Submission Preparation Training - Guide to Submitting Applications for Registration under the Fertilizers Act
4. Information Requirements to Support Registration
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Levels of safety assessment
4.1 Administrative Forms and Fees (Level I, II and III)
This section outlines the five administrative requirements for an application for registration.
1. Include in the Cover Letter:
- Type of submission (new, renewal, amendment)
- Registration Levels (I, II, or III)
- Reference to any applicable submission control number(s) or registration number(s)
- Intended end-use of the product (e.g. agricultural, greenhouse, residential lawn, or indoor plant applications, further manufacturing etc.)
2. Application Form:
- The application form is in Schedule III of the Fertilizers Regulations
- Complete accurately and in its entirety.
- Information on the application form must match the information on the label
- The Fertilizer and Supplement Registration Application Form and the "Guidelines to Completing the Fertilizer or Supplement Registration Application Form" documents are available on the CFIA website.
3. Signing Authority:
To be authorized to sign an application form, you need to:
1) Provide a letter of patent or certificate of incorporation with a list of directors. The person who signs the form must be on the board of directors or on the certificate of incorporation.
If the person who will sign the registration form is not a member of the Board of Directors, then a letter is required from a member authorizing this person to sign on behalf of the company.
2) OR provide a letter signed by an individual with signing authority, identifying the persons authorized to sign the applications for registration.
A corporation may also appoint a person to be a delegated representative (may correspond with CFIA but may not sign the application form)
4. Resident Canadian Agent:
For applicants residing outside Canada, a resident Canadian Agent must be designated, by completing the form "Declaration of Resident Agent Form" found on the CFIA website.
- The Canadian Agent must be a person, not a company;
- The Canadian Agent must be a permanent resident of Canada;
- Any CFIA notice or correspondence may be sent to the Agent.
The declaration must be signed before a justice of the peace, etc.
Defined: any non-related person who is at or above the age of majority in the relevant province and who is of sound mind.
5. Registration Fees:
- The registration fee must accompany the submission.
- All fees, expect an application for registration and an application for re-registration, are subject to the Harmonized Sales Tax (13% HST).
- The fee is payable to the "Receiver General for Canada".
- We accept cheque, money order, or major credit card.
|Renewal of Registration||$250|
|Safety Data review||$500|
|Amendment (other than minor)||$350|
|Research review without safety assessment||$250|
|Research review with safety assessment||$500|
|Research program renewal||$100|
Submit required information either by email (ensure the word "fertilizer" is in the subject line) or by mail.
Pre-Market Application Submissions Office (PASO)
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, ON K1A 0Y9 Canada
Email: firstname.lastname@example.org (January 2016)
4.2 Proposed Marketplace Label (Level I, II and III)
The following is required on product labels:
- Name and address of manufacturer or registrant
- Brand name (optional)
- Name of fertilizer or supplement
- Registration number
- Guaranteed minimum analysis of active ingredients
- Directions for use
- Weight of fertilizer or supplement
- Precautionary statements (MSDS)
- Lot number
- Expiry date, for supplements
Supplement Guaranteed Analysis:
- Active ingredients expressed in percent (%);
- Genus and species of active microorganism;
- Minimum number of active viable cells per gram (i.e. cfu or spores /g).
Labeling requirements vary depending on the product type
4.3 Product Specification (Level I, II and III)
This section outlines four product description requirements necessary for product registration.
