceptable, however, it is strongly recommended that data from both 1x and 2x application rates be provided, as environmental stress in conjunction with intense herbicide application may confound herbicide tolerance results

   The comparison against unsprayed format is still acceptable.

2. since glufosinate ammonium tolerance based on Ms8/Rf3 constructs (Liberty Link™), glyphosate tolerance based on RT73 (aka GT73) construct (Roundup Ready™), imidazolinone tolerance based on pm1+pm2 constructs (Clearfield™ Technology) have all been on the Canadian market over a decade and there are numerous well established registered commercial varieties in each of these herbicide technology classes, direct comparison against a known registered commercial variety in that trait class and with the same genetic construct is acceptable

   All other traits and constructs default to the original 3 trial/3 reps per trial HT test requirement with proof of tolerance via sprayed versus unsprayed data

3. in the case of Interim Canola Registration applications involving Ms8R/Rf3 or, RT73/GT73 or pm1+pm2 HT constructs, 2 herbicide tolerance tests of 2 replications each is the minimum acceptable data set for registration purposes

   This method of HT assessment parallels that used in soybeans in Canada. For candidates tested in the subsequent (public co-operative) year a third station year (1 more additional station year of 3 replications) of data would be required to support national registration. Regardless if the candidate is going through the interim canola or the national registration path, all other traits and constructs default to the original 3 trial/3 reps per trial HT test requirement with proof of tolerance via sprayed versus unsprayed data.

Supplemental information that supports the herbicide tolerance of candidate's varieties (genetic testing, spraying or previous generations and other) can be accepted as well.

Data generated in a greenhouse may be used to reduce the number of station-years of data. Greenhouse data are not intended to completely replace field data.

1) Herbicide treatments

Data must pertain to the exact chemical to which the claim is made:

• used singly (for example not in combination with other products as part of a tank mix or co-pack)
• applied at the rate specified on the Canadian pesticide label for the crop in question
• applied at the growth stage specified on the Canadian pesticide label for the crop in question
• it is highly desirable to assess the impact of application at the 2x rate as sprayer overlap is common in pesticide application

Data generated using another chemical in the same family cannot be extrapolated to demonstrate tolerance to the chemical under consideration.

2) Sample size

The appropriate sample size will depend in part on the crop in question, the generation at which breeder seed was bulked and the test. As a minimum for field testing, an experimental unit (1 replicate) should be made up of at least 100 plants for self-pollinated crops and 250 plants for cross-pollinated crops. Varieties that are bulked at an early stage of development (for example F4) may display a greater amount of heterogeneity than plants bulked at a later stage (for example F7). As a result, it is appropriate to increase the number of plants in the experimental unit for varieties bulked early.

For greenhouse tests, the total number of plants of a single variety in all replicates should be at least 400.

3) Controls

Researchers are strongly encouraged to use both positive and negative controls as part of their experimental design.

Appropriate controls include:

• the candidate variety under untreated or hand weeded conditions

• traditional varieties of similar maturity under conditions of traditional weed control

  Traditional weed control includes the application of herbicides registered for use on that crop kind and used in normal agricultural practice,

• other varieties tolerant of the herbicide under consideration where the varieties are of similar maturity under sprayed and unsprayed conditions

4) Assessment

Crop tolerance data using yield as an indicator are acceptable. Researchers are strongly encouraged to also present data on maturity. Other indicators such as crop injury measurements based on necrosis, chlorosis, and stunting and vigour reduction are acceptable.

Tolerance data based solely on the number of dead plants present following pesticide application are not acceptable.

5) Presentation of data

Crop injury/yield data for the 1x rate and 2x rates should be presented separately. Data should be presented with an appropriate statistical measurement, for example Least Significant Difference or Tukey's test with alpha = 0.05. The C.V. for yield at each location must be presented when yield is used as an indicator for absence of crop damage.

6) Future considerations

In the future, bioassay tests may be accepted providing bridging data are presented showing the relationship of data generated from the bioassay and data generated under the conditions for which the herbicide will be used. Please contact the Variety Registration Office for further information.

Information sheet for data to support herbicide tolerance claims

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Data to support herbicide tolerance claims is required for varieties to which that tolerance is novel to the species, and where the data is not generated under the oversight of a registration recommending committee. Data must be generated in a manner that is statistically valid and based on established scientific principles.

