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[Senate Report 107-322]
[From the U.S. Government Publishing Office]

                                                       Calendar No. 739
107th Congress                                                   Report
                                 SENATE
 2nd Session                                                    107-322

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

 
           FOOD ALLERGEN LABELING AND CONSUMER PROTECTION ACT

                                _______
                                

                October 17, 2002.--Ordered to be printed

                                _______
                                

   Mr. Kennedy, from the Committee on Health, Education, Labor, and 
                   Pensions, submitted the following

                              R E P O R T

                         [To accompany S. 2499]

    The Committee on Health, Education, Labor, and Pensions, to 
which was referred the bill (S. 2499) to establish labeling 
requirements regarding allergenic substances in food, and for 
other purposes, reports favorably thereon with an amendment and 
recommends that the bill (as amended) do pass.

                                CONTENTS

                                                                   Page
  I. Purpose and Summary of the Bill..................................1
 II. Background and Need for the Legislation..........................3
III. Legislative History and Committee Action.........................5
 IV. Explanation of the Legislation and Committee Views...............5
  V. Cost Estimate....................................................9
 VI. Application of Law to the Legislative Branch.....................9
VII. Regulatory Impact Statement.....................................10
VIII.Section-By-Section Analysis.....................................10

 IX. Changes in Existing Law.........................................12

                   I. Purpose and Summary of the Bill

    The Federal Food, Drug, and Cosmetic Act (FFDCA) requires, 
with some exceptions, a complete listing of all the ingredients 
in a food on the food label. Currently, the FFDCA does not 
require the eight major food allergens to be identified, using 
plain English, on the food label when ingredients contain 
allergenic substances. The names of many ingredients do not 
clearly identify in plain English that the ingredient is the 
source of an allergen.
    There are also two exemptions from the requirement that 
each ingredient be listed in the food ingredient label. One 
exemption allows for collective naming of flavors, certain 
colors, and spices. These terms are not completely descriptive, 
however; in particular, they do not identify if any components 
of the flavors, colors, and spices are allergens. Under the 
second exemption, incidental additives, which are food 
substances that are used in insignificant amounts and that do 
not have any technical or functional affect in the food, need 
not be identified in the food label. Although additives that 
contain a major food allergen are not considered to be 
incidental, these ingredients are nonetheless sometimes 
inadvertently left off of the food label.
    Food allergens also may inadvertently find their way into a 
food because of a firm's production practices; for example, 
rework addition, product carryover due to use of common 
equipment or production scheduling. Such practices present an 
unintentional opportunity for a product that contains an 
allergen to come into cross-contact with a product that does 
not intentionally contain that particular allergen. Some food 
manufacturers have added statements, such as ``May contain 
(allergic ingredient),'' to their product labels to alert 
consumers to the possibility that the product may contain an 
allergic substance.
    The term ``gluten-free'' has not been defined by 
regulation. Persons with celiac disease must avoid certain 
types of gluten in foods associated with celiac disease. When 
gluten from certain cereal grains is ingested by individuals 
with celiac disease, damage to the gastrointestinal tract, 
central nervous system, and other organs may occur over time. 
Allowing the term ``gluten-free'' on food labels will assist 
consumers who have celiac disease avoid gluten.
    The committee has approved this legislation to address 
these and other issues related to food allergens and glutens in 
foods that are associated with celiac disease.

 1. THE LEGISLATION REQUIRES PLAIN ENGLISH INGREDIENT LABELING OF THE 
                       EIGHT MAJOR FOOD ALLERGENS

    The legislation amends the FFDCA to require that food 
ingredient statements identify in plain English when the food 
contains a major food allergen. The legislation also provides 
that food ingredient statements will identify when a food 
allergen is contained in spices, flavorings, colorings, and 
incidental additives.

2. THE LEGISLATION PROVIDES FOR A REPORT ON FOOD ALLERGEN CROSS-CONTACT 
    AND ADVISORY LABELING AND FOR BIENNIAL REPORTS ON FOOD ALLERGEN 
                              INSPECTIONS

    The legislation requires the Secretary of Health and Human 
Services (Secretary) to issue a report to Congress about food 
allergen cross contact and advisory labeling. The legislation 
also requires the Secretary to give priority to increasing the 
number of food allergen inspections and it requires biennial 
reports to Congress about such inspections.

