Guide to Submitting Applications for Registration
Under the Fertilizers Act

2. Submission structure and layout

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2.1 Tab 1: Administrative Forms and Fees

This section outlines the core administrative requirements for an application for registration.

2.1.1 - Cover Letter

The applicant is required to state the intent of the submission, thereby ensuring proper submission classification. The following must be indicated in the cover letter:

  • Submission type (e.g. new registration, Re-registration, major amendment, minor amendment);
  • Safety Assessment level (i.e. I, II or III) required (this will be subject to validation by the FSS and the categorization may change following the pre-screening stage of the application);
  • Reference to submission control number of an inquiry (e.g. 12345IQ) and/or previously granted registration number(s) relevant to the current submission, if applicable;
  • Intended end-use of the product (e.g. agriculture, greenhouse, turf, residential lawn, home - indoor, seed inoculation, blending).

2.1.2 - Completed Fertilizer and Supplement Registration Application Form

All sections of the Fertilizer or Supplement Registration Application form must be completely and accurately filled out. As a legal document, the form is required to be completed in its entirety and must exactly match the information stated on the accompanying label. Proponents may reference sections of their submission, if there is insufficient room on the application form. The FSS reserves the right to return a Fertilizer or Supplement Registration Application to the applicant if the form is deemed incomplete. For more information on how to complete the application form, please refer to the Guidelines to Completing the Fertilizer or Supplement Registration Application Form.

2.1.3 - Designation of Signing Authority (T-4-95) and Declaration of Canadian Agent Form

Before proceeding with the registration of a product, it is necessary to provide the FSS with signing authority as outlined in: T-4-95 - Signing Authority, Delegated Representatives and Canadian Agents. Signing authority is the means of explicitly informing the FSS who is authorized to sign a Fertilizer or Supplement Registration Application Form on behalf of the prospective registrant. Signing authority is also used to inform the FSS who they can correspond with regarding the submission. The FSS will not divulge any information regarding the submission or discuss its status with any person(s) who does not have a valid signing authority. A corporation may also appoint a person to be a delegated representative. A delegated representative may correspond with the FSS on matters relating to product registration, re-registration or approval, but may not sign application forms on behalf of the corporation.

It is not mandatory that a registrant/applicant reside in Canada. However, for applicants residing outside of Canada, a Resident Canadian Agent must be designated (by filling out the form in Declaration of Resident Agent Form). The Canadian Agent must co-sign all registration applications (including any re-registrations, amendments, etc.) and may be sent any related 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. An applicant may have more than one Canadian Agent on file. Designation as the Canadian Agent does not automatically mean the person has a signing authority on the file and a separate statement is required to authorize the FSS to communicate with the individual regarding the file.

2.1.4 - Registration Fee

In order for the FSS to process a file, a registration fee must accompany the submission as per the T-4-117 - Fees for Consideration of an Application Made Under the Fertilizer Act. The cost of registration of a product under the Fertilizer Act and Regulations can be found on the application form.

2.2 Tab 2: Proposed Marketplace Label

According to the FzA and FzR every package containing a fertilizer or supplement must have a label, a copy of which must be submitted with the application for registration. The FSS will accept text versions of the label during the initial review stages, but will not register the product without reviewing the final marketplace label. The FSS requires that any hazard or precautionary statements and personal protective equipment requirements that appear on the (M)SDS or their equivalents be incorporated into the product labels. If these are contained within the WHIMS (Workplace Hazardous Materials Information System) box/portion of the label, they need not be duplicated. Additional precautionary statements and/or protective equipment requirements may be requested by the FSS even if they do not appear on the (M)SDS. All text appearing on a label must be legible in English or French or in both English and French.

The label shall not contain:

  1. any incorrect or misleading information or mark; or
  2. a brand or name that would tend to deceive or mislead a purchaser with respect to the identity of the product as a fertilizer or supplement or its safe use.