Please submit the following information with data to support claims of herbicide tolerance:

• number of replicates per site (minimum of 3 replicates required)
• number of station-years of field data (minimum of 3 locations)
• experimental design (for example randomized complete block design)
• specific herbicide used or active ingredient
• rate of application of herbicide
• what controls were used (check all that apply)
• candidate variety under untreated or hand weeded conditions
• traditional varieties of similar maturity under conditions of traditional weed control
• other registered varieties tolerant to herbicide under consideration where the varieties are of similar maturity under sprayed conditions
• other (please describe)

Appendix IX: Recommendations from cereal crop committees in Eastern Canada

In February 1993, representatives of the 3 Eastern cereal variety recommending committees met to define harm as it relates to regional registration. There was a consensus that harm could be caused under the following circumstances:

1. kernel visual distinguishability, (for soft white winter wheat)
2. high susceptibility of diseases that cause the production of mycotoxins in the marketed product.

The Variety Registration Office adopted this definition of harm for the purposes of regional registration for Eastern Canada.

However, in May 2007, the Canadian Grain Commission modified the Canada Eastern White Winter (CEWW) class system to remove the requirement for Kernel Visual Distinguishability (KVD) for white wheat in Eastern Canada. This resulted in the removal of the variety registration requirement relating to KVD for soft white wheat in Eastern Canada. Thus, for soft white wheat in Eastern Canada the definition of harm for the purposes of recommending regional registrations is now solely related to disease susceptibility that causes the production of mycotoxins in the marketed product.

General comments

1. Once a variety has been supported by any 1 recommending committee, it would receive national registration, unless harm as defined above (mycotoxins in marketed product) is present

2. If a wheat or triticale variety is supported for a regional registration, this recommendation should be made based on disease susceptibility which causes the production of mycotoxins in the marketed product

   An explanation should accompany the decision indicating the variety could present problems if granted a national registration. Otherwise, the variety should be supported for a national registration. For example: soft white winter wheat varieties supported in Eastern Canada will be restricted to Eastern Canada due to ineligibility for Western grain grades. Wheat varieties must have a minimum level of resistance to Fusarium head blight to be registered in Eastern Canada. Provincial guidelines within Eastern Canada vary as to the exact requirements. Therefore, the decision of harm due to Fusarium susceptibility will be made individually by each Eastern cereal recommending committee (Ontario, Québec, and Atlantic).

Appendix X: Quality control system requirements for varieties subject to contract registration

Background

These requirements apply to varieties where the biochemical or biophysical characteristics of a variety distinguish it from the majority of registered varieties of the same kind or species and the variety may have an adverse effect on the identity of those registered varieties. Because these varieties have the potential to cause adverse effects if they enter the traditional commodity channel, there must be assurance of appropriate means of control, via "quality control systems" (Q.C.S.). There must be assurance that the systems are in place and that they are effective.

The quality control system was designed to be consistent with other quality management systems designed for seed industry programs. The principles of these quality management systems are:

• show what you propose to do
• do it
• prove it was done

Requirements

As part of the application for restricted (contract) registration of varieties that could otherwise cause adverse effects, the applicant must submit a proposed Q.C.S. to manage potentially adverse effects that could be caused by the variety. The proposed Q.C.S. should be submitted in the form of a quality manual to be used by the relevant parties for the handling of the variety. Components of the Q.C.S. include, but are not limited to, the following:

1. management responsibility
2. training of personnel
3. contract review
4. product identification and traceability
5. inspection and testing
6. methods for control of non-conforming product
7. procedures for corrective action
8. control of records

A) Management responsibility

1. Define the organization's quality policy

   This is a written statement of potential adverse effects that could result if the variety were to enter the traditional commodity channels.

   An example of the quality policy is as follows: the entrance of a high erucic acid rapeseed into traditional canola channels must be prevented as it has the potential to cause adverse effects:

   • if insufficient isolation distances are observed from the production of commodity canola
   • if high erucic acid rapeseed is crushed and the oil is marketed as canola oil:
     • the oil would be in violation of labelling laws as it would not be canola oil
     • the oil would be in violation of food regulations with respect to compositional standards for canola oil and could pose a human health risk due to the presence of elevated levels of erucic acid
   • the sale of non-conforming product could have a negative impact on domestic and international markets of Canadian canola seed and canola oil

2. Indicate who is responsible for ensuring the quality policy is followed and the variety is handled appropriately

   The responsibility, authority and interrelation of all personnel who manage, perform and verify work affecting quality systems shall be identified. The interrelation of personnel should be identified through the use of an organization chart. The applicant should appoint a management representative who, irrespective of other responsibilities, shall have defined authority and responsibility for ensuring that the Q.C.S. is implemented and maintained. Ensure that the person responsible for the disposal of non-conforming product is specifically identified.

