Guide to submitting applications for registration under the Fertilizers Act

The cover letter is an important communication tool that helps our staff understand the context and intent of your application. A clear and well-structured cover letter supports accurate classification and efficient file handling during the pre-screening and review process.

Applicants are to include the following information in the cover letter:

• Application type for example:
  • new registration
  • re-registration
  • major amendment
  • minor amendment
• Safety Assessment level (Level I, II or III)
  Note: we will validate this categorization during pre-screening and may adjust it if necessary.
• Reference numbers, including submission control numbers (for example, for an inquiry: 12345IQ) and any previously granted registration number(s) relevant to the current application
• Intended end-use of the product for example:
  • agriculture
  • greenhouse
  • turf
  • residential lawn
  • home – indoor
  • seed inoculation
  • blending

Important

There is no dedicated upload field for the cover letter in My CFIA. Applicants may attach the cover letter using any available upload field and ensure it is clearly named (for example, Cover_Letter.pdf) so it can be easily identified by our staff.

Before proceeding with the registration of a product, it is necessary to identify an individual who is authorized to represent the Applicant/Canadian Representative and with whom the agency may correspond regarding the application.

We will not divulge any information regarding the application or discuss its status with any person(s) who is not an authorized individual, a profile contact or the requestor.

It is not mandatory that a registrant/applicant reside in Canada. However, for applicants residing outside of Canada, a Resident Canadian Agent must also be identified by filling out the prompted name and address fields in My CFIA. The Canadian Agent may be sent any legal notice or correspondence as appropriate. A Canadian Agent must be a person, not a company and this person must be a permanent resident of Canada.

Identification as the Canadian Agent does not automatically mean the person is an authorized representative. The Canadian Agent will only receive automatic emails and notifications if this person is also an authorized individual, a profile contact or the requestor.

To initiate the review of a file, applicants must pay the applicable registration fee as outlined in Part 5 of our Fees notice.

Fees apply to applications submitted under the Fertilizers Act for:

• new registration
• re-registration
• amendment to an existing registration (major or minor)
• safety assessment of a product

Safety assessment-only requests

If the applicant is requesting a safety assessment only (that is, no registration is being sought), the registration fee does not apply. These requests are categorized as Data with Safety (DS) and only the safety assessment fee is payable at the time of submission.

Safety assessment levels

To ensure consistency for regulated parties, the safety assessment fee is applied to all Level II and Level III safety assessments (see section 2.4.1 for definitions) as defined in this guide.

Product Type (required)

Select the appropriate product type from the dropdown menu.

Definitions are provided here to help you choose the correct category:

1. Commercial fertilizer

Any substance or mixture of substances containing nitrogen, phosphorus, potassium or other plant food, manufactured, sold or represented for use as a plant nutrient.

2. Fertilizer pesticides

A combination product that includes pesticide or disease resistance claims. If the pesticide is not registered under the Pest Control Products Act for the claimed use and application rate, approval and/or registration from the Pest Management Regulatory Agency (PMRA) is required.

3. Home and garden fertilizers

Fertilizers recommended for use exclusively on household plants and urban gardens.

4. Hydroponic fertilizers (soilless)

Fertilizers intended for use in soilless systems. Such as hydroponics.

5. Micronutrients fertilizer

Fertilizers represented to contain 1 or more of the following micronutrients:

• Boron (B)
• Chloride (Cl)
• Copper (Cu)
• Iron (Fe)
• Molybdenum (Mo)
• Manganese (Mn)
• Zinc (Zn)

6. Supplement

Any substance or mixture of substances, other than a fertilizer, that is manufactured, sold or represented for use in the improvement of the physical condition of soils or to aid plant growth or crop yields. The effects conferred by the product may be direct or indirect.

Registrable supplements can be chemical in nature (for example, plant growth regulators and wetting agents) or microbial in nature (contain viable microorganisms).

Note that where a supplement is included in a fertilizer product, the product type is assigned according to the fertilizer type.

7. Private label

Reserved for cases where an applicant wishes to register a fertilizer or supplement product that is already registered under a different name and/or brand. More information is available in T-4-122.

