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

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:

• 1. Outdated definitions. Product definitions and compositional criteria are outdated and no longer reflect modern science, advancements in manufacturing practices and processing standards, industry trends and product types. The most notable example is Schedule II in the current Regulations, which lists primary fertilizer and supplement materials that are exempt from registration. Maintaining a static list in regulation is not a suitable regulatory response given ongoing advances in science and technology. Further, the static nature of the schedule is likely to impose an additional burden on regulated parties, as primary fertilizer and supplement materials, which should otherwise be exempt from registration based on science, are not. If not addressed, the agricultural industry's access to safe products would be impeded.
• 2. Clarity in exemptions. There is an overall lack of clarity around the exemptions from all the provisions of the Fertilizers Act and its Regulations, particularly for imported products intended for export and those imported for manufacturing or further processing purposes and not for direct sale in Canada. This creates confusion among the regulated parties and presents challenges with respect to compliance actions. Also, the current Regulations contain an exemption for fertilizers imported for personal use [section 3(1)(f)] which is perceived as creating an uneven playing field for importers versus domestic manufacturers.
• 3. Inadequate alignment of regulatory oversight with risk profile of regulated products. The current pre-market regulatory oversight is not aligned with the risk profile of the product. Products with a well-established history of safe use continue to require registration prior to commercialization. This results in delays in getting products into the market and impedes access of Canadian agricultural producers and consumers to safe fertilizers and supplements. Furthermore, registration of low-risk products diverts CFIA resources from higher-risk areas and delays registration of innovative products.
• In addition, some product categories are regulated inconsistently. For example, micronutrient fertilizers require registration while micronutrient-NPK mixed fertilizers (NPK fertilizers — three-component fertilizers providing nitrogen, phosphorus, and potassium blended with micronutrients) have been considered to be exempt from registration. As a result, the NPK fertilizer mixtures when blended outside of Canada can be imported without registration. This inconsistency has been used by some industry members to avoid pre-market regulatory oversight. It also created a regulatory option that is only available to foreign manufacturers, thus disadvantaging domestic businesses versus international or foreign businesses with respect to the same type of product.
• Finally, the level of regulatory scrutiny varies depending on the use pattern; the majority of fertilizers intended for specialty markets (including nurseries, commercial greenhouse operations, golf courses as well as home and garden products) are exempt from registration. This is rooted in historical precedent that stems from efficacy (i.e. effectiveness) and product performance considerations (e.g. the potential for greater economic losses in agricultural settings than with specialty uses) rather than actual risks. As efficacy is no longer regulated by the CFIA, the Regulations need to be amended to reflect the focus on safety. Despite the smaller volumes of products used in specialty versus agricultural applications, the exposure scenarios are not lacking potential risks. These risks 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.
• 4. Registration period. In accordance with the current Regulations, products are registered for a three-year period. At that point applicants are required to apply for re-registration in order to continue selling the product in the marketplace (even if no changes have been made to the product during the registration period). The short registration period adds an unnecessary administrative and compliance burden on regulated parties. Similarly, any change to the product label or composition, even if minor (i.e. does not impact the safety of the product), must go through the registration approval process.
• 5. Prescriptive requirements. The format in which applicants are required to submit their requests for registration is highly prescriptive (Schedule III of the Regulations). Regulated parties must apply to re-register products every three years in order to continue to import or sell a product that has already been registered under the Fertilizers Act. The Regulations also require the submission of three copies of the marketplace label, which together with the paper format of the application form do not support an electronic interface with the stakeholder community.
• The labelling requirements in the Regulations are also highly prescriptive (e.g. weight declaration, placement, size) and do not directly impact the safe use of the product.
• 6. Fertilizer-pesticides — Compendium of Fertilizer-Use Pesticides (CFUP). Following the PMRA decision to disallow fertilizer-pesticide combination products intended for use on lawns (home and garden applications), the registration of all the affected fertilizer-pesticide combination products were cancelled by the CFIA. As a result, the utility of the CFUP is highly limited and therefore, it is proposed to be repealed from the Regulations.
• 7. Official Languages Act (OLA). The Regulations currently allow for labels to be in French or English or both. To comply with the OLA, the regulations must require that information related to health, safety or security on product labels be in both official languages.

