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[Senate Hearing 110-935]
[From the U.S. Government Publishing Office]

                                                        S. Hrg. 110-935
 
        ADDRESSING THE CHALLENGE OF CHILDREN WITH FOOD ALLERGIES

=======================================================================

                                HEARING

                               BEFORE THE

                 SUBCOMMITTEE ON CHILDREN AND FAMILIES

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                       ONE HUNDRED TENTH CONGRESS

                             SECOND SESSION

                                   ON

        EXAMINING THE CHALLENGE OF CHILDREN WITH FOOD ALLERGIES

                               __________

                              MAY 14, 2008

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions

  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                                 senate

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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

               EDWARD M. KENNEDY, Massachusetts, Chairman

CHRISTOPHER J. DODD, Connecticut     MICHAEL B. ENZI, Wyoming,
TOM HARKIN, Iowa                     JUDD GREGG, New Hampshire
BARBARA A. MIKULSKI, Maryland        LAMAR ALEXANDER, Tennessee
JEFF BINGAMAN, New Mexico            RICHARD BURR, North Carolina
PATTY MURRAY, Washington             JOHNNY ISAKSON, Georgia
JACK REED, Rhode Island              LISA MURKOWSKI, Alaska
HILLARY RODHAM CLINTON, New York     ORRIN G. HATCH, Utah
BARACK OBAMA, Illinois               PAT ROBERTS, Kansas
BERNARD SANDERS (I), Vermont         WAYNE ALLARD, Colorado
SHERROD BROWN, Ohio                  TOM COBURN, M.D., Oklahoma

           J. Michael Myers, Staff Director and Chief Counsel

                 Ilyse Schuman, Minority Staff Director

                                 ______

                 Subcommittee on Children and Families

               CHRISTOPHER J. DODD, Connecticut, Chairman

JEFF BINGAMAN, New Mexico            LAMAR ALEXANDER, Tennessee
PATTY MURRAY, Washington             JUDD GREGG, New Hampshire
JACK REED, Rhode Island              LISA MURKOWSKI, Alaska
HILLARY RODHAM CLINTON, New York     ORRIN G. HATCH, Utah
BARACK OBAMA, Illinois               PAT ROBERTS, Kansas
BERNARD SANDERS (I), Vermont         WAYNE ALLARD, Colorado
EDWARD M. KENNEDY, Massachusetts     MICHAEL B. ENZI, Wyoming (ex 
(ex officio)                         officio)

                   Mary Ellen McGuire, Staff Director

                 David Cleary, Minority Staff Director

                                  (ii)

  

                            C O N T E N T S

                               __________

                               STATEMENTS

                        WEDNESDAY, MAY 14, 2008

                                                                   Page
Dodd, Hon. Christopher J., Chairman, Subcommittee on Children and 
  Families, opening statement....................................     1
    Prepared statement...........................................     3
Alexander, Hon. Lamar, a U.S. Senator from the State of Tennessee     5
Fauci, Anthony S., M.D., Director, National Institute of Allergy 
  and Infectious Diseases, National Institutes of Health, 
  Bethesda, MD...................................................     7
    Prepared statement...........................................     8
Walters, Teresa, Parent, Aurora, CO..............................    22
Birchfield, Colene, Parent, Ooltewah, TN.........................    24
    Prepared statement...........................................    27
Kosiorowski, Donna, RN, MS, NCSN, Supervisor School Health, West 
  Haven School District, and Connecticut Director, National 
  Association of School Nurses, West Haven, CT...................    30
    Prepared statement...........................................    32
Sampson, Hugh A., M.D., Professor of Pediatrics, Mount Sinai 
  School of Medicine, and President, American Academy of Allergy, 
  Asthma, and Immunology, New York, NY...........................    36
    Prepared statement...........................................    38

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Mary R. Ericson, mother of Kyle Ericson, prepared statement..    53
    Jo Frost (known as TV's Supernanny), prepared statement......    54
    Why the Food Allergy Awareness Plan Works at Washington 
      Elementary School, Donna Rhoads-Frost......................    54

                                 (iii)

  

        ADDRESSING THE CHALLENGE OF CHILDREN WITH FOOD ALLERGIES

                              ----------                              

                        WEDNESDAY, MAY 14, 2008

                                       U.S. Senate,
                    Subcommittee on Children and Families, 
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 2:34 p.m. in 
Room SD-430, Dirksen Senate Office Building, Hon. Christopher 
Dodd, chairman of the subcommittee, presiding.
    Present: Senators Dodd and Alexander.

                   Opening Statement of Senator Dodd

    Senator Dodd. I want to thank you all for being here. We'll 
take a couple of minutes and make some opening comments and 
turn to my good friend Senator Alexander for any opening 
comments he has. Then we'll get to Dr. Fauci and our panelists. 
I'm deeply honored you're all here today and I want to thank 
you for being part of this important hearing.
    Today's hearing will focus on a growing and serious public 
health and safety challenge to our Nation's children, and that 
is food allergies. The number of Americans with food allergies 
has nearly doubled in the past 5 years, from 6 million to some 
say more than 12 million. Rates among children, especially 
young children, have doubled as well. Today more than 3 million 
children have food allergies for which there is no known cure, 
and that number is growing, as is the number of children who go 
into anaphylactic shock because of their allergic conditions.
    It is particularly fitting to be holding this hearing today 
because this week is National Food Allergy Awareness Week. 
National Food Allergy Awareness Week offers us the opportunity 
to heighten food allergy and anaphylactic awareness and 
redouble our efforts to educate schools, child care centers, 
parents, restaurants, and the public at large about the dangers 
associated with them. It's our hope this afternoon that today's 
hearing will shed light on this growing national problem.
    For me this is a very personal issue, one my wife Jackie 
and I face every single day. Our daughter Grace, who is 6\1/2\ 
years of age, has severe food allergies that have sent her into 
anaphylactic shock four times already. It's a terrifying 
moment, one that does not get easier. As parents, we had to 
come to grips with how to manage her condition. We had to 
educate not only ourselves, but everyone in our daughter's 
life, from her school to her teachers, to her friends and their 
parents, to her babysitters.
    As we will hear from our witnesses this afternoon, being 
the parent of a child with a food allergy means being in a 
constant state of awareness and vigilance. It means not only 
having a plan in place at home and at school for avoiding 
contact with your child's known allergy, it means being 
prepared to act immediately should they be accidentally exposed 
to an allergen.
    The best known method of treatment for food allergies is 
strict avoidance of the foods to which children are allergic. 
Even with the best of intentions, each year approximately one 
out of four people with food allergies has an accidental 
exposure that leads to an allergic reaction. As we will hear 
later this afternoon, in the most tragic situations even the 
best laid plans and the most attentive, caring parenting may 
not be enough to save a child's life.
    While any food can potentially cause an allergic reaction, 
eight foods account for about 90 percent of all food allergy 
reactions. They are peanuts, tree nuts, milk, eggs, fish, 
shellfish, soy, and wheat. Each of these foods is so common in 
our society that avoiding them completely is nearly impossible, 
especially in settings outside of the home. That makes readily 
available information particularly crucial.
    Congress took a good step toward improving the ingredient 
labeling of foods, for allergens, when it passed the Food 
Allergen and Consumer Protection Act of 2004. I think we must 
do more, and I believe we can start with our schools, where our 
children spend most of their days. Schools, school 
administrators and teachers are critical partners for managing 
students' food allergies within their walls. In order to manage 
them effectively, I believe it will require guidance from the 
Federal Government on best practices the schools can then 
tailor to their individual needs. In addition, with many of our 
school districts lacking the funding necessary to implement a 
food allergy management plan, it will also take some resources.
    Some States are already doing this and I commend them. 
Connecticut and Tennessee I would point out are two of the 
eight States that are actually taking steps in this area. 
Connecticut, I'm proud to say, was the first in the country to 
enact legislation requiring school-based guidelines concerning 
food allergies and the prevention of life-threatening incidents 
in schools.
    This week I had the wonderful opportunity to visit 
Washington Elementary School in West Haven, CT, where I learned 
about the programs they have put in place to protect the 16 
students in their school in K through 5 in the current student 
population who have food allergies. As they told me, dealing 
with this problem takes time, it takes resources, and it takes 
a willingness on the part of the school and the parents to put 
an effective plan in place.
    Several other States have passed or are close to passing 
laws developing school-based guidelines concerning their food 
allergies; in addition to Tennessee and Connecticut, 
Massachusetts, Vermont, New Jersey, Arizona, Washington, and 
New York. Without Federal guidance and standards, a child's 
health and safety may be protected in one school but not in 
another. Policies may vary among schools within the same school 
district.
    I've introduced legislation called the Food Allergy and 
Anaphylactic Management Act that will address the critical need 
for a uniform and consistent policy for schools with resources 
to help them act. It's all voluntary. It doesn't mandate 
anything, but gives schools ideas that work, so they don't have 
to do it all on their own and start de novo. It is my hope that 
we can move this legislation as soon as possible. What is at 
stake is nothing less than the health and safety of millions of 
our children.
    We have two outstanding panels of witnesses today to help 
us gain a better understanding of why we've seen such a 
dramatic increase in the number of children with food allergies 
and what kind of research is currently taking place. We're 
going to hear from Dr. Tony Fauci, who is the distinguished 
Director of the National Institute of Allergy and Infectious 
Diseases at the National Institutes of Health. We'll also hear 
from Dr. Hugh Sampson, one of the country's preeminent experts 
in food allergies, from Mount Sinai Medical School in New York, 
and the President of the American Academy of Allergy, Asthma, 
and Immunology.
    Many more leaders in the effort to raise public awareness 
and to advocate for families suffering from food allergies are 
in our audience today. I would especially take a moment to 
commend the work of the Food Allergy and Anaphylaxis Network, 
an organization with whom I have worked for many years. One of 
their advocates from Connecticut is here today, Mary Ericson, 
and her son Kyle, who I had the pleasure of meeting yesterday, 
who I'm also proud to say is a devout Red Sox fan, and I thank 
him for that as well. We like to know those things if we can--
who actually looks like a Senator, I think, in that good outfit 
he's got on here today.
    They have been in my office in the past years sharing 
Kyle's personal story with me and others in the Connecticut 
delegation, about what life is like being a 10-year-old with a 
severe allergy problem to peanuts and tree nuts, as Kyle has.
    I ask unanimous consent to put the written testimony of 
Kyle's mom Mary in the record.
    I'd also like to put a statement in the record from a 
lifelong food allergies sufferer, Jo Frost, who's probably 
better known through a role as television's Super-Nanny.
    [The information referred to can be found in Additional 
Material.]
    [The prepared statement of Senator Dodd follows:]

                   Prepared Statement of Senator Dodd

    I want to welcome my colleagues and our distinguished 
witnesses for being here today. Today's hearing will focus on a 
growing and serious public health and safety challenge for our 
Nation's children, and that is food allergies. The number of 
Americans with food allergies has nearly doubled in the past 5 
years, from 6 million to more than 12 million. Rates among 
children, especially young children, have doubled as well. 
Today more than 3 million children have food allergies for 
which there is no known cure--and that number is growing, as is 
the number of children who go into anaphylactic shock because 
of their allergic conditions.
    It is particularly fitting to be holding this hearing today 
because this week is National Food Allergy Awareness Week. 
National Food Allergy Awareness Week offers us the opportunity 
to heighten food allergy and anaphylaxis awareness and re-
double our efforts to educate schools, child care centers, 
parents, restaurants, and the public about the dangers 
associated with them. It is my hope that today's hearing will 
shed light on this growing national problem.
    For me, this is a very personal issue--one my wife Jackie 
and I face every single day. Our daughter Grace has a severe 
food allergy that has sent her into anaphylactic shock four 
times. She is only six years old. It is a terrifying moment--
one that does not get easier. As parents, we had to come to 
grips with how to manage her condition. We had to educate not 
simply ourselves but everyone in our daughter's life--from her 
school and teachers, to her friends and their parents, to her 
babysitter.
    As we will hear from our witnesses, being the parent of a 
child with a food allergy means being in a constant state of 
awareness and vigilance. It means not only having a plan in 
place at home and at school for avoiding contact with your 
child's known allergy, it means being prepared to act 
immediately should they be accidentally exposed to an allergen. 
The best known method of treatment for food allergies is strict 
avoidance of the foods to which children are allergic. But even 
with the best of intentions, each year approximately 1 out of 
every 4 people with food allergies has an accidental exposure 
that leads to an allergic reaction. And as we will hear today, 
in the most tragic situations, even the best laid plans and the 
most attentive, caring parenting may not be enough to save a 
child's life.
    While any food can potentially cause an allergic reaction, 
8 foods account for 90 percent of all food allergy reactions. 
They are peanuts, tree nuts, milk, eggs, fish, shellfish, soy 
and wheat. Each of these foods is so common in our society that 
avoiding them completely is nearly impossible, especially in 
settings outside the home. That makes readily-available 
information particularly crucial.
    Congress took a good first step toward improving the 
ingredient labeling of foods for allergens when it passed the 
Food Allergen and Consumer Protection Act in 2004. But we must 
do more.
    We can start with our schools where our children spend most 
of their days. Schools, school administrators and teachers are 
critical partners for managing students' food allergies within 
their walls. In order to manage them effectively, I believe it 
will require guidance from the Federal Government on best 
practices that schools can then tailor to their individual 
needs. In addition, with many of our school districts lacking 
the funding necessary to implement a food allergy management 
plan, it will also take resources.
    Some States are already doing this. Connecticut and 
Tennessee, two of the States represented here, are among them. 
Connecticut, I am proud to say, was the first State in the 
country to enact school-based guidelines concerning food 
allergies and the prevention of life-threatening incidents in 
schools. This week, I had the opportunity to visit Washington 
Elementary School in West Haven, CT where I learned about the 
programs they have put in place to protect the 16 students in 
the current student body who have food allergies. As they told 
me, dealing with this problem takes time. It takes resources. 
And it takes willingness on the part of the school and the 
parents to put an effective plan in place.
    Several other States have passed laws developing school-
based guidelines concerning food allergies including 
Massachusetts, Vermont, New Jersey, Arizona, Washington and New 
York. But, without Federal guidance and standards, a child's 
health and safety may be protected in one school but not in 
another. Policies may vary even among schools within the same 
school district.
    I've introduced legislation--the Food Allergy and 
Anaphylaxis Management Act--that will address the critical need 
for a uniform and consistent policy for schools with resources 
to help them act. It is my hope that we can move this 
legislation as soon as possible. What is at stake is nothing 
less than the health and safety of our children.
    We have two outstanding panels of witnesses with us today. 
To help us gain a better understanding of why we've seen such a 
dramatic increase in the number of children with food allergies 
and what kind of research is currently taking place. We will 
hear from Dr. Tony Fauci, who is the distinguished Director of 
the National Institute of Allergy and Infectious Diseases at 
the National Institutes of Health. We will also hear from Dr. 
Hugh Sampson, one of this country's preeminent experts in food 
allergies from Mount Sinai Medical School in New York and the 
President of the American Academy of Allergy, Asthma, and 
Immunology.
    Many more leaders in the effort to raise public awareness 
and to advocate for families suffering with food allergies are 
in the audience today. I would especially like to take a moment 
to commend the work of the Food Allergy and Anaphylaxis 
Network, an organization with whom I have worked for many 
years. One of their advocates from Connecticut is here with us 
today. Mary Ericson and her son Kyle are in the audience. They 
have been to my office in past years, sharing Kyle's personal 
story with me and others in the Connecticut delegation about 
what life is like being a 10-year-old with severe allergies to 
peanuts and tree nuts.
    I ask unanimous consent to put the written testimony of 
Kyle's mom Mary in the record. I would also like to put a 
statement in the record from life-long food allergy sufferer Jo 
Frost, who is probably better known through her role as 
television's Supernanny.
    Thank you.
    Senator Dodd. With that, I will turn to the Ranking Member 
of the Children and Families Subcommittee, my distinguished 
colleague from Tennessee, who I'm always proud to work with, 
Senator Alexander, for his opening statement.

                     Statement Of Senator Alexander

    Senator Alexander. Thank you, Senator Dodd.
    Senator Dodd has been a preeminent advocate for children a 
long time before he had any. He's done very important work in 
the U.S. Senate. It's a privilege to work with him on this 
subcommittee. His personal interest in this subject because of 
his own children makes him even more effective. So, I salute 
him for the hearing.
    We're here today to learn about what the Federal Government 
can do to help schools and places outside the home do a better 
job of dealing with and helping children and families of 
children who have food allergies.
    Of course, the other thing we can do in the U.S. Senate is 
to help make Americans aware of this. Most of us are not aware 
of the seriousness of the food allergy problem or have just 
recently become aware of it.
    I want to especially welcome to the hearing Ronda Adkins. 
She and her husband Trace in Tennessee have done a terrific job 
of helping make Tennessee more aware of this problem, and I'm 
sure had a major role in our State's movement to deal with food 
allergies. I'll have a chance in a few minutes to introduce 
Colene Birchfield, a music teacher from Ooltewah who is going 
to be one of our witnesses.
    I'm interested in learning today especially how we can be 
effective. Sometimes we're ham-handed here in the Federal 
Government and we take an action and proclaim a result and it 
really doesn't help that much. Senator Dodd is being very 
sensitive here to think about how can we really make things 
happen in the 105,000 public schools with 55 million students? 
What can we do here that makes it easier for them to do a 
better job.
    So I am anxious to learn. I thank the Senator for having 
the hearing. I thank the families for coming. I recognize this 
is a tremendously serious problem, about which I'm anxious to 
learn more and on which I expect to continue to work.
    Senator Dodd. Very good. Thank you. Thank you very much, 
Senator.
    Dr. Fauci, we thank you immensely for being with us. I have 
a lengthy introduction of you to give this morning, but I'll 
just include it in the record. You've been before this panel I 
don't know how many times over the years and you're so highly 
regarded and respected. I know you hear that from others, but 
we're deeply honored you'd spend some time with us today and 
talk about this, an area you're not unfamiliar with at all 
given your background and experience.
    We welcome you here once again, and thank you for your 
service to our country.
    [The information referred to follows:]

            Introductory Remarks for Anthony S. Fauci, M.D.

     On our first panel, we will hear from Dr. Tony 
Fauci who is the Director of the National Institute of Allergy 
and Infectious Diseases at the National Institutes of Health, a 
position he has held since 1984.
     As NIAID Director, Dr. Fauci oversees a budget of 
$4.4 billion and an extensive research portfolio of basic and 
applied research to prevent, diagnose, and treat infectious 
diseases such as HIV/AIDS, tuberculosis, and malaria. The NIAID 
also supports research on transplantation and immune-related 
illnesses, asthma and allergies.
     His contributions in the field of immune-mediated 
diseases and infectious diseases are tremendous and he has been 
the recipient of some of this Nation's top honors in biomedical 
research and public service.
     He is a native of Brooklyn, NY and did his medical 
training at Cornell University and The New York Hospital.
     We thank you for being here today.

