Issue
Advances in
seed science, technology and plant breeding require changes to
the regulatory framework to ensure appropriate government
oversight without unduly restricting opportunities. Producers
and developers are experiencing an increased demand for niche
market varieties and an increasingly competitive seed trade
environment. The current variety registration system is not
adequately responsive to these changes.
As currently
specified in the Seeds Regulations (the Regulations),
pre-registration testing (field trials and laboratory testing)
and merit assessment are mandatory for the registration of new
varieties. A variety is determined to have merit if it performs
as well as or better than appropriate reference varieties for
one or more criteria established for that crop kind. Currently,
varieties of all crop kinds that require registration are
subject to the same registration requirements. The current
system does not provide a practical alternative in cases where
these requirements are unnecessarily burdensome.
For some
crop kinds, these requirements are not relevant in the
marketplace and may not be of value in determining the
suitability of the variety for producers or the acceptability of
the variety to end users. For example, a new sunflower variety
that has large seeds with an attractive pattern on the shell may
be of great demand in the confectionary market, but it may
currently be ineligible for variety registration because of low
yield. As such, the current registration requirements impose an
undue regulatory burden on developers of varieties of crop kinds
such as sunflower, in that they are required to carry out
testing that they would not otherwise choose to carry out and to
meet merit requirements that are not relevant for the intended
market.
The
requirements may also create a barrier to timely and
cost-effective variety registration since they require time and
resources from both industry and government. For some crop
kinds, the requirement to conduct laboratory tests and field
trials and to assess merit may be considered a regulatory burden
relative to the benefit derived. This burden may lead to a delay
in the commercialization of valuable new varieties and their
availability to producers.
In cases
where variety developers are not able to confidently predict
which varieties will be eligible for registration in the current
registration system, there is an increase in the risk and
uncertainty in the variety development process. This may lead to
reduced investment in research and variety development, which
reduces the industry’s ability to respond to immediate and
changing needs within the sector.
In written
and verbal communications with the Minister of Agriculture and
Agri-Food, the President of the Canadian Food Inspection Agency
(CFIA), and the CFIA’s Seed Section, the seed and crop sectors
have repeatedly indicated dissatisfaction with the current
variety registration system and have clearly emphasized the
urgent need for a more flexible registration system.
To address
these issues, an amendment to the Seeds Regulations is
proposed to increase the flexibility of the regulations that
govern the registration of varieties. The risks to Canadian
agriculture in not moving forward with changes to the variety
registration system may include, but are not limited to, reduced
opportunities for producers, reduced investment in plant
research and plant breeding in Canada, increased barriers to
innovation, and a reduction of Canada’s role in the global trade
of seed.
Objectives
The proposed
amendments divide the list of all crop kinds that require
variety registration into three parts with three levels of
variety registration requirements so that each crop kind can be
placed in the part that is appropriate for the needs of that
specific crop kind.
The
objective of the proposed amendments is to create a regulatory
framework for variety registration that allows for varying
levels of government oversight on a crop-by-crop basis by
removing, where appropriate, any burdensome or ineffective crop
specific pre-registration testing and merit assessment
requirements. Yet government oversight will be maintained to
monitor and trace seed in the marketplace, to ensure the health
and safety requirements are met, to undertake compliance and
enforcement actions, to certify the varietal identity and purity
of seed, to prevent fraud, and to provide appropriate oversight
of plants with novel traits (PNTs).
The proposed
new framework would change registration requirements, reduce the
number of steps and time required to register varieties and
increase the predictability of registration decisions. This
would be accomplished by introducing the flexibility to address
crop-specific needs in the regulatory framework by removing
requirements for pre-registration testing and merit assessment,
where appropriate. Reducing regulatory burden is expected to
lead to greater diversity in the types of varieties available as
merit-based restrictions would be removed for some crop kinds.
Also, it is expected that there would be an increase in
investment in research in new varieties due to greater
predictability in the eligibility of varieties for registration.
It is expected that the cumulative effect would be greater
choice in the varieties available to producers which would
better address producers’ different agronomic needs and end
users’ unique quality needs. The proposed new variety
registration system also aims to reduce time delays in new
varieties becoming available to producers and to remove
potential barriers to innovation. As such, the proposed new
framework aims to reduce regulatory burden for variety
developers and to improve the choices for producers with respect
to the number and diversity of varieties available to them.
The
objectives of the proposed amendments are consistent with
Canada’s federal, provincial, and territorial governments’
Growing Forward policy framework for a profitable and
innovative agriculture, agri-food and agri-based products
industry that seizes opportunities in responding to market
demands and contributes to the health and well-being of
Canadians. In addition, the amendments are in line with the
Government of Canada’s Cabinet Directive on Streamlining
Regulation and with the Paper Burden Reduction
Initiative to reduce regulatory burden.
Description
The
Regulations require that varieties of specified kinds of crops
be registered prior to the sale of seed in Canada and prior to
import of seed into Canada. The purpose of variety registration
is to provide government oversight to ensure that health and
safety requirements are met and that information related to the
identity of the variety is available to regulators to prevent
fraud. It also facilitates seed certification, the international
trade of seed and the tracking and tracing of varieties in
commercial channels. The current Schedule III to the Regulations
lists 52 agricultural field crop kinds of crops that are subject
to variety registration.
Some
agricultural kinds of field crops have been exempted from
variety registration as traditional registration requirements
proved to be ineffective or burdensome for those kinds of crops
(e.g. corn and turf grasses). This led, in part, to a review of
the variety registration system in the late 1990s and,
ultimately, to the proposed more flexible variety registration
system.
Current variety
registration system
The
registration of a new variety currently includes a mandatory
merit assessment to determine whether the variety is equal or
superior to appropriate reference varieties for one or more
criteria established for that kind of crop.
