T-4-103 – Guidelines for Research Authorizations for Testing of Novel Supplements

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1. Introduction

1.1 Purpose

Supplements that are imported into or manufactured in Canada for experimental purposes are exempt from the Act and all provisions of the Regulations except sections 23.1 to 23.4. This document outlines the requirements to apply for and obtain a Research Authorization (RA) to conduct research trials on novel supplements. Research Authorizations are intended to ensure the safety of the environmental release of the supplement, prescribe confinement conditions, protective equipment, and crop disposal methods.

1.2 Regulation of supplements in Canada

Most supplements, other than those listed in section 3.1 and Schedule II of the Fertilizers Regulations must be registered prior to importation or sale in Canada. In order to obtain a registration, applicants must demonstrate that the product is safe with respect to human, animal, plant health and the environment and properly labelled to avoid misrepresentation in the marketplace. When information necessary to support product registration is not available, applicants may wish to conduct scientific research to gather the data. Since 2013 the Canadian Food Inspection Agency (CFIA) no longer regulates product efficacy; as such substantiation of performance claims is not required at the time of registration. Accordingly, the experimental design of the trial and its statistical relevance are not part of the review conducted by the CFIA for the purpose of granting research authorizations. Nevertheless, product proponents may still wish to test product performance in the field and use the data for marketing purposes. For more information on registration of supplements please refer to the Guide to Submitting Applications for Registration under the Fertilizers Act.

1.3 Types of supplement products

Research Authorizations must be obtained prior to the environmental release of all novel supplements, that is, supplements that are not registered and not exempt from registration or that contain a novel trait. Examples of such products include live microorganisms, wetting agents, plant growth regulators, signaling compounds, humates, etc.

2. Definitions

biotechnology:
means the application of science and engineering to the direct or indirect use of living organisms or parts or products of living organisms in their natural or modified forms
environment:
means the components of the Earth and includes:
  1. air, land and water,
  2. all layers of the atmosphere,
  3. all organic and inorganic matter and living organisms, and
  4. and the interacting natural systems that include components referred to in paragraphs (a) to (c)
fertilizer:
means any substance or mixture of substances, containing nitrogen, phosphorus, potassium or other plant food manufactured, sold or represented for use as a plant nutrient
novel supplement:
means:
  1. a supplement that is not registered and not exempt from registration, or
  2. a supplement that is derived through biotechnology and has a novel trait
novel trait:
in respect of a supplement derived through biotechnology, means a characteristic of the supplement that:
  1. has been intentionally selected, created or introduced into a distinct, stable population of the same species through a specific genetic change, and
  2. based on valid scientific rationale, is not substantially equivalent, in terms of its specific use and safety both for the environment and for human health, to any characteristic of a similar supplement that is in use as a supplement in Canada and is considered safe for use as a supplement in Canada
release:
means any discharge or emission of a supplement into the environment or exposure of a supplement to the environment
supplement:
any substance or mixture of substances, other than a fertilizer, that is manufactured, sold or represented for use in the improvement of the physical condition of soils or to aid plant growth or crop yields

3. Exemptions from Research Authorizations

3.1 Product

Several types of products regulated under the Fertilizers Act and Regulations are exempt from the Research Authorization requirement. Applicants wishing to conduct research trials on the following types of products in Canada may do so without obtaining an authorization from the Fertilizer Safety Section (FSS), CFIA:

  1. Fertilizers that are either exempt or require registration under the Fertilizers Act. This includes nitrogen, phosphorous and potassium fertilizers, micronutrient fertilizers, fertilizer pesticides, etc.
  2. Supplement products exempt from registration under the Fertilizers Act (listed in section 3.1 and Schedule II of the Regulations. This includes products such as composts.)
  3. Supplements that are currently registered and are being tested in accordance with their directions for use. Please note that registered supplements are not exempt from the Research Authorization requirement if the directions for use on their approved product label do not cover the use pattern in the trial (e.g. testing a supplement on food while the label directions for use are limited to ornamental plants).

