# T-4-93 – Safety standards for fertilizers and supplements

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Effective October 26, 2020, the amended Fertilizers Regulations are in force. Regulated parties can comply with either the "new" regulations or the "old" regulations for a period of 3 years. This applies to the manufacture, sale, import or export of fertilizers and supplements regulated under the Fertilizers Act.

New regulatory requirements (as of October 26, 2020)

## 1. Purpose

This document is a single source for all standards used by the CFIA to evaluate the safety of fertilizer and supplement products. It applies to products that require registration under the Fertilizers Act as well as those that are exempt from pre-market assessments. This document outlines:

• prohibitions and safety standards in the Fertilizers Regulations
• upper limits and thresholds for contaminants of concern (metals, dioxins and furans, and indicator organisms)
• tolerances for fertilizers guaranteeing micronutrients
• methods acceptable for completing required analyses
• cautionary statement requirements
• Globally Harmonized System (GHS) of classification and labelling of chemicals, administered by Health Canada
• How to contact the CFIA for additional information.

## 2. Prohibitions and standards in the regulations

### 2.1 General prohibition

A person shall not manufacture, sell, import or export any fertilizer or supplement that contains any substance or mixture of substances that present a risk of harm to human, animal or plant health or the environment (except pests) when the fertilizer or supplement is used according to its directions for use or in an amount that is not in excess of the amount that is necessary to achieve its intended purposes.

### 2.2 Safety standards

When used in accordance with directions for use or in an amount that is not in excess of the amount that is necessary to achieve its intended purposes, a fertilizer or supplement must not contain:

• Any substance or mixture of substances that would leave in the tissues of a plant a residue of a poisonous or harmful substance
• Major plant nutrients, secondary nutrients or micronutrients that are present at toxic levels
• 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, unless this use is authorized under a permit issued under section 160 of the Health of Animals Regulations
• 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

### 2.3 List of materials

A fertilizer or supplement that is listed on the List of Materials shall meet the definition in that List that corresponds to that term. If the product is represented to contain a material whose term is set out in the List of Materials it must, in fact, contain that ingredient.

## 3. Upper limits and thresholds

### 3.1 Metals

#### 3.1.1 Background

The metal standards are used to evaluate all products regulated under the Fertilizers Act for which metal concerns have been raised (e.g., recycled materials or materials with naturally elevated metal(s) levels). The standards apply to total (not extractable) metal content and are conservative to account for long term cumulative effects of metals on plant, animal and human health. They further account for metal concentrations in soils, and plant uptake factors such as soil acidity and soil cation exchange capacity. The standards are also protective of the effects of metals in worst-case application scenarios for hydroponics (soilless) applications.

The metals of concern include arsenic (As), cadmium (Cd), chromium (Cr), cobalt (Co), copper (Cu), mercury (Hg), molybdenum (Mo), nickel (Ni), lead (Pb), selenium (Se) and zinc (Zn).

#### 3.1.2 Upper limits/thresholds

Metals limits are predicated on the maximum acceptable cumulative addition to soils over a 45 year time period. The cumulative application approach is intended to account for the persistence of metals in the environment which ultimately determines the level of contamination and long term impacts.

The maximum acceptable metal concentration in a product (in mg metal/kg product) is calculated for each metal using the CFIA standards for maximum acceptable addition to soil and the product's maximum recommended annual application rate. The formula is as follows:

All fertilizers and supplements, including processed sewage, composts and other by-products are required to meet the standards for maximum acceptable cumulative metal additions to soil.

Certain metals such as copper (Cu), molybdenum (Mo) and zinc (Zn) are also essential plant nutrients. Products represented to contain (that is, guarantee) Cu, Mo and Zn that are used to treat a specific nutrient deficiency are not required to have an application rate specified on the label; rather the label states that the application rate is to be based on a soil or tissue test. In those instances, concentrations of the metal may exceed the metal standard (due to limited frequency of application) and the 95th percentile of the provincially recommended agronomic application rate is used in the calculations. These products must still meet the prescribed labelling standards including representation of the element as a plant nutrient, the associated guaranteed analysis and appropriate cautionary statements.

