The Flexible Variety Registration Framework Regulatory Amendment

This document has been prepared as a summary of comments received in response to the Canada Gazette, Part I publication of the proposed regulatory amendment for a flexible variety registration system in Canada. It provides specific CFIA responses to these comments.

Previous consultation regarding creation of a more flexible variety registration framework

This regulatory amendment is based on feedback received during extensive consultation with stakeholders (including variety developers, seed trade, seed growers, producers, general public and other involved government departments and agencies) regarding changes to the variety registration system beginning 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 to introduce 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 June 28, 2008 proposal to amend the Seeds Regulations to establish a more flexible variety registration system. This proposal was pre-published in Canada Gazette, Part I for a 75 day comment period ending September 11, 2008.

Responses received during Canada Gazette, Part I publication

Thirty-five written responses were received during the comment period while another 9 were received for a total of 44 submissions. The CFIA has replied in writing to each respondent. Respondents covered a range from interested individuals through the seed industry value chain: variety developers, distributor/retailers, producers, grain handler, processors, end users (both food and feed) and exporters. The breakdown of respondents follows:

• Sixteen individual variety developer entities: 11 private seed companies, two federal and one provincial research stations, one university crop research centre, one individual plant breeder;
• Seven organizations: Canadian Seed Growers' Association or CSGA (pedigreed seed growers/seed crop certification agency), Canadian Seed Trade Association or (CSTA) (commercial seed trade), National Sunflower Association of Canada or (NSAC) (crop specific grower organization), CropLife Canada (plant protection/biotechnology), AgWest Biotech and BIOTEC Canada (agriculture biotechnology), Canadian Cattlemen's Association (CCA) and the Canadian Forum on Forages and Rangeland or CFFR (growers and end users - animal feed), the National Farmers Union or NFU (national farmer advocacy group);
• Four individual producers/distributors;
• A farm supply company;
• Four individual producers;
• Three processors (one of whom is a producer as well);
• Five individuals;
• A provincial policy recommending body; and
• A grain trading company.

General comments received on the proposed amendment

Comment

There was general support for the proposed new flexible variety registration framework from the CSGA, CSTA and the other five trade organizations, private seed companies, a university, a farm inputs retailer, a crop specific association, and a regional crop recommending committee. This same group also emphasized the need to keep currently exempt crop kinds outside of variety registration while one seed developer commented that there should be a mechanism to exempt a crop kind from registration. A significant subset of this group (trade organizations and private seed companies) expressed the view that this process should be accelerated as there is a need for a registration system that fosters innovation and keeps pace with the rate of change in the marketplace.

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 CFIA's oversight and enforcement role is not compromised. The CFIA appreciates the stakeholder demand for rapid change of the variety registration system. 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. Regulatory change is subject to established processes to ensure the best possible results for Canadians. With regard to the review of all 52 crop kinds subject to registration for crop placement in Schedule III, the CFIA will systematically review them in the most timely manner possible. The proposed crop placements by the CSTA and others will be subject to a rationale for change submission and consultation with stakeholders; changes will be proposed if there is a requisite level of consensus for change.

Comment

On the other hand, there was general opposition to the proposed changes on the part of the NFU and four individuals who submitted comments. The rationale for opposing these changes includes:

1. A questioning of the value to the farmer of the purported benefits of a flexible registration system;
2. A questioning of the use of economic rationale alone to justify the changes;
3. Viewing the proposal as a reduced regulation model for variety developers (i.e., reduced protection and product information for growers); and
4. opposing any changes that foster the increased consolidation of corporate control of the seed trade in Canada.

Finally, the NFU points out that there is no mechanism for the public or for farmers to appeal variety registration decisions.

