Procedures for the Registration of Crop Varieties in Canada

Appendices I to XIII

February 26, 2013

This document replaces the one published on July 1, 2012


Appendices


Appendix I: Crops Kinds Subject to Variety Registration

Part I
(testing, merit and basic registration requirements)

Crop Kind Scientific Name
Alfalfa (forage type) Medicago sativa L. (including M.sativa L. spp. falcata (L.) Arcangeli)
Barley - two-row Hordeum vulgare L. convar. distichon Alef.
Barley - six-row Hordeum vulgare L. convar. hexastichon Alef.
Bean, field Phaseolus vulgaris L.
Bird's foot trefoil Lotus corniculatus L.
Bromegrass, meadow Bromus riparius Rehm.
Bromegrass, smooth Bromus inermis Leysser
Buckwheat Fagopyrum esculentum Moench
Canola, oilseed rape, rapeseed Brassica rapa L. subsp. campestris (L.) A.R. Clapham; B. napus L. var. napus (=B. napus L. var. oleifera Delile); B. juncea (L.) Czern.
Canarygrass, annual Phalaris canariensis L.
Canarygrass, reed Phalaris arundinacea L.
Clover, alsike Trifolium hybridum L.
Clover, red Trifolium pratense L.
Clover, sweet (white blossom) Melilotus alba Medikus
Clover, sweet (yellow blossom) Melilotus officinalis (L.) Lam.
Clover, white Trifolium repens L.
Fababean (small seeded) Vicia faba L.
Fescue, meadow (forage type) Festuca pratensis Hudson
Fescue, red (forage type) Festuca rubra L. subsp. rubra
Fescue, tall (forage type) Festuca arundinacea Schreber
Flax (oilseed) Linum usitatissimum L.
Lentil (grain type) Lens culinaris Medikus
Lupin (grain and forage types) Lupinus spp.
Mustard Brassica juncea (L.) Czern., Sinapis alba (L.) (= B. hirta Moench)
Oat (grain type) Avena sativa L., Avena nuda L.
Orchardgrass Dactylis glomerata L.
Pea, field (commodity type) Pisum sativum L.
Rye (grain type) Secale cereale L.
Ryegrass, annual (forage type) Lolium multiflorum Lam.
Ryegrass, perennial (forage type) Lolium perenne L.
Soybean (oilseed) Glycine max (L.) Merrill
Timothy (forage type) Phleum pratense L.
Tobacco (flue-cured) Nicotiana tabacum L.
Triticale (grain type) X Triticosecale spp.
Wheat, common Triticum aestivum L.
Wheat, durum Triticum turgidum L. subsp. durum (Desf.) Husn. (=T. durum Desf.)
Wheat, spelt Triticum aestivum L. subsp. spelta (L.) Thell. (=T. spelta L.)
Wheatgrass, beardless Pseudoroegneria spicata (Pursh) À. Löve (=Agropyron spicatum (Pursh) Scribn. & J.G. Smith f. inerme (Scribn. & J.G. Smith) Beetle)
Wheatgrass, crested Agropyron cristatum (L.) Gaertner, Agropyron desertorum (Fischer ex Link) Schult.
Wheatgrass, intermediate Elytrigia intermedia (Host) Nevski subsp. intermedia (=Agropyron intermedium (Host) Beauv.)
Wheatgrass, northern Elymus lanceolatus (Scribn. & J.G. Sm.) Gould subsp. lanceolatus (=Agropyron dasystachyum (Hook.) Scribn.)
Wheatgrass, pubescent Elytrigia intermedia (Host) Nevski subsp. intermedia (=Agropyron trichophorum (Link) Richter)
Wheatgrass, Siberian Agropyron fragile (Roth) P. Candargy subsp. sibericum (Willd.) Melderis (=Agropyron sibiricum (Willd.) Beauv.)
Wheatgrass, slender Elymus trachycaulus (Link) Gould ex Shinners subsp. trachycaulus (=Agropyron trachycaulum (Link) Malte ex H.F. Lewis)
Wheatgrass, streambank Elymus lanceolatus (Schribn. & J.G.Smith) Gould subsp. lanceolatus (=Agropyron riparium Scribn. & Smith)
Wheatgrass, tall Elytrigia elongata (Host) Nevski (=Agropyron elongatum (Host) P. Beauv.)
Wheatgrass, western Pascopyrum smithii (Rydb.) À Löve (=Agropyron smithii Rydb.)
Wildrye, Altai Leymus angustus (Trin.) Pilg. (=Elymus angustus Trin.)
Wildrye, Dahurian Elymus dahuricus Turcz ex Grieseb.
Wildrye, Russian Psathyrostachys juncea (Fisch.) Nevski (=Elymus junceus Fisc.)

