Overview

The minor use program brings pest control products to minor (smaller) crop and specialty crop growers in Canada. Pest control products are usually not marketed to these growers because of their limited production areas and high costs associated with registrations.

The program helps ensure that Ontario growers are competitive in the marketplace and have access to the most current integrated pest management (IPM) toolkits for crop protection.

The minor use program has several areas of focus, including :

  • traditional pest control products
  • reduced risk products and biopesticides
  • finding new methods and strategies to manage our numerous crop pests, including insects, diseases and weeds
  • new pest management technologies which replace old pest management technologies

The program’s priority is to pursue IPM tools that help growers :

  • effectively manage key crop pests
  • manage resistance issues
  • sustain the environment

Both conventional and organic crop production systems benefit from an effective and proactive minor use system.

How the program works

The minor use program is administered by Health Canada's Pest Management Regulatory Agency (PMRA). This agency is responsible for assessing and reviewing all the data requirements for pest control product registration in Canada.

All minor use projects are reviewed and assessed by several teams of scientists at the PMRA. Provincial minor use coordinators act as liaisons between the PMRA and growers who are looking for minor use materials. The provincial minor use coordinators are also responsible for coordinating with industry to prioritize each commodity's minor use needs annually.

Minor use proposals must include :

  • letters of support from the registrants and grower organizations
  • completed forms
  • relevant data from worldwide sources

Once the proposal is complete and submitted to the PMRA, a team of reviewers will notify the sponsor of any additional requirements or barriers to registration.

If crop tolerance trials, efficacy trials, residue trials or other trials are required, a research team must be established to carry out the studies according to pre-established guidelines. All residue studies must be Good Laboratory Practices (GLP) compliant.

Once the data is collected and submitted to PMRA a final decision is made on the minor use. Traditionally, minor use projects requiring field data take at least 2 to 3 years to complete.

You can request a summary of all active, historical and registered minor use projects by emailing the provincial minor use coordinator at joshua.mosiondz@ontario.ca.

How minor use priorities are set

Prioritization of all minor use needs happens every year so all levels of government can accurately allocate resources to the most urgent needs.

In Ontario, minor use commodity liaison committees help commodity groups prioritize minor use needs. Crop pests are ranked first, and potential solutions are then chosen when available. A detailed priority list for Ontario is created every year and submitted to AAFC.

A national minor use priority-setting meeting is held every year based on the submitted priorities to determine the top priorities for each commodity and/or crop group. Other non-horticultural minor and specialty crops can also contribute to this process.

The national meeting is organized by AAFC's Pest Management Centre. They conduct the necessary trials for all top priority projects agreed to at this meeting. For the top priority projects, AAFC makes the submission to PMRA and manage the project until its conclusion. All other priorities are the responsibility of the provinces and grower organizations.

Organizations that are involved in setting minor use priorities include but are not limited to :

  • Agriculture & Agri-Food Canada (AAFC)
  • AAFC research facilities
  • Ontario Fruit & Vegetable Growers Association
  • Ontario Processing Vegetable Growers
  • Flowers Canada
  • Canadian Nursery and Landscape Association
  • Canadian Horticultural Council
  • Pulse Canada
  • Ontario Ministry of Environment, Conservation and Parks
  • Ontario Ministry of Agriculture, Food, and Rural Affairs
  • other provincial ministries of agriculture and environment
  • minor and specialty crop commodity organizations
  • universities
  • private consulting firms

Collaboration

Inter-provincial and international collaboration is a significant component of the minor use program in Ontario and Canada. Commodity specialists and grower organizations across Canada work together to discuss minor use needs and establish collaborative projects.

All provincial minor use coordinators meet every year and communicate monthly on topics of mutual interest.

Collaboration with the United States

Canada cooperates with the US minor use program known as the IR-4 Project. In recent years several joint projects were conducted in both countries to secure joint registrations for Canadian and American minor crop growers.

The PMRA also instituted a joint review process for new active ingredients where pest control product companies can submit a registration package to both countries at the same time with the goal of simultaneous registration.

