Regulations Amending the Fertilizers Regulations: SOR/2020-232

Canada Gazette, Part II, Volume 154, Number 23

Registration
SOR/2020-232 October 26, 2020

FERTILIZERS ACT

P.C. 2020-825 October 23, 2020

Her Excellency the Governor General in Council, on the recommendation of the Minister of Agriculture and Agri-Food and the Minister of Health, pursuant to subsection 5(1)^{footnote a} of the Fertilizers Act^{footnote b}, makes the annexed Regulations Amending the Fertilizers Regulations.

Regulations Amending the Fertilizers Regulations

Amendments

1 The long title of the Fertilizers Regulations^{footnote 1} 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2 Section 1 of the Regulations and the heading before it are repealed.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, customer-formula fertilizer, 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mixed fertilizer, shipping bill, specialty fertilizer and supplement in subsection 2(1) of the Regulations are repealed.

(2) The definition lesser plant nutrient in subsection 2(1) of the English version of the Regulations is repealed.

(3) The definition pour cent in subsection 2(1) of the French version of the Regulations is repealed.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 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)

(6) 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)

customer formula fertilizer

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

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 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)

(7) 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)

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

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 present a risk of harm to human, animal or plant health or the environment, except pests, if the fertilizer or supplement is used according to its directions for use, or in amounts not in excess of the amount that is necessary to achieve its intended purposes.

5 (1) 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.

(2) Section 3 of the Regulations is amended by adding the following after subsection (2):

• (3) A fertilizer that is imported into or manufactured in Canada for experimental purposes and that is not a fertilizer-pesticide or a fertilizer that contains a supplement is exempt from the application of section 3 of the Act and of all provisions of these Regulations other than section 2.1, if the residual fertilizer and all plants that are grown in the course of the experiment are destroyed at the end of the experiment.

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 its directions for use are not consistent with those of the product,
  • (v) a micronutrient fertilizer that is not registered, and
  • (vi) a registered micronutrient fertilizer, if its directions for use are not consistent with those of the product;
• (b) a fertilizer that is set out in the List of Materials;
• (c) a customer formula fertilizer; and
• (d) a fertilizer whose active ingredients consist solely of a mixture of fertilizers or fertilizers and supplements, if those fertilizers and supplements 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; and
• (b) a supplement whose active ingredients consist 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) in the case of a mixture containing one or more viable microorganisms as active ingredients, the mixture is not further cultured or manipulated.

(3) 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.

(4) 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) the text that is to be included on the label of the fertilizer or supplement 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 as specified in its directions for use or in an amount that is not in excess of the amount that is necessary to achieve its intended purposes; 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 7 to 12 of the Regulations are replaced by the following:

7 A person shall not change the label, chemical composition or ingredients of a registered fertilizer or supplement if the change can reasonably be expected to affect its performance as a fertilizer or supplement, as the case may be, 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, if the fertilizer or supplement is used as specified in its directions for use or in an amount that is not in excess of the amount that is necessary to achieve its intended purposes, would leave in the tissues of a plant a residue of a poisonous or harmful substance,
  • (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 in an amount not in excess of the amount that is necessary to achieve its intended purposes;
• (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 minimum amount of total nitrogen, available phosphoric acid and soluble potash expressed in per cent;
• (b) the minimum 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 an untreated phosphatic fertilizer, the minimum amount of total phosphoric acid and the minimum amount of available 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 18, 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(3) or (4), 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(3) or (4) shall also be labelled with the registration number of any registered fertilizer or 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 supplement, and their proportions;
• (b) the name and address of the person who packaged the supplement or caused it to be packaged;
• (c) the name of the supplement;
• (d) the volume or the weight of the supplement;
• (e) the lot number of the 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:

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

• (a) the fertilizer or supplement consists of a mixture of fertilizers, a mixture of supplements or a mixture of fertilizers and 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) any information that the person has that relates to whether the mixture complies with these regulations with respect to its safety.

(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 with both versions being of equal prominence and in close proximity to each other.

(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.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issues

In 2011, CFIA initiated a review of its regulations for food safety, plant health and animal health to improve their consistency, reduce complexity and strengthen consumer protection. Modernization of the Fertilizers 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 fertilizer regulatory framework by CFIA identified the following deficiencies that needed to be addressed to support effective and efficient regulatory controls:

