AOAC INTERNATIONAL Today
As the "Association of Analytical Communities,” AOAC INTERNATIONAL is committed to being a proactive, worldwide provider and facilitator in the development, use, and harmonization of validated analytical methods and laboratory quality assurance programs and services. AOAC also serves as the primary resource for timely knowledge exchange, networking, and high-quality laboratory information for its members and customers.
To meet these goals, AOAC has two methods validation programs, the AOAC® Official MethodsSM Program® and the AOAC® Performance Tested MethodsSM Program. AOAC is focusing very closely on streamlining its methods review process and providing new methods in areas of increasing international interest, including dietary supplements, genetically modified organisms (GMOs), and biological threat agents such as Bacillus anthracis.
International laboratory accreditation as a requirement for participation in the global marketplace has given AOAC INTERNATIONAL an opportunity to undertake a leadership role in developing criteria for laboratory accreditation. Members of the AOAC Laboratory Accreditation Criteria Committee (ALACC) have provided laboratory managers with the guidance they need to meet ISO 17025 requirements. The AOAC® Laboratory Proficiency TestingSM Program is also playing a key role by providing laboratories with a means for proving the accuracy and reliability of their test results to both their customers and accrediting bodies. Laboratories must depend on the results from a proficiency-testing program to maintain their business. The AOAC® Laboratory Proficiency TestingSM Program has earned the confidence of its customers by being among the first accredited proficiency testing programs. The program is the only one of its kind in the United States.
AOAC also provides a number of key publications, hosts technical meetings and conferences, and offers training courses in the areas of laboratory management, quality assurance, accreditation, statistics, and measurement uncertainty. Publications include the Journal of AOAC INTERNATIONAL, a scientific, bimonthly online and print publication containing peer-reviewed articles; Inside Laboratory Management, a bimonthly magazine, which keeps members up-to-date with the latest association news and highlights of activities related to AOAC analytical communities and contract efforts; and the Official Methods of Analysis of AOAC INTERNATIONAL (OMA), the compendium of methods adopted by AOAC INTERNATIONAL, which contains over 3000 methods, is distributed throughout the world, and is considered the most authoritative volume in its field.
The History of AOAC
AOAC was founded in 1884 as the Association of Official Agricultural Chemists, under the auspices of the U.S. Department of Agriculture (USDA), to adopt uniform methods of analysis for fertilizers. In 1885, a Convention establishing AOAC as an independent organization was held in Philadelphia, Pennsylvania, USA. Its membership was restricted to analytical chemists in state and federal government positions only—a membership requirement that remained for nearly 100 years.
The early years of AOAC were strongly influenced by Dr. Harvey W. Wiley, a founder of the Association who served as President and Secretary. In 1885, Dr. Wiley oversaw the publication of the AOAC Methods of Analysis, a 49-page bulletin of methods for analysis of fertilizers and precursor to OMA. By 1887, the publication had grown to include methods for feeds and dairy products as well as fertilizers.
Dr. Wiley's interest and concern for the adulteration of foods and drugs led to the study and adoption of official methods for foods in 1889. His research, and that of other AOAC volunteers, led directly to the passage of the 1906 Federal Pure Food and Drug Act. By 1912, AOAC was publishing the Official and Provisional Methods of Analysis of the AOAC.
When the U.S. Food and Drug Administration (FDA) was established as a separate agency from the USDA in 1927, sponsorship of the Association passed to FDA, which was now responsible for regulatory activities and because AOAC methods are so important to regulatory work.
The 1950s were an exciting era of rapid expansion for AOAC. New food legislation was passed and the need for new methods and techniques for regulatory purposes spurred rapid expansion of government laboratory facilities and participation in AOAC. As in the 1890s, AOAC was in the forefront of methods development and validation, and it was during this period that AOAC established itself as a recognized leader in the process of evaluating analytical methods.
In 1965, to recognize the expansion of AOAC's scope of interest beyond agricultural topics, the Association's name was changed to the Association of Official Analytical Chemists. The Association also began looking toward independence from the FDA. With funding secured from federal, state, and industry sources, AOAC became a truly independent organization in 1979.
The 1970s also brought about provisions for membership by scientists from outside the United States. Another significant change was the increased participation and acceptance of non-official (non-government) scientists. Although non-government scientists had always been allowed and encouraged to participate in collaborative studies and to hold methods development positions, it was 1987 before full voting membership was extended to industry scientists. Today, over 60% of AOAC INTERNATIONAL members are working in industry laboratories.
