Vol. 148, No. 12 — June 4, 2014

Registration

SOR/2014-114 May 16, 2014

SEEDS ACT

Regulations Amending the Seeds Regulations

P.C. 2014-569 May 15, 2014

His Excellency the Governor General in Council, on the recommendation of the Minister of Agriculture and Agri-Food, pursuant to subsection 4(1) (see footnote a) of the Seeds Act (see footnote b), makes the annexed Regulations Amending the Seeds Regulations.

REGULATIONS AMENDING THE SEEDS REGULATIONS

AMENDMENTS

1. Subparagraph 67(1)(a)(v) of the Seeds Regulations (see footnote 1) is replaced by the following:

2. Section 71 of the Regulations is replaced by the following:

71. (1) The Registrar must annually establish a list of experts consisting of not less than six and not more than twenty persons whose professional qualifications, experience or achievements in the field of seed or variety development and evaluation render them experts for the purposes of advising the Registrar on matters involving the refusal or cancellation of any registration under this Part.

(2) The Registrar shall not enter the name of any person on the list of experts unless that person consents to advise the Registrar, on request, on matters involving the refusal or cancellation of any registration under this Part without charging any fees or claiming any disbursements.

3. Section 74 of the Regulations and the heading before it are replaced by the following:

CANCELLATION OF REGISTRATION

74. The Registrar must cancel the registration of a variety if

4. (1) Subsection 75(1) of the Regulations is replaced by the following:

75. (1) The Registrar must not cancel the registration of a variety unless the Registrar sends a notice, by registered mail, to the registrant giving the reasons for the cancellation and advising that the registrant may make representations concerning the cancellation to the Registrar in accordance with this section.

(1.1) Subsection (1) does not apply if the registrant has requested the cancellation of the variety.

(2) Subsection 75(3) of the Regulations is replaced by the following:

(3) A registrant who receives a notice referred to in subsection (1) may, within 30 days after the day on which the notice is received, make written representations to the Registrar concerning the cancellation.

(3) Subsection 75(5) of the Regulations is replaced by the following:

(5) If, on conclusion of the review of the representations made under subsection (3), the Registrar determines that the registration must be cancelled, the cancellation is effective on the seventh day after the day on which the notice of that determination is mailed to the registrant.

5. Section 76 of the Regulations is replaced by the following:

76. (1) The Registrar must reinstate the registration of a variety if the former registrant makes a written request to reinstate the registration and the Registrar determines that the reasons for cancelling the registration are no longer valid.

(2) A former registrant who makes a request to reinstate a registration is not required to submit the information referred to in section 67.

6. Schedule III to the Regulations is replaced by the Schedule III set out in the schedule to these Regulations.

COMING INTO FORCE

7. These Regulations come into force on the day on which they are registered.

SCHEDULE
(Section 6)

SCHEDULE III
(Section 65, subsections 65.1(1), (2) and (4) and 67(1.1), section 67.1 and paragraph 68(2)(a))

SPECIES, KINDS OR TYPES OF CROPS SUBJECT TO VARIETY REGISTRATION

Species, Kind or Type Scientific Name
 

PART I
Barley, six-row, two-row Hordeum vulgare L. subsp. vulgare
Bean, faba (small-seeded) Vicia faba L.
Bean, field Phaseolus vulgaris L.
Buckwheat Fagopyrum esculentum Moench
Canola, oilseed rape, rapeseed Brassica rapa L. subsp. campestris (L.) A.R. Clapham or B. napus L. var. napus (= B. napus L. var. oleifera Delile) or B. juncea (L.) Czern.
Flax (oilseed) Linum usitatissimum L.
Lentil (grain type) Lens culinaris Medik.
Mustard, brown, oriental, Indian Brassica juncea (L.) Czern.
Mustard, white (= yellow) Sinapis alba L.
Oat (grain type) Avena sativa L., A. nuda L.
Pea, field (commodity type) Pisum sativum L.
Rye (grain type) Secale cereale L.
Tobacco (flue-cured) Nicotiana tabacum L.
Triticale (grain type) × Triticosecale Wittm. ex A. Camus
Wheat, common Triticum aestivum L.
Wheat, durum Triticum turgidum L. subsp. durum (Desf.) Husn. (= T. durum Desf.)
Wheat, spelt Triticum aestivum L. subsp. spelta (L.) Thell. (= T. spelta L.)
 

