In order to stay current in domestic and international markets, the Canadian seed industry works continuously at evolving the variety registration system. Over the past few years, key stakeholders have been debating how best to move forward in renewing a system that many argue is blanketed in regulation.
Many within the seed industry have long described variety registration in Canada as slow and burdensome. The length of time to get a new variety registered, they claim, puts the Canadian seed industry at a competitive disadvantage in both domestic and international markets.
“The variety registration system we have right now is very slow to respond. It is very cumbersome, and we need to make sure that we have a system in place that will allow producers to get varieties in the same timely basis as our competitors,” says Patty Townsend, CEO of the Canadian Seed Trade Association.
Today, there are 53 crop kinds that are subject to variety registration and a total of 3,136 varieties currently registered. The Canadian Food Inspection Agency moved to streamline the system four years ago when it introduced a flexible variety registration system, with the aim to reduce regulatory burden while continuing to maintain the core benefits of the variety registration system.
While the changes made to the system in 2009 have reduced some of the regulatory burden, most industry professionals feel more change is needed to increase its flexibility. “Everyone along the value chain recognizes that something needs to be done to make a more responsive, nimble system that fosters innovation and allows farmers access to new varieties more quickly. There are just some differences about how we will get there,” says Townsend.
The requirements for new varieties are outlined in the Seeds Regulations in Canada’s Seeds Act. Currently, crop kinds are grouped into one of three tiers, each one having different levels of performance requirements that proposed varieties must meet in order to be considered for registration by the CFIA.
Developing new commercial varieties takes many years of research. Developers typically spend as many as six to 10 years carrying out necessary work to breed the desired mix of traits into their new varieties, and regulatory processes only get engaged once this research is done. Once ready, developers present their work to an industry-led recommending committee to be entered into the committee’s preregistration trials. The length of these trials is entirely determined by the industry experts of the recommending committees and its procedures, which determine how many trials are required to produce reliable quality, disease resistance and agronomic data upon which the committee can make its merit assessment. The number and type of preregistration trials is determined on a crop-by-crop basis by the various recommending committees. Once the committee has determined that the new variety brings value to the sector (has merit), the variety is passed to the CFIA for registration, which typically takes six to eight weeks at the end of this eight- to 10-year developmental process.
For crops in Part I, for example wheat and canola, of Schedule III, an industry-led recommending committee must be in place. Members of the committee set operating procedures that require new varieties to undergo two to three years of preregistration testing as well as merit assessment for key factors such as quality, agronomic performance and disease resistance. If the recommending committee determines that the variety performs as well as, or better than, varieties already available to growers, it is recommended by a vote of committee members and passed on to the CFIA for registration.
In Part II crops, for example safflower, there are requirements for a recommending committee and preregistration testing, but not for merit assessment. Part III crops, for example potato and sunflower, do not require a recommending committee, preregistration testing or merit assessment, as the requirements for these crop types have been deemed by members of their value chains to be excessively burdensome or ineffective. For crops in all three parts, basic variety registration information is required and verified by the CFIA.
Reducing Regulatory Burden
The CFIA has proposed an amendment to reduce the regulatory burden on developers of new oilseed soybean and forage crop varieties. The CFIA recently published an amendment for public comment in the Canada Gazette Part I, proposing to move oilseed soybeans and forages from being listed in Part I of Schedule III of the Seeds Regulations to being listed in Part III of Schedule III. “The intent is to reduce the variety registration burden for these crop kinds by removing the requirement for a merit assessment and preregistration trials,” says Patrick Girard, senior media relations officer for Agriculture and Agri-Food Canada.
In addition to oilseed soybeans, numerous forage crops would be affected, including alfalfa, bird’s-foot trefoil, bromegrasses, canarygrass, lupin, orchardgrass, timothy, fescues, ryegrasses, wheatgrasses, wild ryes and several types of clover.
“Oilseed soybean varieties are currently still subject to full registration with a recommendation committee based on merit,” explains Townsend. “And so our producers and seed companies don’t have the ability to have access to those varieties for at least a year after producers and companies in the United States. This adversely affects our seed companies’ logistics, transportation and entire marketing program. They can’t launch at the same time in the U.S. and Canada, which puts their whole system at risk, and our farmers can’t access those varieties either; therefore, they are not as competitive.”
The CFIA’s proposed amendment, entitled Regulatory Impact Analysis Statement, was published in March. It outlines the issues and amendment objectives as well as the rationale and implementation details of the proposal.
