[House Report 110-571]
[From the U.S. Government Publishing Office]
110th Congress Rept. 110-571
HOUSE OF REPRESENTATIVES
2d Session Part 1
======================================================================
FOOD ALLERGY AND ANAPHYLAXIS MANAGEMENT ACT OF 2008
_______
April 8, 2008.--Ordered to be printed
_______
Mr. Dingell, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 2063]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 2063) to direct the Secretary of Health and
Human Services, in consultation with the Secretary of
Education, to develop a voluntary policy for managing the risk
of food allergy and anaphylaxis in schools, to establish
school-based food allergy management grants, and for other
purposes, having considered the same, report favorably thereon
with amendments and recommend that the bill as amended do pass.
CONTENTS
Page
Amendments....................................................... 1
Purpose and Summary.............................................. 3
Background and Need for Legislation.............................. 4
Hearings......................................................... 4
Committee Consideration.......................................... 4
Committee Votes.................................................. 4
Committee Oversight Findings..................................... 4
Statement of General Performance Goals and Objectives............ 4
New Budget Authority, Entitlement Authority, and Tax Expenditures 5
Earmarks and Tax and Tariff Benefits............................. 5
Committee Cost Estimate.......................................... 5
Congressional Budget Office Estimate............................. 5
Federal Mandates Statement....................................... 6
Advisory Committee Statement..................................... 6
Constitutional Authority Statement............................... 6
Applicability to Legislative Branch.............................. 6
Section-by-Section Analysis of the Legislation................... 6
Changes in Existing Law Made by the Bill, as Reported............ 7
AMENDMENTS
The amendments are as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Food Allergy and Anaphylaxis
Management Act of 2008''.
SEC. 2. FINDINGS.
Congress finds as follows:
(1) Food allergy is an increasing food safety and public
health concern in the United States, especially among students.
(2) Peanut allergy doubled among children from 1997 to 2002.
(3) In a 2004 survey of 400 elementary school nurses, 37
percent reported having at least 10 students with severe food
allergies and 62 percent reported having at least 5.
(4) Forty-four percent of the elementary school nurses
surveyed reported that the number of students in their school
with food allergy had increased over the past 5 years, while
only 2 percent reported a decrease.
(5) In a 2001 study of 32 fatal food-allergy induced
anaphylactic reactions (the largest study of its kind to date),
more than half (53 percent) of the individuals were aged 18 or
younger.
(6) Eight foods account for 90 percent of all food-allergic
reactions: milk, eggs, fish, shellfish, tree nuts, peanuts,
wheat, and soy.
(7) Currently, there is no cure for food allergies; strict
avoidance of the offending food is the only way to prevent a
reaction.
(8) Anaphylaxis is a systemic allergic reaction that can kill
within minutes.
(9) Food-allergic reactions are the leading cause of
anaphylaxis outside the hospital setting, accounting for an
estimated 30,000 emergency room visits, 2,000 hospitalizations,
and 150 to 200 deaths each year in the United States.
(10) Fatalities from anaphylaxis are associated with a delay
in the administration of epinephrine (adrenaline), or when
epinephrine was not administered at all. In a study of 13 food
allergy-induced anaphylactic reactions in school-age children
(6 fatal and 7 near fatal), only 2 of the children who died
received epinephrine within 1 hour of ingesting the allergen,
and all but 1 of the children who survived received epinephrine
within 30 minutes.
(11) The importance of managing life-threatening food
allergies in the school setting has been recognized by the
American Medical Association, the American Academy of
Pediatrics, the American Academy of Allergy, Asthma and
Immunology, the American College of Allergy, Asthma and
Immunology, and the National Association of School Nurses.
(12) There are no Federal guidelines concerning the
management of life-threatening food allergies in the school
setting.
(13) Three-quarters of the elementary school nurses surveyed
reported developing their own training guidelines.
(14) Relatively few schools actually employ a full-time
school nurse. Many are forced to cover more than 1 school, and
are often in charge of hundreds if not thousands of students.
(15) Parents of students with severe food allergies often
face entirely different food allergy management approaches when
their students change schools or school districts.
(16) In a study of food allergy reactions in schools and day-
care settings, delays in treatment were attributed to a failure
to follow emergency plans, calling parents instead of
administering emergency medications, and an inability to
administer epinephrine.
SEC. 3. DEFINITIONS.
In this Act:
(1) ESEA definitions.--The terms ``local educational
agency'', ``secondary school'', and ``elementary school'' have
the meanings given the terms in section 9101 of the Elementary
and Secondary Education Act of 1965 (20 U.S.C. 7801).
(2) School.--The term ``school'' includes public--
(A) kindergartens;
(B) elementary schools; and
(C) secondary schools.
(3) Secretary.--The term ``Secretary'' means the Secretary of
Health and Human Services, in consultation with the Secretary
of Education.