• 1. Outdated definitions. In the former Regulations, 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 former Regulations, which lists primary fertilizer and supplement materials that are exempt from registration. Maintaining a static list in the regulation is not a suitable regulatory response given ongoing advances in science and technology. Further, the static nature of the schedule is imposing additional burden on regulated parties, as primary fertilizer and supplement materials, that should otherwise be exempt from registration based on science, are not. If this is to remain unaddressed, the agricultural industry’s access to safe products will continue to 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 the 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 former Regulations contain an exemption for fertilizers imported for personal use (paragraph 3(1)(f)), which is perceived as creating an uneven playing field for importers versus domestic manufacturers. It also poses safety risks to the Canadian environment if imported products are contaminated with substances of concern (trace metals, pathogens, dioxins and furans, pesticide residues, etc.).
• 3. Inadequate alignment of oversight with risk profile of regulated products. The 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. Similarly, mixtures of fertilizer and supplement products require registration even if the individual components are exempt or registered. 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 micronutrients blended with nitrogen, phosphorus, and potassium are considered exempt from registration. As a result, micronutrients blended outside of Canada with even trace amounts of nitrogen, phosphorus, or potassium could be imported without registration. This inconsistency has been used by some industry members to avoid pre-market regulatory oversight. It also creates a regulatory option that is only available to foreign manufacturers, thus disadvantaging domestic 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 rather than actual risks. As fertilizer and supplement efficacy is no longer regulated by CFIA, the Regulations needed to be amended to reflect focus on product safety. Although used in smaller quantities, in comparison to commercial agricultural applications, specialty products still impose risks including potential contamination of the product with substances of toxicological concern or the inherent risk profile of the active ingredients themselves (e.g. boron, copper, etc.). Product registration allows CFIA to assess the potential product risks and adjust directions for safe use accordingly, thus providing the user or applicator with information that promotes safe use and minimizes exposure.
• 4. Registration period. In accordance with the former 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 amendment 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, etc.) and do not directly impact the safe use of the product.
• 6. Fertilizer-pesticides — Compendium of Fertilizer-Use Pesticides. Following PMRA’s decision to disallow fertilizer-pesticide combination products intended for use on lawns (home and garden applications), the registration of all the affected fertilizer-pesticides were cancelled by CFIA. As a result, the utility of the Compendium of Fertilizer-Use Pesticides is highly limited and thus, it will be repealed from the Regulations.
• 7. Official Languages Act. The former Regulations allow for labels to be in French or English or both. To comply with the Official Languages Act, the amended Regulations will require that information related to health, safety or security on product labels be in both official languages.
  • By addressing these issues through these regulatory amendments, the Government of Canada will support post-pandemic economic recovery by reducing administrative burden and supporting innovation.

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 fertilizer 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 and plant health, and the environment.

The key elements of the fertilizer regulatory framework include pre-market assessment and registration, as well as marketplace monitoring to verify product compliance with safety and labelling requirements. 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 and plant health, and 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. CFIA also monitors fertilizer and supplement products that are in the marketplace to verify their compliance with 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 in an escalating effort to incentivize good behaviour to promote compliance).

CFIA works together with other federal government departments and agencies, such as Health Canada, including its Pest Management Regulatory Agency, Environment and Climate Change 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 fertilizer 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; and waste-derived materials (such as composts, municipal biosolids, paper sludges, digestates, etc.), that are used as recycled sources of plant nutrients and organic matter.

In addition, fertilizer-pesticide combination products are regulated jointly by CFIA and PMRA. PMRA reviews and, as appropriate, approves and registers pesticides under the Pest Control Products Act, including pesticides intended for use in combination with fertilizers. CFIA uses the requirements outlined in the Compendium of Fertilizer-Use Pesticides to confirm compliance of fertilizer-pesticides with the Pest Control Products Act 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 fertilizer 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 Pest Control Products Act with respect to human, animal or plant health, or the environment.

Industry profile

The regulated parties include manufacturers, distributors, wholesalers, retailers, importers and exporters of a wide range of fertilizers and supplements. The 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 2} 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 3} 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 recycled plant nutrients and organic matter. In addition, climate change is driving the development of new product types and categories to offset and minimize nutrient pollution, eutrophication, greenhouse gas emissions and improve the overall sustainability of agricultural practices.

To reduce costs of manufacturing and maximize profit margins, some companies are also 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. As a result, the benefits must be carefully balanced against any potential safety hazards associated with these materials. Given concerns over human, animal or plant health 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.

Innovative products and technologies (e.g. genetic modification of plant growth-promoting microorganisms, gene editing, nanotechnology, synthetic biology, etc.) are changing the market landscape for the fertilizer and supplement 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, public focus on protection of the environment is growing rapidly, particularly with respect to climate change mitigation and adaptation efforts. 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 and the safe use of registered fertilizers.

Objective

The objectives of the regulatory amendments are to

• update product definitions and the compositional criteria of primary materials to bring them up to date with current science, industry trends and international standards;
• use incorporation by reference 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 the 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. Align regulatory intervention and oversight with the potential health and safety risks associated with the product and its use (revised exemptions from registration);
• reduce regulatory and administrative burden on regulated parties by streamlining the registration, re-registration and registration amendment process; and
• modernize labelling requirements to allow more flexibility and limit the mandatory label information. Health and safety information will have to appear in both official languages.

Description

The Regulations will be amended as follows.

Definitions/terminology

Certain product definitions will be amended, added or repealed to align them with current science, industry trends, international standards and to support the revised exemption scheme. For example, the definitions for “micronutrient,” “secondary nutrient” and “active ingredient” will be added, whereas the definitions for “lesser plant nutrient” and “specialty fertilizer” will be removed. There are other concepts, such as microbial consortia and inert ingredients, which will be incorporated into the Regulations.

