Risk Management for Food Allergy

309 Pages·2014·4 MB·English

by  Charlotte Madsen

Food Science and
Technology
International Series
SeriesEditor
Steve L. Taylor University of Nebraska e Lincoln, USA
Advisory Board
Ken Buckle The University of New South Wales, Australia
Mary Ellen Camire University of Maine, USA
Roger Clemens University of Southern California, USA
Hildegarde Heymann University of California e Davis, USA
Robert Hutkins University of Nebraska e Lincoln, USA
Ron S. Jackson Quebec, Canada
Huub Lelieveld Bilthoven, The Netherlands
Daryl B. Lund University of Wisconsin, USA
Connie Weaver Purdue University, USA
Ron Wrolstad Oregon State University, USA
Acomplete list of books inthis series appearsat the end ofthis volume.
Risk Management for
Food Allergy
Edited by
Charlotte Bernhard Madsen
DVM Research Leader Division of Toxicology
and Risk Assessment National Food Institute
Technical University of Denmark
(cid:1)
Rene W. R. Crevel
Safety and Environmental Assurance Center,
Unilever, Sharnbrook, Bedfordshire, UK
Clare Mills
Manchester Institute of Biotechnology,
University of Manchester, UK
Steven L. Taylor
Food Allergy Research & Resource Program,
University of Nebraska, Lincoln, NE, US
AMSTERDAM(cid:129)BOSTON(cid:129)HEIDELBERG(cid:129)LONDON
NEWYORK(cid:129)OXFORD(cid:129)PARIS(cid:129)SANDIEGO
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List of Contributors
Anton Alldrick Campden BRI, Chipping Campden, UK
Ricardo Asero Ambulatorio di Allergologia, Clinica San Carlo, Paderno-
Dugnano, Milano, Italy
Barbara K. Ballmer-Weber Allergy Unit, Department of Dermatology,
University Hospital Z€urich, Switzerland
SusanA.BaranowskyConsumerAffairs,CampbellSoupCompany,Camden,
NJ, US
Joseph L. Baumert Department of Food Science & Technology and Food
Allergy Research & Resource Program, University of Nebraska, Lincoln,
NE, US
Erna Botjes Stichting Voedselallergie (Dutch Food Allergy), Nijkerk, The
Netherlands
Peter Burney National Heart Lung Institute, Imperial College, London, UK
Stella Cochrane Unilever Safety and Environmental Assurance Center,
Sharnbrook, Bedfordshire, UK
Ren(cid:2)e W.R. Crevel Safety and Environmental Assurance Center, Unilever,
Sharnbrook, Bedfordshire, UK
Ross Critenden Valio Ltd, Helsinki, Finland
Anthony E.J. Dubois Department of Paediatric Pulmonology and Paediatric
Allergy, University Medical Center Groningen, University of Groningen,
Groningen, The Netherlands
GeorgeE.DunaifFoodSafety&TechnicalServices,GroceryManufacturers
Association, Washington, DC, US
Audrey DunnGalvin Department of Paediatrics and Child Health, University
College Cork, Cork, Ireland
Montserrat Fern(cid:2)andez-Rivas Allergy Department, Hospital Cl´ınico San
Carlos, IdISSC, Madrid, Spain
B.M.J.Flokstra-deBlokDepartmentofGeneralPractice,UniversityMedical
Center Groningen, University of Groningen, Groningen, The Netherlands
StevenM.GendelFoodandDrugAdministration,CenterforFoodSafetyand
Applied Nutrition, US
Linus Grabenhenrich Institute for Social Medicine, Epidemiology and
Health Economics, Charit(cid:2)e University Medical Center, Berlin, Germany
Kirsten Grinter Nestle Oceania, Rhodes, NSW, Australia
xiii
xiv List of Contributors
Sue Hattersley Food Standards Agency, London, UK
Geert Houben Food & Nutrition, TNO, Zeist, The Netherlands
Steffen Husby Hans Christian Andersen Children’s Hospital at Odense
University Hospital, Denmark
Anneli Ivarsson Department of Public Health and Clinical Medicine,
Epidemiology and Global Health, Ume(cid:3)a University, Sweden
Phil E. Johnson Institute of Inflammation and Repair, Manchester Academic
Health Science Center, Manchester Institute of Biotechnology, University
of Manchester, Manchester, UK