3.2 Contained research trials

The trigger for regulating research trials on novel supplements is their environmental release. Supplements tested in contained facilities (e.g. laboratories, growth chambers, etc.) where appropriate procedures and measures are taken to minimize the risk of environmental release are taken are exempt from the Research Authorization requirement. Applicants wishing to be exempt from the Research Authorization requirement must apply for a Research Waiver (RW). This requires a detailed description of the facility where the trials are to take place and the procedures used while handling the supplement. Research carried out in greenhouses may or may not be considered contained. To qualify as a contained trial, the greenhouse must be adequately contained to prevent the release and spread of the supplement into the environment. The information requirements to obtain a Research Waiver (RW) include the following:

  1. Name of the supplement: includes concentration or guarantee (e.g. cfu/g), Safety Data Sheets (SDS), and source of the material);
  2. Purpose and objective of the research;
  3. Proposed start date the research will take place;
  4. The species of plants to be treated;
  5. The total amount of product required or imported for the experiment (quantity) including rates, and method of application;
  6. Details outlining the disposal plan of the treated plants and product once testing is completed;
  7. Any other information relevant to the safety of the product. This may include risk to the environment and human health and a description of personal protection equipment to be used while handling the product;
  8. Location, address and description of the facility in which the product will be tested. This includes air handling systems, water and effluent handling systems;
  9. Description of the treatment areas, isolation features and containment procedures;
  10. Handling practices to prevent the accidental release into the environment; and
  11. Qualifications and training of the personnel.

The confinement conditions of each facility are reviewed by the FSS on a case by case basis and, if deemed appropriate, the exemption is granted. If there are any questions about how your facility would be classified, please contact the FSS.

4. Categories of Research Authorizations

4.1 Category A (denoted as Research with No Safety Rationale or RN)

Category A is a streamlined regulatory process which targets testing of supplement products that pose negligible risk to plant, animal, human health and the environment (e.g. rhizobia). Once the trial has been assigned to Category A (based on the information provided on the application form) and the appropriate fees have been received by the FSS, applicants will receive a generic Research Authorization that outlines the conditions of the trial. The conditions prescribed in the Authorization must be adhered to throughout the duration of the trial.

4.2 Category B (denoted as Research with Safety Rationale or RS)

Category B applies to novel supplements that have not been previously assessed by the FSS, are genetically modified, or in some way represent a potential risk or unknown risk to human health or the environment. If deemed necessary, the CFIA may impose specific conditions to mitigate the risk, or refuse to authorize the trial.

Once the appropriate information is reviewed and the fees have been received by the FSS, applicants will receive a Research Authorization which describes the specific conditions of the trial. The conditions prescribed in the Authorization must be adhered to throughout the duration of the trial.

4.3 Category C (denoted as Research Renewal or RE)

Category C is reserved for renewals of past research authorization. Renewals include monitoring of a test site without re-application of the supplement and subsequent years of testing of the same supplement on the same crop group. Additional sites may be added upon applicant's request. A new Category C authorization is required for each additional calendar year in which testing takes place, and can be obtained by filling in the same Application Form as for Categories A and B. For Category C, a signed statement indicating that all parameters of the trial are the same as in the previously granted Authorization is required. The responsible researcher or the applicant must sign the declaration. Once the information and the appropriate fees are received by the FSS, the applicant will receive a Research Authorization containing the same conditions as those set out in the previous year (unless new information has come to light to merit changes).

5. Guidelines for research trials

5.1 General criteria

All research trials conducted on novel supplements in Canada must meet the following general criteria:

