Elemental Analysis Manual (EAM)

for Food and Related Products

Send comments or contributions to
EAM@fda.hhs.gov

The U. S. Food and Drug Administration's (FDA) responsibility for maintaining a safe food supply is met in part by monitoring for toxic and nutritional elements in food and related products. FDA collects and analyzes food and foodware from commercial channels of trade for determining regulatory compliance. Analytical data gathered under these monitoring activities are also used for evaluating the extent and significance of these analytes in the food supply.

The Elemental Analysis Manual (EAM) for Food and Related Products provides a repository of the analytical methods used in FDA laboratories to examine food for toxic and nutrient elements for regulatory purposes. The manual also provides general guidance on related aspects of a laboratory analysis.

Introduction

An FDA Elemental Analysis Manual (EAM) was produced in 1982 as an internal document for FDA laboratories. The manual was a compilation of published analytical methods and procedures commonly used at that time by FDA analysts, as well as comments based on the experiences of these analysts in using the methods. The EAM served as a source of information to help standardize the way elemental analyses were conducted in FDA laboratories.

The current online version of the EAM is intended to provide FDA laboratories a source of current information and laboratory procedures for determining the level of toxic and nutrient elements in food and related products. The analytical methods in the EAM are based on published peer reviewed analytical procedures that have been expanded to include our experiences on improving the quality of the analyses. The EAM does not contain all procedures that may be used by FDA laboratories. Another source of procedures used by FDA is the Official Methods of Analysis of AOAC INTERNATIONAL . In addition, compliance programs issued by FDA may have specific analytical instructions and FDA field laboratories use a Laboratory Manual that provides guidance on primary laboratory functions. New analytical procedures will be added to the EAM when they are validated and routinely used by FDA laboratories.

Text for the EAM was peer-reviewed by FDA laboratory scientists in the Center for Food Safety and Applied Nutrition and the Office of Regulatory Affairs. An Elemental Analysis Steering Committee composed of FDA laboratory scientists will maintain the EAM. Sections of the EAM will be added or revised based on their recommendations.

The analytical methods in Section 4 have at least completed a single laboratory validation and are based on analytical procedures that have been published in peer reviewed scientific journals. Some of the EAM methods are based on methods that have successfully completed a multilaboratory study. All methods will complete a single laboratory validation before being listed in the EAM followed by at least an FDA interlaboratory trial. Documentation of the extent of validation is presented as a supplement to the method and will be expanded as additional validation studies are completed.

The EAM is only available through the Internet.

When referring to an EAM method or section the revision number should be included. The following is a suggested format for citing an EAM method:

FDA Elemental Analysis Manual [Internet]. College Park (MD): Food and Drug Administration (US), Center for Food Safety and Applied Nutrition; Section 4.3 [Version 1; 2008 June]. Graphite Furnace Atomic Absorption Spectrometric Determination of Cadmium and Lead in Food Using Microwave Assisted Digestion. Available from:
http://www.fda.gov/EAM (Accessed 2011 November 2).

Send comments 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.

Table of Contents

Glossary