Thomas Keil Institute for Social Medicine, Epidemiology and Health
Economics, Charit(cid:2)e University Medical Center, Berlin, Germany
Rita King British Beer and Pub Association, London, UK
Andr(cid:2)e C. Knulst Department of Dermatology/Allergology, University
Medical Center, Utrecht, The Netherlands
I.S. Leitch Environmental Health Department, Omagh District Council,
Omagh, Co. Tyrone, Northern Ireland
Charlotte BernhardMadsen DVM Research Leader Division ofToxicology
andRiskAssessmentNationalFoodInstituteTechnicalUniversityofDenmark
J. McIntosh Safefood, Eastgate, Little Island, Co. Cork, Ireland
Clare Mills Institute of Inflammation and Repair, Manchester Academic
Health Science Centre, Manchester Institute of Biotechnology, University of
Manchester, UK
Pia Nørhede Division of Toxicology and Risk Assessment, National Food
Institute, Technical University of Denmark, Lyngby, Denmark
Jonathan O’B. Hourihane Department of Paediatrics and Child Health,
Clinical Investigations Unit, Cork University Hospital, Wilton, Cork, Ireland
Cecilia Olsson Department of Food and Nutrition, Ume(cid:3)a University, Sweden
SylviaPfaffFoodInformationService(FIS)Europe,BadBentheim,Germany
David Reading Food Allergy Support Ltd, Aldershot, UK
Ben C. Remington DepartmentofFoodScience&TechnologyandFood
AllergyResearch&ResourceProgram,UniversityofNebraska,Lincoln,NE,US
Robin Sherlock FACTA, Tennyson, Queensland, Australia
Dan Skrypec Kraft Foods, Glenview, IL, US
Steven L. Taylor Food Allergy Research & Resource Program, University
of Nebraska, Lincoln, NE, US
Marjan van Ravenhorst Allergenen Consultancy, Scherpenzeel,
The Netherlands
Jean-Michel Wal INRA, Unit(cid:2)e d’Immuno-Allergie Alimentaire,
Jouy-en-Josas, France
List of Contributors xv
Rachel Ward r.ward Consultancy Limited, Nottingham, UK
Gary Wong Department of Paediatrics, Chinese University of Hong Kong,
New Territories, Hong Kong, China
Laurian Zuidmeer-Jongejan Department of Experimental Immunology,
Laboratory of Allergy Research, Academic Medical Center, University of
Amsterdam, Amsterdam, The Netherlands
Foreword
Ifirstbecameawareoffoodallergenissuesinthelate1990swhenIwasDirector
oftheCenterforFoodSafetyandAppliedNutrition(CFSAN)attheUSFood
andDrugAdministration(FDA).Theagencyhadcontractedwithtwostatesto
survey local food manufacturing plants that made food products (such as
cookies), some of which were intended to contain, and some of which were
intendednottocontain,commonfoodallergenssuchasmilkandeggs.Thestates
collected samples of the products not intended to contain food allergens and
testedthemtoverifythis.Theresultswereastounding,asanalarmingpercentage
ofproductsactuallycontainedmilkoreggswhentheywerenotsupposedto.
This survey caught everyone’s attention. It helped explain two things: (1)
why undeclared food allergens were the number one cause of Class 1 recalls
(those recalls presenting the most serious risk to health) and (2) why the
governmentandthefoodindustryneededtodomuchmoretoreducethelike-
lihoodofthisfromhappening.Afterall,aclearanddependablefoodlabelisthe
onlymeansthatfoodallergicindividuals(andparentsoffoodallergicchildren)
havetopreventillnessandinjury.Accuratefoodlabelsaretrulytheirlifeline.
Intheensuing10+years,muchhasbeendonetoadvancetheawarenessof
food allergenissues and toputin place systems to better protect food allergic
individuals.
(cid:129) USCongresspassedtheFoodAllergenLabelingandConsumerProtection
Act (FALCPA) of 2004, which required the prominent listing e in plain
English e of the eight most common food allergens: peanuts, tree nuts,
milk, eggs,fish,shellfish,soy,and wheat. Today, foodallergicconsumers
(and their parents) have a much easier time determining which foods are
safe for them toeat.