         STATEMENT OF ANTHONY S. FAUCI, M.D., DIRECTOR,

          NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS

     DISEASES, NATIONAL INSTITUTES OF HEALTH, BETHESDA, MD

    Dr. Fauci. Thank you very much, Mr. Chairman and Senator 
Alexander. Thank you for those kind comments and thank you for 
giving me the opportunity to testify before this committee on 
the problem that you outline so well, one that is growing in 
seriousness and in scope.
    I show this first visual here really, which is a quite 
dramatic representation of what some children and even adults 
have to go through. It's a picture, for those who can see it, 
of a young child with a gas mask on and a peanut butter 
sandwich in one hand and milk in another. Although it's an 
exaggerated schematic, what it really tells us is the dire 
straits that many children find themselves in; and also, being 
on the cover of Newsweek, the fact that this is something that 
is now getting growing awareness--which is part of the solution 
of the problem, getting increased awareness.
    I'm going to tell the audience and you some things that 
you, because of your own personal experience, already know and 
that is the scope of food allergy in the United States, with 6 
to 8 percent of children under age 4 have a food allergy and 
about 4 percent of adults; an estimated 30,000 anaphylactic 
episodes per year, which are serious physiological phenomenon 
that can actually lead to the death of an individual. In fact, 
approximately 150 to 200 deaths occur per year, an average of 
about 2 or 3 per week.
    Peanut allergy, as you know, is the most common cause of 
fatal or near-fatal anaphylaxis and some food allergies, such 
as peanut allergy, actually persist throughout life. Other 
allergies, such as with eggs and milk, tend to dissipate as you 
age.
    The treatment and prevention of food allergy. There are few 
treatment options and in fact these have not changed 
significantly over a very long period of time. That'll get to 
the point that I'll make about the need for research and 
getting new people in the field. The treatment is with 
antihistamines, which block some of the mediators that are 
responsible, as well as epinephrine. These are the same things 
that I used in medical school myself decades ago. We haven't 
really had any significant increase in our knowledge about the 
types of therapeutics that need to be used.
    As you know, severe reactions require epinephrine and IV 
fluids. As you mentioned so correctly, allergen avoidance is 
the only prevention approach. The trouble with allergen 
avoidance is that, even innocently on both parts, there's the 
accidental exposure that is all too common, that can lead to 
not only discomfort and even death, but also the constant fear 
that there'll be a catastrophic event beyond the control of the 
individual.
    The NIH has been funding food allergy for several years. I 
show on this slide some good news and some sobering news. If 
you look from 2003 to 2008, there has been a dramatic increase 
in resources from around $2 million up to over $13 million. The 
increase is the good news. The sobering news is that's still 
not nearly enough to do the kinds of things we need to do, 
particularly enticing bright new investigators into the field.
    Speaking of research, there are three major components that 
I put before you. We can definitely go into these a bit more 
during the questions. The first is the basic research on 
immunology and allergic mechanisms, in other words to 
understand the underlying mechanisms of why and how children 
and adults get these types of reactions.
    The other is an epidemiological study, what is the scope 
and the circumstances under which these types of reactions 
occur. Then finally, doing research there is what we call pre-
clinical research, namely either in a test tube or in an 
animal, and some clinical research. A couple examples are shown 
there and are in my written testimony which I've submitted for 
the record. For example, pilot trials of how you desensitize or 
tolerize a child or an adult to not react to exposures, and 
there are alternate methods of administration of allergens 
that'll do that. Also, to question the classic paradigm of 
whether avoidance early on in life or actually exposure to high 
dose early on in life might have the beneficial effect of 
tolerizing an individual.
    I refer specifically to a program that is called 
Exploratory Investigations in Food Allergy. It's a 2008 
initiative for about $3.5 million. The objectives are two-fold 
and important. First and obviously is to study the scientific 
mechanistic studies of food allergies, but even more 
importantly it's to attract new investigators to the field. You 
mentioned we have Dr. Hugh Sampson in the audience, who is a 
superstar in food allergy. The number of his colleagues that he 
would need to push the field forward is really very, very 
small. We need to get a cadre of new, young investigators 
involved in the field, and I'm happy to say that the numbers of 
applications that are coming in in response to that request for 
applications is now, happily, disproportionately weighted 
toward new people who want to get into the field, who've not 
been in the field before.
    Also, as you know, we've partnered, as you mentioned, with 
a number of organizations, including EPA and the Food Allergy 
and Anaphylaxis Network, the Food Allergy Project, et cetera.
    I'd like to close on this last visual, which is something 
that we believe is going to have an important impact. We were 
approached by a number of constituency groups and professional 
societies to take the lead in developing guidelines for the 
diagnosis and the treatment of food allergy. Starting in July 
2008, we will be coordinating the development of guidelines 
that could be used. We anticipate more than 20 professional 
societies, advocacy groups, and other institutes. Hopefully, 
this type of an approach will help not only the clinicians, but 
also their families and the families of the children who are so 
drastically and dreadfully addressed with these particular 
problems.
    Again I want to commend you for calling this hearing 
because we really do need to call attention to it. That's a 
very important part of how we're going to solve this problem.
    Thank you, Mr. Chairman. Thank you, Senator Alexander.
    [The prepared statement of Dr. Fauci follows:]

              Prepared Statement of Anthony S. Fauci, M.D.

    Mr. Chairman and members of the subcommittee, thank you for the 
opportunity to discuss with you today food allergy and the research 
being conducted and supported by the National Institutes of Health 
(NIH) to address this public health problem. Within NIH, the National 
Institute of Allergy and Infectious Diseases (NIAID) is the lead 
institute for research in this area, although other NIH Institutes and 
Centers support basic research relevant to food allergy. I am 
particularly pleased to be here with you as we recognize the 11th 
Annual Food Allergy Awareness Week and commend your efforts to bring 
attention to this important issue.

                        OVERVIEW OF FOOD ALLERGY

    Food allergy is much more than an inconvenience; the effects of 
food allergy can be devastating and sometimes deadly for those 
afflicted. During an allergic response to food, the immune system 
overreacts to certain components of foods, setting off a cascade of 
immunological events that leads to symptoms ranging from itchy hives to 
anaphylaxis. Anaphylaxis is a severe and life-threatening systemic 
allergic reaction characterized by fall of blood pressure, upper airway 
obstruction, and difficulty breathing. Food allergy causes an estimated 
30,000 episodes of anaphylaxis each year, accounting for approximately 
one-third to one-half of all anaphylaxis-related emergency room visits. 
Food allergy also causes an estimated 100 to 200 deaths per year in the 
United States. It is truly sobering to consider that, as a consequence 
of food allergies, two or three otherwise healthy Americans--usually 
adolescents or young adults--may lose their lives this week. Even with 
diligent avoidance of known food allergens, it is estimated that each 
year, one of every four food-allergic individuals will have an 
accidental exposure that leads to a food-induced allergic reaction.
    Food allergies affect approximately 6 to 8 percent of children 
under 4 years of age and about 4 percent of adults in the United 
States. Evidence suggests that the prevalence of food allergy is 
increasing, especially peanut allergies, which tend to persist 
throughout life. Severe, life-threatening reactions occur mostly in 
adolescents and young adults, and peanuts and tree nuts are the most 
common causes of such reactions. Currently, the only proven 
interventions for food allergy are allergen avoidance and treatment 
with antihistamines, and intravenous fluids and epinephrine for more 
severe reactions.
    Food allergy affects the health, nutrition, development, and 
quality of life of children and adults. Because a history of mild 
reactions does not preclude the occurrence of future life-threatening 
reactions, food allergies can also have disconcerting psychological 
effects related to fears of serious reactions and the stigma related to 
avoidance of common foods and social gatherings. As you are undoubtedly 
aware, this is a particular problem for children in school lunchrooms 
and other social settings where others may minimize or fail to 
understand the seriousness of the allergy. The increasing prevalence of 
certain food allergies, their persistence throughout life, the 
potential for fatal allergic reactions, and the lack of preventive 
approaches other than food avoidance have all contributed to the 
emergence of food allergy as an important public health problem.

                 CURRENT NIAID RESEARCH ON FOOD ALLERGY

    NIAID is the principal sponsor of food allergy research within the 
U.S. Government. This support has increased significantly over the last 
5 years, from $1.2 million in fiscal year 2003 to an estimated $13.4 
million in fiscal year 2008, a greater than 10-fold increase. NIAID-
supported food allergy research includes basic and pre-clinical 
research on the immune mechanisms involved in food allergy, research to 
understand the epidemiology and genetics of food allergy, and clinical 
studies to treat and prevent food allergy. Like all of NIH, NIAID 
awards grants to researchers whose investigator-initiated proposals are 
judged in peer review to be of high quality. NIAID also solicits 
research proposals through special initiatives that target particular 
areas of inquiry and foster collaboration within the field. These 
initiatives and networks include the NIAID Consortium of Food Allergy 
Research, the Asthma and Allergic Diseases Cooperative Research 
Centers, the Immune Tolerance Network, and the Inner City Asthma 
Consortium. NIAID also supports intramural investigators on our 
Bethesda, MD, campus who work on allergic diseases and anaphylaxis, 
including a new program focused specifically on food allergy.
    In addition, NIAID supports a much larger portfolio of basic 
research on immunologic and allergic mechanisms that is relevant to the 
problem of food allergies. In fiscal year 2007, support for this 
broader research portfolio totaled more than $500 million. The 
Institute's broad support of basic research in allergy and immunology 
provides a critical foundation that is advancing the field of food 
allergy, providing scientists with a better understanding of how the 
healthy immune system averts the development of allergy and of the 
mechanisms that contribute to allergy. Food allergy is frequently 
accompanied by other allergic diseases including atopic dermatitis 
(eczema) and asthma. The latter is an important risk factor for severe 
allergic reactions to food. Thus, research findings in the broader 
areas of immunology, including asthma and allergic diseases, likely 
will move the field of food allergy forward.
    In the area of basic research in food allergy, researchers are 
studying the molecular structure of food allergens and their 
interactions with the immune system, including the immunoglobulin E 
(IgE) antibodies that mediate allergic reactions to food. For example, 
scientists are analyzing the specific structures, called epitopes, in 
food allergens that are recognized by IgE antibodies. These 
structures--and how they are recognized by the immune system--may 
determine the severity of a person's allergic responses and the 
persistence of allergy throughout his or her life. NIAID-supported 
scientists also are conducting basic research on the components of the 
immune system that play a role in anaphylaxis, studying the molecular 
events that precipitate and characterize anaphylactic reactions, and 
conducting long-term studies of patients with food allergies.
    Pre-clinical studies include the development and characterization 
of animal models of food allergy. Improved mouse models, which have 
been developed in recent years by NIAID-supported researchers, mimic 
many of the important characteristics of human food allergy. Potential 
approaches to treating and preventing food allergy are being evaluated 
in such animal models, as a prelude to human studies. Some experimental 
approaches are relying on the use of allergenic foods as immunother-
apeutics, capable of eliciting immunological tolerance with repeated, 
controlled administration. Other investigators are treating patients 
with structurally modified foods that are less likely to cause serious 
allergic reactions, but which may still elicit a state of tolerance. 
The safety of one such experimental treatment, the use of bacteria 
engineered to produce modified peanut proteins, may eventually be 
tested in non-allergic adult volunteers and, if proven safe, in 
allergic individuals.
    Very little is known about why only certain people develop food 
allergies. Research on the epidemiology and genetics of food allergy 
may provide insight into the genesis of food allergy and suggest 
approaches that may preempt children from developing allergies to 
certain foods. For example, the NIAID-supported Consortium of Food 
Allergy Research is conducting an observational study in which more 
than 400 infants who have allergies to milk or eggs have been enrolled, 
most of whom will lose their allergies to milk and eggs within a few 
years. Some of these children will develop allergy to peanuts. The 
study will follow the children for at least 5 years and study 
immunologic changes that accompany either the loss of allergy to foods 
or the development of allergy to peanut. Another study, the Urban 
Environmental Factors and Childhood Asthma Study, a project of the 
Inner City Asthma Consortium, is an observational study monitoring a 
cohort of children from birth for a number of factors, including the 
appearance of specific IgE antibodies to foods. This study will provide 
epidemiological data to address the relationship between asthma and 
food allergy.
    The results of basic, pre-clinical, and epidemiological research 
have suggested a number of approaches for the prevention and treatment 
of food allergy. These approaches are being evaluated in several 
current and planned clinical trials. For example, in the United States, 
until earlier this year, the pediatric medicine community generally 
recommended avoidance of exposure to peanuts and other common food 
allergens during early life. However, epidemiological studies have 
raised the possibility that early life exposure to peanuts may lower 
the rate of peanut allergy. More than 90 percent of Israeli children 
eat a popular peanut snack called Bamba starting before their first 
birthday, yet the prevalence of peanut allergy in Israel is 10- to 20-
fold lower than in the United States. To test the hypothesis that early 
exposure may prevent food allergies, the NIAID-sponsored Immune 
Tolerance Network is conducting a trial to determine whether feeding a 
peanut-containing snack to young children at risk of developing peanut 
allergy will prevent its development.
    With regard to treatment of established food allergies, a number of 
trials are ongoing or in the planning stages. The Consortium of Food 
Allergy Research is conducting or planning several pilot trials of oral 
and sublingual (under the tongue) immunotherapy in egg- and peanut-
allergic subjects to study safety and the ability of these approaches 
to desensitize subjects with allergies and induce immunological 
tolerance to the test allergens. In addition, the NIAID Asthma and 
Allergic Diseases Cooperative Research Centers are developing a 
clinical trial to evaluate whether, in combination with oral milk, a 
currently licensed drug for allergic asthma can reduce the incidence 
and severity of adverse effects of milk immunotherapy and facilitate 
the development of tolerance in patients with milk allergy.
    The field of food allergy research has benefited greatly from the 
support and involvement of advocacy groups and philanthropic 
organizations. Included among these are the Food Allergy and 
Anaphylaxis Network, the Food Allergy Initiative, and the Food Allergy 
Project, each of which supports public awareness efforts, scientific 
workshops, and/or research projects, either independently or in 
collaboration with NIH.

                              FUTURE PLANS

    In March 2006, as required by the Food Allergen and Consumer 
Protection Act of 2004 (Pub. L. 108-282), NIAID convened the NIH Expert 
Panel on Food Allergy Research. The Panel reviewed basic and clinical 
efforts related to food allergies and made recommendations to the 
Secretary of Health and Human Services for enhancing and coordinating 
research activities related to food allergies. The findings and 
recommendations of the Panel were summarized in a report released in 
June 2007 and available at http://www3.niaid.nih.gov/topics/
foodAllergy/research/Report
FoodAllergy.htm.
    The Panel discussed the challenges that NIH faces in the area of 
food allergy research, including the need to expand the relatively 
small cadre of scientists working in this area. To address this 
concern, in August 2007, NIAID announced a research initiative, 
Exploratory Investigations in Food Allergy, that will support 
innovative pilot studies and developmental research on the mechanisms 
of food allergy, with a goal of attracting additional investigators to 
the field of food allergy research. We are particularly gratified that 
almost all of the applicants for this initiative are new to the field 
of food allergy research and that approximately one-third have not had 
prior NIH funding. Co-sponsors include the Food Allergy and Anaphylaxis 
Network, the Food Allergy Project, and the U.S. Environmental 
Protection Agency. NIAID expects to award grants under this initiative 
this month.
    The Panel also identified a number of impediments, concerns, and 
challenges to the conduct of clinical trials for the prevention and 
treatment of food allergy. One such challenge is the difficulty of 
studying new approaches in pediatric patients, including infants. Other 
concerns relate to the potential for severe reactions to foods or food 
allergens in treatment or prevention trials and the current lack of 
tools to identify those at the highest risk for such reactions. The 
Panel recommended that Secretary of Health and Human Services direct 
the NIH and the Food and Drug Administration (FDA) to resolve 
impediments to the design and conduct of clinical trials for the 
prevention and treatment of food allergy. In response to this 
recommendation, NIH and FDA will convene a workshop next month on the 
design of food allergy clinical trials.
    The Panel also made a number of recommendations regarding the 
future of food allergy research, including those related to clinical 
trials, epidemiology and genetics, basic and pre-clinical studies, and 
research resources. A number of the research activities described 
earlier address these recommendations. NIAID is firmly committed to 
implementing the remaining recommendations.
    In addition to its research portfolio in food allergy, NIAID 
supports other activities to improve the lives of those who are 
affected by food allergy. For example, NIAID is coordinating the 
development of comprehensive clinical guidelines for the diagnosis and 
management of food allergy. This effort will provide guidance to 
clinicians, families, and patients for diagnosing and managing food 
allergies. NIAID will convene a Coordinating Committee in the summer of 
2008 to oversee the drafting of these guidelines. The guidelines will 
be prepared through a two-pronged approach, including an independent 
evidence-based literature review and consensus opinion developed by an 
expert panel. More than 20 professional societies, advocacy groups, and 
NIH Institutes and Centers will be involved in this process.

                               CONCLUSION

    With evidence indicating an increasing prevalence of food allergy 
in the United States, food allergy and associated anaphylaxis have 
emerged as important public health problems, particularly in children. 
Over the last 5 years, NIAID has substantially increased its support 
for basic, clinical and epidemiological research on food allergy and 
anaphylaxis. While much progress has been made in the scientific 
understanding of food allergies and in the public's awareness of 
difficulties in managing them, many challenges remain. NIAID is 
strongly committed to the goal of reducing the burden of food allergy 
for the millions of affected children and their families in the United 
States by continuing and expanding support for research to understand 
food allergies, by bringing new scientists into this research area, and 
by developing interventions for treatment and prevention.

