Food

Elemental Analysis Manual (EAM) for Food and Related Products

The U.S. Food and Drug Administration's (FDA) mission to maintain a safe food supply is met in part by monitoring food and related products for both toxic and nutritional elements. The FDA collects and analyzes food and other materials (foodware, vitamins, supplements, etc.) from commercial channels of trade to determine whether those materials are in compliance with applicable regulations. The analytical data gathered through these monitoring activities are also used for evaluating the extent and significance of these analytes in the food supply.

periodic table with B, Na, Mg, Al, P, K, Ca, V, Cr, Mn, Fe, Co, Ni, Cu, Zn, As, Sr, Mo, CD, Ba, Hg, Tl, and Pb highlightedFDA laboratories perform these sample analyses using sound analytical practices and methodology which are documented in the Elemental Analysis Manual for Food and Related Products (EAM). This resource serves as a reference, for analysts at the FDA and around the world, providing not only general analytical information and procedures and detailed laboratory methods, but also helpful notes from analysts' experiences using these methods.

The content of the EAM is peer-reviewed on an on-going basis and endorsed by an Elemental Analysis Steering Committee, which is composed of FDA laboratory scientists in the Center for Food Safety and Applied Nutrition (CFSAN) and the Office of Regulatory Affairs (ORA). The analytical methods (in Section 4) have been successfully evaluated via at least a single-laboratory validation and are based on analytical procedures previously published in peer-reviewed scientific journals. For some of these methods, detailed proficiency information, obtained via multilaboratory studies, is also available and presented in appendices to the methods.

The EAM is not an exact representation of procedures used at FDA laboratories. Additional procedures (not in the EAM) may be used and some of the included methods are no longer used. Additional methods are drawn from the Official Methods of Analysis of AOAC INTERNATIONALdisclaimer icon. In addition, compliance programs issued by FDA may require specifically-tailored methods not published elsewhere and FDA field laboratories use a separate Laboratory Manual that provides guidance on primary laboratory functions. New methods and procedures are also developed as needed to respond to emergencies. Methods included in the EAM but no longer used at FDA are retained because they are still considered current, relevant for other laboratories, and acceptable for use.

The EAM is only available from this website. A history of the EAM with access to past versions of its content is available from the EAM History and Archive section.

Please send any comments or contributions to EAM@fda.hhs.gov.

The mention of specific items of equipment and chemicals by brand name or the supplying of manufacturer's names and addresses do not constitute endorsement of a product or source by the United States Government.

If you are citing an EAM method or section, it is important to include the revision number, because methods are subject to review and improvement. Although you should follow the Author’s Instructions for your specific publisher, here is a sample citation for an EAM method:

Inductively Coupled Plasma-Mass Spectrometric Determination of Arsenic, Cadmium, Chromium, Lead, Mercury, and Other Elements in Food Using Microwave Assisted Digestion; Official Methods of Analysis of AOAC INTERNATIONAL[U.S. Food and Drug Administration, Internet]; Section 4.7, Version 1.1, 2015. Available from: http://www.fda.gov/EAM (Accessed December 31, 2015).

Table of Contents

1. Regulatory Considerations

1.1 Program Areas (under development)

1.1.1 Chemical Contaminants
1.1.2 Food Labeling and Nutrition
1.1.3 Food Ingredients and Packaging

1.2 Regulatory Operations (Capar) (PDF, 333KB)

1.2.1 Regulatory Procedures Manual
1.2.2 Compliance Policy Guides manual
1.2.3 Compliance Program Guidance Manual
1.2.4 ORA Laboratory Manual

2. Sample Preparation

2.1 Food Edible Portion (Various) (PDF, 61KB)

2.1.1 General Procedures
2.2.2 Degasification of Carbonated Beverages

2.2 Food Homogenization (Mindak, Jacobs, Capar, Cunningham) (PDF, 214KB)

2.2.1 Laboratory Homogenization Equipment
2.2.2 Homogenization Procedures
2.2.2.1 General Procedures
2.2.2.2 Candy Procedures
2.2.2.3 Pills, Capsules, Supplements, etc.

2.3 Digestion and Separation (Mindak, Cheng, Capar) (PDF, 24KB)

2.3.1 Microwave Digestion (general applications)
2.3.2 References to Procedures in Various Methods
2.3.2.1 Leaching Cadmium and Lead from Ceramicware
2.3.2.2 Mercury Separation in Seafood
2.3.2.3 Arsenic Speciation in Rice

2.4 Contamination Control (Mindak, Capar) (PDF, 356KB)

2.4.1 Environmental
2.4.2 Laboratory Ware

3. General Analytical Operations and Information

3.1 Safety (Mindak) (PDF, 344KB)

3.2 Terminology (Cunningham, Mindak, Capar) (PDF, 413KB)

3.2.1 Figures of Merit
3.2.2 Samples and Sample Solutions
3.2.3 Standard Solutions
3.2.4 QC/QA Materials and Solutions

3.3 Uncertainty (Cunningham) (PDF, 555KB)

3.3.1 Types of Uncertainty
3.3.2 Sampling Uncertainty and Nonhomogeneity
3.3.3 Determining Analytical Uncertainty
3.3.4 Uncertainty on a Report of Analysis (under development)
3.3.5 Uncertainty and Method Development - Example for Method 4.4

