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[House Report 110-571]
[From the U.S. Government Publishing Office]

110th Congress                                            Rept. 110-571
                        HOUSE OF REPRESENTATIVES
 2d Session                                                      Part 1

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          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.

                                  
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