Plants > Variety Registration > Review  

Review of the Canadian Seed Variety Registration System

Disclaimer

The information presented in this report represents opinions gathered from written or oral responses, provided by industry stakeholders, to a survey document, written submissions and formal and informal interviews and discussions held either in face to face meetings or via telephone. Although the authors feel that the information collected accurately reflects the diverse opinions and positions of the many different stakeholders impacted by the Plant Variety Registration System, (as set forth in the Seeds Act,) the authors do not warrant that every individual stakeholder's position has been accommodated and that any action or decision taken by CFIA in consideration of this information is justified.  

Table of Contents

I. Executive Summary

The opportunity to make comments concerning the current system for registration of cultivars in Canada encouraged the response of many individuals and stakeholder groups. One hundred and twenty four completed surveys were received as well as over forty written commentaries and letters. Interviews were held by telephone and face-to-face at the various expert committee meetings. The level and extent of the responses received indicates that the stakeholders view this opportunity to comment, and the issues at hand, seriously.

The opinion expressed on the many issues is very diverse and a full majority view on most of the key issues was not evident. Strong differences in perspective exist between stakeholder groups and within the different crop sectors. Despite the many different points of view, there was agreement that changes to current practices are desirable and needed.

Many respondents believe that the current variety registration process is no longer needed and should be abandoned entirely. Others believe current procedures can be simplified and made more responsive and cost effective. There is considerable support for the reduction in the number of crops subject to registration. Most stakeholders believe that at least some form of registration system is needed for crops such as wheat, canola, flax and malting barley, where quality is fundamental to trade in the industry.

The current variety recommending systems are predicated on the comparison of the "merit" of new candidates with a selection of checks. There are great differences in opinion concerning which criteria should be used to determine merit. Never-the-less, the view that merit criteria should be reduced to reflect only the minimum needed to protect the commercial integrity of the crop is widely shared. The majority of stakeholders prefer to retain the current requirement that the performance of candidate lines is equal to or better than the mean of check cultivars.

Despite the many conflicting points of view, it is clear that all stakeholders require information on varietal performance. Many stakeholders believe it is not necessary that this information be generated as part of the regulatory variety registration process. Serious consideration should be given by the CFIA to the complete separation of variety registration activities from variety recommendation trials for all crops in all regions. The latter might be structured as competition trials conducted by industry, (e.g. seed trade, seed growers, farm organizations, industry associations, etc.) that compare new varieties to established cultivars and provide information on performance to interested parties.

For some crops, the implementation of a cataloging system, instead of current variety registration, may be adequate. However, cataloging is not regarded as a viable alternative mechanism to current variety registration procedures in some sectors. If registration was clearly separate from recommendation for all crops in all regions, then interest in a cataloging system may increase. The possibility of using a cataloging system should be raised with the potato sector who may be the first group interested to try out this approach on a pilot basis.

A cataloging system is widely considered to have potential value for tracking plants with novel traits, especially plants originating from recombinant DNA studies. Issues concerning the registration of PNTs have taken on new significance with the recent adverse reactions in Europe. This has resulted in the call for extension of the definition of "harm" to include harm to international markets.

Industry associations having broad representation of seed merchants, seed growers, farm commodity organizations, elevator companies, processors, marketers and exporters, should be consulted by CFIA and have primary input in the assessment of harm to the industry and market channels. Recommending Committees may not have the representation and expertise to assess this trade issue. Contract registration and Identity Preserved production systems are viewed to be useful tools to help industry mitigate the potential harm to the industry and harm to the market channels for plants with novel traits.

II. Introduction

The continued development, production and sale of dependable, high quality, seed is fundamental to the strength of Canadian agriculture. In Canada, we have a seed variety registration system that includes many crops of commercial importance. This registration system was initiated as an amendment to the Seeds Act more than seventy-five years ago. Over the years, the Seeds Act and variety registration have been amended as the needs and requirements of farmers, industry and government have changed.

At present, variety registration is required for approximately thirty crops and is based on the evaluation of the "merit" of new varieties. Responsibility to assess merit resides with Recommending Committees recognized by the Minister. These committees have responsibility to assemble, evaluate and interpret data on candidate variety performance. Although the evaluation of merit is science-based, these Recommending Committees have found merit difficult to define and to be both objective and subjective in nature.

A review in 1992 confirmed that merit should remain the overriding principle guiding the variety registration system. The present guidelines are based on criteria:

1. To ensure that new varieties meet current requirements for resistance to economically important diseases.
2. To ensure high quality products for processors and consumers, and
3. To ensure that agronomically inferior or unadapted varieties are excluded from the Canadian marketplace.

Current regulations provide for four levels of variety registration: national, interim, regional and contract. National registrations are valid in all parts of Canada and impose no restrictions on the production or disposition of the seed or commodity. Interim, regional and contract registrations provide mechanisms for the Minister to limit registration to specific terms and conditions. Such conditions result from processors' needs for large-scale market acceptability tests, regional requirements, emergency situations, isolation, etc.

Contract registration was introduced in 1996 to facilitate the sale and production of seed and plant derived products having biochemical or biophysical characteristics, which distinguish them from traditional varieties of the same crop, such that mixtures might cause harm to the industry or harm to the market channel. Owners of varieties granted contract registration must establish and maintain a quality control system for the management of the potentially adverse effects of the variety in distribution, production, and disposition of seed and progeny from the seed.

A review of the variety registration system was undertaken in 1992 that resulted in the implementation of significant changes. Since 1992, science and the agricultural industry has evolved at a rapid pace. The need to consider pressing domestic and international issues prompted the CFIA to commission this current review. The review process has entailed:

1. Meeting with stakeholders across Canada and polling opinion by responses to survey questions. Stakeholders who wished to provide input to the review process, but did not find the survey questionnaire an appropriate vehicle, were invited to provide written submissions or oral commentary.
2. Identification of areas of general consensus.
3. Identification of issues where consensus is not apparent.
4. Formulation of recommendations for further consideration and the future direction of the registration system.