3.4 Special Calculations (Cunningham, Capar, and Mindak) (Version 3.0; PDF, 202KB)

3.4.1 Fortification Recovery
3.4.2 Other Recovery
3.4.3 Dilution Factor
3.4.4 Converting Units
3.4.5 Percent Difference
3.4.6 Mass Correction Factor (MCF)
3.4.7 References

3.5 Reference Materials (Cunningham, Capar) (PDF, 468KB)

3.5.1 Reference Material Use For Quality Control
3.5.2 In-house Reference Material Development
3.5.2.1 Selection
3.5.2.2 Analytical
3.5.2.3 Random Error and Homogeneity
3.5.2.4 Uncertainties
3.5.2.5 Instructions
3.5.3 Reference Material Re-verification
3.5.4 Reference Material Sources
3.5.5 In-house Reference Material Certificates
3.5.5.1 FDA Cocoa Powder (CP)

3.6 Performance (Mindak, Cheng, Hight, Capar) (PDF, 567KB)

3.6.1 Instrument Performance
3.6.1.1 Graphite Furnace Atomic Absorption Spectrometer
3.6.1.2 Cold Vapor Atomic Absorption Spectrometer
3.6.1.3 Inductively Coupled Plasma-Atomic Emission Spectrometer
3.6.1.4 Inductively Coupled Plasma-Mass Spectrometer
3.6.2 Method Performance

3.7 Typical Element Concentrations (Capar, Cunningham) (PDF, 70KB)

4. Analytical Methods

4.1 Flame Atomic Absorption Spectrometric Determination of Lead and Cadmium Extracted from Ceramic Foodware (version 1.1; No longer used at FDA but sill an acceptable method. Available in "EAM archive - Methods (current)” Zip, 1.4MB)  (Hight)

4.2 Graphite Furnace Atomic Absorption Spectrometric Determination of Lead and Cadmium Extracted from Ceramic Foodware (version 1.2; No longer used at FDA but sill an acceptable method. Available in "EAM archive - Methods (current)” Zip, 1.4MB) (Hight)

4.3 Graphite Furnace Atomic Absorption Spectrometric Determination of Cadmium and Lead in Food Using Microwave Assisted Digestion (version 1.2; No longer used at FDA but sill an acceptable method. Available in "EAM archive - Methods (current)” Zip, 1.4MB) (Mindak, Cheng)

4.3A Appendix A – Supplemental Information on In-house Method Validation (Mindak, Cunningham)

4.3B Appendix B – Supplemental Information on Interlaboratory Trial (Mindak)

4.4 Inductively Coupled Plasma-Atomic Emission Spectrometric Determination of Elements in Food Using Microwave Assisted Digestion (version 1.1; PDF, 1.4MB) (Dolan, Mindak)

4.4A Appendix A – Supplemental Information on In-house Method Validation (Mindak, Capar)

4.5 Cold Vapor Atomic Absorption Spectrometric Determination of Total Mercury in Seafood Using Microwave Assisted Digestion (version 1.0; No longer used at FDA but sill an acceptable method. Available in "EAM archive - Methods (current)” Zip, 1.4MB) (Hight, Cheng)

4.5A Appendix A – Supplemental Information on In-house Method Validation (Cheng)

4.5B Appendix B – Supplemental Information on Method Performance (Cheng)

4.6 Inductively Coupled Plasma-Atomic Emission Spectrometric Determination of Cadmium and Lead Extracted from Ceramic Foodware (version 0.2; PDF, 150KB) (Cheng) (Cheng)

4.7 Inductively Coupled Plasma-Mass Spectrometric Determination of Arsenic, Cadmium, Chromium, Lead, Mercury, and Other Elements in Food Using Microwave Assisted Digestion (version 1.1; PDF, 938KB) (Gray, Mindak, Cheng)

4.8 High Pressure Liquid Chromatographic-Inductively Coupled Plasma-Mass Spectrometric Determination of Methylmercury and Total Mercury in Seafood (version 1.0; PDF, 179KB) (Cheng, Hight)

4.9 Portable Hand Held X-Ray Fluorescence Determination of Toxic Elements (under development)

4.10 High Performance Liquid Chromatography-Inductively Coupled Plasma-Mass Spectrometric Determination of Four Arsenic Species in Fruit Juice (version 1.0; PDF, 407KB) (Various)

4.11 Arsenic Speciation in Rice and Rice Products Using High Performance Liquid Chromatography-Inductively Coupled Plasma-Mass Spectrometric Determination (version 1.0; PDF, 292KB)  (Various)

Glossary (PDF: 174KB)

EAM History and Archive

 

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