Recommending
committees play a key role in the administration of
pre-registration testing and merit assessment for candidate
varieties. The membership of recommending committees includes
scientists, plant breeders, industry representatives and others
who have the expertise required to administer and evaluate the
testing of varieties and to assess their merit. Recommending
committees are approved by the Minister to make recommendations
to the Registrar (CFIA) respecting the testing and merit of
varieties.
Steps to register a
variety in the current variety registration system
(a)
Pre-registration variety testing
To evaluate
new varieties prior to registration, field trials, and sometimes
laboratory tests, are conducted to evaluate agronomic
characteristics, disease tolerance and quality characteristics.
The specific testing requirements vary by the kind of crop. A
standard set of data is collected according to testing protocols
established by recommending committees and approved by the
Registrar (CFIA). Recommending committees review each trial or
test to ensure that the testing was conducted according to
approved protocols.
(b)
Merit assessment
After the
validity of the pre-registration testing is confirmed,
recommending committees carry out a merit assessment based on
the results of pre-registration testing to determine whether
each candidate variety is equal or superior to appropriate
reference varieties for the agronomic, quality and/or disease
characteristics that render the variety of value for a
particular use in a specific area of Canada. The merit
assessment consists of a comparison of the specific
characteristics of the candidate variety with those of standard
reference varieties grown alongside the candidate variety. Merit
criteria are specific to the kinds of crops, are established by
recommending committees and approved by the Registrar (CFIA). In
some cases, merit requirements may be considered burdensome and
a barrier to innovation and investment in the development of
varieties.
(c)
Recommendation for variety registration
Following
the merit assessment, recommending committees make a
recommendation to the Registrar (CFIA) respecting the testing
and merit of the candidate variety.
(d)
Application for variety registration
Registration
of a variety requires submission of an application package to
the CFIA. The application package includes a representative
reference sample, the pedigree of the variety, a description of
the characteristics of the variety, an indication of whether it
is a PNT, a recommendation from a recommending committee and
results of testing that demonstrate merit and support claims.
Information contained in the application must demonstrate that
the variety meets health and safety standards and that the
variety is distinguishable, uniform, and stable.
The
Registrar (CFIA) makes the decision to register a new variety
based on the information in the application for variety
registration.
Proposed variety
registration system
The proposed
system would introduce a range of options with respect to
pre-registration testing and merit assessment requirements for
individual kinds of crops while maintaining an appropriate level
of government oversight. It would impose three unique levels of
requirements for variety registration. In this regard, it is
proposed to partition the list of all kinds of crops requiring
variety registration (Schedule III to the Regulations) into
three parts with differing pre-registration testing and merit
assessment requirements for each part.
The proposed
regulatory amendments include
(a)
partitioning of Schedule III into Parts I, II and III, and
specification of unique requirements for each part;
(b)
placement of crop kinds into Parts I, II and III of Schedule
III;
(c)
changes to the responsibilities of recommending committees to
reflect differences in their roles for recommendation of
varieties in Parts I or II of Schedule III; and
(d)
miscellaneous amendments.
(a)
Registration requirements for varieties of crop kinds in Parts
I, II or III of Schedule III
(i) Basic
requirements for variety registration
Registration
of new varieties of all crop kinds in Schedule III would
continue to require the submission of an application package to
the CFIA and the payment of a fee of $875. The application
package would include a representative reference sample, the
pedigree of the variety, a description of the characteristics of
the variety, an indication of whether the variety is a PNT, and
data to support claims. Information contained in the application
would be required to demonstrate that the variety meets health
and safety standards and that it is distinguishable (unique),
uniform, and stable. This information would maintain the CFIA’s
ability to monitor and trace seed in the marketplace, to
undertake compliance and enforcement actions, to certify the
varietal identity and purity of seed, to prevent fraud, and to
provide appropriate oversight of PNTs.
(ii) Part I
of Schedule III (status quo)
Varieties of
crop kinds in Part I would continue to require pre-registration
testing and merit assessment. An application to the Registrar
(CFIA) for registration containing the information to satisfy
the basic requirements for variety registration (noted above)
would also be required. The registration of varieties would
continue to require testing pursuant to protocols approved by a
recommending committee as well as merit assessment in order to
be registered in Canada. A recommendation from a recommending
committee respecting the testing and merit of a candidate
variety would continue to be required as part of the variety
application package. There would be crop-specific flexibility
with respect to the type of testing and merit assessment
requirements. Subsection 67.1(1) of the Regulations would be
added to clarify the requirements for eligibility for variety
registration of a variety of a crop kind listed in Part I.
In
conjunction with this regulatory change proposal, the CFIA would
continue to revise its policies to increase the flexibility and
effectiveness of the variety registration system. This would
include a revision of policies that require assessment of the
agronomic, quality, and disease merit criteria to allow for
merit to be specifically defined as one type of characteristic
(e.g. quality only) if there is rationale and consensus for this
change.
(iii) Part
II of Schedule III (removal of merit assessment requirement)
Varieties of
crop kinds in Part II of Schedule III would require
pre-registration testing but not merit assessment. An
application to the Registrar (CFIA) for registration containing
the information to satisfy the basic requirements for variety
registration (noted above) would also be required. In addition,
a recommendation from a recommending committee indicating that
the variety has been tested according to approved protocols
would be required as part of the variety application package.
Subsection 67.1(2) of the Regulations would be added to specify
the requirements for eligibility for variety registration of a
variety of a crop kind listed in Part II.
A
significant number of stakeholder groups have indicated their
preference for pre-registration testing to be retained and to be
provided as an option in the proposed system; creation of Part
II provides for this.
