ARCHIVED — Regulations Amending the Seeds Regulations (Part III and Schedule III)

Vol. 143, No. 14 — July 8, 2009

Registration

SOR/2009-186 June 18, 2009

SEEDS ACT

P.C. 2009-990 June 18, 2009

Her Excellency the Governor General in Council, on the recommendation of the Minister of Agriculture and Agri-Food, pursuant to subsection 4(1) (see footnote a) of the Seeds Act (see footnote b), hereby makes the annexed Regulations Amending the Seeds Regulations (Part III and Schedule III).

REGULATIONS AMENDING THE SEEDS REGULATIONS (PART III AND SCHEDULE III)

AMENDMENTS

1. The definitions “merit” and “recommending committee” in section 63 of the Seeds Regulations (see footnote 1) are replaced by the following:

“merit” means, with respect to a variety, that the variety is equal or superior to appropriate reference varieties with regard to any single characteristic or combination of characteristics that renders the variety beneficial for a particular use in a specific area of Canada; (valeur)

“recommending committee” means a committee that is approved by the Minister under section 65.1; (comité de recommandation)

2. The Regulations are amended by adding the following after section 65:

RECOMMENDING COMMITTEES

65.1 (1) The Minister shall approve, for Canada or a region of Canada, a committee to establish and administer protocols for testing the varieties of a species, kind or type of crop listed in Part I of Schedule III, to determine the merit of the varieties and to make recommendations respecting their registration if

(a) the members of the committee have the knowledge and expertise required to establish and administer testing protocols for varieties of that species, kind or type of crop;

(b) the members of the committee have the knowledge and expertise required to determine the merit of the varieties of that species, kind or type of crop;

(c) the testing protocols established by the committee are appropriate for that species, kind or type of crop, are practical and are based on scientific principles;

(d) the procedures established by the committee for determining the merit of varieties of that species, kind or type of crop are appropriate for that purpose and are based on scientific principles;

(e) the operating procedures established by the committee will ensure that its functioning is transparent and that varieties are dealt with in a fair and consistent manner; and

(f) no other committee is approved as a recommending committee for that species, kind or type of crop for Canada or the region.

(2) The Minister shall approve, for Canada or a region of Canada, a committee to establish and administer protocols for testing the varieties of a species, kind or type of crop listed in Part II of Schedule III and to make recommendations respecting their registration if

(a) the members of the committee have the knowledge and expertise required to establish and administer testing protocols for varieties of that species, kind or type of crop;

(b) the testing protocols established by the committee are appropriate for that species, kind or type of crop, are practical and are based on scientific principles;

(c) the operating procedures established by the committee will ensure that its functioning is transparent and that varieties are dealt with in a fair and consistent manner; and

(d) no other committee is approved as a recommending committee for that species, kind or type of crop for Canada or the region.

(3) In carrying out its functions, a recommending committee must apply the testing protocols it has established, act in accordance with its operating procedures and, in the case of a committee approved under subsection (1), apply the procedures it has established to determine the merit of varieties.

(4) For the purposes of subsections 67(1) and 67.1(1), the recommendation of a recommending committee must be based on the following:

(a) in the case of a species, kind or type of crop that is listed in Part I of Schedule III, the results of testing the variety in accordance with the relevant testing protocols and a determination of whether the variety has merit; and

(b) in the case of a species, kind or type of crop that is listed in Part II of Schedule III, the results of testing the variety in accordance with the relevant testing protocols.

3. (1) Subparagraphs 67(1)(a)(v) and (vi) of the Regulations are replaced by the following:

(v) a recommendation that is not more than two years old or, in the case of a forage variety, not more than four years old, from a recommending committee stating whether the variety should be registered,

(vi) the results of the testing on which the recommendation is based,

(2) Subparagraph 67(1)(b)(iii) of the Regulations is replaced by the following:

(iii) for potatoes, a set of photographic slides or digital images that detail plant morphology.

(3) Section 67 of the Regulations is amended by adding the following after subsection (1):

(1.1) Subparagraphs (1)(a)(v) and (vi) do not apply in respect of a species, kind or type of crop that is listed in Part III of Schedule III.

4. The Regulations are amended by adding the following after section 67:

ELIGIBILITY REQUIREMENTS FOR VARIETY REGISTRATION

67.1 (1) A variety of a species, kind or type of crop that is listed in Part I of Schedule III is eligible for registration if

(a) the variety has merit;

(b) the variety has been tested in accordance with the testing protocols of a recommending committee;

(c) the recommending committee has made a recommendation respecting registration of the variety;

(d) the variety or its progeny is not detrimental to human or animal health and safety or the environment when grown and used as intended;

(e) the representative reference sample of the variety does not contain off-types or impurities in excess of the Association’s standards for varietal purity;

(f) the variety meets the standards for varietal purity established by the Association or these Regulations for a variety of that species, kind or type;

(g) the variety is distinguishable from all other varieties that were or currently are registered in Canada;

(h) the variety name is not a registered trademark in respect of the variety;

(i) the variety name is not likely to mislead a purchaser with respect to the composition, genetic origin or utility of the variety;

(j) the variety name is not likely to be confused with the name of a variety that was or currently is registered;

(k) the variety name is not likely to offend the public;

(l) no false statement or falsified document and no misleading or incorrect information have been submitted in support of the application for registration; and

(m) the information provided to the Registrar is sufficient to enable the variety to be evaluated.

(2) A variety of a species, kind or type of crop that is listed in Part II of Schedule III is eligible for registration if the requirements for eligibility set out in paragraphs (1)(b) to (m) are met.

(3) A variety of a species, kind or type of crop that is listed in Part III of Schedule III is eligible for registration if the requirements for eligibility set out in paragraphs (1)(d) to (m) are met.