General exemptions from the fertilizer framework

The Regulations will also be amended to clarify that the exemption from all provisions of the Fertilizers Act and the Regulations includes both products manufactured in Canada and those imported for export or manufacture. The amendments will also remove the exemption for fertilizers imported for personal use. Importation of fertilizers for experimental/research purposes will still be allowed as long as the product is not sold and all the plant material is safely disposed of so that it does not enter the food or feed chains. In addition, the Regulations will also be amended to clarify that the exemption for export from all provisions of the Fertilizers Act applies, except section 5.5, which allows for the issuance of an export certificate or other documentation to facilitate the export of any fertilizer or supplement on request of the applicant.

Exemption from registration/pre-market assessments

The List of Materials that are exempt from registration (Schedule II) will be expanded, and the material definitions and compositional criteria referenced therein will be amended to reflect current science, modern product types, technologies and manufacturing processes. Subsequently, the List of Materials will be incorporated by reference and will contain the terms and definitions for primary fertilizer and supplement materials that will continue to be exempt from registration. The current List of Materials in Schedule II of the Regulations will be repealed upon completion of the transition period. 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 former Schedule II (initiated in 2011 and concluded in 2013). Following the technical review, the revised List of Materials will be expanded to 104 materials, from 56 previously. Since 2013, there have been only minor revisions to the list to better align definitions with Canada’s trading partners.

Other exemptions from registration (for products that will not be included in the List of Materials) will be amended in accordance with the risk profile of the fertilizer or supplement. Therefore, fertilizers or supplements that do not contain substances that are produced by (or derived from) living organisms will continue to be exempted from registration. However,

• products containing unregistered micronutrients alone or in combination with other nutrients, such as nitrogen, phosphorus, and potassium, irrespective of end-use (farm or specialty), will be subject to mandatory registration;
• the current exemption for specialty fertilizers will 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; and
• waste-derived materials used in fertilizers and supplements (including pH adjusters), other than those that appear on the List of Materials (previously Schedule II), will require registration to verify compliance with safety standards prior to reaching the marketplace.

Registration

The former Regulations require that all registration amendments go through the review process by CFIA before the changes to the labels are made. These range from simple formatting changes, to adding new use patterns or altering the composition of the product. The distinction between what constitutes a major vs. minor amendment to product registrations is set out in the Canadian Food Inspection Agency Fees Notice (CFIA Fees Notice) rather than the former Fertilizers Regulations. The amended Regulations will require amending the registration(s) only if the change affects the product’s identity as a fertilizer or supplement, its safety or safe use.

Labelling and record-keeping requirements

The prescriptive labelling requirements that do not directly impact the identity of the product as a fertilizer or supplement, its safety or use will be repealed. In addition, where the Regulations require certain information to appear on the label of a fertilizer or supplement, the information will now be required in both official languages. This change is being made to meet the Official Languages Act requirement that information related to safety needs to be in both official languages.

These amendments will also make 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, but must identify the registration number of the fertilizer and supplement product included in the mixture. In addition, the use pattern of the growing medium or seed has to be consistent with those of the registered or exempt fertilizer or supplement. For example, a micronutrient fertilizer that is registered for use on turf only cannot be applied to seeds of food crops.

Some stakeholders raised concerns during early consultations regarding the release of confidential proprietary information on product labels. In response to these concerns, the amendments will provide two options to achieve compliance with the Regulations: through labelling or record keeping. These options will only be available for those products that are mixtures of fertilizers and/or supplements that are either registered for that purpose or otherwise exempted under paragraph 3.1(1)(d) and 3.1(2)(b) of the Regulations. The record-keeping option will not be applicable to seed or growing media containing fertilizers and supplements.

Option 1

Under this option, the label of exempt mixtures 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 mixture;
• the term for each component of the fertilizer or supplement if the ingredient is on the List of Materials; and
• any other information necessary to show that the product meets an exemption under the Regulations and complies with the safety requirements.

Option 2

Under this option, producers of exempt products, who do not wish to disclose the ingredients on the label, will be required to prepare and keep records for a rolling period of five years from the last point of import or packaging, and to inform the CFIA of the place where the record is located. The information contained in these records will need to substantiate the eligibility of the product for the exemption, and the overall compliance with the safety and labelling standards in the Regulations. The information in the records will need to contain the same information as would be required on the label on each exempt mixture. Upon a request from CFIA officials, product proponents will be required to produce these records and provide them to CFIA in a format and timeframe specified by CFIA officials.

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

The amendments will also extend the validity of the registration period from three to five years. This will result in fewer, 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, will continue to need to comply with the provisions of the Pest Control Products Act with respect to human, animal or plant health, or the environment. CFIA will require that product proponents provide proof of this compliance prior to registration under the Fertilizers Regulations. In addition, the reference to the Compendium of Fertilizer-Use Pesticides will be repealed, since its use has become highly limited.

Additional non-regulatory changes

CFIA has been continuously modernizing its Fertilizer Program policies and requirements. This regulatory initiative represents an opportunity for 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 regulatory amendments, CFIA will also make policy adjustments and administrative refinements of a non-regulatory nature to streamline the product registration process and reduce burden on regulated parties. A fundamental component of these non-regulatory changes is the implementation of a risk-based tiered registration process.

