AGRICULTURAL MATERIALS COMMUNITY
The Agricultural Materials Community is committed to the development and validation of analytical methods that are of the highest priority to the community, provide confidence in analytical results, and are acceptable by governments and industry worldwide. The resulting methods will be used by regulatory and industry scientists alike for many purposes including public health and safety, regulation, trade, monitoring, and quality control. Because confidence in analytical results depends on the quality of the laboratory and the analysts developing and validating these analytical methods, the community is also dedicated in helping qualify laboratories and analysts that lead and participate in these activities.
Formed under the auspices of AOAC INTERNATIONAL, the community represents a diverse cross-section of agricultural products and areas including feeds and forages, plant nutrients, pesticide formulations and residues, veterinary diagnostics, and veterinary drug residues. Members include representatives from state, federal and local governments, industry, trades, and academia, and work through consensus to develop standards. Members serve as a primary resource for timely knowledge exchange, networking and high quality laboratory information for the community. The community is committed to public safety and security of the food supply, (including inputs to the land or animals used for food), to economic growth, and to facilitating trade.
ABOUT AOAC INTERNATIONAL
Founded in 1884, AOAC is an internationally recognized not-for-profit organization with 120 years of methods validation experience. In fact, AOAC has its roots in the analysis of agricultural materials – specifically the analysis of nutrients in fertilizers. In the late 1800s, state laws and regulations were being issued to assure fair trade practices. However, although various methods of analysis were available, analytical results were not comparable to each other and were not sufficiently precise for analysts to duplicate each other’s results. Thus, the Association of Official Agricultural Chemists (today AOAC INTERNATIONAL) was founded because of a need by state agricultural chemists to adopt uniform, validated methods and techniques for regulatory and trade purposes, a need that exists to this day.
Today, AOAC methods are routinely accepted without reservation in compliance action and in court. Many AOAC methods are specifically required in the enforcement of some state, provincial, municipal, and local laws and many federal food standards worldwide. 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).
AOAC’s vision is worldwide confidence in analytical results and its mission is to serve the communities of analytical sciences by providing fit-for-purpose methods and services for assuring quality measurements. Thus, today, as in the past, AOAC is committed to serving analytical communities and working with them to meet their needs.
As an association, AOAC provides a number of fundamental capabilities and services that bring value and assure the success of the work of its communities, namely:
- Ability to leverage its members, some 3,200 scientists, statisticians, and safety advisors, many of whom serve on AOAC committees and have vast experience and expertise.
- As an independent third-party organization, AOAC has the ability to bring together representatives from government, industry, and trades, including international organizations to work through consensus and drive the development and validation of fit-for-purpose methods on a priority basis. Thus, AOAC facilitates the buy-in from all the stakeholders to establish consensus-based methods. Working through volunteers, AOAC provides the ability for transparency in decision-making to the representatives of the community sitting at the table.
- AOAC has the ability to qualify methods, collaborating laboratories, and the analysts to ensure the success of a collaborative study.
Through past experience of working with other communities, AOAC has learned that a study can fail mainly for three reasons: 1) the method itself is not the best method chosen to undergo a collaborative study; 2) the collaborating laboratory is not qualified; and, 3) the analyst is not properly trained to conduct the study, or there is a miscommunication between the study director and the analyst.
AOAC has the necessary processes and procedures in place to subject methods chosen by experts to rigorous single-laboratory validation to help ensure the success of full collaborative studies. AOAC can also use its staff, volunteers, and subcontractors as laboratory assessors to ensure that laboratories have proper SOPs and capabilities to conduct a study adequately. And finally, AOAC has the ability to train the analyst before the study begins by reviewing in great detail the steps that each collaborator must take. All these have worked successfully in the past for the studies run for the U.S. Department of Homeland Security.
- AOAC has the ability to give stakeholders the chance to “associate” -- through its annual meeting, AOAC Section meetings, and electronically through e-AOAC, which contains on-line discussion forums and electronic methods peer-review system to facilitate community members’ work. And, AOAC has the ability to leverage other quality tools such analyst training, proficiency testing, and its Performance Tested Program through the AOAC Research Institute.
- The result of the work of AOAC communities, staff, and network of volunteers are AOAC® Official MethodsSM, the “gold standard” of methods accepted by regulatory agencies and organizations worldwide. Thus AOAC has the ability to facilitate the development and approval of methods that promote trust and confidence in analytical results thereby facilitating interstate and international trade, public trust in manufacturers’ products, and promote public safety and security.
- Finally, by bringing representation from many sources, AOAC helps government agencies, trades, and industry share resources and the costs of methods’ development.
AOAC INTERNATIONAL AND THE PRESIDENTIAL TASK FORCE ON AGRICULTURAL MATERIALS (TFAM)
An AOAC Presidential Task Force on Agricultural Materials was formed to assist the community in meeting its needs by helping the community develop methods of choice for quality assurance, regulation, safety and efficacy testing, and for building public confidence. Members of the Task Force are from various sectors of agriculture including feeds, plant nutrients, pesticides, veterinary diagnostics and veterinary drug residues. The Task Force will meet several times a year. Sub-groups are being formed to determine method priority areas and to help drive needed methods toward validation through AOAC Official Methods Program. Once priority method areas are chosen, the subgroups will form Expert Review Panels to define method performance parameters, acceptance criteria, and review submitted methods.
