GROCERY MANUFACTURERS ASSOCIATION

Managing Allergens
in Food Processing
Establishments

Editors:
Warren E. Stone
and
Kenneth E. Stevenson, Ph.D.
4th EDITION
© 2009
The Grocery Manufacturers Association (GMA) represents the world’s leading food, beverage and consumer products
companies. The Association promotes sound public policy, champions initiatives that increase productivity and growth
and helps to protect the safety and security of the food supply through scientific excellence. The GMA board of directors
is comprised of chief executive officers from the Association’s member companies. The $2.1 trillion food, beverage and
consumer packaged goods industry employs 14 million workers, and contributes over $1 trillion in added value to the
nation’s economy. For more information, visit the GMA website at [Link].

© 2009 by the Grocery Manufacturers Association. All rights reserved.

No part of this publication may be reprinted or reproduced in any way without written consent from GMA.
Managing Allergens
in Food Processing
Establishments

Editors:
Warren E. Stone
and
Kenneth E. Stevenson, Ph.D.
4th EDITION
© 2009
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

FOURTH EDITION, 1st Printing

© 2009 Grocery Manufacturers Association

Washington, D.C.

All rights reserved. No part of this book may be reproduced or altered or utilized in
any form or by any means, electronic or mechanical, including photocopying, record-
ing or by any information storage and retrieval system, without permission in writing
from the copyright owner. Inquires should be addressed to

Grocery Manufacturers Assocation

1350 I Street, NW Suite 300
Washington, D.C. 20005

Printed in the United States of America

Disclaimer

Any guidelines given in Managing Allergens in Food Processing Establishments are

recommendations only. Those involved in managing allergens during the production,
handling, and packaging of foods are advised to become familiar with all local, state
and federal regulations. Recommendations contained herein are not to be construed
as a guarantee that they are sufficient to prevent damage, loss, accidents or injuries
resulting from use of this information. Further, the study and use of this publication by
any person or company is not an assurance that a person or company is proficient in
the operations and procedures discussed in this publication. The use of the statements,
recommendations, or suggestions contained herein is not to be considered as creating
any responsibility on the part of GMA or any organization for damage, loss, accident,
or injury resulting from such use.

Managing Allergens in Food Processing Establishments

Washington, D.C.: Grocery Manufacturers Association (GMA)

76 pp.

ISBN: 0-9785977-3-7

ii
 FOREWORD

FOREWORD

F ood allergies affect an estimated seven to eight million consumers in the United
States. Some evidence suggests that this number could be growing. Although
most food allergies cause relatively mild and minor symptoms, some can
cause severe reactions, and may even be life threatening to some particularly sensitive
individuals. Currently there is no cure for food allergies; the only successful mitigation
for sensitive consumers is to avoid foods containing the causative proteins.
For consumer to avoid foods to which they are allergic, there are two important
facets for food manufacturers: proper labeling of foods and avoiding cross contact
with allergenic foods that are not declared on a product’s label. As simple as this may
sound, experienced food professionals realize that this entails a complex matrix of well
designed and effective protocols. It is critical that the sourcing, storage, use and ship-
ment of allergen-containing foods be actively managed to achieve these two objectives
and thus prevent consumption of undeclared allergens by sensitive consumers.
This book, Managing Allergens in Food Processing Establishments, continues the
tradition established by previous editions to provide information, references and exam-
ples of successful allergen management practices available to today’s food industry.
It is designed for all those engaged in any component of food processing from sourcing
and procurement, to research and development, to quality control and sanitation.
It stresses key components of successful allergen management in food processing
facilities and also provides detailed information regarding biochemical fundamentals
and U.S. regulations surrounding allergen management. It should become a valuable
tool for all those seeking to further the safety of the world’s food supply. ■

Robert E. Brackett, Ph.D.

Senior Vice President and
Chief Science and Regulatory Affairs Officer
Grocery Manufacturers Association

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MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

ACKNOWLEDGMENTS
In addition to the authors listed in each chapter, GMA would like to acknowledge
the input and assistance offered by Joseph Scimeca (Cargill), Cindy McMahan
(McKee Foods), Craig Llewellyn (Kraft), Dave Barnes (Schwan Food Co.), Kevin
Farnum (General Mills), Bruce Ferree (California Natural Products), Rodney Hayes
(McCormick & Co.), Mark Roberts (Hormel) and Tracie Sheehan (Sara Lee), as well
as GMA staff members Jenny Scott, Yuhuan Chen, Allen Matthys, Shannon Cole and
Bradley Shafer in preparing this highly informative document.

AUTHOR AFFILIATIONS
Authors include:

Robert Earl, MPH, RD, Vice President of Science Policy, Nutrition and Health,
Grocery Manufacturers Association

Christie Gray, Manager of Science Policy, Labeling and Standards,

Grocery Manufacturers Association

Regina Hildwine, Senior Director of Science Policy, Labeling and Standards,

Grocery Manufacturers Association

Michael Jantschke, Director of Food Safety, PRO*ACT LLC

Nina G. Parkinson, NGP Consulting, Brentwood, CA

Kenneth E. Stevenson, Ph.D., Consultant, Clio, CA

Warren E. Stone, Director of Science Policy, Compliance and Inspection,

Grocery Manufacturers Association

Jupiter Yeung, Ph.D., Grocery Manufacturers Association

(currently Nestlé Nutrition, Nestlé Product Technology Center)

iv
 TABLE OF CONTENTS

TABLE OF CONTENTS
FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
ACKNOWLEDGMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
AUTHOR AFFILIATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . iv

CHAPTER 1: FOOD ALLERGIES AND ALLERGENS . . . . . . . . . 1

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Food Allergies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Prevalence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Mechanism of Food Allergy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Allergies and Other Adverse Reactions to Food . . . . . . . . . 2
Immunologic Reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Food Intolerance and Other Non-Immunologic Reactions . . . . . . . . 3
Symptoms of Food Allergy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Incidence of Allergic Reactions . . . . . . . . . . . . . . . . . . . . 3
Incidence of Anaphylaxis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Consumer Perceptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Avoiding Food Allergens . . . . . . . . . . . . . . . . . . . . . . . . . 4
Food Allergens, Properties and Characteristics . . . . . . . . . 4
Allergen Thresholds . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Major Food Allergens . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Crustacea . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Egg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Fish . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Milk (Dairy) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Peanut . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Soy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Tree Nuts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Wheat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Nature of Food Allergens . . . . . . . . . . . . . . . . . . . . . . . . . 6
Properties of Food Allergens . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Clinical Allergen Cross-Reactivity . . . . . . . . . . . . . . . . . . . . . . . . . 6
Assessment of Allergenic Potential of Novel Proteins . . . . . . . . . . . 7
Effects of Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Thermal Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Chemical and Physical Treatments . . . . . . . . . . . . . . . . . . . . . . . . 8
Enzymatic Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Summary of Food Processing Effects on Allergens . . . . . . 8
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Food Allergies and Hypersensitivities . . . . . . . . . . . . . . . . . . . . . . 9
Allergens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Risk Assessments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

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MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

CHAPTER 2: BASICS OF FOOD ALLERGEN MANAGEMENT . . 11

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Management’s Responsibilities . . . . . . . . . . . . . . . . . . . . 11
Allergen Management Team . . . . . . . . . . . . . . . . . . . . . . 11
Evaluating the Hazards of Undeclared Allergens . . . . . . . . 12
1. Identify allergen-containing materials
normally associated with each product and process. . . . . . . . . . 12
2. Map the flow of all ingredients, products, and
allergen-containing materials through the process facility. . . . . . 13
3. Identify specific areas/procedures where cross contact
may occur and evaluate the likelihood this could lead to an
undeclared allergen in any finished product. . . . . . . . . . . . . . . . 13
4. Identify potential problems with labels and labeling/packaging
of products containing allergens and evaluate if they could lead
to an undeclared allergen in any finished product. . . . . . . . . . . . 13
5. Identify the potential presence of undeclared allergens in
incoming materials and evaluate the likelihood this could result
in an undeclared allergen in any finished product. . . . . . . . . . . . 14
Employee Allergen Training and Awareness . . . . . . . . . . . 14
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
For Plant Employees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
For the Allergen Management Team . . . . . . . . . . . . . . . . . . . . . . . 15
Laws and Regulations Affecting Allergen Management . . . 15
Good Manufacturing Practices Regulations . . . . . . . . . . . . . . . . . . 15
Relationship of cGMPs to allergen management . . . . . . . . . . . . 15
Sanitary design and construction . . . . . . . . . . . . . . . . . . . . . . 16
Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Buildings and structures . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Air handling systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Employee practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Outside contractors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
cGMP Modernization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
The Food Allergen Labeling and Consumer Protection Act . . . . . . . . 18
Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Written procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Sanitation standard operating procedures . . . . . . . . . . . . . . . . 19
Validation and verification of sanitation procedures . . . . . . . . . . 19
Other allergen management activities . . . . . . . . . . . . . . . . . . . 19
Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Background information on the allergen management program . 20
Monitoring records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Corrective action records . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Verification records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Validation records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Training records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

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 TABLE OF CONTENTS

Evaluation and Auditing . . . . . . . . . . . . . . . . . . . . . . . . . . 21

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Evaluation of Written Allergen Management Procedures . . . . . . . . . 21
Audits of Allergen Management Practices . . . . . . . . . . . . . . . . . . . 22
Allergen Control and Product Development . . . . . . . . . . . . 23
Product Formulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Reformulating Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Factory Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Consumer Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

CHAPTER 3: KEY COMPONENTS OF A FOOD ALLERGEN

MANAGEMENT PROGRAM . . . . . . . . . . . . . . . 25
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Ingredients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Supplier Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Ingredient Receiving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Ingredient Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Process Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Process Design Strategies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Dedicated Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Storage areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Processing lines and equipment . . . . . . . . . . . . . . . . . . . . . . . 29
Utensils, tools, and personnel . . . . . . . . . . . . . . . . . . . . . . . . . 29
Physical Separation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Product containment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Movement of materials and personnel . . . . . . . . . . . . . . . . . . . 30
Equipment barriers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Production Scheduling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Order and timing of production . . . . . . . . . . . . . . . . . . . . . . . . 31
Allergen changeovers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Control of Rework and Work-in-Process . . . . . . . . . . . . . . 31
Storage of Rework and WIP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Prevention of cross contact . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Product identification and inventory control . . . . . . . . . . . . . . . 32
Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
“Like-into-like” practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Re-entry procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

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MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

Cleaning and Sanitizing . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Sanitation Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Wet cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Dry cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
“Push-through” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Allergen-Clean Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Changeover requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Validation of cleaning and sanitation procedures . . . . . . . . . . . 36
Verification of an SSOP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Tracking Allergens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Controls of Food Labels and Packages . . . . . . . . . . . . . . . 38
Design Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Inventory and Processing Controls . . . . . . . . . . . . . . . . . . . . . . . . 39
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

CHAPTER 4: LABELING AND PACKAGING . . . . . . . . . . . . . . 41

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Food Allergen Labeling Law . . . . . . . . . . . . . . . . . . . . . . . 41
Food Labeling Regulations . . . . . . . . . . . . . . . . . . . . . . . . 41
Labeling of FDA-Regulated Foods . . . . . . . . . . . . . . . . . . . . . . . . . 41
Food labeling general requirements . . . . . . . . . . . . . . . . . . . . . 42
Food product naming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Ingredient labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Special ingredient declaration provisions . . . . . . . . . . . . . . . . . 43
Flavor, spice, and color ingredient labeling . . . . . . . . . . . . . . . . 43
Incidental additives labeling provisions . . . . . . . . . . . . . . . . . . 44
Sulfite ingredient labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Special Considerations: Food Allergen Labeling . . . . . . . . 45
Exemptions from FALCPA Requirements . . . . . . . . . . . . . . . . . . . . 46
2006 FDA Final Guidance Regarding FALCPA . . . . . . . . . . 46
Gluten Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Labeling of USDA FSIS-Regulated Foods . . . . . . . . . . . . . . 47
Major Food Allergen Labeling for Wines,
Distilled Spirits and Malt Beverages . . . . . . . . . . . . . . . . 49
International Allergen Labeling Requirements . . . . . . . . . . 49
Mandatory Food Allergen Labeling . . . . . . . . . . . . . . . . . . . . . . . . 49
International Allergen Labeling Websites . . . . . . . . . . . . . . . . . . . 50
Guidelines and Recommendations . . . . . . . . . . . . . . . . . . 50
Food Allergy Issues Alliance Food Allergen Labeling Guidelines . . . . 50
Advisory Labeling for Food Allergens . . . . . . . . . . . . . . . . 50
“May Contain”-Type Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Special Package Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Information Resources . . . . . . . . . . . . . . . . . . . . . . . . . . 51

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 TABLE OF CONTENTS

CHAPTER 5: REGULATORY ISSUES

RELATED TO FOOD ALLERGENS . . . . . . . . . . . . 53
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
FDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Public Health Basis of FDA’s Regulatory Approach . . . . . . . . . . . . . 53
Food Product Enforcement Approaches . . . . . . . . . . . . . . . . . . . . 53
FDA Food Allergen Recalls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Allergens and FDA HACCP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Allergens and FDA’s Reportable Food Registry . . . . . . . . . . . . . . . . 54
FDA 1996 Letter to Food Manufacturers . . . . . . . . . . . . . . . . . . . . 55
FDA 2001 Compliance Policy Guide on Labeling of Food Allergens . 55
FDA 2001 Inspection Guidance on Food Allergens . . . . . . . . . . . . . 55
USDA–FSIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
FSIS Food Product Enforcement . . . . . . . . . . . . . . . . . . . . . . . . . . 56

CHAPTER 6: ALLERGEN TESTING AND RESEARCH . . . . . . . . 57

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Why Test for Food Allergens? . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Detection of Allergens . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
ELISA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Sandwich ELISA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Competitive inhibition ELISA . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Lateral Flow Device Technology . . . . . . . . . . . . . . . . . . . . . . . . . . 58
DNA Detection Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Commercial Allergen Test Kits . . . . . . . . . . . . . . . . . . . . . 59
Availability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Issues with Commercial Kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Rapid Methods and New Technologies . . . . . . . . . . . . . . . 62
Dipstick . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Biosensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Mass Spectrometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Allergen Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Threshold Levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Predictive Models . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Novel Proteins and GMO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
ELISA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
PCR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Biosensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Mass Spectrometry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Others . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

ACRONYMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Editor’s note: All uniform resource locators (URLs) are current as of April 2009.

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MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

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 CHAPTER 1: FOOD ALLERGIES AND ALLERGENS

Chapter 1

FOOD ALLERGIES AND ALLERGENS

Jupiter Yeung, Ph.D.

Introduction the most common allergenic foods on a worldwide basis

were crustacean shellfish, eggs, fish, milk, peanuts, soy-
Each year, millions of Americans have allergic reactions beans, tree nuts, and wheat. This is the same allergen list
to food. Although most food allergies cause relatively mild defined by the Food Allergen Labeling and Consumer
and minor symptoms, some food allergies can cause Protection Act (FALCPA) of 2004 as major food allergens
severe reactions, and may even be life threatening to some ([Link]
particularly sensitive individuals. It is estimated that Although more than 170 foods are associated with spo-
■ approximately 2 percent of adults and about 6–8 radic allergic reactions, these eight foods or food groups
percent of infants and young children in the United cause more than 90% of the food allergies in the United
States suffer from food allergies; and States. For a detailed discussion of FALCPA and other food
labeling regulations please see Chapter 4, “Labeling and
■ each year, roughly 30,000 individuals require emer-
Packaging” and Chapter 5 “Regulatory Issues Related to
gency room treatment and 150 individuals die
Food Allergens.”
because of allergic reactions to food.
Food allergy is a significant public health concern due
to high prevalence and potential severity of the condition Food Allergies
that not only affects the quality of life of the allergic indi-
viduals on a daily basis, but also has social and economic Prevalence
costs nationwide. While our understanding of the mecha-
nism of food allergy has substantially increased over the When asked, many people believe they suffer from
past decade, the increased media and regulatory attention food allergies. For example, surveys of U.S. households
have heightened public awareness regarding the potential in 1996 found that 14–30% of the respondents claimed
consequences of food allergies, particularly for peanuts that one or more household members had food allergies.
and tree nuts. Peanuts and tree nuts are the foods most When specific cases were examined, however, the true
often associated with severe reactions, and they account incidence was much lower.
for more than 90% of the fatalities due to anaphylactic In the United States, the foods that most often cause
reactions to foods in the U.S. (Bock, 2001). allergic reactions in adults include:
Recent evidence suggests that this public health issue is ■ Crustaceans, (e.g., shrimp, crayfish, lobster,
on the rise. In an October 2008 report, the Centers for and crab)
Disease Control and Prevention (CDC) stated that there
■ Peanuts
are some indications that the prevalence of food allergy
may be increasing in the United States and in other coun- ■ Tree nuts, (e.g., almonds, Brazil nuts, cashews, hazel
tries, especially among children (Branum and Lukacs, nuts (filberts), macadamia nuts, pecans, pine nuts,
2008). The report indicated that during the 10-year period pistachios and walnuts)
1997 to 2006, food allergy rates increased significantly ■ Fish
among both preschool-aged and older children. The report ■ Eggs
additionally said that in 2007, the reported food allergy
rate among all children younger than 18 years was 18% In children, the most common foods that cause prob-
higher than in 1997. In 2002 a random digit-dial telephone lems in the U.S. are
survey found that that the prevalence of peanut allergy for ■ Eggs
children in the U.S., determined by the survey, rose from
■ Milk
0.4% in 1997 to 0.8%.
The 1995 Food and Agriculture Organization (FAO) ■ Peanuts
Technical Consultation on Food Allergies concluded that ■ Tree nuts

1
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

Although younger children are more likely to “out-

Allergies and Other
grow” their food allergies, it is apparent that older children Adverse Reactions to Food
and adults also lose their reactivity if the responsible food
allergen is eliminated from their diets. Children are more
likely to outgrow allergies to milk, egg, or soy than aller- The term “food hypersensitivity” refers to an abnormal
gies to peanuts. About one third of children and adults physiological response to a particular food. Food hyper-
will lose their clinical reactivity after 1 to 2 years of aller- sensitivities can be divided into two major categories:
gen avoidance. food allergy and food intolerance. Both involve abnormal
Up to 80% of infants with egg allergy are able to con- responses to a particular food in some sensitive individu-
sume egg products by five years of age, and up to 85% als, while that same food is safe for most people. The dif-
of children with cow’s milk allergy are tolerant of milk by ferences between food allergy and intolerance are signifi-
age three. In contrast, people with peanut, tree nut, fish, cant but poorly understood by consumers, and that often
or Crustacea sensitivities are less likely to lose their clini- leads to confusion when they describe adverse reactions
cal reactivity. For example, recent studies have shown that to foods.
only 10% to 22% of peanut-allergic children appeared to As stated above, a true food allergy is an abnormal
lose their sensitivity over time. immunologic reaction resulting from exposure to a food.
By contrast, there are other adverse reactions to foods that
are non-immunologic, and hence are not food allergies.
Mechanism of Food Allergy These food intolerances include: (1) abnormal physiologi-
An allergy is an exaggerated immune response to a for- cal responses to a food or a food additive
eign protein or food. A food allergy is an abnormal reac- (e.g., sulfite in fruits); (2) metabolic disorders, such as
tion of the body’s immune system to a specific food or an an enzyme deficiency (e.g., lactase deficiency); (3) food
ingredient in a food that the body perceives as a threat. poisoning, a toxic reaction (e.g., histamine in scombroid
In susceptible individuals, the body reacts to normally fish); and (4) pharmacological reactions, due to chemicals
harmless food substances, such as peanuts or eggs, by that produce a drug-like effect (e.g., tyramine in aged
producing an antibody called immunoglobulin E (IgE). cheese).
When sensitized people are exposed to a food to which
they are allergic, the immune system rallies its defenses
and launches its chemical weapons to attack and destroy
Immunologic Reactions
the substance. In the process, some unpleasant, extreme A true food allergy is an IgE-mediated disorder in
cases, life-threatening reactions may occur. In contrast, which ingestion of a food elicits an abnormal immunologi-
food intolerance such as irritable bowel syndrome is not cally-mediated clinical response. The classic IgE-mediated
an allergy, since it does not involve the immune system. reaction is the most thoroughly studied and important
Food intolerance is discussed in detail below. food allergy mechanism because of the associated life-
An allergic reaction is not a single clinical manifestation threatening reactions in some people.
but rather a variety of symptoms depending on the sensi- Celiac disease (CD) is a common autoimmune response
tivity of the individual. For example, a food protein can to ingested gluten potentially leading to malabsorption,
cause hives in one individual, atopic dermatitis in another, chronic diarrhea, abdominal distention, flatulence, and
severe gastrointestinal symptoms in yet another, and no weight loss or failure to thrive. CD is a cell-mediated,
symptoms in other individuals. Interestingly, some food rather than IgE-mediated, immune disease that can occur
proteins, such as proteins in peanuts, tree nuts, and fish in individuals with a genetic predisposition. Its prevalence
are more likely to cause severe systemic anaphylactic reac- is approximately 1% of the U.S. population. The severity
tions, whereas other allergens more commonly cause gas- of CD varies from a debilitating malabsorption syndrome
trointestinal symptoms. to a “silent,” sub-clinical disorder. Chronic ingestion of
gluten-containing wheat, rye, or barley grains by patients
with CD can be associated with increased risk of lym-
phoma. While people may eventually outgrow some IgE-
mediated food allergies, CD is a lifelong sensitivity, and
sensitive individuals must avoid gluten-containing grains
for life.

2
 CHAPTER 1: FOOD ALLERGIES AND ALLERGENS

Food Intolerance and Other Anaphylaxis, the most severe form of allergic reaction,
Non-Immunologic Reactions is potentially life threatening. An anaphylactic reaction is,
in fact, a condition that involves several parts of the body
Food intolerance is an adverse reaction to a food sub- simultaneously experiencing allergic reactions. Symptoms
stance without the involvement of the immune system, that may include itching, hives, swelling of the throat, dif-
but the reaction often mimics the symptoms caused by ficulty breathing, low blood pressure, and unconscious-
a true food allergy. Food intolerances are more common ness usually appear rapidly, often within minutes of expo-
than food allergies. The reactions are usually localized, sure to the allergen. Immediate medical attention is
temporary and seldom life threatening. People who have necessary when anaphylaxis occurs.
these conditions can usually tolerate the offending food in People with oral allergy syndrome (OAS) typically suf-
small amounts. A good example of food intolerance is lac- fer from at least two allergies: a food allergy to fresh fruits,
tose intolerance, which is caused by an enzyme deficiency vegetables and/or certain nuts, as well as hayfever caused
that prevents the milk sugar lactose from being digested. by tree or grass pollen allergy. OAS is a form of contact
A person who is lactose intolerant may experience a num- allergy confined almost exclusively to the oropharynx and
ber of symptoms, including bloating, abdominal pain, and rarely affects other target organs. Symptoms, such as itch-
gas after ingesting dairy products or ingredients containing ing, tingling, and swelling of the lips, tongue, and throat,
lactose. are generally short-lived and are most commonly associat-
Sulfite hypersensitivity affects a small number of peo- ed with the ingestion of various fresh fruits and vegeta-
ple in the general population. Sulfite is a common preser- bles. Consumers with OAS can usually ingest these foods
vative used in food processing. Sensitivity occurs most in the cooked form without difficulty.
often in asthmatic adults, and rarely includes anaphylaxis.
Adverse reactions to sulfites in non-asthmatics are
extremely rare. Reactions vary widely, and the majority of
the reactions are mild. These manifestations may include Incidence of Allergic Reactions
dermatological, respiratory, or gastrointestinal symptoms.
Histamine fish poisoning (HFP) is a chemical intoxica- Incidence of Anaphylaxis
tion that occurs after eating temperature-abused fish in
which bacteria have converted histidine to histamine. It is estimated that 30,000 emergency room visits per
Although HFP is generally associated with high levels of year are the result of food-induced anaphylaxis in the U.S.
histamine in fish of particular species, its pathogenesis has Anaphylaxis is difficult to manage. Severe reactions can
not been clearly elucidated. For example, it is not known happen unexpectedly and may progress rapidly. Fatalities
why histamine consumed in temperature-abused fish is due to anaphylactic reactions to foods are not common,
more toxic than pure histamine taken orally. and are estimated at about 150 deaths per year in the U.S.
Peanuts and tree nuts account for more than 90% of these
fatalities. Death is usually caused by respiratory failure,
Symptoms of Food Allergy and sensitive individuals who have asthma are at greatest
A true food allergy and its symptoms can take on many risk for severe reactions.
forms. Regardless of the type of allergy, most allergic reac-
tions are mild, but sometimes a very serious or fatal attack
can occur. The symptoms of an allergic reaction can vary
Consumer Perceptions
and reactions can be more or less severe on different occa- Although double blind, placebo-controlled food chal-
sions. The most common symptoms of an allergic reaction lenge (DBPCFC) studies suggest that the prevalence of
include: food allergies is about 2% in adults, many more people
■ Coughing believe that they suffer from such allergies. This is a wide-
spread and persistent international problem with signifi-
■ Dry, itchy throat and tongue
cant consequences. The perception by consumers that
■ Itchy skin or rash they have a food allergy can lead to potentially deleterious
■ Nausea and feeling bloated dietary manipulations or may delay a more appropriate
■ Swelling of the lips and throat diagnosis and treatment. For example, it has been well
documented that unnecessarily restrictive diets, when
■ Diarrhea and vomiting
undertaken in response to a perceived food allergy, can
■ Wheezing and shortness of breath lead to malnutrition and even death. Self-diagnosis and
■ Runny or stuffy nose empirical treatment should be avoided.
■ Sore, red, and itchy eyes

3
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

Avoiding Food Allergens determined. Although researchers have tried to find struc-
tural properties that are common to all allergens, no such
As long as there are no curative treatments for food unique structural features have been identified to date.
allergies, susceptible individuals must avoid exposure to
the offending food(s). The elimination of offending food
proteins in one’s diet is not a trivial task. Sensitive con-
sumers and care providers must be vigilant in reading Allergen Thresholds
ingredient labels every time they purchase or consume a
food product. Allergic individuals should never consume The amount of allergen required to elicit symptoms
any products listing items they are allergic to in the ingre- depends on the allergenicity of the protein and the degree
dient panel of product labels. This includes the advisory of sensitivity of allergic consumers. The threshold level or
“May Contain” labeling listing items to which they are minimum elicitation dose for a food allergen is defined as
sensitive. Highly refined oils such as peanut oil and soy the lowest dose of the offending food that would elicit
oil do not contain enough residual protein, if present at mild objective symptoms in the most sensitive individuals.
all, to elicit an allergic reaction, and should be regarded The amount of allergenic protein is generally expressed as
as safe (Hefle and Taylor, 1999). However, cold pressed total protein derived from the allergenic food group. The
or “extruded” oil may contain allergenic proteins. Patients No Observed Adverse Effect Level (NOAEL) is the dose of
with prior severe allergic reactions to food ingestion or the allergen where no one in the study reacts. The Lowest
those with underlying asthma are at particular risk. Observed Adverse Effect Level (LOAEL) is the lowest dose
Allergies to peanuts, tree nuts, fish, and shellfish are of the allergen where at least one person had a minor
responsible for the majority of the severe, acute reactions. observed reaction such as hives or stomach cramps. For
In addition to elimination of the offending food, an safety assessment purpose, NOAELs or LOAELs can be
emergency plan must be in place to treat severe reactions used to establish thresholds based on literature reports in
caused by accidental ingestion. Allergic individuals should combination with appropriate uncertainty factors. Because
consult their personal physicians to develop such a plan. many of the clinical studies do not demonstrate NOAEL,
(e.g., at least one subject reacts at the lowest dose tested)
the results are commonly presented as LOAELs. The
threshold dose (e.g., minimum eliciting dose) inducing a
Food Allergens, Properties symptom is known to vary substantially among individu-
als. Toxicologists typically apply a 10-fold uncertainty fac-
and Characteristics tor to account for the variability within individuals.
However, this has not been validated in the case of allergic
Food allergens are proteins in the food that enter your responses. LOAELs have been identified for many IgE-
bloodstream after the food is digested. From there, they go dependent food allergies. The LOAELs from the available
to target organs, such as your skin or nose, and cause data have been summarized by the FDA Threshold
allergic reactions. Working Group, [Link]
An allergen nomenclature system has been adopted to [Link], as follows:
describe food allergens. Allergens are designated accord-
ing to the accepted taxonomic name of their source; the Summary of Published LOAELs for Food Allergens
first three letters of the genus, followed by the first letter
Food Range of LOAEL (mg protein)
of species, and then an Arabic number. The numbers are
assigned to these allergens according to the order of their Egg 0.13–1.0
identification. For example, the first allergen described in
Peanut 0.25–10
peanuts, Arachis hypogaea, is designated Ara h 1.
While food groups from which staple foods are derived Milk 0.36–3.6
contain tens of thousands of different proteins, relatively
Tree Nuts 0.02–7.5
few are allergenic. Most allergens are molecules that
appear to be major protein components within a particular Soy 88–522
food. For example, the major peanut allergen Ara h 1 is
Fish 1–100
part of a peanut storage protein that constitutes 12–16%
of a peanut’s total proteins. On the other hand, the major
codfish allergen only makes up a small fraction of the total Gluten thresholds are based on reported gastrointestinal
protein of the codfish. effects related to CD. A threshold for CD has been report-
A number of major food allergens have recently been ed in the range 20–100 ppm gluten (milligrams of gluten
characterized, and their amino acid sequences have been per kilogram of food.) FDA has proposed a maximum of

