Guide to Submitting Applications for Registration
under the Fertilizers Act

Appendices

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Appendix 1: Mandatory List of Tabs and Sub-Tabs

Figure 1: Format of the submission
Long Description: This image represents the mandatory format for submitting an application for registration under the Fertilizers Act.

This image includes a structured list of tabs and sub-tabs to assist applicants in preparing well organized submissions. The entitled tabs and sub-tabs include:

  • Administrative Forms and Fees
    • Cover Letter
    • Application Form
    • Signing Authority
    • Fees
  • Marketplace Label
  • Product Specifications
    • List of ingredients
    • Manufacturing Process
    • Quality Assurance/Control
    • Product Qualities
  • Results of Analysis
  • Safety Rationale and Supplemental Data
    • Hazard Characterization
    • Risk Assessment
    • References/Data

Safety assessment levels and required sections by TAB

Safety Assessment Level I: Complete Tabs 1-3
Safety Assessment Level II: Complete Tabs 1-4
Safety Assessment Level III: Complete Tabs 1-5

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

The presence of an active or inert ingredient in the product may trigger additional safety requirements. If a product includes one or many bolded materials from the table below, it requires registration prior to import or sale in Canada (with the exception of treated seeds or potting soils that contain registered "bolded" ingredients). 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 checkmark
VAMs (Vesicular Arbuscular Myccorhizae) provided the species is substantially equivalent/representative of VAM group checkmark
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. checkmark
Bacillus subtilis provided the strain is representative of the species, is not genetically modified and does not produce any human enterotoxin. checkmark
Level II
Tabs 1, 2, 3 Tab 4 - Metals Tab 4 - Dioxins Furans Tab 4 - Indicator Organisms Tab 5
Mineral derived nutrients (require registration if single ingredient, for farm use and not on Schedule II) checkmark checkmark Table Note 3
Biochar checkmark checkmark checkmark
Micronutrients Table Note 4 checkmark checkmark Table Note 3
Humic and Fulvic Acids checkmark checkmark checkmark Table Note 6
Plant extracts and residues checkmark checkmark checkmark
Seaweed checkmark checkmark checkmark
Farm Fertilizers containing Cement Kiln Dust checkmark checkmark Table Note 5 checkmark
Farm Fertilizers containing Compost checkmark checkmark checkmark
Farm Fertilizers containing Meals checkmark checkmark checkmark
Farm Fertilizers containing Processed sewage including composts thereof checkmark checkmark checkmark checkmark
Farm Fertilizers containing Pulp and paper sludge checkmark checkmark checkmark checkmark
Farm Fertilizers containing Wood ash checkmark checkmark checkmark
Farm Fertilizers containing Organic waste checkmark checkmark checkmark
Silica checkmark checkmark
Basalt checkmark checkmark
Fish fertilizer checkmark checkmark checkmark

Table Notes

Table note 3

source dependent.

Return to table note 3  referrer

Table Note 4

micronutrients only require registration when they are not combined with any other type of nutrient (i.e. nitrogen, phosphorous, or potassium), with the exception of chelator derived nitrogen.

Return to table note 4  referrer

Table Note 5

require Thallium and Vanadium testing in addition to the 11 standard metal analytes.

Return to table note 5  referrer

Table Note 6

non-coal derived humic and fulvic acids requires indicator organisms analysis.

Return to table note 6  referrer

Level III
Tabs 1, 2, 3 Tab 4 - Metals Tab 4 - Dioxins Furans Tab 4 - Indicator Organisms Tab 5
Polymer coated fertilizers Table Note 7 checkmark checkmark
Polymeric soil stabilizers checkmark checkmark
Wetting agents and surfactants checkmark checkmark
Nano-encapsulated fertilizers and nano-materials Table Note 8 checkmark checkmark
Plant growth regulators and Plant signalling compounds (e.g. Gibberellin, Cytokines, NAA, LCOs, Salicylic Acid, Chitosan, Hesperetin, Naringenin) other than Level I IBA as described above checkmark checkmark
Registerable supplement(s) that would themselves require a full safety data package, blended with fertilizer. checkmark Table Note 9 Table Note 9 Table Note 9 checkmark
Inoculant extenders sold with an unregistered inoculant checkmark checkmark checkmark
Viable microorganism(s) other than those described in Level I checkmark checkmark checkmark
Metabolites of organism(s) checkmark checkmark checkmark

Table Notes

Table Note 7

polymer coated fertilizers require safety assessment even if exempt from registration.