    3. THE LEGISLATION PROVIDES FOR ENHANCED SURVEILLANCE AND FOR A 
                RESEARCH PLAN RELATING TO FOOD ALLERGENS

    The legislation requires the Centers for Disease Control 
and Prevention (CDC) to track food-allergic-related deaths and 
other clinically significant and serious adverse events. It 
also directs the National Institutes of Health (NIH) to convene 
a panel of experts to develop a plan for research activities 
concerning food allergies.

 4. THE LEGISLATION PROVIDES THAT THE FOOD CODE ADDRESS FOOD ALLERGENS 
AND FOR TECHNICAL ASSISTANCE TO STATES REGARDING EMERGENCY TREATMENT OF 
                       ALLERGIC RESPONSES TO FOOD

    The legislation directs the Secretary to pursue revision of 
the Food Code to provide guidelines for preparing allergen-free 
foods in food establishments. It also directs the Secretary to 
provide technical assistance relating to emergency treatment of 
allergic responses to foods.

5. THE LEGISLATION PROVIDES FOR VOLUNTARY ``GLUTEN-FREE'' LABELING AND 
    TWO REPORTS ON CELIAC DISEASE AND LABELING OF GLUTENS IN FOODS 
                     ASSOCIATED WITH CELIAC DISEASE

    The legislation requires the Secretary to contract with the 
Institute of Medicine to provide a report to Congress and the 
Secretary about the glutens in foods that are associated with 
celiac disease. The legislation requires the Secretary to 
define the term ``gluten-free'' for voluntary use in food 
labeling. In addition, the legislation requires the Secretary 
to submit a report to Congress about the labeling of gluten in 
foods that are associated with celiac disease.

              II. Background and Need for the Legislation

    Seven million Americans suffer from food allergies, 
approximately 2 percent of adults and 5 percent of infants and 
young children. Recent studies estimate that 150 Americans die 
each year and that 30,000 individuals require emergency room 
treatment because of allergic responses to food. Eight major 
foods or food groups--milk, eggs, fish, Crustacean shellfish, 
tree nuts, peanuts, wheat, and soybeans--account for 90 percent 
of food allergies. There is currently no cure for food 
allergies. Instead, people with a food allergy must avoid the 
food to which they are allergic.
    To avoid an allergen, food-allergic consumers must 
carefully read the labels for every food product they consume. 
This task is complicated because the names of many ingredients 
do not clearly identify that they are derived from an allergen. 
Currently, ingredients that may cause allergic reactions are 
listed on food labels using terms that do not identify the 
allergen in plain English. For example, whey and casein are 
foods derived from milk that cause allergic reactions in those 
allergic to milk. Currently, whey and casein are required to be 
identified in the food ingredient list only as whey and casein, 
however. A recent study showed that many parents of children 
with food allergy were unable to identify correctly several 
ingredients derived from major food allergens in each of 
several food labels. Use of plain English in food labels to 
identify the presence of the eight major food allergens will 
make the food label much more useful to consumers with food 
allergies.
    In addition, currently spices, flavorings, and certain 
colorings and incidental additives are exempt from ingredient 
labeling requirements and need only be identified collectively 
as spices or flavorings, for example. Because some of these 
ingredients contain allergens, this exemption can pose a health 
threat to susceptible consumers, even though spices, 
flavorings, colorings, and incidental additives are generally 
present in foods in only small quantities. Requiring the use of 
plain English to identify the presence of the eight major food 
allergens used in spices, flavors, and certain colors and 
incidental additives will also make the food label more useful 
to allergic consumers.
    Food allergens sometimes inadvertently find their way into 
a food because of a firm's production practices; for example, 
rework addition, product carryover due to use of common 
equipment or production scheduling. Such practices present an 
unintentional opportunity for a product that contains an 
allergen to come into cross-contact with a product that does 
not intentionally contain that particular allergen. This 
problem of unintentional ``cross-contact'' deserves study and 
further action by both FDA and the food industry.
    Although FDA and the industry must identify and implement 
practicable steps to eliminating the possibility of cross-
contact, it may be that, in some instances, even such 
procedures will not be sufficient to eliminate the presence of 
an allergen. In such instances, it will be appropriate for food 
manufacturers to use advisory labeling (such as ``may 
contain'') to indicate the possible presence of food allergens 
in a food product. Many food manufacturers currently use such 
advisory language. Many do so appropriately, given the current 
state of knowledge about processes and technologies to reduce 
cross-contact. Yet there is concern among the food allergenic 
community that some members of the food industry use advisory 
labeling inappropriately, or not at all when they should. FDA 
and the food industry should carefully consider the use of 
advisory labeling, which can save the life of a consumer when 
it is appropriately used.
    Although several studies have provided estimates, the 
prevalence of food allergies is uncertain. Currently, the CDC 
does not sufficiently track data on the prevalence of food 
allergies, incidence of clinically significant and serious 
adverse events related to food allergies, and the use of 
different modes of treatment for and prevention of allergic 
responses to foods. The CDC should improve the collection of 
this information to better determine the national significance 
of food allergies.
    Research on food allergies is being conducted by public and 
private organizations. TheNIH should conduct a comprehensive 
review of completed and ongoing studies on food allergies. Based on 
their findings, NIH should make recommendations identifying clinical 
research that should be conducted.
    Numerous food establishments, including restaurants, 
grocery store delicatessens and bakeries, and school cafeterias 
are working to better serve those consumers with food 
allergies. Private guidelines demonstrating and recommending 
ways to prepare allergen-free foods have helped to educate such 
food establishments. Revision of the Food Code to include 
similar recommendations, however, will help to better alert the 
food establishments to the problem food allergies pose to 
public health and make the distribution of such information 
more widespread.
    Not all States and localities provide emergency medical 
technicians with adequate training to treat successfully a 
patient undergoing a food allergic response. The government 
should provide technical assistance to such States and 
localities to enhance their preparedness to address emergencies 
caused by food allergens.
    Celiac disease is an immune-mediated disease. When gluten 
from certain cereal grains is ingested by individuals with 
celiac disease, damage to the gastrointestinal tract, central 
nervous system, and other organs may occur over time. The 
response to glutens by those with celiac disease is not an 
allergic response. A multicenter, multiyear study estimated the 
prevalence of celiac disease in the United States to be 0.5 to 
1 percent of the general population. The current recommended 
treatment is avoidance of glutens in foods that are associated 
with celiac disease. Allowing a clearly defined ``gluten-free'' 
claim to appear on the labels of food products will assist 
individuals with celiac disease to avoid the glutens associated 
with the disease.