  1. Research trials must be conducted by a qualified researcher using scientifically valid methods. The researcher(s) responsible for the field trials must have successfully completed a Bachelor's or higher degree in agriculture or a related scientific field, or have previous experience in carrying out scientifically sound research trials on agricultural products.
  2. Good laboratory practices (GLP) and appropriate quality control procedures must be followed. The company or research institute does not necessarily need to be GLP certified.
  3. The research institution must ensure the safety of its employees throughout the duration of the trial.
  4. The research must be conducted in areas where spread of the supplement being tested outside the test site is not likely to occur (example: via run-off, erosion, drift, leaching, etc.) and bystander exposure to the supplement or to treated plants or soil is limited.
  5. Treated plants, growing media and unused product must not be sold or distributed and all supplement and plant material, including harvested crops, from the treated sites must be safely disposed of at the completion of testing, unless a waiver from the crop destruct requirement has been granted by the FSS (please see below for more details). Applicants are required to propose a method of safe disposal which may vary based on the nature of the supplement (microbial vs. chemical), the probability of its spread and establishment in the environment, and the relative risk associated with the release. For further guidance on safe crop disposal methods please contact the FSS, CFIA.

5.2 Crop Destruct Waiver (CDW)

The crop destruct requirement may be waived by the FSS if an appropriate comprehensive safety assessment (denoted as Data with Safety or DS) has been conducted, and the supplement has been deemed safe when used according to directions. The safety assessment must be completed by the CFIA prior to submitting an application for a Research Authorization and a waiver request. Applications for comprehensive safety assessment for the purpose of obtaining a crop destruct waiver will be placed in the file review queue and will not be accelerated. The CFIA's service delivery standard for a DS is equivalent to a New Registration with Data, found in Appendix B of the Trade Memorandum T-4-122 Service Delivery Standards for Fertilizer and Supplement Registration – Related Submissions under the Fertilizers Act and Regulations.

Applicants that have been granted a waiver from the crop destruct requirement can: 1) conduct farm-scale trials (>1ha); 2) use farmer fields as opposed to research facilities to conduct the testing; and 3) use or sell the treated crop. Please note that crop destruct waivers do not authorize the sale and/or distribution of the supplement product itself.

5.3 Number of applications

For all categories of Authorizations, an application form must be submitted for every year of testing for each product and crop species or crop group. Provided that the product, trial method and crop species or crop group are the same, trials conducted at multiple sites may be reported under the same Research Authorization. If applicants wish to report multiple trials conducted on crops from the same crop group under one application, a scientifically valid rationale demonstrating crop similarity must be submitted to and approved by the FSS. This rationale should include taxonomic or otherwise physiologically relevant evidence indicating that the crop species within the group will respond to the supplement under test in the same/similar manner. Please note that obtaining a research authorization for a crop group does not automatically guarantee that the supplement will be granted registration for that crop group. Safety data may be required for each crop species individually.

6. Documentation required for all trials (RN, RS and RE)

All applicants wishing to conduct research trials on novel supplements must submit the following documentation to the FSS of the CFIA:

a) Application form

All applicants are required to complete the Application for Research Authorization form (Appendix A). This form must be filled out in its entirety and signed by the applicant and the responsible researcher.

b) Experimental-use label

An experimental-use label or information sheet(s) is required to accompany the test product and must be included together with the application form. The purpose of the experimental-use label or information sheet is to ensure that applicators of the product are provided with the appropriate use, handling and disposal instructions. These labels or sheets must also be provided to the researcher in charge, and made available to all workers who will be directly involved in the trial. Once approved by the FSS, the experimental-use label or information sheets must be affixed to the supplement container(s) to be used during the trial. The information should be legibly typed in either official language and should correspond to the directions for use in the intended research project.

The following information is required to appear on the experimental-use label or information sheet accompanying the product.

  • "Read Label Before Using" statement (mandatory)
  • "For Experimental Use Only" statement (mandatory)
  • "Not for sale." "Not for distribution to any person other than a researcher or cooperator" statements (mandatory)
  • Name, product identifier (mandatory)
  • Name and address of the manufacturer (mandatory)
  • Net contents (mandatory)
  • Active ingredient and its concentration or guarantee (mandatory)
  • Directions for use including crop species, method of application and application rate (mandatory)
  • Storage requirements, expiry date (if applicable)
  • Product disposal and (if applicable) sterilization methods (the label should indicate that "any unused product should be returned to the manufacturer unless appropriate sterilization methods are available") (mandatory)
  • Crop disposal method (must correspond to the method prescribed in the Research Authorization) (mandatory)
  • Hazard warnings and precautions (if applicable)
  • First aid information (if applicable)
  • Personal protective equipment during transport, mixing, loading, application, disposal and spill cleanup (if applicable)
  • Method of equipment cleaning or sterilization
  • Name and contact information for the researcher in charge and cooperator (mandatory)