Note: the application rate and the metal concentration must be presented on the same basis (i.e. both dry weight or both as is).

Note: the Canadian Council of Ministers of the Environment (CCME), Bureau de normalisation du Québec (BNQ) and many provinces also have guidelines for metals in soils, or in sludge, compost, and other products that are land applied. We recommend that you contact your provincial or territorial government to obtain additional information.

Adding a guarantee for Selenium (Se) or Cobalt (Co) to a fertilizer makes the product a registrable fertilizer containing a supplement as these (Se and Co) are not essential nutrients for all plant species.

The above limits have been applied to hydroponics (soilless) products with an application rate conversion from ml/L or g/L to a per hectare unit.

A compliance verification tool – an excel spreadsheet that automates metal standard calculations, (for hydroponics products, select the use pattern: hydroponics – soilless media), is available upon request from cfia.paso-bpdpm.acia@inspection.gc.ca. It is intended to assist manufacturers and product proponents as well as CFIA inspectors in determining compliance of the final product with the standards.

#### 3.1.3 Results of analysis

To demonstrate compliance with the trace metals standards, proponents are required to provide results of analyses for the 11 metals of concern discussed above: As, Cd, Co, Cu, Cr, Hg, Mo, Ni, Pb, Se, and Zn. The number of metal analyses that are required at the time of new registration or re-registration, corresponds to the total number of batches/lots of product manufactured within a five (5) year interval preceding the submission of an application for a new or re-registration. This is depicted in Table 2. Analyses provided must be reflective of the batches manufactured over the five year period. For example, if five analyses are required, it is recommended to submit one analysis from each calendar year. Products generated by continuous process require 6 sets of analysis evenly spread over the five (5) year interval preceding submission.

Where results of requisite number of analyses are not available (e.g. because product is not yet being manufactured) please contact the Fertilizer Safety Section for guidance. These will be considered on a case-by-case basis.

Table 2: CFIA fertilizer requirements for metals analyses
# of Batches/Lots produced within the 5 years preceding the submission # of Sample analyses required
1 1
2 to 4 2
5 to 9 3
10 to 16 4
17 to 25 5
26+ Schedule to be provided by stakeholder and approved by the CFIA To be determined

### 3.2 Dioxins and Furans

#### 3.2.1 Background

Polychlorinated dibenzo-p-dioxins (dioxins; PCDDs) and polychlorinated dibenzofurans (furans; PCDFs) are highly persistent environmental contaminants. They are found in all living organisms at very low levels and can bio-accumulate in food chains due to their lipophilic characteristics. The requirement for dioxin and furan analysis is dependent on the ingredients (and their sources) used in a product.

#### 3.2.2 Upper limits/thresholds

The CFIA standard for maximum acceptable cumulative addition to soils of dioxins and furans is 5.355 mg TEQ/ha over 45 years (where TEQ = Toxic Equivalency Quotient). Like the CFIA metals standards, the application rate of a product is a crucial element in determining acceptable product dioxins/furans concentrations and the 45 year cumulative application approach is employed to account for environmental persistence and long-term impacts. Table 3 lists the congeners to be analyzed in determining total product dioxins and furans concentration.

Dioxins and Furans congeners for which results of analysis are required in determination of total product dioxins and furans concentration.