PART II
Safflower Carthamus tinctorius L.
 

PART III
Alfalfa (forage type) Medicago sativa L.
Bird’s foot trefoil Lotus corniculatus L.
Bromegrass, meadow Bromus riparius Rehmann
Bromegrass, smooth Bromus inermis Leyss.
Canarygrass, annual Phalaris canariensis L.
Canary grass, reed Phalaris arundinacea L.
Clover, alsike Trifolium hybridum L.
Clover, red Trifolium pratense L.
Clover, sweet (white blossom) Melilotus albus Medik.
Clover, sweet (yellow blossom) Melilotus officinalis (L.) Lam.
Clover, white Trifolium repens L.
Fescue, meadow (forage type) Festuca pratensis Huds.
Fescue, red (forage type) Festuca rubra L. subsp. rubra
Fescue, tall (forage type) Festuca arundinacea Schreb.
Lupin, lupine (grain and forage types) Lupinus spp.
Orchardgrass Dactylis glomerata L.
Potato (commercial production) Solanum tuberosum L.
Ryegrass, annual (forage type) Lolium multiflorum Lam.
Ryegrass, perennial (forage type) Lolium perenne L.
Soybean (oilseed) Glycine max (L.) Merr.
Sunflower (non-ornamental) Helianthus annuus L.
Timothy, common (forage type) Phleum pratense L.
Wheatgrass, beardless Pseudoroegneria spicata (Pursh) Á. Löve (= Agropyron spicatum (Pursh) Scribn. & J. G. Smith f. inerme (Scribn. & J.G. Smith) Beetle)
Wheatgrass, crested Agropyron cristatum (L.) Gaertn. or A. desertorum (Fisch. ex Link) Schult.
Wheatgrass, intermediate Elytrigia intermedia (Host) Nevski subsp. intermedia (= Agropyron intermedium (Host) Beauv.)
Wheatgrass, northern Elymus lanceolatus (Scribn. & J.G. Sm.) Gould subsp. lanceolatus (= Agropyron dasystachyum (Hook.) Scribn.)
Wheatgrass, pubescent Elytrigia intermedia (Host) Nevski subsp. intermedia (= Agropyron trichophorum (Link) Richter)
Wheatgrass, Siberian Agropyron fragile (Roth) P. Candargy subsp. sibiricum (Willd.) Melderis (= Agropyron sibiricum (Willd.) Beauv.)
Wheatgrass, slender Elymus trachycaulus (Link) Gould ex Shinners (= Agropyron trachycaulum (Link) Malte ex H.F. Lewis)
Wheatgrass, streambank Elymus lanceolatus (Scribn. & J.G. Sm.) Gould subsp. lanceolatus (= Agropyron riparium Scribn. & Smith)
Wheatgrass, tall Elytrigia elongata (Host) Nevski (= Agropyron elongatum (Host) P. Beauv.)
Wheatgrass, western Pascopyrum smithii (Rydb.) Á. Löve (= Agropyron smithii Rydb.)
Wildrye, Altai Leymus angustus (Trin.) Pilg. (= Elymus angustus Trin.)
Wildrye, Dahurian Elymus dahuricus Turcz ex Griseb.
Wildrye, Russian Psathyrostachys juncea (Fisch.) Nevski (= Elymus junceus Fisch.)

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

1. Background

Pursuant to the Seeds Act, the Seeds Regulations (the Regulations) prescribe requirements to safeguard that seeds sold in, and imported into Canada meet established standards for quality, and are labelled in order to be properly represented in the marketplace. Seeds of varieties of most agricultural crop kinds are subject to mandatory variety registration which serves several purposes: (i) confirms that health and safety requirements are met, (ii) provides identification and traceability of plants with novel traits, (iii) assures that varieties meet the internationally recognized definition of a variety, (iv) acts as the repository for official variety descriptions, and the official reference seed sample, which are used to verify varieties throughout their commercial lifespan, and (v) plays a role in maintaining and improving quality standards, disease tolerance, and agronomic performance.

