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

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Appendix 1: List of mandatory tabs and sub-tabs

Figure 1: Format of the submission. Description follows.
Description of graphic - Mandatory list to a submission for Registration

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

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

Level I
Tabs 1, 2, 3 Tab 4 - Metals Tab 4 - Dioxins Furans Tab 4 - Indicator Organisms Tab 5
Indole-3-butyric acid (IBA) at a concentration not exceeding 1% of the product excluding products for spray application Check
VAMs (Vesicular Arbuscular Myccorhizae) provided the species is substantially equivalent/representative of VAM group Check
Rhizobia (species of the genera Rhizobium, Bradyrhizobium, Mesorhizobium and Sinorhizobium) provided the species is substantially equivalent/representative of the rhizobia group, and is not genetically modified. Check
Bacillus subtilis provided the strain is representative of the species, is not genetically modified and does not produce any human enterotoxin. Check
Level II
Tabs 1, 2, 3 Tab 4 - Metals Tab 4 - Dioxins Furans Tab 4 - Indicator Organisms Tab 5
Mineral derived nutrients Check Check source dependent
Micronutrients Check Check source dependent
Plant extracts and residues Check Check Check
Seaweed Check Check Check
Fertilizers containing Cement by-products Check Check Table Note b Check
Fertilizers containing Compost Check Check Check
Fertilizers containing Meals Check Check Check
Fertilizers containing Processed sewage including composts thereof Check Check Check Check
Fertilizers containing Pulp and paper sludge Check Check Check Check
Fertilizers containing Wood ash Check Check Check
Fertilizers containing Organic waste Check Check Check
Silica Check Check
Fish fertilizer Check Check Check
Biochar Check Check

Table Note

Table note b

require Thallium and Vanadium testing in addition to analysis of the 11 standard metals.

Return to table note b  referrer

Level III
Tabs 1, 2, 3 Tab 4 - Metals Tab 4 - Dioxins Furans Tab 4 - Indicator Organisms Tab 5
Polymer coated fertilizers Check Check
Polymeric soil stabilizers Check Check
Wetting agents and surfactants Check Check
Nano-encapsulated fertilizers and nano-materials Table Note c Check Check
Plant growth regulators and Plant signalling compounds (for example Gibberellin, Cytokines, NAA, LCOs, Salicylic Acid, Chitosan, Hesperetin, Naringenin) other than Level I IBA as described above Check Check
Registrable supplement(s) that would themselves require a full safety data package, blended with fertilizer. Check ingredient dependent ingredient dependent ingredient dependent Check
Viable microorganism(s) other than those described in Level I Check Check Check
Metabolites of organism(s) Check Check Check

Table Note

Table Note c

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

Return to table note c  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:

1000000 mg kg × [ maximum acceptable cumulative metal addition to soil over 45 years ( kg metal / ha ) 45 years × annual application rate ( kg product / ha • yr ) ]

All fertilizers and supplements, including processed sewage, composts and other by-products are required to meet the standards for maximum acceptable cumulative metal additions to soil.

Certain metals such as copper (Cu), molybdenum (Mo) and zinc (Zn) are also essential plant nutrients. Products represented to contain (for example guarantee) Cu, Mo or Zn that are used to treat a specific nutrient deficiency are not required to have an application rate specified on the label; rather the label states that the application rate is to be based on a soil or tissue test. In those instances, concentrations of the metal may exceed the metal standard (due to limited frequency of application) and the 95th percentile of the provincially recommended agronomic application rate is used in the calculations. These products must still meet the prescribed labelling standards including representation of the element as a plant nutrient, the associated guaranteed analysis and appropriate precautionary statements. Table 5 shows the acceptable metals concentrations for products at different application rates.

