[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) * * *
* * * * * * *