In July 2009, the Regulations were amended to create a flexible variety registration system to address the diverse needs of the various crop sectors in Canada. The goal was to create a framework to reduce the regulatory burden of variety registration. This was accomplished by dividing the list of all crop kinds that require variety registration, found in Schedule III of the Regulations, into three parts representing three levels of variety registration requirements. For all parts, a completed basic variety registration package is required, including information demonstrating conformity with minimum health and safety standards, information confirming the identity of new varieties, information supporting the verification of claims (e.g. disease resistance), and information required for seed certification purposes. However, the three parts each have different pre-registration testing (field trials and laboratory testing) and merit assessment requirements. In all three parts, the Canadian Food Inspection Agency (CFIA) maintained the authority to decline registration of varieties that may be detrimental to animal or human health as well as the safety of the environment. One crop kind was included in the new Part II (safflower) and two crops in the new Part III (potato and sunflower), while the majority of crop kinds remained in Part I (status quo). It was intended that future placement of crop kinds within the three parts would take place through regulatory amendments.

In addition to the completed application package, the parts in the current Regulations require the following:

When the tiered registration system was put in place, the CFIA committed to considering proposals to decrease regulatory burden through moving crop kinds from Part I to Parts II or III on a priority basis, based on the strength of the rationale and degree of consensus within each crop value chain. A crop value chain comprises every value-adding stakeholder and activity along each step of a crop variety’s development, distribution, production and end use. The CFIA created a guidance document for crop-specific stakeholders to help facilitate the process.

Seed is either sold as pedigreed or common; common seed must meet basic purity standards which limit the presence of weed seeds or seeds of other crop types (e.g. corn seed in a lot of soybean seed). Whereas common seed of most crop kinds subject to variety registration is not allowed to be sold with a variety name, pedigreed seed is sold as specific varieties, which are the result of breeding lines developed at public and private institutions. As a result, pedigreed seed, in addition to being inspected for weed seeds and seeds of other crops, is inspected during field production for the presence of other varieties of seed of the same crop type (e.g. seed of the pea variety Venture in a lot of seed of the pea variety Vortex). Buying pedigreed seed allows the farmer to be sure that the crop will meet certain performance standards. Today, there are 53 crop types subject to variety registration and a total of 3 329 varieties currently registered. More than 1 100 varieties have been registered in the past six years.

The seed industry contributes $3.95 billion dollars per year to the Canadian economy and employs 14 200 Canadians. Of that $3.95 billion, $361 million is contributed by plant breeding and research programs, and $1.1 billion from seed production. The remainder is contributed by seed processing and marketing. In 2010, there were 3 735 pedigreed seed producers and over 500 000 hectares of pedigreed seed production.

There is a wide variety of public and private breeding programs in Canada. In 2012, the private sector invested over $99 million in plant breeding and research programs in Canada; by 2013, it planned to invest $106 million.

Although this amendment will benefit both large multinational and small local breeding companies, the smaller companies will see a greater benefit, as the reduced costs for variety registration will represent greater relative savings.  They will also be able to recoup the costs of their breeding programs faster as pedigreed seed will be available earlier, allowing them to stay competitive within the market.  This amendment will also increase the number of varieties being registered by smaller companies as they will not have to decide which varieties they can afford to send for pre- registration testing. In general, this regulatory change will allow farmers faster access to a wider selection of new varieties of seed produced by both large and small breeding programs.

2. Issues

This amendment addresses two issues in the current Regulations: compliance burden within the seed variety registration process and the distinction between suspension and cancellation of a seed registration.

In response to industry needs and to reduce regulatory burden on small business, the CFIA is reducing the variety registration requirements for oilseed soybeans and forages by moving these crop kinds from Part I to Part III of Schedule III to the Regulations. Part III of Schedule III provides a sufficient level of regulatory oversight as new oilseed soybean and forage varieties still require a standard application package. A completed standard application package provides adequate information to enable the CFIA to continue to protect health and safety, prevent deception, and facilitate seed certification. The necessity for pre-registration testing and merit assessment, as well as their associated monetary and temporal costs and any uncertainty in the outcome of the process is removed.

This amendment further addresses comments made by the Standing Joint Committee for the Scrutiny of Regulations (SJCSR) concerning the practical difference between the suspension and cancellation of variety registration, and whether it is practical to distinguish between the two, given that either may be reinstated without requiring a new application. As the effect appears to be the same in either case, the Regulations are amended to simply provide for cancellation.

3. Objectives

The fundamental objective of this amendment is to reduce regulatory burden on developers of new oilseed soybean and forage crop varieties and facilitate market entry. The amendments will allow quicker access to new varieties for both producers and end users versus the status quo, increase innovation within the seed and crop sectors, and generate cost savings for industry. This amendment will not make any changes to the existing minimum variety registration requirements.