    Senator Dodd. Thank you, doctor. Thank you very, very much. 
Those charts and graphs I think are very, very helpful and give 
you some sense of this.
    Why do you think this is happening? What do you attribute 
it to? I've read the stories, read the Newsweek article. That 
was the jacket. I read everything that comes along about this, 
I think like most parents would. Share with us what you think 
is going on. Why are we getting this explosion in the number of 
people who are suffering from food allergies?
    Dr. Fauci. You know, the correct answer is that we don't 
know. There are a number of hypotheses and I know you've heard 
of them, but for the sake of everyone here there are, for 
example, the hygienic hypothesis, that as we get more public 
health hygiene we get less exposed to environmental microbes, 
as well as common things that stimulate the immune system, that 
the immune system is not properly trained to control aberrant 
reactions to things that they shouldn't be reacting to, which 
is the reason why people in developing nations who get exposed 
to things in the environment--dirt, microbes, et cetera--seem 
to have much less allergies in general and even food allergies.
    The other is a pollution hypothesis, where by the 
pollutants in the air we're stimulating and activating the 
immune system, which then in synergy interacts with the 
response that you might have to a food allergen. If your immune 
system wasn't so revved up, it may be that you would not have 
that aberrant response.
    Then there's things like food processing, change in food 
processing, presenting food to the body in a different way. We 
get hints of that from the Chinese, for example, who boil 
peanuts as opposed to what we do generally, is roasting 
peanuts.
    Then the whole issue of: are we approaching the problem 
well enough, are we thinking that total avoidance is the 
answer, and might we by avoiding it actually have the 
paradoxical effect of not training the body to respond well. 
That's one of the studies we have, to see if high dose early 
exposure--a typical example of this possible hypothesis is that 
in Israel, where it's 10 to 20 times less food allergies than 
the United States, they actually expose children to a certain 
kind of a food called Bamba, which is a peanut candy, which 
they get very early in life. You would think that that would be 
precipitating if all things being equal, that that's the cause 
of these things, these early exposures. In fact, it's just the 
opposite, we believe.
    All of these things are open to study, which is the reason 
why we're excited about getting more people involved.
    Senator Dodd. You mentioned the difficulty we have in 
getting these investigators. A report, a 2006 ``Report of the 
NIH Expert Panel on Food Allergy Research'' showed the fact 
that only 15 percent of the current NIAID support for food 
allergy research is through investigator-initiated awards, 
compared to approximately 60 percent of investigator-initiated 
awards for the full spectrum of NIAID-supported research.
    Can you explain why that is such?
    Dr. Fauci. Absolutely. That falls exactly, Senator, into 
the issue that I'm trying to make. There are two types of 
awards. The awards are investigator-initiated, as you say, 
where the idea comes from the investigator, they put in an 
application, it competes in a peer review function with all of 
the other grants that come in. When a field is a hot field, 
when a lot of people are involved and a lot of people are 
interested in it, you don't have to worry about beating the 
bushes to get people to send grants in. You have more 
applications than you know what to do with.
    If you have a hot field like HIV-AIDS or certain cancers, 
et cetera, there's a lot of investigators around.
    When you need to jump-start a field early on, what you do 
is you put out a request for applications and you set aside a 
certain amount of money to tell investigators: ``Come on, we 
really want you to get involved.'' Once you get the cycle 
going, it then self-sustains itself. That's what we're really 
trying to do now, is to jump-start it so we get enough people 
that we don't have to go out and ask them to hand in grants; 
they will actually hand it on on their own initiative.
    Senator Dodd. Well, I hope we'll see a change in that.
    Let me go back to the resources. Again, I appreciate the 
fact that there's been a jump from $1.2 million in 2003 to an 
estimated $13.4 million in fiscal year 2008. We're still 
talking about, quick math, we're talking about a dollar a 
person if you accept the statistics that more than 12 million 
people in the country have food allergies.
    How much of that amount is actually being spent by NIAID 
versus other institutes?
    Dr. Fauci. Almost all. NIAID is the major institute in 
spending in food allergy. I might point out--and this by no 
means is an excuse for that, what is clearly obviously a 
relatively low amount--is that there is about $500 million that 
we've invested in mechanisms of allergic responses and 
immunological responses, which aren't specifically coded as 
food allergy, but that play into understanding the mechanisms 
that will ultimately allow us to ask specifically food allergy-
related questions.
    Again I want to underscore, Mr. Chairman, that's not an 
excuse for not doing more in the other. There is indeed a 
pretty good matrix and base of research that goes into 
understanding immunological mechanisms.
    Senator Dodd. You anticipated my next question. How much of 
that money is actually in research?
    Dr. Fauci. It's all. Everything I'm talking about is 
research.
    Senator Dodd. It's all research.
    Dr. Fauci. It's all. Everything that comes out of NIAID and 
NIH is research dollars.
    Senator Dodd. So that $13.4 million is really all research?
    Dr. Fauci. It's all research.
    Senator Dodd. And how does that compare? I'm looking, and 
you're right and I appreciate you mentioning, we have I think 
it's an estimated 1.2 million Americans living with HIV-AIDS, a 
serious problem obviously. I forget the numbers, but the 
numbers are obviously vast in excess of $13.4 million.
    Dr. Fauci. It's $2.9 billion.
    Senator Dodd. Billion.
    Dr. Fauci. Right.
    Senator Dodd. For 1.2 million. Again, we want to be careful 
here, apples and oranges.
    Dr. Fauci. Right.
    Senator Dodd. I'm not trying to suggest somehow that we 
shouldn't be making an effort there. By comparison, with 13 
million people and a growing number--do you see any indication 
that these numbers are sort of leveling off, or do you 
anticipate the increase in the number of people suffering with 
this are going to increase? Any indication on the research 
you've done so far? Are we looking at a growing problem or is 
it one that's stabilizing?
    Dr. Fauci. Again, we don't know, and I think that's the 
reason why we want to wed understanding the basic pathogenic 
mechanisms--it can give us a better feel of what it is that's 
responsible for the increase. Whenever you see an increase, 
there's always two possibilities: either we're recognizing more 
of something that was always there or it's actually increasing. 
I think it's both, but I think--I don't think--I know it's 
unquestionably increasing, and the question is, in order to do 
something about that we've got to figure out what the 
fundamental mechanisms are, are any one or more of those 
hypotheses that I mentioned correct, and if so should we be 
able to use our fundamental knowledge of the pathogenesis to 
make those numbers go down.
    A typical example, Mr. Chairman, is that if something like 
an earlier exposure to an allergen in a population in which X 
percent are predisposed genetically or otherwise to get 
allergy, if you then do that would you then negate a certain 
percentage of those from progressing on to allergy, the way we 
suspect might be going on, for example, in Israel or in China, 
where they process the food differently.
    We need to understand the basic pathogenic mechanism and 
then I'll be able to with confidence answer your question that 
now we know why it's happening, we're trying to do something 
about it.
    The pollutant hypothesis, that's something that as 
pollution keeps going, if in fact that is contributing in some 
manner or form to that, I think that's going to follow the 
curve of how bad pollution is in certain cities.
    Senator Alexander. You talked about jump-starting an effort 
to attract more investigators. What amount of money would it 
take to do that?
    Dr. Fauci. Well, you know, it's interesting. Right now it 
doesn't take as much as you would like to ultimately have. Let 
me explain what I mean by that specific answer. If you said, 
I'm going to put in several hundreds of millions of dollars 
into food allergy right now, we don't have the investigators 
around to spend that money well. We could double what we do 
right now and get people interested in it, and maybe even more 
than that. Once you do that, you'll have an increase that would 
almost be exponential as opposed to linear.
    Quite frankly, Senator Dodd mentioned the whole idea with 
HIV, where we're spending $2.9 billion now because of the--for 
the scope of the problem. Again, we don't want to compare 
apples and oranges, but in the beginning we had very few 
investigators who were interested in studying HIV. Once we got 
a cadre of people, then the amount of funds that we could 
meaningfully spend went like this. In the beginning the 
increases were modest to get people involved in it.
    I think that same sort of phenomenon on a lesser scale, 
obviously, we'll see with training people for doing research 
with food allergies.
    Senator Alexander. Double means twice $13 million?
    Dr. Fauci. Yes.
    Senator Alexander. The $13 million is the number that 
you're spending.
    Dr. Fauci. The $13 million is what we're spending right 
now.
    Senator Alexander. This would be basically to attract 
investigators to a ``hot topic,'' to say, bring us your best 
ideas.
    Dr. Fauci. Bring us your best ideas.
    Senator Alexander. We can have a peer review examination to 
see which are the most promising ideas--
    Dr. Fauci. Exactly.
    Senator Alexander [continuing]. And send them off and see 
what comes of it.
    Dr. Fauci. Right, exactly. Also, it's a signal to young 
people who are coming out of their residencies, who are coming 
out of their fellowships, is what is a field that's attracting 
interest, where I know there's a commitment at every level, at 
the level of the administrations, the Congress, and the 
scientific community and the constituency groups, that we want 
to go after that.
    When they sense that, they're not stupid. When they need to 
make a decision about where they want to go and they see that 
this is a field that's going to be supported, because even a 
field that doesn't attract a lot of interest, once you start 
probing and you start understanding the pathogenic mechanisms 
that's what excites young investigators, that can we probe and 
really figure out what's going on, as opposed to a field that 
looks like it might be a dead end, that nothing really exciting 
is happening.
    The money's going to do two things. It's going to open up 
the doors of knowledge, but it's going to be a good inducement 
for young people to get involved in the field that they know 
people like you and I are interested in pushing the envelope 
on.
    Senator Alexander. This would be an appropriation to NIH 
for this specific purpose?
    Dr. Fauci. Yes.
    Senator Alexander. It seems the allergy--this phenomenon 
seems to have just come out of the blue to most people over the 
last 10 years, though not to the families that have been 
individually affected, but to the public at large. This is new 
to the experience of most people and an alarming thing.
    I had to telephone a friend, whose name I won't mention, 
who I appointed judge 25 years ago when I was governor, and he 
and his wife went out to a reception at a friend's house and 
she had one of these allergies and ate the wrong thing and died 
that night because of it.
    Obviously these have been--the peanut allergy and others--
around for a while, but it does seem like there is an explosion 
of it that we need to understand.
    Let me now go to the other area. It seems like the two 
areas we're focusing on are enough money and the mechanism for 
the research to try and understand what has happened, so we can 
figure out what to do that might immunize or prevent it. The 
other side is awareness, and we're talking about schools. You 
say in your testimony there's a particular problem for children 
in school lunch rooms and other social settings where others 
may minimize or fail to understand the seriousness of the 
allergy.
    We've got 105,000 public schools. In your experience, 
what's the most effective thing we could do to help those in 
school lunch rooms understand the seriousness of this?
    Dr. Fauci. I think all one needs to do is to look at what 
the Chairman himself has been trying to do with his 
legislation, and that is to get the kinds of guidelines and in 
many cases hopefully even mandatory guidelines so that when 
people who go to school, nurses in school, teachers in school, 
understand this problem right up front.
    It's amazing--and even not only in schools, but even in 
some emergency rooms, to educate people. If someone comes in--
and I've seen this myself. It's scary to see. Someone will come 
into an emergency room with an anaphylactic reaction to what is 
apparently or possibly, maybe highly likely, a food allergy, 
you treat the anaphylactic reaction, the person does well, and 
you go out, and you don't inform them that they need to get 
under the care of a physician to investigate what the source of 
that anaphylactic reaction is, what one can do to actually 
prevent it from occurring again.
    It's very heavily steeped in the kind of education and 
pursuing of guidelines that the chairman himself has been 
trying to push.
    Senator Alexander. I'm not trying to be rude. We have 1 
minute before the next vote.
    Senator Dodd. We'll come right back, take a recess for 5 
minutes and we'll be right back. Thanks.
    [Recess.]
    Senator Dodd. The committee will come back to order. Thank 
you, doctor, very much. We won't keep you a great deal longer.
    Senator Alexander. Mr. Chairman, I might have missed the 
last part of his answer. He was saying nice things about the 
guidelines that you're suggesting. What I was trying to make 
sure I understood were the most effective things that we could 
do here, that would take into account that the 105,000 schools 
are different schools in different places--and my old bias as 
governor is that decisions made closer to the child usually are 
better decisions, so to get your advice about how Federal 
guidelines interact with State--might interact with State 
efforts to encourage an awareness in the lunch rooms of food 
allergies, what would your advice be?
    Dr. Fauci. My advice would be to pursue the model from the 
Federal--we all agree, those of us who work at the grassroots 
level, that it's best to have it at that level. But not 
infrequently in guidelines that I've been involved with in a 
variety of diseases, that when the local level are looking for 
guidance they don't like to be dictated down from above, but 
they do use that as a model for the things they incorporate 
locally.
    That's why when I see legislation that is talking about 
setting some guidelines that could serve as standards locally, 
that even if that isn't something that some of the localities 
would embrace the fact that you've set the model, they very 
often very, very closely draw from that model.
    In that respect, the kinds of legislation that I mentioned, 
Senator Dodd's bill that he has proposed and other such 
guidelines, are going to be very important.
    Senator Alexander. Thank you.
    Thank you, Mr. Chairman.
    Senator Dodd. Thank you, very much.
    Let me just pick up. Some of this you've already 
addressed--I was thinking, going over the questions coming 
back, that you mentioned Israel, you mentioned China. I've 
always read it as developed or industrialized countries versus 
less well developed, although Israel is certainly the former, 
although we learned this morning about China and the stories 
about how many gaps exist between poverty and wealth in the 
country--and I've always drawn, when I've read those stories, 
my assumption has been, going back to the first answer you gave 
to the question of why are we seeing more of this, and it's 
the--I'm not going to be terribly technical in this, but the 
idea that we're far more sanitary today.
    In fact, Jackie and I were talking to a woman the other day 
who is about to have a child in June, and we were talking about 
this subject over dinner. She said her gynecologist was 
recommending she drink tap water and not bottled water. I've 
always assumed that the notion of industrialized versus 
developing countries had to do with the quality of sanitation 
in a lot of areas, where we're less exposed to certain 
bacteria, and therefore we don't build up the natural 
immunities to some of them.
    You seem to be suggesting something more than just that.
    Dr. Fauci. No, actually there are a couple of things. It so 
happens that parts of China are a developing country, but there 
happen to be just customs in that country of processing. It has 
to do with two things. Some countries, be they developing or 
not, might process food a little bit differently, that could 
give an unrecognized difference in the allergic response.
    The issue of low-middle income and less hygiene has to do 
with the very powerful hygienic hypothesis, that has not 
necessarily been proven, and the hygienic hypothesis is exactly 
what you say, Mr. Chairman, that you have children running 
around exposed to a lot of environmental antigens from the 
very, very beginning, so their immune system develops what's 
called a regulatory mechanism, so that when they get confronted 
with something that they may be predisposed to have a hyper-
reaction to, they have a lot of control mechanisms in place.
    If you are pristine in your hygiene, you prevent the immune 
system of infants and very, very young children from getting 
that type of normal bombardment of antigens, and then when they 
do see something like a food that they may be predisposed to 
have an allergic reaction to, instead of having a sub-clinical 
or barely recognizable one, they may have a severe one.
    Senator Dodd. Let me jump to the issue of investigators. 
Again, I think I sort of got a chicken and egg answer, I 
thought, from you. The more research money you put out there, 
the more investigators you get. Is that really what needs to be 
done here more than anything else, or is there something else 
we can be doing to attract more investigators to move into this 
area?
    Dr. Fauci. There's both. There's no doubt that the 
investigators go where the money is. If they see a field that's 
really clearly underfunded, they are not going to be associated 
with senior people like Dr. Sampson, who actually are thriving 
in that environment because there's money there for good ideas. 
If there's no money for good ideas, you're not going to have 
young people--it is a chicken and egg hypothesis, Mr. Chairman, 
because if you don't have money to attract the young people 
into training programs like that, then you're cutting off the 
supply of new ideas, because, although there are a lot of 
brilliant older people, some of the crazy, off-the-wall ideas 
come from very young people who are early on and are not jaded 
by a bunch of failures, and they say, ``why don't we try 
this,'' and all of a sudden you have a really brilliant 
hypothesis that's being formulated.
    So it is chicken-egg.
    Senator Dodd. What sort of coordination is there between 
the FDA and what NIAID is doing?
    Dr. Fauci. We communicate and interact with FDA all the 
time, particularly when we are in the process of a clinical 
trial to test a new intervention. We go right from the 
beginning. Unlike some of the old days, where you would do a 
clinical trial and then you'd get a result and then you'd 
present it to the FDA, almost for the first time they're seeing 
what your ideas were, what your hypothesis was, now we start 
with the FDA right from the very beginning.
    Senator Dodd. They've been cooperative. Are they doing any 
work independently that you're aware of?
    Dr. Fauci. Very much so. The FDA does some research. They 
do it in areas such as diagnostics and other types of research. 
Our relationship with the FDA is quite good.
    Senator Dodd. What has NIH done with regard to that 2006 
expert panel, and the recommendations made by the panel? Has 
NIH taken any specific steps on these recommendations?
    Dr. Fauci. Oh, a lot, yes. The expert panels have made a 
number of recommendations that we have been in fact 
implementing. Particularly an important one is to set up a 
panel to look at the safety of certain types of clinical 
trials. We are faced with an interesting, risky issue vis-a-vis 
clinical trials, because when you have a disease that isn't as 
acutely and dramatically life-threatening as anaphylaxis and 
you're going to try an intervention, not infrequently you'll 
test one medication against another or one intervention against 
another, and if you are incorrect there's no dire consequence 
to the patient because it's easy to take care of, it's nonlife-
threatening.
    When you have a disease like anaphylaxis and you're trying 
to see if desensitization or early challenge with a high dose 
versus avoidance, and you're looking at that question, which is 
an absolutely critical question, what happens if you're wrong? 
You can trigger a kind of anaphylactic reaction that could 
actually, and hopefully wouldn't happen but sometimes does, 
kill the subject in the clinical trial.
    The panel that you're referring to has now gotten together 
a group to very carefully set some guidelines about the kinds 
of safety precautions that must be built into a clinical trial 
if you're going to take the safety of young children or anybody 
into risk. Even if the greater good is to get knowledge that 
might help thousands, you still have to worry about the few 
that are in the clinical trial. And we're very heavily involved 
in that.
    Senator Dodd. I'm going to be careful not to quote Dr. 
Sampson, but I heard him yesterday talk about testing we've 
done with animals in these areas, and it's been rather exciting 
and positive in terms of--I can't recall whether he talked 
about--whether we actually tried higher dose exposure and how 
that worked or not.
    Dr. Fauci. It's the hypothesis that we're all cautiously 
excited about, because whenever you're doing biological 
experiments there's often a lot of failures. It's trying to 
test if maybe the original paradigm needs to be stricken down 
and instead of compulsive avoidance when you have the suspicion 
that there might be a food allergy, to actually give the child 
a higher dose of it very early on. We used to refer to that as 
high zone tolerance, namely you bombard the body with something 
and it learns to cope with it because it develops regulatory 
mechanisms and it doesn't bother them after that.
    Senator Dodd. Let me come back to the question I raised 
with you earlier, just addressing asthma as well in this 
context. I asked you about why this seems to be on the rise and 
I thought I understood your answer here. Is it unusual for 
noninfectious diseases to increase with such rapidity? We're 
also seeing the rate of asthma and other allergic and 
immunological disorders. Last week there was World Asthma Day 
and, looking at some numbers, more than 16 million adults, and 
nearly 7 million children have asthma, leading to nearly 1.8 
million emergency department visits and half a million 
hospitalizations each year.
    Again, partly we're better able to detect it. Also--are 
there other examples historically, talking about noninfectious 
diseases, such as these, where we've seen a rapid increase?
    Dr. Fauci. Well, the increases are generally not rapid. 
They are significant and noticeable, and then once they 
increase people start looking for them more and then you get 
the added issue of noticing things more that you wouldn't 
notice.
    What we're seeing is a combination, not only with this--and 
I'll give you an example in a second--that there is clearly 
more of this, and as there is more of it and we do things like 
we're doing today, people generally are going to be more aware 
of it.
    Now, when you have a cataclysmic thing like anaphylaxis, 
everybody notices anaphylaxis. You can't say, ``well, there was 
a lot of anaphylaxis going around, but we didn't notice it.'' 
You notice anaphylaxis when it's there. So that's not the kind 
of thing.
    There are, for example, some noninfectious diseases, some 
of which have to do with environmental or other things that are 
related to behavior. Some things environmental we can't help. 
We did an asthma study in our Inner City Asthma Consortium 
where it was very, very clear that young children, particularly 
minority children living in poorly maintained projects in which 
there were cockroaches, etc, all of a sudden we were seeing an 
incredible rise in that, mostly because of the crowding there.
    When you have air pollution, which stimulates an organ 
system such as the lung to get more hyper-irritated, that is 
something that's noninfectious. There's the eating habits in 
this country which are leading to the epidemic of obesity. 
That's not infection. There is the whole smoking problem that 
we're just starting to see now--I know, I'm sure you read about 
it most recently--that the life expectancy, particularly among 
women, that was going up and up and up, is now starting to 
level off and even come down. We're starting to see the late 
effects of the women having more freedom to go and do what they 
want to do in the sense of society and smoking more. Thirty 
years later, you see lung cancer and heart disease in women 
going up. That's not an infectious disease, but something 
changed. What changed? Women smoked more decades ago.
    There are five or six or seven examples of that.
    Senator Dodd. How about genetics?
    Dr. Fauci. You know, genetics change, but they change over 
generations and generations, and when you get mutations and 
things like that.
    There are things--and it also relates a bit to the kinds of 
things that we're studying with food allergy that are--now that 
we have the genome sequence, we now know all of the different 
components of it, and there are things called single nucleotide 
polymorphisms, or SNPs, and that's just a big word to mean that 
in a stretch of nucleotides--that's a gene that you might have 
and I might have, the same gene--mine is a little bit of what's 
called, has a change or a polymorphism. It's a little bit 
different, which means that I might have a propensity to 
anything from diabetes to schizophrenia to bladder cancer or 
what have you, that even though the gene is very similar 
between you and I, because of that polymorphism I have a 
propensity to that.
    When we learn a lot more about that, we'll be able to 
predict, prevent, and preemptively do things about certain 
diseases. Certainly something like a food allergy may in the 
future--we can't do it now; we don't have the level of 
sophistication of what the genetic propensity is. Once we get 
those kinds of things that are easily doable relatively 
cheaply, we'll be able to tell a family, there's a reasonable 
chance that this might happen, so you better be on the guard 
for that.
    Senator Dodd. How about outgrowing food allergies? We've 
heard certainly in talking to our pediatric allergist that 
there are certain foods where there's a good chance Grace will 
grow out of her allergies to them, and others probably not. 
What percentage--you mentioned earlier--I think you did, 
anyway--that many would outgrow a lot of these and that's the 
good news. Do you have any numbers at all?
    Dr. Fauci. No. If you talk about egg and milk allergies, a 
fair percentage if not the majority of people will outgrow 
that. If you look at peanut allergy, it's different. If you 
look at crustacean allergy, there are adults who, as you say, 
the sad cases, which I've seen myself, if someone goes into a 
restaurant and thinks they're getting X soup and they're really 
getting soup with a little bit of contamination, and they get 
anaphylactic reaction. Adults clearly get that.
    So crustacean and peanut allergies generally not as much as 
something like egg or milk, which you can grow out of.
    Senator Dodd. Well, this has been terrific. You're very 
patient, too. Thank you immensely.
    We'll leave the record open. We may have some additional 
questions to submit to you. It was very, very helpful, and 
thank you for your kind comments about the proposed legislation 
as well. One of the things we do in the bill--the House passed 
a bill. The one difference we have in our bill are the grants, 
$30 million nationwide for schools to apply. It's really more 
the funding and technical assistance in putting these 
guidelines in place that school districts would like.
    The money goes directly to the school district, not to the 
State, going to your point earlier. This would bypass the 
administrative costs in the State, where that money can be lost 
very readily.
    We'll hear in a moment from the Supervisor of School Health 
for West Haven, CT, where again I don't think there was any 
money really available from the State. There may have been. 
Nonetheless, because there were State guidelines it really was 
a great help and assistance.
    Dr. Fauci. Thank you very much, Mr. Chairman, Senator 
Alexander.
    Senator Dodd. Thank you. Glad to have you with us.
    Let me invite our second panel to join us, and I appreciate 
their patience as well. Teresa Walters, our first witness, is 
currently living in Aurora, CO, with her husband Rick and her 
12-year-old stepson. She's with us today because 7 years ago 
Ms. Walters learned firsthand how tragic life-threatening food 
allergies can be. Her son Nathan suffered from a known peanut 
allergy. He was given a peanut butter cookie while on a class 
field trip and had an anaphylactic reaction. By the time 
medical attention was administered, not unlike your story, 
Lamar, she lost Nathan, and that's how quickly this can happen. 
I'm very grateful to Ms. Walters for being here today with us, 
to share with us her story. She's a committed advocate for 
research and educational programs so that other parents don't 
have to experience the same tragedy that she did. We thank you 
immensely for being here with us today. You're very gracious to 
come and tell the story. It's not easy, but it means a lot. If 
we can use this forum as an educational tool, then your 
presence here in some small way will make a big difference in 
other people's lives, and I hope you'll appreciate that. So I 
thank you for coming to be with us.
    Dr. Hugh Sampson, you've already been sort of introduced by 
Dr. Fauci. He's called you a superstar. My introduction is 
modest by comparison, doctor. He is one of the leading experts 
in this area, a professor of pediatrics and chief of the 
Division of Pediatric Allergy and Immunology, Director of the 
Jaffe Food Allergy Institute at the Mount Sinai School of 
Medicine, New York. He's also President of the American Academy 
of Allergy, Asthma and Immunology. We thank you immensely, 
doctor, for being with us.
    Ms. Donna Kosiorowski is someone I know. We spent Monday 
together. She is from West Haven, CT. She is the Supervisor of 
School Health in West Haven, CT. She is also the Connecticut 
Director of the National Association of School Nurses.
    Ms. Kosiorowski started her nursing career in Bridgeport, 
CT in 1971. For 23 years she's been a member of the educational 
team of Connecticut public schools. She and her husband, a 
retired State trooper, reside in Shelton, CT. As I previously 
mentioned, Ms. Kosiorowski and her team graciously hosted me on 
Monday at the Washington Elementary School. I was very 
impressed with what a great job they're doing at that school in 
this area.
    Do you want to introduce Colene?
    Senator Alexander. Sure, I'd like to.
    Colene Birchfield and her family live in Ooltewah.
    Senator Dodd. I couldn't pronounce the name of the town 
anyway.
    Senator Alexander. It's a good Cherokee name, Ooltewah, TN.
    She's a music teacher in an elementary school. She's an 
operatic singer or has been, and choral music, the daughter of 
an Air Force colonel, and we are delighted to have her here 
today to help us understand food allergies.
    Thank you.
    Senator Dodd. Thank you all very much. We'll begin with 
you, Ms. Walters. Thanks for being with us.