In 1980, the formation of geographically defined chapters, called Sections, was approved. AOAC's first Sections were established in North America, beginning with the Pacific Northwest Section in 1981. The Sections program expanded internationally with the founding of the Europe Section in 1989.
By 1991, the Association had long ceased to be limited to regulatory (Official) analytical chemists in the United States. During the 1980s and 1990s, the attention of the analytical community—particularly the segment focused on foods—had changed dramatically from chemical to microbiological food contaminants. Additionally, as a result of expansion of international trade, there was increasing demand for quality control of laboratories and international laboratory accreditation.
Consequently, in that year, the name of the Association was changed to AOAC INTERNATIONAL. The new name retained the initials by which the Association had been known for over 100 years, while eliminating reference to a specific scientific discipline or profession, and reflecting the expanding international membership and focus of AOAC as the "Association of Analy1tical Communities. "
The Association Today
To attain the vision of “worldwide confidence in analytical results,” AOAC serves the communities of analytical sciences by providing the tools and processes necessary for community stakeholders to collaborate and, through consensus building, develop fit-for-purpose methods and services for ensuring quality measurements. This is AOAC’s mission.
Leveraging the knowledge, experience, and expertise of more than 3000 members with one-third of its members outside the United States, AOAC has developed a proven model to achieve its mission and vision and bring value to the analytical communities that it serves. What do we mean by an AOAC community?
An AOAC community is a group of analytical scientists in a specific area who share AOAC’s vision of worldwide confidence in analytical results and who are brought together by a leader or “champion” to do together what they cannot do alone. Representatives of a community include scientific experts from various government agencies, industry, trade associations, international organizations, and academia. Stakeholders of a community work through consensus to prioritize methods needs, establish performance criteria for the methodology, and drive the development and validation of the best and most needed methods. The validation is conducted according to established and internationally recognized AOAC validation guidelines. This fact and recognition brings tremendous value to those who come to AOAC to validate methods. With over 120 years of methods validation experience, we know how to do validation and have the ability to facilitate the development and approval of methods that promote trust and confidence in analytical results, thereby facilitating and promoting interstate and international trade, public trust in manufacturers’ products, and public safety and security.
Because confidence in analytical results also depends on other complementary tools, the community may opt to have AOAC qualify the laboratories doing the analyses, train the analysts, and provide proficiency testing samples.
Under the auspices of AOAC INTERNATIONAL, communities engage in open communication and decision-making based on consensus, sharing resources both financial and expertise, and preventing duplication of efforts. The result: Only those methods that are of utmost importance to the communities are adopted. The methods that result from the communities’ work are accepted internationally and are used by regulatory and industry scientists alike for many purposes, including public health and safety, regulation, trade, monitoring, and quality control. AOAC has a number of communities in various stages of development, including food safety and security, agricultural materials, marine and freshwater toxins, dietary supplements, food allergens, disinfectants, and biological threat agents.
AOAC Capabilities and Value to the Global Analytical Communities It Serves
As an association, AOAC provides a number of fundamental capabilities and services that make it a valuable partner to government agencies, industry, and international organizations in meeting their needs for quality measurements.
Experience and Recognition for Providing Confidence in Analytical Results
AOAC has global brand recognition. The result of the work of AOAC communities, staff, and network of volunteers are AOAC® Official MethodsSM, the “gold standard” of methods accepted and recognized by regulatory agencies and organizations worldwide. In fact, many AOAC methods are specifically required in the enforcement of some state, provincial, municipal, and local laws and many federal food standards worldwide.
AOAC has had official observer status in Codex Alimentarius since its inception, allowing AOAC the ability to give input on the development of international standards for foods and agriculture. Because of AOAC’s proven recognition and credibility, if an AOAC method is available, it generally will be accepted into a Codex standard. As of today, the majority of the analytical methods cited in Codex standards are those of AOAC. With Codex being an organization supported by the World Health Organization (WHO) and Food and Agriculture Organization (FAO) of the United Nations, representing 168 countries worldwide, AOAC methods are recognized at the highest level in the world and, thus, are generally the methods of choice by governments of those countries.
AOAC “Official Methods of Analysis” have been defined as “official” by regulations promulgated for enforcement of the Food, Drug, and Cosmetic Act (21 CFR 2.19), recognized in Title 9 of the USDA-FSIS Code of Federal Regulations, and in some cases by the U.S. Environmental Protection Agency.
