[Federal Register Volume 72, Number 14 (Tuesday, January 23, 2007)]
[Proposed Rules]
[Pages 2795-2817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-843]


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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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Federal Register / Vol. 72, No. 14 / Tuesday, January 23, 2007 / 
Proposed Rules

[[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: <a href="/cdn-cgi/l/email-protection#82f0eaedece6e3ace9e3ece7c2e4e6e3aceaeaf1ace5edf4"><span class="__cf_email__" data-cfemail="74061c1b1a10155a1f151a11341210155a1c1c075a131b02">[email protected]</span></a>.

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). Both of these documents are dated March 2006.
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.
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Free Food Labeling held in College Park, MD, pp. 1-3, August 19, 
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pertaining to the Center for Food Safety and Applied Nutrition, Food 
and Drug Administration Public Meeting on Gluten-Free Food held in 
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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.
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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.
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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, 
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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


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