(cid:129) The US National Institutes for Health (NIH) have significantly increased
the amount of funding devoted to studying potential cures for food aller-
gies, thereby recognizing that food allergies are a significant health issue
that needs to beaddressed.
(cid:129) Thereismuchgreaterpublicawarenessthatafoodallergicindividualcanbe
placedinalife-threateningsituationifthewrongfoodallergenisconsumed.
Thisawarenesshasledtogreatervigilanceinpublicschoolsandthepassage
ofstatelawsdirectingthatambulancescarrythedrugepinephrineewhich
isneededalmostimmediatelyforemergencytreatment.
(cid:129) Most recently, in late 2010, US Congress passed sweeping food safety
legislation e called the US FDA Food Safety Modernization Act
(FSMA)ewhichincludedaclearmandateforgreatercontroloffoodaller-
gens during the foodmanufacturingprocess.
xvii
xviii Foreword
Suchprogressdoesnothappenbyaccident.Thehardworkofmany,many
peopleandorganizationshasbeenbroughttobear.Threestandoutforspecial
mention.
(cid:129) First was the creation of the Food Allergy and Anaphylaxis Network
(FAAN) over 20 years ago by two parents of a food allergic child, Anne
Munoz-Furlong and Terry Furlong. Having nowhere to turn for reliable
information, they decided to research the issue themselves and become
a clearing-house for objective, scientific information to share with other
parents like themselves. The organization grew into a membership of
over30,000,andFAANbecametheworldleaderinfoodallergyeducation.
I had the honor to serve on the FAAN Board of Directors for six years
(servingasChairforoneyear)andcanattesttothevaluesanddedication
thisgrouphasbroughttobear.Morerecently,FAANmergedwiththeFood
AllergyInstitute(FAI)group,withgreatsuccessinraisingmoneyforclin-
icalresearchtoformtheconsolidatedgroupcalledFoodAllergyResearch
and Education (FARE).
(cid:129) Second was the establishment of a clinical research program at Mt. Sinai
hospital in New York. Headed by Hugh Sampson, M.D., this facility has
become the national leader in food allergy clinical research. It has close
ties to FARE and both of its predecessor organizations. It is hoped that
more research programs will arise around the country to add to our base
of expertise, and the increased number of US National Institute of
Health grants referenced above should facilitate reachingthis goal.
(cid:129) Third is a group at the University of Nebraska, headed by Stephen L.
Taylor, Ph.D., called the Food Allergy Research and Resource Program
(FARRP). This group is the national leader in understanding how to
detect and measure food allergens in food and in assessing the risk to
health, if any, of tiny amounts offood allergens. It is hoped that research
of this type will help establish ‘thresholds’ for food allergens e
meaning, safe levelsthatfood companiescan test against.
Despite such progress, many challenges remain. Awareness of the food
allergy issues needs to be maintained and even enhanced, education of new
parents with food allergic children is a continuing necessity, advocacy for
strongerlawscontinues,andresearchneedstobecontinueduntilacureisfound.
What I have learned most over the past decade is that with food allergies,
therearenovillainseonlyvictimsebutalsomanychampionstryingtoprotect
them. Thankfully, the number of champions is constantly growing. Those
contributing to this book are high among them and deserve our collective
admiration and gratitude.
Joseph A.Levitt1
1Mr.LevittisapartnerintheWashington,D.C.,officeofHoganLovellsUSLLP,wherehe
counselsfoodcompanieson,amongothermatters,foodallergen-relatedissues.Heisthe
formerDirectorofFDA’sCenterforFoodSafetyandAppliedNutrition(CFSAN).Heisalso
aformerBoardMemberandChairoftheFoodAllergyandAnaphylaxisNetwork(FAAN).
Introduction
Youcan’thavenoriskatallyouknow,evenifthechildneverleavesthehouse,
so youhave todeal with risk... we just wanta better way
(MotherofCarla,aged10,US).
like sometimesyoucan’tfindthe cause[ofareaction].itjusthappens,you
know.notknowingmakesyouworriedandunsureofyourself.whenIhave
afirstbitelike,ifI’mnotathome,Ithinkisthisit?....willIdie?....whatcanyou
do?