             III. Legislative History and Committee Action

    On May 9, 2002, Senator Kennedy, for himself and Senator 
Clinton, introduced S. 2499, to amend the FFDCA to require 
plain English labeling of the eight major food allergens in 
food ingredient labeling.
    On September 25, 2002, the committee held an executive 
session to consider S. 2499. Senator Kennedy, for himself and 
Senators Gregg, Clinton, Roberts, and Frist, offered a 
substitute amendment as modified that was considered as 
original text by the committee. The committee approved S. 2499, 
as amended, by unanimous voice vote.

         IV. Explanation of the Legislation and Committee Views

Requirement of Plain English Labeling of the Eight Major Food Allergens

    The legislation amends section 201 of the FFDCA to define 
the term ``major food allergen.'' It is defined to mean the 
eight most significant food allergens--milk, egg, fish (e.g., 
bass, flounder, or tuna), Crustacean shellfish (e.g., crab, 
lobster, or shrimp), tree nuts (e.g., almonds, pecans, or 
walnuts), wheat, peanuts, and soybeans--and any proteinaceous 
substance derived from one of these eight food allergens, 
unless the Secretary determines that the substance does not 
cause an allergic response that poses a risk to human health. 
Fish, Crustacean shellfish, and tree nuts are collective names 
that include a variety of different items. For example, the 
term ``tree nuts'' refers to a variety of individual nuts, 
including almonds, Brazil nuts, cashews, chestnuts, filberts/
hazelnuts, macadamia nuts, pecans, pine nuts, pistachios, and 
walnuts. Similarly, the term ``Crustacean shellfish'' refers to 
crabs, crawfish/crayfish, lobster, prawns, and shrimp. The term 
``fish'' refers to a variety of different fish. The committee 
intends that the Secretary will provide guidance to industry on 
the information that would be useful for making a determination 
that a proteinaceous substance derived from one of the eight 
major food allergens does not cause an allergic response that 
poses a risk to human health. The committee also intends that 
the Secretary provide an appropriate process for providing such 
information to the Secretary that minimizes the burden on the 
food manufacturer.
    The legislation also amends section 403 of the FFDCA to 
provide two new misbranding provisions. The first of these, 
section 403(t), requires that the eight major food allergens be 
labeled on foods that are not raw agricultural products. Under 
section 403(t), manufacturers will have two options as to how 
they must label the eight major food allergens on such foods. 
Under either plain English allergen labeling option, the term 
for a major food allergen--milk, egg, wheat, peanuts, soybeans, 
or, in the case of the collective terms ``fish,'' ``Crustacean 
shellfish,'' or ``tree nuts,'' the common or usual name for the 
relevant specific members of the class, such as ``tuna,'' 
``shrimp,'' or ``almond''--will appear in the food label if the 
food is, or intentionally bears or contains, a major food 
allergen as defined in section 201(ll). These plain English 
allergen labeling requirements apply only to foods for which an 
ingredient list is required in a label or labeling under the 
FFDCA.
    Manufacturers may choose to summarize the allergen 
information using the terms for the major food allergens from 
which any ingredients in the food are derived in a statement at 
the end of, or immediately adjacent to, the ingredient list. 
This information must appear in a type size no smaller than the 
type size used in the ingredient list.
    Alternatively, manufacturers may place the term for the 
appropriate major food allergen in parentheses within the 
ingredient list after the common or usual name of the 
ingredient derived from that major food allergen. There are two 
exceptions to this requirement. First, the listing of the term 
for the food allergen is not required to appear in parentheses 
after an ingredient name if the ingredient name uses the term 
for the major food allergen (for example, ``milk'' need not 
appear in parentheses after ``milk'' or ``milk by-product,'' 
nor need ``almond'' appear after ``almond''). Second, the term 
for a food allergen need not be placed after an ingredient if 
the term for that food allergen appears elsewhere in the 
ingredient list; the food allergen term need only appear once 
in the ingredient statement.
    These two options can be illustrated by an example. If a 
food were to have as ingredients semolina, rice flour, rolled 
oats, pine nuts, tomato juice, whey, sodium caseinate, and 
natural flavoring, with the natural flavoring including peanuts 
as a constituent, the major food allergens in the food could be 
labeled in two ways. First, the following statement could 
appear at the end of, or immediately adjacent to, the list of 
ingredients: ``Contains wheat, milk, pine nuts, and peanuts.'' 
Second, the ingredient list could read: ``Ingredients: semolina 
(wheat), rice flour, rolledoats, pine nuts, tomato juice, whey 
(milk), sodium caseinate, and natural flavoring (peanuts).''
    These two examples illustrate several aspects of the 
allergen labeling requirements. In the second example, ``milk'' 
does not appear in parentheses after ``sodium caseinate'' 
because it has already appeared after ``whey.'' In the 
examples, the natural flavoring includes peanuts as a 
constituent and so peanuts is labeled as an allergen in the 
food. In other words, the food allergen labeling requirement 
applies to spices, flavorings, colorings, and incidental 