4
 CHAPTER 1: FOOD ALLERGIES AND ALLERGENS

20 ppm gluten level for gluten-free claims in food prod- tions. The prevalence of fish allergy is reported to be 0.4%
ucts, [Link] of the general population. The major codfish allergen,
For further discussion of allergen thresholds and their Gad c 1, has been purified and characterized. Gad c 1
application in food processing allergen management belongs to a group of muscle tissue proteins, which are
programs, see Chapter 6. only found in the muscles of amphibians and fish. The
existence of structurally related proteins in different fish
species may explain cross reactivity in fish-allergic individ-
uals; Gad c 1 shares similar proteins with hake, carp, pike,
Major Food Allergens and whiting. Cooking appears to reduce the allergenicity
of fish, but does not eliminate it. In one clinical study,
Crustacea fish-allergic patients did not react when challenged with
canned tuna or salmon.
The class Crustacea or shellfish includes shrimp, crab,
lobster, and crayfish; crab and shrimp are the most com-
monly consumed shellfish in the U.S. The prevalence of
Milk (Dairy)
shellfish allergy in the U.S. is reported to be 2% of the Cow’s milk accounts for most of the milk consumed in
general population, or approximately 6 million Americans. the U.S. IgE-mediated reactions to cow’s milk are among
The major shellfish allergen has been identified as tropo- the most common food allergies. Cow’s milk contains a
myosin, a major muscle protein. Individuals with a history number of different proteins that are usually grouped into
of shrimp allergy also demonstrate allergic reactions to two categories: caseins, which constitute 80% of the total
other shellfish. Tropomyosin in shrimp accounts for protein; and whey proteins, which make up 20%. Casein
approximately 20% of its dry weight, and is the only and ß-lactoglobulin (whey fraction) appear to be the
major allergenic protein identified in shrimp. The presence major allergens in cow’s milk. Life-threatening and fatal
of shared antigenic determinants was shown among vari- reactions to milk have been reported. Individuals who are
ous shellfish, including white shrimp, blue crab, crawfish, allergic to cow’s milk will often seem to have serum IgE
and lobster. However, the biochemical identity of these antibodies to goat or sheep’s milk. However, these find-
cross-reactive molecules is unknown. Life-threatening ings have not been confirmed by DBPCFC studies. Never-
reactions to crustacean allergens have been observed, and theless, it has been shown that nine out of ten cow’s milk-
fatal reactions to shrimp and crab have been documented. allergic children who ingested goat’s milk had reactions
There are over 90 different species of shrimp and allergic similar to those provoked by cow’s milk.
individuals may react differently to various species with
various protein concentrations.
Peanut
Peanuts are one of the most allergenic foods and are
Egg likely to induce severe reactions. Peanut seeds contain an
Egg allergy is one of the most frequently implicated average of 29% protein, customarily classified as albumins
causes of immediate food-allergic reactions in children in or globulins. Most of the storage proteins are globulins,
the U.S. Although there is extensive cross-reactivity which make up 87% of the total proteins. Three major
among the egg proteins from various bird species, chicken peanut allergens, Ara h 1, Ara h 2 and Ara h 3, have
eggs, which are widely used for human consumption, tend recently been identified and characterized. These major
to be slightly more allergenic. Most egg allergens are in the peanut allergens have been found to be resistant to food
egg white (albumin) rather than in the yolk. Egg white processing and stable to digestion. In contrast to crude
proteins have been studied extensively, and most have peanut oil, highly refined (refined, bleached, and deodor-
been purified and their amino acid sequences determined. ized) peanut oil does not contain a significant amount of
The predominant protein in the egg white is ovalbumin, residual protein (Hefle and Taylor, 1999).
constituting 54% of the total protein. Other major proteins
in the egg white are ovotransferrin (12%), ovomucoid
(11%), ovomucin (3.5%), and lysozyme (3.4%).
Soy
Ovomucoid (Gal d 1), a glycoprotein, has been implicated Soy allergy affects approximately 1 percent of people in
as the most important and potent allergen in eggs. the United States. Globulins are the major proteins in soy-
beans. Extraction techniques can produce two globulin
fractions, both of which contain allergenic components.
Fish These fractions have been used to classify the various soy-
Fish is one of the most commonly implicated allergenic bean protein components. Soybeans, like peanuts, are
foods and has been involved in fatal anaphylactic reac- legumes that have multiple allergens. One of the primary

5
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

allergens, Gly m 1, has at least 16 soybean-specific IgE- (gliadins), rye (secalin), barley (hordein), and oats
binding epitopes (the site on the surface of an antigen (avenin). The relative concentration of omega-gliadin
molecule to which an antibody attaches itself). It has been varies from cereal to cereal. Wheat alpha-amylase
shown that 88 mg of soy can trigger allergic reactions in a inhibitor is a major wheat allergen. Individuals suffering
DBPCFC study. The estimated amounts of soy ingested in from both wheat allergy and celiac disease are sensitive to
several fatal food allergy cases in Sweden ranged from 1 to gluten protein fractions. To date, wheat is the only major
10 grams. allergen that has had no reported fatalities.

Tree Nuts
Tree nuts are shell (nut) fruits of various plant families; Nature of Food Allergens
they include almonds, Brazil nuts, cashews, filberts/
hazelnuts, macadamia nuts, pecans, pine nuts, pistachios, Properties of Food Allergens
and walnuts, to name a few. Two major allergens were
identified in almonds. An extensive number of almond Although the precise properties that render a food mol-
proteins bind with IgE. The major allergen in Brazil nuts ecule allergenic are unknown, some general characteristics
is a high-methionine protein that is composed of two sub- of allergenic food proteins have been identified. Generally,
units. Pistachios, which are a member of the cashew and many major food allergens are also major food proteins.
mango family (Anacardiacea), also have a prominent IgE- Food allergens are comprised of very stable molecules that
binding protein. In studies of hazelnut allergies, 6–12 mg tend to retain their allergenicity even after exposure to
of hazelnuts triggered an asthmatic attack in susceptible food processing, cooking, and digestive enzymes in the
individuals. human gut. However, several food allergens have been
Individuals with tree pollen allergies also frequently identified that are not highly resistant to these processes.
suffer intolerances to nuts, fruits, and vegetables. In Food allergens must be polyvalent molecules with at
Northern Europe, up to 70% of patients with birch pollen least two or more IgE antibody binding sites. Generally,
allergy demonstrate intolerance to these foods, in contrast most food allergens are primarily glycoproteins with acid
to 19% of patients not allergic to birch pollen. Apples and isoelectric points. However, since these characteristics also
hazelnuts are the most common offenders, although reac- apply to most antigens, they are not considered a distin-
tions to botanically unrelated fruits, such as kiwi, have guishing feature of food allergens.
been reported. Individuals who suffer from grass or rag-
weed pollen allergies report intolerance to fruits in the
gourd family, and banana, a non-gourd. A great majority
Clinical Allergen Cross-Reactivity
of these cross-reactions manifest themselves as OAS, but Cross-reactivity among foods of similar food types,
a certain percentage of individuals experience systemic as well as between foods and seemingly unrelated sub-
symptoms. For further discussion of cross-reactivity, see stances, has been demonstrated. For many years, it has
the section titled “Clinical Allergen Cross-Reactivity” later been known that foods within a related group or family
in this chapter. can cross-react. For example, approximately 25% of
While FALCPA lists “tree nuts” as a major food allergen wheat-allergic children react to other cereal grains (barley,
category, the statute only lists three examples of tree nuts: oats, or rye). However, some cross-reactivities are of clini-
almonds, pecans, and walnuts. In October 2006, FDA cal insignificance.
further defined “tree nuts” for FALCPA labeling purposes The molecular basis of cross-reactivity was recently
in the fourth edition of the Guidance for Industry on reviewed. Numerous plant-derived proteins are responsi-
FALCPA. For further details on this guidance, see ble for allergies. Homologous animal proteins include
([Link] muscle proteins, enzymes, and various serum proteins.
or Chapter 4, “Labeling and Packaging.” Certain foods (e.g., peanuts) are able to sensitize and elicit
reactions after oral exposure and could trigger responses
that generalize to related foods (legumes). Other foods
Wheat (e.g., apples) with labile proteins are not strong oral sensi-
In the U.S., wheat is a dietary staple. Approximately tizers. In this latter group of foods, however, sensitization
25% of wheat-allergic children react to other cereal grains to homologous proteins encountered through respiratory
such as rye and barley. The wheat proteins include the exposure (e.g., birch pollen) may mediate reactions to
globulins, prolamins, and glutelins. Gluten is a protein cross-reacting proteins in the food, with generally mild
mixture of prolamins (glutenin and gliadin). The propor- clinical manifestations.
tion of glutenin to gliadin in the protein mixture is approx- With the increase in latex IgE-mediated allergies noted
imately equal. Prolamins can be isolated from wheat in the last decade, cross-reactions of latex with various

6
 CHAPTER 1: FOOD ALLERGIES AND ALLERGENS

foods have been reported. Latex allergy sufferers may terion for predicting allergenicity. Clearly, further criteria
experience systemic reactions to avocados, chestnuts, must be developed to describe the allergenic potential of
bananas, kiwis, papayas, and figs. Latex antigens show proteins. The evidence to date suggests that we cannot yet
shared antigenic determinants with other fruits that are precisely predict the potential allergenicity of a molecule
not botanically related. In addition to the cross-reactivities for which there is no prior human exposure. In the future,
noted above, latex cross-reactions have been associated we may be able to use animal models that have been suffi-
with celery, passion fruit, and peach. ciently validated as surrogates for human IgE antibody
The strongest cross-reactivities among tree nuts follow responses. Until then, based on our knowledge of food
botanical family associations: (1) walnut and pecan in the allergens, we can only make educated guesses about the
family Juglandaceae and (2) cashew and pistachio in the potential allergenicity of these proteins.
family Anacardiaceae. Walnut, pecan, and hazelnut form
a group of strongly cross-reactive tree nuts. Hazelnut,
cashew, Brazil nut, pistachio, and almond form a group
of moderately cross-reactive tree nuts. Cross-reactivities Effects of Processing
between these groups are less pronounced.
Thermal Processing
Assessment of Allergenic Potential Food processing and home cooking have a profound
of Novel Proteins effect on foods. Food allergens are generally more resistant
to these processes than other food proteins. However, this
New proteins that are derived from biotechnology are is not true for all food allergens. The allergenicity of many
called novel proteins. While the potential exists for a novel fresh fruits and vegetables is decreased or removed by rel-
protein to be allergenic, to date there is no evidence that atively mild processes, such as gentle heating or mashing.
any novel protein derived from biotechnology has induced Tuna and salmon were less allergenic canned than raw,
allergic reactions. Based on current knowledge of the but this trend does not apply to all fish. For example, cod-
properties of known food allergens, it is difficult to predict fish allergen, Gad c 1, is heat resistant, and canning will
the allergenicity of a novel protein to which there is no not reduce its allergenicity.
prior human exposure. However, an analysis of the follow- In some cases, heat can increase the allergenicity of
ing issues can be conducted when assessing a novel certain foods; an individual may be allergic to roasted
protein: pecans, but not raw ones. Heating can also make some
■ Source of transferred genetic material: Particular cau- allergenic proteins more allergenic by binding with sugar,
tion must be exercised if the source of this material via the Maillard reaction (a chemical reaction between an
contains known allergens. amino acid and a reducing sugar, usually requiring heat),
as demonstrated with ß-lactoglobulin in milk and Ara h 1
■ Heat and processing stability: Labile allergens
in peanuts.
in foods that are eaten cooked or undergo other
Products of Maillard reactions in milk and peanuts are
processing steps before consumption are of less
associated with increased allergenicity. Although some
concern.
researchers claim that the IgE-binding properties of raw
■ Effect of pH and/or gastric juices: Most allergens are and roasted peanuts are equal, others have found that
resistant to gastric acidity and to digestive proteases. roasted peanuts bind IgE at higher levels than raw
■ Molecular weight: Most known allergens are peanuts, and that the IgE-recognition sites in roasted
between 10,000 and 70,000 molecular weight. peanuts differ from those of raw peanuts. Roasting might
■ Sequence homology: The amino acid sequence of increase the allergenicity of peanut proteins by increasing
many allergens is readily available. the availability of allergic binding sites on the proteins that
were previously unexposed. It also might enhance other
Using the accumulated knowledge of food allergen pro- allergenic properties, such as resistance to heat, degrada-
tein structure, the allergenicity of several novel proteins tion, and digestion.
has been assessed. This assessment has been primarily Another study demonstrated that frying and boiling,
based on the lability or resistance of a protein to process- which are common methods of preparing peanuts in
ing activities and enzymatic degradation. However, many China, produce fewer allergenic peanut products when
food proteins that are not allergenic are stable to process- compared with roasting, the standard method of cooking
ing and enzymatic digestion. Conversely, some proteins peanuts in the U.S. The apparent degree of IgE binding to
have been shown to be allergenic yet are sensitive to pro- Ara h 1, Ara h 2, and Ara h 3 was lower in fried and
cessing and/or enzymatic digestion. This indicates that boiled peanuts than in roasted peanuts.
resistance to digestion or processing is not an absolute cri- When a food is fried, crumbs of the food are often left

7
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

in the frying oil. Industrial frying operations often re-use By contrast, minimally processed or cold-pressed oils may
their frying oil as much as possible. When oil is used to contain substantial amounts of residual protein that could
fry allergen-containing products and then re-used to fry a pose a health risk to allergic consumers.
product that does not contain allergens, or the same aller- Other physical treatments may influence allergenicity.
gen, government inspection personnel in the U.S. have Treatments such as ultrafiltration, homogenization, extru-
questioned the potential this situation creates for cross sion, or milling, either by themselves or in combination,
contact. Some sources claim that this oil should be dis- have been studied in order to determine their potential to
carded after being used to fry an allergen-containing prod- produce hypoallergenic products. New processing tech-
uct. Such an approach carries serious economic and envi- nologies, such as high-pressure treatments and irradiation
ronmental ramifications for food processors. have demonstrated reduction, but not elimination, of aller-
To address this issue, the Grocery Manufacturers genicity in milk and seafood products.
Association (GMA) undertook a study to determine if
gluten, milk, soy or egg allergens were present in used
industrial fryer oil and to examine the effectiveness of
Enzymatic Treatment
treatments such as filtering or screening the oil to remove Food allergens are relatively resistant to chemical and
these allergens (Wang, 2008). The samples used in the enzymatic hydrolysis. For example, peanut, soy, egg, and
study included commercially untreated and treated (e.g., fish allergens have been reported to resist proteolysis.
filtered or screened) oils collected from seven industrial Nevertheless, the use of proteolytic enzymes to remove
frying operations. Of untreated oils analyzed for gluten allergenicity is successful in the production of hypoaller-
using the RIDASCREEN®FAST gliadin test (r-Biopharm genic infant formulas, but this approach has had limited
AG), 6.1% tested positive; 10.6% of untreated oils tested success when applied to other allergenic foods. Extensive
positive for milk allergen using the Veratox® milk test hydrolysis of casein or whey does reduce, but not elimi-
(Neogen), but none of the untreated oils tested positive for nate, milk allergenicity. Consequently, milk allergic infants
egg using the Veratox® egg test (Neogen) or soy using the occasionally have adverse reactions to hypoallergenic
Veratox® soy test (Neogen). (The limit of quantification of infant formulas.
the test kits was 10 ppm for gliadin and 2.5 ppm for milk, Enzymatic hydrolysis may not be applicable to some
egg and soy.) The study did not assess whether residual products due to economic and/or quality reasons. For
allergens could be transferred to subsequent product in a example, hydrolysis of proteins produces peptides and free
frying operation. All treated oils tested negative for gluten amino acids that may affect the flavor or a food product.
and the three allergens. These results suggest that filters The higher the content of free amino acids, the more bitter
or screens in commercial fryers are effective for removing the taste. Also, proteolysis of allergens denatures proteins,
residues of gluten and milk allergens. Thus, oils used to induces conformational changes of IgE-binding epitopes
fry products containing wheat and milk could safely be of the protein, and/or may expose the otherwise fold-
reused without creating a potential for cross contact by ed/hidden epitopes of other allergenic sites, thereby creat-
gluten and milk allergens. The study suggested that egg ing new allergens or neoallergens. A neoallergen is a pro-
and soy allergens may not be imparted to frying oil, and tein whose allergenicity may be enhanced or elicited
therefore oil used to fry products containing egg and soy through processing steps.
could safely be used to fry non-egg, non-soy foods without
creating an opportunity for cross contact. However, these
results are considered preliminary, since in many cases
positive controls did not test positive. Summary of Food Processing
Effects on Allergens
Chemical and Physical Treatments Allergenic proteins remain virtually unaffected by
Food allergens are known to tolerate acidic and alkaline various food processing treatments. Thermal processing,
pH conditions and remain functional. They have to “sur- chemical, physical and enzymatic treatments cannot be
vive” in these harsh conditions in the stomach and gut in counted on to convert allergenic components into non-
order to exert their physiological effects. For example, allergenic ones. ■
Ara h 1 is stable at pH 2.8 and 11.0. Allergens from fruits
and vegetables are usually acid-labile; hence, raw fruits
and vegetables are usually associated with OAS.
Processing can result in the partial or complete removal of
allergenic qualities of a food, such as the removal of pro-
teins during oilseed processing, which renders the highly
refined oils safe for consumption by allergic individuals.

8
 CHAPTER 1: FOOD ALLERGIES AND ALLERGENS

REFERENCES [Link]. 2007, Soy Allergy. Available at:

[Link]
soy-allergy/DS00970. Accessed April 6, 2009.
Food Allergies and
McGough, N. and J.H. Cummings. (2005) Celiac disease:
Hypersensitivities a diverse clinical syndrome caused by intolerance of
wheat, barley and rye. Proc. Nutr. Soc. 64(4):434–450.
Bock S.A., A. Munoz-Furlong and H.A. Sampson. (2001)
Fatalities due to anaphylactic reactions to foods. Sicherer, S.H. and H.A. Sampson. (2006) Food allergy.
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Primer):S470–475.
Bock S.A., A. Munoz-Furlong and H.A. Sampson. (2007)
Further fatalities caused by anaphylactic reactions to Sloane, D. and A. Sheffer. (2001) Oral allergy syndrome.
food, 2001–2006. J. Allergy Clin. Immunol. Allergy Asthma Proc. 22: 321–325.
119(4):1016–1018.
Teuber, S.S. and K. Beyer. (2004) Peanut, tree nut and seed
Burks, W. and B.K. Ballmer-Weber. (2006) Food allergy. allergies. Curr. Opin. Allergy Clin. Immunol. 4(3):
Mol. Nutr. Food Res. 50(7):595–603. 201–203.
Branum, A.M. and S. L. Lukacs. (2008) Food allergy Wang, J. and H.A. Sampson. (2007) Food anaphylaxis.
among U.S. children: trends in prevalence and hospital- Clin. Exp. Allergy. 37(5):651–660.
izations, NCHS data brief, Centers for Disease Control
Wild, L.G. and S.B. Lehrer. (2005) Fish and shellfish
and Prevention. Available at: http://
allergy. Curr. Allergy Asthma Rep. 5(1):74–79.
[Link]/nchs/data/databriefs/[Link].
Accessed April 6, 2009. Wilson, B.G. and S.L. Bahna. (2005) Adverse reactions to
food additives. Ann. Allergy Asthma Immunol.
Cordle, C.T. (2004) Soy protein allergy: incidence and rela-
95(6):499–507; quiz 507, 570.
tive severity. J. Nutr. 134(5):1213S–1219S.
Craig, D., G. Robins and P.D. Howdle. (2007) Advances in
celiac disease. Curr. Opin. Gastroenterol. 23(2):142–148.
Allergens
Crevel, R. (2005) Industrial dimensions of food allergy. Asero, R. (2006) Plant-derived food allergens: an
Proc. Nutr. Soc. 64(4):470–474. overview. Allerg. Immunol (Paris). 38(7):220–223.
Crittenden, R.G. and L.E. Bennett. (2005) Cow’s milk Bannon, G.A. (2004) What makes a food protein an aller-
allergy: a complex disorder. J. Am. Coll. Nutr. 24(6 gen? Curr. Allergy Asthma Rep. 4(1):43–46.
Suppl):582S–91S.
Burks, W., R. Helm, S. Stanley and G.A. Bannon. (2001)
Fleischer, D.M. (2007) The natural history of peanut and Food allergens. Curr. Opin. Allergy Clin. Immunol.
tree nut allergy. Curr. Allergy Asthma Rep. 7(3): 1(3):243–248.
175–181.
Bush, R.K. and S.L. Hefle. (1996) Food allergens,
Goetz, G.W., B.A. Whisman and A.D. Goetz, (2005) Cross Crit. Rev. Food Sci. Nutr. 36(S):119–163.
reactivity among edible nuts: double immunodiffusion,
Hefle, S.L (1999) Impact of processing on food allergens.
crossed immunoelectrophoresis and human specific IgE
Adv. Exp. Med Biol. 459:107–119.
serologic surveys. Ann. Allergy Asthma Immunol.
95(1): 45–52. Hefle, S.L. and S.L. Taylor. (1999) Allergenicity of edible
oils. Food Technol. 53(2): 62–70.
Grimshaw, K.E. (2006) Dietary management of food
allergy in children. Proc. Nutr. Soc. 65(4):412–417. Metcalfe, D.D. (2005) Genetically modified crops and
allergenicity. Nat. Immunol. 6(9):857-860.
Keet, C.A. and R.A. Wood. (2007) Food allergy and
anaphylaxis. Immunol. Allergy Clin. North Am. Nowak-Wegrzyn, A. (2007) Food allergy to proteins.
27(2):193–212. Nestlé Nutr. Workshop Ser. Pediatr. Program 59:17–31.
Lester, M.R. (1995) Sulfite sensitivity: significance in Taylor, S.L. (2006) Review of the development of method-
human health. J. Am. Coll. Nutr. 14: 229–232. ology for evaluating the human allergenic potential of
novel proteins. Mol. Nutr. Food Res. 50(7):604–609.
Lehane, L. and J. Olley. (2000) Histamine fish poisoning
revisited. Int. J. Food Microbiol. 58(1–2):1–37.

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Wang, H., S. Gee and J.M Yeung. (2008) A food industry Risk Assessments
survey on possibility of residual allergens in fryer oils
during commercial frying operations. Presented at the Hischenhuber, C., R. Crevel, B. Jarry, M. Maki, D.A.
Food Safety & Security Summit. Washington, DC. Moneret-Vautrin, A. Romano, R. Troncone and R. Ward.
March 17–19, 2009. (2006) Review article: safe amounts of gluten for
patients with wheat allergy or celiac disease.
Aliment. Pharmacol. Ther. 23(5):559–575.
Simons, F.E., A.J. Frew, I.J. Ansotegui, B.S. Bochner,
D.B. Golden, F.D. Finkelman, D.Y. Leung, J. Lotvall,
G. Marone, D.D. Metcalfe, U. Muller, L.J. Rosenwasser,
H.A. Sampson, L.B. Schwartz, M. van Hage and A. F.
Walls. (2007) Risk assessment in anaphylaxis: current
and future approaches. J. Allergy Clin. Immunol.
120(1 Suppl):S2–24.
Taylor, S.L., S.L. Hefle, C. Bindslev-Jensen, S.A. Bock,
A.W. Burks, L. Christie, D.J. Hill , A. Host. J.O’B
Hourihane, G. Lack, D.D. Metcalfe, L.A. Moneret-
Vautrin, P.A. Vadas, F. Rance, D.J. Skrypec,
T.A. Trautman, I.M. Ymanand R.S. Zeiger. (2002)
Factors affecting the determination of threshold doses
for allergenic foods: how much is too much?
J. Allergy Clin. Immunol. 109: 24–30.
Wensing, M., A.H. Penninks, S.L. Hefle, J.H. Akkerdaas,
R. van Ree, S.J. Koppelman, C.A. Bruijnzeel-Koomen
and A.C. Knulst. (2002) The range of minimum provok-
ing doses in hazelnut-allergic patients as determined by
double-blind, placebo-controlled food challenges.
Clin. Exp Allergy 32(12):1757–1762.
Wensing, M., A.H. Penninks, S.L. Hefle, S.J. Koppelman,
C.A. Bruijnzeel-Koomen and A.C. Knulst. (2002)
The distribution of individual threshold doses eliciting
allergic reactions in a population with peanut allergy.
J. Allergy Clin. Immunol. 110(6):915–920.

10
 CHAPTER 2: BASICS OF FOOD ALLERGEN MANAGEMENT

Chapter 2

BASICS OF FOOD ALLERGEN

MANAGEMENT
Warren E. Stone / Michael Jantschke / Kenneth E. Stevenson, Ph. D.
Nina G. Parkinson

Introduction ing sure that such policies and associated procedures are
in place, management must also ensure that these policies
Allergen management is generally thought of in terms are communicated to all employees. This includes present-
of the specific things that can be done to prevent or mini- ing the essentials to key personnel, incorporating the
mize the potential for cross contact and achieve proper primary objectives in the corporate policy for food safety,
labeling of foods that contain allergens. However, in order posting brief outlines in conspicuous places such as
to accomplish these goals, it is important to establish employee bulletin boards, arranging workshops/training
appropriate policies and provide for an infrastructure that sessions to provide details to employees, and ensuring
will facilitate management of allergens with the end result that all employees have access to the allergen manage-
that there are no undeclared allergens in the products. ment plan.
The preliminary tasks involved in setting up an allergen By conducting periodic reviews and/or audits, manage-
management program include: achieving commitment ment can determine if established procedures are in place
from senior management, establishing allergen manage- and if they are being followed. This powerful tool provides
ment policies, providing sufficient resources to support evidence that the allergen management program is in
allergen management, providing employee training and place and effective.
awareness, adhering to current Good Manufacturing Another key role for management is to provide
Practices (cGMPs), establishing a documentation system resources to develop and implement the allergen manage-
that includes written procedures, operational and verifica- ment policies and procedures. This includes establishing
tion records, and systematic audits. an allergen management team, ensuring that all products
and processes have been evaluated for the level of risk,
providing funds and personnel to support allergen man-
agement, and providing allergen management training.
Management’s Responsibilities
Management has the ultimate responsibility for ensur-
ing that their company’s products are safe and meet appli- Allergen Management Team
cable laws and regulations. As a part of those responsibili-
ties, they must provide the framework for an effective One of the first steps in developing an allergen manage-
allergen management program. One of the key elements of ment program is the formation of an allergen management
that program is the establishment of allergen management team. This team should be a multidisciplinary unit that
policies and procedures. This includes having written pro- has members representing food safety, quality assurance,
cedures that, when implemented, minimize the chances manufacturing, engineering, warehousing, research and
of undeclared allergens being present in any of their prod- development and regulatory affairs. Assembling a highly
ucts. These policies include requirements to determine visible team that is given authority and responsibility rep-
allergens present in the facility, identify procedures to pre- resents another form of communicating management’s
vent cross contact, ensure that proper labeling procedures commitment to food safety and the allergen management
are used, evaluate hazards associated with allergens in the program. It is important to have representatives from man-
facility, and incorporate allergen management concerns ufacturing/operations on the team, since line personnel
into the product development process. In addition to mak- play a key role in allergen management. In addition, the

11
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

team should include members that have direct and imme- evaluate the hazard of undeclared allergens being present
diate contact with suppliers. in products made at their facility:
While some members of the team may have extensive ■ Identify allergen-containing materials associated with
knowledge of allergens or procedures for allergen manage- each product and process.
ment, this is not a requirement for membership on the
■ Map the flow of all allergen-containing ingredients,
team. Some, particularly smaller, companies may not have
products and materials through the process facility.
personnel with such knowledge and therefore may need to
hire consultants or obtain assistance from other outside ■ Identify specific areas/procedures where cross con-
experts. tact may occur and evaluate the likelihood that this
The allergen management team will have the lead could lead to an undeclared allergen in any finished
responsibility for developing procedures in accordance product.
with the company’s allergen management policies and ■ Identify potential labeling/packaging problems and
objectives. Since the allergen management plan will be assess the likelihood that they could lead to an un-
facility, product and line specific, the team members must declared allergen in any finished product.
have extensive knowledge concerning the establishment’s ■ Identify the potential presence of undeclared aller-
structures, equipment, operational procedures, personnel gens in incoming materials and evaluate the likeli-
practices, ingredients, products, sanitation programs, and hood that this could result in an undeclared allergen
labels. They also must have current information and in any finished product.
knowledge concerning allergens, best practices for allergen
management, and regulations pertaining to allergens and It is often helpful to perform the first two tasks before
allergen labeling. attempting to undertake the remaining ones. It is impor-
The primary objectives of the allergen management tant for the allergen management team to document their
team are to ensure that: (1) no products contain unde- evaluations of each risk identified. These records should
clared allergens; and (2) products containing allergens are be retained for reference when determining methods to
labeled correctly. Thus, the team will need to analyze the minimize the risk of undeclared allergens, as well as when
risks associated with allergens by identifying known and there is a need to review and/or update the allergen man-
potential sources of allergens present in ingredients, pro- agement plan.
cessing aids and products. Once the sources of allergens
are known, the team must identify potential areas of cross
contact or incomplete declaration of allergens on labels
1. Identify allergen-containing
and packaging and develop procedures to minimize their materials normally associated
occurrence. Their allergen management plan will include
written allergen management strategies based upon a risk
with each product and process.
evaluation that takes into account specific ingredients, The purpose of this key procedure is to identify aller-
equipment, operations, practices and products. In addi- gens known to be present in the ingredients, processing
tion, the team must develop procedures to ensure the plan aids, products and packaging materials. This identifies the
provides control of allergens, records are available to doc- specific allergens and allergen-containing materials that
ument implementation of the plan, and routine audits/ are present in the facility. It also provides information that
reviews are conducted to verify adherence to the plan. will be used in determining the flow of allergens through-
out the facility and subsequent evaluation of potential
cross contact of these allergens with non-allergen contain-
Evaluating the Hazards ing products.
Additional procedures should be in place to evaluate all
of Undeclared Allergens new products and ingredients. For further information
regarding new products and ingredients see the section on
If a hazard evaluation is not conducted properly and “Allergen Control and Product Development” later in this
the points that merit control within a particular allergen chapter.
management plan are not identified, the plan will not be If a food plant exports products, the plant should also
effective in preventing undeclared allergens from reaching consider allergens that need to be identified according to
the marketplace regardless of how well it is followed. A importing country regulations. For example, an exporter
thorough evaluation of allergen hazards for the develop- sending products to the European Union (EU) also needs
ment of comprehensive allergen management plans actu- to identify celery, mustard, lupine and sesame seeds in
ally involves two stages: hazard identification as well as addition to “the big eight” recognized in the U.S.
hazard evaluation. The following are general procedures ([Link]
the allergen management team can follow to identify and allergenic/?lang=en).