(iv) Part
III of Schedule III (Listing)
Varieties of
crop kinds in Part III would not require pre-registration
testing or merit assessment. Therefore, a recommendation from a
recommending committee would not be required. However, an
application to the Registrar (CFIA) for registration containing
the information to satisfy the basic requirements for variety
registration (noted above) would still be required. Subsection
67.1(3) of the Regulations would be added to specify the
requirements for eligibility for registration of a variety of a
crop kind listed in Part III.
(b)
Placement of crop kinds in Parts I, II and III of Schedule
III
Once the
framework for the flexible registration system is established,
it is expected that a series of additional changes to
registration requirements for individual crop kinds would be
considered. In order for a specific crop kind to move from one
part of Schedule III to another, a regulatory amendment would be
required. These subsequent regulatory amendments would proceed
once rationale and consensus for change have been established
through the CFIA’s consultation with individual crop sectors.
Throughout
CFIA’s recent public consultations, it was emphasized that the
proposed amendments are intended to create the framework for a
flexible registration system and not to proceed with placement
of crop kinds within the proposed Schedule III that differ from
the status quo. However, current requirements for drafting of
regulations dictate that in order to create the new framework,
at least one crop kind must be listed in each of the three
proposed parts of Schedule III.
Therefore,
each of the proposed parts of Schedule III would list at least
one crop kind. Part III would list non-ornamental sunflower and
potatoes for commercial production; Part II would list buckwheat
and safflower; and Part I would list all remaining crop kinds
requiring variety registration.
Crop kinds
that were previously exempt from registration and not listed in
Schedule III (e.g. corn, food-type soybean, and turf grasses)
would continue to be exempt from variety registration in Canada
at this time.
(c)
Responsibilities of recommending committees
Section 65.1
of the Regulations would be added to define the responsibilities
of recommending committees with respect to crop kinds listed in
Part I or II of Schedule III. The definition of a recommending
committee would also be amended. The Registrar would continue to
review recommending committees’ protocols annually to determine
whether the established pre-registration testing and merit
assessment procedures are based on scientific principles and are
appropriate to the committee’s mandate under the authority of
the Regulations. In addition, the Registrar would continue to
review the governance procedures of the committee itself to
verify that it is operating in a fair, consistent, transparent,
and efficient manner.
In practical
terms, the role of recommending committees would remain
unchanged for varieties of crop kinds in Part I. Recommending
committees would continue to play a key role in the
administration of pre-registration testing and merit assessment
for candidate varieties.
For crop
kinds in Part II, the role of recommending committees would be
to determine the testing requirements and to ensure that the
testing of candidate varieties has been carried out using
appropriate protocols; no assessment of merit would be required.
For crop
kinds in Part III, recommending committees would not be
required.
(d)
Miscellaneous amendments
The proposed
amendments include some miscellaneous amendments not resulting
from the creation of the framework for a flexible variety
registration system. In order to align the Regulations with
current regulatory drafting guidelines, Section 72, “Refusal to
Register” would be reworded and moved to Section 67.1,
“Eligibility Requirements for Variety Registration.” This
amendment would be strictly to reverse the negative language of
the stipulations for refusal to register to change them to
requirements for eligibility for registration. This amendment
would not change the requirements for registration currently in
practice. For example, the current stipulation to refuse a
registration when “the variety is indistinguishable from a
variety already registered” would be changed to a stipulation
that a variety is eligible for registration if “the variety is
distinguishable from all other varieties registered in Canada”.
However, in practice, there would be no change in the
Registrar’s procedures to assess the distinguishability of a
variety based on the pedigree of the variety.
In addition,
to respond to technological advances, an amendment would be made
to subparagraph 67(1)(b)(iii) of the Regulations to
allow submission of digital images or photographic slides that
detail plant morphology for potato varieties.
Regulatory and non-regulatory options considered
The
following options were considered.
Option one —Status quo
Currently,
varieties of all crop kinds requiring variety registration are
subject to mandatory pre-registration testing and merit
assessment requirements. However, these requirements are not
effective for all crop kinds and, therefore, specific needs of
individual crop sectors may not be addressed in the current
system. In addition, these pre-registration testing and merit
assessment requirements add to the time and resource costs of
commercialization of new varieties. The lack of flexibility in
the current system reduces opportunities for the introduction of
innovative new varieties of some crop kinds and creates barriers
to diversification, innovation and competitiveness.
This option
does not adequately address the changing needs of seed and crop
sector stakeholders or the differences among individual crop
sectors.
Option two — Removal of
variety registration
The seed and
crop sectors generally oppose the wholesale de-regulation of
seed. Variety registration is intricately woven into the
Canadian seed certification system and the structure of the seed
regulatory system. Removal of variety registration has the
potential to reduce consumer acceptance of and confidence in
Canadian seed. This option would reduce the CFIA’s capacity to
monitor and trace seed in the marketplace, and may negatively
impact the CFIA’s ability to ensure the integrity and the safety
of seed in Canada. Alternative mechanisms would need to be
developed to satisfy requirements for the international trade of
seed which requires that varieties be registered on an official
list.
Option three — Flexible
variety registration (preferred option)
A dynamic,
flexible registration system that accommodates the needs of all
crop kinds on a crop-by-crop basis would enable appropriate,
timely, and cost-effective responses to changing conditions in
the agricultural sector and, where appropriate, would reduce
regulatory burden while maintaining appropriate government
oversight. This could be accomplished by creating three
regulatory options (Parts I, II and III of Schedule III to the
Regulations) with varying registration requirements. For all
parts, variety registration requirements would continue to
include basic registration requirements that would enable the
CFIA to ensure that health and safety requirements are met, that
information related to the identity of the variety is available
to regulators to prevent fraud, and to facilitate seed
certification, the international trade of seed, and the tracking
and tracing of varieties in commercial channels. The three parts
would have different pre-registration testing and merit
assessment requirements. Over time, crop kinds would be placed
in the most appropriate part based on the level of government
oversight required for the crop kind.