5. (1) The portion of subsection 68(1) of the Regulations before paragraph (a) is replaced by the following:

68. (1) Subject to subsections (2) and (3), if the requirements set out in sections 67 and 67.1 are met, the Registrar shall

(2) Paragraph 68(2)(a) of the Regulations is replaced by the following:

(a) in the case of a variety of a species, kind or type of crop that is listed in Part I or II of Schedule III, if a minimum of one year of testing demonstrates that the variety may be eligible for registration but that further testing is required before a final decision can be rendered, the registration shall be limited to an initial period of not more than three years that shall be extended on written request by the applicant if eligibility for registration continues to be demonstrated, but under no circumstances shall the total duration of the registration exceed five years;

6. Section 72 of the Regulations and the heading before it are repealed.

7. Paragraph 74(4)(b) of the Regulations is replaced by the following:

(b) the variety has been found to be indistinguishable from another variety that was or currently is registered in Canada;

8. Schedule III to the Regulations is replaced by the Schedule III set out in the schedule to these Regulations.

COMING INTO FORCE

9. These Regulations come into force on the day on which they are registered.

SCHEDULE
(Section 8)

SCHEDULE III
(Section 65, subsections 65.1(1), (2) and (4) and 67(1.1), section 67.1 and paragraph 68(2)(a))

SPECIES, KINDS OR TYPES OF CROPS SUBJECT TO VARIETY REGISTRATION

SPECIES, KINDS OR TYPES OF CROPS SUBJECT TO VARIETY REGISTRATION

Species, Kind or Type	Scientific Name
	PART I
Alfalfa (forage type)	Medicago sativa L.
Barley, six-row, two-row	Hordeum vulgare L. subsp. vulgare
Bean, faba (small-seeded)	Vicia faba L.
Bean, field	Phaseolus vulgaris L.
Bird’s foot trefoil	Lotus corniculatus L.
Bromegrass, meadow	Bromus riparius Rehmann
Bromegrass, smooth	Bromus inermis Leyss.
Buckwheat	Fagopyrum esculentum Moench
Canarygrass, annual	Phalaris canariensis L.
Canarygrass, reed	Phalaris arundinacea L.
Canola, oilseed rape, rapeseed	Brassica rapa L. subsp. campestris (L.) A.R. Clapham or B. napus L. var. napus (= B. napus L. var. oleifera Delile) or B. juncea (L.) Czern.
Clover, alsike Clover, red Clover, sweet (white blossom) Clover, sweet (yellow blossom)	Trifolium hybridum L. Trifolium pratense L. Melilotus albus Medik. Melilotus officinalis (L.) Lam.
Clover, white	Trifolium repens L.
Fescue, meadow (forage type)	Festuca pratensis Huds.
Fescue, red (forage type)	Festuca rubra L. subsp. rubra
Fescue, tall (forage type)	Festuca arundinacea Schreb.
Flax (oilseed)	Linum usitatissimum L.
Lentil (grain type)	Lens culinaris Medik.
Lupin, lupine (grain and forage types)	Lupinus spp.
Mustard, brown, oriental, Indian	Brassica juncea (L.) Czern.
Mustard, white (= yellow)	Sinapis alba L.
Oat (grain type)	Avena sativa L., A. 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.) Merr.
Timothy, common (forage type)	Phleum pratense L.
Tobacco (flue-cured)	Nicotiana tabacum L.
Triticale (grain type)	x Triticosecale Wittm. ex A. Camus
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) Á. Löve (= Agropyron spicatum (Pursh) Scribn. & J.G. Smith f. inerme (Scribn. & J.G. Smith) Beetle)
Wheatgrass, crested	Agropyron cristatum (L.) Gaertn. or A. desertorum (Fisch. 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. sibiricum (Willd.) Melderis (= Agropyronsibiricum (Willd.) Beauv.)
Wheatgrass, slender	Elymus trachycaulus (Link) Gould ex Shinners (= Agropyron trachycaulum (Link) Malte ex H.F. Lewis)
Wheatgrass, streambank	Elymus lanceolatus (Scribn. & J.G. Sm.) Gould subsp. lanceolatus (= Agropyron riparium Scribn. & Smith)
Wheatgrass, tall	Elytrigia elongata (Host) Nevski (= Agropyron elongatum (Host) P. Beauv.)
Wheatgrass, western	Pascopyrum smithii (Rydb.) Á. Löve (= Agropyron smithii Rydb.)
Wildrye, Altai	Leymus angustus (Trin.) Pilg. (= Elymus angustus Trin.)
Wildrye, Dahurian	Elymus dahuricus Turcz ex Griseb.
Wildrye, Russian	Psathyrostachys juncea (Fisch.) Nevski (= Elymus junceus Fisch.)
	PART II
Safflower	Carthamus tinctorius L.
	PART III
Potato (commercial production)	Solanum tuberosum
Sunflower (non-ornamental)	L. Helianthus annuus L.

REGULATORY IMPACT
ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issue

Advances in seed science, technology and plant breeding require regular changes to the seed regulatory framework to ensure appropriate government oversight without unduly restricting opportunities. Variety developers and crop producers are experiencing an increased demand for niche market varieties and an increasingly competitive seed trade environment. The current variety registration system was not adequately flexible to facilitate these changes.

As previously specified in the Seeds Regulations (the Regulations), pre-registration testing (up to three years of field trials and laboratory testing) and merit assessment were mandatory for the registration of new varieties. Varieties of all crop kinds that require registration were subject to the same types of registration requirements (including agronomic pre-registration testing and merit assessment). The previous system did not provide a practical alternative in cases where these requirements are unnecessarily burdensome.

A variety is determined to have merit if it performs as well as or better than appropriate reference varieties for one or more criteria established for that crop kind. For some crop kinds, these merit requirements are not relevant in the marketplace and may not be of value in determining the suitability of the variety for producers or the acceptability of the variety to end users.

