Foods Program Compendium of Analytical Laboratory Methods
The FDA Foods Program Compendium of Analytical Methods (“the Compendium”) contains analytical methods that have a defined validation status and are currently used by FDA regulatory laboratories. The validation status of a method may have been established through the FDA Foods Program Method Development, Validation, and Implementation Program (MDVIP) using the Foods Program Method Validation Guidelines. In cases where methods were not evaluated under the MDVIP, internal FDA Foods Program committees have established the equivalency of the method validation level to the FDA guidelines. There are slight differences in the historical approaches for inclusion of methods in the Compendium for the chemistry and microbiology disciplines. For the chemistry discipline, methods at all validation levels may be included in the Compendium. The Bacteriological Analytical Manual, which primarily contains multi-laboratory validated methods, is the main component of the microbiology portion of Compendium. MDVIP multi-laboratory validated methods pending inclusion in the BAM are also listed.
More details on the respective areas of the Compendium are given below.
FDA Foods Program Compendium of Analytical Laboratory Methods: Chemical Analytical Manual (CAM)
The Chemical Analytical Manual (CAM) lists validated methods that FDA regulatory laboratories currently use to determine food and feed safety. Methods that have been multi-laboratory validated using the FDA Foods Program Guidelines for the Validation of Chemical Methods are listed in the CAM indefinitely. Methods whose validation status was established before the 2014 institution of the FDA Foods Program Guidelines for the Validation of Chemical Methods are posted for a fixed and limited duration (subject to renewal) after their validation status has been judged to be equivalent to that outlined in the Foods Program Method Validation Guidelines. Methods developed due to an emergency need, with limited validation, are posted for one year. Methods with single-laboratory validation status are posted for up to two years, and older methods judged to have validation status equivalent to multi-laboratory validation are posted for three years. The cover page for each method provides general information about the scope and application of the method, and includes any recent extensions to new analytes, matrices, or platforms. The CAM does not list all methods currently in use by FDA, but it is updated continuously and will eventually include all chemical methods used in FDA labs.
CAM Methods
The Chemical Analytical Manual (CAM) lists validated methods that FDA regulatory laboratories currently use to determine food and feed safety. Methods that are no longer in use by the Foods Program have been archived and are included below for reference purposes only.
Note: Version numbers are assigned to individual methods. Version number .01 identifies the first version. Increments of the hundredths digit (e.g., .02, .03, .04 ) designate major revisions.
Method C-003
Principal Analytes: Aflatoxin B1, B2, G1, G2; deoxynivalenol; fumonisin B1, B2, B3; HT-2 toxin, ochratoxin A, T-2 toxin, zearalenone
Method C-004
Principal Analytes: Sulfite (free sulfite and some bound sulfites)
Method C-005
Principal Analytes: Pentobarbital
Method C-010
Principal Analytes: Perfluoroalkyl and polyfluoroalkyl (PFAS) compounds
FDA Foods Program Compendium of Analytical Laboratory Methods: Microbiological Methods
The FDA Foods Program Compendium of Microbiology Methods includes the Bacteriological Analytical Manual (BAM) and microbiology methods validated under the Guidelines for the Validation of Analytical Methods for the Detection of Microbial Pathogens but not yet entered into the BAM. FDA's Bacteriological Analytical Manual 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 they are added to the BAM. During this time, the new methods will be listed below until their addition to the BAM. Microbiological methods are validated under the MDVIP at four levels (or their equivalents): Level 1: Emergency Use; Level 2: Single Laboratory Validation; Level 3: Single Laboratory Validation Plus Independent Laboratory Validation Study; and, Level 4: Full Collaborative Multi-laboratory Validation (MLV) Study (10 labs). Virtually, all methods included in the microbiological methods portion of the Compendium have MLV status. For a list of other microbiological methods used by the FDA, which have not reached multi-laboratory validation status, please see “Other FDA Microbiological Methods of Interest.”
BAM Link and Validated Methods Pending Addition to the BAM
| Matrix | Analyte(s) | Name of Method/Resource | Validation Status |
|---|---|---|---|
| Multiple | Foodborne pathogens | Bacteriological Analytical Manual (BAM) | BAM |
| Multiple | Cyclospora | Molecular Detection of Cyclospora cayetanensis in Fresh Produce Using Real-Time PCR | MDVIP Level 4 (multi-laboratory) |
| Multiple | Salmonella | Screening of Salmonella in Foods and on Environmental Surfaces by Real-Time Quantitative PCR (qPCR) | MDVIP Level 4 (multi-laboratory) |
| Multiple | Listeria | Molecular Verification of Listeria spp. isolates and Molecular Identification of Listeria monocytogenes Serogroups Using Real-Time PCR (qPCR) | MDVIP Level 4 (multi-laboratory) |
| Tattoo inks | Nontuberculous mycobacteria | Isolation and Identification of Nontuberculous Mycobacteria in Tattoo Inks: See BAM, Chapter 23A. | MDVIP Level 4 (multi-laboratory) |
| Multiple | Salmonella | Confirmation of Salmonella isolates by Real-time Polymerase Chain Reaction (PCR): See BAM, Chapter 5.E.9.c. | MDVIP Level 4 (multi-laboratory) |
| Multiple | Salmonella | Salmonella Serotype Prediction Using the GalaxyTrakr SeqSero2 Workflow: See BAM, Chapter 5.E.11 | MDVIP Level 4 (multi-laboratory) |
| Soft fruit | Norovirus and Heptatits A | Concentration, Extraction, and Detection of Norovirus and Hepatitis A virus in Soft Fruit: See BAM, Chapter 26 | MDVIP Level 4 (multi-laboratory) |
| Molluscan shellfish | Norovirus and Hepatitis A | Concentration, Extraction, and Detection of Norovirus and Hepatitis A virus in Molluscan Shellfish: See BAM, Chapter 26 | MDVIP Level 4 (multi-laboratory) |
| Animal foods | Salmonella | Screening of Salmonella in Animal Food by Loop-mediated Isothermal Amplification (LAMP): See BAM, Chapter 5.C.28. | MDVIP Level 4 (multi-laboratory) |
| Scallops, finfish | Norovirus and Hepatitis A | Concentration, Extraction, and Detection of Norovirus and Hepatitis A virus in Scallops and Finfish Meat: See BAM, Chapter 26 | MDVIP Level 4 (multi-laboratory) |
| Agricultural water | Cyclospora cayetanensis | Dead-End Ultrafiltration (DEUF) for the Detection of Cyclospora cayetanensis from Agricultural Water; see BAM, Chapter 19C. | MDVIP Level 4 (multi-laboratory) |
| Agricultural water | Cyclospora cayetanensis | Recovery and Detection of Cyclospora cayetanensis from Agricultural Water; see BAM, Chapter 19C. | MDVIP Level 4 (multi-laboratory) |