Option three
is recommended. It would establish a flexible variety
registration system to accommodate specific needs of different
crop sectors and, where appropriate, reduce regulatory burden
while maintaining appropriate government oversight. This option
is expected to support the long-term growth of the seed sector
and Canadian agriculture, to allow for innovation, and to
provide for producer choice while continuing to maintain CFIA’s
role in health and safety, fraud prevention, facilitation of
seed certification, the international trade of seed, and the
tracking and tracing of varieties in commercial channels.
Benefits and costs
General
characterization of the current seed and crop sectors
The seed and
crop sectors in Canada include developers of varieties, seed
growers, seed companies, crop and livestock producers, grain
handlers and agri-food processors. In 2007, there were
approximately 200 active, recognized plant breeders, including
approximately 85 public and 115 private breeders (Canadian Seed
Growers’ Association [CSGA]), approximately 4 500 seed growers
were CSGA members (not including potatoes), approximately 800
seed potato growers were identified in Canada (CFIA Seed Potato
Section), and over 130 seed companies were members of the
Canadian Seed Trade Association (CSTA). It was estimated that
195 000 farmers produced field crops in Canada in 2006
(Statistics Canada). The 2006 Census of Agriculture also
reported the production of all kinds of crop on over 35.9
million hectares with a value of over $14 billion for 2006
(Statistics Canada).
International trade of seed significantly contributes to
Canada’s economy. The total seed exports from Canada were valued
at over $340 million for the 2006-2007 season (CSTA) with seed
potato exports of approximately $41 million for that same period
(Industry Canada). In addition, in 2007, CSTA estimated that the
total value of the seed sector was $770 million (not including
seed potatoes).
Currently,
over 2 700 varieties of the 52 kinds of crop requiring variety
registration are registered in Canada. On average, more than 160
new varieties are registered each year.
Impacts of proposed
flexible variety registration system
The
stakeholders who would be affected by the proposed amendments
include developers of varieties, seed growers, producers
(farmers), down-stream processors and end-users. Due to data
limitations on the expected impacts on stakeholder groups, a
general qualitative impact assessment rather than a quantitative
benefit-cost analysis is presented below for the impacts
associated with the creation of a more flexible variety
registration framework. More specific impacts for the four kinds
of crop that would be placed in Parts II and III of Schedule III
are available online at www.inspection.gc.ca.
No costs or
benefits would accrue solely for establishing a more flexible
variety registration framework; however, the framework would
create the potential for costs and benefits to accrue in the
future each time the variety registration requirements for a
kind of crop are changed. Since any of the 52 kinds of crop
requiring registration could be placed in Part II or III at some
point in the future, the impacts described below could apply in
the future to a large portion of the seed and crop sectors.
However, regulatory change and crop-specific impact assessments
would be required to change registration requirements for
individual kinds of crop in the future.
In
accordance with the Cabinet Directive on the Environmental
Assessment of Policy, Plan and Program Proposals, a
preliminary scan of environmental effects was conducted. The
scan concluded that minimal environmental effect will occur in
the undertaking of this proposal and the requirement for
detailed analysis is not warranted.
Potential
impacts — Part I of Schedule III
There would
be no incremental impacts associated with the creation of Part I
as this is the status quo.
Potential
impacts — Parts II and III of Schedule III
The removal
of pre-registration testing (Part III) and merit assessment
requirements (Parts II and III) would reduce the regulatory
burden and associated costs for developers of new varieties for
those crop kinds listed in Parts II and III. It is expected that
the reduced regulatory burden would lead to more timely
availability of varieties on the marketplace and would foster
innovation and investment in variety development. Consequently,
this is expected to lead to an eventual increase in the number
and diversity of registered varieties that would better address
producers’ different agronomic needs and end users’ unique
quality needs. The increased number of variety applications
would not likely increase the CFIA resources required to review
variety applications as it would be offset by the absence of
pre-registration testing and merit assessment data to be
reviewed.
Since
recommending committees’ assessment of the merit of candidate
varieties would no longer be required for variety registration,
developers would no longer have to assume the risks and costs
associated with investment in variety development without the
certainty that the variety would be eligible for registration.
This would allow the decision to commercialize new varieties to
be made solely by the developers and not to be dependent upon a
recommendation from a recommending committee.
Removal of
merit assessment requirements for new varieties for crop kinds
listed in Parts II and III would result in new varieties being
eligible for registration without restrictions on the types of
varieties or their performance. This would permit varieties to
be marketed that would not have met merit requirements as
defined in the current system. This would allow producers to
decide which varieties have merit for their individual farms,
instead of being restricted to varieties that the current system
has determined to have merit. This could, however, increase the
risk of economic losses to producers should they grow a variety
that is not suitable for their region or for the desired end
use. As in the current system, producers would have to carefully
research varieties prior to making purchasing decisions.
Specific
impacts — Part II of Schedule III (Removal of merit assessment
requirements)
For new
varieties of crop kinds in Part II, the time delays in new
varieties becoming available to producers could be reduced. For
example, to register a buckwheat variety in Canada under the
current regulations, four station-years of data are required to
be collected over a minimum of two years of variety registration
trials. For safflower, 15 station-years of data must be
collected over a minimum of three years of variety registration
trials. Reduced registration requirements may enable a somewhat
quicker return on the developer’s investment in research and
development. This efficiency would mainly be associated with the
elimination of the time required to wait for the recommending
committees to carry out the merit assessment.