The Red Tape Reduction Commission (RTRC) advised the Government of Canada on ways to reduce the regulatory compliance burden on businesses in cases where that compliance burden is inhibiting growth, productivity, competitiveness and innovation, while maintaining the environment and the health and safety of Canadians. A red tape irritant recognized by the RTRC was that delayed approvals for new products puts Canadian industry at a competitive disadvantage in both domestic and international markets. These regulatory amendments reduce the compliance burden of variety registration and were specifically included in the commitments made by the CFIA in their response plan to recommendations made by the RTRC. The more flexible variety registration framework was developed in 2009 to respond to the specific needs of different crop sectors in Canada, and to reduce regulatory burden while maintaining an appropriate level of government oversight. These amendments to further reduce the registration requirements for oilseed soybean and forages will significantly reduce the regulatory compliance burden and improve the timeliness of variety registration.

An additional objective of this amendment is to implement the suggested recommendations of the SJCSR, which will simplify and eliminate the confusion between suspension and cancellation of variety registration. As recommended, the Regulations will simply provide for cancellation.

4. Description

The amendment will move oilseed soybean and forage species (alfalfa, bird’s foot trefoil, bromegrasses, canarygrass, alsike clover, red clover, sweet clover, white clover, fescues [forage type], lupin, orchardgrass, ryegrasses, timothy, wheat grasses, and wild ryes) from Part I to Part III of Schedule III to the Regulations.

Within the current tiered registration system, oilseed soybeans and forage crop varieties are registered under Part I. In addition to a completed application for variety registration, new varieties of oilseed soybeans and forage crops require pre-registration testing and merit assessment before being registered by the CFIA. For new oilseed soybean varieties, these requirements add one to two years to the registration process and cost approximately $750 in pre-registration testing fees per variety; as most forage species are perennials, new varieties require three to five years of testing at a cost of approximately $1,500 in pre-registration testing fees per forage variety.

Due to the compounded risk of failure associated with multi-year trials (e.g. flooding or drought), the upfront investment incurred for forages is higher and the risk of a negative merit assessment outcome is higher as opposed to annual crops. Although forage crop testing is well established in some regions, the overall number of test sites has decreased as a result of reduced public funding and other resource limitations. In addition, forage varieties are registered nationally although their fitness might vary significantly between the region where they are grown and the region where the pre-registration testing was conducted. Finally, as the release of data from pre-registration trials is at the discretion of the variety developer and outside of the CFIA’s mandate, producers must rely on other available sources of performance data, such as post-registration trials, to make appropriate variety selections for their area.

Movement of oilseed soybeans and forages to Part III will not result in any significant cost savings for government. While the removal of merit assessment under Part III will marginally reduce the length of time to review individual soybean and forage applications by the CFIA staff, there will be a corresponding and offsetting increase in the number of applications for registration.

Placement of oilseed soybeans and forages in Part III will provide more timely access to new soybean and forage varieties for both producers and end users, increase innovation and competition within the seed and crop sectors, and result in cost savings for industry due to the reduced regulatory burden. These benefits will accrue as a result of the removal of the financial, time, and resource investments currently required to meet existing standardized pre-registration test requirements (field trials and laboratory testing). It will also reduce the degree of risk associated with the merit assessment outcome.

This amendment will also remove the suspension and reinstatement of variety registration, with the result that the Regulations would only provide for the cancellation of variety registration. This will address comments made by the SJCSR about the practical difference between the suspension and the cancellation of variety registration, as the effect is the same in either case.

5. Consultation

Prior to prepublication of proposed amendments in the Canada Gazette, Part I, on March 9, 2013, specific consultations on changing the requirements for oilseed soybeans and forages were held during national stakeholder meetings, crop recommending committee meetings and industry-led conference calls, and through discussion documents and direct correspondence. Soybean value chain participants throughout the consultation included commercial plant breeders, university research programs, seed companies, public and private plant breeders, major industry associations and interested individuals. Forage value chain participants at various stages of the consultation included the Canadian Forage and Grasslands Association, the Canadian Seed Trade Association, the Canadian Seed Growers’ Association, primary producers, seed companies, plant breeders, forage recommending committee and interested individuals.