Brand name (if applicable)

Enter the brand name exactly as it appears on the marketplace label.

The brand refers to any distinctive mark or trade name, other than the name and grade required by the Fertilizers Regulations, that is applied by the manufacturer, registrant or vendor to distinguish the fertilizer or supplement from any other product.

Note: If the brand name differs in French and English, enter both versions.

Product name and/or grade (required)

Enter the product name exactly as it appears on the marketplace label. If the name is the same in English and French, then enter it identically in both fields.

When applicable, the product name must contain:

• the grade: amount of total nitrogen, available phosphoric acid and soluble potash in a fertilizer, expressed in percent as N-P-K
  Values may be whole numbers or decimals.
• the percentage and name of the guaranteed pesticide active ingredient.

For more information on the product name and identity, please see section 2.6 Proposed Marketplace Label

Important: we reserve the right to refuse an application if the submitted information is incomplete.

All ingredients in the product, both active and inert, must be clearly identified and listed in this section. Submitted information is for CFIA evaluators only and is treated as Confidential Business Information (CBI). It is protected under the Access to Information and Privacy acts and will not be disclosed without the registrant's written consent.

If the registrant is unable to obtain proprietary ingredient details, the distributor or manufacturer may submit it directly to PASO, at cfia.paso-bpdpm.acia@inspection.gc.ca. These submissions will be flagged as third-party proprietary and kept confidential.

If your response to file review requirements includes third-party CBI, clearly indicate this in your response. Only mark the task as complete in My CFIA once you have confirmation that the third party has submitted the required information to us.

2.2.2.1 - Input materials

For all materials used in the production of a registerable fertilizer or supplement, except microbial inocula described in section (2.2.2.2), the following information is required:

Note: multiple sources for an ingredient may be listed at the time of product registration and used interchangeably. However, any changes to the ingredients, sources, suppliers or formulation after registration require a major amendment unless we have approved an ingredient source change (See section 4.5 of T-4-122 for more information on Ingredient Source Change Inquiries).

See table 2 for the preferred method to submit the required input materials.

2.2.2.2 - Microbial inocula

For products that contain naturally occurring viable microorganism(s) the following information is required:

• purpose of the microbial strain
• taxonomic identification to genus and species level; subspecies and strain (when available)
• analytical results supporting taxonomic classification (include raw data)
• relationship to known pathogens (for example, phylogenetic trees or comparative sequence alignments)
• origin of the microorganism (isolation source and location) or strain bank accession number and culture certificate from a recognized culture collection (for example, ATCC)

Identification requirements

Strong and defensible taxonomic identification, preferably to the strain level, is essential for hazard characterization. We recommend a polyphasic approach, combining:

• phenotypic analysis (for example, morphology, biochemical traits)
• molecular tools for example:
  • DNA
  • RNA
  • protein-based methods

Methods should complement each other to ensure accurate identification and clear differentiation from pathogenic or toxigenic species.

Microbial consortia

For microbial consortia (defined as complex microbial community derived from a single natural environment and maintained without further manipulation), provide:

• description of the source environment (for example, soil based or rhizosphere associated consortium)
• processing details confirming the original composition is maintained without further manipulation

Where possible, all individual species should be identified. If precise identification is not feasible, classification to genus or family-level may be used. When taxonomic groupings are provided, the consortium must be screened for hazardous species relevant to the intended product type.

Applicants should select appropriate indicators based on the product type and source. For example, screening may include species pathogenic to humans such as:

• Salmonella spp.
• Listeria monocytogenes
• Vibrio spp.
• Campylobacter spp.
• Clostridium spp.
• Bacillus anthracis
• Pseudomonas aeruginosa
• Yersinia spp.
• Candida albicans
• Aspergillus fumigatus
• Faecal coliforms
• Enterococci
• Rotavirus
• Norovirus
• Ascaris lumbricoides

Note that the Fertilizer Safety Section may request additional indicator screening during the review process. Pathogenicity testing should be conducted on the final product formulation.

For additional information, consult T-4-126 Identification and taxonomic classification of microorganism(s) represented for use as supplements under the Fertilizers Act.