Results of
the required pre-registration testing may continue to be made
publicly available for some crop kinds in Part II and would
therefore be available for producers to make purchasing
decisions. The decision to make testing results publicly
available would continue to be that of the recommending
committees, as it is in the current system.
Specific
impacts — Part III of Schedule III (Removal of pre-registration
testing and merit assessment requirements)
For new
varieties of crop kinds in Part III, the time delays in new
varieties becoming available to producers could be reduced by
one to three years; this would enable a significantly quicker
return on the developer’s investment in research and
development. For example, to register a potato variety in Canada
under the current regulations, six station-years of data must be
collected over a minimum of two years of variety registration
trials, costing approximately $6,000. The efficiency would
mainly be associated with the elimination of the requirement for
one to three years of pre-registration testing but also with the
time saved in removing the delay associated with waiting for the
recommending committees to evaluate the testing and to assess
merit.
Pre-registration testing would not be required; therefore,
producers would need to rely on company-generated performance
information or other third-party generated information when
making purchasing decisions (e.g. provincially-generated
performance information). Consequently, there may be a cost to
developers to carry out additional post-registration testing
themselves and a cost to producers in terms of the time required
to assess the results of this post-registration testing.
Moreover,
with the removal of pre-registration testing and merit
assessment, the costs associated with the operations of the
recommending committees would be eliminated. These costs include
the variety registration trials, sample and site evaluations,
and meetings. This would result in a cost savings primarily to
developers but also to all those involved in the recommending
committees, including seed trade members, processors, growers,
producers, and government. The recommending committees’
meetings, however, are often seen as providing the benefit of
being a venue to exchange information among representatives of
the value chain. With the removal of the requirements for
recommending committees for crops in Part III, this information
exchange function would be lost if another venue is not
identified to carry out this function.
Impacts associated with
the placement of crop kinds in Part II or III of Schedule III
In addition
to creating a framework for a flexible variety registration
system, this proposed amendment also includes the placement of
two crop kinds into each of the new parts of Schedule III as
follows: buckwheat and safflower in Part II (pre-registration
testing but not merit assessment) and non-ornamental sunflower
and potatoes for commercial production in Part III (removal of
pre-registration testing and merit assessment requirements). All
of the general impacts associated with the creation of Parts II
and III listed above would apply to these crop kinds.
Since there
is little investment in buckwheat or safflower research in
Canada, merit assessment imposes a disproportionate burden on
the small buckwheat and safflower sectors. Continuing to require
pre-registration testing may, however, reduce risk for producers
in this developing industry.
It would be
particularly beneficial to remove the burden of merit assessment
for sunflowers, since there is no plant breeding of sunflower
varieties in Canada and, due to the burden of pre-registration
testing and merit assessment in Canada, foreign varieties are
not often registered in Canada even though they may be well
suited to Canadian agriculture and markets. Also, the removal of
the burden of merit assessment for potatoes would be beneficial,
since the merit criteria are not necessarily indicative of the
usefulness of the variety for its intended end use.
For more
detailed information with respect to the potential impacts of
the proposed regulatory change, please see www.inspection.gc.ca.
Rationale
The proposed
option of creating a flexible variety registration system that
would address the specific needs of different crop kinds on a
crop-by-crop basis is the preferred option. It would provide the
potential for a very dynamic system that enables appropriate,
timely, and cost-effective responses to changing conditions in
the marketplace. Although only the four crop kinds placed in
Parts II and III of Schedule III would benefit directly from
reduced variety registration requirements at this time, the
establishment of the flexible registration framework would
enable many of the 52 crop kinds requiring registration to
benefit in the future.
Removal of
pre-registration testing (Part III) and merit assessment
requirements (Parts II and III) would reduce the regulatory
burden and associated costs for developers of new varieties for
those crop kinds listed in Parts II and III by reducing the
cost, time and unpredictability of the registration process. It
is expected that increased variety development would be
stimulated for crop kinds in Parts II and III due to the
reduction in regulatory burden and that an eventual increase in
the number of registered varieties available to growers and
producers would result. In addition, the time required for a new
variety to become available to Canadian producers would be
reduced by up to three years for some crop kinds.
The proposed
amendments support the intended objective of creating a
framework that provides varying levels of government oversight
for varieties of crop kinds, on a crop-by-crop basis. All crop
kinds would no longer be subject to same requirements or to the
same level of government oversight. However, basic variety
registration requirements for all crop kinds requiring
registration would maintain the CFIA’s ability to ensure that
health and safety requirements are met, to monitor and trace
seed in the marketplace, to undertake compliance and enforcement
actions, to certify the varietal identity and purity of seed, to
prevent fraud, to verify claims, and to provide appropriate
oversight of PNTs.
The proposed
system has received general support from traditional seed sector
stakeholder groups. The flexibility of the proposed registration
system is expected to stimulate or increase innovation and
competitiveness and thereby to support continued or increased
investment in public and private variety development in Canada
and to increase opportunities for producers.
As the
proposed amendments will not include any changes to existing
fees, the User Fees Act does not apply. The
appropriateness of the fees for each of the three Parts will be
reviewed in the future in consideration of the CFIA Fee
Moratorium.
The
objectives of the proposed amendments are consistent with
Canada’s federal, provincial, and territorial governments’
Growing Forward policy framework for a profitable and
innovative agriculture, agri-food and agri-based products
industry that seizes opportunities in responding to market
demands and contributes to the health and well-being of
Canadians. The amendments are also in line with the Government
of Canada’s Paper Burden Reduction Initiative which endeavours
to reduce undue regulatory burden by improving the efficiency of
existing regulations to help increase productivity and
profitability and to promote competition. Regulatory reductions
associated with the proposed amendments would include, for crop
kinds in Part III, a decrease in the amount of laboratory
testing and field trial data required, as well as a reduction in
the number and complexity of required forms. Finally, the
amendments are also in line with the Cabinet Directive on
Streamlining Regulation.