ISSUES & NEEDS
Given the wide scope of the Agricultural Materials Community, the needs, method priorities, and scientific expertise may differ somewhat for each area, and even within an area depending on whether the primary interest is public safety, economic, regulatory, or involves trade. However, the community has identified issues and needs that cut across all areas.
- Need for uniform methods mutually recognized by federal and state governments for regulatory purposes
Product regulations vary from state to state. Companies that sell products must register and adjust product ingredients and claims using different methods according to the state’s regulations. In addition, the federal government may approve products using in-house methods or those submitted by a manufacturer. States must then regulate the products using different analytical methods or try to identify and obtain analytical methods used in the approval of the product. Uniform acceptance criteria and mutually acceptable methodologies are needed for regulatory purposes.
- Need for internationally recognized methods
Uniform methods are needed to provide uniform results. Companies that do business internationally need analytical methods that are accepted worldwide to facilitate trade.
- Need for Developing Methods With Increased Specificity
Methods that reflect new analytical technology and provide increased applicability to the products in the current marketplace are needed in all areas of agriculture. For example, in the area of animal drugs in feeds, the new animal drug application (NADA) process has been operational for many years, and the number of ingredients used in animal feed today has expanded greatly from the time of NADA submittal. Thus new methods are needed that reflect current applications and new technologies.
- Need for confidence in analytical results
Federal, state and local governments as well as industry need reliable analytical methods to make science-based decisions and trust each other’s data. Without reliable methods, federal and state governments are ill equipped to assure the quality and safety of products for animal and human consumption. Manufacturers who are eager to create a level playing field with their competitors or who move their products across borders also need reliable analytical methods to prove their products are safe and meet label claims. Method priorities need to be determined, acceptance criteria defined, and the methods that meet defined criteria need to be collaboratively studied to provide a level of confidence acceptable to governments and industry.
- Need for reliable analytical methods as part of emergency preparedness
When analytical methods are needed to test for chemical analytes and/or pathogens in an emergency situation for example, laboratories must often react by using in-house or unproven methods in response to those emergencies. Long term planning and a systematic approach of setting method priority areas, finding best methods, pushing methods through to proper validation, and making those methods available to the laboratories that need them are crucial in today’s world.
- Need to qualify laboratories and analysts
To ensure that a method is reliable and performs as stated in many hands, a multi-laboratory collaborative study is required. A method may fail not because it is a bad method but because of poor communication between the study director and collaborating analysts, or because a laboratory does not have the capability to perform the tests adequately. There is a need to assess the suitability of collaborating laboratories and a need for training in the use of the methods so analysts are fully prepared to carry out an analysis.
PROGRAM OF WORK TO MEET THE NEEDS OF THE AGRICULTURAL MATERIALS COMMUNITY
To ensure that the Community’s mission and objectives are successful, the program of work will follow a proven model established by AOAC. This model has been successful for other communities working with AOAC, namely the Homeland Security and Dietary Supplements communities. The community’s program will follow systematic procedures and processes:
- Stakeholder Involvement
With the help of AOAC staff and volunteers, the TFAM will identify and gather stakeholders from federal, state, industry, trade, and international organizations -- representatives from each of the areas of agricultural materials.
- Setting Priorities
The TFAM will establish criteria for prioritizing method areas. The criteria may be based on nutrition, public safety and security, interstate commerce, international trade, may be economic, or based on other criteria as determined by the Task Force sub-group. Each will be ranked according to degree of importance. The group will then set method priorities. They will decide in order of priority the most important methods needed by the community.
- Establishing Method Performance Criteria
Methods that come forward for validation must meet the needs of the regulators and/or the regulated industry. The criteria may vary depending on the agricultural area. Subgroups or Expert Review Panels for each method area will be formed to establish the criteria for method performance.
- Finding the Best Method
Methods will be identified and collected. Expert Review Panels (ERPs) for each of the areas will review submissions based on established performance criteria and either choose the best method or identify gaps in methodology. If there are gaps in methodology, the ERPs may actually assemble the right method from pieces of methods under consideration.
- Validating Fit-for-Purpose Methods Quickly
Of late, AOAC has become very good at establishing timelines and, with its experienced staff and volunteers, method processes can keep moving so methods can be collaborated, reviewed and validated in 6 - 12 months.
- Publishing and Disseminating Approved Methods
Approved methods will be published in the Journal of AOAC INTERNATIONAL, in the Official Methods of Analysis of AOAC INTERNATIONAL and will be posted on AOAC’s website for widest possible distribution, immediately after approval as “First Action.”
- Identifying Financial Support
Financial support will be needed to help the community accomplish its mission and goals. The community will work with AOAC to help identify and get financial support from the organizations and government agencies that will benefit from the work of the community.