Canadian Food Inspection Agency - Revised Canadian Food Inspection Agency (CFIA) Proposals to Amend the Variety Registration System, September 5, 2002

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Revised Canadian Food Inspection Agency (CFIA) Proposals to Amend the Variety Registration System

September 5, 2002

Introduction

As a result of meetings with various recommending committee and commodity organizations this past winter/spring, the Canadian Food Inspection Proposal of January, 2002 has been further revised.

It should be noted that since several key activities are yet to be completed by the Canadian Food Inspection (i.e. Benefit/Cost Analysis, drafting and Gazetting of amendments to Seed Regulations), the Timelines for implementation are only estimates. Until such time as amended Regulations have completed the Canada Gazette Part II process, the existing registration system and merit requirements are still in effect.

Any revisions made to the Proposal, will be posted on the Canadian Food Inspection Website at: www.inspection.gc.ca/english/plaveg/variet/vartoce.shtml.

1. Mandatory Registration:

Mandatory registration will be required for seed of varieties of all agricultural crop kinds (including potatoes) and PNTs that are imported, advertised or sold in Canada.

For all crop kinds, complete Listing type information (including variety name, pedigree, varietal description, legal reference sample, etc.) will be required for registration. Listing requirements may be met by the provision of information from Plant Breeders' Rights forms, CSGA's form 300 or from foreign certification authorities.

In addition:

1.1	Certain crops will require some form of prior merit assessment (Agronomics and/or Disease and/or Quality) in combination with evidence of collection of performance information. (See Schedule A)
1.2	Other crops will require evidence of collection of performance information only. (See Schedule B)
1.3	Other crops, will require neither a prior merit assessment nor collection of performance information. (See Schedule C)

"Evidence of Collection" - means either an affidavit from the applicant or a letter from a third party indicating appropriate performance information has been collected.

2. Performance Information:

Performance information means a minimum of one year of performance testing in at least one specific area in Canada or, where applicable in the US, that has been conducted by or overseen by a third party prior to an application being made for registration of a variety.

2.1	A third party includes recommending committees, regional/provincial testing organizations, grower associations with technical capabilities to conduct performance information trials. Companies or research organizations that are ISO certified for Research may also be considered acceptable.
2.2	Performance information will have to be conducted using scientifically valid testing procedures, including appropriate check variety(s), replications, etc.
2.3	Performance information will not be used by a recommending committee to determine if a variety should be supported for registration.
2.4	In the case of Schedule A (ii), (iii) and (iv) crops, since several years of testing will be required to collect sufficient disease and/or quality information, the agronomic performance information may be generated concurrently or even as part of the disease and/or quality trials.
2.5	In the case of Schedule B crops, although only one growing season of performance information may have been generated in order to qualify for registration, if the buyers of seed believe this information is insufficient for them to make a buying decision; they can decide not to purchase the variety.
2.6	The Seeds Regulations may require that a seller of seed make the performance information available to a seed purchaser upon request.

3. Recommending Committees:

All Recommending Committees involved in some form of prior merit assessment of crops in Schedule A will continue to be recognized under Part III of the Seeds Regulations.

3.1	These committees need to start reassessing their function with respect to their future involvement in assessing varieties for the revised merit criteria only or merit assessment in combination with performance information testing.
3.2	These committees must reassess their structure with respect to membership and equality in voting.
3.3	These committees also need to consider the merit criteria for Schedule A crops that "must" versus "should" be met in order to be recommended for registration.
3.4	Committees and organizations not recognized for merit testing will continue to have an important role in conducting and/or overseeing performance information testing criteria and possibly develop a mechanism to make performance information publicly available.
3.5	Recommending and/or performance testing committees will determine in which cases US data may be used to meet merit criteria and/or performance information.

4. Kernel Visual Distinguishability (KVD)

Until such time as rapid testing techniques are available to replace KVD as a segregation tool, Kernel Visual Distinguishability (KVD) requirements will be retained for durum, spring and winter wheat, rye and triticale for the CWB Area and white winter wheat classes in Eastern Canada.