Return to table note 7  referrer

Table Note 8

all products in part or in whole comprised of nano-materials require full safety assessment.

Return to table note 8  referrer

Table note 9

Basic Results of Analysis required depending on the ingredients.

Return to table note 9  referrer

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:

equation
Description

The maximum acceptable concentration of a metal of concern in a product is equal to one million times the maximum acceptable cumulative addition of the metal of concern to soil over 45 years divided by the product's annual application rate times 45.

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.

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

Table 3. CFIA Fertilizer and Supplement Metals Standards and Examples of Maximum Acceptable Metal Concentrations Based on Annual Application Rates
Metal Maximum Acceptable Cumulative Metal Additions to Soil over 45 Years
(kg metal/ha)
Examples of Maximum Acceptable Product Metal Concentration Based on Annual Application Rates
(mg metal/kg product) 4400 kg/ha - yr
Examples of Maximum Acceptable Product Metal Concentration Based on Annual Application Rates
(mg metal/kg product) 2000 kg/ha - yr
Examples of Maximum Acceptable Product Metal Concentration Based on Annual Application Rates
(mg metal/kg product) 500 kg/ha - yr
Arsenic (As) 15 75 166 666
Cadmium (Cd) 4 20 44 177
Chromium (Cr) 210 1060 2333 9333
Cobalt (Co) 30 151 333 1333
Copper (Cu) 150 757 1666 6666
Mercury (Hg) 1 5 11 44
Molybdenum (Mo) 4 20 44 177
Nickel (Ni) 36 181 400 1600
Lead (Pb) 100 505 1111 4444
Selenium (Se) 2.8 14 31 124
Thallium (Tl) Table Note 10 1 5 11 44
Vanadium (V) Table Note 10 130 656 1444 5777
Zinc (Zn) 370 1868 4111 16444

Table Notes

Table note 10

Note that not all products require results of analysis for Thallium and Vanadium. These are an example of additional results that may be requested based on product or material type, on a case-by-case basis.

Return to table note 10  referrer

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 paso-bpdpm@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

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:

equation
Description

The maximum acceptable concentration of dioxins and furans in a product is equal to one million times the maximum acceptable cumulative addition of dioxins and furans to soil over 45 years divided by the product's annual application rate times 45.

In addition, a maximum product concentration of 100 ng TEQ/kg product is being considered to protect workers and bystanders. Table 4 shows the dioxin/furan acceptable concentrations for products at different application rates.

CFIA Fertilizer and Supplements 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 mentioned above (below Table 1) is available from paso-bpdpm@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 5. Maximum Acceptable Level of Indicator Organisms in Fertilizers and Supplements
Indicator Organism Level Minimum Detection Limit
Salmonella Not Detectable less than 1 CFU (Colony Forming Unit)/25 grams
Faecal Coliforms 1000 MPN (Most Probable Number)/ gram less than 2 CFU/gram

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

A compliance verification tool mentioned above (below Table 1) is available from paso-bpdpm@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 6. 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%.

Appendix 4: Toxicological Hazards Characterization

Ingredient Identification
Characteristic
Ingredient
Chemical Abstract Number (CAS#)
Relative Concentration in final product
Physical Chemical Properties
Exposure Model Inputs Hazard Criteria Value Reference(s)
Organic carbon partitioning coefficient (Koc)
Log Octanol Water partitioning coefficient (Log Kow)
Water Solubility at 25°C
Vapour Pressure
Persistence Air ≥ 2 days
Persistence Water ≥ 6 months
Persistence Soil ≥ 6 months
Persistence Sediment ≥ 1 year
Bioaccumulation, Bioconcentration, Biomagnification Factors > 5000
Mammalian Hazard Profile
Endpoint by Exposure Route Hazard Criteria Table Note 11 Test Organism Term Effect Dose Reference(s)
Oral Acute LD50 ≤ 500 mg/kg bw
Oral Subchronic LO(A)EL ≤ 90 mg/kg bw
Oral Subchronic NO(A)EL ≤ 30 mg/kg bw
Oral Chronic LO(A)EL ≤ 30 mg/kg bw
Oral Chronic NO(A)EL ≤ 10 mg/kg bw
Dermal Acute LD50 ≤ 500 mg/kg bw
Dermal Irritation/Sensitization
Inhalation Acute LD50 ≤ 1500 mg/m3
Ocular Irritation
Carcinogenicity For each ingredient where there is indication of carcinogenicity proceed to Appendix 5. Table Note 11
Clastogenicity and Mutagenicity For each ingredient where there is indication of clastogenicity or mutagenicity proceed to Appendix 5.
Reproductive/Developmental Toxicity, Teratogenicity For each ingredient where there is indication of reproductive/developmental toxicity, teratogenicity proceed to Appendix 5.
Endocrine Disruption For each ingredient where there is indication of endocrine disruption proceed to Appendix 5.