CFIA response

1. This amendment 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. 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.
2. The proposed changes are justified based on economic rationale, including an anticipated reduction in regulatory burden, increased innovation and increased market efficiency. However, there has been no 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. Even the 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.
3. This amendment is designed to create a flexible registration system. It creates the framework or mechanism for future potential crop specific amendments to move a given crop to a reduced regulatory regime for registration. Any future crop movement from one part of Schedule III to another will require a regulatory amendment. The success of a crop specific proposal to move from one part to another in Schedule III will depend on:
   (i) the written rationale presented by the crop specific stakeholders (which includes producers) and (ii) providing evidence of consultation and consensus among stakeholders. While this may, depending on the crop, result in a reduction in regulatory burden for the variety developer, any reduction in the oversight role of the CFIA will have been justified and deemed valid by the Minister as a result of the rationale accompanying the proposal for that crop.
4. The proposed changes will benefit variety developers as a whole and do not confer advantage on any one company or group of companies. It can be argued that the reduced regulatory burden that may result is actually of higher relative value to smaller companies with less financial resources. Market forces independent of the variety registration system will be the determinants of corporate consolidation, as they are in many other sectors of our economy.

Specific comments received on the Parts I, II, III categories of Schedule III

(a) Schedule III, Part I (crop kinds requiring merit and pre-market assessment)

Comment

The NFU expressed concern over the danger of allowing the definition of merit to be reduced to as little as one trait. CSTA as well as two of its member companies emphasized that the recommending committees must have full authority to make test protocol recommendations to the CFIA as well as in recommending which characteristic(s) are in the definition of merit for a given crop.

CFIA response

This amendment allows for crop specific stakeholders to propose a definition of merit with a single trait or more. To change the definition of merit, a rationale and consensus for the proposed change are required. The potential impact to the crop and crop sector will be carefully considered before approval or refusal of procedural changes. As is the current protocol, recommending committee procedures (including the assessment of merit) for assessment and recommendation of a variety are subject to annual approval by the CFIA on behalf of the Minister.

(b) Schedule III, Part II (crop kinds requiring pre-market assessment)

Comment

The NFU expressed concern regarding the removal of merit as it would allow for the possible introduction of inferior varieties. The CSTA questioned the value of Part II and pointed out that the registration requirements need to be clarified. The CSTA and two of its member companies also pointed out that it needs to be clear that this category only requires evidence of testing prior to registration. Another CSTA member company inquired whether private company data or a declaration of performance signed by the breeder would suffice for registration of varieties of crop kinds in Part II. An individual expressed surprise that more crop kinds were not proposed to go into Part II in this amendment.

CFIA response

Schedule III, Part II (no merit requirement, pre-market assessment requirement) is a registration regime that requires recommending committees. 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, balanced with standardized testing requirements prior to registration. Applications for variety registration will include all the basic information required for Part III plus proof of pre-market field testing according to an approved recommending committee's crop specific protocols.

(c)Schedule III, Part III (crop kinds requiring basic registration requirements)

Comment

Here again, the NFU expressed concern regarding the removal of merit as it would 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.

CFIA response

Part III is the basic requirement for registration of varieties. It does not require a recommending committee; there is no merit consideration and no pre-market assessment requirement. Basic variety registration will still allow the CFIA 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.

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 and protection of the seed trade.

Genetically engineered crop varieties will continue to be subject to stringent food, feed and environmental safety assessments. These assessments are separate from the variety registration requirements. The proposed registration system does not speed up this assessment process.

Comment

The CSTA and one of its member companies emphasized that the registration process for Part III must be kept simple, timely, and not overly onerous.

CFIA response

For crop kinds in Part III the registration process should be quicker. Part III requires only the minimum information required to carry out the mandate of the CFIA and the Seeds Regulations.

Comments on the Crop Placement Process

Comment

1. The CSTA emphasized the need for a predictable, transparent process for moving crop kinds between the proposed three parts of Schedule III. The CSTA, three of its member companies, AgWest Biotech, CropLife, BioteCanada, a university crop breeding centre, and the CCA all expressed the view that the process for moving crop kinds between parts of Schedule III should be an administrative process or at least, subject to annual review. The CSTA, two of its member companies, BioteCanada, CCA, and a University plant breeding centre all emphasized the need to move forward more quickly on the placement of major crop species into the three parts of Schedule III. The CSTA submitted a list of crop kinds for which they would like to see immediate changes in placement of crop kinds in Schedule III (see crop specific comment section).
2. AgWest Biotech and a University crop breeding centre identified the need for greater clarity on the proposed requirement for industry consensus and their view that public breeding concerns must be taken into account.
3. The CSTA also mentioned that the movement of kinds or types of crop kinds between Parts of Schedule III must be able to occur quickly in order to react to changing technology and market demand. BioteCanada, CropLife, two CSTA member seed companies, a university crop development centre expressed support for the CSTA proposed crop placements.

