Information for Sponsors of User - Requested Minor Use Label Expansions (URMULEs)

Table of Contents

1. Key steps to consider
2. Funding of Minor Use Projects
3. Related Links

Key steps to consider

• 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, 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
• The "Proposal for an URMULE" form required to initiate the process is available electronically on the PMRA website. See Related Links below.
• 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 CDMS website (see related links) 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 (See Related Links) 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
• 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 use project
• 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 for harmonization
• Send complete electronic copies of the submission via email with a covering letter to the provincial minor use coordinator, Mr. Jim Chaput, OMAFRA, 1 Stone Rd. W., 1^st floor, Guelph, Ontario N1G 4Y2
• 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 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 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 the package
• 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 by growers. The use is then listed with the final registration notice on this webpage.
• 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. All registrations achieved will be posted on OMAFRA's minor use webpage also.

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 use commodities
• 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 residue trials.

Related Links

• Pest Management Regulatory Agency - Proposal for an URMULE form
• PMRA Label Web Site
• CDMS Web Site
• Ontario Minor Use Program
• Current Minor Use Registrations, Priorities and Projects
• Ontario Emergency Use Registrations