Table Notes

Table note 11

Cancer potency factor (q1*)

Return to table note 11  referrer

Aquatic Hazard Profile
Category Hazard Criteria Table Note 12 Test Organism Term Effect Concn Reference(s)
Vertebrate (e.g. Rainbow trout (Oncorhynchus mykiss), Brook trout (Salvelinaus fontinalis), Fathead minnow (Pimephales promelas), Bluegill sunfish (Lepomis macrochirus)) Acute: Lowest EC50 or LC50 < 0.1 ppm
Invertebrate (e.g. Daphnia (Daphnia sp., Ceriodaphnia dubia), Zebra fish (Brachydanio rerio), Worm (Lumbriculus variegatus)) Acute: Lowest EC50 or LC50 < 0.1 ppm
Benthic (e.g. Amphipod (Hyallela azteca), Midge larvae (Chironomus tentans, Chironomus riparius)) Acute: Lowest EC50 or LC50 < 0.1 ppm
Algae (e.g. Pseudokrchneriella subcapitata, Champia parvula) Acute: Lowest EC50 or LC50 < 0.1 ppm

Table Notes

Table note 12

For each ingredient where any of the hazard criteria are met, proceed to Appendix 5

Return to table note 12  referrer

Appendix 5: Toxicological Exposure and Risk Assessment

Only to be populated for high hazard ingredients (i.e. 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
(e.g. 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, A (mg/kg bw/d) Show derivation and associated modelling assumptions
Risk Assessment
Assumption/Derivation/Rationale
Critical endpoint and critical, B (mg/kg bw/d) and/or
Cancer potency factor, q1* (mg/kg bw/d)-1
As identified in Appendix 4
Margin of Safety (B/A) and/or
Incremental Lifetime Cancer Risk (ILCR) (q1* x A)

Bystander/Indirect

Exposure Assessment
Assumption/Derivation/Rationale
Method of exposure
(e.g. drift, re-entry, soil contact or consumption, potable water, plant residues)
Application rate
Area of application
Frequency of exposure
Application setting (e.g. agriculture, greenhouse, residential)
Re-entry Interval
Expected route(s) of exposure
(e.g. 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, A (mg/kg bw/d) Show derivation, identify model used and associated modelling assumptions
Risk Assessment
Assumption/Derivation/Rationale
Critical endpoint dose, B (mg/kg bw/d) and/or
Cancer potency factor, q1* (mg/kg bw/d)-1
As identified in Appendix 4
Margin of Safety (B/A) and/or
Incremental Lifetime Cancer Risk (ILCR) (q1* x A)

Environmental

Exposure Assessment
Assumption/Derivation/Rationale
Expected target environmental media
(e.g. 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, C (ppm)
(e.g. 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), D (mg/kg bw/d)
(if applicable, e.g. avian/terrestrial vertebrate toxicity)
Show derivation, identify model used and associated assumptions (e.g. daily soil/granule ingestion rate)
Risk Assessment
Assumption/Derivation/Rationale
Organism(s) of concern and associated critical environmental concentration(s), E (ppm) As identified in Appendix 4
Organism(s) of concern and associated critical dose, F (mg/kg bw/d)
(if applicable e.g. avian/terrestrial vertebrate toxicity)
As identified in Appendix 4
Risk Quotient (E/C)
Margin of Safety (F/D)
(if applicable e.g. avian/terrestrial vertebrate toxicity)

B The critical effect is typically the first adverse effect that occurs with increasing dose; the critical dose is the dose at which this adverse effect is observed.

The carcinogenic potency factor (q1*) is a measure of the relative strength of a non-threshold carcinogen.