additives. Only the peanut constituent of the natural flavoring 
ingredient is identified, however; the other constituents of 
the flavoring--or indeed of any spice, coloring, or incidental 
additive--are not required to be listed under either plain 
English labeling option permitted under the legislation.
    The term ``pine nuts'' is in the summary of allergy 
information in the first example, but it need not appear after 
``pine nut'' in the ingredient list in the second example 
because the repetition is unnecessary. The first example 
illustrates the committee's intent that the term for the 
relevant specific member of the class ``fish'' or ``Crustacean 
shellfish'' or ``tree nuts'' is required to be used whenever an 
ingredient is, or is derived from, an example from one of these 
food categories. The second example illustrates the committee's 
intent that an ingredient whose common or usual name uses the 
term for the major food allergen--in the example, ``pine nuts'' 
clearly uses the term for pine nuts--need not be followed by a 
parenthetical repeating the term. Finally, all major food 
allergens are required to be labeled consistently: either in 
the summary of allergen information at the end of, or 
immediately adjacent to, the ingredient list, or using 
parentheses after ingredients.
    The committee intends that the use of the term ``milk'' in 
either of these examples does not violate the standard of 
identity for milk established under FDA regulations. Used in 
this context, the term ``milk'' is used to identify a major 
food allergen and not the identity of the ingredient or the 
food.
    The legislation gives FDA the authority to modify or 
eliminate these requirements by regulation. This authority is 
limited in a few respects, however. First, FDA may modify one 
or both labeling options. Second, FDA may not eliminate all 
major food allergen labeling by eliminating both labeling 
options; rather, FDA may eliminate only one of the approaches. 
Third, and most significantly, FDA must demonstrate in the 
regulation that modification or elimination of an allergen 
labeling requirement is necessary to protect public health. The 
committee considers this standard to impose a high burden on 
the Secretary to justify changing these requirements of the 
legislation.
    Section 403(t) is limited to foods that are not raw 
agricultural products. Accordingly, this legislation does not 
change the applicability of current misbranding and 
adulteration provisions to foods that are raw agricultural 
products. In particular, raw agricultural products into which 
major food allergens have been introduced by any means would be 
considered to be misbranded by FDA if not appropriately labeled 
under sections 201(n) and 403(a)(1) of the FFDCA, and even so 
may be considered to be adulterated by FDA under section 
402(a)(1).
    In addition, the legislation amends section 403A of the 
FFDCA to give the modification to the ingredient label required 
by section 403(t) the same preemptive effect over State and 
local ingredient labeling that the current ingredient labeling 
has.
    The labeling requirements of section 403(t) become 
effective for foods labeled on or after January 1, 2006. This 
effective date gives the food industry time to provide this 
essential public health information on the labels of their 
foods. Importantly, this requirement does not require the 
relabeling of food products that are in the marketplace before 
the effective date. In other words, this legislation does not 
require food products to be pulled from the marketplace and 
relabeled in conformance with the requirements of this 
legislation if they were labeled before January 1, 2006.
    The committee understands that many foods are already 
labeled in conformity with one of the plain English allergen 
labeling options, and it expects that most foods will be 
labeled in compliance with these requirements before January 1, 
2006. In any case, all foods that intentionally bear or contain 
major food allergens must be labeled by January 1, 2006. This 
fixed date by which all affected foods must be relabeled will 
give consumers greater certainty that they will be able to rely 
on food labels as of that date.
    The committee intends the requirements of section 403(t) to 
be self-implementing. FDA will not be required, nor is it 
necessary for FDA, to issue regulations to implement section 
403(t). FDA may issue guidance, should the agency find that 
guidance would assist manufacturers or distributors, 
particularly small businesses, to comply with the requirements 
in this legislation.
    The legislation also adds a second misbranding provision to 
account for other food allergens. In particular, section 403(u) 
provides that FDA has the authority to require by regulation 
appropriate labeling of any spice, flavoring, coloring, or 
incidental additive that is, or includes as a constituent, a 
food allergen that is not a major food allergen. In addition, 
the legislation provides that the amendments made by it do not 
otherwise alter FDA's authority to require the labeling of 
other food allergens that are not major food allergens. 
Finally, the legislation amends section 403A of the FFDCA to 
give requirements under section 403(u)--which provides for an 
exception to a current labeling exemption for spices, 
flavorings, colorings, and incidental additives that has 
preemptive effect over State and local labeling requirements--
the same preemptive effect over State and local labeling 
requirements that the current exemption has.

