PMRA Guidance Document, Guidance for User Requested Minor Use Label Expansion

Health Canada – Pest Management Regulatory Agency
28 July 2022

Summary

This document informs the provinces and territories, registrants, user groups, and other stakeholders about the PMRA’s policy governing the URMULE program. This document describes the criteria, data requirements, and process for the addition of new minor uses to technical grade active ingredients and end-use products currently registered in Canada.

This document replaces the publication, Regulatory Directive DIR2001-01, User Requested Minor Use Label Expansion.

Document history (revision/update)

Updated

Update/Rationale

10 March 2022

Update to content and requirements.

Previous version dated 14 February 2001

Updated to provide current information and regulations to users.

The URMULE program

“Minor use” pesticides are crop-protection products – typically fungicides, insecticides, and herbicides. Usually, they are applied to low acreage, high-value crops, or where pest control is only required for a small portion of the overall crop acreage. These crops include vegetables, fruits, specialty crops, herbs, and spices, and nursery and landscape plants, and flowers. Often, these crops are of high-value, and are sometimes called “minor crops”; they are grown on significantly smaller areas of land compared to the large acreages of crops like corn, canola, soybeans, and wheat. Specific minor uses of a product lead manufacturers to conclude that projected sales will be too low to justify the support of a Canadian registration. Consequently, these products or use of a product may not be accessible to Canadian growers who consider these uses as essential to cost-effective pest control.

The URMULE program considers the expansion of a label for a new minor use of a pesticide. The technical grade active ingredient and the end-use product must be currently registered in Canada. The label expansion is registered only if the risk to human health and the environment is acceptable, and it has the requisite value. This minor use registration is consistent with all registration decisions made under the Pest Control Products Act.

URMULE is a cooperative program that involves the participation of sponsor groups, provincial and forestry minor use coordinators, provincial and federal government agencies, and product registrants.

Agriculture and Agri-Food Canada and Health Canada roles in the URMULE program

Agriculture and Agri-Food Canada (AAFC) has continued to provide funding and infrastructure support to Canadian growers for their improved access to products that would otherwise not be available to meet their minor use needs. This support helps to address their evolving crop protection needs and to improve their competitiveness in the global marketplace. This initiative has allowed the development of a collaborative minor use support system between AAFC and Health Canada. Agriculture and Agri-Food Canada’s Pest Management Centre (AAFC – PMC) uses these funds to conduct trials for the generation of value and residue data required for the registration of new minor use label expansions. Federal funding allows Health Canada’s PMRA to increase its capacity to review minor use applications that are submitted by both PMC, and the provinces.

National minor use research priorities are selected annually by grower representatives at the Canadian Pest Management Priority Setting Workshop. Additionally, close collaboration has been established with the Interregional Research Project #4 (IR-4) in the United States to maximize efficiencies in the generation of data and reports, and also with the United States Environmental Protection Agency in the review of data. These collaborations help to reduce duplication in the registration of new pesticide minor uses.

Information about the PMC and the established priorities and status of specific pesticide/crop projects can be found at the Pest Management Centre on the Agriculture and Agri-Food Canada website.

For more information, order a full copy (Publication request) or contact the Pest Management Information Service.

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