Information requirements for microorganisms modified by molecular biological techniques

For microorganisms that have been genetically modified using molecular biological techniques, the following information must be provided.

1. Genetic modification overview

• Flow diagram illustrating the genetic modification process, including:
  • map of the inserted construct
  • insertion site (chromosomal or plasmid)
  • copy number
  • cloning vector(s) used
  • promoter sequences
  • selectable marker genes, including any antibiotic resistance genes
  • for genome editing techniques (for example, CRISPR/Cas9 – Clustered Regularly Interspaced Short Palindromic Repeats/CRISPR-associated protein 9), provide:
    • description of the editing mechanism
    • target site(s) and intended edits
    • results of off-target effect assessments
    • confirmation of whether any foreign DNA remains in the final product

2. Genetic and functional characterization

• Detailed description of the gene product(s), including their properties and intended functions
• Identification of any altered metabolic pathways resulting from the genetic insertion
• Assessment of unintended effects on gene expression (for example, up-regulation or down-regulation of other genes)
• Evaluation of the stability of the inserted genetic material

3. Environmental and safety considerations

• Potential for horizontal gene transfer, including:
  • mechanisms of transfer (transformation, transduction, conjugation)
  • mobile genetic elements involved for example:
    • plasmids
    • bacteriophages
    • integrative conjugative elements
    • transposons
    • insertion sequences
    • integrons
    • gene cassettes
    • genomic islands
• Procedures and tests used to detect and quantify the modified microorganisms
• For endophytes, assessment of potential presence in the edible portion of the crop

4. Purity of inoculum

Applicants must provide substantiation of inoculum purity, including:

Seed stock quality control

• Description of quality control parameters used to monitor, identify and purify the microorganism from the seed stock (primary inoculum)
• Name and address of the company maintaining the seed stock

Final inoculum quality control

• Description of the manufacturing process
• Quality control parameters used to monitor identity and purity of the final inoculum (typically mixed with inert ingredients)

2.2.2.3 - Composition of the final product

The identity and relative proportions as weight/weight percentages (totalling 100%) must be provided for all ingredients present in the final product including:

• all active and inert ingredients
• contaminants
• residuals
• reaction by-products
• degradation products

The input materials may be the same as the final product constituents providing there are no chemical

reaction(s) or metabolic by-products generated during the manufacture/storage of the final product prior to

sale and no growth of new microorganism(s) is taking place.

Final product safety data sheet should be provided with the application, if available.

For example:

• granular
• liquid
• pH
• color
• odor
• size guide number (SGN)

Applicants must provide a detailed description of the manufacturing process for the final product, accompanied by a flowchart that summarizes each step. This overview is used to assess the potential for secondary reactions, formation of by-products and/or microbial contamination.

The description must include:

• each step of the production process, in sequential order
• the point at which feedstock is incorporated, including its proportion by weight
• associated processing conditions for each step, such as:
  • temperature
  • pressure
  • duration
  • type of processing equipment used

To substantiate consistency in production and safety of the final product, applicants are required to provide details relating to QA and QC procedures used during manufacture process:

• substantiation of the conformance of raw materials to specifications and standards (with analysis or accreditation when applicable)
• indication of material(s) being tested (for example raw, intermediary or final product)
• specification of analyses and sensitivity of test methods (limits of detection and/or limits of quantification)
• identification of "pass" criteria
• testing frequency (for example per batch or unit time) and point of sampling during production
• monitoring of manufacturing conditions (for example time, pressure, moisture content); and
• fate of noncompliant batches/lots (for example reprocessing, disposal)

Applicants must provide the minimum or actual percentage of each plant nutrient or other active ingredient being guaranteed:

• major nutrients (that is, N, P, K) and secondary nutrients (that is, Ca, Mg, S) must be guaranteed on a minimum basis.
• micronutrients (that is, B, Cl, Cu, Fe, Mn, Mo, Zn) must be guaranteed on an actual basic

For guidance on guarantees for other active ingredients, refer to T-4-130: Labelling Requirements for Fertilizers and Supplements.

Note: only guarantees that appear on the marketplace label should be included in this section.

All active ingredients must be guaranteed and the values must match those on the marketplace label.