The requirements may also create a barrier to timely and cost-effective variety registration since they require time and resources from both industry and government. For some crop kinds, the requirement to conduct laboratory tests and field trials and to assess merit may be considered a regulatory burden relative to the benefit derived. This burden may lead to a delay in the commercialization of valuable new varieties and their availability to producers. For this reason, many foreign varieties may never be registered in Canada.

In cases where variety developers are not able to confidently predict which varieties will be eligible for registration due to merit requirements, there is an increase in business risk and uncertainty in the variety development process. This may lead to reduced investment in research and variety development, which reduces the industry’s ability to respond to immediate and changing needs within the sector.

In written and verbal communications with the Minister of Agriculture and Agri-Food, the President of the Canadian Food Inspection Agency (CFIA), and the CFIA’s Seed Section, the seed and crop sectors have repeatedly indicated dissatisfaction with the current variety registration system and have clearly emphasized the urgent need for a more flexible registration system.

To address these issues, the amendments to the Seeds Regulations increase the flexibility of the regulations that govern the registration of varieties. The risks to Canadian agriculture in not moving forward with changes to the variety registration system may include, but are not limited to, reduced opportunities for producers, reduced investment in plant research and plant breeding in Canada, increased barriers to innovation, and a reduction of Canada’s role in the global trade of seed and grain.

Objectives

These amendments divide the list of all crop kinds subject to variety registration into three parts with three levels of variety registration requirements such that each crop kind can be placed in the part that is appropriate for the needs of that specific crop kind.

The objective of these amendments is to create a regulatory framework for variety registration that allows for varying levels of government oversight on a crop-by-crop basis by removing, where appropriate, any burdensome or ineffective crop specific pre-registration testing and merit assessment requirements. Government oversight will be maintained to monitor and trace seed in the marketplace, to ensure health and safety requirements are met, to undertake compliance and enforcement actions, to certify the varietal identity and purity of seed, to prevent fraud, and to provide appropriate oversight of plants with novel traits (PNTs).

The new framework changes registration requirements, reduces the number of steps and time required to register varieties and increases the predictability of registration decisions. This is accomplished by introducing the flexibility to address crop-specific needs in the regulatory framework by removing requirements for pre-registration testing and also merit assessment in some cases, where appropriate. Reducing regulatory burden is expected to lead to greater diversity in the types of varieties available as merit-based restrictions will be removed for some crop kinds. Also, it is expected that there would be an increase in investment in research in new varieties due to greater predictability in the eligibility of varieties for registration. It is expected that the cumulative effect would be a greater choice in the varieties available to producers which would better address producers’ and end users’ needs. This change in the variety registration system also aims to reduce time to market resulting in new varieties becoming available to producers more rapidly, fostering innovation and development. As such, the new framework aims to reduce regulatory burden for variety developers and to improve the choices for producers with respect to the number and diversity of varieties available to them.

The objectives of these amendments are consistent with Canada’s federal, provincial, and territorial governments’ Growing Forward policy framework for a profitable, innovative agriculture and agri-food industry that seizes opportunities corresponding to market demands, while contributing to the health and well-being of Canadians. In addition, these amendments are in line with the Government of Canada’s Cabinet Directive on Streamlining Regulation and also with the Paper Burden Reduction Initiative to reduce regulatory burden.

Description

The Regulations require that varieties of specified crop kinds be registered prior to the sale of seed in Canada and prior to import of seed into Canada. The purpose of variety registration is to provide government oversight to ensure that health and safety requirements are met and that information related to the identity of the variety is available to regulators to prevent fraud. It also facilitates seed certification, the international trade of seed and the tracking and tracing of varieties in commercial channels.

Flexible variety registration system

The amended system introduces a range of options with respect to pre-registration testing and merit assessment requirements for individual crop kinds while maintaining an appropriate level of government oversight. It imposes three unique levels of requirements for variety registration. The list of all crop kinds requiring variety registration (Schedule III in the Regulations) is partitioned into three Parts with differing pre-registration testing and merit assessment requirements for each Part.

These amendments include:

(a) Registration requirements for varieties of crop kinds in Parts I, II, or III of Schedule III;

(b) Placement of crop kinds in Parts I, II, and III of Schedule III;

(c) Responsibilities of recommending committees; and

(d) Miscellaneous amendments.

(a) Registration requirements for varieties of crop kinds in Parts I, II, or III of Schedule III

(i) Basic requirements for variety registration

Registration of new varieties of all crop kinds in Schedule III requires the submission of an application package to the CFIA and the payment of a fee of $875. The application package must include a representative reference seed sample, the pedigree of the variety, a detailed description of the characteristics of the variety, an indication of whether the variety is a PNT, and data to support claims. Information contained in the application is required to demonstrate that the variety meets health and safety standards and that the variety is distinguishable (unique), uniform, and stable. This information supports the CFIA’s ability to monitor and trace seed in the marketplace, to undertake compliance and enforcement actions, to certify the varietal identity and purity of seed, to prevent fraud, and to provide appropriate oversight of PNTs.

(ii) Part I of Schedule III (status quo)

Varieties of crop kinds in Part I continue to require pre-registration testing pursuant to protocols approved by a recommending committee and a recommendation from a recommending committee respecting the testing and merit of the candidate variety in order to be registered in Canada. An application to the Registrar (CFIA) for registration containing the information to satisfy the basic requirements for variety registration (noted above) is also required. There is crop-specific flexibility with respect to the type of testing and merit assessment requirements. Subsection 67.1(1) of the Regulations has been added to clarify the requirements for eligibility for variety registration of a variety of a crop kind listed in Part I.

This regulatory amendment includes a clarification in the definition of merit. The addition of “any single characteristic or combination of characteristics” in the merit definition will allow the merit assessment criteria (agronomic, quality and disease) to be specifically defined as one or more assessment criteria (for example, quality only) if there is rationale and consensus for this change.

