Canada Gazette, Part I, Volume 152, Number 49: Regulations Amending the Fertilizers Regulations

December 8, 2018

Statutory authority
Fertilizers Act

Sponsoring agency
Canadian Food Inspection Agency

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issues: A systematic review of the Fertilizers Regulations (Regulations) conducted by the Canadian Food Inspection Agency (CFIA) has identified a number of deficiencies. Pre-market regulatory oversight is not adequately aligned with the risk profile of regulated fertilizer and supplement products, and fertilizers and supplements with a well-established history of safe use continue to require registration prior to commercialization. This impedes access of Canadian agricultural producers, growers and consumers to safe fertilizers and supplements and results in delays in getting a product to market. In addition, there are inconsistencies in how similar products with equivalent risk profiles are regulated. These inconsistencies have resulted in an uneven playing field where certain domestic products require product registration while similar imported products do not. The Regulations are outdated and do not reflect modern science, advances in manufacturing practices, industry trends, international norms, or emerging risks. Furthermore, the Regulations lack flexibility and contain prescriptive requirements that add an unnecessary burden on regulated parties. Finally, the existing labelling requirements related to health and safety information are currently not in compliance with the Official Languages Act (OLA).

Description: To align pre-market regulatory oversight with the risk profile of the product and to facilitate market access for safe and innovative fertilizers and supplements, a revised scheme of exemptions from registration is proposed. Accordingly, low risk fertilizers and supplements would be subject to reduced regulatory scrutiny, while those with higher or unknown risks would be subject to registration (even if currently exempt). To support implementation, product proponents would be required to either prepare and keep records that demonstrate how the product meets the exemption criteria, or disclose this information on the product label. Certain definitions in the Regulations would also be amended, added, or removed to enable implementation of the revised exemption scheme.

Amendments are also proposed to clarify that both domestically produced and imported products intended for export or for manufacturing purposes would be exempt from all provisions of the Fertilizers Act and the Regulations. The exemption for fertilizers imported for personal use would be removed.

It is also proposed to streamline labelling requirements while requiring bilingual labelling of core product information (e.g. directions for use), as required under the OLA. Several administrative changes are proposed, including the following: removing the application form from the Regulations, extending the registration period from three to five years and repealing the Compendium of Fertilizer-Use Pesticides (CFUP). Moving forward, all fertilizers and supplements that are pesticides or that contain pesticides would have to conform to the provisions of the Pest Control Products Act (PCPA) with respect to human, animal or plant health, or the environment.

Cost-benefit statement: The proposed regulatory amendments would benefit consumers by reducing the risks of commercial fertilizers and supplements being contaminated with hazardous substances, safeguarding the food and feed production continuum, and protecting users, handlers and bystanders from the potential health hazards due to product exposure. The proposal would also benefit industry by supporting innovation, creating a more even playing field, extending the registration period from three to five years, and supporting future e-submissions. The proposed amendments would also protect environment and ecosystem health by focusing regulatory oversight on products with higher risk profiles.  There would be additional costs to industry to comply with the changes to the labelling and registration requirements.

All the costs and some of the benefits associated with the proposal were monetized. The present value (PV) over 10 years of estimated benefits was $1,260,664 ($179,490 annualized) and the estimated costs were $309,837 ($44,114 annualized). As the estimated benefits exceed the costs, the present value of an estimated net benefit was $950,827 ($135,376 annualized). Since the regulatory proposal is considered low impact, not all of the benefits were monetized.

“One-for-One” Rule and small business lens: The “One-for-One” Rule applies and the proposal is considered to be an “OUT.” The savings to industry because of the reduction in administrative burden is $30,107 annualized, or $251 per business.

The small business lens (SBL) also applies. A flexible implementation option would allow regulated parties to comply with either the current or the amended regulations for a period of three years. The choice of the flexible option over the initial option for regulatory implementation would increase annualized savings to industry by $18,982, or $164 per impacted small business.

Domestic and international coordination and cooperation: A review of frameworks and approaches in 30 other countries revealed that the Canadian approach to regulating fertilizers and supplements safety and labelling would be largely aligned with that of most jurisdictions around the world. The regulatory proposal would, however, introduce unique Canadian requirements for the mandatory information on a fertilizer or supplement label to appear in both official languages in accordance with the OLA.

The CFIA continues to cooperate with the Pest Management Regulatory Agency (PMRA) with respect to fertilizer-pesticide combinations and products with both pesticidal and supplemental properties. Products that are pesticides or that contain pesticides would have to conform to the provisions of the PCPA with respect to human, animal or plant health, or the environment.

Manufacture, use and disposal of fertilizers and supplements are regulated by provincial, territorial and municipal jurisdictions. Through provincial and municipal programs (recycling of containers and collection of residual products), the responsibility for environmental stewardship is placed on the manufacturers of the product. The Fertilizers Act and the Regulations operate independently of these programs; however, some provincial or municipal jurisdictions may reference the Regulations in their program design. The CFIA continues to support provincial jurisdictions to raise awareness of the regulatory proposal and the revised exemption scheme. The CFIA has also engaged the Canadian Council of Ministers of the Environment to highlight the proposed revisions to the exemption scheme as a key element that may influence provincial, territorial and municipal recycling program designs.

Background

Regulatory authority

Fertilizers (plant nutrients) and supplements (substances other than fertilizers that improve the physical condition of soils or aid crop yield) are regulated under the fertilizers regulatory framework. The Fertilizers Act and the Regulations require that all fertilizers and supplements that are imported into or sold in Canada be properly labelled and be safe with respect to human, animal or plant health, or the environment.

The key elements of the fertilizers regulatory framework include pre-market assessment and registration, as well as marketplace monitoring to verify product compliance with safety and labelling requirements. Under the current Regulations, some fertilizers (and most supplements) are subject to registration and require a comprehensive pre-market assessment prior to their import or sale in Canada. The pre-market assessments consist of detailed, science-based evaluations of product safety information and labelling. Evaluators use supporting information submitted by the applicant (or available in the public domain) to evaluate the safety of the product and its use with respect to human, animal or plant health, or the environment. Products that are exempt from registration are still subject to regulation and must meet all the prescribed requirements at the time of sale or import. The CFIA also monitors fertilizer and supplement products that are in the marketplace to verify their compliance with the prescribed standards. Products that are found to be non-compliant are subject to regulatory action, which may include product detention (stop sale) and, in some cases, prosecution (e.g., for repeat offenders as an escalating effort to curb behaviour).

The proper use and safe disposal of these products are controlled by provincial and municipal rules and regulations. The CFIA works together with other federal government departments and agencies such as the Pest Management Regulatory Agency (PMRA), Environment and Climate Change Canada and Health Canada, as well as municipalities, provinces, and territories to monitor and verify that all fertilizers and supplements meet science-based standards for safety.

Regulated products

The fertilizers framework covers a wide range of products sold for agricultural and specialty markets (the latter includes commercial applications such as nurseries, greenhouses, golf courses, as well as home and garden products). Regulated products consist of traditional nitrogen, phosphorus and potassium (N, P, and K) fertilizers, micronutrient fertilizers, plant growth regulators, microbial supplements, waste-derived materials (such as composts, municipal biosolids, paper sludges and digestates) used as recycled sources of plant nutrients, and organic matter.

In addition, fertilizer-pesticide combination products are regulated jointly by the CFIA and the PMRA. The PMRA reviews and, as appropriate, approves and registers pesticides under the provisions of the Pest Control Products Act (PCPA), including pesticides intended for use in combination with fertilizers. The CFIA uses the requirements outlined in the Compendium of Fertilizer-Use Pesticides (CFUP) to confirm compliance of fertilizer-pesticides with the PCPA prior to registration.

Effective January 1, 2013, the PMRA disallowed fertilizer-pesticide combination products intended for use on lawns (home and garden applications). However, fertilizer-pesticides intended for agricultural uses, as well as products consisting of a single active ingredient with both fertilizers and pesticidal properties (e.g. corn gluten meal and ferrous sulphate), are still allowed. Registrants of fertilizer-pesticides that are exempt from the PMRA prohibition are still required to obtain a “letter of no objection” from the PMRA to support registration under the Fertilizers Act to indicate ongoing compliance with the provisions of the PCPA with respect to human, animal or plant health, or the environment.

