PMRA Guidance Document, Value Guidelines for New Plant Protection Products and Label Amendments

Health Canada – Pest Management Regulatory Agency
27 July 2023

Summary

This document outlines the general principles of pesticide value assessment in Canada. It describes the types of information that could be provided to register new plant protection products and to support label amendments, and provides guidance on summarizing value information prior to submission to the Pest Management Regulatory Agency (PMRA).

Document history (revision/update)

Updated:	Update/Rationale:
July 2023	Updated to current formatting guidelines and to make minor amendments to be consistent with the PMRA Guidance Document, Tank Mix Labelling (16 March 2023).
April 2016	Initial creation. This document replaced Regulatory Directive DIR2003-04, Efficacy Guidelines for Plant Protection Products and incorporated information presented in Regulatory Proposal PRO2010-07, Value Guidance – Benefit Information and Use History as well as stakeholder comments on Regulatory Proposal PRO2010-07. The information in this document reflects the value approach that the PMRA has implemented as described in DIR2013-03, Value Assessment of Pest Control Products.

Introduction

The purpose of this document is to outline the general principles of pesticide value assessment in Canada. It describes the types of information that could be provided to register new plant protection products and to support label amendments, and provides guidance on summarizing value information prior to submission to the Pest Management Regulatory Agency (PMRA).

The value of a pest control product, as defined by the Pest Control Products Act, refers to the product's actual or potential contribution to pest management, taking into account its conditions or proposed conditions of registration. This includes the product's efficacy, effect on host and rotational crops, health, safety and environmental benefits, and social and economic impact. The value assessment is an evaluation of these various components and provides the baseline for health and environmental risk assessments, and risk management decision making. In determining acceptable value, a weight of evidence approach is taken that considers all the factors that may contribute to a product's value.

Previously, the PMRA relied primarily on efficacy information to establish the value of proposed uses of pesticides. The current approach is based on the weight of evidence from both efficacy and benefits information. It can include information on various components, which includes experimental data generated from research trials, use history information from other jurisdictions, existing scientific literature, scientific rationales and benefit information. The PMRA's approach to value assessment was developed in consultation with stakeholders and in consideration of approaches by other regulatory agencies. The consideration of the definition of value as stated in the Pest Control Products Act provides flexibility in fulfilling information requirements, which will help reduce the regulatory burden for applicants. It will also provide opportunities for alignment with Organisation for Economic Co-operation and Development (OECD) countries and increase efficiency of the value assessment process.

This value guidelines document is meant to serve as a general guideline and should be interpreted as such. As the specific details regarding the use of a pest control product can vary, there is a need for flexibility in interpretation and application of the guidance regarding the manner in which value requirements can be addressed. The guidelines in this document are primarily for applications to register pesticide products based on new or registered active ingredients and to amend the labels of currently registered pesticide products (for example, to add a new crop or pest).

This document consists of two parts: general principles and considerations for value assessments and preparation of the value information package. Under considerations for value assessments, guidance is provided regarding benefit and efficacy information that could be used to support an application to register a new use or to add new uses to registered labels. Benefit information is discussed with some examples to clarify the kind of information that may be provided to the PMRA. The section on efficacy includes guidance on conducting research trials, information on rate justification, extrapolation principles, and updated approaches to value assessments for certain types of applications. The second part provides information on the importance of pre-submission consultations and guidance for organizing the various elements of the value package.

Information provided in this document applies to all pesticide uses for plant protection products. Applicants should also consult published guidelines for specific uses, where appropriate, such as guidelines for non-conventional products (PMRA Guidance Document, Registration of Non-Conventional Pest Control Products). Guidance for antimicrobial pesticides and structural pesticides will also be available on the Policies and Guidelines page on Canada.ca.

For more information please contact the Pest Management Information Service.