# New regulations: Guide to submitting applications for registration under the Fertilizers Act Appendices

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## Appendix 1: List of mandatory tabs and sub-tabs

Figure 1: Format of the submission. All Tabs are mandatory and omitting any Tabs will result in the application for registration being rejected / returned to applicant during the first response stage. Please adhere to the headings of each tab as identified in the guide.

## Appendix 2: Product ingredients and associated safety data requirements

Safety data requirements vary depending on the nature of the product and its risk profile. The presence of an active or inert ingredient in the product may trigger additional safety requirements. The following table details a number of common product ingredients and the associated safety data requirements. Note that all products comprising or containing industrial by-products or recycled organic materials require Tab 4 (Results of analysis).

Level I
Tabs 1, 2, 3 Tab 4 - Metals Tab 4 - Dioxins Furans Tab 4 - Indicator Organisms Tab 5
Indole-3-butyric acid (IBA) at a concentration not exceeding 1% of the product excluding products for spray application Check
VAMs (Vesicular Arbuscular Myccorhizae) provided the species is substantially equivalent/representative of VAM group Check
Rhizobia (species of the genera Rhizobium, Bradyrhizobium, Mesorhizobium and Sinorhizobium) provided the species is substantially equivalent/representative of the rhizobia group, and is not genetically modified. Check
Bacillus subtilis provided the strain is representative of the species, is not genetically modified and does not produce any human enterotoxin. Check

Note: this does not constitute a comprehensive list of product /ingredient - specific requirements.

## Appendix 3: Metals, dioxins/furans standards and maximum acceptable level of indicator organisms in fertilizers and supplements

### Metals 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 (identified in Table 3) 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 (for example guarantee) Cu, Mo or 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 precautionary statements. Table 5 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 (for example 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.

Note that Selenium and Cobalt are considered supplemental active ingredients as they are not essential nutrients for all plant species. Including Selenium or Cobalt in a fertilizer product formulation makes the product a registrable fertilizer containing a supplement.

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.

### Dioxins/Furans Standard

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 bioaccumulate in food chains due to their lipophilic characteristics. 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 6 lists the congeners to be analyzed in determining total product dioxins and furans concentration.

Table 6. Dioxins and furans congeners for which results of analysis are required in determination of total product dioxins and furans concentration
Compound Toxic Equivalency Factors (TEF)
Chlorinated dibenzo-p-dioxins 2,3,7,8-TCDD 1
Chlorinated dibenzo-p-dioxins 1,2,3,7,8-PCDD 1
Chlorinated dibenzo-p-dioxins 1,2,3,4,7,8-HCDD 0.1
Chlorinated dibenzo-p-dioxins 1,2,3,6,7,8-HCDD 0.1
Chlorinated dibenzo-p-dioxins 1,2,3,7,8,9-HCDD 0.1
Chlorinated dibenzo-p-dioxins 1,2,3,4,6,7,8-HCDD 0.01
Chlorinated dibenzo-p-dioxins OCDD 0.0001
Chlorinated dibenzofurans 2,3,7,8-TCDF 0.1
Chlorinated dibenzofurans 1,2,3,7,8-PCDF 0.05
Chlorinated dibenzofurans 2,3,4,7,8-PCDF 0.5
Chlorinated dibenzofurans 1,2,3,4,7,8-HCDF 0.1
Chlorinated dibenzofurans 1,2,3,6,7,8-HCDF 0.1
Chlorinated dibenzofurans 1,2,3,7,8,9-HCDF 0.1
Chlorinated dibenzofurans 2,3,4,6,7,8-HCDF 0.1
Chlorinated dibenzofurans 1,2,3,4,6,7,8-HCDF 0.01
Chlorinated dibenzofurans 1,2,3,4,7,8,9-HCDF 0.01
Chlorinated dibenzofurans OCDF 0.0001
Non-ortho substituted PCBs 3,3',4,4'-PCB 0.0001
Non-ortho substituted PCBs 3,4,4',5-PCB 0.0003
Non-ortho substituted PCBs 3,3',4,4',5-PCB 0.1
Non-ortho substituted PCBs 3,3',4,4',5,5'-PCB 0.03
Mono-ortho substituted PCBs 2,3,3',4,4'-PCB 0.00003
Mono-ortho substituted PCBs 2,3,4,4',5-PCB 0.00003
Mono-ortho substituted PCBs 2,3',4,4',5-PCB 0.00003
Mono-ortho substituted PCBs 2',3,4,4',5-PCB 0.00003
Mono-ortho substituted PCBs 2,3,3',4,4',5-PCB 0.00003
Mono-ortho substituted PCBs 2,3,3',4,4',5'-PCB 0.00003
Mono-ortho substituted PCBs 2,3',4,4',5,5'-PCB 0.00003
Mono-ortho substituted PCBs 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 (5.355mg TEQ/ha) and the product's maximum recommended annual application rate as follows:

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

A maximum product concentration of 100 ng TEQ/kg product is considered protective for workers and bystanders. Table 7 shows the dioxin/furan acceptable concentrations for products at different application rates.

