Essential Oil-based Personal Insect Repellent External Advisory Panel: Terms of Reference

Health Canada's Pest Management Regulatory Agency (PMRA) is responsible for administering the Pest Control Products Act. Under the Act, pesticides must be assessed before they are sold or used in Canada in order to determine that they do not pose unacceptable risks to humans or the environment and have value when used according to the label instructions. This assessment applies to both conventional chemical pesticides and non-conventional substances used as pesticides. As part of Health Canada's ongoing commitment to regulatory modernization, the establishment of this advisory panel will provide a review of the current approach to the regulation of personal insect repellents containing plant-derived essential oils.

The Terms of Reference for the Essential Oil-based Personal Insect Repellent External Advisory Panel (EOPIR EAP) adhere to Health Canada's Policy on External Advisory Bodies (2011) which sets out best practices and standards for the establishment and management of advisory bodies.

The Terms of Reference of the EOPIR EAP were endorsed on June 11, 2015.

On this page:

• 1.0  Mandate
• 2.0  Reporting Structure/Governance
• 3.0  Membership Nomination Process
• 4.0  Roles and Responsibilities
• 5.0  Management and Administration

1.0 Mandate

In 2012, the PMRA finalized its Regulatory Directive entitled "Guidelines for the Registration of Non-Conventional Pest Control Products", which provides a flexible, tiered approach to information requirements specifically for non-conventional pest control products. While PMRA's current position is that the tiered approach provided in this guideline is applicable to insect repellents containing plant-derived essential oils, it is recognized that the nature of exposure to these types of products is different from other types of non-conventional pesticides. Specifically, even though they are derived from natural sources, these products are applied directly to the skin and often the directions on the product labels allow for repeated application.

The advisory panel will be asked to confirm that the existing tiered approach to information requirements can be applied to these types of products (for example, insect repellents containing plant-derived essential oils). The advisory panel will also be asked to provide input on approaches to assessing potential data gaps either through the tiered approach described in DIR2012-01 or through an alternative approach recommended by the advisory panel.

Scope/objective: The EOPIR EAP will be composed of scientific experts in the field. The advisory panel will provide PMRA with guidance on:

• The acceptability of the current tiered approach to information requirements for assessing health risks of essential oil-based personal insect repellents.
• The acceptability of using such a tiered approach to address the uncertainty and data gaps in the database for a previously registered pest control product, citronella oil.

In recent years, a number of non-conventional pesticides have been approved by the PMRA (including some personal insect repellents containing soybean oil and oil of lemon eucalyptus) and this experience will be used to inform the review of the regulatory framework.

Following this advisory panel consultation, comments will be solicited from the public, industry, and other stakeholders on a proposed regulatory approach before finalizing the regulatory framework.

Consistent with the December 2014 Information Sheet "Review of the Regulatory Approach for Personal Insect Repellents Containing Plant-Derived Essential Oils", published on Health Canada's website, methyl eugenol, a contaminant of concern that could be present in these products, is considered to be outside the scope of the advisory panel's discussion.

2.0 Reporting Structure/Governance

The reporting structure/governance of this advisory panel reflects the guidance as provided in Health Canada's Policy on External Advisory Bodies (2011), which also establishes best practices and standards for managing advisory bodies upholding the principles of openness, transparency and accountability.

Health Canada is represented by the Director General of PMRA's Health Evaluation Directorate, Dr. Peter Chan, who is the executive secretary to the EOPIR EAP (see section 4.4).

3.0 Membership Nomination Process

Members of the EOPIR EAP are recruited through a targeted nomination process based on their extensive scientific knowledge, expertise, and experience, including the use of non-animal testing approaches and technical expertise in the field of natural health products.

The goal of this process is to ensure that, together, advisory body members have a range of knowledge, expertise, and experience and reflect a variety of perspectives. Health Canada promotes diversity and inclusiveness in advisory body membership.