        STATEMENT OF TERESA WALTERS, PARENT, AURORA, CO

    Ms. Walters. Chairman Dodd, Ranking Member Alexander, and 
distinguished members of the committee, thank you for inviting 
me here today. It is also a pleasure to address this panel that 
contains my home State Senator from Colorado. This committee is 
doing a great service to the millions of families around the 
country who have children with life-threatening food allergies.
    I'm especially appreciative of Senator Dodd's efforts to 
champion S. 1232 and provide greater resources for schools who 
are struggling daily with the challenges posed by food 
allergies. You've already heard some information about 
childhood food allergies and the speakers that follow me will 
share their perspectives as doctors, nurses, teachers, and 
parents of food-allergic children. You've heard food allergies 
referred to as life-threatening and you may consider that 
overly dramatic. After all, a lot of medical conditions can be 
life-threatening if they're not treated properly. I'm here 
today to share my perspective as a mother who found out 
firsthand what ``life-threatening'' means.
    Almost exactly 7 years ago, my son Nathan died from a 
severe allergic reaction to peanuts. He was 9 years old. 
Nathan's third grade class in Washington State was scheduled to 
go to a local farm along with two additional third grade 
classes. By the time the bus got to the farm, it was close 
enough to lunch time that the school lunches were passed out. 
Lunch consisted of a peanut butter and jelly sandwich, trail 
mix with peanuts, and a peanut butter cookie. A special lunch 
was supposed to have been ordered for Nathan, but it wasn't. He 
received the same lunch as the other kids.
    When he realized what was in his sack lunch, he returned 
the sandwich and trail mix to his teacher and told him that he 
couldn't have those things, he was allergic to peanuts. His 
teacher commended his awareness and Nate returned to his 
friends thinking that he could eat what looked like a sugar 
cookie. Nathan didn't realize that he was eating a peanut 
butter cookie and didn't recognize the taste.
    When he was about halfway through, he commented to his 
friends that his tummy felt funny and alerted his teacher that 
he didn't feel well. His teacher recruited the assistance of a 
parent volunteer who was also a nurse practitioner to sit with 
Nathan on the bus so the other kids wouldn't have to miss out 
on their field trip. Nathan had with him his inhaler and his 
EpiPen.
    Nathan sat on that bus for 2 to 3 hours. When the field 
trip was over, it was decided that a parent would drive Nathan 
home rather than back to school; the nurse practitioner would 
go along. Witnesses say that Nathan was unable to walk 
unassisted at this point and looked like Elephant Man. By this 
time he had been given a few sips of Sprite and his inhaler. He 
was laying down in the back seat and Nathan finally left the 
farm, approximately 3 hours after ingesting a few bites of 
cookie.
    A few minutes into the drive, the nurse practitioner asked 
the parent driver if she thought it was advisable to give 
Nathan his EpiPen. The other parent didn't know what that was, 
but recognized that Nathan was in serious trouble and quickly 
pulled into a fire station a few miles away from the farm. 
Nathan had stopped breathing and his heart had stopped beating 
by now.
    One of the women ran into the fire station and asked if 
oxygen was available. Most of the firefighters were out of the 
station on training, but one of the volunteer firefighters was 
there. He called 911, followed the woman to the car, and he was 
the one who finally administered Nathan's EpiPen. He also began 
CPR.
    Less than 1 minute later, paramedics arrived and took over 
lifesaving efforts while racing to the hospital. I am told that 
the doctors worked on him for over an hour, past the point of 
any hope.
    My understanding is that Nathan might have survived if he 
had been given his EpiPen, especially considering how close 
emergency medical care was. I know he would have survived if 
his health care plan had been followed, if his school had 
received additional training on the severity and risks of food 
allergies.
    As I'm sure you can imagine, the death of my son was simply 
devastating. It was a year before I could even think about 
going back to work and not a day goes by that I don't think 
about him and wonder what he would be doing now if he were 
still here with us. I live in Colorado now and I remarried a 
year ago.
    Fifteen years after being adamant about not wanting to go 
through the terror of possibly having another child with severe 
food allergies, my husband and I recently found out some 
wonderful news: I am 4 months pregnant with our first child 
together. We're doing all the usual pregnancy things--eating 
right, taking care of myself, making sure I get a lot of sleep. 
No doctor can tell me what I can do to make sure that my 
daughter does not develop a severe food allergy like Nathan 
did. The doctors simply don't know why Nathan had a food 
allergy and they can't tell us why so many more are developing 
these life-threatening allergies every year.
    I appreciate what this committee is doing today to focus 
attention on the issue of life-threatening food allergies. This 
issue is not going away. There are a lot of important public 
policy issues facing this Congress and our Nation. Focusing on 
childhood food allergies needs to move up on our priority list. 
I urge you to do what you can to make sure that no parent has 
to endure what Nathan's dad and I have.
    Congress has the power to increase research funding, to 
protect children in the school environment, and to raise public 
awareness so that food allergies are treated like the life-
threatening serious medical condition that they are. Much more 
needs to be done.
    Thank you.
    Senator Dodd. Thank you, very, very much, Teresa; very, 
very compelling testimony. You're a courageous woman. Good 
luck. I'm very excited for you.
    Let me turn to you if I can, Colene. Then we'll come back 
and, doctor, I'm going to ask you to be our last witness, so we 
can hear these other people talk and then we'll hear from you.
    Colene.

            STATEMENT OF COLENE BIRCHFIELD, PARENT, 
                          OOLTEWAH, TN

    Ms. Birchfield. Good afternoon, Chairman Dodd, Ranking 
Member Alexander, and distinguished members of the committee. 
It is my privilege to appear before my home State Senator from 
Tennessee today. I am thankful to the committee for taking the 
time to address this alarming national children's health issue. 
I would also like to express my support for Senator Dodd's 
bill, S. 1232, and applaud the bill's focus in providing our 
Nation's schools with the necessary resources to protect 
children who suffer from life-threatening food allergies.
    When people hear the word ``allergy'' they usually think of 
a runny nose, watery eyes, or sneezing. As I learned when my 
son was 3 months old, life-threatening food allergies are 
something very different. Ryan was given milk formula and 
immediately began showing signs of an anaphylactic reaction. 
Within minutes he was covered head to toe in hives, was 
vomiting, and looked pale.
    We rushed him to the emergency room. With Ryan being so 
young and it being the height of flu season, the ER told us it 
was likely the flu and to just take him home and feed him like 
normal. It wasn't until his second reaction that we learned a 
milk allergy was the cause.
    We spent the next several months educating ourselves as 
much as possible how to live with food allergies. We thought we 
had things covered, only to find out at about 10 months that 
Ryan was also allergic to egg.
    Time is of the essence with any allergic reaction, 
precisely because there is no way to know the severity of a 
reaction in advance. We learned this the hard way. We are 
Ryan's own parents and we almost waited too long to seek 
treatment for him. When he was 6 years old, Ryan had contact 
with both milk and Bermuda grass, to which he is also severely 
allergic. Contact with these allergens caused an anaphylactic 
reaction and it wasn't immediate. Ryan came in from playing 
outside and just said he needed to sit down. He looked pale. We 
initially thought he could just be tired. We sat him down, and 
he immediately started coughing. We gave him Benadryl, as we 
thought he was starting to have a reaction.
    Within a couple of minutes, Ryan started sneezing 
uncontrollably and could hardly breathe. We have a peakflow 
meter with which to test his breathing. When Ryan is healthy 
his peak flow is at 225. At the time of his reaction he could 
barely hit 25.
    At this point we decided we had to give Ryan the 
epinephrine. While my husband injected Ryan, I called 911. 
Epinephrine saved our son's life that day. We spent the night 
in the ER and came home more afraid than ever, but in a way 
also empowered that we had been able to handle the situation.
    Then I thought, if it took me, his mother, that long to 
react, how long will it take if the reaction happens at school? 
Do educators and school staff know enough to be able to handle 
such a life-threatening situation in a timely manner? What 
would the kids in his classroom do? Consider the teacher, 
babysitter, or sports coach who now needs to distinguish 
between the common cold and a life-threatening allergic 
reaction.
    Efforts to protect our children in school and other social 
settings are very important. However, what we need more than 
anything else is research to find a cure for life-threatening 
food allergies. Ryan participated in an exciting research study 
based at Duke University Medical Center in North Carolina. On 
each visit Ryan was given small amounts of milk protein, 
exposing him to the very thing to which he is deathly allergic. 
The hope was that over time he would build up a sort of 
immunity--they call it de-sensitization--and would be able to 
tolerate milk later in his life.
    The first visit caused an anaphylactic reaction almost 
immediately. The doctors and nurses were very well prepared, 
but it was still frightening.
    I was asked by a friend who has a child with a peanut 
allergy how I could sit there and purposely cause my son to 
have that reaction. My answer is simple: How could I not afford 
him the opportunity for a lifetime without the risk of this 
type of reaction occurring again? We are willing to subject our 
son to this kind of risk because he faces a greater risk every 
single day of his life simply by living in a world filled with 
foods that can harm him.
    Our participation in the Duke study is a good example of 
just how desperate parents of food-allergic children are to 
find any kind of relief for our children. Research is our only 
hope for a long-term solution to these deadly allergies. 
There's no distance I wouldn't travel for the possibility of 
alleviating the daily risk Ryan faces. The old saying ``No 
risk, no reward'' is how I feel about the research. There's 
never a guarantee that these research studies are going to cure 
my child, but how could I not afford him the opportunity to 
try.
    There's currently no treatment for life-threatening food 
allergies. Instead, children and their families must maintain a 
constant level of vigilance to avoid any kind of contact with 
the allergenic food. My child is allergic to milk, egg, and 
peanuts, and avoiding these staples of the American food supply 
is a constant struggle.
    When people hear that a child has a food allergy, they 
often only look for that main word, i.e. ``milk'' or 
``peanut,'' on the ingredient list to tell whether a food 
includes that allergen. What they don't realize is that an 
allergy to milk, for example, means that the child cannot come 
into contact with any food containing any one of the many milk 
proteins that exist. If you don't read the label correctly your 
child's life could be at risk.
    Mitigating risk for an infant is far simpler than when they 
enter the school system. My personal experience with schools is 
that the focus is primarily on peanut food allergies. While I 
am grateful that there is some awareness of the impact of a 
peanut allergy in a social or public situation, I think it's 
important for schools to understand that the potential for a 
life-threatening reaction is also present for those with other 
food allergies.
    We also found that each school, regardless of whether they 
are in the same county, has their own guidelines for how to 
handle children with food allergies in a social setting. When 
registering my children for our current schools, I found out 
that the protocol is to lock the medication in the nurse's 
office. All the staff members are trained to use an EpiPen, but 
in the time it would take for a staff member to go to the 
nurse's office, unlock the medication, and bring it to him, 
Ryan could die.
    The school lunch room poses a host of other challenges. 
When Ryan entered school there was another child enrolled who 
had a severe peanut allergy and the school accommodated that 
child by allocating a peanut-free table. I was told that Ryan 
could and should sit at the peanut-free table. While the school 
saw this as a safety precaution, Ryan is allergic to more than 
just peanuts. He was now sitting at a table with a child who 
certainly wouldn't have peanuts, but did bring Cheetos and egg 
products daily to the table and was sitting within inches of 
Ryan. This solution didn't help mitigate the risk for Ryan and 
it separated him from his own class. That is why it's so 
important to educate schools that one-size-does-not-fit-all 
when it comes to food allergies.
    Each and every day Ryan is placed in scenarios beyond his 
or our control. Children like Ryan are vulnerable to allergic 
reactions not only at school cafeterias and restaurants, but in 
any public setting, from birthday parties to an afternoon spent 
at a friend's house.
    As children grow up they are going to test boundaries and 
push limits. It's a natural part of their maturation process. 
With a food-allergic child, the teenage years can be 
particularly frightening as the kids struggle to fit in and 
prove their normalcy. One of my greatest fears is that my son 
will play down or try to hide his allergies from his peers out 
of a desire to not want to be different. If the people around 
him do not understand his allergies, they can't help him in a 
emergency situation.
    You, members of the U.S. Senate, can help my son and 
millions of other children like him. Establishing Federal 
guidelines and resources for the management of food allergies 
in schools is essential to protect our children who suffer from 
this life-threatening medical condition. There are only a 
handful of research centers like Duke around the country that 
are currently doing any kind of food allergy research.
    We have personally been forever affected by this research. 
As of November 2007, because of Duke's research on milk de-
sensitization, Ryan is able to tolerate milk without reaction. 
We are a unique glimpse at what can be accomplished. Much more 
research can and needs to be done. We need new research 
studies, more researchers and doctors investigating the 
disease, and funding to allow the best scientific minds in the 
field to find a cure. We need advocates for our children to 
educate the public on just how serious this disease is and to 
urge the entire community to cooperate in the vital mission of 
keeping our children safe.
    Like any parent, I simply want my child to have the 
opportunity to grow and flourish in his life and to reach his 
potential without limitations. On behalf of Ryan and the 
millions of other kids just like him, I thank you for your 
consideration of this vital funding need. Please understand 
that supporting these efforts will truly make a difference 
forever in many families' lives.
    [The prepared statement of Ms. Birchfield follows:]