Industry profile

The regulated sector consists of manufacturers, distributors, wholesalers, retailers, importers and exporters of a wide range of fertilizers and supplements. The regulated sector consists of both well-established multinational corporations and small businesses.

As of December 2015, Canada had 271 establishments primarily engaged in fertilizer manufacturing; 185 establishments had employees and 50 reported having no employees. footnote 1 Nearly all of the establishments had fewer than 100 employees — there were only 11 medium and large establishments in the industry.

With respect to product use in Canada, in 2011, over 24 million hectares (69% of total Canadian crop farms) footnote 2 were treated with commercial fertilizers and over 2.7 million hectares were treated with manure. Agricultural producers spend more on fertilizers and supplements than any other agricultural input (seeds and pesticides combined).

Risks and emerging trends

The context in which fertilizers and supplements are manufactured and used is changing. The change is being driven by global demands for improved yields, a rapid pace of innovation in product development, improvements in manufacturing practices as well as growing pressures to recycle waste materials (waste diversion) as sources of plant nutrients and organic matter. To reduce costs of manufacturing and maximize profit margins, some companies are sourcing fertilizer materials, including micronutrients, from domestic industrial waste streams or from other countries with varying levels of regulatory oversight.

The increasing interest in recycling by-products, industrial and/or organic wastes for application as fertilizers and supplements (e.g. soil amendments) can result in benefits through the return of nutrients to soil and the subsequent improvement of its physical condition. However, the use of recycled by-products also presents new and emerging risks due to the potential presence of biological and chemical contaminants. Therefore, the benefits must be carefully balanced against any potential safety hazards associated with these materials. Given that concerns over human, animal or plant health or the environment can be effectively alleviated with adequate treatment, careful consideration of the sources of waste-derived materials and the level of processing and treatment used during their manufacture is essential in determining the risks.

In addition, the increasing frequency and volume of Internet shopping offers venues for consumers and home and garden enthusiasts to obtain products from around the world which, if not adequately regulated, increase the possibility of risk.

Innovative products and technologies (e.g. genetically modified microbial inoculants, signalling compounds, nanomaterials) are changing the market landscape for the fertilizers and supplements sectors. Innovative fertilizers and supplements can enhance agricultural and horticultural yields, allowing Canadian growers to stay competitive while meeting rising productivity demands. Although economically beneficial to the agricultural sector, the new level of complexity demands a continued focus on the safety of novel products and technologies.

Finally, there is increasing public focus on the protection of the environment. The food production continuum continues to challenge governments to strengthen their regulatory frameworks and to protect citizens from health threats associated with the food supply, and more broadly, protect the environment. This is done by promoting the use of sustainable agricultural practices.

Issues

In 2011, the CFIA initiated a review of its regulations for food safety, plant health and animal health to improve their consistency, reduce their complexity and strengthen consumer protection. Modernization of the Regulations is part of this multi-year initiative that is expected to increase responsiveness to industry changes, address gaps, weaknesses and inconsistencies, and provide clarity and flexibility to assist regulated parties in fulfilling their obligations. A comprehensive review of the fertilizers regulatory framework by the CFIA has identified the following deficiencies that need to be addressed to support effective and efficient regulatory controls:

Objectives

The objectives of the regulatory proposal are to

Description

The Regulations would be amended as follows.

Definitions/terminology

Certain product definitions would be amended, added, or repealed to align them with current science, industry trends, and international standards and to support the proposed revised exemption scheme. This would include the addition of definitions for “micronutrient,” “secondary nutrient” (English version), “active ingredient” and the removal of “lesser plant nutrient” (English version) and “specialty fertilizer.” The word “term” would also be introduced to align the language used in the Regulations with that of other international standards.

General exemptions from the fertilizers framework

The Regulations would be amended to clarify that the exemption from all provisions of the Fertilizers Act and its Regulations includes both products manufactured in Canada and imported products intended for export or manufacture; the proposed amendment would also remove the exemption for fertilizers imported for personal use. The Regulations would also be amended to clarify that the exemption for export from all provisions of the Fertilizers Act applies, with the exception of section 5.5, which allows for the issuance of an export certificate or other documentation to facilitate the export of any fertilizer or supplement.

Exemption from registration/pre-market assessments

It is proposed to expand the list of primary fertilizer and supplement materials that are exempt from registration and amend the material definitions and compositional criteria referenced there to reflect current science, modern product types, technologies and manufacturing processes. These fertilizers and supplements currently appear on Schedule II to the Regulations, but it is proposed to repeal that Schedule and instead incorporate by reference a technical document (called the List of Materials) containing the terms and definitions for primary fertilizer and supplement materials that would continue to be exempt. The CFIA has a rigorous and detailed scientific assessment framework and data requirements that must be met before a fertilizer or supplement material can be added to the List of Materials or its compositional criteria can be amended. This framework was developed in consultation with stakeholders during the technical review of the current Schedule II (initiated in 2011 and concluded in 2013). Following the technical review, the revised list of materials was expanded to 104 materials, up from 56 previously. Since 2013, there have been only minor revisions to the proposed list to better align definitions with Canada’s trading partners.

It is also proposed to amend other exemptions from registration (for products that will not be included in the List of Materials) in accordance with the risk profile of the fertilizer or supplement. Therefore, mixed fertilizers or supplements that do not contain substances that are produced by (or derived from) living organisms would continue to be exempt from registration. However,

Registration

Another proposal is to redefine major and minor amendments to registrations, which can range from simple label formatting changes to adding new use patterns or altering the composition of the product. While the current Regulations prescribe that no changes can be made to the product or its label without amending the registration accordingly, the distinction between what constitutes a major or minor amendment to product registrations is set out in the Canadian Food Inspection Agency Fees Notice (CFIA Fees Notice). It is proposed that the Regulations require re-registration if the change affects whether it is a fertilizer or supplement, or if it impacts its safety or use.

Labelling and record keeping requirements

It is proposed to repeal the prescriptive labelling requirements that do not directly impact the identity of the product as a fertilizer or supplement, its safety or use. In addition, it is proposed that where the Regulations require information to appear on the label of a fertilizer or supplement, the information would be required to be in both official languages. This change would be made because of the OLA requirement that information related to safety needs to be in both official languages.

This proposal also makes changes to the labelling requirements for growing media and seeds that contain or are treated with a registered or exempt fertilizer or supplement. The labels for these products do not have to include the directions of use for the fertilizer or supplement.

Some stakeholders raised concerns during consultations regarding the release of confidential proprietary information on product labels. In response to these concerns, the proposal would provide two options for compliance with the Regulations: labelling or record keeping. These options would only be available for those products that are mixtures of fertilizers and/or supplements that would be exempt from registration under paragraphs 3.1(1)(d) and 3.1(2)(b) of the Regulations.

Option 1

Under this option, the label of exempt products would include a listing of the ingredients that qualify the product for exemption from registration. Specifically,

Option 2

Under this option, producers of exempt products who do not wish to disclose the ingredients on the label would be required to prepare and keep records, for a rolling period of five years from the last point of import or packaging. The information contained in these records would need to substantiate the eligibility of the product for an exemption and would need to contain the same information as would be required on the label on each exempt product. Upon a request from CFIA officials, product producers would be required to produce these records and provide them to the CFIA in a format and timeframe specified by the CFIA officials.

The package label would also need to include a statement that the fertilizers or supplements in the mixture are registered or are exempt from registration.