Objectives

The objectives of the regulatory proposal are to

• Update product definitions and the compositional criteria of primary materials to bring these up to date with current science, industry trends and international standards. Incorporation by reference will be used to enable regular updates to the List of Materials as new information comes to light.
• Clarify the general exemptions from all provisions of the Fertilizers Act and its Regulations to facilitate the import of products intended for export or manufacturing purposes.
• Introduce a risk-based approach to support innovation and expedite time to market for safe fertilizers and supplements while maintaining high product safety standards. Regulatory intervention and oversight would be commensurate with the potential health and safety risks associated with the product and its use (revised exemptions from registration).
• Reduce the regulatory and administrative burden on regulated parties by streamlining the registration, re-registration and registration amendment process.
• Modernize labelling requirements to remove prescriptiveness and limit the mandatory label information. Health and safety information would be required to appear in both official languages.

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,

• products containing unregistered micronutrients alone or in combination with other nutrients, such as N, P and K irrespective of end-use (farm or specialty) would be subject to registration;
• the current exemption for specialty fertilizers would be removed (along with the definition of "specialty fertilizer") to eliminate inconsistency in how "like" products are regulated and to align pre-market regulatory oversight with the risk profile of the product and potential exposure;
• waste-derived materials used in fertilizers and supplements (including pH adjusters), other than those that appear on the proposed List of Materials (current Schedule II), would require registration to verify compliance with safety standards prior to reaching the marketplace; and
• fertilizers and supplements that are modified with an ingredient that is not a fertilizer or supplement (for example polymers, nanomaterials) would be exempt from registration only if
  • the ingredient is an inert ingredient (for the purposes of this proposal an inert ingredient is any substance that is not a fertilizer, supplement or pesticide and that is intentionally added to a fertilizer or supplement as a filler or to improve its physical characteristics, such as sprayability or spreadability, but not change its performance as a fertilizer or supplement); or
  • the ingredient is part of a registered fertilizer or a registered supplement that contains the same active ingredients in the same portions as the fertilizer or supplement.

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,

• the registration number of any registered product incorporated into the final product;
• the term for each component of the fertilizer or supplement, if any, that is on the List of Materials; and
• any other information necessary to show that the product meets an exemption under the proposed Regulations.

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

• Fertilizer and supplement manufacturers, importers and exporters;
• Fertilizer and supplement distributors and retailers;
• Government (Canadian Food Inspection Agency, Pest Management Regulatory Agency, Transport Canada, Global Affairs, Environment and Climate Change Canada and provincial and territorial governments); and
• Consumers.

Monetized benefits

Industry

• (a) Administrative cost savings for exemption from product registration

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.

• (b) Administrative cost savings for extension of the registration period

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

• Increased flexibility by implementing outcome-based provisions where appropriate (i.e. enabling efficiency). For example, the data and information required to support product registration would have to substantiate its safety, but the approach used would be up to the applicant.
• New opportunities to market products by only requiring core information on product labels and allowing for the use of more flexible formats (e.g. placement of information).
• Fewer registration amendments since they would no longer be required for changes to labels and product formulations that do not impact the safety of the product, its identity as a fertilizer or supplement, or its safe use. In addition, there would be expedited changes to product labels resulting from redefining major and minor amendments.
• The proposal, when combined with the program modernization (non-regulatory changes), would allow lower-risk fertilizers and supplements to be subject to reduced regulatory scrutiny to facilitate new product introduction into the marketplace. In addition, by expanding the List of Materials exempt from registration and allowing for combinations being exempt, the proposal would encourage fertilizer companies to venture into the creation of new and economically profitable products.
• A more level playing field for the fertilizer industry by eliminating the specialty fertilizer category. Micronutrients sold alone or in mixtures with other nutrients would now be required to be registered.
• Opportunities for reduced administrative burden through the availability of a more flexible registration application format that would support electronic submissions (versus the current, prescriptive paper-based format).
• Competitiveness of Canadian growers by allowing for innovative agricultural inputs that can enhance agricultural and horticultural yields. This, in turn, is anticipated to promote growth in the Canadian fertilizer and supplement industry.