The major focus of the review is the evaluation of the existing registration system as described in the Seeds Act. The following issues are of central importance:

1. Should there be a variety registration system at all?  If so, how should it be changed to accommodate the needs of all stakeholders. If the variety registration system is no longer needed, what, if any, system should be implemented in replacement?
2. If a variety registration system is maintained, should evaluations of cultivar performance be based on merit as currently defined?
3. What crops should continue to be subject to registration and which crops should be exempt? Should any new crops be considered for registration?
4. What information should be acceptable for the registration process ?
5. What procedures are appropriate to accommodate plants with novel traits (PNTs?) Is the existing definition of "harm to the industry" relative to PNTs appropriate given recent international events?

III. Results

A) Background:

A survey questionnaire was designed as an instrument to encourage feedback on the issues that effect variety registration. Some individuals and organizations felt that this questionnaire was not the preferred vehicle to offer opinion. These parties were encouraged to provide a written or verbal contributions, and most responded.

It should also be understood that responses to the survey were made in some instances by individuals and in other cases by persons representing an entire group or organization. No attempt has been made to add weight to responses for the purposes of tabulating results or preparing graphical representations. The results were used only to indicate trends and diversity of opinion. Thus, the numeric values expressed in tables and graphs are only an indication of a range of views. To see the differences in responses more easily, graphical presentations of disagreement, with the subject of each question, are presented as negative values. This was done for visual impact only.

The opinion collected from surveys, written submissions, telephone and personal interviews, is described in this report in the order presented in the survey questionnaire.

A summary of the results from 124 completed surveys is presented in Tables 1 and 2. To determine if different segments of the industry hold differing views, responses were tabulated for four specific crop kinds: forages, cereals, canola and potato. These results are presented in Tables 3-10. It is apparent that views differ, not only by the major crop of interest, but by business vs research orientation or by private vs public sector employment. In order to explore these differences further, results were divided, (somewhat arbitrarily,) into three groups representing company, trade organization and government views. These results are shown in Tables 11-16. Representative excerpts of comments made on the survey questionnaire or from written commentaries are presented in Appendix B.

B) Section 1. The Need for a Variety Registration System

i) Analysis of Survey Responses:

Section 1 of the survey questionnaire was comprised of three questions directed to the need for a variety registration system. It is noted that many groups, especially those from the private sector, oppose the continued use of a variety registration system. Input from these organizations maybe under-represented in the responses to the survey questionnaire as some decided to not complete the survey. Many, but not all, such organizations submitted written affidavits describing their views. This information is considered in Section ii.

Q1. Should there be a variety registration system in Canada?

The large majority of respondents indicated support for some level of variety registration, (see Table 1 & 2.)  However, it is clear from subsequent questions and written submissions that this support should not be assumed to be a strong endorsement of the current system as now practiced. Support for registration is weakest in the industrial sector, (Table 11 & 12,) especially among potato growers, (Table 9 & 10, Fig 2.)

Q2. Should all crops of commercial importance be registered?

There was considerable difference in opinion on this topic, (see Table 1 & 2.) A significant number of responses indicate that not all crops currently subject to registration should be continued, (Table 1 & 2.)  By far the strongest support for removing crops from registration, comes from the private sector, (Table 11 & 12.)   Generally, support for continued registration is weakest for small acreage and specialty crops. The greatest overall support is for crops where quality is a critical issue.

Q3. Are changes needed to the variety registration system?

The overwhelming response is yes, from all sectors, and all groups (see Tables 1-16, Fig 3.)

ii) Comments from Written Affidavits and Interviews

Written submissions were received by separate cover or as part of completed surveys. Interviews were conducted by telephone or in person at various meetings. A wide range of written comments were received from a diverse cross section of stakeholders. A brief summary of the points raised in a representative sample of these submissions is presented in Appendix B.

The written submissions present a wide range of views concerning the fundamental issue of whether there should be a variety registration system at all, and if it is to be retained, how it should be changed. A considerable number of parties provided written submissions opposed to the current variety registration system.

Support for some form of variety registration was also provided in written responses by trade organizations, expert committees, private companies, plant breeders, CSTA, and CSGA. The majority of supporting organizations recognize, however, that changes to the current system would be beneficial. Many proposed changes that would be suitable for their individual crops and regions. (see Appendix B - WS 001B, 002, 004, 005, 007, 015, 016, 020, 024, 035, 039, 042, for examples.)

The Canadian Seed Trade Association membership has debated and considered issues related to variety registration for some time. The CSTA prepared a position paper that appears to represent middle ground for those in the industry who favour retention and constructive change of the current variety registration system. Highlights of the CSTA position paper are presented below. Further comments are found in Appendix B.

CSTA , - Points from the Position Paper

• Key elements of change in recent times include: more private involvement in cultivar development, recognition of regional adaptation, diversification of varieties with special traits and declining public sector testing resources.
• The CSTA supports the principle and mandates of the variety registration system.
• The challenge for each crop committee is to determine which traits are critical for the health of the industry.
• The CSTA draws distinction between testing for registration and testing for recommendation.
• The CSTA recognizes that novel trait testing requirements are not linked to variety registration.
• If a species does not appear to have any traits that are critical to the health of the industry and should be set as minimum standards, then remove the species from registration testing.
• The CSTA requires that procedures be science based and predictable.
• There should be clear guiding principles for recommending committees.
• The Variety Registration Office should not expect that one crop committee can be used as model for all.