5. Interim Registration

5.1	It will apply to Section (i), (ii), (iii) and (iv) of Schedule A crops only
5.2	Present requirements will be retained: ie. - Minimum one year of data - Up to three years of initial interim registration - Five years maximum interim registration

6. Contract Registration

6.1	Terms and conditions including reproductive isolation requirements, isolation distances and post-harvest land-use restrictions will be set on a case by case basis, according to potential for harm.
6.2	The appropriate recommending committees, Plant Biosafety Office, CSGA and other organizations as appropriate will be used to advise the VRO regarding reproductive isolation methods and post-harvest land-use requirements.
6.3	Seeds Regulations will be amended to allow for:
	Suspension/cancellation of registration where quality management systems and/or terms and conditions of the contract registration are not maintained Ability to refuse applications for a two-year period from applicants with a history of non-compliance Provision for a review of the Quality Management System (QMS) if the distributor changes

7. Other Changes to Part III of the Seeds Regulations

7.1	Refusal of applications for a two year period from applicants where false or misleading information has previously been provided
7.2	Refusal of applications where a suitable growing region cannot be identified
7.3	Onus will be on registrant for costs of collection, storage and disposal of suspended and cancelled varieties
7.4	Frequency of establishment of the list of experts will be decreased

8. Changes to Part I of the Seeds Regulations

8.1	In the case of varieties of Schedule A (i, ii, iii and iv) crop kinds, for which some form of prior merit assessment is required, only pedigreed seed will be permitted to be imported.
8.2	Farmers wishing to import varieties for own use will be required to meet the same registration requirements as varieties being offered for sale in Canada
8.3	Coloured and mung beans will be removed from the Schedule II which will allow the use of variety names on non pedigreed seed of these crops.

9. Registration of Varieties of Previously Exempted Crops

9.1	When the Regulations come into effect, anyone proposing to import and/or sell seed of a new variety will be required to apply to the VRO to have the variety registered under the requirements of the appropriate Schedule.
9.2	The purpose of registering previously exempted varieties is to establish a baseline of information for the varieties being imported and/or commercialized when the Regulation amendments take effect.
9.3	For varieties of agricultural crops preciously exempted from registration and imported or sold in Canada prior to the Regulation amendments taking effect, the following is proposed: - seed importers and sellers will be given a specific grace period (eg. 1 year) to apply to the VRO (at no or minimal cost) to have their varieties listed (Schedule C). - reference samples will only be required for varieties which have not already been entered into the CSGA crop certification system. - application requirements may be met by providing information previously provided to either the CSGA via their Form 300 (Certification Eligibility Application), or to the PBR Office via a PBR application. - once the grace period (eg. 1 year) is over, any varieties not listed will be considered as unregistered and will no longer be allowed to be imported and/or sold in Canada.

10. Benefit/Cost Analysis

10.1	The Benefit/Cost Analysis is being completed and will form part of the preamble when the amendments to the Seeds Regulations go forward to Canada Gazette Part I.

11. Mechanisms to Address Market Acceptance/International Regulatory Approval of GM Crops

11.1	The Variety Registration system is not the appropriate mechanism to delay the release of a transgenic variety which may not have regulatory approval or market acceptance in foreign markets. Legislative authority does not exist in the Seeds Act to create such a Regulation.
11.2	Marketing organizations/industry committees should deal with current and emerging issues

12. Challenges in Varietal Purity and Identity

To address problems with varietal purity in higher generation seed (breeder and select), the Canadian Food Inspection encourages a voluntary industry-driven (versus mandatory) approach to the implementation of Quality Management Systems at the plant breeder (public and private) level. The Canadian Seed Growers' Association, which officially recognizes plant breeders for pedigreed seed certification eligibility, is considering amendments to their Breeder Seed Production Regulations that would require third-party audited Quality Management systems for plant breeders.

13. Heritage/Organic Varieties

13.1	There is support for the production of varieties organically, but they should be subject to the same requirements under the Seeds Regulations and pedigreed seed crop production regulations as varieties grown using traditional crop management practices
13.2	There is no support to create an exemption from the requirements of the Seeds Act and Regulations beyond what exists now for the production and sale of unregistered varieties including "heritage" varieties
13.3	Organic farm organizations should request membership on the Recommending Committees.
13.4	Organic organizations should participate in the performance testing committees, especially for crops where "merit" will no longer be a prerequisite for registration.