Food Allergy Surveillance, Research, and Response

    The committee is concerned that the prevalence of food 
allergies is uncertain and the incidence of clinically 
significant and serious adverse events is not being 
systematically monitored. In response to these concerns, the 
legislation requires the Centers for Disease Control and 
Prevention to better capture information on the prevalence of 
food allergies, the incidence of clinically significant or 
serious adverse events related to food allergies, and the use 
of different modes of treatment for and prevention of allergic 
responses to foods. In addition, the legislation requires the 
National Institutes of Health to convene a panel of nationally 
recognized experts to review current clinical research efforts 
and develop a plan for expanding research activities concerning 
food allergies.
    The legislation directs the Secretary, in the Conference 
for Food Protection, to pursue revision of the Food Code to 
provide recommendations and guidance on preparing allergen-free 
foods in food establishments. The Secretary should refer to 
private guidelines, including the Food Allergy and Anaphylaxis 
Network and Food Allergy Initiative's document entitled: Food 
Allergy Training Guide for Restaurants and Food Services, as a 
model during development.
    Finally, the legislation directs the Secretary to provide 
technical assistance to States and localities about treatment 
of food allergic responses by trauma care and emergency medical 
services. Currently, the preferred treatment for anaphylaxis 
from food allergy is an auto-injector epinephrine device. The 
legislation does not specify this treatment, however, so that 
the Secretary will continue to provide such technical 
assistance as new treatments are developed.