Registration application form, Declaration of Resident Canadian Agent form, and registration period

Rather than the current prescriptive paper-based format for submitting registration applications (Schedule III of the current Regulations), it is proposed to move to a more flexible format that would support electronic processing of registration submissions in the future. Repealing this prescriptive application form would provide industry with greater flexibility, reduce costs and lessen administrative burden. In the proposed Regulations, the requirement to submit information for registration would be outcome based (i.e. the information would have to be sufficient to support the identity of the product as a fertilizer or supplement and to substantiate its safety). The format would be up to the discretion of the applicant as long as it meets the objective specified in the proposed Regulations. Guidance materials would be made available to assist applicants and prospective registrants in fulfilling this obligation. Similarly, the Declaration of Resident Canadian Agent form (Schedule IV) would be repealed. With these changes, the amended Regulations would no longer contain any schedules.

It is also proposed to extend the validity of the registration period from three to five years. This would result in less frequent re-registrations, thereby lowering administrative and compliance burden on regulated parties.

Fertilizer-pesticides and supplement-pesticides

All fertilizers and supplements that are, or contain pesticides, must comply with the provisions of the PCPA with respect to human, animal or plant health or the environment. It is proposed that the CFIA would require product proponents to provide proof of this compliance prior to registration under the Regulations. In addition, it is proposed that the CFUP would be repealed since it is no longer used.

Additional non-regulatory changes

The CFIA has been continuously modernizing its Fertilizer Program policies and requirements. This regulatory initiative represents an opportunity for the CFIA to make additional, more progressive changes to the program’s administration, including a further shift towards risk-based approaches.

To maximize the benefits of the proposed regulatory amendments, the CFIA is also proposing policy and administrative refinements of a non-regulatory nature to streamline the product registration process and reduce the burden on regulated parties. A fundamental component of these non-regulatory changes is the implementation of a risk-based tiered registration process.

Regulatory and non-regulatory options considered

Option 1: Maintain status quo — no change

The current regulatory framework consists of both registration (pre-market assessments) and marketplace monitoring of fertilizer/supplement products (post-market surveillance). In general, fertilizers and supplements require registration unless they are explicitly exempt in the Regulations. Therefore, there are a number of products (some fertilizers and most supplements) that are subject to registration and a comprehensive pre-market assessment prior to importation or sale in Canada.

The current Regulations are outdated, have been determined to be overly prescriptive in some areas, and not aligned with the risk profile of the regulated products. They also impose unnecessary regulatory burden on stakeholders (particularly those whose products are safe and have a well-established history of use and relevance in agricultural/farming practices).

Furthermore, some similar products are regulated inconsistently and the regulatory oversight is based on end-use and efficacy considerations as opposed to risk associated with the exposure patterns. In addition, several definitions in the current Regulations are not aligned with current science, industry trends, and international standards. Therefore, maintaining the Regulations in their current form is not considered an effective option to achieve the objectives and mandate of the CFIA or to support effective and efficient program delivery and administration.

Option 2: Risk-based approach (preferred option)

This option supports a risk-based regulatory model whereby products that are deemed safe and have a well-established history of use and marketplace acceptance are subject to reduced regulatory scrutiny. This option represents a blend of regulatory and non-regulatory changes and includes revising the list of products exempt from registration in the Regulations (regulatory amendment) and adopting a tiered assessment process (administered through policy) for products that are subject to mandatory registration.

The registration exemptions would focus on the nature of the material (i.e. product ingredients) rather than how the products are used (as is the case with the current Regulations). This model is anticipated to facilitate product approvals (new registrations and re-registrations) and ongoing compliance with safety requirements and standards. This option also reduces the number of products subject to rigorous requirements (comprehensive reviews) while still maintaining human, animal, or plant health and environmental protection objectives.

This is the preferred option as it would provide for a more flexible, efficient and risk-based regulatory framework. It would support innovation and facilitate access of Canadian farmers and consumers to safe fertilizers and supplements while protecting the health and safety of Canadians, the food and feed production continuum and the environment.

Benefits and costs

The cost-benefit analysis assessed the potential impacts (i.e. costs and benefits) representing the differences between the baseline scenario and the regulatory scenario. The baseline scenario describes the situation under the current federal regulatory framework. The regulatory scenario describes the future situation when the proposed changes to the Regulations come into force.

The detailed methodology, assumptions and descriptions have been fully documented in a cost-benefit analysis report which is available from the CFIA upon request. The key impacts are summarized below. Note that as the regulatory proposal is considered low impact, not all of the benefits were monetized.

Affected stakeholders

The stakeholders who would be impacted by the proposed Regulations are

Monetized benefits

Industry

Businesses with products requiring registration under the current regulation that would be exempted would save the application costs of product registration and re-registration. This includes avoidance of the following tasks: preparation and submission of required documentation, data validation, and record keeping.

The extension of the registration period from three years to five years would reduce the frequency with which applicants need to approach the CFIA and complete the tasks necessary to re-register their products.

Qualitative benefits

The proposed regulatory changes would lead to the following:

Industry

Canadians/consumers

Government

The CFIA anticipates that the above-mentioned efficiencies would improve the existing service delivery standards for registration applications (assuming the number of applications received annually does not fluctuate significantly from historical trends).

Monetized costs

Industry

Businesses with products exempt from registration under the current regulations would assume the incremental application costs of product registration and re-registration (tasks defined previously). In some infrequent cases, product safety data would also be required to support the application (e.g. analysis for trace metals, dioxins, furans, and pathogen indicators).

All impacted businesses would need to spend time to review the changes in the Regulations affecting their operations.

Methodology

Key overarching assumptions/sources

Key assumptions

Two small businesses (seven products footnote 3) would have to assume this cost. The cost to meet safety data requirements is $15,000 per product. footnote 4

The incremental labelling cost was estimated assuming $0.002 per $1 of annual revenue, footnote 5 average revenue of $1 million per small business footnote 6 and $32 million for medium/large business, footnote 7 and that four small businesses and two large businesses would carry this cost (given the three-year implementation option available).

The proposed Regulations would result in some products becoming exempt from registration, as well as some products requiring registration. Overall, there would be an estimated 61 fewer products to register and re-register over the 10-year period (i.e. 131 products that would not require registration, less 70 products that would require registration).

In addition, there would be 185 existing products estimated to require re-registration over the 10 years. By extending the registration period from 3 to 5 years, for each of these products, industry would avoid one re-registration over the 10 years (i.e. by reducing the frequency of re-registration from twice to once).

Other impacts/fees

For the 61 products noted above, industry would save the fees footnote 8 related to the registration and one re-registration over the 10-year period. For the 185 existing products noted above, industry would save the fees related to one re-registration. Based on the current fee schedule, the present value (PV) over 10 years of total savings to industry would be $82,850 ($11,796 annualized). Meanwhile, there would be a corresponding reduction in government revenues.

Note: The CFIA conducted consultations on a proposed restructuring of its cost recovery regime in 2017. During these consultations, it was noted that CFIA fees are currently well below the cost to deliver services. The CFIA is continuing to examine its cost recovery structure and will consult stakeholders again before any restructuring takes place. For the purpose of this cost-benefit analysis, the fees charged to the industry are assumed to reflect 10% of the government costs of providing the service to the industry. This implies that there would be resource savings for the Government (net of reduced revenues), which were estimated at PV over 10 years of $745,650 ($106,164 annualized).

Refer to the “‘One-for-One’ Rule” section for details on the administrative burden activities.

Estimated results

The results below reflect all monetized costs and some of the benefits that would be incurred by the fertilizer industry and the Government. All other benefits were presented qualitatively above.

The monetized benefit of the regulatory proposal is $1,260,664 over 10 years, or $179,490 annualized (Table 1). The estimated monetized cost is $309,837 over 10 years or $44,114 annualized (Table 2). The breakdown by cost and benefit category is also shown in the tables. The overall result is a net benefit of $950,827 in PV over 10 years or $135,376 annualized (Table 3).