SEC. 4. ESTABLISHMENT OF VOLUNTARY FOOD ALLERGY AND ANAPHYLAXIS
MANAGEMENT POLICY.
(a) Establishment.--Not later than 1 year after the date of enactment
of this Act, the Secretary shall--
(1) develop a policy to be used on a voluntary basis to
manage the risk of food allergy and anaphylaxis in schools; and
(2) make such policy available to local educational agencies
and other interested individuals and entities, including
licensing child care providers, preschool programs, and Head
Start, to be implemented on a voluntary basis only.
(b) Contents.--The voluntary policy developed by the Secretary under
subsection (a) shall contain guidelines that address each of the
following:
(1) Parental obligation to provide the school, prior to the
start of every school year, with--
(A) documentation from the student's physician or
nurse--
(i) supporting a diagnosis of food allergy
and the risk of anaphylaxis;
(ii) identifying any food to which the
student is allergic;
(iii) describing, if appropriate, any prior
history of anaphylaxis;
(iv) listing any medication prescribed for
the student for the treatment of anaphylaxis;
(v) detailing emergency treatment procedures
in the event of a reaction;
(vi) listing the signs and symptoms of a
reaction; and
(vii) assessing the student's readiness for
self-administration of prescription medication;
and
(B) a list of substitute meals that may be offered to
the student by school food service personnel.
(2) The creation and maintenance of an individual health care
plan tailored to the needs of each student with a documented
risk for anaphylaxis, including any procedures for the self-
administration of medication by such students in instances
where--
(A) the students are capable of self-administering
medication; and
(B) such administration is not prohibited by State
law.
(3) Communication strategies between individual schools and
local providers of emergency medical services, including
appropriate instructions for emergency medical response.
(4) Strategies to reduce the risk of exposure to anaphylactic
causative agents in classrooms and common school areas such as
cafeterias.
(5) The dissemination of information on life-threatening food
allergies to school staff, parents, and students, if
appropriate by law.
(6) Food allergy management training of school personnel who
regularly come into contact with students with life-threatening
food allergies.
(7) The authorization and training of school personnel to
administer epinephrine when the school nurse is not immediately
available.
(8) The timely accessibility of epinephrine by school
personnel when the nurse is not immediately available.
(9) Extracurricular programs such as non-academic outings and
field trips, before- and after-school programs, and school-
sponsored programs held on weekends that are addressed in the
individual health care plan.
(10) The collection and publication of data for each
administration of epinephrine to a student at risk for
anaphylaxis.
(c) Relation to State Law.--Nothing in this Act or the policy
developed by the Secretary under subsection (a) shall be construed to
preempt State law, including any State law regarding whether students
at risk for anaphylaxis may self-administer medication.
SEC. 5. VOLUNTARY NATURE OF POLICY AND GUIDELINES.
The policy developed by the Secretary under section 4(a) and the food
allergy management guidelines contained in such policy are voluntary.
Nothing in this Act or the policy developed by the Secretary under
section 4(a) shall be construed to require a local educational agency
or school to implement such policy or guidelines.
Amend the title so as to read:
A bill to direct the Secretary of Health and Human
Services, in consultation with the Secretary of Education, to
develop a voluntary policy for managing the risk of food
allergy and anaphylaxis in schools.
PURPOSE AND SUMMARY
The purpose of H.R. 2063, the ``Food Allergy and
Anaphylaxis Management Act of 2008'', is to provide schools
with uniform guidance on how to create appropriate management
and emergency plans for children with food allergies.
BACKGROUND AND NEED FOR LEGISLATION
Each year, millions of Americans have allergic reactions to
food. Although most food allergies cause relatively mild and
minor symptoms, some food allergies can cause severe, even
life-threatening, reactions. Following ingestion of food
allergens, a person with food allergies may experience a
severe, life-threatening allergic reaction called anaphylaxis.
This can lead to a number of symptoms, including tingling
sensation in the mouth; swelling of the tongue and throat;
difficulty breathing; hives; vomiting; abdominal cramps;
diarrhea; drop in blood pressure; loss of consciousness; and
death.
There is no cure for food allergies. Strict avoidance of
food allergens--and early recognition and management of
allergic reactions to food--are important measures to prevent
serious health consequences since food allergies can be life
threatening. Each year in the U.S., it is estimated that
anaphylaxis to food results in 30,000 emergency room visits,
2,000 hospitalizations, and 150 deaths.
The risk of an allergic student's accidental exposure to
foods can be reduced in the school setting if schools work with
students, parents, and physicians to minimize risks and provide
a safe educational environment for food-allergic students.
HEARINGS
There were no hearings held in connection to the bill
reported by the Committee.
