Overview of requirements for research involving a chemical 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 DIR98-05: Chemical Pesticides Research Permit Guidelines or the criteria set out in the Pest Control Product Regulations.

Types of submissions

Pest control products containing chemical active ingredient(s) may qualify for either a research authorization, research notification or an exemption. In addition to this document, Appendix IV in DIR98-05: Chemical Pesticides Research Permit Guidelines provides detailed information on these categories.

Laboratory trials

Research conducted solely in a laboratory is exempt from requiring a research authorization or research notification unless the research involves human test subjects. All trials using human test subjects require a research authorization.

Restrictions relevant to both research notifications and exemptions

Research notification and exemptions are only possible if:

1. It does not involve the application of a pest control product applied to a body of water or where runoff water may remove residues from the research site.
2. It does not involve human test subjects.
3. It does not involve the use of an antimicrobial agent.
4. It does not involve aerial application.
5. It does not involve the use of a pest control product in any of the following areas:
   • greenhouses,
   • residential areas (including lawns, gardens and parks),
   • industrial premises, and
   • food-handling areas.
6. It does not involve the use of a pest control product for either structural pest control or fumigation.
7. 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.
8. Treated crops are not sold for human consumption or for feed for meat or dairy animals, or for chickens or other fowl that supply eggs for human consumption, unless the residues conform with the existing maximum residue limits (MRLs) as defined in Division 15 of the Food and Drugs Regulations.
9. For registered active ingredients, there is reasonable expectation that the research will not increase occupational exposure above the level that is expected when the pest control product is used in accordance with its conditions of registration. This may include new formulations and new uses of a registered active ingredient. New uses with potential to increase worker exposure include those that involve a major change in use-pattern or within a use-pattern, significant changes in application methodology, or bystander access.

Additional criteria for an exemption

1. For pest control products containing an unregistered active ingredient, the application of the test product is carried out by the researcher alone:
   1. on a maximum of 5 hectares (ha) of land owned or operated by the research establishment; or
   2. on a maximum of 1 ha or 5% of the total area of the crop under research, whichever is less, for land owned or operated by a co-operator
2. For pest control products containing a registered active ingredient, the application of the test product is carried out by the researcher or co-operator on a maximum of 10 ha or 20% of the total area of the crop under research, whichever is less. The land used in the trial may be owned or operated by the research establishment or co-operator.

Additional criteria for a research notification

1. For pest control products containing an unregistered active ingredient, the application of the test product is carried out by the researcher alone:
   1. on 5 to 50 ha of land owned or operated by the research establishment or
   2. on 1 to 5 ha of land owned or operated by a co-operator
2. For pest control products containing a registered active ingredient, the application of the test product is carried out by the researcher or co-operator on 10 to 50 ha of land owned or operated by the research establishment or co-operator.

Criteria for a research authorization

If the proposed research does not meet all the criteria for a research notification or exemption, then an application for a research authorization must be submitted. As well, refer to Appendix I in DIR98-05: Chemical Pesticides Research Permit Guidelines for limitations on research authorizations.

Timeframes for review

The timeframes for reviewing 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 product contains both registered and unregistered active ingredients, the longer timeframe will be required.

The timeframe for reviewing a research notification involving 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 6003 (Forms – Registrants and applicants) which can be sent directly to the 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 6011 (Forms – Registrants and applicants) and the appropriate fee;
8. Material Safety Data Sheets; and
9. Data may also be required. Refer to Appendix I, IIA and IIB in DIR98-05: Chemical Pesticides Research Permit Guidelines

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 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 Pest Management Regulatory Agency (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. It is also recommended that the Canada Border Services Agency 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 PMRA staff. 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 products 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.