Regulatory development

Consultation

The regulatory modernization amendments were developed in consultation with the stakeholder community, namely the Canadian Fertilizer Products Forum. This forum is an industry consultative body for the fertilizers and supplements sectors.

In March 2012, a preliminary stakeholder panel meeting was held during which the modernization of the Fertilizer Program was launched, 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. CFIA also co-hosted a regulatory workshop with the Canadian Fertilizer Products Forum 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 CFIA’s website for public comments.

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 were addressed in 2015 before prepublication in the Canada Gazette, Part I.

CFIA also consulted on the List of Materials, which will be incorporated by reference, through working group meetings 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 aims 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 updates at the Canadian Fertilizer Products Forum annual meetings. The purpose of these presentations has been to update stakeholders on the progress of the proposed regulatory amendments. This has allowed the Canadian Fertilizer Products Forum to stay current with the proposed regulatory amendments, timelines and any delays on an annual basis.

Canada Gazette, Part I, consultation

The regulatory amendments to the Fertilizers Regulations were prepublished in the Canada Gazette, Part I, on December 8, 2018, for a 75-day consultation period. The comment period ended on February 21, 2019. CFIA also notified its international partners through a World Trade Organization notification to which no comments were received. In addition, CFIA held webinars to further explain the content and impacts of the proposed changes on the regulated sector. Over 170 participants attended the online sessions on February 7, 2019.

CFIA received 13 detailed submissions outlining questions and proposed adjustments to the regulatory text during the comment period. Submissions were received from

• national industry associations;
• producer organizations;
• individual fertilizer and supplement companies;
• municipal waste processing firms; and
• not-for-profit organizations.

Overall, the modernization of the Fertilizers Regulations and its underlying principles received strong support from all respondents. This included support for

• risk-based approaches and aligning pre-market assessment with the risk profile of the product;
• addressing inconsistencies and the way certain products with similar risk profiles are regulated;
• modernizing the Regulations to reflect industry trends and advances in manufacturing practices;
• taking emerging risks and regulatory trends in other jurisdictions into consideration; and
• creating outcome-based regulations and a less prescriptive approach for the regulated community.

Certain elements of the regulatory proposal were specifically well supported. This included

• extending the registration period from three to five years;
• transitioning Schedule II to the List of Materials incorporated by reference;
• requiring amendments to product registrations and CFIA approval only if the change affects the product’s identity as a fertilizer or supplement, its safety or safe use, thus creating a non-notifiable category of label changes;
• flexible labelling and record-keeping requirements; and
• less prescriptive application format to support electronic submissions and adoption of risk-based approaches to safety evaluations.

Two specific elements of the regulatory proposal were met with strong opposition:

• (1) Guaranteeing the actual content of nutrients including macronutrients (nitrogen [N], phosphorus [P], and potassium [K]) and secondary nutrients (calcium [Ca], magnesium [Mg], and sulphur [S]) instead of the minimum level.
• Stakeholders responded negatively to the Canada Gazette, Part I, proposal that major and secondary nutrients be guaranteed on an actual basis (rather than on a minimum basis). CFIA considered the issues raised by stakeholders and reviewed international norms surrounding the proposal for guaranteed analyses on fertilizer labels. In addition, the CFIA looked at alternative means of delivering its environmental protection mandate. CFIA determined that guaranteeing macro- and lesser nutrients on a minimum basis (except micronutrients) is an acceptable alternative option as long as the nutrient content in the product does not exceed upper limits that pose environmental safety risks associated with potential over-application and nutrient leaching. The option to revert to the current Regulations, by guaranteeing macro- and less nutrients on a minimum basis was chosen in order to effectively address feasibility irritants identified by the industry respondents while respecting CFIA’s safety mandate.
• (2) Limitations on including multiple microbial products in mixtures of registered or exempt fertilizers or supplements. The regulatory proposal that was prepublished in the Canada Gazette, Part I, called for mandatory registration and pre-market assessment for all mixtures containing more than one microbial inoculant even if the inoculant itself was already registered for that use (i.e. for the purpose of using it in the mixture). This was identified as a significant barrier to innovation and an unnecessary burden to industry, especially if the microbial inoculant is already registered and has been assessed for safety.
• CFIA considered its approach and the amended Regulations will permit the use of multiple products containing viable microorganisms in exempt or registered fertilizers and supplements only if each supplement is
  • (a) exempt from registration or is registered for the proposed use of the mixture which means that the directions for use (e.g. food vs. non-food crops) must be consistent; and
  • (b) the mixture is not further cultured and manipulated. This is intended to minimize contamination and the introduction of new safety risks once the mixture is generated/manufactured.

Some elements, such as replacing registration numbers on mixtures with a record-keeping option, were met with mixed reactions from a selected group of stakeholders. However, that option was introduced specifically to alleviate concerns raised by the home and garden sector with respect to feasibility of implementation, maintaining the confidentiality of proprietary information, and the cost and burden associated with the label requirements. As the record-keeping option provides flexibility to regulated parties, it also offers CFIA the ability to verify compliance with the provisions in the Regulations.

