Discussion Document: Reconsideration of Decisions Under the New Pest Control Products Act

October 01, 2007
ISBN: 978-0-662-46894-3 (978-0-662-46895-0)
Cat. No.: H113-19/2007-1E (H113-19/2007-1E-PDF)
(DIS2007-01)

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This draft guidance document is intended to provide stakeholders and the Health Canada Pest Management Regulatory Agency (PMRA) with information and guidance regarding the reconsideration-of-decision process (reconsideration process) as specified in the Pest Control Products Act and the proposed Review Panel Regulations. Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. This document is intended to be used in conjunction with the Pest Control Products Act and the proposed Review Panel Regulations. The document is not to be considered a substitute for the Act and/or the proposed Review Panel Regulations, nor should it be used as a stand-alone document.

Table of Contents

• 1.0 The Reconsideration-of-Decision Process
• 2.0 Filing a Notice of Objection
  • 2.1 Reviewing a Notice of Objection
    • 2.1.1 Recommendations to Establish a Panel
    • 2.1.2 Criteria for Establishing a Review Panel
  • 2.2 Notice to Establish a Review Panel
  • 2.3 Terms of Reference for Review Panels
  • 2.4 Establishing Review Panels
    • 2.4.1 Removal of Panel Members
  • 2.5 Review Panel Proceedings
    • 2.5.1 Admissibility of Evidence
    • 2.5.2 Consideration of Confidential Information
• 3.0 Review Panel Report and the PMRA's Final Decision

• Appendix I Reconsideration-of-Decision Process Map
• Appendix II Notice of Objection Form

1.0 The Reconsideration-of-Decision Process

The new Pest Control Products Act came into force on 28 June 2006. A number of provisions under the Act provide for increased transparency and public participation.

As per the new legislation, any person who provides a scientific basis may file a notice of objection (notice) requesting the reconsideration of a major registration decision within 60 days after the decision is made public. Major registration decisions are decisions granting or denying an application to register a new active ingredient for use in Canada; granting or denying an application to effect a major amendment to a registration; or confirming, amending or cancelling a registration of a pest control product (pesticide) on completion of a re-evaluation or special review. Conditional registrations, granted under the new Pest Control Products Regulations, are not subject to the reconsideration of decision provisions under the Pest Control Products Act unless they are converted into a full registration or renewed. When a registrant applies to convert a conditional registration to full registration or to renew a conditional registration, a consultation must take place on the proposed decision and the reconsideration process applies.

Any person who believes there is a scientific basis for requesting a reconsideration of decision may file a notice of objection. Notices will be reviewed and recommendations will be forwarded to PMRA senior management to determine if there is need to obtain the advice of a panel of experts in relation to the objection. PMRA officials are duly qualified to act on behalf of the Minister of Health in accordance with the Interpretation Act. A review panel (panel) will be established depending:

• on whether the information in the notice raises scientific-founded doubt as to the validity of the evaluations, on which the decision was based, of the health and environmental risks and the value of the pesticide; and
• on whether the advice of the expert scientists would assist in addressing the subject matter of the objection.

This document is intended to provide information and guidance regarding the reconsideration process specified in the Pest Control Products Act and the proposed Review Panel Regulations published in the Canada Gazette, Part I. It describes the various steps in the reconsideration process. A process map is provided in Appendix I.

2.0 Filing a Notice of Objection

A notice requesting a reconsideration of decision must include standard information such as the name of the person who is filing the objection (objector), the substantive issue(s) to which the objection relates (i.e. the health risks, environmental risks and/or value of the active ingredient and/or product) and the scientific basis for the objection. The objector is responsible for ensuring that the notice is complete and accurate. A sample form for filing an objection is attached in A notice requesting a reconsideration of decision must include standard information such as the name of the person who is filing the objection (objector), the substantive issue(s) to which the objection relates (i.e. the health risks, environmental risks and/or value of the active ingredient and/or product) and the scientific basis for the objection. The objector is responsible for ensuring that the notice is complete and accurate. A sample form for filing an objection is attached in Appendix II.

