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

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## 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.

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@canada.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@canada.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@canada.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.

Fertilizer Safety Section
c/o (care of) Pre-market Application Submission Office (PASO)