Ongoing
consultation with seed sector stakeholders will enable a
continuous assessment of the functioning of the amended variety
registration system and serve to clarify issues that may be of
concern. Should significant issues arise, the opinions,
requests, and needs of seed sector participants would be
solicited, considered, and, as appropriate, incorporated into
any subsequent amendments to the Regulations or to procedures
and policies employed in the implementation of the proposed
flexible variety registration system.
Consultation
Consultation regarding
creation of a more flexible variety registration framework
Since 1998,
the CFIA has been consulting on ways to improve the variety
registration system. A review of the Canadian variety
registration system was conducted from October 1998 to March
1999. This review led to a regulatory proposal to amend the
variety registration system. The proposal was circulated widely
for consultation until late March 2000. There was, however, a
lack of consensus on changes to the variety registration system,
particularly with respect to crop placement in the proposed
system. The failure to reach consensus provided the impetus for
the creation of the Seed Sector Alliance (SSA) in 2003. The SSA
was an umbrella group composed of the CSGA, the CSTA, the
Canadian Seed Institute (CSI), and the Grain Growers of Canada
(GGC).
The SSA
conducted an in depth Seed Sector Review that resulted in the
establishment of the National Forum on Seed (NFS) in 2005. Under
the auspices of the NFS, a series of variety registration
working group meetings were held to further stakeholder
understanding of the variety registration system, to identify
opportunities for improvement, and to develop consensus on the
need for and nature of change to the variety registration
system. These working group meetings were instrumental in
assisting the CFIA to develop a proposal to modernize the seed
regulatory framework which was made public in October 2006.
Shortly
thereafter, the CFIA launched a series of regional workshops,
two national meetings and an on-line consultation workbook to
elicit responses to the Proposal to Facilitate the
Modernization of the Seed Regulatory Framework. The on-line
workbook included questions relating to the creation of a more
flexible variety registration system. Workshop participants and
respondents to the on-line survey included representatives of
farm organizations, industry associations, commercial
enterprises and government as well as individual farmers,
producers, seed growers, developers of varieties, analysts,
processors, civil society organizations, and the general public.
For the
majority of the six-month on-line consultation period, from
October 2006 to March 2007, the comments on the modernization
proposals were positive. There were concerns expressed regarding
implementation issues, oversight, and the balance of roles
between government and industry under the proposed system.
Respondents valued the flexibility, reduced regulatory burden,
and reduced information requirements. There was a general
consensus that removing merit assessment as a requirement for
variety registration for some crop kinds would allow
registration of many more new, innovative, and niche varieties.
However, in
the final 18 days of the on-line consultation period an influx
of negative comments were posted by members of the general
public and some producers. These responses expressed concerns
that the proposal would enhance corporate control over seed,
fast-track variety registration for genetically engineered crops
and related products of biotechnology, and reduce government
protection for seed users and the public. Most of these concerns
were beyond the scope of the consultation and were not relevant
to the questions posed or this proposed amendment, since the
proposed amendments would not affect the current regulatory
framework and process for the health, safety and environmental
impact assessment of new varieties including those that are
genetically engineered.
In general,
throughout the development process there has been support for
the proposed concept of a more flexible variety registration
system. Wide-ranging and in-depth comments were received,
demonstrating the importance of this issue to seed sector
stakeholders and the broader agriculture industry. Respondents
provided valuable insights into the practical implementation of
the proposal as well as raising critical and thoughtful comments
which have been included in subsequent analysis and development
of the proposed amendments to the Regulations.
Over the
past decade, the CFIA has put forward several proposals to
increase the flexibility of the registration system. The most
recent consultations in 2006 and 2007 centered on a proposal to
create a two-tiered registration system. However, it became
evident during the drafting of the Regulations that a
three-tiered system was necessary. As such, the first tier has
been split into the proposed Parts I and II and the second tier
is now proposed as Part III of Schedule III in the current
proposal.
Previous
proposals also included crop-specific advisory bodies to assist
with issue identification and consensus building for crop
placement; however, there are a number of outstanding issues
that need to be addressed before moving forward, including
resourcing and the determination of the degree of recognition
required for these groups. This has not prevented the CFIA from
moving forward with proposals on crop-specific policy and
regulatory change while the process for establishing
crop-specific groups is established.
Consultations regarding
crop placement in different parts of Schedule III
Consultations regarding future requirements for pre-registration
testing and merit assessment for each crop kind were conducted
at two national stakeholder meetings in March and November of
2007. Interested individuals from the seed and crop value chains
participated in table discussions where they investigated
regulatory options within the proposed flexible registration
system and made recommendations to the CFIA on the preferred
requirements for their crop kinds. The CFIA has also received
direct communication from stakeholders indicating their views
with respect to support for the placement of specific crop kinds
in the new framework. In addition, feedback was received through
the on-line consultation and other traditional stakeholder
channels.
At the
CFIA’s National Workshop on Seed Program Modernization in
November 2007, there was general agreement that the variety
registration requirement for pre-registration testing of
buckwheat varieties is necessary since there is currently no
provincial performance testing or alternative mechanism for
generation of this testing data. The inclusion of buckwheat in
Part II would remove the burdensome merit requirement while
maintaining a mechanism for pre-registration data generation.
The CFIA has
received stakeholder input indicating a preference to remove the
merit requirement for registration of new safflower varieties
but to continue to require performance testing to provide data
with respect to agronomic adaptation.
Communications with members of the sunflower industry and with
an organization representing the value chain indicate that
removing merit assessment and performance testing for
non-ornamental sunflowers would be preferable. There was
consensus for the removal of the pre-registration testing and
merit requirements for non-ornamental sunflowers at the CFIA’s
National Workshops on Seed Program Modernization in March and
November of 2007.
