How does AOAC create standards via the Stakeholder Panel Process?
AOAC INTERNATIONAL’s
governance
structure is articulated in its bylaws which are implemented by a
volunteer Board of Directors. The AOAC Board of Directors, elected by the AOAC membership, sets the
strategic direction, has sole fiduciary responsibility and establishes policies for the association. The
AOAC Board of Directors delegates implementation of its policies to staff and various appointed
volunteer boards, committees and panels.
AOAC’s volunteer consensus standards development process includes the following types of standing
consensus committees:
Official Methods Board:
Implementation of the policies and procedures is delegated to the Official
Methods Board (OMB). The OMB shall serve the Association in a scientific and advisory capacity on
standards and methods and the process of their adoption. The OMB provides oversight of AOAC’s
voluntary consensus standards and conformity assessment activities. The OMB operates according to an
approved Terms of Reference and answers to the AOAC Board of Directors. The OMB will carefully vet
the stakeholder panel chair and representative stakeholders for balance and to ensure all perspectives
are represented in the consensus voting process. Additionally, the OMB vets and approves all members
of the expert review panels for expertise, balance and conflict of interest. OMB assigns an OMB member
to liaise with the stakeholders and expert review panels.
Advisory Panel:
This panel identifies key stakeholders and subject matter experts, frames the issues,
determines ingredients, and sets priorities for the stakeholder panel. The panelists are generally
comprised of those entities providing financial support and recommended key stakeholders. The
solicitation refers to an external advisory panel (EAP) which will be noted as the advisory panel in the
remainder of the proposal.
Stakeholder Panel:
This panel is comprised of anyone with a material interest. Participants include, but
are not limited to: product manufacturers, analyte/method subject matter experts, technology
providers, method experts, government and regulatory agencies, contract research organizations,
reference materials developers, ingredient manufacturers, method end users, academia, non-
governmental organizations (ISO, IDF, etc…), AOAC volunteers, and others as identified. AOAC ensures a
balanced group of voting stakeholders. Stakeholders engage and deliberate on the priority objectives as
determined by the advisory panel. Stakeholder panel accomplish its work via working groups to draft
standards.
All stakeholders may share and contribute to the discussions; however consensus of the stakeholders is
demonstrated via voting conducted with a vetted, balanced representative group of stakeholders in
which all identified and perspectives are represented. Stakeholder panels deliberate and reach
consensus on standards. To ensure stakeholder panel meetings include a process in which all
stakeholders are afforded due process, the latest edition of Robert’s Rules of Order serves as the
parliamentary procedure framework by which stakeholder panel deliberations are facilitated.
Working Groups:
AOAC stakeholder panel working groups provide scientific credibility by establishing
draft standard method performance requirements {SMPRs). The working groups use the AOAC SMPR
Guideline as a template from which to discuss and consider method applicability, analytical range,
sensitivity, specificity, limit of quantitation and limit of detection, repeatability, recovery and