                Prepared Statement of Colene Birchfield

    Good afternoon Chairman Dodd, Ranking Member Alexander and 
distinguished members of the committee. It is my privilege to appear 
before my home State Senator from Tennessee today. I deeply appreciate 
the opportunity to help the committee gain a greater understanding of 
the personal difficulties that food allergic children and their 
families face every day. The number of children suffering from life-
threatening food allergies is dramatically increasing nationwide, and I 
am thankful to the committee for taking the time to address this 
alarming national children's health issue.
    As an educator--I teach music education to elementary school 
children at Apison Elementary School in Ooltewah, TN--I would also like 
to express my support for Senator Dodd's bill, S. 1232, and applaud the 
bill's focus in providing our Nation's schools with the necessary 
resources to protect children who suffer from life-threatening food 
allergies. Senator Dodd's bill, and the committee's recognition of the 
importance of childhood food allergies, is encouraging, but there 
remains much to be done in the effort to prevent and cure food 
allergies.
    When people hear the word ``allergy,'' they may think of a runny 
nose or the sniffles. As I learned when my son Ryan was 3 months old, 
life-threatening food allergies are something very different than hay 
fever--and parents like me literally fear for our children's lives 
every day because an allergic individual's reaction to food can be so 
severe. Probably the scariest aspect of an allergic reaction to food is 
that each reaction can manifest in a different way. While one reaction 
might begin with a rapid succession of sneezing, another reaction may 
begin with lethargy, or hives. It's difficult enough for a parent to 
sometimes realize that their own child is having a reaction. Imagine a 
teacher who now needs to distinguish between the common cold and an 
allergic reaction. Our experience has been that many teachers just 
haven't been given the proper amount of education to understand how to 
identify a reaction and then how to treat one.
    At 3 months old, Ryan was given milk formula and immediately began 
to vomit. Within minutes, he was covered head to toe in hives. Without 
hesitation, we took him to the emergency room. With Ryan being so 
young, and it being the height of flu season, the ER told us it was 
likely the flu and to just take him home and feed him like normal. 
Since I was mostly breast feeding at the time, it took probably another 
week before Ryan was fed another formula bottle. At that time, he 
reacted in the exact same way. We again rushed to the ER. This time, 
the doctor confirmed that a milk allergy was the likely culprit. Ryan 
needed to stay in the ER for several hours and be monitored to ensure a 
secondary reaction didn't occur. My husband and I were overwhelmed, as 
neither of our families had any members with food allergies. We spent 
the next several months educating ourselves as much as possible how to 
live with food allergies. We thought we had things covered, only to 
find out at about 10 months that Ryan was also allergic to egg. We had 
fed him a jar of baby food that contained egg. This time, Ryan first 
swelled up around his mouth and broke out into hives. We recognized 
this reaction, even though it started a bit differently and immediately 
gave him the Benadryl. Thankfully, he had only had a bite and we were 
able to contain that reaction at home. It wasn't until he was a year 
old that Ryan was finally able to be formally tested for food 
allergies. The tests confirmed that he was severely allergic to both 
milk and egg. With Ryan now eating table food, we sprung into action to 
educate everyone around us. We carried cards that contained key words 
to identify the proteins for egg and milk that would help us with 
reading ingredients. Often times, we find that when people hear that a 
child has a food allergy, they only look for that main word (i.e., milk 
or egg) to tell whether a food includes that allergen. What they don't 
realize is that an allergy to milk for example, means that the child 
cannot come into contact with any food containing any one of the 19-
some odd milk proteins that exist. When reading labels, we must be 
diligent to look for all the variations of these protein words.
    There is no ``treatment'' for life-threatening food allergies. 
Instead, children and their families must maintain a constant level of 
vigilance to avoid any kind of contact with the allergenic food. My 
child is allergic to milk, egg and peanut and avoiding these staples of 
the American food supply is a constant struggle. Here's an experiment 
you can try at home--go to your pantry and try to find even five foods 
that do not contain milk, egg or peanut. Now imagine that if you didn't 
read the label correctly, your child's life could be at risk. It is 
heart-wrenching from a parent's perspective to know that even with a 
high level of individual and parental responsibility, my child could 
still be endangered by a well-intentioned but unedu-
cated teacher, caregiver, sports coach or even a server in a 
restaurant.
    As you can imagine, mitigating risk for an infant is far simpler 
than when they enter the school system. When Ryan began pre-school and 
then grade school, we were faced with a whole new world of 
complications for managing his medical condition. While some school 
systems have a broad program for handling medication, many individual 
schools have discretion to develop further, their own protocol for 
handling individual situations. My personal experience with schools is 
that the focus is primarily on peanut food allergies. While I am 
grateful that there is some awareness for the impact of a peanut 
allergy in a social/public situation, I think it's important for 
schools to understand that the potential for a life threatening 
reaction is also present for those with other food allergies. When 
registering my children for our current school, I was told that the 
school nurse is only in the building 2 days/week. This school's 
protocol is such that they lock medication in the nurse's office. All 
staff members are trained to use an EpiPen, of which we were thankful. 
The problem, as I explained to the staff, was that in the time it would 
take for a staff member to go to the nurse's office, unlock the 
medication, and bring it to him, Ryan could die. Oftentimes, I get 
looked at and even remarks that I am being overly dramatic. They fail 
to realize that the rapid progression of anaphylactic reaction is a 
clearly documented medical emergency and should be treated as such. I 
insisted that Ryan needed to have the medication with him at all times. 
Time is of the essence in the event of any reaction. Going from a mild 
to a sever reaction can take seconds. I asked the school how they 
handle the lunchroom for children with allergies. This was the first 
year that our school has had a child with food allergies. There was 
another child enrolled who has a severe peanut allergy and the school 
accommodated him by allocating a ``Peanut-Free'' table. There is very 
limited space in the cafeteria, so this was the only exception made. I 
was told that Ryan could and should sit at the peanut-free table. While 
the school saw this as a safety precaution, I saw it as just as large a 
risk as if Ryan were integrated with all the other kids at any other 
table. The reason being, Ryan is allergic to more than just peanuts. He 
was now sitting at a table with a child who certainly wouldn't have 
peanuts, but did bring Cheetos and egg products daily to the table and 
was sitting within inches of Ryan. This solution didn't help mitigate 
the risk for Ryan and it separated him from his own class. I will never 
feel entirely comfortable with the cafeteria situation, but I do know 
that I've educated the students in Ryan's class enough that they truly 
look out for him at lunch. Ryan now eats lunch with his class. He 
brings a ``placemat'' to put his food on, as the tables just get wiped 
off and not washed. Ryan's teacher delivers his medication to the 
lunchroom with Ryan each and every day.
    As I said earlier, time is of the essence with any reaction. We 
learned this the very hard way. I share my story of Ryan's anaphylactic 
reaction to everyone who is willing to listen. We are his parents and 
we almost waited too long. Ryan had what one ER doctor we saw called a 
``perfect storm'' reaction. He had contact with both milk and Bermuda 
grass, to which he is also allergic. Contact with these allergens 
caused an anaphylactic reaction. Ryan came in and just said he needed 
to sit down. He looked pale. We sat him down and he immediately started 
coughing. Now, Ryan had been playing outside, so we initially thought 
he could just be tired. Well, only seconds passed and we decided we 
better give him Benadryl, as we thought he was starting to have a 
reaction. Within a couple of minutes, Ryan started sneezing 
uncontrollably and could hardly breath. We have a peak flow meter with 
which to test Ryan's breathing. When he is healthy, Ryan's peak flow is 
at 225. At the time of his reaction, he could barely hit 25. At this 
point, we decided we had to give Ryan the epinephrine. While my husband 
injected, I called 911. Epinephrine saved our son's life that day. We 
spent the night in the ER and came home more afraid than ever, but in a 
way, more empowered that we were able to handle the reaction.
    The first thought that entered my mind when I came home was how 
fearful I am that if it took me, his mother, that long to react, how 
long will it take if the reaction happens at school? Do educators know 
enough to be able to handle such a life threatening situation in a 
timely manner? Do the kids know enough to tell that something is not 
right with Ryan?
    Parents have to rely on everyone around their child to manage his 
food allergy. That's a scary scenario. Even simplicities such as 
playing on a playground are concerns for those with food allergies. 
While there isn't always food present on the playground, the risk is 
still present. Imagine a child who ate peanut butter and jelly and got 
peanut butter on their hands. They have not washed their hands and then 
go out to the playground. When the child who now has peanut residue 
touches the playground equipment, my child now becomes at risk. Ryan 
can react simply by touching something that contains the food residue 
to which he's allergic. Food allergy awareness and education needs to 
encompass the many different ways a child can be exposed. Many parents, 
myself included, with children who have severe food allergies carry 
wipes around and clean areas where their children play. We walk around 
perceived as being overly-protective, or perhaps even crazy, paranoid 
parents--just to try and reduce risk wherever possible. We're NOT 
crazy. We're scared. Allergen protein can be as life threatening to my 
child as a gun in the hands of a toddler.
    Each and every day Ryan is placed in scenarios beyond his or our 
control. Children like Ryan are vulnerable to allergic reactions not 
only at school cafeterias and restaurants, but in any public setting, 
from childhood parties to an afternoon spent at a friend's house. Ryan 
has been invited to a sleepover at a classmate's home. I could not 
allow him to attend, because of his food allergies. There's just not 
enough understanding by the general public as to how serious this is. 
Ryan recently attended a birthday party where kids were jumping on a 
trampoline. The birthday boy had a bag of Cheetos in his hand and 
decided to jump on the trampoline with them. Ryan immediately told the 
boy he couldn't be around him if the child was going to have Cheetos on 
his hand, as it could hurt him. Ryan proceeded to get off the 
trampoline and would not go back on. Seems like such a simple thing to 
most people. To me, that was a huge victory. I've educated Ryan enough 
that he is able to stand up for his own safety. I can only hope and 
pray that this will continue. As children grow up, they are going to 
test boundaries and push limits--a natural part of the maturation 
process. With the food allergic child, the teenage years can be 
particularly frightening as the kids struggle to fit in and ``prove'' 
their normalcy. One of my greatest fears is that my son will play down 
or try to hide his allergy from his peers out of a desire to not want 
to be ``different.'' If the people around him do not understand his 
allergies, they cannot help him in an emergency situation.
    Efforts to protect our children in school, and other social 
settings are very important. However, what we need more than anything 
else is research to find a cure for life-threatening food allergies. 
Ryan participated in an exciting research study based at Duke 
University Medical Center in North Carolina. On each visit, Ryan was 
given small amounts of milk protein, exposing him to the very thing to 
which he is deathly allergic. The first visit caused an anaphylactic 
reaction that came on with rapid speed. The doctors and nurses were 
very well prepared, as they expected this type of reaction. I was asked 
by a friend who has a child with a peanut allergy how I could sit there 
and purposely cause my son to have that reaction. Well, my answer is 
simple. How could I not afford him the opportunity for a lifetime 
without the risk of this type of reaction occurring again? The hope was 
that, over time, he would build up a sort of immunity--they call it 
desensitization--and would be able to tolerate milk later in his life. 
Our participation in the Duke study is a good example of just how 
desperate parents of food allergic children are to find any kind of 
relief for our children. We drove 7\1/2\ hours each way to get to Duke 
because there are no facilities that we know of closer to home that are 
doing this kind of work. We stayed in town near Duke when we would have 
to make the visits and there was a constant danger that my son would 
have a severe, adverse reaction to the treatment. In fact, numerous 
times, Ryan had little mini reactions, like hives on his back or a few 
coughs. The doctors are, after all, feeding him something that could 
kill him.
    Why are we willing to subject our son to this risk? Because he 
faces a greater risk every single day of his life simply by being 
surrounded by foods that can harm him. Research is our only hope for a 
long-term solution to these deadly allergies. There's no distance I 
wouldn't travel for the possibility of alleviating the daily risk Ryan 
faces. You know, the old saying ``No Risk, No Reward'' is how I feel 
about the research. There's never a guarantee that these research 
studies are going to ``cure'' my child. To not participate is almost 
guaranteeing the status quo--enrolling in the study offers hope. At the 
very least, we've contributed to the research. At best, we may have 
found a way to live without fear that our child could die from food.
    You can help us. Millions of parents just like me are counting on 
the U.S. Congress to increase the amount of research that is conducted 
on life-threatening food allergies. There are only a handful of 
research centers like Duke around the county that are currently doing 
any kind of food allergy research. After 11 months of participation in 
Duke's Research Study, Ryan is now able to tolerate milk. This is a 
huge victory for both Ryan and the study itself. Ryan can now come into 
contact with any milk protein and not have to reach for the EpiPen. The 
study has proven to work in his case. There is still much more research 
to be done. For example, we know that as long as Ryan has a daily dose 
of milk protein, he's ok. What we don't know is what happens if he goes 
without for days on end. This is where the research still needs to 
continue. We are a unique glimpse at what can be accomplished. The 
Federal Government currently spends under $10 million a year funding 
research on food allergies. That is simply not enough. We need new 
research studies, more researchers and doctors investigating the 
disease, and funding to allow the best scientific minds in the field to 
find a cure.
    Like any parent, I simply want my child to have the opportunity to 
grow and flourish in his life, and to reach his potential without 
limitations. On behalf of Ryan and the millions of other kids just like 
him, I am begging for your help.
    Thank you!

    Senator Dodd. Excellent testimony. Thank you very, very 
much, Colene. We appropriate it.
    Donna, nice to have you with us again.

STATEMENT OF DONNA KOSIOROWSKI, RN, MS, NCSN, SUPERVISOR SCHOOL 
 HEALTH, WEST HAVEN SCHOOL DISTRICT, AND CONNECTICUT DIRECTOR, 
 NATIONAL ASSOCIATION OF SCHOOL NURSES, WEST HAVEN, CONNECTICUT

    Ms. Kosiorowski. Thank you, Mr. Chairman, Mr. Alexander, 
and members of the subcommittee. It was my privilege to have 
you visit us in West Haven and it's my privilege to testify 
before you now. I'm also very honored to be here as a 
representative of the National Association of School Nurses.
    I commend the subcommittee for bringing attention to the 
fact that more needs to be done regarding food allergy and 
anaphylactic management in schools. My testimony will explain 
that school nurses are indeed seeing more and more children 
with food allergies, and I'm also going to share some of my 
personal experience with the issue during my 23 years as a 
school nurse. I'd like to offer Connecticut's response to these 
life-threatening incidents in school as a model for other 
States.
    School nursing today is very different than it was years 
ago. Even the last 10 years has seen drastic changes in school 
health. With inclusion, school nurses are now required to take 
care of every student and every health need.
    School nurses definitely do report an increase among 
students with food allergies. Approximately 5 to 6 percent of 
the general pediatric population has an incidence of food 
allergy. However, children with food allergies can have good 
school attendance with a school nurse there to keep them 
healthy and safe while they're at school with us. I think 
you'll agree that healthy children learn better.
    Therefore, school nurses are working toward ensuring that 
all school districts will have the opportunity to consider 
adopting Federal guidelines concerning the management of food 
allergies. Health needs and problems are not something that 
children leave at home. When they come to spend 6 or 8 hours a 
day in school with us, their health problems and needs come 
with them.
    A recent law in Connecticut required the State Department 
of Education to develop guidelines for managing food allergies 
in our schools. The management plans allow for consistency when 
developing standardized and individualized health care plans 
for children throughout their school career.
    With or without guidelines for food allergy management, 
schools are still obligated to maintain the health and safety 
of all students, including those with food allergies. Therefore 
it is necessary for the Secretary of Health and Human Services 
to consult with the Secretary of Education on the development 
of a voluntary policy for managing the risk of food allergy and 
anaphylaxis in schools.
    In States like Connecticut we are very fortunate because we 
have a high ratio of school nurses to students. We have a plan 
of care developed and implemented by the school nurse. In a 
State like Tennessee, guidelines are on the books, but in 2007 
Tennessee ranked 40th in the Nation for the school nurse-to-
student ratio, which means that on average there's 1 nurse for 
1,628 students. Who will be there in schools without nurses to 
implement the guidelines and ensure the safety of children 
needing rescue medication like epinephrine?
    Having school-based food allergy management grants would 
greatly help local educational agencies throughout the country 
in need of creating and implementing the guidelines.
    I'd like to spend the rest of the time I have sharing some 
reactions and how we make a difference in the lives of real 
school children when you prepare properly. Anaphylaxis has 
different symptoms in different people. Before there were 
guidelines, a girl with known food allergies--I call her 
``Sarah''--went to the nurse three times in the same day 
complaining about a stomach ache. On the third time that the 
nurse sent her back to class, Sarah never made it. She died of 
an anaphylactic reaction.
    This tragedy was clearly a result of not having a 
standardized plan in place and a nurse who was not properly 
trained to recognize the symptoms related to anaphylaxis. Lack 
of training plus no guidelines is a recipe for disaster.
    On a positive note, a family recently came to Connecticut 
from another State and wanted to register their little boy for 
kindergarten. The mother told the school nurse--and that school 
nurse was Sue, Senator Dodd--that her child, who I'll call 
``Danny,'' had severe food allergies and had been hospitalized 
several times for anaphylaxis. The mother claimed Danny had 
been denied entry to school in the other State because there 
was no plan in place for a child with his special needs.
    The nurse was able to assure the mother that the 
Connecticut school district was ready and able to accommodate 
her child. Because of Connecticut's strong guidelines and 
proper training of nurses and school personnel, Danny has 
remained safe in school with us the entire time he's been in 
our district.
    On behalf of the National Association of School Nurses, I 
urge this subcommittee to move legislation that will provide a 
voluntary policy for managing food allergy and anaphylaxis in 
schools and will establish school-based food allergy management 
grants. Food allergies are the ghost in the room. When they 
make their presence known, school nurses and school staff must 
be fully prepared to make sure no child succumbs to a 
preventable medical emergency.
    Thank you.
    [The prepared statement of Ms. Kosiorowski follows:]

         Prepared Statement of Donna Kosiorowski, RN, MS, NCSN

    Mr. Chairman, Mr. Alexander, and members of the subcommittee, I am 
Donna Kosiorowski, a practicing School Nurse Supervisor from West 
Haven, CT School District, who is privileged to be here today 
representing the National Association of School Nurses (NASN) on the 
issue of addressing food allergies in schools. I commend the 
subcommittee for bringing attention to the fact that more needs to be 
done to prepare our Nation's schools to manage the risk of food allergy 
and anaphylaxis.
    My testimony will explain that School Nurses are seeing increasing 
numbers of students with food allergies and the essential need to be 
prepared in the event a student has an anaphylactic reaction. I will 
also share with the members of the subcommittee personal experience 
with this issue over the course of my 23 years in school nursing and 
offer Connecticut's response to these life threatening incidents in 
school as a model for other States.
    NASN's membership of over 13,000 School Nurses are performing 
duties today that go well beyond what school nursing was like 30-40 
years ago when health care costs were affordable and children with 
chronic health conditions were not ``main-streamed.'' Even over the 
last 10 years, there have been rapid societal changes reflected in 
schools. Today, Federal laws like the Individuals with Disabilities 
Education Act (IDEA), result in children attending school in wheel 
chairs, on tube feedings, ventilators, central lines, pumps and other 
complex technologies. School Nurses are there to meet the needs of all 
students and the importance of managing life-threatening food allergies 
in the school setting is something that School Nurses are currently 
addressing. This life-threatening issue is recognized by NASN through 
the position statements we have included with our testimony and the 
informational resources we provide to our members.
    School Nurses report an increase in the types of food allergies and 
other allergies in their school population. Approximately 5 to 6 
percent of the general pediatric population have an incidence of food 
allergy, with eight foods (peanuts, shellfish, fish, tree nuts, eggs, 
milk, soy, and wheat) accounting for 90 percent of allergic reactions. 
However, children with food allergies can have good school attendance 
when a School Nurse is there to help them be healthy and safe at 
school. I think you will agree with the research that Healthy Children 
Learn Better. Knowing that healthy children learn better, School Nurses 
are working towards ensuring that all school districts will have the 
opportunity to consider adopting Federal guidelines concerning the 
management of food allergies. Health needs and problems are not 
something children can leave at home. When they come to school, their 
health needs and problems come with them. They spend 6-8 hours per day 
at school. Data clearly demonstrate that fatalities associated with 
anaphylaxis occur more often away from home and are associated with the 
absence or delayed use of epinephrine. The School Nurse is a reliable 
and trusted health care provider and parents feel comfortable 
consulting with the School Nurse. It is the School Nurse who is often 
the child's first and only access into the health care system. We 
provide frontline care and if society wants children ``not to be left 
behind,'' then nurses need to be there to help them stay healthy and in 
school so they can achieve academic success.
    Now let me share with you Connecticut's 2006 law requiring the 
State Department of Education to develop guidelines for managing food 
allergies in school, which includes Food Allergy Management Plans. The 
Management Plan is the basis for the development of guidelines 
implemented at the school level and provide for consistency across the 
State and in schools. The guidelines clearly outline prevention, 
education, awareness, communication and emergency response.
    Consistency is important because all children must have 
standardized and appropriate individualized health care plans, 
developed through a formal process. This is protection for the children 
and families and consistency helps to prevent litigations. Plans should 
be based on medically accurate information and evidence-based practices 
using a process to identify, manage, and ensure continuity of care for 
students throughout their school career. Connecticut law allows School 
Nurses to train teachers, principals, coaches, and, in the case of 
epinephrine auto-injector, paraprofessionals, to administer medications 
to students with known allergies, not limited to food.
    With or without guidelines for food allergy management, schools and 
school boards are obligated to maintain the health and protect the 
safety of any child with a health problem, including food allergies. 
Therefore, it is necessary for the U.S. Secretary of Health and Human 
Services to consult with the Secretary of Education on the development 
of a voluntary policy for managing the risk of food allergy and 
anaphylaxis in schools so that children are protected in a research-
based and consistent manner. The Federal mandates of IDEA and Section 
504 of the Rehabilitation Act require schools that receive Federal 
funding to provide certain medical services. In fortunate States, like 
Connecticut, who have a high ratio of school nurses-to-students, a plan 
of care is prepared and implemented by the school nurse. In a State 
like Tennessee, there are guidelines on the books, but the school 
nurse-to-student ratio is ranked 40th in the Nation, which means that 
on average there is 1 nurse: 1,628 students. Who will be there in those 
schools without nurses to implement the guidelines and ensure the 
safety of the children needing ``rescue medication'' like epinephrine? 
Having school-based food allergy management grants would greatly help 
local educational agencies throughout the country who are in need of 
creating and implementing guidelines, and hopefully as a result more 
school nurses will be placed in the schools to lead the effort.
    Following are actual examples of how preparations for possible 
anaphylactic reactions make a difference in the lives of real school 
children.
    Anaphylaxis has different symptoms in different people. Before 
Connecticut had their guidelines in place and they were implemented 
throughout the State, a girl with known food allergies, who I will call 
Sarah, came to the school nurse complaining of a stomach ache. Three 
times throughout the course of the day, the nurse sent her back to 
class. On her last trip back to the classroom, Sarah died from an 
anaphylactic reaction. This tragedy was clearly a result of not having 
a standard plan in place and a nurse who had not been properly trained 
to recognize all of the symptoms related to anaphylaxis. Lack of 
training plus no guidelines is a recipe for trouble.
    On a positive note, when a family recently came to Connecticut from 
another State and wanted to register their little boy for kindergarten, 
the mother told the school nurse that her child, who I will call Danny, 
had severe food allergies and had been hospitalized several times for 
anaphylaxis. She further stated that the hospitalizations required 
intensive care and a tube to help him breathe. The mother claimed Danny 
had been denied entry to the school in the other State because there 
was no plan for ``a child like him'' and his health condition could not 
be managed safely in school. The previous school suggested 
consideration of home schooling. When coming to Connecticut, the mother 
was armed with information and knew the laws were on her side. The 
family was prepared to fight to get Danny into school with a plan to 
accommodate his special needs. Fortunately, the nurse was able to 
assure the mother that the Connecticut school district was ready and 
able to accommodate her child. Because Connecticut has strong 
guidelines, and nurses and other appropriate school staff have been 
trained for emergency situations, including established procedures with 
community EMS providers, Danny has remained safely in school.
    Guidelines are a safeguard and protect both the child and the 
school district. Lack of guidelines can result in litigation and 
ultimately tragic deaths, as I described earlier. In Connecticut, I am 
aware of two court cases that were won by the school district because 
guidelines were implemented, individualized health care plans put in 
use, and staff training provided. Having a school district with every 
nurse trained to apply the same standard of care based on current 
guidelines is an ideal situation which has been honored by the courts. 
State guidelines give nurses a place to start and a process to follow 
which safeguards the student and the districts throughout the State. 
Although voluntary, the issuance of Federal guidelines would greatly 
help support students who move from one State to another.
    On behalf of the National Association of School Nurses, I implore 
this subcommittee to move legislation that will provide a voluntary 
policy for managing the risk of food allergy and anaphylaxis in schools 
and will establish school-based food allergy management grants. With 
the growing number of students affected by food allergies, it is 
imperative that School Nurses have the support of the Federal and State 
governments for the development of individualized health care plans, 
emergency plans, and procedures for safe medication administration and 
storage. Food allergies can be like a ghost hiding in the room. When 
they make their presence known, School Nurses want to stand fully 
prepared to make sure each and every child does not succumb to a 
preventable medical emergency.
                                 ______
                                 
   National Association of School Nurses (NASN), Position Statement--
      The Role of School Nurses in Allergy Anaphylaxis Management

                                HISTORY

    Anaphylaxis can be deadly to children as well as adults. Among the 
general population, 1 to 2 percent are described as at risk for 
anaphylaxis from food and insects and a somewhat lower percentage are 
at risk from drugs and latex. Approximately 5 to 6 percent of the 
general pediatric population have an incidence of food allergy, with 
eight foods (peanuts, shellfish, fish, tree nuts, eggs, milk, soy, and 
wheat) accounting for 90 percent of allergic reactions. Food allergies 
are, in fact, the leading cause of anaphylaxis outside the hospital 
setting, accounting for an estimated 30,000 emergency room visits 
annually. It is estimated that 100 to 200 people die each year from 
food allergy-related reactions, and approximately 50 people die from 
insect sting reactions.

                          DESCRIPTION OF ISSUE

    Care must be taken to differentiate between a true allergic 
response and an adverse reaction. True allergies result from an 
interaction between the allergen and the immune systems. Anaphylaxis is 
a potentially fatal reaction of multiple body systems. It can occur 
spontaneously. Data clearly demonstrate that fatalities associated with 
anaphylaxis occur more often away from home and are associated with the 
absence or delayed use of epinephrine.

                               RATIONALE

    Education and planning are key to establishing and maintaining a 
safe school environment for all students. Those responsible for the 
care and well-being of children must be aware of the potential dangers 
of allergies. Prevention of allergy symptoms involves coordination and 
cooperation within the entire school team and should include parents, 
students, school nurses, and appropriate school personnel. Early 
recognition of symptoms and prompt interventions of appropriate therapy 
are vital to survival.