COMMITTEE CONSIDERATION
On Tuesday, March 11, 2008, the Subcommittee on Health met
in open markup session and favorably forwarded H.R. 2063,
amended, to the full Committee for consideration, by a voice
vote. On Thursday, March 13, 2008, the full Committee met in
open markup session and ordered H.R. 2063 favorably reported to
the House, as amended by the Subcommittee on Health, by a voice
vote. No amendments were offered during full Committee
consideration.
COMMITTEE VOTES
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There were no record votes taken on amendments or in connection
with ordering H.R. 2063 reported to the House. A motion by Mr.
Dingell to order H.R. 2063 favorably reported to the House, as
amended, was agreed to by a voice vote.
COMMITTEE OVERSIGHT FINDINGS
Regarding clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the oversight findings of the
Committee regarding H.R. 2063 are reflected in this report.
STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES
The objective of H.R. 2063 is to direct the Secretary of
Health and Human Services (HHS), in consultation with the
Secretary of Education, to develop a voluntary policy for
managing the risk of food allergy and anaphylaxis in schools.
NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX EXPENDITURES
Regarding compliance with clause 3(c)(2) of rule XIII of
the Rules of the House of Representatives, the Committee finds
that H.R. 2063 would result in no new or increased budget
authority, entitlement authority, or tax expenditures or
revenues.
EARMARKS AND TAX AND TARIFF BENEFITS
Regarding compliance with clause 9 of rule XXI of the Rules
of the House of Representatives, H.R. 2063 does not contain any
congressional earmarks, limited tax benefits, or limited tariff
benefits as defined in clause 9(d), 9(e), or 9(f) of rule XXI.
COMMITTEE COST ESTIMATE
The Committee adopts as its own the cost estimate on H.R.
2063 prepared by the Director of the Congressional Budget
Office pursuant to section 402 of the Congressional Budget Act
of 1974.
CONGRESSIONAL BUDGET OFFICE ESTIMATE
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate on
H.R. 2063 provided by the Congressional Budget Office pursuant
to section 402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, March 31, 2008.
Hon. John D. Dingell,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 2063, the Food
Allergy and Anaphylaxis Management Act of 2008.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Andrea Noda.
Sincerely,
Robert A. Sunshine
(For Peter R. Orszag, Director).
Enclosure.
H.R. 2063--Food Allergy and Anaphylaxis Management Act of 2008
H.R. 2063 would require the Secretary of Health and Human
Services, in consultation with the Secretary of Education, to
develop a policy for managing the risk of food allergies and
anaphylaxis in schools. (Anaphylaxis is a severe allergic
reaction that involves multiple organs.) The bill would require
that the policy be made available to schools within one year of
enactment. Implementation of the policy by schools would be
voluntary.
The Centers for Disease Control and Prevention received an
appropriation of $491,000 for fiscal year 2008 to develop
guidelines for schools regarding food allergies and
anaphylaxis. Because the development of the policy set forth in
H.R. 2063 currently is underway, CBO estimates that the bill
would not result in any additional federal spending.
H.R. 2063 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act and
would not affect the budgets of state, local, or tribal
governments.
The CBO staff contact for this estimate is Andrea Noda.
This estimate was approved by Peter H. Fontaine, Assistant
Director for Budget Analysis.
FEDERAL MANDATES STATEMENT
The Committee adopts as its own the estimate of Federal
mandates regarding H.R. 2063 prepared by the Director of the
Congressional Budget Office pursuant to section 423 of the
Unfunded Mandates Reform Act.
ADVISORY COMMITTEE STATEMENT
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act would be created by H.R.
2063.
CONSTITUTIONAL AUTHORITY STATEMENT
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for H.R. 2063 is provided in the
provisions of Article I, section 8, clause 1, that relate to
expending funds to provide for the general welfare of the
United States.
APPLICABILITY TO LEGISLATIVE BRANCH
The Committee finds that H.R. 2063 does not relate to the
terms and conditions of employment or access to public services
or accommodations within the meaning of section 102(b)(3) of
the Congressional Accountability Act of 1995.
SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION
Section 1. Short title
Section 1 establishes the short title of the Act as the
``Food Allergy and Anaphylaxis Management Act of 2008''.
Section 2. Findings
Section 2 sets out the findings of the Act.
Section 3. Definitions
Section 3 sets out the definitions of the Act.
Section 4. Establishment of voluntary food allergy and anaphylaxis
management policy
Section 4 directs the Secretary of HHS, in consultation
with the Secretary of Education, to develop a voluntary risk-
management policy for food allergy and anaphylaxis in schools
and to make such policy available to local educational agencies
and other interested parties. It sets out the contents and
guidelines of such policy. It specifies that State law is not
preempted, either by the Act or by such policy, including any
State law regarding self-administered medication for students
at risk of anaphylaxis.
CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED
Regarding clause 3(e) of rule XIII of the Rules of the
House of Representatives, H.R. 2063 does not amend any existing
law.