Federal Register Proposed Rule - 72 FR 2795 January 23, 2007: Food Labeling; Gluten-Free Labeling of Foods

[Federal Register: January 23, 2007 (Volume 72, Number 14)]

[Proposed Rules]
[Page 2795-2817]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23ja07-10]
 
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Proposed Rules
                                                Federal Register
________________________________________________________________________
 
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
 
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[[Page 2795]]
 
 
 
DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
 
21 CFR Part 101
 
[Docket No. 2005N-0279]
RIN 0910-ZA26
 
 
Food Labeling; Gluten-Free Labeling of Foods
 
AGENCY: Food and Drug Administration, HHS.
 
ACTION: Proposed rule.
 
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SUMMARY: The Food and Drug Administration (FDA) is proposing to define
the term ``gluten-free'' for voluntary use in the labeling of foods, to
mean that the food does not contain any of the following: An ingredient
that is any species of the grains wheat, rye, barley, or a crossbred
hybrid of these grains (all noted grains are collectively referred to
as ``prohibited grains''); an ingredient that is derived from a
prohibited grain and that has not been processed to remove gluten
(e.g., wheat flour); an ingredient that is derived from a prohibited
grain and that has been processed to remove gluten (e.g., wheat
starch), if the use of that ingredient results in the presence of 20
parts per million (ppm) or more gluten in the food; or 20 ppm or more
gluten. A food that bears the claim ``gluten-free'' or similar claim in
its labeling and fails to meet the conditions specified in the proposed
definition of ``gluten-free'' would be deemed misbranded. FDA also is
proposing to deem misbranded a food bearing a gluten-free claim in its
labeling if the food is inherently free of gluten and if the claim does
not refer to all foods of that same type (e.g., ``milk, a gluten-free
food'' or ``all milk is gluten-free''). In addition, a food made from
oats that bears a gluten-free claim in its labeling would be deemed
misbranded if the claim suggests that all such foods are gluten-free or
if 20 ppm or more gluten is present in the food. Establishing a
definition of the term ``gluten-free'' and uniform conditions for its
use in the labeling of foods is needed to ensure that individuals with
celiac disease are not misled and are provided with truthful and
accurate information with respect to foods so labeled. This proposed
action is in response to the Food Allergen Labeling and Consumer
Protection Act of 2004 (FALCPA).
 
DATES: Submit written or electronic comments by April 23, 2007.
 
ADDRESSES: You may submit comments, identified by Docket No. 2005N-
0279, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following ways:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov.
 
Follow the instructions for submitting comments.
    <bullet> Agency Web site: http://www.fda.gov/dockets/ecomments.
 
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
    Submit written submissions in the following ways:
    <bullet> FAX: 301-827-6870.
    <bullet> Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described in the
Electronic Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to http://www.fda.gov/ohrms/dockets/default.htm

 
, including any personal information provided. For detailed
 
instructions on submitting comments and additional information on the
rulemaking process, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm
 
and insert the docket number(s), found in brackets in the heading of
this document, into the ``Search'' box and follow the prompts and/or go
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
 
FOR FURTHER INFORMATION CONTACT:  Rhonda R. Kane, Center for Food
Safety and Applied Nutrition (HFS-820), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD, 301-436-2371, FAX: 301-436-
2636, e-mail: rhonda.kane@fda.hhs.gov.
 
SUPPLEMENTARY INFORMATION:
 
Table of Contents
 
I. Background
    A. Celiac Disease
    B. Prevalence of Celiac Disease in the United States
    C. Gluten and the Grains of Concern for Individuals with Celiac
Disease
    1. Meaning of the Term ``Gluten''
    2. Grains of Concern to Individuals with Celiac Disease
    3. Uncertainty About Including Oats in the Diet of Individuals with
Celiac Disease
    D. FDA's Prior Statements on Gluten-Free Food Labeling
    E. Food Allergen Labeling and Consumer Protection Act of 2004 and
Related Activities
    1. Food Allergen Labeling and Consumer Protection Act of 2004
    2. FDA's Threshold Working Group and Its Report on Approaches to
Establish Thresholds
    3. Food Advisory Committee Meeting of July 13-15, 2005
    4. Gluten-Free Food Labeling Public Meeting of August 19, 2005
II. Proposed Rule
    A. Legal Basis
    B. Definitions and Criteria for the Use of the Term Gluten-Free in
Food Labeling
    1. Definitions of the Terms ``Prohibited Grains'' and ``Gluten''
    2. Definition of the Term ``Gluten-Free''
    3. Use of the Term Gluten-Free in the Labeling of Foods That
Inherently Do Not Contain Gluten
    4. Use of the Analytical Methods-Based Approach in this Proposed
Rule to Set a Threshold Level of 20 ppm to Define the Term Gluten-Free
 
[[Page 2796]]
 
    C. Compliance and Enforcement of an FDA Gluten-Free Food Labeling
Claim
III. Preliminary Regulatory Impact Analysis
    A. Need for This Regulation
    B. Proposed Regulatory Options
    C. Impacts of the Proposed Regulatory Options
    1. Option One: Take No Action
    2. Option Two: Take the Proposed Action--Do Not Permit Firms to
Make Gluten-Free Claims on Foods Containing the Prohibited Grains or
Ingredients That Have Been Derived From Those Grains and Have Not Been
Processed to Remove the Gluten; Do Not Permit Firms to Make Gluten-Free
Claims on Foods Containing Ingredients Derived From the Prohibited
Grains That Have Been Processed to Remove the Gluten, If the Level of
Gluten Is 20 ppm or Greater; Do Not Permit Firms to Make Gluten-Free
Claims on Foods Containing 20 ppm or More Gluten, Regardless of How the
Gluten Got Into the Food; and Restrict Wording of Gluten-Free Claims on
Foods That Inherently Do Not Contain Gluten
    a. Overview
    b. Costs
    c. Benefits
    d. Summary
    3. Option Three: Take the Proposed Action, Except Do Not Permit
Firms to Make Gluten-Free Claims on Foods Containing Ingredients
Derived From the Prohibited Grains That Have Been Processed to Remove
The Gluten, If the Level of Gluten Is Some Specified Level Other Than
20 ppm, and Do Not Permit Firms to Make Gluten-Free Claims on Foods If
the Level Of Gluten Is Some Specified Level Other Than 20 ppm,
Regardless of How the Gluten Got Into the Food
    a. Overview
    b. Costs
    c. Benefits
    d. Summary
    4. Option Four: Do Not Permit Firms to Make Gluten-Free Claims on
Foods Containing 20 ppm or More Gluten, Regardless of the Ingredients
They Use to Make Them, and Restrict the Wording of Gluten-Free Claims
on Foods That Inherently Do Not Contain Gluten
    5. Option Five: Take the Proposed Action, Except Delete Wording
Requirements for Gluten-Free Claims on Foods That Inherently Do Not
Contain Gluten
    6. Option Six: Take the Proposed Action, but Also Define the Food
Labeling Claim ``Low Gluten''
    7. Option Seven: Take Proposed Action, Except Include Oats in the
List of Grains That We Propose to Prohibit in Foods That Firms Label as
Gluten-Free
IV. Regulatory Flexibility Analysis
    A. Proposed Regulatory Options
    B. Impacts of the Proposed Regulatory Options on Small Entities
    1. Option One: Take No Action
    2. Option Two: Take the Proposed Action--Do Not Permit Firms to
Make Gluten-Free Claims on Foods Containing the Prohibited Grains or
Ingredients That Have Been Derived From Those Grains and Have Not Been
Processed to Remove the Gluten; Do Not Permit Firms to Make Gluten-Free
Claims on Foods Containing Ingredients Derived From the Prohibited
Grains That Have Been Processed to Remove the Gluten, If the Level of
Gluten Is 20 ppm or Greater; Do Not Permit Firms to Make Gluten-Free
Claims on Foods Containing 20 ppm or More Gluten, Regardless of How the
Gluten Got Into the Food; and Restrict Wording of Gluten-Free Claims on
Foods That Inherently Do Not Contain Gluten
    3. Option Three: Take the Proposed Action, Except Do Not Permit
Firms to Make Gluten-Free Claims on Foods Containing Ingredients
Derived From the Prohibited Grains That Have Been Processed to Remove
the Gluten, If the Level of Gluten Is Some Specified Level Other Than
20 ppm, and Do Not Permit Firms to Make Gluten-Free Claims on Foods If
the Level of Gluten Is Some Specified Level Other Than 20 ppm,
Regardless of How the Gluten Got Into the Food
    4. Option Four: Do Not Permit Firms to Make Gluten-Free Claims on
Foods Containing 20 ppm or More Gluten, Regardless of the Ingredients
They Use to Make Them, and Restrict the Wording of Gluten-Free Claims
on Foods That Inherently Do Not Contain Gluten
    5. Option Five: Take the Proposed Action, Except Delete Wording
Requirements for Gluten-Free Claims on Foods That Inherently Do Not
Contain Gluten
    6. Option Six: Take the Proposed Action, but Also Define the Food
Labeling Claim ``Low Gluten''
    7. Option Seven: Take Proposed Action, but Include Oats in the List
of Grains That We Propose to Prohibit in Foods That Firms Label as
Gluten-Free
V. Unfunded Mandates
VI. Executive Order 13132: Federalism
VII. Environmental Impact Analysis
VIII. Paperwork Reduction Act of 1995
IX. Comments
X. References
 
I. Background
 
A. Celiac Disease
 
    Celiac disease (also known as celiac sprue and gluten-sensitive
enteropathy) is a chronic inflammatory disorder of the small intestine
in genetically susceptible individuals triggered by ingesting certain
storage proteins, commonly referred to as ``gluten,'' that naturally
occur in some cereal grains (Refs. 1 through 3). In such individuals,
the consumption of gluten stimulates the production of antibodies and
inflammatory cells, resulting in an abnormal immune response, which
damages the tiny, fingerlike protrusions called ``villi'' that line the
small intestine and function to absorb nutrients from food (Ref. 4).
Over time, continued dietary exposure to gluten can destroy the
intestinal villi of individuals who have celiac disease, leading to a
lack of absorption of nutrients and wide variety of other serious
health problems (Ref. 4).
    The symptoms and clinical manifestations of celiac disease are
highly variable among affected individuals and differ in severity. The
reasons for this variability are unknown, but may depend upon the age
and immunological status of the individual, the amount, duration or
timing of the exposure to gluten, and the specific area and extent of
the gastrointestinal tract involved by disease (Ref. 5). Symptoms of
celiac disease may be: (1) ``Classical,'' affecting the digestive tract
(e.g., abdominal bloating; cramping and pain; chronic diarrhea;
vomiting; constipation) and resulting in gastrointestinal
malabsorption; or (2) ``atypical,'' affecting mainly other parts of the
body (e.g., fatigue; irritability; behavior changes; bone or joint
pain; tingling numbness in the legs; ulcers in the mouth; tooth
discoloration or loss of enamel; itchy skin rash with blisters called
dermatitis herpetiformis) (Refs. 1, 4, 6, and 7).
    A large portion of the subpopulation that has celiac disease may
not experience any symptoms at all and are classified as having
``silent'' or ``latent'' forms of celiac disease (Refs. 1 and 8).
Persons who have the silent form of celiac disease have most of the
diagnostic features commonly seen in individuals with classical or
atypical celiac disease, such as specific serum antibodies and evidence
of damaged intestinal villi. Those who have the latent form of celiac
disease have specific serum antibodies, but no
 
[[Page 2797]]
 
evidence of damaged intestinal villi (Ref. 1).
    In addition to the aforementioned clinical symptoms and ailments,
celiac disease is associated with a number of significant health
problems and disorders, including but not limited to: Iron-deficiency
anemia, vitamin deficiencies, protein-calorie malnutrition, weight
loss, short stature, growth retardation in children, delayed puberty,
infertility, miscarriage, and osteoporosis (Refs. 1, 6, 9, and 10).
Individuals with unmanaged celiac disease are at an increased risk of
developing other serious medical conditions, such as Type I diabetes
mellitus, intestinal cancers, and both intestinal and extraintestinal
non-Hodgkin's lymphomas (Refs. 7 and 11 through 13).
    Celiac disease has no cure, but individuals who have this disease
are advised to avoid all sources of gluten in their diet (Refs. 1 and
6). Over time, strictly avoiding consumption of all sources of gluten
can resolve the symptoms, mitigate and possibly reverse the damage, and
reduce the associated health risks of celiac disease (Ref. 14). For
some individuals with celiac disease, failure to avoid consumption of
gluten can lead to severe and sometimes life-threatening complications
that can affect multiple organs of the body (Refs. 5, 6, and 15).
 
B. Prevalence of Celiac Disease in the United States
 
    Precise prevalence data for celiac disease are not available. The
overall prevalence of celiac disease in the U.S. is currently estimated
to range from about 0.4 percent to about 1 percent of the general
population, or approximately 1.5 to 3 million Americans (Refs. 1 and
16). However, the number of Americans with physician-diagnosed celiac
disease is estimated at between 40,000 (Ref. 17) and 60,000 (Ref. 18).
    This discrepancy between estimated prevalence and diagnosed cases
has been linked primarily to the fact that celiac disease can be silent
or latent. Some researchers have suggested that the true prevalence is
underreported (Ref. 8). Silent and latent forms of celiac disease may
go undetected in individuals for years before they develop symptoms
causing them to seek medical attention (Ref. 13). In addition, celiac
disease is often mistaken for other gastrointestinal malabsorption
disorders that have similar diarrheal symptoms (e.g., irritable bowel
syndrome), which further delays its diagnosis (Ref. 19). Only recently
has the medical community become more aware of the need to screen for
celiac disease when patients experience health problems that may be
associated with the disease or when patients have family members,
especially first- and second-degree relatives, who have celiac disease
(Ref. 1).
 
C. Gluten and the Grains of Concern for Individuals with Celiac Disease
 
1. Meaning of the Term ``Gluten''
    There is no single definition of the term ``gluten.'' Technically,
the term ``gluten'' refers to a specific complex of proteins that forms
when wheat flour is mixed with a liquid and physically manipulated,
such as in the kneading of a bread (Ref. 20). This complex of proteins
is composed of both ``gliadins'' and ``glutenins,'' which are found in
approximately equal proportions in most wheat varieties (Refs. 21
through 23). The gliadins belong to a category of proteins called
``prolamins'' and the glutenins belong to a category of proteins called
``glutelins'' (Refs. 20 and 24).
    Although, strictly speaking, ``gluten'' pertains only to wheat
proteins, this term is frequently used to refer to the combination of
prolamin and glutelin proteins naturally occurring in other grains,
including those that have not been demonstrated to cause harmful
effects in individuals with celiac disease (e.g., ``corn gluten'' and
``rice gluten'') (Ref. 25). However, in discussions of celiac disease
in the medical literature, the term ``gluten'' is used to refer to
either gluten in wheat or collectively to the proteins (e.g., prolamins
and glutelins) in just those grains that have been demonstrated to
cause harmful health effects in individuals who have celiac disease
(Refs. 3 and 25).
2. Grains of Concern to Individuals With Celiac Disease
    The grains that are reported to contain gluten that can cause
harmful health effects in individuals with celiac disease and should be
avoided by them are as follows: Wheat (including durum wheat, spelt
wheat, and kamut), rye, barley, and crossbred hybrids of these grains
(e.g., triticale, which is a cross between wheat and rye), and possibly
oats (Refs. 26 through 30). Rye, barley, and triticale are
taxonomically very closely related to wheat and contain peptides
structurally similar to those found in wheat (Refs. 30 and 31).
Although oats are not as closely related to wheat (Ref. 30), they are
reported to contain some peptides similar to those found in wheat,
which may help to explain why some individuals with celiac disease are
sensitive to oats (Ref. 32). In contrast, the cereal grains believed to
be well tolerated by individuals with celiac disease and which are not
taxonomically as closely related to wheat and are not reported to
contain similar peptides to those found in wheat include: Amaranth,
buckwheat, corn (maize), Indian ricegrass, Job's tears, millet, quinoa,
ragi, rice, sorghum, teff (tef), and wild rice (Refs. 26, 27, 29
through 31, 33, and 34).
    There is evidence that both the prolamins (i.e., gliadins) and
glutelins (i.e., glutenins) in wheat adversely affect individuals with
celiac disease (Refs. 2, 27, and 35 through 37). Wheat gliadin subtypes
alpha, beta, gamma, and omega have been shown to cause damage to the
intestinal tract of individuals with celiac disease (Refs. 38, 39, and
40, p. 41). Moreover, it is also believed that the prolamins in rye
(i.e., secalins) and the prolamins in barley (i.e., hordeums) are
responsible for causing adverse health effects in individuals with
celiac disease (Refs. 13, 23, 28, 41, and 42). Oats also have prolamins
(i.e., avenins) that have some amino acid sequences similar to those
occurring in wheat and are believed to be harmful to a small subset of
individuals with celiac disease (Ref. 32). Although the prolamins of
the aforementioned grains and the wheat glutelins are recognized to
cause adverse health effects in individuals with celiac disease, all
cereal grains contain other types of proteins, including albumins and
globulins, which are not currently associated with celiac disease
(Refs. 20 and 21). There is still much unknown about all the specific
proteins in the different grains that can affect individuals with
celiac disease (Ref. 43).
3. Uncertainty About Including Oats in the Diet of Individuals With
Celiac Disease
    Currently, there is no general agreement among experts about the
extent to which oats present a hazard for individuals with celiac
disease. Whether oats should or should not be consumed by individuals
with celiac disease has been the subject of controversy for more than
50 years (Ref. 44). There are inconclusive and conflicting results from
research on the effects of oat consumption on individuals with celiac
disease.
    Some of this research, in particular early research, suggests that
oat consumption is harmful to individuals with celiac disease (Refs. 26
and 28). More recent studies found that 1 of 19 study participants
(Ref. 45) and 4 of 9 participants (Ref. 32) could not tolerate an
average of about 50 grams dry weight of oats. The oats used in both
studies
 