International collaboration

Increased cooperation with the European Union, Australia, the Organization for Economic Cooperation & Development OECD pesticide program and the global minor use community will lead to further advancements in the minor use program in Ontario and Canada.

How minor use projects are funded

Conducting efficacy, crop tolerance and residue trials in several crop zones can be expensive and burdensome for most minor use commodities.

Residue studies are the most expensive to coordinate and finance because they must be conducted under good laboratory practices (GLP) compliant standards and in more than one crop zone

Projects ranked as A priorities at the Canadian national minor use priority setting workshop are fully funded by the AAFC Pest Management Center.

Other projects which provinces and grower organizations wish to sponsor and that have a data requirement need to seek funding from other sources. Email the provincial minor use coordinator at joshua.mosiondz@ontario.ca to learn more about funding for minor use data requirements.

In Ontario, sponsors of minor use projects should consult with the provincial minor use coordinator about funding options. Limited funds are available for these projects, however efficacy and crop tolerance trials typically cost significantly less than residue trials.

The applicant for funding should be a commodity organization which represents the crop that requires minor use research on an already submitted URMULE project.

When seeking funding for minor use projects, provide details on actual project costs including plot set-up, application costs, harvesting costs, efficacy evaluations, crop tolerance evaluations, transportation costs, travel allowances and laboratory analyses.

Sponsors

A sponsor is an individual or an organization representing a pest control product user or a pest control product user group. Sponsors are responsible for identifying candidate pest control products that should satisfy user needs.

Sponsors are typically :

  • Agriculture and Agri-Food Canada (AAFC) pest management center
  • provincial crop specialists
  • university or federal researchers
  • grower organizations

Once a sponsor is identified and agrees to act as a sponsor, they are a key contact point for between the PMRA and the provincial minor use coordinator.

Sponsors must consider the minor use priorities of the commodity group before completing an application. Other alternatives or substitutions can be considered if justification is provided.

User Requested Minor Use Label Expansion Program (URUMULE)

Products which are already labeled in Canada on another major or minor crop are eligible for the User Requested Minor Use Label Expansion (URMULE) program. URMULEs can be sponsored by :

  • Agriculture and Agri-food Canada (AAFC)
  • grower organizations
  • crop specialists
  • individuals

To be eligible for a URMULE :

  • the active ingredients and requestedend-use product must be labeled in Canada
  • the registrant must be willing to add the new use to the label
  • there must be sufficient information to assess the safety, merit and value of the proposed new use

All non-AAFC URMULE proposals must be reviewed and approved by a provincial minor use coordinator.

The following should not be considered for label expansion unless a justifiable emergency situation exists or the review of all available scientific data concludes there is no risk of harm :

  • pest control products placed under re-evaluation or special review by the Pest Management Regulatory Agency (PMRA)
  • products prohibited in other jurisdictions for environmental or health reasons

How to apply for an URMULE

Potential sponsors interested in applying for an URMULE should reach out to the provincial minor use coordinator at joshua.mosiondz@ontario.ca with a proposed solution, use pattern, and small rationale explaining the proposed use.

The Proposal for an URMULE form required to initiate the process is available electronically on the PMRA website. The sponsor should complete all sections of the form in as much detail as possible.

If the product and use is labeled in the USA be sure to request the same rate and use pattern as is registered there unless there is some reason why this rate and use pattern does not apply to Canada. US labels are available from the Crop Data Management Systems (CDMS Labels) or they may also be available from the US registrant's website. This ensures that any data to be reviewed by the PMRA is comparable to what EPA in the USA has reviewed. This includes post-harvest intervals, timing of applications, intervals between applications, labeled pests and formulations.

If the use is not labeled in the USA, then request a use rate and pattern that matches the current Canadian label for other uses where appropriate. If the use rate and pattern are unique, then more data will be required to support your case. Current Canadian labels for the product are also available from the PMRA label website or they may also be available from the Canadian registrant's website.

  • Be sure to also match as closely as possible all other 'Good Agricultural Practices' (GAP) to other areas where the use pattern is already labeled where this is appropriate.