12
 CHAPTER 2: BASICS OF FOOD ALLERGEN MANAGEMENT

2. Map the flow of all ingredients, an allergen residue or obtaining a positive test for an
products, and allergen- undeclared allergen. In other cases the evidence for poten-
tial cross contact may not be as clear, such as observing
containing materials through hard-to-clean areas in equipment, or evaluating cleaning
the process facility. procedures and finding they do not appear sufficient to
ensure equipment is free from allergenic residues. At times
Flow diagrams of the movement of materials and it may be difficult to evaluate whether a condition or pro-
processes in the facility can be used for “allergen map- cedure is likely to result in cross contact. For example,
ping.” This procedure provides details on the flow of aller- vacuums, airflow, design of equipment/structures and fol-
gen-containing materials through the facility and will be lowing GMPs can be used to minimize the presence of and
a valuable tool in identifying areas where potential cross potential for uncontrolled migration of concentrated aller-
contact may occur. It is important to consider all products, gen dust. However, it may not be possible to eliminate all
procedures and processes. Thus, in addition to the normal concentrated dust in some operations associated with
flow of materials through the facility, the allergen map dried ingredients or powders containing allergens. In such
should include procedures for rework, seasonal and co- instances, the allergen management team still must evalu-
packed products, alternate processes, corrective actions ate the likelihood of occurrence of cross contact of the
and emergency procedures. Block flow diagrams are gen- allergen based upon specific conditions in the operation
erally used for this purpose, and they should be verified and determine if their findings indicate an undeclared
as accurate and complete by an on-site inspection of the allergen could be present in one of their products.
facility, equipment, operations and procedures. This aller-
gen map should be updated at least annually or when
changes are made, and should be checked periodically via
4. Identify potential problems with
on-site audits to determine if it is accurate and complete. labels and labeling/packaging
of products containing allergens
3. Identify specific areas/ and evaluate if they could lead
procedures where cross contact to an undeclared allergen in any
may occur and evaluate the finished product.
likelihood this could lead to
Correct labeling of allergen-containing products is the
an undeclared allergen in any primary means processors have to alert food-allergic indi-
finished product. viduals that products contain allergens. Issues related to
labeling of products containing allergens, including exam-
This is one of the most difficult and time-consuming ples of methods to alert allergic consumers to the presence
procedures that the allergen management team will con- of allergens, are presented in Chapters 4 and 5.
duct during the development of their allergen manage- Food manufacturers should analyze their current opera-
ment plan. First, the procedure involves detailed identifi- tions to determine if there are any potential problems
cation of the potential for cross contact with an allergen associated with labels, label design and development,
in the facility. In addition to the map showing the flow of proper labeling and packaging. They should then evaluate
allergen-containing materials through the facility, the aller- the likelihood that any of these could lead to an unde-
gen management team must use detailed information clared allergen being present in a product. This could
related to plant equipment, operating practices, and sani- include developing and reviewing statements concerning
tation procedures. This could involve gathering informa- allergens on labels, label inventory control and usage,
tion from observations, inspections/audits, discussions handling obsolete labels, and procedures for labeling,
with employees, and testing programs. Information from including regular, bulk, and specialty items. Improper
external sources such as equipment manufacturers, suppli- labeling of products containing allergens is the leading
ers, regulatory agency alerts and guidelines, and scientific cause of recalls in the U.S., Canada, Australia and New
literature may also prove useful. Zealand (Food Standards Australia New Zealand, 2008;
Second, the procedure evaluates the likelihood that Health Canada, 2003; Vierk, 2002). Details on control of
cross contact could lead to the presence of an undeclared label/package design, label inventory and label applica-
allergen in a finished product made in the facility. This is tion can be found in Chapter 3.
often subjective in nature, since it involves determination
of the potential for various events to occur. In some
instances this may be determined directly, such as finding

13
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

5. Identify the potential presence General

of undeclared allergens in Studies have shown that the way adults approach
learning varies tremendously. Adults acquire knowledge,
incoming materials and evaluate experience, and personalities during their lifetimes that
the likelihood this could result will influence how they react to information being pre-
sented. Some people learn by listening or reading, while
in an undeclared allergen in any others learn by doing activities or looking at visual aids.
finished product. It is important to try to incorporate different types of pre-
sentations during training sessions. This includes using
As discussed in the section on ingredients and supplier written materials (outline of presentation), audio-visuals
control in Chapter 3, it is important to ensure there are no (slides, including photographs or drawings) and examples
undeclared allergens present in incoming materials. Food that can be passed around or shown, such as an ingredi-
manufacturers need to work with their suppliers to deter- ent label for a product containing allergens. Many people
mine if there is a potential for the inadvertent presence of also like to hear anecdotes or examples that pertain to the
allergens in goods received from these vendors. If an information being presented.
undeclared allergen is present in an ingredient, or other Records documenting each employee’s attendance in
incoming material, it is virtually impossible for the manu- training sessions should be kept on file. Information such
facturer to detect it. In this scenario, it is highly likely that as the date of the training session, who delivered it and
the manufacturer would subsequently produce a product an outline summarizing the information delivered (or the
that contained an undeclared allergen. Therefore, it is syllabus, if available) should be documented. Further-
imperative that manufacturers ensure their suppliers have more, a sign-in sheet proving the employee’s attendance
adequate allergen management practices. should be kept.
It is important to have detailed knowledge of the sup-
plier’s operations in order to make informed decisions.
Key information such as the nature of the material sup-
For Plant Employees
plied, allergen-containing materials produced or handled All permanent and temporary employees should com-
by the vendor, supplier procedures related to allergen plete a comprehensive and documented education session
management, audits of supplier facilities, the relation on food allergens. The sessions should be part of new-
between the vendor and its suppliers, and records can be employee orientation, as well as ongoing training, which
used to identify the potential and evaluate the likelihood is offered several times a year.
for the inadvertent presence of undeclared allergens in the For training to be effective, adult learners need to know
supplier’s goods. For example, an incoming spice blend how the information being presented pertains to them as
may contain undeclared allergens if the supplier also pack- individuals and to their jobs. During company-specific
ages breadcrumbs (wheat) or dry cheese blends (milk) on training sessions, the information presented should target
the same equipment. To minimize this possibility, a thor- the types of products the company manufactures, indicate
ough review and audit of the supplier’s operation could policies and procedures the company has adopted to man-
be required in order to determine the likelihood that some age allergens, and explain how these will affect each par-
batches of the spice blend may contain unlabelled aller- ticipant’s job.
gens. Additional information on evaluating suppliers can Consideration should be given to the fact that the par-
be found in GMA’s Food Supply Chain Handbook ticipants have varying backgrounds and levels of knowl-
([Link] edge, and that they may not be accustomed to sitting for
GMA_SupplyChain2.pdf). extended periods. For these reasons the information pre-
sented must be relevant, applicable and brief. Managers
should employ some type of mechanism to assess that
training has been effective. This could be testing, either
Employee Allergen Training written or practical, job shadowing, intense record review,
in-plant audits, etc. An outline of the information that
and Awareness could be covered includes:
Everyone involved in the manufacture of foods needs to
(1) What are food allergies and allergens?
have an understanding of what allergens are and why it is
a) Proteins that cause allergic reactions in sensitive
important to control them. The following provides some
people
approaches that may be used to relay this information to
b) Major food allergens (note which ones pertain to
employees involved in the manufacture of foods, as well
their operation)
as those that are members of the allergen management
team.

14
 CHAPTER 2: BASICS OF FOOD ALLERGEN MANAGEMENT

(2) What are the health consequences for food-allergic Laws and Regulations
consumers?
a) Simple to life-threatening reactions Affecting Allergen
b) Time of onset
c) Duration of symptoms
Management
(3) Cross contact issues The Federal Food, Drug and Cosmetic Act (FFDCA), as
a) Equipment and utensils amended, is the principal food law of the United States
b) Cleaning procedures ([Link]
c) Employee practices It applies to all food commodities in interstate commerce,
d) Accurate ingredient and batch management except meat, poultry and egg products and includes ingre-
dients and raw materials used in the preparation of food
(4) Labeling and mislabeling issues
products. Meat, poultry, and egg products are covered by
a) Consumers’ use of ingredient labels to determine
the Federal Meat Inspection Act, the Poultry Products
the presence of an allergen
Inspection Act, or the Egg Products Inspection Act, as
b) Labels must be accurate.
appropriate.
c) Product liability risk
Key provisions of these acts deal with the issue of adul-
(5) Examples of recalls terated food. For example, section 402 (a)(4) of the FFDCA
([Link] and states that a food is adulterated “if it has been prepared,
[Link] packed, or held under insanitary conditions whereby it
Open_Federal_Cases/) may have become contaminated with filth, or whereby it
a) Statistics (how many products involved in a may have been rendered injurious to health.” For further
specific period of time) detail on the FFDCA, please see Chapter 4 of this manual.
b) Majority involve improper labeling practices such
as labels where ingredients were inadvertently
left out, or the wrong label was used
Good Manufacturing Practices
Regulations
For the In order to establish criteria for complying with these
Allergen Management Team sections of the FFDCA dealing with adulterated food, the
U.S. Food and Drug Administration (FDA) promulgated
In addition to the information presented above, the good manufacturing practices regulations in 1969. These
allergen management team needs additional information so called “umbrella GMPs” covered only very basic
and training to do an effective job. requirements for food processing, handling and storage.
In 1986, the FDA incorporated provisions of other product
(1) Other technical details about allergens and concerns
specific regulations into the umbrella GMPs and published
about them
the revised current good manufacturing practices regula-
a) In addition to the “8 Major Food Allergens,”
tions. These “cGMPs” were indexed as Title 21 of the
other foods that may be considered allergens
Code of Federal Regulations, Part 110 (21 CFR 110)
b) Allergens vs. food hypersensitivities and food
([Link]
intolerances
c) Adherence to avoidance diet for allergen-sensitive
individuals Relationship of cGMPs
(2) Staying current on regulatory issues, legislation and to allergen management
research
a) Internet, trade journals, trade associations Like other food safety programs, allergen management
b) How to test for the presence of allergen depends on a foundation of other plant control programs
residuals for success. These programs provide the basic environ-
c) How to evaluate allergen hazards mental and operating conditions that are necessary for
d) Where to find accurate information on allergens effective control. Without programs such as the cGMPs,
specific allergen management measures may be ineffective
(3) An understanding of plant practices
in assuring the production of safe foods. Furthermore, the
(4) An understanding of consumer behavior cGMPs simplify the development and maintenance of an
allergen management program.
For cGMP compliance programs to be effective, they
have to be properly developed and implemented. Such

15
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

programs should be adequately documented, using writ- of product is run or whether wet, dry, or “push-through”
ten procedures and monitoring records. Furthermore, the cleaning is used. The following list presents some of the
procedures should be routinely verified to assure that they most desirable features of easily cleanable equipment.
are being followed and that they are effective. Employee ■ All surfaces and areas should be readily accessible
training and management support are also important com- and should be designed for quick dismantling with
ponents of a well run sanitation program. simple or no tools.
As discussed earlier, the main objective of the cGMPs
■ All food contact surfaces should be smooth, non-
is to assure that foods are wholesome and unadulterated.
porous and non-absorbing, and able to withstand
In other words, the various sections of the regulation deal
detergent, sanitizing solutions and hot water.
with issues that indirectly influence food safety. Some of
these sections are more relevant to the issue of allergen ■ There should be no interior ledges, recesses, unfin-
management than others. For example, the sanitary design ished welds to ensure product cannot be “held-up”
and maintenance of facilities and equipment and employ- and not removed during changeovers. All permanent
ee practices can have a direct bearing on the effectiveness joints should be butted and continuously welded.
of an allergen management program. Because of the ■ All corners should be round or coved.
importance of particular cGMP activities, additional infor- ■ Structural components should be round or tubular
mation on them is provided in the subsequent sections of to avoid accumulation of debris and to facilitate
this chapter. cleaning
■ Mixing blades should be welded to the drive shaft
Sanitary design and construction or be of one piece construction. Shaft and blades
should be removable.
Sections 110.20 and 110.40 of the cGMP regulation pro-
vide minimum requirements for the sanitary design and ■ All pulleys, belt idlers, and other conveyor compo-
construction of equipment and plant facilities. Additional- nents should be of sealed drum, one-piece construc-
ly, various organizations publish sanitary design standards tion. Conveyor guards, splashguards and deflectors
in the form of voluntary guidelines such as the American should be easily removed or of open construction
Meat Institute (AMI) Sanitary Design Principles, 3A to permit cleaning. Fabric or belting with exposed
Sanitary Standards, etc. For further information see absorbent core should not be used.
[Link], which contains the AMI ■ Pipes, fittings, pumps, etc. should be readily dis-
standards. The 3A standards can be purchased at mantled for cleaning and inspection or cleanable by
[Link] clean-in-place (CIP) procedures. All threads should
By incorporating sanitation features into the design and be located outside.
construction of buildings and equipment, cleanup efforts ■ Liquid handling equipment or equipment that
can be maximized. This is important because many aller- requires wet cleaning should be constructed for easy
gen management tools rely on a certain level of accessibil- draining.
ity and cleanability of food-contact and non-food-contact
■ All product zones should be covered. The covers
surfaces to be effective.
should be easily removable for cleaning.
Sections 110.20 and 110.40 of the cGMP regulation pro-
vide some minimum requirements for the sanitary design For further information on sanitary design of equip-
and construction of equipment and plant facilities. ment, see the references at the end of this chapter.
Additionally, various organizations publish sanitary design
standards in the form of voluntary guidelines, such as the Buildings and structures
American Institute of Baking, and NSF International. Poorly designed or constructed food processing plants
are often plagued by inherent sanitation problems. Poor
plant layout and lack of sanitary design features may
Equipment
result in a situation where sanitary conditions cannot be
The primary goal of sanitary equipment design is to maintained in the facility, thus compromising the success-
construct equipment that remains as clean as possible ful management of allergens. Section 110.20 (b) of the
during operation and that is easily accessible and clean- cGMPs states, “plant buildings and structures shall be
able. Since most pieces of equipment contain food-contact suitable in size, construction and design to facilitate
surfaces, cleanability issues have a direct impact on the maintenance and sanitary operations for food manufactur-
ability to remove allergen-containing material from such ing purposes.” Good sanitary design reduces the time
surfaces. required for equipment cleaning. Reduced down time
Specific design features often vary from equipment to for cleaning will inevitably lead to the opportunity for
equipment and depend on other factors such as what type increased production.

16
 CHAPTER 2: BASICS OF FOOD ALLERGEN MANAGEMENT

Although building requirements often depend on ■ High efficiency particulate air (HEPA) filters can
specifics of the operation, certain sanitary design features maximize air quality.
are universally applicable to successful allergen manage- ■ All components of an air handling system should be
ment programs (adapted from Katsuyama, 1993): on preventive maintenance and sanitation schedules.
■ There should be sufficient space for the various plant ■ Makeup air units and air ducts should have access
operations, including cleaning and sanitizing. for cleaning and inspection.
■ Overhead piping and ductwork in processing areas ■ Intake and exhaust stacks should not be located in
should be minimized or avoided entirely, if possible. close proximity to each other.
■ Floors should be constructed to withstand cleaning, ■ Ceiling cooling units and fans should be cleaned and
sanitizing solutions, steam and hot water, acids, sanitized on a regular basis to prevent the accumula-
sugars, fats and heavy traffic. tion of food residues, some of which could contain
■ Floors should be sloped to provide adequate allergenic components.
drainage.
■ The juncture between floors and walls should be Further information on sanitary design of equipment
coved to avoid dust collection and provide for ease and facilities is available from the references included at
of cleaning. the end of this chapter.
■ Walls should be smooth, flat, and resistant to wear
and corrosion Maintenance
■ Ceilings with exposed beams and other structural The role of maintenance of plant structures and equip-
components should be designed to eliminate crevices ment in complying with the cGMPs and managing aller-
and ledges. gens is often under appreciated. Deteriorating building,
facilities, equipment and utensils make cleaning and sani-
Air handling systems tizing activities difficult and can lead to chronically insani-
tary conditions in a plant.
The cGMPs require plants to have adequate ventilation Preventive maintenance is an essential component of a
in order to maintain sanitary operations. Section 110.20 (b) plant’s operation affecting allergen management, produc-
specifies that plants “provide adequate ventilation or con- tivity, downtime, sanitary conditions and regulatory com-
trol equipment to minimize odors and vapors…in areas pliance. In order to make a preventive maintenance pro-
where they may contaminate food; and locate and operate gram effective, maintenance employees should adhere to
fans and other air blowing equipment in a manner that practices that allow them to accomplish the goals of the
minimizes the potential for contaminating food, food program while minimizing any adverse effects of their
packaging materials, and food-contact surfaces.” activities on plant sanitation and food safety.
Regardless of the specifics of a particular system, all Considerable effort should be made to educate mainte-
air handling systems consist of two principal components. nance workers about their role in maintaining sanitary
The exhaust component provides for the removal of air conditions in the plant, preventing allergen cross contact,
from equipment and the plant environment. The makeup preventing contamination and assuring food safety.
air component introduces outside air into the plant. The Companies should adopt special training requirements for
interaction of these two components affects parameters their maintenance staff. In addition to basic GMP training,
such as air pressure differential and airflow through the instruction in the fundamentals of sanitary design, sani-
plant. tary procedures during and after any maintenance job,
Sanitary design features of air handling systems address potential for allergen cross contact during mismanaged
primarily the issue of microbial contamination. However, maintenance activities and the importance of those con-
inadequate sanitation of the hardware components of an cepts to proper allergen management should be stressed.
air handling system, negative air pressure in areas where Performance reviews of maintenance employees could
food is exposed, and lack of control over makeup air can include evaluation for compliance with allergen control
also contribute to the spread of allergen-containing materi- procedures and other GMPs.
al in a plant.
In order to minimize the potential for the accumulation
Employee practices
and spread of allergens in the air handling system of a
processing facility, the following basic sanitary design and The importance of good personnel practices for produc-
construction features are recommended: ing food that is free of undeclared allergens cannot be
■ All recirculated air should be filtered. The filter size overemphasized. The success or failure of any GMP pro-
can fluctuate depending on the air quality required. gram is directly related to the degree of employee confor-

17
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

cGMP Modernization
mance to the program requirements. The cGMP regulation
states in section 21 CFR 110.10 (b) “all persons working in In late 2002, the Center for Food Safety and Applied
direct contact with food, food-contact surfaces, and food- Nutrition (CFSAN) formed a cGMP Modernization
packing materials shall conform to hygienic practices Working Group. The objective of the group was to exam-
while on duty to the extent necessary to protect against ine the general food cGMP regulation and determine
contamination of food.” whether it was in need of updating. The working group
Over the years, companies have developed their own concluded that there had been changes in both the food
programs to comply with the regulation and to implement industry and in the science of food safety that indicated a
personnel practices. When a hazard evaluation has indi- need for modernizing the regulation. In 2003, the working
cated potential exposure to allergen cross contact, these group initiated a review of past recalls to identify those
practices, when tailored to particular operations, can serve areas where GMP-type controls could have the greatest
to minimize the potential for cross contact from unde- impact on assuring food safety. In 2004, the working
clared allergens. group presented its preliminary findings from this review
■ Smocks, uniforms or other suitable types of clean and engaged the public in three public meetings calling for
washable outer garments should be worn at all comments on food cGMP modernization.
times. According to CFSAN, “There was…broad support for
the need to address the problem of undeclared food
■ In some cases, specific color smocks, uniforms,
allergens” ([Link]
hairnets etc. could be used by all employees, visitors
[Link]#summary). Those who commented on the
and contractors in specific allergen areas.
need for food allergen controls offered several suggestions.
■ Supervisory and processing personnel should be Based on these suggestions, the working group recom-
adequately trained in allergen control procedures. mended that an allergen control program address six ele-
■ Personnel traffic patterns should be restricted for ments of control:
allergen control. This includes maintenance, man- ■ Training of processing and supervisory personnel
agement, contractors and visitors.
■ Segregation of food allergens during storage and
■ Employees should wash hands between allergen and handling
non-allergen lines and change gloves, if appropriate.
■ Validated cleaning procedures for food contact
■ Consider separate tools or tool pouches for allergen equipment
lines or implement an effective tool cleaning proce-
■ Prevention of cross contact during processing
dure.
through measures such as:
■ Store employee lunches and other personal items – Scheduling of production runs
only in designated places and never in production – Control of rework
areas. – Use of dedicated production lines
In addition to complying with basic GMP issues, ■ Product label review
employees also need to adhere to procedures developed
■ Supplier control program for ingredients and labels
to manage allergens in a facility. Consistent compliance to
a company’s allergen management program is key to the The group also recommended that processors maintain
success of any allergen control efforts. a copy of the allergen control plan at the processing facili-
ty and update the plan as necessary.
Outside contractors
The hiring of outside contractors for certain jobs pres-
The Food Allergen Labeling and
ents a special and serious challenge. Oftentimes these Consumer Protection Act
individuals have little or no experience working in a food
plant. At the very least, all contractors should be instruct- The Food Allergen Labeling and Consumer Protection
ed in basic allergen management and GMP requirements Act (FALCPA; [Link]
before they are allowed to enter the facility. Special super- [Link]) addresses plain language labeling of foods
vision is often needed to guarantee their compliance with that contain major food allergens. FALCPA identifies eight
these rules and to minimize the potential for allergen cross food groups as the major food allergens: milk, eggs, fish,
contact as a result of their activities. Compliance with crustacean shellfish, tree nuts, peanuts, wheat, and soy-
allergen management practices, as well as other plant beans. Detailed guidance on FALCPA can be found at
rules, should be written into contracts or purchase orders [Link] and in
when dealing with outside service providers. Chapter 4.

18
 CHAPTER 2: BASICS OF FOOD ALLERGEN MANAGEMENT

Documentation Validation and verification

of sanitation procedures
Written Procedures
The effectiveness of sanitation procedures used as part
As with any other formal facility program, the manage- of an allergen management program can be validated to
ment of allergens relies heavily on employee conformance ensure the procedure removes all appreciable residues of
with the intent and specifics of the program. The best way target allergens. Visual inspection followed by allergen
to assure conformance is by developing written proce- testing would be one approach to validating the effective-
dures that provide enough detail and information for ness of allergen-cleaning procedures. In cases where a test
employees to follow. Such procedures should be easy to kit is unavailable, visual verification may be the only tool
understand, applicable to the operation, and current. The available. Bioluminescence or ATP sanitation monitoring
absence of written procedures does not necessarily mean systems can also be used for validation, but processors
that the program will fail to accomplish its goals, but there should be aware of its limitations. These are discussed
is ample historical evidence that a written and well-docu- in detail in Chapter 3. An ongoing verification program
mented program has a better chance of success. should be established to ensure that the validated program
is being followed. Verification may include visual inspec-
tion, allergen testing or other measures. Allergen testing
Sanitation standard operating procedures
can be accomplished by either in-house or outside labora-
Allergen management depends to a large degree on tory services using commercially available allergen test
maintaining sanitary conditions in a plant that go beyond kits. Testing for the presence of residual allergen proteins
basic food plant sanitation or cGMP compliance. There- could be done on the final rinse of a CIP cycle or on food
fore, detailed procedures on how to achieve these condi- contact surface swab samples after clean up operations.
tions should be developed. At the very least, these sanita- Limitations and proper use of food contact surface swab-
tion standard operating procedures (SSOPs) should bing are discussed in the “Validation of cleaning and sani-
contain the following information. tation procedures” section of Chapter 3. “Push-through”
■ The name and objective of the procedure methods may require product testing of the first product
packaged for consumption after an allergen-clean
■ Detailed work instructions
changeover to determine that removal of allergenic ingre-
■ List of personal protective equipment, tools, cleaning dients is complete. Any results from finished product
agents and sanitizers needed sampling that indicate the presence of an undeclared
■ The frequency at which the procedure is performed allergen(s) will require appropriate action(s). It is recom-
■ What to do if the procedure cannot be carried out mended that all finished product be retained under the
company’s control until the lab results are received.
■ What records to maintain
For further information on validation of sanitation pro-
■ Responsible personnel cedures, see Chapter 3. For more information on allergen
For certain food commodities, the development, imple- testing, including potential limitations of test kits, see
mentation, and/or maintenance of written SSOPs are Chapter 6.
required by regulation such as for meat and poultry (9
CFR 416.11.) For juice products (21 CFR 120.6) and
Other allergen management activities
seafood products (21 CFR 123.11) records documenting the
monitoring of SSOPs are required, but there is no require- In addition to sanitation issues, other key components
ment that the SSOPs be written. It is important to note of an allergen management program also have to be docu-
that these regulatory requirements address general food mented. Detailed standard operating procedures (SOPs)
plant sanitation and are not explicitly intended to manage should be developed for measures such as control of
allergens. Conformance with these regulations may or may ingredients, storage and handling of ingredients and pack-
not serve to adequately control allergens in a processing aging material, scheduling, control of rework and work-in-
plant. For further details and guidance regarding sanita- process (WIP) materials. The corresponding allergen pro-
tion methods and procedures, see the Cleaning and gram monitoring procedures should be developed in the
Sanitizing section of Chapter 3. form of an SOP. Furthermore, it is important to verify that
these allergen management and monitoring procedures are
effective and being implemented. Therefore, written proce-
dures should be developed for conducting such verifica-
tion activities. The content of all these SOPs should mirror
the type of information given in the SSOP section.
Company batch sheets/formula sheets etc. should

19
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

specifically identify those ingredients that are allergenic mentation of the allergen management measures, or lack
to alert operators that they are dealing with allergens and thereof. The purpose for monitoring is to assure that vali-
must use special handling procedures. This is especially dated procedures are being followed. A secondary use of
useful when the allergen may not be easily identified monitoring data is the analysis of trends, which may pro-
(e.g., “albumin” instead of “eggs.”) vide a mechanism for detecting potential problems before
they become acute. Examples of monitoring activities for
allergen management include:
Records
■ Confirmation that the proper ingredient statement is
Records are written evidence that procedures and on the finished product
processes are being followed in accordance with the
■ Confirmation of clean equipment after a changeover
requirements of the allergen management program. They
from an allergen-containing product to products not
are necessary for maintaining the basic integrity of the
containing that allergen
program. For example, many verification activities rely on
a review of pertinent records. Records also provide a tool ■ Comparing ingredient statements on finished product
for identifying potential problems and data trends, as well packaging upon receipt to approved formulations in
as provide proof that corrective actions were taken in order to verify that all allergens present are listed
response to an actual problem. and properly declared
Records should be filled out accurately and at the time ■ Confirmation by receiving personnel that allergenic
when the observation was made. The use of standardized ingredients have been properly marked before place-
forms and checklists is recommended. Personnel who are ment into storage (e.g., prominent label, specific col-
involved in the preparation of records should be qualified ored placards, wrapped in colored shrink wrap)
and trained. Only designated personnel, with specialized ■ Tracking the amount of allergen used as a means of
training in allergen management, should be authorized to indicating potential mistakes prior to shipping
review these records.
■ Documentation that rework is being properly used.
■ Confirmation of operational practices such as using
Background information on the a specific colored utensil for specific allergens
allergen management program Monitoring records should provide enough information
for the person performing the monitoring and the reviewer
Written information that supports the rationale for the to determine if a given allergen management procedure
program is the cornerstone of any recordkeeping system. was conducted properly or if corrective actions are need-
This information is necessary to prove that the program, ed. Such information should include the following:
if implemented properly, will manage the risks associated ■ Date and time of the activity
with allergens. Examples of such documents include the
■ Name, initials or signature of the person performing
following:
the activity
■ Hazard evaluation, including the identification of
■ Product description, size, line number, item number
allergens of concern, product flow of allergen-con-
etc.
taining materials, potential cross contact areas,
and potential packaging and labeling problems ■ Actual observation
■ List of the allergen management measures, including ■ Performance standards if any (yellow shrink wrap
the rationale for specific procedures and any support present, red scoops used)
data ■ Whether or not a particular criterion was met
■ Validation of sanitation procedures, where appro- ■ Initials or signature of the reviewer and date
priate reviewed
■ The reasoning behind all monitoring, corrective
action, and verification activities Corrective action records
■ List of other plant operations programs that impact,
and how they impact, the management of allergens If monitoring or verification activities indicate non-
adherence to an allergen management procedure, or
potential product contamination with an undeclared aller-
Monitoring records gen, corrective actions need to be implemented to deal
with the affected product. Such corrective actions must be
These records are perhaps the most important daily documented and the resultant record should contain the
operations records, since they document the proper imple- following information:

