Transparency: Consultation Documents, Public Registry, Reading Room

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Christopher Pollard
Section Head, Quality Systems Section
Submission and Information Management Division
Registration Directorate

The Pest Control Products Act (PCPA)

• Three key principles of the PCPA:
  • strengthening health and environmental protection
  • making the registration system more transparent
  • strengthening post-registration control of pesticides
• Under the Act, the public can:
  • obtain information about applications to register or amend a product
  • provide comments on proposed decisions before finalized
  • review evaluation reports and final decision documents
  • Inspect Confidential Test Data (CTD) after a final decision
  • Appeal process for major registration decisions

Link to PMRA website

Link to information on the PMRA website:

Home : Public Registry : Public Involvement

Transparency Overview

Register (S 42): Body of information to which the rules of disclosure apply. S 42 specifies the mandatory content.

Register:

• Application Info
• Consultations
• Notices (12,19)
• CTD - CBI
• New/Old Uses
• Decisions
• Evaluation
• CTD - Not CBI

Public Registry (S 42): Info in the Register that the public may obtain a copy of under the Act - made available to the public in as convenient a manner practicable.

Register:

• Application Info
• Consultations
• Notices (12,19)
• CTD - CBI
• New/Old Uses
• Decisions
• Evaluation
• CTD - Not CBI

Reading Room (S 43): The Minister shall permit the person to inspect confidential test data in the Register...

Register:

• Application Info
• Consultations
• Notices (12,19)
• New/Old Uses
• Decisions
• Evaluation

• CTD - CBI
• CTD - Not CBI

Confidential Test Data

• Scientific test data submitted by applicants.
• PMRA conducts a health and environmental risk assessment and a value assessment based on these data.
• The public can now inspect the confidential test data supporting the decision to register a new pesticide active ingredient, or a major amendment, re-evaluation or special review of a registered pesticide.

Confidential Business Information

• The PCPA defines CBI as:
  • manufacturing or quality control processes;
  • methods for determining the composition of the product;
  • monetary value of pesticide sales, and other financial or commercial information; and
  • the identity and concentration of formulants and contaminants in a pesticide, other than those considered to be of health or environmental concern.

Inspection of Test Data

• Data that are relevant to the decision are:
  • Accessible for inspection at the time of decision
  • Available through the Reading Room in Ottawa
  • Continue to be protected by Access To Information Act,
  • Inspection does NOT put the data into the public domain
  • No copy can be made (S 43(8))
  • Note-taking is permitted, with conditions
• An application with an affidavit is required to view:
  • Purpose of request
  • Must be no intent to misuse the data or make it available to others for purpose of registering or amending a pesticide anywhere (S 43(1)) (fines and/or prison);
• PCPA defines CBI must notify registrant of inspection

Purpose of Reading Room

• The objective of the reading room is:
  • to facilitate an understanding of regulatory decisions concerning pesticides
  • for the purpose of requesting the reconsideration of a registration decision
• The accessibility of confidential test data previously unavailable to the public will bolster Canadians' confidence in the pesticide regulatory system
• Created to enhance transparency and facilitate public participation in regulatory decision-making process

Pilot of Reading Room: November 1, 2007

• Goal of the pilot: determine if access and review of CTD facilitates the understanding of a decision and consequently contributes to enhancing transparency
• Four members of the PMRA advisory committee (academics, NGOs, IPM specialist) invited to inspect CTD
• Initial feedback: Access to CTD, on its own, is not useful in understanding the regulatory decision

Public Registry

• What will you see?
  • Single Public Registry on PMRA Site:
    • Lists "open" registration applications (specifying active ingredient, applicant)
    • Lists all actives for which re-evaluation has started but has not yet been completed
    • Lists all registered products and product labels.
• Evaluation reports, consultation documents are added "as soon as reasonably practicable" after a decision is rendered.

Transparency Documents

• After a decision to register a pesticide or after re-evaluation, the public is encouraged to review the published evaluation report and decision documents, which explain the risk and value assessments supporting a registration decision and include a summary of the information considered.
• 3 types of documents are required by PCPA 2002:
  • Consultation Document
  • Decision Document
  • Evaluation Report

Consultation Document

• Proposed Registration Decision or Proposed Re-evaluation Decision; used to consult the public regarding decision to register, major new use or the re-evaluation of a pest control product.
• Overview
  • short, plain language summary to provide a high level rationale for the proposed decision,
  • a summary of the risks and risk mitigation measures.
• Comprehensive Science Assessment
  • sufficient detail to provide for a meaningful consultation,
  • science assessment components.

Decision Document

• Registration Decision (RD) document and Re-evaluation Decision (RVD) document
  • after public comments are considered and a decision is made,
  • reiterates the decision outlined in the proposed or consultation document,
  • includes a summary and outcome of any comments received on the proposed decision.

Evaluation Report

• Reports of the evaluation of the health and environmental risks and the value of registered pest control products prepared by the Minister
  • A summary of the information considered and contains any confidential test data and confidential business information that the Minister considers appropriate,
  • Science assessment components,
  • ER references data used in risk assessment,
  • Similar to consultation document, available when a separate consultation document is not published

Additional Information Considered

• PCPA provides HC with authority to consider additional information in an evaluation (Section 7(5),19(1))
  • Information or data not supplied by applicant/registrant
• A reference to this information in the evaluation report will satisfy the requirement to provide access in the Register (PCPR Section 10)
• Applicant/registrant must have an opportunity to "make representation" on any such data before evaluation is competed (Section 7(5),19(1))
  • If information is confidential to the provider, the registrant must submit an affidavit agreeing to return it and to not copy, share or use it for any other purpose

Limitations to Public Information

• Modifying provisions (PCPR, Section 14(1)):
  • When a conditional registration is granted:
    • No consultation or decision documents are required for conditional registration decisions on new actives or major new uses.
    • Consultation, access to test data and reconsideration opportunity are delayed until conditions of registration are met (i.e. data are submitted and evaluated) or until registration is renewed.
    • Evaluation report is available.
• Where application to register is withdrawn before registration decision is made or where registration is denied.
  • Evaluation report, test data, etc. will NOT be put in the Public Register or the Reading Room.
  • Need to consult on decision to deny registration.

Transitional Provisions

• Section 81 states that the Act applies to:
  • Applications for which a regulatory decision is made after the PCPA came into force on 29 June 2006.
    • Applies to all submissions in progress or made after 29 June 2006
  • Products registered prior to "in force" date
    • Test data supporting decisions made before the "in force" date are not accessible unless and until the product is consulted on under the new PCPA
      • conversion of conditional registration
      • a major new use application
      • re-evaluation
      • when studies are cross-referenced in a new application
      • ONLY data relevant to the new decision are put in the Register and made accessible

Transition Challenges

• Transparency is:
  • New for Industry, the PMRA and the public
  • Involves increased workload for both industry and the PMRA
  • Involves new processes and new electronic tools
• CBI protection
  • PMRA can only protect CBI that has been designated and verified
  • Applicant/registrant designation and segregation in test data must be submitted under the new Act
  • Applicant designation is required for previously submitted data; PMRA will segregate