                               CONCLUSION

    It is the position of the National Association of School Nurses 
that schools have a basic duty to care for students, utilizing 
appropriate resources and personnel. School nurses are uniquely 
prepared to develop and implement individualized health care plans 
within State nurse practice act parameters and to coordinate the team 
approach required to manage students with the potential for 
experiencing allergic reactions.

                          REFERENCES/RESOURCES

American Academy of Allergy, Asthma and Immunology Board of Directors 
    (1998). Position Statement--Anaphylaxis in Schools and Other Child-
    Care Settings. Journal of Allergy Clinical Immunology: 102(2), 173-
    175.
Food Allergy Network (2001). Information about anaphylaxis: Commonly 
    asked questions about anaphylaxis. www.foodallergy.org.
Mudd, K. E. & Noone, S. A., (1995). Management of severe food allergy 
    in the school setting. Journal of School Nursing: 11(3), 30-32.
National Association of School Nurses (2000). Position Statement--
    Epinephrine Use in Life-Threatening Emergencies. Scarborough, ME: 
    Author.

Adopted: November 2001.
                                 ______
                                 
   National Association of School Nurses (NASN), Position Statement--
            Epinephrine Use in Life-Threatening Emergencies

                                SUMMARY

    It is the position of the National Association of School Nurses 
that school nurses create and manage the implementation of emergency 
care plans for the treatment of life-threatening allergies in the 
school setting. State regulations, including nurse practice acts, will 
govern the need for protocols, standing orders, and/or individual 
orders for epinephrine administration.

                                HISTORY

    An increasing number of school students and staff have diagnosed 
life-threatening allergies, an abnormal immunologic response. Exposure 
to the affecting allergen can trigger anaphylaxis, an overwhelming 
systemic response, characterized by drop in blood pressure, respiratory 
distress, loss of consciousness, and potential death. Anaphylaxis 
requires emergent medical intervention with an injection of epinephrine 
but does not eliminate the need to call Emergency Medical Services 
(EMS). Epinephrine injection will stop the allergic response by opening 
the bronchiole airway passages for 10-20 minutes until more 
comprehensive emergency medical intervention can be obtained through 
the EMS system.

                          DESCRIPTION OF ISSUE

    Avoidance of triggers, early recognition of symptoms, and immediate 
treatment are essential to the management of life-threatening 
allergies. There are both students and staff who have known life-
threatening allergies, as well as those who have not been identified. 
Intervention with epinephrine is vital to saving lives.
    Unfortunately, allergens of concern are readily encountered in the 
school environment and include food (5 percent children), insects (1 
percent population), latex (1 percent population with increased 
incidence for those with spina bifida), medications, and exercise 
induced. Foods of primary concern are peanuts, tree nuts, fish, eggs, 
milk, wheat, and corn. Peanut allergy is rarely outgrown in adulthood. 
Allergy to cow's milk is more prevalent in children whereas shellfish 
allergy is more common in adults. Insects of concern are the species of 
Hymenoptera and include honeybees, wasps, yellow jackets, and hornets. 
Wasps and hornets are capable of stinging multiple times. Antibiotics 
are responsible for the majority of medication allergies and are less 
frequently present in the school setting (Mayo Clinic, Food Allergy).

                               RATIONALE

    Medication and emergency policies in school districts must be 
developed with the safety of all students and staff in mind. Easy 
access to and correct use of epinephrine are necessary to avoid life-
threatening complications.
    The school nurse, parent, health care provider, and student should 
evaluate the self-managed administration of epinephrine by a student on 
a case-by-case basis. Written permission from the parent and health 
care provider must be obtained for students with known life-threatening 
allergies who will self-medicate or who will have epinephrine 
administered by a school district employee. The decision to allow a 
student to self-carry and self-administer epinephrine should take into 
consideration the age/developmental level of the student, the school 
nurse's assessment of the student's ability to self medicate, the 
recommendations of the student's parent and health care provider, the 
need for a back-up supply, the specific school environment and the 
availability of a professional school nurse. The decision to delegate 
epinephrine administration to unlicensed assistive personnel is 
determined by State law and the professional nursing judgment of the 
school nurse (NASN, 2002).
    An individual health care plan that includes periodic monitoring 
and nursing assessment, emergency plans, and evaluation should be 
written by the school nurse and maintained for every student with 
prescribed epinephrine. The school nurse should provide training for 
school staff in the recognition of life-threatening allergic reactions 
and the appropriate first aid/emergency measures that should be taken 
as determined by district policy and State law.
    School districts must establish direction for handling episodes of 
anaphylaxis in students and staff with no previous history of life-
threatening allergies. State laws governing nursing practice will 
determine the need for protocols, policies and procedures in the 
management of injectable epinephrine in the school setting.

                          REFERENCES/RESOURCES

American Academy of Allergy, Asthma, and Immunology, 611 East Wells 
    Street, Milwaukee, WI 53202. http://www.aaaai.org.
Asthma and Allergy Foundation of America (AAFA), 1233 20th Street, NW, 
    Suite 402, Washington, DC 20036. http://www.aafa.org.
H.R. 2023 Asthmatic Schoolchildren's Treatment and Health Management 
    Act of 2004. www.SchoolAsthma.com.
Lieberman, P., Kemp, S.F., Oppenheimer, J., Lang, D.M., Bernstein, 
    I.L., Niklas, R.A., et al. (2005). The diagnosis and management of 
    anaphylaxis: An updated practice parameter. [Supp. 2] The Journal 
    of Allergy and Clinical Immunology. 115(3).
Litarowsky, J.S., Murphy, S.O., & Canham, D.L. (2004). Evaluation of an 
    anaphylaxis training program for unlicensed assistive personnel. 
    Journal of School Nursing. 20(5), 279-284.
Mayo Clinic. Food Allergy. Retrieved April 2005 from http://
    www.mayoclinic.com/invoke.cfm?id=DS00082.
National Association of School Nurses. (2002) Position statement: 
    Delegation. Scarborough, ME: Author.
National Jewish Medical and Research Center. http://
    www.nationaljewish.org/diseaseinfo/diseases/allergy/index.aspx.
Sicherer, S.H., Simons, F.E., (2004). Quandaries in prescribing an 
    emergency action plan and self-injectable epinephrine for first-aid 
    management of anaphylaxis in the community. The Journal of Allergy 
    and Clinical Immunology. 115(3), 575-583.
Smit, D., Camerson, P.A., & Rainer, T.H. (2005) Anaphylaxis 
    presentations to an emergency department in Hong Kong: Incidence 
    and predictors of biphasic reactions. Journal of Emergency 
    Medicine. 28(4), 381-388.
Weiss, C., Munoz-Furlong, A., Ferlong, T.J., Arbit, J. (2004). Impact 
    of food allergies on school nursing practice. Journal of School 
    Nursing. 20(5), 268-278.

Adopted: November 2000; Revised: June 2005.

    Senator Dodd. Thank you, Donna, very, very much. I 
appreciate your good work over the years, too; very proud of 
you----
    Ms. Kosiorowski. Thank you very much.
    Senator Dodd [continuing]. And the work you've done.
    Doctor, I'm glad to hear you again, for a second time. I 
heard you yesterday and you were terrific, and glad you're here 
today as well.

       STATEMENT OF HUGH A. SAMPSON, M.D., PROFESSOR OF 
  PEDIATRICS, MOUNT SINAI SCHOOL OF MEDICINE, AND PRESIDENT, 
AMERICAN ACADEMY OF ALLERGY, ASTHMA, AND IMMUNOLOGY, NEW YORK, 
                               NY

    Dr. Sampson. Thank you, Senator. Mr. Chairman, Ranking 
Member Mr. Alexander, and members of the subcommittee, I'm very 
pleased to be here today to participate in this important 
hearing on the challenges confronting food allergic children 
and their families.
    I have spent over 25 years conducting research and caring 
for children with food allergic disorders. I would like to 
thank you, Senator Dodd, for holding this important hearing 
during Food Allergy Awareness Week. Families across America are 
working this week to educate their communities about food 
allergies and it is inspiring to them to see your support.
    I am also grateful for your leadership as sponsor of S. 
1232, the Food Allergy and Anaphylaxis Management Act, and your 
support for Federal policies to protect food allergic children.
    While I know you are well aware of the impact of food 
allergies, Senator Dodd, I would like to provide some general 
information for the benefit of committee members. A food 
allergy occurs when a person's immune system attacks harmless 
proteins in our food. The immune system is the part of the body 
that usually fights infections and other harmful organisms. In 
this case the responses are misdirected. The food is 
misidentified as the body's enemy and the immune system attacks 
the food as it would a parasite or an infection. Foods most 
commonly responsible for allergic reactions are milk, egg, 
peanut, tree nuts, fish, and shellfish.
    While most children outgrow milk and egg allergies; peanut, 
tree nuts, fish and shellfish allergies are usually lifelong. 
More than 10 million Americans have food allergy, including 
almost 3 million children, and the prevalence of food allergies 
and associated anaphylaxis is increasing. In a national survey, 
we found that the rates of peanut allergy doubled in children 
less than 5 years of age from 1997 to 2002. Similar findings 
have been reported in the United Kingdom and other 
industrialized countries.
    Through research, we are trying to identify the cause of 
this dramatic increase. There are several theories under 
investigation, as Dr. Fauci mentioned, including the hygienic 
hypothesis, which states that children in our culture are 
exposed to fewer germs; the lack of exposure seems to affect 
the normal programming of the immune system, thereby making it 
less effective at distinguishing harmful pathogens from 
harmless food.
    Another theory suggests that children who have compromised 
skin barriers, such as children with atopic dermatitis or 
eczema, are sensitized to food through contact with food 
proteins in body creams or residual food on the hands of their 
parents, caregivers, or siblings. The majority of young 
children with food allergies and atomic dermatitis develop 
respiratory allergies and asthma, something called the allergic 
march. These children are at greatest risk for severe and 
occasionally fatal anaphylactic reactions.
    The impact of food allergies in the real world of children 
and families is far more difficult to describe. Food is at the 
center of almost all our social activities and therefore the 
potential threat is everywhere. As I found with my daughter who 
is allergic to egg and now walnuts, parents must spend hours in 
grocery stores scrutinizing labels and phoning companies to get 
clarification on ingredient labels. They also live every day 
knowing their child can walk out the door to day care or school 
or church or to camp and end that day in the emergency room or 
worse.
    Data from an FDA survey published this January suggests 
that there are at least 125,000 emergency room visits each year 
for food allergy, that about 15,000 of these are for 
anaphylactic reactions, with over 3,000 ending in 
hospitalizations. Other surveys suggest even higher numbers of 
anaphylaxis cases and provide estimates of 100 to 150 deaths 
due to food allergy each year.
    So what can be done? I would strongly support the five 
steps forward for food allergy initiative announced yesterday 
by the Food Allergy and Anaphylaxis Network (FAAN), which was 
endorsed by the American Academy of Allergy, Asthma, and 
Immunology and over 64 organizations from across the country. 
These five steps include: passage of S. 1232, the Food Allergy 
and Anaphylaxis Management Act; development of national 
guidelines for the diagnosis and management of food allergy for 
health care professionals; significantly increased funding for 
research in food allergy and anaphylaxis; expand efforts by the 
U.S. Food and Drug Administration to improve food allergen 
labeling; and creation of a national clearinghouse at the 
Center for Disease Control and Prevention and food allergy for 
the general public as well as health care professionals.
    If these recommended policy initiatives are implemented, we 
will reduce the incidence of fatal food allergic reactions in 
our country.
    I would like to focus on the need for expanded research. 
Dr. Fauci and the NIAID are to be commended for their recent 
initiatives in the area of food allergy. In my 25 years in food 
allergy research, I have seen the field move from just trying 
to understand the manifestations of food allergy to the point 
where new therapeutic strategies are at hand, some now starting 
in human trials. However, I can tell you with absolute 
certainty that unless Congress provides NIH with significant 
funding increases for research on food allergy and anaphylaxis 
we will not make progress toward the potential breakthroughs.
    I agree with FAAN, which is recommending annual increases 
of $10 million each year for the next 5 years to pursue the 
goals of the expert panels Dr. Fauci mentioned and carry out 
promising clinical trials under way. I strongly encourage this 
subcommittee to formally recognize this need and encourage the 
Appropriations Committee to provide this additional support.
    It is important to recognize the size of this problem--over 
10 million Americans and their families affected--and that most 
of the research necessary to improve methods for preventing and 
treating food allergy simply is not being done.
    Once again, I would like to thank you, Senator Dodd and the 
subcommittee, for convening this important hearing. Thank you.
    [The prepared statement of Dr. Sampson follows:]

              Prepared Statement of Hugh A. Sampson, M.D.

    My name is Hugh Sampson, and I am pleased to be here today to 
participate in this important hearing on the challenges confronting 
food-allergic children and their families. I am the Chief of the 
Pediatric Allergy and Immunology Division and the Director of the Jaffe 
Food Allergy Institute at the Mount Sinai School of Medicine in New 
York. I have spent over 25 years conducting research and caring for 
children with food allergic disorders. I am also president of the 
American Academy of Allergy, Asthma, and Immunology (AAAAI), an 
international organization of over 6,500 allergist/immunologists, 
allied health professionals, and others with a special interest in the 
research and treatment of allergic diseases.
    I would like to begin by thanking you, Senator Dodd, for holding 
this important hearing during Food Allergy Awareness Week. Families 
across America will be working this week to educate their communities 
about food allergies, and it is inspiring for them to know that you are 
doing the same here in the U.S. Senate. In addition, I am grateful for 
your leadership as the sponsor of S. 1232, the Food Allergy and 
Anaphylaxis Management Act, and for your support for Federal policies 
to protect food allergic-children. Passage of your legislation is 
critically important to the ability of schools and parents to assure 
the safety of children with food allergies.
    In addition, I am pleased to have the opportunity to express the 
strong support of the AAAAI for the ``Five Steps Forward for Food 
Allergy'' initiative announced just yesterday by the Food Allergy and 
Anaphylaxis Network (FAAN), a national organization dedicated to 
raising public awareness of food allergies through education and 
advocacy. I serve as Medical Director of FAAN, and believe that if the 
five recommended policy initiatives are implemented, we will reduce the 
incidence of fatal food allergic reactions in our country.

                       BACKGROUND ON FOOD ALLERGY

    While I know you are well aware of the impact of food allergies, 
Senator Dodd, I would like to provide some general information for the 
benefit of the committee members. A food allergy occurs when a person's 
immune system ``attacks'' harmless proteins in our food. The immune 
system is the part of the body that usually fights infections and other 
harmful substances, but in this case the responses are misdirected. A 
food is misidentified as the body's enemy, and the immune system 
``fights'' the food as it would a parasite or infection.
    In children, the most common foods causing significant reactions 
are milk, egg, peanuts, tree nuts, fish, shellfish, soy and wheat, 
while in adults the most common foods are shellfish, peanuts, tree nuts 
and fish. Most children outgrow their allergies to many foods, but not 
typically to peanuts, nuts, fish, and shellfish, which are often 
considered life-long allergies.
    In the majority of food allergic reactions, the symptoms will begin 
within minutes after an exposure, although a delay of up to an hour or 
more is possible. Some reactions can be mild including itchy skin and 
rashes, itchy mouth, and stomach aches. The more severe and life-
threatening anaphylactic reactions can include swelling, hives, welts 
or itchiness of the skin; digestive symptoms such as severe stomach 
pain, nausea, vomiting, and diarrhea; respiratory symptoms such as 
hoarseness, difficulty swallowing, trouble breathing, wheezing, 
repetitive coughing, and in the worst cases, throat closing; and 
reduced blood circulation resulting in paleness, dizziness, passing 
out, low blood pressure, and even loss of pulse. Sometimes a reaction 
will subside and then start up again 1 to 3 hours later. There are also 
a number of gastrointestinal allergies that come on more slowly but can 
lead to abdominal pain and nausea, weight loss and failure to thrive.
    There is no cure for food allergy. Strict avoidance of the allergy-
causing food is the only way to avoid a reaction, but even trace 
amounts of a food allergen invisible to the naked eye, such as residual 
food on dishes and utensils simply wiped clean, can cause a severe 
reaction. In some cases the food does not even have to be swallowed. 
Inhaled food proteins vaporized during cooking have caused severe and 
even fatal reactions in some individuals. Prompt administration of 
epinephrine, also called ``adrenaline,'' is the best method we now have 
for controlling a severe reaction. It is available by prescription as a 
self-injectable device.
    More than 10 million Americans have food allergies, including 
almost 3 million children. The prevalence is highest in young children, 
with 6-8 percent of children under 4 years of age affected by food 
allergies. The prevalence of food allergies and associated anaphylaxis 
is increasing. For example, in a national survey, we found that the 
rates of peanut allergy doubled in children less than 5 years of age 
from l997 to 2002, and similar findings were reported in the U.K. 
Globally, food allergies are most prevalent in industrialized countries 
like ours with similar lifestyles and eating habits. Through research, 
we are trying to identify the causes of this dramatic increase. There 
are several theories under investigation including the question of 
whether children in our culture are exposed to fewer germs, thereby 
requiring the immune system to be less active in fighting germs and 
somehow making it less effective at identifying certain foods as 
harmless. The onset of food allergy is often preceded by atopic 
dermatitis, commonly known as eczema, in which the normal skin barrier 
is defective. Another theory suggests that contact with creams 
containing food proteins or residual food on the hands of parents, 
caregivers and siblings may sensitize these children to the food. Other 
theories include the rise in consumption of omega-6-containing foods 
and decreased consumption of omega-3 polyunsaturated fatty acid-
containing foods, reduced dietary antioxidants, and excess or 
deficiency of vitamin D. The majority of young children with food 
allergies and atopic dermatitis go on to develop respiratory allergies 
and asthma, something allergists call the ``allergic march.'' In 
addition, children with food allergies and asthma are more likely to 
suffer from severe asthma, and are at greatest risk for severe and 
occasionally fatal anaphylactic reactions. We believe that a better 
understanding of the inter-relationship of these diseases is critical 
to developing new methods to prevent and treat food allergies.
    This gives you some idea of the challenges that food allergies 
present to health care professionals. The impact in the real world of 
children and families is far more difficult to describe. Food is at the 
center of almost all of our social functions, and therefore presents a 
potential threat to the food allergic individual everywhere he or she 
turns. As I found with my second daughter, who has allergy to walnuts, 
parents must spend hours in grocery stores scrutinizing labels and 
phoning companies to get clarification on ingredient labels. In 
addition, many parents of a child with food allergies live every day 
knowing their child can walk out the door to day care, or school, or 
church, or camp, or literally any place in which food is served and end 
that day in the emergency room, in the hospital, or in an intensive 
care unit on a ventilator, or rarely, even dead. Data from an FDA 
survey published in January of this year, utilizing the National 
Electronic Injury Surveillance System of selected emergency departments 
around the United States, suggest that there are about 125,000 
emergency room visits each year for food allergy, and that about 15,000 
of these are for anaphylactic reactions, with over 3,000 ending in 
hospitalizations. Somewhat alarming was the fact that only 43 percent 
of the anaphylactic cases were accurately diagnosed by the emergency 
room staff, a finding frequently reported in similar surveys, 
emphasizing the need for better health education training and 
guidelines for health care professionals. Other surveys suggest even 
higher numbers of anaphylaxis cases, and while accurate data is very 
difficult to come by, it is estimated that anaphylaxis caused by food 
allergy results in 100-150 deaths each year in our country. Death can 
be sudden, sometimes occurring within minutes. You can imagine how the 
life of an entire family is completely disrupted as they strive to 
avoid this fate. Far worse, imagine seeing your daughter die in a 
shopping mall while you are out looking for her prom dress, or your 
young son go into shock and eventually die from tasting some of a 
peanut snack unbeknownst to you while you are watching the Super Bowl 
together, or learning that your son died on a camp canoe trip from an 
anaphylactic reaction due to residual peanut butter on a knife used to 
make his sandwich.

                            RECOMMENDATIONS

    As I noted earlier, the American Academy of Allergy, Asthma & 
Immunology and I, personally, strongly support the ``Five Steps Forward 
for Food Allergy'' advocacy initiative announced yesterday by FAAN with 
the endorsement of nearly 70 organizations from across the country. 
These five steps include:

    1. Passage of S. 1232, the Food Allergy and Anaphylaxis Management 
Act, to help schools create guidelines for managing food-allergic 
children;
    2. Creation of a national clearinghouse at the Centers for Disease 
Control and Prevention on food allergy for the general public as well 
as health care professionals;
    3. Development of national guidelines for the diagnosis and 
management of food allergy for health care professionals;
    4. Significantly increased funding for research on food allergy and 
anaphylaxis; and
    5. Expanded efforts by the U.S. Food and Drug Administration to 
improve food allergen labeling.