3. Provide commitment that the quality policy for the variety is understood, implemented and maintained at all levels of the organization

4. Submit procedures for the Q.C.S. procedures, internal quality audits, and their documentation

   The Q.C.S. should be reviewed at appropriate intervals by the designated management representative to ensure its continuing suitability and effectiveness. Records of such reviews shall be maintained.

B) Training of personnel and communication

1. Submit and maintain documented procedures for identifying and addressing Q.C.S. training needs on a routine basis

   Personnel performing specific assigned tasks shall be qualified on the basis of appropriate education, training and/or experience, as required.

2. Provide appropriate training of all personnel involved in the Q.C.S.

   Appropriate records of training shall be maintained and be available upon request.

3. Indicate the level of availability of Q.C.S. procedures documents to personnel, the frequency of review of Q.C.S. documents and the means of ensuring that obsolete documents are removed from all points of issue or use
4. Indicate how the results of internal quality audits of product and quality management systems will be communicated to personnel having responsibility in the area audited

C) Contract review

1. The management representative shall describe and maintain the procedures in place for reviewing contracts to ensure compliance of the quality policy
2. Each contract should be reviewed by the management representative to ensure that:
   1. the quality policy is adequately addressed
   2. all parties involved have the capacity to meet contractual requirements

Records of such contract reviews should be maintained.

D) Product identification and traceability

The management representative shall establish and maintain documented procedures and records for identifying the variety during all stages of seed and crop production, handling, processing, storage, delivery and use. This will include procedures for monitoring of growers' fields, identifying harvested product, processed product, etc. to ensure that the quality policy has been addressed by contract adherence.

Where isolation distances are required, documentation of actual isolation distances used must be maintained. Any non-conforming procedures or product must be identified, including deficiencies in documentation.

E) Inspection and testing

The management representative shall establish and maintain documented procedures for inspection and testing to ensure the specific product quality requirements are met including the testing of harvested products.

F) Control of non-conforming product or process

1. The management representative shall establish and maintain procedures to ensure that any seed or harvested product that does not conform to the specified standards is prevented from entering traditional commodity markets or being used as seed for further planting

   (This could include ensuring non-conforming product is rendered unviable for seed purposes.) This procedure must ensure that non-conforming materials are identified, documented and segregated. Where the non-conformity relates to a requirement under the Seeds Regulations, the procedures must stipulate that the Director of the Plant Production Division is contacted.

2. The management representative shall maintain records detailing the nature of non-conformities and the disposition of any non-conforming product or process

   This should include contract review, documentation or record control procedures that do not conform to the prescribed process.

3. Where isolation distances are required from surrounding traditional commodity crops, and where these distances were not maintained, details must be provided on the disposal of seed or grain produced within the required isolation zone

G) Corrective and preventive action

1. The management representative shall document and maintain procedures for:
   1. investigating causes of non-conformities
   2. immediately notifying those individuals/growers/organizations concerned
   3. developing and implementing a corrective action plan to prevent recurrence
   4. analysing all processes, work operations, quality records and service reports to detect, identify and eliminate potential causes of non-conforming product
   5. initiating preventive actions to address potential non-compliance
      • by monitoring and following up on corrective action implementation and its effectiveness
      • by implementing and recording changes to documented procedures resulting from corrective action
2. The management representative shall document the corrective actions taken to address specific non-compliances

H) Control of records

1. Records shall be maintained by all parties involved to demonstrate achievement of the required quality policy and the effective operation of the Q.C.S.

   Pertinent sub-contractor, grower and processor quality records are elements of this system.

2. The management representative shall maintain procedures for identification, collection, indexing, filing, storage, maintenance and disposition of quality records including:
   1. product identification and traceability
   2. monitoring, audit, inspection and testing results
   3. records of non-conformance
   4. disposal/action records
   5. reviews of Q.C.S.
   6. training of personnel on the Q.C.S.
   7. contract reviews
   8. record retention times
3. Records must be clear, legible, readily retrievable and accessible

General information

The Q.C.S. manual should be submitted as part of the application for registration. The manual should be written so that:

1. all required activities are described
2. all Seeds Regulations requirements are comprehensively covered
3. the language can be easily understood by the individuals who have to read it, follow it and implement it
4. it is free of ambiguity and conflicting statements
5. it clearly specifies individual responsibilities
6. all required documents and records are identified and their use explained
7. there is a mechanism for ensuring that documentation is kept up to date and properly supported

8. in the case of wheat and barley suitable for Western Canada, the Variety Registration Office will share the quality control system with, and obtain agreement from, the Canadian Grain Commission to ensure that regulatory concerns under their legislative mandates are met

   This organization is currently developing criteria for acceptance of quality systems.