20
 CHAPTER 2: BASICS OF FOOD ALLERGEN MANAGEMENT

■ Product description, size, item number if any ducted the training, and what topics were covered. For
■ Date and time of the measurement/observation more information on allergen training, see the section on
“Employee Allergen Training/Awareness” earlier in this
■ Description of problem
chapter.
■ Corrective action taken
■ Current product disposition (e.g., product placed on
hold, product sent for relabeling)
■ Date, name, and signature of responsible person
Evaluation and Auditing
■ Date, name, and initials of the reviewer
■ Final product disposition, (including quantity
General
reworked, released to stock, destroyed, etc.) Once the allergen management program’s policies and
when known procedures are developed and in place, it is important to
verify that they are effective and being followed. In addi-
Verification records tion to routine verification procedures, a key means of
confirmation is to periodically audit the overall allergen
Verification is those activities, other than monitoring, management plan. The audit should include evaluation
that ensure the allergen management system is operating of written allergen management procedures, as well as
according to plan. All verification activities should be doc- checking the compliance of actual daily practices with
umented on appropriately designed forms or checklists. those established procedures. The results of these audits
For some verification measures, such as audits, more for- should be used to determine if the current allergen man-
mal reports may be necessary to properly record the activ- agement program is comprehensive and effective and if
ity. On the other hand, record reviews can be documented the program is being implemented as written. This in turn
on the primary monitoring, corrective action, and verifica- will determine if any modifications are needed in the writ-
tion records. ten allergen management plan, its implementation or in
Examples of verification records that may be part of employee training practices.
allergen management programs include pre-op sanitation Audits can be done in a variety of ways. Often most
inspections, equipment calibration logs, allergen test audits are conducted internally by Quality Assurance per-
results, label reviews and yearly audit reports. Because of sonnel or by a corporate auditing group. However, with
the diverse nature of these activities, the content of the the increasing awareness of the importance of allergen
corresponding records will vary greatly. However, all veri- management, there is also an increase in the number of
fication records should contain the following minimum customers that are conducting audits of their suppliers’
information: operations, or hiring specially trained third-party auditors
■ The nature of the verification activity to do it for them. Due to the importance of allergen man-
agement to food safety and the increased incidence of
■ The date and time of the activity
recalls related to undeclared allergens, this trend will most
■ The outcome of the activity likely continue.
■ The need for corrective action, if any
■ Name and initials of the person conducting Evaluation of Written
the activity
■ Date, name and initials of the reviewer
Allergen Management Procedures
In order to conduct a proper evaluation of the allergen
Validation records management program, the first step should be to gather
written materials that detail company policies and proce-
Validating the effectiveness of sanitation procedures dures for allergen management. These documents should
with allergen test kits, or by other means, can be a valu- reveal the level of awareness that the company manage-
able tool to support allergen management programs. ment has with respect to allergen management and the
Any testing records used to validate sanitation procedure level of commitment that the company is making to assure
effectiveness should also be retained. that none of its products contains an undeclared allergen.
Documents to review may include:
Training records ■ Company or corporate policy on management
of allergens
Records of employee training should contain the date
■ Allergen management team
and time of the training session, who attended, who con-

21
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

■ Procedures for approval of vendors

scope of the audit, the audits could include on-site review
■ Hazard evaluation (analysis of the potential for of operations and practices, interviews with employees
undeclared allergens in company products) and reviews of applicable records.
■ List of allergens used in the facility The on-site review of operations and practices could
■ Material flow map for allergen-containing materials include observations of the following:
■ Allergen management procedures (including ration- ■ Facility and operations to determine if current
ale for using specific procedures and any accompa- allergen flow diagrams are accurate, complete and
nying monitoring, corrective action and verification up to date
procedures) ■ Ingredient, WIP and finished goods storage areas and
■ Allergen training records handling practices
■ Sanitation Standard Operating Procedures (SSOPs), ■ Methods used for physical separation, product con-
including validation information and verification tainment and product identification
procedures ■ Production practices, including production
scheduling
At the current time there is no federal regulation or ■ Movement of allergen-containing materials
other widely accepted document to use as a “standard” for
■ Use and segregation of specific utensils, implements
evaluating allergen management policies and procedures.
and tools
While there are some specific regulations regarding prod-
uct labeling (see FALCPA above, or Chapter 4) and some ■ Procedures for rework and WIP materials
information on procedures that regulators will use in ■ Procedures for the pre-approval of labels and
inspections and compliance decisions, this information is packaging ingredient statements
not appropriate to use for the entire allergen management ■ Procedures for assuring proper labeling of finished
program. Thus, companies will need to establish their goods
own criteria for their risk-based allergen management pro-
■ Handling of obsolete labels or packaging
grams, based upon information from the scientific litera-
ture, current industry practices, trade journals, regulatory ■ Sanitation procedures and any validation testing that
agencies and trade associations. indicates those procedures are effective in removing
These evaluations should focus on evaluating the poli- residuals of target allergens
cies and procedures that are in place in order to determine ■ Post-cleaning verification to ensure the absence of
if they will assure that undeclared allergens will not rea- allergens prior to processing a product containing no
sonably be present in a company’s products. Usually the or different allergens
evaluations are conducted at least annually and any time ■ Monitoring, corrective action and verification prac-
there is a significant change that could affect the manage- tices related to the proper management of allergens
ment of allergens. The need for an evaluation could be
triggered by changes in ingredients, suppliers, products, Interviews of employees can be used to determine their
equipment, sanitation chemicals, plant procedures, infor- knowledge of the specific allergen management operations
mation concerning allergens, regulatory guidelines or reg- and procedures associated with their jobs. This includes
ulations. If deficiencies are detected in any component of line workers as well as supervisors who have specific
the allergen management program, corrective steps should duties related to the allergen management program. In
be taken immediately to develop more effective policies or addition, the interviews of employees will help determine
procedures. if there are procedures that may need to be changed and
if the company’s training program is effective.
There are a number of different types of allergen man-
agement records that should be reviewed. These include:
Audits of
■ List of allergens
Allergen Management Practices ■ Map of allergen-containing material flow
The purpose of auditing allergen management activities ■ Monitoring records
is to determine if they are being conducted according to ■ Corrective action records
the written allergen management procedures. Thus, the ■ Verification records
written allergen program provides the basis for the audit.
■ Incoming inspection records of labels or packaging
Most often, these audits are conducted on overall allergen
containing ingredient statements
management activities, but at times they may be conduct-
ed on specific operations and activities. Regardless of the ■ SSOP procedures, including validation data if any

22
 CHAPTER 2: BASICS OF FOOD ALLERGEN MANAGEMENT

■ Training records Reformulating Products

■ Label or packaging development and approval Reformulation of a product to include allergen-contain-
records ing ingredients may lead to contamination of other lines or
■ Previous allergen audit reports and follow up reports products in the absence of proper controls. When modify-
to correct deficiencies, if any, found in those reports ing formulas or extending new varieties of existing prod-
ucts, companies should consider whether an allergen-con-
The auditor should review the facility allergen map and taining ingredient is critical to the product character.
any changes to the allergen management program since While there may be business reasons for choosing such an
the last audit. Typically, an audit will also include a review ingredient, deliberate formula modifications that introduce
of selected monitoring, SSOP and corrective action records allergens should be made with caution. The addition of
generated since the last audit. These records should be a new allergenic ingredient to a plant’s inventory will
reviewed to make sure that they are filled out correctly require, at minimum, reassessment of allergen manage-
and are complete. Part of the auditor’s review should be ment practices.
to make sure that record reviews were conducted promptly Reformulating existing products to include new aller-
and the reviewer’s signature is on the records. In addition, genic ingredients not previously part of the formula
particular attention should be addressed to making sure requires clear communication with the consumer. Allergen
that the monitoring, corrective action, and verification sensitive consumers, who may have been consuming the
records were made in accordance with the allergen man- product for some time, need to be informed of the new
agement procedures. potential hazard. This could be in the form of a label
The auditor should review any previous allergen man- banner or highlight indicating something like “Now
agement audit reports that are available. The previous with peanuts!”
audit reports will detail deficiencies that were identified Businesses may also want to consider discontinuing,
during the audits, and may provide evidence of chronic reformulating, or contract-packing minor lines that are the
problems in the allergen management program. sole users of allergenic ingredients in a factory’s product
line. Even the presence of one allergenic ingredient calls
for a plant to have an allergen management program.

Allergen Control and Factory Trials

Product Development Factory trials of products containing allergens require
strict measures to avoid allergen cross contact with exist-
Product Formulation ing products. This is especially true if the factory does not
already handle allergens or a particular allergen. Infor-
Whenever possible, product developers should not mation on the potential presence of a new allergenic ingre-
include any allergenic ingredient in a product that is not dient should be made available to those factory personnel
critical to the identity of the product (e.g., peanut in responsible for allergen management plans before any
peanut butter candy.) By using allergen-containing ingre- new allergenic ingredients are delivered to the factory.
dients only when they are essential, companies will have To deal with the new ingredient, the factory may have to
fewer allergenic materials in their plants and lessen the coordinate activities among receiving, storage, production,
opportunity for cross contact with other products. For inventory control, quality, and sanitation departments.
example, using corn flour instead of wheat flour, vegetable
shortening instead of butter, or a highly refined oil instead
of a cold pressed one all reduce the presence of allergen-
Consumer Testing
containing ingredients in a factory. Product development laboratories create numerous
Even when a particular allergenic ingredient may be variations of proposed items before culminating in a deci-
crucial to product character, proper investigation can be sion for final merchandise. Often these concept products
made to select the ingredient with the least potential for are affixed with laboratory generated labels stating simply
cross contact. For example, peanut butter would be far “New Product #1” and “New Product #2.” Since these are
less likely to spread allergenic dust than crushed peanuts not yet products for sale, FALCPA and other labeling regu-
or peanut meal, but it is more difficult to remove without lations do not apply. These test or concept items will not
mechanical, detergent washing. be sampled by the general public, but rather by corporate
buyers, taste panels and other specific individuals.
Samples of these new products leaving the product
development kitchen, even for modest “sales presenta-
tions” should be clearly marked as containing allergenic

23
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

ingredients. Labeling on containers should contain

REFERENCES
common names of allergens such as “milk” or “eggs.”
Deibel, K., T. Trautman, T. DeBoom, W.H. Sveum,
Such terms should be used in place of, or in addition
G. Dunaif, V.N. Scott and D.T. Bernard. (1997)
to, less common names such as “casein” or “albumin.”
A comprehensive approach to reducing the risk of
These products mentioned above are not to be con-
allergens in foods. J. Food Protect. 60:436–441.
fused with test product samples distributed to the trade.
Any item distributed by a company to the general trade, Food Standards Australia New Zealand. (2008)
even “free samples,” store giveaways and those included Food recall statistics. Available at:
in mail or newspapers, to name a few, must be in full [Link]
compliance with all relevant labeling requirements, foodrecalls/[Link].
including FALCPA. Accessed May 29, 2008
Participants in consumer taste panels should be
Health Canada (2003) Allergen related recalls (1997–2001).
screened for potential allergen sensitive individuals,
Available at: [Link]
when appropriate. This includes everyone from pro-
securit/eval/reports-rapports/
fessional taste panel participants to ad hoc groups of
allergen_paper-evaluation_allergene-[Link].
plant employees. ■
Accessed May 29, 2008.
Imholte, T.J. and T. Imholte-Tauscher. (1999) Engineering
for Food Safety and Sanitation—A Guide to the Sanitary
Design of Food Plants and Food Plant Equipment. 2nd
ed. Technical Institute of Food Safety, Medfield, MA
Katsuyama, A.M. (1993) Principles of Food Processing
Sanitation, 2nd Edition. The Food Processors Institute.
Washington, D.C.
Taylor, S.L. and S.L. Helfe. (2005) Allergen control,
Food Technol. 59(2) 40–43, 75.
Vierk, K., K. Falci, C. Wolyniak and K. Klontz. (2002)
Recalls of foods containing undeclared allergens
reported to the U.S. Food and Drug Administration,
fiscal year 1999, J. Allergy Clin. Immunol. 2002;
109:1022–1026.

24
 CHAPTER 3: KEY COMPONENTS OF A FOOD ALLERGEN MANAGEMENT PROGRAM

Chapter 3

KEY COMPONENTS OF
A FOOD ALLERGEN
MANAGEMENT PROGRAM
Warren E. Stone
Michael Jantschke / Kenneth E. Stevenson, Ph. D.

Introduction key components in managing food allergens in a food

processing environment.
Several factors are involved in developing and imple-
menting an effective allergen management program.
An allergen management team should be established
(see Chapter 2 for details.) The allergen management team Ingredients
will assess the hazards associated with food allergens, and
then use various means to decrease the allergen hazards Supplier Control
associated with their operations and products. These
assessments of allergen vulnerabilities and the choice Many companies have procedures in place to control
of particular procedures to decrease them are product, the purchase of raw ingredients and other materials to
process, and facility specific. ensure that they comply with applicable laws, regulations
Since almost all allergens enter facilities in ingredients and specifications. Food processors and their suppliers
or processing aids, a company’s relationship with suppli- should work together to assure that ingredients and pack-
ers is important, especially as it pertains to knowledge of aging materials are labeled properly. This assurance is
the supplier’s allergen control procedures. Tools to en- particularly critical with regard to food allergens, since
hance this knowledge could include the use of specifica- improper labeling presents a food safety hazard. Prior to
tions, continuing guarantees, a supplier approval process, approving suppliers, companies should verify that the sup-
as well as supplier surveys regarding management of food plier has procedures in place that can be used to highlight
allergens. These allergen management procedures are the presence of allergens and to minimize the potential for
especially important when a supplying company produces the inadvertent presence of allergens in the materials that
products that contain allergens and others that do not. they provide. In addition, customers should require evi-
Components such as process design, including the use of dence that their suppliers have written allergen control
dedicated systems, physical separation, production sched- programs in place to help minimize the inadvertent pres-
uling, and control of rework and work-in-process (WIP), ence of an allergen in ingredients and other materials.
can be used effectively to minimize cross contact. With Customers and suppliers should agree who is respon-
most products and processes, cleaning and sanitation, sible for transporting ingredients. Companies should then
particularly “allergen-clean” procedures, are paramount confirm that transportation practices do not present any
in ensuring that allergen cross contact does not occur. In potential for inadvertent cross contact with undeclared
addition, traceability programs are important in tracking allergens. This is especially true for bulk ingredients such
receipt, use and shipment of allergen-containing materials as eggs, flour, and milk. If ingredients will be stored at a
in a facility. Since labeling errors are the primary cause of third-party warehouse (operated by neither the supplier
allergen-related food product recalls, programs also must nor the customer) storage practices at this warehouse
be in place to ensure that allergen-containing product is should also be examined.
put in the right package with the correct label. The follow- Customers often require that suppliers fill out a ques-
ing provides important information associated with these tionnaire or “supplier survey” to determine the level of

25
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

risk associated with material they are receiving. Supplier Particular attention should be directed at determining
surveys are an important tool in obtaining pertinent infor- if any allergens are handled and/or produced in the sup-
mation concerning ingredients. These surveys also can plier’s facility that are not part of the supplied ingredients
convey to suppliers the importance that their customers or materials. Many nut companies handle more than one
place on quality and safety issues, including allergen man- type of nut. Therefore, it is important for a customer
agement and control. Completion of this survey, along receiving pecans to know if their supplier is handling
with other requirements, may be a component in consider- other nuts, such as peanuts, on the same equipment or
ing the supplier as an “approved supplier.” While the sup- in the same facility. Likewise, suppliers of corn may also
plier survey may include questions regarding a variety of handle soybeans in the same facility.
items related to safety and quality, it should include ques- In addition to developing pertinent purchasing specifi-
tions related specifically to the facility’s allergen manage- cations, customers usually require a Letter of Guarantee
ment plan and/or the potential cross contact of allergens. (LOG) indicating that materials received from the supplier
These may include questions related to: have been manufactured and/or handled in a manner that
■ Management’s commitment to allergen management assures that the specifications were met and that the mate-
rials comply with applicable laws and regulations. In cer-
■ Allergen management education and training
tain instances, the customer may require that a Certificate
■ The facility’s allergen management plan of Analysis (COA) accompany each lot of material from
■ The supplier’s raw material program, including raw the suppler. The COA is used to indicate that a particular
material specifications lot has been tested and meets the specification. For exam-
■ Inspections of incoming and outgoing carriers/loads ple, if the customer is aware that its supplier of chocolate
also manufactures milk chocolate in the same facility, they
■ Handling and storage of raw materials
may require a COA that shows the chocolate does not con-
■ Production zones/process separation and scheduling tain detectable milk residue.
■ Equipment and utensils While requirements will depend on the material
■ Protection from cross contact involved, its specification(s), site-specific procedures, and
specific customers, information included on a COA could
■ Control of factory air flow
include:
■ Verification of previous loads hauled by bulk
■ Full description of the commodity
transporters
■ Name of supplier
■ Verification of tanker wash outs
■ Lot number(s) for products in the shipment
■ Handling of re-used shipping containers
(totes, bulk bags) ■ Date of production
■ Traffic patterns ■ Customer’s specification number
■ Cleaning and sanitation practices/allergen-clean ■ Date product was shipped
procedures ■ Quantity of product covered by the COA
■ Sanitary design of equipment and facilities (e.g., 40 cases at 70 lbs. each)
■ Product traceability/recall and recovery program, ■ The specification to be met
including rework and WIP ■ Laboratory conducting the testing
■ Validation of allergen-clean cleaning procedures ■ Results of analyses
With respect to the specific items being supplied, the ■ Methods of analysis (method number from AOAC,
customer should seek additional information concerning FDA etc.)
the formula and all ingredients/components, with an ■ Descriptions of sampling plans used to generate
emphasis on: results contained on the COA
■ The specific common name of any allergen that is ■ Signature of analyst or person issuing the COA
present (e.g., milk vs. whey or casein)
Another important means of control is the development
■ The specific name (and source) of each ingredient
of a feedback mechanism to alert the buyer of any
that is derived from an allergen-containing source,
changes at the supplier’s facility that might alter the aller-
including preservatives, emulsifiers, colors, carriers,
gen status of the supplied material. One practice would
processing aids, etc., and whether allergenic protein
be to require ample advance notice prior to change of an
from such a source is present
allergen ingredient to allow the receiving plant time to
■ The specific name of each fat or oil, and whether it change their allergen management plan. For example,
is highly refined or cold pressed did the reformulation of an ingredient render the material

26
 CHAPTER 3: KEY COMPONENTS OF A FOOD ALLERGEN MANAGEMENT PROGRAM

allergen-containing, or was the type of soybean oil

Ingredient Storage
changed from highly processed to a less processed one Receipt and movement of allergens or allergen-contain-
such as cold-pressed oil? Oftentimes, great pains are taken ing ingredients to storage areas should be done in a man-
by the buyer to establish the initial allergen status of an ner that minimizes the chance of cross contact in the facil-
ingredient, but little effort is made to track significant ity. The exact nature of these storage procedures and areas
changes concerning the supplier or the ingredient over will depend upon the nature of the allergen and the struc-
time. This requirement should be delineated in the cus- ture and operations in the facility. In some cases, it is suf-
tomer’s purchasing specification and purchasing contracts. ficient to use diligent management of clean and closed
Ongoing interactions with approved suppliers are neces- containers in a manner that would preclude the risk of
sary to ensure that allergen management practices are cross contact. In situations where the risk of product or
being sustained. ingredient transfer in storage/warehousing is increased,
Since specifications, LOGs, and surveys may not reveal it may be necessary to use segregated storage.
all potential sources of allergens, many companies now The most important aspect of allergen-containing ingre-
rely upon audits of their suppliers. For further informa- dient storage is minimizing the risk of allergen cross con-
tion, see the section on auditing contained in Chapter 2. tact via the use of effective ingredient handling and stor-
age practices that assure the following:
Ingredient Receiving ■ No cross contact with non-allergenic ingredients
– Primary ingredient and finished product packages
Receiving personnel should obtain specialized training are designed to contain the product contents in a
in procedures for proper receipt, handling and storage of manner in which the material inside would neither
allergen-containing ingredients. These procedures should be cross contacted by another ingredient nor cross
be documented in a standard operating procedure (SOP). contact another ingredient. Hence, closed packag-
The customer should inspect all ingredients and/or ing can serve as a very effective allergen separation
other materials and their carriers prior to acceptance. tool.
The inspection should determine if there are allergen-con-
■ No mistaken retrieval of an allergen-containing
taining materials in the load or if the opportunity exists for
ingredient during processing
cross contact, where the packaging integrity of allergen-
– To help provide such assurance, food processors
containing ingredients was compromised. To accomplish
may define separate storage areas for allergen-
this goal, in the case of packaged goods, the inspection
containing ingredients; use dedicated pallets
could include an evaluation of the sanitary condition of
or bins, colored placards or pallet tags; colored
the carrier’s cargo area and appearance of boxes, bags and
shrink wrap; or employ other inventory control
cartons. The delivery vehicle’s cargo area should be
techniques.
inspected after unloading as well.
Many facilities use color coding or other special mark- ■ Bulk storage silos or tank farms need stringent con-
ing procedures to assure that allergens are visibly marked trols to ensure non-allergen components are not
upon receipt. This provides a clear indication that these mixed with allergen-containing ones, e.g.,
materials contain allergens and therefore require special – Computerized verification checks where proper
precautions and handling procedures throughout the valve configuration and tank destination is
facility. Employees should be trained to understand any checked against raw materials chosen from a menu
color coding or other marking procedures used for allergen – Lockouts over valve openings with restricted
control. access to the keys
Some allergen-containing ingredients are received in – Requirements for two different employees to
bulk and are delivered by tanker trucks or railcars. Proper inspect and sign-off on a valve and tank set up
controls must be in place to ensure the integrity of the before receiving the product
ingredients at all times. Such controls include tamper-evi-
dent seals on entry and discharge points, verification of Process Design
prior adequate washout, prior load information, and clean
transfer areas and equipment. The inadvertent cross contact of food with allergen-con-
Receiving personnel should verify that goods are being taining materials can occur during the entire manufactur-
received from an “approved supplier.” Approved supplier ing process, including storage, handling, processing, pack-
status ensures that the supplier’s allergen management aging, and clean-up. How ingredients, raw materials, WIP,
procedures have been reviewed and found to be accept- rework, products, and packaging materials move through
able. a facility are key factors in determining if this potential
threat is real. Obviously, the better a process system is
designed to minimize allergen-related problems, the lower

27
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

the hazard of cross contact will be. For further informa- Control is attained entirely by procedural means, which
tion, see the section on allergen changeovers on page 31. are relatively easy to implement, yet more vulnerable to
The potential for allergen cross contact can be reduced human error than line dedication and physical separation.
by physical and temporal means. Physical means include Oftentimes, scheduling is not used alone to reduce risk,
measures such as dedicating lines and equipment for the rather it is considered an adjunct to other measures.
production of allergen-containing products and physically Production scheduling is addressed in detail in a subse-
separating unit operations based on the presence or quent section of this chapter.
absence of allergen-containing material. Temporal means The question of which measures a company should
include measures such as daily scheduling and specifying employ in order to reduce the hazard of allergen cross
the order of addition of allergen ingredients in order to contact is difficult to answer. In fact, the measures
limit the potential for cross contact of allergens during employed often will differ from plant to plant and even
handling and processing. Of course, all these measures product to product due to differences such as equipment
depend heavily on the existence of other support programs design and accessibility, forms and amounts of the aller-
such as good sanitary design of equipment and an effec- gens, numbers of changeovers, etc. Aside from the bottom
tive sanitation program. line statement that a food product must not contain unde-
clared allergens, there are no binding performance stan-
dards or even industry expectations to guide processors
Process Design Strategies in their choice.
When building a new facility, it is relatively easy to Procedural control measures are generally less costly
incorporate the necessary design features to minimize to implement and often do not require major changes in
the potential for cross contact of allergens into the overall plant operations. How well they reduce risk depends on a
plant layout and process design. Processing systems combination of factors such as the nature of the product,
should be designed to prevent the accumulation of food employee practices, and the quality of other support pro-
residues and facilitate cleaning and inspection operations. grams. Sometimes procedural measures by themselves
On the other hand, dealing with allergen cross contact may not be sufficient to manage the hazards. In these
issues in an existing facility is usually more challenging. cases, some degree of line dedication and/or physical
Most food processors fall into the latter category. The chal- separation could be necessary to adequately minimize
lenge is to adequately manage allergens in the facility with the potential for cross contact. The decision to determine
minimal disruption to existing operations and processes. which measures are needed should be based on the analy-
The use of dedicated systems is considered the most sis of the risk to the consumer of producing a product con-
effective method for dealing with allergen cross contact taining an undeclared allergen. Such an analysis needs to
issues. While a company may not be able to isolate entire consider the properties of the ingredients used, the nature
processing lines and pieces of equipment for the produc- of the process system, the products produced and the sta-
tion of products containing a specific allergen, the dedica- tus of all relevant support programs. For further informa-
tion of utensils, tools, storage areas, smocks or uniforms, tion see the section on “Evaluating the Hazards of
and even personnel is often possible. Such procedural con- Undeclared Allergens” located in Chapter 2.
trol measures significantly reduce the hazard of allergen
cross contact and can be implemented without major capi-
tal investment. The manner in which each of these meas-
Dedicated Systems
ures is used will be based upon the hazards of allergen Although the best way to minimize allergen cross con-
cross contact that exist in the specific food handling/ tact is to dedicate an entire plant to the production of
processing situation. products that contain a particular allergen or allergens,
When the use of dedicated systems is not feasible, con- this is quite an unrealistic scenario for most companies.
trol can be enhanced by physically separating unit opera- The next best thing is to use dedicated storage areas, lines
tions handling allergen-containing materials from the rest and equipment for the manufacture of allergen-containing
of the plant. The degree of separation is a function of pro- products.
cedural measures, such as controlling the movement of
materials and personnel throughout the facility, and physi-
Storage areas
cal containment of allergen-containing products in tanks,
pipes, and enclosed processing rooms. Adequate control A number of ingredient storage issues were discussed
can be achieved through diligent adherence to the proce- previously. The potential problems associated with storing
dures and proper supervision. allergen and non-allergen items together can be avoided
Production scheduling can be a powerful tool to mini- by designating specific storage areas for allergen-contain-
mize the risk of cross contact associated with producing ing ingredients and products. However, many food manu-
allergen-containing products on shared equipment. facturers and ingredient suppliers store a wide array of

28
 CHAPTER 3: KEY COMPONENTS OF A FOOD ALLERGEN MANAGEMENT PROGRAM

ingredients, including materials that may contain multiple Depending on the manufacturing conditions and the
food allergens. While dedicated storage may not be practi- type of product or ingredients being handled, the spread
cal under these conditions, there remains a need to dili- of allergen-containing residues via employees also may be
gently manage cross contact through the strict use of clean a concern. Production, quality control, maintenance and
and closed container requirements. Further information supervisory staff all could inadvertently contribute to this
regarding dedicated storage systems is discussed above. problem. The main concern lies with production line
workers who come in direct contact with allergen-contain-
ing products. In some instances, companies may assign
Processing lines and equipment
employees to work exclusively with products that contain
Each operation should assess the need for dedicating specific allergens in order to prevent these potential prob-
equipment and systems for the production of allergen-con- lems.
taining products. By linking specific food contact surfaces
and immediately adjacent areas to specific products, the
potential for any incidental carryover of a particular aller-
Physical Separation
gen to other products is significantly reduced. When processing lines dedicated to different allergens
The dedication of processing systems can take different or dedicated to products with and without allergens are
forms. In one application of this principle, an entire sec- not feasible, or when equipment lines and facilities are
tion of a facility is set aside for the manufacture of a par- used for products that contain allergens as well as prod-
ticular allergen-containing product. None of the processing ucts that do not, the probability of cross contact due to
lines in that section has any cross connections to other changeovers or cross connections is increased. In such
lines in the plant. The section may or may not be separat- cases, a processor should consider taking steps to physi-
ed from the rest of the facility by walls or other enclo- cally separate allergen and non-allergen-containing prod-
sures. In other applications, only a particular processing ucts as much as practical.
line and adjacent equipment are set up for a particular In order to physically separate various unit operations
allergen-containing product. Other lines producing other or subcomponents of such units, a variety of measures
products that do not contain allergens may be close by, can be taken, including the following:
but there is no physical connection between those lines, ■ Use of walls, doors, or designated rooms to contain
nor is there any shared equipment. product
■ Protection of product conveyors; absence of convey-
Utensils, tools, and personnel or crossovers
Production utensils and implements, maintenance ■ Labeled, locked out, physically separated, or recon-
tools, and operations personnel are often overlooked as figured equipment
contributing factors in the spread of allergens in a plant. ■ Designated staging areas for allergen-containing
Production utensils are especially of concern, since they materials, including rework
often come in direct contact with ingredients or products. ■ Controlled traffic of materials and personnel
By dedicating utensils and tools, whenever possible, to
specific processing lines or products, the potential for
inadvertent cross contact with non-allergen-containing Product containment
products is greatly reduced. The utensils should be sub-
jected to an allergen-clean sanitation procedure before The containment of a product and its ingredients in a
reuse. processing system will minimize the potential spread or
As far as maintenance tools are concerned, their move- drift of a particular allergen-containing product to other
ment from one area in the facility to another at the com- products. This can be accomplished by physically separat-
pletion of a repair or routine maintenance activity can ing the systems from the environment or with design and
present a problem. If the direction of this movement is procedural controls.
from a line that handles a particular allergen-containing
material to an area where non-allergen-containing prod- ■ Housing the processing system in a separate room
ucts or materials with different allergens are handled, would attain the most complete form of product con-
allergen-containing residue on these tools could inadver- tainment, but this is often impractical. The move-
tently be transferred between areas. In order to minimize ment of materials in and out of the room, if not con-
the risk of allergen cross contact, appropriate practices trolled properly, can compromise the success of the
should be in place to assure proper cleaning of these system. When retrofitting an existing establishment,
tools and/or dedicating these tools to specific lines and partitioning of the facility is not always desirable,
products. since it can lead to operational and sanitation prob-

29
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

– Controlling surrounding dust sources

lems such as compromises in drainage or managed
– Using equipment shrouds or covers
air flow.
– Using negative air ionization
■ Another method of separating a processing system
from the plant environment is by enclosing most of Allergen testing possibly can be employed to determine
its parts. To what level this can be done will depend if the spread of allergenic dust presents a hazard to other
on the specific system. For example, liquid products products
are largely handled in closed pipes, tanks, pumps, Movement of materials and personnel
heat exchangers and fillers. Such a setup guarantees
a high level of containment, but is the most difficult The movement of ingredients, raw materials, WIP,
to inspect for proper cleaning. Conversely, products rework, finished products and waste materials during
in a nut roasting operation are handled rather openly operation is unavoidable. If not controlled, this can
in shakers, size graders, and conveyors until they are become a major contributor to cross contact problems in
sealed in the final package. Here some degree of con- a facility. Control has to be maintained at all stages of the
tainment could be achieved by partially or complete- process, but some unit operations are more susceptible to
ly covering conveying equipment, hoppers and stor- such problems than others. For example, rework materials
age silos. often require considerable handling and thus present spe-
cial challenges for a processor.
■ Proper line design and configuration can aid in con-
Containment and separation issues uniquely associated
taining allergen-containing product. Line crossovers
with ingredients, WIP, and rework materials are discussed
should be avoided at all cost. Where pre-existing
in the corresponding sections of this chapter. In addition,
lines contain such crossovers and they cannot be
a number of universally applicable measures may be taken
re-configured, additional barriers such as pans and
to ensure the physical separation of allergen-containing
shields need to be installed at the crossover points.
and non-allergen-containing products during their trans-
The points along the line where allergen-containing
port from point A to point B. Some of these measures are
ingredients and rework materials are added to the
as follows:
product stream should be located as far downstream
(e.g., closest to the filling and packaging equipment) ■ Allergen-containing materials should be staged in
as possible. This setup minimizes the exposure of designated areas before being moved to a processing
the equipment on the line to the allergen-containing line. Positioning of the staging area(s) requires fore-
material. Lastly, processing lines should be config- thought and planning. Staging allergens close to the
ured with sufficient space between them to minimize line minimizes potential exposure after opening the
any cross contact as a result of normal product original or WIP storage container. Staging allergen-
spillage and splattering. containing materials far away from the line mini-
mizes processing exposure prior to opening the
■ There are also procedural means of containing prod-
containers. Whatever the staging location, it should
uct. For example, spillage of allergen-containing
also facilitate the transport of materials to the line
materials can occur when they are introduced into
without the need to cross other lines on which non-
the process stream. For each processing system, pro-
allergen-containing products are produced, unless
cedures should be developed that identify appropri-
containment of the allergen can be absolutely
ate practices for adding allergen-containing ingredi-
assured.
ents and minimizing spillage. What to do with any
spilled material, how to clean up the affected area, ■ Allergen-containing materials that are moved
and ways to prevent the spread of the spilled materi- between locations should be in their original
al to other parts of the plant also should be included package or otherwise covered, contained and
in the procedure. properly identified.
■ For some allergens (peanut meal, soy flour, pow- ■ Waste materials (spills, defective and unusable prod-
dered milk and eggs etc.), dust generation during ucts, used ingredient packaging) that contain aller-
handling of allergen-containing items can be a prob- gens should be collected continually during produc-
lem. In cases such as these, procedures need to be tion and placed in covered collection bins. These
put in place to instruct employees how to minimize bins should be labeled and/or color coded to identify
such dust formation. Some methods used to reduce their contents.
dust formation include: ■ Collection bins should be moved carefully to avoid
– Adding liquid ingredients to mixers before or at the cross contact with other processing lines. The most
same time as powders direct transport route should be identified. Emptied
– Using of a dust collection system, also known as a bins should not be used for other purposes prior to
local exhaust ventilation systems receiving an allergen-clean sanitation treatment.