[[Page 2798]]
 
were tested to ensure that they did not contain gluten proteins from
wheat, rye, or barley.
    However, multiple studies in the last 10 years have shown that the
ingestion of oats in the diet of individuals who have celiac disease,
in both children and adults, does not necessarily lead to increased
intestinal or skin symptoms or to altered intestinal pathology, and
appears to be preferred to a diet without oats (Refs. 46 through 51).
The average amount of oats consumed by participants in each of these
studies differed, ranging from about 15 grams to 60 grams dry weight
per day. A long-term study that lasted 5 years concluded that
individuals with celiac disease prefer and can tolerate without harmful
effects a daily average consumption of 34 grams dry weight of oats
(Ref. 49).
    Although the total number of individuals with celiac disease who
are sensitive to oats is unknown, the findings of many of the
contemporary studies suggest that the proportion of individuals with
celiac disease who cannot tolerate oats in daily amounts of about 50 or
less grams dry weight is probably very low. One celiac expert suggests
that the size of this subpopulation is likely to be less than one
percent of individuals with celiac disease (Ref. 52).
    Despite the evidence that the consumption of oats does not present
a risk for most individuals with celiac disease, a major obstacle
impeding general acceptance of oats in the diet of individuals with
celiac disease is the concern about the commingling\1\ of oats with
wheat, rye or barley that can occur during grain production, transport,
storage, or processing (Refs. 44 and 53). Due to this concern, Farrell
and Kelly (Ref. 7) advise individuals with newly diagnosed celiac
disease not to consume oats until their disease is in remission (e.g.,
intestinal tract has healed). Some celiac disease treatment or research
centers in the United States report that they do not support the
inclusion of oats in the diet of individuals with celiac disease,
whereas other centers do, stating that oats can enhance the nutrient
density and fiber content of a diet that avoids all sources of gluten
and possibly improve compliance with this very restrictive diet (Refs.
54 through 56).
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    \1\The cited references use the term ``contamination,'' but
other references use the term ``commingling.'' For purposes of this
proposed rule, FDA has opted to use the term ``commingling,'' and
considers that term to mean ``the process of mixing.''
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    Thompson (Ref. 57) conducted a small, non-randomized mail survey
using a questionnaire about the acceptability of several foods in diets
that do not contain gluten. Thirty seven questionnaires, completed by
celiac disease organizations (United States and foreign), physicians,
and dietitians/nutritionists, were submitted in response to the survey.
Only five (i.e., 1 foreign celiac association and 4 physicians) of the
33 respondents who answered the question about oats considered oats to
be an acceptable food, and none of the four U.S. celiac disease
associations that responded to the survey considered oats to be an
acceptable food for individuals with celiac disease. The reasons given
by respondents for their lack of acceptance of oats included concerns
about the possibility that oats may cause adverse health effects in
individuals with celiac disease either directly or due to the presence
of gluten from another grain (e.g., wheat, rye, or barley), and about
the insufficiency of long-term research that identifies the amount of
oats that can be tolerated by individuals with celiac disease.
    According to more recent position statements of 3 of the 4 major
celiac associations in the United States that responded to the earlier
survey conducted by Thompson (Ref. 57), one of these associations
continues to take the position that oats are not an acceptable food for
individuals with celiac disease; but, the other two of these
associations are not opposed to the inclusion of oats in the diets of
individuals with celiac disease, provided that the oats do not contain
gluten from other grains and that the daily amount of oats consumed is
limited to 1 cup cooked (Ref. 56). Both of the latter associations
state that oats can add soluble fiber and nutrients to a diet that
avoids all sources of gluten; but, direct individuals with celiac
disease to consult with their health care providers before introducing
oats into their diet. Also, both of these associations recommend that
individuals with celiac disease who consume oats should have their
levels of antibodies specific to celiac disease monitored periodically.
    The recent National Institutes of Health Consensus Conference
Statement on Celiac Disease (Ref. 1) does not identify oats as being
one of the grains that individuals with celiac disease should avoid.
Instead, this statement indicates that it appears that most individuals
with celiac disease can include oats in their diet without harmful
health effects, but that it may not be practical to do so because oats
may contain gluten from other grains due to commingling during their
processing. Similarly, the 2006 edition of the American Dietetic
Association (ADA) Nutrition Care Manual (ADA Manual) recommends that
individuals with celiac disease avoid wheat (including wheat in all of
its varieties, such as spelt, and in all of its forms, such as wheat
starch), rye, barley and their crossbred hybrid varieties (e.g.,
triticale), but does not advise individuals with celiac disease to
presumptively exclude oats from their diet (Ref 58). Instead, the ADA
Manual states: ``* * *Findings from in vivo research on the safety of
oats suggest that most persons with celiac disease can safely consume
moderate amounts of uncontaminated oats without adversely affecting the
intestinal mucosa * * *.'' (Ref. 59). However, the ADA Manual
acknowledges that ``* * *limited evidence suggests that in some persons
with celiac disease, the consumption of uncontaminated oats may result
in mucosal inflammation* * *.'' Further, the ADA Manual advises that
individuals with celiac disease consult with their physicians and
dietitians before deciding to consume oats and that any daily intake
should be limited to about 50 grams of dry oats that ideally have been
tested to ensure that they do not contain gluten from wheat, rye, or
barley. The ADA Manual also reports that some oat millers have
established comprehensive clean-out procedures and control programs to
address the problem of commingling of oats with wheat, rye, and barley.
In addition, in a letter submitted in response to FDA's 2005 public
meeting on gluten-free (see section I.E.4 of this document for details
about this meeting), ADA expressed support for FDA establishing a
definition of gluten-free for oats that is tied to testing that ensures
that those oats do not contain gluten from other grains, so that those
oats could bear a gluten-free labeling claim (Ref. 60).
    The commingling of oats with wheat, rye, barley or their crossbred
hybrids or with the grains generally considered to be acceptable for
individuals with celiac disease (e.g., corn and rice) can occur at any
step in the farm-to-table continuum. This is due to the common
practices of growing crops in rotation and in close proximity to one
another as well as using the same equipment and storage bins to harvest
and hold different grains (Ref. 53). Accordingly, the official U.S.
standard for a given grain typically allows for the presence of a small
percentage of other grains (Ref. 61).
    It is believed that most oat products commercially available in the
United States contain some gluten from wheat, rye, or barley as a
result of commingling during the oats' growth, harvesting,
 
[[Page 2799]]
 
transport, storage, or processing (Refs. 43, 44, 53, 62, and 63). In
2004, Thompson reported that in a recent study 4 samples of each of 3
brands of oat products marketed in the United States were analyzed in
duplicate for gluten from wheat, rye, and barley using an enzyme-linked
immunosorbent assay (ELISA)-based method (Ref. 63). Ten of the 12
samples, representing all 3 brands of oat products, were reported to
contain an amount of gluten ranging from 12 to 1861 ppm, depending upon
the individual sample and brand tested. Thompson concluded that none of
these brands could be considered a reliable source of oats free of
potentially harmful gluten from other grains.
    In another study, Hernando and colleagues (Ref. 64) collected 108
samples of commercial oat products (e.g., rolled oats, oat flakes, and
oat flours) from Europe, the United States and Canada. The samples were
analyzed for gluten from wheat, rye, and barley using an ELISA-based
method. In addition, analysis of the samples by polymerase chain
reaction (PCR) was used to identify the particular grains present.
Consistent with the previous findings of Thompson, the presence of
gluten from other grains was found to be widespread. Seventy-nine
percent of the oat samples were reported to contain gluten from wheat,
rye, and/or barley at a level ranging from less than 3 to 8,000 ppm
gluten (Ref. 64). Sixty-one percent of the samples contained more than
200 ppm gluten. Hernando and colleagues also reported barley to be the
predominant grain present.
    Although there appears to be widespread commingling of oats with
other grains, it appears that this commingling is preventable. Two
manufacturers who submitted written responses to FDA's 2005 public
meeting on gluten-free food labeling report that the oats they market
in the United States do not contain gluten from wheat, rye, and barley
(Refs. 65 and 66). Examples of the types of special measures reported
by one or both manufacturers to ensure that their oats do not contain
gluten from wheat, rye, and barley are as follows: (1) Contracting with
farmers who are experienced with growing crops to ensure their purity;
(2) using only oat seed certified to be pure; (3) planting oats only in
fields that have not produced wheat, rye, or barley in either 2 or 3
years; (4) establishing a 25- or 30-foot buffer zone separating their
oat crops from other crops; (5) conducting periodic inspections to
remove any stray wheat, rye, or barley plants growing in their fields;
(6) using only dedicated or thoroughly cleaned equipment and facilities
to harvest, transfer, store, and process their oats; (7) having an
 
independent lab test samples of their freshly harvested and milled
oats, using an ELISA-based method designed to detect gluten naturally
occurring in wheat, rye, and barley; and (8) milling their oats in
dedicated facilities that either only mill oats or only mill oats and
soy.
 
D. FDA's Prior Statements on Gluten-Free Food Labeling
 
    Currently, there is no FDA regulation that specifically defines the
term ``gluten-free.'' In the preamble to a final rule on the
declaration of ingredients on food packaging published in the Federal
Register of January 6, 1993 (58 FR 2850 at 2864), FDA advised that the
term ``gluten-free'' can be used in the labeling of foods, provided
that when such claim is used, it is truthful and not misleading.
Generally, and absent regulations to the contrary, FDA would regard a
claim that a food is ``free'' of a substance as false or misleading if
the food contains that substance. FDA also noted that the term
``gluten-free'' may be misleading when the food ordinarily does not
contain gluten. Although FDA did not define the term ``gluten,'' FDA
referred to the grains wheat, barley, rye, oats and millet as those
``which commonly contain gluten'' (FR 2850 at 2863).
    FDA's view that the term ``gluten-free'' may be misleading when a
food is inherently free of gluten is consistent with FDA regulations
governing the use other ``free'' claims. FDA has issued regulations
that establish requirements for a ``free'' labeling claim made about a
food inherently free of calories (Sec.  101.60(e)(ii) (21 CFR
101.60(e)(ii)), of nutrients (e.g., sodium, Sec.  101.61(b)(1)(iii) (21
CFR 101.61(b)(1)(iii)) and fat, Sec.  101.62(b)(1)(iii) (21 CFR
101.62(b)(1)(iii)), and of other food components (e.g., cholesterol,
Sec.  101.62(d)(1)(ii)(E)). FDA considers ``calorie-free,'' ``sodium-
free,'' ``fat-free,'' and ``cholesterol-free'' labeling claims made for
a food that inherently does not contain these substances to be
misleading to consumers without additional clarifying wording
indicating that all foods of the same type, not just the brand of food
bearing that ``free'' labeling claim, are also free of the stated
substance. Consistent with how FDA has regulated other ``free'' claims,
the agency would consider a gluten-free labeling claim made for a food
that inherently does not contain gluten to be misleading if it is not
accompanied by additional wording to clarify that all foods of the same
type, not just the brand of food bearing the gluten-free claim, are
also free of gluten.
    As discussed elsewhere in this preamble, FDA proposes to define
prohibited grain to include all species of wheat, rye, barley, and
their crossbred hybrids. FDA's proposed definition of prohibited grain
would exclude all other grains, including oats and millet.
 
E. Food Allergen Labeling and Consumer Protection Act of 2004 and
Related Activities
 
1. Food Allergen Labeling and Consumer Protection Act of 2004
    FALCPA, Title II of Public Law 108-282, was enacted on August 2,
2004. Section 206 of FALCPA directs the Secretary of Health and Human
Services (HHS), in consultation with appropriate experts and
stakeholders, to issue a rule to define, and permit use of, the term
gluten-free on the labeling of foods. FALCPA directs the issuance of a
proposed rule by no later than 2 years after the law's enactment date,
and a final rule by no later than 4 years after the law's enactment
date. FDA is publishing this proposed rule in response to this
directive.
2. FDA's Threshold Working Group and Its Report on Approaches to
Establish Thresholds
    FALCPA does not require FDA to establish a threshold level for
gluten. Nonetheless, an important scientific issue associated with the
issuance of this proposed rule is the potential existence of a
threshold level below which it is unlikely that an individual with
celiac disease would experience an adverse health effect.
    To address this issue, among others, FDA established an internal,
 
interdisciplinary group (the Threshold Working Group) to review the
scientific literature on the issue of a threshold level for gluten. The
Threshold Working Group's draft report, Approaches to Establish
Thresholds for Major Food Allergens and for Gluten in Food (the draft
Thresholds Report) (Ref. 67), summarized the current state of
scientific knowledge with respect to a dose-response relationship for
gluten, and presented the following four potential approaches that FDA
might consider in establishing such a threshold level, if the agency
chose to do so (Ref. 67, pp. 2 and 38 through 41):
    <bullet> Analytical methods-based--thresholds are determined by the
sensitivity of the analytical method(s) used to verify compliance.
    <bullet> Safety assessment-based--``safe'' level is calculated
using the No Observed Adverse Effect Level (NOAEL)
 
[[Page 2800]]
 
from available human challenge studies, applying an appropriate
``uncertainty factor'' multiplier to account for knowledge gaps.
    <bullet> Risk assessment-based--examines known or potential adverse
heath effects resulting from human exposure to a hazard; quantifies the
levels of risk associated with specific exposures and the degree of
uncertainty inherent in the risk estimate.
    <bullet> Statutorily-derived--uses an exemption articulated in an
applicable law and extrapolates from that to other potentially similar
situations.
    The report also noted that any decisions on approaches to establish
a threshold for gluten likely would require consideration of additional
factors not addressed in the report, such as ease of compliance and
enforcement, concerns of stakeholders (i.e., industry, consumers, and
other interested parties), economics (e.g., cost/benefit analysis),
trade issues, and legal authorities.
    A notice of availability for the draft Thresholds Report was
published in the Federal Register (70 FR 35258, June 17, 2005) and the
report was made available through FDA Docket No. 2005N-0231 and the
Center for Food Safety and Applied Nutrition (CFSAN) Web site
(http://www.cfsan.fda.gov/~dms/alrgn.html). FDA requested that interested
persons submit comments and any scientific data or other information
relevant to the draft Thresholds Report to the docket during a 60-day
comment period ending August 16, 2005. The Threshold Working Group
considered the comments, data, and information submitted, and made
appropriate revisions to the Thresholds Report. On May 25, 2006, FDA
posted its response (Ref. 68) to the comments, data, and other
information that the agency received on its draft Thresholds Report
(http://www.cfsan.fda.gov/~dms/alrgcom.html).
FDA also posted the revised Thresholds Report (Ref. 69)
(http://www.cfsan.fda.gov/~dms/alrgn2.html

 
3. Food Advisory Committee Meeting of July 13 through 15, 2005
    In the Federal Register of May 23, 2005 (70 FR 29528), FDA
announced that FDA's Food Advisory Committee (FAC) would be holding a
public meeting on July 13 through 15, 2005, to evaluate the draft
Thresholds Report. One purpose of the meeting was for the FAC to
determine whether the four approaches considered in the draft
Thresholds Report for establishing a threshold level for gluten were
scientifically sound. FDA invited experts to address a number of
specific issues related to sensitivities to gluten. In addition, FDA
invited interested members of the general public to present their
comments and any scientific data or other information relevant to the
issues pending before the FAC.
    During the public meeting, the FAC heard presentations from invited
experts on the diagnosis and treatment of celiac disease, the quality
of life issues faced by those who have celiac disease and their
families, the relationship between gluten proteins in various grains
and celiac disease, analytical methods for detecting and measuring the
levels of gluten in food, the value and use of prospective and
retrospective gluten tolerance studies, and a summary of existing
national and international definitions of gluten-free standards for
food labeling. Further, members of the general public, including those
representing trade associations, industry, consumers, and other
stakeholders, gave brief presentations before the FAC to share their
perspectives on some of the same topics addressed by the invited
experts.
    Approximately 140 persons attended the FAC meeting. The speaker
presentations, public comments, FAC discussions, and the FAC responses
to a set of specific questions and the charge to the FAC posed by CFSAN
are recorded in the transcript of the meeting, which is available
through the FDA Docket No. 2005N-0231 and is posted at CFSAN's Web site
(http://www.fda.gov/ohrms/dockets/ac/cfsan05.html). Copies of the
transcript materials that specifically address the topics of celiac
disease and a gluten threshold level are also available through the FDA
Docket No. 2005N-0279 pertaining to this rulemaking. A summary of the
FAC responses to the questions is provided in the Summary Minutes (Ref.
70).
    The FAC concluded that the draft Thresholds Report ``includes a
comprehensive evaluation of the currently available data and
descriptions of all relevant approaches that could be used to establish
[a] threshold * * *for gluten in food'' (Ref. 70, p. 1). The FAC also
identified the risk-assessment approach as the strongest of the four
approaches proposed in the draft Thresholds Report, assuming the
availability of sufficient data (Ref. 70, p. 1).
    FDA received about 20 public responses, each containing one or more
comments, to the FAC meeting and to the notice of availability and
request for comments on the draft Thresholds Report. (Some of these
responses concerned food allergens and are not relevant to this
proposal.) Approximately half of the total number of responses
mentioned wheat or gluten, and the majority of the responses submitted
about gluten addressed issues or provided data directly related to the
report's suggested approaches to establishing a threshold level for
gluten. Pertinent comments were considered by FDA in the development of
this proposed rule. All written responses submitted to FDA about the
FAC meeting and the draft Thresholds Report are available through FDA
Docket No. 2005N-0231, and copies of those responses that specifically
mentioned wheat or gluten are also available through FDA Docket No.
2005N-0279.
4. Gluten-Free Food Labeling Public Meeting of August 19, 2005
    In the Federal Register of July 19, 2005 (70 FR 41356), FDA
announced that it would be holding a public meeting on August 19, 2005,
to discuss the topic of gluten-free food labeling. Interested persons
were given until September 19, 2005, to comment on a list of specific
questions concerning food manufacturing, analytical methods, and
consumer purchasing practices and views about gluten-free foods (70 FR
41356 at 41357). In addition, FDA invited experts to address these
issues at the meeting, and invited members of the general public,
including individuals with celiac disease and their caregivers, to
share their views about foods produced and labeled as ``gluten-free.''
    More than 80 persons attended the public meeting on gluten-free
food labeling. In response to the notice and public meeting, FDA
received more than 2,400 responses, each containing one or more
comments, about the public meeting or the list of questions cited in
the notice announcing the meeting. The vast majority of these responses
were from individuals with celiac disease, their caregivers, and celiac
disease associations, with a much smaller number of responses being
from the food industry. All written responses submitted to FDA in
response to the gluten-free public meeting and the questions posed in
the corresponding Federal Register meeting notice are available through
the FDA Docket No. 2005N-0279.
    Most of the consumers' comments said that they appreciate and use
gluten-free labeling claims to identify packaged foods they can eat
when trying to avoid gluten. Many consumers stated that a gluten-free
labeling claim makes it easier to grocery shop, saving the consumers
both time and the frustration
 
[[Page 2801]]
 
experienced when reading often lengthy and complicated ingredients
lists that they stated they do not understand. Many consumers also
stated that they currently purchase only or primarily packaged foods
bearing a gluten-free labeling claim, and that a standardized
definition of the term gluten-free for foods marketed in the United
States would provide them with more assurance that foods bearing this
claim are appropriate for individuals trying to avoid gluten. The
comments reflected a consensus of opinion among individuals with celiac
disease and the organizations, which represent them that wheat, rye,
and barley should be excluded from any products labeled as gluten-free.
However, opinions expressed in comments from these individuals and
organizations varied with respect to whether oats should be excluded
from any products labeled as gluten-free.
    Industry comments indicated that currently there is no universal
understanding among manufacturers of what the term gluten-free means
and there is no uniform industry standard for producing foods bearing
this labeling claim. Several industry comments expressed the opinion
that a standardized definition for gluten-free could assist industry by
promoting fair competition among packaged foods marketed as gluten-free
in the United States, because all manufacturers would have to adhere to
the same requirements if they label their products gluten-free.
    Based upon comments that FDA received during this public meeting or
that were submitted in writing to the related FDA Docket No. 2005N-
0279, FDA believes that a uniform definition of the term gluten-free
would prevent confusion and uncertainty among both consumers and food
manufacturers about what this food labeling claim means.
 