At a national stakeholder workshop in October 2009, discussions were held on the potential impacts of movement of oilseed soybeans and forages to Part II or III of the tiered registration system. Participating stakeholders indicated support for movement to Part III, citing faster producer access to new varieties and reduced regulatory burden for variety developers. Discussions also indicated that impacts on seed growers would be neutral because decisions about which varieties to increase are primarily made by private variety developers and seed companies, not individual seed growers.

A discussion document seeking feedback on the impacts of movement of forages to Parts II and III was distributed to approximately 1 500 seed stakeholders in March 2010. A similar discussion document on oilseed soybean variety registration was distributed in October 2010. In March 2010, the forages consultations were followed up with a targeted face-to-face meeting. A teleconference call on oilseed soybean variety registration requirements was also held in November 2010. Support for the amendments was established through these channels, as well as through direct correspondence from interested and affected stakeholders.

The movement of oilseed soybeans to Part III of the registration system is well supported by all key stakeholders and is expected to cause little to no controversy. While there is a clear consensus among key stakeholders to place minor forage species in Part III, some stakeholders indicated that Part II might be more appropriate for major forage species in order to provide performance information to growers. However, this rationale is not entirely valid. During consultations with forage stakeholders, the CFIA clarified that Part II registration requires pre-registration field testing, but the resulting data can only be used to evaluate whether the test was conducted according to the protocols established by that committee. Data from pre-registration trials cannot be evaluated by the recommending committee for agronomic performance (merit assessment), and therefore, cannot influence the committee’s recommendation for registration for that variety. Data from pre-registration trials also cannot be released by the CFIA as it is not public domain information. The applicants and the committee may choose to share pre-registration data but this cannot be mandatory. In addition, some forage recommending committees currently accept foreign data in lieu of Canadian data (although the data must be collected from similar agro-climatic zones) with the result that pre-registration test results, if disseminated by the variety’s developers or representatives, may not be representative of a variety’s performance in Canada and would be of limited use to Canadian growers. For these reasons, the stakeholder rationale for moving major forage crops to Part II is not entirely valid.

Placing oilseed soybeans and forages in Part III of the variety registration framework will remove the existing requirement for standardized pre-registration testing and merit assessment. Merit assessment determines whether a candidate variety performs as well as or better than appropriate reference commercial varieties with respect to characteristics that render the variety beneficial for a particular use in a region of Canada. As a result, absence of the requirement for merit assessment in Part III may result in registration, and subsequent cultivation, of varieties that are less agronomically adapted to their area. However, this is expected to have minimal impact on consumer protection given that in the existing system, varieties are granted national registration based on performance data from regional trials so producers must already conduct their own research to satisfy themselves they are selecting the best varieties for their farm. This is also unlikely given that variety developers are driven by the needs of producers and end users. In addition, since unregistered varieties may currently be imported into Canada for the purposes of seed multiplication and re-export, research or seeding by the importer, the potential for cultivation of less agronomically adapted varieties already exists. Part III registration requirements for forages and oilseed soybeans will provide a more streamlined option for registering varieties in these cases and will provide the CFIA with the basic information about the identity and health and safety of the variety.

Prepublication results

Prepublication of the proposed amendments in the Canada Gazette, Part I, on March 9, 2013, was followed by a 75-day comment period which ended on May 23, 2013. In total, the CFIA received 3 077 written comments. Of these responses, 2 925 (95%) were form letters submitted as part of a letter-writing campaign. Apart from this campaign, a total of 153 unique responses were received — 136 from individuals (134 were related to the campaign, but the content of the letter varied enough to warrant being considered as a unique response), 11 from stakeholder organizations, and 6 from private seed companies.

There were three main arguments contained in the form letter, which were:

(1) Oilseed soybeans and forages should remain in Part I to maintain government oversight and regulation. However, the movement of oilseed soybeans and forages to Part III will not affect the CFIA’s ability to monitor, trace and regulate the sale of seed of varieties in the marketplace and related compliance and enforcement actions. Keeping these crop types in Part I will continue to delay the availability to new varieties to producers and retain the associated regulatory burden. It should be noted that without exception, all key value chain stakeholder organizations and private seed companies who responded to this consultation, outside of the letter-writing campaign, favoured the movement of oilseed soybean and forage species out of Part I.