c) Trial Maps

It is the responsibility of the applicant to provide the FSS with the geographical location of the trial site including legal land descriptions and detailed maps. General test locations may be provided with the application forms, but the exact maps must be submitted no later than 21 days after trial establishment. Maps of all field trials must be legible and precise so as to allow CFIA inspectors to locate the trial site this year and in subsequent years, if need be. Maps should be on a blank page with crisp line drawings and block letters. Maps on lined or graph paper, or photocopies of road or topographical maps will not be accepted. The following information must be clearly printed on each map:

  1. The location of the trial site (city, town, province). For trial sites established within town/city limits, include the physical street address. For trial sites established outside town/city limits, include the distances and directions from the nearest town/city, as well as legal land description.
  2. Which direction is North indicated at the top of the page
  3. GPS co-ordinates of the trial site and 3 permanent surrounding landmarks. If this is not possible, a minimum of 3 separate measurements from two permanent nearby landmarks to two of the site corners (to the nearest ½ m) must be provided for precise location of the site.

    Global Positioning System (GPS) coordinates can also be used to mark the outer limits of the test area (example; for a rectangular plot, at the four corners) and three permanent surrounding landmarks. The permanent markers (landmarks) must be found within a 10km radius of the field site. If using a building or other large object as your permanent marker, please be specific as to which part of the building was used as a reference (example; south-west corner of the red barn). In addition, please choose well-spaced landmarks (do not take 3 reference measurements from the same building). Please note, that maps are still required even if trial locations are identified using GPS coordinates (the GPS coordinates should be marked on the map).

  4. Exact trial dimensions and a description of surrounding crops.
  5. The name and phone number of the field contact.
  6. The Submission Control Number designated by the FSS of CFIA (required on the final map only) and treatments present at that trial location.
  7. The date of the trial establishment.

An example of an acceptable map (with and without GPS coordinates) is provided in Appendix B of this document.

7. Documentation required for trials categorized as RN, and RS

a) Trial Design

A description of the trial design and treatment regime is required for trials categorized RN and RS. This includes the total trial size and the individual plot size(s), description of the treatments, number of replicates, seeding rate, and the specific details on the rates and method of application of the novel supplement. In order to mitigate the spread of the supplement in the environment, buffer areas surrounding and between plots may also be required.

b) Constituent materials

All ingredients must be identified including the source and proportion of these materials. Safety Data Sheets (SDS) which serve as basis for preliminary safety evaluation should also be provided for individual ingredients and final product. An SDS should provide a detailed explanation of precautionary and protective measures.

c) Microbial Inocula

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

  1. purpose of the microbial strain;
  2. taxonomic identification of the microorganism to the genus and species level; subspecies, and strain;
  3. analytical results substantiating the taxonomic ID and classification;
  4. methodology used to identify all microorganisms found in the final product;
  5. relationship to known pathogens (e.g. phylogenetic trees);
  6. origin of the microorganism (when, where and from which material it was isolated). If it is an environmental isolate; or strain bank accession numbers if the strain has been deposited in a recognized culture collection, e.g., American Type Culture Collection (ATCC) or other.

d) Manufacturing process and quality control procedures

A brief description of the manufacturing process accompanied by a flow chart used as an overview of the process, together with the quality control procedures implemented to ensure purity of the final product and consistency in production is required. If the information is not available to the applicant, it may be provided directly by the manufacturer of the product. In such cases confidential business information shall not be disclosed to any person or party including the applicant without written authorization of the manufacturer.

e) Crop Disposal

All supplement and plant material, including harvested crops from the treated sites, must be safely disposed of at the completion of testing, unless a CDW has been granted by the FSS. Applicants are required to propose a method of safe disposal, along with a rationale based on the nature of the supplement (microbial vs. chemical), the probability of its spread and establishment in the environment, and the relative risk associated with the release.