(iii) Part II of Schedule III (removal of merit assessment requirement)

Varieties of crop kinds in Part II of Schedule III require pre-registration testing but not merit assessment. An application to the Registrar (CFIA) for registration containing the information to satisfy the basic requirements for variety registration (noted above) is also required. In addition, a recommendation from a recommending committee indicating that the variety has been tested according to approved protocols is required as part of the variety application package. Subsection 67.1(2) of the Regulations has been added to specify the requirements for eligibility for variety registration of a variety of a crop kind listed in Part II.

A significant number of stakeholder groups have indicated their preference for pre-registration testing to be retained. The creation of Part II in Schedule III provides for this. Safflower is the only crop currently included in Part II.

(iv) Part III of Schedule III (Listing)

Varieties of crop kinds in Part III do not require pre-registration testing or merit assessment. Therefore, a recommendation from a recommending committee is not required. However, an application to the Registrar (CFIA) for registration containing the information to satisfy the basic requirements for variety registration (noted above) is still required. Subsection 67.1(3) of the Regulations has been added to specify the requirements for eligibility for registration of a variety of a crop kind listed in Part III. Potatoes for commercial production and non-ornamental sunflower are included in Part III.

(b) Placement of crop kinds in Parts I, II, and III of Schedule III

Now that the framework for the flexible registration system has been established, it is expected that a series of proposals for and subsequent changes to registration requirements for individual crop kinds will occur. In order for a specific crop kind to move from one Part of Schedule III to another, a regulatory amendment is required. These subsequent regulatory amendments could proceed once a rationale and consensus for change have been established through the CFIA’s consultation with individual crop sectors.

Crop kinds that were previously exempt from registration and not listed in Schedule III, e.g. corn, food-type soybean, and turf grasses continue to be exempt from variety registration in Canada at this time.

(c) Responsibilities of recommending committees

Section 65.1 of the Regulations has been added to define the responsibilities of recommending committees with respect to crop kinds listed in Part I or II of Schedule III. The definition of a recommending committee has also been amended. The Registrar will continue to review recommending committees’ protocols annually to determine whether the established pre-registration testing and merit assessment procedures are based on scientific principles and are appropriate to the committee’s mandate under the authority of the Regulations. In addition, the Registrar will continue to review the governance procedures of the committee itself to verify that it is operating in a fair, consistent, transparent, and efficient manner.

In practical terms, the role of recommending committees remains unchanged for varieties of crop kinds in Part I. Recommending committees continue to play a key role in the administration of pre-registration testing and merit assessment for candidate varieties for registration in Canada.

For crop kinds in Part II, the role of recommending committees is to determine the pre-registration testing requirements and to ensure that the testing of candidate varieties has been carried out using appropriate test protocols. No assessment of merit is required.

For crop kinds in Part III, recommending committees are not required.

(d) Miscellaneous amendments

Miscellaneous amendments not resulting from the creation of the framework for a flexible variety registration system are also being implemented at this time. In order to align the Regulations with current regulatory drafting guidelines, the section pertaining to ‘Refusal to Register’ (Section 72) has been reworded and moved to ‘Eligibility Requirements for Variety Registration’ (Section 67.1). These amendments reverse the negative language of the stipulations for refusal to register to change them to requirements for eligibility for registration. These amendments do not change the requirements for registration currently in practice. For example, the current stipulation to refuse a registration when “the variety is indistinguishable from a variety already registered” has been changed to a stipulation that a variety is eligible for registration if “the variety is distinguishable from all other varieties registered in Canada”. However, in practice, there is no change in the Registrar’s procedures to assess the distinguishability of a variety based primarily on the pedigree of the variety.

In addition, to respond to technological advances, an amendment has been made to subparagraph 67(1)(b)(iii) of the Regulations to allow submission of digital images or photographic slides that detail plant morphology for potato varieties.

Regulatory and non-regulatory options considered

Three options were considered as possible solutions to address issues concerning the variety registration system prior to this regulatory change. The first option considered was to maintain the current system with no changes. This option is not appropriate as it does not adequately address the changing needs of seed and crop sector stakeholders or the differences among individual crop sectors. Further, there clearly is general stakeholder agreement that there are issues with variety registration in Canada that need to be addressed.

The second option considered was the complete elimination of the variety registration system. Variety registration is intricately woven into the Canadian seed certification system and the structure of the seed regulatory system. The seed and crop sectors generally oppose the wholesale de-regulation of seed, as value is seen in maintaining a registration system. This option does not provide for government oversight of the seed marketplace. As such, this is not the preferred option.

The third option considered was the creation of a flexible variety registration system. This is the preferred option as it addresses the issues identified with the previous regulatory framework for variety registration. This option is being implemented through this regulatory amendment to establish a flexible variety registration system to accommodate specific needs of different crop sectors and, where appropriate, reduce regulatory burden while maintaining appropriate government oversight. This regulatory amendment is expected to support the long-term growth of the seed sector and Canadian agriculture, to allow for innovation, and to provide for producer choice while continuing to maintain CFIA’s role in health and safety, fraud prevention, facilitation of seed certification, the international trade of seed, and the tracking and tracing of varieties in commercial channels.

Benefits and costs

General characterization of the seed and crop sectors

The seed and crop sectors in Canada include developers of varieties, seed growers, seed companies, crop and livestock producers, grain handlers and agri-food processors. In 2007, there were approximately 200 CSGA (Canadian Seed Growers Association) recognized plant breeders, including approximately 85 public and 115 private breeders, approximately 4 500 seed growers were CSGA members (not including potatoes), approximately 800 seed potato growers were identified in Canada (CFIA Seed Potato Section), and over 130 seed companies were members of the Canadian Seed Trade Association (CSTA). It was estimated that 195 000 farmers produced field crops in Canada in 2006 (Statistics Canada). The 2006 Census of Agriculture also reported the production of all crop kinds on over 35.9 million hectares with a value of over $14 billion for 2006 (Statistics Canada).