Canadians/consumers

• Reducing the risk of fertilizers and supplements being contaminated with hazardous substances.
• Further safeguarding the food and feed production continuum from contamination risks (from farm gate to plate risk mitigation model).
• Strengthening the protection of users, handlers and bystanders from potential health hazards associated with exposure to the product.

Government

• Align CFIA regulatory oversight with the risk profile of the product (risk-based approach) and increase flexibility and responsiveness of the regulatory framework to industry needs.
• By exempting additional fertilizer and supplement materials from registration and introducing a tiered registration process, the CFIA anticipates a more efficient use of resources with a focus on higher-risk products.
• The proposed extension of the registration period from three years to five years would also result in fewer re-registrations annually, reducing resource demands on CFIA evaluators involved in pre-market assessments of these types of products.

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

• (a) Administrative cost for product registration

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).

• (b) Familiarization of regulatory requirements

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

• (c) Labelling
  • (i) Bilingual labelling
    • Businesses that are not in compliance with the bilingual labelling requirement would incur incremental costs (translation, printing) to change the label of packaged fertilizer or supplement products.
  • (ii) Labelling or record keeping: exemption from registration scheme
    • Option 2 (record keeping) was considered to be the least costly option for meeting the exemption. The additional costs to business of option 2 would depend on the number of impacted products, the time spent on preparing, keeping and furnishing the records, and the salary of the employee who would perform the task.

Methodology

Key overarching assumptions/sources

• The monetized costs and benefits were estimated over a period of 10 years starting in 2020.
• Because regulated parties would be allowed to comply with all of the current or the amended Regulations for a period of three years, the analysis assumes that business decisions would be determined by maximizing benefits and minimizing costs.
• Values are reported in 2012 prices, and were discounted to the base year (2020, the year of implementation) using a 7% discount rate.
• Sources included industry surveys (2012, 2013, 2015), CFIA data from the registered sector and North American Industry Classification System (NAICS) data.

Key assumptions

• Product safety data to support registration (cost)
  

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}

• Bilingual labelling (cost)

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).

• Product registration (benefit/cost) and re-registration (benefit)

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
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).
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

"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

• One hundred thirty-one (131) products currently registered would no longer require registration. ^{footnote 9}
• Seventy (70) products currently exempted would require registration.
• The time to perform the tasks is as follows: preparation and submission of required documentation (9.94 hours), data validation (11.44 hours) and record keeping (3.67 hours). ^{footnote 10}
• With the current three-year registration period, there are on average 185 new re-registrations. Based on survey data, the time to perform the re-registration tasks accounts for about 30% of the total time to register a product.
• Wage rate (including overhead) ^{footnote 11}
  • Senior management: $59.80/hour
  • Employee: $25.30/hour

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}

• The administrative time to keep the record is estimated at 0.25 hours per business.
• The administrative time to furnish a copy to an inspector is estimated at 0.05 hours per business.

(c) Familiarization of regulatory requirements

Assumptions

• Familiarization/learning of regulatory changes (7.22 hours) ^{footnote 13} — 50% of time spent by senior management and 50% spent by employees.
• Wage rate (including overhead):
  • Senior management: $59.80/hour ^{footnote 14}
  • Employee: $25.30/hour

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
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)
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

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)

Short description	Initial OptionImmediate Enforcement		Flexible Option (Recommended) 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:

• fertilizer-pesticide means a fertilizer that is or contains a pesticide; (engrais-antiparasitaire)
• grade means the amount of total nitrogen, available phosphoric acid and soluble potash in a fertilizer, expressed in per cent; (catégorie)
• organic matter means the matter remaining after removal of the moisture and total ash fractions from substances derived from living organisms; (matière organique)
• registrant means a person who has registered a fertilizer or supplement under these Regulations; (inscrit)

(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:

• customer-formula fertilizer means a fertilizer prepared in accordance with a written formula that sets out the name, amount and guaranteed analysis of each ingredient and the signature of the person for whose use for fertilizing purposes it has been prepared; (engrais préparé selon la formule du client)
• per cent means per cent by weight; (pourcentage)
  

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

• principe nutritif secondaire Calcium, magnésium ou soufre. (secondary nutrient)