In contrast to the CSTA position several organizations believe that the current variety registration system is an impediment to the development of the agricultural industry and should be dismantled entirely or greatly changed. Some representative opinion is presented in Appendix B, (see: WS 003, 006, 010, 022, 036, 038, 044, 045, 046, 047.) Examples of comments include:

WS 003:

• System does nothing to protect producers from obsolete and unadapted varieties
• Entire system could be replaced by a strong provincial recommending system
• A cataloging system that provides knowledge of varieties to be produced by pedigree system and eligible for certification may be suitable.
• The public sector tends to underrate the importance of market reputation in private sector cultivar development.
• Changes are needed to the current system: simplification, cost reduction, establish uniformity.
• Reduce the number of crops subject to registration.
• Varietal registration on the basis of specific geographical areas is nonsense
• Interim registrations make it difficult for companies to justify effort of seed multiplication.

WS:010

• View that Canadian variety registration system is failing in its objective to provide growers with the best cultivars - market should decide what varieties are grown after deregulation.
• The present system does not attempt to provide the grower with information on which is the best variety to plant or produce data that allows the comparison with previously registered varieties.
• The system does not attempt to prohibit production of varieties that may cause harm to the industry..
• Market decides what quality parameters should be. It is the domain of the producer and marketer to decide what the market wants. The present system does not address the rapid segmentation of the market.

WS 045

• The current system can be completely discarded and replaced with simple cataloging.
• The rapid movement of world commerce toward the use of identity preservation renders the current system obsolete and obstructionist.
• The current system should be dropped for every species that does not have a statutory or legal definition of quality.

Section 1 Discussion:

It is readily apparent that there is no simple majority view representing a single solution to the basic issue of whether a variety registration system is needed or appropriate for Canada.

Although strong support for some type of registration system was expressed in both completed surveys and written comments, it is clear that all sectors feel that changes should be made to the current variety registration procedures and requirements. Many respondents favour simplification for the major crops and elimination of the registration requirement for minor crops and crops where quality is not a fundamental concern.

Despite this general interest in simplification, there are two different perspectives. To a significant degree these different points of view reflect the private sector vs public sector. Historically, varietal development for most crops has been pioneered by public sector (government and university) breeders who strived to develop superior and widely adapted varieties. Superiority was delineated through evaluation of "merit" that included many parameters of crop performance. The requirement for truly superior performance resulted in the registration of a relatively small number of new cultivars each year.

More recently, cut backs in public breeding support and substantial new investment by the private sector in cultivar development has resulted in increased pressure to change regulations and licence more cultivars. The perspective of private breeding organization is easy to understand; if they are investing in the development of new varieties they need to be able to sell their materials in the market place. A restrictive registration system, or in fact any registration system, can be a significant impediment to the realization of a return on investment.

Although there is no simple answer to whether there should be a variety registration system and if there is one, how it should be modified, there was a consensus that everyone requires information on the performance of varieties. To various degrees, the current variety registration system provides all levels of the industry with at least some information on varietal performance. Opinions vary on how well this is achieved. The key point is that performance information is needed on varieties.

Section 2: The Registration Process

i) Analysis of Survey Responses:

This section of the survey explores the current registration process. Registration is based on the principle that any new varieties must have "merit". The definition of just what constitutes merit, however, is a subject of debate. Currently merit includes by definition:

Q4. Should registration be based solely on merit (as is the case now?)

The responses to this question indicate considerable differences of opinion. (see Tables, Fig 4.) It is clear that the polarization is predominantly between private sector and non-private sector interests. The strongest rejection of the relevance of merit (as currently defined,) emanates from the potato sector.

Q5. Should the approach to variety registration and regulation be solely science based and consider merit only from a scientific viewpoint?

The responses to this question indicate differing opinions in all sectors not just the private sector. The largest disagreement with the current merit assessment is from the potato sector.

Q6. Should social, political or trade factors also be considered within the context of merit in variety registration?

There are major differences of opinion in all sectors (see Tables, Fig 5.) The greatest level of disagreement is evident from the private sector and from the forage sector.

Q7a Should merit be based on the principle of "better than" rather than "equal to" in important traits and characteristics ?

As expected, the difference in perspective found in the responses to the above questions is continued here. Generally, private sector responses favour the "equal to mean of checks" position, whereas the public sector has a stronger leaning towards "better than". The strongest rejection of the "better than" position is from the potato sector.

Q7b. If you believe that the principle of " better than" should be used, please define better than as:  (four choices)

The responses to this question are not detailed in theTables but can be found in Appendix A. Approximately 2/3 of respondents answered this question with the majority, (60%) selecting iii, "equal to the mean of the checks". The remainder chose either i, " better than the best check variety" (30% ) or ii, "better than all other varieties in the trial", (10%.)

Q8 In general should merit include:

a) Agronomic characteristics?

Opinion on this issue was divided. The majority of respondents feel that agronomic characteristics should be included in consideration of merit. However, a large number of respondents have the opposite opinion. The respondents opposed are almost entirely from the private sector, with those primarily involved with potato being the most averse.

b) Disease resistance?

Opinion was divided on this issue along the same lines. However, more respondents feel disease resistance is a valid criterion for registration. Those in the private sector opposing this position believe farmers should have the choice of which lines they want to grow. It is believed that as long as information concerning disease and the level of resistance available, farmers can make an informed choice. It is widely stated by private companies that if a farmer buys a seed variety that does not perform to expectations, then no further purchases will be made from this company.

c) Quality Information ?

The majority of respondents feel that quality information is a relevant criterion to determine merit especially for crops where the industry is dependent on meeting defined quality standards. However, some disagreement was noted from private sector, especially potato breeders.

d) Marketability?