Appendix 6: Microbial Hazard Characterization (Checklist)

Organism Hazard Yes/No References
Human Pathogenicity/Toxicity
Human Sensitization/Irritation
Human Dermatophytic potential
Human Toxigenicity Table Note 13
Mammals Pathogenicity/Toxicity
Mammals Sensitization/Irritation
Mammals Dermatophytic potential
Mammals Toxigenicity Table Note 13
Other terrestrial vertebrates (e.g. birds) Pathogenicity/Toxicity
Other terrestrial vertebrates (e.g. birds) Sensitization/Irritation
Other terrestrial vertebrates (e.g. birds) Toxigenicity Table Note 13
Terrestrial plants/crops Pathogenicity/Toxicity
Terrestrial plants/crops Growth inhibition
Terrestrial plants/crops Post-harvest spoilage
Terrestrial invertebrates (e.g. bees, earthworms, springtails) Pathogenicity/Toxicity
Aquatic vertebrates (fishes) Pathogenicity/Toxicity
Aquatic invertebrates (benthic, epibenthic) Pathogenicity/Toxicity
Aquatic plants (algae) Pathogenicity/Toxicity

Table Notes

Table note 13

Hazard to a toxin can be estimated using established chemical models (see Appendix 4)

Return to table note 13  referrer

Appendix 7: Microbial Exposure Characterization - Factors to Consider

Natural occurrence:
Category References
Geographical distribution
Natural habitats: soils, water, atmosphere, on or inside of living organisms (e.g. endophyte, epiphyte)
Hosts (symbiotic, saprophytic or pathogenic relationships)
Food/feed crops on which the microorganism is found in nature
Residues on food/feed (accumulation of the microorganism or its metabolites in the edible portion of the plant) Table Note 14

Table Notes

Table Note 14

Residue data are used to estimate the dietary exposure of humans and livestock to microbial toxins.

Return to table note 14  referrer

Physiological properties:
Category References
Growth parameters (e.g. temperature, pH, osmotic minima, maxima and optima)
Nutritional dependence, oxygen requirements, energy sources
Susceptibility to antibiotics, metals and environmental factors such as sunlight and desiccation
Favorable conditions for toxin production Table Note 15

Table Notes

Table Note 15

Exposure to a toxin can be estimated using established chemical models (see Appendix 5).

Return to table note 15  referrer

Description of the life cycle:
Category References
Characteristics of the different forms of the microorganism during its life cycle (e.g. 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 (e.g. 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 (e.g., loss of biodiversity, loss of habitat, serious disease).
  • 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.
  • 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.
  • 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

Corn Gluten Meal
Common Name: Table Note 17 Corn gluten meal
Guaranteed analysis: Table Note 16 Table Note 17 Corn gluten meal (actual) Table Note 16
Approved For Use: Table Note 17 In specialty lawn/turf fertilizers containing compatible fertilizer constituent materials.
Approved Claims: Table Note 16 Table Note 17

Pre-emergence inhibition of large and smooth crabgrass, white clover and dandelion seed germination in residential lawns where established perennial ryegrass or established Kentucky bluegrass are the predominant grass species.

Pre-emergence inhibition of large crabgrass, white clover and dandelion seed germination in public areas such as sports fields, parks, golf areas, and sod farms, where established perennial ryegrass or established Kentucky bluegrass are the predominant grass species.

Application Rates: Table Note 16 Table Note 17 9500 - 9800 g of corn gluten meal / 100m2
Directions For Use: Table Note 16 Table Note 17

May inhibit weed seed germination when used in conjunction with a sound lawn (or turf) maintenance program. Table Note 16

Established weeds at time of application will not be inhibited. Table Note 16

Do not apply the product on newly seeded grass as it may inhibit seeds from germinating, wait until after first mowing when root systems are established. Table Note 16

If over-seeding or re-sodding in the spring, do not apply the product in the spring. If over-seeding or re-sodding in the fall, do not apply the product in the fall. Table Note 16

For best results: Apply to established turf twice a year; once in the early spring 2 weeks before weed seed germination, and once in the late summer or early fall after heat stress has passed. Table Note 16

Apply when soil is moist and when rain is forecasted within 2 days of treatment. If rainfall does not occur within 2 days of treatment, irrigation is required. Excessive moisture at time of treatment may reduce the effectiveness of the product. Table Note 16

Do not apply under windy conditions.

Product application dates may vary for both the spring and late summer/early fall application from year to year according to weather conditions.

The inhibitory effect of the product to weed seeds generally dissipates in five weeks following application.

Apply to a mature lawn having a well-developed root mass.

Large crabgrass seeds germinate when soil temperature reaches 12.8°C.