Celiac Disease and Gluten Labeling

    The legislation directs the Secretary to contract with the 
Institute of Medicine to conduct a review of the science 
relating to the glutens in food that are associated with celiac 
disease, the means of preventing and treating celiac disease, 
and the methodologies for detecting such glutens in food. This 
research should include information on both the sensitivity of 
individuals with celiac disease to gluten from different cereal 
grain sources and on gluten threshold levels (the amount of a 
gluten necessary to elicit the symptoms of celiac disease). The 
Institute of Medicine will provide a report to the Secretary 
and to Congress on this review not later than 2 years after the 
date of enactment of the legislation.
    The committee expects this report to inform a rule making 
required by the legislation, by which the Secretary is to 
define and permit the use of the term ``gluten-free'' as a 
voluntary claim on the food label. The committee intends that 
this ``gluten-free'' claim not be a claim for special dietary 
use, a nutrient content claim, or a health claim. Further, the 
committee intends that, under the regulation, foods that are 
ordinarily gluten-free may be appropriately identified as a 
gluten-free food in food labeling. The legislation requires 
that the proposed rule allowing this claim be issued not later 
than 4 years after the date of enactment of the legislation, 
and that the final rule be issued not later than 6 years after 
the date of enactment of the legislation.
    The committee also expects the Institute of Medicine report 
to inform a report by the Secretary to Congress on whether 
additional requirements for the labeling of gluten in food 
associated with celiac disease are warranted and necessary to 
better inform individuals with celiac disease. If the Secretary 
finds that other labeling of gluten in food associated with 
celiac disease is warranted and necessary, the report is to 
identify the types of such labeling and should describe why the 
different types of labeling are warranted and necessary.

                            V. Cost Estimate

    Due to time constraints the Congressional Budget Office 
estimate was not included in the report. When received by the 
committee, it will appear in the Congressional Record at a 
later time.

            VI. Application of Law to the Legislative Branch

    S. 2499 adds two misbranding provisions to section 403 the 
FFDCA to provide, first, that food labels include plain English 
labeling of the eight major food allergens and second, that 
food allergens other than the eight major food allergens can be 
identified when they are contained in spices, flavorings, 
colorings, or other incidental additives. It also requires 
reports to the Congress by the Department of Health and Human 
Services and the Institute of Medicine about various issues 
relating to food allergens, celiac disease, and gluten, and 
requires certain other actions by the Department relating to 
food allergens and gluten. As such, it has no application to 
the legislative branch.

                    VII. Regulatory Impact Statement

    The legislation requires foods that contain one or more of 
the eight major food allergens to be labeled so as to disclose 
the presence of those allergens in plain English. Because many 
in the food industry have already begun the process of labeling 
their products to disclose these allergens, and because the 
legislation requires food manufacturers to comply with this 
requirement by January 1, 2006, by which time most in the food 
industry may be expected to produce new labels for their foods 
notwithstanding the requirements of this legislation, the costs 
to most members of the food industry and to the food industry 
in aggregate of this requirement will be minimized. 
Accordingly, S. 2499 is not expected to increase costs to 
government.

                   VIII. Section-by-Section Analysis

Sec. 1. Short Title

Sec. 2. Findings

Sec. 3. Food Labeling; Requirement of Information Regarding Allergenic 
        Substances

    Section 3 amends the FFDCA to define the term ``major food 
allergen'' to mean one of the eight major food allergens (milk, 
egg, fish (e.g., bass, flounder, or tuna), Crustacean shellfish 
(e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, 
pecans, or walnuts), wheat, peanuts, and soybeans) and any 
proteinaceous substance derived from one of these eight food 
allergens, unless the Secretary determines that the substance 
does not cause an allergic response that poses a risk to human 
health. Section 3 amends the FFDCA to require that food 
ingredient statements identify in plain English when a food 
that is not a raw agricultural product is, or intentionally 
bears or contains, a major food allergen. Section 3 requires 
that this information appear consistently within each such 
food's label in one of two ways, either within the ingredient 
list in parentheses after the first ingredient that is derived 
from the allergen, or in summary form at the end of, or 
immediately adjacent to, the ingredient list. Section 3 
requires that food ingredient statements identify in one of 
these ways when a major food allergen is used in spices, 
flavorings, colorings, and incidental additives. Section 3 
requires all foods that are not raw agricultural products and 
that are, or that intentionally bear or contain, major food 
allergens to be so labeled by January 1, 2006. Section 3 also 
amends the FFDCA to give the plain English allergen labeling 
the samepreemptive effect over State and local ingredient 
labeling as current ingredient labeling.
    Section 3 provides that the FDA has the authority to 
require by regulation appropriate labeling of any spice, 
flavoring, coloring, or incidental additive that is, or 
intentionally includes as a constituent, a food allergen that 
is not a major food allergen. Section 3 also provides that this 
regulatory exception to the current labeling exemption for 
spices, flavorings, colorings, and incidental additives has the 
same preemptive effect over State and local labeling 
requirements as the current exemption. In addition, section 3 
provides that the amendments made by it do not otherwise alter 
FDA's authority to require the labeling of other food allergens 
that are not major food allergens.