The opinions on this issue are divided. A considerable number of private sector respondents are opposed to consideration of marketability as a registration criterion. This view is strongest in the forage sector.

Q. 9 Should merit include emphasis on the acceptance of a variety for end use in,

a) Domestic markets only ?

The responses to this question indicate that all sectors and groups agree that this is not appropriate. This is mirrored by the responses to Q 9b,

b) Domestic and international markets, The majority of respondents, regardless of sector agree.

Q10a is directed to the time allocation for interim registrations. There is good agreement that the period should not be extended to longer than five years.

Q10b asks if interim registration should be the rule rather than the exception. There is good agreement that this is not desirable, although there is some indication of agreement from the potato sector.

Q10c asks if registration should be automatically granted for varieties that have been tested in one province or in the U.S.A. There is some support for this concept from the private sector, (largely potato.)  However, there is very strong opposition to this idea from the government and trade organization sectors. Information from a part of Canada with similar climate was considered to have more potential value than U.S. information.

Q10d asks if variety registration should be automatically excluded from a region in which it was not tested because of potential harm, (as opposed to demonstrated harm?)

The responses to this question indicate that most respondents do not agree.

ii) Comments from Written Affidavits and Interviews.

In parallel with the responses from completed survey questionnaires, the comments from written submissions and interviews about merit were highly divergent. Many groups favor a strong science based merit system that includes consideration of agronomic performance, disease resistance and quality considerations, (WS 002, WS 015, WS 016, WS 018, WS 020, WS 042.) Other factors such as political or trade issues, are also viewed as needing consideration. Recommending committees are viewed by many to be best qualified to determine which merit characteristics are appropriate for individual crops, example WS 024:

.....currently supports the maintenance of merit equal to or superior to checks, yield important but other factors affect consideration, ......(recommending committee) is the best qualified organization to determine which traits are of importance to the industry

In general, the private sector indicates a preference for only minimal criteria for determination of merit and feel strongly that market forces should determine which varieties are sold by the trade and accepted by farmers. See for example, comments from   WS 006, WS 036, or WS 046 Appendix B:

• Strongly opposed to revisiting variety registration requirement for corn.
• many crops do not need any system, quality issues important

  RE: Canola

• registration should be retained in a simplified form
• only quality traits to be included as criteria

  RE: Alfalfa

• A merit based registration system provides no value what so ever.
• Remove all forage crops from registration requirement

  RE: Soybeans

• Merit based registration system is of no value, remove soybean from requirement.
• Can see no justification for need of minimum oil and protein standard.

  RE: Soft White and Red Winter Wheat.

• Consider removing all Eastern cereals from a registration requirement.

  RE Sunflowers

• Registration unnecessary, Provincial Recommending Committees unable to provide adequate testing services, companies do not want to pay high testing and registration fees
• Current registration system is hindering the introduction of new varieties that are already known to be vastly superior because of requirement for three years of Canadian data.

Discussion: Section 2.

There is considerable diversity of opinion and no consensus concerning the value of merit as a determining factor in variety registration. The situation is further complicated by the fact that many believe merit is a moving target. The assessment of merit may be highly subjective and committee rules are often amended to reflect changes in any number of factors.

The current definition of merit includes consideration of economically important diseases. However, there is a great difference of opinion concerning the need of having disease resistance as a criterion for registration. There is consensus that information on diseases resistance is important. However, a typical private sector opinion is that farmers should be able to choose the variety they plant and determine the extent to which they need disease resistance varieties on their farm.

In our own discussions, it became apparent that there are two types of disease situation. The first category are those diseases that simply affect performance and yield of a crop, such as blackleg in canola. The argument has been advanced that farmers should decide if they need to plant a variety with known tolerance to these sorts of diseases or not.

The second type of disease problem is of a more serious nature which includes diseases that require quarantine. Such diseases could cause harm to the industry by spreading, or affecting the safety of the commodity (e.g. toxin contamination of food.)  Clearly these types of disease situations represent a more critical issue for variety registration.

The current definition of merit includes assurance of quality. There is good agreement in all sectors that quality is of paramount importance for crops such as canola, wheat and malting barley. Opinions differ, however, on what criteria should be used for the registration process. The private sector suggests the minimum criteria should be restricted to the quality established by statutory, legal or trade definitions and that the market place should determine other parameters, (e.g. WS 036, WS 046.)

WS 036

• It is the position of .... that testing for registration purposes be restricted to analysis of fatty acid profiles and glucosinolate levels relative to standards such that candidate lines can be shown to meet the definition of canola
• Continued evaluation of canola for agronomic characteristics be discontinued for registration but may be used for information purposes, until better systems evolve.
• .... believes that evaluation of oil and protein levels be discontinued as a requirement for registration.

WS 046

• We believe the present merit based variety registration system is inherently an impediment to Canada's ability to remain competitive on the world market.
• The present system is not driven by the realities of a free marketplace where producers can make varietal selections based on economic yield and processing customers can move quickly to respond to changing consumptive patterns.
• The system is designed to encourage conformity rather than innovation
• Quality assurance has been a key factor in the pooling system for grain handling. Therefore, industry stakeholders must define the minimum quality criteria that the varieties of each crop type must achieve for unrestricted production.

The current definition of merit also considers unadapted varieties. The logic of this has been questioned, (e.g. WS018, Appendix B,) as all varieties with a national registration will be unadapted in at least some locations in Canada.

No clear consensus or understanding exists for the official meaning of merit and how it should be applied, if at all.

The concept of registration based on merit is embraced by many, but not all, public sector respondents, (see survey responses WS 061, WS 045.)

• Merit: only for demonstrated catastrophic harm to the industry by disease, or large-scale harm to the industry or statutory requirements.