Chlorinated dibenzo-p-dioxins
Compound Toxic Equivalency Factors (TEF)
2,3,7,8-TCDD 1
1,2,3,7,8-PCDD 1
1,2,3,4,7,8-HCDD 0.1
1,2,3,6,7,8-HCDD 0.1
1,2,3,7,8,9-HCDD 0.1
1,2,3,4,6,7,8-HCDD 0.01
OCDD 0.0001
Chlorinated dibenzofurans
Compound Toxic Equivalency Factors (TEF)
2,3,7,8-TCDF 0.1
1,2,3,7,8-PCDF 0.05
2,3,4,7,8-PCDF 0.5
1,2,3,4,7,8-HCDF 0.1
1,2,3,6,7,8-HCDF 0.1
1,2,3,7,8,9-HCDF 0.1
2,3,4,6,7,8-HCDF 0.1
1,2,3,4,6,7,8-HCDF 0.01
1,2,3,4, 7,8,9-HCDF 0.01
OCDF 0.0001
Non-ortho substituted PCBs
Compound Toxic Equivalency Factors (TEF)
3,3',4,4'-PCB 0.0001
3,4,4',5-PCB 0.0003
3,3',4,4',5-PCB 0.1
3,3',4,4',5,5'-PCB 0.03
Mono-ortho substituted PCBs
Compound Toxic Equivalency Factors (TEF)
2,3,3',4,4'-PCB 0.00003
2,3,4,4',5-PCB 0.00003
2,3',4,4',5-PCB 0.00003
2',3,4,4',5-PCB 0.00003
2,3,3',4,4',5-PCB 0.00003
2,3,3',4,4',5'-PCB 0.00003
2,3',4,4',5,5'-PCB 0.00003
2,3,3',4,4',5,5'-PCB 0.00003

The maximum acceptable product dioxins/furans concentration (in ng TEQ/kg product) is calculated using the CFIA standard for maximum acceptable 45-year cumulative dioxins/furans addition to soil (5.355 mg TEQ/ha) and the product's maximum recommended annual application rate as follows:

$1000000\frac{\mathrm{ng}}{\mathrm{mg}}×\left[\frac{\mathrm{5.335 mg TEQ / ha}}{45 years×annual application rate\left(\mathrm{kg product / ha / yr}\right)}\right]$

A maximum product concentration of 100 ng TEQ/kg product is considered protective for workers and bystanders. Table 4 shows the dioxin/furan acceptable concentrations for products at different application rates.

Maximum acceptable cumulative PCDD/Fs additions to soil over 45 Years Examples of maximum acceptable PCDD/Fs concentration based on annual application rates 4400 kg/ha – yr (mg TEQ/ha) (ng TEQ/ha) 5.355 27 59.5

A compliance verification tool mentioned above (below Table 1) is available from cfia.paso-bpdpm.acia@inspection.gc.ca upon request. The calculator includes functionality for Persistent Organic Pollutants limits.

### 3.3 Indicator organisms

#### 3.3.1 Background

Monitoring for microbial contaminants in fertilizers and supplements must be carried out to provide information on the adequacy of pathogen-reducing processing or sterilization steps and the microbial condition of the final product. Given their widespread presence in the environment, Salmonella and Faecal coliforms are used as indicators of microbial contamination and effectiveness of treatment process. This practice is aligned with the United States Environmental Protection Agency's Part 503 Rule. The requirement for indicator organism testing allows for detection of any re-growth of bacteria and substantiates the effectiveness of pathogen reduction processes in place.

#### 3.3.2 Upper limits/thresholds

Table 5: Maximum acceptable level of indicator organisms in fertilizers and supplements
Indicator organism Level Minimum detection limit
Salmonella Not Detectable less than 1 CFU (Colony Forming Unit) / 25 grams
Faecal Coliforms 1000 MPN (Most Probable Number) / gram solid less than 2 CFU / gram

Tests for indicator organisms are required to meet the minimum detection limits specified in Table 5.

A compliance verification tool mentioned above is available from cfia.paso-bpdpm.acia@inspection.gc.ca upon request. The calculator includes functionality for indicator organism limits.

The FSS reserves the right to require analyses for additional pathogenic organisms depending on the nature of the product, as assessed on a case-by-case basis.