It would be prudent for applicants to consult with these organizations on the quality control system during its development and before the variety is presented to the registration recommending committee.

Appendix XI: Committees recommending varieties for registration

The names and addresses of the contact persons for each of the following committees are available on the CFIA website.

Cereals and oilseeds

• Prairie Recommending Committee for Wheat, Rye and Triticale
• Prairie Recommending Committee for Oilseeds
• Prairie Recommending Committee for Barley and Oats
• Western Canada Canola/Rapeseed Recommending Committee
• Ontario Cereal Crops Committee
• Ontario Oil and Protein Seed Crops Committee
• Quebec Cereal Committee
• Quebec Oil and Protein Crop Committee
• Atlantic Cereal Committee

Bean and special crops

• Ontario Pulse Crop Committee
• Prairie Recommending Committee for Pulses and Special Crops
• Ontario Tobacco Evaluation
• Quebec Oil and Protein Crop Committee

Appendix XII: Guide to commonly used pedigree nomenclature systems

Guide to commonly used pedigree nomenclature system

The use of the following commonly used pedigree nomenclature systems is encouraged.

1. Historic notation system (no reference)

In this system, the female (mother plant) name (pollen receiver) is written on the left side of the cross designator.

Note: The female is always first. The cross designator used is 'x'. The male (pollinator) name (father) is written after the cross designator 'x'.

Brackets are used to denote pedigrees of 1 parent in a cross. The order of crossing is indicated with nesting of brackets following the mathematical hierarchy of bracketing.

For example:

1. female = A, Male = B, cross: (A x B)
2. female = (A x B), Male = C, cross: ([A x B] x C)

2. Purdy notation system (Purdy, H. W., et. al., 1968, Crop Sci. 8: 405-406.)

In the Purdy system, a cross is denoted with a forward slash '/' rather than with an 'x'. So 'A x B' in old notation = 'A/B' in Purdy notation. A second cross is indicated by 2 forward slashes (//) and each additional cross is shown by placing the cross order number between the slashes (/n/).

For example:

1. female = A, Male = B, cross: A/B
2. female = A × B, Male = C, cross: A/B//C
3. female = A × B, Male = C × D, cross: A/B//C/D
4. female = [(A x B) x C], Male = D, cross: A/B//C/3/D

A backcross is shown using an asterisk '*' and the number of times the specified parent was backcrossed.

For example:

1. a backcross 1 or BC1 line = A/2*B
2. a backcross 2 or BC2 line = A/3*B
3. a backcross "n" or BC "n" line = A(n+1)* B

3. Dendrogram or family tree method

Appendix XIII: Submission of fees

As of December 1, 1997, fees are charged for the evaluation of variety registration applications, and related services. Fees for all variety registration related activities are detailed in the CFIA Fees Notice. These fees are updated annually on March 31 based on the Consumer Price index.

All payments must be made in Canadian funds. No Goods and Services Tax apply.

If you are applying through MyCFIA, you will be invoiced directly.

If you are applying by email or mail, the following information will apply:

1. Cheques or money orders must be made payable to the Receiver General for Canada

Please ensure that all cheques can be drawn from a Canadian bank.

Cheques/money orders submitted in foreign funds will be returned and the application review will not be initiated.

2. To pay by credit card:

Submit the following information:

• type of credit card (Visa, MasterCard and American Express will be accepted)
• card holder name
• company name
• telephone number
• credit card number
• expiry date

Applicants are responsible to clearly communicate the service requested (as per above) along with the appropriate fee.

Where a variety has been previously granted an interim registration and where the variety is currently being considered for permanent registration, the fee for permanent registration applies.

Interim registration fees:

Upon receipt of the application fee, a variety will be granted an interim registration for 1 year. If the variety has interim registration support for 2 or 3 years, the applicant has 2 options:

• if the annual renewal fees are paid at the time of the initial registration, the registration will automatically be granted for the full duration

• if the applicant chooses to only pay for an initial interim registration, then the interim registration will only be granted for 1 year

  If the registrant wishes to have the interim registration renewed, then an application for renewal, a copy of the original letter of support and the renewal fee(s) will be required prior to the expiration of the registration.

Note:

• once review of an application has been initiated, no refund will be issued
• a fee submission form which is part of the application form should be used and submitted with each application package, if applying via email or mail.