Registration based on merit is largely opposed by the private sector, particularly the potato sector. There is further disagreement on whether merit should be considered only from a scientific view point or if political, social and trade factors should also be included in the merit determination.

Recent developments in Europe and the collapse of the International Bio-Safety Protocol discussions are germane. At the present time varieties that could cause " harm " to the industry may not be registered. The term harm has been restricted to domestic concerns, however, the growing problem with the acceptance of plants with novel traits (PNTs) in the international market place has generated very real concerns. Letters were received from groups interested in flax and canola cultivar registration, requesting that the definition of harm be extended to include impact on foreign markets (e.g. WS 001A, WS030, WS034.)  This difficult issue is increasing in importance because of these recent developments. The concept of harm is considered again in Section 5.

Further disagreement was evident for basing merit on the principle of "equal to" rather than " better than". The argument against the current definition of merit is the subjective nature of the valuation and the inclusion of factors not specifically enumerated in the official definition. The private sector position is that they need to be able to sell varieties to justify the investment in breeding. Thus, as long as new varieties are at least equal to current varieties, they should have the freedom to market these varieties and farmers should have the freedom to choose to plant them.

Generally this view is extended to diminish the relevance of agronomic, disease and marketability attributes in a decision for registration. Despite these differences in opinion, all sectors appreciate the importance of maintaining the quality of the products.

There was also good agreement that merit should include emphasis on end-use in international as well as domestic markets.

There was agreement that interim registrations should not extend past five years and that such registration should not be the rule rather than the exception. The views expressed on automatically granting registration based on performance elsewhere were, as would be expected, are conservative.

Section 3: Registration Process:Recommending Committees and Data

i) Analysis of Survey Responses:

This section of the questionnaire explores issues related to the registration process and Recommending Committees.

Q11. Do the current Recommending Committees provide an objective means to evaluate credible scientific data?

Overall the response to this question was positive, however, there were some concerns expressed, especially from the private sector (see Fig. 5.)

Q12. What data should be accepted for registration purposes by recommending committees?

There was almost unanimous agreement that official variety trials provide suitable data for evaluation. There was good agreement that performance data generated by companies under ISO certification was acceptable, except for some concern expressed by the potato sector. Opinion was divided about the appropriateness of U.S. and foreign data, but there was good support for data generated in other Canadian locations.

Q13. Should all valid scientific data, regardless of source, be considered by recommending committees ?

Although the majority opinion was yes, there were differences. The key to this issue is likely the interpretation of the meaning of valid and the concern of some respondents that data, even if valid, from regions different in climate is of no value in determining performance in Canada.

Q14. Do you believe recommending committees have the capacity to objectively determine the validity of data? If not, is there an alternative mechanism ?

Generally there was good agreement that these committees have this capacity. There were a few detractors, however, no concrete mechanism for an alternative was advanced.

Q15. Does there continue to be a need for objective inspection/validation variety registration trials regardless of where they are grown, or by whom?

Responses to this question indicate that there is reasonable agreement but some from the private sector, (predominantly potato sector) feel this is no longer relevant.

ii) Comments from Written Affidavits and Interviews:

Some comments were received that indicated some respondents felt that recommending committees may not be completely objective in their evaluations, but that this was not a major issue. It is noted that some committees, especially those relating to cereals, are dominated by government representatives. With the increasing involvement of the private sector in breeding , including breeding of new varieties of cereals, it is probably desirable that these committees review their membership to make sure that the composition is reflective of the industrial activity.

Written submissions do not differ significantly from the survey results concerning the data that is acceptable for registration purposes. Data from official trials and from similar climatic locations in Canada is preferred. It was felt that some of the existing Recommending Committees, especially forage committees, are not using all of the data that is available or that trials are not held in the best locations. The use of company generated data is considered valid if sites are inspected. Information from the U.S. or other locations is not considered reliable of performance in Canada but could be considered on a case by case basis. The private sector is more open to using data from other locations.

It is generally agreed that Recommending Committees have the capacity to objectively determine the validity of data. However, it was noted that having this capacity does not guarantee that data is actually viewed objectively.

Discussion: Section 3.

Overall there is good agreement that current Recommendation Committees can provide appropriate guidance on variety performance. There are reservations expressed by the private sector, especially from companies involved in potato and canola cultivar development. Generally data generated by official trials and within company programs in Canada is considered acceptable provided that the regions from which the data are generated are similar in climate to the proposed cultivar growing region. Data from elsewhere are considered less useful. For some crops, e.g. potatoes, small scale plot trials are not considered to reliably indicate performance in larger scale production.

To a large degree, the data that are considered for registration reflects the merit criteria that are established by each Recommending Committee. If merit criteria were eliminated or simplified, as many proponents prefer, then the differences of view on the validity of data would likely be less divergent.

Section 4 : Crops That Should Be Registered and the Type of Registration Process.

i) Analysis of Survey Responses:

This section explores which crops should be subject to registration and what type of registration process is appropriate.

Q 16. Which crops currently subject to variety registration on the basis of merit should continue to be registered on this basis?

Greatest support for continued registration was expressed for crops where quality is an important differentiating attribute in world markets. Canola, flax , soybean, wheat and malting barley were most frequently cited. There was also general agreement that some minor crops be exempted, e.g. buckwheat, canarygrass, lupin, safflower and tobacco.

The survey results for question 16 are as follows:

Number of Respondents Indicating a Registration Requirement

Q17. This question asked what, if any crops now exempt from registration should be added to a merit based system.

Only a few respondents suggested that particular crops now exempt from registration should become subject to registration. Crops suggested a few times include: industrial hemp, ginseng and chickpea. Others mentioned include: fibre flax, milkvetch, forage bluegrass, Jerusalem Artichoke and linola.