Table 1: Benefits and savings (Can$, constant year 2012 prices, 2020 PV base year, 7% discount rate, 10-year period)

Benefits and Savings

Total (PV)

Annualized Value

Administrative cost savings for exemption from product registration

$121,919

$17,358

Administrative cost savings for extension of registration period

$310,245

$44,172

Registration and re-registration fees (savings to industry)

$82,850

$11,796

Registration and re-registration government resources
(savings to Government [CFIA]; net of reduced revenues)

$745,650

$106,164

Total monetized benefits

$1,260,664

$179,490

Table 2: Costs (Can$, constant year 2012 prices, 2020 PV base year, 7% discount rate, 10-year period)

Costs

Total (PV)

Annualized Value

Administrative cost of product registration and product safety data to support registration

$155,572

$22,150

Familiarization of regulatory changes

$14,576

$2,075

Labelling or record keeping: exemption from registration scheme

$3,690

$525

Labelling: bilingual

$136,000

$19,363

Total costs

$309,837

$44,114

Cost-benefit statement

Table 3: Cost-benefit statement table 1 note * (Can$, constant year 2012 prices, 2020 PV base year table 1 note **, 7% discount rate)

Costs, Benefits and Distribution

First Year

Final Year

Total (PV)

Annualized Value

Table 1 Notes

Table 1 Note *

Figures may not add up to totals due to rounding.

Return to table 1 note * referrer

Table 1 Note **

The analysis covered a 10-year time period starting in 2020.

Return to table 1 note ** referrer

A. Quantified impacts (in dollars)

Benefits

Fertilizer industry

$68,529

$37,275

$515,014

$73,326

 

Government

$99,218

$53,968

$745,650

106,164

Total benefits

$167,747

$91,243

$1,260,664

$179,490

Costs

Fertilizer industry

$8,669

$22,425

$309,837

$44,114

Total costs

$8,669

$22,425

$309,837

$44,114

Net benefit (benefits less costs)

$950,827

$135,376

B. Qualitative impacts

Positive impacts

Fertilizer industry

  • Supports innovation.
  • Extends registration validity to five years.
  • Aligns with modern science, and international standards.
  • Facilitates market access by reducing burden on low-risk, well-established products.
  • Creates level playing field for importers and domestic manufacturers.
  • More flexible application form that would support future E-submissions.

Consumers

  • Protects consumers by minimizing the risks of fertilizers and supplements contaminated with hazardous substances.
  • Safeguards the food and feed production continuum.
  • Strengthens the protection of users, handlers and bystanders from potential health hazards associated with exposure to the product.

Government

Focuses CFIA resources on high-risk products

  • More efficient use of CFIA resources (less time spent due to products becoming exempt and fewer re-registrations; additional time spent due to new product registrations).
  • Improves the existing service delivery standards for registration applications (assuming the number of applications received annually does not fluctuate significantly from historical trends).

“One-for-One” Rule

The “One-for-One” Rule applies and the proposed Regulations are considered an “OUT” because of the overall reduction of the administrative burden to industry stakeholders. The savings are $30,107 annualized or $251 per business.

Following the “One-for-One” Rule of the Treasury Board Secretariat of Canada (TBS), a 7% discount rate and 10-year forecast period for the valuation of INs and OUTs were used. The price base year is 2012 (all valuations were presented in constant dollar 2012 prices) and the present value base year for the valuation is 2012.

The assumptions used to calculate the administrative costs and benefits are presented below. Note that in all cases, the standard cost model was used, which takes into account the time required for individuals to perform a task, the individuals’ wage rate and how often the task must be performed. Further details are available in the cost-benefit analysis report, which is available upon request.

(a) Product registration and re-registration

Assumptions

The savings from the proposal to exempt additional products from registration and to extend the registration period from three to five years would exceed the potential increase in the administrative costs to register the additional products that are otherwise exempt under the current regulatory regime.

(b) Labelling or record keeping: exemption from registration scheme

Assumptions footnote 12

(c) Familiarization of regulatory requirements

Assumptions

The estimated annualized values of administrative impacts for the “One-for-One” Rule are presented in Table 4.

Table 4. Estimated annualized values of administrative impacts for the “One-for-One” Rule table 2 note * (Can$, constant year 2012 prices, 2012 PV base year table 2 note **, 7% discount rate)

Cost or Benefit Type

Task Description

Annualized Values

Table 2 Notes

Table 2 Note *

Figures may not add up to totals due to rounding.

Return to table 2 note * referrer

Table 2 Note **

The analysis covered a 10-year time period starting in 2020.

Return to table 2 note ** referrer

BENEFIT

Extension of registration period (labour)

Preparation and submission of registration and re-registration application

$13,606

Data validation

$15,659

Record keeping

$5,024

Other administrative tasks

$9,883

BENEFIT: Products exempted from registration (labour)

Preparation and submission of registration and re-registration application

$5,347

Data validation

$6,154

Record keeping

$1,974

Other administrative tasks

$3,884

COST: Products required to be registered (labour)

Preparation and submission of registration and re-registration application

$2,857

Data validation

$3,288

Record keeping

$1,055

COST: Familiarization of regulatory requirements

Familiarization/learning

$2,075

COST: Labelling exemption from registration (labour)

Record keeping

$475

Furnish copy of record to inspector

$50

Total annualized administrative impact on all businesses (OUT)

$30,107 table 2 note ** (in constant 2012 dollars, 2012 PV base year)

Estimated number of affected businesses

120

Average annualized administrative impact per affected business (OUT)

$251 table 2 note ** (in constant 2012 dollars, 2012 PV base year)

Small business lens

The small business lens (SBL) applies to this regulatory proposal because it would impact 116 small businesses in the fertilizers industry. Based on the TBS definition of small business (employer with fewer than 100 employees) and NAICS criteria, approximately 97% of businesses are small in the fertilizers industry. Small businesses would benefit from savings because of the proposed regulatory changes.

The SBL requires that two regulatory options for small business are assessed with one of the options being chosen for regulatory implementation. The estimation of small business costs and savings follows the TBS guideline.

1. Initial option

The initial option is the immediate enforcement of the proposed amendments to the Regulations for all-sized businesses (small, medium and large) and would require regulated parties to comply with the amended Regulations immediately.

The total savings under the proposed initial option is $102,717 (present value over 10 years, in 2012$) or $14,625 in annualized value. The average savings per small business would be $126.

2. Flexible option (recommended)

The flexible (recommended) option would allow regulated parties to comply with either the current or the amended Regulations for a period of three years, allowing impacted businesses to take immediate advantage of burden reductions offered by the regulatory amendments or wait and adjust to the new additional requirements.

The total savings under the flexible option is $236,045 (present value over 10 years) or $33,607 in annualized value. The average savings per small business is $290.

The choice of the flexible (recommended) option over the initial option would increase annualized savings to industry by $18,982. This corresponds to $164 per small business.

Table 5 presents the estimated savings to the industry for the flexible and initial options by impact category and cost description.

Table 5: Regulatory flexibility analysis statement (Can$, 2012$, 2020 PV base year, 7% discount rate)

 

Initial Option

Flexible Option

(Recommended)

Short description

Immediate Enforcement

Implementation over Three Years

Number of small businesses impacted

116

116

 

Annualized Value ($)

Present Value ($)

Annualized Value ($)

Present Value ($)

Compliance costs

$34,769

$244,200

$16,089

$113,000

Administrative savings

$49,393

$346,917

$49,696

$349,045

Total savings (all small businesses)

$14,625

$102,717

$33,607

$236,045

Total savings per impacted small business

$126

$885

$290

$2,035

Risk considerations

Small businesses may not be ready and the possibility of non-compliance is likely to be high

Compliance promotion negligible as small business would have additional time to be ready

Consultation

The regulatory modernization proposal was developed in consultation with the stakeholder community, namely the Canadian Fertilizer Products Forum (CFPF). The CFPF is a permanent consultative body for the fertilizers and supplements sectors.

In March 2012, a preliminary stakeholder panel meeting was held during which the modernization of the Fertilizers Program was discussed, leading to the establishment of four working groups to facilitate dialogue and provide CFIA with consensus-based recommendations. Each working group consisted of participants from various industry sectors, retail and wholesale chains, producer and farmer organizations, provincial ministries of the Environment, U.S. regulatory bodies and U.S.-based companies. The CFIA also co-hosted a regulatory workshop with the CFPF in October 2012 with close to 100 participants from government departments, industry associations and producers. At the workshop, the regulatory proposal was discussed in detail, and areas where consensus had not been reached were noted for further analysis.

