Ontario Minor Use Program
Table of Contents
- Areas of Focus
- The Process
- Information for Sponsors
- More Information
This web page is a current link to information you need about minor
use initiatives and issues. The minor use program remains as a top
priority of almost all specialty crop growers, processing companies,
retailers and consumers who want safe and nutritious local food.
A coordinated and dedicated effort is required to ensure that Ontario's
growers are competitive in the marketplace and have access to the
most current Integrated Pest Management (IPM) toolkits for crop
Areas of Focus
The minor use program is necessary to bring pest control products
to Canadian minor crop and specialty crop growers that otherwise
would not be marketed to them because of their unique and/or limited
production area. The minor use program has several areas of focus
and includes traditional pest control products as well as reduced
risk products and biopesticides. A key area of focus is to continuously
find new methods and strategies to manage our numerous crop pests
which may include insects, diseases and weeds. New pest management
technologies which replace old pest management technologies is a
key area of focus. Obtaining IPM tools that help growers effectively
manage key crop pests, manage resistance issues and sustain the
environment are given priority. Both conventional and organic crop
production systems can benefit from an effective and proactive minor
Pest control products placed under re-evaluation or special
review by the Pest
Management Regulatory Agency (PMRA) or products prohibited in
other jurisdictions for environmental or health reasons, should
not be considered for label expansion unless a justifiable emergency
situation exists or at such time that the review of all available
scientific data concludes there is no risk of harm.
The minor use program is administered by Health Canada's Pest Management
Regulatory Agency (PMRA). This agency is responsible for assessing
and reviewing all of the data requirements for the registration
of pest control products in Canada. All minor use projects must
be reviewed and assessed by several teams of scientists at the PMRA.
It is the role of the provincial minor use coordinators to act as
liaison between the PMRA and those who wish to pursue needed minor
use materials. The provincial minor use coordinators are also responsible
to prioritizing each commodity's minor use needs annually. A large
number of other individuals in various companies and organizations
are also involved in this effort and include organizations such
as Agriculture & Agri-Food Canada (AAFC), the Ontario Fruit
& Vegetable Growers Association, Ontario Processing Vegetable
Growers, Flowers Canada, the Canadian Nursery and Landscape Association,
the Canadian Horticultural Council, Pulse Canada, Ontario Ministry
of Environment, other provincial ministries of agriculture and environment,
all other minor and specialty crop commodity organizations as well
as the research facilities of AAFC, universities and private consulting
firms. In other words a collaborative, coordinated team effort is
required for our minor use system to be successful.
Pest Management Centre is responsible for organizing the national
minor use priority setting meeting annually and will conduct the
necessary trials for all top priority projects agreed to at this
meeting. For the top priority projects, AAFC will make the submission
to PMRA and manage the project until its conclusion. All other priorities
are the responsibility of the provinces and grower organizations.
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 AAFC, grower organizations,
crop specialists or other persons. All non-AAFC URMULE proposals
must be reviewed and approved by a provincial minor use coordinator.
Minor use proposals must include letters of support from the registrants,
grower organizations, completed forms and as much relevant data
as is available 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 for or barriers to registration.
If crop tolerance trials, efficacy trials, residue trials or other
trials are required, then a research team must be established to
carry out the necessary 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
can be made on the minor use. Traditionally minor use projects requiring
field data take at least 2-3 years to complete.
Prioritization of all minor use needs must occur on an annual basis
so that all levels of government can accurately allocate resources
to the most urgent needs. In Ontario, minor use commodity liaison
committees serve as the main vehicle for commodity groups to prioritize
minor use needs. Crop pests are ranked first and potential solutions
are then chosen when available. Each year a detailed priority list
for Ontario is established and provided to AAFC. A national minor
use priority-setting meeting will be held annually to determine
the top priorities for each commodity and/or crop group. Other non-horticultural
minor and specialty crops can also contribute to this system of
priority-setting on a national basis.
Information for Sponsors
- According to Pest Management Regulatory Agency (PMRA) Regulatory
Directive 2001-01, a sponsor is an individual or an organization
representing a pest control product user or a pest control product
user group and is responsible for identifying candidate products
that should satisfy user needs
- Typically sponsors are the Agriculture & Agri-Food Canada
(AAFC) pest management center, provincial crop specialists, university
or federal researchers and grower organizations
- Once a sponsor is identified and agrees to act as such, they
remain as a key contact point for the minor use submission 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
- To be eligible for an URMULE the active ingredients and an end-use
product must be labeled in Canada
(see PMRA labels), the registrant must be willing to add the
new use to the label and there must be sufficient information
to assess the safety, merit and value of the proposed new use
- Furthermore, Pest control products placed under re-evaluation
or special review by the Pest Management Regulatory Agency (PMRA)
or products prohibited in other jurisdictions for environmental
or health reasons, should not be considered for label expansion
unless a justifiable emergency situation exists or at such time
that the review of all available scientific data concludes there
is no risk of harm.