## 4. Tolerances for fertilizers guaranteeing micronutrients

### 4.1 Background

Micronutrients (Boron (B), Chlorine (Cl), Copper (Cu), Iron (Fe), Manganese (Mn), Molybdenum (Mo) and Zinc(Zn)) are essential plant nutrients that are required in small amounts, and their deficiency can negatively impact plant growth and crop yield. However, when applied in excess, micronutrients can have adverse health effects on animals, plants and the environment. Micronutrients can also persist and accumulate in soil (leading to environmental impacts) or in hydroponic growing media. This accumulation increases the risks of uptake by crops, resulting in potential feed and food contamination, adverse animal and human health effects and long term environmental impacts.

To mitigate the risks of over-application and promote safe use, fertilizers represented to contain micronutrients (guaranteeing micronutrients) either alone or in combination with other nutrients are subject to registration and pre-market assessment prior to importation and sale in Canada irrespective of the end use pattern (see registration triggers – Link + micronutrient T-memo). Upper tolerances for micronutrient guarantees have been established to enable compliance verification both at the premarket assessment stage as well as marketplace monitoring and enforcement. The tolerances are based on analytical variability associated with product analysis and sampling error as well as attainability based on modern manufacturing practices.

### 4.2 Tolerances

For a given guarantee (left column), the permissible exceedance (numerical value) is added to the guarantee yielding the maximum allowable content (right column).

Table 6: Upper tolerances for fertilizers represented to contain micronutrients
Guarantee range Permissible guarantee exceedance
< 0.0033 0.0013
0.0033-0.0099 0.0040
0.010-0.032 0.010
0.033-0.099 0.031
0.10-0.32 0.077
0.33-0.99 0.23
1.0-3.2 0.60
3.3-9.99 1.0
≥ 10 10% of Guarantee

Note: tolerances vary depending on the range of the micronutrient guaranteed – the tolerance is greater in the low range guarantee and smaller if the concentration in the product is higher. For example, a 0.24% Cu guarantee has a permissible exceedance of 0.077, for a maximum acceptable Cu content of 0.317%. On the upper end 11% Cu guarantee has a permissible exceedance of 10% of the guarantee, in this case 1.1%, for a maximum acceptable Cu content of 12.1%.

### 4.3 Results of analysis requirement

Proponents of micronutrient fertilizers are also required to provide results of analysis for guaranteed micronutrients in addition to the results of analysis for the reportable metals (As, Cd, Cr, Co, Cu, Hg, Mo, Ni, Pb, Se, Zn) at the time of registration and re-registration to ensure that the actual content of the nutrient in the product does not exceed the guarantee by an amount that is higher than the allowable tolerance. The number of analyses required will be based on the number of batches produced as per the current policy – for details please refer to Table 2 above.

#### 5. Cautionary statement requirements

As per the Fertilizers Regulations, a statement setting out any precaution that is necessary to mitigate a risk of harm to human, animal or plant health or the environment (except pests) may be required on the label/package of any regulated fertilizer or supplement product. The Regulations do not specify the exact wording of the precautionary statement required and these are determined on case-by-case basis depending on the ingredients in the product, its risk profile and intended use pattern.

Note: given that Boron is a Category 1B reproductive toxicant, all fertilizers with Boron (Boric acid and its salts) content greater than 0.3% of the final product require the following statement on the product label: "May damage fertility or the unborn child".

Note: fertilizers or supplements containing Health Canada identified priority allergen(s) have the potential to induce skin and respiratory allergic responses in users. Priority allergens include eggs, milk, mustard, peanuts, crustaceans and molluscs, fish, sesame seeds, soy, sulphites, tree nuts, wheat or triticale. If a fertilizer or supplement contains one or more of these ingredients, a cautionary statement similar to the following must be present on the product label: "Caution: This product contains (list priority allergen(s)). Adverse reactions may occur in sensitive persons. If skin contact occurs, wash with soap and water. Wear dust mask and protective gloves. If allergic reaction occurs, seek medical attention".