Recommendations from the working groups, feedback from the October 2012 regulatory workshop and results of the environmental scans were used to revise the regulatory proposal that was published in July 2013 on the CFIA’s Internet site for public comments.

The CFIA held another regulatory workshop in October 2013 to further discuss stakeholders’ comments received as part of the face-to-face and web-based consultations, and to refine the proposal, as appropriate. Though stakeholders were generally supportive of the final proposal, a few members of the home and garden subsector continued to strongly oppose some elements. The stakeholders’ remaining concerns and the CFIA’s responses are outlined below:

  1. General exemptions. The proposal to clarify the general exemptions from all provisions of the Fertilizers Act and its Regulations for products manufactured domestically and imported, for manufacturing or export purposes, received support from the industry as it sees it as a means of levelling the playing field between imports and domestically produced products. However, some concerns were expressed that this exemption may facilitate “dumping” of hazardous waste in Canada, as it would allow companies to import material with impurities, process it and export a refined, clean product leaving the impurities in the country. In respect of the waste disposal as a result of manufacturing or processing, it is currently and will continue to be regulated by provincial and municipal jurisdictions.
  2. A few members of the home and garden subsector expressed concerns over the proposed registration of fertilizers containing unregistered micronutrients (such as NPK micronutrient blends). The concerns are centred around the added burden and costs this amendment would have on the home and garden subsector. The home and garden subsector is comparatively small, representing approximately 1% of total fertilizer use. The CFIA’s position is that this proposed amendment is primarily intended to eliminate the inconsistency with which like products are currently regulated. Specifically, domestically manufactured NPK micronutrient blends must use registered micronutrients, while products blended outside of Canada are exempt. This regulatory option has been used by some international and foreign companies to avoid premarket regulatory oversight. This has resulted in an uneven playing field between domestic versus imported products and is not consistent with a risk-based approach or focus on safety. Domestic exposure scenarios for the home and garden subsector are different than other specialty uses or the agricultural setting (lower volume of product used) but are not lacking risks (for example risks to children or pets playing on lawns or to people who consume food from home vegetable gardens where contaminated fertilizers have been applied). These may originate from contamination of the product with substances of toxicological concern or the inherent risk profile of the active ingredients themselves (e.g. boron, copper). Product registration allows the CFIA to assess the potential risks and adjust directions for use accordingly, thus providing the user or applicator with information that promotes safe use and minimizes exposure. The majority of micronutrients require registration under the current regime. Furthermore, mineral NPK blends containing registered micronutrients would continue to be exempt from registration. More generally, mixtures of ingredients that are registered or otherwise exempt from registration would be exempt irrespective of end-use pattern.
  3. The removal of the blanket exemption for specialty fertilizers was also met with some opposition. Specialty fertilizer markets include a wide range of commercial facilities such as nurseries, greenhouses, and golf courses, as well as the home and garden subsector. The CFIA’s position is that the current exemption represents another inconsistency in how products with similar risk profiles are regulated and is rooted in historical precedent stemming from efficacy and quality considerations (higher economic losses associated with poor performing products on farm versus specialty). As CFIA no longer regulates or verifies product efficacy, the removal of the delineation between farm and specialty uses is intended to eliminate this inconsistency and reflect the focus on safety only. It is considered to represent a risk-based approach, which aligns regulatory oversight with the risk profile of the ingredients and their sources and enhances consumer and applicator protection against potential safety risks. The exposure scenarios (e.g. worker exposure risks) in commercial specialty settings (e.g. greenhouses, nurseries, golf courses) are different from the home and garden or large-scale agricultural settings and need to be considered when registering the product prior to sale or import. For example, the risk of inhalation and dermal exposure in enclosed commercial facilities is higher than in open field crop production. The majority of low-risk fertilizers currently exempt from registration under the “specialty” provision would continue to be exempt (e.g. fertilizers that do not contain materials produced by or derived from living organisms).
  4. The proposed requirement to list the ingredients (and their sources) that qualify a product for exemption was met with the strongest opposition. According to stakeholder feedback, specifically the home and garden sector, it would introduce a significant burden and prohibitive incremental costs on regulated parties. In addition, concerns regarding the disclosure of proprietary or confidential business information (trade secrets) were expressed. In response to stakeholders’ concerns, the CFIA has adjusted the design of the proposed Regulations to offer an option to regulated parties to either list the ingredients on the label, as originally proposed, or prepare and keep records that contain the same information as would be required on the label substantiating that the product meets the exemption criteria.

    This approach would provide a flexible option for those businesses who opposed the proposal on the basis that proprietary information would be revealed on the label and for those stakeholders who had expressed concerns over perceived increased costs to revise labels.

    Finally, the CFIA would also highlight that businesses who do not wish to disclose the ingredients on the label or keep records may still register the final mixture as a separate product. Based on discussions with affected businesses, these alternatives would appear to largely alleviate the concerns of the stakeholders.

  5. The proposed labelling changes (including bilingual labelling of information related to health and safety, and streamlining the mandatory information on labels) received general support from industry. However, some industry members expressed concern over the feasibility of making all these label changes on small packages, and the additional (financial) burden that the proposed labelling changes would impose on businesses. Some stakeholders suggested that marketplace labels should be provided only at the end of the registration or product approval process and making text labels permissible before that point, which is in line with what the CFIA is proposing. However, in order to facilitate enforcement and ensure that consumers of fertilizer products are not misled as to the application of the product, a copy of the final marketplace label would be required at the final stage of registration. In order to register a product, the requirements of the Fertilizers Act and the Regulations must be met in respect of the product (including the product label), meaning that the CFIA can refuse to register a product if the label is not in compliance. The requirement to have health and safety-related information on labels in both English and French is necessary for compliance with the OLA and must be implemented. However, the CFIA is proposing a flexible implementation of the regulatory amendments — a three year period whereby the regulated parties can choose to comply with either the existing Regulations or the amended Regulations. This would provide industry with sufficient time to exhaust the existing product stock and make required changes to labels as part of its regular business cycle and product re-branding or take immediate advantage of the cost savings and burden reductions associated with the other regulatory provisions (for example additional exemptions from registration).
  6. Industry members were very supportive of the proposed additions to Schedule II of the Regulations (list of primary fertilizer and supplement materials exempt from registration) but have expressed concerns with the length of the process required to update the Schedule should it remain in the Regulations. To that effect, the CFIA is proposing to incorporate the List of Materials by reference into the Regulations based on the authorities granted by the Agricultural Growth Act, which received royal assent on February 25, 2015. As such, Schedule II would cease to exist as part of the Regulations and would be replaced by the List of Materials available on the CFIA website. This approach would facilitate more regular updates without a regulatory amendment process. These amendments and updates would be conducted in close consultation with stakeholders via established channels such as the CFPF and in accordance with the assessment framework developed during the 2011–2014 technical review of the Schedule. Incorporating the document by reference does not alter its intended objective (exemption from registration), nor does it alter the consultative process through which it would be amended.
  7. A question was raised by an Ontario provincial government representative with respect to the eligibility criteria for minor and major amendments to registrations and the non-notifiable category of label changes (non-regulatory change). It is proposed that the Regulations be amended to allow label and product formulation changes that do not impact the identity of the product as a fertilizer or supplement, its safety or use, to be made without CFIA pre-approval (non-notifiable category of changes). In addition, redefining major and minor amendments would further facilitate and expedite changes to product labels. The specific eligibility criteria for label changes that meet the definition of a minor or major amendment would not be prescribed in the amended Regulations but rather would be outlined in guidance materials and policy documents. The CFIA Fees Notice would also require changes to reflect the new definitions of major amendments (which would require detailed review) and minor amendments (which would be more streamlined and faster to process than major amendments).
  8. Some industry members, particularly those in the home and garden subsector, have indicated that requiring registration of products that are currently exempt under the Fertilizers Act will impose significant incremental costs associated with the requirements of provincial recycling programs. Through these provincial and municipal programs, responsibility for environmental stewardship is often placed on the manufacturers of the products and this may mean that a fertilizer or supplement manufacturer is responsible for paying eco-fees. The Fertilizers Act and its Regulations operate independently of these recycling programs; however, some provincial (for example the Stewardship Ontario program) or municipal jurisdictions may reference the Regulations in their recycling programs. The CFIA acknowledges that there may be indirect impacts in terms of how these products are treated under provincial recycling systems. While these programs are not under the CFIA’s jurisdiction, CFIA will commit to raising awareness with provincial authorities so that they can better understand how referencing these Regulations may impact their stakeholder communities.