It is also noteworthy that some respondents suggested that hybrid corn should be subject to registration. It did not appear, however, that these individuals were actively involved in maize cultivar development.

Q18. This question is directed to the potential value of a catalog system in Canada.

Opinion expressed by respondents on the value of a catalog system was highly divided. (see Fig. 6) The cereals sector seems rather opposed, (WS 045 and WS 046 are exceptions,) whereas this concept is considered favourably by the potato sector. Generally many public sector respondents are not in favor of this approach. Some of the sub questions proved to be confusing to respondents and many indicated that they did not know how to answer these questions, (e.g. 18 c.)  Many respondents were not familiar with a catalog system, and so they could not comment from an experienced position.

Q19. This question asks if registration without merit would inhibit the collection of regional/provincial performance information.

Opinion is divided on this issue. Public sector respondents tend to think that collection of performance data would be inhibited while private sector respondents do not. In support of the private sector position, corn seed marketers cite the example that the corn market place is working very well and that substantial performance data is available to corn growers for their purchase decisions.

ii) Comments from Written Affidavits and Interviews:

Written responses concerning which crops should be subject to registration are similar to survey results. Many recommend that minor crops or crops not subject to quality concerns be dropped from registration. Crops suggested include: lupin, bromegrass, wheatgrass, ryegrass, buckwheat, beans, tobacco and safflower. It was also suggested that potato is suitable for a catalog system.

Concerning crops that could be added to the list requiring registration, there were few comments except for industrial hemp. Letters and supporting documentation were received that suggested a past commitment of the CFIA to consider industrial hemp, (see WS 027, WS 048,) for cultivar registration. There is moderate support for the registration of hemp from both written submissions and comments added to survey responses. According to WS 027, a cataloging system of some type would be adequate.

Written submissions and interviews with potato growers suggest the potato sector has the greatest interest in a cataloging system. (see WS 043.)  Never-the-less, opinion on this is still rather divided, (WS 028, 039, 041) and a clear cut consensus that cataloging was the best approach for potato was not achieved.

Other sectors appear to be less familiar with the cataloging system and more guarded in considering such an approach. It is clear, however, that if a credible system were in place that generated appropriate data on cultivar performance then interest in cataloging for registration purposes may increase (see WS003.)

Discussion Section 4:

Submissions and survey responses indicate support for decreasing the complexity of the registration system. There is considerable support for the view that only crops dependent upon quality as an industry standard require a registration system. Greatest support for continued registration because of quality is evident for wheat, canola, malting barley and flax.

There is a widely held view that certain speciality or modest acreage crops should be dropped from registration. Suggestions include: bromegrass, buckwheat, canarygrass, lupin, orchardgrass, safflower, tobacco, and wild rye. There is moderate support for adding industrial hemp to a registration requirement list. There are some special issues with hemp and this request is rather unique.

The responses from this section indicate that the potential of a cataloging system in replacement of the current variety registration system is not considered that attractive by many of the respondents. Interest in this cataloging is strong in the private sector, especially for potatoes. It is probable that many respondents are not fully familiar with the advantages or possible disadvantages of a cataloging system.

Section 5: Plants With Novel Traits (PNTs)

i) Analysis of Survey Responses

This section asks questions concerning plants that have been genetically modified. Concern for this issue sharpened considerably within the last few weeks, because of an unexpectedly severe adverse reaction to engineered food products in Europe.

Q20. Should all plants with novel traits be subject to some form of variety registration (including those crops presently exempted?)

There was general agreement that this is probably a good idea. Some disagreement was expressed by the private sector (all crop sectors.)

Q21. Should some form of variety registration (with or without merit) be used as a mechanism for the recall and disposal of plants with novel traits, (PNTs), not in compliance with regulations, including those crops presently exempt from registration?

There was considerable support for this concept with some reservation expressed by the private sector, largely the canola sector (see Fig. 7.)

Q22. This question addresses the concept of harm which is currently only applied to domestic situations. Should the definition of harm be extended to include harm to export markets?

There is considerable difference of opinion concerning the application of harm to export markets. Opposition to this concept was expressed predominantly from parts of the private sector. The consideration of harm is an important issue, especially for the canola sector.

Q23. If the definition of harm were expanded, would this make Canada vulnerable to non-tariff trade barriers?

No consensus was possible for this question as most respondents indicated that they do not know.

Q24. Should a proponent of a plant with a novel trait (PNT) variety have the responsibility to ensure that the sake of their proprietary PNT or PNT products does not interfere with the potential for acceptance and sale of the generic commodity or products derived therefrom in domestic an or international markets?

There was good agreement that this should be so. Not surprisingly, some private sector respondents were not in favour.

Q25 If the definition of harm were expanded, would some of the new or proposed variety registration mechanisms be appropriate?

There was no clear agreement and many respondents indicated that they did not know.

ii) Comments from Written Affidavits and Interviews

It is generally agreed that some sort of system is needed for tracking plants with novel traits, especially those that result from recombinant DNA methods. This is a political and trade issue and as such is viewed by many respondents to not be a responsibility of variety registration. Respondents did not respond to any extent regarding the usefulness of registration as a mechanism to recall and dispose of non-compliant PNTs.

The issue of a new cultivar causing harm to the industry has become a topic of considerable concern. Many respondents commented on this issue and letters requesting that harm be extended to export markets have been received from the oilseed sector (canola and flax.)

Comments relevant to the issue of harm include:

WS 003

• Plants with novel traits must have restricted access to the market place, however we can not be unduly influenced by foreign countries. Issue of harm becomes a political and trade issue beyond the realm of variety registration. Question of who defines harm

WS 010

• If there must be a variety registration system it should be based on products that will not cause harm to the industry. Harm should consist of quality and novel trait trade issues. It is essential that the industry itself determine what may cause harm. Issue such as yield, disease, oil and protein content should be abandoned as part of the registration system.