II. Proposed Rule
 
A. Legal Basis
 
    Section 206 of FALCPA directs the Secretary of HHS, in consultation
with appropriate experts and stakeholders, to issue a proposed rule to
define, and permit use of, the term ``gluten-free'' on the labeling of
foods. FDA has authority to issue this proposed rule under sections
403(a)(1), 201(n), and 701(a) of the act (21 U.S.C. 343(a)(1), 321(n),
and 371(a). Section 403(a)(1) of the act states that, ``A food shall be
deemed to be misbranded if its labeling is false or misleading in any
particular.'' In determining whether food labeling is misleading,
section 201(n) explicitly provides for consideration of the extent to
which the labeling fails to reveal facts ``material with respect to the
consequences which may result from the use of the [food] to which the
labeling * * *relates under * * *such conditions of use as are
customary or usual.'' Section 701(a) of the act vests the Secretary
(and by delegation, FDA) with authority to issue regulations for the
efficient enforcement of the act.
    As directed by FALCPA, FDA is proposing to define the term
``gluten-free'' for voluntary use in the labeling of foods. FDA is also
proposing to define various terms corresponding to certain specified
grains and proteins that would be prohibited from use as ingredients or
sources of ingredients used to make a food bearing a ``gluten-free''
labeling claim. Further, FDA is proposing to specify how a voluntary
gluten-free labeling claim must be worded for oats and for other foods
that inherently do not contain any gluten. Any use of the term
``gluten-free'' in the labeling of food that does not conform to the
proposed regulatory definitions and requirements would render that food
misbranded.
    In enacting FALCPA, Congress recognized the importance to
individuals with celiac disease of avoiding gluten (FALCPA, section
202(6)(B)). To address this issue, section 206 of FALCPA directs FDA to
issue a regulation to define and permit use of the term ``gluten-
free.'' As discussed elsewhere in this preamble, currently there is
neither a regulatory definition of the term ``gluten-free,'' nor is
there agreement among manufacturers or consumers as to what this term
means. In the course of consulting with experts and stakeholders, FDA
has learned that different manufacturers have different and
inconsistent definitions of the term ``gluten-free.'' Consumers with
celiac disease and their caregivers, who rely on ``gluten-free''
labeling claims to make purchasing decisions, believe that a
standardized definition of the term is needed to ensure that those
consumers know what to expect when purchasing foods labeled as gluten-
free. Therefore, FDA believes that establishing a definition of the
term ``gluten-free'' and uniform conditions for its use in the labeling
of foods is needed to ensure that individuals with celiac disease are
not misled and are provided with truthful and accurate information with
respect to foods so labeled.
 
B. Definitions and Criteria for the Use of the Term Gluten-Free in Food
Labeling
 
1. Definitions of the Terms ``Prohibited Grains'' and ``Gluten''
    To facilitate proposing a definition of the term ``gluten-free,''
FDA proposes to also define the terms ``gluten'' and ``prohibited
grains.'' FDA proposes in Sec.  101.91(a)(2) to define the term
``gluten'' to mean the proteins that naturally occur in a prohibited
grain and that may cause adverse health effects in persons with celiac
disease (e.g., prolamins and glutelins). FDA proposes in Sec.
101.91(a)(1) to define the term ``prohibited grain'' to mean any of the
following grains or their crossbred hybrids (e.g., triticale, which is
a cross between wheat and rye): (1) Wheat, meaning any species
belonging to the genus Triticum; (2) rye, meaning any species belonging
to the genus Secale; and (3) barley, meaning any species belonging to
the genus Hordeum. As discussed in section I.C of this document, the
scientific literature reports general agreement among celiac disease
experts that naturally occurring prolamins or glutelins in wheat, rye,
barley, and their crossbred hybrids can cause serious adverse health
effects in individuals with celiac disease and should be excluded from
their diet.
    FDA is not proposing to include oats in the definition of a
prohibited grain. As discussed in section I.C.3 of this document, the
unconditional exclusion of oats from the diet of individuals with
celiac disease is not supported by the National Institutes of Health
Conference Development Conference Statement on Celiac Disease (Ref. 1)
or by the American Dietetic Association (Ref. 58). FDA recognizes that
a small percentage of individuals with celiac disease may not be able
to tolerate some of the proteins that naturally occur in oats. However,
it appears that a great majority of individuals with celiac disease can
tolerate a daily intake of a limited amount (e.g., 50 grams) of oats
that are free of gluten from wheat, rye, barley or their crossbred
hybrids. Oats are reported to add variety, taste, satiety, dietary
fiber, and other essential nutrients to the diet of individuals with
celiac disease; thereby making their diet more nutritious and appealing
(Refs. 44, 51, 56, and 71). Inclusion of oats in the diet of
individuals with celiac disease who can tolerate oats may therefore
result in the improved nutritional and health status of those
individuals (Refs. 55 and 71).
    According to comments FDA received in response to its August 2005
public meeting on gluten-free labeling, at least two food manufacturers
can produce
 
[[Page 2802]]
 
oats that do not contain gluten from wheat, rye, barley, or any of
their cross-bred hybrids. Allowing such oats to bear a gluten-free
labeling claim would make them easier to identify and perhaps would
encourage other manufacturers to produce such oats. Conversely,
including oats in the definition of prohibited grain could eliminate
any incentive for manufacturers to produce oats free of gluten from
other grains because those manufacturers would have no way of
distinguishing their products in the marketplace. FDA requests comments
on whether the agency should include oats in the definition of a
prohibited grain.
2. Definition of the Term ``Gluten-Free''
    FDA proposes in Sec.  101.91(a)(3) to define the claim ``gluten-
free'' to mean that a food bearing the claim in its labeling does not
contain any of the following: (1) An ingredient that is a prohibited
grain; (2) an ingredient that is derived from a prohibited grain and
that has not been processed to remove gluten; (3) an ingredient that is
derived from a prohibited grain and that has been processed to remove
gluten, if the use of that ingredient results in the presence of 20 ppm
or more gluten in the food (i.e., 20 micrograms or more gluten per gram
of food); or (4) 20 ppm or more gluten.
    Examples of a prohibited grain include, but are not limited to,
barley, common wheat, durum wheat, einkorn wheat, emmer wheat, kamut,
rye, spelt wheat, and triticale. Examples of ingredients that are
derived from a prohibited grain and that have not been processed to
remove gluten include, but are not limited to:
    <bullet> Farina, flour made from any of the proposed prohibited
grains, graham, and semolina;
    <bullet> Hydrolyzed wheat protein, vital gluten, wheat bran, and
wheat germ; and
    <bullet> Barley malt extract or flavoring and malt vinegar.
    Because these ingredients are derived from a prohibited grain and
have not been processed to remove gluten, they are presumed to contain
gluten.
    Examples of ingredients that are or are sometimes derived from a
prohibited grain and processed to remove gluten include, but are not
limited to:
    <bullet> Food starch--modified (modified food starch); and
    <bullet> Wheat starch.
    Although these ingredients have been processed to remove gluten,
FDA recognizes that there may be different methods of deriving these
ingredients, and that some methods may remove less gluten than others.
Therefore, FDA proposes to prohibit a food that contains one of these
ingredients from bearing a gluten-free labeling claim if the use of the
ingredient results in the presence of 20 ppm or more gluten in the
food.
    A food may contain 20 ppm or more gluten even though the food does
not contain an ingredient derived from a prohibited grain. For example,
a food that contains an ingredient derived from oats may contain 20 ppm
or more gluten if the oats were commingled with a prohibited grain
during their harvest, transport, or storage. FDA believes that
manufacturers who elect to use the labeling claim ``gluten-free''
should make certain that foods so labeled do not contain 20 ppm or more
gluten, regardless of whether or not those foods contain an ingredient
that is derived from a prohibited grain. Under proposed Sec.
101.91(b)(1), a food that bears the claim ``gluten-free'' or similar
claim in its labeling and fails to meet the conditions specified in the
proposed definition of ``gluten-free'' would be deemed misbranded.
3. Use of the Term Gluten-Free in the Labeling of Foods That Inherently
Do Not Contain Gluten
    FDA proposes in Sec.  101.91(b)(2) to deem misbranded any food,
with the exception of a food made from oats, that does not inherently
contain any gluten from a prohibited grain and that bears the claim
``gluten-free'' in its labeling, unless the food complies with the
following two requirements: (1) The wording of the claim in the
labeling of the food clearly indicates that all foods of the same type,
not just the brand bearing this labeling claim, are gluten-free (e.g.,
``milk, a gluten-free food,'' ``all milk is gluten-free'') and (2) the
food does not contain 20 ppm or more gluten. Examples of foods that
inherently do not contain gluten include, but are not limited to:
    <bullet> Different types of milk not flavored with ingredients that
contain gluten (e.g., fresh fluid whole, low fat and nonfat milks;
evaporated milk; nonfat dry milk; sweetened condensed milk);
    <bullet> 100 percent fruit or vegetable juices; fresh fruits and
vegetables that are not coated with a wax or resin that contains
gluten; and frozen or canned fruits and vegetables not made with added
ingredients that contain gluten; and
    <bullet> A variety of single ingredient foods, e.g., butter; eggs;
lentils; legumes like dried beans and peas, peanuts, and soybeans;
seeds like flax, poppy and sesame; tree nuts like almonds, pecans, and
walnuts; non-gluten containing grains like corn, millet and rice; fresh
fish like cod, flounder and haddock; fresh shellfish like clams,
lobster, and octopus; honey; and water, including bottled waters like
distilled and spring.
    FDA's proposed requirement for the labeling of foods, other than
foods made from oats, that inherently do not contain gluten is
consistent with the general principles established at Sec.
101.13(e)(2) (21 CFR 101.13(e)(2)) for existing FDA regulations on
``free'' labeling claims made for foods inherently free of calories,
nutrients (e.g., sodium, fat), and other food substances (e.g.,
cholesterol). If a single brand of food inherently free of the
substance that is the subject of its ``free'' labeling claim does not
also include additional qualifying language, consumers may mistakenly
assume that only that particular brand of the food is free of the
substance and may not understand that other brands of the same type of
food that do not make a ``free'' labeling claim are also free of the
substance (Ref. 72). Therefore, FDA views the use of a gluten-free
labeling claim for a food inherently free of gluten to be potentially
misleading without the inclusion of additional qualifying language.
    Although oats are inherently free of gluten as defined in this
proposed rule, FDA proposes in Sec.  101.91(b)(3) to deem misbranded a
food made from oats that bears a gluten-free labeling claim if the
claim refers to all such foods as being gluten-free or if it contains
20 ppm or more gluten. By ``food made from oats,'' FDA means oats, any
food that contains oats, and any food that contains any ingredient
derived from oats. The proposed gluten-free labeling claim restriction
in Sec.  101.91(b)(3) is based on evidence of the presence of gluten
from prohibited grains in a number of commercially available brands of
foods made from oats, as discussed in section I.C.3 of this document.
In light of that evidence, FDA believes that a gluten-free labeling
claim that suggests that all foods made from oats are gluten-free would
be misleading.
    The agency is interested in receiving comments and scientific
information on whether a gluten-free claim on an inherently gluten-free
food, other than foods made from oats, would be misleading in the
absence of additional qualifying language. In addition, FDA is
interested in receiving comments and scientific information on whether
the proposed examples of how a claim should be worded in the labeling
of a food inherently free of gluten (e.g., ``milk, a gluten-free
food,'' ``all milk is gluten-free'') would effectively inform consumers
that all brands of the same type of food are also free of gluten, or
whether there are more appropriate ways to communicate this message to
 
[[Page 2803]]
 
consumers. Further, FDA requests comments on the agency's proposal to
restrict the types of gluten-free labeling claims that can be made for
oats.
4. Use of the Analytical Methods-Based Approach in This Proposed Rule
to Set a Threshold Level of 20 ppm to Define the Term Gluten-Free
    As discussed in section I.E.2 of this document, the draft
Thresholds Report describes four approaches FDA could use to establish
a threshold level for gluten that could be the basis for decisions on
whether to use the term ``gluten-free'' on product labels (Refs. 67,
pp. 2, 38 through 41, and 54 through 61). The draft Thresholds Report
concludes that it currently is not possible for FDA to use the
quantitative risk assessment-based approach due to the lack of
sufficient data from human clinical trials and the lack of sufficient
data on exposure, and that the statutorily-derived approach is not
viable in the absence of applicable statutory provisions (Refs. 67, pp.
4, 60, and 61). The draft Thresholds Report concludes that two
approaches are viable for FDA to establish a threshold level for
gluten: (1) The safety assessment-based approach and (2) the analytical
methods-based approach (Ref. 67, pp. 4 and 57 through 60). The revised
Thresholds Report identifies the same four approaches and conclusions
(Ref. 69, pp. 2, 4, 42 through 45, and 61 through 65).
    FDA is planning to conduct a safety assessment for gluten that is
consistent with the safety assessment-based approach described in the
draft and revised Thresholds Reports (Ref. 67, pp. 38, 39, and 58
through 60 and Ref. 69, pp. 42, 43, and 62 through 64). FDA requests
comments providing data relevant to the planned safety assessment,
including in particular clinical research and studies designed to
measure chronic exposure, that satisfy the data quality criteria
discussed in the revised Thresholds Report. We intend to publish a
notice in the Federal Register seeking comment on the draft safety
assessment and its potential use in the final rule, and will consider
public and peer-review comments in revising the safety assessment, as
appropriate. In developing a final rule on gluten-free labeling, we
intend to consider the safety assessment as well as comments received
in response to this proposed rule and the notice concerning the safety
assessment. Further, as noted in both the draft and revised Thresholds
Reports, FDA's establishment of a threshold level for gluten may
require consideration of other factors not addressed in that report,
such as ease of compliance and enforcement, stakeholder concerns,
economics, trade issues, and legal authorities (Ref. 67, p. 41 and Ref.
69, p. 45). This may be true regardless of which approach FDA uses to
establish a threshold level for gluten in the final rule (e.g., an
analytical methods-based approach or a safety assessment-based
approach).
    Pending the receipt of comments submitted in response to this
rulemaking and the outcome of the planned safety assessment, FDA is
currently proposing to use the analytical methods-based approach to
establish a threshold level of 20 ppm gluten (i.e., a food labeled
gluten-free cannot contain 20 ppm or more gluten) as one of the
criteria for defining the term ``gluten-free.'' Given the current
unavailability of appropriate test methods that can reliably and
consistently detect gluten at levels below 20 ppm,\2\ FDA tentatively
concludes that gluten-free labeling on a food that contains less than
20 ppm gluten would be neither false nor misleading, so long as it
conforms to other pertinent requirements of this proposed rule.
---------------------------------------------------------------------------
 
    \2\The revised Thresholds Report (Ref. 69, pp. 59 and 60)
identifies specific criteria for evaluating gluten detection
analytical methods that are appropriate for establishing a gluten
threshold level based upon an analytical methods-based approach. In
reviewing the available methods that meet all of the stated criteria
(Ref. 73), FDA has tentatively concluded that currently there are no
available and appropriate test methods that can reliably and
consistently detect gluten in a variety of food matrices at levels
below 20 ppm.
---------------------------------------------------------------------------
 
    Based upon the current state of technology concerning available and
appropriate analytical methods that can detect one or more gluten
proteins naturally occurring in wheat, rye, and barley, FDA has
tentatively determined that ELISA-based methods can be used to reliably
and consistently detect gluten at a level of 20 ppm in a variety of
food matrices, including both raw and cooked or baked foods (Ref. 73).
ELISA-based methods detect the prolamins in wheat, rye, and barley,
which can serve as a biomarker for the presence of those grains, their
cross-bred hybrids, or their other naturally occurring proteins. FDA is
tentatively considering using an ELISA-based method that has been
validated in Europe at the 20 ppm gluten detection level and has been
published in the peer-reviewed scientific literature (Ref. 74). FDA has
been advised that this method is currently under review by AOAC
INTERNATIONAL (Ref. 75). In addition, we are aware that an evaluation
of other ELISA-based methods that detect gliadin, a gluten protein, was
recently published in the peer-reviewed scientific literature (Ref.
76). FDA requests comments on the appropriateness of 20 ppm gluten as
the proposed threshold level as determined using an ELISA-based method.
    As new, more sensitive methods of detection are developed, use of a
methods-based approach, if not tempered by consideration of other
factors, could result in a threshold level that is lower than the
proposed threshold level of 20 ppm gluten. For example, the
manufacturer of a test kit that uses an ELISA-based method that has
been validated at the 160 ppm gluten detection level (Ref. 77) is
seeking validation of that method at the 5 ppm gluten detection level
(Ref. 78).
    Given the possibility that new, more sensitive methods of detection
will be developed in the near future, FDA requests comments on what
effects the adoption of a lower threshold level would have on
individuals with celiac disease and on industry. FDA is interested in
receiving scientific data or other information that addresses the
question of whether the adoption of a lower threshold level would be of
benefit to individuals with celiac disease. FDA is also interested in
receiving comments and supporting data on whether the use of a lower
threshold level could reduce the commercial availability in the United
States of foods labeled gluten-free and whether that reduced
availability could negatively impact individuals with celiac disease
(e.g., by making it more difficult for them to comply with dietary
restrictions, perhaps leading to increased health risks).
    In addition, FDA requests comments on whether a safety assessment
or risk assessment that addresses gluten threshold levels for
individuals with celiac disease has been conducted by other entities.
FDA also requests information on any gluten tolerance studies that have
been published in the scientific literature since March 2006 when FDA
posted the revised Thresholds Report.
    FDA recognizes that even those foods that comply with the proposed
threshold level of 20 ppm gluten nonetheless may contain some gluten up
to 20 ppm. FDA questions whether the potential presence of some gluten
up to 20 ppm would be a material fact that, if omitted, would make a
``gluten-free'' claim potentially misleading. FDA requests comments on
whether the use of additional qualifying language (e.g., ``does not
contain 20 ppm or more gluten per gram of food'') would be necessary to
inform individuals with celiac disease that a food labeled as gluten-
free nonetheless may contain the amount of gluten permitted under
 
[[Page 2804]]
 
whatever threshold level is established in the final rule.
    FDA is aware that at least one other regulatory body outside the
United States has developed a two-tiered approach to gluten-related
food labeling. Australia and New Zealand have established standards for
``gluten-free'' (meaning no detectable gluten) and ``low-gluten''
(meaning no more than 20 milligrams gluten per 100 grams of the food,
which is equivalent to no more than 200 ppm gluten in the food) (Ref.
79). As discussed in section III.C.6 of this document, one regulatory
option (Option Six) was to develop a 2-tiered approach to a gluten-
related food labeling in the United States. However, it is unclear what
the scientific basis for such an approach would be; a safety assessment
could provide a basis for a threshold, as described in the draft and
revised Thresholds Reports, but would not provide a basis for a two-
level approach. Thus, FDA tentatively concludes that this approach is
not feasible because we do not have sufficient scientific data to
recommend a specified level of gluten to define the term ``low
gluten.'' In the absence of such information, use of the term ``low
gluten'' in the labeling of food could make that labeling potentially
misleading. FDA requests comment on this tentative conclusion,
including comment on a possible scientific basis for setting a level of
gluten to be defined as ``low gluten.''
    Also, in the absence of a regulatory definition of ``low-gluten,''
FDA is concerned that different and inconsistent definitions of that
term may be developed and used by industry, and that use of the term
under such circumstances could mislead consumers. Therefore, FDA is
considering whether it is necessary to prohibit use of the claim ``low-
gluten'' and similar claims in the labeling of foods. FDA requests
comment on this potential prohibition.
 
