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AOAC INTERNATIONAL
AOAC INTERNATIONAL is a 120 year-old not-for-profit
scientific association committed to worldwide confidence in analytical results. In fact, “worldwide confidence in analytical
results” is AOAC’s vision.
To attain the vision, 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 assuring quality measurements. This is AOAC’s mission.
Leveraging the knowledge, experience, and expertise of more
than 2,700 of its members with one-third of its members outside the US, AOAC
has developed many competencies, programs, and a proven model to achieve its
mission and vision and bring value to the analytical communities that AOAC
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. Following a proven AOAC model, 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 and this fact and
recognition brings tremendous value to those who come to AOAC to validate
methods. With 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.
Under the auspices of AOAC INTERNATIONAL,
communities have the ability for open communications and decision making based
on consensus, sharing of resources both financial and expertise, preventing
duplication of efforts, and validating methods that are of outmost importance
to the communities. 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, and disinfectants.
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 & 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 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 there is an AOAC method available, it generally
will be accepted into a Codex standard. As of today, 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 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 USDA-FSIS Code of Federal Regulations, and
in some cases by the US Environmental Protection Agency.
Ensuring Broad-Based Stakeholder
Involvement
AOAC’s strength is our 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 done by consensus of the group. AOAC works very closely with trade associations since they
represent the industry to ensure industry’s participation in methods selection
and validation.
Providing Transparency and Independent Evaluation
AOAC’s two
greatest assets are 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 where AOAC publishes all of
its validation data in a scientific peer-review journal, the Journal of AOAC
INTERNATIONAL, which can be found in libraries and institutions worldwide.
In
addition, because AOAC gathers representatives from many federal and state
government agencies, industry, trades, and international organizations, AOAC
provides the ability for transparency in decision-making to the representatives
of the community sitting at the table.
Finally,
as an independent, non-governmental organization, AOAC brings credibility and
defensibility to the analytical methods used for regulation or for
demonstrating regulatory compliance.
Providing Leveraging Opportunities and Method Acceptance
In gathering groups of
stakeholders, AOAC has been able to provide a neutral, science-based forum for
the gathering of many agencies and the industries they regulate. AOAC has learned to be appropriately
inclusive in building stakeholder groups and this has resulted in many
opportunities to share expertise and resources. Although one governmental agency or industry, in and of itself,
may lack the resources to carry out the work of methods validation, it can very
easily form partnerships with other agencies and the industry to get the job
done. Sharing resources also prevents
duplication of effort and promotes acceptance of the methods by the entire
community. For
example analytes, such as pesticides, pathogens, or heavy metals may be of
interest to multiple government agencies and industries. Collaborating together to have analyte and
matrix extensions leverages a community’s resources and allows members to work
together and to benefit together.
Providing Tools to Keep the
Process Moving
AOAC has learned that relying on
volunteer-based method authors and study directors is the number one cause of delay
in the validation system. With its
experienced staff and volunteers, AOAC establishes timelines and provides a
streamlined and efficient system that routinely validates methods in 12 months
and can validate a method in 6 months.
This includes providing stakeholders with the chance to “associate” –
through AOAC’s annual meeting, stand-alone meetings/topical conferences or in
conjunction with other professional meetings, AOAC regional Section meetings
and “virtually” through e-AOAC, which contains on-line discussion forums
and electronic methods peer-review system to facilitate community members’
work. AOAC has 16 Sections worldwide
including Sections in the US, China, Europe, Japan, Latin American & Caribbean,
Canada, and Taiwan which can be used as forums to keep the process moving,
forums for training, forums for evaluating methods, and forums for transferring
the AOAC experience.
Providing
Added Confidence in Analytical Results
AOAC provides greater confidence in analytical results by offering other
quality measurement tools. For example,
AOAC validating a method successfully within one laboratory gives some
confidence in analytical results. AOAC
then validating the method successfully through a collaboratively studied gives
an analyst even more confidence. Even
more confidence can be achieved when AOAC provides analyst training in the use
of approved analytical methods.
Finally, AOAC’s proficiency testing program is available for analysts to
test themselves to see if they are getting the right results and to see how
they compare to other analysts.
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 community 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.
1. 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,” petitions the AOAC Board of Directors (BoD) to initiate a
presidential task force to 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 help seek financial help to help support its activities.
2. Setting
Priorities
After the
task force is in place, the stakeholders must determine priority areas for the
community, and this may be determined by a sub-set 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.
3. 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.
For quite some time, the reality of science has not always been
considered in establishing criteria for method performance. To ensure all this, AOAC task forces form
sub-groups of experts who establish the performance criteria on which methods
will be chosen for validation.
4. Finding 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 (ERP) will identify and collect methods for
a particular analyte or for specific matrices and, based on the performance
criteria established by the ERP and, with science-based peer review, select the
method(s) 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.
