Science & Research

Compendium of Analytical Laboratory Methods for Food and Feed Safety

The intent of this Compendium is to provide access to FDA regulatory methods currently being used for food and feed safety programs, including a searchable archive of validated methods and links to other on-line manuals/compendia of methods. We also provide links to the method development, validation, and implementation (MDVIP) guidelines of the Office of Foods and Veterinary Medicine (FVM), as well as a list of methods currently undergoing validation. Prior to selecting a method for use, one must consider whether a method is fit for its intended purpose (“fit for use”), the intended matrix, instrumentation availability and suitability, the expertise of laboratory personnel, and other factors.

This web page is a work-in-progress, and methods will be added over the coming months. FVM programs currently have many methods that have been in use since before the implementation of the of the MDVIP guidelines in 2014. These older methods are currently being prioritized for evaluation prior to posting, in order to ensure the level of validation and the method format. Some of the methods will require evaluation of laboratory verification and quality control data before posting. All methods following the current guidelines will be posted at regular intervals following final review, approval, and formatting. Future plans include the addition of a searchability function, once additional methods have been uploaded or linked.

Chemical Analytical Methods

Allergens

Chemotherapeutics

Colors (FD&C) and Color Additives

Dietary Supplements

Food Additives

Pesticides/Herbicides

Toxic Elements

High Performance Liquid Chromatography-Inductively Coupled Plasma-Mass Spectrometric Determination of Four Arsenic Species in Fruit Juice

Arsenic Speciation in Rice and Rice Products Using High Performance Liquid Chromatography-Inductively Coupled Plasma-Mass Spectrometric Determination

Microbiological Analytical Methods

FDA's Bacteriological Analytical Manual (BAM) presents the agency's preferred laboratory procedures for microbiological analyses of foods and cosmetics. As new methods are validated for use in FDA laboratories, there is a delay before chapters are updated and they are added to the BAM. In these instances, the new methods will be listed individually below until the BAM has been updated.

A Real-Time PCR Assay for Detection of Cyclospora cayetanensis on Fresh Produce

Other Analytical Methods

Regulatory Fish Encyclopedia

The Regulatory Fish Encyclopedia (RFE) is a compilation of data in several formats that assists with the accurate identification of fish species. It was developed by FDA's RFE Team of scientists at the Seafood Products Research Center (SPRC, Seattle District), and the Center for Food Safety and Applied Nutrition (CFSAN) to help federal, state, and local officials and purchasers of seafood identify species substitution and economic deception in the marketplace. Information and methods in the RFE include visual images, chemical taxonomic data, tissue protein profiles (Isoelectric Focusing Electrophoresis, IEF), and DNA sequence patterns (DNA Barcoding).

Macroanalytical Procedures Manual (MPM)

The Macroanalytical Procedures Manual includes methods for detecting filth, decomposition, and foreign matter in regulated products, including methods of inspection using the unaided senses (sight, smell, taste) or microscopy.

Defect Levels Handbook

Levels of natural or unavoidable defects in foods that present no health hazards for humans. Each listing indicates the analytical methodology (Defect Method) used, as well as the parameters for the defect (Defect Action Level).

National Shellfish Sanitation Program

The National Shellfish Sanitation Program (NSSP) is the federal/state cooperative program recognized by the U. S. Food and Drug Administration (FDA) and the Interstate Shellfish Sanitation Conference (ISSC) for the sanitary control of shellfish produced and sold for human consumption. The purpose of the NSSP is to promote and improve the sanitation of shellfish (oysters, clams, mussels and scallops) moving in interstate commerce through federal/state cooperation and uniformity of State shellfish programs. The NSSP Guide for the Control of Molluscan Shellfish contains lists of Approved Methods for Marine Biotoxin Testing (page 276), and Approved Limited Use Methods for Marine Biotoxin Testing (page 278). Method references are in the footnotes of the table.

Page Last Updated: 10/05/2016
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