In addition, the Regulations require that product proponents and importers disclose the list of ingredients that present a risk of harm to the health of ANY human or animal that do not appear on the label to the requester in English or in French.

## 6. Methods

To be accepted, a method of analysis used to test a fertilizer or supplement must be specific for the purpose of the analysis, selective, reliable, and accurate for the active ingredient in the formulated product.

## 7. Globally harmonized system of classification and labelling of chemicals

In order to facilitate international trade and enhance human and environmental health protection, the global regulatory community has developed a standardized Globally Harmonized System of Classification and Labelling of Chemicals (GHS) to which Canada is a signatory. GHS is administered by Health Canada under the Hazardous Products Regulations. Suppliers, importers and producers are responsible for classifying hazardous products and preparing labels and safety data sheets.

For more information go to: GHS: OSH Answers Fact Sheets and WHMIS Transition.

## 8. Contact information

Fertilizer Safety Section
c/o (care of) Pre-market Application Submission Office (PASO)
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9 CANADA
Telephone: 1-855-212-7659
Email: cfia.paso-bpdpm.acia@inspection.gc.ca

Old regulatory requirements (until October 26, 2023)

PDF (1,234 kB)

## 1. Introduction

### Purpose

This document is a single source for all standards currently used by the CFIA to evaluate the safety of fertilizer and supplement products. As per the Fertilizers Regulations, products cannot contain any substance in quantities likely to be detrimental or injurious to vegetation, animals, public health or the environment when used as directed or any substance that would, when applied according to directions, leave in the tissues of a plant a residue of a poisonous or harmful substance. The standards outlined in this document are intended to provide guidance to stakeholders in substantiating the safety of their regulated products. Specifically, this document outlines standards and guidelines for potential contaminants (metals, dioxins, furans, and pathogens), tolerances for guaranteed metals and reference information on the globally harmonized system of classification and labelling of chemicals, which is administered by Health Canada. This document also outlines the safety fees associated with different submission types.

## 2. Contaminants

### 2.1 Metals

#### Background

The metals standards are used to evaluate and manage all products regulated under the Fertilizers Act and for which metal concerns have been raised (e.g., recycled materials or materials with naturally elevated metal(s) levels). The standards apply to total (not extractable) metal content and are conservative to account for long term cumulative effects of metals on plant, animal and human health. They further account for metal concentrations in soils, and plant uptake factors such as soil acidity and soil cation exchange capacity.

#### Standards

The metals of concern include arsenic (As), cadmium (Cd), chromium (Cr), cobalt (Co), copper (Cu), mercury (Hg), molybdenum (Mo), nickel (Ni), lead (Pb), selenium (Se) and zinc (Zn). Accumulation of these metals in soil over the long term may lead to plant, animal, environmental or human toxicity. The maximum concentration of metals permitted in a product depends on the application rate of the product.

Metals standards are predicated on the maximum acceptable cumulative addition to soils over a 45 year time period, as opposed to the actual concentration of the metal in the product. The application rate of a product is a crucial element in determining acceptable product metal concentrations. The 45 year cumulative application approach is intended to account for the persistence of metals in the environment which ultimately determines the level of contamination and thus, long term impacts.

The maximum acceptable product metal concentration (in mg metal/kg product) is calculated for each metal using the CFIA standards for maximum acceptable 45-year cumulative metal additions to soil and the product's maximum recommended annual application rate as follows:

All fertilizers and supplements, including processed sewage, composts and other by-products are required to meet the standards for maximum acceptable cumulative metal additions to soil. Certain metals such as copper (Cu), molybdenum (Mo) and zinc (Zn) are also essential plant nutrients. Products represented to contain (i.e. guarantee) Cu, Mo and Zn that are used to treat a specific nutrient deficiency are not required to have an application rate specified on the label, rather the label states that the application rate is to be based on a soil or tissue test. In those instances concentrations of the metal may exceed the metal standard (due to limited frequency of application) and the 95th percentile of the provincially recommended agronomic application rate for the guaranteed nutrient is used in the calculations. These products must still meet the prescribed labelling standards including representation of the element as a plant nutrient, the associated guaranteed analysis and appropriate precautionary statements.