30
 CHAPTER 3: KEY COMPONENTS OF A FOOD ALLERGEN MANAGEMENT PROGRAM

Unless allergen-containing materials are handled in

Production scheduling
self-contained processing systems with dedicated person- Controlling the production schedule for allergen-con-
nel, the potential spread of allergens needs to be consid- taining products can be a powerful tool to reduce the risk
ered. The specifics of personnel traffic control will depend of allergen cross contact. Such control can be achieved
to a large degree on other allergen management activities through various means, including setting the order of pro-
such as the relative isolation of allergen-containing lines duction, running lines for longer hours without changing
and the level of physical containment associated with a over from one product to another, running allergen-con-
specific processing system. However, some control meas- taining product lines when other lines are idle, and run-
ures are applicable to a broad range of operations; for ning allergenic product last in a series of product runs.
example, non-authorized employees should not work in
or walk through areas where allergen-containing materials
Order and timing of production
are handled.
If allergen-containing products are produced on lines
that also are used to run non-allergen-containing products,
Equipment barriers
the potential hazard of carryover of allergens to other
In processing systems where equipment is shared in the products is high in the absence of adequate control meas-
manufacture of allergen-containing and non-allergen-con- ures. Scheduling can be used as an effective control tool
taining products, the maintenance of separation between by producing the allergen-containing food last in a series
the two is paramount. In many cases, physical barriers of product runs followed by a validated allergen-clean
separate various parts of the equipment, so that allergen- sanitation step. This cleaning step should be properly doc-
containing ingredients are limited to certain parts of the umented, verified, and signed off by authorized personnel
system. For example, a pipe that supplies a batch tank before non-allergen-containing product is run again on the
with an allergen-containing ingredient can be disconnect- line. Validation and verification of sanitation procedures
ed from the tank and capped when not in use. Whenever are covered in a subsequent section of this chapter.
the construction of a piece of equipment allows its com-
ponents to be physically disconnected, this option should
Allergen changeovers
be chosen.
Another way of physically separating equipment parts Whenever a non-allergen-containing product is run on
is the use of valves. Good sanitary design of the equip- equipment that was recently used for the manufacture of
ment, appropriate cleaning procedures, and the proper an allergen-containing product, the hazard of inadvertent
choice and maintenance of the valves are all extremely allergen carryover increases. The more frequent these
important in preventing cross contact problems. Thorough product changeovers occur, the greater the hazard
inspections of valves for potential leakage should be becomes. Setting the order of production and proper
conducted routinely. Where practical, valves should be cleaning of processing equipment to an allergen-clean
secured in the proper position. This can be accomplished level goes a long way toward managing that hazard.
by locking the valves in the proper positions, or by remov- During cleaning, surrounding equipment not involved
ing the valve handles once the valves are properly posi- in the changeover should be protected from inadvertent
tioned. Newer systems controlled by programmable logic splashing with allergen-containing product during the
controllers (PLCs) or other computer-driven systems can sanitation process. Using protective screens or wrapping
have the proper valve configuration programmed into adjacent equipment in plastic are two common methods
them to match a preset requirement specific to a formula of providing protection. In addition, extending operating
or product. hours of an allergen-containing run will reduce the num-
Regardless of which lockout method is used, authorized ber of required changeovers, which in turn will reduce the
personnel should inspect the physical barriers in a pro- risk of cross contact.
cessing system before production can commence. The
inspection results should be used to determine if the line
is ready to proceed or not. All inspection and verification
information should be documented, signed and dated by Control of Rework and
an authorized individual.
Work-in-Process
The term “rework” refers to finished or partially fin-
ished products that are reincorporated into the manufac-
turing process. For example, ice cream in bulk containers
left over from the last production run and reintroduced

31
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

into the processing line to manufacture another ice cream cases.) These packages are designed to withstand the nor-
product is considered rework. Likewise, if a finished prod- mal wear and tear of distribution without loss of container
uct is added back to the same product line because of a integrity. The sturdiness of the packages also minimizes
packaging defect, the add-back material is considered the potential for their allergen-containing contents to be
rework. WIP items are partially finished products that released into the environment. In other words, the basic
are in between different production stages. For instance, integrity of the packaging materials, combined with pal-
minor ingredients that are premixed, transferred to totes, letization features such as stretch wrap, greatly lowers the
and moved to another processing line are considered WIP. chance for cross contact of allergen-containing materials
Salami that is sliced and then stored in a cooler overnight with other products in the storage area. Rework and WIP
before use as a pizza topping is another example of WIP materials, on the other hand, are usually stored in tempo-
material. rary containers such as totes, pails, and carts. Moreover
Both of these types of products present special chal- the types of closures for these containers can range from
lenges for an allergen management program. The main non-existent to flimsy (cardboard covers, foil wrap) to
concern is the wrongful inclusion of a material that con- secure (fastened lids).
tains an allergen in a product that does not list this aller- The following measures should be considered to mini-
gen on the final product packaging as an ingredient. The mize the potential for cross contact of allergen-containing
accidental cross contact of allergen-containing materials rework and WIP materials during storage:
with a non-allergen-containing product during holding or ■ Allergen-containing rework and WIP materials
storage is also a concern. should be stored in a way that minimizes the risk of
The generation of WIP products is usually unavoidable allergen cross contact. This may include storage in
in a processing operation but the same cannot be said of sturdy containers with secure covers and the use of
rework. Since rework that contains an allergen is inherent- interior disposable plastic liners.
ly risky to handle, any efforts by a company to reduce
■ Dedicated containers, lids, pallets, etc. may be used
or eliminate rework will significantly reduce the hazards
for these materials. When that is not feasible, the
involved. Some companies have restricted the use of
containers and lids should be washed using an
rework material containing allergens to the exact product
allergen-clean procedure before being reused.
that generated the rework or to “like product,” (see page
33 for a detailed definition) but that is not feasible for all ■ Single service articles such as tray liners should not
operations. be reused.

Storage of Rework and WIP Product identification and inventory control

Whenever possible, rework or WIP products that con- In order to avoid the accidental use of an allergen-con-
tain allergens should be used immediately during a pro- taining material in a non-allergen-containing product,
duction run, preferably on the same shift. When that is rework and WIP need to be properly identified and accu-
not possible and rework/WIP have to be stored until fur- rately inventoried during storage. All containers should be
ther use, care must be taken to prevent any cross contact clearly marked to indicate the presence of allergens in a
of these materials with other products, raw materials, or product. This can be accomplished by using labels or
ingredients in the storage area. Furthermore, rework/WIP color schemes, or a combination thereof.
materials should be clearly identified to minimize the If labels are used, they could contain the following
possibility of their use on the wrong processing line. information, at a minimum:
Appropriate inventory and traceability records need to be ■ Name of the rework, or WIP material
kept in order to document control of these materials dur-
■ Name of the allergen
ing storage and to be able to appropriately trace allergen-
containing materials. ■ Date/time of manufacture
■ Date/time put into storage
Prevention of cross contact ■ Date/time for using rework/WIP, where appropriate

The procedures for ingredient control, which were dis- In operations that deal with few allergenic ingredients,
cussed previously in this chapter and in Chapter 2, can a color scheme could be adequate where a given color
also be applied to rework and WIP. However, there is one designates the presence of the specific allergen or allergen
significant difference between regular ingredients and handling tool. If a color scheme is used to identify a single
rework/WIP materials that can affect the ability to control allergen, the name of the allergen may not have to be
incidental cross contact. Ingredients usually are received given. In facilities that handle numerous allergens, color
in their original package (e.g., cans, drums, bins, bags, schemes may be used in addition to other identification

32
 CHAPTER 3: KEY COMPONENTS OF A FOOD ALLERGEN MANAGEMENT PROGRAM

allergen-containing items, which product the materi-

systems. The information from the container tags should
als will be added to, the production line and date,
be entered into an inventory control record. Scanning
and the batch number.
technology or bar coding systems are more accurate than
manual systems when used properly. Whether using man- ■ Transfer: The transfer of rework and WIP materials
ual or computer-driven programs, a positive release sys- from the staging area to the processing line should
tem could enhance control when appropriate signature be accomplished without cross contact with other
requirements are in place to control the release of allergen- ingredients or products. Keeping the cross contact
containing products from storage. potential in mind when choosing the location of
staging and re-entry areas will go a long way toward
achieving this goal. If at all possible, containers that
Use hold allergen-containing materials should be mov-
As mentioned earlier, the main concern with allergen- able without the use of equipment, (e.g., totes on
containing rework and WIP is the wrongful inclusion of wheels.) If the use of lifting equipment, such as lift
these materials in a product that does not list a particular trucks, is unavoidable, great care must be taken to
allergen as an ingredient. The proper handling of these prevent the spread of allergen-containing debris to
items before and during add-back is critically important other parts of the plant. In operations where a haz-
for their exclusion from these products. ard evaluation (see Chapter 2) has indicated a likeli-
hood of cross contact such equipment could be dedi-
cated to the handling of a particular allergen-
“Like-into-like” practices containing material. If that is not feasible, the equip-
Allergen-containing rework must only be added back to ment should be thoroughly cleaned, preferably
products that contain the same allergen (for product label- before being allowed to exit the area where cross
ing considerations, as well as safety). This practice is contact can take place.
referred to as “like-into-like.” For example, chocolate ice ■ Re-entry points: For a given processing line, desig-
cream may be added to chocolate fudge ice cream that nated re-entry points for allergen-containing materi-
contains peanuts, almonds and pistachio nuts (provided als should be identified. These points should be
that all of the ingredients in the chocolate ice cream also chosen with the goal of preventing accidental cross
are in the chocolate fudge ice cream) but not the reverse. contact with non-allergen-containing products.
On the other hand, almond-containing cookie dough must Thus, they should be in close proximity to the
not be added to dough that does not contain almonds. staging areas, easily accessible from those areas and
For like-into-like practices to be effective, the rework located away from production lines and equipment
containers need to be properly labeled or color coded, or that are used to manufacture non-allergen-containing
both, and the add-back process must be carried out cor- products. If necessary, the re-entry points should be
rectly. Tracking the allergen-containing materials through physically shielded to minimize the potential for
the entire process also needs to be documented, including cross contact.
reconciling rework at the end of the day or shift. One ■ Re-entry equipment: If at all feasible, re-entry equip-
option to control rework and reduce human error could be ment, utensils and implements should be dedicated
to scan bar codes of rework/WIP before use. A computer- for handling a specific allergen. Such dedicated use
ized system could check the item against a predetermined minimizes the possibility of carry-over of an allergen
list of allowable uses by product. from the equipment to products that contain a differ-
ent allergen or none at all. Where this is not feasible,
Re-entry procedures allergen clean sanitation procedures must be in place
to lower the risk of incidental cross contact.
Whenever rework and WIP are generated, their re-entry
into the process stream should be tightly controlled in By carefully setting up staging and re-entry areas and
order to minimize the potential for faulty product mixing. equipment, the risk of cross contact through handling
The level of control is a function of various factors, such allergen-containing rework and WIP is greatly reduced.
as the staging and transfer of these materials, the re-entry However, without properly developed and executed re-
points in the process, and the equipment used for add- entry procedures, the necessary level of control cannot be
back. achieved. These procedures could contain the following
■ Staging: It is highly recommended to assemble all elements:
allergen-containing items for a specific batch in a ■ Work instructions on staging and transferring aller-
dedicated staging area before transfer to the line. gen-containing materials, including information on
Batch sheets should be attached to the assembled what records to keep and what equipment to use
materials with information on the identity of the

33
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

■ Work instructions on how to safely add back aller-

gen-containing materials, including proven methods
Cleaning and Sanitizing
of preventing spillage, dispersion, and other forms
of avoiding accidental cross contact; and, required Sanitation Basics
records such as batch sheets
As mentioned before, a company’s sanitation program
■ Work instructions on how to handle re-entry equip- plays a vital role in the management of allergens. Without
ment before, during, and after add-back, including effective cleaning procedures, it would be rather difficult
inspection and cleaning procedures to implement many of the control measures that are nec-
■ Verification procedures, including record review and essary to achieve the objectives of the allergen program.
positive release requirements For sanitation measures to be effective, the following
■ Recordkeeping procedures conditions should be met:
■ Responsible personnel ■ Equipment and plant structures must be cleanable,
accessible, and comply with sanitary design stan-
■ Work instructions on how to dispose of spillage
dards.
■ The cleaning step must result in the removal of food
Documentation soils, chemical residues, and microorganisms.
In addition to the various operational controls dis- ■ The sanitation crew must be trained, competent, and
cussed, the introduction of rework and WIP materials into well staffed.
the process stream must be documented. Without such ■ Sanitation systems and tools must be appropriate for
documentation, measures to prevent accidental product the job.
mixing or cross contact cannot be tracked, or verified. ■ Enough time must be allotted to do an adequate
Moreover, stringent recordkeeping and close supervision cleaning job.
are some of the most effective means of controlling the
■ Sanitation efficacies must be independently verified.
element of human error.
The documentation system should track the allergen- In the context of allergen management, the main pur-
containing rework/WIP materials from generation to stag- pose of sanitation is the removal of product residues using
ing to add-back. While specific systems often differ from proper cleaning techniques. Therefore, the rest of this sec-
plant to plant, certain basic records are necessary to keep tion will primarily focus on cleaning issues. Much of the
track of the movement of these materials. In particular: information presented here was adapted from Katsuyama
■ At the re-entry point, the pre-authorized production (1993) and Imholte and Imholte-Tausher (1999).
batch sheet should be reconciled with the informa-
tion on the staged containers. A note of this reconcil- Wet cleaning
iation step should be entered onto the batch sheet,
along with the operator’s initials and the time of the Most food operations rely on the use of water and
activity. detergents and the proper application of cleaning equip-
ment to keep their facilities clean. This form of cleaning is
■ During add-back, the following information should
commonly referred to as “wet cleaning.” Wet cleaning is
be entered on the batch sheet: (a) Identity of the
preferred where feasible since allergenic proteins tend to
allergen; (b) amount of rework/WIP material added;
be soluble in hot water. Detergents can also be useful in
(c) time of addition; (d) batch number and e) pro-
removing proteins. When detergents and/or sanitizers are
duction line number.
employed, their concentration should be checked with suf-
■ If the re-entry equipment is cleaned after add-back, ficient frequency to ensure they are at the desired level,
the prescribed cleaning steps should be documented. and the results documented on appropriate forms. Clean-
■ Verification activities need to be documented to in-place (CIP) systems are clearly beneficial where feasible
assure the integrity of the control system. Such activ- because they can be engineered to be very consistent once
ities include the inspection of re-entry equipment validated and properly maintained.
after cleaning, positive release measures, periodic The effectiveness of wet cleaning differs depending on
audits and record review. the type of food, the food-contact surface and the concen-
■ Records of added rework and WIP should be recon- tration of the detergent in the cleaning solution. For exam-
ciled with other production records to make sure ple, hot water was able to remove cold milk residues, but
that all the materials are accounted for at all times. not those of hot milk or peanut butter on some types of
A record of this activity should be kept, preferably surfaces. Hot chlorinated alkali detergent and acid deter-
on a daily basis. gent solutions prepared using the manufacturer’s suggest-
ed concentrations and temperature were effective in

34
 CHAPTER 3: KEY COMPONENTS OF A FOOD ALLERGEN MANAGEMENT PROGRAM

removing the residues from allergens such as peanut but- tered in larger operations. These systems have more power
ter, milk and egg (Jackson et al., 2006). than portable systems, and more than one person can use
The basic steps in a cleaning and sanitizing regimen the system at the same time. A typical system consists of
typically are as follows: inlet valve stations with hoses, smooth-flow tubing, sepa-
■ Removal of gross food residues rators, and exhausters (vacuum cleaner pumps). Central
vacuum cleaners, if they are used, should be used with
■ Use of chemical cleaning agents to remove
caution because these tend to have lengthy pipes that are
visible residue
difficult to clean and maintain. If the hoses are portable,
■ Water rinse of the cleaning agent and food residue care must be taken to see that the hoses do not contribute
mix to the spread of allergens.
■ Application of a sanitizer to kill, remove, and inhibit Central vacuum systems should be on a preventive
remaining microorganisms maintenance program. In some cases gauges or indicators
■ Final water rinse to remove the sanitizer, when may be used as verification that the system is operating
required properly.
Other techniques used in dry cleaning may include
For further information on wet cleaning techniques see carbon dioxide or grit blasting, salt cleaning and alcohol
the above references, or contact a sanitation chemical wipes. Validating such cleaning procedures is discussed
supplier. below.

Dry cleaning “Push-through”

Dry foods rely on low water activity for their microbio- Push-through is another approach used in dry cleaning
logical stability. The product residues left behind on operations, often with highly viscous products. Push-
equipment by these foods also do not have enough avail- through involves pushing product through a process sys-
able moisture to support microbial growth. However, if tem until all allergenic residues have been eliminated from
water is introduced during wet cleaning, microorganisms the system. Push-through can be accomplished with the
may start to grow in product residues. Therefore, for subsequent product or with some inert ingredient such as
cleaning dry food lines, activities such as scraping, vacu- salt or flour (assuming wheat is declared). This method
uming, brushing, or wiping are often employed. Wet can be especially useful in locations such as piping sys-
cleaning, if done at all, is restricted to disassembled equip- tems where product contact surfaces are not entirely
ment parts, and these equipment parts are often cleaned accessible. Push-through should not be used without
in a separate location. In addition, these parts must be proper validation, which will be discussed below.
completely dried before reassembly.
In most operations, dry cleaning activities should be
conducted daily. Which cleaning measures are used will
Allergen-Clean Procedures
depend on the nature of the products, equipment design The management of the risks posed by allergens relies
features, and the potential for spreading product residue heavily on the maintenance of a high level of sanitation in
during cleaning. For example, compressed air is effective the production facility. In order to achieve such sanitary
in removing soil from hard-to-reach areas, and drying conditions, certain conditions must be met.
damp equipment. But its practicality is limited because it ■ First, processing equipment and plant structures
also disperses dust and other debris, and can blow aller- should be constructed with good sanitary design fea-
gens from one area to another. Therefore, it should only tures. Cleaning procedures work on the assumption
be used with discretion. Residues of high-fat products, that the surfaces are cleanable. Whenever this is not
such as nut butter, can be scraped from equipment sur- the case, sanitation problems invariably will ensue.
faces, but this method would be ineffective in removing
■ Secondly, the cleaning procedures used should be
flour dust in a mill, where vacuums are essential.
proven effective under normal conditions in the facil-
Vacuum cleaning is one of the most effective means of
ity.
removing particles from surfaces without spreading dust.
This method also does not require a secondary means for ■ Thirdly, cleaning and changeover procedures need to
collecting the debris. Portable vacuum systems are usually be proven effective; the results of the procedure(s)
used in smaller operations or to do small cleaning jobs in should be validated to ensure that residues of target
a larger facility. These units are highly mobile and easy to allergens have been removed.
use. Because of their mobility, care has to be taken to pre- ■ Lastly, the proper implementation of these validated
vent these units from contributing to the spread of aller- procedures should be monitored and verified.
gens in a plant. Central vacuum systems may be encoun-

35
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

of product residues (e.g., inside pipe surfaces.)

The issues of sanitary design and documenting moni-
toring and verification activities were addressed in ■ The type of allergen of concern should be taken into
Chapter 2 and, therefore, do not require further elabora- consideration. For example, allergens known to
tion here. However, the question of the efficacy of a partic- cause anaphylaxis, such as peanuts, may require
ular sanitation measure needs to be looked at in greater more extensive changeover procedures than lower-
detail. To do that, it will be helpful to describe the concept risk allergens such as wheat.
of “allergen-clean.” Allergen-clean usually means that ■ Enough time should be allocated for the sanitation
food-contact surfaces and areas around and above the pro- crew to do an adequate sanitation job. Because of
cessing line are visibly clean, e.g., free of visible residue. the higher expectation for cleanliness of allergen-
Please note that this concept is based on the premise that clean surfaces, it often takes significantly longer to
the absence of visible residue equates to the absence of accomplish the cleaning goals as compared to other
detectable allergen-containing residue. This basic assump- sanitation measures.
tion was valid when detection of allergens on food-contact Based on an evaluation of these types of issues, the
surfaces was difficult, if not impossible, to accomplish. procedures should be written in the form of SOPs, which
With the availability of allergen test kits, it is conceivable include forms and checklists that are used to document
that in the future allergen-clean may mean the absence the SOPs. The recommended elements of a changeover
of detectable allergen-containing residues on food-contact procedure could include the following:
surfaces. While there is no generally recognized threshold ■ The name and objective of the procedure, including
level, or actionable levels, for allergens, allergen manage- a definition of allergen-clean and the targeted
ment should be risk based. For more information on test allergen(s).
kits, see Chapter 6.
■ Detailed work instructions, including the sequence
of cleaning steps; how to clean; what surfaces are
Changeover requirements cleaned, and how (clean-out-of place (COP), CIP,
or manually);
Unless an entire processing line or particular pieces of
equipment are dedicated to the manufacture of products ■ How the procedure is monitored, and by whom.
that contain a specific allergen, the issue of cross contact ■ How the efficacy of cleaning is verified, including
due to shared equipment is real and must be addressed. any allergen-clean performance criteria, what kind
Whenever an allergen-free product is run after an allergen- of inspections or tests are performed, how to per-
containing item, or when products that contain different form them, how often to perform them, and respon-
allergens are produced in sequence, special changeover sible personnel.
sanitation measures should be taken between production ■ What to do in the case of a failure, who determines
runs. These sanitation measures need to be adequate to a failure has occurred, and who is authorized to
render the processing equipment allergen-clean. initiate corrective actions.
Written changeover sanitation procedures should be
■ Who is authorized to determine that the processing
developed for each processing system. These procedures
system is allergen-clean and that production can
should be developed with regard to the following issues:
commence.
■ The system should be evaluated to ascertain its
■ What records and sign-off signatures are required
cleanability. If the evaluation reveals potential prob-
before a system is cleared for production.
lems, such as equipment dead spots or inaccessible
system components, the affected parts should be ■ Who subsequently reviews these sign off documents
modified or replaced to make them cleanable. If that and in what time frame.
cannot be done, modifications of the cleaning and
verification procedures most likely will be necessary. Validation of cleaning and
■ A definition of allergen-clean, along with correspon- sanitation procedures
ding performance criteria should be developed.
These criteria should specify clearly the expected
Validated cleaning procedures are an integral part of an
outcome of the cleaning procedures.
effective food allergen control program. It is important,
■ Procedures should be developed to validate that however, to distinguish between validation and verifica-
allergen residues have been removed. tion, particularly for the day-to-day operation of an aller-
■ Procedures should be developed to verify that a sys- gen control program. Validation entails collecting and eval-
tem is allergen-clean. In the case of product zones uating scientific and technical information to determine
that cannot be inspected, alternate testing proce- that a process, when properly implemented, will effective-
dures need to be implemented to verify the removal ly control a hazard or produce a desired endpoint. Within

36
 CHAPTER 3: KEY COMPONENTS OF A FOOD ALLERGEN MANAGEMENT PROGRAM

an allergen control program, a cleaning procedure would Testing by contract laboratories can also be used to val-
be considered “validated” when the procedure is shown to idate SSOPs. Regardless of whether test kits or contract
adequately remove targeted food allergens from food con- labs are used, all validation tests should be performed
tact surfaces. A validated process needs to be documented enough times to provide statistical confidence that suc-
to assure consistent implementation. cessful results can be repeated. After initial validation, the
The validation of sanitation practices for shared equip- tests should be repeated occasionally to verify continued
ment is very important to the overall allergen management successful performance. Any changes in an SSOP or the
program. Once visually clean can be achieved on a reliable detection of the allergen of concern may require reassess-
basis, additional validation should be provided to demon- ment and possibly re-validation. Changes in product for-
strate that allergenic proteins are removed when sanitation mulation, preparation procedures or processing operations
standard operating procedures (SSOPs) are followed. may also trigger a need for reassessment of the SSOP.
Allergen-specific test kits can provide additional validation Bioluminescence or ATP sanitation monitoring systems
data to indicate effectiveness of SSOPs designed to remove should not be used exclusively for validation of allergen-
allergenic residues. Commercial test kits, both quantitative clean SSOPs. ATP testing may not have the required sensi-
and qualitative, are available from several companies and tivity to provide specific validation of adequate SSOPs for
can be used to validate sanitation practices for the two reasons. First, allergenic proteins can exist on a sur-
removal of peanut, egg, milk, wheat, soy, crustacean shell- face at a level of concern and still be below the detection
fish, and some tree nuts. For more information on test level of an ATP system. Secondly, it is unknown how
kits, see Chapter 6. much of an ATP result is due to the presence of allergenic
SSOPs designed to remove allergenic residues from pro- proteins and how much is from something else (LeBlanc,
cessing equipment are an integral part of any changeover 2006). Once SSOPs are validated using allergen test kits or
from a product containing a specific allergen to one that an outside lab, ATP values could be correlated with a suc-
does not. One protocol that can be used to validate SSOP cessful completion of the validated SSOP. ATP could then
effectiveness in removing allergenic residues is to analyze be used as verification of a successful clean up.
the first product produced after the changeover for the
presence of the allergen(s) present in the prior product
Verification of an SSOP
produced. Test kits may be used to determine if detectable
residues exist in the first product manufactured after While validation is designed to check the adequacy of
changeover, assuming that this is the product most likely the SSOP, verification, on the other hand, includes those
to be contaminated if cleanup is inadequate. When using activities, other than monitoring, that determine the vali-
CIP systems, examination of the final rinse water for aller- dated procedure is being implemented properly and the
genic residues can also serve to validate an SSOP. system is operating according to the plan.
An alternative validation protocol is to use a qualitative The following verification methods can be used to
test kit to assess whether equipment surfaces are free of determine the allergen-clean status of a processing system:
allergenic residues after application of an SSOP. However, ■ A visual inspection or pre-op inspection is a com-
like microbial surface swabs, it is impossible to predict monly used verification method. Here, accessible
how much contamination might exist in the finished prod- equipment surfaces are checked for the presence
uct based on a positive swab test of a food contact sur- of visible residue. Less accessible equipment parts,
face. When using this technique, it is advisable to swab such as pumps, valves, and pipes may have to be
areas that are especially difficult to clean. “Dead spots” in taken apart or left un-assembled after cleaning so
the processing systems (valves, joints, corners, etc.) pres- they can be visually inspected.
ent cleaning challenges and should be included in the
■ ATP bioluminescence technology can be used for
sampling plan. A positive swab test would indicate more
verification of a previously validated clean-up proce-
cleaning is needed until a negative result can be obtained.
dure. The use of ATP technology is often paired with
For more information on effective product changeovers,
visual inspections of processing systems
see the section above.
Validation is particularly important in the case of ■ Verification can include periodic evaluation using
“push-through” situations. In some cases involving push- allergen test kits. By periodically testing equipment
through of thick, highly viscous liquids, allergen residues surfaces, final CIP rinse water, or the first product off
have been found hours after changeover (Taylor and Hefle, a freshly cleaned line, the efficacy of the SSOP can
2005). In this case, only dedicated processing equipment be verified. Kits are available for peanut, egg, milk,
can realistically prevent cross contact. In other cases, how- wheat, soy, crustacean shellfish, and some tree nuts.
ever, push-through has been effective and test kits are one Others test kits are expected to be developed in the
of the best methods to determine the volume of push- near future. For more information on test kits, see
through needed to prevent allergen cross contact. Chapter 6.