Precautions: Table Note 16 Table Note 17

Keep Out Of Reach Of Children [On Main And Secondary Panels]. Table Note 16 Table Note 17

Read The Label Before Using [On Main Panel]. Table Note 16 Table Note 17

Caution Eye Irritant [On Main Panel]. Table Note 16 Table Note 17

Potential Sensitizer [On Main Panel]. Table Note 16 Table Note 17

May cause sensitization. Table Note 16

Avoid contact with skin, eyes or clothing. Table Note 16

Avoid inhaling dusts. Table Note 16

For good hygiene practice, wear a long-sleeved shirt, long pants, closed footwear and gloves when handling the product. Table Note 16

It is recommended that a dust mask be worn when transferring the product to the spreader. Table Note 16

Should not be applied if the applicator or a member of the household has a sensitivity or allergy to corn. Table Note 16

First Aid: Table Note 16 Table Note 17

If Swallowed: Table Note 16 Table Note 17 Rinse mouth and throat with copious amounts of water. Do not induce vomiting. Table Note 16

If On Skin/Clothing: Table Note 16 Table Note 17 Take off contaminated clothing. Wash skin with plenty of soap and water. Table Note 16

If Inhaled: Table Note 16 Table Note 17 Move to fresh air. Table Note 16

If In Eyes: Table Note 16 Table Note 17 Hold eye open and rinse slowly and gently with water. Remove contact lenses if present, then continue rinsing eye. Table Note 16

General: Table Note 16 Table Note 17 Seek medical attention immediately if irritation or signs of toxicity occur and persist or is severe. Take container, label or product name and registration number with you when seeking medical attention. Table Note 16

Toxicological Information: Table Note 16 Table Note 17 Treat symptomatically. Table Note 16
Storage: Table Note 16 Table Note 17 Keep in cool, dry conditions, away from seed, fertilizer and other pesticides. Keep away from fire, open flame, or other sources of heat. Table Note 16
Disposal: Table Note 16 Table Note 17 Do not re-use empty container. Dispose in accordance with municipal or provincial regulations if applicable. If no such regulations apply, wrap and dispose of empty container with household garbage.
Notice To User: Table Note 16 Table Note 17 This product is to be used in accordance with the directions on this label. It is an offence under the Pest Control Products Act to use this product under unsafe conditions.
Accepted Compatible Pesticide Active Ingredients: Table Note 17 None
Approved Brands Of Pesticide Products: Table Note 17 Refer to the corn gluten meal section PMRA's approved brands of pesticide products

Table Notes

Table note 16

The headings or statements must appear on the label. Note: The other statements are recommended but not required.

Return to table note 16  referrer

Table note 17

Must be capitalized on the label unless otherwise indicated.

Return to table note 17  referrer

Note: 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.

Note: Text in square brackets [ ] is additional information and should not be included on the label.

Ferrous Sulphate
Common Name: Table Note 19 FERROUS SULPHATE Table Note 19
Guaranteed Analysis: Table Note 18 Table Note 19 Ferrous Sulphate (actual) Table Note 18
Approved For Use: Table Note 19 In specialty lawn/turf fertilizers containing compatible fertilizer constituent materials.
Approved Claims: Table Note 18 Table Note 19 Controls moss in lawns.
Application Rates: Table Note 18 Table Note 19 250 - 980 g of Ferrous sulphate / 100m2
Directions For Use: Table Note 18 Table Note 19

In lawns: Moss will take over under conditions of poor light, poor drainage and inadequate plant food. Prune trees to open up and reduce shade. Improve drainage with tiling, slit trenching or contouring.

Fertilize on a regular basis.

For immediate control of moss water lawn thoroughly. Spray on recommended rate. Water in to wash off grass blades; then with-hold water for several days. May also be applied at dry rate, but water in thoroughly immediately after application.

Precautions: Table Note 18 Table Note 19

KEEP OUT OF REACH OF CHILDREN. Table Note 18 Table Note 19

READ LABEL BEFORE USING [on main panel]. Table Note 18 Table Note 19

Harmful if swallowed. Table Note 18

Avoid contact with eyes, skin and clothing. Table Note 18

Avoid breathing dust or spray mist. Table Note 18

Store in its original container tightly closed and away from children and pets. Table Note 18

Wash hands after use.

May stain stone, brick masonry or light coloured sidings.

May corrode bare metal.

Flush off spills with clear water.

Do not use on cement products such as sidewalks, patios, blocks, stucco, etc.

First Aid: Table Note 18 Table Note 19

If Swallowed: Table Note 19 Get medical attention or contact poison control centre.

If In Eyes: Table Note 19 Flush with plenty of water and get medical attention or contact poison control centre.