International trade of seed significantly contributes to Canada’s economy. The total seed exports from Canada were valued at over $340 million for the 2006–2007 season (CSTA) with seed potato exports of approximately $41 million for that same period (Industry Canada). In addition, in 2007, CSTA estimated that the total value of the seed sector was $770 million (not including seed potatoes).

Currently, over 2 700 varieties of the 52 crop kinds requiring variety registration are registered in Canada. On average, more than 160 new varieties are registered each year.

Impacts of the flexible variety registration system

The stakeholders affected by these amendments include developers of varieties, seed growers, producers (farmers), down-stream processors, and end-users. Due to data limitations on the expected impacts on stakeholder groups, a general qualitative impact assessment rather than a quantitative benefit-cost analysis is presented below for the impacts associated with the creation of a more flexible variety registration framework. More specific impacts for the four crop kinds that were originally proposed to be placed in Parts II and III of Schedule III are available online at www.inspection.gc.ca.

No changes to costs or benefits would accrue solely by establishing a more flexible variety registration framework; however, the framework creates the potential for changes to costs and benefits to accrue in the future each time the variety registration requirements for a crop kind are changed. Since any of the 52 crop kinds requiring registration could be placed in Part II or III at some point in the future, the impacts described below could apply in the future to a large portion of the seed and crop sectors. Regulatory change and crop-specific impact assessments would be required, however, to change registration requirements for individual crop kinds in the future.

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan of environmental effects was conducted. The scan concluded that minimal environmental effect will occur in the undertaking of this proposal and the requirement for detailed analysis is not warranted.

Potential impacts — Part I of Schedule III

There would be no incremental impacts associated with the creation of Part I as this is essentially the status quo.

Potential impacts — Parts II and III of Schedule III

The removal of pre-registration testing (Part III) and merit assessment requirements (Parts II and III) reduces the regulatory burden and associated costs for developers of new varieties for those crop kinds listed in Parts II and III. It is expected that the reduced regulatory burden will lead to more timely availability of varieties in the marketplace and would foster innovation and investment in variety development. Consequently, this is expected to lead to an eventual decrease in the time to market and an increase in the number and diversity of registered varieties that will better address producers’ different agronomic needs and end users’ unique quality needs. The increased number of variety applications will not likely increase the CFIA resources required to review variety applications as it would be offset by the absence of pre-registration testing and merit assessment data to be reviewed.

Since recommending committee assessment of the merit of candidate varieties is no longer required for variety registration, developers no longer have to assume the risks and costs associated with investment in variety development without the certainty that the variety will be eligible for registration. This allows the decision to commercialize new varieties to be made solely by the developers and not to be dependent upon a recommendation from a recommending committee.

Removal of merit assessment requirements for new varieties of crop kinds listed in Parts II and III results in new varieties being eligible for registration without restrictions on the types of varieties or their performance. This permits varieties to be marketed that would not have met merit requirements as defined in the current system. This allows producers to decide which varieties have merit for their individual farms, instead of being restricted to varieties that the current system has determined to have merit. This could, however, increase the risk of economic losses to producers should they grow a variety that is not suitable for their region or for the desired end use. As in the current system, producers will have to carefully research varieties prior to making purchasing decisions.

Specific impacts — Part II of Schedule III (Removal of merit assessment requirements)

For new varieties of crop kinds in Part II, the time delays in new varieties becoming available to producers could be reduced. For example, to register a safflower variety in Canada, fifteen field tests of data collected over a minimum of three years of variety registration trials were required for registration prior to this regulatory amendment. The implementation of the reduced registration requirements may enable a somewhat quicker return on the developer’s investment in research and development. This efficiency is mainly associated with the elimination of the time required to wait for the recommending committees to carry out the merit assessment.

Results of the required pre-registration testing may continue to be made publicly available for some crop kinds in Part II and would therefore be available for producers to make purchasing decisions. The decision to make testing results publicly available would continue to rest with the recommending committees.

Specific impacts — Part III of Schedule III (Removal of pre-registration testing and merit assessment requirements )

For new varieties of crop kinds in Part III, the time delays in new varieties becoming available to producers could be reduced by one to three years; enabling a significantly quicker return on the developer’s investment. For example, to register a potato variety in Canada before this regulatory amendment, six field tests of data collected over a minimum of two years were required, costing approximately $6 000. The efficiency is mainly associated with the elimination of the requirement for one to three years of pre-registration testing but also with the time saved in removing the delay associated with waiting for the recommending committees to evaluate the testing and to assess merit. The work associated with the development of a complete description of the variety will still be required prior to variety registration.

Pre-registration testing is not required, therefore, producers will need to rely on company-generated performance information or other third-party generated information when making purchasing decisions, e.g. provincially-generated post-registration performance testing information. Consequently, there may be a cost to developers to carry out additional post-registration testing themselves as part of their marketing and also a cost to producers in terms of the time required to assess the results of this post-registration testing.

Moreover, because of the removal of pre-registration testing and merit assessment for crops in Part III , the recommending committees will no longer play a role for these crops and the costs associated with the operations of the recommending committees will therefore be eliminated. These costs include the variety registration trials, sample and site evaluations, and meetings.

This results in a cost savings primarily to developers but also to all those involved in the recommending committees, including seed trade members, processors, growers, producers, and government. Although the recommending committees meetings were often seen as a benefit for the exchange information among representatives of the value chain, the exchange of information among the representatives could continue to take place through another venue if it was desired.

Impacts associated with the placement of crop kinds in Part II or III of Schedule III

In addition to creating a framework for a flexible variety registration system, these amendments also include the placement of crop kinds into each of the new Parts of Schedule III as follows: safflower in Part II (pre-registration testing but no merit assessment) and non-ornamental sunflower and potatoes for commercial production in Part III (removal of pre-registration testing and merit assessment requirements). All of the general impacts associated with the creation of Parts II and III listed above apply to these crop kinds.