There were also some comments regarding clarity of language and definitions. CFIA considered all input in revising the Regulations and adjusted the text wherever it was appropriate or needed.

Provincial, territorial and municipal governments

Provincial and territorial levels of government have policies and programs related to fertilizer and supplement manufacture, safe 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, composts, etc.). Several municipal waste processors register products with the CFIA.

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

Post-pandemic engagement

In the summer of 2020, industry stakeholders continued to strongly support this initiative because of its contribution to economic recovery by

• reducing the burden on the fertilizer and supplement industry;
• facilitating access to safe fertilizers and supplements for Canadian farmers and consumers; and
• supporting innovation.

Expressed support for this initiative, and urgency for moving forward was received from a cross section of the fertilizer and supplement sector, including the majority of the main fertilizer companies in Canada. CFIA therefore continues to be confident that there is broad support to move forward quickly with this initiative.

Instrument choice

Option 1: Maintain status quo — no change

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

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

Option 2: Risk-based approach (chosen 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 will be 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 amendments) and adopting a tiered assessment process (administered through policy) for products that are subject to mandatory registration.

The registration exemptions will focus on the nature of the material (i.e. product ingredients) rather than how the products are used (as is the case with the former Regulations). This model is anticipated to facilitate product approvals (new registrations and re-registrations) and improve 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 chosen option as it will provide for a more flexible, efficient and risk-based regulatory framework. It supports innovation and facilitates 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.

Regulatory analysis

Benefits and costs

The cost-benefit analysis assessed the potential impacts (i.e. costs and benefits) representing the differences between the baseline and the regulatory scenario. The baseline scenario describes the situation under the former federal regulatory framework. The regulatory scenario describes the future situation when 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 CFIA upon request. The key impacts are summarized below. Note that as the regulatory amendments are considered low impact, not all of the benefits were monetized.

Affected stakeholders

The stakeholders impacted by the Regulations are

• the fertilizer industry:
  • fertilizer and supplement manufacturers, importers and exporters; and
  • fertilizer and supplement distributors and retailers;
• the government (Canadian Food Inspection Agency, Pest Management Regulatory Agency, Transport Canada, Global Affairs Canada, Environment and Climate Change Canada and provincial, territorial and municipal governments); and
• consumers, growers and farmers.

Monetized benefits

Industry

(a) Administrative cost savings from exemption from product registration

Stakeholders who will be exempted from product registration will 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 from extension of the registration period

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

Qualitative benefits

Industry

• Increased flexibility by implementing outcome-based provisions where appropriate (i.e. enabling efficiencies). For example, the data and information required to support product registration will have to substantiate its identity as a fertilizer or supplement and its safety, but the approach utilized will 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 it will not be required to obtain prior approval from CFIA 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.
• The regulatory amendments, when combined with CFIA program modernization (i.e. non-regulatory changes), will reduce regulatory scrutiny for lower risk fertilizers and supplements and facilitate new product introduction into the marketplace. In addition, by expanding the List of Materials exempt from registration and allowing for combinations being exempt, fertilizer companies will be able to venture into the creation of new and economically profitable products.
• Eliminating the specialty fertilizer category will result in a more level playing field for the fertilizer industry. Micronutrients sold alone or in mixtures with other nutrients will now require registration. Under the previous regime, micronutrient fertilizers required registration, while macronutrient — nitrogen (N), phosphorus (P) and potassium (K) [NPK] — blends were exempt. This has created an uneven playing field that disadvantaged the domestic industry. With the regulatory change, there will be no specialty fertilizer category, and micronutrients sold alone or in mixtures with other nutrients will require registration.
• Opportunities for reduced administrative burden through the availability of a more flexible registration application format which will support electronic submissions (versus the previous prescriptive paper-based format).
• Increased 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

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

Government

• Align CFIA’s regulatory oversight with the risk profile of the product (i.e. risk-based approach) and increased 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, 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 will also result in fewer re-registrations annually, reducing resource demands on CFIA evaluators involved in pre-market assessments of these types of products.

Monetized costs

Industry

• (a) Administrative cost for product registration
• Businesses with products subject to registration will incur the application costs of product registration and re-registration (tasks defined previously). In most cases, product safety data will also be required to support the application (e.g. analysis for trace metals, dioxins and furans, and pathogen indicators), but extensive or comprehensive reviews (level III assessments) will only be applicable to higher- or unknown risk profile products.
• (b) Familiarization with information obligations
• All impacted businesses will have 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 will incur incremental costs (translation, printing) to change the label of packaged fertilizer or supplement products.
  • (ii) Labelling or record keeping: exemption from registration scheme
  • Record keeping is less costly than labelling and assumed to be the choice of businesses for meeting the exemption. The additional costs to business associated with record keeping will depend on the number of impacted products, time spent on preparing, keeping and furnishing the records, and the salary of the employee who will 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 will be allowed to comply with all of the former or the amended Regulations for a period of three years, the analysis assumed that business decisions will 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.
• Data sources included
  • industry surveys conducted in 2012, 2013 2015;
  • CFIA data from the registered sector; and
  • North American Industry Classification System (NAICS).