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

• active ingredient means an ingredient of a fertilizer or supplement to which its performance as a fertilizer or supplement is attributed; (composant actif)
• List of Materials means the document entitled Primary Fertilizer and Supplement Materials prepared by the Agency and published on its website, as amended from time to time; (Liste des composants)
• lot number means a combination of letters or numbers or both that allows a lot of a fertilizer or a supplement to be traced in manufacture and distribution; (numéro de lot)
• micronutrient means boron, chlorine, copper, iron, manganese, molybdenum or zinc; (oligo-élément)
• micronutrient fertilizer means a fertilizer that is represented to contain a micronutrient; (engrais d'oligo-élément)
• pest has the same meaning as in subsection 2(1) of the Pest Control Products Act; (parasite)
• supplement-pesticide means a supplement that is or contains a pesticide; (supplément-antiparasitaire)

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

• secondary nutrient means calcium, magnesium or sulphur; (principe nutritif secondaire)

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

• engrais préparé selon la formule du client Engrais préparé selon une formule écrite qui précise le nom, la quantité et l'analyse garantie de chaque composant et qui porte la signature de la personne pour laquelle il a été préparé et qui doit l'utiliser aux fins de fertilisation. (customer-formula fertilizer)
• pourcentage Pourcentage, au poids. (per cent)

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:

• (a) manure that is sold in its natural condition and that conforms to the standard set out in paragraph 9(a), other than manure that is a fertilizer or supplement referred to in section 2.1; and
• (b) a fertilizer or supplement that is imported or manufactured in Canada that is used for manufacturing purposes only and that requires further treatment, other than mixing, blending, repackaging or application to seeds.

(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:

• (a) a fertilizer (in this paragraph referred to as the "product") unless it contains any of the following:
  • (i) a substance produced by or derived from a living organism,
  • (ii) a pesticide,
  • (iii) a supplement that is not registered and is not set out in the List of Materials,
  • (iv) a registered supplement, if the directions for use of the product are not consistent with those of the registered supplement,
  • (v) a micronutrient fertilizer that is not registered,
  • (vi) a registered micronutrient fertilizer, if the directions for use of the product are not consistent with those of the registered micronutrient fertilizer, and
  • (vii) an ingredient that is not a fertilizer or supplement, unless the ingredient is
    • (A) also an ingredient in a registered fertilizer that contains the same active ingredients in the same proportions as the product, or
    • (B) an inert ingredient;
• (b) a fertilizer that is set out in the List of Materials;
• (c) a customer-formula fertilizer; and
• (d) a fertilizer that consists solely of a mixture of fertilizers that are exempt from registration or are registered for the proposed use of the mixture.

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

• (a) a supplement set out in the List of Materials;
• (b) a supplement that consists solely of a mixture of supplements, if
  • (i) each supplement in the mixture is exempt from registration or is registered for the proposed use of the mixture, and
  • (ii) no more than one of the supplements in the mixture contains an active ingredient that is a viable microorganism; and
• (c) a supplement that is produced by combining either of the following with a supplement that is registered or that is exempt from registration:
  • (i) an ingredient that is not a supplement or pesticide and that is also an ingredient in a registered supplement that contains the same active ingredients in the same proportions as the supplement with which the ingredient is combined, or
  • (ii) an inert ingredient.

(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

• (a) is exempt from registration; or
• (b) is registered for use with those seeds.

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

• (a) is exempt from registration; or
• (b) is registered for use in growing media and its directions for use are consistent with those of the growing media.

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:

• (a) a copy of the label with which it is intended to be labelled in the marketplace; and
• (b) any other information that is sufficient to determine whether it is a fertilizer or a supplement and its composition and its safety.

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

• (a) information establishing that the fertilizer-pesticide or supplement-pesticide complies with the provisions of the Pest Control Products Act and its regulations with respect to human, animal or plant health or the environment; and
• (b) any decision the Minister of Health has issued under the Pest Control Products Act with respect to any components of the fertilizer-pesticide or supplement-pesticide that are pesticides.

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

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

• (a) provide the name and address of an agent or mandatary who resides in Canada to whom any notice or correspondence under the Act may be sent; and
• (b) inform the President of the Agency if there is a change of address or if the agent or mandatary ceases to represent the applicant.