Product disposal often involves returning all unused product to the manufacturer for proper destruction (autoclaving, incineration, etc.). Crop destruct methods include, but are not limited to: collection and sterilization of all treated plant material, incineration, landfill disposal, harvesting and burning plant residual material on site, deep burial to a depth of >1m (meter), incorporation into the soil, disposal in accordance with standard provincial and municipal regulations and others.

8. Additional Information required for trials categorized RS, or Category B

In addition to the above mentioned information, including the application form and the experimental-use labels, the following additional information must be submitted for Category B authorizations:

a) Safety rationale

A safety rationale, based on experimental data and/or published scientific literature must be provided for the product and all its ingredients. In this rationale, please identify any potential risks the supplement may pose towards human health and the environment and discuss all studies where adverse effects associated with the use of the active ingredients were reported. Please note that this safety rationale is not considered a "full safety assessment" for product registration and commercial release. Additional information may be required at the time of product registration, or for a crop destruct waiver for certain products.

The following information is required to substantiate the safety of the supplement:

Hazard Characterization

Table 1 below highlights the data required for microbial hazard characterization. Applicants must provide the FSS with information regarding each row of the table, with appropriate reference(s). We recommend that the applicant uses this table as a checklist to assist in providing all relevant information that is required. The information presented should be referenced, and a copy of each referenced publication/documentation or analytical/study report must be provided in the submission.

Table 1: Microbial Hazard Characterization (Checklist)
Organism Hazard Yes/No References
Humans Pathogenicity/Toxicity
Humans Sensitization/Irritation
Humans Dermatophytic potential
Terrestrial plants/crops Pathogenicity/Toxicity
Terrestrial plants/crops Growth inhibition
Non-Target Species:
  • (i) Mammals
  • (ii) Other terrestrial vertebrates (e.g. birds), invertebrates (e.g. bees, earthworms, springtails)
  • (iii) Aquatic vertebrates (fish), invertebrates (benthic, epibenthic) or aquatic plants (algae)
Pathogenicity/Toxicity

Exposure Characterization

The tables below highlight the factors that need to be addressed in order to characterize the exposure to the microorganism. Applicants must provide the FSS with information regarding each row of the table, with appropriate reference(s). We recommend that the applicant uses this table as a checklist to assist in providing all relevant information that is required.

Table 2: Microbial Exposure Characterization – Factors to Consider
Product Use Pattern
Category References
Crops/plants on which the product is intended to be used Experimental-use label or information sheet(s)
Application methodology/equipment Experimental-use label or information sheet(s)
Application rate Experimental-use label or information sheet(s)
Frequency of application Experimental-use label or information sheet(s)
Direct exposure (worker/bystander by dermal, inhalation and ingestion exposure routes) and Indirect exposure (soil, ground water, plant uptake) route(s)
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)
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)
Physiological properties
Category References
Growth parameters (e.g. temperature, pH, osmotic minima, maxima and optima)

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

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

For more guidance in preparing complete and well-structured safety rationales, please refer to Tab 5 in the Guide to Submitting Applications for Registration under the Fertilizers Act.

b) Monitoring plan and procedure

A monitoring plan of the spread and establishment of the supplement in the environment throughout the duration of the trial must be provided. The methodology used to identify and trace the novel chemical or microorganism must be approved by the FSS prior to implementation.

Sampling and testing of non-edible and edible plant parts, in cases where the product may lead to residues in the plant/crop or in cases of endophytic colonization, may also be required as part of the monitoring plan.

Release of some novel supplements for scientific research may require that the experimental site be monitored after termination of the trial. In such cases, the sampling protocols and the analytical methods used to detect and monitor the persistence of the supplement in the environment must be approved by the FSS prior to trial establishment. Once approved, the monitoring plan and procedures shall be included in the Research Authorization as one of the conditions of the release.