The Chair and advisory body members are appointed by the executive secretary. Appointments are made at the discretion of the executive secretary and may be ended without consultation for a variety of reasons (see section 3.9).

3.1 Membership Considerations

The mandate of the EOPIR EAP defines its membership.

The EOPIR EAP will have five members. Membership should include, but is not limited to, the following areas of knowledge, expertise, and experience:

• scientific or technical knowledge;
• specialized expertise;
• recognition as a leader in the field;
• any other relevant background that will bring useful input to the advisory body and complement the knowledge, expertise, and experience of other members.

Membership may include, but is not limited to, people with the following backgrounds:

• scientists, researchers, academics, and individuals with specialized expertise;
• experts professionally recognized in their fields;
• industry experience (except where the advisory body's mandate is to provide advice on specific matters relating to the review of a regulated product).

Membership may include, but is not limited to, the following sectors:

• academia;
• government organizations;
• non-governmental organizations;

To preserve the independence of the federal government as a decision maker, a federal employee can neither chair nor be a member of an advisory body and cannot participate in the formulation of an advisory body's advice to Health Canada.

3.2 Affiliations and Interests

To be considered for appointment, potential members of the advisory panel are required to complete and return the Affiliations and Interests Declaration Form.

In keeping with the Privacy Act, a completed Affiliations and Interests Declaration Form is considered confidential. Health Canada will not make public any information in the form without the member's permission. However, as a condition of membership, members will allow Health Canada to publish on its website, a Summary of Expertise, Experience, and Affiliations and Interests, based on the completed declaration form.

In addition to publishing the summary, Health Canada or the Chair will also ask members to make a verbal statement of their relevant affiliations and interests at the beginning of an advisory body meeting.

Members must update their declaration in writing whenever their situation changes. Health Canada will review declarations before making appointments and on an ongoing basis, at least on an annual basis, as well as any time the advisory body mandate is changed.

Members are expected to conduct themselves in an appropriate manner. They may not use their position on an advisory body for their private gain or for the gain of any other person, company, or organization.

3.3 Confidentiality

To support their ability to provide well-informed advice, EOPIR EAP members may receive confidential information. Everyone must sign a Confidentiality Agreement before participating in the EOPIR EAP as a member, presenter, or observer.

The Confidentiality Agreement prohibits the disclosure of any confidential information received through participation in the advisory body, including information received orally or in writing, through email correspondence, telephone calls, print materials, meeting discussions, etc.

Health Canada will mark information according to the level to which it is protected under the Policy on Government Security.

The Chair will ensure that everyone participating in the meeting, telephone discussion, email exchange, or in another form of communication has received clear instructions on the confidentiality of the proceedings.

3.4 Security Clearance

All members are required to attain an appropriate security clearance.  Health Canada provides the required forms to candidates for appointment.

3.5 Indemnification

All members serve on the EOPIR EAP on a volunteer basis. Health Canada undertakes to provide its volunteer advisory body members with protection against civil liability provided the volunteer member acts in good faith, within the scope of their volunteer duties; and does not act against the interests of the Crown.

Members act collectively as an advisor to Health Canada with respect to the mandate of their advisory body but they are not final decision-makers. The Department has the ultimate responsibility and accountability for any decision resulting from the advice received from an external advisory body.

3.6 Travel and Expenses

Members will be reimbursed for expenses incurred on approved travel for the EOPIR EAP such as trip costs and accommodation, according to the Treasury Board of Canada Secretariat Directive on Travel, Hospitality, Conference and Event Expenditures.

3.7 Tenure

Members are appointed by the executive secretary until the summer of 2016.

3.8 Resignation Process

It is preferable for a member to provide 14 days' notice of the intent to resign. The resignation letter must be in writing and be addressed to the executive secretary and to the Chair. The letter should state the effective date of the resignation.

3.9 Reasons for Termination

Health Canada may end a member's appointment by writing to the member stating the reasons the appointment is being concluded and the effective date. Appointments may end for a variety of reasons:

• the member's term is complete;
• the mandate of the advisory body has been completed;
• the advisory body's mandate has changed, thus requiring a different membership, etc.