To avoid misleading representation:

• derivation statements and ingredient lists are not required on labels of registered products, as these do not need to demonstrate exemption status
• if a derivation statement is included on the label, it must be complete (include all active input materials) and be clearly separated from the Guaranteed Analysis section using a form of visual delineation (for example, spacing, line or border)

To reduce the burden on stakeholders and streamline registration under the Fertilizers Act and regulations, we use a tiered safety assessment approach. The extent of safety data required depends on the product type, its composition and its risk profile.

• All applications must include core product information (Safety assessment level I)
• Some applications require analytical data (Safety assessment level II) to verify consistency in production, effectiveness of treatment and purity with respect to contaminant levels
• Higher-risk or unknown-risk products require a full safety assessment (Safety assessment level III), including scientific rationales, supplemental safety data and/or additional analytical results

The appropriate safety assessment level (I, II or III) is determined based on:

• product ingredients (active and inert) and their sources
• potential residues, contaminants and degradation by-products
• manufacturing process
• use pattern, application rate and frequency

Refer to table 3 for the information requirements for each safety assessment level.

A summary of information requirements for a variety of product ingredients can be found in appendix 2.

Additional notes

• We reserve the right to request additional safety data, rationales or analyses for any product regulated under the Fertilizers Act, if safety concerns arise during application review
• Applicants are encouraged to use the product specific Inquiry (IQ) process to clarify information requirements before submitting an application
• After the IQ process, if questions remain, a pre-submission consultation may be requested to obtain regulatory guidance

For more details, refer to Guidelines for Pre-submission Consultations for Fertilizer and Supplement Products Regulated Under the Fertilizers Act and regulations

The results of analysis required in support of a registration vary depending on product type and the source of ingredients. Examples of ingredient-specific results of analysis that are required to be included in an application are provided in appendix 2.

Outlined in appendix 3 are the safety standards and limits used by us to assess product safety and efficiency of treatment or processing for:

• trace metals
• dioxins and dioxin-like compounds
• indicator organisms

This appendix also includes the upper tolerances for guarantees related to micronutrient content in fertilizers.

Sampling and lab analysis submission guidance

Product samples must be collected at intervals that allow for assessment of production consistency. Examples include:

• at regular time intervals
• upon receipt of raw materials
• per lot or batch

Applicants must indicate the number of batches produced annually.

All results of analysis required by us must meet the following criteria:

• printed on laboratory letterhead
• signed by the analyst
• include:
  • sample identification
  • sample preparation method(s)
  • test method(s) used, including limits of detection (LOD) and/or limits of quantitation (LOQ)
  • identification of the certifying or accrediting body for the laboratory

2.4.2.1 - Metals analysis requirements

To demonstrate compliance with our trace metals standards, applicants must submit results of analysis for the following 11 metals of concern:

• arsenic (As)
• cadmium (Cd)
• cobalt (Co)
• copper (Cu)
• chromium (Cr)
• mercury (Hg)
• molybdenum (Mo)
• nickel (Ni)
• lead (Pb)
• selenium (Se)
• zinc (Zn)

Number of analyses required

The number of metal analyses required depends on the total number of batches or lots produced in the 5 years prior to application (for new registrations or re-registrations). Sampling requirements are outlined in table 4.

Analyses must reflect the actual production over the 5-year period. For example, if 5 analyses are required, it is recommended to submit 1 analysis from each calendar year.

For products manufactured via continuous processes, 6 sets of analyses must be submitted, evenly distributed across the 5-year period. If the product is not yet manufactured and results are unavailable, contact the Fertilizer Safety Section for guidance. These cases will be assessed individually.

2.4.2.2 - Dioxins and dioxin-like compounds analysis requirements

To demonstrate compliance with the CFIA Fertilizer Dioxin and Dioxin-like compound standards, applicants must submit 1 set of TEQ analyses for dioxins and furans (see tables 7 and 8, appendix 3).

Note: submission of dioxin and dioxin-like compounds analyses is not required for all products.

2.4.2.3 - Indicator organisms analysis requirements

We use Salmonella and faecal coliforms as indicator organisms to assess pathogen contamination and the effectiveness of the treatment process.