Sec. 4. Report on Food Allergens

    Section 4 requires the Secretary to issue a report to 
Congress by June 30, 2004, analyzing the ways in which foods, 
during manufacturing and processing, can be unintentionally 
contaminated with major food allergens (cross-contact); 
estimating how common these practices are; recommending methods 
that can be used to reduce or eliminate cross-contact of foods 
with the major food allergens; describing the types of advisory 
labeling used by the food industry, the conditions of 
manufacture associated with use of advisory labeling, and the 
extent of use of advisory labeling; determining how consumers 
with food allergies or the caretakers of consumers would prefer 
information about the risk of cross-contact be communicated on 
food labels; and identifying the circumstances, if any, under 
which advisory labeling could appropriately be used.

Sec. 5. Inspections Relating to Food Allergens

    Section 5 requires the Secretary to give priority to 
increasing the number of inspections to ensure that foods 
comply with practices to reduce or eliminate cross-contact of a 
food with major food allergen residues and that food allergens 
are properly labeled. Section 5 also requires biennial reports 
to Congress to include information on the number of inspections 
conducted in the previous year and the number of facilities and 
food labels that were found to be in compliance or out of 
compliance; the nature of the violations found; the number and 
classification of voluntary recalls of foods with undeclared 
major food allergens; the extent of use of advisory labeling 
and the appropriateness of that use; and the extent to which 
the Secretary and the food industry have effectively addressed 
cross-contact issues.

Sec. 6. Labeling of Glutens and Celiac Disease

    Section 6 requires the Secretary to contract with the 
Institute of Medicine, in conjunction with celiac disease 
experts, for a report, to be issued not later than 2 years 
after the date of enactment of the legislation to the Secretary 
and Congress, reviewing the science relating to glutens in 
foods that are associated with celiac disease, the means of 
preventing and treating celiac disease, and the methodologies 
for detecting such glutens in foods. Section 6 requires the 
Secretary, after reviewing the Institute of Medicine report, to 
issue a rule not later than 6 years after the date of enactment 
of the legislation defining and permitting voluntary use of the 
term ``gluten-free'' on food labeling. In addition, section 6 
requires the Secretary to submit a report to Congress that 
assesses whether additional requirements for the labeling of 
gluten are warranted and necessary to better inform individuals 
with celiac disease, and if other labeling is warranted and 
necessary, that identifies the types of such labeling.

Sec. 7. Data on Food-Related Allergic Responses

    Section 7 requires the Secretary, not later than 1 year 
after the date of enactment of the legislation, to complete a 
study to determine whether existing systems of reporting, 
collecting, and analyzing national data accurately capture 
information about the prevalence of food allergies, the 
incidence of clinically significant or serious adverse events 
related to food allergies, and the use of different modes of 
treatment for and prevention of allergic responses to foods, 
and to identify new or alternative systems or enhancements of 
current systems to better collect such information. On 
completion of this study, section 7 requires the CDC to improve 
the collection of such information, and publish it as it 
becomes available. Not later than 30 months after the date of 
enactment of the legislation, the Secretary must submit a 
report on the progress made in conducting the study and 
enhancing food allergy surveillance. Section 7 authorizes the 
appropriation of such sums as may be necessary to carry out its 
purposes.

Sec. 8. Food Allergies Research

    Section 8 directs the NIH to convene a panel of nationally 
recognized experts to review current basic and clinical 
research efforts related to food allergies and to develop a 
plan for expanding, intensifying, and coordinating research 
activities concerning food allergies. Section 8 requires the 
Secretary to submit the plan to Congress not later than 1 year 
after the date of enactment of the legislation.

Sec. 9. Food Allergens in the Food Code

    Section 9 directs the Secretary, in the Conference for Food 
Protection, as part of its cooperative activities between the 
States under section 311 of the Public Health Service Act, to 
pursue revision of the Food Code to provide guidelines for 
preparing allergen-free foods in food establishments, including 
in restaurants, grocery store delicatessens and bakeries, and 
elementary and secondary school cafeterias.

Sec. 10. Recommendations Regarding Responding to Food-Related Allergic 
        Responses

    Section 10 directs the Secretary to provide technical 
assistance relating to the use of different modes of treatment 
for and prevention of allergic responses to foods when it 
provides technical assistance relating to trauma care and 
emergency medical services under Section 1202(b)(3) of the 
Public Health Service Act.