Since there is little investment in safflower research in Canada, merit assessment imposes a disproportionate burden on the small safflower sector. Continuing to require pre-registration testing may, however, reduce risk for producers in this developing industry.

It is particularly beneficial to remove the burden of merit assessment for sunflowers, since there is no plant breeding of sunflower varieties in Canada and, due to the burden of pre-registration testing and merit assessment in Canada, foreign varieties are not often registered in Canada even though they may be well suited to Canadian agriculture and markets. This puts our sunflower growers at a particular disadvantage to American growers in obtaining the most current varieties.

Similarly, the removal of the burden of merit assessment for potatoes will be beneficial, since the merit criteria are not necessarily indicative of the usefulness of the variety for its intended end use.

Rationale

Based on the assessment of responses from the pre-publication in the Canada Gazette, Part I, and throughout the many previous years of consultation, the CFIA is implementing these amendments to create the framework for a flexible variety registration system. These amendments to create a flexible variety registration system address the specific needs of each of the different crop kinds on a crop-by-crop basis. It provides the framework for a more dynamic system that enables appropriate, timely, and cost-effective responses to changing conditions in the marketplace.

These amendments support the intended objective of creating a framework that provides varying levels of government oversight for varieties of crop kinds, on a crop-by-crop basis. All crop kinds will no longer be subject to the same requirements or to the same level of government oversight. However, basic variety registration requirements for all crop kinds requiring registration would maintain the CFIA’s ability to ensure that health and safety requirements are met, to monitor and trace seed in the marketplace, to undertake compliance and enforcement actions, to certify the varietal identity and purity of seed, to prevent fraud, to verify claims, and to provide appropriate oversight of PNTs.

Throughout CFIA’s recent public consultations, it was emphasized that these amendments were intended to create the framework for a flexible registration system and not to proceed with placement of crop kinds within Schedule III that differ from the status quo. In order to create the new framework, at least one crop kind must be listed in each of the three Parts of Schedule III. Therefore, each Part of Schedule III includes at least one crop kind. Part III includes non-ornamental sunflower and potatoes for commercial production; Part II includes safflower; and Part I includes all of the remaining crop kinds requiring variety registration.

During the pre-publication comment period, the CFIA received comments from a buckwheat grower and marketer as well as the Buckwheat Workers Group. They emphasized their satisfaction with the current merit recommendation system for buckwheat and several major buckwheat stakeholders have justified the continuation of the current merit recommendation system for buckwheat. Therefore, buckwheat will remain in Part I in this regulatory amendment thus maintaining the status quo. The CFIA will continue to consult with the buckwheat sector to ensure that buckwheat is placed in the appropriate Part of Schedule III for the long-term benefit of this crop sector.

Although only the three crop kinds placed in Parts II and III of Schedule III benefit directly from reduced variety registration requirements at this time, the establishment of the flexible registration framework enables many of the 52 crop kinds requiring registration to benefit in the future.

Removal of pre-registration testing (Part III) and merit assessment requirements (Parts II and III) reduces the regulatory burden and associated costs for developers of new varieties for those crop kinds listed in Parts II and III by reducing the cost, time and unpredictability of the registration process. It is expected that variety development effort would be stimulated for crop kinds in Parts II and III due to the reduction in regulatory burden and further, that an eventual resultant increase in the number of registered varieties available to growers would occur. In addition, the time required for a new variety to become available to Canadian producers (product development cycle) could be reduced by up to three years for some crop kinds.

While these amendments have received general support from traditional seed sector stakeholder groups, concerns have been raised regarding the potential negative impact of the removal of the merit assessment of new varieties as a part of the registration system.

Opposing views also encompassed issues related to globalization of the seed industry, policies on genetically modified technology and these amendments contributing to a variety ‘treadmill’ (constant barrage of new products). While these concerns are important, they cannot be addressed through this regulatory amendment. These particular issues involve several other Government of Canada portfolios; they are not specific to variety registration.

The flexibility of this registration system is expected to stimulate or increase innovation and competitiveness and thereby to support continued or increased investment in public and private variety development in Canada and to increase opportunities for producers.

In keeping with the goal of increased flexibility and effectiveness of variety registration, this regulatory amendment includes a clarification in the definition of merit. To ensure the flexibility in determining “merit” for each specific crop kind in Part I, the definition of merit was modified to clearly state that merit could be based on as little as one criterion such as a quality characteristic rather than a combination of agronomics, disease or quality characteristics. As with any changes in crop placement, changes to merit criteria will only proceed once the rationale and requisite consensus have been established. While not part of the Canada Gazette, Part I, pre-publication, this change in the definition of merit is consistent with the concept of increased flexibility within the regulatory framework and is a response to stakeholder requests for additional clarity regarding merit assessments.

As these amendments do not include any changes to existing fees, the User Fees Act does not apply. The appropriateness of the fees for each of the three Parts will be reviewed in the future.

The objectives of these amendments are consistent with Canada’s federal, provincial, and territorial governments’ Growing Forward policy framework for a profitable and innovative agriculture, agri-food and agri-based products industry that seizes opportunities in responding to market demands and contributes to the health and well-being of Canadians. These amendments are also in line with the Government of Canada’s Paper Burden Reduction Initiative which endeavours to reduce undue regulatory burden by improving the efficiency of existing regulations to help increase productivity and profitability and to promote competition. Regulatory reductions associated with these amendments include, for crop kinds in Part III, a decrease in the amount of laboratory testing and field trial data required, as well as a reduction in the number and complexity of required forms. Finally, these amendments are also in line with the Cabinet Directive on Streamlining Regulation.

Ongoing consultation with seed sector stakeholders will enable a continuous assessment of the functioning of the amended variety registration system and serve to clarify issues that may be of concern. Should significant issues arise, the opinions, requests, and needs of seed sector participants would be solicited, considered, and, as appropriate, incorporated into any subsequent amendments to the Regulations or to procedures and policies employed in the implementation of the flexible variety registration system.