Table 7. Dioxin and furan standards and examples of maximum acceptable PCDD/Fs concentrations in based on annual application rates
Maximum acceptable cumulative PCDD/F additions to soil over 45 Years (mg TEQ/ha) Examples of maximum acceptable PCDD/F concentration based on annual application rates
(ng TEQ/ha) 4400 kg/ha - yr
Examples of maximum acceptable PCDD/F concentration based on annual application rates
(ng TEQ/ha) 2000 kg/ha - yr
PCDD/F 5.355 27 59.5

A compliance verification tool is available from cfia.paso-bpdpm.acia@inspection.gc.ca upon request. The calculator includes functionality for persistent organic pollutants limits.

### Indicator Organisms

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.

Table 8. 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 less than 2 CFU/gram

Tests for indicator organisms are required to meet the minimum detection limits specified in Table 8.

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

The CFIA 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.

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.

### Upper tolerances

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.

Table 9. 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

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

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%.

## Appendix 4: Toxicological hazards characterization

Ingredient identification
Characteristic
Ingredient
Chemical Abstract Number (CAS#)
Relative Concentration in final product

## Appendix 5: Toxicological exposure and risk assessment

Only to be populated for high hazard ingredients (those that meet any of the Hazard Criteria identified in Appendix 4)

### Mixer/Applicator

Exposure Assessment
Assumption/Derivation/Rationale
Application methodology/equipment
Application rate
Area of application (ha)
Frequency of application
Expected route(s) of exposure
(for example dermal, inhalation) based on application method and product and constituent physico-chemical properties
Mitigative Factors Limiting Exposure
Personal Protective Equipment (PPE)
Dermal Absorption Factor (if applicable) (% of oral dose) (DAF) Provide value and associated reference
Estimate of exposure, α (mg/kg bw/d) Show derivation and associated modelling assumptions
Risk Assessment
Assumption/Derivation/Rationale
Critical endpoint and critical, β (mg/kg bw/d) and/or
Cancer potency factor, q1* (mg/kg bw/d)-1
As identified in Appendix 4
Margin of Safety (β/α) and/or
Incremental Lifetime Cancer Risk (ILCR) (q1* x α)

### Bystander/Indirect

Exposure Assessment
Assumption/Derivation/Rationale
Method of exposure
(for example drift, re-entry, soil contact or consumption, potable water, plant residues)
Application rate
Area of application
Frequency of exposure
Application setting (for example agriculture, greenhouse, residential)
Re-entry Interval
Expected route(s) of exposure
(for example dermal, inhalation) based on application method and product and constituent physico-chemical properties
Environmental media concentration (ppm) (as required) Exceedance of persistence screening criteria (Appendix 4) must be accounted for in this derivation
Estimate of exposure, α (mg/kg bw/d) Show derivation, identify model used and associated modelling assumptions
Risk Assessment
Assumption/Derivation/Rationale
Critical endpoint dose, β (mg/kg bw/d) and/or
Cancer potency factor, q1* (mg/kg bw/d)-1
As identified in Appendix 4
Margin of Safety (β/α) and/or
Incremental Lifetime Cancer Risk (ILCR) (q1* x α)

### Environmental

Exposure Assessment
Assumption/Derivation/Rationale
Expected target environmental media
(for example soil, air, aquatic, sediment) based on application method and product and constituent physico-chemical properties
Application methodology/equipment
Application rate
Frequency of application
Environmental media concentration estimate, γ (ppm)
(for example impregnated granule, soil, sediment or aquatic concentration)
Show derivation, identify model used and associated modelling assumptions
Exceedance of persistence and/or biomagnification/bioaccumulation/ bioconcentration screening criteria (Appendix 4) must be accounted for in this derivation
Organism(s) of concern exposure estimate(s), δ (mg/kg bw/d)
(if applicable, for example avian/terrestrial vertebrate toxicity)
Show derivation, identify model used and associated assumptions (for example daily soil/granule ingestion rate)