Part II
(testing and basic registration requirements)

Crop Kind Scientific Name
Safflower Carthamus tintorius L.

Part III
(basic registration requirements)

Crop Kind Scientific Name
Potato (commercial production) Solanum tuberosum L.
Sunflower (non-ornamental) Helianthus annuus L.

 


Appendix II: Legal Reference Sample Size Requirements and Checklist

2 kilograms

  • Barley
  • Fababean
  • 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

In order to prevent loss of valuable germplasm and to ensure genetic preservation of Canadian varieties, the Canadian Seed Growers' Association (CSGA) requires that a representative sample of Breeder Seed of each crop variety developed in Canada (past and present), with the exception of hybrid and composite varieties, be deposited in the central genebank, as part of the permanent national germplasm collection. A representative sample of the variety (minimum 12,000 seeds) should be sent at the time of applying for registration to:

Dr. Ken Richards
Plant Gene Resources of Canada
Agriculture and Agri-Food Canada
Saskatoon Research Centre
107 Science Place
Saskatoon, Saskatchewan S7N OX2

(See "Canadian regulations and procedures for production of breeder seed crops" available on the CSGA website at www.seedgrowers.ca.)

The genebank 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 fax a copy of the seed tag to the Variety Registration Office for verification before sending in the sample. Our fax number is 613-773-7144.

Breeder Seed Samples

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

check box Variety Name (experimental number is acceptable if the name is not finalized);

check box Crop Kind;

check box Crop Certificate Number;

check box Pedigreed Status;

check box Signature of the CSGA recognized plant breeder;

check box Lot number (if applicable); and

check box Name of company (Optional)

Foreign produced samples

check box year of production is on the tag;

check box tag is from an official seed certification agency; OR

check box 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.

check box Germination analysis is required for samples that are produced more than one 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 both eastern and western 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 the east, 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 allowed in foundation seed of canola must be submitted with the application. For hybrid canola varieties, these levels must be provided for certified seed. For composite canola varieties, these levels must be provided for 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 one 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 two 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

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 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 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, 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 (e.g. 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) Objective descriptive form

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

2) Colour slides

Applications for registration of potatoes must include one colour slide 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 photographs 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 slides is required for permanent and new interim registrations.

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

Requirements for the submission of digital photos in lieu of a slide set for variety registration:

Digital photos may be submitted for the registration of potato varieties in lieu of a slide set. 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).

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 (e.g.: 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:

PHOTO IMAGE CONTENT *PHOTO FILE NAME
a typical tuber varietyname_tuber.jpg
the apical end of the tuber varietyname_apical.jpg
a tuber cut lengthwise varietyname_length.jpg
a typical sprout varietyname_sprout.jpg
a typical complete inflorescence varietyname_inflorescence.jpg
a typical flowering plant in the field varietyname_floweringplant.jpg
a typical compound leaf varietyname_leaf.jpg

*Either the proposed variety name or the experimental designation of the variety may be used in the file name

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

Digital Photo Declaration Form

(Note: 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:

