Category A and B Submissions

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Canadian Pesticide Regulation Course - February 27-28, 2008 - Submission Categories

Richard Kenny
Acting Section Head
Screening and Pre-submission Consultation Section
Submission and Information Management Division
Registration Directorate

Submission Categories

• Category A
  • New technical grades of active ingredients (TGAI) or integrated system products (ISP) and their related end-use products (EPs) and/or manufacturing concentrates (MAs)
  • Major new uses (addition of a new Use-site Category to the use pattern for a existing registered TGAI)
  • Establishment of import maximum residue limits (MRL) for a new active ingredient not registered in Canada
  • User Requested Minor Use Registration (URMURS)

• Category B
  • To register new pest control products (active ingredient is currently registered) or amend existing products where data is required
  • Applications to register or amend EPs must be accompanied by:
    • The necessary supporting data OR
    • Letter of Access to a current database (LOA/LOC) AND
    • Reference to a precedent product
  • Examples: Changes in product chemistry for TGAI or ISP, changes in product chemistry for EPs or MAs, changes in labelling, conversion or renewal of conditional registration.
  • Category B submissions that require only value (Part 10) data are eligible to be reclassified as Category C "Fast Track" submissions. REG2002-04 outlines the criteria to qualify for a Category C "Fast Track".
  • Determining the correct category type can be found under REG2003-02, Guidance on Selecting the Correct Category for Pest Control Product Submissions

Submission Requirements

E-Index (www.pmra-arla.gc.ca/english/appregis/eprs-e.html)

• Cover Letter
• Application Form (Form 6005)
• Statement Product Specification Form (Form 6003)
• Fee Form and applicable fees (Form 6011)
• Proposed electronic label (text, pdf normal)
• Letter(s) of confirmation of source of supply
• Letter(s) of authorization to cite data previously submitted by another company
• Letter(s) of authorization designating agent, formulator, consultant, etc.
• Latest versions of all forms are required
  • All forms can be obtained on the PMRA website at www.pmra-arla.gc.ca/english/appregis/fillforms-e.html

Data Requirements

• Based upon Use-site Category (USC)
  • 33 USC (e.g. Terrestrial Food Crops, Turf, Swimming Pools)
  • Each USC has a table that outlines the required data for that USC and is used as reference for Category A submission.
  • Separate tables for active ingredient and end-use products. Import MRL tables are also available for agricultural uses.
  • Each study on the table is identified by a numeric data code (DACO) for each data requirement as listed on tables. Data Code = DACO
  • Data waivers submitted to address a DACO part must be included in the e-Index under the >DACO number. A waiver must be based on scientific rationale.
  • Category A DACO tables are available on the PMRA website at www.pmra-arla.gc.ca and are organized into 3 categories: Agriculture & Forestry, Industry, and Society.
  • Category B submissions may include more than one amendment and therefore require the combination of a number of Category B DACO tables. These DACO tables are available upon request.
  • E-Index will also accept the USEPA and OECD numbering format.
  • The Crosswalk is a comparative table containing the PMRA (DACO), USEPA (OPPTS and OPP) and OECD (IIA) data numbering system.
  • Crosswalk tables are available on our website under the Use-site Category heading.

Fees

• Outlined in Guidance on Pest Control Products Cost Recovery Fees, April 16, 1997.
• Fee Form lists the amount for each DACO part.
  • e.g. Toxicology, Chemistry
• When data is submitted to address a DACO as outlined on the DACO table, the corresponding Part on the Fee Form must be paid.
  • e.g. DACO 4.6.1 - 4.6.6 (Toxicology Acute Studies) falls under Part 4C on the Fee Form.
• Data that has been previously reviewed and found to be acceptable may not be subject to fees if cited in a subsequent submission.
• All data, rationales and waivers submitted are subject to fees (e.g. if one study is submitted to cover a data part, the full amount as outlined on the Fee Form will be charged).
• Reduced Fee Requests should be accompanied by a rationale and only apply to new registrations.
• Products that are exempt from data fees. Fee required for label review only. See Appendix III of the Cost Recovery document for a complete list.
  • Microbials and Pheromones
  • Food Grade active ingredients
  • Certain Essential Oils
  • URMULES
  • Minor Uses

Management of Submission (MOSP)

• Steps outlined in PRO96-01, Management of Submission Policy (MOSP)
  • Receipt/Verification
  • Screening
  • Review/Evaluation
  • Proposed Decision
  • Consultation (new active ingredients and major new uses)
  • Label Verification/Registration

• Timelines
  • For submission categories, time frames are defined in the MOSP
  • Examples of timelines not found in the MOSP:
    • Joint Review - time frame negotiated
    • Category C "Fast Track" (Efficacy only), REG2002-04
    • Reduced Risk, DIR2002-02

Submission Deficiencies

• Deficiencies in a submission may be identified at any level of the submission process (e.g. Verification,Screening or Review).
• Deficiencies are relayed to the applicant by means of a Clarification email/fax or Deficiency letter.
• Clarification email/fax are used for clarification requests that can be satisfied within 10 days.
• Examples of Clarification email/fax may include:
  • Confidential Statement of Ingredients requests
  • Clarifications on the Statement of Product Specification Form or Application Form
• Deficiency letters are sent when information is missing that would prevent the submission from advancing for review or decision.
• Examples of deficiencies that would require a Deficiency Letter
  • Missing data
  • Confidential Statement of Ingredients that have not been addressed by Clarification e-mail/fax
• Some common deficiencies
  • Verification
    • Missing or corrupt e-Index
    • Missing forms/payments
  • Screening
    • Formulant Issues (i.e. Confidential Statements of Ingredients)
    • Missing data
  • Preliminary Review
    • Inadequate waiver requests
    • Provisions of supporting data
    • Clarification on formulation of test substance

References

• Guidance on Pest Control Product Cost Recovery Fees
• PRO96-01, Management of Submission Policy
• DIR2003-01, Organizing and Formatting A Complete Submission for Pest Control Products
• REG2003-01, Guidance on Selecting the Correct Category for Pest Control Products
• DIR2006-05, Requirements for Submitting Data Index, Documents and Forms
• DIR2007-03, Protection of Proprietary Interests in Pesticide Data in Canada