## Appendix 7: Microbial exposure characterization - Factors to consider

Description of the life cycle
Category References
Characteristics of the different forms of the microorganism during its life cycle (for example motile cells, dormant cysts, spores)
Mechanism for reproduction and dispersal
Mechanism for survival (in adverse conditions)
Potential for dispersal of traits or gene transfer (mandatory for microorganisms modified by molecular biological techniques)
Unusual properties
Category References
Unusual properties of the notified strain that differ from the classical description of the species (mandatory for microorganisms modified by molecular biological techniques)
Product Use Pattern
Category References
Crops/plants on which the product is intended to be used Label
Application methodology/equipment Label
Application rate Label
Frequency of application Label
Expected route(s) of exposure (for example dermal, inhalation, ingestion)

## Appendix 8: Considerations for classification of microbial hazard severity and exposure level

Classification Considerations for classification
Hazard Severity
Considerations for classification
Exposure Level
High
• Significant uncertainty in the identification, characterization or possible effects.
• Disease in healthy humans/animals/plants is severe or may be lethal.
• Disease in susceptible humans/animals/plants may be lethal.
• Lethal or severe (irreversible) effects in laboratory mammals/plants at maximum hazard dose.
• Potential for horizontal transmission/community-acquired infection.
• Irreversible adverse effects (for instance loss of biodiversity, loss of habitat, serious disease).
• Identified as Risk Level II by the Public Health Agency of Canada (ePATHogens Risk Group Database)
• Microbes identified as high priority for antimicrobial resistance
• Microbes contributing to the release of antibiotics listed as high priority for antimicrobial resistance
• The release quantity, duration and/or frequency are high.
• The organism is likely to survive, persist, disperse proliferate and become established in the environment.
• Dispersal or transport to other environmental compartments is likely.
• The nature of release makes it likely that susceptible living organisms will be exposed.
• In relation to exposed organisms, routes of exposure are permissive of toxic or pathogenic effects in susceptible organisms.
• Presence of residue on food/feed (microorganism or its toxins).
Medium
• Case reports of human/animal/plant disease in the scientific literature are limited to susceptible populations or are rare, localized and rapidly self-resolving in healthy humans/animals/plants.
• Effects at maximum hazard dose in laboratory mammals/plants are not lethal, and are rapidly self-resolving.
• Low potential for horizontal transmission/community-acquired infection.
• Some adverse but reversible or self-resolving effects.
• Microbes listed at a lower priority level for antimicrobial resistance
• Microbes contributing to the release of antibiotics listed at a lower priority for antimicrobial resistance
• It is released into the environment, but quantity, duration and/or frequency of release is moderate.
• It may persist in the environment, but in low numbers.
• The potential for dispersal/transport is limited.
• The nature of release is such that some susceptible living organisms may be exposed.
• In relation to exposed organisms, routes of exposure are not expected to favour toxic or pathogenic effects.
Low
• No case reports of human/animal/plant disease in the scientific literature, or case reports associated with predisposing factors are rare and without potential for secondary transmission and any effects are mostly mild, asymptomatic, or benign.
• No adverse effects seen at maximum dose in laboratory mammals/plants by any route of exposure.
• Well characterized and identified with no adverse environmental effects known.
• May have theoretical negative impacts for a short period but no predicted long term effect for microbial, plant and/or animal populations or ecosystems.
• Has a history of safe use over several years.
• Identified as Risk Level I by the Public Health Agency of Canada
• Microbes not listed as a concern for antimicrobial resistance
• Microbes that do not contribute to the release of antibiotics
• It is used in containment (no intentional release).
• The nature of release and/or the biology of the microorganism are expected to contain the microorganism such that susceptible populations or ecosystems are not exposed.
• Low quantity, duration and frequency of release of microorganisms that are not expected to survive, persist, disperse or proliferate in the environment where released.

Source: Adapted from Environment Canada and Health Canada (2011): Framework for Science-Based Risk Assessment of Micro-Organisms Regulated under the Canadian Environmental Protection Act, 1999

Note: Combinations of the factors within each generalized hazard severity or exposure level above are possible and would affect the overall hazard or exposure assessment.

## Appendix 9: Labelling requirements for fertilizer-pesticides permitted for home and garden uses

1. The headings or statements in bold type must appear on the label, but do not have to be displayed in bold type. The other statements are recommended but not required.
2. Text in capital letters must be capitalized on the label unless otherwise indicated.
3. The exact wording of all statements is encouraged but not mandatory as long as the meaning is the same. No contradictory information may appear on the label.
4. Text in square brackets [ ] is additional information and should not be included on the label.

## Appendix 10: Information resources - Toxicology

Canadian Centre for Occupational Heal and Safety (CCOHS)

Committee on Standards, Equity, health and safety at work (CNESST)

United Nations

United States