Amending to the Seeds Regulations (Part III and Schedule III) to Create a More Flexible Variety Registration System

Questions and Answers

Background

What is variety registration?

Variety registration is a pre-market assessment activity performing a “gate keeper” role by allowing CFIA oversight of the varieties available in the marketplace. The purpose of variety registration is to ensure that health and safety requirements are met and that information is available to regulators to prevent fraud, as well as facilitating seed certification, and the international seed trade. To date, pre-registration testing and merit assessment is also required prior to registration to demonstrate that the variety performs equal to or better than reference varieties. The regulatory amendments change the pre-registration testing and merit assessment of varieties of some crop kinds.

What is merit?

A variety is determined to have merit if it performs as well as or better than standard reference varieties with respect to agronomic (e.g. yield, time to maturity), quality (e.g. protein and oil content) or disease tolerance characteristics. Merit of varieties is evaluated by groups of experts known as recommending committees through a series of field and laboratory tests completed over a period of up to three years. Recommending committees are designated by the Minister to make recommendations to the CFIA with respect to the merit of varieties. The testing protocols and merit assessment criteria used by recommending committees are regularly reviewed and approved by the CFIA.

Previously, varieties of all crops subject to registration were required to demonstrate merit. This regulatory amendment creates a registration system where the requirement for merit evaluation to be removed for some crops.

What crops require variety registration?

Most agricultural crops are subject to variety registration, the notable exceptions include corn, chickpeas, sorghum, food-type soybeans and turf grasses. These exempt crops are either crops that are relatively new to Canada (e.g. chickpeas) or crops that were exempted from registration in the 1990s because the respective crop value chains determined that the merit requirement for registration was posing an undue regulatory burden. These crops were exempted from variety registration because there was no flexibility in the registration system to register varieties without merit requirements. This lack of flexibility to address crop-specific needs and undue regulatory burden was the impetus for the review of the variety registration system in 1998.

Regulatory Changes

Why are changes to the variety registration system required?

The previous system was a “one size fits all” approach to registration, meaning all crops are subject to the same basic requirements. Stakeholders have identified that this approach is no longer viable because different crop sectors have different challenges and opportunities and, as such, the registration system has imposed an undue regulatory burden on some crops. An amendment to the Seeds Regulations is required to change the variety registration system to allow for varying levels of regulatory oversight with reduced regulatory burden that provides different registration requirements for different crops.

What is the objective of the amendment?

The objective of the amendment is to create a more flexible variety registration system that will address the specific needs of different crop sectors while maintaining an appropriate level of government oversight, including environmental, food and feed safety and the integrity of the seed certification system. The amendment also aims to reduce regulatory burden, support innovation, enhance competitiveness and improve the diversity of varieties available to producers.

What are the changes to the variety registration system?

The new framework includes three regulatory options with varying registration requirements. Basic variety registration requirements to protect health and safety, prevent fraud and facilitate seed certification will not change, however the three flexible registration options will include the following additional requirements:

Option I: Pre-registration testing and merit assessment to ensure that varieties meet minimum standards. This option is intended for crop kinds for which there is a need for regulatory oversight to ensure that varieties meet minimum standards

Option II: Pre-registration testing to provide official oversight of the validity of pre-registration testing. This option is intended for crop kinds for which official oversight to confirm the validity of pre-registration testing data is required, but for which merit assessment is overly burdensome or does not effectively predict the usefulness of varieties in the marketplace.

Option III: No additional requirements. New varieties of crop kinds included in this option are subject only to basic variety registration requirements to allow an appropriate level of regulatory oversight for crop kinds where merit assessment and pre-registration testing are burdensome or ineffective.

The goal of these amendments is to create the framework for the flexible system. In order to create the framework, it is necessary to include crop kinds in each option. As such, three crops for which there is rationale and consensus for change in registration requirements are be placed in the newly created options: safflower is included in Option II and non-ornamental sunflower and potatoes for commercial production are included in Option III. All other crop kinds are listed in Option I or remain exempt from variety registration as per the status quo.