The following is required on product labels:

2.2.1 - Fertilizer

  1. the name and address of the manufacturer of the fertilizer or of the registrant or, in the case of a fertilizer that is not registered, the name and address of the person who caused the fertilizer to be packaged;
  2. the brand of the fertilizer, if any;
  3. the name of the fertilizer;
  4. the registration number of the fertilizer, where applicable;
  5. the guaranteed analysis (expressed in percent);
  6. the directions for use;
  7. the weight of the fertilizer;
  8. where the fertilizers with the exception of specialty fertilizers that guarantee boron, copper, iron, manganese, molybdenum or zinc, the following cautionary statement:
    "Caution: This fertilizer contains (specify name of lesser plant nutrient) and should be used only as recommended. It may prove harmful when misused.";
  9. where a fertilizer contains corn gluten meal or iron sulphate represented for use on lawns (home and garden) and has been approved for use with a fertilizer by the PMRA, appropriate precautionary statements (refer to Appendix 9);
  10. in the case of a fertilizer that is or contains any prohibited material, as defined in subsection 162(1) of the Health of Animals Regulations, other than a rendered fat, conspicuous statements written legibly and indelibly in both official languages that indicate that:
    1. feeding the product to cattle, sheep, deer or other ruminants is illegal and subject to fines or other punishment under the Health of Animals Act,
    2. the product is not to be used on pasture land or other grazing areas for ruminants,
    3. the product is not to be ingested, and
    4. a person should wash his or her hands after the person uses the product;
  11. the lot number of the fertilizer, unless the fertilizer is a customer-formula fertilizer; and
  12. if sold in bulk, all labelling information is required on the shipping bill or on a statement accompanying the shipment.

2.2.2 - Supplement

  1. the name and address of the manufacturer of the supplement or the name and address of the registrant or, in the case of a supplement that is not registered, the name and address of the person who caused the supplement to be packaged;
  2. the name of the supplement;
  3. the weight of the supplement;
  4. the directions for use of the supplement;
  5. the lot number of the supplement;
  6. the guaranteed analysis (as applicable):
    1. the minimum amount of the active ingredient in the supplement, expressed in per cent;
    2. the genus and species of viable microorganisms; and
    3. the minimum number of viable cells of each microorganism per gram of product, expressed, for example, in CFU or spores per gram;
  7. in the case of a supplement in which the active ingredient may deteriorate, the date beyond which the supplement is not intended for use;
  8. where the supplement contains viable microorganisms, the label may require cautionary statements and/or recommend personal protective equipment, in order to minimize dermal/respiratory sensitization/irritation potential.
  9. in the case of packages of pre-inoculated or coated pre-inoculated seed, the minimum guarantee of the inoculant or the following statement "The product is treated with (species name or genus of the active microorganism(s)) inoculum.";
  10. where the supplement is represented to contain supplemental metal, such as cobalt, the following cautionary statement:
    "Caution: This fertilizer contains (specify name of the supplemental metal) and should be used only as recommended. It may prove harmful when misused.";
  11. in the case of a supplement that is or contains prohibited material, as defined in subsection 162(1) of the Health of Animals Regulations, conspicuous statements written legibly and indelibly in both official languages that indicate that:
    1. feeding the product to cattle, sheep, deer or other ruminants is illegal and subject to fines or other punishment under the Health of Animals Act,
    2. the product is not to be used on pasture land or other grazing areas for ruminants,
    3. the product is not to be ingested, and
    4. a person should wash his or her hands after the person uses the product;
  12. the registration number of the supplement if the supplement is required to be registered; and
  13. if sold in bulk, all labelling information is required on the shipping bill or on a statement accompanying the shipment.

2.3 Tab 3: Product Specification

All ingredients in the product and their sources must be identified and listed under this tab. In addition, a detailed description of the manufacturing process preferably in the form of a flow chart is required together with all relevant quality control/assurance procedures used to ensure consistency in production and purity of the final product. This information is the minimum necessary for FSS to conduct a preliminary assessment of the product and determine if additional information is required. It is intended for FSS evaluators only and it is considered and treated as Confidential Business Information (CBI). CBI shall not be divulged or released without explicit authorization (in writing) of the registrant. If the registrant has or anticipates any difficulties in obtaining this information (due to its proprietary nature) it may be submitted by the distributor or manufacturer directly to the CFIA.