C. Compliance and Enforcement of an FDA Gluten-Free Food Labeling Claim
 
    As previously discussed, FDA has identified a method that can
reliably detect the presence of 20 ppm gluten in a variety of food
matrices, including both raw and cooked or baked products. However,
determinations of compliance with the proposed regulation need not be
based on analysis of a food. In the enforcement of FDA-regulated food
labeling claims, the agency routinely uses a variety of techniques,
such as label reviews, onsite inspections of food manufacturers, and
analysis of food samples. FDA does not necessarily analyze a food when
other information or evidence exists that would enable the agency to
determine that the food is misbranded. For example, if flour derived
from spelt or kamut, which are species of wheat, is declared in the
ingredient list for a bread labeled gluten-free, FDA would not have to
analyze the product to deem it misbranded. This is because all flours
made from cereal grains contain those grains' naturally occurring
proteins. Likewise, if an FDA inspector were to observe the
manufacturing of such a bread with spelt or kamut flour, the agency
would not have to analyze the product to deem it misbranded.
    There are circumstances when FDA may seek to analyze a food to
determine if it is misbranded, such as in cases when FDA investigates
complaints from consumers who report experiencing adverse health
effects after eating a product, and an FDA label review or onsite
inspection of the manufacturing facility is insufficient to identify
whether there is a problem with the food. For example, an ingredient
may not have been declared on the food label or a declared ingredient
may inadvertently contain an undeclared substance. In such cases, an
analysis of the food may be the only way to identify the presence of
the substance that is the subject of the ``free'' labeling claim.
 
III. Preliminary Regulatory Impact Analysis
 
    FDA has examined the impacts of this proposed rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). We believe that this
proposed rule is not a significant regulatory action under the
Executive Order.
 
A. Need for This Regulation
 
    FALCPA directs the Secretary of HHS to issue, in consultation with
appropriate experts and stakeholders, a rule to define and permit use
of the term ``gluten-free'' on the labeling of foods.
 
B. Proposed Regulatory Options
 
    We considered several regulatory options or alternatives: (1) Take
no action; (2) take the proposed action--i.e., do not permit firms to
make gluten-free claims on foods containing (a) the prohibited grains;
(b) ingredients derived from the prohibited grains that have not been
processed to remove the gluten; (c) ingredients derived from the
prohibited grains that have been processed to remove gluten, if the use
of such ingredients results in the presence of gluten in the food at a
level of 20 ppm or more; or (d) 20 ppm or more gluten from any source.
We are also proposing as part of this option to restrict the wording of
gluten-free claims on foods that inherently do not contain gluten; (3)
take the proposed action, except enforce the prohibition when the level
of gluten exceeds some specified level other than 20 ppm in situations
in which the gluten that is present in the food is (a) from ingredients
derived from a prohibited grain that have not been processed to remove
the gluten or (b) from commingling; (4) do not permit firms to make
gluten-free claims on foods containing 20 ppm or more gluten,
regardless of the ingredients they use to make them, and restrict the
wording of gluten-free claims on foods that inherently do not contain
gluten; (5) take the proposed action, except delete the wording
requirements for gluten-free claims on foods that inherently do not
contain gluten; (6) take the proposed action, but also define the food
labeling claim ``low gluten;'' and (7) take the proposed action, except
include oats in the list of grains that we propose to prohibit in foods
that firms label as gluten-free. We request comments on these options
as well as suggestions for other regulatory policy options that we
should consider. We will address any significant comments or
suggestions in the analysis of the final rule.
 
C. Impacts of the Proposed Regulatory Option
 
    The primary impacts of the regulatory alternatives that we discuss
in the following analysis are costs for firms to make any necessary
changes to food labels and the impact of any label changes on consumer
search costs. A decrease in search costs is a benefit; an increase in
search costs is a cost.
1. Option One: Take No Action
    We can only define costs and benefits relative to a baseline. We
usually select the option of taking no action as the baseline because
it helps readers identify the costs and benefits of actions that change
the status quo. By definition, the baseline itself has no costs or
benefits. This does not mean that we ignore the costs and benefits of
taking no action. Instead, it means that we express the costs and
benefits of
 
[[Page 2805]]
 
taking no action in the costs and benefits of the other regulatory
options.
2. Option Two: Take the Proposed Action--Do Not Permit Firms to Make
Gluten-Free Claims on Foods Containing the Prohibited Grains or
Ingredients That Have Been Derived From Those Grains and Have Not Been
Processed to Remove the Gluten; Do Not Permit Firms to Make Gluten-Free
Claims on Foods Containing Ingredients Derived From the Prohibited
Grains That Have Been Processed to Remove the Gluten, if the Level of
Gluten Is 20 ppm or Greater; Do Not Permit Firms to Make Gluten-Free
Claims on Foods Containing 20 ppm or More Gluten, Regardless of How the
Gluten Got Into the Food; and Restrict Wording of Gluten-Free Claims on
 
Foods That Inherently Do Not Contain Gluten
    a. Overview. We are proposing to prohibit firms from making gluten-
free claims on the labels of foods that contain any of the following:
(1) Ingredients that are any of the species of the grains wheat, rye,
barley, or a crossbred hybrid of these grains (e.g., triticale) (these
grains are collectively referred to as ``prohibited grains,'' a term we
propose to define in this rule); (2) ingredients that have been derived
from a prohibited grain and have not been processed to remove the
gluten; (3) ingredients that have been derived from a prohibited grain
and have been processed to remove the gluten, if the use of such
ingredients results in the presence of gluten in the food at a level of
20 ppm or more; and (4) 20 ppm or more gluten from any source. We do
not specify a particular level for the first two categories of
substances because we would not need to test such products to determine
the presence of gluten. Instead, we would be able to determine the
presence of gluten by (1) reading the labels of the foods bearing
gluten-free claims to determine if firms declared any of the prohibited
grains or ingredients derived from the prohibited grains that have not
been processed to remove the gluten in the ingredient list or (2) by
conducting onsite inspections of manufacturing facilities to observe if
firms were using any of the prohibited grains or ingredients derived
from the prohibited grains that have not been processed to remove the
gluten to make a food labeled gluten-free. Specifying a level of 20 ppm
for the third and fourth categories of substances enables us to test
food containing those substances to determine if they contained gluten.
The third category of substances refers to ingredients that have been
derived from a prohibited grain but have been processed to remove the
gluten. Some common examples from among the many ingredients in this
category are wheat starch, malt extract, and malt vinegar. Depending on
the effectiveness of the procedures used, people may be able to remove
all the gluten from those ingredients. Thus, we would not be able to
determine if food that firms made using those ingredients contained
gluten by simply reading the ingredient list. The fourth category of
substances refers to gluten from any source including commingling with
any of the prohibited grains. We would not be able to determine if food
contained gluten due to commingling by reading the ingredient list.
    Not permitting gluten-free claims on foods that firms make using
the prohibited grains and ingredients that have been derived from them
and have not been processed to remove the gluten would have no impact
on current labeling because we already do not permit firms to make
gluten-free claims on foods that contain gluten, and any product that
firms make using prohibited grains and ingredients that have been
derived from them and have not been processed to remove the gluten
would contain gluten. Similarly, specifying 20 ppm or more gluten as
the amount of gluten that would cause a food bearing a gluten-free
labeling claim to be misbranded, if the gluten that is present in the
food is from ingredients that have been derived from a prohibited grain
and have been processed to remove the gluten or from any other source,
would have no impact on current food labeling. Although to date we have
not identified a maximum level of gluten that would be permissible in a
food bearing a gluten-free claim, we generally would regard a claim
that a food is ``free'' of a substance as false or misleading if the
food actually contains that substance. As we discussed earlier in this
preamble, a method exists that can reliably and consistently detect the
presence of gluten at a level of 20 ppm. If we were to take enforcement
action against a product with a gluten-free claim under our existing
regulations and policies, we would use this test to determine whether a
food bearing a gluten-free claim is misbranded. Therefore, these two
elements of the proposed rule do not change the status quo and cannot
generate costs or benefits.
    We recognize that some firms may currently be making gluten-free
claims on the labels of products that contain gluten at levels of 20
ppm or more. Any costs to these firms from changing product labels are
not costs of this rule but of the existing statute that prohibits false
or misleading labeling. We are also proposing to restrict how firms may
word gluten-free claims that appear on inherently gluten-free food. In
addition to the requirement that such food not contain 20 ppm or more
gluten from any source, we also propose that if a food, other than a
food made from oats, that inherently does not contain gluten bears a
gluten-free labeling claim, then the wording of the claim must clearly
indicate that all foods of the same type, not just the brand bearing
this labeling claim, are gluten-free. Two examples of the wording of a
claim that would meet both criteria are ``milk, a gluten-free food''
and ``all milk is gluten-free.'' Currently, we determine whether a
gluten-free claim on an inherently gluten-free product is misleading on
a case-by-case basis. Therefore, this element could generate both costs
and benefits. We also propose that a food made from oats can bear a
gluten-free labeling claim if the wording of the claim does not refer
to all foods of the same type as gluten-free. This element could also
generate both costs and benefits.
    b. Costs. Restricting the wording of gluten-free claims on
inherently gluten-free foods could generate compliance costs because it
would require firms to remove or change current gluten-free claims on
inherently gluten-free foods that use wording that does not meet our
proposed requirements. We searched the Food Labeling and Packaging
Survey 2000 (FLAPS 2000) database for foods bearing gluten-free claims
and found the following types of foods: Yeast, enriched rice drink, pad
Thai noodles (rice noodles and sauce), and rice pudding. In addition,
we found ``wheat gluten-free'' claims on yeast and a soy protein shake.
We would not classify as inherently gluten-free any of the foods that
we identified in FLAPS as bearing gluten-free claims because firms
could formulate or manufacture those types of foods to contain gluten.
Based on this information, we estimate that this element of the
proposed rule would generate minimal or no relabeling costs.
    In addition, this element might generate increased search costs for
some consumers by suppressing the use of gluten-free claims on
inherently gluten-free food other than foods made from oats. The
incentive for firms to use these claims increases with the ability of
the claims to increase profits. Gluten-free claims that consumers
interpret to refer to a particular brand probably increase that
particular firm's profits more than gluten-free claims that consumers
interpret to refer to general product types because such brand-specific
claims provide consumers a reason to buy a particular brand of product
while
 
[[Page 2806]]
 
product-type claims only provide consumers a reason to buy any product
within a given product-type category. Therefore, requiring firms to use
wording that refers to general product types would reduce to some
degree the incentives for firms to use gluten-free claims and,
therefore, would probably reduce the number of such claims appearing on
inherently gluten-free food. However, some firms may still use gluten-
free claims to influence consumers choosing between general product-
type categories. The cost generated by this potential reduction in the
use of gluten-free claims on inherently gluten-free food depends on the
usefulness of such claims for consumers. Reducing the use of gluten-
free claims would not generate costs for consumers who are already
aware of inherently gluten-free foods because they would not need such
claims to identify those foods. However, reducing the use of gluten-
free claims could generate costs for consumers who are not aware that
some inherently gluten-free foods are gluten-free because they might
currently use such claims to help identify those foods as foods they
can eat when following a diet that does not include gluten. We do not
have sufficient information to estimate this potential cost.
    c. Benefits. Restricting the wording of gluten-free claims on
inherently gluten-free foods other than foods made from oats might
generate benefits for some consumers by making any gluten-free claims
that do appear on inherently gluten-free food more informative. These
benefits would depend on the usefulness of such information for
consumers. The wording restrictions would not benefit consumers who
already know that inherently gluten-free foods are gluten-free either
from prior knowledge or because they infer it from the existence of
gluten-free claims on multiple foods within a given product category.
However, the wording restrictions would benefit consumers who are
unaware that certain inherently gluten-free foods are inherently free
of gluten. The optimal level of informative labeling would balance the
countervailing impacts of the potential reduction in the number of
gluten-free claims and the increase in the information content of each
gluten-free claim. We do not have sufficient information on consumers'
knowledge of inherently gluten-free food or on the number of such foods
that firms might choose to identify as inherently gluten-free in the
future to estimate these benefits.
    Restricting the wording of gluten-free claims on foods made from
oats might generate benefits for some consumers by making any gluten-
free claim that does appear on those foods less likely to mislead
consumers by implying that those foods cannot contain gluten via
commingling with the prohibited grains. We do not have sufficient
information on the impact on consumers of avoiding potential confusion
about the possibility that foods made from oats may contain gluten via
contact with the prohibited grains or on the number of foods made from
oats that firms might choose to label as gluten-free in the future to
estimate these benefits.
    d. Summary. Not permitting gluten-free claims on foods that firms
make using the prohibited grains or ingredients that have been derived
from them and have not been processed to remove the gluten would not
generate costs or benefits. Similarly, not permitting gluten-free
claims on foods that firms make using ingredients that have been
derived from prohibited grains and have been processed to remove the
gluten and on foods that contain gluten from any other source, if those
foods contain 20 ppm or more gluten, would also not generate costs or
benefits. Both of these proposed requirements are consistent with how
we would currently enforce our existing statute that prohibits false or
misleading labeling statements. Restricting the wording of gluten-free
claims on foods that inherently do not contain gluten might require
some firms to change product labels. However, we were unable to
identify any such foods. Therefore, we estimate that these costs would
be minimal. Restricting the wording of gluten-free claims on inherently
gluten-free foods may also generate future costs and benefits by
changing the incentives to use such claims and changing the information
content of gluten-free claims on affected foods. We do not have
sufficient information to quantify these potential costs and benefits.
3. Option Three: Take the Proposed Action, Except Do Not Permit Firms
to Make Gluten-Free Claims on Foods Containing Ingredients Derived From
the Prohibited Grains That Have Been Processed to Remove The Gluten, if
The Level of Gluten Is Some Specified Level Other Than 20 ppm, and Do
Not Permit Firms to Make Gluten-Free Claims on Foods If the Level Of
Gluten Is Some Specified Level Other Than 20 ppm, Regardless of How the
Gluten Got Into the Food
    a. Overview. Under this option, we could specify a threshold level
that was either higher or lower than 20 ppm gluten for deeming a food
labeled gluten-free to be misbranded, when the gluten that is present
in that food is from ingredients that have been derived from the
prohibited grains and have been processed to remove the gluten or from
any other source. However, we have chosen to analyze alternative levels
higher than 20 ppm gluten because we do not know of any currently
available and appropriate test methods that can reliably and
consistently detect gluten at levels below 20 ppm. Specifying a level
higher than the proposed level of 20 ppm gluten would expand the number
of foods that would be eligible to bear gluten-free claims and would
generate both costs and benefits. We do not need to specify precisely a
level above the proposed level of 20 ppm in order to analyze this
option. We note that if we were to choose this option, then we would
need additional scientific data to analyze the costs and benefits of
whatever level we chose.
    Specifying a level higher than 20 ppm gluten would not generate
compliance costs for industry because gluten-free claims are voluntary
and no firms would need to remove existing labeling claims that are
appropriate under the statute. However, it could generate search costs
for some consumers. As we discussed in section I.A of this document,
the symptoms of celiac disease are highly variable among affected
individuals. We don't know the reasons for this variability. Some
individuals with celiac disease may be unable to tolerate whatever
level of gluten we might specify. Individuals who cannot tolerate
whatever level of gluten we might specify might nevertheless continue
to rely on gluten-free claims to identify appropriate foods and might
suffer adverse health consequences from doing so. However, we assume
that most consumers who use gluten-free claims to identify appropriate
foods will have been diagnosed with celiac disease and will be under a
physician's care for that condition. Therefore, sensitivity to whatever
level of gluten we might allow would probably be detected within a
short time and these individuals would probably not continue to rely on
gluten-free claims to identify appropriate foods. The more likely
consequence, and the consequence that we base the remainder of our
analysis upon, is that consumers who are sensitive to gluten at this
higher level would no longer be able to rely on gluten-free claims to
identify foods that are safe for them to eat and would need to take
other steps to identify these foods. This would increase the cost for
these consumers to
 