Table 1 shows the acceptable metals concentrations for products at different application rates.

A compliance verification tool - an excel spreadsheet that automates metal standard calculations

Note: The application rate and the metal concentration must be presented on the same basis (i.e. both dry weight or both as is).

Note: The Canadian Council of Ministers of the Environment (CCME), Bureau de normalisation du Québec (BNQ) and many provinces also have guidelines for metals in soils, or in sludge, compost, and other products that are land applied. We recommend that you contact your provincial government to obtain additional information.

Including a guarantee for Selenium or Cobalt makes the product a registrable supplement because these are not nutrients essential for all plant species.

A compliance verification tool – an excel spreadsheet that automates metal standard calculations is available upon request from cfia.paso-bpdpm.acia@inspection.gc.ca. It is intended to assist manufacturers/proponents and CFIA inspectors in determining conformance of the final product with the standards.

#### Cautionary statement requirement

A fertilizer other than a specialty fertilizer that has intentionally incorporated in it or is represented to contain B, Co, Cu, Fe, Mn, Mo, Se or Zn or has a natural high content of one or more of these lesser plant nutrients, requires the following cautionary statement on the label:

"Caution: This fertilizer contains (specify name of lesser plant nutrient) and should be used only as recommended. It may prove harmful when misused."

Given that fertilizer and supplement users rely on appropriate and clearly visible handling and safety instructions on labels, this cautionary statement serves to inform consumers/users of potential hazard(s) associated with product misuse.

Additionally, given that Boron is a Category 1B reproductive toxicant, all fertilizers with Boron content greater than 0.3% of the final product require the following statement on the product label: "May damage fertility or the unborn child"

#### Results of analysis and methods

To demonstrate conformance with the trace metals standards, proponents are required to provide results of analyses for the 11 metals of concern discussed above: As, Cd, Co, Cu, Cr, Hg, Mo, Ni, Pb, Se, and Zn. The number of metal analyses that are required at the time of new registration or re-registration, corresponds to the total number of batches/lots of product manufactured within a three (3) year interval preceding the submission of an application for a new or re-registration as follows in Table 2.

Table 2: CFIA fertilizer sampling requirements for metals analyses
# of Batches/Lots produced within the 3 years preceding the submission # of Sample analyses required
1 1
2 to 4 2
5 to 9 3
10 to 16 4
17 to 25 5
26+ Schedule to be provided by stakeholder and approved by the CFIA To be determined

Analytical methods currently used for metal testing by CFIA laboratories are available on request from the Food Safety Science Services Division (FSSSD) Laboratory Coordination CFIA.LCD-DCL.ACIA@inspection.gc.ca.

Please be advised that the CFIA is not responsible to notify and/or distribute any future amendments or versions of the documents. The protocols are fit for a specific defined use and intended for CFIA regulatory testing only – CFIA is not responsible for the use of this protocol for any other purpose. Neither CFIA nor the Government of Canada is liable for any results obtained through the use of these protocols or procedures.

#### Globally harmonized system of classification and labelling of chemical

In order to facilitate international trade and enhance human and environmental health protection, the global regulatory community has developed a standardized chemical hazard classification and hazard communication called Globally Harmonized System of Classification and Labelling of Chemicals (GHS) to which Canada is a signatory. GHS is administered by Health Canada under the Hazardous Products Regulations. Suppliers, importers and producers are responsible for classifying hazardous products and preparing labels and safety data sheets. Please consult the following links for the Canadian transition timeline and additional information regarding the GHS: OSH Answers Fact Sheets and WHMIS Transition.