2.3.1 - List of Ingredients

2.3.1.1 - Input materials

For all materials used in the production of a registerable fertilizer or supplement, except microbial inocula described in section (2.3.1.2), the following information is required:

  1. Name of the material;
  2. Chemical Abstracts Service number (CAS #, if available);
  3. Manufacturer;
  4. Country of origin;
  5. Source: e.g. manufactured (e.g. dyes, chelators), harvested (e.g. seaweed, straw, yucca), mined (e.g. ores), by-product (e.g. baghouse/electrostatic dust, klinker, slag, electrolysis, ash), recycled organics* (e.g. source separated organics, compost, biosolids, pulp and paper), synthesized (describe the chemical reaction and any residuals and reaction by-products);
  6. Manufacturing/purification processes of the ingredient, if applicable;
  7. Concentration of the material in the final product;
  8. Purpose of the material; and
  9. Material Safety Data Sheets (MSDS) or Safety Data Sheets (SDS) which serve as basis for preliminary safety evaluation, identifying points (such as possible contaminants) which may need to be examined in greater detail. An (M)SDS should also provide a detailed explanation of precautions and protective measures. The Workplace Hazardous Materials Information System (WHMIS) provides criteria for developing an (M)SDS.

* Recycled organics are required to indicate their inputs or feedstocks

Multiple sources of an ingredient may be identified at the time of product registration and used interchangeably during the manufacture of the product. Note: any new changes to the ingredients, their sources or their supplier(s) after registration require a major amendment.

2.3.1.2 - Microbial Inocula

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

  1. Purpose of the microbial strain in the supplement;
  2. Taxonomic identification of the microorganism to the genus and species level; subspecies, and strain information may also be required depending on the nature of the microorganism),
  3. Analytical results (including criteria and raw data) substantiating the taxonomic ID and classification;
  4. Relationship to known pathogens (e.g. phylogenetic trees);
  5. Origin of the microorganism (when, where and from which material it was isolated) if it is an environmental isolate; or the strain bank accession numbers if the strain has been deposited in a recognized culture collection, e.g., American Type Culture Collection (ATCC) or other.

Strong and defensible taxonomic identification, preferably to the strain level, is important for the hazard characterization of the microorganism. The choice of methods for microbial identification is at the discretion of the applicant. However, the FSS recommends that applicants adopt an integrated polyphasic approach that includes phenotypic analysis (e.g. analysis of morphological traits or biochemical characteristics) along with molecular tools (e.g. DNA, RNA or protein based methods), to accurately identify the microorganism. The strengths and weaknesses of the various identification methods should be taken into consideration, such that the methods chosen complement each other to result in a conclusive and definitive identification of the microorganism, and allow for clear differentiation of the organism from any closely related pathogenic and/or toxigenic species and strains. Please consult Identification and taxonomic classification of microorganism(s) represented for use as supplements under the Fertilizers Act for further detail.

Additionally for microorganisms modified by molecular biological techniques the following information is required:

  1. Flow diagram representing the genetic modification process including:
    1. the map of the construct inserted in the host,
    2. location (chromosomal or plasmid),
    3. copy number,
    4. cloning vector(s) used,
    5. promoter sequences,
    6. selectable marker genes including any antibiotic resistance genes.
  2. Detailed description of the gene product(s), their properties and functions;
  3. Description of the metabolic pathways altered by the insertion;
  4. Unintended effects on gene expression (down-regulation or up-regulation of other genes);
  5. Stability of the inserted genetic material;
  6. Horizontal gene transfer potential: capacity to transfer the genetic material between the organism and non-target species, the mechanisms of possible transfer (transformation, transduction or conjugation) and the elements involved (plasmids, bacteriophages, integrative conjugative elements, transposons, insertion sequences, integrons, gene cassettes and genomic islands);
  7. Procedures and tests to detect and quantify the modified microorganisms.

Substantiation of the purity of the inoculum is also required and includes:

  1. A description of the quality control parameters used to monitor, identity and purify the microorganism from the seed stock (primary inoculum), and the company name and address that keep the seed stock;
  2. The manufacturing process and quality control parameters used to monitor the identity and purity of the final inoculum (used as an ingredient in the final product, generally mixed with inert ingredients); and
  3. (M)SDS of the inoculum, if available.

2.3.1.3 - Composition of the Final Product

  1. 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 and 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.
  2. (M)SDS, if available.

2.3.2 - Method of Manufacture

A description of the manufacturing process of the final product accompanied by a flowchart used as an overview of the process to determine if there is any potential for secondary reactions, formation of by-products and/or microbial contamination. This description must specify each production step, including point of feedstock incorporation and its proportion by weight and associated conditions, such as temperature, pressure, time, and processing equipment.