The CFIA also consulted on the List of Materials, which will be incorporated by reference, through working group meetings that took place from 2012 to 2014. The results of these consultations were industry requesting more flexibility to add terms and definitions to the List of Materials through incorporation by reference. The List of Materials is aiming to align approved terms and definitions used by U.S. state officials. This being said, while most states focus on efficacy, product performance and guarantees, the Canadian system focuses on the safety of products.

Since 2013, CFIA has given annual updates at the CFPF annual meetings. The nature of these presentations has been to update the CFPF on the progress of the proposed fertilizers regulatory amendments. This has allowed the CFPF to stay current with the proposed regulatory amendments, timelines and any delays.

Provincial/territorial and municipal governments

Provincial and territorial levels of government have policies and programs related to fertilizer and supplement manufacture, use, safe disposal, and environmental stewardship. Some municipalities sell fertilizers and supplements derived from municipal and industrial wastes (including biosolids or processed sewage, paper sludge, compost). Several municipal waste processors register products with the CFIA.

A survey of municipal governments conducted by the CFIA in 2013 indicated that a majority of respondents do not anticipate that the proposed regulatory changes would have an impact on their operations, with a minority indicating it may be impacted to a small extent by proposed changes to product labelling or registration. The CFIA continues to work with provincial jurisdictions to assess the impacts of the regulatory changes on local regulations and requirements.

Regulatory cooperation

The CFIA conducted a scan of international jurisdictions and their approaches to the regulation of fertilizers and supplements, with a particular focus on (1) safety provisions and requirements; (2) labelling; and (3) product registrations and approvals.

The intent of the review was to determine the spectrum of regulations used internationally, the level of regulatory intervention employed by other federal and state regulatory bodies and how they compare to the regulatory framework in Canada. Only countries that have well-developed regulatory frameworks, including the United States, Australia, and the European Union were included in the analysis. In addition, as the United States regulates fertilizers at a state level, those states with a higher volume of sales (tonnage) and use of fertilizer products were chosen, while ensuring representative and balanced geographic distribution.

The review of 30 international frameworks and approaches revealed that the Canadian approach to regulating fertilizers and supplements safety and labelling is largely aligned with most jurisdictions around the world. Canada’s safety standards and precautionary statement requirements in particular are similar to those of the majority of other jurisdictions. Guaranteed analysis is required on product labels in the majority of other countries and states. Prescriptive labelling is common; however, mandatory disclosure of all ingredients on the label is rare. As in Canada, the majority of international regulatory bodies register fertilizers and supplements and monitor the marketplace for compliance with standards and requirements.

An evaluation of the impacts on imported products could not be completed, as the domestic programs of trading partner nations have a different focus than the safety focus of Canada’s Fertilizer Program. Fertilizers and supplements are not regulated at the federal level in the United States but rather at the state level. While Canada has some similar safety requirements to some states such as California, Washington and Oregon, many states in the United States do not focus on safety oversight. Internationally, fertilizer programs focus on verifying guaranteed product efficacy and some safety elements.

The regulatory proposal would introduce unique Canadian requirements for the core safety information to appear in both official languages on labels. While this bilingual labelling requirement promotes compliance with the OLA, it does not align with the United States or other jurisdictions. The proposed modernization of the Regulations would, however, maintain certain key product definitions, e.g. the definition of “major plant nutrient,” and provisions such as the mandatory guaranteed analysis section on labels, in accordance with international standards and norms.

The comprehensive review of Schedule II materials and their associated compositional criteria may be viewed as bringing the Regulations more in line with the Uniform Bill of the Association of American Plant Food Control Officials (AAPFCO) in the United States.

The CFIA consulted with other government departments on the development of these proposed amendments, especially with the PMRA with respect to how these proposed amendments would affect fertilizer-pesticide combination products and other dual property products (pesticide and supplement). Even though the proposal would repeal the CFUP from the Regulations, products that are or contain pesticides will continue to have to be compliant with the provisions of the PCPA with respect to human, animal or plant health or the environment and will require proof of conformance as a prerequisite of registration under the Fertilizers Act. In addition, non-compliance with the provisions of the PCPA with respect to human, animal or plant health or the environment will be grounds for refusal or cancellation of registration under the Fertilizers Act.

Rationale

The context in which fertilizers and supplements are manufactured and used is changing. The change is being driven by global demands for improved yields, a rapid pace of innovation in product development, improvements in manufacturing practices as well as growing pressures to recycle waste materials (waste diversion) as sources of plant nutrients and organic matter.

Innovative products and technologies (e.g. microbial inoculants, signalling compounds, nanomaterials) are also changing the market landscape for the fertilizers and supplements sectors. Innovative fertilizers and supplements can enhance agricultural and horticultural yields, allowing Canadian growers to stay competitive while meeting rising productivity demands. Although economically beneficial to the agricultural sector, the new level of complexity demands a continued focus on the safety of novel products and technologies.

In addition, the increasing frequency of Internet shopping offers venues for consumers and home and garden enthusiasts to obtain products from around the world, which, if not adequately regulated, increases the possibility of risk.

The proposed amendments to the Fertilizers Regulations would address the outdated nature of the regulations governing fertilizers and supplements imported into or sold in Canada in order to better reflect modern science, current manufacturing practices, industry trends, and address emerging risks associated with regulated products, and more effectively meet the CFIA’s mandate.

These regulatory amendments would also focus regulatory scrutiny on product safety. By shifting its focus, the CFIA is better positioned to address emerging risks such as contaminants (chemical and biological), poor sources of primary materials, waste diversion into fertilizer streams, and toxic residues in feed and food. The CFIA would also be positioned to contribute to addressing concerns over nutrient pollution, watershed contamination and eutrophication (oversupply of nutrients), which are often attributed to fertilizer use. The latter can impact the overall environmental sustainability of agricultural practices, which, in recent years, has become a significant preoccupation of regulatory jurisdictions both domestically and internationally. This approach would also increase consistency in approaches between regulatory bodies, such as the PMRA, in achieving broad Government of Canada environmental protection and sustainability objectives.

The regulatory and non-regulatory changes proposed would also offer an opportunity to shift towards risk-based approaches whereby regulatory intervention and level of pre-market oversight are commensurate with the risk profile and exposure pattern of regulated products.

Another key objective of the regulatory proposal is to lessen the administrative and compliance burden on regulated parties and reduce the prescriptiveness of the regulatory requirements that result from the current Regulations. The regulatory proposal would also increase international harmonization and alignment with other regulatory bodies and key trading partners.

The CFIA anticipates that the regulatory modernization of the Fertilizers Program, developed in consultation with stakeholders, would bring benefits to the fertilizers and supplements industry, regulated parties, small business owners, users, producers and consumers. The added flexibility is intended to support innovation, reduce the regulatory burden, and expedite time to market for safe fertilizers and supplements, thus facilitating farmers’ access to innovative agricultural inputs.

Implementation, enforcement, and service standards

In order to minimize the impact on industry, specifically to the operation of small business, a flexible option of a three-year implementation is proposed. In accordance with this proposal, the stakeholders would be able to comply with the current Regulations or the amended Regulations for a period of three years from the date of registration of the amended Regulations.