Additional assumptions

• Product safety data to support registration (cost)

Seven products^{footnote 4} from two small businesses will incur this cost. The cost to meet safety data requirements is $15,000 per product.^{footnote 5}

• Bilingual labelling (cost)

The incremental labelling cost was estimated assuming $0.002 per $1 of annual revenue,^{footnote 6} average revenue of $1 million per small business^{footnote 7} and $32 million for medium/large business.^{footnote 8} Four small businesses and two large businesses will incur this cost (given the three-year implementation option available to regulated parties).

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

The regulatory amendments will result in some products becoming exempt from registration while other products will require registration. Overall, there will be an estimated 61 fewer products to register and re-register over the 10-year period (i.e. 131 products that will not require registration less 70 products that will require registration).

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

Other impacts/fees

For the 61 products noted above, industry will save the fees^{footnote 9} related to both the registration and one re-registration over the 10-year period. For the 185 existing products noted above, industry will save the fees related to one re-registration. Based on the current fee schedule, the present value over 10 years of total savings to industry will be $82,850 ($11,796 annualized). Meanwhile, there will be a corresponding reduction in government revenues, as the fees are simply transfer payments from one party to another.

Note: CFIA consulted on a proposed restructuring of its cost recovery regime in 2017. During this consultation, it was noted that CFIA fees are currently well below the cost to deliver services. 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 will be resource savings for the government (i.e. net of reduced revenues), which were estimated at a 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.

Cost-benefit statement

Number of years: 10 (2020 to 2029)
Base year for costing: 2012
Present value base year: 2020
Discount rate: 7%

The results below reflect all monetized costs and some of the benefits that will be incurred by the fertilizers industry and the Government. All other benefits are presented under the “Qualitative impacts” section.

The estimated monetized cost of the regulatory amendments is $309,837 (present value) over 10 years or $44,114 annualized (Table 1) while the monetized benefit is estimated at a present value of $1,260,664 over 10 years or $179,490 annualized (Table 2). The net present value is therefore estimated at $950,827 over 10 years or $135,376 annualized (Table 3).

Table 1. Monetized costs (in Canadian dollars)

Impacted Stakeholder	Description of Cost	Base Year (2020)	Year 4 (2023)	Final Year (2029)	Total (Present Value)	Annualized Value
Industry	Product registration and product safety data to support registration	$6,729	$16,898	$11,260	$155,572	$22,150
	Familiarization of information obligations	$1,940	$1,583	$1,055	$14,576	$2,075
	Labelling or record keeping: exemption from registration scheme	0	$401	$267	$3,690	$525
	Label change to meet bilingual requirement	0	$14,772	$9,843	$136,000	$19,363
All stakeholders	Total costs	$8,669	$33,654	$22,425	$309,837	$44,114

Table 2. Monetized benefits (in Canadian dollars)

Impacted Stakeholder	Description of Benefit	Base Year (2020)	Year 4 (2023)	Final Year (2029)	Total (Present Value)	Annualized Value
Government	Registration and re-registration government resources (savings to government [CFIA]; net of reduced revenues)	$99,218	$80,992	$53,968	$745,650	$106,164
Industry	Cost savings from exemption from product registration	$16,223	$13,243	$8,824	$121,919	$17,358
	Cost savings from extension of registration period	$41,282	$33,699	$22,455	$310,245	$44,172
	Registration and re-registration fees (savings)	$11,024	$8,999	$5,996	$82,850	$11,796
	Industry benefits	$68,529	$55,940	$37,275	$515,014	$73,326
All stakeholders	Total benefits	$167,747	$136,932	$91,243	$1,260,664	$179,490

Table 3. Summary of monetized costs and benefits (in Canadian dollars)

Impacts	Base Year (2020)	Year 4 (2023)	Final Year (2029)	Total (Present Value)	Annualized Value
Total costs	$8,669	$33,654	$22,425	$309,837	$44,114
Total benefits	$167,747	$136,932	$91,243	$1,260,664	$179,490
NET IMPACT				$950,827	$135,376

Qualitative impacts

Positive impacts and impacted stakeholders

Fertilizers industry

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

Canadian 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

• Allows for the focus of 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).

Small business lens

The small business lens applies because it will impact 116 small businesses in the fertilizers industry. Based on the Treasury Board Secretariat of Canada (TBS) definition of small business (employer with less than 100 employees) and the North American Industry Classification System criteria, approximately 97% of businesses are small in the fertilizers industry. The regulatory amendments will provide regulated parties three years to comply with the requirements.

The total present value of costs to small businesses is $113,000 (Table 4) over 10 years. The total present value of benefits is $349,045 (Table 5) over 10 years, resulting in a net benefit (i.e. benefits minus costs) of $236,045 (Table 6). This corresponds to an annualized average net benefit per impacted small business of $290. In addition, there are qualitative benefits to small business such as innovation opportunities.