WS 036

• It is the opinion of ..... that, for the purposes of defining "harm to the industry," it is critical that any adopted wording be restricted in scope such that harm may only be defined with respect to meeting the canola definition, and nothing else. No special consideration should be given to PNTs, other than that they should have received food, feed and environmental clearance from the respective agencies of the Government of Canada.

WS 047

• Defining harm only as our domestic consumptive market limits the scope in most crops to less than 35 % of the total production.
• We would define harm as follows: " Harm is the aggregate reduction in present and future global marketability of a product caused by the introduction of a new quality or trait, after taking into consideration any new value created by the introduction of that quality or trait."
• We have the capacity to maintain the identity of products throughout the system without causing harm.

Discussion of Section 5:

Overall there was good agreement that plants with novel traits, (PNTs), should be subject to some form of registration, (could be a catalog). This might serve as a convenient mechanism to recall such varieties in the event of an unanticipated problem. The issue of harm to the industry has taken on greater significance with recent developments in Europe.

It is generally accepted as obvious that crop industries based on quality parameters can be undermined by adulteration by poor quality materials. In this regard it is conventional wisdom that the registration system has an obligation to identify and control the production of varieties that could impact negatively on quality standards. At the present time, these considerations only extend to the harm that could be caused to domestic markets.

The appreciation of the unexpected severe reaction in Europe to PNTs because of a scare over genetically engineered potatoes, is causing waves of concern for seed producers and exporters. The request for the extension of harm to include impacts on foreign markets has been made in response to these developments.

These recent events are certainly troubling. However there is no consensus as to how harm should be defined. It is obvious that certain markets could and have been closed to Canada. However, the best mechanism to deal with this issue is yet to be determined. The trade has suggested this is best handled by international harmonization of science-based safety assessment of PNTs. Genetically engineered biotechnology products demonstrated to be safe are a benefit to farmers and the entire food industry chain, including consumers. It is unreasonable to expect that crops of the future will not possess even more sophisticated genetically engineered traits. The regulatory process needs to be responsive to change and not inhibitory to progress; however, it must not compromise basic requirements for food, feed and environmental safety.

IV. Future of Agricultural Biotechnology

The survey questionnaire was designed to encourage feedback on the current variety registration system and how it may be changed to accommodate current issues. In view of the effort that has been expended by respondents and the interest of the CFIA to accommodate the needs of the many stakeholders affected by variety registration it is reasonable to consider as well what the future may hold for Canadian agriculture.

As mentioned above the regulatory climate has to be responsive to change and not be inhibitory to innovation. Currently the implementation of the first wave of biotechnology products and genetic engineering methods are beginning to affect commercial agriculture. Despite the recent emotional responses in Europe to genetically modified foods, it is clear that new, and far more products of biotechnology, will be developed and introduced. The current negative over reaction has probably resulted, at least in part, from fears arising from the mad cow disease.

Although this problem is serious there is no reason to believe that biotechnology products will not be accepted as safe in time, by the public at large, and that many more sophisticated products will be developed and introduced into commerce. In this regard problematic virus promoters and antibiotic selection genes can be easily avoided and soon will be eliminated from many commercial products. In addition technology to limit the spread of transgenes between species and even between cultivars of the same species is being developed and will be used to ameliorate environmental concerns and fears of molecular pollution of our major commodities.

In the future we can expect that all crops will contain at least some, and likely numerous, transgenes that increase productivity and lessen the impact of diseases, pests and environmental parameters. Crops that do not contain such genes will be the exception rather than the rule. In addition to the increase in the diversity of transgenes, the fractionation of the major crop species will continue. More and more individual and specialty uses of common crops will be developed and systems to keep them separate will be required.

In addition to the proliferation of the multiple variations of common crops, many methods are currently under development to use plants as bioreactors for the commercial scale production of an enormous variety of products from therapeutic and diagnostic agents, edible vaccines to industrial enzymes and chemical feed stocks. Collectively these new developments are termed molecular farming, which has the potential to revolutionize agriculture as we know it today.

All of these developments will take place in a relatively short time frame and will directly impact the variety registration process . In order to be prepared, a flexible and responsive system of plant variety registration that can meet the needs of a rapidly evolving industry needs to be contemplated today.

V. Discussion and Conclusions

Opinions on the many issues facing the Variety Registration System are very diverse. A consensus view on most of the key issues was not evident from the present review. Differences in perspective were evident between private sector vs public sector respondents and between different crop sectors.

Despite the differences of opinion on the best system, there is general agreement that changes to current practices are desirable and needed. Many believe the current procedures can be simplified and made more cost effective. Additionally there is considerable support for the reduction in the number of crops where a formal variety registration procedure is undertaken. It is generally accepted that registration is more critical for crops where quality parameters are fundamental to the trade in the industry. Crops such as canola, malting barley and wheat are considered in this category.

There is general agreement that the registration requirement for crops such as buckwheat, tobacco, safflower, Faba bean and lupin can be eliminated.

The current recommending systems are based on the comparison of the "merit" of new candidate varieties against a selection of check cultivars. To a large degree the assessment of merit is science based and trade, political and cultural factors are not routinely included in analysis. There are great differences in opinion concerning the criteria that should be used to determine merit. These considerations are confounded by the fact that the definition of merit ( directed to diseases, quality and adaptation) does not directly include many of the agronomic characters that are considered by some of the Recommending Committees.