(Fran,aged12,Ireland)
These statements from chapter 1 describe the reality of living with severe
food allergy.
Managing food allergy on an individual level is the responsibility of the
individual and those looking after that individual. In the modern world this is
very, very difficultwithouthelp from society.
Foodisanessentialpartofourlives.Weeatapproximatelyfivetimesaday,
very often away from home. Food allergic individuals have to rely on the
informationaboutthefoodtheyeatfromthepersonsproducingtheirfood.They
have to trust that food producers, both in industry and catering, know how
crucial it is that the information they provide is correct. This means that,
although the individual has to manage his or her food allergy, the food
producers need tomanage allergenicfoods.
Foodproducersneedtomanagemanydifferentrisks.Thisiscostly,andan
important driving force in prioritizing has been legal and regulatory
requirements.
HISTORY OF ‘ALLERGY’ LABELING
In the eighties, international food labeling was extremely focused on food
additives. This resulted in labeling rules where ingredients such as milk or
wheat did not have to be declared on the label if they were constituents of
compoundingredients(theso-called25%rule),whereasfoodadditivesalways
had to be labeled. This rule could result in ingredient lists dominated by
additives and made it almost impossible for food allergic individuals to get
appropriate informationfrom ingredient lists.
In order to change international food labeling rules to make them more
helpfultofoodallergicindividuals,aNordicinitiativeledbyNorwayin1993
presented a document (Consideration of Potential Allergens in Food) to the xix
xx Introduction
Codex Committee on Food Labeling. The documents suggested changing the
25% rule on compound ingredients to a 5% rule and suggested a list of aller-
genicfoodsthatshouldalwaysbedeclared.Thematterwasdiscussedagainin
1994and1995,andinNovember1995aFAOTechnicalConsultationonFood
Allergens was held. The recommendations from this consultation were to
change the 25% rule as suggested. The suggested list of allergenic foods was
slightly modified. After several years of further discussion the Codex
Alimentarius Commission adopted the proposal in June 1999.
Severalcountrieschangedtheir food labeling rules inaccordancewith the
Codex.In the EUthe 25%rulewas totallyabandonedin 2004.
Thechangeinlabelingrulesandtheincreasedfocusonallergenicfoodshas
been an advantage for the allergic consumer, but it also created unforeseen
problems. These arise from insufficient scientific knowledge on safe levels of
food allergens.The EuropeanFoodSafety Authority concluded in2004 that:
Thedosesofallergenscapableoftriggeringfoodallergicreactionsare
variable andcan bevery small,i.e.,inthe milligramor microgram
range. The informationcurrently available isinsufficient todrawfirm
conclusionsregardingthelowestdosethatcouldcauseanadverseeffect
(threshold).
For this reason, the authorities were not able to advise industry on what
amounts of food allergen could be considered effectively harmless and help
them todevelopoperational standards.
Thisagainledindustrytodevelopvariouslabelssuchas‘maycontainnuts’
or‘manufacturedinafacilitythatalsohandlesnuts’,becausetheywerenotable
to guarantee the total absence of allergenic food in their products and no one
couldtellthemwhentheirproductsweresafeenough.Afurtherconsequenceof
thelackofguidancewasthatcriteriaforusingsuchlabelingvariedacrossthe
food industry.
WHERE ARE WE NOW e THE BOOK
Unfortunatelywehavenotsolvedallthequestionsthatarisewhendealingwith
allergenicfoodinfoodproduction,butmuchhashappened.Thisbookpresents
the newest knowledge on food allergy and food allergen management and
includes suggestions for practical management offood allergens.
The book is organized in four sections. Section 1, Food Allergy: Causes,
Prevalence,andImpacts,providesabackgroundforunderstandingthecontext
and rationale for food allergyas a problem in society. It givesan overview of
how patients experience daily life with food allergy and how it impacts their
lives.Itdescribesfoodallergyasadiseaseandlistswhichfoodscauseallergyas
well as the epidemiology of food allergy. Section 2, Allergen Thresholds and
Risk Assessment, describes how clinicians determine the amount of allergenic
foodcausingareaction.Itsuggestsquantitiesofdifferentallergenicfoodsthat
can be considered topresent minimal risk and describes how theyare derived