Expert Panel for Fragrance Safety Operating Procedures
Amended September 21, 2016
1.0 The Role of the Expert Panel
The Research Institute for Fragrance Materials, Inc. (“RIFM”) seeks the opinion and advice of an independent and autonomous committee, known as the Expert Panel for Fragrance Safety (“Expert Panel”), to further the goals and objectives of RIFM. The primary purpose of the Expert Panel is to help protect the public health by evaluating the safety of fragrance materials under conditions of intended use.
To accomplish this purpose, the Expert Panel is composed of individuals of diverse background and expertise who periodically meet to review data regarding the safe use of fragrance materials referred to it by RIFM, recommend studies when appropriate, and evaluate the safety of fragrance materials under conditions of intended use.
The principal objective of the Expert Panel is to provide scientific safety assessments upon which the International Fragrance Association (“IFRA”) issues guidelines and recommendations.
2.0 Relationship of RIFM and the Expert Panel
Maintaining the scientific integrity, independence and autonomy of the Expert Panel is critical to RIFM. Safeguards to assure this shall be established and followed.
The Expert Panel, together with RIFM’s President, periodically shall review the RIFM Scientific Program. RIFM’s President shall report to the RIFM Board of Directors on anticipated or recommended changes to the program by the Expert Panel. The RIFM President shall serve as the primary liaison between the Expert Panel and the RIFM Board of Directors. To facilitate effective communications, the Expert Panel, its Chair or Expert Panel member designee(s) shall endeavor to meet at least once a year with the Chair of the RIFM Board of Directors. At least every three (3) years, the Chair of the Expert Panel or his/her designee(s) from the Expert Panel and RIFM’s President shall coordinate the undertaking of a review of the RIFM Scientific Program, facilitate the preparation of a report thereon for submission to the Expert Panel and, upon approval by the Expert Panel, provide the report to the RIFM Board of Directors.
The RIFM President, assisted by RIFM staff, is responsible for ensuring the availability of appropriate information for consideration by the Expert Panel and on each meeting’s agenda topics.
3.0 Deliberations by the Expert Panel
The Expert Panel is expected to come to a conclusion regarding the safety of a fragrance material that has been submitted to it for review, or to report that insufficient or inconclusive data prevents the Expert Panel from coming to a conclusion. The conclusion of the Expert Panel shall be based on the available information, including scientific data relevant for the safety assessment of fragrance materials.
The Chair of the Expert Panel, other Expert Panel members, and the RIFM President shall adhere to a process that assures full and adequate consideration of the available information and the expertise of the members of the Expert Panel, individually and collectively. The deliberations of the Expert Panel regarding a fragrance material shall be conducted in a closed or open session, at the discretion of the Expert Panel.
4.0 Safety Assessments by the Expert Panel
A conclusion by the Expert Panel regarding the safety of a fragrance material under the conditions of intended use is the Expert Panel’s statement of its interpretation of the available scientific information (a “Safety Assessment”). A Safety Assessment by the Expert Panel shall apply to a specific fragrance material. The Panel will report the conditions for the fragrance material’s intended use under which the Safety Assessment by the Expert Panel was derived.
After deliberating and upon reaching a Safety Assessment regarding the safety of a fragrance material under conditions of intended use, the Expert Panel shall prepare and adopt a clear written statement of its conclusion. A Safety Assessment by the Expert Panel shall enable the development by IFRA of a Code of Practice Standard on the safe use of the material, if risk management measures are necessary.
5.0 Communication of Safety Assessments by the Expert Panel
Upon the Expert Panel reaching a conclusion regarding the safety of a fragrance material, the Chair of the Expert Panel shall inform the RIFM President of the Expert Panel’s Safety Assessment. The RIFM President, assisted by RIFM staff, then will communicate the Expert Panel’s Safety Assessment to RIFM’s Board of Directors, RIFM’s General Counsel, IFRA and other applicable persons and entities.
6.0 The Identification of Materials for Assessment by the Expert Panel
Materials to be evaluated by the Expert Panel should be limited to identifiable single chemical entities (individual fragrance materials) or naturally occurring composites such as essential oils that are clearly defined as to source and preparation.
7.0 Meetings of the Expert Panel; Quorum
The Expert Panel shall meet at least three (3) times per calendar year.
The Expert Panel shall conduct its meetings using procedures agreed upon by the Expert Panel. Unless otherwise agreed, the Expert Panel will follow standard rules of order to conduct its meetings.
The Expert Panel shall elect from its members a Chair who will serve a term of two (2) years. Election of the Chair shall occur biennially at the last meeting of the calendar year.
The RIFM President shall prepare the agenda for each meeting for approval by the Chair and distribution to the members prior to the meeting. The RIFM President shall solicit agenda topics from members of the Expert Panel when appropriate.
