How to Apply for a User Requested Label Expansion

The following is an overview of the application process for a new use to the label of a pesticide that is registered in Canada. Before applying for a new use, please read PMRA Guidance Document, Guidance for User Requested Minor Use Label Expansion.

Step 1: Eligibility for the User Requested Minor Use Label Expansions Program

• the active ingredient and the end-use product are currently registered in Canada;
• the manufacturer must be willing to add the new use to the product label; and
• there is enough information to assess the safety, merit and value of the proposed new use.

Step 2: Contact your Provincial Minor Use Coordinator

All 10 Canadian provinces have a coordinator who represents user interests on pesticide registrations.The person or user group intending to use the User Requested Minor Use Label Expansions (URMULE) program must contact their Provincial Minor Use Coordinator (PMUC). The PMUC will add the requested new use to the National Need List that is maintained by Agriculture and Agri-Food Canada (AAFC).

The National Need List is a list of all minor uses requested by growers across Canada. Using this list, stakeholders will decide which uses will have their data generation trials financed and conducted by AAFC The decisions are made at the priority-setting meeting organized by AAFC in March of each year. These lists ( Entomology, Pathology, and Weeds) can be found on the web site of the Pest Management Center.

Step 3: Presubmission Consultation

Pest Management Regulatory Agency (PMRA) offers to establish a use specific list of information items that are needed to register a requested use. To obtain this list a Presubmission Consultation Request (PSCR) is submitted to the PMRA.

This request includes the following:

• a cover letter signed either by the PMUC or a study director from AAFC;
• a letter of support from the pesticide manufacturer;
• a completed Proposal for User Requested Minor Use Label Expansions form; and
• a proposed supplemental label that describes the application of the product and any required safety measures that are specific for the new use.

The PMRA verifies that the program criteria are met and the proposal is complete. PMRA then determines what information is needed in addition to the data that is already available to the Agency since the original registration of the product. Generally, the PMRA will require data on efficacy, crop tolerance, food residues and information on occupational exposure that is specific to the proposed use.

The PMRA will forward this list (DACO table) to the PMUCs or AAFC depending on who has submitted the request.

Step 4: Data Generation

After the data needs are identified, it is the applicant's responsibility to either find or generate the data listed on the DACO table and then to submit these to the PMRA for review. The review of a complete URMULE submission can take up to 247 days, depending on the amount and complexity of the data to be reviewed.

Step 5: Pest Management Regulatory Agency Registration Decision

After the data review and evaluation have been completed, the PMRA will inform the applicant and the product registrant in writing of its decision on whether or not there is sufficient information to add the new use to the product label.