Table 5. Metals standards and examples of maximum acceptable metal concentrations based on annual application rates
Metal Maximum acceptable cumulative metal addition to soil over 45 years
(kg metal/ha)
Examples of maximum acceptable concentration of a metal based on annual application rate (mg metal/kg product)
4400 kg/ha - yr
Examples of maximum acceptable concentration of a metal based on annual application rate
(mg metal/kg product) 2000 kg/ha - yr
Examples of maximum acceptable concentration of a metal based on annual application rate
(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 d 1 5 11 44
Vanadium (V) Table Note d 130 656 1444 5777
Zinc (Zn) 370 1868 4111 16444

Table Note

Table note d

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 d  referrer

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

Note: The Canadian Council of Ministers of the Environment (CCME), Bureau de normalisation du Québec (BNQ) and many provinces also have guidelines for metals in soils, or in sludge, compost, and other products that are land applied. We recommend that you contact your provincial government to obtain additional information.

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

A compliance verification tool, an excel spreadsheet that automates metal standard calculations, is available upon request from cfia.paso-bpdpm.acia@inspection.gc.ca. It is intended to assist manufacturers/proponents and CFIA inspectors in determining conformance of the final product with the standards.

Dioxins/Furans Standard

Polychlorinated dibenzo-p-dioxins (dioxins; PCDDs) and polychlorinated dibenzofurans (furans; PCDFs) are highly persistent environmental contaminants. They are found in all living organisms at very low levels and can bioaccumulate in food chains due to their lipophilic characteristics. The CFIA standard for maximum acceptable cumulative addition to soils of dioxins and furans is 5.355 mg TEQ/ha over 45 years (where TEQ = Toxic Equivalency Quotient). Like the CFIA metals standards, the application rate of a product is a crucial element in determining acceptable product dioxins/furans concentrations and the 45 year cumulative application approach is employed to account for environmental persistence and long-term impacts. Table 6 lists the congeners to be analyzed in determining total product dioxins and furans concentration.

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

The maximum acceptable product dioxins/furans concentration (in ng TEQ/kg product) is calculated using the CFIA standard for maximum acceptable 45-year cumulative dioxins/furans addition to soil (5.355mg TEQ/ha) and the product's maximum recommended annual application rate as follows:

1000000 ng mg × [ 5.335 mg TEQ / ha 45 years × annual application rate ( kg product / ha • yr ) ]

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

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

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

Indicator Organisms

Monitoring for microbial contaminants in fertilizers and supplements must be carried out to provide information on the adequacy of pathogen-reducing processing or sterilization steps and the microbial condition of the final product. Given their widespread presence in the environment, Salmonella and Faecal coliform density are used as indicators of microbial contamination and effectiveness of treatment process, a practice aligned with the United States Environmental Protection Agency's Part 503 Rule. The requirement of indicator organism testing allows for detection of any regrowth of bacteria and substantiates the sufficiency of pathogen reduction processes in place.

Table 8. Maximum acceptable level of indicator organisms in fertilizers and supplements
Indicator organism Level Minimum detection limit
Salmonella Not Detectable less than 1 CFU (Colony Forming Unit) / 25 grams
Faecal Coliforms 1000 MPN (Most Probable Number)/ gram less than 2 CFU/gram

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

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

The CFIA reserves the right to require analyses for additional pathogenic organisms depending on the nature of the product, as assessed on a case-by-case basis.

Please refer to Health Canada's Compendium for Microbiological Analysis for examples of standard methods. To be accepted, a method must be proven to be specific, selective, reliable, and accurate for the active ingredient in the formulated products.

Upper tolerances

To promote safe use and enable compliance verification both at the premarket assessment stage as well as marketplace monitoring and enforcement, upper tolerances for micronutrient guarantees have been established. The tolerances are based on analytical variability associated with product analysis and sampling error as well as attainability based on modern manufacturing practices.