The CFIA Fees Notice would also require amendments to reflect the new definitions of major amendments (which would require a detailed review) and minor amendments (which would be more streamlined and faster to process than major amendments). Specific criteria would be suggested in guidance documents to assist applicants in understanding the eligibility criteria for minor and major amendments.

In addition to regulatory amendments, the CFIA would also implement additional policy and administrative refinements of a non-regulatory nature to streamline the product registration process and reduce the burden on regulated parties. A fundamental component of these non-regulatory changes would be the implementation of a risk-based, tiered registration process.

The categorization of products that require registration (i.e. that are not exempt in the Regulations [Tier I] into their respective assessment tiers [Tier II or III]) would be based on scientific criteria and a risk assessment of the product in question. This would include an evaluation of the safety of the ingredients (both active and inactive/inert), their sources, method of manufacture and, where applicable, results of analysis for biological and/or chemical contaminants and/or nutrient leaching potential into the environment.

The distinction between Tiers II and III would not be prescribed in the amended Regulations but would rather be administered through policy, allowing for changes and refinements as new science comes to light. Through this process, products that are deemed to pose lower risks would receive registration based on minimum evidence and data (Tier II). On the other hand, products that do not satisfy the Tier II criteria would be subject to a comprehensive (Tier III) review, which would require the submission of additional data and/or scientific rationales.

The CFIA has procedures in place (such as pre-submission consultations, industry guidance materials and the enquiry process) to assist applicants and prospective registrants in determining the level and extent of information that would be required to support the registration of their product. This model is anticipated to facilitate product approvals (new registrations and re-registrations) and ongoing compliance with safety requirements and standards.

As processes, procedures and policies associated with the delivery (post-market surveillance) of the Fertilizers Program are in place and are not fundamentally changing as a result of the proposed amendments, no incremental resources are anticipated to be required from the CFIA to implement the amended Regulations and to conduct the requisite marketplace monitoring activities. To enforce the proposed Regulations, the CFIA inspectors would verify that labels meet the requirements and unregistered products are in fact eligible for an exemption based on the listing of ingredients and their sources on the label or records provided by the product proponent. Streamlining labelling requirements would further facilitate marketplace label reviews.

The CFIA intends to update all of its internal guidance materials and provide training on the new requirements to operational staff during or prior to the implementation of the amended Regulations.

Product pre-market assessments and registration procedures would change moderately due to the new exemption scheme, modified labelling requirements and the tiered registration process. Where information that is available from a review or evaluation of a fertilizer or supplement conducted by a government of a foreign jurisdiction or international organization or association is provided with an application, it would be reviewed as part of the pre-market assessment and registration process. However, the required competencies for evaluators, including scientific knowledge and expertise, to complete the assessments would not change. The resource pressures and demands on the CFIA Fertilizer Safety Section may increase should the number of applications received annually by the CFIA grow substantially. With the removal of efficacy requirements in 2013, the complexity of submissions (multiple active ingredients) has already increased, and the CFIA is working to ensure that an adequate assessment capacity is in place and maintained to facilitate timely file reviews and consistent adherence to service delivery standards.

Since all regulated parties would have to demonstrate and provide proof of conformance of fertilizers and supplements that are or contain pesticides with the provisions of the Pest Control Products Act (PCPA) with respect to human, animal or plant health or the environment, the CFIA is working with the PMRA to develop processes and procedures with the objective that registrations can be issued without delay for all affected products to enhance consistency in regulatory approaches. Non-compliance with the provisions of the PCPA would serve as grounds for refusal or cancellation of registration under the Fertilizers Act under the new regime.

The CFIA has developed training materials for product producers and manufacturers to assist in preparing registration submissions. This training has already been delivered twice. Adjustments would be made to the training material to reflect the new amended requirements and it would be delivered to the stakeholders to ensure a smooth transition to the amended Regulations. Similarly, industry guidance materials (available on the CFIA website) would be amended to reflect the regulatory changes.

Service delivery standards for file review were implemented in 2009. These are of a maximum of three reviews whereby applicants have to address deficiencies identified during the review of the product information conducted by the CFIA. The timelines include CFIA review plus industry response time and vary depending on the complexity of the submission and its completeness. The submissions do not need to undergo all three reviews — if the application is complete and the product is deemed to meet the regulatory requirements for safety and labelling it can be issued registration after only one review (which significantly shortens the approval time required prior to entering the marketplace). The regulatory proposal is intended to facilitate the adherence to service delivery standards.

Regarding the proposed removal of Schedule II from the Regulations and its incorporation by reference into the Regulations, the CFIA has in place a rigorous and detailed scientific assessment framework and data requirements that must be met before a fertilizer or supplement material is added to the list or its compositional criteria can be amended. This framework was developed in consultation with stakeholders during the technical review of current Schedule II. The CFIA will continue working with stakeholders on improving the framework and would make the revised List of Materials available on its website in both official languages.

Contact

Dr. Ewa Madey
National Manager
Fertilizer Safety Section
Canadian Food Inspection Agency
Room 334 East, 2nd Floor
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9
Telephone: 613-773-7754
Fax: 613-773-7163
Email: cfia.fertilizermodernization-modernisationengrais.acia@canada.ca

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to subsection 5(1) footnote a of the Fertilizers Act footnote b, proposes to make the annexed Regulations Amending the Fertilizers 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 Dr. Ewa Madey, National Manager, Fertilizer Safety Section, Canadian Food Inspection Agency, Floor 2, Room 334 E, 59 Camelot Drive, Ottawa, Ontario K1A 0Y9 (tel.: 613-773-7754; fax: 613-773-7163; email: cfia.fertilizermodernization-modernisationengrais.acia@canada.ca).

Ottawa, November 29, 2018

Jurica Čapkun
Assistant Clerk of the Privy Council

Regulations Amending the Fertilizers Regulations

Amendments

1 The long title of the Fertilizers Regulations footnote 15 is replaced by the following:

Fertilizers Regulations

2 Section 1 of the Regulations and the heading before it are repealed.

3 (1) The definitions brand, Compendium of Fertilizer-Use Pesticides, Director, environment, farm fertilizer, fertilizer, mixed fertilizer, shipping bill, specialty fertilizer and supplement in subsection 2(1) of the Regulations are repealed.

(2) The definition lesser plant nutrient in subsection 2(1) of the English version of the Regulations is repealed.

(3) The definitions engrais préparé d’après la formule du client and pour cent in subsection 2(1) of the French version of the Regulations are repealed.

(4) The definitions fertilizer-pesticide, grade, organic matter and registrant in subsection 2(1) of the Regulations are replaced by the following:

(5) The definitions customer-formula fertilizer and per cent in subsection 2(1) of the English version of the Regulations are replaced by the following:

(6) The definition principe nutritif secondaire in subsection 2(1) of the French version of the Regulations is replaced by the following:

(7) Subsection 2(1) of the Regulations is amended by adding the following in alphabetical order:

(8) Subsection 2(1) of the English version of the Regulations is amended by adding the following in alphabetical order:

(9) Subsection 2(1) of the French version of the Regulations is amended by adding the following in alphabetical order:

4 The heading after section 2 of the Regulations is replaced by the following:

General Prohibition

2.1 A person shall not manufacture, sell, import or export any fertilizer or supplement that contains any substance or mixture of substances in quantities that, if the fertilizer or supplement is used according to its directions for use, present a risk of harm to human, animal or plant health or the environment (except pests).

5 Subsection 3(1) of the Regulations is replaced by the following:

3 (1) The following fertilizers and supplements are exempt from the application of the Act and these Regulations:

(1.1) A fertilizer or supplement, including one that is imported, that is not intended for sale or use in Canada and that is intended for export and labelled accordingly is exempt from the application of the Act, other than section 5.5, and the application of these Regulations.

6 Section 3.1 of the Regulations is replaced by the following:

3.1 (1) The following fertilizers are exempt from registration, if they do not contain seeds or growing media:

(2) The following supplements are exempt from registration, if they do not contain seeds or growing media:

(3) For the purposes of subsections (1) and (2), an inert ingredient is a substance that is not a fertilizer, supplement or pesticide and that is added to a fertilizer or supplement as a filler or to improve its physical characteristics such as sprayability or spreadability, but not to change its performance as a fertilizer or supplement, as the case may be.

