Occupational Alliance for Risk Science

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Occupational Alliance for Risk Science Workplace Environment Exposure Level (WEEL) Committee CHARTER VERSION 1.0 December 2011

Page 2 I. ORGANIZATION: There shall be a standing Committee for the Toxicology for Excellence for Risk Assessment (TERA) Advisory Board of Director s Occupational Alliance for Risk Assessment (OARS) Workplace Environment Exposure Level (hereafter referred to as the Committee ) comprised of members confirmed by the Chair of the Committee as ratified by the Committee membership. The Committee functions at the prerogative of the Advisory Board and TERA, and is accountable to the Advisory Board of Directors through the Chair of the Committee, the assigned Board Coordinator and the TERA President. A. MEMBERSHIP: Committee membership is not limited. Full membership will be open to individuals who have a high level of education, professional certification and experience in relevant disciplines which include industrial hygiene, toxicology, pharmacology, biostatistics, epidemiology, occupational medicine, risk assessment, engineering, and risk communication. The Committee shall try to include an appropriate and/or reasonable balance of representation from industry, academia, government and consultants. It is noted that members shall not serve on the Committee as official representatives of their employers, and they shall conform to applicable Conflict of Interest guidelines (COI). Committee assignments are for a one-year period. Members are reassigned on recommendation by the Committee Chair and approval by the Committee executive. Each year the Committee Chair nominates or ratifies qualified members through submission of the roster. There are no limits on the duration/frequency with which individuals may serve on the Committee. Should a Committee member be unable to participate in scheduled meetings, or otherwise demonstrate a lack of commitment to WEEL development during one full year, that member may be removed by the Committee Executive. Commitment to the Committee must include more than one of the following elements: participating in meetings (in person or via teleconference), acting on subcommittees, authoring WEELs, voting on ballots, providing review comments to authors, developing or presenting Continuing Education (CE) courses, and membership on the Committee Executive or the OARS Advisory Board. B. SELECTION OF OFFICERS AND RESPONSIBILITIES 1. Committee Executive Composition The Committee Executive consists of the Chair, Vice-Chair, Secretary, and immediate Past-Chair (or, if not available, a previous past-chair assigned by the Executive). 2. Selection The Committee has adopted secretary/vice chair/chair ascension to promote continuity in learning and functions. The Chair will poll Committee members for nominations for candidates for Secretary. Nominations for Secretary will open at the Fall meeting of the Committee. Voting for Secretary shall proceed by formal ballot to all full members of the Committee. In addition to the Secretary, the ballot will include the names of the members ascending to the Vice-Chair and Chair positions. Ballot voting will occur prior to the first meeting of the next calendar year, and election results will be announced immediately thereafter. 2

Page 3 The terms of office for all three positions are one calendar year, beginning each January. A major Committee activity requiring continuity or an inability to continue with the ascension plan may require that an officer remain for a maximum of 3 consecutive years in their office. 3. Roles and Responsibilities a. Chair The Committee Chair is the primary leader and motivator of Committee activities. He or she is accountable to the OARS Advisory Board, and ultimately TERA through the TERA liaison. Preside over the Committee meetings and interface with the Advisory Board and TERA. Call Executive Committee Meetings as necessary and establish the agenda for such meetings. Executive meetings will typically be via teleconference. Monitor the progress of individual assignments and goals and ensure that they are accomplished within the time frames set jointly with the Advisory Board. Execute business plans within the allocated budget. Ensure the planning and contribution of topics, sessions, arrangers, etc. for the TERA Boot Camp(s) and ensure that all related paperwork is submitted on time. Prepare and submit administrative reports including membership roster, annual report, and performance evaluation. Obtain guidance from TERA on the propriety of Committee actions relative to any ethical or legal conflict of interest. Ensure that active members receive recognition for their services to include documentation of service for certification or maintenance of professional credentials where applicable. Reply personally to anyone interested in participating in the Committee and encourage participation of new members. Understand and support the OARS mission statement and strategic plan. Work with TERA and the Advisory Board to develop and implement goals that complement the OARS mission and strategic plan and ensure that those goals are communicated to Committee participants. Adhere to established guidelines and policies when providing oral or written presentations on behalf of OARS. b. Vice-Chair The Committee Vice-Chair supports the Chair in Committee operations. Review and propose revisions to the charter as needed. Monitor and report desired Committee membership balance. Act as Chair in his/her absence. Submit a business plan and budget request to the Board for the coming year on behalf of the Committee. Support the Chair in their leadership capacity throughout the year as requested. Assume the Chair role in the event the Chair is not able to serve. 3