37
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

The outcome of the verification activities will deter- was shipped. To gather the necessary information, an
mine whether a system is considered allergen-clean. All effective record keeping system is obligatory. It is also
verification activities and results should be recorded on important to reconcile the information to rule out unac-
appropriate forms or checklists, and signed off by author- counted losses of allergen-containing materials.
ized personnel. This determination, in turn, should be Production losses of materials are a normal part of any
used by authorized personnel for a positive release of the operation, but these losses have to be accounted for in
system for the next production run. Any devices used for the context of the overall mass balance of ingredients
verification, such as allergen test kits and ATP meters, and products.
should be appropriately calibrated, and a calibration The backbone of any tracking program is proper docu-
record should be maintained as well. mentation and record keeping. Records should be devel-
oped to assist in documenting the use of all ingredients,
including allergens. Appropriate records could be receiving
documents, storage inventories, batching sheets, WIP
Tracking Allergens rework, product inventories, and shipping records. In
addition, regularly scheduled audits should be conducted
In June of 2002 Congress passed the Public Health to insure that receipt and usage of allergens or allergen-
Security and Bioterrorism Preparedness and Response Act containing materials are being adequately controlled.
of 2002 (the Bioterrorism Act). The Bioterrorism Act man- Even with good documentation and product accounting
dates that all members of the food chain shall be able to systems in place, the tracking of materials through a facili-
trace goods one step forward and one step backward; ty can be quite challenging. For example, when a bulk
in other words, locate where all incoming lots came from shipment of rye flour is added to a storage silo that con-
and where all finished lots were shipped. Companies who tains rye flour from a previous delivery, it will be exceed-
cannot perform these duties can be found in violation of ingly difficult to maintain the identity of the specific ingre-
the act. dient lots. Another common tracking problem is due to the
Traceability is often used as an umbrella term for the practice of carrying over partial product lots from one pro-
various components of a company’s product tracking sys- duction day to the next. A lot that is carried over to anoth-
tem. At its simplest, this term means that a company is er day will end up in finished product produced on more
able to trace an ingredient lot back at least one step, e.g., than one day, and without accurate records it would be
to the supplier. In order to accomplish this, well-developed impossible to conduct a traceback investigation of this
and tightly controlled vendor programs are a necessity. material.
Many facilities have written procedures designed to
control and track the use of ingredients, raw materials,
and packaging materials in their plants. These include pro-
grams to keep track of allergens from receipt through use Controls of Food Labels
in products. These types of programs are necessary to gen-
erate information on where ingredients were used and
and Packages
how products were handled. They are also an important
prerequisite for a company’s recall program. Control of food labels and packages in the food produc-
Another component is a company’s recall capability. tion plant is as important as other food allergen manage-
The firm must be able to trace materials through its pro- ment techniques in ensuring that allergen sensitive con-
duction system and connect them to finished products in sumers do not consume a food to which they are allergic.
the marketplace. If products need to be recalled, the nec- Food manufacturers must get a product into the right
essary system and management structure must be in place package with the correct product label that accurately
to accomplish the task. A common tool used to verify a reflects the contents of a product. Food label and package
company’s recall program is to conduct mock recalls or control techniques also help to prevent product misbrand-
product tracing exercises. ing that may result in regulatory violations and/or product
Lastly, a system needs to be in place to account for the recalls. Currently, labeling errors are the primary cause
receipt, use, and shipment of ingredients and products of allergen-related food product recalls. Two important
within a facility. This is especially important for allergen- aspects of label management include controls for design
containing materials. In order to minimize the potential and controls for inventory and label application.
for the inadvertent inclusion of an allergen, it is important
to know how much of an allergen was received and how
much is in inventory; how much, when, and in what
product it was used; if it was part of a carried-over or
reworked product; and how much of the finished product

38
 CHAPTER 3: KEY COMPONENTS OF A FOOD ALLERGEN MANAGEMENT PROGRAM

Design Controls ■ Proper packaging staging control procedures should

Food labels and pre-printed packages should be be implemented. Only labels for the product current-
designed under procedures to ensure accurate fulfillment ly being packaged should be staged in the packaging
of label design orders from customers. Procedures may area. Samples of packaging film should be checked
include these elements: for accuracy before the roll is placed on the packag-
■ Orders in writing for art work and labeling copy ing machine.
■ Sufficient knowledge of regulatory requirements, ■ Another technique to consider is accounting for
including declaration of allergens, to ensure compli- numbers of labels used versus quantity of packages
ant label and package designs produced during a production run. Units produced
should approximately equal labels used. If these
■ The use of commonly understood terms in consumer
two numbers are different, it could indicate that the
friendly language for all allergenic ingredient declara-
wrong label was used or there are unlabeled pack-
tions (e.g. milk, not whey or casein)
ages in the production run.
■ Procedures to confirm accurate listing of product
■ Food processors should educate line personnel on
ingredients
techniques for ensuring that product labels are
■ Design and copy proofreading switched appropriately at product changeover.
■ Written approval of label and package proofs Systems for confirming correct product and label
■ Identity coding (color and/or numerical) of printed changeover may be warranted. These techniques
labels and packages are important, particularly when applying labels
to product that is held in inventory in unlabeled
■ Lack of co-mingling when shipping labels and pre-
containers.
printed packages
■ During processing, product containers and labels
Suppliers should provide customers with detailed writ- should be inspected to reconcile allergen-related
ten specifications for label and package artwork and copy. label information on the containers with the ingredi-
Customers should make label content decisions before ent specifications of the product.
ordering label and package design services. Suppliers ■ The use of colored striping on the edges of packages
may request that customers transmit label copy to design that are stacked flat in packaging machines should
services so that re-keying of the text is minimized. It may be considered. That practice is especially valuable
be appropriate to have labels reviewed and approved by for allergen-containing products because it would
several individuals, particularly for foods containing aller- reduce the chances for error by line operators.
gens, prior to printing. ■ Remove unused packaging and labels after the run.
Unused packaging materials that are returned to
Inventory and Processing Controls the warehouse at the completion of a production run
must not be mixed with other packaging materials
Tracking and inventory control systems should be in during storage. Proper inventory control procedures
place to monitor finished products and their labels back should be in place and effective. Packaging stored in
through all phases of production. The food industry boxes, such as plastic cups and lids, should have the
employs a wide range of in-plant measures to control boxes sealed shut.
packaging and labeling. A company may choose from a
variety of available measures according to their opera- Some companies have successfully used bar code scan-
tional capabilities and needs. The following list provides ning technology. The scanning system must be able to ver-
examples of such measures: ify bar codes and remove incorrect packaging during all
■ Any packaging that includes ingredient statements actual operating conditions and line speeds. The scanners
(labels, cups, film, external cartons, etc.) should be should be properly maintained, standardized, and func-
checked upon receipt against approved standards to tional during packaging of all products on lines that pro-
ensure the labeling statements are correct and any duce allergen-containing products. The scanner functional-
other additional allergen labeling requirements are ity should be tested and documented at start-up, shut
present. down, and at least once per shift. If the scanner malfunc-
tions while producing an allergen-containing product, an
■ A management system should be in place to assure
alternate method of packaging verification should be used.
that out-of-date or old labels or packaging are dis-
The incident should be documented, along with informa-
carded in a timely manner. Periodic audits should be
tion on the nature of the alternate packaging verification
conducted to verify compliance.
method, product disposition, and repair of the unit. ■

39
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

REFERENCES
Deibel, K., T. Trautman, T. DeBoom, W.H. Sveum, Katsuyama, A.M. (1993) Principles of Food Processing
G. Dunaif, V.N. Scott and D.T. Bernard. (1997) A com- Sanitation, 2nd Edition. The Food Processors Institute,
prehensive approach to reducing the risk of allergens Washington, D.C. 20005.
in foods. J. Food Prot. 60:426–441.
LeBlanc, D. (2006) ATP Systems are not designed for total
GMA (Grocery Manufacturers Association). (2008) plate counts or detecting food allergens.
Food Supply Chain Handbook. GMA, Washington, DC. [Link], 08/01/2006.
Available at: [Link] Accessed October 23, 2007.
publications/GMA_SupplyChain2.pdf.
Pennsylvania State University. Negative air ionization,
Imholte, T.J. and T.K. Imholte-Tauscher. (1999) Pennsylvania State University Department of
Engineering for Food Safety and Sanitation—A Guide to Architectural Engineering. Available at:
the Sanitary Design of Food Plants and Food Plant [Link]
Equipment. Technical Institute of Food Safety, neg_ion.asp. Accessed January 16, 2008.
Medfield, MA.
Swanson, K.M.J. (2005) Food allergens—the “other” food
Hefle, S.L. and S.L. Taylor. (1999) Allergenicity of edible safety issue. Dairy Foods, February 2005.
oils. Food Technol. 53(2) 62–68, 70. Available at: [Link]
Articles/Plant_Operations/
Jackson, L.S, M.A. Al-Taker, T. Fu and S.M. Gendel (2006) f1f242e57e0a7010VgnVCM100000f932a8c0.
Cleaning strategies and validation to prevent allergen Accessed April 19, 2008.
cross-contact in food processing operations. Presented
at the 232nd meeting of the ACS. San Francisco, CA Taylor, S.L. and S.L. Hefle. (2005) Allergen control.
September 10–14. Food Technol., 59(2):40–43, 75.

Jackson, L.S, M.A. Al-Taker, M. Moorman, J. Devries, R.

Tippet, K.M.J. Swanson, T. Fu, R. Salter, G. Dunaif, S.
Estes, S. Albillos and S. Gendel. (2008) Cleaning and
other control and validation strategies to prevent aller-
gen cross-contact in food processing operations.
J Food Prot. 71:445–458.

40
 CHAPTER 4: LABELING AND PACKAGING

Chapter 4

LABELING AND PACKAGING

Regina Hildwine / Robert Earl, RD, MPH / Christie Gray

Introduction Food Labeling Regulations

Food labeling, especially the ingredient declaration, is Labeling of most packaged food in the United States
the primary vehicle for informing individuals about the is governed by the Federal Food Drug and Cosmetic Act
presence of allergens that are part of a food product for- (FFDCA), as amended, and the Fair Packaging and
mulation. Most often, ingredient declarations appear on Labeling Act (FPLA), as amended. These statutes, and
the information panel of food labels. In addition to the implementing regulations promulgated by the U.S. Food
ingredient declaration, food labeling components useful to and Drug Administration (FDA), contain all the significant
individuals with food allergy include required labeling of federal legal requirements for the labeling of most pack-
foods that contain major food allergens, as well as adviso- aged, processed foods. As noted before, FALCPA is an
ry allergen statements accompanying, or adjacent to, the amendment to the FFDCA that was enacted in 2004.
ingredient declaration. Food products under the jurisdiction of the FDA include
Food label reading is essential for individuals with food all processed foods except for those meat, poultry and egg
allergy and their caregivers. Individuals with food allergies products that are governed by mandatory inspection pro-
are instructed to read labels consistently, even on repeat visions of the U.S. Department of Agriculture (USDA),
purchase or use of a packaged food item. Whenever food Food Safety and Inspection Service (FSIS), under the Meat
allergic consumers purchase and use packaged foods, they Inspection Act, the Poultry Products Inspection Act and
must read the ingredient list and any other supplemental the Egg Products Inspection Act.
food allergen information on the label, in order to observe In many respects, the labeling requirements for FSIS-
any significant product formulation changes that would be regulated foods are similar to the labeling requirements for
essential to food allergy management. FDA-regulated foods. However, there are some important
differences, so processors of meat and poultry products
should be aware of the labeling rules that apply to them.

Food Allergen Labeling Law Labeling of FDA-Regulated Foods

In recent years, the prevalence of food allergies among In most cases, information on food allergens will
certain populations, especially young children, and the appear on a food product “label,” although this informa-
persistent level of recalls related to undeclared food tion may also appear on “labeling,” particularly in the
allergens, raised the issue of food allergen controls and case of unpackaged food. There are subtle differences
labeling. between “labeling” and the “label” that are important to
In August 2004, Congress enacted the Food Allergen understand. The term “labeling” means all labels and
Labeling and Consumer Protection Act (FALCPA), an other written, printed, or graphic material, either attached
amendment to the Federal Food, Drug, and Cosmetic Act. to an article or any of its containers or wrappers or accom-
Food allergen labeling requirements under FALCPA took panying the article. It is not necessary for “accompanying”
effect January 1, 2006. FALCPA applies to all FDA regulat- material to be attached to the product container for it to
ed foods that are not raw agricultural commodities. Details be considered “labeling.” Clearly, when the laws and regu-
of FALCPA labeling requirements are presented later in lations refer to “labeling,” the requirements encompass
this chapter. “labels.” To make the requirements even clearer, FDA
labeling regulations usually specify explicitly “label or
labeling,” assuring that it is understood that the require-
ments apply to both types of display.
All the printing and graphics on the outer surface of
the immediate food product container are considered the

41
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

“label,” as are all the printing and graphics on wrap and tree nuts. These terms will seldom, if ever, appear as
labels, and spot labels, or printing on bottles, cans, or an unmodified statement of identity. For example, for crus-
caps. Hang tags accompanying a food package are con- taceans, crab (snow crab, king crab, etc.), crayfish, lobster,
sidered “labeling,” as are any package inserts which are and shrimp, are the terms that would be required to iden-
not viewed through a transparent wrapper or covering. tify the food. For fish, the common or usual name of the
Brochures and other point of sale materials accompanying fish species must be declared. Both crustaceans and fish
a food product are also considered “labeling,” particularly names must follow the terminology set forth in FDA’s
if they name or feature the food product that they accom- Seafood List. The statement of identity must express the
pany. true nature of the food with precision; pecans could not
be labeled as walnuts, and “tree nuts” would be too broad
a term to be useful as a statement of identity. For a con-
Food labeling general requirements
sumer allergic to one, but not all, foods in a class, the
Food labels are required to include several elements, specific common or usual name is essential to determine
which are generally found on the principal display panel if the food is appropriate to eat.
(PDP) and the information panel. The PDP is the part of a
food label that is most likely to be displayed, presented,
Ingredient labeling
shown, or examined under customary conditions of dis-
play for retail sale. The information panel is generally con- Ingredient declaration is a required food label element,
tiguous and immediately to the right of the PDP, as viewed and there are very few instances where a packaged food is
by the consumer. not required to display its ingredients. All ingredients of a
Several label elements are always required on the prin- FDA-regulated food must be declared on the label, except
cipal display panel. These elements include the statement for a few specific exemptions noted at 21 CFR 1.24 and
of identity of the food, and the net quantity of contents 21 CFR 101.100. Mandatory ingredient declaration also
statement. Mandatory label elements that typically appear now applies to all ingredients of standardized foods.
on the information panel include the ingredient declara- Ingredients must be declared by common or usual name,
tion, nutrition label, and packer/distributor statement in descending order of predominance by weight, on either
(name and address). the principal display panel or the information panel
(21 CFR 101.4(a)(1)).
Food processors should remember that ingredient label-
Food product naming
ing is required for in-pack samples of food products, or
All food products must have a statement of identity, for packages of food that are designed for in-home tests or
which is the name of the food. If the food has a defined otherwise not offered for sale to consumers. There are no
name, either by standard of identity or by an established exemptions from ingredient labeling for these types of
common or usual name, that term is the statement of products.
identity. If the food does not have an established name, For ingredients present in the food at 2 percent or less
then an appropriately descriptive term is a correct identity by weight, the strict order of predominance rule may be
statement. If the nature of the food is obvious to a con- modified, provided a quantifying phrase is included at
sumer, the food may be named by a fanciful term com- the end of the ingredient list. The quantifying phrase, for
monly used by the public for such a food. example, “contains 2 percent or less of…” or “less than 2
The food’s statement of identity may be the first place percent of…,” must precede the list of ingredients present
on a label where a food-allergic consumer encounters the in the food below the quantitative threshold. The list of
name of the food allergen of concern. For some foods, the ingredients to which the phrase applies then may be listed
name of the food allergen is part of a standardized name in any order (21 CFR 101.4(a)(2)).
or common or usual name of the food expressed in the Compound ingredients, or ingredients which them-
statement of identity. For example, buttermilk, peanut but- selves consist of two or more components, may be
ter, cracked wheat, and milk chocolate all include the declared by one of two methods. The more common
commonly understood names of food allergens as part of method permitted under FDA rules is to declare the ingre-
their common or usual names or standardized names. dient by its common or usual name, and then in parenthe-
However, there are many food products where the name of ses to declare all the ingredients of that ingredient, in
the allergen does not appear in the name of the food. The descending order of predominance by weight. Optional
standardized foods semolina and bleached flour, for exam- ingredients of standardized foods that must ordinarily be
ple, do not include the term “wheat” in their names. declared as part of the common or usual name of the stan-
In addition, some food-allergic consumers may be aller- dardized food may also be declared in the parentheses in
gic to classes of foods, and may describe their allergies as this instance. The other permitted compound ingredient
related to those food classes, such as crustaceans, fish, declaration option is to list the components of the ingredi-

42
 CHAPTER 4: LABELING AND PACKAGING

ent, by their common or usual names in descending order “or,” “and/or,” or the phrase “contains one or more of the
of predominance by weight with respect to the finished following:” fats and oils (21 CFR 101.4(b)(14)).
food, without naming the compound ingredient itself This ingredient labeling provision is most likely to draw
(21 CFR 101.4(b)(2)). the attention of soy allergic consumers, as soybean oil is
widely used in the food supply and is commonly noted in
“and/or” fat and oil ingredient statements. Most soybean
Special ingredient declaration provisions
oil that is used in commercial food processing has been
There are a number of special ingredient declaration bleached, refined, and deodorized, so that it does not
provisions that are relevant to the declaration of food retain residual amounts of allergenic protein from soy-
allergens, including permission to declare certain foods by beans.
class names, and the permitted use of “and/or” ingredient Disjunctive ingredient labeling also is permitted in the
labeling for fats and oils, fish protein, and certain types of case of fish proteins that are common ingredients in suri-
food additives. mi, or seafood analogs. When processed seafood products
A number of ingredients may be declared by class contain fish protein ingredients consisting primarily of the
names. These include several dairy products and their myofibrillar protein fraction from one or more fish species,
concentrates and derivatives: skim milk, milk, bacterially and the manufacturer is unable to adhere to a constant
cultured milk, buttermilk, whey, cream, and butter oil. pattern of fish species in the fish protein ingredient,
Eggs, egg whites, egg yolks, and their derivative products because of seasonal or other limitations of species avail-
may also be declared by class names (21 CFR 101.4(b)(3)– ability, the common or usual name of each individual
(12)). Presentation of this information by class name may fish species need not be listed in descending order of
simplify ingredient lists; however, FALCPA labeling predominance. Fish species not present in the fish protein
requirements would still apply in order to make it clear to ingredient may be listed if they are sometimes used in the
an allergic individual what the major food allergens are in product. Such ingredients must be identified by words
the ingredient declaration. indicating that they may not be present, such as “or,”
Special labeling provisions apply to foods that claim to “and/or,” or “contains one or more of the following.”
be “non-dairy” foods but contain a caseinate ingredient. Fish protein ingredients may be declared in the ingredient
These foods must note the source of the caseinate in statement by stating the specific common or usual name
parentheses on their ingredient declarations, as in “sodi- of each fish species in parentheses following the collective
um caseinate (a milk derivative)” (21 CFR 101.4(d)). name “fish protein,” e.g., “fish protein (contains one or
This type of labeling typically appears on a non-dairy more of the following: pollock, cod, and/or Pacific whit-
creamer. This labeling creates what some milk allergic ing)” (21 CFR 101.4(b)(23)). Declaration of fish ingredients
consumers view as an internal conflict, in that the food by common name in addition to the general term “fish” is
claims not to be a dairy product, yet it includes dairy- useful to the individual with fish allergy.
derived ingredients. In some cases, the common or usual “And/or” ingredient-labeling provisions apply for leav-
name of an ingredient may be unfamiliar to consumers, ening ingredients, yeast nutrients, dough conditioners, and
and many consumers may not realize the ingredient is firming agents (21 CFR 101.4(b)(16)–(19)). These additives
derived from, or contains, a major food allergen. FALCPA typically do not contain food allergens, but they may be
labeling requirements considered this and it is now man- associated with foods that contain allergenic ingredients
dated that major food allergens be declared on the food such as wheat, milk, egg, or soy.
label by the common or usual name. Some food compa-
nies have chosen product names that do not use the “non-
Flavor, spice, and color ingredient labeling
dairy” descriptor, while others provide food allergic con-
sumers with label statements that reinforce the message Special ingredient labeling rules apply to flavor, spice
that milk derivatives are present. and color ingredients used in foods. The label of a food to
Special ingredient labeling options may be used for cer- which flavor or spice is added may use the class names
tain blends of fats and oils. If the food is entirely a blend “spice,” “natural flavor,” or “artificial flavor,” or any com-
of fats and oils, or if the blend of fats and oils is the pre- bination thereof, as the case may be. Ingredients that may
dominant ingredient in the food, then all the oils in the use the class name “spice” are defined in FDA regulations,
blend must be listed in descending order of predominance and “natural flavor” and “artificial flavor” denote the use
by weight. However, if the blend of fats and oils is not the of manufactured flavors, including extractives, distillates,
predominant ingredient, the declaration of the oils in the oleoresins, and synthesized flavorings. Certain food ingre-
blend need not be in descending order of predominance dients that are used to give flavor to food are not consid-
by weight. In addition, the individual oils in the blend ered part of the spice and flavor class naming provisions.
may be labeled to indicate each may not always be pres- Onion powder, granulated onions, garlic powder, and cel-
ent in the food, by using disjunctive labeling, for example, ery powder, and other ingredients obtained by cutting,

43
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

grinding, drying, pulping, or similar processing of tissues It is now required to declare major food allergens that
derived from fruit, vegetable, meat, fish, or poultry, must are present in flavors, spice blends, and colors, even if
be declared by their common or usual names. Any sodium they are permitted to be declared by class names under
chloride used as an ingredient in food must be declared by the law. FALCPA removed the ingredient labeling exemp-
its common or usual name “salt.” Any monosodium gluta- tions for food allergens present in flavors and colors.
mate used as an ingredient in food must be declared by its Food manufacturers must label food products that contain
common or usual name “monosodium glutamate” (21 CFR ingredients, including a flavoring or coloring, that are, or
101.22(h)). contain, a major food allergen using plain English to iden-
FDA also has ruled that protein hydrolysates function in tify the allergens. The requirements for FALCPA allergen
foods as both flavorings and flavor enhancers. As a result, labeling are described in more detail in a later section of
any protein hydrolysate used in food for its effects on fla- this chapter.
vor must be declared by its specific common or usual
name as defined by regulation, and may not be declared
Incidental additives labeling provisions
simply as “flavor,” “natural flavor,” or “flavoring” (21 CFR
101.22(h)(7)). This requirement affects such ingredients Incidental additives that are present in a food at
as hydrolyzed soy protein, autolyzed yeast extract, and insignificant levels, and which do not have any technical
hydrolyzed wheat gluten. It is important to note that the or functional effect in the food, are exempt from mandato-
ingredient class name “hydrolyzed vegetable protein” is ry ingredient labeling provisions. For the purposes of this
not an appropriate common or usual name, and the pro- exemption, incidental additives are:
tein source must be included in the name (21 CFR 102.2). ■ Substances that have no technical or functional
Foods that use color additive ingredients have special effect, but are present in a food because they were
ingredient labeling rules that differentiate certified colors incorporated into the food as an ingredient of anoth-
and those that are not subject to certification. Certified er food, in which the substance did have a functional
colors and their lakes must be declared by the name of or technical effect
the color additive, such as “Yellow 5,” “FD&C Red 40,”
■ Processing aids, defined as:
or “Blue 1 Lake” (21 CFR 101.22(k)(1)). Color additives
– Substances that are added to a food during the
not subject to certification may be declared as “Artificial
processing, but are removed in some manner from
Color,” or “Color Added,” or by an equally informative
the food before it is packaged in its finished form
term that makes clear that a color additive has been used
– Substances that are added to a food during
in the food. It may also be declared by its common or
processing, are converted into constituents normal-
usual name, with the notation that it is a color, as in
ly present in the food, and do not significantly
“titanium dioxide (color)” (21 CFR 101.22(k)(2)).
increase the amount of the constituents naturally
There have been reports that two related food colors
found in the food
not subject to certification, carmine and cochineal extract,
– Substances that are added to a food for their
have caused allergic reactions in some people. FDA was
technical or functional effect in the processing,
petitioned to require the declaration of these colors by
but are present in the finished food at insignificant
name. In January 2006, FDA proposed to revise its require-
levels and do not have any technical or functional
ments for cochineal extract and carmine by requiring their
effect in that food
declaration on the label of all food and cosmetic products
– Substances migrating to food from equipment or
that contain these color additives. Food industry com-
packaging, or otherwise affecting food, which are
ments noted that the industry does not object to the pro-
not food additives as defined in the FFDCA; or if
posed rule for the labeling of carmine and cochineal
they are food additives, they are used in conformi-
extract, as many food companies that use these colors
ty with food additive rules (21 CFR 101.100(a)(3))
elect to declare them by their common or usual names.
FDA on January 5, 2009 (74 FR 207) published a final rule Ingredients that are typically the beneficiaries of the
to require, effective January 5, 2011, the declaration by incidental additives exemption are those carried over from
name of carmine and cochineal extract when these color a component in the food. For example, a dry seasoning
additives are used in foods. may include silicon dioxide as a flow agent to prevent cak-
When a color has been added to butter, cheese, or ice ing of the powder. If this seasoning were used in a liquid
cream, it need not be declared in the ingredient list unless or viscous food product, such as a soup or casserole dish,
the declaration is required by a regulation in the color the silicon dioxide would have no functional effect in the
additive rules (unless an allergen is present—see below). finished food. In such a food product, a seasoning would
Voluntary declaration of all colorings added to butter, usually be used as a minor component of the product for-
cheese, and ice cream, however, is recommended (21 CFR mula, and the silicon dioxide would likely be present at a
101.22(k)(3)). small enough level to be considered “insignificant” in the

44
 CHAPTER 4: LABELING AND PACKAGING

finished food. Since the silicon dioxide would meet both

Special Considerations:
conditions for the incidental additives exemption—present Food Allergen Labeling
in the finished food at an insignificant level, and having
no technical or functional effect in the finished food— FALCPA defined the eight major food allergens, which
the silicon dioxide would not be required to be declared account for more than 90% of all food allergies. A “major
on the ingredient list of the finished food. food allergen” is an ingredient that is one of the following
With respect to food allergens, FALCPA removed the foods or food groups, or is an ingredient that contains
ingredient labeling exemption for incidental additives. protein derived from peanuts, soybeans, milk, eggs, fish,
All incidental additives that contain protein derived from crustacean shellfish, tree nuts or wheat. Several of these
major food allergens must be labeled according to the law. major food allergens are classes of foods, rather than indi-
vidual foods:
Sulfite ingredient labeling Fish: involves numerous species.
While sulfites are not considered food allergens, the Crustacean shellfish: crab (snow crab, king crab, etc.),
labeling of sulfite ingredients (sulfur dioxide, sodium sul- crayfish, lobster and shrimp. A declaration of the
fite, sodium bisulfite, potassium bisulfite, sodium meta- “species” of fish or crustacean shellfish for purposes of
bisulfite, and potassium metabisulfite) is important for the complying with section 403(w)(2) should be made using
small segment of the population who can develop short- the acceptable market name provided in FDA’s Seafood
ness of breath or fatal shock shortly after exposure to sul- List. The list is available at [Link]
fite preservatives. Sulfites are capable of producing severe ~frf/[Link].
asthma attacks in sulfite-sensitive asthmatics. For that rea-
Tree nuts: almonds, beech nuts, Brazil nuts, butternuts,
son, in 1986 the FDA banned the use of sulfites on fresh
cashews, chestnuts, chinquapins, coconuts, fil-
fruits and vegetables (except potatoes) intended to be sold
berts/hazelnuts, ginkgo nuts, hickory nuts, lichee nuts,
or served raw to consumers.
macadamia nuts, pecans, pine nuts, pili nuts, pistachios,
Labeling of sulfites is related to the incidental additive
sheanuts and walnuts. The FDA Guidance released in
provisions in FDA’s labeling rules. Sulfites added to all
October 2006 expanded the list of tree nuts. This is FDA’s
packaged and processed foods must be listed on the prod-
current best judgment as to those nuts that are “tree nuts”
uct label in conformity with the regulatory requirements.
within the meaning of FALCPA. As with any guidance,
Any sulfiting agent that has been added to any food, or
FDA may revise this list.
to any ingredient in any food, and which has no technical
effect in that food, will be considered to be present in an FALCPA requires food manufacturers to label food prod-
insignificant amount only if no detectable amount of the ucts that contain an ingredient that is or contains protein
agent is present in the finished food. A detectable amount from a major food allergen in one of two ways. The first
of sulfiting agent is 10 parts per million or more of the sul- option for food manufacturers is to include the name of
fite in the finished food according to the analytic method the food source in parentheses following the common or
described in the regulation. FDA regulations mandate that usual name of the major food allergen in the list of ingre-
sulfites detectable in foods at 10 parts per million or more dients, in instances when the name of the food source of
must be declared on the ingredient declaration. This is the the major allergen does not appear elsewhere in the ingre-
only FDA incidental additives provision that quantifies dient statement. For example:
what is meant by “insignificant amount.”
Ingredients: Sugar, bleached enriched flour (wheat
Similar declaration provisions apply explicitly to sulfites
flour, malted barley flour, niacin, iron, thiamin mononi-
in foods with standards of identity, as elaborated at 21
trate, riboflavin, folic acid), peanut butter (peanuts,
CFR 130.9. Any standardized food that contains a sulfiting
dextrose, hydrogenated rapeseed and cottonseed oil,
agent or combination of sulfiting agents, which is func-
salt), partially hydrogenated soybean and/or cotton-
tional in the food and provided for in the applicable stan-
seed oil, molasses, baking soda, salt, corn starch, egg,
dard, is deemed misbranded unless the presence of the
nonfat milk, soy flour.
sulfiting agent or agents is declared on the label of the
food. Detectable levels of sulfites, which are not provided The second option is to place the word “Contains”
for in a standard, but which are indirect food additives followed by the name of the food source from which the
following Good Manufacturing Practices (GMPs) do not major food allergen is derived, immediately after or adja-
cause the food to violate the standard of identity if the sul- cent to the list of ingredients, in type size that is no small-
fite ingredients are declared in the ingredient statement. er than the type size used for the list of ingredients.
For example:
Contains Wheat, Peanut, Milk, Egg, and Soy

