U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
January 2000


Elemental Analysis Manual

for Food and Related Products

The Food and Drug Administration's (FDA) responsibility for maintaining a safe food supply is met in part by monitoring for toxic and nutritional elements and radionuclides 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 is being developed to provide a repository of the analytical methods used in FDA laboratories to examine food for toxic and nutrient elements and radionuclides for regulatory purposes. The manual will also provide general guidance on related aspects of a laboratory analysis. This ambitious task is being accomplished by the EAM Editorial Board and other appointed technical experts. Sections of the EAM will be issued as they become available.

Currently, the EAM's table of contents (including cover and staff) (44 KB) and two analytical methods, foodware by flame AAS (80KB) and foodware by graphite furnace AAS (revised April, 2000) (182KB), are available in Adobe Acrobat portable document format (pdf).

Table of Contents

Introduction

Chapter 1 Regulatory Considerations

1.1 Regulatory Authority

Food
Food Labeling
Food Additives
Foodware
Food Packaging
Special Nutritional Foods

1.2 Regulatory Operations

Regulatory Procedures Manual
Compliance Policy Guides
Compliance Program Guidance Manual
Investigations Operation Manual
Laboratory Procedures Manual

1.3 Analytical Methods for Regulatory Analysis

Choice of Method
Documentation

Chapter 2 Preparation of Analytical Samples

2.1 Portion of Laboratory Sample to be Analyzed

Food
Foodware
Packaging
Special Nutritional Foods

2.2 Test Sample Preparation

Compositing
Comminuting Equipment
Comminuting Procedures
Test Sample Decomposition

Chapter 3 General Analytical Operations and Information

3.1 Basic Analytical Techniques

Contamination Control
Special Calculations
Analytical Limits

3.2 Sources of Calibration Standards

Elements
Organometallics

3.3 Sources of Reference Materials

Certifying Organizations
In-House Reference Materials

3.4 Equipment Performance Checks

General Laboratory Equipment
Special Laboratory Equipment
Analytical Instruments

3.5 Components of an Analysis SOP

3.6 Analytical Method Validation

3.7 Equipment Information

Analytical Instruments
General Laboratory Equipment

3.8 Typical Element Concentrations

Food
Dietary Supplements
Herbal Supplements
Medical Foods
Foodware

Chapter 4 Analytical Methods

Introduction

Performance Based Methods
Addition of New Methods
Extenstion of EAM Methods

4.1 Flame Atomic Absorption Spectrometric Determination of Lead and Cadmium Extracted from Ceramic Foodware ( PDF, 80 KB)

4.2 Graphite Furnace Atomic Absorption Spectrometric Determination of Lead and Cadmium Extracted from Ceramic Foodware Revision 1 (PDF, 182 KB) *Updated* April 2000

Index

 

For further information about the Elemental Analysis Manual, contact Stephen Capar, scapar@cfsan.fda.gov.


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