According to the statement, “a complete standard application package provides adequate information to enable the CFIA to continue to protect health and safety, prevent fraud and facilitate seed certification. The necessity for preregistration testing and merit assessment as well as associated monetary and temporal cost and any uncertainty in the outcome of the process would be removed.”
The final decision for registering varieties identified in the amendment would remain the responsibility of the CFIA, which pledges to “continue to prevent fraudulent practices via the characterization and identification of varieties and ensure an appropriate level of regulatory oversight that is commensurate with risk, thereby maintaining market confidence in [a] regulatory framework.”
The proposed amendment comes after considerable discourse on the topic since October 2009. This includes the circulation of discussion documents seeking feedback, question and answer sessions at industry gatherings, and numerous teleconference and face-to-face meetings — all in pursuit of building consensus for the proposed change.
According to Brian Lemon, director of field crops and inputs with the CFIA, “It was important to build consensus among all the various value chain groups, who sometimes have differing perspectives. Producers’ interests, as well as the interests of processors, breeders and the seed companies, all needed to be heard and considered as consensus was developed.” Thus discussions had to involve all aspects of the value chain, including seed companies, producers, public and private plant breeders, university researchers, recommending committees and major industry associations such as CSTA and the Canadian Seed Growers’ Association.
Coming to a consensus is not an easy task with numerous players and differing opinions. However, the CFIA statement says, “the movement [of oilseed soybeans to Part III] is well supported by all key stakeholders and is expected to cause little to no controversy.”
Benefits of Proposed Amendment
While the CFIA maintains the proposed changes will not affect consumer protection, it is expected to impact numerous stakeholders within the seed industry, including seed growers, suppliers, public and private variety developers, and recommending committees.
The CFIA also believes the proposed amendment will benefit companies from large multinational corporations to local breeding operations in terms of timeliness, increased innovation and cost savings. These benefits include the removal of the time delays and uncertainties associated with the current regulatory requirements, savings from the removal of preregistration testing fees, quicker commercialization of new varieties and faster returns on research and development investment. In addition, the amendment is expected to reduce business risk and improve the ability of seed developers to adapt to changing markets.
Although much of its focus has been on oilseed soybean and forage crops, CFIA and value chain members are open to evaluating the variety registration process for all crop kinds, where stakeholders may wish to change parts. The CFIA says it’s committed to considering proposals to decrease the regulatory burden by moving crop kinds from Part I to Part II or Part III on a priority basis. The agency adds that any changes will be based on the strength of the rationale and the degree of consensus within each crop value chain.
Department of Agriculture Urging Change
In February 2013, Agriculture Minister Gerry Ritz addressed a letter to all 17 recommending committee chairs. The letter called on the committees to re-examine how they operate as well as to reassess their current procedures such as data requirements and number of years of preregistration testing.
“The recommending committees have been asked to include recommendations in response to the minister’s letter in the next annual update of their operating procedures, due to be submitted to the CFIA for approval in fall/winter 2013–2014,” says Girard. Some crop value chains have begun to discuss the evolution of variety registration requirements for their crops in response to broader changes in the crop production sector.”
Since then, the Prairie Recommending Committee for Wheat, Rye and Triticale, for one, has struck a working group from its membership to review those areas of the operating procedures that were raised in Ritz’s letters.
“Eleven people were selected from the approximately two dozen members that volunteered to assist in this task,” says Brian Beres, chair of the committee. “The working group members chosen represent all points along the value chain for wheat including producers, breeders, agronomists, pathologists, grain quality experts, grain merchants and end users. The affiliations range from public institutions, universities, grower commissions and private industry including life sciences companies.”
The committee informed the minister of its strategy for reviewing operating procedures in early May, Beres says, adding the working group plans to hold meetings every two weeks until the process is complete.
Minister Ritz has also pledged to hold both formal and informal stakeholder engagement on the variety registration issue, which are expected to begin soon.
“If we can work towards a more flexible system that still maintains environmental safety and health and safety — which is the responsibility and requirement of regulation — then we will have companies that will look more towards investment in those crops, as well as the development and plant breeding in those crop areas, which will only bring more availability to our farmers and make us more competitive in the marketplace,” says Townsend.
Jen Golletz
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Visit CFIA at inspection.gc.ca/plants/variety-registration/registered-varieties-and-notifications for further updates on the proposed amendment. |