45
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

FALCPA requires the type of tree nut (e.g., almonds, 1. FDA produced an extensive list of nuts that are con-
pecans, walnuts); the type of fish (e.g., bass, flounder, sidered “tree nuts” for purposes of section 201(qq)
cod); and the type of crustacean shellfish (e.g., crab, lob- of FALCPA. This list reflects FDA’s current best judg-
ster, shrimp) to be declared. In addition, it requires that ment as to those nuts that are “tree nuts.” This list
food manufacturers label food products that contain ingre- has caused some discussion within the food industry.
dients, including a flavoring, coloring, or incidental addi-
2. A declaration of the “species” of fish or Crustacean
tive that are, or contain, a major food allergen, using plain
shellfish for purposes of complying with section
English to identify the allergens.
403(w)(2) should be made using the acceptable
market name provided in FDA’s Seafood List.
Exemptions from FALCPA FDA’s Seafood List is a compilation of existing
acceptable market names for imported and do-
Requirements mestically available seafood. The list is available
at [Link]
Under FALCPA, raw agricultural commodities are
exempt from labeling, as are highly refined oils derived 3. The term “wheat” in section 201(qq) means any
from one of the eight major food allergens and any in- species in the genus Triticum. Thus, for the purposes
gredient derived from such highly refined oil. Additional of section 201(qq), wheat would include grains such
exemptions to FALCPA include exemptions through a suc- as common wheat (Triticum aestivum L.), durum
cessful notification that indicates there is no allergenic wheat (Triticum durum Desf.), club wheat (Triticum
protein present, or an exemption through a successful compactum Host.), spelt (Triticum spelta L.), semoli-
petition that states the food does not cause a harmful na (Triticum durum Desf.), Einkorn (Triticum mono-
allergic reaction. To achieve an exemption through the coccum L. subsp. monococcum), emmer (Triticum
notification process, the notifier must submit scientific turgidum L. subsp. dicoccon (Schrank) Thell.), kamut
evidence that demonstrates the food ingredient does not (Triticum polonicum L.), and triticale ( x Triticosecale
contain allergenic protein. To achieve an exemption ssp. Wittm.).
through a petition, scientific evidence must be provided
4, Single ingredient foods must comply with the aller-
that demonstrates the food ingredient does not cause an
gen declaration requirements in section 403(w) (1).
allergic response that poses a risk to human health. If the
A single ingredient food that is, or contains protein
Secretary of Health and Human Services grants either the
derived from milk, egg, fish, crustacean shellfish,
petition or the notification, the result is that the ingredient
tree nuts, wheat, peanuts, or soybeans, may identify
in question is not considered a “major food allergen” and
the food source in the name of the food (e.g., “all-
is not subject to the labeling requirements. For more infor-
purpose wheat flour”) or use the “Contains” state-
mation on the notification and petition process as well as
ment format. FDA recommends that if a “Contains”
those notifications and petitions submitted to FDA for
statement format is used, the statement be placed
approval, please go to FDA’s food allergen website:
immediately above the manufacturer, packer, or
[Link]
distributor statement. For single ingredient foods
intended for further manufacturing where the
“Contains” statement format is used, the statement
2006 FDA Final Guidance should be placed on the principal display panel of
the food.
Regarding FALCPA The FDA Guidance for Industry: “Questions and
Answers Regarding Food Allergens, including the
In October 2006, FDA released the 4th edition of Food Allergen Labeling and Consumer Protection Act
“Guidance for Industry: Questions and Answers Regarding of 2004 (Edition 4),” can be accessed at
Food Allergens, including the Food Allergen Labeling and [Link]
Consumer Protection Act of 2004.” This is a revision to the
third edition of a guidance document. This revision con- Soy lecithin: In April 2006, FDA released Guidance,
tains questions and answers relating to food allergens, “Labeling of Certain Uses of Lecithin Derived from Soy.”
including questions and answers about FALCPA. This This Guidance can be accessed at
guidance document helps explain what FALCPA is and [Link]
how industry can follow the requirements in this law. Exemptions to FALCPA do not include soy lecithin. While
New to this edition are the following: FDA did identify a period of enforcement discretion, that
period ended in October 2007. FDA currently expects
processors to label all uses of soy lecithin.

46
 CHAPTER 4: LABELING AND PACKAGING

Gluten Labeling Labeling of USDA

FDA proposed to define the term “gluten-free” for vol- FSIS-Regulated Foods
untary use in the labeling of foods. A definition for the
term “gluten-free” established by FDA would assist those
who have celiac disease (also known as celiac sprue or Mandatory inspection provisions of the USDA’s Food
gluten-sensitive enteropathy) and their caregivers to iden- Safety and Inspection Service (FSIS), under the Meat
tify packaged foods that are safe for persons with celiac Inspection Act, the Poultry Products Inspection Act and
disease to eat. FALCPA directed the Secretary of Health the Egg Products Inspection Act govern meat, poultry and
and Human Services to issue a proposed rule to define processed egg products. Meat and poultry products regu-
and permit the use of the term “gluten free” on the label- lated by FSIS include major species of meat and poultry
ing of foods. (such as beef, pork, lamb, chicken, and turkey) present in
Gluten describes a group of proteins found in certain a food in quantities of at least 3% raw or 2% cooked meat
grains (wheat, barley, and rye.) Gluten is not considered a or poultry. FSIS has developed separate sections of its reg-
major food allergen. It is of concern to people with celiac ulations for meat and for poultry. Labeling requirements
disease because they cannot tolerate gluten. Celiac disease for meat are in 9 CFR Part 317 and the rules for poultry are
is a chronic digestive disease that damages the small intes- in 9 CFR Part 381. While there are many similarities, label-
tine and interferes with absorption of nutrients from food. ing rules for meat and for poultry have some subtle differ-
Recent findings estimate that 2 million people in the U.S. ences. In this manual the regulatory citations are for meat
have celiac disease or about one in 133 people. regulations; usually there is a corresponding rule in poul-
FDA held a public meeting in August 2005 to obtain try regulations.
expert comment and consultation from stakeholders to FSIS has mandatory inspection provisions for the meat,
help FDA develop a regulation to define and permit the poultry and egg products it regulates, and inspected prod-
voluntary use on food labeling of the term “gluten-free”. ucts carry an inspection seal to this effect. FSIS requires
The transcript from this public meeting can be accessed HACCP to be in place at all meat and poultry processing
at: [Link] plants, and the Agency has noted that hazards that are
The meeting focused on food manufacturing, analytical reasonably likely to occur may include food allergens.
methods, and consumer issues related to reduced levels There is currently no requirement that egg products be
of gluten in food. produced under HACCP, although regulations are being
On January 23, 2007, FDA issued a proposed rule (72 developed.
FR 2795) to define the term “gluten-free” for voluntary In addition to mandatory inspection and HACCP provi-
use in the labeling of foods. FDA’s proposal is to define sions, FSIS requires prior approval for food labels. FSIS
“gluten free” to mean that the food does not contain any also has authority to inspect all labeling, formulation,
of the following: an ingredient that is any species of the and processing records for products under its jurisdiction.
grains wheat, rye, barley, or a crossbred hybrid of these Complex labels, including labels with nutrition labeling,
grains (all noted grains are collectively referred to as or labels bearing any type of claim, must be approved by
“prohibited grains”); an ingredient that is derived from FSIS prior to use. A food company may execute some
a prohibited grain and that has not been processed to types of label changes without seeking subsequent label
remove gluten (e.g., wheat flour); an ingredient that is approval from FSIS. This “generic approval” permission
derived from a prohibited grain and that has been covers label modifications such as net weight declarations,
processed to remove gluten (e.g., wheat starch), if the use name and address changes, addition or removal of promo-
of that ingredient results in the presence of 20 parts per tional offers, coupons, or recipes on labels, changes to
million (ppm) or more gluten in the food; or 20 ppm or vignettes, certain adjustments to nutrition labeling, and
more gluten. FDA also proposed to deem misbranded a quantitative changes to ingredients in the formulation that
food bearing a gluten-free claim in its labeling if the food result in no alteration of order of prominence require-
is inherently free of gluten and if the claim does not refer ments (9 CFR 317.5).
to all foods of that same type (e.g., “milk, a gluten-free FSIS requires that the food label bear a statement of
food” or “all milk is gluten-free”). Additionally, a food identity that represents the true nature of the food. FSIS
made from oats that bears a gluten-free claim in its label- has many more product definitions than FDA, including
ing would be deemed misbranded if the claim suggests food product standards set through policy rather than
that all such foods are gluten-free or if 20 ppm or more through regulations. FSIS standards largely determine the
gluten is present in the food. names under which a product may be marketed. If a meat
or poultry product conforms to a standard in regulations
or a policy standard, the product must be named accord-
ing to that standard. If the product does not conform to
the standard, it may not use the standardized name and

47
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

may not be confusingly similar (9 CFR 317.2(c)(1)). If the than nutritional, and from which no portion of any
product is fabricated from two or more ingredients, FSIS volatile oil or other flavoring principle has been removed.”
rules mandate that it must include on its label the word Spices recognized by FSIS include the substances listed as
“ingredients” followed by a list of the ingredients, in spices in FDA’s GRAS and GRAS affirmation regulations.
descending order of predominance by weight (9 CFR While FSIS does not consider onions, garlic, and celery
317.2(c)(2)). All egg products must be labeled with the to be spices, they may be considered “flavoring.”
common or usual name and (if the product is comprised FSIS policy notes that reaction or process flavors must
of two or more ingredients) the ingredients listed in the maintain the identity of the animal or plant sources of the
order of descending proportions. There are a number of proteins in the reaction flavor. Consequently, the ingredi-
parallels between FSIS ingredient labeling rules and FDA ent declaration must note the proteins of animal source
regulations, but there are also a number of differences. and plant-based food allergens.
One key difference is that there are fewer ingredient label- Some voluntary label information is permitted by FSIS,
ing exemptions in FSIS regulations. FSIS has no provisions subject to prior label approval, provided it is truthful and
in regulations for an “incidental additives” labeling not misleading. Because of the label approval process,
exemption. Any such exemptions are established case-by- FSIS may be more restrictive in the types of voluntary
case by FSIS. The Agency also requires that proteinaceous labeling it will authorize, but the agency encourages label-
ingredients always be declared. Rework is permitted, but ing that provides health information to consumers. FSIS
must be strictly limited to “like-into-like” rework, and all has expressed support for certain types of label statements
ingredients and sub-ingredients must be labeled. that advise food allergic consumers in plain language that
FALCPA’s requirements apply only to those foods regu- food allergens are present. For example, FSIS has approved
lated by the FDA under FFDCA and do not apply to FSIS. label statements such as “Contains: milk, wheat gluten,
However, there is an indirect impact due to the presence soy” following an ingredient declaration, and has author-
of allergens in meat and poultry product ingredients. ized informative statements such as “whey (from milk)”
FSIS considers ingredients that are potential sources of within an ingredient list, to clarify that the source of an
food sensitivities, including food allergies and intoler- ingredient is a food allergen. All label statements advising
ances, to be of public health concern. FSIS issued Notice about food allergens are subject to prior label approval,
45-05 in July 2005 because they recognized that there had and they would be evaluated case-by-case.
been a number of product recalls due to the non-declara- In limited situations, FSIS will consider approving
tion of ingredients of public health concern. FSIS issued informative label statements that advise consumers that
Notice 72-05 in November 2005 in response to questions a product’s manufacturing environment may introduce
arising from the issuance of FSIS Notice 45-05. Along with unintended allergens into foods. FSIS may consider
this Notice was a question and answer document which approving statements such as “Produced in a plant that
helps answer many of the questions about “ingredients of uses peanuts” or “may contain milk.” FSIS would not
public health concern.” This document can be accessed at approve such label statements if the agency believes they
[Link] would be used in place of good manufacturing practices
FAQs_for_Notice_45-05/[Link]. or effective sanitation standard operating procedures
FSIS Notice 45-05 describes certain food ingredients (SSOPs). The FSIS policy on these informative label
that have been associated with adverse reactions, such as statements is that they may only be used in cases where
food allergies and intolerances. This list includes the same establishments show that adequate SSOPS cannot effec-
list of eight major food allergens as listed under FALCPA- tively eliminate allergen cross contact. Requests to FSIS for
wheat, Crustacea (e.g., shrimp, crab, lobster), eggs, fish, consideration of these label features must be submitted to
peanuts, milk, tree nuts (e.g., almonds, pecans, walnuts), the agency as a policy inquiry, and not as label approval
and soybeans. Also listed are other potential causes of submissions.
adverse reactions in sensitive individuals: Ingredients, The FSIS guidance on voluntary allergen labeling state-
such as monosodium glutamate (MSG), sulfites, lactose, ments may be viewed at: [Link]
and Yellow 5 (tartrazine). FSIS currently permits and Regulations_&_Policies/Labeling_Allergens/[Link].
encourages the same type of “plain English” labeling as
provided for in the FALCPA for meat, poultry, and egg
products under the jurisdiction of FSIS.
There also are special FSIS labeling rules for flavoring
components, which may be identified on the label as
“spice,” “natural flavor,” “natural flavoring,” “flavor,” and
“flavoring.” FSIS recognizes that spice “means any aro-
matic vegetable substance in the whole, broken, or ground
form, whose primary function in food is seasoning rather

48
 CHAPTER 4: LABELING AND PACKAGING

Major Food Allergen Labeling Treasury published frequently asked questions concerning
for Wines, Distilled Spirits major food allergen labeling for wine, distilled spirits and
malt beverages. The questions and answers can be
and Malt Beverages accessed on-line at:
[Link]
The labeling of major food allergens for wines, distilled
spirits, and malt beverages, enforced by the Alcohol and
Tobacco Tax and Trade Bureau (TTB) is not covered in this International Allergen
manual. However, we have provided the information on
the interim rule issued by TTB.
Labeling Requirements
On July 25, 2006 (71 FR 42260), TTB issued an interim Allergens are a public health issue worldwide. Allergen
rule that parallels the recent amendments to the Federal labeling is important in order to assist food allergic con-
Food, Drug and Cosmetic Act contained in FALCPA. This sumers to identify more easily when a packaged food was
interim rule allows for the voluntary labeling of major made using an ingredient that contains a food allergen in
food allergens on the labels of wines, distilled spirits, and order to avoid consuming it. The U.S. abides by the label-
malt beverages. The interim rule adopts labeling standards ing requirements set forth by FALCPA. However, in other
for major food allergens used in the production of alcohol nations and regions, labeling requirements, as well as
beverages subject to the labeling requirements of the what is considered a food allergen, are different from the
Federal Alcohol Administration Act. The TTB also issued U.S. The chart below lists what should be labeled under
a notice of proposed rulemaking (71 FR 42329) that pro- mandatory food allergen labeling in several countries
poses to make major food allergen labeling mandatory. around the world and recommendations by Codex
On March 21, 2007 the TTB–U.S. Department of Alimentarius.

Mandatory Food Allergen Labeling

Australia & Hong
U.S. Canada EU New Zealand Japan Korea Kong Codex

Wheat/Gluten X X X X X X X X

Egg X X X X X X X X

Milk X X X X X X X X

Peanut X X X X X X X X

Crustaceans X X X X crab X X

Fish X X X X mackerel X X

Soy X X X X X X X

Tree nuts X X X X X X

Sesame X X X

Sulfite >10 ppm * X X X X X

Celery X

Mustard X

Buckwheat X X

Others lupin
(lupine) pork

peach

tomato
* While sulfites are not allergens, when present in quantities greater than 10 ppm they are required to be declared on labels as designated in this table.

49
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

International Allergen Advisory Labeling

Labeling Websites for Food Allergens
More detailed information on allergen labeling for a In addition to the required label elements of identity
specific country can be accessed at the following websites. statements and ingredient declarations, many food proces-
sors communicate information about the presence and
USA:
potential presence of food allergens through advisory
[Link]
labeling. This advisory labeling takes two general forms,
Australia–New Zealand: “may contain”-type statements and special package
[Link] statements.
[Link]
Canada: “May Contain”-Type Labeling
[Link]
In some circumstances, food processors may elect to
allerg/[Link]
use advisory statements that a food “may contain” a food
Codex Alimentarius: allergen in order to connote risk, and to advise the food-
[Link] allergic consumer to avoid eating the food. For this reason,
fs_management/No_03_allergy_June06_en.pdf allergen advisory statements must be clear and used judi-
ciously so as not to restrict food choices unnecessarily for
EU:
food-allergic consumers, and to prevent the consumer
[Link]
from ignoring the advisory statements.
[Link]?uri=CELEX:32003L0089:EN:HTML
FALCPA does not address the use of advisory or “may
Hong Kong: contain [allergen]” statements describing the potential
[Link] presence of unintentional ingredients in food products
food_leg_lgfa.html resulting from the food manufacturing process. Some food
processors, on a voluntary basis, advise food allergic con-
Japan:
sumers regarding the potential presence of food allergens.
[Link]
FDA Guidance states, and the food industry recognizes,
allergies/[Link]
that advisory labeling such as “may contain [allergen]”
Korea: should not be used as a substitute for adherence to cur-
[Link] rent good manufacturing practices (GMPs) and should be
considered only after rigorous food allergen controls are
in place. Any advisory statements such as “may contain
[allergen]” must be truthful and not misleading.
Guidelines and In 2002, FSIS issued a policy statement that altered its
long-held position that it would not approve labels that
Recommendations include “may contain” allergen statements. In its new
policy, FSIS clarified that it would consider approving
Food Allergy Issues Alliance informative label statements that advise consumers that
a product’s manufacturing environment may introduce
Food Allergen Labeling Guidelines unintended allergens into foods. For greater detail, see the
The Food Allergy Issues Alliance (FAIA) is a group of previous section of this chapter titled “Labeling of USDA
food trade associations and other interested organizations FSIS-regulated foods”
that convene to discuss issues related to food allergies. If a food processor is contemplating the use of a “may
Their Food Allergen Labeling Guidelines were issued in contain”-type label statement for food allergens, the
May 2001, with support from GMA and 17 other food, processor should assess its existing operational practices
health, and consumer organizations, and one academic and evaluate the hazard that a food allergen may come
research advisor. Most of these recommendations were into contact with a food where its presence is not intend-
adapted into FALCPA requirements. ed. It is recommended that the food processor conduct
this evaluation to ensure appropriate use of the food aller-
gen advisory statement. The evaluation should incorporate
a review of all the applicable techniques of food allergen
management, detailed elsewhere in this manual, that are
used or could be used in the food plant environment. As
part of the assessment, the food processors should deter-

50
 CHAPTER 4: LABELING AND PACKAGING

mine, through visual examination, product testing, or ed are helpful to their decision making process are:
other means, including prior history of the product, ■ May contain [allergen]
whether the food allergen is likely to be present in some
■ Processed on equipment that also processes
or all of the food products that are not intended to include
[allergen]
allergenic ingredients. It is recommended that food proces-
sors undertake any reasonable and feasible changes to Food-allergic consumers have reported that they find
operations after conducting the assessment and before less helpful statements such as “Processed in a plant that
deciding to use “may contain”-type labeling. also processes [allergen],” since this does not clearly
The evaluation components listed above are from describe the potential that the unintended food allergen
FAIA’s Food Allergen Labeling Guidelines. For a full may be present. Statements such as “may contain tree
text regarding FAIA’s “Advisory Labeling of Major Food nuts” are often seen as too broad to be helpful to con-
Allergens” please see [Link] sumers that may be allergic to one or several, but not
news/docs/[Link]?docid=816. After having all, of the foods in a class of foods. Label statements such
completed this evaluation, a food processor or ingredient as “may contain traces of [allergen]” or “may contain an
manufacturer may appropriately decide that “may con- occasional [allergen]” are considered inappropriate as they
tain”-type labeling is necessary, but this should be used focus on quantitative issues that food allergic consumers
only when all four of the following criteria are met: find difficult to evaluate.
1. A food allergen is present in the food plant and con-
stitutes a risk of presence in food products that are Special Package Statements
not intended to include the allergen as an ingredient;
Many food processors, on a voluntary basis, supple-
2. The risk of presence of the food allergen in food ment the ingredient declaration with additional food label
products that are not intended to include the allergen statements that advise food-allergic consumers of the pres-
cannot reasonably and feasibly be minimized with- ence of food allergens. These label statements function to
out major revisions to manufacturing processes or alert the food-allergic consumer that food allergens are
equipment above and beyond GMPs; present, and often direct the consumer to the ingredient
list for further details. Some statements are placed on the
3. The food allergen is likely to be present in some, but
principal display panel to describe the overall product,
not all, of the food product where its presence is not
such as “Now formulated with soy protein” or “Made with
intended; and
walnuts and pecans.” Other statements appear at the flap
4. Consuming the food allergen in a product where its where a box or other package is opened, often stating
presence is not intended would constitute a health information such as “food-allergic consumers, see ingredi-
hazard to a consumer allergic to the allergen. ent list” or “food-allergic consumers, contains wheat
ingredients.”
If some, but not all, of these four criteria are met, food Food processors should strive to provide consistent
and ingredient manufacturers should consider additional food allergen labeling on a specific food product, even if
food allergen control and/or labeling strategies other than it is produced in different locations or in different package
allergen advisory statements. For example, if the unintend- sizes, or if the labeling is otherwise revised. Such label
ed food allergen is always present in the product, it would consistency would be useful to food-allergic consumers.
be appropriate to declare the allergenic ingredient in the
ingredient list, and it may be appropriate to reevaluate
production scheduling and sanitation techniques.
When all four criteria are satisfied, an allergen advisory Information Resources
statement should be placed conspicuously at the end of,
or in close proximity to, the ingredient declaration. FDA maintains a significant information resource
When using an ingredient that utilizes an allergen ad- on food allergy regulatory issues on its web site at
visory statement, the food processor should consider the [Link]
four criteria when deciding whether to carry that allergen USDA FSIS also provides substantial information
advisory statement forward to the label of its food or use on its labeling policies, including those for allergens,
an alternate statement. at [Link]
Allergen advisory statements should be as accurate and labeling_&_consumer_protection/[Link].
conspicuous as possible to help food allergic consumers Many of the above labeling requirements and the
make a clear decision about whether or not the food is regulation thereof are described in detail in Chapter 5. ■
appropriate for them to eat. Some examples of “may con-
tain”-type labeling that food allergic consumers have stat-

51
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

52
 CHAPTER 5: REGULATORY ISSUES RELATED TO FOOD ALLERGENS

Chapter 5

REGULATORY ISSUES RELATED TO

FOOD ALLERGENS
Christie Gray / Regina Hildwine / Robert Earl, MPH, RD

Introduction detecting them in foods; and maintain surveillance over

foods through plant inspections, laboratory analyses, and
As a part of its routine regulatory functions, FDA enforcement actions when necessary.
inspects a variety of packaged foods to ensure that manu- Section 402 of the FFDCA addresses food adulteration
facturers are properly labeling for major food allergens issues, noting that a food is adulterated if, among other
under the Food Allergen Labeling and Consumer Pro- criteria, it “bears or contains any poisonous or deleterious
tection Act (FALCPA). A food product that contains an substance which may render it injurious to health.” Food
undeclared major food allergen may be subject to recall. products that are prepared, packed, or held under insani-
In addition, a food product that is not properly labeled tary conditions whereby they may have become contami-
according to FALCPA may be misbranded and subject to nated with filth or rendered injurious to health are also
seizure and removal from the market place. For a detailed deemed to be adulterated. Thus, foods that are produced
discussion of FALCPA, see Chapter 4. without good controls against food allergen cross contact
FALCPA’s requirements apply to all packaged foods sold may be considered adulterated.
in the United States that are regulated under the Federal Section 403 of the FFDCA itemizes the circumstances
Food, Drug, & Cosmetic Act (FFDCA), including both under which food will be considered misbranded and
domestically manufactured and imported foods. FDA thus subject to enforcement action. Misbranding relates
regulates all foods except meat products, poultry, and to information included in, or omitted from, the “label”
processed egg products, which are regulated by the Food or “labeling” of food products. Misbranding covers man-
Safety and Inspection Service (FSIS) of the U.S. Depart- datory food labeling requirements, standardized foods,
ment of Agriculture (USDA). imitation foods, special dietary foods, prohibition of false
Although specific allergen labeling regulations have not or misleading claims, and deceptive packaging. Food prod-
been promulgated for FSIS-regulated foods, accurate and ucts with undeclared allergens would be deemed to be
complete ingredient labeling of FSIS regulated products misbranded.
is important to prevent a recall because of an undeclared Section 403 of the FFDCA has been amended to include
allergen. the new labeling requirements of FALCPA

Food Product
FDA Enforcement Approaches
Public Health Basis of There is a wide range of enforcement tools available to
FDA for situations where a violation of laws or regulations
FDA’s Regulatory Approach has occurred. These range from warning letters to
seizures.
Under the FFDCA, FDA has a central assignment—to FDA generates warning letters to individual companies
assure that the products it regulates are safe and truthfully detailing purported violations of laws and regulations that
labeled. The Agency has the authority to set food stan- FDA has observed, often in the course of a food plant
dards, including labeling rules; evaluate food packaging inspection. Companies that receive a warning letter from
for potential health hazards; conduct research to reduce FDA have a specified time period in which to respond to
food-borne disease, to determine specific health impacts of the Agency and present plans for remedying the violative
hazardous substances in food and to develop methods for situation. As warning letters are a matter of public record,

53
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

FDA believes that a warning letter to one firm will be reaction, but that violate FDA labeling or manufacturing
instructive to all other firms that may need to modify regulations. Although sulfites are not considered a major
their procedures and practices accordingly. food allergen in the United States, they can cause harmful
Product recalls govern situations when a company reactions in people who are sensitive to sulfites.
recovers products that have been introduced into the Undeclared sulfites may result in a Class I, Class II, or
marketplace (interstate commerce). Recalls typically result Class III recall, depending on the sulfite level present in
when a product violates the law or regulations, and the the food.
use of the product presents a danger to health or signifi-
cant consumer deception and immediate action is neces-
sary. The manufacturer or distributor of the product vol-
Allergens and FDA HACCP
untarily initiates most recalls of FDA-regulated products. FDA requires in the HACCP regulations for juice prod-
In other instances, FDA informs a company of findings ucts (21 CFR 120) that allergens be considered in the haz-
that one of its products is defective and suggests or ard analysis. Manufacturers are required to evaluate the
requests a recall. In virtually all cases, the company likelihood of occurrence of undeclared allergens in juice
will comply. products and processes, because of either an added ingre-
If the firm does not recall the product, then FDA may dient or inadvertent addition due to cross contact, and
seek legal action under the FFDCA. Legal actions may establish appropriate controls in their HACCP plans for
include seizure of available product, administrative deten- those allergens that are reasonably likely to occur. FDA is
tion of a product, and/or injunction against the firm, particularly concerned about undeclared allergens in
including a request for recall of a product issued by the juices packaged on the same lines as dairy products. FDA
court. In most cases, however, the mere threat that FDA has outlined its expectations for allergen control in Juice
will issue a press release stating that a firm has refused HACCP Hazards and Controls Guidance (1st edition, 2004,
to recall a product that it has determined to be unsafe or available at [Link]
otherwise illegal is sufficient to convince the firm to agree ~dms/[Link]). FDA expects similar hazard analy-
to recall the product. sis and appropriate controls in seafood HACCP programs.
FDA has outlined its expectations for allergen control in
the Fish and Fisheries Products Hazards and Controls
FDA Food Allergen Recalls Guidance (3rd edition, 2001, available at http://
Situations where the presence of major food allergens [Link]/~comm/[Link]), and a greater
are not declared on food labels would necessitate a food emphasis on allergen control is expected when FDA pub-
product recall. Because of the need for speedy removal of lishes the 4th edition of the seafood HACCP guidance.
a product from the market, which otherwise could cause
serious harm or death to the vulnerable allergic con-
sumers, FDA will encourage a firm to undertake a volun-
Allergens and FDA’s
tary recall in the case of allergens that are not declared on Reportable Food Registry
a product’s label.
During Fiscal Year (FY) 1999 to FY 2004, there were Section 417 (Reportable Food Registry) of the FFDCA
462 recalls of FDA-regulated products due to the presence requires that the responsible party submit a report to FDA
of undeclared allergens in a food. In terms of food product within 24 hours if the firm finds or discovers a situation in
categories, bakery products, ice cream products, and fish- which there is a reasonable probability that the use of, or
ery products represented the three largest groups of prod- exposure to, food or feed produced or manufactured,
ucts recalled. Egg, milk, peanut, and tree nut ingredients processed, packed, or held in that establishment will
were the four major food allergens most frequently associ- cause serious adverse health consequences or death to
ated with recalls. The increase is is a result of enhanced humans or animals (reportable food). The person who
concerns related to food allergens, and the availability of registered the facility with FDA as required under FFDCA
more accurate and faster methods to evaluate and test section 415(a) is defined as the “responsible party” who
food products for allergens. must submit this information.
FDA classifies recalls involving food with undeclared The responsible party is not required to submit a report
major food allergens as Class I recalls. This classification if the requirements of Sec 417(d)(2) are met. These
level reflects the fact that undeclared food allergens have requirements include:
caused or may cause serious health problems or death.
1. the adulteration originated with the responsible
Class II recalls are issued for food products that might
party;
cause a temporary health problem, or pose only a slight
threat of a serious nature. Class III recalls are for food
products that are unlikely to cause any adverse health

54
 CHAPTER 5: REGULATORY ISSUES RELATED TO FOOD ALLERGENS

2. the responsible party detected the adulteration prior The FDA CPG, “Statement of Policy for Labeling and
to any transfer to another person of such article of Preventing Cross-contact of Common Food Allergens,”
food; and can be accessed at [Link]
OHRMS/DOCKETS/98fr/[Link].
3. the responsible party:
a) corrected such adulteration; or
b) destroyed or caused the destruction of such article FDA 2001 Inspection Guidance
of food
on Food Allergens
Food containing an undeclared allergen would be
considered a reportable food. In August 2001, the FDA finalized, “Guidance on
Inspections of Firms Producing Food Products Susceptible
to Contamination with Allergenic Ingredients,” as refer-
FDA 1996 Letter ence material for investigators and other FDA personnel.
to Food Manufacturers This guidance covers the following problem areas:
1. Products that contain one or more allergenic ingredi-
In 1996, FDA’s CFSAN published a “notice to manufac-
ents, but the label does not declare the ingredient in
turers” letter regarding the label declaration of food aller-
the ingredient statement;
gens. The letter reiterated the legal and regulatory require-
ments for labeling of food allergens and use of Good 2. Products that become contaminated with an aller-
Manufacturing Practices (GMPs) in food production. genic ingredient due to the firm’s failure to exercise
The agency noted that some manufacturers voluntarily adequate control procedures, such as improper
labeled their products with statements such as “May rework practices, allergen carry-over due to use of
contain (allergen).” FDA advised that such precautionary common equipment and production sequencing,
labeling should not be used in lieu of adherence to GMPs, inadequate cleaning;
because adhering to GMPs is essential for effective reduc-
3. Products that are contaminated with an allergenic
tion of adverse reactions. The agency urged manufacturers
ingredient due to the nature of the product or the
to take all steps necessary to eliminate cross contact and
process; e.g., use of common equipment in chocolate
to ensure the absence of the identified allergen.
manufacturing where interim wet cleaning is not
The June 1996 FDA letter to manufacturers
practical and only dry cleaning and product flushing
can be accessed at:
is used;
[Link]
4. A product containing a flavor ingredient that has an
allergenic component, but the label of the product
FDA 2001 Compliance Policy Guide only declares the flavor, such as natural flavor. Under
on Labeling of Food Allergens current regulations, firms are not required to declare
the individual components of flavors, certain colors,
In May 2001, FDA issued a Compliance Policy Guide and spices. However, firms are encouraged to specifi-
(CPG) on food allergens, “Statement of Policy for Labeling cally label allergenic components/ingredients that are
and Preventing Cross-contact of Common Food Allergens.” in spices, flavors, and colors;
The CPG on food allergens provided guidance to the
5. Products that contain a processing aid that has an
Agency’s compliance staff, field investigators, and the
allergenic component, but the label does not declare
regulated industry on actions (declaration of misbranding
it. Processing aids that contain allergenic ingredients
or adulteration) the Agency might have taken under the
are not exempt from ingredient declaration under
FFDCA and regulations based on the Act. Much of the
the incidental additives regulation (21 CFR
CPG has since been mandated by the enactment of
101.100(a)(3)), and therefore, must be declared.
FALCPA. Further, the CPG stated that the exemption from
ingredient labeling found at 21 CFR 101.100(a)(3) for inci-
dental additives does not apply to ingredients that contain
allergenic protein.
The CPG outlined circumstances where allergens could
be unintentionally added to a food such as the use of
rework, product carry-over, or the presence of an aller-
genic product above exposed product lines. The CPG indi-
cated that such practices may render a product injurious
to health or adulterated under FFDCA section 402(1)(4).

