ARCHIVED — Vol. 147, No. 10 — March 9, 2013

Regulations Amending the Seeds Regulations

Statutory authority

Seeds Act

Sponsoring agency

Canadian Food Inspection Agency

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

1. Background

Pursuant to the Seeds Act, the Seeds Regulations (Regulations) prescribe requirements to ensure 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) ensures that health and safety requirements are met; (ii) provides identification and traceability of plants with novel traits; (iii) ensures 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 for 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, basic variety registration information continued to be required, including information demonstrating conformity with minimum health and safety standards, information confirming the identity of new varieties, information supporting the verification of claims, 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 Parts Ⅱ and III, while the remainder 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:

  • Crop kinds in Part Ⅰ require pre-registration testing (field trials and sometimes laboratory testing) and merit assessment by a recommending committee to ensure that the candidate seed varieties meet minimum standards. Recommending committees, which are approved by the Minister under the Regulations, are comprised of public and private sector crop experts. Their role is to establish protocols for pre-registration testing (subject to review by CFIA) and to assess the merit of the seed variety. A seed variety is determined to have merit if it performs as well as or better than appropriate commercial reference varieties for one or more criteria as established for that crop kind. If the recommending committee determines that the variety has merit, it will recommend that CFIA register that seed variety.
  • Crop kinds in Part Ⅱ require pre-registration testing with oversight by a recommending committee but do not require merit assessment. This Part is intended to address crop kinds where oversight to confirm the validity of pre-registration testing data is useful, but where merit assessment does not effectively predict the utility and value of varieties in the marketplace. In this case, the recommending committee will review the results of the pre-registration tests to ensure compliance with the test protocols but will not assess a variety’s merit. If the recommending committee finds that the variety has complied with the pre-registration test requirement(s), it will recommend that CFIA register that variety.
  • Crop kinds in Part Ⅲ do not require pre-registration testing or merit assessment. Crop kinds are included in this Part where pre-registration testing and merit assessment are deemed to be excessively burdensome or ineffective. There is no recommending committee involved for Part Ⅲ crops and application for registration is made directly to CFIA.

When the tiered registration system was put in place, 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. 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 3 136 varieties currently registered.

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 2007, the private sector invested over $56 million in plant breeding and research programs in Canada; by 2012, it planned to invest $106 million.

Although this amendment would benefit both large multinational and small local breeding companies, the smaller companies would see a greater benefit as the reduced costs for variety registration would represent greater relative savings. The smaller companies would also be able to recoup the costs of their breeding programs faster as pedigreed seed would 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 would not have to decide which varieties they can afford to send for pre-registration testing. In general, this regulatory change will allow farmers to access more quickly a wider selection of new varieties of seed produced by both large and small breeding programs.

2. Issue

This proposed amendment addresses two issues in the current Regulations: the 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 the regulatory burden on small business, the CFIA is proposing to reduce 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 and new oilseed soybean and forage varieties would 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 fraud, 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 would be removed.

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

3. Objectives

The fundamental objective of the proposed amendment is to reduce the regulatory burden on developers of new oilseed soybean and forage crop varieties and facilitate market entry. It is anticipated that a portion of the proposed amendments would allow both producers and end users to access new varieties more quickly than in the status quo, increase innovation within the seed and crop sectors, and generate cost savings for industry. This proposal would 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 ensuring that the environment and the health and safety of Canadians are not compromised. A red tape irritant recognized by the RTRC was that delayed approvals for new products put Canadian industry at a competitive disadvantage in both domestic and international markets. These proposed regulatory amendments to reduce the compliance burden of seed registration were specifically included in the commitments made by the CFIA in its 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 proposed amendments to further reduce the registration requirements for oilseed soybean and forages would significantly reduce the regulatory compliance burden and improve the timeliness of variety registration.

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

4. Description

The proposed amendment would 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 up-front investment needed for forages is greater and the risk of a negative merit assessment outcome is higher, as opposed to those for 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 is not expected to result in cost savings for the Government. While the removal of merit assessment under Part Ⅲ would marginally reduce the length of time needed by CFIA staff to review individual soybean and forage applications, it is anticipated that there would also be a corresponding and offsetting increase in the number of applications for registration.

Placement of oilseed soybeans and forages in Part Ⅲ is expected to provide more timely access to new soybean and forage varieties to 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 would 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). The degree of risk associated with the merit assessment outcome would also be reduced.

This amendment would 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 would address comments made by the SJCSR about the practical difference between the suspension and cancellation of variety registration, as the effect is the same in either case.

5. Consultation

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, the forage recommending committee and interested individuals.

At a national stakeholder workshop in October 2009, discussions were held on the potential impacts of moving oilseed soybeans and forages to Part Ⅱ or Part 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 moving forages to Part Ⅱ and Part Ⅲ was distributed to approximately 1 500 seed stakeholders in March 2010. A similar discussion document on 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 on soybean variety registration requirements was also held in November 2010. Support for the proposed amendments has been established through these channels, as well as through direct correspondence from interested and affected stakeholders.

The movement of 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 it 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.

