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Vol. 140, No. 50 — December 16, 2006 Review Panel RegulationsStatutory authority Pest Control Products Act Sponsoring department Department of Health REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations.) Description Pest control products (pesticides) are regulated in Canada under the federal Pest Control Products Act (PCPA). Health Canada's Pest Management Regulatory Agency (PMRA) administers the PCPA and the Pest Control Products Regulations (PCPR) on behalf of the Minister of Health. A new PCPA was brought into force with the PCPR on June 28, 2006. The PCPA (sections 35 to 40) provides a process for the reconsideration of major registration decisions whereby any person may file a notice of objection within 60 days of these decisions. Major registration decisions are decisions made by the PMRA to grant or deny applications to register new active ingredients, or to register or amend major new uses based on scientific data and risk assessments. A decision to maintain, amend or cancel a registration following a re-evaluation or special review is also considered a major registration decision. All these decisions are subject to consultation with the public prior to being finalized. The proposed Review Panel Regulations (RPR) would elaborate administrative matters concerning the process so as to make the timely resolution of reconsideration questions predictable and transparent. The proposed RPR specifies
As detailed in the PCPA, the review panel will be required to give any person a reasonable opportunity to make representation in respect of the decision under review in accordance with the terms of reference. Review panel hearings will be open to the public, subject to certain requirements respecting the protection from disclosure of confidential information. A review panel's report and recommendations will be advisory only and not binding on the Minister. After considering the review panel's report, the Minister will notify the public of the confirmation, reversal or variation of the decision and provide the reasons and a summary of the decision. Alternatives Using policy directives instead of regulations or relying solely on the provisions of the PCPA was considered. Based on experience with review boards under the previous PCPA, regulations on the administrative aspects of the reconsideration process will be useful to forestall procedural uncertainties regarding the establishing of review panels and the selection of panel members. Regulations would enhance the predictability and transparency of the administration of the process so as to facilitate the timely resolution of reconsideration questions. Benefits and costs Benefits The proposed RPR would contribute to the effective administration of the reconsideration process provided by the PCPA, enhancing predictability and transparency by formally specifying administrative matters about the process (e.g. what will be taken into account when determining whether to establish a review panel). The PCPA allows any person to file notices of objection on major registration decisions. It was also determined through a strategic environmental assessment that this regulatory initiative would result in no potential environmental impact. Costs to industry and Government Regulations providing clarity on the administrative aspects of a reconsideration process described in the PCPA are not expected to add costs. The Regulations will help prevent delays in the processing of notices of objection, the decision whether to establish a review panel and the selection of panel members. The Regulations do not introduce any additional steps to the process already provided by the PCPA. Conclusion The benefits of the proposed RPR in enhancing predictability and transparency of the process clearly outweigh the costs to industry and Government related to the implementation of the RPR. The cost-efficiency of the RPR will be evaluated periodically. Consultation Extensive consultation on the subject was conducted during the passage of the PCPA and the development of the proposed RPR. A discussion document entitled Preliminary Consultation on a Regulation Respecting Reconsideration of Registration Decisions was published for comments on the PMRA's Web site on June 30, 2003. Discussions also took place at meetings of the Pest Management Advisory Council (PMAC), the Federal-Provincial-Territorial Committee on Pest Management and Pesticides, the Economic Management Advisory Committee, and the North American Free Trade Agreement Technical Working Group on Pesticides. Suggestions for improvements were incorporated, where possible. The comments received and responses are summarized below. Scope of the Review Panel Regulations In response to concerns, the scope of the proposed RPR has been limited to general administrative matters only so as to allow for greater flexibility and responsiveness in addressing reconsideration questions. Certain aspects (e.g. the identity of potential panel members, logistics for panel meetings, the form for notification of the establishment of a panel) have not been included because they are likely to change periodically with time and context. Such aspects and further details of the process