If at any point in time during or after completion of the research project, it is determined that the release of the supplement has any adverse effects on plant, animal, and human health or the environment, appropriate measures such as fumigation of the soil and/or post-harvest land restrictions will be implemented at the cost of the applicant and/or responsible researcher.

c) Confinement procedures

A detailed description of the confinement procedures intended to mitigate the establishment and spread of the supplement in the environment must be submitted for research trials conducted both in a greenhouse and in the field. These include but are not limited to descriptions of the packaging of the supplement during shipment and storage, timing and application methods, implementation of buffer zones (if required), research area entry restrictions, equipment cleanup and sterilization, etc. If deemed necessary the CFIA may impose additional confinement conditions on the trials to mitigate the spread of the supplement.

d) Contingency plan

All applicants must provide a contingency plan designed to mitigate any adverse effect(s) of an accidental release of the supplement. This includes a detailed description of cleanup and disposal procedures in cases of accidental spill or release of the product, treated plant material or growing medium contaminated with the supplement.

9. Administrative requirements and submission review procedures

9.1 Submission deadlines

All application packages must be submitted at least 90 days prior to the trial start date. This service delivery standard does not include industry response time (i.e. the time in which a file is on hold waiting for payment, additional information, clarification or confirmation from the applicant).

If submissions are received past the specified deadline, the FSS cannot guarantee that review of the information will be completed in time for the planting season.

9.2 Submission review procedures

All applicants requesting a Research Authorization are required to fill out a generic application form (Appendix A) that provides basic information about the supplement under test and the trial. Based on this information, the FSS assigns an appropriate research category, identified additional information (if any) required, and requests the appropriate fees. The three categories of Research Authorization are described in sections above.

The First Response to the Applications for Research Authorization will be completed within 30 days of their receipt. Once the application form has been assessed, the FSS will assign a Research Authorization Category to the trial, inform the applicant in writing of the decision, and request any additional information (if applicable) and the appropriate fees.

Once the fees are received and the information provided satisfies the requirements of the Regulations, a First Review will be conducted. The FSS will provide a draft of the RA to the applicant to ensure its accuracy and to confirm that it reflects the proposed field trial plan.

Any amendments or changes received from the applicant will then be assessed by the FSS, denoted as a Second Review, and the Research Authorization will subsequently be finalized.

Please note that the research trials cannot commence before receiving the Research Authorization and the trials must be conducted in accordance with the conditions prescribed therein.

9.3 Fees

  1. Category A (RN) – Research program review without a Safety Rationale $250.00 + HST

    This type of review involves an assessment of all applicable safety and field trial information related to the specific research trial.

  2. Category B (RS) – Research program review with a Safety Rationale $500.00 + HST

    This type of review includes an assessment of all applicable safety and field trial information as well as an assessment of the safety rationale of the novel supplement.

  3. Category C (RE) – Research program renewal $100.00 + HST

9.4 Amendments

Amendments to the application or the final Research Authorization must be submitted to the FSS for approval prior to implementation. This includes minor amendments to the application, such as adding or removing trial sites or changes in the total trial area.

10. Importation for research purposes

Applicants wishing to import novel supplements into Canada for experimental purposes must first apply for a Research Authorization. Only if the research trials are authorized may the supplement be imported and the quantity shall not exceed the total amount of product required to conduct the testing. In some cases applicants may also be required to obtain an Import Permit from the Animal and/or Plant Health Import/Export Office, CFIA.

11. Sale and advertising of supplements used in research trials

Unregistered supplements that have been exempt from registration for scientific purposes cannot be sold, distributed or offered for sale in Canada.

12. Inspection

All research trials on novel supplements conducted in Canada may be subject to inspection by CFIA inspectors. The FSS will generate a detailed inspection report form designed to verify compliance of the trial with all conditions prescribed by the Authorization. The CFIA inspectors may require assistance from the researcher/cooperator of the trial to fill out all the required information on the report form. Cooperation of the researchers is greatly appreciated. Following the field inspection, the inspector will send a completed report form to the FSS for review and follow up. Any changes to the research protocol must be submitted to and approved by the FSS prior to trial inspection.