Page 4 c. Secretary The Committee Secretary ensures that the Committee follows the rules and procedures as set forth in the Charter and AOPs. Ensure arrangements for meetings have been made in consultation with, and the assistance of, TERA staff. Coordinate joint meetings and educational sessions with other interested OEL setting groups. With guidance from the Chair and Vice-Chair, develop an agenda for each meeting. Ensure that the minutes of each meeting, including Executive Committee meetings, are accurately recorded and distributed to all members, liaisons, associates, and the TERA liaison. Circulate WEEL Ballots and tabulate results. Maintain a voting record for each ballot that is filed with the Minutes. Communicate ballot comments to authors for resolution and to Scientific Content Quality Coordinator for review. Maintain and distribute WEEL status and action item lists. Work in conjunction with the Chair and Vice-Chair to accomplish Committee goals. Provide changes and updates to the OARS website coordinator. Maintain a record of member meeting attendance, WEEL documentation preparation and presentation and voting (participation). d. Past-Chair The Past-Chair serves as an important link between the current and previous Committees and is a member of the Executive Committee. Encourage membership participation and spearhead WEEL outreach activities. Work with the Chair to accomplish Committee goals. Ensure continuity of procedures and processes. Act as the Committee representative to the OARS Advisory Board Fill in for other Executive Committee members, as needed. 4

Page 5 C. Appointed Positions and Responsibilities 1. Selection A Publications Coordinator and Scientific Content Quality Coordinator will be appointed by the Chair for a period of at least one year, with extended tenure as determined by the Executive Committee. 2. Roles and Responsibilities a. Publications Coordinator The Publications Coordinator tracks WEEL documentation that has passed ballot to ensure that all references cited in the document are present for the records to be maintained at TERA, and that all materials necessary for publication are forwarded to TERA in a timely manner. Conduct a thorough review of the reference documents and how they are cited and track document publication status as outlined in the WEEL Development AOP. Communicate regularly with the Secretary regarding the status of each WEEL under review. b. Scientific Content Quality Coordinator The Scientific Content Quality Coordinator reviews balloted WEEL documents to ensure that comments have been addressed and that substantive changes have not been made subsequent to balloting. Review final draft WEEL documents as described in the WEEL Development and Post-Ballot WEEL Documentation Quality Assurance Scientific Review AOPs. Communicate regularly with the Secretary regarding the status of each WEEL under review. D. Responsibilities of Full Members 1. Roles and Responsibilities Full members produce WEELs and are required to participate in this process by: a) serving as primary researcher and author of documents, b) reviewing documents authored by other members, c) attending Committee meetings (in person or via teleconference), d) voting and commenting on all documents sent to ballot and e) participating in the development or presentation of CE courses. Each member will act in accordance with the TERA Code of Ethics and the Committee Conflict of Interest policy. Each member is expected to maintain active participation in the Committee. Voting on ballots is the most important aspect of participation. Return of ballots in a timely manner is mandatory for all full members. The Executive Committee may recommend that the Board revoke the membership of any individual for non-participation. 5