How will the role of the Recommending Committees change?

The amendment clarifies the roles and responsibilities of the recommending committees in the flexible registration framework. The recommending committees will continue to recommend varieties for registration for crops that require pre-registration testing or merit assessment. However, for crops that no longer require merit assessment the committee will only be determining whether required tests were completed according to the established protocols. For crops which are no longer subject to pre-registration testing or merit assessment, there will be no role for the recommending committees and they will no longer be approved by the Minister.

Why does the amendment change the registration requirements of only three crops?

The primary objective of this amendment is to create the framework for a new flexible tiered variety registration system, as this was the focus of the consultations. Previous consultations on regulatory proposals to change the registration requirements for individual crops have highlighted the diversity of interests and the complexity of issues among regions and crop sectors in Canada. Therefore, a stepwise approach has been taken to first achieve consensus on a new registration framework and then through consultation with individual crop sectors changes to crop placement in the framework could occur. However, in order to create the tiered framework, regulatory drafting conventions required crops to be placed in each of the tiers.

How were the three crops chosen for the changes to crop placement?

Three crops for which merit has been identified as imposing an undue regulatory burden are included in the new tiers: one minor crop (safflower) and two crops for which there was significant crop sector consensus for change (non-ornamental sunflower and potatoes for commercial production).

Safflower is placed in the new registration option with pre-registration testing without merit assessment because they are minor crops with very little plant breeding in Canada. Safflower was identified as a candidate for this option as there are so few new varieties being developed, and there are no significant economic diseases or quality issues that warrant continuing the costs for merit assessment given the amount of production and the low level of risks to the sector. Removal of merit assessment for this crop should result in increased diversity and more timely access to new varieties while still ensuring that objective performance information is available to seed growers and producers in making seed purchasing decisions.

Feedback throughout the consultation process identified clear rationale for placement of non-ornamental sunflowers and potatoes for commercial production in the new registration option that no longer requires pre-registration testing or merit assessment. For both potatoes and sunflowers, the merit and testing requirements were ineffective in determining the value of varieties to end-users. For example, for these crops the value of new varieties to end-users tends to be based on criteria that are too subjective to be effective as merit criteria, or based on data-generated by processing companies which doesn’t always correspond to the recommending committee’s merit determination. The consultations also indicated a significant level of consensus among stakeholders in their complete crop value chains for this change.

What is the process for future crop placement changes?

Future changes for additional crops to move to the new registration options are expected for many crops. A clear rationale and a demonstration of an appropriate level of consensus for the change within the crop value chain are required to implement changes to the registration requirements for additional crops. A regulatory amendment will also be required.

Have stakeholders been consulted on the amendment?

Yes. The amendment is based on feedback received during extensive consultation with stakeholders 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 collaborated in the development of a new proposal to introduce a flexible variety registration framework. Consultations on this proposal were initiated in 2006 and included a six month online consultation, five regional and two national stakeholder meetings. These consultations led to the publication of proposed changes to Seeds Regulations in Canada Gazette, Part I for a 75-day comment period ending September 11, 2008.

What feedback did the CFIA receive during the Canada Gazette, Part I publication?

Overall, responses to the consultations demonstrated strong support from a majority of the stakeholders for the proposed changes and many urged the CFIA to move forward quickly with these changes. However, some opposition was expressed by non-governmental groups and producer groups who are concerned about increased corporate control and fast-tracked registration of genetically modified crop varieties.

A total of forty-four submissions were received in response to pre-publication of the amendments in Canada Gazette, Part I. There was general support for the proposed new flexible variety registration framework from seed stakeholders. Many trade organizations and private seed companies also expressed the view that the process for changing the placement of crops in the newly created Parts should be accelerated.