(2) This amendment would make it easier to register genetically modified (GM) alfalfa varieties. However, the safety evaluation of plants with genetic modifications is outside the scope of these variety registration and these amendments. GM traits must pass safety assessments for food, feed, and environmental release, which are conducted by Health Canada and two separate directorates within the CFIA, and not by the Variety Registration Office. No variety with a genetic modification can be registered until it has passed each of the three safety assessments. Therefore, concerns regarding the safety of GM varieties are not relevant to these amendments.

(3) The amendment would allow variety registrants to deregister their varieties on request. The letter argued that variety developers should not be allowed to cancel their varieties on request, thereby making seed of those varieties illegal to grow and sell in Canada. As there is no procedural difference between suspension and cancellation of variety registrations, the SJCSR requested that suspension be removed from the Regulations. As a result of this request, sections that concern suspension of variety registration were amended. The ability of registrants to request the cancellation of the registration of their own varieties has existed in the Regulations since 1996 and, therefore, is not new.

Outside of responses received from the letter-writing campaign, respondents presented two main arguments, both of which support the movement of oilseed soybean and forage species out of Part I:

(1) Place major forages in Part II

Three key respondents representing over 200 000 Canadian farms and associations indicated a preference to place the major forage crop types (alfalfa, bromegrass, red clover, timothy, and orchardgrass) in Part II rather than Part III, with the remaining minor forages being placed in Part III. These respondents stated that producers should have access to performance data, which is currently available through pre-registration testing, to reduce the risk of planting a variety which may underperform in their region.

This rationale is not valid as national registration is supported by regional pre-registration trials, which may not accurately capture the performance of the variety across Canada. Furthermore, pre-registration trials are not robust performance trials, and there is no mandate in the Regulations to ensure the provision of performance data to growers. If placed in Part II, new varieties of major forages would continue to be subject to a three- to five-year registration delay, thereby maintaining economic and temporal barriers against the introduction of new forage varieties to Canadian producers and markets. As it has never been the intention of the variety registration system to ensure the provision of the regional performance testing results, the rationale for placement of major forages in Part II is not considered valid. As most recently registered forage varieties result from foreign breeding programs, eliminating pre-registration testing will increase foreign interest and result in a larger number of varieties available to Canadian producers in a timely manner.

(2) Place oilseed soybeans and/or all forages in Part III

Eleven respondents supported the movement of oilseed soybeans and/or all forages to Part III of the Regulations. These respondents represent over 67 000 farms, associations, seed companies and individuals. Respondents indicated this change would reduce the uncertainty of variety registration and increase Canadian access to innovative or niche varieties in a timely manner, enabling Canadian producers to remain competitive in domestic and international markets.

Without exception, all key value chain stakeholder organizations and private seed companies who responded to this consultation favoured the movement of oilseed soybean and forage species out of Part I.

Based on the responses that were received during the consultation period following the prepublication of these amendments in Part I of the Canada Gazette, the stakeholder consensus resulting from consultations conducted between 2007 to 2012, and the rationales provided for change, oilseed soybean and forage crop types are moved to Part III of Schedule III to the Seeds Regulations. This change will allow producers to have more choice and freedom through timely access to innovative varieties by reducing the regulatory burden and requirements of variety registration.

6. “One-for-One” Rule

This regulatory amendment to remove pre-registration testing and merit assessment from oilseed soybean and forage variety applications will impact variety developers and the oilseed soybean and forage crop recommending committees.

The CFIA estimates that the total administrative savings to all stakeholders resulting from this amendment will be $109,515 annually or a present value of $2.4 million over a 10-year period. There are 56 stakeholders impacted, and each stakeholder will save $1,956 per year.

The amendment to remove the pre-registration testing will reduce record keeping and reporting time by 16 hours for every oilseed soybean and forage variety developed by a stakeholder. This will generate an administrative savings of approximately $73,636 annually for all impacted businesses.

In addition, the removal of merit assessment will reduce the administrative costs to stakeholders by $45,804 annually. The amendment will eliminate the need for the recommending committee members to fund their attendance at meetings during which data packages are reviewed and merit is assessed.

Calculations of administrative costs were done using information provided by industry, based on consultations conducted in March 2012. At the end of September 2012, industry was contacted again to validate and confirm the relevant numbers used in determining administrative and compliance costs that they provided through previous consultations. Every Canadian representative who registered an oilseed soybean or forage variety in the past five years was contacted to verify the accuracy of the following average numbers: hours spent on compliance activities, hours spent on administrative activities, and the hourly wage of the person responsible for carrying out compliance and administrative activities. In total, 32 companies were contacted. Six responses were received. The numbers contributed in the responses were averaged and used to estimate cost savings.