2.3.3 - Quality Assurance and Quality Control Procedures

In order to substantiate consistency in production and safety of the final product, proponents are required to provide the following details relating to Quality Assurance (QA) and Quality Control (QC) procedures used during manufacture process:

  1. Substantiation of the conformance of raw materials to specifications and standards (with analysis or accreditation when applicable);
  2. Indication of material(s) being tested (e.g. raw, intermediary or final product);
  3. Specification of analyses and sensitivity of test methods (limits of detection and/or limits of quantification);
  4. Identification of "pass" criteria;
  5. Testing frequency (e.g. per batch or unit time) and point of sampling during production;
  6. Monitoring of manufacturing conditions (e.g. time, pressure, moisture content); and
  7. Fate of noncompliant batches/lots (e.g. reprocessing, disposal).

2.3.4 - Physical Characteristics of the Final Product

For example: granular, liquid, pH, color, odor, size guide number (SGN).

2.4 Tab 4: Results of Analysis

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 a submission are provided in Appendix 2. The safety standards and limits for trace metals, dioxins and furans and indicator organisms (Salmonella and Fecal Coliform) used by the FSS to assess product safety and efficiency of treatment or processing are outlined in Appendix 3.

Product samples must be taken at intervals enabling assessment of the consistency in production (e.g. at regular time intervals, upon receipt of raw materials, per lot/batch, etc.). Applicants are required to indicate the number of batches produced annually and the manufacturing date of each batch that was analyzed. All results of analyses submitted to the FSS must be printed on laboratory letterhead, bear the signature of the analyst, indicate sample preparation method(s) and the test method(s) used together with limits of Quantitation (LOQ) and/or limits of detection (LOD). The methods used must be validated to ensure adequate sensitivity and reproducibility of results. For additional information refer to the Guidance Document Good Laboratory Practices Protocol for Fertilizer and Supplements Registrations.

2.4.1 - Metals

To demonstrate compliance with the trace metals standards, proponents must provide results of analyses for the following 11 metals: Arsenic (As), Cadmium (Cd), Cobalt (Co), Copper (Cu), Chromium (Cr), Mercury (Hg), Molybdenum (Mo), Nickel (Ni), Lead (Pb), Selenium (Se), and Zinc (Zn) (see Table 3, Appendix 3). The number of metal analyses that are required to demonstrate compliance, 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 (refer to Table 2 below).

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

2.4.2 - Dioxins and Furans

To demonstrate compliance with the CFIA Fertilizer Dioxin and Furan Standards, proponents must provide one (1) set of TEQ dioxins and furans analyses (see Table 4, Appendix 3). Note: Not all level II safety assessments require the submission of dioxin and furan analyses.

2.4.3 - Indicator Organisms

Salmonella and Faecal coliforms are currently used by the CFIA as indicators of pathogen contamination and effectiveness of the treatment process. To demonstrate compliance with the CFIA requirements, proponents must provide four (4) sets of result of analyses from four different lots/batches of the final product for faecal coliform and Salmonella. Samples must be taken at intervals of at least two weeks for continuous or semi-continuous batches, or at intervals that correspond to the actual batch manufacture (see Table 5, Appendix 3).

2.5 Tab 5: Safety Rationale and Supplemental Data

Product safety assessments are conducted using the universal four (4) step risk assessment framework that is also employed by other CFIA programs (e.g. plant, animal, food), sister government departments or Agencies (e.g. Health Canada, Environment Canada, Pesticide Regulatory Management Agency (PMRA), and international counterparts (e.g. US Environmental Protection Agency (EPA)). The four steps of the framework consist of: hazard identification, dose-response assessment (hazard characterization), exposure assessment and risk characterization.

  • Hazard identification is a determination of the adverse human health and environmental effects.
  • Dose-response assessment is a quantification of the relationship between administered/received dose and biological response of an individual or population.
  • Exposure assessment predicts the anticipated level of human and organism contact and/or uptake and environmental media concentrations that arise as a result of product use.
  • Risk assessment is a deterministic or probabilistic estimate of the incidence of the adverse human and ecological effects on the basis of the hazard characterization and what is known about exposure; this is the basic risk assessment paradigm (Risk = Hazard × Exposure).

The information detailed in this section is required to substantiate the safety of a product with respect to human, plant, and animal health and the environment when the product is used as directed. Based on the assessment, additional information may be requested by the FSS. The safety rationales and supplemental data are only required for level III full safety assessments and are determined based on the risk profile of the product. This Tab has been broken down into three (3) sections: Toxicological Risk Profile; Microbial Risk Profile; and References and Supplemental Documentation. The FSS strongly recommends that applicants seek assistance/advice from scientific professionals with an expertise in human and environmental toxicology and/or microbiology to assist in preparing documentation required under this tab.