The National Farmers Union and the four individuals who submitted comments questioned the value to the producer of the purported benefits of a flexible registration system and view the proposal as a reduced regulation model for variety developers with reduced protection and product information for growers, and opposing any changes that may foster the globalization of the seed trade in Canada.

A majority of responses from potato and sunflower industry representatives reiterated their positions in favour of placement of potatoes in Part III.

Have the regulations changed since the proposal in Canada Gazette, Part I?

Yes. To incorporate feedback from stakeholders, the regulations being published in Canada Gazette, Part II include several differences from the original Canada Gazette, Part I proposal.

Definition of Merit
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 change in the merit definition with the text: “any single characteristic or combination of characteristics” will allow 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.

Buckwheat
Following the National Workshop on Seed Program Modernization on October 28, 2008, further comments were received from a buckwheat grower and marketer as well as the Buckwheat Workers Group. These stakeholders indicated their concern regarding buckwheat moving to Part II and, more specifically, regarding the removal of the requirement for merit assessment. This group emphasized their satisfaction with the current merit recommendation system for buckwheat. As several major buckwheat stakeholders have justified the continuation of the current merit recommendation system for buckwheat, buckwheat will remain in Part I in this regulatory amendment. The flexible variety registration system is now in place to accommodate any future change in crop placement for buckwheat, as with any other crop kind currently in Part I. 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 the crop sector.

When do the amendments come into effect?

The amendments to the regulations will come into effect when published in the Canada Gazette, Part II, on July 8, 2009.

Impacts

What overall impact will the amendments have?

The amendment will reduce regulatory burden on the seed sector by creating registration options that reduce the impediments to timely and cost effective variety registration associated with pre registration testing and merit assessment. This is expected to encourage innovation and competitiveness in the seed sector, because there will no longer be registration requirements dictating the types of varieties eligible for variety registration. If a company invests in research and development of new types of varieties, there will be fewer regulatory roadblocks prior to commercialization. This should result in more timely access to new varieties due to fewer steps being required prior to registration, and increased choice in the number of varieties available to producers, seed growers and end users. Cost savings will also accrue for variety developers due to the removal of pre registration testing and/or merit assessment requirements and reductions in registration fees.

How will the amendments impact producers?

The reduced regulatory burden associated with the new registration options is expected to result in more timely access to new varieties (by up to three years) due to less testing being required prior to registration, and increased diversity of varieties, as a result of the removal of merit assessment, which will provide more choices to producers. However, the onus is on developers to continue to conduct sufficient performance testing to support claims and for seed growers and producers to continue to adequately research varieties prior to purchasing seed. Producers are also expected to benefit from increased innovation and competitiveness as a result of the more timely access to new and improved, value-added, and niche-market varieties that are in demand in the marketplace.

Will the amendments system allow for faster commercialization of genetically engineered (GE) crops?

Not necessarily. GE crop varieties will continue to be subject to stringent food, feed and environmental safety assessments. These assessments are separate from the variety registration requirements which assess the distinguishability, uniformity, stability and performance of seed varieties before commercialization. The registration system does not necessarily slow down the commercialization of GE crops varieties as companies may complete any pre-registration testing in confined field trails while the safety assessment is being completed.

Will the amendments result in increased corporate control or support multinational companies?

The flexible variety registration system will be more responsive to crop sector challenges and support innovation and diversification which should benefit all members of the crop value chain. It is anticipated that small to medium sized businesses will especially benefit from the reduction in regulatory burden.

What effect will the amendments have on Canada’s obligations under international agreements?

The amendments are not expected to affect Canada's obligations to the international seed certifying organizations to which it belongs. Seed certification continues to ensure that seed produced in Canada meets appropriate international standards.

What effect will the amendments have on the Government?

It is anticipated that increased variety development will be stimulated for crop kinds with reduced registration requirements and will result in an eventual increase in the number of varieties eligible for registration. The increased number of variety registration applications will not likely increase the CFIA resources required to review variety applications as it will be offset by the absence of pre-registration testing and merit assessment data to be reviewed.