Ensuring Broad-Based Stakeholder Involvement
Providing Transparency and Independent Evaluation
AOAC’s strength is its ability to bring the right group of stakeholders through analytical communities to “associate” and to guide a program of work. Involving stakeholders from many sectors, including government agencies, industry, trades, academia, and international organizations, not only takes advantage of collective wisdom, but also creates buy-in and acceptance of decisions. That buy-in and acceptance of decisions is achieved by consensus of the group. AOAC works very closely with trade associations because they represent the industry to ensure industry’s participation in methods selection and validation.
AOAC’s two greatest assets are, first, its status as an international not-for-profit scientific association that provides independent volunteer-based assessment of methods. This status facilitates the buy-in from all the stakeholders to establish volunteer, consensus-based methods that are validated using AOAC guidelines.
The second greatest asset is in terms of transparency. AOAC publishes all of its validation data in a scientific peer-reviewed journal, the Journal of AOAC INTERNATIONAL, which can be found in libraries and institutions worldwide in both print and online formats. In addition, because it gathers representatives from many federal and state government agencies, industry, trades, international organizations, and academia, AOAC provides the ability for transparency in decision-making to the representatives of the community sitting at the table.
Finally, as an independent, third party organization, AOAC brings credibility and defensibility to the analytical methods used for regulation or for demonstrating regulatory compliance.
The AOAC Model: Here’s How It All Works
AOAC has in place a very effective system for establishing AOAC analytical communities, priorities for analytical work, and being proactive. This system or model has proven to be very effective for the Department of Homeland Security and for the Dietary Supplements communities in driving the best methods toward successful validation. It is currently the basis for all other AOAC communities in various stages of development and involves the following steps.
Opportunities and Benefits of Involvement
- Formation of a Community
Recognizing the need for greater confidence in analytical results in a specific scientific area, a group that may be from a government agency or from industry, headed by a “champion,” may petition the AOAC Board of Directors to initiate a presidential task force and lay the groundwork for the work of the community. The need may be based on one or many factors, such as public safety or environmental issues; the need for government, industry, or international bodies to use the same methods; need for modern methods (more efficient, sensitive, and reliable); public confidence in the product; fair competition; and uniform methods needed for interstate commerce or international trade. The Board of Directors not only evaluates the need for forming the community, but also determines whether it is a priority area for AOAC and within its scope and mission. Once the Board of Directors gives its approval, an AOAC presidential task force, representative of major community stakeholders from different sectors, is formed to begin the work of the community. The group or agency may provide the necessary financial infrastructure support for the work of the community, or may help seek financial aid to support its activities.
- Identifying Financial Support
When stakeholders come together to discuss the needs of the community, two of the most frequently asked questions are, “How do we get financial support?” and “Who pays for the validation fees?” It is true that financial support will be needed to conduct the validation studies and to support the work of the community. Financial support may come before the formation of a Task Force because of a specific need coming from a government agency, or it may come after the Task Group has identified priority areas. In the latter case, the community works with AOAC to help identify financial support from the organizations and government agencies that will benefit from the work of the community. In other cases, because of the worldwide need for the work of AOAC and its work in Codex, organizations and governments simply decide to donate funds to AOAC.
- Setting Priorities
After the task force is in place and funding is secured, the stakeholders must determine priority areas for the community, and this may be determined by a subset of the community. AOAC has learned that priorities must be established so that individuals do not commandeer the resources of the association (or the federal government) and clutter the validation systems with low-priority work. AOAC priority ranking subcommittees, one for the Dietary Supplements Task Group, for example, have been able to blend several criteria (public safety, economic impact, research priorities) into a rational mechanism for determining method priority areas and the order in which analytical methods are validated.
- Establishing Performance Criteria
AOAC has learned that there must be clear and careful communication among the stakeholders in order to bring about validated methods that do their job in the real world. For quite some time, methods have come forward for validation that simply do not meet the needs of either the regulators or the regulated industry, and the reality of science has not always been considered in establishing criteria for method performance. To remedy all this, AOAC task forces form subgroups of experts who establish the performance criteria on which methods will be chosen for validation.
- Finding and Selecting the Best Method
AOAC has learned that an individual, or even a single agency, may not be able to determine the best method to do a job. AOAC’s Expert Review Panels (ERPs) will review the available methods for a particular analyte or for specific matrixes and, based on the performance criteria established by the community and with science-based peer review, select the method that will best accomplish the task for which it is intended. Far more importantly, the ERPs have been able to identify gaps in methodology and actually assemble the right method from pieces of methods under consideration.