Between 1992
and 2007, the CFIA received feedback from potato-recommending
committees and from an organization representing the potato
value chain recommending that potatoes be moved to a
registration option that does not include pre-registration
testing or merit requirements. At the CFIA’s National Workshops
on Seed Program Modernization held in March and November 2007,
there was agreement that the merit and pre-registration testing
requirements for potatoes should be removed.
The CFIA
also heard feedback on crop placement in a more flexible variety
registration system for additional crop kinds. Additional
changes in crop placement in the Parts of Schedule III are
expected as the rationale is identified and consensus for change
is reached for other crop kinds. Where appropriate, the CFIA
will work with stakeholders to identify and address this need
for change for additional crop kinds in the future.
Implementation, enforcement and service standards
Implementation plan
The
following groups will be included in communications with respect
to the proposed regulatory amendments: CSGA, CSTA, CSI, GGC,
NFS, other seed and crop sector associations, plant breeders and
developers of varieties, seed analysts (including Commercial
Seed Analysts Association of Canada), grain and crop producers,
provincial and regional governments, crop specific associations
(e.g. Pulse Canada, National Sunflower Association of Canada,
Canadian Horticulture Council), CFIA Operations, Programs and
Policy, and Science Branch staff as appropriate, and Federal
government departments and agencies as appropriate.
Compliance and
enforcement
The proposed
flexible registration system would continue to maintain the
CFIA’s ability to monitor, trace, and regulate the sale of seed
of varieties in the marketplace and to undertake compliance and
enforcement actions. Current CFIA procedures for carrying out
those activities will continue to be carried out following the
implementation of the flexible variety registration system.
Service standards
The time
required for the CFIA to process complete and accurate
applications varies depending on the extent of review required,
how complete the applications are and the number of applications
pending at any one time. The CFIA has a service standard whereby
eight weeks is required for the CFIA to process a complete
application and register a variety. The applicant’s response
time to requests for additional information may lengthen the
time required to register a variety. For the majority of crop
kinds, the time from receipt of a completed variety application
package to the registration of a new variety will be unchanged.
For buckwheat, safflower, non-ornamental sunflower, and potato
(commercial production), the time for CFIA staff to review the
variety application package may be somewhat reduced as the
requirements for submission of testing and merit assessment data
are reduced.
3.
(1) Subparagraphs 67(1)(a)(v) and (vi) of the
Regulations are replaced by the following:
(v) a
recommendation that is not more than two years old or, in the
case of a forage variety, not more than four years old, from a
recommending committee stating whether the variety should be
registered,
(vi) the
results of the testing on which the recommendation is based,
(2)
Subparagraph 67(1)(b)(iii) of the Regulations is
replaced by the following:
(iii) for
potatoes, a set of photographic slides or digital images that
detail plant morphology.
(3)
Section 67 of the Regulations are amended by adding the
following after subsection (1):
(1.1)
Subparagraphs (1)(a)(v) and (vi) do not apply in
respect of a species, kind or type of crop that is listed in
Part III of Schedule III.
4.
The Regulations are amended by adding the following after
section 67:
Eligibility Requirements for Variety Registration
67.1
(1) A variety of a species, kind or type of crop that is listed
in Part I of Schedule III is eligible for registration if
(a)
the variety has merit;
(b)
the variety has been tested in accordance with the testing
protocols of a recommending committee;
(c)
the recommending committee has made a recommendation respecting
registration of the variety;
(d)
the variety or its progeny is not detrimental to human or animal
health and safety or the environment when grown and used as
intended;
(e)
the representative reference sample of the variety does not
contain off-types or impurities in excess of the Association’s
standards for varietal purity;
(f)
the variety meets the standards for varietal purity established
by the Association or these Regulations for a variety of that
species, kind or type;
(g)
the variety is distinguishable from all other varieties that
were or currently are registered in Canada;
(h)
the variety name is not a registered trademark in respect of the
variety;
(i)
the variety name is not likely to mislead a purchaser with
respect to the composition, genetic origin or utility of the
variety;
(j)
the variety name is not likely to be confused with the name of a
variety that was or currently is registered;
(k)
the variety name is not likely to offend the public;
(l)
no false statement or falsified document and no misleading or
incorrect information have been submitted in support of the
application for registration; and
(m)
the information provided to the Registrar is sufficient to
enable the variety to be evaluated.
(2) A
variety of a species, kind or type of crop that is listed in
Part II of Schedule III is eligible for registration if the
requirements for eligibility set out in paragraphs (1)(b)
to (m) are met.
(3) A
variety of a species, kind or type of crop that is listed in
Part III of Schedule III is eligible for registration if the
requirements for eligibility set out in paragraphs (1)(d)
to (m) are met.
5.
(1) The portion of subsection 68(1) of the Regulations before
paragraph (a) is replaced by the following:
68.
(1) Subject to subsections (2) and (3), if the requirements set
out in sections 67 and 67.1 are met, the Registrar shall
(2)
Paragraph 68(2)(a) of the Regulations is replaced by
the following:
(a)
in the case of a variety of a species, kind or type of crop that
is listed in Part I or II of Schedule III, if a minimum of one
year of testing demonstrates that the variety may be eligible
for registration but that further testing is required before a
final decision can be rendered, the registration shall be
limited to an initial period of not more than three years that
shall be extended on written request by the applicant if
eligibility for registration continues to be demonstrated, but
under no circumstances shall the total duration of the
registration exceed five years;
6.
Section 72 of the Regulations and the heading before it are
repealed.
7.