The proposal to place oilseed soybeans and forages in Part Ⅲ of the variety registration framework would 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. The 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 ensure they are selecting the best varieties for their farm. Such a result 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 would provide a more streamlined option for registering varieties in these cases and would ensure that the CFIA has basic information about the identity and health and safety of the variety.

6. “One-for-One” Rule

The proposed regulatory amendment to remove pre-registration testing and merit assessment from oilseed soybean and forage variety applications is expected to 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 the proposed regulatory amendment would 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 is expected to save $1,956 per year.

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

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

Preliminary 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 would be affected by the proposed regulatory amendment. The removal of the pre-registration testing and merit assessment would 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 proposed amendments would 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 regulatory proposal meets the fundamental objective of reducing regulatory burden on developers of new oilseed soybean and forage crop varieties and facilitating market entry. It would 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 is expected to 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 would 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 would 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 would 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. The smaller companies would also be able to recoup the costs of their breeding programs faster as pedigreed seed would 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 to access more quickly a wider selection of new varieties produced by both large and small breeding programs.

Movement of oilseed soybeans and forages to Part Ⅲ is not expected to result in cost savings for government. While the removal of merit assessment under Part Ⅲ would marginally reduce the length of time to review individual soybean and forage applications by CFIA staff, it is anticipated that there would also be a corresponding and offsetting increase in the number of applications for registrations.

Consumers and businesses beyond the agriculture sector are not expected to be affected by the regulatory proposal.

9. Implementation, enforcement and service standards

This proposal would come into force upon registration.

The proposed movement of oilseed soybeans and forages to Part Ⅲ would 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 the proposed Regulations are implemented, applications for registration of all new oilseed soybean and forage varieties could be made without the requirement for pre-registration testing data or recommendation of merit from the recommending committee.

Compliance with the proposed amendments would 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 CFIA staff to review the variety application package may be somewhat reduced as there would no longer be requirements for submission of testing and merit assessment data. However, there may be a corresponding and offsetting increase in the number of applications for registration. The CFIA would continue to track application review times to ensure the service standard is being met.

Notification of the proposed amendment would 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 would also communicate and coordinate directly with the current soybean and forage variety registration recommending committees as these groups would no longer require official recognition by the CFIA as recommending bodies. CFIA notifications would include seed and crop sector associations, plant breeders and developers of varieties, seed analysts, grain and crop producers, provincial crop specialists, crop-specific associations, 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

Appendix: Small Business Lens Checklist

1. Name of the sponsoring regulatory organization:

Canadian Food Inspection Agency

2. Title of the regulatory proposal (should match the RIAS title):

Regulations Amending the Seeds Regulations

3. Is the checklist submitted with a RIAS for the Canada Gazette, Part Ⅰ or Part Ⅱ?

Checked checkbox Canada Gazette, Part Ⅰ

Checkbox Canada Gazette, Part Ⅱ

A. Small business regulatory design

I

Communication and transparency

Yes

No

N/A

1.

Are the proposed Regulations or requirements easily understandable in everyday language?

Checked checkbox Checkbox Checkbox

2.

Is there a clear connection between the requirements and the purpose (or intent) of the proposed Regulations?

Checked checkbox Checkbox Checkbox

3.

Will there be an implementation plan that includes communications and compliance promotion activities, that informs small business of a regulatory change and guides them on how to comply with it (information sessions, sample assessments, toolkits, Web sites, etc.)?

Checked checkbox Checkbox Checkbox

4.

If new forms, reports or processes are introduced, are they consistent in appearance and format with other relevant government forms, reports or processes?

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No new forms, reports or processes are being introduced.

II

Simplification and streamlining

Yes

No

N/A

1.

Will streamlined processes be put in place (e.g. through BizPaL, Canada Border Services Agency single window) to collect information from small businesses where possible?

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Relevant information from small businesses is collected directly during the registration process.

2.

Have opportunities to align with other obligations imposed on business by federal, provincial, municipal or international or multinational regulatory bodies been assessed?

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No ongoing obligations are affected by this amendment.

3.

Has the impact of the proposed Regulations on international or interprovincial trade been assessed?

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4.

If the data or information, other than personal information, required to comply with the proposed Regulations is already collected by another department or jurisdiction, will this information be obtained from that department or jurisdiction instead of requesting the same information from small businesses or other stakeholders? (The collection, retention, use, disclosure and disposal of personal information are all subject to the requirements of the Privacy Act. Any questions with respect to compliance with the Privacy Act should be referred to the department’s or agency’s ATIP office or legal services unit.)

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Variety registration is an independent system and is not connected with any other department.

5.

Will forms be pre-populated with information or data already available to the department to reduce the time and cost necessary to complete them? (Example: When a business completes an online application for a licence, upon entering an identifier or a name, the system pre-populates the application with the applicant’s personal particulars such as contact information, date, etc. when that information is already available to the department.)

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Applications for variety registration are not submitted online and so there is no system in place to pre-populate application forms.

6.

Will electronic reporting and data collection be used, including electronic validation and confirmation of receipt of reports where appropriate?