1. List of Ingredients
Identification, description, and purpose of all materials used in the production of the end-product, including:
- Name and purpose of the material
- Source of materials:
- Country of Origin;
- Origin of material (by-product of another process, mined, synthesized, harvested e.g. seaweed)
- CAS #'s, if applicable
- Concentration of materials in the final product
- MSDS for ingredients and final product
For products that contain microorganisms:
Identification of the Microorganism
- Purpose of the microbial strain
- Relationship to known pathogens
- Identification and taxonomic classification (genus, species, strain) with an analytical report substantiating the identification
- Origin: when, where, environmental isolate or certificate from repository i.e. American Type Culture Collection (ATCC), Canadian Collection of Fungal Cultures (CCFC)
For products that contain GM microorganisms:
Additional Data includes:
- Flow diagram of the genetic modification
- Description of the gene product(s), function and properties
- Description of the metabolic pathways altered by the insertion
- Unintended effects on gene expression
- Stability of the inserted genetic material
- Horizontal gene transfer potential
- Procedures and tests to detect and quantify the modified microorganism
2. Method of Manufacture
- Description of production/formulation/blending process
- Description must specify each production step and associated conditions such as temperature, pressure, process time
- Identify raw materials, and point of incorporation
- Identify chemical reactions, and potential for reaction of by-products
- A flow chart diagram
3. QA/QC Procedures
Provide Quality Assurance / Quality Control (QA/QC) procedures used during the manufacture of the product to ensure consistency in production, and purity of the final product. For example:
- Indication of materials being tested (raw, intermediary or final product)
- Testing frequency (per batch or unit time)
- Monitoring manufacturing conditions (time, pressure, moisture content)
- Point of sampling/monitoring during production
- Substantiation of the conformance of raw materials to standards (with analysis or accreditation i.e. ISO)
- Sensitivity of test methods; and identification of "pass" criteria
Purity of Inoculum
QA/QC used to monitor, identify, and purify the microorganism from the seed stock (primary inoculum); including company name/address that keeps the seed stock
QA/QC used to monitor the final inoculum (used as an ingredient in the final product)
QA/QC used to monitor the final product
4. Other Qualities
Physical characteristics of the final product (e.g. granular, liquid, particle size, colour and odour, density, melting point, boiling point, pH, solubility, size guide number etc.)
4.4 Results of analysis (Level II and III)
This section specifies the product-based results of analysis (RoA) that are required for product registration.
Arsenic (As), Cadmium (Cd), Cobalt (Co), Copper (Cu), Chromium (Cr), Mercury (Hg), Molybdenum (Mo), Nickel (Ni), Lead (Pb), Selenium (Se), and Zinc (Zn).
The number of metals analyses corresponds to the total number of batches/lots of product manufactured within a three (3) year interval
Salmonella (must be absent / non-detectable).
Faecal coliform (levels must be below 1000 MPN per gram).
4 sets of analyses from 4 different lots/batches of the final product for Faecal coliforms and Salmonella.
|Dioxins and Furans:||1 set of analysis for the seventeen (17) most toxic congeners|
|Fertilizer or Supplement||Compliance Analysis|
|Biochar||Metals, Dioxins and furans|
|Humic and fulvic acids||Metals|
|Seaweed||Metals, indicator organisms|
|Cement Kiln dust||Metals, Dioxins and furans|
|Compost and meals||Metals, indicator organisms|
|Processed sewage including composts||Metals, indicator organisms, dioxins and furans thereof, pulp and paper sludge|
|Wood ash||Metals, dioxins and furans|
Not a comprehensive list and source dependent
- Samples must be taken at intervals enabling assessment of the consistency in production (e.g. regular time intervals, upon receipt of raw materials, per lot/batch, every 2 weeks for continuous or semi-continuous batches)
- Indicate the number of batches produced annually and the manufacturing date of each batch analyzed.
- RoA to be printed on lab letterhead, bear signature of the analyst, indicate sample preparation methods, method of analysis, and limits of detection
4.5 Safety Rationale and Supplemental Data (Level III)
1. Hazard Assessment
Identification and characterization of potential adverse effects on human, animal and plant health, and the environment
2. Exposure Assessment
Predicts the extent and duration of the exposure
3. Risk Assessment and Mitigation Measures
The risk assessment is based on the hazard, and what is known about exposure Risk = Hazard x Exposure
A) Toxicological Risk Profile
Toxicological Hazard Characterization
The applicant is responsible to identify all potential hazards associated with each ingredient in the product, including:
- Human Health Hazards:
Acute (oral, dermal, inhalation); Subchronic (oral); Irritation (ocular, dermal); carcinogenicity; reproductive and developmental toxicity; endocrine disruption
- Environmental Hazards:
Aquatic hazard profile (toxicity to vertebrates, invertebrates, benthic organisms, and algae)
To assist in this characterization, all fields in Appendix 4 (in the supporting Guide) must be completed for all ingredients.