[[Page 2807]]
 
find appropriate foods. The increased search costs might cause these
consumers to conduct fewer searches for appropriate foods, which could
lead them to reduce their compliance with a diet that does not include
gluten and increase their risk of various adverse health effects. In
addition, increased search costs for some consumers would tend to
discourage firms from continuing to produce or develop new foods that
contain no gluten because it could reduce their ability to inform
consumers of such foods using gluten-free labeling claims, although
they could continue to inform consumers about these foods in other
ways. This might further reduce the compliance of these consumers with
a diet that does not include gluten and generate additional adverse
health effects.
    Under this option, the potential benefits of specifying a level
greater than 20 ppm gluten, when the gluten that is present in the food
is from ingredients that have been derived from a prohibited grain and
have been processed to remove the gluten or from any other source, are
similar in nature but opposite in effect to the costs and would accrue
to different consumers. Consumers who can tolerate whatever level we
specify would value our adopting that level because it might allow them
to use gluten-free claims to identify a greater range of appropriate
foods. This reduction in search costs could lead these consumers to
conduct additional searches for appropriate foods, which could lead to
them to increase their compliance with diets that do not include gluten
and lower their risk of adverse health effects. In addition, the
decreased search costs for these consumers would tend to encourage
firms to produce or develop foods with up to the specified level of
gluten, which could increase these consumers' compliance with a diet
that does not include gluten and further reduce their risk of adverse
health effects.
    We do not know how much some consumers and firms would value our
specifying a level higher than 20 ppm gluten. The potential value for
consumers who would benefit from this option is probably lower on a
per-person basis than the corresponding potential loss for consumers
who would be unable to tolerate the level of gluten allowed under the
specified level because the incremental effect on a given individual's
search costs of gluten-free claims appearing on some additional foods
is smaller than the incremental effect of losing the use of gluten-free
claims on all foods. However, we do not know how many consumers can and
cannot tolerate particular levels of gluten. Therefore, we cannot draw
any conclusions on the net benefits of specifying different levels.
    This option would include the provisions restricting the wording of
gluten-free claims on inherently gluten-free food. Therefore, it would
also generate the costs and benefits that we associated with those
provisions in our discussion of Option Two (the proposed action)
previously discussed.
    b. Costs. As we discussed in the preceding overview, this option
would increase search costs for consumers who are unable to tolerate
the specified level of gluten. However, as we discussed in section I of
this document, accurately estimating the prevalence of celiac disease
in the United States is difficult for a variety of factors. These
factors also demonstrate that individuals vary for many reasons in
their sensitivity to gluten. One researcher who did attempt to identify
a level that all celiac patients can tolerate was Fasano (Ref. 80),
who, based on data from Catassi, et al., (Ref. 81) and Collin, et al.,
(Ref. 82), suggested that all individuals with celiac disease may be
able to tolerate between 20 and 100 ppm. (See Ref. 69 at pp. 39 and 40
for further discussion of this literature.) Some researchers address
this issue in the context of wheat starch because wheat starch is a
common ingredient that contains varying and sometimes very low levels
of gluten (Refs. 41, 82, and 83). In general, as we discussed in both
the draft and revised Thresholds Reports (Ref. 67, pp. 35 and 36 and
Ref. 69, pp. 39 and 40) , the studies are inconclusive about the safety
and subjective acceptability of foods that contain 20 ppm or more
gluten for individuals with celiac disease. To reflect this
uncertainty, we assume that 0 percent to 100 percent of consumers with
celiac disease are unable or unwilling to tolerate 20 ppm or more
gluten over the long term and, therefore, would be unable to continue
to use gluten-free claims to identify appropriate foods under this
option.
    Physicians have diagnosed approximately 40,000 to 60,000 people as
having celiac disease in the United States (Refs. 17 and 18). We assume
that physicians have prescribed a diet that does not include gluten for
all consumers they have diagnosed with celiac disease. If 0 to 100
percent of these consumers cannot tolerate 20 ppm or more gluten, and
if all of these consumers currently use gluten-free claims to identify
appropriate foods, then 0 to 60,000 people who currently use gluten-
free claims would be unable to continue to do so.
    We assume that only consumers who have been diagnosed with celiac
disease, or those who buy food for such consumers, are currently using
gluten-free claims to find appropriate foods. However, some consumers
who have not been diagnosed as having celiac disease may also follow a
diet that does not include gluten on their own initiative if they are
experiencing symptoms of gluten intolerance. We consider this group to
illustrate the consequences of our assumption that only those consumers
who have been diagnosed with celiac disease use gluten-free claims on
product labels.
    As we explained in section I.B of this document, the prevalence of
celiac disease in the United States, including both symptomatic and
asymptomatic individuals, ranges from about 0.4 percent to about 1.0
percent (Refs. 1 and 16), although the actual prevalence may be higher
or lower. Based on this information, we assume that 0.4 percent to 1.0
percent of the United States population may have celiac disease. One
study found that 40 percent of children and 60 percent of adults who
were newly diagnosed with celiac disease were symptomatic (Ref. 84).
Therefore, we assume the overall rate of new celiac patients who are
symptomatic is between 40 percent and 60 percent.
    The U.S. population in August 2005 was approximately 297 million
(Ref. 85). If the overall prevalence of celiac disease is between 0.4
percent and 1 percent, then approximately 1.2 million to 3.0 million
people in the United States have celiac disease. If 40 percent to 60
percent of people with celiac disease have symptoms of that disease,
then between 500,000 and 1.8 million people in the United States have
symptoms associated with celiac disease. Earlier we noted that only
40,000 to 60,000 people in the United States have been diagnosed with
celiac disease. Subtracting this number of people from the estimated
number of people in the United States who have symptoms associated with
celiac disease and rounding to the nearest tenth of one million implies
that approximately 0.4 million to 1.8 million people have undiagnosed
celiac disease and exhibit some symptoms of that disease. If some of
these consumers, or those who buy food for these consumers, are
currently using gluten-free claims to identify appropriate foods, then
the consequences of revising the criteria for using those claims would
be much greater than we have estimated based only on consumers who have
been diagnosed with celiac disease.
 
[[Page 2808]]
 
    Any consumers who currently rely on gluten-free claims to identify
appropriate foods and who would be unable to continue to use those
claims because they cannot tolerate the level of gluten allowed under
the specified level would probably need to spend additional time
identifying appropriate foods. In the comments that we received during
the public meeting on gluten-free food labeling, some comments said
they spent up to an extra 10 hours per week shopping, while other
comments said they spent five times as much time shopping as they did
before they started a diet that does not include gluten. One consumer
group reported that some consumers on a diet that does not include
gluten said they spent an extra 30 minutes per week shopping, while
other consumers said they spent twice as much time shopping as they did
before they started a diet that does not include gluten (Ref. 86). This
group did not report how much time the consumers spent shopping before
they started a diet that does not include gluten. However, in the
analysis of a previous and unrelated rule, we estimated that the
average shopping time for all grocery store purchases was 46.2 minutes
per week (68 FR 51738 at 51744, August 28, 2003). This average would
have included those on special diets such as diets that do not include
gluten. However, most people are not on special diets. Therefore, we
interpret the information from this consumer group to mean that some
consumers on a diet that does not include gluten who reported spending
twice as much time shopping spent about 90 minutes shopping per week.
This group did not report on the smallest amount of extra time that
these consumers spent shopping; but, we assume that all consumers on a
diet that does not include gluten would spend at least some extra time
shopping. We have chosen 10 minutes per week as a reasonable estimate
of this minimum amount of extra shopping time. We assume that the
results reported by the consumer group are more representative of the
average consumer on a diet that does not include gluten than the
results reported by these individual consumers, who might not be
typical of the average consumer on a diet that does not include gluten.
Based on this information, we assume that being on a diet that does not
include gluten increases food shopping time by 10 to 46 minutes per
week.
    We do not know the difference in search times for those who can use
gluten-free labels and those who cannot. The range in search costs that
we reported previously probably includes consumers who make
considerable use of gluten-free claims to identify foods and consumers
who do not. Many consumers who can make considerable use of gluten-free
claims probably still need to expend at least some additional time
searching for foods relative to the average consumer because relatively
few foods bear gluten-free claims. In addition, some consumers who use
gluten-free claims to identify acceptable foods may also read
ingredient lists to confirm the absence of gluten (Ref. 87). Therefore,
the ability to use gluten-free claims probably leads to a relatively
small reduction in extra shopping time for consumers on diets that do
not include gluten. We do not have sufficient information to estimate
the time savings associated with being able to use existing gluten-free
claims; but, we have chosen a range of 10 to 50 percent of the
difference between the low end and the high end of the range of total
extra shopping time, or 0 minute to 18 minutes per week, as the extra
shopping time that the ability to use gluten-free claims could
reasonably be expected to eliminate. We request comments on this
assumption.
    Consumers who cannot rely on gluten-free claims and who buy foods
in conventional grocery stores probably expend the most extra time
shopping because they would have to rely on ingredient lists or take
other approaches to identifying appropriate foods. These consumers
might need to learn more about food ingredients or use references on
food ingredients. In addition, some of these consumers may call or
write manufacturers to ask about ingredients. Some consumers may look
up information on foods on the Internet. Finally, some of these
consumers may refer to reference lists of gluten-free foods that some
celiac organizations publish for this purpose. Consumers who cannot
rely on gluten-free claims and who buy gluten-free foods in specialty
stores or from mail order firms probably have lower search costs
because some of these sources may identify foods that do not contain
gluten. However, gluten-free foods are typically more expensive when
purchased in specialty stores or from mail order firms than when
purchased in conventional grocery stores; so, the reduction in search
cost is offset by increased product prices.
    Based on this information, we assume that losing the ability to
rely on the relatively small number of existing gluten-free labels may
increase search costs by 0 to 18 minutes per week. Multiplying this
range by the number of consumers who we estimated might lose the use of
gluten-free labeling, 0 to 60,000, results in a potential increase in
search costs of 0 to 18,000 hours per week. The average value of 1 hour
of leisure time should be similar to the average value of 1 hour of
working time, which was $26.05 in September 2005 for nonfarm private
and State and local Government workers in the United States (Ref. 88).
Therefore, we estimate the cost associated with potential increases in
search costs for some consumers to be $0 to $24 million per year.
    If specifying a level higher than 20 ppm gluten increases product
search costs for some consumers, then it may also lead those consumers
to conduct fewer searches for appropriate foods, which could reduce
their compliance with diets that do not include gluten. Some consumers
already have difficulty following a diet that does not include gluten.
One recent study said that the literature suggests that only 17 percent
to 65 percent of patients who are prescribed a diet that does not
include gluten manage to adhere to that diet (Ref. 89). An earlier
study found that only 2 percent of 130 patients who had been diagnosed
with celiac disease managed to adhere to a diet that does not include
gluten (Ref. 90). One article said that poor compliance with diets that
do not include gluten was at least partially due to the inconvenience
of purchasing and preparing gluten-free food and the higher prices of
gluten-free foods (Ref. 46). Search costs are one measure of the
inconvenience of purchasing gluten-free food and probably also play a
role in the higher cost of such foods.
    Some studies have found relatively high compliance rates for diets
that do not include gluten that allow ingredients that may have trace
amounts of gluten, such as wheat starch. This suggests that compliance
with diets that do not include gluten that allow such ingredients may
be higher than compliance with diets that do not include gluten that do
not allow such ingredients. One article noted that 85 percent of celiac
patients in Finland manage to adhere over the long-term to a diet that
does not include gluten that allows wheat starch (Ref. 82). Similarly,
one study that was conducted in Finland found that 88 percent of the
patients in that study adhered to a diet that does not include gluten
that allowed wheat starch (Ref. 89). These percentages are higher than
the 2 percent to 65 percent compliance rates for diets that do not
include gluten that we mentioned in the preceding paragraph, which were
from articles that appear to have interpreted any gluten
 
[[Page 2809]]
 
intake as a failure to comply with a diet that does not include gluten.
If there is a difference in compliance rates, then part of this
difference may be because gluten-intolerant consumers who can tolerate
foods made with ingredients that may contain trace amounts of gluten,
such as wheat starch, can more easily find appropriate and acceptable
foods. For example, one study found that 13 of the 17 consumers in that
study preferred a product made with wheat starch containing
approximately 15 ppm gluten to foods made with rice flour or cornstarch
that were entirely gluten-free (Ref. 83). On the other hand, Thompson
(Ref. 41) contended that there is no evidence that compliance is higher
among patients following diets that do not include gluten that allow
foods made with wheat starch than among those following diets that do
not include gluten that do not allow foods made with wheat starch. For
example, some of the differences in the compliance rates that appear in
different articles may be due to differences in the usual diets of
various countries or other factors that are unrelated to whether the
diet includes products that contain trace amounts of gluten such as
wheat starch.
    Of course, factors other than search costs and product costs may
affect compliance with a diet that does not include gluten. For
example, one article that looked at 55 cases of persisting celiac
disease caused by non-compliance with a diet that does not include
gluten found that 73 percent of those patients were not aware of the
continuing nature of the disease and thought they had recovered from a
temporary illness, while 27 percent were aware of the continuing nature
of the disease but were unable to maintain compliance without
additional dietary counseling (Ref. 90). The authors suggested that the
principal reason for non-compliance with a diet that does not include
gluten might be the lack of morbidity associated with chronic untreated
celiac disease. They noted that although a few patients had experienced
lassitude, abdominal discomfort, or occasional diarrhea, the symptoms
were not compelling. Another study also suggested that one potential
reason for intentional non-compliance with a diet that does not include
gluten is that many non-compliant patients have no symptoms and normal
hematological and biochemical profiles despite notable mucosal villous
atrophy and inflammation (Ref. 83).
    Based on this information, we assume that if this option raised
search costs for some consumers, then it could lead them to decrease
their compliance with a diet that does not include gluten. However, we
do not have sufficient information to estimate the incremental change
in compliance rates.
    If this option reduced some consumers' compliance with a diet that
does not include gluten, then it could generate adverse health effects
for those consumers. The adverse health effects associated with celiac
disease are highly variable among affected individuals. We do not know
the reasons for this variability, but it may depend on the age and
immunological status of the individual; the amount, duration, or timing
of the exposure to gluten; and the specific area and extent of the
gastrointestinal tract involved by disease (Ref. 5). We discussed the
adverse health effects associated with gluten consumption by celiac
patients in section I.A of this document. Although decreased compliance
with a diet that does not include gluten would probably generate some
adverse health effects, the literature is not clear on the effect of
changes in compliance on health outcomes. Based on this information, we
conclude that any decrease in compliance with a diet that does not
include gluten could generate additional cases of various adverse
health effects. However, we cannot estimate the number of cases from
this effect because we do not have sufficient information on the impact
of this option on product search costs, the impact of product search
costs on compliance rates, or the impact of changes in compliance rates
on the risk of various adverse health effects.
    Finally, any reduction in the usefulness of gluten-free claims for
some consumers might discourage firms from continuing to produce or
developing foods with a level of gluten below the specified level.
Firms could use other truthful and not misleading wording on food
labels to inform consumers that a product was not made with gluten-
containing ingredients or contained less than the specified level of
gluten. However, these other types of label statements might not be as
effective as gluten-free claims. This potential reduction in the number
of foods with a level of gluten below the specified level might further
increase search costs for consumers who desire such foods and might
further reduce their compliance with diets that do not include gluten.
We do not have sufficient information to estimate these potential
costs.
    This option would also generate the costs that we associated with
restricting the wording of gluten-free claims on inherently gluten-free
food in our discussion of Option Two. We do not have sufficient
information to estimate these costs.
    c. Benefits. As we discussed in the preceding overview, specifying
a level higher than 20 ppm gluten might generate benefits because it
would enable firms to use gluten-free claims on additional foods.
Consumers who can tolerate the specified level of gluten could use
gluten-free claims to more easily identify appropriate foods.
    We do not know how many existing foods contain particular levels
higher than 20 ppm because no information is available on the amount of
gluten in different grain-derived food ingredients or finished food
(Ref. 69, p. 37). However, the gluten in many foods that contain trace
amounts of gluten comes from ingredients such as wheat starch, malt
extract, or malt vinegar. The level of gluten in wheat starch varies
between 14 ppm and 740 ppm (i.e. 7 ppm to 370 ppm prolamin, which
corresponds to 14 ppm to 740 ppm gluten) (Ref. 41). One small survey of
24 wheat-starch derived flours in Finland found levels of less than 20
ppm up to 160 ppm gluten (Ref. 82). The gluten levels in these products
were distributed approximately as follows: 58 percent had 20 ppm or
less, 13 percent had more than 20 ppm up to 40 ppm, 13 percent had more
than 40 ppm up to 60 ppm, 0 percent had more than 60 ppm up to 80 ppm,
8 percent had more than 80 ppm up to 100 ppm, 0 percent had more than
100 ppm up to 140 ppm, and 8 percent had more than 140 ppm up to 160
ppm. One study analyzed gluten levels in 2 brands of wheat starch and
found levels of approximately 15 ppm (0.75mg/100g) and 560 ppm (28mg/
100g) (Ref. 83). One article noted that improved gluten detection
techniques have demonstrated that some food made with wheat starch
contains more gluten than the current Codex standard for gluten-free
foods would allow (Ref. 91). Codex Standard 118-1981 (amended 1983) for
gluten-free foods that is in effect today defines ``gluten-free'' to
mean that the total nitrogen content of gluten-containing cereal grains
used to make a product cannot exceed 0.05 gram nitrogen per 100 grams
dry cereal grain (Ref. 92). However, some authors have attempted to
estimate what this Codex restriction means in terms of ppm of gluten.
One study estimates that the current Codex standard allows gluten-free
products to contain up to 500 ppm (50 mg/100 g) (Ref. 93). Other
studies estimate that the current Codex standard allows gluten-free
products to contain up to 600 ppm gluten (60 mg/100 g) (Refs. 94 and
89). Based on this information, we assume wheat starch contains between
14 ppm and 740 ppm gluten. The level of gluten
 