7. Small business lens

Twenty-nine small businesses will be affected by the regulatory amendment. The removal of the pre-registration testing and merit assessment will reduce the administrative burden (record keeping, reporting, and reviewing of data packages) and the compliance cost associated with pre-registration testing activities of small businesses. The amendment will generate an annualized average savings of $114,426 per year or $3,946 annually per stakeholder, representing a present value of $803,682 in savings over 10 years.

8. Rationale

This amendment meets the fundamental objective of reducing regulatory burden on developers of new oilseed soybean and forage crop varieties and facilitating market entry. It will also achieve the objective of removing the confusion between suspension and cancellation of variety registration, as identified by the SJCSR.

The removal of pre-registration testing and merit assessment from forage and soybean variety applications will impact stakeholders within the seeds and crops industries, including public and private variety developers, seed suppliers, seed growers, the CFIA, and the soybean and forage crop recommending committees. Most of the impact will take the form of benefits, including removal of the time delays and uncertainties associated with the current regulatory requirements, savings from pre-registration testing fees, faster commercialization of new varieties, and faster return on research and development investment. This will reduce business risk, improve the ability of developers to adapt to changing markets (e.g. increased yields, disease resistance, niche markets), and realize an earlier and more significant return on their investment.

Though this amendment will benefit both large multinational and small local breeding companies, the smaller companies will see more benefit as the reduced costs for variety registration will represent greater relative savings.  They will also be able to recoup the costs of their breeding programs faster as pedigreed seed will be available earlier, allowing them to stay competitive within the market.  This amendment may also increase the number of varieties being registered by smaller companies as they will not have to decide which varieties they can afford to send for pre-registration testing.  In general, this regulatory change will allow farmers faster access to a wider selection of new varieties produced by both large and small breeding programs.

Movement of oilseed soybeans and forages to Part III may not result in any significant cost savings for Government. While the removal of merit assessment under Part III will marginally reduce the length of time to review individual oilseed soybean and forage applications by the CFIA staff, there may also be a corresponding and offsetting increase in the number of applications for registrations.

Consumers and businesses beyond the agriculture sector will not be affected by the regulatory amendment.

9. Implementation, enforcement and service standards

This amendment will come into force upon registration.

The movement of oilseed soybeans and forages to Part III will not affect the CFIA’s ability to monitor, trace and regulate the sale of seed of varieties in the marketplace and related compliance and enforcement actions. This amendment will not impact current implementation and enforcement activities.

Once implemented, applications for registration of all new oilseed soybean and forage varieties will be made without the requirement for pre-registration testing data or recommendation of merit from the recommending committee.

Compliance with the amendments will continue to be achieved through the registration of new oilseed soybean and forage varieties. The CFIA’s established service standard to process a complete application and register a new variety is eight weeks. The time required for the CFIA to process applications varies depending on the extent of review required, degree of completeness of the applications and the number of applications pending at any one time. The applicant’s response time to requests for additional information may lengthen the time required to register a variety. For oilseed soybean and forage crops, the time for the CFIA staff to review the variety application package will be somewhat reduced, as there would no longer be requirements for submission of testing and merit assessment data. However, there will be a corresponding and offsetting increase in the number of applications for registration. The CFIA will continue to track application review times to verify the service standard is being met.

Notification of the amendment will be posted on the CFIA’s Web site and distributed to seed stakeholders currently on the CFIA’s email distribution list which is continually updated. The CFIA will also communicate and coordinate directly with the current oilseed soybean and forage variety registration recommending committees as these groups will no longer require official recognition by the CFIA as recommending bodies. The CFIA notifications will include seed and crop sector associations, plant breeders and developers of varieties, seed analysts, grain and crop producers, provincial crop specialists, crop specific associations, the CFIA staff and federal government departments and agencies as appropriate.

10. Contact

Michael Scheffel
National Manager
Seed Section
Field Crops and Inputs Division
Plant Health and Biosecurity Directorate
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9
Telephone: 613-773-7142
Fax: 613-773-7144
Email: seedsemence@inspection.gc.ca