**Note: 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 must be submitted for permanent 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 two potato leaf triplets (one 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:
    • check box the variety name,
    • check box indicate Reference sample for Variety Registration,
    • check box lot number (if applicable),
    • check box crop certificate number,
    • check box pedigree status, and
    • check box 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, K2H 8P9

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 (e.g. 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 (e.g. 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 (e.g. new edible oil) or that may have a new impact on human/animal health, (e.g. 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 three 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 (e.g. 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 (e.g. 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 (e.g. 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 three replicates, per site
  • minimum three station-years of field data (i.e. three locations in one year),
  • appropriate sample sizes/experimental units,
  • appropriate experimental design (i.e. 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 and the consistent performance of a number of different genetic backgrounds, two replicates per site with a minimum of three station-years of data will be accepted for glyphosate tolerant soybean varieties derived from GTS 40-3-2 and/or MON89788 constructs. All other traits and constructs default to the 3 trial/3reps per trial minimum HT 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 LinkTM), glyphosate tolerance based on RT73 (aka GT73) construct (Roundup ReadyTM), imidazolinone tolerance based on pm1+pm2 constructs (ClearfieldTM 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/3reps 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 COOP) year a third station year (one 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/3reps per trial HT test requirement with proof of tolerance via sprayed versus unsprayed data.

Supplemental information that supports the herbicide tolerance of candidates 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 (i.e. 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 can not 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 (one 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 (i.e. F4) may display a greater amount of heterogeneity than plants bulked at a later stage (i.e. 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, 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, i.e. 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

PDF (73 kb)

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 three replicates required):

Number of station-years of field data (minimum of three locations):

Experimental design (e.g. randomized complete block design):

Specific herbicide used or active ingredient:

Rate of application of herbicide:

What controls were used? (Check all that apply)

check box Candidate variety under untreated or hand weeded conditions.

check box Traditional varieties of similar maturity under conditions of traditional weed control.

check box Other registered varieties tolerant to herbicide under consideration where the varieties are of similar maturity under sprayed conditions.

check box Other (please describe)


Appendix IX: Recommendations from Cereal Crop Committees in Eastern Canada

In February 1993, representatives of the three 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 one 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 at: http://www.inspection.gc.ca/english/plaveg/variet/proced/comte.shtml

FORAGES

  • Alberta Forage Variety Committee
  • Saskatchewan Advisory Committee on Forage Crops
  • Manitoba Forage Crops Committee
  • Ontario Forage Crops Committee
  • Quebec Forage Committee
  • Atlantic Field Crops Committee Forage Crops Task Group

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 Oilseed Committee
  • Atlantic Field Crops Committee Cereal Crops Task Group

BEAN AND SPECIAL CROPS

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

Appendix XII: Guide to commonly used pedigree nomenclature systems

Guide to Commonly Used Pedigree Nomenclature Systems

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 one 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 two 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 x B, Male = C, cross: A/B//C
  3. Female = A x B, Male = C x 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

Dendrogram of Family Tree Method
Description of Dengrogram 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:

Application for permanent registrations (national, regional or contract) = $875.00
Application for interim registrations = $200.00
Annual Renewal of interim registrations = $100.00
Reinstatement of a suspended or cancelled registration = $200.00
Amending a variety name = $200.00

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

  1. type of credit card (Visa, MasterCard and American Express will be accepted)
  2. card holder name
  3. company name
  4. telephone number
  5. credit card number
  6. 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 $200.00 application fee, a variety will be granted an interim registration for one year. If the variety has interim registration support for two or three years, the applicant has two options:

  1. if the annual renewal fees are paid at the time of the initial registration, the registration will automatically be granted for the full duration. (e.g. for a three year interim registration, the fee would be $400.00).
  2. if the applicant chooses to only pay for an initial interim registration, then the interim registration will only be granted for one 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:

  1. Once review of an application has been initiated, no refund will be issued.
  2. A fee submission form which is part of the application form should be used and submitted with each application package.

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