CFIA response

1. With the implementation of the current regulatory amendment, a framework now exists for changing the placement of crops in the flexible variety registration system. Changes to crop placement (movement to Part I, II or III in Schedule III) will require regulatory amendment and, as such, cannot be an administrative process. A regulatory amendment to change a crop's placement between the Parts of Schedule III would proceed once the rationale for change and a requisite level of consensus across the crop value chain have been established. The process for developing the rationale is outlined in a draft guidance document presented at the National Workshop on Seed Program Modernization on October 28, 2008 and available from the Variety Registration Office, CFIA. It is the intention of the CFIA to review all 52 crops subject to registration with a view to developing a rationale by way of consultation with crop specific stakeholders and seeking consensus. The CFIA would initiate a crop placement change amendment where deemed appropriate. Any resulting amendment proposal will be subject to the regulatory process (Ministerial approval, Treasury Board approval, Canada Gazette, Part I publication and comment period, Canada Gazette, Part II publication).

   The CFIA will work with stakeholders on a crop by crop basis to pursue appropriate placement for each crop. The CFIA encourages stakeholder driven initiatives for crop placement and will work with stakeholders to develop a rationale for change and a proposed amendment. The CFIA will treat the crop kinds for which there is clear rationale and consensus on a priority basis, such that proposals for change in crop placement should advance to the Canada Gazette, Part I in a timely manner.

2. It is understood that consensus is not necessarily unanimity. Crop placement rationale must build a clear case for movement based on creating value and/or growth in the market for that crop. Public breeders are clearly crop specific stakeholders to be considered when developing a rationale and consensus for change.
3. The goal of this amendment is to address the shortcomings of the current variety registration system with respect to lack of flexibility to address changing technology and market demands, while ensuring that the CFIA's oversight and enforcement role is not compromised. While there is recognition that increased flexibility is advantageous, regulatory policies and processes must be followed to bring about change. The proposed crop placements by the CSTA and others will be subject to the aforementioned process, including the development of the rationale for change, consultation with stakeholders, consensus building followed and the regulatory change process.

Specific Comments on Crop Placement

Comment

The CSTA, one of its member companies, two potato breeders, a representative of a provincial government, and an AAFC biologist submitted rationale and support for movement of potatoes for commercial production to Part III. One AAFC employee emphasized that total glycoalkaloid test standards should remain in place and available at reasonable cost to both public and private breeders. The NFU expressed surprise on behalf of its eastern potato producer members and is opposed to movement to Part III.

CFIA response

Potatoes for commercial production are now listed in Part III because there is rationale and consensus for the movement of potatoes to Part III. The CFIA also received input from potato producers supporting this change.

Comment

A large number of stakeholders (seed companies, producers, retailers, distributors, grain trading company) including the NSAC and the CSTA submitted rationale and support for movement of non-ornamental sunflowers to Part III. The Saskatchewan Sunflower Committee was opposed to movement to Part III due to the removal of pre-registration testing information. One seed company commented that if sunflower continues status quo, then the focus should be more on producer driven traits, e.g., seed yield, height, seed oil content.

CFIA response

Non-ornamental sunflowers are now listed in Part III because there is rationale and consensus for the movement of sunflowers to Part III. The CFIA also received input from sunflower producers supporting this change.

Comment

The buckwheat sector raised concerns regarding the proposed movement of buckwheat to Part II of Schedule III, specifically 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.

CFIA response

Buckwheat was originally proposed to move to Part II, Schedule III in the Canada Gazette, Part I pre-publication. The CFIA has recognized that the timing was not ideal to move forward with this change since there is a lack of consensus as confirmed by comments and rationale received from the buckwheat sector. Buckwheat is currently included in Part I, as per the status quo.