To demonstrate compliance, applicants must submit 4 sets of analysis results from 4 distinct lots or batches of the final product, tested for both faecal coliforms and Salmonella.

For continuous or semi-continuous production, samples must be collected at intervals of at least 2 weeks. For batch production, sampling intervals must reflect the actual manufacturing schedule (see table 9, appendix 3).

2.4.2.4 - Upper tolerances for nutrient guarantees in micronutrient fertilizers

To demonstrate compliance with our upper tolerances for fertilizers represented to contain micronutrients, applicants must submit results of analysis for:

• Any guaranteed micronutrient(s):
  • boron (B)
  • chloride (Cl)
  • copper (Cu)
  • iron (Fe)
  • manganese (Mn)
  • molybdenum (Mo)
  • zinc (Zn)

Note: this requirement for micronutrient analysis is in addition to the trace metals analysis outlined in section 2.4.2.1.

Analytical results must be submitted at the time of registration and re-registration to confirm that the actual nutrient content does not exceed the guaranteed amount by more than the allowable tolerance. Tolerance limits are provided in table 10, appendix 3.

The number of required analyses is based on the number of batches produced in the 5 years preceding the application, as outlined in table 4.

2.4.2.5 - Per and polyfluroroalkyl substances (PFAS) standard for commercial biosolids

Under the interim PFAS standard, biosolid fertilizers that require registration must demonstrate compliance with our specifications for perfluorooctane sulfonate (PFOS).

To be imported into or sold in Canada, these products must contain less than 50 parts per billion (ppb) of PFOS on a dry weight basis. PFOS is used as an indicator of PFAS contamination.

Required documentation

Applicants must submit the following with their registration application:

• a laboratory report (certificate of analysis) showing PFOS testing results
• a completed attestation form

For the attestation form, sampling and testing guidance, refer to T-4-132: PFAS Standard for Commercial Biosolids Imported or Sold in Canada as Fertilizers

For products requiring a Level III full safety assessment, applicants must provide a scientific safety rationale and any supplemental data necessary to support the product's safety when used as intended. These assessments follow the 4-step risk assessment framework used by us and other regulatory bodies for example:

• Health Canada
• Environment Canada
• Pest Management Regulatory Agency
• U.S. Environmental Protection Agency (EPA)

The 4 steps of risk assessment

1. Hazard identification
   Identification of potential adverse effects on human health or the environment.
2. Dose-response assessment
   Evaluation of the relationship between the dose received and the biological response in individuals or populations.
3. Exposure assessment
   Estimation of the level of human, animal or environmental exposure resulting from product use, including uptake and concentrations in environmental media.
4. Risk characterization
   Integration of hazard and exposure data to estimate the likelihood and severity of adverse effects.
   Risk = Hazard x Exposure

Purpose of safety rationale

The safety rationale should demonstrate that the product, when used as directed and not in excess of its intended purpose, poses no unacceptable risk to:

• human health
• plant and animal health
• the environment

We may request additional information based on the product's risk profile.

The safety rationale can have up to 3 parts:

• toxicological risk profile
• microbial risk profile
• references and supplemental documentation

Applicants are expected to provide detailed scientific information in each section to support the safety and quality of their product. The level of detail required should be proportionate to the safety risk profile of the product, higher-risk products may require more extensive data and justification. To ensure the submission is complete and scientifically sound, applicants are strongly encouraged to consult with qualified professionals in toxicology and/or microbiology prior to submission.

Waiver requests

If there are scientific grounds to believe that a specific information requirement is not applicable or unnecessary for the safety assessment of a product or ingredient, applicants may request a waiver.

Waiver requests must be supported by a sound scientific rationale.

2.4.3.1 - Toxicological risk profile

2.4.3.1.1 - Toxicological hazard characterization

For products or ingredients without a well-established history of safe use in fertilizers or supplements, applicants must complete the hazard characterization table in appendix 4.

If any elements in the table are not applicable or relevant, applicants must provide a scientifically supported rationale, with references from the literature to justify their exclusion.