### 2.2 Dioxins and Furans

#### Background

As with the metal standards, the current limits for dioxins and furans are predicated on the application rate of a product and the maximum acceptable cumulative addition to soil. The requirement for dioxin and furan analysis is dependent on the ingredients (and their sources) used in a product.

#### Standards

The CFIA standard for maximum acceptable cumulative addition to soils of polychlorinated dibenzo-p- dioxins (dioxins; PCDD) and polychlorinated dibenzofurans (furans; PCDF) is 5.355 mg TEQ/ha over 45 years (where TEQ = Toxic Equivalency Quotient). Like the CFIA metals standards, the application rate of a product is a crucial element in determining acceptable product dioxins/furans concentrations and the 45 year cumulative application approach is employed to account for environmental persistence and long-term impacts.

The maximum acceptable product dioxins/furans concentration (in ng TEQ/kg product) is calculated using the CFIA standard for maximum acceptable 45-year cumulative dioxins/furans addition to soil (5.355mg TEQ/ha) and the product's maximum recommended annual application rate as follows:

$1000000\frac{\mathrm{ng}}{\mathrm{mg}}×\left[\frac{\mathrm{5.335 mg TEQ / ha}}{45 years×annual application rate\left(\mathrm{kg product / ha • yr}\right)}\right]$

In addition, a maximum product concentration of 100 ng TEQ/kg product is being considered to protect workers and bystanders. Table 3 shows the dioxin/furan acceptable concentrations for products at different application rates.

Maximum acceptable cumulative PCDD/Fs additions to soil over 45 years(mg TEQ/ha) Examples of maximum acceptable PCDD/Fs concentration based on annual application rates (ng TEQ/ha)4400 kg/ha – yr Examples of maximum acceptable PCDD/Fs concentration based on annual application rates (ng TEQ/ha)2000 kg/ha – yr 5.355 27 59.5

A compliance verification tool mentioned above (below Table 1) is available from cfia.paso-bpdpm.acia@inspection.gc.ca upon request. The calculator includes functionality for Persistent Organic Pollutants limits.

### 2.3 Indicator organisms

#### Background

Monitoring for microbial contaminants in fertilizers and supplements must be carried out to provide information on the adequacy of pathogen-reducing processing or sterilization steps and the microbial condition of the final product. Given their widespread presence in the environment, Salmonella and Faecal coliform density are used as indicators of microbial contamination and effectiveness of treatment process, a practice aligned with the United States Environmental Protection Agency's Part 503 Rule. The requirement of indicator organism testing allows for detection of any regrowth of bacteria and substantiates the sufficiency of pathogen reduction processes in place.

#### Standards

Table 4: Maximum acceptable level of indicator organisms in fertilizers and supplements
Indicator organism Level Minimum detection limit
Salmonella Not Detectable less than 1 CFU (Colony Forming Unit) / 25 grams
Faecal Coliforms 1000 MPN (Most Probable Number) / gram solid less than 2 CFU / gram

Tests for indicator organisms are required to meet the minimum detection limits specified in Table 4.

A compliance verification tool mentioned above (below Table 1) is available from cfia.paso-bpdpm.acia@inspection.gc.ca upon request. The calculator includes functionality for Indicator organism limits.

The FSS reserves the right to require analyses for additional pathogenic organisms depending on the nature of the product, as assessed on a case-by-case basis.

#### Methods

Please refer to Health Canada's Compendium for Microbiological Analysis for examples of standard methods. To be accepted, a method must be proven to be specific, selective, reliable, and accurate for the active ingredient in the formulated products.

