Overview of requirements for research involving pheromone and other semiochemical active ingredients

Note: This document is meant to provide a brief summary of the requirements for a research authorization or exemption. It does not replace the more detailed description in the PRO2002-02: Guidelines for the Research and Registration of Pest Control Products Containing Pheromones and Other Semiochemicals or the criteria set out in the Pest Control Product Regulations.

Types of submissions

Pest control products containing pheromone and semiochemical active ingredient(s) may qualify for either a research authorization or exemption. There are no research notifications for pheromones and semiochemicals. All research involving human test subjects require a Research Authorization.

Criteria for a research authorization exemption

1. If the proposed research is conducted solely in a laboratory, it is exempt from requiring a research authorization.
2. The proposed research is also exempt from requiring a research authorization if it meets all the following criteria:
   1. It does not involve human test subjects.
   2. It does not involve aerial application.
   3. It does not involve the application of a pest control product to water.
   4. It does not involve the use of a pest control product in any of the following areas: greenhouses, residential areas (including lawns, gardens, parks), industrial premises and food-handling areas.
   5. It does not involve the use of a pest control product for either structural pest control or fumigation.
   6. 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.
   7. For active ingredients other than an arthropod pheromone:
      • For a pest control product containing an unregistered active ingredient other than an arthropod pheromone,application of the test product is carried out by the researcher alone on a maximum of 5 hectares (ha) of land owned or operated by the research establishment.
      • For a pest control product containing a registered active ingredient other than an arthropod pheromone,application of the test product is carried out by the researcher or co-operator on a maximum of 10 ha of land owned or operated by the research establishment or co-operator.
      • For active ingredients that is an arthropod pheromone:
        1. the application of the product is carried out on a maximum of 100 ha of land owned or operated by the research establishment or co-operator and the maximum use rate does not exceed 375 g of active ingredient/ha/year; and
        2. if used in a food or feed crop, the pheromone is contained in an affixed solid matrix dispenser or in a retrievable-sized polymeric matrix dispenser and the dispenser is not in direct contact with the crop.

Criteria for a research notification

A research notification is not possible for pest control products containing a pheromone or semiochemical.

Criteria for a research authorization

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

Timeframes for review

The timeframes for reviewing a research authorization application 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.

Documentation required for research authorizations

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

1. cover letter;
2. e-Index;
3. completed Application for Research Authorization;
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;
9. Data may also be required. Refer to Section 4.2 in PRO2002-02: Guidelines for the Research and Registration of Pest Control Products Containing Pheromones and Other Semiochemicals.

Sale of products under research

Pest control products which are not registered under the Pest Control Products Act and its 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 pest control product for the unregistered uses under research.

Expiry date

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

Applicant responsibilities after the issuance of a research authorization

After the issuance of a research authorization:

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 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 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 PMRA. 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 are not transferable.