The provincial minor use coordinator will reach out to the registrant of the product to determine their support of the proposed use. If accepted, the registrant’s regulatory affairs team will provide a new draft label with the proposed use included, supporting data where possible, and a letter of support for the label expansion.

  • The letter must be specific to the proposed use, including the product name, PCP number, crop and rates of application. The letter should also indicate whether the company intends to use the assumption of risk statement for efficacy and crop tolerance
  • The provincial minor use coordinator can request all available efficacy, crop tolerance and/or residue data that the registrant or the US IR-4 Program may have and also add any new data that they themselves or in collaboration with researchers have generated All data required by PMRA is submitted as a complete package with other required documents by the provincial minor use coordinator.
  • The sponsor may also consider attaching letters of support from a grower’s organization indicating their interest in the minor use project with the submission package.
  • If applicable, the sponsor should also consult with other provinces or states where a similar interest exists to verify if these jurisdictions have any additional supporting documentation.
  • It is important to note that any data added to the minor use proposal after the submission is sent to PMRA, will delay the PMRA review of the URMULE. Therefore, it is vital that all available data be submitted up front with the original proposal OR that all required data is provided in a complete package after the PMRA provides a DACO table if a deficiency is identified in the original submission. If incomplete data is submitted following the issue of a DACO table, the submission will be returned to the submitter without review.
  • Be sure to review all submitted efficacy, crop tolerance and residue data to ensure that the rates, use pattern, post-harvest intervals, formulations, etc. match the minor use request. Residue data or crop tolerance data at rates higher than the minor use request may also be considered.
  • When submitting a minor use proposal be sure to consider all pertinent justifications such as fit with IPM programs, resistance management concerns, replacement of old technology, status as a reduced-risk material, new, introduced pest problem, new crop requiring protection and/or status as an export crop with a need for harmonization.
  • Send complete electronic copies of the submission via email with a covering letter to the provincial minor use coordinator.
  • The submission will then be reviewed for completeness and accuracy, signed and forwarded to the PMRA's Minor Use Team. This initial URMULE submission is considered as the pre-submission consultation. Other provincial minor use coordinators and AAFC's minor use center will also be consulted prior to submission.
  • Upon receipt at the PMRA, the submussion begins screening and a trackingnumber is assigned to the URMULE ( D.3.1 Number). This number remains with the proposal until the file and its contents are checked for completeness, and inclusion of all required materials from the sponsor at which time the project becomes a submission. A submission number (D.3.2) is then assigned to the URMULE request, and the submission begins scientific review.
  • If more data or information are required as a result of the pre-submission consultation, the PMRA will issue a DACO code deficiency, the sponsor is responsible for collecting all the necessary data requested by the DACO code and returning it in an additional package to the PMRA.
    • Additional data that may be requested includes efficacy evaluations, crop tolerance evaluations, residue studies, processing studies, plant metabolism studies, soil dissipation studies, occupational exposure studies and crop rotational studies. These requirements are provided to the provincial coordinator and copied to the sponsor by PMRA in the form of a deficiency letter, including a DACO table. Typically, only efficacy, crop tolerance and residue studies can be conducted by the sponsor in collaboration with research personnel. Other required data sets will typically require the registrant to support and generate the requested data.
  • Sponsors should review the PMRA requirements with the provincial minor use coordinator before proceeding with any trials.
  • Sponsors should share or copy all correspondence they receive from the PMRA with the provincial minor use coordinator so that appropriate responses can be generated where necessary.
  • If the PMRA accepts all the data and decides that the risks and value are acceptable for registration, they notify the sponsor, the registrant and the provincial coordinators of this acceptability. If the label expansion involves a food or feed use and it is necessary to establish a new Maximum Residue Limit (MRL), then the PMRA initiates the process to amend the MRL's.
  • The registrant applies for amended registration, new use form, application fee form, appropriate fees and English and French electronic copies of the final supplemental label which is assigned a Category C.6.3 submission number. Once accepted, the supplemental label is copied to the registrant, sponsor and the provincial minor use coordinators and the product can be used by growers.
  • It is the responsibility of the sponsor, registrant and provincial minor use coordinator to ensure that all users of the product be advised of the new registration via the normal publication and notification channels.