Table 9. Upper tolerances for fertilizers represented to contain micronutrients
Guarantee range Permissible guarantee exceedance
< 0.0033 0.0013
0.0033-0.0099 0.0040
0.010-0.032 0.010
0.033-0.099 0.031
0.10-0.32 0.077
0.33-0.99 0.23
1.0-3.2 0.60
3.3-9.99 1.0
≥ 10 10% of Guarantee

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

Please note that the tolerances vary depending on the range of the micronutrient guaranteed – the tolerance is greater in the low range guarantee and smaller as the concentration in the product is higher. For example, a 0.24% Cu guarantee has a permissible exceedance of 0.077, for a maximum acceptable Cu content of 0.317%. On the upper end 11% Cu guarantee has a permissible exceedance of 10% of the guarantee, in this case 1.1%, for a maximum acceptable Cu content of 12.1%.

Appendix 4: Toxicological hazards characterization

Ingredient identification
Characteristic
Ingredient
Chemical Abstract Number (CAS#)
Relative Concentration in final product
Physical chemical properties
Exposure model inputs Hazard criteria Table Note e 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

Table Note

Table note e

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

Return to table note e  referrer

Mammalian hazard profile
Endpoint by Exposure Route Hazard criteria Table Note f Test organism Term Effect Dose Reference(s)
Oral Acute (LD50, NOEL, NOAEL) LD50 ≤ 500 mg/kg bw
Oral Subchronic LO(A)EL, NO(A)EL LO(A)EL ≤ 90 mg/kg bw
Oral Subchronic LO(A)EL, NO(A)EL NO(A)EL ≤ 30 mg/kg bw
Oral Chronic LO(A)EL, NO(A)EL LO(A)EL ≤ 30 mg/kg bw
Oral Chronic LO(A)EL, NO(A)EL NO(A)EL ≤ 10 mg/kg bw
Dermal Acute (LD50, NOEL, NOAEL) LD50 ≤ 500 mg/kg bw
Dermal Irritation/Sensitization
Inhalation Acute (LD50, NOEL, NOAEL) LD50 ≤ 1500 mg/m3
Ocular Irritation
Carcinogenicity Indication of positive result for these endpoints triggers safety rationale q1*
Clastogenicity and mutagenicity Indication of positive result for these endpoints triggers safety rationale
Reproductive/Developmental Toxicity, Teratogenicity Indication of positive result for these endpoints triggers safety rationale
Endocrine Disruption Indication of positive result for these endpoints triggers safety rationale

Table Note

Table note f

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

Return to table note f  referrer

q1*: cancer potency factor a measure of the relative strength of a non-threshold carcinogen.

Aquatic hazard profile
Category Hazard criteria Table Note g Test organism Term Effect Concn Reference(s)
Vertebrate (for example. 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 (for example Daphnia (Daphnia sp., Ceriodaphnia dubia), Zebra fish (Brachydanio rerio), Worm (Lumbriculus variegatus)) Acute: Lowest EC50 or LC50 < 0.1 ppm
Benthic (for example Amphipod (Hyallela azteca), Midge larvae (Chironomus tentans, Chironomus riparius)) Acute: Lowest EC50 or LC50 < 0.1 ppm
Algae (for example Pseudokrchneriella subcapitata, Champia parvula) Acute: Lowest EC50 or LC50 < 0.1 ppm

Table Note

Table note g

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

Return to table note g  referrer

Appendix 5: Toxicological exposure and risk assessment

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

Mixer/Applicator

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

Bystander/Indirect

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

Environmental

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

ε 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.

Appendix 6: Microbial hazard characterization (checklist)

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

Table Note

Table note h

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

Return to table note h  referrer

Antimicrobial resistance
Hazard Yes/No References
Microorganisms Resistant to medically important antimicrobials Table Note i
Microorganism Contributes to environmental release of antibiotics Table Note i

Table Note

Table note i

For antimicrobial resistance, hazard is determined by classification as high priority or critical importance by the World Health Organization or Health Canada (see Appendix 11).