Small business lens summary

• Number of small businesses impacted: 116
• Number of years: 10 (2020 to 2029)
• Base year for costing: 2012
• Present value base year: 2020
• Discount rate: 7%

Table 4. Compliance costs, in Canadian dollars

Activity	Annualized Value	Present Value
Labelling	$16,089	$113,000
Total compliance cost	$16,089	$113,000

Table 5. Administrative benefits, in Canadian dollars

Activity	Annualized Value	Present Value
Registration and re-registration application	$15,465	$108,613
Data validation	$17,798	$125,005
Record keeping	$5,201	$36,534
Other administrative tasks	$11,232	$78,893
Total administrative benefit	$49,696	$349,045

Table 6. Total compliance and administrative benefits, in Canadian dollars

Totals	Annualized Value	Present Value
Net benefit (all impacted small businesses)	$33,607	$236,045
Benefit per impacted small business	$290	$2,035

One-for-one rule

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

Following the one-for-one rule TBS guidelines, 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 associated cost of labour (wage and overhead), the number of business required to perform the task, and how often the task must be performed. Further details are 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 will no longer require registration.^{footnote 4}
• Seventy (70) products currently exempted will be required to be registered.
• The time to perform the tasks includes preparation and submission of required documentation (9.94 hours), data validation (11.44 hours) and record keeping (3.67 hours).^{footnote 10}
• With the previous 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

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 provide a copy to an inspector is estimated at 0.05 hours per business.

c. Familiarization of information obligations

Assumptions

• Familiarization/learning of information obligations because of regulatory changes (7.22 hours)^{footnote 10} — 50% of this time spent is by senior management and 50% spent by employees.
• Wage rate (including overhead)
  • Senior management: $59.80/hour^{footnote 11}
  • Employee: $25.30/hour

The estimated annualized values of administrative impacts for the one-for-one rule are presented in Table 7.

Table 7. Estimated annualized values of administrative impacts for the one-for-one rule (in Canadian dollars, constant year 2012 prices, 2012 present value base year, 7% discount rate, 10-year period)

Cost/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 information obligations	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
Estimated number of affected businesses		120
Average annualized administrative impact per affected business (OUT)		$251

Regulatory cooperation and alignment

CFIA conducted a scan of international jurisdictions and their approaches to 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 U.S., Australia, and the European Union were included in the analysis. In addition, as the U.S. 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 former regulations and the current Canadian approach to regulating fertilizers and supplements safety and labelling are currently 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 U.S. but rather at the state level. While Canada has some similar safety requirements as some states such as California, Washington and Oregon, many states in the U.S. do not focus on safety oversight. Internationally, fertilizers programs focus on verifying guaranteed product efficacy and some safety elements.

The regulatory amendments will introduce unique Canadian requirements for the core safety information to appear in both official languages on fertilizer and supplement labels. While this bilingual labelling requirement is necessary to ensure compliance with the Official Languages Act, it does not align with the U.S. or other jurisdictions. The modernization of the Regulations will, however, maintain certain key product definitions, e.g. the definition of “major plant nutrient,” and provisions such as the mandatory minimum guaranteed analysis section on labels, in accordance with the 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 U.S.

CFIA consulted with the other government departments on the development of these amendments, especially with the PMRA with respect to how these amendments would affect fertilizer-pesticide combination products and other dual property products (pesticide and supplement). Even though the amendments will repeal the reference to the Compendium of Fertilizer-Use Pesticides from the Regulations, products that are or contain pesticides will continue to have to be compliant with the provisions of the Pest Control Product Act with respect to human, animal or plant health or the environment and will require proof of compliance 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.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required.

Gender-based analysis plus

The regulatory amendments will affect various stakeholder groups in very different ways. It is important to provide an analysis of the distribution of the costs and benefits among stakeholder groups to help understand the differentiated impacts. This analysis is focused on the distribution of potential economic impacts of the regulatory amendments to the industry and consumers/end users of fertilizer products, by geographic region and province in Canada.

1. Impact by geographic breakdown

Based on the North American Industry Classification System (32531), Quebec and Ontario have the highest number of fertilizer establishments/producers and will be impacted the most. The results of the analysis are presented in Table 8.

Table 8. Impact by geographic breakdown

Province or territory	Percent Distribution
Ontario	17%
Quebec	36%
British Columbia	15%
Prairies (Alberta, Manitoba, Saskatchewan)	18%
Atlantic provinces (New Brunswick, Newfoundland and Labrador, Nova Scotia, Prince Edward Island)	14%
Territories (Nunavut, Northwest Territories, Yukon Territory)	0%
CANADA	100%

2. Use of commercial fertilizers by province

Canadian agriculture relies heavily on commercial fertilizers as well as manure to replenish the soil’s nutrients. Expenditures for fertilizers amounted to $5.1 billion representing about 11.49% of farm operating expenses in Canada in 2015. A total of 98 650 farms reported using (ARCHIVED) commercial fertilizers.

The relative importance of commercial fertilizer and lime areas over the provincial cropland varied greatly from one province to another. For example, commercial fertilizers were applied to 79.4% of total cropland in Manitoba in 2010. In contrast, they were applied to about half the cropland in Quebec and British Columbia. These regional differences can be traced to the crop mix grown and the type of soil.

