Registration
SOR/2008-22 January 31, 2008

PEST CONTROL PRODUCTS ACT

Review Panel Regulations

P.C. 2008-0178 January 31, 2008

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 67(1) of the Pest Control Products Act (see footnote a), hereby makes the annexed Review Panel Regulations.

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 decides 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.

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). The Health Canada Pest Management Regulatory Agency (PMRA) administers the PCPA and its regulations on behalf of the Minister of Health. A new PCPA was brought into force on June 28, 2006.

The PCPA (sections 35-40) 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 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 public consultation prior to being finalized. Conditional registrations, granted under the Pest Control Products Regulations, are not subject to the reconsideration of decision provisions under the PCPA, unless they are converted into a full registration or are renewed. When a registrant applies to convert a conditional registration to full registration, or to renew a conditional registration, a consultation must take place and the reconsideration process applies to the resulting regulatory decision.

The Review Panel Regulations (RPR) elaborate administrative matters concerning the process so as to make the timely resolution of reconsideration questions predictable and transparent. The RPR specifies:

• what notices of objection shall include, e.g., the scientific basis for the objection to the evaluations of the health and environmental risks and the value of the pest control products on which the decision was based;
• what shall be taken into account when determining whether to establish a review panel;
• what the qualifying criteria are for review panel members, e.g., must possess scientific knowledge that allows them to evaluate the subject matter of the objection;
• when changes to the composition of review panels shall be made;
• what expenses panel members shall be paid; and
• what security measures shall be applied for the protection of confidential information considered by review panels.

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 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, the reasons, and provide a summary without undue delay.

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 establishment of review panels and the selection of panel members. Regulations will 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 RPR will contribute to the effective administration of the reconsideration process provided by the PCPA, enhancing predictability and transparency by formally specifying administrative matters for the process (e.g., what will be taken into account when determining whether to establish a review panel). It was determined through a strategic environmental assessment that this regulatory initiative will result in no 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 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 PMRA’s Web site on June 30, 2003. The RPR was pre-published in the Canada Gazette, Part I, on December 16, 2006 for a 75-day comment period.

Comments were received from three respondents. Comments and responses are summarized below.

Respondents requested the Regulations include a process for stakeholders to comment, refute or appeal the recommendations of the panel before a decision is made by the Minister. No revision was made since it would be redundant with provisions of the PCPA whereby anyone will have full opportunity to present their evidence and arguments to the panel. The report will summarize the evidence and the arguments and provide an assessment, indicating where the panel agrees and disagrees with the hearing representations.

Respondents requested the Regulations specify timelines for the reconsideration process. No revision was made so as to maintain flexibility and responsiveness in addressing reconsideration questions. It would be difficult to predict what timelines are appropriate because they would vary on a case-by-case basis. The Minister will determine terms of reference for each panel review which will suggest target timelines for conducting and completing the review.

Respondents requested the Regulations set the minimum number of panel members at two instead of one. The minimum number of one panel member was retained. The Minister will select as many experts as needed to assess the representations. This will ensure there is no unnecessary systematic redundancy in expertise on a panel and prevent delays in the process due to possible difficulties in finding additional members.

Respondents requested the Regulations require that affected registrants or applicants, who may be impacted by a reconsideration of a decision, be notified of the establishment of a review panel. No revision was made since the PCPA already provides for such notification to take place.

Respondents requested further details on how the reconsideration process will be administered. A guidance document will be published to complement these Regulations.

Compliance and enforcement

The PCPA and its regulations put in place details of prohibited activities, and along with enforcement programs and activities, encourage voluntary compliance with the requirements of the regulatory system. A significant part of the regulatory system is an effective system of enforcement that is designed and intended to serve two major purposes: (a) to encourage voluntary compliance; and (b) to put the Minister in a position to take appropriate action where non-compliance poses a threat to human health and safety and the environment that the regulatory system is intended to protect.

At any time during the reconsideration process, where confidential information is made available by the Minister in confidence to persons to enable them to carry out various purposes in the public interest, for example, a review panel, those to whom confidential information is provided (i.e., review panel members and participants) must protect it from unauthorized disclosure or use. Failure to comply is a contravention for which enforcement action may be taken. A guidance document will outline procedures regarding the use of confidential information during panel hearings.

It is in the public interest that a review panel and, therefore, the Minister be able to rely on the validity of information provided in connection with the determination of the registrability of a pesticide. Deliberately misleading a review panel is a contravention for which enforcement action may be taken.

The monitoring of compliance with the PCPA and regulations is effected by officials within the PMRA in relation to the areas of the regulatory system that they administer. Inspectors are designated and authorized to request and collect information to determine whether products or persons are complying with the legislative requirements, and to investigate possible contraventions. They are authorized to require that persons take appropriate actions to bring themselves into compliance with the legislative requirements. Where it is considered appropriate, enforcement action can be taken against persons in contravention. Possible enforcement actions range from corrective education actions to prosecution and are selected based on the degree of harm resulting from the non compliance in conjunction with other mitigation circumstances, e.g., history of compliance.

It is expected that the availability of significant sanctions for contraventions of the Act and regulations will encourage voluntary compliance and reduce the need for enforcement actions. The goal of any enforcement response is to achieve and maintain compliance.

Contact

Francine Colbourne
Policy, Communications and Regulatory Affairs Directorate
Pest Management Regulatory Agency
Health Canada
2720 Riverside Drive
Address Locator 6607D1
Ottawa, Ontario
K1A 0K9
Telephone: 613-736-3678
Fax: 613-736-3659
Email: pmra_regulatory_affairs-affaires_reglementaires_arla@
hc-sc.gc.ca

Footnote a
 S.C. 2002, c. 28

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