User Requested Minor Use Label Expansion (URMULE)

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Susan B. Wong
Minor Use Coordinator
Value and Sustainability Assessment Directorate

Scope

• Introduction: definition, criteria, overview
• Process steps (D 3.1, D 3.2 and C 6.3)
• Registrant roles
• Future direction
• Issues
• Conclusions

URMULE Definition

• A necessary use expansion of a registered pest control product for which the anticipated volume of sales is insufficient to persuade a manufacturer to register the new use in Canada
• An URMULE may be registered on a major crop if the use represents an occasional need or is limited to a small percentage of the total area of the crop

URMULE Program

• PMRA DIR2001-01 outlines the policy and process (currently under review)
• Criteria for program consideration:
  • The active ingredient and the end-use product must be registered in Canada
  • Registrant supports the addition of the new use to its label
  • There must be sufficient information to assess the safety, merit and value of the proposed new use

URMULE: A Cooperative Program

• Cooperators:
  • Sponsors (Grower groups)
  • Registrants
  • AAFC/PMC
  • Provincial/Forestry Minor Use Coordinators

Presubmission Consultation Process (D 3.1)

• AAFC/PMUCs
  • Initiates proposal based upon an identified need
  • AAFC submissions based on priority setting meetings
  • Obtains registrant letter of support and proposed label, submits a cover letter with the use pattern
  • Completes the Proposal for an URMULE Form (PUF) and attests to the legitimacy of the need
  • Attaches supporting efficacy, crop tolerance and/or residue data
  • Forwards proposal package to the PMRA
  • Unregistered actives are not required to have a D 3.1, however if a Category A submission is close to completion (label verification stage), it is required
• PMRA:
  • Screens to ensure consistency between the PUF, Letters of support and the cover letter.
  • Considers existing data (significantly impacted by database age/completeness)
  • Identifies data required to support the proposal
  • Issuance of letter if new data is required
  • If there is enough information in the database, it will proceed to a D 3.2 submission.
  • 97 calendar day target performance standard

Submission Process (D 3.2)

• AAFC/PMUCs
  • Addresses data requirements and submits to PMRA (from either registrant, IR-4, literature or must generate)
• PMRA
  • Target regulatory decision made in 247 days. Review
    (180 day performance standard).
  • If acceptable, the registrant is requested to submit the proposed label with the accepted minor use (C 6.3)

Label Review (C 6.3)

• Registrant
  • Submits proposed label with accepted minor use
  • Complete form #6023 (Proposed New Uses and/or Uses to be Withdrawn from the Label)
  • Complete an Application Form and Fee form with associated fee of $154
• PMRA
  • Label review
  • Registration Decision and issuance of amended registration certificate
  • Completion of an Evaluation Report, which is important for a Proposed MRL document to be completed for consultation
  • Release appropriate information to the Public Registry

Joint Reviews

• All candidates for joint reviews are proposed by IR-4 and AAFC and must have had a presubmission consultation (D 3.1)
• All candidates must have joint residue trials conducted co-operatively by IR-4 and PMC
• The candidates and the number chosen for JR are dependent on the workload and resource issues with both the EPA and PMRA
• Advantages are a simultaneous registration decision and harmonized MRLs
• The PMRA and the EPA meet to discuss and organize which agency is the lead in each JR
• JR program has completed 9 submissions and currently 3 in review. Expect to receive another 4.
• The Minor Use Joint Reviews have resulted in 51 new uses

Present and Future Direction

• Continued work with Joint Reviews
• Data protection
• CropLife discussions:
  • Aerial use
  • Standard statements regarding phytotoxicity
  • Efficacy data (extrapolation)
  • Liability statement
  • Crop grouping

Adding Minor Uses

• Registrants encouraged to include minor crops in their initial Category A submissions
• 2006-2007 New Uses
  • Tech Gap submissions: 429
  • URMULES: 147
  • CAT A, B,C: 32
  • AAFC: 55

New Minor Crop Use Registrations from 2003 to 2007