- The "Proposal
for an URMULE form" required to initiate the process is available
electronically on the PMRA website.
- 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
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
- Submit an electronic copy of a new draft supplemental label
for the proposed new use. You must obtain this from the registrant
along with their letter of support. Current Canadian labels for
the product are also available from the PMRA
label website or they may also be available from the Canadian
- 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
- Obtain a letter of support from the registrant of the pest control
product. This letter of support must be signed by the registrant's
Regulatory Affairs section and 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 registrant must also provide with the letter,
a draft supplemental label for the new minor use.
- The sponsor 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. If the available
data is deemed to be complete and is deemed to be sufficient for
a registration decision, this can be submitted to PMRA. Otherwise
all data required by PMRA is submitted as a complete package after
the PMRA issues a DACO (data code) table.
- The sponsor may also consider attaching letters of support from
a growers organization indicating their interest in the minor
- 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 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
- 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 office a pre-submission number is assigned
to the URMULE (PSC D.3.1 Number). This number remains with the
proposal until any additional data required as a result of the
pre-submission consultation is received from the sponsor at which
time the project becomes a submission. A submission number (D.3.2)
is then assigned to the URMULE request
- According to the PMRA's Regulatory Directive 2001-01, the pre-submission
period is 97 calendar days from the date of receipt by the PMRA.
All other provinces are notified of the submission so that national
coordination can occur where necessary
- If more data or information are required as a result of the
pre-submission consultation, the sponsor is responsible for collecting
all the necessary data and submitting it in one package to the
- 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 letter, DACO table and a residue trial
specification form. Typically only efficacy, crop tolerance and
residue studies can be conducted by the sponsor in collaboration
with research personnel.
- Sponsors should review the PMRA requirements with the provincial
minor use coordinator before proceeding with any trials. If residue
trials are required, they should not be started until a 'Residue
Trial Specification Form' is received from the PMRA
- 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
- The sponsor should arrange for appropriate research personnel
and facilities to conduct necessary field trials. All residue
trials must be conducted under Good Laboratory Practices (GLP)
compliance and protocols
- All data must be organized and submitted according to PMRA protocols.
All data submitted in support of the URMULE should be sent to
the provincial minor use coordinator and the registrant. The data
package will then be reviewed by the provincial coordinator and
fowarded to PMRA.
- The data package must include a cover letter clearly referencing
the corresponding PSC (D.3.1) number and the data included in
- At this stage the URMULE project becomes a 'submission' at the
PMRA and is assigned a new 'submission number'. (D.3.2) The review
process at this stage is 247 days depending on the amount and
complexity of the data to be reviewed
- If the PMRA accepts all of 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 submits an application for amended registration,
new use form, application fee form, a fee of $154.00 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
- 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.
Funding of Minor Use Projects
- The costs of conducting efficacy, crop tolerance and residue
trials in several crop zones can be very burdensome for most minor
- Residue studies which must be conducted under GLP compliant
standards and in more than 1 crop zone are the most expensive
to coordinate and finance
- Projects ranked as 'A' priorities at the Canadian National
Minor Use Priority Setting Meeting annually, will be fully funded
by the AAFC Pest Management Center. Other projects which provinces
and grower organizations wish to sponsor and that have a data
requirement will be required to seek funding from other sources.
- Information can be obtained from your provincial minor use coordinator
about funding for minor use data requirements.
- 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.
- Applicants should review funding proposals with their provincial
minor use coordinator.
- In Ontario, sponsors of minor use projects should consult with
the provincial minor use coordinator regarding funding options.
Limited funds are available for such projects, however efficacy
and crop tolerance trials typically cost significantly less than
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 can work together
to discuss minor use needs and establish collaborative projects.
All of the provincial minor use coordinators must meet annually
and communicate monthly on topics of mutual interest. Cooperation
with the US minor use program known as the 'IR-4' is important.
In recent years several joint projects have been conducted on both
sides of the border in an attempt to secure joint registrations
for both Canadian and American minor crop growers. The PMRA has
also instituted a 'joint review' process for new active ingredients
whereby pest control product companies can submit a registration
package to both countries at the same time with the goal of simultaneous
registration. Increased cooperation with the European Union (EU),
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
Ontarios minor use priorities are established annually by
various minor use commodity liaison committees. A summary of all
active, historical and registered minor use projects is also available.
For a copy of these tables, consult the provincial
minor use coordinator.
For more information:
Toll Free: 1-877-424-1300