PMRA Guidance Document, Guidance for the Registration of Microbial Pest Control Agents and Products
Health Canada - Pest Management Regulatory Agency
17 November 2021
Summary
This guidance document outlines the requirements for the registration of microbial pest control agents (MPCAs) and end-use products proposed for pest management in Canada at this time. MPCAs are naturally occurring or genetically modified microorganisms, including bacteria, algae, fungi, protozoa, viruses, mycoplasmae or rickettsiae, and related organisms.
| Updated: | Update/Rationale: |
|---|---|
| November 2021 | Revised to update content and wording to align with current requirements for registration of microbial pest control agents and their products. This document replaces DIR2001-02, Guidelines for the Registration of Microbial Pest Control Agents and Products. |
| March 2001 | Publication of original document: DIR2001-02, Guidelines for the Registration of Microbial Pest Control Agents and Products. |
Purpose
The purpose of this document is to provide guidance on the scientific and technical information required to register MCPAs and associated pest control products. The information presented for MPCAs and end-use products should be considered as supporting information to the Pest Control Products Act and Pest Control Products Regulations. Applicants should carefully review this document and consult with the PMRA prior to making a registration submission.
The registration requirements outlined in this guidance document were developed to address the assessment of human health risk, environmental risk, and value of end-use products that contain naturally occurring and genetically modified bacteria, algae, fungi, protozoa, viruses, mycoplasmae or rickettsiae, and related organisms, as the active ingredient. Because of the specific nature of these active ingredients, PMRA's assessment of these products includes an evaluation of aspects such as product characterization, manufacturing and quality control, which are distinct from those of conventional pest control products. In other words, the organization of the information parallels that for conventional pest control products while taking into account unique aspects of these types of active ingredients, such as biological properties, host range, potential pathogenicity, infectivity and the abilities to persist, multiply and disseminate in the environment.
Because MPCAs represent a diverse range of microorganisms, not all studies or data requirements may be appropriate for a specific microorganism. Applicants should consider the unique characteristics of their microorganism when addressing specific data requirements and protocols, and are encouraged to consult with the PMRA before testing begins. In addition, waivers requests for certain data requirements will be considered when accompanied by a sound scientific rationale.
Health Canada's PMRA and the United States Environmental Protection Agency (USEPA) are committed to joint reviews and work sharing of microbial pesticide evaluations on a regular basis. Consequently, the PMRA and the USEPA have established a process for the joint review of microbial pest control products for which the proposed use pattern is common to both countries. Joint reviews increase the efficiency of the registration process, facilitate simultaneous registration in Canada and the United States, and increase access to new pest management tools in both countries. Efficient work sharing requires a shared understanding of the responsibilities of each agency, as well as common procedures and time frames. For additional information, please consult the document NAFTA Technical Working Group on Pesticides: Procedures for Joint Review of Microbials and Semiochemicals, which can be found on the Pesticides section of Canada.ca.
For more information, please contact the Pest Management Information Service.