(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

• (a) the application is in respect of a fertilizer or supplement that is not exempt from registration;
• (b) the fertilizer or supplement does not present a risk of harm to human, animal or plant health or the environment (except pests) if it is used in accordance with its directions for use or applied in commonly used amounts; and
• (c) the label with which the fertilizer or supplement is intended to be labelled in the marketplace meets the requirements set out in sections 16 to 21.

(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:

• (a) any of the provisions of the Act or these Regulations;
• (b) any of the provisions of the Health of Animals Act or of regulations made under that Act that refer to products of a rendering plant, animal by-products, animal food, animal products or manure; or
• (c) any of the provisions of the Pest Control Products Act or of regulations made under that Act with respect to human, animal or plant health or the environment.

(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:

• (a) whether cancellation of the registration is necessary in order to mitigate risk of harm to human, animal or plant health or the environment;
• (b) whether the cancellation is unnecessary because the contravention has been corrected or is expected to be corrected in a timely way without risk of harm to human, animal or plant health or the environment; and
• (c) whether there is a history of contravention of the provisions referred to in paragraphs (1)(a) to (c) in respect of the fertilizer or supplement.

(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,

• (a) a fertilizer or supplement shall not contain
  • (i) any substance or mixture of substances that would leave in the tissues of a plant a residue of a poisonous or harmful substance if the fertilizer or supplement is used as specified in its directions for use or applied in commonly used amounts,
  • (ii) except in accordance with a permit issued under section 160 of the Health of Animals Regulations for the purpose of section 6.4 of those Regulations, proteins derived from specified risk material, in any form, that was removed from the carcasses of cattle or that is contained in the carcasses of cattle that died or were condemned before they otherwise would have been slaughtered for human consumption as food, or
  • (iii) major plant nutrients, secondary nutrients or micronutrients that are present at toxic levels if the fertilizer or supplement is used as specified in its directions for use or applied in commonly used amounts;
• (b) a fertilizer-pesticide or supplement-pesticide shall not be nor contain a pesticide that does not comply with the requirements of the Pest Control Products Act in respect of the approved use and the application rate for that pesticide;
• (c) a fertilizer or supplement that is represented to be a fertilizer or supplement whose term is set out in the List of Materials shall meet the definition in that List that corresponds to that term; and
• (d) a fertilizer or supplement that is represented to contain a fertilizer or supplement whose term is set out in the List of Materials shall contain an ingredient that meets the definition in that List that corresponds to that term.

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,

• (a) the amount of total nitrogen, available phosphoric acid and soluble potash expressed in per cent;
• (b) the amount of each secondary nutrient, expressed in per cent on an elemental basis;
• (c) the amount of each micronutrient, expressed in per cent on an elemental basis;
• (d) in the case of a fertilizer that is represented as phosphatic fertilizer, the amount of total phosphoric acid expressed in per cent;
• (e) except in the circumstances in which paragraph (f) applies, the genus and species of each active ingredient that is a microorganism as well as the following information:
  • (i) for each microorganism that is a viable cell, the number of viable cells per gram of that microorganism, and
  • (ii) for each microorganism that is not a viable cell, another descriptor of the concentration of that microorganism on a per gram basis;
• (f) if the fertilizer or supplement contains an active ingredient that is a complex community of microorganisms that is taken from a single natural environment and whose composition is maintained without further manipulation, a descriptor of the concentration of viable microorganisms on a per gram basis;
• (g) if the fertilizer or supplement contains an active ingredient that is intended to neutralize acidity,
  • (i) the amount of calcium and magnesium, if any, expressed in per cent on an elemental basis,
  • (ii) its neutralizing value, expressed in per cent of the acid neutralizing capacity of calcium carbonate, and
  • (iii) the range of particle sizes of solid materials;
• (h) if the fertilizer or supplement contains an active ingredient that is an acidifying material intended to increase the hydrogen ion concentration of a growing medium, its acidifying value, expressed in per cent of the basic neutralizing capacity of hydrochloric acid;
• (i) in the case of a fertilizer or supplement that is represented to contain organic matter, the amount of organic matter expressed in per cent and the moisture content expressed in per cent; and
• (j) the amount of any other active ingredient expressed in per cent.