(4) Despite subsections (1) and (2), a mixture of supplements or fertilizers that contain active ingredients which are viable microorganisms is not exempt from registration.

(5) Seeds that are treated with fertilizers, supplements or both are exempt from registration if each of those fertilizers and supplements

(6) A growing medium that contains fertilizers, supplements or both is exempt from registration if each of those fertilizers and supplements

7 (1) Subsections 5(2) and (3) of the Regulations are replaced by the following:

(2) Every application shall be made to the President of the Agency.

(3) Every application shall be accompanied by the following information with respect to the fertilizer or supplement to which the application relates:

(4) Every application in respect of a fertilizer-pesticide or supplement-pesticide shall be accompanied by

(2) Subsection 5(6) of the Regulations is replaced by the following:

(6) An applicant who is not resident in Canada shall

(3) Subsections 5(7) to (9) of the Regulations are replaced by the following:

(7) An application in respect of a fertilizer-pesticide or supplement-pesticide shall be refused if there are reasonable grounds to believe that the fertilizer-pesticide or supplement-pesticide is or contains a pesticide that does not comply with the provisions of the Pest Control Products Act or its regulations with respect to human, animal or plant health or the environment.

(8) The fertilizer or supplement shall be registered and a registration number shall be assigned to it if the President of the Agency’s evaluation of the application in respect of that fertilizer or supplement and of all information that is provided by the applicant or that is publicly available indicates that

(9) Every registration of a fertilizer or supplement expires at the end of the 60-month period that begins on the day on which a registration number is assigned to the fertilizer or supplement.

8 Sections 6 to 12 of the Regulations are replaced by the following:

7 A person shall not change the label, chemical composition or ingredients of a fertilizer or supplement that is registered, if the change could reasonably be expected to make it cease to be a fertilizer or a supplement, as the case may be, or to have an impact on its safety or its use, unless the registration is amended accordingly.

8 (1) Subject to subsection (4), the President of the Agency may cancel the registration of any fertilizer or supplement if he or she believes on reasonable grounds that, with respect to that fertilizer or supplement, any of the following are contravened:

(2) In deciding whether to cancel a registration in accordance with subsection (1), the President of the Agency shall take information related to the following factors into account:

(3) If the President of the Agency intends to cancel a registration, he or she shall forward to the registrant by registered mail a notice indicating that the registration is to be cancelled, along with the reasons for the proposed cancellation unless, within 30 days after the day on which the notice was mailed, the registrant notifies the President that they wish to have an opportunity to be heard in respect of the proposed cancellation.

(4) If the registrant notifies the President of the Agency that they wish to have an opportunity to be heard, the President shall notify the registrant by registered mail of the date and time of a hearing to determine whether the registration shall be cancelled and any details required to allow the registrant to participate. The hearing shall be held within 30 days after the day on which the President receives notice that the registrant wishes to have an opportunity to be heard.

(5) If a registrant fails to notify the President of the Agency that they wish to have an opportunity to be heard or fails to satisfy the President that the registration should not be cancelled, the President may cancel that registration.

Standards

9 For the purpose of paragraph 3(b) of the Act,

9 Section 15 of the Regulations and the heading after it are replaced by the following:

15 (1) The guaranteed analysis of a fertilizer or supplement shall include, if applicable,

(2) If subsection (1) requires the concentration of an active ingredient to be expressed in per cent, but the active ingredient is present in a concentration of less than 0.001%, the guaranteed analysis may instead indicate its concentration, on a per gram basis, using another unit of measure.

(3) In addition to the information required under subsection (1), the guaranteed analysis of a fertilizer-pesticide or supplement-pesticide shall include the concentration of each active ingredient, as defined in subsection 2(1) of the Pest Control Products Act, of the pesticide expressed in accordance with subparagraph 26(1)(h)(iii) of the Pest Control Products Regulations.

Labelling

15.1 Every person who packages, or causes to be packaged, a fertilizer or supplement or who imports a packaged fertilizer or supplement shall ensure that the package is labelled in accordance with sections 16 to 21.

10 (1) Subsections 16(1) to (3) of the Regulations are replaced by the following:

16 (1) Subject to section 17, a package containing a fertilizer, other than a customer-formula fertilizer, or a supplement shall be labelled with

(2) A fertilizer or supplement that is exempt from registration under subsection 3.1(5) or (6) shall also be labelled with the registration number of any registered fertilizer or registered supplement it contains.

(3) The information that is required under subsection (1) to be shown on a label of a registered fertilizer or supplement shall be consistent with the information provided with respect to that fertilizer or supplement that was evaluated in accordance with subsection 5(8).

(2) The portion of subsection 16(4) of the Regulations before paragraph (a) is replaced by the following:

(4) A package containing a customer-formula fertilizer that has intentionally incorporated in it, or is represented to contain, a pesticide or a micronutrient shall be labelled with

(3) Paragraphs 16(4)(b) and (c) of the Regulations are replaced by the following:

(4) Paragraph 16(4)(g) of the Regulations is replaced by the following:

(5) Subsection 16(4) of the Regulations is amended by striking out “and” at the end of paragraph (h) and by repealing paragraph (i).

(6) Subsections 16(5) and (6) of the Regulations are replaced by the following:

(5) A package containing a customer-formula fertilizer that does not have intentionally incorporated in it, and is not represented to contain, a pesticide or a micronutrient shall be labelled with

(6) If any person requests a document in English or French that lists the ingredients that are contained in a fertilizer or supplement that present a risk of harm to the health of any human or animal and that do not appear on the label, the document shall be provided by

(7) Subsection (1) does not apply to a package containing only peat, peat moss, sphagnum moss, coconut coir, tree bark, perlite or vermiculite, as those terms are defined in the List of Materials, or any combination of those materials, if the package is labelled with

11 Sections 18 and 19 of the Regulations are replaced by the following:

17 (1) Paragraphs 16(1)(d) and (k) do not apply if

(2) The person shall keep the record for at least five years beginning on the day on which the mixture was imported, packaged or caused to be packaged, at that person’s place of business in Canada or, if they do not have one, at another place of business in Canada, and inform the President of the Agency of the place where the record is located.

19 (1) All the information that is required by these Regulations to appear on a label shall be printed conspicuously, legibly and indelibly in English and French.

(2) The label of a fertilizer or supplement shall not have printed on it any incorrect or misleading information or symbol that could reasonably be expected to mislead a purchaser with respect to whether the labelled product is a fertilizer or a supplement, as the case may be, or to the safety, composition or directions for use of the fertilizer or supplement.

12 Section 20 of the Regulations is repealed.

13 (1) Subsection 21(1) of the Regulations is replaced by the following:

(2) Subsections 21(3) to (7) of the Regulations are replaced by the following:

14 The heading before section 22 and sections 22 and 23 of the Regulations are replaced by the following:

Analysis

15 (1) Subsection 24(2) of the Regulations is replaced by the following:

(2) Subsection 24(4) of the Regulations is replaced by the following:

16 Schedules II to IV to the Regulations are repealed.

Transitional Provisions

17 (1) In this section, former Regulations means the Fertilizers Regulations as they read immediately before the day on which these Regulations come into force.

(2) Nothing in these Regulations prohibits the manufacture, sale, import or export of fertilizers and supplements in accordance with the former Regulations.

(3) If a fertilizer or supplement is manufactured, imported or sold in accordance with the former Regulations and not in accordance with these Regulations, any subsequent sale or export of the fertilizer or supplement must be in accordance with the former Regulations.

(4) If a fertilizer or supplement is manufactured, imported or sold in accordance with these Regulations and not in accordance with the former Regulations, any subsequent sale or export of the fertilizer or supplement must be in accordance with these Regulations.

(5) Subsections (1) to (4) cease to have effect on the third anniversary of the day on which these Regulations come into force.

Coming into Force

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