[[Page 2810]]
 
in products made with wheat starch would be significantly lower,
depending upon the amount of wheat starch used in proportion to the
other ingredients to make the products. However, we do not have data on
the level of gluten in products made with wheat starch. Foods made with
malt extract may also contain low levels of gluten (Ref. 95). Firms
produce malt extract from malt grain derived from barley. Depending on
the extraction technique, malt extract may contain residual amounts of
gluten. One study tested some foods containing malt extract and found
gluten in some samples of chocolate powder, chocolate milk, and
chocolate bars, but not in breakfast cereals (Ref. 91). Foods that
firms manufacture using other ingredients, such as oats, may also
contain gluten if these other ingredients are commingled with grains
like wheat, rye, barley, or triticale (Refs. 63 and 64).
    Some individuals with celiac disease may be able to tolerate levels
of gluten higher than 20 ppm in ingredients such as wheat starch, malt
extract, and malt vinegar. These consumers may be able to use current
ingredient labeling to identify appropriate foods if firms list these
types of ingredients on product labels and no other potential sources
of gluten appear on the ingredient lists. However, these consumers
would not always be able to use ingredient lists to determine whether a
product contains gluten because some ingredients' common or usual names
do not identify their food sources and some ingredients can be derived
from grains that contain gluten or from grains that do not contain
gluten. In some cases, firms may include ingredients containing trace
amounts of gluten in other listed ingredients that have collective
names such as flavors and colors. Other consumers may be able to
tolerate the lower but not the higher levels of gluten that might occur
in foods that contain these ingredients. These consumers would not be
able to rely on current ingredient labeling because some foods that
contain these ingredients could contain more than whatever amount of
gluten higher than 20 ppm those consumers can tolerate. These consumers
would need to take additional steps to identify foods that contain
gluten at the levels they can tolerate. These additional steps might
involve using references on gluten levels in different foods, calling
manufacturers, or buying foods through specialty vendors that select
appropriate foods or provide advice on acceptable foods. Using a level
higher than 20 ppm gluten could decrease search costs for both groups
of consumers, but the effect would be larger for consumers who cannot
use the ingredient list to identify appropriate foods.
    We do not know how many consumers can tolerate any particular level
of gluten. In the preceding discussion of costs, we estimated that 0 to
100 percent of the 40,000 to 60,000 consumers who we estimated to be
currently on a diet that does not include gluten cannot tolerate an
amount of gluten higher than 20 ppm. The corresponding estimate of the
percentage of consumers who can tolerate a level of gluten higher than
20 ppm also ranges from 0 percent to 100 percent, which corresponds to
0 to 60,000 consumers.
    We also do not know the impact on search costs for these consumers.
In the preceding cost discussion, we estimated that being on a diet
that does not include gluten increases product search time by 10 to 46
minutes per week. We do not know how much of this increased time cost
comes from reading ingredient labels to identify ingredients that may
contain low levels of gluten or taking other steps to determine the
gluten levels of foods that have these ingredients as the only sources
of gluten. However, a reasonable estimate of the increased time cost is
10 to 50 percent of the difference between the low end and high end of
the range of total extra shopping time, or 0 minute to 18 minutes per
week after rounding. Therefore, we assume that allowing gluten-free
claims to appear on foods with levels of gluten higher than 20 ppm
could reduce consumers' search costs by 0 to 18 minutes per week. We
request comments on this assumption. Multiplying the estimated number
of consumers who have been diagnosed with celiac disease by the number
of minutes results in a potential search cost savings of 0 to 18,000
hours per week. The average value of one hour of leisure time should be
similar to the average value of 1 hour of working time, which was
$26.05 in September 2005 (Ref. 88). Therefore, we estimate the
potential benefit of reduced product search costs to be $0 to $18
million per year.
    Any decrease in search costs for some consumers could lead those
consumers to conduct additional searches for appropriate foods, which
might increase their compliance with a diet that does not include
gluten. If these consumers increased their compliance with a diet that
does not include gluten, then they may reduce their risk of adverse
health effects. This option might also encourage firms to develop new
foods with the specified level of gluten because it would improve the
ability of firms to signal to consumers through the use of gluten-free
labeling claims that a given product contains less than the level of
gluten. The development of new foods might also further facilitate
compliance with a diet that does not include gluten for consumers who
can tolerate the specified level of gluten, which could lead to
additional health benefits. We do not have sufficient information to
estimate these benefits.
    This option would also generate the benefits that we associated
with restricting the wording of gluten-free claims on inherently
gluten-free food in our discussion of Option Two. We do not have
sufficient information to estimate these benefits.
    d. Summary. The element of this option that specifies a level
higher than 20 ppm gluten, when the gluten that is present in the food
is from ingredients that have been derived from a prohibited grain and
have been processed to remove the gluten or from any other source,
would allow firms to make gluten-free claims on the labels of some
foods that contain less than this level of gluten and would generate
both costs and benefits. The costs would accrue to consumers who cannot
tolerate the specified level of gluten and the benefits would accrue to
consumers who can tolerate the specified level of gluten. We do not
have sufficient information to compare the impact of this option on
these two groups of consumers. Using the full range of 0 percent to 100
percent of consumers diagnosed with celiac disease as potentially
falling into either group gives countervailing search costs and
benefits of $0 to $18 million per year. Changes in search costs could
also generate countervailing health effects for these two groups of
consumers. The optimal rule from a cost-benefit perspective would
balance the cost of reducing the usefulness of gluten-free claims for
consumers who have a relatively high degree of sensitivity to gluten
with the benefit of making gluten-free claims as useful as possible for
consumers who are attempting to control their intake of gluten but are
relatively less sensitive to gluten. However, we do not have sufficient
information to quantify these effects or to estimate the optimal level
of gluten.
    The element of this option that would restrict the wording of
gluten-free claims on inherently gluten-free food could also generate
costs and benefits. Costs would result from a potential reduction in
the likelihood that firms will use gluten-free claims on inherently
gluten-free food, while the benefits would result from the greater
information content or the reduced potential for misleading consumers
of
 
[[Page 2811]]
 
any such claims that do appear on these foods. We do not have
sufficient information to determine the net effect of these
countervailing influences.
4. Option Four: Do Not Permit Firms to Make Gluten-Free Claims on Foods
Containing 20 ppm or More Gluten, Regardless of the Ingredients They
Use to Make Them, and Restrict the Wording of Gluten-Free Claims on
Foods That Inherently Do Not Contain Gluten
    Under this option, we would allow firms to make gluten-free claims
on food that they make from any type of ingredient if the food does not
contain 20 ppm or more gluten. This option would generate the same
costs and benefits as Option Two except that applying the 20 ppm level
to food that contains one or more of the prohibited grains or that
contains ingredients that have been derived from them and have not been
processed to remove the gluten would represent a change from our
current approach to such claims. Our current approach to claims of the
form ``substance X-free'' is that a product that bears such a claim on
its label cannot contain any level of substance X. Applying this
approach to gluten-free claims implies that we do not allow firms to
use gluten-free claims on foods they make from these substances
regardless of the level of gluten in that food. Option Two maintains
our current approach for these foods. Therefore, applying the level of
20 ppm to this food would generate costs and benefits that we did not
discuss under Option Two.
    As a practical matter, any product that firms make from one or more
of the prohibited grains will contain 20 ppm or more gluten. Therefore,
the impact of applying the level to food that contains one or more of
the prohibited grains is the same as the impact of our current position
of prohibiting gluten-free claims on the labels of food containing
these grains. Therefore, this change will not generate costs or
benefits relative to the baseline.
    In contrast, a food that contains ingredients that have been
derived from a prohibited grain and have not been processed to remove
the gluten may contain less than 20 ppm gluten. Therefore, applying the
level to this category of food would result in costs and benefits
relative to the baseline of our current position. These costs and
benefits would be in addition to the costs and benefits that we
discussed under Option Two.
    The cost of applying the level to food that contains ingredients
that have been derived from a prohibited grain and have not been
processed to remove the gluten is that we would need to test the food
to determine if it can bear a gluten-free claim. Enforcement actions
that require testing are significantly more costly for us than
enforcement actions that only require us to read ingredient lists on
food labels. However, we have not analyzed the difference in costs for
enforcement actions that require testing and those that do not. In
addition, we cannot estimate how many times we would need to take
enforcement actions against this type of food. Therefore, we cannot
estimate this additional cost.
    This provision would not generate costs for consumers because
consumers who cannot tolerate 20 ppm gluten are unable to rely on
gluten-free claims to identify acceptable products under our current
approach and would also be unable to do so under the proposed
requirements of Option Two. This is because both our current approach
to claims of the general form ``substance X-free'' and the approach
expressed in Option Two allow firms to make gluten-free claims on
products that contain less than 20 ppm gluten if the gluten that is
present in the food is from a source other than an ingredient that is a
prohibited grain or that has been derived from a prohibited grain and
has not been processed to remove the gluten.
    The benefit of applying the level of 20 ppm to food that contains
ingredients that have been derived from a prohibited grain and have not
been processed to remove the gluten is that firms would be able to
begin using gluten-free claims on this type of food, provided that the
food did not contain 20 ppm or more gluten. This would generate
benefits for consumers who can tolerate up to 20 ppm gluten because
they would be able to rely on gluten-free claims to identify additional
products. We do not have sufficient information to estimate this
benefit.
    In summary, this option would have the same costs and benefits as
Option Two except for the costs and benefits of applying the level of
20 ppm to food that contains ingredients that have been derived from a
prohibited grain and have not been processed to remove the gluten. We
do not have sufficient information to quantify these countervailing
costs and benefits. Therefore, we cannot compare the net benefits of
this option to the net benefits of Option Two.
5. Option Five: Take the Proposed Action, Except Delete Wording
Requirements for Gluten-Free Claims on Foods That Inherently Do Not
Contain Gluten
    We could take the proposed action but delete the requirements
relating to the wording of gluten-free claims on foods that inherently
do not contain gluten. In that case, we would continue the status quo
approach of determining whether such claims are misleading on a case-
by-case basis. This would eliminate the costs and benefits of the
proposed requirements that we discussed under Option Two. Therefore,
this option would not generate any costs or benefits.
6. Option Six: Take the Proposed Action, But Also Define the Food
Labeling Claim ``Low Gluten''
    Under this option, we would specify requirements for a ``gluten-
free'' labeling claim as directed by FALCPA and also specify
requirements for a less restrictive ``low gluten'' labeling claim that
firms could use on foods that contained a relatively low level of
gluten at some specified level higher than 20 ppm. Firms can already
use ``low gluten'' claims if those claims are truthful and not
misleading. However, we currently do not have a position on the level
of gluten that renders a ``low gluten'' claim truthful and not
misleading. Determining an appropriate level of gluten to use in
defining ``low gluten'' on a cost benefit basis would require, among
other things, dose-response data on the health impacts of various
levels of gluten on those with celiac disease. We do not have
sufficient scientific data to recommend a specified level of gluten to
define the term ``low gluten.'' Nevertheless, we address significant
regulatory options in regulatory impact analyses irrespective of their
feasibility.
    This two-tier approach could generate higher benefits than Option
Two in two ways. First, by establishing explicit criteria for using
``low gluten'' claims, we might encourage firms to use such claims.
Second, by basing the use of ``low gluten'' claims on a particular
level of gluten, we would standardize the meaning of ``low gluten''
claims and make them more useful for consumers. Encouraging the use of
``low gluten'' claims and standardizing the level of gluten in foods
bearing such claims might generate benefits because a combination of
``gluten-free'' claims and ``low gluten'' claims would provide claims
that might be useful for both more sensitive and less sensitive
consumers, which would increase the
 
[[Page 2812]]
 
number of consumers who find such claims useful and decrease the number
of consumers who might be unable to continue to use these claims to
identify appropriate foods.
    However, this option may also generate costs beyond those we
discussed under Option Two. First, some firms may already be using
``low gluten'' claims. If we define that term relative to a particular
level of gluten, then some of these firms may need to change product
labels. We were unable to identify any foods bearing ``low gluten''
labels in the FLAPS database. Therefore, we estimate that any labeling
costs would be minimal. Second, the presence of two claims
corresponding to different levels of gluten might confuse some
consumers and lead them to consume foods with more gluten than they
intend to consume. Encouraging the use of ``low gluten'' claims might
exacerbate this potential problem. While many consumers may be familiar
with ``free'' and ``low'' content claims in the context of nutrients,
we have not previously defined ``low'' claims for other food substances
that some consumers may need to totally avoid. We do not have
sufficient information to estimate the costs and benefits of this
option.
7. Option Seven: Take Proposed Action, Except Include Oats in the List
of Grains That We Propose to Prohibit in Foods That Firms Label as
Gluten-Free
    We could also expand the list of prohibited grains to include oats.
Some consumers with celiac disease may be unable to tolerate some of
the proteins that naturally occur in oats and may prefer to avoid oats
in addition to avoiding the proposed prohibited grains and ingredients
people make from those grains discussed in Option Two. However, other
consumers with celiac disease may be able to tolerate the proteins that
naturally occur in oats and, therefore, may wish to consume oats when
following a diet that does not include gluten. This option could
generate some relabeling costs because we currently allow firms to use
gluten-free claims on foods that contain oats but do not contain gluten
from commingling with a prohibited grain. These firms would need to
remove the gluten-free claims from foods made from oats if we were to
include oats in the list of prohibited grains. We do not know how many
foods are made from oats and do not contain gluten, nor do we know the
percentage of such foods that bear gluten-free claims. We searched the
FLAPS 2000 database and did not find any foods that contained oats and
had a gluten-free claim. Therefore, we estimate that any labeling costs
would be minimal.
    In addition, if we included oats in the list of prohibited grains,
then we would reduce the usefulness of those claims for consumers who
wish to avoid gluten but can tolerate the naturally occurring proteins
in oats. The increase in search costs for these consumers could be
considerable because oats are a common food ingredient that can be
particularly important for celiac patients who wish to avoid wheat,
rye, barley, and their crossbred hybrids. An increase in search costs
for these consumers may decrease their compliance with a diet that does
not include gluten and possibly increase their risk of adverse health
 
effects.
    However, this option would generate benefits for consumers who wish
to avoid gluten and also wish to avoid oats because, if we include oats
in the list of prohibited grains, then these consumers would be able to
use gluten-free claims to identify appropriate foods. Expanding the
usefulness of gluten-free claims for these consumers would reduce their
search costs, possibly increase their compliance with a diet that does
not include gluten, and possibly reduce their risk of adverse health
effects.
    As we discussed in detail at section I.C.3 of this document, the
literature is divided on the percentage of consumers with celiac
disease who can tolerate oats, even when steps have been taken to
prevent commingling with prohibited grains such as wheat and rye. Based
on this information, we assume that some consumers with celiac disease
may wish to avoid oats and that the usefulness of gluten-free claims
for these consumers could depend on whether or not we include oats in
the list of proposed prohibited grains. However, we do not have
sufficient information to estimate the number of such consumers or the
net impact of including oats in the proposed prohibited list of grains.
 
IV. Regulatory Flexibility Analysis
 
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. We are not proposing to change our current position
with respect to the grains or proteins that we associate with gluten or
the level of gluten that we would use to determine compliance with the
requirements for using gluten-free claims. Further, we know of no foods
that inherently do not contain gluten and that bear gluten-free claims
that do not meet our proposed wording restrictions and that are
produced by small entities. Therefore, the agency certifies that the
proposed rule would not have a significant economic impact on a
substantial number of small entities.
 
A. Proposed Regulatory Options
 
    We considered the following regulatory options: (1) Take no action;
(2) take the proposed action--do not permit firms to make gluten-free
claims on foods containing the prohibited grains or ingredients that
have been derived from them and have not been processed to remove the
gluten; do not permit firms to make gluten-free claims on foods
containing ingredients derived from the prohibited grains that have
been processed to remove the gluten, if the level of gluten is 20 ppm
or greater; do not permit firms to make gluten-free claims on foods
containing 20 ppm or more gluten, regardless of how the gluten got into
the food (i.e. declared ingredient, undeclared ingredient, contaminant,
etc.); and restrict the wording of gluten-free claims on foods that
inherently do not contain any gluten; (3) take the proposed action,
except do not permit firms to make gluten-free claims on foods
containing ingredients derived from the prohibited grains that have
been processed to remove the gluten, if the level of gluten is greater
than some specified level higher than 20 ppm, and do not permit firms
to make gluten-free claims on foods if the level of gluten is greater
than some specified level higher than 20 ppm, regardless of how the
gluten got into the food; (4) do not permit firms to make gluten-free
claims on foods containing 20 ppm or more gluten, regardless of the
ingredients they use to make them, and restrict the wording of gluten-
free claims on foods that inherently do not contain gluten; (5) take
the proposed action, except delete the wording requirements for gluten-
free claims on foods that inherently do not contain gluten; (6) take
the proposed action, but also define the food labeling claim ``low
gluten;'' and (7) take the proposed action, except include oats in the
list of grains that we propose to prohibit in foods that firms label as
gluten-free.
 
B. Impacts of the Proposed Regulatory Options on Small Entities
 
1. Option One: Take No Action
    Taking no action would have no impact on small entities.
 
[[Page 2813]]
 
2. Option Two: Take the Proposed Action--Do Not Permit Firms to Make
Gluten-Free Claims on Foods Containing the Prohibited Grains or
Ingredients That Have Been Derived From Those Grains and Have Not Been
Processed to Remove the Gluten; Do Not Permit Firms to Make Gluten-Free
Claims on Foods Containing Ingredients Derived From the Prohibited
Grains That Have Been Processed to Remove the Gluten, if the Level of
Gluten Is 20 ppm or Greater; Do Not Permit Firms to Make Gluten-Free
Claims on Foods Containing 20 ppm or More Gluten, Regardless of How the
Gluten Got Into the Food; and Restrict Wording of Gluten-Free Claims on
Foods That Inherently Do Not Contain Gluten
    We are not proposing to change how we currently enforce our
existing statute that prohibits false or misleading labeling other than
instituting new wording requirements for gluten-free claims on foods
that inherently do not contain gluten. This element may generate
compliance costs for small entities. However, as we discussed in the
preceding regulatory impact analysis, we know of no such foods.
Therefore, we estimate that this proposed rule would generate minimal
or no costs for small entities. We request information on the impact of
the proposed action and all other options on small entities.
3. Option Three: Take the Proposed Action, Except Do Not Permit Firms
to Make Gluten-Free Claims on Foods Containing Ingredients Derived From
the Prohibited Grains That Have Been Processed to Remove the Gluten, If
the Level of Gluten Is Some Specified Level Other Than 20 ppm, and Do
Not Permit Firms to Make Gluten-Free Claims on Foods If the Level of
Gluten Is Some Specified Level Other Than 20 ppm, Regardless of How the
Gluten Got Into the Food
    This option would have the same minimal impact on small entities as
Option Two. As we discussed in the preceding preliminary regulatory
impact analysis, we could analyze levels either higher or lower than 20
ppm, but we have chosen to analyze levels higher than 20 ppm because we
do not know of any currently available and appropriate test methods
that can reliably and consistently detect gluten at levels below 20
ppm. Under Option Three, specifying a level higher than 20 ppm gluten
would not generate additional compliance costs for small entities
because gluten-free claims are voluntary and no small firms would need
to remove existing labeling claims that complied with our existing
position. Therefore, we estimate that this option would also generate
minimal or no costs for small entities.
4. Option Four: Do Not Permit Firms to Make Gluten-Free Claims on Foods
Containing 20 ppm or More Gluten, Regardless of the Ingredients They
Use to Make Them, and Restrict the Wording of Gluten-Free Claims on
Foods That Inherently Do Not Contain Gluten
    This option would have the same minimal impact on small entities as
Option Two. Under Option Four, applying the level of 20 ppm to all
foods, regardless of the ingredients firms use to make them, would not
generate additional compliance costs for small entities because gluten-
free claims are voluntary and no small firms would need to remove
existing labeling claims that they would not already have had to remove
under our existing approach to regulating gluten-free food labeling.
Therefore, we estimate that this option would also generate minimal or
no costs for small entities.
5. Option Five: Take the Proposed Action, Except Delete Wording
Requirements for Gluten-Free Claims on Foods That Inherently Do Not
Contain Gluten
    Taking the proposed action except deleting the wording requirements
for gluten-free claims would eliminate any impact on small entities.
6. Option Six: Take the Proposed Action, but Also Define the Food
Labeling Claim ``Low Gluten''
    Establishing requirements for ``low gluten'' claims might generate
compliance costs for small entities. As we discussed in the preceding
regulatory impact analysis, we currently allow ``gluten-free'' claims
that are truthful and not misleading. If we define ``low gluten'' based
on a particular level of gluten, then some small firms might need to
change their product labels. However, we were unable to identify any
foods bearing ``low gluten'' claims in the FLAPS database. Therefore,
we estimate that any labeling costs associated with this provision
would be minimal. In addition, the provision dealing with gluten-free
claims on foods that inherently do not contain gluten would have a
minimal impact on small entities. Therefore, we estimate that this
option would have minimal or no impact on small entities.
7. Option Seven: Take Proposed Action, but Include Oats in the List of
Grains That We Propose to Prohibit in Foods That Firms Label as Gluten-
Free
    Including oats in the list of prohibited grains may generate
relabeling costs for some small firms because we currently allow firms
to make gluten-free claims on foods that contain oats but do not
contain any of the prohibited grains or ingredients derived from those
grains provided that any gluten present is less than 20 ppm. We do not
know how many small firms produce foods that contain oats but do not
contain any of the prohibited grains or ingredients derived from those
grains and that bear gluten-free claims. We searched the FLAPS 2000
database and did not find any foods that contained oats and bore
gluten-free claims. Therefore, we estimate that any costs that might
accrue to small entities from this option would be minimal.
 