5.
Method Validation
Once the
best method(s) are 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 and 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 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 before the AOAC Official
Methods Board for review and first action approval of the method.
6. 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
there is a miscommunication between the study director and the analyst. AOAC can set up training with the
collaborators to review in great detail the steps that each collaborator must
take and to conduct on-site visits of each collaborating laboratory to ensure
they have the necessary capabilities, equipment, personnel, and quality
assurance procedures.
7. Disseminating
and Updating Approved Methods
The methods are published in the Journal
of AOAC INTERNATIONAL, and if approved “first action” in the Official
Methods of Analysis of AOAC INTERNATIONAL (OMA). They will also be posted on AOAC’s website for widest possible
distribution.
The methods need to be
continuously reviewed and updated by community stakeholders to ensure currency
and relevancy to the analytical community.
8.
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 prior to the formation of a Task Force because of a specific
need coming from a government agency, or financial support 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.
A number of stakeholders have come to AOAC to form
communities to evaluate analytical systems in support of their community’s
needs. Two, Homeland Security and
Dietary Supplements, are supported and directed by the U.S. Department of
Homeland Security (DHS), The Department of Defense (DoD), and the National
Institutes of Health, Office of Dietary Supplements (NIH/ODS),
respectively.
AOAC is now working to be a valuable partner to other U.S.
government agencies, including the Food and Drug Administration, the U.S.
Department of Agriculture, Department of Defense, the Environmental Protection
Agency, and the FBI. AOAC is also
involved with international organizations including Codex Alimentarius,
International Dairy Federation, WHO, WTO and the UN.
Community on Dietary Supplements
In September 2001, AOAC joined in
collaboration with the National Institute of Health, Office of Dietary
Supplements and FDA to identify and validate methods for ingredients in dietary
supplements. The goals are to bring
together industry and government to identify and prioritize those dietary
supplement ingredients for which analytical methods are most needed, and to
develop 20 AOAC Official MethodsSM in five years under the NIH/FDA
contract.
The Dietary Supplements community
representing the global marketplace was the first community that set the stage
for building a methods validation program of work based on transparency and
consensus building. AOAC Expert Review
Panels used in all communities were fashioned after the National Institute of
Health model. All of AOAC’s
communities today are based on the model developed under the NIH/FDA contract.
Although the NIH/ODS is providing
the financial infrastructure for the work of the community, today AOAC seeks
industry involvement through financial and in-kind support. AOAC believes it is crucial for the industry
to be involved in validating analytical methods for dietary supplements
because: 1) it will level the playing field; 2) maintain public confidence in
supplement products by preventing lower quality products from hurting the
industry; and 3) because it will prepare the industry for regulatory compliance
in the face of U.S. FDA’s Good Manufacturing Practices.
DHS/DoD
Shortly after September 11th
terrorist attacks, the U.S. was faced with an outbreak of anthrax. Accurate and reliable methods were needed to
detect B. anthracis in order to protect public health. While rapid and traditional methods exist
for the detection, isolation, and confirmation of B. anthracis, none
have completed a formal third-party independent evaluation, such as FDA
clearance for clinical specimens or AOAC certification for environmental
samples. The Department of Homeland Security recognized the need for an
independent evaluation of these methods and in June 2003, partnered with AOAC
to fund the validation of existing methods for B. anthracis. A task
force was formed that included representatives from industry, academia, and
many government agencies including CDC, FBI and CIA, to help in the selection
of the methods and design of the studies. Using AOAC, a neutral third-party
organization, representatives from the many agencies and from industry were
able to work together and come to consensus decisions, which made the work of
the group successful.
Based on selection criteria
developed by the Task Force, five best methods were selected and underwent
validation through the AOAC harmonized Performance Tested MethodsSM
program, which provides an independent third-party
review of test kit performance claims. The harmonized PTM studies are
now being followed by full collaborative studies involving eight
laboratories.
To ensure the success of the
validation studies, the community was also able to identify complementary
analytical tools that included analyst training and assessing the suitability
of collaborating laboratories that participated in the study. AOAC found that these are key to the
determination of method performance.
Safety and Security
AOAC is now forming a broad-based stakeholder
community to evaluate systems in support of our homeland safety and
security. Representation will include
many government agencies, including The Department of Homeland Security, FDA,
USDA, CDC, FBI, DoD, The Secret Service, CIA, as well as industry, trade
organizations, and academia. The
purpose is to review numerous threat agents that have been identified,
determine the various matrices in which these agents might appear, and assess
the feasibility and probability of such agents being added to those
matrices. The process of establishing
priorities will be a continuous process so that it is able to respond to
changing conditions. Once priorities
are set, the community will drive the most needed methods to validation. The intent is for the community not to stop
there and, using AOAC tools and capabilities, provide analyst and end-user
training in the use of the methods.