A quorum of the Expert Panel shall be two-thirds of its members.
The RIFM President shall notify each member of the Expert Panel of the date, time and place of each meeting of the Expert Panel at least one hundred eighty (180) days prior to such meeting.
8.0 Members of the Expert Panel; Tenure; Staggered Terms
Candidates for membership to the Expert Panel shall be evaluated by the Expert Panel or a subcommittee thereof. New members shall be selected solely by the Expert Panel.
Each member of the Expert Panel shall be confirmed by a majority vote of the Expert Panel for an initial term of three (3) years. Members of the Expert Panel may be reconfirmed for two additional terms, each of five (5) years, at the discretion of the Expert Panel. No person becoming a member of the Expert Panel on or after January 15, 2015 shall serve on the Expert Panel for more than thirteen (13) years unless such requirement is waived by a two-thirds vote of the Expert Panel.
To the extent possible, the Expert Panel shall nominate members for staggered terms in an effort to ensure that no more than one or two terms shall expire each year. The Expert Panel on an ad hoc basis may extend the length of a member’s term for the purpose of establishing staggered terms for members of the Expert Panel.
9.0 Size of the Expert Panel
The Expert Panel shall determine the number of members of the Expert Panel, provided, however, that the number of members shall not be less than eight (8).
10.0 Qualifications of Members
Each candidate for nomination to the Expert Panel shall be a recognized authority in a particular specialty, have experience in safety assessments, and have a full commitment to participation in the deliberations of the Expert Panel. To the extent possible, the composition of the Expert Panel shall reflect the expertise necessary for the Expert Panel to fulfill its obligations and mission.
The Expert Panel Conflict of Interest Statement shall be provided to each proposed member of the Expert Panel. Prior to the Expert Panel’s nomination of a member, such proposed member shall review and agree to comply with the Conflict of Interest Statement.
11.0 Resignation and Termination of a Member
A member may resign at any time by providing written notice to the Expert Panel Chair or Vice-Chair.
The termination of a member may occur if a member (i) misses two (2) or more meetings in a calendar year or three (3) or more meetings in any twenty-four (24) month period, or (ii) acts contrary to the provisions of these Operating Procedures or the Expert Panel Conflict of Interest Statement. Termination of a member shall occur upon a majority vote of the Expert Panel (but excluding the member under consideration).
12.0 Honoraria and Other Compensation
Members of the Expert Panel shall be provided an honorarium for their participation at the scheduled meetings of the Expert Panel. The honorarium also shall cover preparation time and routine technical review between meetings.
When a member’s effort extends beyond the usual two or three days set aside for meetings and standard preparation time and routine technical review between meetings, the member shall be reimbursed for his/her expert time. In the event a member contemplates requesting compensation for expert time or RIFM initiates a project involving expert time of a member, the member, prior to undertaking such work, shall confer with the RIFM President and reach agreement as to the appropriate compensation, the project objectives, approximate amount of time involved, and requirements for periodic reports in support of requested compensation and deliverables. Expert Panel members acknowledge that (i) a few hours spent on several occasions between scheduled Expert Panel meetings shall be covered by the regular honorarium, and (ii) half days and full days spent on a single project shall constitute compensable expert time.
The daily honorarium rate paid to members for meetings of the Expert Panel shall be $3,000 per day. Any expert time for participation in other meetings or the conduct of projects shall be compensated at the rate of $1,000 per day.
13.0 Reimbursement for Expenses
Members of the Expert Panel shall be reimbursed for reasonable out-of-pocket expenses incurred in connection with attendance at Expert Panel meetings.
14.0 Legal Advisor
14.1. Appointment of Legal Advisor. Subject to legal conflict of interests and the Expert Panel’s discretion, RIFM’s General Counsel shall also serve as legal advisor to the Expert Panel.
14.2. Consultation with Legal Advisor. The Expert Panel shall consult with legal counsel regarding the implementation of these Expert Panel Operating Procedures, standard rules of order for the conduct of meetings, the process for nominating and approving members, procedural matters during the course of deliberations regarding the safety of a fragrance material, conflicts of interest and other legal matters and questions related to the conduct and deliberations of the Expert Panel.
14.3. Annual Legal Review. The Expert Panel’s legal advisor shall attend at least one (1) Expert Panel meeting each calendar year to review current legal issues affecting the Expert Panel, conflict of interest guidelines, questions regarding Expert Panel procedures and guidelines, and other legal matters that may be raised by the Expert Panel.
15.0 Advisory Panel
The Expert Panel, in consultation with RIFM, may propose and work with the RIFM President and RIFM to establish an advisory panel to provide technical assistance to RIFM and the Expert Panel.