V. Unfunded Mandates
 
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $115 million, using the most current (2003) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
 
VI. Executive Order 13132: Federalism
 
    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive order requires agencies to ``construe * * * Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.''\3\ Here, FDA has determined that the exercise of
State authority would
 
[[Page 2814]]
 
conflict with the proposed exercise of Federal authority under the act.
---------------------------------------------------------------------------
 
    \3\Because we have determined that the act preempts State law
because the exercise of State authority conflicts with the exercise
of Federal authority under that statute, we need not construe our
statutory rulemaking authority as required by section 4(b) of the
Executive order.
---------------------------------------------------------------------------
 
    FDA is the expert Federal agency charged by Congress with ensuring
that food labeling is truthful and not misleading. Under section
403(a)(1) of the act, a food is deemed misbranded if its labeling is
false or misleading in any particular. In determining whether labeling
is misleading, FDA takes into account not only representations made or
suggested by statement, word, design, device, or any combination
thereof, but also the extent to which the labeling fails to reveal
facts material in the light of such representations or material with
respect to consequences which may result from the use of the article to
which the labeling relates under the conditions of use prescribe in the
labeling thereof or under such conditions of use as are customary or
usual (section 201(n) of the act).
    In section 206 of FALCPA, Congress directs FDA to issue a proposed
rule to define and permit use of the term ``gluten-free'' on the
labeling of foods, in consultation with appropriate experts and
stakeholders. As discussed elsewhere in this preamble, FDA has
consulted with numerous experts and stakeholders in the development of
this proposed rule. FDA has learned that different manufacturers
currently have different and inconsistent definitions of the term
``gluten-free,'' and that individuals with celiac disease need a
standardized definition of the term ``gluten-free'' to help them make
purchasing decisions that will support their need to avoid consumption
of gluten. Therefore, FDA believes that establishing a definition of
the term ``gluten-free'' and uniform conditions for its use in the
labeling of foods is needed to ensure that individuals with celiac
disease are not misled and are provided with truthful and accurate
information with respect to foods so labeled. If State authorities were
permitted to impose labeling requirements that are inconsistent with
those proposed in this rule, the federal objective of standardizing use
of the term ``gluten-free'' in the labeling of foods to ensure that
such labeling is neither false nor misleading would be frustrated.
    Section 4(c) of Executive Order 13132 instructs us to restrict any
Federal preemption of State law to the ``minimum level necessary to
achieve the objectives of the statute pursuant to which the regulations
are promulgated.'' This proposed rule would meet the preceding
requirement because it would preempt state law only to the extent
required to preserve Federal interests. Section 4(d) of Executive Order
13132 states that when an agency foresees the possibility of a conflict
between State law and federally protected interests within the agency's
area of regulatory responsibility, the agency ``shall consult, to the
extent practicable, with appropriate State and local officials in an
effort to avoid such a conflict.'' Section 4(e) of the Executive order
provides that ``when an agency proposes to act through adjudication or
rulemaking to preempt State law, the agency shall provide all affected
State and local officials notice and an opportunity for appropriate
participation in the proceedings.'' FDA's Division of Federal and State
Relations intends to invite the States' participation in this
rulemaking by providing notice via fax and e-mail transmission to State
health commissioners, State agriculture commissioners, and food program
directors as well as FDA field personnel of FDA's publication of this
proposed rule. The notice would provide the States with further
opportunity for input on the rule. It would advise the States of FDA's
possible action and encourage the States and local governments to
review the notice and to provide any comments to the FDA Docket Number
2005N-0279, opened in the [enter date] Federal Register by [enter
date]. FDA is providing an opportunity for State and local officials to
comment on this proposed rule. The agency intends to comply with all of
the applicable requirements under Executive Order 13132 to ensure that
this proposed rule is consistent with the Executive order.
    FDA's Division of Federal-State Relations intends to invite the
States' participation in this rulemaking by providing notice via fax
and e-mail transmission to State health commissioners, State
agriculture commissioners, and food program directors as well as FDA
field personnel of FDA's publication of this proposed rule. The notice
would provide the States with further opportunity for input on the
rule. It would advise the States of FDA's possible action and encourage
the States and local governments to review the proposed rule and to
provide any comments to the FDA Docket No. 2005N-0279, opened in the
July 19, 2005, Federal Register, by April 23, 2007. FDA is providing an
opportunity for State and local officials to comment on this proposed
rule.
 
VII. Environmental Impact Analysis
 
    FDA has tentatively determined under 21 CFR 25.30(k) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
 
VIII. Paperwork Reduction Act of 1995
 
    FDA has tentatively concluded that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
 
IX. Comments
 
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified by Docket No. 2005N-0279. If you base
your comments on scientific evidence or data, please submit copies of
the specific information along with your comments. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
 
X. References
 
    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
FDA has verified the cited Web site addresses, but is not responsible
for subsequent changes to them after this document publishes in the
Federal Register.
    1. National Institutes of Health (NIH), NIH Consensus
Development Conference on Celiac Disease, ``National Institutes of
Health Consensus Development Conference Statement,'' NIH, Bethesda,
MD, pp. 1-15, June 28-30, 2004, accessible at

http://consensus.nih.gov/2004/2004CeliacDisease118html.htm
 on June 22, 2006.
     2. Shan, L., O. Molberg, I. Parrot, et al., ``Structural Basis
for Gluten Intolerance in Celiac Sprue,'' Science, 297:2275-2279,
2002.
    3. Jabri, B., D.D. Kasarda, and H.R Green, ``Innate and Adaptive
Immunity: The Yin and Yang of Celiac Disease,'' Immunological
Reviews, 206:219-231, 2005.
    4. National Digestive Disease Information Clearinghouse,
National Institute of Diabetes and Digestive and Kidney Diseases,
National Institutes of Health (NIH), ``Celiac Disease,'' NIH
Publication No. 06-4269, pp. 1-11. October 2005, accessible at
http://digestive.niddk.nih.gov/ddiseases/pubs/celiac/ on June
 
22, 2006.
    5. Dewar, D., S.P. Pereira, and P.J. Ciclitira, ``The
Pathogenesis of Coeliac Disease,'' International Journal of
Biochemistry & Cell Biology, 36:17-24, 2004.
 
[[Page 2815]]
 
    6. Fasano, A. and C. Catassi, ``Current Approaches to Diagnosis
and Treatment of Celiac Disease: An Evolving Spectrum,''
Gastroenterology, 120(3):636-651, 2001.
    7. Farrell, R.J. and C.P. Kelly, ``Celiac Sprue,'' New England
Journal of Medicine, 346(3):180-188, 2002.
    8. M[auml]ki, M. and P. Collin, ``Coeliac Disease,'' Lancet,
349:1755-1759, 1997.
    9. Fasano, A., ``Celiac Disease--How to Handle a Clinical
Chameleon,'' New England Journal of Medicine, 348:2568-2570, 2003.
    10. Catassi, C. and A. Fasano, ``Celiac Disease as a Cause of
Growth Retardation in Childhood,'' Current Opinion in Pediatrics,
16:445-449, 2004.
    11. Catassi, C., E. Fabiani, G. Corrao, et al., ``Risk of Non-
Hodgkin Lymphoma in Celiac Disease,'' Journal of the American
Medical Association, 287(11):1413-1419, 2002.
    12. Peters, U., J. Askling, G. Gridley, et al., ``Causes of
Death in Patients With Celiac Disease in a Population-Based Swedish
Cohort, `` Archives of Internal Medicine, 163:1566-1572, 2003.
    13. Green, P.H.R. and B. Jabri, ``Coeliac Disease,'' Lancet,
362:383-391, 2003.
    14. Pietrzak, M.M., C. Catassi, S. Drago, et al., ``Celiac
Disease: Going Against the Grains,'' Nutrition in Clinical Practice,
16:335-344, December 2001.
    15. Corrao, G., G.R. Corazza, V. Bagnardi, et al., ``Mortality
in Patients With Coeliac Disease and Their Relatives: A Cohort
Study,'' Lancet, 358:356-361, 2001.
    16. Rostom, A., C. Dub[eacute], A. Cranney, et al., ``Celiac
Disease,'' Evidence Report/Technology Assessment Number 104,
Prepared by the University of Ottawa Evidence-Based Practice Center
Under Contract No. 290-02-0021 for the Agency for Healthcare
Research and Quality (AHRQ), U.S. Department of Health and Human
Services, Rockville, MD, AHRQ Publication No. 04-E029-2, p. 140,
September 2004.
    17. Hamilton, F., ``Celiac Disease-A Not So Uncommon Disorder,''
Presentation, Transcript of the Center for Food Safety and Applied
Nutrition, Food and Drug Administration Public Meeting on Gluten-
Free Food Labeling held in College Park, MD, p. 33, August 19, 2005,
accessible at http://www.fda.gov/ohrms/dockets/dockets/05n0279/05n-0279-tr00001-01-vol16.doc
 on June 22, 2006. (Also see errata sheet
for transcript accessible at
http://www.fda.gov/ohrms/dockets/dockets/05n0279/05n-0279-tr00001-02-erratta-vol16.doc
on June 22, 2006.)
    18. Peterson, T., ``Goodbye to Gluten,'' The Salt Lake Tribune,
September 12, 2005.
    19. Sanders, D.S., M.J. Carter, D.P. Hurlstone, et al.,
``Association of Adult Coeliac Disease With Irritable Bowel
Syndrome: A Case-Control Study in Patients Fulfilling ROME II
Criteria Referred to Secondary Care,'' Lancet, 358:1504-1508, 2001.
    20. Brown, A., Understanding Food Principles and Preparation,
Second Ed., Wadsworth/Thomson Learning, Belmont, CA, pp. 402-403 and
420-421, 2004.
    21. Pomeranz, Y., Modern Cereal Science and Technology, VCH
Publishers, Inc., New York, NY, pp. 40-42, 44, and 53, 1987.
    22. Skerritt, J.H. and A.S. Hill, ``Enzyme Immunoassay for
Determination of Gluten in Foods: Collaborative Study,'' Journal of
the Association of Official Analytical Chemists, 74(2):257-264,
1991.
    23. Hischenhuber, C., R. Crevel, B. Jarry, et al., ``Review
Article: Safe Amounts of Gluten for Patients With Wheat Allergy or
Coeliac Disease,'' Alimentary Pharmacology & Therapeutics,
23(5):559-575, March 1, 2006.
    24. Shewry, P.R., N.G. Halford, P.S Belton, et al., ``The
Structure and Properties of Gluten: An Elastic Protein From Wheat
Grain,'' Philosophical Transactions of the Royal Society of London.
Series B, Biological Sciences, 357:133-142, 2002.
    25. Kasarda, D.D., Personal Communication, January 22, 2005.
    26. Dicke, W.K., H.A. Weijers, and J.H van de Kamer, ``Coeliac
Disease. II. The Presence in Wheat of a Factor Having a Deleterious
Effect in Cases of Coeliac Disease,'' Acta Paediatricia, 42:34-42,
January 1953.
    27. van de Kamer, J.H., H.A. Weijers, and W.K. Dicke, ``Coeliac
Disease. IV. An Investigation Into the Injurious Constituents of
Wheat in Connection With Their Action on Patients With Coeliac
Disease,'' Acta Paediatrica, 42:223-231, May 1953.
    28. Baker, P.G. and A.E. Read, ``Oats and Barley Toxicity in
Coeliac Patients,'' Postgraduate Medical Journal, 52:264-268, May
1976.
    29. Anand, B.S., J. Piris, and S.C. Truelove, ``The Role of
Various Cereals in Coeliac Disease,'' Quarterly Journal of Medicine,
New Series 47(185):101-110, 1978.
    30. Kasarda, D.D., ``What We Know About Grain Safety,'' Paper
Presented at the Columbia University Celiac Disease and Other Food
Intolerances Conference, Columbia University Medical Center, New
York, NY, Program Description & Objectives, pp. 23-33, October 22,
2004.
    31. Kasarda, D.D., ``Grains in Relation to Celiac Disease,''
Cereal Foods World, 46(5):209-210, 2001.
    32. Arentz-Hansen, H., B. Fleckenstein, O. Molberg, et al.,
``The Molecular Basis for Oat Intolerance in Patients With Celiac
Disease,'' PLoS Medicine, 1:84-92, October 2004.
    33. Johnson, D.L., D. Sands, and A. Pilgeram, ``Indian
Ricegrass: A Gluten-Free Cereal,'' Presentation Abstract, The
Association for the Advancement of Industrial Crops Annual Meeting,
Saskatoon, Saskatchewan, Canada, Program and Abstracts, p. 16,
August 25-28, 2002, accessible at http://www.aaic.org/02progrm.htm

on June 22, 2006.
    34. Kupper, C., ``Dietary Guidelines for Celiac Disease and
Implementation,'' Presentation Abstract, National Institutes of
Health (NIH), NIH Consensus Development Conference on Celiac
Disease, Bethesda, MD, pp. 91-95, June 28-30, 2004, accessible at
 
http://consensus.nih.gov/2004/2004CeliacDisease118Program.pdf on
June 22, 2006.
    35. van de Wal, Y., Y.M.C. Kooy, P. van Veelen, et al.,
``Glutenin Is Involved in the Gluten-Driven Mucosal T Cell
Response,'' European Journal of Immunology, 29(10):3133-3139, 1999.
    36. Vader, W., Y. Kooy, P. van Veelen, et al., ``The Gluten
Response in Children With Celiac Disease is Directed Toward Multiple
Gliadin and Glutenin Peptides,'' Gastroenterology,122(7):1729-1737,
2002.
    37. Molberg, O., N.S. Flaete, T. Jensen, et al., ``Intestinal T-
Cell Responses to High-Molecular-Weight Glutenins in Celiac
Disease,'' Gastroenterology, 125(2):337-344, 2003.
    38. Ciclitira, P.J., D.J. Evans, N.L.K. Fagg, et al., ``Clinical
Testing of Gliadin Fractions in Coeliac Patients,'' Clinical
Science, 66:357-364, 1984.
    39. Ellis, H.J., E.L. Pollock, W. Engel, et al., ``Investigation
of the Putative Immunodominant T Cell Epitopes in Coeliac Disease,''
Gut, 52:212-217, 2003.
    40. European Food Safety Agency (EFSA), ``Opinion of the
Scientific Panel on Dietetic Products, Nutrition and Allergies on a
Request from the Commission Relating to the Evaluation of Allergenic
Foods for Labelling Purposes,'' EFSA-Q-2003-016, EFSA Journal,
32:40-45, 146, 147, 152, 155-157, 159, 160, 167, 169, 171, 174, 181,
187, 189, 192, 193, and 195, 2004, accessible at
http://www.efsa.europa.eu./en/science/nda/nda_opinions/341.html
 on June 27, 2006.
    41. Thompson, T., ``Wheat Starch, Gliadin, and the Gluten-Free
Diet,'' Journal of the American Dietetic Association, 101(12):1456-
1459, December 2001.
    42. Kagnoff, M.F., ``Overview and Pathogenesis of Celiac
Disease,'' Gastroenterology, 128:S10-S18, April Supplement, 2005.
    43. Kasarda, D.D., ``Celiac Disease and Safe Grains,'' Web page,
July 2003, accessible at http://wheat.pw.usda.gov/ggpages/topics/Celiac.vs.grains.html
 on June 22, 2006.
 