Sources of information

Hazard characterization may be based on:

• peer-reviewed scientific literature
• international regulatory databases
• in vitro or in vivo toxicity studies
• predictive modelling (if experimental data are unavailable)
• surrogate data (from similar substances), with a rationale demonstrating similarity in physical, chemical and toxicological properties

See appendix 10 for useful information sources to support hazard determination.

Additional considerations

Applicants must identify any known:

• other hazard endpoints (for example, allergenicity)
• route-specific hazards (for example, pulmonary carcinogenicity from chronic inhalation)
• species-specific hazards (for example, avian toxicity)

We may request additional data depending on the risks identified.

High-hazard ingredients

An ingredient is considered high hazard if it meets 1 or more of the following criteria (see appendix 4 for full definitions):

• high acute toxicity
  • LD₅₀ less than equal to 500 mg/kg (oral)
  • LC₅₀ less than equal to 1,500 mg/m³ (inhalation)
• subchronic toxicity
  • NO(A)EL less than equal to 30 mg/kg bw/day
  • LO(A)EL less than equal to 90 mg/kg bw/day
• chronic toxicity
  • NO(A)EL less than equal to 10 mg/kg bw/day
  • LO(A)EL less than equal to 30 mg/kg bw/day
• positive results for:
  • Carcinogenicity
  • Clastogenicity
  • Mutagenicity
  • Reproductive or developmental toxicity
  • Teratogenicity
  • Endocrine disruption
• high acute aquatic toxicity
  • Lowest EC₅₀/LC₅₀ less than 0.1 ppm

If any of these criteria are met, a toxicological exposure assessment and risk assessment must be completed (see sections 2.4.3.1.2 and 2.4.3.1.3).

Low-hazard ingredients

Ingredients that do not meet any of the hazard criteria do not require an exposure or risk assessment. Completion of sections 2.4.3.1.2 and 2.4.3.1.3 is not required for these ingredients.

2.4.3.1.2 - Toxicological exposure assessment

Applicants must complete appendix 5 for all materials that meet the high hazard criteria outlined in appendix 4. This includes:

• active and inert ingredients
• residuals
• contaminants
• degradation products

Exposure routes to address

Both direct and indirect exposure routes must be considered:

• Direct exposure:
  • occupational mixer
  • loader
  • applicator/user
• Indirect exposure:
  • bystander
  • groundwater contamination
  • residues on food or feed crops
  • contact with or ingestion of contaminated soil

Factors influencing exposure

The relevance of each exposure route depends on:

• intended use pattern (for example, agricultural field versus potting mix)
• target species (for example, ornamental versus food crops)
• application frequency and rate
• physicochemical properties of the product and its constituents

These factors must be clearly identified in appendix 5 and used to define realistic exposure scenarios.

Worst-case scenarios and label considerations

Applicants must consider worst-case exposure scenarios, including:

• use by custom applicators (considered the highest occupational exposure frequency by us)
• label statements that limit exposure, such as:
  • personal protective equipment (PPE) recommendations
  • safe handling and disposal instructions
  • precautionary statements
  • use restrictions (for example, "Do not use on food crops or grazing lands")
  • post-entry intervals, if applicable

These label elements should be integrated into the exposure estimates to reflect realistic mitigation strategies.

2.4.3.1.3 - Toxicological risk assessment

Applicants must characterize the toxicological risk for each high-hazard ingredient by integrating the hazard characterization and exposure assessment across all relevant exposure scenarios. The risk characterization must be documented in appendix 5.

We will review and validate the submitted risk characterizations. If necessary, additional data may be requested to refine the hazard or exposure assessments. We may also require risk mitigation measures to ensure safe use of the product, which may include:

• use of personal protective equipment (PPE)
• safe handling and disposal procedures
• precautionary label statements
• use pattern restrictions (for example, food versus non-food crops)
• post-entry intervals, if applicable

2.4.3.2 - Microbial risk profile

2.4.3.2.1 - Microbial hazard assessment

For products or ingredients without a well-established history of safe use in fertilizers or supplements, applicants must conduct a microbial hazard assessment. The purpose is to characterize each microorganism and identify potential adverse effects on humans, animals, plants and the environment. These effects may include but are not limited to:

• pathogenicity
• toxicity
• sensitization
• toxigenicity
• antimicrobial resistance

Hazards may arise from the microorganism itself, its metabolites or toxins or its genetic material.