AOAC is proposing to leverage the
entire association in support of homeland security – the expertise,
competencies, and commitment of all of AOAC’s communities and the volunteers
that support the work of the association.
Agricultural Materials
An
AOAC Presidential Task Force was formed in September of 2003 to help the
agricultural materials community in meeting its needs for analytical methods
for regulatory, quality assurance, safety and efficacy testing, and for
building public confidence. Members of
the Task Force include stakeholders from state, local and federal governments,
industry, and trade associations.
International representation is currently being sought.
Because of the broad nature of
agricultural materials, sub-groups have been formed to define the work of the
community. Sub-groups include feeds and forage/nutritive value; veterinary diagnostics;
fertilizers; and feed additives and contaminants. The sub-groups will
define analytical methods performance parameters, methods acceptance criteria,
review submitted methods, and drive the best methods toward validation. Foods will be added to the community in the
near future and sub-groups will be formed based on the foods chosen to be part
of the scope of the task force. The task force has met and will continue to
meet several times a year. The community
is committed to public safety and security of the food supply, (whether inputs
to the land or animals used for food), to economic growth, and to facilitating
trade through the development of uniform analytical methods pertinent to
agriculture.
Marine and Freshwater Toxins
Marine and freshwater toxins require extensive monitoring programs and have a significant economic and human health impact. Although there is a strong and global need for improved testing methods for these toxins, the demand for new, officially validated methods has not been met. A Task Force on Marine and Freshwater Toxins was proposed in late 2003 and after appointing the Task Force chair AOAC approved, over the first several months of 2004, the Terms of Reference and a list of 13 voting members. As of late October, 2004, the Task Force has grown to over 70 members in more than a dozen countries and is now active in focusing efforts, setting priorities, and generally finding means to guide and accelerate validation. Key aspects of Task Force success are strong stakeholder orientation and a set of carefully developed analytical methods criteria for prioritizing and selecting methods. The criteria were developed with extensive input from an international mix of federal agencies, academics, and industry, and are based on health threat posed by a toxin group, mouse replacement, method performance, and practicality. Two methods, an ELISA assay for domoic acid, and a pre-column oxidation LC method for saxitoxins, were previously subjected to interlaboratory validation studies and have been approved by the Task Force for Official Method of Analysis review. A joint WHO/FAO consultation has now cited the work of the Task Force in a report to be released to Codex Alimentarius. More information on the Task Force can be found at http://www.aoac.org/marine_toxins/task_force.htm.
Other AOAC Communities and Activity
Areas
AOAC has a number of other communities
in the making with task forces defining the scope of work and gathering
stakeholders. They include Food Allergens, and Disinfectants. A task force on Microbiology Criteria is currently being
formed to re-evaluate AOAC’s microbiology guidelines and to gather stakeholders
to identify microbiology priority method areas. Other areas of interest include low carbohydrates in foods
and alcoholic beverages, antioxidants in foods, and biotechnology.
Over the past several years, AOAC
INTERNATIONAL has effected considerable change in its ability to serve the
U.S. Government. Much of this
change has been the result of AOAC’s execution of programs of work through
analytical communities supported by, and directed by, the Department of
Homeland Security, the Department of Defense, and the National Institutes of
Health Office of Dietary Supplements.
AOAC INTERNATIONAL is now in a position to be a highly valuable partner
to the U.S. Food and Drug Administration, U.S. Department of Agriculture, U.S.
Environmental Protection Agency, the FBI, and the U.S. Army.
AOAC is also involved in
many international initiatives with standard setting entities and is
working to increase international communications and membership. AOAC remains very involved in global
standardization issues through the input of its International Coordination
Committee, the AOAC Liaison Committee, via its role as an NGO member of the
Codex Committee on Materials Analysis and Sampling (CCMA), and finally as Secretariat
of the InterAgency Meeting (IAM).
Today, AOAC is assisting the U.S. delegation in drafting an Analytical
Terminology paper for submission to CCMAS.
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 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.
- Become
an expert reviewer, part of a sub-groups or Expert Review Panel
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.
Benefits of Involvement
For individual members, AOAC offers a chance to
“associate” with your peers through the communities, the AOAC committees, the
annual meeting, section meetings, Task Force meetings, and electronically
through e-AOAC, which contains on-line discussion forums and electronic
methods peer-review system to facilitate community members’ work. AOAC also provides other learning and
quality tools such 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 their science skills, and learn 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 IS 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:
Anita Mishra
Principal Scientific Liaison, Government and Industry
AOAC INTERNATIONAL
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)
Fax: +1.301.924.7089
E-mail: amishra@aoac.org
Web: www.aoac.org
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