Prior to filing any notice, the objector can apply to consult the confidential test data supporting the registration decision. If the product is registered, this confidential test data will be available for public inspection in the Reading Room. The PMRA places a higher priority on applications to inspect data associated with a recent regulatory decision for which the 60-day reconsideration period is still open. As the time frame to submit a notice is established by legislation, applications to inspect the confidential test data in question should be received well in advance of the closing date of the reconsideration period for processing if the intention is to consider submitting a notice. Further details for accessing the confidential test data are provided on the PMRA's website.

Where an objector refers to information such as scientific reports or confidential test data to provide evidence for the notice, the objector should include this information as part of the scientific basis of the objection. The objector should also explain how the information in the notice raises scientifically founded doubt as to the validity of the evaluations on which the decision was based. Where the scientific information provided is new information (e.g. a new epidemiology study), the information will be reviewed to determine its admissibility in the reconsideration process. The information provided may instead be subjected to other kinds of review (e.g. special review) rather than a review panel examination. It is important to note that the reconsideration process is not an opportunity to add to the content of the original submission (e.g. the addition of a new use) or to circumvent established processes for amending registrations.

Individuals submitting an objection must also provide some personal information prescribed by the proposed Review Panel Regulations and defined in the Privacy Act (e.g. name, address). This personal information may be made public as authorized by the Pest Control Products Act and its Regulations for the purpose of the reconsideration process.

2.1 Reviewing a Notice of Objection

All notices will be reviewed once the 60-day filing period has ended. The objector is responsible for ensuring the information provided to the PMRA is complete; normally, there will be no additional opportunity to file additional objections or amend a submitted objection.

2.1.1 Recommendations to Establish a Panel

The PMRA will take all reasonable measures to ensure impartiality when determining if a panel should be established. The notice, including the scientific rationale, will be reviewed by a team of PMRA evaluators who were not involved in the original registration decision. This team will provide recommendations on the validity and the scientific plausibility of the issue(s) raised in the notice. These recommendations will be considered by PMRA senior management, who will determine if a panel should be established.

2.1.2 Criteria for Establishing a Review Panel

The decision whether to establish a panel must be made on the merits of the case presented by the objector who filed the notice. In general, the following criteria will be considered in determining whether to establish a panel:

• whether the information in the notice raises doubt as to the interpretation of the scientific information, on which the decision was based;
• whether the information in the notice raises any disagreements as to the applied methodology of the scientific information, on which the decision was based;
• whether the information in the notice raises concern(s) as to the relative weights given to data impacting on the risk assessment of the scientific information, on which the decision was based;
• whether the information in the notice raises concern(s) regarding the conclusion reached during the decision making process;
• whether the advice of one or more expert scientists would be useful and appropriate in responding to the issue(s) identified in the notice; and
• whether the Minister has not already received such above noted advice.

Objections that concern matters of regulatory practice, claim allegations of bias and/or concern an issue on which the PMRA has available recent independent expert opinion would not normally be referred to a panel. Providing knowingly false or misleading information to a review panel is an offence under the Pest Control Products Act and may be subject to prosecution.

2.2 Notice to Establish a Review Panel

When it is determined that the objection has merit and advice of scientific expert(s) would be useful and appropriate in responding to the issue(s) identified in the notice, a panel will be established. The objector who filed the notice and the affected registrant(s) or applicant(s) will be advised. A notice on the establishment of a panel will be placed in the Public Registry on the PMRA's website.

Where issue(s) raised in the notice have or may have merit, but can be resolved quickly and efficiently without the need for advice of scientific expert(s), the objector will be informed and no panel will be established.

If the objection raises sufficient concern that the registration may pose unacceptable risks, the registration decision may be suspended until a final decision is made on completion of the review and all matters are resolved. In such a situation, a suspension will continue until the PMRA makes a final decision on completion of the review or until the panel is dissolved. Where a request to reconsider a registration decision is refused, the reasons for refusal will be communicated in writing, without delay, to the objector who filed the notice. The reasons for refusal will be placed in the Public Registry on the PMRA's website.

