Overview of requirements for research involving a microbial active ingredient

Note: This document is meant to provide a brief summary of the requirements for a research authorization or research notification. It does not replace the more detailed description in the PRO93-05: Research Permit Guidelines for Microbial Pest Control Agents or the criteria set out in the Pest Control Product Regulations.

Types of submissions

Pest control products containing microbial active ingredient(s) may qualify for either a research authorization, research notification, or an exemption.

The only time a pest control product containing microbial active ingredients(s) is exempt from requiring a research authorization or research notification is when the research is conducted solely in a laboratory and does not involve human subjects.

Criteria for an exemption

The proposed research is conducted solely in a laboratory and does not involve human subjects.

Criteria for a Research Notification

For a pest control product containing microbial active ingredient(s) to be eligible for a research notification, the research must meet the following criteria:

1. It does not involve human test subjects.
2. It does not involve aerial application.
3. It does not involve the use of a pest control product that contains a formulant that is on Part 1 of the List of Pest Control Product Formulants and Contaminants of Health or Environmental Concern or a contaminant that is on Part 3 of that List.
4. The micro-organism is indigenous to the area where it is intended to be used.
5. The application of the pest control product is carried out:
   1. on a maximum of 10 hectares (ha) of land per ecozone owned or operated by the research establishment
   2. on a maximum of 1 ha of surface area per ecozone for bodies of water that are wholly contained on land owned or operated by the research establishment.
6. With the exception of pest control products containing Bacillus thuringiensis registered for use on agricultural crops, treated food and feed crops from research sites and meat, milk and eggs must not be sold (i.e., crop destruct).

Criteria for a research authorization

If the proposed research does not meet the criteria for a research notification or exemption, then an application for a research authorization must be submitted.

Timeframes for review

The timeframes for reviewing an application for a research authorization are as follows:

1. Pest control product containing an unregistered active ingredient is 180 days.
2. Pest control product containing a registered active ingredient is 90 days.

Please note: In situations where a pest control product contains both registered and unregistered active ingredients, the longer timeframe will be required.

The timeframe for reviewing a research notification containing either a registered or unregistered active ingredient is 30 days.

Documentation required for research authorizations and research notifications

The basic documentation required to be submitted for each application for a research authorization and research notification is:

1. cover letter;
2. e-index;
3. completed Application for Research Authorization or Notification of Pesticide Research;
4. completed Statement of Product Specification form (Forms – Registrants and applicants) which can be sent directly to the Pest Management Regulatory Agency (PMRA) by the manufacturer;
5. electronic proposed experimental label which is specific to the research;
6. research plan (including site information, list of co-operators, etc., if applicable);
7. completed Fee Form (Forms – Registrants and applicants) and the appropriate fee;
8. Material Safety Data Sheets; and
9. Data may also be required. Refer to Section 5 in PRO93-05: Research Permit Guidelines for Microbial Pest Control Agents.

Sale of products under research

Pest control products which are not registered under the Pest Control Products Act and Pest Control Products Regulations will not be eligible for sale under a research authorization. For a currently registered pest control product, it is not permissible to sell that product for the unregistered uses under research.

Expiry date

A Research Authorization/Notification Certificate expires on 31 December of the year in which it is issued unless another expiry date is specified in the Certificate. Research authorizations/notifications are not renewable.

Applicant responsibilities after the issuance of a research authorization and research notification

After the issuance of a research authorization or research notification:

1. It is the responsibility of the applicant to ensure that all label revisions requested by the PMRA are made and that all conditions of the research authorization and research notification are followed.
2. Certain provinces may require a provincial authorization to conduct any research with pest control products. It is the responsibility of the applicant to ensure that this documentation has been obtained.
3. For pest control products being imported, it is the responsibility of the applicant to ensure that appropriate documentation has been obtained. A Declaration by Importer of Control Products form must be completed. It is also recommended that border services be contacted to ensure that all documentation has been obtained.
4. It is the responsibility of the applicant to ensure that co-operator information is submitted to the PMRA and the appropriate PMRA Regional Offices prior to application of the test product.
5. For all field research activities including those that do not require an authorization, there should be appropriate warning signs posted adjacent to the treated site.
6. All field research programs are subject to audit by staff of the Pest Management Regulatory Agency. The researchers and co-operators must provide any information requested.
7. A research establishment must keep records that contain:
   1. the name and quantity of every pest control product used,
   2. the name of researchers and co-operators,
   3. the test locations of the research sites,
   4. a description of the application methods, and
   5. the test data generated.
8. Research authorizations/notifications are not transferable.