    44. Thompson, T., ``Oats and the Gluten-Free Diet,'' Journal of
the American Dietetic Association, 103(3):376-379, March 2003.
    45. Lundin, K.E.A., E.M. Nilsen, H.G. Scott, et al., ``Oats
Induced Villous Atrophy in Coeliac Disease,'' Gut, 52(11):1649-1652,
2003.
    46. Janatuinen, E.K., P.H. Pikkarainen, T.A. Kemppainen, et al.,
``A Comparison of Diets With and Without Oats in Adults With Celiac
Disease,'' New England Journal of Medicine, 333(16):1033-1037, 1995.
    47. Hardman, C.M., J.J. Garioch, J.N. Leonard, et al., ``Absence
of Toxicity of Oats in Patients With Dermatitis Herpetiformis,'' New
England Journal of Medicine, 337(26):1884-1887, 1997.
    48. Janatuinen, E.K., T.A. Kemppainen, P.H. Pikkarainen, et al.,
``Lack of Cellular and Humoral Immunological Responses to Oats in
Adults With Coeliac Disease,'' Gut, 46(3):327-331, 2000.
    49. Janatuinen, E.K., T.A. Kemppainen, R.J. Julkunen, et al.,
``No Harm From Five Year Ingestion of Oats in Coeliac Disease,''
Gut, 50(3):332-335, 2002.
    50. H[ouml]gberg, L., P. Laurin, K. Faith-Magnusson, K., et al.,
``Oats to Children With Newly Diagnosed Celiac Disease: A Randomized
Double Blind Study,'' Gut, 53:649-654, 2004.
    51. Per[auml]aho, M., P. Collin, K. Kaukinen, et al., ``Oats Can
Diversify a Gluten-Free Diet in Celiac Disease and Dermatitis
Herpetiformis,'' Journal of the American Dietetic Association,
104(7):1148-1150, July 2004.
    52. Kelly, C., Public comment number EC4 submitted on July 28,
2005 to Docket No. 2005N-0231 pertaining to Center for Food
 
[[Page 2816]]
 
Safety and Applied Nutrition, Food and Drug Administration Draft
Report entitled ``Approaches to Establish Thresholds for Major Food
Allergens and for Gluten in Food,'' pp. 1-2, June 2005, accessible
at http://www.fda.gov/ohrms/dockets/dockets/05n0231/05N-0231-EC4.htm
 
on June 22, 2006.
    53. Kasarda, D.D., Agricultural Research Service, Western
Regional Research Center, U.S. Department of Agriculture, ``Grains
in Relation to Celiac (Coeliac) Disease,'' Web page, updated 1999,
accessible at http://wheat.pw.usda.gov/ggpages/topics/celiac.html on June 22, 2006.
    54. Cureton, P., ``Celiac Consumer: Survey Results,''
Presentation and Remarks During Question and Answer Period,
Transcript of the Center for Food Safety and Applied Nutrition, Food
and Drug Administration Public Meeting on Gluten-Free Food Labeling
held in College Park, MD, pp. 214-215 and 236-237, August 19, 2005,
accessible at

http://www.fda.gov/ohrms/dockets/dockets/05n0279/05n-0279-tr00001-01-vol16.doc on June 22, 2006.
(Also see errata sheet for transcript accessible at
http://www.fda.gov/ohrms/dockets/dockets/05n0279/05n-0279-tr00001-02-erratta-vol16.doc
on June 22, 2006.)
    55. Lee, A., Remarks During Question and Answer Period,
Transcript of the Center for Food Safety and Applied Nutrition, Food
and Drug Administration Public Meeting on Gluten-Free Food Labeling
held in College Park, MD, pp. 237-238, August 19, 2005, accessible
at http://www.fda.gov/ohrms/dockets/[fxsp0]dockets/05n0279/05n-0279-
tr00001-01-vol16.doc on June 22, 2006. (Also see errata sheet for
transcript accessible at
http://www.fda.gov/ohrms/dockets/dockets/05n0279/05n-0279-tr00001-02-erratta-vol16.doc on June
22, 2006.)
    56. Case, S., Gluten-Free Diet: A Comprehensive Guide, Expanded
Edition, Case Nutrition Consulting, Regina, Saskatchewan, Canada,
pp. 21-24, 28, and 29, 2006.
    57. Thompson, T., ``Questionable Foods and the Gluten-Free
Diet,'' Journal of the American Dietetic Association, 100(4):463-
465, April 2000.
    58. American Dietetic Association (ADA), ``Celiac Disease-
Nutrition Care-Grains to Avoid,'' ADA Nutrition Care
Manual(copyright), American Dietetic Association, Chicago, Illinois,
1 electronic page, 2006, accessible at http://www.nutritioncaremanual.org
on June 26, 2006.
    59. American Dietetic Association (ADA), ``Celiac Disease-
Nutrition Care-Oats,'' ADA Nutrition Care Manual(copyright),
American Dietetic Association, Chicago, Illinois, 2 electronic
pages, 2006, accessible at http://www.nutritioncaremanual.org on June 26,
2006.
    60. Hager, M., American Dietetic Association, Public comment
letter EC-1482 submitted on September 20, 2005, to Docket No. 2005N-
0279 pertaining to the Center for Food Safety and Applied Nutrition,
Food and Drug Administration Public Meeting on Gluten-Free Food
Labeling held in College Park, MD, pp. 1-3, August 19, 2005,
accessible at http://www.fda.gov/ohrms/dockets/dockets/05n0279/05n-0279-EC1482-Attach-1.pdf

on June 22, 2006.
    61. U.S. Department of Agriculture, ``Official United States
Standards for Grain, Subpart A-General Provisions,'' pp. A1-A5, June
1999, accessible at http://151.121.3.117/reference-library/standards/810101.pdf
 on June 2005. [Note standards for specific grains are accessible at 
http://www.gipsa.usda.gov/GIPSA/webapp?area=home&subject=grpi&topic=sq-ous
on June 22, 2006.]
    62. American Gastroenterological Association, ``Medical Position
Statement: Celiac Sprue,'' Gastroenterology, 120:1522-1525, 2001.
    63. Thompson, T., ``Gluten Contamination of Commercial Oat
Products in the Unites States,'' New England Journal of Medicine,
351(19):2021-2022, 2004.
    64. Hernando A., J.R. Mujico, D. Juanas, et al., ``Confirmation
of the Cereal Type in Oat Products Highly Contaminated With
Gluten,'' Journal of the American Dietetic Association, 106(5):665,
May 2006.
    65. Armour, B. and T.B. Perry, Cream Hill Estates Ltd., Public
comment letter EMC299 submitted on November 19, 2005, to Docket No.
2005N-0279 pertaining to the Center for Food Safety and Applied
Nutrition, Food and Drug Administration Public Meeting on Gluten-
Free Food Labeling held in College Park, MD, pp. 1-3, August 19,
2005, accessible at 
http://www.fda.gov/ohrms/dockets/dockets/05n0279/05n-0279_emc-000299-03.pdf
 on June 22, 2006.
    66. Smith, S., Gluten Free Oats LLC, Public comment letter
EMC301 submitted on March 20, 2006 to Docket No. 2005N-0279
pertaining to the Center for Food Safety and Applied Nutrition, Food
and Drug Administration Public Meeting on Gluten-Free Food held in
College Park, MD, pp. 1-2, August 19, 2005.
    67. The Threshold Working Group, ``Approaches to Establish
Thresholds for Major Food Allergens and for Gluten in Food,'' Draft
Report, Center for Food Safety and Applied Nutrition, Food and Drug
Administration, College Park, MD, pp. 1-103, June 2005, accessible
at http://www.fda.gov/ohrms/dockets/dockets/05n0231/05n-0231-rpt0001.pdf and

http://www.cfsan.fda.gov/~dms/alrgn.html on June 22, 2006.
    68. Food and Drug Administration, ``FDA's Responses to Public
Comments on the Draft Report `Approaches to Establish Thresholds for
Major Food Allergens and for Gluten in Food,''' Web site posting,
March 2006, accessible at http://www.cfsan.fda.gov/~dms/alrgcom.html
on June 22, 2006.
    69. The Threshold Working Group, ``Approaches to Establish
Thresholds for Major Food Allergens and for Gluten in Food,''
Revised Report, Center for Food Safety and Applied Nutrition, Food
and Drug Administration, College Park, MD, pp. 1-106, March 2006,
accessible at http://www.cfsan.fda.gov/~dms/alrgn2.html on June 22,
2006.
    70. Food Advisory Committee, Center for Food Safety and Applied
Nutrition, Food and Drug Administration, ``Summary Minutes for the
Food Advisory Committee Meeting on `Advice on CFSAN's Draft Report:
Approaches to Establish Thresholds for Major Food Allergens and for
Gluten in Food,''' Greenbelt, MD, pp. 1-11, July 13-15, 2005,
accessible at http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4160t1-01.pdf
and http://www.fda.gov/ohrms/dockets/ac/cfsan05.html
 on June 22, 2006.
    71. St[oslash]rsrud, S., L.R. Hulth[eacute]n, and R.A. Lenner,
et al., ``Beneficial Effects of Oats in the Gluten-Free Diet of
Adults With Special Reference to Nutrient Status, Symptoms and
Subjective Experiences,'' British Journal of Nutrition, 90:101-107,
2003.
    72. Burke, S.J., S.J. Milberg, and W.W. Moe, ``Displaying Common
but Previously Neglected Health Claims on Product Labels:
Understanding Competitive Advantages, Deception, and Education,''
Journal of Public Policy & Marketing, 16(2):242-255, Fall 1997.
    73. Gendel, S.M., Memorandum to the Administrative Record for
the Gluten-Free Food Labeling Proposed Rule, pp. 1-5 (with 31
attachments), May 12, 2006.
    74. M[eacute]ndez, E., V. Carmen, U. Immer, et al., ``Report of
a Collaborative Trial to Investigate the Performance of the R5
Enzyme Linked Immunoassay to Determine Gliadin in Gluten-Free
Food,'' European Journal of Gastroenterology & Hepatology,
17(10):1053-1063, 2005.
    75. Johnson, K., Personal Communication, March 16, 2006.
    76. Matsuda, R., Y. Yoshioka, H. Akiyama, et al.,
``Interlaboratory Evaluation of Two Enzyme-Linked Immunosorbent
Assay Kits for the Detection of Egg, Milk, Wheat, Buckwheat, and
Peanut in Foods,'' Journal of AOAC INTERNATIONAL, 89(6):1600-1608,
November/December 2006.
    77. AOAC INTERNATIONAL, Official Method 991.19: ``Gliadin as a
Measure of Gluten in Foods.'' Chapter 32, Cereal Foods, Official
Methods of Analysis of AOAC INTERNATIONAL, 18th Ed., AOAC
INTERNATIONAL, Gaithersburg, MD, pp. 15-17, 2005.
    78. Fielder, R., Personal Communication, May 10, 2006.
    79. Food Standards Australian New Zealand, ``Australian New
Zealand Food Standards Code: Chapter 1--General Food Standards, Part
1.2--Labelling and Other Information Requirements, Standard 1.2.8--
Nutrition Information Requirements,'' pp. 1 and 16-17, 2006,
accessible at http://www.foodstandards.gov.au/foodstandardscode June
27, 2006.
    80. Fasano, A., Personal Communication, November 22, 2004.
    81. Catassi, C., E. Fabiani, G. Iacono, et al., ``Toxicity of
Gluten Traces in Patients on Treatment for Celiac Disease. Results
of a Prospective, Placebo-Controlled, Double-Blind, Randomized
Study,'' Presentation Abstract No. S1775, Digestive Disease Week,
May 14-19, 2005, accessible at http://precis.preciscentral.com/files/source/67/html/45832.htm

 on June 22, 2006.
    82. Collin, P., L. Thorell, K. Kaukinen, et al., ``The Safe
Threshold for Gluten Contamination in Gluten-Free Products. Can
Trace Amounts Be Accepted in the Treatment of Coeliac Disease?''
Alimentary Pharmacology & Therapeutics, 19(12):1277-1283, June 2004.
    83. Chartrand, L.J., P.A. Russo, A.G, DuHaime, et al., ``Wheat
Starch Intolerance in Patients With Celiac Disease,'' Journal of
 
[[Page 2817]]
 
the American Dietetic Association, 97(6):612-618, June 1997.
    84. Fasano, A., I. Berti, T. Gerarduzzi, et al., ``Prevalence of
Celiac Disease in At-Risk and Not-At-Risk Groups in the United
States. A Large Multicenter Study,'' Archives of Internal Medicine,
163:286-292, 2003.
    85. U.S. Census Bureau, Population Division, ``U.S. POPClock
Projection,'' Web page, accessible at http://www.census.gov/population/www/popclockus.html
 on August 18, 2005
 
    86. Blast, A., National Foundation for Celiac Awareness, Public
Statement, Transcript of the Center for Food Safety and Applied
Nutrition, Food and Drug Administration Public Meeting on Gluten-
Free Food Labeling held in College Park, MD, p. 287, August 19,
2005, accessible at http://www.fda.gov/ohrms/dockets/dockets/05n0279/05n-0279-tr00001-01-vol16.doc
 June 22, 2006. (Also see
errata sheet for transcript accessible at 
http://www.fda.gov/ohrms/dockets/dockets/05n0279/05n-0279-tr00001-02-erratta-vol16.doc
 June 22, 2006.)
    87. Schluckebier, M., ``Food Labeling Concerns for CD/DH,''
Presentation, Transcript of the Center for Food Safety and Applied
Nutrition, Food and Drug Administration Public Meeting on Gluten-
Free Food Labeling held in College Park, MD, p. 200, August 19,
2005, accessible at http://www.fda.gov/ohrms/dockets/dockets/05n0279/05n-0279-tr00001-01-vol16.doc

 on June 22, 2006. (Also see
 errata sheet for transcript accessible at
http://www.fda.gov/ohrms/dockets/dockets/05n0279/05n-0279-tr00001-02-erratta-vol16.doc
 on June 22, 2006.)
    88. Bureau of Labor Statistics, U.S. Department of Labor (USDL),
``Employer Costs for Employee Compensation Summary,'' USDL: 05-2279,
December 9, 2005.
    89. Kaukinen, K., P. Collin, K. Holm, et al., ``Wheat Starch-
Containing Gluten-Free Flour Products in the Treatment of Coeliac
Disease and Dermatitis Herpetiformis. A Long Term Follow-Up Study,''
Scandinavian Journal of Gastroenterology, 34:163-169, 1999.
    90. McCrae, W.M., M.A. Eastwood, M.R. Martin, et al.,
``Neglected Coeliac Disease,'' Lancet, 1:187-190, 1975.
    91. Sdepanian V.L., I.C.A. Scaletsky, U. Fagundes-Neto, et al.,
``Assessment of Gliadin in Supposedly Gluten-Free Foods Prepared and
Purchased by Celiac Patients,'' Journal of Pediatric
Gastroenterology and Nutrition, 32:65-70, January 2001.
    92. Codex Alimentarius Commission, Food and Agriculture
Organization (FAO) of the United Nations, World Health Organization
(WHO), Joint FAO/WHO Food Standards Programme, Codex Committee on
Nutrition and Foods for Special Dietary Uses, Twenty-fifth Session,
``Proposed Draft Revised Standard for Gluten-Free Food At Step 7,''
Comments from Sweden, Finland, AOECS-Association of European Coeliac
Societies, IWGA-International Wheat Gluten Association, CX/NFSDU 03/
4-Add. 1, pp. 1-11, October 2003.
    93. Lohiniemi, S., M. M[auml]ki, K. Kaukinene, et al.,
``Gastrointestinal Symptoms Rating Scale in Coeliac Disease Patients
on Wheat Starch-Based Gluten-Free Diets,'' Scandinavian Journal of
Gastroenterology, September, 35(9):947-949, October 2000.
    94. Per[auml]aho, M., K. Kaukinen, K. Paasikivi, et al.,
``Wheat-Starch-Based Gluten-Free Products in the Treatment of Newly
Detected Coeliac Disease: Prospective and Randomized Study,''
Alimentary Pharmacology & Therapeutics, 17(4):587-594, February
2003.
    95. Faulkner-Hogg, K.B., W.S. Selby, and R.H. Loblay, ``Dietary
Analysis in Symptomatic Patients With Coeliac Disease on a Gluten-
Free Diet: The Role of Trace Amounts of Gluten and Non-Gluten
Products,'' Scandinavian Journal of Gastroenterology, 34(38):784-
789, August 1999.
 
List of Subjects in 21 CFR Part 101
 
    Food labeling, Nutrition, Reporting and recordkeeping requirements.
    For the reasons discussed in the preamble, the Food and Drug
Administration proposes to amend 21 CFR part 101 as follows:
 
PART 101--FOOD LABELING
 
    1. The authority citation for 21 CFR part 101 continues to read as
follows:
 
    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.
    2. Section 101.91 is added to subpart F to read as follows:
 
 
Sec.  101.91  Gluten-free labeling of food.
 
    (a) Definitions. (1) The term ``prohibited grain'' means any one of
the following grains or their crossbred hybrids (e.g., triticale, which
is a cross between wheat and rye):
    (i) Wheat, including any species belonging to the genus Triticum;
    (ii) Rye, including any species belonging to the genus Secale; or
    (iii) Barley, including any species belonging to the genus Hordeum.
    (2) The term ``gluten'' means the proteins that naturally occur in
a prohibited grain and that may cause adverse health effects in persons
with celiac disease (e.g., prolamins and glutelins).
    (3) The labeling claim ``gluten-free'' or similar claim (e.g.,
``free of gluten,'' ``without gluten,'' ``no gluten'') means that the
food bearing the claim in its labeling does not contain any of the
following:
    (i) An ingredient that is a prohibited grain (e.g., spelt wheat);
    (ii) An ingredient that is derived from a prohibited grain and that
has not been processed to remove gluten (e.g., wheat flour);
    (iii) An ingredient that is derived from a prohibited grain and
that has been processed to remove gluten (e.g., wheat starch), if the
use of that ingredient results in the presence of 20 parts per million
(ppm) or more gluten in the food (i.e., 20 micrograms or more gluten
per gram of food);
    (iv) 20 ppm or more gluten.
    (b) Requirements. (1) A food that bears the claim ``gluten-free''
or similar claim in its labeling and fails to meet the conditions
specified in paragraph (a)(3) of this section will be deemed
misbranded.
    (2) With the exception of foods made from oats, a food that does
not inherently contain any gluten from a prohibited grain (e.g., milk,
corn, frozen concentrated orange juice) and that bears the claim
``gluten-free'' in its labeling will be deemed misbranded unless:
    (i) The claim refers to all foods of that same type (e.g., ``milk,
a gluten-free food,'' ``all milk is gluten-free''); and
    (ii) The food does not contain 20 ppm or more gluten.
    (3) A food made from oats that bears the claim ``gluten-free'' or
similar claim in its labeling will be deemed misbranded if the claim
refers to all foods of the same type (e.g., ``all oats are gluten-
free'') or if the food contains 20 ppm or more gluten.
    (c) Compliance. When compliance with paragraph (b) of this section
is based on an analysis of the food, FDA will use a method that can
reliably detect the presence of 20 ppm gluten in a variety of food
matrices, including both raw and cooked or baked products.
 
    Dated: January 16, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-843 Filed 1-22-07; 8:45 am]
 
BILLING CODE 4160-01-S