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Process Overview for Re-evaluation Program

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Kit Nelson
Section Head
Re-evaluation Coordination 1 Section
Re-evaluation Management Directorate

Outline of Presentation

• New product evaluation vs. re-evaluation
• Re-evaluation program structure
• Re-evaluation process
• Challenges
• Beyond current program

New Product Evaluation vs. Re-evaluation

• New Product Evaluation
  • Products/uses that are not currently registered or in marketplace
  • Product-based evaluation prior to registration
• Re-evaluation
  • Products currently registered, in marketplace
  • Supporting database and evaluation criteria for original registrations may not meet current standards
  • Bring active ingredient and uses up to modern equirements/standards

PMRA Re-evaluation Program

• Regulatory Directive DIR2001-03
• Approximately 400 active ingredients registered prior to 1995 are subject to current program
• Rely as much as possible on available recent reviews (e.g. EPA, OECD)
• Target for completion linked to USEPA's re-registration program target (2008)

PMRA Re-evaluation Program Structure

• Four sub-programs
• Program 1:
  • Complete and acceptable foreign reviews
  • Reviews are used as basis for decision making
  • Additional evaluation of specific aspects, where necessary
• Program 2:
  • No foreign reviews available or substantial in-house reviews underway
  • Cover full range of review areas (e.g. chemistry, toxicology, exposure, environment)
  • Data call-in needed
• Program 3:
  • EPA or other foreign reviews, recent in-house reviews or monitoring information available
  • Rely heavily on available reviews, with some targeted assessment areas
  • Assessments focus on central issues of PCPA (e.g. aggregate exposure, cumulative exposure, susceptible population subgroups)
• Program 4:
  • Special Reviews, limited in focus
  • Initiated to address a specific concern -exposure aspect or use pattern
  • Typically detailed in-house reviews, supplemented by foreign reviews where available

Stages of Re-evaluation Process

• PMRA identifies review approach
• Announce initiation of re-evaluation and confirm registrant support
• If needed, require data call-in or request specific studies from list (index)
• Request refined information on use pattern
• Proceed with reviews in various science areas
• Additional questions re: U.S. vs. Canadian use patterns
• If needed, publish Preliminary Risk Assessment
• Publish Proposed Re-evaluation Decision (PRVD)
• PRVD comment period 45-60 days
• Consider comments and revise decision if needed
• Publish Re-evaluation Decision (RVD)
• Implement decision via label amendments or discontinuation of products/uses

Re-evaluation Data Requests

• Announcement stage -supported uses and data call-in and/or list of available studies (section 16)
• Studies from registrant-supplied list, new studies, DERs or other information to proceed with review (section 19)
• Condition of continued registration -additional data to confirm assumptions used in assessment (section 12)

Timelines

• New Product Evaluation
  • Performance targets for Category A, B submissions
  • Proceed when all/most of information is provided
• Re-evaluation timelines depend on:
  • Program and availability of foreign reviews
  • Timeliness of registrant response
  • Complexity of data
  • Science issues/activities in Canada and U.S.

Common Challenges

• Timeliness of response from registrants to requests for data and information
• Responsiveness to parallel activities in U.S (reduced use pattern or mitigation options)
• Accuracy of product usage information
• Clarity of PMRA proposals and requirements

Beyond Current Program

• Cyclical review 15 years after initial registrations
• Co-operative workshare with EPA on some chemicals
• EPA Registration Review schedule available
• Program is under development:
  • 2 chemicals identified as pilots
    • clomazone and clofentazine

Further reading

• Regulatory Directive DIR2001-03, PMRA Re-evaluation Program
• An electronic copy of the Re-evaluation Summary Table will be provided via email by request only.
• Some recent examples:
  • PRVD Nicosulfuron
  • RVD Fenbutatin Oxide