- Method Validation
Once the best method is chosen, AOAC recommends undergoing single lab validation based on a study protocol that is reviewed by the Expert Review Panel and the appropriate AOAC methods committee. Single laboratory validation shows how a method performs within one laboratory. A full collaborative study shows how a method performs in many laboratories. The value of single laboratory validation is that it can give a good idea of method performance and provide some measure of its ability to successfully complete a full collaborative study. But it is important to note that single laboratory validation should not be viewed as an endpoint.
To ensure the success of the full collaborative study involving 8–10 laboratories, the method protocol is designed using AOAC® Official MethodsSM Program guidelines and is approved by the appropriate AOAC methods committee and General Referee. The ERP also provides review comments. AOAC volunteer methods committees are composed of seven or more experts in the topic area who review recommendations of the General Referee, Study Director, and ERP, and provide overall written reviews of the study. After the study is completed, the Study Director analyzes the data and, based on the results, writes the collaborative study manuscript and submits it for method committee review. If successfully completed, the study is then submitted to the AOAC Official Methods Board for review and first action approval of the method.
- Qualifying the Analyst and Collaborating Laboratory
AOAC has learned that a study can fail if the collaborating laboratory is not qualified and the analyst is not properly trained to conduct the study, or if there is a miscommunication between the study director and the analyst. AOAC can conduct on-site visits of each collaborating laboratory to ensure that they have the necessary capabilities, equipment, personnel, and quality assurance procedures, and then set up training with the collaborators to review in great detail the steps that each collaborator must take in order to meet the necessary standards.
Disseminating and Updating Approved Methods
The methods are published in the Journal of AOAC INTERNATIONAL, and in OMA if approved “First Action.” They will also be posted on AOAC’s Website for widest possible distribution. Methods are available for comment for 1 year.
The methods need to be continuously reviewed and updated by community stakeholders to ensure currency and relevancy to the analytical community.
There are numerous ways individual members and government agencies, industry, academia, and international organizations can become involved in the Association.
Become part of the leadership team. Become a "champion " who leads the efforts of a community or member of a task force. The leadership team determines the scope of work of the community, the stakeholders who will make up the community, and the government agencies and industry representatives that should be part of a community. They determine priority areas the community will work on and drive best methods toward validation. Members also help identify funding sources for the validation work of the community.
Benefits of Involvement
Become an expert reviewer, working group member, or an Expert Review Panel member for determining method performance criteria, identifying methods, and choosing best methods. Members may be part of a team of scientists, statisticians, and safety advisors, many of whom serve on AOAC committees and have vast experience and expertise.
Participate in the methods validation process as a Study Director, General Referee, or member of a Methods Committee that includes a statistician, safety advisor, and group of experts who review study protocols and results of validation.
Participate as a collaborating laboratory. AOAC communities look for qualified laboratories to conduct multi-laboratory validation of analytical methods.
Provide samples. Products may be donated for use in single- or multi-laboratory studies to evaluate the performance of analytical methods.
Provide financial infrastructure for the work of the communities.
Submit a manuscript for consideration of publication to the Journal of AOAC INTERNATIONAL; act as a peer-reviewer for Journal manuscripts.
For individual members, AOAC offers a chance to “associate” with your peers through the communities, AOAC committees, annual meeting, section meetings, Task Force meetings, and electronically through e-AOAC, which contains on-line discussion forums and an electronic methods peer-review system to facilitate community members’ work. AOAC also provides other learning and quality tools, such as analyst training on how to validate methods, proficiency testing, and rapid testing. Thus, for individuals who get involved, AOAC offers a shared sense of purpose, satisfaction of making a difference, and personal growth by having individuals hone their leadership and science skills, and by learning to work through consensus.
For the analytical community as a whole, the benefit of AOAC is the community infrastructure and proven processes that AOAC provides to enable analytical scientists to “associate” and develop together the methods and tools that result in confidence in analytical measurements. As an independent organization, AOAC provides a place for representatives from many agencies and organizations to validate needed methodology that all the parties at the table can agree on. And AOAC leverages the knowledge and scientific expertise of its 3,200 members to provide the independent scientific peer-review and approval of the methods submitted by the communities. The communities and member volunteers ARE the Association.
Finally, by associating through AOAC, the communities benefit from the cost savings of sharing resources, avoid duplication of efforts, are able to leverage the collective wisdom of experts, and ultimately achieve trust in analytical results with all the economic and public safety and security benefits associated with it.
For more information on AOAC or its analytical communities, contact:
Executive, Scientific Business Development
481 North Frederick Avenue, Suite 500
Gaithersburg, MD 20877-2417 USA
Toll Free from North America: +1.800.379.2622
Phone: +1.301.924.7077 extension 131 (Worldwide)