Comment

The CSTA and two of its member companies and the Canadian Cattlemen's Association proposed moving all forages to Part III. The Canadian Forum on Forages and Rangelands differed however, in that they have a list of forages they would propose move into Part II of Schedule III. The Canadian Forum on Forages and Rangelands presented a rationale that proposed moving the following forage crop kinds to Part II: alfalfa, bromegrass, red clover, orchardgrass, and forage timothy. They also proposed moving the remaining forages to Part III.
One private seed company commented that merit should only be required for quality in canola (by default, Part I).

Comment

The CSTA and two of its member companies supported movement of soybeans to Part III of Schedule III whereas another one of their member companies supported removal of merit but proof of agronomic testing in Canada (by default, Part II).

Comment

The CSTA and one of its member companies expressed support for moving field beans to Part III of Schedule III. An individual commented that he understood there was support to move beans to Part II.

Comment

One public sector breeder supported either exempting hulless oats from registration or changing the requirements to make them equal to that of forage oats.

Comment

One private seed company supported moving rye to Part II or III of Schedule III.

Comment

One private seed company supported moving lupin, safflower, spelt, and tobacco to Part III of Schedule III.

CFIA response

With regard to the six additional crop specific comments (forages, oilseed soybean, field bean, hulless oat, rye, lupin, safflower, spelt, and tobacco) the CFIA acknowledges the desire for movement however, any changes in crop placement have to be subject to clear stakeholder consultation, consensus, development and submission of a rationale for change, and finally an amendment proposal to the Seeds Regulations.

Comment

An individual commented that they had understood that Health Canada had supported the addition of industrial hemp to the list of crop kinds that require variety registration (Schedule III).

CFIA response

There is no plan to add industrial hemp to Schedule III. Currently exempt crops (e.g., hemp) remain status quo.

Comments on Recommending Committees

Comment

The CSTA and one of its member companies generally supported the proposed regulations with regard to the establishment and operation of recommending committees but also pointed out that there is a need for regular review to ensure compliance with subsection 65.1. Two private seed companies expressed the sentiment that some crop recommendation committees have become entrenched and recommended a time limit for membership on crop recommendation committees be instituted.

CFIA response

The current amendment adds section 65.1 to the Regulations 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.

Comments on Contract Registration

Comment

The CSGA 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.

CFIA response

This regulatory amendment does not contain changes to contract registration requirements. Contract registration will be reviewed in a separate initiative.

Comments on the Wording in the Proposed Amendment

Comment

The CSTA was supportive of the improved clarity regarding the listing of the requirements for variety registration versus listing of the criteria for refusing registration. They also commented that the definition of merit should be revised to clearly indicate that merit for a given crop may be based on any one single trait or a combination of traits.

CFIA response

In response to the comment received, additional clarity has been added to the definition of merit, recognizing merit may be conferred by one or more traits.

Comment

The CSTA also commented on the acceptance of the term distinguishability regarding a variety submitted for registration and cautioned against any future use of the term distinctness which is the term used for Plant Breeders' Rights (PBR).

CFIA response

The variety registration process will continue to operate on the basis of distinguishability as a requirement for registration. There is no change from the status quo. The term distinctness is a requirement for the granting of Plant Breeders' Rights, but is not a variety registration requirement.

Comments received on the consultative process

Comment

One seed company expressed concerns that the consultative process was too demanding on a small group of industry professionals.

CFIA response

The CFIA recognizes and is appreciative of the time and resources invested by stakeholders to engage in the consultative process. Attending CFIA scheduled consultative meetings, while ideal, are not the only way to participate. If it is not possible to engage directly, one can engage in the consultative process by contacting the CFIA via letters, e-mail, or phone with one's input, and consulting the CFIA web site for updates on the Seed Program Modernization Initiative.

Comments regarding the crop specific consultative process

Comment

The CSGA emphasized the continued need for crop specific consultations on the movement of crops within the tiers in order to maintain stakeholder confidence in the system. The NFU raised concerns that the crop specific consultative process will be controlled by industry organizations.