(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

• (a) the name and address of the manufacturer of the fertilizer or supplement or of the registrant or, in the case of a fertilizer or supplement that is not registered under these Regulations, the name and address of the person who packaged or caused the fertilizer or supplement to be packaged;
• (b) the name of the fertilizer or supplement;
• (c) if the fertilizer or supplement is registered, its registration number;
• (d) if the fertilizer or supplement is exempt from registration and contains one or more registered fertilizers or registered supplements, the registration number of each of those registered fertilizers or registered supplements;
• (e) unless the fertilizer or supplement is exempt from registration under subsection 3.1(5) or (6), its directions for use;
• (f) the weight of the fertilizer or supplement;
• (g) the guaranteed analysis;
• (h) a statement setting out any precaution that is necessary to mitigate a risk of harm to human, animal or plant health, or the environment (other than pests);
• (i) if the fertilizer or supplement is or contains prohibited material as defined in subsection 162(1) of the Health of Animals Regulations, statements that indicate that
  • (i) feeding the fertilizer or supplement to cattle, sheep, deer or other ruminants is prohibited and punishable under the Health of Animals Act,
  • (ii) the fertilizer or supplement is not to be used on pasture land or other grazing areas for ruminants,
  • (iii) the fertilizer or supplement is not to be ingested, and
  • (iv) a person must wash their hands after they use the fertilizer or supplement;
• (j) the lot number of the fertilizer or supplement; and
• (k) if the fertilizer or supplement is exempt from registration, the term for each component of the fertilizer or supplement, if any, that is set out in the List of Materials, and any other information that is sufficient to demonstrate that the fertilizer or supplement is exempt.

(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:

• (b) a statement setting out any precaution that is necessary to mitigate a risk of harm to human, animal or plant health, or the environment (other than pests);
• (c) the lot number of the fertilizer;

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

• (g) the name and address of the person who is to use the fertilizer; and

(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

• (a) the name and address of the manufacturer of the fertilizer and the name of the person who is to use the fertilizer;
• (b) a statement setting out any precaution that is necessary to mitigate a risk of harm to human, animal or plant health, or the environment;
• (c) the lot number of the fertilizer;
• (d) the guaranteed analysis; and
• (e) the weight of the lot or shipment.

(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

• (a) the person who packaged the fertilizer or supplement or caused it to be packaged; or
• (b) in the case of an imported fertilizer or supplement, the person who imported it.

(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

• (a) a statement indicating which of those materials are present in the fertilizer or supplement, and their proportions;
• (b) the name and address of the person who packaged the fertilizer or supplement or caused it to be packaged;
• (c) the name of the fertilizer or supplement;
• (d) the volume or the weight of the fertilizer or supplement;
• (e) the lot number of the fertilizer or supplement; and
• (f) a statement setting out any precaution that is necessary to mitigate a risk of harm to human, animal or plant health, or the environment.

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

• (a) the fertilizer or supplement consists of a mixture of fertilizers or supplements;
• (b) the package is labelled with a statement indicating that the fertilizers or supplements in the mixture are registered or are exempt from registration; and
• (c) the person who packaged the mixture or caused it to be packaged or, in the case of an imported mixture, the person who imported the mixture maintains a record, as a document in English or in French, that contains
  • (i) the registration number of each registered fertilizer and each registered supplement, if any, in the mixture; and
  • (ii) other information that demonstrates that the mixture is exempt from registration.

(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:

• 21 (1) Subject to subsection (5), the name of a fertilizer that contains any major plant nutrient shall include the grade designation in the manner required by subsection (3) in the order required by subsection (4).

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

• (3) A grade shall be stated as a hyphenated numerical series.
• (4) If a grade is used on the label of any fertilizer, the numerals shall represent guarantees expressed in per cent for total nitrogen, available phosphoric acid and soluble potash, listed in that order.
• (5) A fertilizer that is intended for daily feeding and that is not intended for further dilution is not required to have its grade stated as part of its name.

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

Analysis

• 23 A method of analysis that is used to test a fertilizer or supplement shall be specific to the purpose of the analysis, reliable and accurate.

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

• (2) If an article is detained under subsection (1), an inspector shall deliver or send to the owner or person in possession of the article a notice of detention.

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

• (4) If an article is released from detention, an inspector shall deliver or send to the owner or person in possession of the article a notice of release.

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.