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Plant Products Plant Production Main Page - Seed Section - Variety Registration Acts and Regulations Reference Material Variety Notifications

Please note that varieties of all crops in this Appendix are registered on the basis of merit.

APPENDIX II

Reference Sample Size Requirements

5 grams

Flue cured tobacco
Parental lines of hybrid and composite canola

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 Oil and Protein Seed Crops Committee (OOPSCC). 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 Brassisca 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.
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 seed. Standards for maximum levels of erucic acid should be set at levels consistent with the new definition of canola to be implemented 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 must be submitted with the variety registration application package. These must be 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 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 OECD Seed Scheme List of Cultivars. For hybrid canola varieties to be added to the OECD list, the applicant must supply descriptions of each inbred parent as well as the hybrid variety.

APPENDIX IV

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.
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, (eg. 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.
     
   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 V

Action by Variety Registration Office on
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 has adopted this definition of harm for the purposes of regional registration.

General comments:

1. Once a variety has been supported by any one recommending committee, it would receive national registration, unless one of the two circumstances stated above apply.
2. If a wheat or triticale variety is supported for a regional registration, this recommendation should be made based on a Canadian Grain Commission kernel description indicating the variety could present problems if granted a national registration. Otherwise, the variety should be supported for a national registration.

APPENDIX VI

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 harm 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 harm, 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:

A) Management Responsibility:

1. 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 harm:
   • 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:

   a.	the quality policy is adequately addressed;
   b.	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 Plant Health and 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:
     

   a.	faire enquête sur les causes des non-conformités;
   b.	aviser immédiatement les particuliers/les producteurs/les organismes concernés;
   c.	élaborer et mettre en oeuvre un plan d'action pour corriger les non-conformités et éviter qu'elles ne se reproduisent;
   d.	analyser tous les processus, les opérations, les registres de qualité et les rapports de service afin de déceler, de définir et d'éliminer les causes possibles des non-conformités;
   e.	prendre des mesures visant à prévenir les futures non-conformités, c'est-à-dire :
   		surveiller et assurer l'application des mesures correctives et vérifier leur efficacité;
   		effectuer les modifications qui s'imposent aux procédures écrites et les noter.

 

2. Le représentant de la direction doit tenir registre des correctifs appliqués pour résoudre les non-conformités particulières.

H) Control of Records:

APPENDIX VII

Contact Persons for Committees
Recommending Varieties for Registration

APPENDIX VIII

Obtaining Copies of the Seeds Act and Regulations

The Seeds Act and Regulations can be accessed on the Canadian Food Inspection Agency web site at www.cfia-acia.agr.ca.

If hard copies of the Seeds Act and Regulations are required, fees are charged for material as follows:

A shipping and handling charge of $5.00 ($8.00 outside Canada) applies to each request. Canadian residents should include 7 percent GST.

Payment should be by cheque or money order only, in advance in Canadian funds drawn from a Canadian bank and made payable to the Receiver General for Canada.

Please address requests for these publications to:

Seed Section
Plant Health and Production Division
Canadian Food Inspection Agency
59 Camelot Drive
Nepean, Ontario K1A 0Y9

For additional information, please contact the Seed Section at:

Telephone: (613) 225-2342
Facsimile: (613) 228-6629

APPENDIX IX

Submission of Fees

As of December 1, 1997, fees are charged for the evaluation of variety registration applications, and related services:

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

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.

To pay by Credit Card:

Submit the following information:

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:

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 is attached and should be used and submitted with each application package.

Fee Submission for Variety Registration

Payment must be made in Canadian funds. No Goods and Services Tax applies.

To be completed by Applicant

NOTE: Once review of an application has been initiated, no refund will be issued.

Areas in grey are for office use only

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