An appointment may also be ended for cause when, for example, a member:

• fails to act according to the Terms of Reference;
• breaks the Confidentiality Agreement; or
• misses three consecutive meetings without a satisfactory reason.

4.0 Roles and Responsibilities

4.1 Members

Members of the EOPIR EAP have a responsibility to Health Canada and, by extension, to Canadians, to give their best advice to Health Canada. To do so, they must consider all input received that is related to the mandate of the advisory body.

Other responsibilities include to:

1. be available and prepared to participate in advisory body meetings, including Internet meetings, email exchanges, conference calls, and videoconferencing;
2. be available and prepared to attend a public input activity related to the advisory body's mandate, if requested;
3. participate in the discussions on the advisory body's recommendations, advice, or report to Health Canada;
4. notify the secretariat and the Chair of any changes in their affiliations and interests related to the advisory body's mandate during the time they are members of the advisory body;
5. make an oral statement of affiliations and interests at the beginning of a meeting, if requested to do so by the Chair;
6. direct any media inquiries to the secretariat and notify the secretariat about the inquiry;
7. attend a public consultation, if requested to do so by the executive secretary.

4.2 Chair

A member of an advisory body who serves as the Chair has additional responsibilities, including to:

1. chair advisory body meetings;
2. invite members to make a presentation at a meeting, when relevant and appropriate;
3. facilitate a full and frank discussion among advisory body members in fulfillment of the advisory body's mandate, including in formulating its recommendations, advice, or report to Health Canada;
4. identify when information and discussions are considered confidential and clarify expectations regarding this protected information;
5. seek consensus on the advisory body advice among all advisory body members, and if there is not agreement, ensure that this diversity of opinion is noted in the meeting records or report;
6. ensure the preparation of the meeting records or report and the delivery of the advisory body's advice to Health Canada;
7. act as the media spokesperson for the advisory body;
8. support, in any other way, the fulfillment of the advisory body's mandate.

4.3 Secretariat

The secretariat is housed in the PMRA's Microbial and Biochemical Evaluation Section (MBES). The secretariat is the administrative liaison between advisory body members and Health Canada and is a resource for members.

The secretariat provides Health Canada with leadership and strategic advice in the management of the advisory body and works closely with the Chair and executive secretary.

In addition, the responsibilities of the secretariat include to:

1. coordinate the member appointment process;
2. coordinate the preparation of materials for advisory body members and meetings, observers, and others, and coordinate the timing of their distribution;
3. assist with the work of the advisory body, as required;
4. provide administrative support to advisory body members;
5. support public access to information about the advisory body, as appropriate;
6. act as a liaison between Health Canada and the advisory body, including seeking input from Health Canada's scientific, technical, programs, and policies subject-matter experts;
7. assist the Chair in carrying out the Chair's responsibilities;
8. carry out any additional duties as appropriate to support the advisory body, including a risk assessment and mitigation strategies for members who volunteer on an advisory body;
9. undertake any tasks delegated to it by the executive secretary;
10. report to the executive secretary on the activities of the advisory body;
11. assist with a review or audit of the advisory body, as required.

4.4 Executive secretary

The advisory body's executive secretary is represented by the Director General of PMRA's Health Evaluation Directorate, Dr. Peter Chan, and makes decisions about the administration and operation of the advisory body. The executive secretary works closely with the Chair and secretariat.

The executive secretary, or a delegate, reports back to the advisory body at the beginning of each meeting on next steps and, if applicable, the impact of the advice received.

4.5 Media and communications

The executive secretary, in consultation with the Chair, will appoint a member to be the spokesperson to speak to the media on behalf of the advisory body when required.

A member may discuss advisory body work with the media or at conferences or other external events only with prior permission from the executive secretary.

All media requests related to the advisory body's statements or activities will be directed to Health Canada's Media Relations, who will coordinate responses with the executive secretary and the designated media spokesperson.