3. Use of commercial household fertilizer

Canadians purchase fertilizer for home use. The percentage of Canadian households having used chemical fertilizers decreased from 47% in 1994 to 21% in 2011, and then increased to 28% in 2015. The increase could be due to a growth in homes with lawns and gardens, changing lawn and garden care preferences, and new substitute low-risk/safer products that are not covered by pesticide restrictions. Between 1997 and 2015, the number of single-detached homes grew by 71%; between 2011 and 2015, it has grown by 21%.

Table 9. Percentage of households with a lawn or garden using chemical pesticides and fertilizers by province, Canada, 1994 and 2015
Note: Values marked with an “E” should be used with caution. Source: Environment and Climate Change Canada (2017), Canadian Environmental Sustainability Indicators: Household use of chemical pesticides and fertilizers.

Region	Percentage of households using chemical fertilizers in 1994	Percentage of households using chemical fertilizers in 2015
Newfoundland and Labrador	26	22
Prince Edward Island	23	17-E
Nova Scotia	35	19
New Brunswick	36	20
Quebec	41	15
Ontario	51	29
Manitoba	39	31
Saskatchewan	57	53
Alberta	58	50
British Columbia	47	27

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, increase the possibility of risk.

The amendments to the Fertilizers Regulations will 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 CFIA’s mandate.

These regulatory amendments will also focus regulatory scrutiny on product safety. By shifting its focus, CFIA is better positioned to address emerging risks such as contaminants (chemical and biological), poor sources of primary materials, waste diversion into fertilizer streams, toxic residues in feed and food. CFIA will also be better positioned to contribute to addressing concerns over nutrient pollution, watershed contamination and eutrophication (oversupply of nutrients) which are often attributed to fertilizer use and contribute to climate change. 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 will 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 will 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 amendments is to lessen the administrative and compliance burden on regulated parties and reduce the prescriptiveness of the regulatory requirements that result from the former Regulations. The regulatory amendments also increase international harmonization and alignment with other regulatory bodies and key trading partners.

CFIA anticipates that the regulatory modernization of the fertilizers program, developed in consultation with stakeholders, will 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.

In the summer of 2020, CFIA re-examined the Fertilizer Modernization initiative in the context of the COVID-19 pandemic and economic recovery. The assessment indicated that the initiative is very well positioned to support the fertilizer and supplement industry in a post-pandemic context as it offers net benefits to industry, including small businesses, and a reduction in the administrative burden when compared to the current requirements.

Implementation, compliance and enforcement, and service standards

A flexible option of a three-year implementation period will minimize the impact on industry, specifically to the operation of small business. In accordance with the amendments, the stakeholders will be able to comply with the former Regulations or the amended Regulations for a period of three years from the date of registration of the amended Regulations.

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

In addition to regulatory amendments, CFIA is also implementing 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 is the implementation of a risk-based, tiered registration process.

The categorization of products that require registration will be based on scientific criteria and risk assessment of the product in question. This will include evaluation of the safety of the ingredients (both active and inactive/inert), their sources, the 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 will not be prescribed in the Regulations but rather will 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 will receive registration based on minimum evidence and data (Tier II). On the other hand, products that do not satisfy the Tier II criteria will be subject to a comprehensive (Tier III) review which could require the submission of additional data and/or scientific rationales.

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 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 amendments, no incremental resources for CFIA are anticipated to be required to implement the amended Regulations and to conduct the requisite marketplace monitoring activities. To enforce the amended Regulations, CFIA inspectors will 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 review of records provided by the product proponent. Streamlining labelling requirements will further facilitate marketplace label reviews.

The CFIA is in the process of updating all of its internal guidance materials and preparing training on the new requirements to operational staff during the phase-in implementation of the amended Regulations.

Product pre-market assessments and registration procedures will change moderately due to the new exemption scheme, modified labelling requirements and the tiered registration process. The required competencies for evaluators, including scientific knowledge and expertise, to complete the assessments will not change. The resource pressures and demands on CFIA may increase should the number of applications received annually by CFIA grow substantially. With the removal of efficacy requirements in 2013, the complexity of submissions (multiple active ingredients) has already increased and CFIA is working to ensure adequate assessment capacity is in place and maintained to facilitate timely file reviews and consistent adherence to service delivery standards.

Since all fertilizers and supplements that are or contain pesticides will have to demonstrate and provide proof of conformance with the provisions of the Pest Control Products Act with respect to human, animal or plant health or the environment, CFIA is working with 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 Pest Control Products Act will serve as grounds for refusal or cancellation of registration under the Fertilizers Act under the new regime.

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

Service delivery standards for file review were implemented in 2009. These consist of a maximum of three reviews whereby applicants have to address deficiencies identified during the review of the product information conducted by 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 amendments are intended to facilitate the adherence to service delivery standards.

Regarding the removal of Schedule II from the Regulations and its incorporation by reference into the Regulations, 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. Stakeholders will also be consulted on all changes to the List of Materials. This framework was developed in consultation with stakeholders during the technical review of the former Schedule II. CFIA will continue working with stakeholders on improving the framework and will make the revised List of Materials available on its website in both official languages.

Contact

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