55
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

The FDA inspection guidance outlines determinations In 2006, nine of 34 FSIS-related recalls were for unde-
inspectors should make with additional guidance from clared food allergens, of which six were Class I, and three
the FDA CFSAN Office of Field Programs. Specific areas were Class II. In 2007, 12 of 57 FSIS-related recalls were
mentioned include: for undeclared allergens (9) or mislabeling (3). Eight of
■ Product development these were Class I and four were Class II. In 2008, seven
of 53 FSIS-related recalls were for undeclared allergens.
■ Receiving
Three of these were Class I recalls and four were Class II.
■ Equipment FSIS currently encourages, but does not require,
■ Processing FALCPA-compliant labeling. USDA, at the present time, has
■ Final product testing no requirement for the plain-language major food allergen
labeling mandated by FALCPA (e.g., “milk” as opposed
■ Labeling
to “whey” or “casein”). FSIS also pre-approves all product
■ Establishment Inspection Reports (EIR) labels. For a general discussion of USDA FSIS’s approach
The FDA Inspection Guidance, “Guidance on to allergen labeling please see “Labeling of USDA FSIS-
Inspections of Firms Producing Food Products Susceptible regulated foods” located in Chapter 4. ■
to Contamination with Allergenic Ingredients,” can be
accessed at [Link]
98fr/[Link].

USDA FSIS
FSIS Food Product Enforcement
Under the Meat Inspection Act, the Poultry Products
Inspection Act, and the Egg Products Inspection Act, FSIS
has mandatory inspection authority for meat, poultry, and
most egg products. FSIS requires HACCP programs to be
in place (9 CFR 417) at all meat and poultry processing
plants. The Agency has noted that hazards that are reason-
ably likely to occur may include food allergens. FSIS has
generally accepted the allergens noted in FALCPA to be
food safety concerns in HACCP plans.
FSIS has the legal authority to detain and/or seize
meat, poultry and egg products when there is reason to
believe they are hazardous to public health. However, in
most cases when meat, poultry or egg products are found
to be contaminated, adulterated, or misbranded, industry
will, either on its own accord or at the request of FSIS,
voluntarily recall the product in cooperation with federal
and state agencies.
In past years, FSIS recalls for undeclared food allergens
were relatively rare. In 2000, for example, only eight of 76
FSIS-related recalls cited “undeclared substances” as the
reason for the recall. Of these, one was a Class I recall,
four were Class II, and three were Class III. Some of the
undeclared substances were not major food allergens as
defined in FALCPA, but they were other undeclared ingre-
dients such as FD&C Yellow No. 5 or monosodium gluta-
mate, which FSIS includes in their list of “Ingredients of
Public Health Concern” (FSIS Notice 45-05). However,
FSIS recalls for undeclared food allergens appear to be
increasing in number. In 2002, 21 of 113 FSIS-related
recalls were conducted for undeclared food allergens.

56
 CHAPTER 6: ALLERGEN TESTING AND RESEARCH

Chapter 6

ALLERGEN TESTING AND RESEARCH

Jupiter Yeung, Ph.D.

Introduction In companies that use push-through procedures to

clean equipment during product changeovers, testing can
Until 1988, when Yunginger et al. reported an acciden- allow the company to determine exactly how much push-
tal death due to food-induced anaphylaxis, allergic reac- through product is necessary to achieve the level of clean-
tions to food were not considered a significant public liness necessary for an allergen-clean changeover. Testing
health risk. Subsequent reports of fatalities and illnesses can eliminate guesswork, and save product from going to
due to food allergies increased the awareness of both regu- waste or from having to be reworked.
lators and the industry that a small segment of the popula- Testing CIP solutions, final product, and certain equip-
tion could experience serious reactions to food allergens. ment after the sanitation procedures have been performed
With the increased attention to public health concerns may identify potential sources of cross contact, and also
due to allergic reactions to food, especially allergen-related validate effectiveness of cleaning during changeover.
recalls, and decreased consumer confidence in our food For further information on allergen-clean sanitation proce-
safety system, there was a need for quick and accurate dures, including verification and validation, see Chapter 3.
methods to detect allergens in food.
Prior to the current emphasis on immunochemical
methods for the detection of allergens, most of the detec-
tion methods used organoleptic techniques, such as sub- Detection of Allergens
jective sensory (smell and taste) tests, or chromatographic
fatty acid profile analyses. Unfortunately, these sensory ELISA
and chromatographic methods were neither specific to the
allergenic proteins, nor sensitive enough to test for aller- The acronym ELISA stands for enzyme-linked
gen residues. Methods currently used to test for allergens, immunosorbent assay. Immunochemical methods for the
including commercially available test kits, are primarily analysis of environmental contaminants are relatively new
based upon immunochemical procedures, although recent- in the analytical chemistry arena. These methods are
ly some DNA-based PCR kits have also been developed. based on the use of a specific antibody as a detector for
Recent development of mass spectrometry for qualitative the analyte of interest, such as a food allergen. Immuno-
confirmation of presumptive positives is promising, while assays are rapid, sensitive and selective, and are generally
its use as a quantitative tool remains challenging. cost effective. Immunoassays can be designed as rapid,
field-portable, semi-quantitative methods or as standard
quantitative laboratory procedures. They are well suited
Why Test for Food Allergens? for the analysis of large numbers of samples and often do
Food manufacturers protect those with food allergies by not require lengthy sample preparation.
having comprehensive programs in place to prevent cross ELISA tests are based on the use of an enzyme to
contact and clearly labeling their products with a detailed detect the binding of antigen (Ag) and antibody (Ab).
list of ingredients. Testing for the presence of food aller- The enzyme converts a colorless substrate (chromogen)
gens may verify that programs designed to prevent the to a colored product, indicating the presence of the Ag:Ab
unintended inclusion of an undeclared food allergen are in complex. In the food industry, ELISA tests usually are
fact effective. The inclusion of such an undeclared allergen used to detect antigens in a sample. There are two tech-
would most likely lead to a product recall. Product recalls niques for Ag measurement, the “sandwich technique”
can cost food companies millions of dollars, deflate con- and the “competitive inhibition technique.” Almost all
sumer confidence and damage the overall reputation of allergen ELISA test kits use the sandwich technique.
a brand.

57
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

Sandwich ELISA Ag coating on the wells. The second Ab-enzyme conjugate

Sandwich ELISA assays are sensitive tests that can will detect the bound Ag:Ab complex in the wells. A color-
detect and quantify the concentration of specific soluble less substrate of the enzyme is added. In this format, the
proteins. The basic sandwich ELISA method (Fig. 1) color produced is inversely proportional to concentration
employs highly purified, specific Abs (capture antibodies), of the analyte, e.g., the higher the color the lower the con-
which are adsorbed or “coated” onto plastic microwell centration of the protein.
plates. The immobilized Abs serve to specifically capture
their corresponding Ags, such as food allergens, present
in samples. After washing away unbound material, the
Lateral Flow Device Technology
captured Ags are detected using enzyme-conjugated Abs A promising approach in rapid food allergen detection
(detector antibodies). Following the addition of a chro- is the use of a lateral flow device, (LFD or dipstick) for-
mogenic substrate-containing solution, the level of colored mat, which is widely used in clinical chemistry, e.g. preg-
product generated by the bound, enzyme-linked antibod- nancy or glucose tests. Such tests are inexpensive, rapid
ies can be conveniently measured spectrophotometrically and can be done anywhere. They can be used on-site
using an ELISA-plate reader at an appropriate wavelength. rather than in the laboratory, hence permitting early detec-
While sandwich ELISA results are read against a standard tion of potential problems, such as ineffective cleaning
curve, the intensity of the color change is roughly propor- of equipment. Ab-based dipsticks for peanut, milk and
tional to the concentration of allergen in the sample, e.g., gluten are available. The lateral flow technology (Fig. 2)
the more intense the color change, the higher the amount uses antibodies labeled with gold nanoparticles, which are
of allergen in the sample. Commercial peanut test kits are inherently red in color. The end-point is determined by the
examples of sandwich ELISA. formation of a red sample line and a control line. Similar
LFD test kits for other allergens are being developed.
Competitive inhibition ELISA
The competitive inhibition ELISA (Fig. 1) is another
DNA Detection Methods
technique that can be used to detect an allergen in a sam- Polymerase chain reaction (PCR) techniques have been
ple. It is based on the principle that an Ag in the sample used widely to detect the presence of DNA in samples. In
will bind to an Ab and then compete for the binding of the recent applications, these techniques have been used to

FIGURE 1: Principles of ELISA and Competitive Inhibition ELISA

(Image by Malcolm O’Neill, Complex Carbohydrate Research Center and the University of Georgia ([Link]); used with permission.)

58
 CHAPTER 6: ALLERGEN TESTING AND RESEARCH

FIGURE 2: A typical lateral flow device

detect the adventitious presence of genetically modified Traditionally, standard PCR procedures are very labor
materials for corn, soybean, canola, cotton, rice and other intensive, and they are not very sensitive. The detection
economically important crops. PCR technology can be system for PCR is gel based, and ethidium bromide stain-
used to determine the presence of genetic material (stan- ing of the gel is not very quantitative. The recent develop-
dard PCR), or to quantify the percentage of target DNA ment of quantitative, real-time PCR uses fluorogenic
present in the test sample (quantitative, real-time PCR). probes in a closed tube format, and this technique has the
Since protein is translated from its genetic material, PCR advantages of essentially no carry over contamination and
techniques can be used to amplify the allergen DNA using greater sensitivity. Also, quantitative PCR, including data
specific DNA markers/primers and subsequently detecting analysis, is readily automated.
them via labeled, hybridized probes. These procedures A patent protects the PCR technique. For commercial
provide an alternative confirmatory test for positive ELISA use of this method in the area of in vitro diagnostics, users
results. However, it is important to note that the presence must obtain a license from Hoffmann-LaRoche, Basel,
of residual allergen DNA in a processed food does not Switzerland. In addition, the purchase of a PCR detection
guarantee the presence of the corresponding protein, and kit does not give the buyer or user the right to carry out
the DNA itself is not allergenic. PCR without a license.
Three major steps in a PCR technique are repeated for
30 or 40 cycles (Fig. 3). This is done on an automated
cycler, which can heat and cool the tubes with the reac-
tion mixture in a very short time. Commercial Allergen Test Kits
1. Denaturation: The double helix melts (opens) to
An allergen test kit is a packaged system of the key
yield single-stranded DNA, and all enzymatic
components for detecting or measuring a specific allergen
reactions stop.
in a food matrix within a laboratory or non-laboratory
2. Annealing: The polymerase attaches to the single- environment. The key components include standard cali-
stranded DNA and starts copying the template bases. brators, Ab-coated wells, Ab-enzyme conjugate, color sub-
strate, stopping solution, extraction buffer, and washing
3. Extension: Bases (complementary to the template)
buffer that may be readily prepared by the user of the kit.
are coupled to the primer on the 3´ side, i.e. a base is
Test kits include directions for use and are often self-con-
added complementary to each template base: A to T,
tained, complete analytical systems, but they also may
G to C, and vice versa.
require additional supplies and equipment.

59
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

FIGURE 3: Principle of PCR

Availability Issues with Commercial Kits

In the mid-1990s, commercial allergen kits came to the Detection of food allergens by ELISA is a unique biolog-
market offering laboratories the opportunity to analyze ical assay characterized by the recognition and binding of
peanut proteins in processed food products or in samples specific antibodies and antigens/allergens. Food allergens
taken from various places in a processing facility. are proteins of diverse structural and chemical properties
Most currently available allergen test kits are ELISA-based in a wide mixture of food matrices. From the analytical
methods, but PCR-type kits are starting to emerge. PCR point of view, the integrity of the protein structure is criti-
methods are more commonly used in genetically modified cal. However, most ELISA allergen test kits do not clearly
organism (GMO) testing. At the present time, there are define the target protein, which are typically a complex
eight allergen kit manufacturers (Table 1); in the near mixture of soluble allergenic and non-allergenic proteins.
future, we expect that more manufacturers will be pro- Meanwhile, most food products are heat treated, and food
ducing a wider range of allergen kits for use in the food processes such as roasting and extrusion can significantly
industry. influence the availability of certain proteins, e.g., heat pro-
motes protein aggregation and thus reduces its solubility,
Contacts and Distributors: and affinity to antibodies. For these reasons, the proteins
in the sample extract might not be fully comparable to
Neogen Corporation
that of the calibration standards.
[Link] Ph: 800-234-5333
Other than the PCR kits, all eight commercial kit manu-
r-Biopharm facturers use the same ELISA technology for the detection
[Link] Ph: 877-789-3033 of food allergens; hence, they all share the same pitfalls.
Using peanut as an example, one manufacturer claims a
Morinaga from Crystal Chem
detection limit of 0.5 ppm peanut proteins while the other
[Link] Ph: 630-889-9003
three claim detection limits ranging from 1–5.0 ppm
Hallmark and Diffchamb from ELISA Technologies peanuts. It should be emphasized that these reporting
[Link] Ph: 904-462-4546 units are not equivalent. Peanut seeds contain about 25%
peanut proteins. Accuracy of detection limits is further
ELISA Systems
complicated by the fact that the nature of the peanuts, raw
[Link] Ph: 734-268-6062
or roasted, remains uncertain. Similarly, the reporting
Tepnel Life Sciences units used in kits for the determination of milk vary. For
[Link] Ph: 44 (0)1244 280202 example, Neogen reports results as ppm milk (powder or
liquid milk?), and Morinaga expresses results as ppm milk
protein (total protein or soluble protein?). While Tepnel
reports results in ppm casein or ppm β-lactoglobulin

60
 CHAPTER 6: ALLERGEN TESTING AND RESEARCH

Table 1: Commercially available kits for food allergen (April 2008)

Neogen Tepnel ELISA

Corporation r-Biopharm Life Sciences Systems Hallmark Diffchamb Morinaga

ELISA Peanut Peanut Almond Almond Wheat Gluten Peanut

Total Milk BLG* Peanut BLG* Lupin Prolamins Egg
Casein Egg Casein Crustacea Casein
Egg Hazelnut BLG Buckwheat BLG
Almond Almond Egg Casein Wheat
Hazelnut Wheat/Gliadin Soy Egg
Gliadin/Gluten Wheat/Gluten Hazelnut
Soy Sesame Peanut
Shellfish Mustard
Walnut Sesame
Hazelnut Soy
Gliadin
Gluten

Dipstick Peanut Peanut Almond Wheat

Milk Gluten Peanut
Hazelnut Gluten
Casein
Hazelnut
Egg
Shellfish

PCR Peanut Peanut

Gliadin Milk
Hazelnut Soy
Almond
Soy
Walnut
Celery
Mustard
Sesame
Fish

*BLG, β-lactoglobulin

(BLG), they provide a conversion factor to calculate ppm parties. Even though the NIST peanut butter reference
milk powder. R-Biopharm also provides a conversion fac- materials may not be the best reference for peanut test
tor to convert ppm BLG to ppm total milk protein. Clearly, kits, its adoption in the AOAC collaborative study for
without a harmonized reporting unit for milk, and other peanut has proved to be fruitful. Now the peanut kits from
food allergens, there is a tendency to compare just the different manufacturers that obtained AOAC Performance
numbers (x ppm) without the consideration of the units Tested Method status yield essentially the same results
(x ppm milk powder, or x ppm BLG). from a homogeneous sample. Unfortunately, harmonized
Lack of standard reference materials is the principal reference material is not available for wheat or gluten.
obstacle for food allergen detection methodology. Without Data obtained by GMA from six commercial gluten test
standard reference materials from recognized bodies, such kits gave very divergent results for the same homogeneous
as the Institute for Reference Materials and Measurements samples, thus creating confusion for the food industry and
in the EU, or the National Institute of Standards and regulatory agencies. In order to resolve questions regard-
Technology (NIST) in the U.S., kit manufacturers will con- ing commercial test kit methods, reference standards must
tinue to use their own standards which may or may not be available globally from a recognized body, and a collab-
be characterized or commercially available to all interested orative study must be performed to validate the reliability

61
MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

and validity of the method. Without the reference stan- tional speed. Rapid methods usually do not require a labo-
dard, other issues such as false positives, false negatives, ratory and results can be obtained on site. This type of
sensitivity, matrix interference and recovery cannot be procedure may be vital for allergen screening at remote
adequately assessed. sites, such as food processing plants. The results from
To date, the AOAC Research Institute (AOACRI) has rapid tests can be displayed immediately and also archived
granted Performance Tested Methods status to three for documentation. Such tools can be of great benefit to
peanut test kits from 3 participating manufacturers the food processor, enabling management decisions to be
(Tepnel, Neogen, and r-Biopharm, made early in the production cycle.
[Link]
and more recently to a gliadin test kit from r-Biopharm.
The Performance Tested Methods Program offered by
Dipstick
AOAC RI provides an independent third-party review of See Lateral Flow Device Technology under the
test kit performance claims. Test kits found to be in con- Detection of Allergens section.
formance with their claims are granted Performance
Tested Methods status.
One of the difficulties facing the manufacturers of aller-
Biosensors
gen test kits is the extent of assay validation necessary. Biosensors offer the possibility of in-line detection of
The intended use of a test kit is usually not defined for allergens. These devices provide near real-time data and
specific matrices, but rather is given in general terms such require only minimal technical training to operate.
as “to detect peanuts in foods.” However, the potential Biosensors are based on the coupling of two components:
uses of kits by the food industry, regulatory agencies and a sensor chip, a bioactive receptor such as an Ab that cap-
research community are extensive, and the kits may be tures the analyte of interest, and a transducer that con-
used for tests associated with a variety of complex food verts the biochemical recognition step into a quantifiable
matrices. This makes full validation that covers all possi- optical signal. For example, surface plasmon resonance
ble applications virtually impossible. In instances when a (SPR) biosensors use a direct sensing technique that can
defined market need is known, then specific support stud- detect refractive index changes that occur in the vicinity
ies can be performed, e.g., validation studies on the detec- of a thin metal film surface where Ab complexes with Ag.
tion of peanuts in chocolate. Otherwise, the responsibility The change in refractive index is proportional to the con-
for validating the kit in a specific food matrix is left to the centration of the analyte under investigation, and is con-
investigator. Furthermore, even if the kit was properly vali- tinuously monitored (Fig 4). For this type of assay, the
dated for the intended purpose, end users should still do whole process takes less than 5 minutes. The SPR-based
their own in-house evaluation of the limit of detection biosensor has been successfully used for the determina-
(LOD), limit of quantification (LOQ), precision, and tion of proteins, mycotoxins, drug residues, pesticides, and
ruggedness, since proficiency of the analysts may vary proteins, including peanut allergen. It should be possible
widely. to use SPR technology for the detection of all food aller-
For details regarding potential uses and interpretation gens since they are all proteins.
of results from allergen test kits see Chapters 2 and 3.

Rapid Methods
FIGURE 4: Principles of SPR biosensor
and New Technologies (Image courtesy of Prof. P. Somasundaran of Columbia University.)

Automation and rapid methods are dynamic areas of

interest for the detection of allergens in foods, both in the
laboratory environment and in food processing plants.
Assays can be automated to reduce hands-on manipula-
tions in conventional tests, speed up analyses, and reduce
human errors. The difficulty in adapting test kits for use in
food plants is to enable the assays to be conducted quickly
and accurately under operational conditions and with non-
technical staff. Nevertheless, several rapid methods have
been developed that can be used to analyze allergens with
accuracy, simplicity of operation and acceptable opera-

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 CHAPTER 6: ALLERGEN TESTING AND RESEARCH

Mass Spectrometry genicity of novel proteins. Current animal models under

A correct identification of allergenic proteins can be development are rodent, swine, and dog. Each model pres-
achieved by using methods with a very high specificity. ents opportunities for a fuller understanding of the allergic
This is possible by using mass spectrometry (MS). A com- response, yet, such experiments have not led to the devel-
bination of liquid chromatography with MS detection can opment of relevant biological models that can be extrapo-
provide an unambiguous identification of proteins or pep- lated to humans. Further research is needed on the devel-
tides originating from a food product or commodity. This opment of animal models to assess their predictive
type of method has recently been employed successfully accuracy.
for the detection of peanut and milk allergens in food
matrices. Despite the need for costly and specialized
equipment, MS-based methods provide high specificity
Novel Proteins and GMO
and the advantage of detecting multiple, unrelated food All foods are potential sources of allergens for certain
allergens in a single analysis. For example, in an oat flour sensitive individuals. Although the risk of an allergic reac-
sample, oat, wheat gliadin, and soy peptides were detect- tion to food is very low, questions are being asked about
ed in a single MS/MS analysis. whether novel proteins derived from biotechnology are
likely to cause food allergies similar to foods from conven-
tionally bred crops and animals. At the present time, there
are no scientific data to support that genetically modified
Allergen Research crops or novel proteins can induce an allergic reaction.
Scientists and medical experts have developed a deci-
Threshold Levels sion tree procedure for testing such products; this proce-
dure was formalized and published by Metcalfe et al.
There have been many clinical reports of extreme sensi- (1996). Since then, the decision tree process has been
tivity to low doses of food allergens. Many factors may accepted and used by industry and the regulatory
affect the threshold level in an individual exposed to an agencies. The same decision tree was adopted by the
allergen during the course of his or her daily life. Some of FAO/WHO in 2000, and updated in 2001 (http://
these factors are intrinsic and unavoidable, e.g., heredi- [Link]/docrep/007/y0820e/[Link]).
tary. Other factors may be predictable but not easily con- However, none of the proposed changes, such as number
trollable, such as asthma, and exposure to allergens during of amino acids used in sequence homology evaluations
the pollen season. Tremendous efforts have been made, and the conditions of digestibility studies, have been com-
and are ongoing, to elucidate the threshold levels for food pletely evaluated and validated to determine their predic-
allergens. It is hoped the threshold level concept will tive value against known allergens and non-allergens.
answer the common question in food processing plants of During an experimental program to modify soybeans,
“how clean is allergen-clean.” Some issues related to food scientists at the University of Nebraska found that the
allergens will only diminish if thresholds are established modified soybeans contained a known allergen from Brazil
for major food allergens; hence, food manufacturers can nuts. These findings were made public and the seed com-
determine when “May contain” labeling should be used, pany discontinued the Brazil nut/soybean development
and subsequently such advisory labeling can be applied program. This case represents the successful application
uniformly across the industry. In addition, knowledge of the 1996 decision tree, and a straightforward case of
of threshold levels will assist the regulatory agencies in preventing the introduction of a known allergen.
developing guidelines on action levels for allergens in A novel protein that has no history of allergenicity or
foods. For more information regarding allergen threshold previous human exposure presents a unique challenge
levels, see Chapter 1. with respect to determining if it is an allergen. There is
a need to test products where genes have been inserted
not only from sources known to contain allergens, but
Predictive Models also from sources not known to be allergenic. There are
The factors contributing to the severity of the allergic numerous methods used to determine whether a new pro-
response and the immunopathogenic mechanisms under- tein from a transgenic crop is likely to be an allergen.
lying food allergy are not completely characterized. The These methods include comparing the sequence homology
potential for animal models for food allergy have been of the protein with known allergens, using animal models
receiving increasing attention as research tools to answer and determining the stability of a protein or protein frag-
some of the difficult questions regarding food-allergy dis- ments to digestion in simulated gastric fluid. It is generally
ease. Most of the food-allergy animal models developed to recognized, however, that these test methods are potential-
date have been designed to test for the therapeutic treat- ly inaccurate and they have not been validated. ■
ment of allergic disease and to predict the potential aller-

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MANAGING ALLERGENS IN FOOD PROCESSING ESTABLISHMENTS

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Hematol. 7:59–67. Sampson, S.L. Taylor, and R.L. Fuchs. (1966)
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Mohammed, I., W.M. Mullett, E.P.C. Lai, and J.M. Yeung. Yunginger, J.W., K.G. Sweeney, W.G. Stumer, L.A.
(2001) Is biosensor a viable method for food allergens Giannandrea, J.D. Tiegland, M. Bray, P.A. Benson,
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ACRONYMS HFP: Histamine fish poisoning

IgE: Immunoglobulin E
Ab: Antibody
LFD: Lateral flow device
Ag: Antigen
LOAEL: Lowest Observed Adverse Effect Level
AMI: American Meat Institute
LOD: Limit of detection
AOAC: Formerly known as the Association of Official
Analytical Chemists, the organization is current- LOG: Letter of guarantee
ly known as AOAC International.
LOQ: Limit of quantification
AOAC RI: AOAC Research Institute
MS: Mass spectrometry
BLG: β-lactoglobulin
MSG: Monosodium glutamate
CD: Celiac Disease
NIST: National Institute of Standards and Technology
CDC: Centers for Disease Control and Prevention
NOAEL: No Observed Adverse Effect Level
CFR: Code of Federal Regulations
OAS: Oral Allergy Syndrome
CFSAN: Center for Food Safety and Applied Nutrition
ORA: Office of Regulatory Affairs
cGMP: Current Good Manufacturing Practices
PCR: Polymerase chain reaction
CIP: Clean-in-place
PDP: Principal display panel
COA: Certificate of analysis
PLC: Progammable logic controller
COP: Clean-out-of-place
PPM: Parts-per-million
CPG: Compliance policy guide
SOPs: Standard operating procedures
DBPCFC: Double Blind, Placebo-Controlled
SPR: Surface plasmon resonance
Food Challenge
SSOP: Sanitation standard operating procedures
EIR: Establishment inspection report
TTB: (Alcohol and Tobacco) Tax and Trade Bureau
ELISA: Enzyme-linked immunosorbent assay
WIP: Work-in-process
EU: European Union
USDA: United States Department of Agriculture
FAIA: Food Allergy Issues Alliance
FALCPA: The Food Allergen Labeling and
Consumer Protection Act
FAO: Food and Agriculture Organization
(of the United Nations)
FDA: Food and Drug Administration
FFDCA: Federal Food Drug and Cosmetic Act
FPLA: Fair Packaging and Labeling Act
FR: Federal Register
FSIS: Food Safety and Inspection Service
FY: Fiscal year
GMA: Grocery Manufacturers Association
GMO: Genetically modified organisms
GMPs: Good manufacturing practices
HACCP: Hazard Analysis and Critical Control Points

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