Consultation

The regulatory amendments are based on the feedback received during extensive consultation with stakeholders (including variety developers, the seed trade, seed growers, producers, the general public and other involved government departments and agencies) regarding changes to the variety registration system which began in 1998. Initially, difficulties were experienced in achieving stakeholder consensus due to the lack of an effective stakeholder engagement forum. In 2005, the National Forum on Seed, an industry-led, government-enabled, stakeholder forum, was established and this group collaborated on the development of a new proposal for a flexible variety registration framework. Consultations on a flexible (tiered) variety registration system were initiated in 2006 and included a six month online consultation, five regional and two national stakeholder meetings.

These consultations led to a proposal to amend the Regulations to establish a more flexible variety registration system. This proposal was pre-published in the Canada Gazette, Part I, on June 28, 2008, for a 75-day comment period which ended September 11, 2008.

The following is a summary of comments received from stakeholders. The CFIA response to the comments received follows.

Comments received

Thirty-five written responses were received during the Canada Gazette, Part I, pre-publication period and another nine were received afterward. Respondents represented a range of perspectives, from interested individuals through to the seed industry value chain: variety developers, distributor/retailers, producers, grain handlers, processors, end users (both food and feed) and exporters.

The majority of stakeholders who responded supported the new flexible variety registration framework. Those who responded in support of the new framework include the Canadian Seed Growers’ Association (CSGA), the Canadian Seed Trade Association (CSTA), five trade associations, private seed companies, a university, a farm inputs retailer, a crop specific association, and a regional crop recommending committee. Many stakeholders expressed the view that this process should be accelerated as there is a need for a registration system that is simple and not overly onerous in order to foster innovation and keep pace with the rate of change in the marketplace.

A minority of stakeholders who responded were opposed to the proposed amendments. Some of the stakeholders who were opposed to the proposed amendments include the National Farmers Union (NFU) and some individuals. The reasons for opposing these amendments include: a questioning of the value to the farmer of the purported benefits of a flexible registration system; a questioning of the use of economic rationale alone to justify the changes; viewing the proposal as a reduced regulation model for variety developers, and concerns that this could potentially lead to reduced protection and product information for growers; and opposing any changes that might appear to foster the increased corporate control of the seed trade in Canada. The NFU pointed out that there is no mechanism for the public or for farmers to appeal variety registration decisions.

A stakeholder expressed concern over the danger of allowing the definition of merit to be reduced to as little as one trait for crop kinds in Part I of Schedule III, while three stakeholders emphasized that recommending committees should have authority to make test protocol recommendations to the CFIA and recommend which characteristic(s) are included in the definition of merit.

There was concern that the removal of merit in Parts II and III might allow for the possible introduction of inferior varieties. There was also concern that this change would lead to more rapid commercial introduction of genetically engineered varieties. One organisation questioned the value of Part II and indicated that the registration requirements need to be clarified and should only require evidence of testing prior to registration.

The buckwheat sector raised concerns regarding the CFIA proposed movement of buckwheat to Part II. Concerns were raised that the registration system needs to continue to include a merit assessment of the quality of buckwheat varieties prior to their entry into the Canadian marketplace to protect the quality of the export crop.

A large number of stakeholders submitted rationale and support for movement of non-ornamental sunflowers and potatoes to Part III. However, one stakeholder was opposed to movement of potatoes to Part III and another stakeholder was opposed to movement of sunflowers to Part III due to their preference for pre-registration testing information.

The majority of stakeholders who responded were of the view that there is a need for a predictable, transparent, annual process for moving crop kinds between the proposed three parts of Schedule III. Many supported moving forward quickly on the placement of major crop species into the three parts of Schedule III. Stakeholders submitted varying opinions on where in Schedule III to place forage crop kinds (alfalfa, bromegrass, red clover, ochardgrass and forage timothy) and other crops such as soybeans, field beans, rye, lupin safflower, spelt, tobacco, rye, and oats. Many also emphasized the need to keep currently exempt crop kinds outside of variety registration, and some commented that there should be a mechanism to exempt a crop kind from registration.

Stakeholders supported amendments to the wording in the Regulations to provide additional clarity. There was also support for changes to the Regulations to clarify the roles and responsibilities of recommending committees.

One stakeholder was concerned that some of their comments in the past were considered outside the purview of these proposed regulatory amendments even though these changes will have much broader implications. The stakeholder commented that the consultation process, to date, appeared not to take farmers’ views into account and was concerned that future crop specific consultative processes will be controlled by industry organizations. Another stakeholder expressed concerns that the consultative process was too demanding on a small group of industry professionals.

A stakeholder emphasized the need for the implementation of a revised risk-based contract registration system to address the shortcomings in flexibility of the current system for some stakeholders. They warn that, without change, crop sectors that continue to be subject to merit assessment may not have adequate opportunity to move specific varieties through to registration when there is market demand but the varieties fail to meet the merit criteria for one or two traits.

Three stakeholders expressed concerns regarding a farmer’s need to have the right to save seed. Concerns about the amount of control of the Canadian seed business held by large multinational chemical/seed/trait companies, and concerns that the CFIA should not de-register varieties where there is no cause in order to enable free farmer access after the expiration of plant breeder’s rights (PBR) were expressed. They also suggested removing the seed and trait corporations’ ability to sue farmers over issues related to seed/trait usage and replace it with a third-party ownership verification and dispute arbitration mechanism. One stakeholder would also like to see genetic use restriction technologies banned in Canada and an increase in the funding of public sector variety breeding.

Three individuals expressed concern over genetically engineered crop kinds from the perspective of health, safety, impact on biodiversity, and threat to organic food production. Another stakeholder would like to see plant with novel trait requirements removed in order to foster innovation and align with the international community. One individual expressed concern with respect to the continually escalating input costs required to produce sufficient food for the world.