CFIA response

There are a number of outstanding issues that need to be addressed before moving forward with the proposal to establish/recognize a formal process for crop specific discussions. However, it should be noted that crop specific stakeholder consultations and consensus are integral to the crop placement process and are incorporated into the draft Guidance document on the information requirements for impact assessments of changes in variety registration requirements (crop placement). The CFIA will ensure that there is the opportunity for input from the full crop specific value chain when considering changes in crop placement. The consultative process is not controlled by any one or any one group of stakeholders. All stakeholders in the crop value chain have the opportunity to comment.

Comments regarding the scope of the consultative process

Comment

The NFU commented that the consultation process, to date, appeared not to take farmers' views into account. The NFU raised concerns that their comments in the past were considered outside the purview of this proposed regulatory amendment even though these changes will have much broader implications. One private seed company expressed appreciation that the consultative process to date has noted when comments may be outside the scope of the proposed variety registration system changes.

CFIA response

Every effort has been made to ensure that all stakeholders, including producers, have been treated fairly during CFIA led consultations on the proposed amendment. All comments are taken into consideration during CFIA deliberations. There have been comments made that are outside the mandate of the proposed changes. While these comments are noted and shared with other departments, as appropriate, it should be noted that the CFIA's mandate is confined by the Seeds Act. The CFIA does not have the authority to operate outside this mandate and as such, it is not able to directly address some comments received.

Comments received that were outside of the scope the proposed amendment

Comment

One individual expressed concern with respect to the continually escalating input costs required to produce sufficient food for the world.

CFIA response:

This amendment reduces costs to the variety developer (in direct cost and in reduced time/effort to market) and does not result in any direct or indirect increase in variety cost to the grower.

Comment

The Canadian Cattlemen's Association would like to see plant with novel trait requirements dropped entirely in order to foster innovation and align with the international community.

CFIA response:

The regulatory process for plants with novel traits is independent of variety registration and handled by a different section in the Plant Health and Biosecurity Directorate, CFIA. This is not part of the Flexible Variety Registration amendment, however, the CFIA is continuing to work with industry stakeholders to address concerns that have been raised about the regulatory trigger for plants with novel traits and novel livestock feeds.

Comment

Three individuals expressed concern over genetically engineered crop kinds from the perspective of health, safety, impact on biodiversity, and threat to organic food production.

CFIA response:

All plant products of biotechnology require rigorous pre-market food, feed and environmental safety assessments. This process is separate from variety registration.

Comment

The NFU and two individuals expressed concerns regarding: (a) a farmer's need to have the right to save seed. The NFU expressed concerns about: (b) the amount of control of the Canadian seed business held by large multinational chemical/seed/trait companies, and concerns that: (c) 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). They also suggested: (d) 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. The NFU would also like to see: (e) genetic use restriction technologies banned in Canada and (f) an increase in the funding of public sector variety breeding.

CFIA response:

1. Variety registration, does not limit the farmer's right to farm save seed. Limitations on farm saved seed are a result of intellectual property limitations and usually associated with patented technology that may be present in a variety, and/or variety-specific contractual obligations. Variety de-registration results in the removal of a variety from the market place and this can, in effect limit farm saved seed. This amendment does not contain any changes to variety de-registration; it remains status quo.
2. Corporate consolidation in the seed business is subject to international and local market forces and is independent of variety registration requirements.
3. Varieties may be de-registered at the request of the registrant. The Variety Registration Office (VRO) requires that the registrant submit a plan for removal of the variety from the market. The VRO is currently reviewing variety de-registration policies and looking for means to improve communication regarding upcoming de-registrations.
4. PBR and patent rights infringement and the settlement of both are clearly a matter for the courts. Both PBR and the patent office operate under their own Acts of Parliament. The VRO and the Seed Section have no jurisdiction in these matters.
5. Genetic use restriction technologies (GURTs) will, if brought forward for approval, be subject to the same scrutiny and safety assessments as other PNTs. To date, no such technologies have been submitted to the CFIA for regulatory authorization. A different section of the Plant Health and Biosecurity Directorate, CFIA is responsible for regulating such products; it is beyond the scope of variety registration.
6. Increased funding of public sector variety breeding is an issue outside of the scope of variety registration and CFIA's mandate.