There are two diametrically opposed points of view of the current variety registration system, one that prefers to increase the stringency of registration requirements to select only a few truly superior cultivars; and one that prefers a relaxation of registration requirements promoting a market driven approach. This is indicative of the predominant public sector vs private sector perspectives.

It is clear that the current variety registration system can not accommodate these opposing points of view. It is also obvious, that all levels of the industry, from farmers to processors and exporters, need information on cultivar performance that includes disease reactions, quality parameters, adaptation and other agronomic information. We believe these differences in perspective would be reduced and potentially eliminated if variety registration were truly distinct from variety recommendation for all crops.

At present the registration process provides only some of the information on cultivar performance that is needed by the industry. It has been suggested that registration could be greatly simplified, even to the level of cataloging, if a separate system to generate performance information were available to make variety recommendations to farmers. If this approach were taken, an issue such as disease resistance, one of the current components of merit, need not be a factor for variety registration but could be included in the evaluation for variety recommendation.

At the present time the possibility of replacing variety registration with a form of cataloging is not widely regarded as a viable alternative. If registration was completely separate from recommendation, interest in a cataloging system for many crops may increase. Currently only the potato sector seems to have given much consideration to the merits of a catalog system. Even here, opinion is still divided.

It may be possible to determine if a catalog approach would be acceptable by inviting one or more crop sectors to develop and implement a catalog on a trial basis. The potato sector may be willing as a group to attempt such a task. Other crops not subject to rigorous quality issues may also be good test cases.

There is general agreement that a form of cataloging could be useful to track and control production of plants with novel traits, (PNTs), especially plants that have originated from genetic engineering of new agronomic traits such as insect or herbicide tolerance. Cataloging should be extended to include PNTs from crops currently exempt from registration requirements.

The issues concerning registration of PNTs have taken on new significance with the recent developments in Europe. The latest, unanticipatedly strong, emotional reaction to highly questionable research on the safety of plants with recombinant virus promoters is symptomatic of the continuing problem of consumer confidence in biotechnology. These issues are certainly represent a very serious concern for trade in genetically engineered products. It has resulted in calls for the extension of the definition of " harm" as a criterion for registration to include "harm to foreign markets".

It is understandable that an industry based on quality, such as canola and wheat, could be effected by the cultivation and marketing of varieties of inferior quality. The difficulty with accommodating a trade concern, based on an emotional reaction, is that variety registration would then, no longer be, science-based. Biotechnology products registered to date, that include recombinant DNAs, have been thoroughly tested and determined to be safe using a rational science-based system.

The fact that the recent developments in Europe represent a major concern for marketing of Canadian agricultural products does not mean that such considerations should necessarily impact the variety registration process. The European reaction is a trade issue and should be addressed in that forum.

Industry associations with broad membership of seed merchants, processors, marketers, seed growers, farm commodity organizations, elevator companies, processors and marketers should be consulted by CFIA for input into the assessment of harm to the industry. Contract registration and Identity Preservation production systems may be useful vehicles to help industry mitigate the potential harm to the industry and the market channel.

In consideration of the information gathered and our analysis of the key factors of importance, the following recommendations are made:

1) The CFIA Should Make Changes to Variety Registration Procedures to Accommodate the Changing Needs of the Agricultural Industry.

• Simplify the system. Although consensus on many issues was not evident, the clear message from stakeholders is that changes to the existing system are needed including simplification, cost reduction and greater cooperation between committees in different regions.
• Separate clearly the function of testing for variety registration from recommendation for all crops. The CFIA needs to encourage the development of strong but separate evaluation systems for recommending varieties and disseminating information on variety performance to farmers.
• Reduce the number of crops species requiring registration. Stakeholders have identified which crops may be deregulated and which crops, because of quality and safety issues, should remain subject to variety registration.
• Implement a test cataloging system for a crop such as potato, or other crops, as a prototype for potential future applications.

2) The CFIA Needs to Improve the Variety Registration Process.

• Require the review of the membership of all Recommending Committees to ensure that they are balanced and representative of stakeholders and have the required expertise.
• Ensure that the definition of merit reflects the needs of the sector.
• Request that Recommending Committees review the requirements for merit for each crop subject to registration recognizing the separation of variety registration from variety recommendation.
• Provide greater autonomy to Recommending Committees to determine the requirements for individual crops.

3) The CFIA Should Initiate the Development of a Catalog System to Track and Regulate Plants with Novel Traits.

• Develop, in view of both domestic and international events, a cataloging system to track and potentially regulate PNTs of all crops, including those not currently subject to registration.
• Separate the safety assessment of a novel traits from variety registration and recommendation.
• Separate requirements for seed certification, pedigree production and seed exports from variety registration for crop production, processing, and utilization.

4) The CFIA Should Work with Stakeholders to Establish a Contemporary Definition of "Harm to the Industry"

• The possibility that certain PNTs could represent a threat to international trade is a trade issue that should be separated from variety registration and variety recommendation.

5) The CFIA Needs to Continue Efforts to Counteract Negative Public Opinion By Promoting the Established Safety-based Approach for Evaluation of Foods Containing Plants with Novel Traits.

• The CFIA/AAFC should increase efforts directed to consumer education to improve both foreign and domestic market acceptance of foods containing PNTs or GMOs.
• The CFIA should build on its established and recognized science-based approach to the evaluation of PNTs in order to counter the growing adverse emotional reactions to foods prepared with modern technology.

A process map which might be considered for new plant varieties is illustrated in Fig 1.

Figure 1

Continue:

VI. Tables
VII. Figures
Annexe A: Questions
Appendix B: Excerpts of Written Comments

Prepared by:

The FAAR Biotechnology Group Inc.
S. J. Campbell Investments Ltd.
Goodfellow Agricola Consultants Inc.

March 1999