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Chemistry International
Vol. 24, No. 3
May 2002

 

Validated Analytical Methods—AOAC’s Experience Over 100 Years


by Albert Pohland

The AOAC INTERNATIONAL is an organization devoted to the validation and use of chemical and microbiological analytical methods. It was organized in 1886 as the Association of Official Agricultural Chemists by a group of chemists whose interest was in harmonizing methods of analysis for fertilizers. The first president was Dr. Harvey W. Wiley, the director of the Bureau of Chemistry of the U.S. Department of Agriculture. Dr Wiley’s interests turned eventually to foods, and specifically, to additives then used commonly in foods. Dr. Wiley was able to show that many of these food additives were significantly toxic and harmful to consumers when ingested. Because of Dr. Wiley’s pioneering work on food additives, the U.S. Congress passed the 1906 Pure Food and Drug Act, which resulted eventually in the establishment of the U.S. Food and Drug Administration (FDA).

The AOAC headquarters building in Gaithersburg, Maryland, USA

Of course, Dr. Wiley realized that to provide regulatory control over food additives, or any contaminant for that matter, one had to develop good analytical methodology and show that these methods, when used in more than one laboratory, gave equivalent results. In addition, it was necessary to be able to estimate the expected variability to be encountered between qualified laboratories using the method. Today we refer to this as the method reproducibility, relative standard deviation, or uncertainty. Based upon the pioneering efforts of Dr. Wiley, the procedure by which one measures a method’s capabilities through the conduct of a collaborative study (roundrobin, ring test, or multilaboratory collaborative study) were developed through a cooperative effort of government, industry, and academic scientists over a period of many years. The function of the AOAC was to independently evaluate the results obtained in such studies. Within the AOAC, an Official Methods Board (OMB) was established to serve this peer-review function.

When the OMB was convinced that methods could yield equivalent results when performed by competent analysts, they were termed "official methods." The first compilation of official methods was published in 1920 as the Official Methods of Analysis of the AOAC (OMA). The 17th edition of this compendium was published in June 2000 and contains over 2000 methods. When the FDA was established in the 1930s, the Bureau of Chemistry was moved into the new agency. The FDA wrote into its regulations that "it is the policy of the U.S. Food and Drug Administration in its enforcement programs to utilize the methods of analysis of the AOAC as published in the latest edition of their publication, Official Methods of the Analysis of the AOAC International, and the supplements thereto . when available and applicable."

As time passed, within the FDA the focus shifted away from food additives to food contaminants, so that the OMA soon contained official methods for pesticides, heavy metals, industrial chemicals, animal drugs, cosmetics and colors, natural toxicants, and more. Each category of methods became a chapter in OMA. At the same time, the procedures for validation of methods were continually improved. Details of the validation procedures used by the AOAC in its method validation programs may be found on the AOAC Web site. These procedures were eventually harmonized through IUPAC and are today internationally accepted. Many of the AOAC methods are now incorporated in Codex standards as "reference methods."

In 1979, as a result of an effort to "privatize" some parts of the U.S. federal government, the AOAC was converted into a nonprofit, nongovernmental organization. Whereas at one time 80%–90% of the AOAC membership was government employees, today only about 20% is government, with about 65% industrial. Almost 50% of the members reside outside of the United States. These members value AOAC as a source of validated analytical methods, as a publication outlet for scientific papers, and as a venue for interacting with analytical chemists, microbiologists, and food scientists worldwide.

In recent years, the need for microbiological methods and the validation of such methods has resulted in an increasing number of microbiologists within the AOAC. In 1990, this fact, along with an increasing international membership, motivated the AOAC to change its name to AOAC INTERNATIONAL, with AOAC referring to the Association of Analytical Communities.

As an organization of chemists and microbiologists, the AOAC continues to focus on the crucial issues surrounding validation of analytical methods. The AOAC has recently initiated a multiyear collaborative effort to develop an Internet-accessible, electronic database of methods used in the analysis of foods, which are categorized according to the degree to which they have been validated. The AOAC has recently established three task forces focused on the development and validation of analytical methods for the following: (1) dietary supplements, (2) food allergens, and (3) agricultural biotechnology (i.e., methods for analysis of foods for genetically engineered organisms). The AOAC is a member-responsive organization, providing many products and services:

  • For the research scientist, the Journal of AOAC INTERNATIONAL is a highly respected outlet for publication.
  • For the laboratory manager, the Technical Division on Laboratory Management and a Technical Division on Reference Materials offers training in laboratory quality assurance and laboratory certification, and, most important, provides A2LA-certified, laboratory-proficiency testing programs.
  • For all members, AOAC provides—through the AOAC Web site and through the highly regarded member journal, Inside Laboratory Management— a connection to approximately 4000 individuals worldwide, in government, industry, and academia.

All of these products and services are available through the AOAC Web site.

The importance of validated analytical methods in world trade, in providing local and international product regulation, in informing consumers through product labels, and in protecting consumers from terrorist acts, cannot be underestimated. The AOAC has been, and will be in the future, a principal source of such validated methods.

Albert Pohland is director of the Office of International Activities at AOAC INTERNATIONAL.

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