If On Skin: Table Note 19 Wash with soap and water. Table Note 18

Disposal: Table Note 18 Table Note 19 Discard empty container in household garbage.
Accepted Compatible Pesticide Active Ingredients: Table Note 19 None
Approved Brands Of Pesticide Products: Table Note 19 Refer to the ferrous sulphate section PMRA's approved brands of pesticide products

Table Notes

Table note 18

The headings or statements must appear on the label. Note: The other statements are recommended but not required.

Return to table note 18  referrer

Table note 19

Must be capitalized on the label unless otherwise indicated.

Return to table note 19  referrer

Note: 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.

Note: Text in square brackets [ ] is additional information and should not be included on the label.

Appendix 10: Information Resources - Toxicology

Canadian Resources

Canadian Centre for Occupational Heal and Safety (CCOHS)

1. CCOHS: http://ccinfoweb.ccohs.ca/

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

2. Repository Toxicology: http://www.csst.qc.ca/en/prevention/reptox/Pages/to-english-users.aspx

Environment Canada

3. Domestic substances list: https://www.canada.ca/en/environment-climate-change/services/canadian-environmental-protection-act-registry/substances-list/domestic.html

Health Canada

4. First Priority Substances List (PSL1) Assessments: http://www.hc-sc.gc.ca/ewh-semt/pubs/contaminants/psl1-lsp1/index_e.html

5. Second Priority Substances List (PSL2): Assessments http://www.hc-sc.gc.ca/ewh-semt/pubs/contaminants/psl2-lsp2/index_e.html

International Resources

Australian Government

6. Department of Health, National Industrial Chemicals, Notification and Assessment Scheme, Priority Existing Chemical Assessments: https://www.nicnas.gov.au/chemical-information/pec-assessments

United Nations

7. Food and Agriculture Organization (FAO), The Codex Alimentarius: http://www.fao.org/faostat/en/#home

8. International Programme on Chemical Safety (IPCS) INCHEM: http://www.inchem.org/

United States

9. Agency for Toxic Substances and Disease Registry (ATSDR), Toxic Substances Portal: https://www.atsdr.cdc.gov/

10. Centers for Disease Control and Prevention (CDC), The National Institute for Occupational Safety and Health (NIOSH): https://www.cdc.gov/niosh/npg/npgsyn-a.html

11. Department of Commerce, National Institute of Standards and Technology (NIST), NIST Chemical WebBook, SRD 69: http://webbook.nist.gov/chemistry/name-ser/

12. Environmental Protection Agency (EPA), Ecotox: http://cfpub.epa.gov/ecotox/

13. Environmental Protection Agency (EPA), Integrated Risk Information System https://www.epa.gov/iris

14. National Library of Medicine, Toxicological Data Network: ChemIDplus https://chem.nlm.nih.gov/chemidplus/

Appendix 11: Information Resources - Microbiology

Canadian Departments/Agencies

Canadian Food Inspection Agency (CFIA)

1. Animal pathogens

2. Plant Pests regulated by Canada

Environment Canada

3. Environment Canada and Health Canada. 2011. Framework for Science-Based Risk Assessment of Micro-Organisms Regulated under the Canadian Environmental Protection Act, 1999.

4. Environment Canada, Report EPS 1/RM/44. March 2004. Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms.

5. Environment Canada, Report EPS 1/RM/46. March 2005 (with June 2007 amendments). Guidance document on statistical Methods for Environmental Toxicity Tests.

6. Environment Canada. December 2013. Organisms on the Domestic Substances List (DSL) (Contains several risk group 2 microorganisms).

Health Canada/Public Health Agency of Canada

7. Human pathogen list: Chapter 2 of the Health Canada Laboratory Biosafety Guidelines provided a list of infectious agents by Risk Group. For questions about the Risk Group classification of specific organisms, please contact the Office of Laboratory Security.

8. Non-pathogenic organisms that do not require permit to import into Canada

International Resources

American Type Culture Collection (ATCC)

9. Cultures from the ATCC Bacteriology Collection

OECD (Organisation for Economic Co-operation and Development)

10. OECD (Organisation for Economic Co-operation and Development). 1998a. Principles of Good Laboratory Practice (as revised in 1997), No 1 - OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, ENV/MC/CHEM(98)17, 41 p., Environment Directorate, Paris, France.

11. OECD (Organisation for Economic Co-operation and Development). 1999d. The application of the GLP principles to Short Term Studies, No 7 (revised) - OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, ENV/JM/MONO(99)23, 16 p., Environment Directorate, Paris, France.

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