Toxicological Exposure Assessment
The applicant is responsible to provide the exposure assessment for all ingredients and potential contaminants. Factors to consider include:
- Routes of exposure: direct (applicator/user) and indirect (bystander, groundwater, contaminated soil contact, and food/feed consumption)
- Intended use patterns (e.g., agricultural field use vs potting mixes; ornamental plant species vs food crops)
- Application rate and frequency of application
- Protective measures, such as personal protective equipment, re-entry restrictions, and post-harvest intervals
- Must consider worst case exposure scenarios/studies
All fields in Appendix 5 (in the supporting Guide) for all constituent materials for which a high hazard level has been identified (Appendix 4) must be completed.
Toxicological Risk Assessment
The applicant is responsible to provide estimates of risk by combining the hazard characterization with exposure assessment.
The risk estimates derived by the applicant are subject to review and validation by the Fertilizer Safety Section (FSS) and additional information/ test data may be required in order to refine the exposure and hazard assessments and/or further mitigative measures may be imposed to facilitate safe use of the product.
Risk = Hazard x Exposure
B) Microbial Risk Profile
Microbial Hazard Assessment
The applicant is responsible to identify all potential hazards associated with the microorganism, including:
- Human, Animal and Plant Health Hazards:
- Toxin production potential
- Pathogenicity profiles
- Allergenicity / Sensitization potential
- Environmental Hazards:
- Effects on target and non-target species
- Resistance to adverse environmental conditions (e.g., cold tolerance)
- Resistance to selectable traits (antibiotic, heavy metal resistance)
To assist in this characterization, all fields in Appendix 6 (in the supporting Guide) must be completed.
Microbial Exposure Assessment
The applicant is responsible to provide the exposure assessment of the microorganism. Factors to consider include:
- Natural occurrence (e.g. geographical distribution, hosts)
- Physiological properties (e.g. growth parameters - temp, pH)
- Description of the life cycle, including potential for dispersal
- Product use pattern, and expected routes of exposure (e.g. dermal, inhalation, ingestion)
To assist in the exposure assessment, applicants must complete all fields in Appendix 7 (in the supporting Guide).
Microbial Risk Assessment
The risk assessment conclusion is based on the hazard and exposure. The FSS will review and validate the risk estimates derived by the applicant and additional safety data may be required.
Considerations for classification of microbial hazard severity and exposure levels are summarized in Appendix 8 of the guide, for your information.
Where appropriate, any preventative risk mitigation measures may be required.
Example of a Precautionary Statement:
"This product may contain fungi and/or bacteria and may cause adverse effects in individuals who are allergic to certain microorganisms including moulds and otherwise immunocompromised individuals. Avoid exposure through inhalation or open wounds and eyes. Wear standard protective clothing and equipment during product handling and storage. Use this product in well ventilated areas"
In cases where information or elements of it are not available for a given ingredient, information pertaining to a similar substance or microorganism may be submitted (surrogate data).
This requires a rationale demonstrating similarity between the substances of interest and its surrogate including all relevant characteristics (physical, chemical, or toxicological).
Surrogate data for microorganisms must be substantiated by a comparison of the organism under review and its surrogate with respect to pathogenicity, toxigenicity and its behaviour in the environment (persistence, life cycle, invasiveness etc.)
List of Products Requiring a Safety Rationale and Supplemental Data (Level III assessment)
- Polymeric soil stabilizers and wetting agents
- Registerable supplement(s)
- Nano-encapsulated fertilizers and nano-materials
- Plant growth regulators (other than IBA)
- Inoculant extenders sold with an inoculant
- Viable microorganisms
- Metabolites of organisms
- Plant signalling compounds (e.g. LCOs, Hesperetin, Naringenin)
Note: this is not a comprehensive list
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