Checkbox Checkbox Checked checkbox

This amendment will not result in any changes to data collection, validation, and confirmation methods.

7.

Will reporting, if required by the proposed Regulations, be aligned with generally used business processes or international standards if possible?

Checkbox Checkbox Checked checkbox

This amendment does not contain any reporting requirements.

8.

If additional forms are required, can they be streamlined with existing forms that must be completed for other government information requirements?

Checkbox Checkbox Checked checkbox

Additional forms are not being required.

III

Implementation, compliance and service standards

Yes

No

N/A

1.

Has consideration been given to small businesses in remote areas, with special consideration to those that do not have access to high-speed (broadband) Internet?

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There is nothing in this amendment which would affect remotely located small businesses more or less than other small or large businesses.

2.

If regulatory authorizations (e.g. licences, permits or certifications) are introduced, will service standards addressing timeliness of decision making be developed that are inclusive of complaints about poor service?

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Regulatory authorizations are not being introduced.

3.

Is there a clearly identified contact point or help desk for small businesses and other stakeholders?

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B. Regulatory flexibility analysis and reverse onus

IV

Regulatory flexibility analysis

Yes

No

N/A

1.

Does the RIAS identify at least one flexible option that has lower compliance or administrative costs for small businesses in the small business lens section?

Examples of flexible options to minimize costs are as follows:

  • Longer time periods to comply with the requirements, longer transition periods or temporary exemptions;
  • Performance-based standards;
  • Partial or complete exemptions from compliance, especially for firms that have good track records (legal advice should be sought when considering such an option);
  • Reduced compliance costs;
  • Reduced fees or other charges or penalties;
  • Use of market incentives;
  • A range of options to comply with requirements, including lower-cost options;
  • Simplified and less frequent reporting obligations and inspections; and
  • Licences granted on a permanent basis or renewed less frequently.
Checkbox Checked checkbox Checkbox

The proposed amendment would remove the existing requirement for standardized pre-registration testing and merit assessment. An additional amendment would remove the suspension and reinstatement of seed variety registration, and the Regulations would only provide for its cancellation. These amendments would generate savings rather than additional costs to the stakeholders. Therefore, there is no need for a flexible option.

2.

Does the RIAS include, as part of the Regulatory Flexibility Analysis Statement, quantified and monetized compliance and administrative costs for small businesses associated with the initial option assessed, as well as the flexible, lower-cost option?

  • Use the Regulatory Cost Calculator to quantify and monetize administrative and compliance costs and include the completed calculator in your submission to TBS-RAS.

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The potential savings, rather than costs, to stakeholders resulting from the proposed amendment were quantified using the Regulatory Cost Calculator.

3.

Does the RIAS include, as part of the Regulatory Flexibility Analysis Statement, a consideration of the risks associated with the flexible option? (Minimizing administrative or compliance costs for small business cannot be at the expense of greater health, security, or safety or present environmental risks for Canadians.)

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There is no need for a regulatory flexibility analysis because the proposed amendment will eliminate existing requirements and will provide savings to the industry.

4.

Does the RIAS include a summary of feedback provided by small business during consultations?

Checked checkbox Checkbox Checkbox

V

Reverse onus

Yes

No

N/A

1.

If the recommended option is not the lower-cost option for small business in terms of administrative or compliance costs, is a reasonable justification provided in the RIAS?

Checkbox Checked checkbox Checkbox

There are no anticipated additional costs to the stakeholders, hence, there was no lower-cost option presented in the RIAS.

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to subsection 4(1) (see footnote a) of the Seeds Act (see footnote b), proposes to make the annexed Regulations Amending the Seeds Regulations.

Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part Ⅰ, and the date of publication of this notice, and be addressed to Michael Scheffel, National Manager, Seed Section, Canadian Food Inspection Agency, 59 Camelot Drive, Ottawa, Ontario K1A 0Y9 (tel.: 613-773-7142; fax: 613-773-7144; email: Michael.Scheffel@inspection.gc.ca).

Ottawa, February 28, 2013

JURICA ČAPKUN
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE SEEDS REGULATIONS

AMENDMENTS

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

  • (v) a recommendation that is not more than two years old from a recommending committee stating whether the variety should be registered,

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

  • (a) the variety has demonstrated susceptibility to disease or such inferior quality as to have an adverse effect on Canadian agriculture and the food system;

  • (b) the variety has demonstrated significant levels of contamination such that the genetic purity of the variety has been jeopardized;

  • (c) the variety has been altered in such a manner that it differs from the representative reference sample;

  • (d) the variety or its progeny may be detrimental to human or animal health and safety or the environment;

  • (e) false or misleading information was submitted in support of the application for registration;

  • (f) the variety name became a registered trademark in respect of that variety after registration;

  • (g) the variety has been altered in such a manner as to convert it to a variety that is registered under a different name;

  • (h) the variety has been found to be indistinguishable from another variety that was or currently is registered in Canada;

  • (i) the variety is no longer subject to the variety registration requirements; or

  • (j) the registrant has requested the cancellation of the registration of the variety.

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.)

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