Where there are reasonable scientific grounds to believe that an information requirement identified in this tab is neither necessary, nor applicable to the safety assessment of a product/ingredient, a waiver from the information requirement or elements of it may be requested, and must be accompanied by a sound scientific rationale.

2.5.1 - Toxicological Risk Profile

2.5.1.1 - Toxicological Hazard Characterization

All fields of the table found in Appendix 4 must be completed for ingredients that warrant a level III safety assessment (i.e. for products or ingredients that do not have a well-established history of safe use in fertilizers and supplements). The alternative to this requirement is to provide a literature-supported scientific rationale explaining why elements of the table are either not applicable or relevant to the ingredient. If other hazard endpoints (e.g. allergenicity), route-specific hazards (e.g. pulmonary carcinogenicity with chronic inhalation exposure) or species-specific hazards (e.g. avian toxicity) are known to the applicant, it is their responsibility to identify them. Additional information may be required by the FSS depending on risks identified.

Toxicological hazard characterization may be based on information found in published peer-reviewed scientific literature, international regulatory databases, in vitro and in vivotoxicity testing/studies and, in the absence of experimental data, modelling. Information pertaining to a similar substance may be submitted (surrogate data). This requires a bridging rationale demonstrating similarity between the substances of interest and its surrogate including all relevant characteristics (physical, chemical, or toxicological).

Where an ingredient has:

  • high acute toxicity (LD50 ≤ 500mg/kg, ≤ 1 500mg/m3),
  • subchronic toxicity (NO(A)EL ≤ 30mg/kg bw/d; LO(A)EL ≤ 90mg/kg bw/d),
  • or chronic toxicity (NO(A)EL ≤ 10mg/kg bw/d; LO(A)EL ≤ 30mg/kg bw/d),
  • exhibits carcinogenicity, clastogenicity, mutagenicity, reproductive or developmental toxicity, teratogenicity or endocrine disruption (a positive result),
  • or is of high acute aquatic toxicity (lowest EC50/LC50<0.1ppm),

it is considered a high hazard ingredient. For high hazard ingredients (i.e. those that meet any of the Hazard Criteria identified in Appendix 4) the Toxicological Exposure and Risk Assessment must be conducted (as detailed in sub-tab 2.5.1.2 and 2.5.1.3). Ingredients that do not meet any of the hazard criteria do not require an Exposure Assessment or Risk Assessment and completion of sub-tab 2.5.1.2 and 2.5.1.3 is not mandatory. Appendix 10 provides a list of useful information resources to aid in the hazard determination.

2.5.1.2 - Toxicological Exposure Assessment

Applicants must populate all fields of the table found in Appendix 5 for all constituent materials (active and inert), residuals, contaminants and degradation products for which a high hazard level has been identified, as per the endpoint-specific Hazard Criteria found in Appendix 4. Both direct routes of exposure (occupational mixer, loader, applicator/user) and indirect routes of exposure (by-stander, groundwater, food or feed crop residue, contaminated soil contact and consumption) must be addressed. The choice of appropriate or relevant routes of exposure is based on the intended use pattern of the product (e.g. agricultural field use vs. potting mixes; ornamental plant species vs. food crops), frequency and rates of application as well as the physicochemical properties of the product and its constituents. These are important factors in determining human, animal, non-target plant and environmental exposure scenarios and must be identified in Appendix 5. Applicants must consider worst-case exposure scenarios. Label statements intended to limit exposures such as recommendations for protective equipment to be used, safe handling and disposal procedures, precautionary statements and use pattern restrictions (e.g. do not use on food crops or grazing lands) as well as post-entry intervals (if applicable) should be integrated in the estimates of human and environmental exposure. The FSS considers the custom-applicator scenario as the worst-case frequency of occupational exposure.

2.5.1.3 - Toxicological Risk Assessment

Applicants must generate estimates of risk (to be populated in Appendix 5) by combining the hazard and exposure assessments for each high hazard ingredient under all relevant exposure scenarios characterized in sub-tab 2.5.1.2. The FSS will review and validate the risk estimate(s) derived by the applicant. Additional information/test data may be required in order to refine the exposure and hazard assessments and/or require mitigative measures such as protective equipment to be used, safe handling and disposal procedures, precautionary statements, use pattern restrictions (e.g. food vs. non-food crop) and any post-entry intervals, if applicable to facilitate safe use of the product.