will be provided in a guidance document and terms of reference as determined by the Minister under subsection 35(6) of the PCPA. Persons involved in the administration of the process Respondents requested that officials involved in the administration of the process (e.g. advising on the acceptability of notices of objection or on the selection of review panel members) be identified in the RPR. It was also requested that a person independent from the PMRA be responsible for making decisions in the process so as to ensure impartiality. Registrants expressed interest in being involved in all decisions that are part of the reconsideration process. The suggestions were not adopted as the names of officials could not be referred to in legislation and PMRA officials are most knowledgeable about the basis on which the registration decisions are made under the PCPA. All reasonable measures will be taken to ensure impartiality. Furthermore, the public, including the registrants, will have the opportunity to make representation and participate in the review panel proceedings. The decision-making process will be described in a guidance document. Review panel composition Respondents requested that members of PMAC and registrants be eligible to be panel members. It was also requested that the RPR include criteria for selecting panel members (e.g. members to possess expertise in evaluating whether the applicant met the burden of proof, whether the risks and value of the pesticide are acceptable, and whether the risks met the PCPA's definition of "acceptable risks"). In response, the proposed RPR include criteria for selecting panel members. Each person selected would be required to possess scientific knowledge that allows them to evaluate the subject matter of the objection. Screening criteria are also proposed to ensure the objectivity of the panel members as advisors to the Minister. In that regard, members cannot be chosen to represent particular interest groups or whose affiliations or activities place them in an actual or potential conflict of interest. The members must be, and be seen to be, capable of evaluating and assessing objectively the representations to be made to the panel by interested parties who participate in the review. Candidates who possess qualifications that are consistent with the panel's mandate would be identified once it is decided a panel will be established, and the members would be selected by applying the criteria specified in the RPR. Compliance and enforcement The PMRA promotes, maintains and enforces compliance with the PCPA through compliance promotion programs, inspections, both monitoring and surveillance, and investigations. The programs aim to educate, facilitate and promote compliance as well as to communicate regulatory information. Monitoring inspections are designed to determine the level of compliance of users, distributors and registrants of pesticides with specific terms and conditions of registration and re-evaluation and the provisions of the PCPA and regulations. Subsection 40(2) of the PCPA provides the authority to prosecute individuals who provide false or misleading information in relation to the reconsideration of decisions. Enforcement response actions may include education (written and oral), administrative monetary penalties or warnings under the Agriculture and Agri-Food Administrative Monetary Penalties Act and prosecutions under the PCPA. The goal of any enforcement response is to achieve and maintain compliance. Since the majority of the regulated community will comply with the law if they understand it and have the capacity to comply, many violations are dealt with and corrected using education as a means to address non-compliance situations and behaviour. In general, compliance with the PCPA and the Regulations is achieved through a network of officers and inspectors across Canada. Health Canada regional staff also have formal agreements providing a basis to collaborate with provincial pesticide regulatory officials in investigations and in the development and delivery of programs. The PMRA will follow an established compliance policy to promote and enhance fair treatment of the regulated community. The document is available on the PMRA Web site at www.pmra-arla.gc.ca. Francine Brunet, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Health Canada, 2720 Riverside Drive, Address Locator 6607D1, Ottawa, Ontario K1A 0K9, 613-736-3678 (telephone), 613-736-3659 (fax), pmra_regulatory_affairs-affaires_reglementaires_arla@hc-sc.gc.ca (email). Notice is hereby given that the Governor in Council, pursuant to subsection 67(1) of the Pest Control Products Act (see footnote a), proposes to make the annexed Review Panel Regulations. Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Francine Brunet, Alternative Strategies and Regulatory Affairs Division, Pest Management Regulatory Agency, Department of Health, Address Locator 6607D1, 2720 Riverside Drive, Ottawa, Ontario K1A 0K9 (fax: 613-736-3659; e-mail: pmra_regulatory_affairs-affaires_reglementaires_arla@hc-sc.gc.ca). Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act. Ottawa, December 7, 2006