2.3 Terms of Reference for Review Panels

The PMRA will determine the terms of reference (ToR) that will establish the panel's mandate and provide guidance to persons interested in making representations by identifying the specific issues(s) that the panel will consider. The ToR will require that the panel focus on the review of science and the review be limited to issue(s) that can be properly dealt with by persons with scientific expertise without relying on persons trained in law. The ToR will also suggest target timelines for the panel procedures and may require a detailed workplan on how the milestones will be achieved and regular status updates for tracking purposes. The ToR will be made available in the Public Registry on the PMRA's website. Any requests for revision to the ToR must be submitted to the PMRA for consideration.

2.4 Establishing Review Panels

Without undue delay, the PMRA will contact potential panel members who have expertise relevant to the ToR and examine their credentials (e.g. professional credentials, educational background). Panel members will be required to possess scientific knowledge and be capable of evaluating and assessing objectively the representations made to the panel by interested parties who participate in the review. The PMRA will select as many experts as are needed to evaluate and assess the representations. All panel members will also be required to meet conflict of interest and security clearance requirements. Any person who was involved with decisions related to the registration decision will not be eligible to become a panel member. Each panel member will be paid travel and living expenses in accordance with applicable Treasury Board of Canada directives.

2.4.1 Removal of Panel Members

Panel members that are unable to perform their duties can be removed. Members can also be removed if a conflict of interest arises or if a member requests to be removed from the panel for other reasons. Another qualified person shall be selected to replace a member unless the review can be properly completed by the remaining members.

2.5 Review Panel Proceedings

The panel is responsible for determining the acceptability of the request(s) to make a representation and the admissibility of evidence based on whether they are relevant to the ToR. In all cases, the panel will advise the person(s) who made the request(s) of its decision and the reasons for accepting or refusing the request(s), or portions thereof.

If it will not impair anyone's ability to participate effectively in a hearing, the chairperson may allow teleconferencing or videoconferencing equipment to be used to make representations. A panel may also conduct any or all of the review using documentary submissions only.

All participants, other than panel members, are responsible for the costs of participating in the hearings.

2.5.1 Admissibility of Evidence

The panel may receive and accept any evidence or information it considers relevant to its mandate, regardless of its admissibility in a court of law. The conduct of the review will not be hampered by judicial rules of evidence or procedure. The panel has the authority to determine what information is relevant to the ToR, the level of credibility of the information and what weight to give to it. In addition, the panel may request and receive information and advice from persons who have not made an application to participate in the hearings.

2.5.2 Consideration of Confidential Information

Panel members and participants in a hearing will have access to confidential information that is in the Register. They are required to take all reasonable precautions to avoid any prohibited disclosures of the information. The review panel hearings will be closed to the public when confidential information is being discussed to prevent public disclosure. Participants making representations are responsible for notifying the panel in advance if they wish to discuss confidential information at the hearing. The panel will note items of the hearing agenda that are restricted to panel members and participants only.

To access confidential information that is not in the Register, participants must submit a request to the panel in the form of a sworn affidavit or statutory declaration. Requests must contain an undertaking not to disclose the information or data to any other person and not to use it for any purpose other than for participation in the hearing. Only the hearing participants who have satisfied the access request requirements will be permitted to be present at such hearings.

3.0 Review Panel Report and the PMRA's Final Decision

At the conclusion of its review, the panel will provide a report to the PMRA without undue delay. The report will contain its findings, analysis and recommendation(s). It will summarize the evidence and the arguments and provide an assessment, indicating where the panel agrees and disagrees with the presentations. If the panel is unable to reach unanimity on a recommendation, the panel's report will document the differences of position of the panel members. Recommendations provided by the panel to the Minister are not binding. The panel's report will be placed in the Public Registry on the PMRA's website.

Once the panel report is submitted, the PMRA may request clarification from the panel members with respect to specific recommendations. The PMRA's confirmation, reversal or variation of the registration decision (e.g. an amendment to a label), along with the reasons and summary of the information considered, will be made available in the Public Registry on the PMRA's website. No further opportunity for formal consultation on the confirmation, reversal or variation of the PMRA's decision will follow the reconsideration of a decision. In taking the final decision, the same scientific standards will be applied as during the registration process.

Appendix I Reconsideration-of-Decision Process Map

 

Appendix II Notice of Objection Form