Paragraph 74(4)(b) of the Regulations is replaced by
the following:
(b)
the variety has been found to be indistinguishable from another
variety that was or currently is registered in Canada;
8.
Schedule III of the Regulations is replaced by Schedule III set
out in the schedule to these Regulations.
COMING INTO FORCE
9.
These Regulations come into force on the day on which they are
registered.
Question
L’avancement
de la science des semences, de la technologie et de la sélection
des plantes, exige que des changements soient apportés au cadre
réglementaire afin d’assurer une surveillance gouvernementale
appropriée sans restreindre indûment les possibilités. Une
demande accrue pour les variétés des marchés à créneaux se fait
sentir chez les producteurs et les créateurs qui évoluent dans
le monde de plus en plus concurrentiel du commerce des semences.
Le système actuel d’enregistrement des variétés ne réagit pas
adéquatement à ces changements.
Tel qu’il
est actuellement indiqué dans le Règlement sur les semences
(le Règlement), il faut procéder à une épreuve préalable à
l’enregistrement (les essais au champ et les essais en
laboratoire) et à une évaluation de la valeur avant
d’enregistrer de nouvelles variétés. On considère qu’une variété
a de la valeur si elle présente une performance égale ou
supérieure à celle de variétés de référence pertinentes en
fonction d’un ou de plusieurs critères établis pour ce type de
culture. Actuellement, les variétés de tous les types de
cultures qui doivent faire l’objet d’un enregistrement sont
assujetties aux mêmes exigences en matière d’enregistrement. Le
système actuel n’offre pas d’autres solutions pratiques dans les
cas où ces exigences sont trop lourdes.
Pour
certains types de cultures, ces exigences ne sont pas
pertinentes sur le marché et peuvent être inutiles lorsqu’il
s’agit de déterminer la pertinence de la variété pour les
producteurs ou l’acceptabilité de la variété pour les
utilisateurs finaux. Par exemple, une nouvelle variété de
tournesol dont les semences de grande taille présentent un
tégument au motif attrayant pourrait faire l’objet d’une grande
demande sur le marché de la confiserie, mais il se pourrait
qu’elle soit inadmissible à l’enregistrement en raison de son
faible rendement. Par conséquent, les exigences actuelles
relatives à l’enregistrement imposent un fardeau réglementaire
indu aux créateurs de variétés de certains types de cultures
tels que le tournesol, puisque ceux-ci se trouvent dans
l’obligation d’effectuer des examens qu’ils n’effectueraient pas
autrement et de respecter des exigences en matière de valeur qui
ne sont pas pertinentes pour le marché visé.
Les
exigences peuvent également dresser un obstacle à
l’enregistrement opportun et rentable des variétés puisqu’elles
nécessitent du temps et des ressources tant de l’industrie que
du gouvernement. Pour certains types de cultures, l’exigence
voulant que l’on procède à des essais en laboratoire, aux essais
au champ et à une évaluation de la valeur peut être considérée
comme un fardeau réglementaire par rapport aux bénéfices
retirés. Ce fardeau peut alors entraîner un retard dans la
commercialisation de nouvelles variétés utiles et leur
disponibilité pour les producteurs.
Dans les cas
où les créateurs de variétés ne sont pas en mesure de prévoir
avec assurance quelles variétés seront admissibles à
l’enregistrement dans le système d’enregistrement actuel, il y a
une augmentation du taux de risque et d’incertitude dans le
processus de création de nouvelles variétés. Cette situation
peut entraîner une réduction des investissements dans la
recherche et dans la création de nouvelles variétés, réduisant
ainsi la capacité de l’industrie de répondre à des besoins
immédiats et changeants au sein du secteur.
Dans les
communications écrites et verbales du ministre de l’Agriculture
et de l’Agroalimentaire, de la présidente de l’Agence canadienne
d’inspection des aliments (ACIA) et de la Section des semences
de l’ACIA, les secteurs des semences et des cultures ont à
maintes reprises exprimé leur insatisfaction à l’égard du
système actuel d’enregistrement des variétés et ont clairement
souligné l’urgence d’accroître la souplesse de ce système.
Pour
s’attaquer à ces questions, une modification au Règlement
est proposée pour accroître la souplesse de la
réglementation qui régit l’enregistrement des variétés. Le fait
de ne pas modifier le système d’enregistrement des variétés
présente des risques pour l’agriculture canadienne, notamment
moins de débouchés pour les producteurs, une diminution de
l’investissement dans la recherche sur les plantes et la
sélection des plantes au Canada, des obstacles encore plus
grands à l’innovation ainsi qu’une réduction de la place occupée
par le Canada dans le commerce mondial des semences.
Objectifs
Les
modifications proposées divisent la liste de tous les types de
cultures qui doivent être enregistrés en trois parties
comprenant trois niveaux d’exigences relatives à
l’enregistrement des variétés afin que chaque type de culture
soit classé dans la partie pertinente à ses besoins
particuliers.
Les
modifications proposées visent à établir un cadre réglementaire
pour l’enregistrement des variétés qui prévoirait divers degrés
de surveillance gouvernementale en fonction des cultures. Le
cadre permettrait d’éliminer, le cas échéant, toute exigence
lourde ou inefficace quant à l’épreuve préalable à
l’enregistrement et à l’évaluation de la valeur d’une culture
tout en maintenant la surveillance gouvernementale afin de
surveiller et retracer les semences sur le marché, de s’assurer
que les exigences en matière de santé et de sécurité sont
respectées, de prendre des mesures pour vérifier le respect de
la réglementation et pour veiller à son application, de
certifier l’identité de la variété de semence ainsi que sa
pureté, de prévenir la fraude et de surveiller adéquatement les
végétaux à caractères nouveaux (VCN).
Le nouveau
cadre proposé permettrait de modifier les exigences en