2.5.2 - Microbial Risk Profile

2.5.2.1 - Microbial Hazard Assessment

A hazard assessment characterizes the microorganism and identifies the potential adverse effects (i.e., pathogenicity/toxicity, sensitization, toxigenicity) on humans, animals and plants, and on the environment. The hazards may be posed by the microorganism itself, its metabolites/toxins or its genetic material.

Source of hazard information include test data, a review of case reports and analytical studies from the scientific literature, and research investigations (completed or ongoing). Hazard information considered in the assessment may be for the specific microorganism being assessed, or a suitable surrogate, if there is insufficient information on the specific microorganism and the choice of surrogate is supported by a sound scientific rationale. Factors affecting the severity (degree) of hazard may be strain specific and therefore the assessment must address the factors known or suspected to be produced by the strain, as well as those known or suspected to be produced by other strains of the species (or genus). The severity of hazard may also be affected by the life stage of the organism. For this reason, all stages of the life cycle of the microorganism and their potential effects must be considered.

Ideally, test/study data are used to evaluate the potential adverse effects of the specific microorganism being assessed. Testing typically starts with a maximum hazard dose (maximum label dose/rate). If adverse effects are reported at this dose, a range of lesser doses may be used to establish a dose-response relationship, and ideally to identify an appropriate statistical endpoint, such as median infective, effective or lethal dose or concentration (ID50/IC50, ED50/EC50, LD50/LC50) (Environment Canada, EPS 1/RM/46, March 2005). Recommended methodology for testing the pathogenicity/toxicity of microorganisms on human, animals and plants are available in the "Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms" (Environment Canada, Report EPS 1/RM/44, March 2004). Appendix 11 describes the documents referenced in this section and additional useful information resources. A study report should be prepared for each study. The OECD's Principles of Good Laboratory Practice (GLP) include guidance on reporting study results (OECD; 1998a). The extent of compliance with OECD's Principles of Good Laboratory Practice should be indicated.

Appendix 6 highlights the data required for microbial hazard characterization. Applicants must provide the FSS with information regarding each row of the table, with appropriate reference(s), in a separate document entitled "Technical information - Hazard Characterization". We recommend that the applicant uses Appendix 6 as a checklist to assist in providing all relevant information that is required. The information presented should be referenced, and a copy of each referenced publication/documentation or analytical/study report must be provided in the submission.

2.5.2.2 - Microbial Exposure Assessment

Information considered in the exposure assessment may be for the specific microorganism being assessed, or a suitable surrogate, if there is insufficient information on the specific microorganism and the choice of surrogate is supported by a sound scientific rationale.

An exposure assessment identifies the mechanisms by which a microorganism is introduced into a receiving environment, considers its environmental expression and fate, and estimates the likelihood, magnitude, frequency, duration, and/or extent of human and environmental exposure. Exposure to the microorganism may be direct (e.g., through contact with product) or indirect. Indirect exposure assessment considers how the microorganism is released into the environment through known, proposed or predicted uses, and the environmental fate of the microorganism, its genetic material, toxins and metabolites.

Appendix 7 highlights the factors that need to be addressed in order to characterize the exposure to the microorganism. Applicants must provide the FSS with information regarding each row of the table, with appropriate reference(s), in a separate document entitled "Technical information - Exposure Characterization". We recommend that the applicant uses Appendix 7 as a checklist to assist in providing all relevant information that is required.

2.5.2.3 - Microbial Risk Assessment

The risk assessment conclusion is based on the hazard, and on what is known about exposure. Considerations for classification of microbial hazard severity and exposure level are summarized in Appendix 8. Where appropriate, any preventative risk mitigation measures such as protective equipment to be used, safe handling and disposal procedures, precautionary statements and use pattern restrictions (e.g. do not use on food crops or grazing lands) as well as post-entry intervals maybe required to minimize worker and environmental exposures.

2.5.3 - References and Supplemental Documentation

All published information used to fulfill the requirements under Tab 5 must be cited in-text (author/source, year) and also provided in a list of references under this sub-tab. Each document must be properly referenced (authors, document name, source, date and page numbers).

Also, copies of all published information referenced under Tab 5 and analytical results used or mentioned in Tab 4 and Tab 5 must be provided under this sub-tab. All models or modelling software employed in support of the safety rationale must be cited in-text (model, version) and must also be provided in the list of references under this tab.

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