5.0 Management and Administration

5.1 Transparency

Health Canada is committed to transparency as an operating principle. Transparency of the EOPIR EAP is served by:

• ensuring that meeting schedules are predictable, where possible;
• posting advisory body materials on Health Canada's website.

  These materials include the following:

  • Terms of Reference
  • Member names including membership term
  • Summary of Expertise, Experience, and Affiliations and Interests
  • Biographies of members
  • Agenda

5.2 Meeting Agendas

The executive secretary, in consultation with the Chair and with input from the members, sets the meeting agenda, including identifying questions and issues for discussion.

5.3 Meeting Notice and Invitations

All meetings between Health Canada and EOPIR EAP members are scheduled by the executive secretary or secretariat, in consultation with the Chair. Meetings may be limited to advisory body members only or may be opened to Health Canada staff, presenters, and observers by invitation.

The secretariat sends out the invitations to attend a meeting.

5.4 Frequency, Type, and Location of Meetings

One in-person meeting will be held in the fall of 2015 in the National Capital Region.  Additional meetings or teleconferences between Health Canada and EOPIR EAP members may be held on an as-needed basis at the discretion of the executive secretary, in consultation with the Chair.

For teleconferences and other similar meetings, members must make every effort to ensure that a secure line is used and that no one else can listen to the proceedings unless the person has been previously approved by the Chair and secretariat.

5.5 Observers

The secretariat, or the Chair in consultation with the executive secretary, may allow individuals, organizations, or members of the general public to observe a meeting or part of a meeting. Observers may not provide input on agenda items or participate in the discussions, unless specifically invited to do so by the Chair.

As part of the opening remarks at an advisory body meeting, the Chair will:

1. identify, by name and organization, the people attending all or part of the meeting as observers;
2. confirm with the secretariat that the observers have signed the Confidentiality Agreement and met Reliability Check standards, if required;
3. state the requirements and expectations regarding any confidential matters being discussed at the meeting;
4. clarify that observers may not participate in the discussions, either by speaking or by otherwise expressing their support for or disagreement with what is being said, unless specifically invited to do so by the Chair (the Chair may ask observers who do not respect these rules to leave the meeting).

5.6 Invited Presenters

The secretariat, or the Chair in consultation with the executive secretary, may invite individuals with particular expertise or experience to provide input on a specific topic or agenda item. Invited guests may participate in the discussions if the Chair specifically invites them to do so, but they do not participate in the formulation of advice.

5.7 Requirements of Presenters and Observers

Health Canada may require an invited presenter or observer to complete:

• Declaration of Affiliations and Interest Form
• Confidentiality Agreement
• Personnel Screening, Consent and Authorization Form

5.8 Public Input

As indicated in the December 2014 Information Sheet "Review of the Regulatory Approach for Personal Insect Repellents Containing Plant-Derived Essential Oils", Health Canada intends on seeking public input on the results of the advisory body review through public consultation in 2016.

5.9 Deliberations and Reports

Advice from the EOPIR EAP will be provided to Health Canada in the form of a review which is expected to be completed and published for consultation in 2016.

The EOPIR EAP is encouraged to reach a consensus in providing advice whenever possible. When a consensus is not possible, the meeting record will reflect the diversity of opinions.

The EOPIR EAP must have quorum when making recommendations or providing advice to Health Canada. Two thirds of the members, including the Chair, must be present to have quorum.

Minutes and/or records of proceedings will summarize the proceedings to effectively reflect the advice offered. Remarks are not attributed to individuals in the minutes or records of proceedings.

Minutes and/or records of proceedings will be prepared by the secretariat and circulated to members for review and confirmation. Formal reports of the EOPIR EAP will be prepared by the Chair in consultation with other advisory panel members.

The final formal report of the EOPIR EAP may be posted on Health Canada's website.

5.10 Review

As the lifetime of the EOPIR EAP is expected to conclude in 2016, a review of this advisory body will not be necessary.