## 3. Tolerances for fertilizers guaranteeing micronutrients

### Background

Micronutrients (Boron, Chlorine, Copper, Iron, Manganese, Molybdenum and Zinc) are essential plant nutrients that are required in small amounts, and their deficiency can negatively impact plant growth and crop yield. However, when applied in excess, micronutrients can have adverse health effects on animals, plants and the environment (both chronic and acute overexposure risks). Micronutrients can also persist and accumulate in soil (leading to environmental impacts) or in hydroponic growing media. This accumulation increases the risks of uptake by crops, resulting in potential feed and food contamination, adverse animal and human health effects and long term environmental impacts.

To mitigate the risks of over-application and promote safe use, fertilizers represented to contain micronutrients (guaranteeing micronutrients) are required by the Regulations to include guaranteed analysis (actual concentration of the nutrient in the product) and directions for use (application rate, frequency, timing and target crop) on the label. As indicated above, in cases when the product is used to treat specific nutrient deficiency, the directions for use must indicate that the application rate is to be based on a soil or tissue test. In either case, the appropriate application rate relies on the accuracy of the guarantee.

To promote safe use and enable compliance verification both at the premarket assessment stage as well as marketplace monitoring and enforcement, upper tolerances for micronutrient guarantees have been established. The tolerances are based on analytical variability associated with product analysis and sampling error as well as attainability based on modern manufacturing practices.

### Tolerances

Table 5: Upper tolerances for fertilizers represented to contain micronutrients.
For a given guarantee (left column), the permissible exceedance (numerical value) is added to the guarantee yielding the maximum allowable content (right column).
Guarantee range Permissible guarantee exceedance
<0.0033 0.0013
0.0033-0.0099 0.0040
0.010-0.032 0.010
0.033-0.099 0.031
0.10-0.32 0.077
0.33-0.99 0.23
1.0-3.2 0.60
3.3-9.99 1.0
≥10 10% of Guarantee

Please note that the tolerances vary depending on the range of the micronutrient guaranteed – the tolerance is greater in the low range guarantee and smaller as the concentration in the product is higher. For example, a 0.24% Cu guarantee has a permissible exceedance of 0.077, for a maximum acceptable Cu content of 0.317%. On the upper end 11% Cu guarantee has a permissible exceedance of 10% of the guarantee, in this case 1.1%, for a maximum acceptable Cu content of 12.1%.

### Results of analysis requirement

Proponents of micronutrient fertilizers are also required to provide results of analysis for guaranteed micronutrients in addition to the results of analysis for the reportable metals (As, Cd, Cr, Co, Cu, Hg, Mo, Ni, Pb, Se, Zn) at the time of registration and re-registration to ensure that the actual content of the nutrient in the product does not exceed the guarantee by an amount that is higher than the allowable tolerance. The number of analyses required will be based on the number of batches produced as per the current policy – for details please refer to Table 2 above.

## 4. Fees for applications made under the Fertilizers Act

### Background

Fees for consideration of an application made pursuant to the Fertilizers Act are prescribed in the Canadian Food Inspection Agency Fees Notice. The fees have two important aspects:

1. They increase as the complexity of the required evaluation increases. This means that an application for registration of a product that does not require a comprehensive safety evaluation is less costly than an application that does.
2. The fees are payable at the time at which an application is made. This means that the applicable fees are due when the application is made, regardless of whether or not an application results in the granting of a registration under the Act.

• Fees described in the CFIA's Fees Notice apply to applications made under the Fertilizers Act to:
• register;
• re-register;
• amend a registration; or
• assess the safety of a product.
• In cases when the applicant requests a safety assessment only (no registration) the registration fee is not charged and the safety assessment fee is payable when the request is submitted.

### Fees

In order to ensure the consistency in the collection of fees and predictability for regulated parties, the safety fees are to be applied to all Level II and Level III safety assessments as defined in the Guide to Submitting Applications for Registration Under the Fertilizers Act.

## 5. Additional information

Fertilizer Safety Section
c/o (care of) Pre-market Application Submission Office (PASO)
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9 CANADA
Telephone: 1-855-212-7659
Email: cfia.paso-bpdpm.acia@inspection.gc.ca

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