Page 6 From the WEEL status list, each member is to select candidate chemicals to author and other candidate substances for which he/she will act as a subcommittee reviewer. Current members are expected to complete at least one new WEEL each year. New members should submit their first WEEL draft for review by the third meeting after joining the Committee. If this is not done, they may be dropped from the Committee. Serving on the task group appointed to complete WEEL revisions may substitute for authoring new WEELs. WEEL documentation will be developed according to Committee AOPs. When a WEEL is approved for ballot, the author is expected to make any final changes and send the revised draft to the Secretary for balloting, no later than two months after the meeting in which the document was approved to be balloted. When a WEEL has been approved by ballot, the author is expected to resolve comments, document their resolution, incorporate all final changes and send the revised document to the Scientific Content Quality Coordinator within two months of receiving the ballot comments. Upon acknowledgement by the Scientific Content Quality Coordinator that the comments have been adequately addressed, the author is expected to immediately forward the final WEEL and full reference package, including any other supporting documentation, to the Publication Coordinator. II. MISSION STATEMENT A collaborative initiative with the goal of promoting worker health protection through increased access to high quality occupational exposure limits, enhancements in methods for establishing worker-health exposure guidelines, and education and training in occupational risk assessment methods. III. COMMITTEE FUNCTION: The WEEL Committee is a group of professional experts that sets health-based occupational exposure limits irrespective of technical feasibility or political and economic impact. The Committee serves a vital role to the industrial hygiene profession and industrial workplace in general by developing scientificallybased occupational exposure limits where no valid guidance exists for chemical exposure. Candidate chemicals are chosen from various sources including HPV (USEPA High Production Volume lists) and those solicited from stakeholders. There are assigned to the committee on a priority basis from the OARS Advisory Board. WEELs are derived using scientifically sound, state-of-the-art risk assessment procedures and a multi-tiered review process. Guided by the Committee AOPs, a WEEL is derived from an extensive review of all available relevant information of sufficient quality. The WEEL is intended to be an airborne chemical concentration to which nearly all workers may be repeatedly exposed, for a working lifetime, without experiencing adverse health effects. However, compliance with these guides does not guarantee protection of the worker, particularly those with underlying health conditions which make them unusually responsive to some chemicals. 6

Page 7 IV. COMMITTEE OPERATION: A. The Committee normally meets twice each year. To maximize efficiency meetings are held based on the number of draft documents to review, with a target of approximately twenty per year. Additional teleconferences may be convened at the call of the Chair. B. A quorum for conducting normal business of the Committee shall be a simple majority of the full members of the committee, present in person or by teleconference. Normal business considered at Committee meetings will be decided by a simple majority of those present and voting. C. Committee meetings will be open to other interested parties subject to the approval of the Chair. The Committee will listen to and consider comments, thoughts, and ideas from interested parties. No Committee proceedings will be considered confidential, except when an Executive Session is declared in order to discuss information of a confidential nature. Executive Sessions explicitly shall not include any discussions related to assessment of scientific data, texts of WEEL documents or recommended limits. All meetings will be conducted in such a manner that non-committee member attendees do not detract from the Committee s business. D. The Committee maintains and publishes a working list of candidate materials for WEEL preparation. E. Individual Committee members are assigned a candidate substance from the working list, and volunteer to serve as primary researchers and author for that substance, avoiding those which would create a conflict of interest. F. Individual Committee members are responsible for developing a working draft of the document for their assigned WEEL according to Committee AOPs in collaboration with their subcommittee reviewers. G. Draft WEEL documents are circulated to the Committee membership for review and discussion at regular meetings. Drafts are revised and recirculated as necessary. WEEL updates which are more than 10 years old may be given priority. H. Initiation of formal balloting of a draft WEEL document is subject to approval by simple majority vote at a regular Committee meeting at which a quorum is present. I. Final approval of a proposed WEEL and its supporting documentation requires a two-thirds majority of non-abstaining full members on a ballot sent to all full members of the Committee. J. The Charter will be reviewed annually and modified as necessary, subject to Advisory Board approval. The AOPs will also be reviewed annually and revised as necessary, subject to approval by a simple majority of all the Committee members. In order to ensure that all Committee members have an opportunity to contribute to and comment on proposed Charter or AOP revisions, voting on such revisions will be by formal ballot (written or electronic) sent to all members. K. Each WEEL may be reevaluated by the Committee whenever new, significant information becomes available, or at least every ten years. Each WEEL document will show the date of the original WEEL, and all revision dates. L. Detailed information about operations is or may be contained in the following AOPs: Membership Selection Conflict of Interest WEEL Chemical Selection Literature Search Strategy Document Requests for Contractor WEEL Development Resolution of External Comments Travel Fund Policy Document Management Process Post-Ballot WEEL Documentation Quality Assurance Scientific Review Document Retention. 7