MARY O'NEILL REVIEW PANEL REGULATIONS INTERPRETATION 1. The following definitions apply in these Regulations. "Act" means the Pest Control Products Act. (Loi) "objector" means a person who objects to a decision referred to in paragraph 28(1)(a) or (b) of the Act and who files a notice of objection under section 35 of the Act. (opposant) "participant" means, in the context of a review panel hearing, an objector or a person who makes representations under subsection 35(7) of the Act. (participant) "terms of reference" means, with regard to a review panel, the terms of reference determined under subsection 35(6) of the Act. (mandat) NOTICE OF OBJECTION 2. A notice of objection referred to in subsection 35(1) of the Act shall include (a) the name and address of the objector or, if the objector is a corporation, its corporate name and any other name registered with a province by which the objector identifies itself; (b) the decision to which the notice relates and the date on which the decision was made; (c) the scientific basis for the objection to the evaluations, on which the decision was based, of the health and environmental risks and the value of the pest control product; and (d) the evidence to support the objection, including scientific reports or test data. ESTABLISHING REVIEW PANELS 3. The Minister shall take the following factors into account in determining whether it is necessary to establish a review panel: (a) whether the information in the notice of objection raises scientifically 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 pest control product; and (b) whether the advice of expert scientists would assist in addressing the subject matter of the objection. REVIEW PANEL COMPOSITION 4. If the Minister determines that it is necessary to establish a review panel of one or more persons, each person selected by the Minister shall (a) possess scientific knowledge that allows them to evaluate the subject matter of the objection; (b) not have been employed in any department, in any division or branch of the federal public administration, in any corporation or in any parent Crown corporation as set out, respectively, in Schedules I, I.1, II and III to the Financial Administration Act, within one year before the day on which they are appointed to the review panel; (c) have provided the Minister with a written statement indicating that they are free from any actual or potential conflict of interest that relates to the decision under review; and (d) have undertaken in writing to disclose to the Minister in writing, without delay, any actual or potential conflict of interest that may arise and affect their duties as a member of the review panel. 5. (1) If the review panel is made up of one member, that member is the chairperson and if it is made up of more than one member, the chairperson is the member designated by the Minister. (2) The chairperson shall preside at review panel hearings and shall direct and manage the activities of the review panel within the terms of reference and in accordance with any procedure determined under subsection 35(6) of the Act. 6. The Minister shall designate another member of the review panel to act in the place of the chairperson if the chairperson is absent or unable to act. REMOVAL OF MEMBER 7. The Minister shall remove a review panel member at the member's request or if (a) the member does not satisfy the criteria in section 4; (b) the member refuses or is unable to carry out their responsibilities within a reasonable time; (c) there are reasonable grounds to believe that the removal is necessary to ensure the objectivity of the review panel; or (d) the member is employed in a department, in a division or branch of the federal public administration, in a corporation or in a parent Crown corporation as set out, respectively, in Schedules I, I.1, II and III to the Financial Administration Act. 8. If a person is removed from the review panel, the Minister shall select as a replacement another person who satisfies the criteria in section 4 unless the Minister has reasonable grounds to believe that the review may be completed by the remaining members. EXPENSES 9. Each member of a review panel shall, in accordance with any applicable Treasury Board directives, be paid reasonable travel and living expenses that are incurred by them while performing their functions away from their ordinary place of residence. SECURITY MEASURES 10. (1) As a security measure under subsection 44(6) of the Act, only participants in a review panel hearing are permitted to be present while information referred to in that subsection to which the public may not have access under subsection 42(4) of the Act and may not inspect under section 43 of the Act is being considered at the hearing. (2) A participant in a hearing shall submit to the review panel an affidavit made under oath or a statutory declaration under the Canada Evidence Act made before a commissioner for oaths or for taking affidavits stating that the person undertakes (a) not to disclose the information referred to in subsection (1) to any other person; and (b) not to use it for any purpose other than for participation in the hearing. COMING INTO FORCE 11. These Regulations come into force on the day on which they are registered. [50-1-o] S.C. 2002, c. 28 |
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