SCHEDULE A

Crop Kinds Subject to Some Form of Prior Merit Assessment (Agronomics and/or Disease and/or Quality).

i) Agronomics, Disease and Quality Merit Assessment

Feed, Forage and Malting Barley (Western Canada)
Feed and Milling Wheat (Western Canada)

ii) Disease and Quality Merit Assessment plus Evidence of Collection of Agronomic Performance Information

Oilseed Flax
Milling Oats
Malting Barley (Eastern Canada)
Milling Wheat (Eastern Canada)
Mustard
Field Peas
Sunflowers
Tobacco (flue-cured)

iii) Quality Merit Assessment plus Evidence of Collection of Agronomic and Disease Performance Information

Canola/Oilseed rape

iv) Disease Merit Assessment plus Evidence of Collection of Agronomic Performance Information

Feed or Forage Barley (Eastern Canada)
Fibre Flax
Feed or Forage Oats
Rye, Triticale
Feed Wheat (Eastern Canada)
Spelt

v) Health and Safety Requirements Only

Industrial Hemp (THC content only)
Lupins (alkaloid content only)
Potatoes (TGA content only)

Other crops as health and safety issues arise

SCHEDULE B

Crop Kinds Subject to Evidence of Collection of Agronomic, Disease and Quality Performance Information as Appropriate

Field Bean (Navy)
Buckwheat
Annual Canarygrass
Chickpeas
Fababeans
Lentils
Safflower

Forage species

Alfalfa (forage type)
Birds foot trefoil
Bromegrass, hybrid
Bromegrass, meadow
Bromegrass, smooth
Canarygrass, reed
Clover, alsike
Clover, Kura
Clover, red
Clover, sweet
Clover, white
Fescue, meadow (forage type)
Fescue, tall (forage type)
Lolium x Festuca hybrids
Orchardgrass
Pea (forage type)
Ryegrass, annual (forage type)
Ryegrass, intermediate
Ryegrass, perennial (forage type)
Soybean (forage type)
Timothy, common (forage type)
Vetch, milk cicer (forage type)
Wheatgrass, crested
Wheatgrass, intermediate
Wheatgrass, pubescent
Wildrye, Altai
Wildrye, Dahurian
Wildrye, Russian

SCHEDULE C

Crop Kinds Subject to Listing-type Registration Information Only

Millet
Mung beans
Coloured Beans
Corn, field, hybrid
Crop kinds exempt from Schedule II where variety names are used on non-pedigreed seed (e.g. Kentucky Bluegrass)
Varieties bred in Canada for multiplication under OECD for export
Crop kinds in Schedule II of Seeds Regulations not subject to requirements under Schedules A or B
Soybeans

Forage Species

Alkaligrass, weeping
Bentgrass, colonial (browntop)
Bentgrass, creeping
Bentgrass, velvet
Blue grama
Bluegrass, annual
Bluegrass, Canada
Bluegrass, fowl
Bluegrass, Kentucky
Bluegrass, rough
Bluegrass, wood
Bromegrass, sweet
Clover, crimson
Clover, hop or yellow
Clover, hop, large
Clover, hop, small (suckling)
Clover, Persian
Clover, strawberry
Clover, subterranean
Crested dogtail
Fescue, Chewings
Fescue, fine-leaved (forage type)
Fescue, hard
Fescue, red and creeping red
Fescue, sheep
Fescue, various-leaved
Foxtail, creeping
Foxtail, meadow
Kale (forage type)
Lespedeza, common or Kobe
Lespedeza, Korean
Lespedeza, sericea or Chinese

Little bluestem bunchgrass
Lupin (forage type)
Medick, black
Millet, foxtail or Italian
Millet, Japanese
Millet, pearl
Millet, proso
Needle-and-thread grass
Needlegrass, green
Oatgrass, tall
Phacelia
Prairie Junegrass
Redtop
Sainfoin
Sorghum
Spike trisetum
Sudangrass
Timothy, dwarf
Vetch, crown (forage type)
Vetch, hairy (forage type)
Vetch, Hungarian (forage type)
Vetch, kidney (forage type)
Vetch, spring or common (forage type)
Wheatgrass, awned
Wheatgrass, beardless
Wheatgrass, hybrid
Wheatgrass, northern
Wheatgrass, Siberian
Wheatgrass, slender
Wheatgrass, streambank
Wheatgrass, tall
Wheatgrass, western

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