CFIA Response

The purpose of this amendment is to address the shortcomings of the current variety registration system with respect to changing technology and market demands, while ensuring that the CFIA’s oversight and enforcement roles are not compromised. The CFIA is responding to stakeholder demand for rapid changes to the variety registration system. However, previously, a lack of consensus among stakeholders in the seed industry delayed the modernization of the variety registration system. A concerted CFIA effort of consultation and consensus building over several years has finally led to the current flexible variety registration amendment.

The amendments will be beneficial to many. In part, these amendments will benefit farmers by reducing the regulatory burden on variety developers, resulting in the grower having more choices, new opportunities, and a higher value, more globally competitive crop to grow. In addition, the proposed changes are justified based on economic rationale, including an anticipated reduction in regulatory burden, increased innovation and increased market efficiency through reduced time to market and the removal of uncertainty.

The amendment will not compromise in the CFIA’s ability to maintain an appropriate level of regulatory oversight and the ability to enforce compliance with standards under the Seeds Act. The CFIA’s ability to ensure that health and safety requirements are met, to monitor and trace seed in the marketplace, to undertake compliance and enforcement actions, to certify the varietal identity and purity of seed, to prevent fraud, to verify claims, and to provide appropriate oversight of PNTs is in no way diminished by this amendment. Even the future movement of crop kinds to Part III of Schedule III would not result in complete de-regulation — varieties of the crop kind would continue to be subject to basic variety registration requirements.

Any future crop movement from one part of Schedule III to another will require a regulatory amendment. These regulatory changes would be subject to established processes to ensure the best possible results for Canadians. Changes in crop placement in Schedule III would be proposed if there is a rationale and a requisite level of consensus for change.

Concerns have been raised regarding the removal of merit, or substantial changes in the merit definition. Prior to the removal of the merit requirement or substantial changes in the definition of merit for a crop kind, a rationale and consensus for the proposed change are required. The potential impact of the amendment on the crop sector would be carefully considered.

The basic variety registration requirements for registration of crop kinds in Part III will still allow for regulatory oversight by the CFIA. This type of registration is viewed to be appropriate for situations where the crop stakeholders in Canada find value in only the basic variety registration requirements. This would be applicable to crop kinds where quality, pathology, agronomy testing and evaluation for variety registration are deemed of little or no consequence to our market. An example of this occurs in non-ornamental sunflowers where there is no breeding in Canada, hence virtually all our varieties are foreign and the crop harvest is primarily exported. The varieties coming into Canada are bred for regions that are known to be similar to the areas where sunflower is grown in Canada. Historically the Canadian merit assessment and variety recommendation process meant varieties had to wait one to three years before entering the Canadian market. This put Canadian growers at a distinct disadvantage to their foreign competition (older, less desirable varieties). The minimum requirements found in Part III are sufficient for the CFIA to fulfill its mandate of oversight of the seed trade and consumer protection, without unduly restricting producer access to new varieties.

Questions have been raised regarding the functioning of Part II. For Part II, the crop specific standardized pre-market testing requirements will be detailed in the recommending committees’ procedures document. This document is subject to annual approval by the CFIA. The value of Part II is in the reduced regulatory burden as a result of the removal of the merit requirement, while continuing to maintain a standardized testing system.

Additional comments were received but were outside of the scope of these particular amendments to the variety registration system. For example, these amendments do not contain changes to contract registration requirements or the variety de-registration process.

All plant products of biotechnology require rigorous pre-market food, feed, and environmental safety assessments. This process is separate from variety registration. Also, the funding of public sector variety breeding is an issue outside of the scope of variety registration and CFIA’s mandate. Furthermore, variety registration does not limit a farmer’s right to save seed.

Implementation, enforcement and service standards

Implementation plan

The following groups will be included in communications with respect to this regulatory amendment: Recommending committees, CSGA, CSTA, Canadian Seed Institute (CSI), Grain Growers of Canada (GGC), NFS, NFU, other seed and crop sector associations, plant breeders and developers of varieties, seed analysts, grain and crop producers, provincial and regional governments, crop specific associations, e.g. Pulse Canada, NSAC, Canadian Horticulture Council (CHC), CFIA Operations, Programs and Policy, and Science Branch staff as appropriate, and Federal government departments and agencies as appropriate. The CFIA will also send individual responses to all comments received in response to the publication of the proposed regulatory amendments in the Canada Gazette, Part I.

The CFIA will communicate the requirements for the registration of varieties in the newly created Parts II and III of Schedule III through revisions to the Procedures for the Registration of Crop Varieties in Canada, available on the CFIA Web site at www.inspection.gc.ca/english/plaveg/variet/proced/regproe.shtml.

Compliance and enforcement

This flexible variety registration system continues to maintain the CFIA’s ability to monitor, trace, and regulate the sale of seed of varieties in the marketplace and to undertake compliance and enforcement actions. CFIA procedures for carrying out these activities continue following the implementation of the flexible variety registration system.

Service standards

The time required for the CFIA to process applications when complete and accurate varies depending on the extent of review required, and the number of applications pending at any given time. The CFIA has a service standard whereby up to eight weeks is required for the CFIA to process a complete application and register a variety. The applicant’s response time to requests for additional information may lengthen the time required to register a variety. For the majority of crop kinds, the time from the receipt of a complete variety application package to the registration of a new variety is unchanged. For safflower, non-ornamental sunflower, and potato for commercial production, the time for CFIA staff to review the variety application package may be somewhat reduced as the requirements for submission of testing and merit assessment data are reduced.

Contact

Michael Scheffel
National Manager
Seed Section
Field Crops Division
Plant Health and Biosecurity Directorate
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9
Telephone: 613-221-7541
Fax: 613-228-4552
Email: seedsemence@inspection.gc.ca

Footnote a
S.C. 2001, c. 4, s. 117

Footnote b
R.S., c. S-8

Footnote 1
C.R.C., c. 1400