Return to table note i  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 (for example 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 j

Table Note

Table Note j

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

Return to table note j  referrer

Physiological properties
Category References
Growth parameters (for example 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 k

Table Note

Table Note k

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

Return to table note k  referrer

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

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

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

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

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

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

  1. The headings or statements in bold type must appear on the label, but do not have to be displayed in bold type. The other statements are recommended but not required.
  2. Text in capital letters must be capitalized on the label unless otherwise indicated.
  3. The exact wording of all statements is encouraged but not mandatory as long as the meaning is the same. No contradictory information may appear on the label.
  4. Text in square brackets [ ] is additional information and should not be included on the label.
Corn Gluten Meal
COMMON NAME: CORN GLUTEN MEAL
GUARANTEED ANALYSIS: Corn gluten meal (actual)
APPROVED FOR USE: In specialty lawn/turf fertilizers containing compatible fertilizer constituent materials.
APPROVED CLAIMS:

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: 9500 - 9800 g of corn gluten meal / 100m2
DIRECTIONS FOR USE:

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

Established weeds at time of application will not be inhibited.

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.

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.

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.

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.

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:

KEEP OUT OF REACH OF CHILDREN [on main and secondary panels].

READ THE LABEL BEFORE USING [on main panel].

CAUTION EYE IRRITANT [on main panel].

POTENTIAL SENSITIZER [on main panel].

May cause sensitization.

Avoid contact with skin, eyes or clothing.

Avoid inhaling dusts.

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

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

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

FIRST AID:

IF SWALLOWED: Rinse mouth and throat with copious amounts of water. Do not induce vomiting.

IF ON SKIN/CLOTHING: Take off contaminated clothing. Wash skin with plenty of soap and water.

IF INHALED: Move to fresh air.

IF IN EYES: Hold eye open and rinse slowly and gently with water. Remove contact lenses if present, then continue rinsing eye.

GENERAL: 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.

TOXICOLOGICAL INFORMATION: Treat symptomatically.
STORAGE: Keep in cool, dry conditions, away from seed, fertilizer and other pesticides. Keep away from fire, open flame, or other sources of heat.
DISPOSAL: 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: 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: NONE
APPROVED BRANDS OF PESTICIDE PRODUCTS: Refer to the corn gluten meal section PMRA’s approved brands of pesticide products
Ferrous Sulphate
COMMON NAME: FERROUS SULPHATE
GUARANTEED ANALYSIS: Ferrous Sulphate (actual)
APPROVED FOR USE: In specialty lawn/turf fertilizers containing compatible fertilizer constituent materials.
APPROVED CLAIMS: Controls moss in lawns.
APPLICATION RATES: 250 - 980 g of Ferrous sulphate / 100m2
DIRECTIONS FOR USE:

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:

KEEP OUT OF REACH OF CHILDREN.

READ LABEL BEFORE USING [on main panel].

Harmful if swallowed.

Avoid contact with eyes, skin and clothing.

Avoid breathing dust or spray mist.

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

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:

IF SWALLOWED: Get medical attention or contact poison control centre.

IF IN EYES: Flush with plenty of water and get medical attention or contact poison control centre.

IF ON SKIN: Wash with soap and water.

DISPOSAL: Discard empty container in household garbage.
ACCEPTED COMPATIBLE PESTICIDE ACTIVE INGREDIENTS: None
APPROVED BRANDS OF PESTICIDE PRODUCTS: Refer to the ferrous sulphate section PMRA's approved brands of pesticide products

Appendix 10: Information resources - Toxicology

Canadian Resources

Canadian Centre for Occupational Heal and Safety (CCOHS)

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

Environment and Climate Change Canada

Health Canada

International Resources

United Nations

United States

Appendix 11: Information resources – Microbiology

Canadian departments/agencies

Canadian Food Inspection Agency (CFIA)

Environment and Climate Change Canada

Health Canada/Public Health Agency of Canada

International Resources

American Type Culture Collection (ATCC)

World Health Organization

OECD (Organisation for Economic Co-operation and Development)

  • 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.
  • 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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