13. Records and data reporting

In addition to monitoring via data collection, the trials must be monitored by the responsible researcher on a regular basis (minimum frequency of once every four weeks). This is to assess the health of the plants, containment of the crop within the field trial plots, and the health of any adjacent vegetation, etc. Treatment plots should also be compared to control plots to identify any potential negative effects of the novel supplement. Observations should be recorded accordingly. The FSS does not provide templates for these observations.

Any unanticipated effect that may be attributed to the release or spread of the novel supplement must be reported immediately upon its observation to the CFIA. If any adverse effects associated with the release of the supplement are noted the CFIA may cancel the research authorization and require corrective actions to mitigate the risks.

14. Contact

Please submit the requested information to the Pre-Market Application Submissions Office (PASO) by email at paso-bpdpm@inspection.gc.ca (please ensure the word "fertilizer" is in the subject line) or by mail. Please provide an accompanying cover letter with the intent of the submission.

For payment, please submit the information directly to PASO via phone, fax or mail.

Pre-market Application Submissions Office (PASO)
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario K1A 0Y9
Telephone: 1-855-212-7695
Fax: 613-773-7115
paso-bpdpm@inspection.gc.ca

Appendix A

Application Form for Research Authorization

Application for Research Authorization Under the Fertilizers Act and Regulations

This document acts as written notification of the proposed release of the novel supplement to the Minister. The information provided in this document is required by the Canadian Food Inspection Agency for the purpose of evaluating the proposed release of the novel supplement. Some information may be accessible or protected as required under the provisions of the Access to Information Act. Information that could cause you or your organization injury if released is protected from disclosure as defined in section 20 of the Access to Information Act.

Please download the Application for Research Authorization CFIA/ACIA 5475.

Note: Application must be received at least 90 days prior to trial establishment. One application is required per product per crop/crop group. Type or print clearly. Leave shaded areas blank.

Statement of Responsibility

  1. The product will be tested in areas where movement out of the test site is not likely to occur (e.g. via run-off, erosion, leaching, etc.) and bystander exposure to the product or to treated plants or soil will be limited;
  2. I will be responsible for, and assume the costs of, the safe disposal of the novel supplement and all crops produced on the land or growing medium to which the novel supplement is applied;
  3. Treated plants, growing media and unused product will not be sold or distributed and crop harvested from the treated plots will be safely disposed of at the termination of the testing; unless a waiver from the crop destruct requirements has been granted by the FSS (please attach a copy of the waiver);
  4. I will notify the researchers and/or the research employees involved in the project regarding the conditions of the authorization and provide them with the experimental-use label or information sheet;
  5. I will immediately notify the CFIA if any new information regarding risks to the environment or to human health associated with the release of the novel supplement come to light;
  6. I will provide official maps of all trial sites to the CFIA no later than 21 days following the commencement of the trial; and
  7. I will immediately report any unanticipated effect attributable to the release of the novel supplement.

Appendix B

Examples of Acceptable Maps

Acceptable Maps Example 1. Description follows.
Description of image – Acceptable Maps Example 1

The following text appears at the top left corner of the image:

Field Trail Subcon# 12345RS
Minto, MB Established 15 May 2007
Surrounding crops: corn, wheat
Field Contact: Joseph Schumaker
320-555-1234

Below the text is a map.

A the top there is an arrow pointing up with an N showing that the top of the map is facing north.

The map shows two lines that intersect at the top left corner of the map. The vertical line represents R.R.#4 and the horizontal line represents Highway 345.