    I would like to focus specific attention on the need for expanded 
research. In recent years, experts have been convened to identify the 
most promising avenues of research on food allergy and anaphylaxis:

     In March 2006, the NIH Expert Panel on Food Allergy, 
convened by the National Institute of Allergy and Infectious Disease 
(NIAID), released a report detailing an agenda of research questions 
that should be pursued if we are to succeed in identifying vaccines or 
improved treatments for food allergy. The report recommended additional 
basic and pre-clinical research on specific questions; clinical trials 
to evaluate promising new approaches to the prevention and treatment of 
food allergies; and expanded studies of the epidemiology and genetics 
of food allergy. The report also recommended that efforts be undertaken 
by the NIH and the FDA to resolve impediments to the design and conduct 
of clinical trials for the prevention and treatment of food allergy. 
Unfortunately, due to grossly inadequate funding, most of the research 
recommended in this report has not been pursued.
     In February 2006, the Journal of Allergy and Clinical 
Immunology published the report of a symposium on anaphylaxis convened 
by the NIAID, the Academy, FAAN and others. This report detailed an 
agenda of research questions to be pursued to enable us to better 
understand anaphylaxis and improve methods for prevention and 
treatment. Again, due to grossly inadequate funding, most of these 
research initiatives have not been pursued.

    Dr. Fauci is to be commended for the initiatives the NIAID has 
undertaken in the area of food allergy. I have been fortunate to be 
funded by the NIH for the past 25 years to support my research in food 
allergy. In that period of time, the field has moved from just trying 
to understand the manifestations of food allergy to the development of 
new diagnostic and treatment modalities, several of which are now just 
starting in clinical trials. However, I can tell you with absolute 
certainty that unless the Congress provides NIH with significant 
funding increases for research on food allergy and anaphylaxis, we will 
NOT make progress toward break-throughs in the prevention and treatment 
of food allergies. In addition, an investment must be made in the 
training of researchers in the field of allergy to pursue a 
significantly expanded research agenda in the areas of food allergy and 
anaphylaxis. FAAN is recommending annual increases of $10 million per 
year for 5 years (an additional $50 million over 5 years) to bring the 
budget for research on food allergy and anaphylaxis to a level that 
will allow us to pursue the research recommended in the two reports I 
have cited and to support the promising clinical trials underway. I 
strongly encourage this committee to formally recognize this need and 
encourage the Appropriations Committee to provide this additional 
support at a minimum. I understand that the Federal budget is extremely 
tight at this time. However, it is important to recognize the size of 
this problem, over 10 million Americans and their families affected, 
and that most of the research necessary to improve methods of 
preventing and treating food allergy simply is not being done.

                               CONCLUSION

    Once again, I would like to thank you, Senator Dodd, for convening 
this important hearing. The American Academy of Allergy, Asthma and 
Immunology looks forward to working with you to achieve the enactment 
of S. 1232. In addition, we hope you and all members of this committee 
will support the initiatives included in FAAN's ``Five Steps Forward 
for Food Allergy'' statement and that you will take steps to address 
the totally inadequate funding for research on food allergy.
    Thank you for the opportunity to participate in this hearing. I 
would be happy to answer any questions.

    Senator Dodd. Well, thank you very, very much, all of you. 
Very, very helpful testimony, and I'm very grateful to you for 
your sharing with us your personal stories as well as the work, 
doctor, you're doing in this field.
    Let me begin, if I can, with you Teresa and with Colene. 
What advice or comments might you have for other parents, whose 
children have food allergies and those who don't, about being 
prepared. You've been through this, obviously. I think 
sometimes, with all due respect to Senators and doctors, people 
listen to other parents. Are there any thoughts you want to 
share, advice you can give parents?
    Ms. Walters. I think my biggest piece of advice for other 
parents would be, don't let other people tell you how to react 
to your child's food allergies. Don't let them tell you that 
you're being overprotective.
    Senator Dodd. We have a story I told, I think I told Lamar 
this story. One of the problems we've had, we fly a lot, 
obviously, going back and forth to Connecticut a lot. Without 
naming any particular airlines, the difficulty sometimes of 
getting them to understand that peanuts--calling ahead of time, 
stopping at the gate before you get in, getting on the plane. 
Invariably, the flight attendants have not been told by 
anybody. So they look at you with annoyance.
    We actually had a flight one time where the flight 
attendant told us we had to get off the plane, because every 
other flight they served peanuts on. We were in Phoenix, AZ, on 
our way back home to Connecticut, a long day with a 2-year-
old--less than a 2-year-old; with a 1-year-old--and they said 
we had to get off the plane because that was the choice.
    Needless to say, we stayed on the plane and there were no 
peanuts served. Nevertheless, it took me battling to do it. I 
shouldn't have to battle for this.
    We had a woman behind us one day eating something with 
peanut butter, and I said, I apologized and explained that my 
daughter had a severe allergy and could have a potentially 
serious reaction to peanut butter. Her comment was: ``What, is 
she going to break out in a little rash?'' I almost felt like 
saying, well, maybe I shouldn't bother in a sense, with that 
reaction, letting other people sort of cause you to be less 
than vigilant. It's a good piece of advice.
    Colene.
    Ms. Birchfield. I would echo her sentiment. As a parent, I 
think that the key piece is to trust yourself and only 
yourself, and educate yourself as much as you can, try to 
educate everybody around you. You may ruffle some feathers 
along the way, but it's necessary. You must be the advocate for 
your child.
    Senator Dodd. Do you have any--do either of you have a 
history in your family of food allergies?
    Ms. Birchfield. None in my family or my husband's.
    Senator Dodd. How about you?
    Ms. Walters. I have very minor food allergies. I'm the only 
person in my family who does, though.
    Senator Dodd. But nothing as serious as you had in the case 
here?
    Ms. Walters. No.
    Senator Dodd. Getting people educated about EpiPen and 
Twinject--we did it the other day in Connecticut. It was very 
good. The woman I was sitting next to, Donna, actually got up--
I don't know if they covered it that night on television; I 
didn't watch the news. She actually went through a whole 
demonstration for our local TV station on how to use an EpiPen. 
I thought it was pretty good. They seemed to be interested as 
well in how it worked.
    Any thoughts you'd have as parents or Donna on how we can 
do a better job of educating the use with EpiPen, the 
importance of it?
    Ms. Kosiorowski. Fox News actually did a good job, and they 
had Chris on.
    I think that it's repetition, it's reinforcement. You can't 
teach it once and expect that people are going to remember. You 
have to teach. For the school nurses, we teach the school 
staff. For the parents, because our nurse is also a parent of a 
child, you have to educate their friends, their friends' 
families, anyplace they go. I think you just have to practice 
and repeat and just be vigilant. You can never let your guard 
down.
    Senator Dodd. Tell me, if you could, Donna, about the Good 
Samaritan laws, because we run into it all the time, you'll 
have people in various States say: ``Look, just the liability; 
the insurance is too much''; we refuse to administer this kind 
of--applying the EpiPen. I mean, they just don't do it. We've 
heard this in a number of places.
    Are you familiar with this, what I'm talking about?
    Ms. Kosiorowski. Yes.
    Senator Dodd. What are some States doing? Are there States 
or localities that are handling this better than others?
    Ms. Kosiorowski. I can't answer that except for 
Connecticut. Health care providers are obviously covered under 
the requirements of their license and I'm covered under the 
Nurse Practice Act. The Good Samaritan law actually applies to 
teachers, principals, people that respond with good intent, so 
that they won't be held liable for harm if they mean to do 
well. That's a concern that our teachers and our staff 
certainly have as far as liability. We tell them, if you're 
trained, if you do the right thing with the right intentions, 
then you'll be OK and that law will cover you.
    Senator Dodd. In the absence of that, you can understand 
why there's a reluctance because of the fear of litigation that 
goes on in certain areas.
    Ms. Kosiorowski. I think--again, I can only address 
Connecticut. I included in my testimony, there were two cases 
in Connecticut where the courts found actually in favor of the 
school districts because they had guidelines in place, they had 
a standard of care that was shared throughout the district, and 
we also share the same standard of care throughout the State, 
so that we do have a guideline in place.
    I think you're more liable without guidelines than you are 
with them.
    Senator Dodd. Is that a Connecticut case?
    Ms. Kosiorowski. Yes, it was. There were two.
    Senator Dodd. And they held for the school district?
    Ms. Kosiorowski. Yes, that we did everything we could, we 
did it right, we weren't discriminating against any one child 
because we had the same guidelines, with individual plans for 
each child.
    Senator Dodd. Dr. Sampson, again thank you immensely for 
your work. I asked Dr. Fauci some of the questions and I would 
be curious as to your response as well, to some of these 
questions regarding the increase, what appears to be a dramatic 
increase. Clearly some of it is better detection and people 
getting diagnosed. Give us your appraisal of all of this, where 
things are, what direction we're heading in, and whether or not 
we're looking at just better detection, or is there a real 
rapid increase in food allergies?
    Dr. Sampson. Based on the studies we did, I would say 
without question there's an increase going on, that when we did 
the national survey looking at the prevalence of peanut allergy 
we used the exact same methods so that we would be sure there 
was no change in the way we tried to gather the questions that 
might influence people to answer in a different way. We're very 
confident in those figures, that there was a doubling of peanut 
allergy in that 5-year period. We are just about to do a third 
survey now, another 5 years on, to look at it.
    As I said, we know from other countries, such as the United 
Kingdom, where they are reporting exactly the same thing. I'm 
sure that there is more awareness. I know when I talk to people 
about food allergy now compared to when I started doing this, 
people are more aware of it. I think, as Dr. Fauci pointed out, 
it's not hard to miss anaphylaxis. You can't be having it in 
the past and not know it was there. I think there's no question 
that it's increasing.
    As he also pointed out, and I'm sure you want to know and 
we want to know, is why is that happening? There are lots of 
theories out there. We need more people looking into it. We 
need more research trying to address it. I think one of the 
things we can take away is when we look at the countries that 
are affected, it's countries like ours. It's the way we prepare 
food. It's the way--our customs in eating, our customs in 
introducing children to foods that are having the problem.
    You can go to the Scandinavian countries, which have a very 
similar lifestyle as we do, but they introduce foods in a 
different way, and you're not seeing peanut allergy at the same 
rate that we see it here. We need to look into these things. We 
need to look at how the foods are prepared, as Dr. Fauci 
brought up, with the idea of the dry roasting of the peanut 
that we do primarily here, as compared to boiling.
    One of the things I point out to people, we developed a 
mouse model of peanut anaphylaxis and in order to sensitize 
that mouse to be able to anaphylax we have to use dry roasted 
peanuts. It will not work if we feed it boiled peanuts.
    There are things about the structure of these proteins, the 
processing, that we need to know more about.
    Senator Dodd. That's phenomenal. I remember you talking 
about that yesterday, just the preparation and how it works.
    Can you talk more about what studies have shown with regard 
to the early exposure to the allergens? I was thinking as you 
were just commenting on the last question of something that 
people I remember telling Jackie and me some time ago, that in 
the first 3 months after a child has arrived that you ought to 
keep them away from all of these, these foods, because just the 
maturation of the--
    Mrs. Dodd. Years.
    Senator Dodd. Years. What did I say, months?
    Mrs. Dodd. Months.
    Senator Dodd. I meant years. Thank you, Jackie. That's the 
reason you're here.
    Dr. Sampson. I was going to say, I think the thing that we 
realize now--the American Academy of Pediatrics just came out 
with new recommendations--is that the results of the studies 
are conflicting. We're not really sure what is the best 
direction. As Dr. Fauci pointed out, initially we thought the 
best thing to do was to completely avoid the particular food 
for a period of time, until the immune system was mature and we 
thought would be able to handle it more effectively.
    One of the things that we have found out is it's almost 
impossible, with the way we prepare foods in this country, to 
completely avoid milk, completely avoid egg, completely avoid 
peanut, and those low-level exposures may be more of a problem 
than just feeding it to somebody. We have some studies that do 
suggest that if you could, in fact, totally prevent exposure 
you may be OK, but that's really not something that's possible.
    We have to look at a new paradigm which was brought up, 
that maybe we need early exposure of higher amounts to force 
the immune system to become more tolerant. This is something 
that has to be looked into.
    Senator Dodd. You mentioned the $10 million a year for 5 
years. Senator Alexander raised the issue earlier, Dr. Fauci 
talked about I think, what did he say, doubling the amount was 
his number. It was something like $26 million. Flesh out that 
number for me a bit. Why the magic number? What is it about 
your number?
    Dr. Sampson. My number that's better? One of the things I'm 
looking at is we have a consortium on food allergy research 
that's funded by the NIH and we are conducting studies such as 
desensitization to egg, sublingual immunotherapy to peanut. We 
have various studies. We have five centers involved in this, 
Duke being one, Arkansas, Hopkins, Denver, and Yale. We are 
really underfunded for what we're trying to do.
    If we had more funding, we would be able to bring more 
centers, which would allow us to move it forward more quickly 
and would also give us the personnel to be able to do these 
studies. Right now I'm aware of five different ways that we can 
try to treat food allergy that have been looked at in various 
model systems and I think it behooves us to look at these as 
quickly as possible. If one of those works we are way ahead of 
where we are now.
    Senator Dodd. Would you share with us--I heard you 
yesterday, but would you share with Senator Alexander and the 
committee?
    Dr. Sampson. One of the ones that was brought up is this 
oral immunotherapy. This is something that really was started 
back in the early 1900s, but they didn't understand it and 
there were problems. Now it's being looked at in a very careful 
way and we're trying to understand some of the basic immunology 
that is brought about by doing this.
    There's another form where we're trying to add an anti-IGE 
antibody, something called Zoler, which causes the immune 
system to process these proteins in a different way and may be 
actually able to prevent a lot of the side effects we see with 
oral immunotherapy, but also make the body become tolerant more 
quickly.
    There is another called sublingual immunotherapy, with 
special cells in the floor of the mouth that process food 
proteins and take them to an area that's more likely to bring 
on this regulatory effect that Dr. Fauci had mentioned earlier.
    We also have a recombinant protein vaccine that we've 
developed, and this is one we've been working on with the group 
at Yale, where we can basically turn off the immune response, 
at least in our animal model. This is something that we're 
hoping to bring into clinical trials as quickly as possible.
    Now, I have a colleague of mine that came with me to New 
York from Hopkins who was very interested in herbal 
preparations, and she has actually developed this preparation 
that totally blocks anaphylaxis in the food allergic animal 
model. This is something that we are just starting human trials 
with. We have an IND from the FDA to do it, but again we're the 
only place doing it. So you can imagine it's not moving along 
at a very fast rate.
    If we had something like 5 centers involved, 10 centers 
involved, this kind of research could be looked at much more 
quickly.
    Senator Dodd. The herbal one is one out of China, is that 
correct?
    Dr. Sampson. She actually developed this--she trained in 
China. Interestingly, there's nothing in ancient Chinese 
medical literature about food allergy. Knowing about other 
disorders, she came up with this initial formulation that we've 
slightly modified. I have to tell you, when we started I was 
very skeptical and made her do it over and over and over again. 
It's very effective and I have to admit that there is no 
evidence that any of the particular herbs in this formulation 
cause any serious side effects. They have all been used for 
centuries, and to me it seems like a very low-risk way. If it 
happens to work, it will be a phenomenal protection for people 
with any kind of food allergy leading to anaphylaxis.
    Senator Dodd. Very exciting.
    Lamar.
    Senator Alexander. Well, that is extraordinarily 
interesting.
    May I ask you about labeling, Dr. Sampson. A young friend 
of mine, a mother who has been living in London the last couple 
of years, has said to me a couple of times that labeling in 
England is better than labeling here. Can you talk to me about 
that? Are there things we should be doing that would improve 
labeling here, that would be helpful to parents or others?
    Dr. Sampson. I think the intent of the Food Allergy 
Protection Act that Senator Dodd brought up earlier is a great 
idea. Having had to stand in these stores and try to figure out 
what sodium caseinate or potassium caseinate or whey is, when 
all it means is milk--for me, I'm used to seeing those names. 
That has been a tremendous improvement.
    The thing that has sort of an unexpected side effect of 
that is when companies are very fearful of possible 
contamination, and if they don't list a particular food, say 
peanut, they know that in rare occasions if you make a product 
on the same line that had processed something that had peanut 
in it, that there's a possibility of contamination.
    We're now starting to get all these labels that say ``May 
contain peanut,'' ``Made in a plant that contained peanut.'' I 
think there are about 40 different variations that can be 
there. We need to have the confidence in the label when it says 
or it doesn't say peanut, that we know that it's safe. All 
these variations are making especially my teenage population 
that I see start to ignore them. We know that some of those are 
going to contain peanut protein in it.
    Senator Alexander. Is it true that Europe and/or London has 
a different labeling system?
    Dr. Sampson. The main difference I think is that they don't 
have all these variations on the label. Now, that's not to say 
that that is necessarily better, but it's certainly easier for 
the patient.
    Senator Alexander. Do any of the other witnesses have a 
comment on labeling?
    Ms. Birchfield. Well, I agree with what Dr. Sampson said. 
It's just, as a parent the way the labeling has now come, where 
you have in big bold letters ``Contains milk, egg, or peanut.'' 
Sometimes mistakes are made. I don't trust the labeling system 
still. I still rely on reading the sodium caseinate and every 
individual ingredient because I feel like if I don't I'm still 
putting my child at risk.
    I think part of the problem with the labeling, too, is that 
once you have it down you have to read it again because the 
labeling keeps changing, the ingredients keep changing. You 
can't assume the same product you ate last week will be what 
you're eating today.
    Dr. Sampson. We've actually had situations where in one 
part of the country it contains the milk protein, in another 
part of the country it doesn't. Patients just have to be 
constantly vigilant.
    Senator Alexander. Ms. Birchfield, in your experience with 
the Tennessee law do you see things that need to be improved in 
that?
    Ms. Birchfield. Well, I wanted to just add something to 
what the doctor just said about one part of the State being 
different than the other. Going back to the school setting, a 
good example is when I went in to read ingredients for chicken 
patties that the Tennessee schools serve at Attison Elementary 
where my child attends, Ryan can eat that brand--it's Tyson 
chicken patties--when I buy them at the grocery store. However, 
he cannot eat them when the school serves them, because the 
distribution center from which they get their patties puts an 
egg--puts egg in those chicken patties, whereas the 
distribution centers that make the ones that go to the grocery 
stores do not contain egg.
    It just becomes a big challenge when you're trying to 
figure out what's safe and what's not.
    Senator Alexander. The comment was made that there's one 
nurse for every 1,600 children in Tennessee. Does that mean 
there needs to be a school nurse in every school?
    Ms. Kosiorowski. I wouldn't sit here and make that 
recommendation. I think you have to look at the acuity of the 
students. My reason for quoting the statistic was because in 
Connecticut one of the reasons why we feel we're fairly 
successful is we do have a good nurse-to-student ratio, in that 
we have about one nurse for 504 students. That I think you have 
to look realistically at what a nurse can safely manage in 
terms of keeping the kids safe.
    Senator Alexander. If there is no school nurse, can the 
staff--can teachers be trained to deal with this?
    Ms. Kosiorowski. Every State has different laws in terms of 
what can be delegated and what cannot. In Connecticut we can 
train principals and teachers to administer medication, but you 
do have to make sure that there's a nurse, if not on site, 
available for supervision, consultation, and you have to make 
sure that she's there to do the initial training and then to 
reinforce her training throughout the school year, or his, 
because we do have male school nurses too.
    Senator Alexander. Maybe it was Ms. Walters who mentioned, 
or someone mentioned, that the medicine was locked in the 
office of the--
    Ms. Birchfield. That was me. Now, Tennessee, as you know, 
does have the Management Act for the guidelines for the 
management of food allergies. All of the staff at our school, 
they are trained with how to use the EpiPen. That trickles down 
from the principal all the way to the custodial workers. 
Everybody knows how to use one.
    The issue that I have is how they get it, because if it's 
locked up it's hard for them to get to the medication. The 
training doesn't help if they can't get to the medication.
    Senator Alexander. Where should it be in your opinion?
    Ms. Birchfield. Now, the principal at our school is very 
gracious and willing to work with me. In addition to having 
Ryan's medication locked up in the nurse's office--
coincidentally, our nurse is only in the building 2 days a 
week. It's locked in the nurse's office, but she also allowed 
for my son to carry his medication with him. So his teacher 
created a little system, a bag that she keeps, and it travels 
with him to the playground, to gym, to music. Everywhere Ryan 
goes, his medication goes with him.
    Senator Alexander. Is Ryan the only child in the school in 
Oolteway with a food allergy?
    Ms. Birchfield. There's one other child who has a peanut 
allergy, and I'm not currently aware what he does with his 
medication.
    Senator Alexander. You mentioned the Good Samaritan laws 
and the effect, the beneficial effect, that they would have in 
encouraging staff members to take the actions they should take. 
Would there be any risk that a model set of guidelines would 
make schools feel they'd need to automatically adopt it, 
otherwise there would be liability for not adopting it?
    Ms. Kosiorowski. Again, I could only talk about 
Connecticut. Our guidelines do include the Good Samaritan Act. 
I think you have to make people feel comfortable, you have to 
make your staff feel comfortable, that they're going to be 
protected, because liability is a concern for them.
    I'm not sure whether the Good Samaritan Act would apply in 
other States. In Connecticut we do include that.
    I would like to share some information in regard to the 
locking of the EpiPens if I may.
    Senator Alexander. Certainly.
    Ms. Kosiorowski. In Connecticut we develop our care plans 
based on individual needs and the abilities of the child. We do 
allow some children to carry their EpiPen with them. Age has 
very little to do with it. It's the ability of the child to 
understand the process when they use the EpiPen. We've also 
worked out plans where teachers would carry the pen with them 
and would pass it from teacher to teacher.
    There are a lot of different ways. We try very hard not to 
lock the epinephrine up because we want it where the child is.
    Senator Alexander. Well, Senator Dodd, this has been very 
helpful to me and I'm sure to anyone watching. I want, Ms. 
Walters, to especially thank you for coming and telling your 
story. To all of you, this has been a big help to me, and I 
thank Chris for his leadership.
    Senator Dodd. Thanks very much.
    You know, I can't resist. First of all, just a question. 
There is the concern, well, is there some danger in using an 
EpiPen? Is there some sort of a medical reaction? I know the 
answer to that, but, doctor, would you or Donna, either one of 
you respond?
    Dr. Sampson. I think if people are shown how to use it, I'm 
not aware of anybody who's ever had a serious reaction 
following the use of an EpiPen. It's a relatively safe drug 
used the way it's administered by the EpiPen. Especially in 
children, the risk is very negligible.
    Senator Dodd. Donna, why don't you stand up. You brought an 
EpiPen with you.
    Ms. Kosiorowski. I did.
    Senator Dodd. This is being shown on CSPAN. Can you show us 
how it works?
    Ms. Kosiorowski. Sure. I just want to say, we have a well 
known allergist in Connecticut, Dr. Rosen, who you may be 
familiar with. He said you're not going to hurt anybody by 
giving them epinephrine, but you could kill them by not giving 
it.
    Senator Dodd. That's right.
    Ms. Kosiorowski. Senator Alexander, if I may, I'm not 
making a recommendation, but I will say I think every child 
deserves a school nurse.
    [Laughter.]
    Senator Dodd. I would have been shocked to hear otherwise.
    Now show us how it works.
    Ms. Kosiorowski. In order to be fair, epinephrine--EpiPens 
are a brand name. We also have something called a ``Twinject.'' 
It's very simple to use. These are trainers, so I don't want 
anybody to get excited. All of them have directions right on 
the label. You snap the cap off, the top of the cap. It's grey 
on this particular thing. It's grey. You want to make sure you 
don't have your finger on the bottom because you're going to 
stick yourself, and you don't want to have it up here. You want 
to hold it like this, and you want to go into the lateral, the 
side aspect of the thigh, and you inject it right in there. You 
can go right through the clothing.
    You have to count to 10 very slowly--one-one thousand, two-
one thousand--up to 10, to make sure that that medication goes 
in. You take it out very carefully, because there's going to be 
a needle sticking out and you don't want to stick yourself.
    Then our procedure in our school district is anyone who 
gets epinephrine automatically goes to the emergency room in an 
ambulance, because you may need subsequent----
    Senator Dodd. The first thing you do is give the 
epinephrine, then you call 911.
    Ms. Kosiorowski. Yes.
    Senator Dodd. That's the order.
    Ms. Kosiorowski. Yes. Yes, you don't wait.
    Senator Dodd. What people may find startling, how much does 
an EpiPen cost?
    Ms. Kosiorowski. Well, we talked about that and one of the 
parents in our district told us that they buy two, because they 
tell you to have a backup. That's why I bought two. $245. With 
insurance, they paid $45. For families that don't have 
insurance, the cost is just unbelievable.
    Senator Dodd. And it's life-saving.
    Senator Alexander. How quickly do you need to administer 
that?
    Senator Dodd. Oh, quickly.
    Ms. Kosiorowski. As soon as you know that they're having an 
anaphylactic reaction. You don't wait.
    Dr. Sampson. Yes, the sooner the better. The analogy we 
always use is a snowball rolling down a snowy hill. If you stop 
the snowball while it's this big at the top, it's very easy. 
Once it's moving and it's big, it may not be effective. Once 
the reaction is too far along, then the epinephrine may not 
even be effective. So the sooner the better.
    Senator Dodd. We should say, by the way, under the proposed 
bill we have, whatever State laws exist regarding the use of 
EpiPens are grandfathered in, so that there's no reason to go 
back and rewrite State legislation in this area. It 
automatically covers them in those situations as well.
    I thank you for your demonstration on that.
    I was going to ask you, doctor, if you could, what is your 
assessment of the state of surveillance efforts for food 
allergies at the Federal level, and do you believe there's a 
need for a national registry of food allergies?
    Dr. Sampson. One of our biggest problems in trying to 
provide you with information is there is no good source of 
national data. I think one of the things that would help us 
understand the size of the problem and how to react to the 
problem better would be to have a clearinghouse, such as the 
CDC, that provides us with a register of actual numbers of 
reactions.
    Most of the information we get are reports that people just 
find out about through reports in newspapers or members of 
FAAN, for example, who have heard about a reaction in their 
area. There is no organized approach currently standing to help 
us know how big the problem is.
    Senator Dodd. Well, that's something we might want to 
consider even with this legislation. It may be an advantage to 
have that.
    Have we tried to do this? Does it take legislation? 
Couldn't they just do this on their own?
    Dr. Sampson. I would probably defer to you on that, but I 
would think so.
    Senator Dodd. Let's inquire about that. Let me get a letter 
drafted and see if they can't just do this.
    I wonder if you could discuss the--and I think you did 
already to some degree--the hygienic hypothesis in dealing with 
these noninfectious disorders?
    Dr. Sampson. What lies behind the hygienic hypothesis is 
the fact that we have evolved as a species over the centuries 
with all these organisms that we confront all the time, and we 
have something called the primitive immune system, or the 
innate immune system, that requires interaction with these 
various bacteria and other organisms to set up the normal 
responsiveness of our immune system.
    As Dr. Fauci also mentioned, without that stimulation you 
don't set the program for the immune system correctly. So that 
now, rather than seeing foods as harmless or other things, such 
as pollens or different substances in the environment that 
shouldn't bother any of us, the immune system in these 
individuals see this as a threat, and the IGE system or the 
allergic system that leads to most of the problem with food 
allergy was really evolving to protect us against parasitic 
infection and respond to parasitic infection, and that response 
has to be very severe. It's like using the cannon instead of 
the pistol in order to stop that.
    Now, without exposure to many of these organisms and 
bacteria, which would allow us to program correctly, it now 
sees the food protein as though it were a parasite and causes 
this tremendous response of the body to try to protect us, and 
in fact it's misdirected and misfiring.
    Senator Dodd. Well, I guess more research will tell us and 
give us more confirmation of that approach.
    You know, one area that, again someone raised it earlier 
because we talked about someone going into a restaurant and 
ordering a soup and ending up having a product in the soup that 
would cause someone to go into anaphylaxis--what advice to 
parents on going to restaurants? How do you try and deal with 
that situation? Do you have any advice on that?
    Dr. Sampson. Yes. We actually encourage parents to be 
pretty aggressive, and sort of joke about sending them for 
aggressiveness training. You need to feel very confident when 
you tell one of the wait staff that you have a potentially 
life-threatening peanut allergy or milk allergy, and you need 
to be certain that there's no possibility that peanut or milk 
could be touching a particular food, and they go back into the 
kitchen. If they come back 10 seconds later and say, ``no, it's 
fine,'' they clearly have not talked to the chef.
    We even tell parents, if you're at all concerned--you go 
back and you talk to the staff back in the kitchens and the 
chefs and make sure that they really understand the potential 
for the problem, and then if you're not comfortable you should 
just leave, that you shouldn't even attempt to eat anything if 
you're not comfortable.
    Senator Dodd. That's good advice, very good advice.
    Donna, I wonder if--one of the things I was impressed with 
the school in West Haven, the Washington School--and I 
mentioned this in front of Dr. Sampson yesterday and others who 
were in the room--I liked the way you set that table aside, 
obviously, and you had the specifics on the milk allergy 
because even the physical contact could cause a reaction.
    I also loved the fact that you have seats at that table for 
children who are getting their lunches prepared at school, 
where they are very careful about what's in those lunches, so 
that it's not a table exclusively for children with food 
allergies, because I think one of the real problems here is 
making someone feel as though they are so different, that those 
kind of pressures, particularly when they get older, will 
result in that young person saying: ``I don't want to be 
different; I'm just not going to do this,'' and I'm going to 
then subject myself to many kinds of risks.
    The fact that it was inclusive and allowed for their 
buddies and their pals to be sitting at that same table with 
them made a big difference, it seems to me.
    Have you had instances--I'd like to hear about: No. 1, any 
kind of bullying that goes on; and No. 2, parents of 
nonallergic children, how they react to some of these things; 
and schools? Is there annoyance. Has there been anything at all 
you want to share with us on this committee about the problems 
you're seeing as a result of your efforts that you've made in 
West Haven, for instance?
    Ms. Kosiorowski. I think one of the keys is because Chris 
and Sue--those are two nurses in our district--are experts in 
food allergies and they've done a lot of training throughout 
the State and throughout the district. If the principal were 
here, he would tell you, this is what he says: ``We don't 
isolate the kids, we don't let the allergies define who they 
are. We try to integrate them.'' We do have kids with peanut 
allergies and kids with milk allergies at the same table, but 
the kids with the milk allergies sit at the end. It's an 
opportunity to teach the other kinds about tolerance, about 
respect for other kids, about understanding that everybody's 
different.
    We've had a few minor situations where, you know, if 
somebody knows somebody's got a milk allergy they'll take a 
piece of cheese and wave it in front of their face. The 
principal at that school is a real advocate for tolerance for 
all kids and he really takes that on.
    When the kids understand what can happen, they have been 
extremely--I think kids are great. I think that if they 
understand and you talk to them, they have been extremely 
wonderful about doing this. It's really nice for kids because 
they don't want to be isolated from their friends; it's really 
nice for them to have the opportunity to sit together.
    Senator Dodd. That's great. That's wonderful.
    I thank all of you. This has been very, very helpful. We 
have 11 co-sponsors of the bill already and I'll be talking to 
as many of my colleagues here in the Senate about this, and of 
course you shouldn't feel reluctant about contacting any member 
of the Senate that you'd like them to join us in this effort.
    The House has passed a bill. It does not include the grant 
money, which we think is very important, an important element. 
We're going to keep insisting upon that, so there's going to be 
resources. Schools are feeling a lot of pinching going on 
financially, for all the obvious reasons we're aware of. 
Providing at least the availability of some grant money that 
would allow them to put the guidelines into effect can be 
helpful. The money goes back to the school districts, by the 
way, not the States.
    We'll leave the record open. I'm sure there are going to be 
additional questions for you in the coming days. This has been 
tremendously helpful.
    Again, Ms. Walters, we thank you very, very much for being 
here. It means a great deal to have you here.
    To you, Colene, we thank you very much for sharing your 
story with us.
    Donna, I'm proud to represent you. You did a great job here 
as a Connecticut witness.
    Dr. Sampson, we all admire immensely what you're doing. 
It's very exciting to hear you talk about some of these things. 
We want to keep you engaged and keep you informed. Any 
additional ideas and thoughts you have for us up here, we 
welcome them.
    Kyle, we thank you, young man from Madison, CT, who's here, 
sat very patiently through all of this. I began to think maybe 
you thought being in school was maybe not a bad alternative to 
this. If you got to avoid school for a day, which was the 
better choice, sitting in a committee talking a lot of these 
$20 words and the like. I'm very glad you came by.
    Kyle, your allergies are to peanuts and tree nuts, right? 
Kyle, is that right?
    Mr. Ericson. Yes.
    Senator Dodd. Well, thank you very much for being here. 
It's nice to have you. Did you want to stand up so we can just 
see you here? You're a good young man, very good. Thank you 
very much. Thank your mom for bringing you down, and dad.
    The committee will stand adjourned. We'll keep working on 
this. Good information, a good education session. Donna, you 
did a great job demonstrating the EpiPen, too.
    The committee will stand adjourned.
    [Additional material follows.]