To support the hazard assessment, applicants must gather information from reliable sources such as:

• experimental test data
• case reports
• peer-reviewed scientific literature
• completed or ongoing research studies

If data on a microorganism are limited, applicants may use a scientifically justified surrogate organism, provided the rationale is clearly documented.

The assessment must account for strain-specific factors and all life stages of the microorganism, as these can influence the severity of the hazard.

Where possible, applicants should base the evaluation of adverse effects on test or study data specific to the microorganism. In alignment with the Microbial Risk Assessment Framework (MRAF) under the New Substances Notification Regulations (Organisms) of the Canadian Environmental Protection Act, 1999, testing must begin at the maximum label dose. If adverse effects are observed, applicants must conduct additional testing at lower doses to establish a dose-response relationship and determine key statistical endpoints, such as:

• ID₅₀/IC₅₀ – median infectious dose or inhibitory concentration
• ED₅₀/EC₅₀ – median effective dose or concentration
• LD₅₀/LC₅₀ – median lethal dose or concentration

Applicants are encouraged to consult the Environment Canada Guidance Document for Testing the Pathogenicity and Toxicity of New Microbial Substances to Aquatic and Terrestrial Organisms (Second Edition, 2016) for recommended methodologies.

Applicants must refer to appendix 6 for a detailed list of required data elements for microbial hazard characterization. It is recommended to use appendix 6 as a checklist to ensure completeness. All supporting information must be properly referenced and copies of cited publications, documents or study reports must be included in the submission.

Appendix 11 provides references cited in this section and additional resources to support the hazard assessment.

2.4.3.2.2 - Microbial exposure assessment

Applicants must conduct an exposure assessment to identify how the microorganism may enter the receiving environment and to characterize its environmental fate and behaviour. The assessment must determine the potential human and environmental exposure in terms of

• likelihood
• magnitude
• frequency
• duration
• extent

Both direct exposure (for example, contact with the product) and indirect exposure (for example, environmental release during intended uses) must be evaluated.

For indirect exposure, applicants must assess:

• the fate of the microorganism
• its genetic material, toxins and metabolites
• its endophytic potential
• the likelihood of occurrence in the edible portion of the crop

If data on the specific microorganism are limited, applicants may use a scientifically justified surrogate, with supporting rationale clearly documented and supported by references.

Applicants must refer to appendix 7, which outlines key considerations for characterizing microbial exposure. It is recommended to use appendix 7 as a checklist to ensure all relevant exposure-related factors are addressed.

2.4.3.2.3 - Microbial risk assessment

Applicants must base the risk assessment conclusion on both the characterized hazard and the available exposure information.

To support this process, appendix 8 summarizes key considerations for classifying the severity of microbial hazards and the level of exposure.

Where the risk characterization indicates potential concern for human health or the environment, risk mitigation measures may be required. These measures can include, but are not limited to:

• use of personal protective equipment (PPE)
• implementation of safe handling and disposal procedures
• inclusion of precautionary labelling statements
• restrictions on use, such as:
  • prohibiting application on food crops
  • grazing lands
  • pasture areas
• establishment of post-entry intervals to reduce exposure for workers and bystanders

Applicants must identify and propose appropriate mitigation measures based on the nature and severity of the risk. We will review the proposed measures and may request additional controls to ensure the safe use of the product.

2.4.3.3 - References and supplemental documentation

All published information used to fulfill the requirements under Safety Risk Assessment, Safety Rationale (tab 5) must be:

• cited in-text using author/source and year
• listed in a reference section under this sub-tab, including full citation details:
  • authors
  • document name
  • source
  • date
  • page numbers

Applicants must also provide:

• copies of all referenced documents that are not publicly available (that is, not accessible via open-access links)
• direct links to open-access sources, where available – uploading is not required for publicly accessible materials
• analytical results used or mentioned in tab 4 and tab 5
• citations for all models or modelling software used to support the safety rationale (including model name and version), both in-text and in the reference list under this tab