                      IX. Changes in Existing Law

    In compliance with rule XXVI paragraph 12 of the Standing 
Rules of the Senate, the following provides a print of the 
statute or the part or section thereof to be amended or 
replaced (existing law proposed to be omitted is enclosed in 
black brackets, new matter is printed in italic, existing law 
in which no change is proposed is shown in roman):

FEDERAL FOOD, DRUG, AND COSMETIC ACT

           *       *       *       *       *       *       *

    Sec. 201. For the purposes of this Act--
    (a)(1) * * *

           *       *       *       *       *       *       *

    (ll) The term ``major food allergen'' means any of the 
following:
          (1) Milk, egg, fish (e.g. bass, founder, or tuna), 
        Crustacean shellfish (e.g. crab, lobster, or shrimp), 
        tree nuts (e.g. almonds, pecans, or walnuts), wheat, 
        peanuts, and soybeans.
          (2) A proteinaceous substance derived from a food 
        specified in paragraph (1) (unless the Secretary 
        determines that the substance does not cause an 
        allergic response that poses a risk to human health).

           *       *       *       *       *       *       *

    Sec. 403. A food shall be deemed to be misbranded--
    (a) * * *

           *       *       *       *       *       *       *

    (t)(1) If it is not a raw agricultural commodity and it is, 
or it intentionally bears or contains, a major food allergen, 
unless either--
          (A) Contains, which statement is followed by the name 
        of the food source as described in section 201(ll)(1) 
        from which the major food allergen is derived, follows 
        immediately after or is adjacent to (in a type size no 
        smaller than the type size used in the list of 
        ingredients) the list of ingredients required under 
        subsections (g) and (i); or
          (B) the common or usual name of the major food 
        allergen in the list of ingredients required under 
        subsections (g) and (i) is followed in parentheses by 
        the name of the food source as described in section 
        201(ll)(1) from which the major food allergen is 
        derived, except that the name of the food source is not 
        required when--
                  (i) the common or usual name of the 
                ingredient uses the term used to describe a 
                major food allergen in section 201(ll)(1), or
                  (ii) the name of the food source as described 
                in section 201(ll)(1) appears elsewhere in the 
                ingredient list; and
          Provided all major food allergens are labeled in a 
        consistent manner either as specified in clause (A) or 
        as specified in clause (B).
    (2) The information required under this subsection may 
appear in labeling in lieu of appearing on the label only if 
the Secretary finds that such other labeling is sufficient to 
protect the public health. A finding by the Secretary under 
this subparagraph is effective upon publication in the Federal 
Register as a notice (including any change in an earlier 
finding under this subparagraph).
    (3) Notwithstanding subsection (g), (i), or (k), or any 
other law, a spice, flavoring, coloring, or incidental additive 
that is, or that intentionally bears or contains, a major food 
allergen shall be subject to the labeling requirements of this 
subsection.
    (4) The Secretary may by regulation modify the requirements 
of subparagraph (A) or (B) of paragraph (1), or eliminate 
either the requirement of subparagraph (A) or the requirement 
of subparagraph (B), if the Secretary determines that the 
modification or elimination of the requirement is necessary to 
protect the public health.
    (u) Notwithstanding subsection (g), (i), or (k), or any 
other law, a spice, flavoring, coloring, or incidental additive 
that is, or that intentionally bears or contains, a food 
allergen (other than a major food allergen), as determined by 
the Secretary by regulation, shall be disclosed in a manner 
specified by the Secretary by regulation.

           *       *       *       *       *       *       *

    Sec. 403A. (a) Except as provided in subsection (b), no 
State or political subdivision of a State may directly or 
indirectly establish under any authority or continue in effect 
as to any food in interstate commerce--
          (1) any requirement for a food which is the subject 
        of a standard of identity established under section 401 
        that is not identical to such standard of identity or 
        that is not identical to the requirement of section 
        403(g), except that this paragraph does not apply to a 
        standard of identity of a State or political 
        subdivision of a State for maple syrup that is of the 
        type required by sections 401 and 403(g).
          (2) any requirement for the labeling of food of the 
        type required by section 403(c), 403(e), or 
        [403(i)(2)], 403(i)(2), 403(t), or 403(u) that is not 
        identical to the requirement of such section, except 
        that this paragraph does not apply to a requirement of 
        a State or political subdivision of a State that is of 
        the type required by section 403(c) and that is 
        applicable to maple syrup.
          (3) * * *

           *       *       *       *       *       *       *

                                
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