At the bottom of the R.R.#4 line is a box the represents a corner store and the letter G. Towards the top of the R.R.#4 line where the line intersects Highway 345 is the letter F. Toward the bottom of the R.R.#4 line, there is a short line and at the end of the line there is the letter E that represent a house. Above the house, there is a rectangular that represent the plot which is 20mx30m and a letter (A, B, C, D) in each corner. Next to the house on the right there is a box that contains the following text:

GPS Service Provider:
Date/Time of reading:
Below the house, there is a box that contains the following text:
GPS coordinates
Plot
NW corner: A 99 99.99N 99 99.99W
NE corner: B 99 99.99N 99 99.99W
SW corner: C 99 99.99N 99 99.99W
SE corner: D 99 99.99N 99 99.99W
Reference Points
SW corner of house 245 R.R.#4:
E 99 99.99N 99 99.99W
Centre of Intersection of Hwy 345 and R.R.#4:
F 99 99.99N 99 99.99W
NE corner of Corner Store 367 R.R.#4:
G 99 99.99N 99 99.99W

Acceptable Maps Example 2. Description follows.
Description of image – Acceptable Maps Example 2

The following text appears at the top left corner of the image:
Field Trail Subcon# 12345RS
Minto, MB Established 15 May 2007
Surrounding crops: corn, wheat
Field Contact: Joseph Schumaker
320-555-1234

Below the text is a map.

A the top there is an arrow pointing up with an N showing that the top of the map is facing north.

The map shows two lines that intersect at the top left corner of the map. The vertical line represents R.R.#4 and the horizontal line represents Highway 345.

20 m from Highway 345 on R.R.#4, there is a Hydro Pole #3 and 45m to the right of this pole there is a Plot 20mx30m. 85m from Highway 345 on R.R.#4, there is a driveway of 31m and at the end of the driveway there is house, where the address is 245 R.R.#4, Minto, MB

Appendix C

Submission Completeness Checklist for Research Authorizations

Submission Completeness Checklist for Research Authorizations – PDF (128 kb)

Documentation Required for all Research Trials – RN, RS, and RE (Categories A, B and C)

Additional Documentation Required for RN, and RS (Categories A and B)

  • Description of trial design and the treatment regime for the trials. This should include specific details on the rates and method of application of the novel supplement.
  • Constituent materials: identification and description of all materials used in the production of the end-product, the source and proportion of these materials (include all extenders, carriers, etc.).
  • SDS for ingredients and/or final product, including precautions and protective measures.
  • For microorganisms: provide the purpose of the microbial strain; taxonomic identification of the microorganism to the genus and species level, subspecies, and strain; methodology used to identify all microorganisms found in the final product; relationship to known pathogens; and the origin/source from which they were obtained (environmental isolate or strain bank accession numbers, if the strain has been deposited in a recognized culture collection).
  • Method of manufacture and quality control procedures in place to ensure consistency in production and freedom of the final product from contaminants at levels which may be harmful to human health, plant health or the environment.
  • Detailed method(s) of crop disposal to be implemented following the trial period. As per T-4-103, crop destruction waivers are administered outside of the research authorization process and will not be accelerated to meet service delivery timelines associated with research applications.

Additional Documentation Required for RS (Category B)

  • Rationale for product safety: identify potential risks the supplement may pose towards human health and the environment, supported by data or literature.

Hazard Characterization: Human, Terrestrial plants/crops, and Non-target species. Please refer to Table 1 for more information.

Exposure Characterization: Product use pattern, Natural occurrence, Description of life cycle, and Physiological properties. Please refer to Table 2 for more information.

For additional guidance, please see Tab 5 of the Guide to Submitting Applications for Registration.

  • Monitoring Plan and Procedure: A monitoring plan of the spread and establishment of the supplement in the environment throughout the duration of the trial must be provided.
  • Confinement Procedures: This includes but are not limited to descriptions of the packaging of the supplement during shipment and storage, timing and application methods, implementation of buffer zones (if required), research area entry restrictions, equipment cleanup and sterilization, etc.
  • Contingency Plan: This includes a detailed description of cleanup and disposal procedures in cases of accidental spill or release of the product, treated plant material or growing medium contaminated with the supplement

The Fertilizer Safety Section reserves the right to require additional information, data, rationale or results of analysis to support the issuance of a research authorization for any novel supplement as regulated under the Fertilizers Act and Regulations.

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