                          ADDITIONAL MATERIAL

     Prepared Statement of Mary R. Ericson, Mother of Kyle Ericson

                              KYLE'S STORY

     Diagnosed with life-threatening allergy to peanuts and 
tree nuts at 14 months old.
     Has had reactions from contact with trace amounts of 
peanut--Examples: Sitting in a shopping cart at a grocery store where a 
previous child had eaten something with nuts; petting a dog who had 
just eaten a dog biscuit with peanut butter in it.
     Has been in daycare, camps and afterschool programs most 
of his life as both parents (John and I) work full-time.
     Was unable to safely attend the public school in Madison 
(New Haven County--CT) when entering first grade because the 
afterschool staff ``were not permitted'' to administer an EpiPen. The 
stated reason was that their ``insurance carrier wouldn't cover the 
liability.'' We received a letter from the town informing us of this. 
That same letter stated that Kyle would, however, be allowed to ``self-
administer.''
    Note:

    1. The school doesn't allow children to carry or administer any 
medication until they are in 6th grade and have parent and doctor 
permission.
    2. At 6 years old, Kyle couldn't open a bottle of Benadryl and was 
not capable of using an EpiPen under healthy circumstances, let alone 
while experiencing an anaphylactic reaction!
    3. We tried to fight this with extensive documentation, references 
to the ADA, doctors' notes, and finally a private attorney. On August 
6, 2004 we sent the Town of Madison a notice of intent to file formal 
complaint with the U.S. Office of Civil Rights specific to Section 504 
and ADA violation per the town's policy on self-administration of 
medications to treat life-threatening allergic reactions in the Madison 
Before/After School Program. All of this was to no avail. We enrolled 
Kyle in our local Catholic school--which does accommodate his needs 
both during the school day and in the aftercare program--where he and 
his brother now both attend.

     Lacking federally endorsed guidelines for the management 
of food allergies, we have had to educate all of Kyle's caretakers, 
teachers, and school staff (including the nurses) about the nature of 
food allergies, the precautions that must be taken, and what to do in 
the event he accidentally comes in contact with or ingests nuts. Note 
that the guidance we have provided school staff and caretakers is often 
different from guidance provided by other parents.

     Kyle is now 10 years old; his 8-year-old brother Nicholas 
has no allergies. Neither parent has any food allergies.
     Kyle is the oldest of my parent's nine grandchildren; two 
of the nine (including Kyle) have peanut and tree nut allergies--that's 
more than 22 percent. Another two of the nine are still babies, so we 
don't know for sure about them yet.

    While the Catholic school our children attend does an excellent job 
managing food allergies, there are still challenges today for children 
in both public and private schools:

     While legislation has been proposed in CT to have school 
bus drivers carry and be trained to administer EpiPens, currently, if a 
child has a reaction on a bus the driver is supposed to pull over, call 
911 and wait.
     There are no consistent guidelines for managing food 
allergies in schools. So the management plan for one family from one 
doctor may be very different from those provided by other families and 
doctors. This creates uncertainty, concern and even hesitation among 
school staff and caretakers.
     The level of federally supported awareness programs and 
research is insufficient given the dramatically increasing statistics 
on children with food allergies.

    While efforts within legislative scope are addressing the issues in 
schools, food allergies affect families every day in ways most people 
don't think about. Kids like Kyle help to make the severity of food 
allergies real to others who are still uninformed about just how 
serious this issue is. He's a great, smart, funny and active American 
kid. But, he . . .

     has to have an EpiPen and Benadryl with him everywhere he 
goes;
     wears a MedicAlert bracelet all the time;
     can't sit with most of his friends at lunch at school; he 
sits at a nut-free table can't drink out of water fountains (in case 
someone who ate nuts drank from the fountain and left traces);
     is sometimes afraid to go over friends houses because 
there could be hidden traces of nuts around (like the dog biscuit 
incident);
     can't go to Red Sox baseball games (or others, but he 
LOVES the Red Sox) because there are no food-free sections where he can 
safely sit without worrying about coming in contact with peanuts;
     has to have someone wipe down a seat in movie theaters to 
avoid contacting traces of nuts from previous people;
     is occasionally teased and bullied because of his allergy, 
the same way a child with a more visible physical disability might be 
teased;
     gets embarrassed on airplanes when they announce that 
there is a child allergic to peanuts on board;
     has no memory of even one day when he wasn't aware that he 
could die from a peanut.

    Please accept my sincere thanks for your attention to food 
allergies, and my family's gratitude to Senator Dodd for his strong, 
personal commitment to this cause.

                     Prepared Statement of Jo Frost

    For as long as I can remember as a little girl, I have lived with 
the burden of food allergies. Exposure to nuts and shellfish could send 
me to the hospital, gasping for air. The fear is real; it always has 
been and will continue to be a daily reality. When you suffer from 
extreme food allergies like I do, it is hard to trust restaurants, 
waiters, school cafeterias and even food packaging labels. This fear 
and lack of trust will remain with me like the memories of fighting for 
my life as each attack became worse. As a public figure and advocate 
for children, I feel it is my duty to help give a voice to those 
suffering with similar food allergy issues, so they don't have to grow 
up with that same fear instilled in them. Senator Dodd's Food Allergy 
and Anaphylaxis Management Act will allow children with these allergies 
to have a safe place where they don't have to worry if their lunch mate 
has brought a peanut butter sandwich in or if the school lunch they're 
eating has been cooked in peanut oil. Children should be free and open 
to learning and experiencing new things, school is a place to cultivate 
their learning and a safe haven from the world. A child should not have 
to worry about how close their inhaler or EpiPen is to their lunch tray 
or even if they might die while trying to retrieve it. Imagine being 
the parent (or perhaps you already are) of one of these children. You 
live in that same constant fear, the inability to control the situation 
or to protect your child. You drop them off at school, hoping, praying 
other parents won't forget and that fish/dairy won't be the only option 
on the school menu. Having to teach your children that it is not rude 
to not accept a sweet gesture of sharing another's lunch but merely a 
precaution to stay safe from what could be fatal.
    I, as well as over 15 million others, am the people living with 
this raw reality of facts you've heard in this act. The fatal results 
of anaphylactic shock, the rise of peanut allergies and the knowledge 
that only eight foods account for 90 percent of food allergies. Eight 
simple foods while 3 million children suffer from these allergies, 
30,000 of them are brought to the emergency room as a result of 
exposure and 200 die--remember that exposure to anaphylaxis to death 
can occur within minutes. Think of the weight of these numbers: 15 
million vs. eight foods. The value of life and well-being is 
immeasurable, but here we're being presented with numbers to solidify 
something that should be a natural human right. I urge you all to 
support the act put forth by Senator Dodd. Work with me to protect 
these children, their health and most importantly, their lives so that 
they can have a future.
                                 ______
                                 
        Why the Food Allergy Awareness Plan Works At Washington 
           Elementary School Submitted by Donna Rhoads-Frost

    I am the parent of two children with life-threatening allergies. 
They also have other, less severe, food allergies. In the 8 years my 
children attended this school they experienced no food allergic 
reaction. In the same time period outside of school they experienced 
five adverse food reactions. How is that possible in an environment 
that would seem prone to allergen exposure?

    1. A well-trained, knowledgeable, and caring nurse.
    2. An administrative staff that was trained by the nurse in food 
allergy awareness.
    3. A pool of volunteer teachers willing to take responsibility for 
the life of a child.
    4. Exposure controls put in place and constantly monitored (i.e., 
peanut-free tables, notices of children with food allergies, recurrent 
training).
    5. Personnel in food service who care and are aware of the risks of 
food allergies.
    6. Teaching children in an environment that encourages 
consideration and respect for each other. This included a food allergy 
presentation in each classroom.
    7. Children learn how to keep themselves safe over the course of 
their schooling here. To sit where it is safe for them to eat. They 
know adults are aware of their allergies. They know their teacher 
carries an EpiPen and food allergic students are encouraged to take 
responsibility for themselves as they progress. This prepares them for 
the middle school and high school environment where there are currently 
no controls for food allergy.

    What could be better?

    1. Funding to train all the teachers in a school. You cannot rely 
on just a handful of volunteers.
    2. Awareness training for all nursing and administrative staff in a 
school system.
    3. Discounts and funding for schools to purchase EpiPens on an 
annual basis. Many schools go without them or they are expired.
    4. Food allergy awareness training for food service personnel.
    5. A mechanism within the school lunch food program to avoid 
peanut/nut additives at the national level.

    [Whereupon, at 4:53 p.m., the hearing was adjourned.]

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