[Federal Register Volume 80, Number 222 (Wednesday, November 18, 2015)]
[Proposed Rules]
[Pages 71990-72006]
[FR Doc No: 2015-29292]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2014-N-1021]
RIN 0910-AH00

Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed
Foods

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to
establish requirements concerning ``gluten-free'' labeling for foods
that are fermented or hydrolyzed or that contain fermented or
hydrolyzed ingredients. These additional requirements for the ``gluten-
free'' labeling rule are needed to help ensure that individuals with
celiac disease are not misled and receive truthful and accurate
information with respect to fermented or hydrolyzed foods labeled as
``gluten-free.'' There is uncertainty in interpreting the results of
current gluten test methods for fermented and hydrolyzed foods on a
quantitative basis that equates the test results in terms of intact
gluten. Thus, we propose to evaluate compliance of such fermented and
hydrolyzed foods that bear a ``gluten-free'' claim with the gluten-free
labeling rule based on records that are made and kept by the
manufacturer of the food bearing the ``gluten-free'' claim and made
available to us for inspection and copying. The records would need to
provide adequate assurance that the food is ``gluten-free'' in
compliance with the gluten-free food labeling final rule before
fermentation or hydrolysis. In addition, the proposed rule would
require the manufacturer of fermented or hydrolyzed foods bearing the
``gluten-free'' claim to document that it has adequately evaluated the
potential for gluten cross-contact and, if identified, that the
manufacturer has implemented measures to prevent the introduction of
gluten into the food during the manufacturing process. Likewise,
manufacturers of foods that contain fermented or hydrolyzed ingredients
and bear the ``gluten-free'' claim would be required to make and keep
records that demonstrate with adequate assurance that the fermented or
hydrolyzed ingredients are ``gluten-free'' in compliance with the
gluten-free food labeling final rule. Finally, the proposed rule would
state that we would evaluate compliance of distilled foods by

verifying the absence of protein using scientifically valid analytical
methods that can reliably detect the presence of protein or protein
fragments in the distilled food.

DATES: Submit either electronic or written comments on the proposed
rule by February 16, 2016. Submit comments on information collection
issues under the Paperwork Reduction Act of 1995 by December 18, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-N-1021 for Food Labeling; Gluten-Free Labeling of Fermented or
Hydrolyzed Foods. Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at http://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, 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.
    Submit comments on information collection issues to the Office of
Management and Budget in the following ways:
     Fax to the Office of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>, or email to
<EMAIL_ADDRESS>All comments should be identified with the
title Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed
Foods.

FOR FURTHER INFORMATION CONTACT: With regard to the proposed rule:
Carol D'Lima, Center for Food Safety and Applied Nutrition (HFS-820),
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD
20740,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>.
    With regard to the information collection issues: FDA PRA Staff,
Office of Operations, Food and Drug Administration, 8455 Colesville
Rd., COLE-14526, Silver Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Rule

    Need for the rule: Celiac disease, a hereditary, chronic
inflammatory disorder of the small intestine, has no cure, but
individuals who have this disease are advised to avoid all sources of
gluten in their diet to protect against adverse health effects
associated with the disease. In the Federal Register of August 5, 2013
(78 FR 47154), we published a final rule that defines the term
``gluten-free'' and establishes requirements for the voluntary use of
that term in food labeling. The final rule (now codified at Sec.
101.91 (21 CFR 101.91)) is intended to ensure that individuals with
celiac disease are not misled and are provided with truthful and
accurate information with respect to foods so labeled. The regulation
provides that ``[w]hen compliance with [the rule] is based on an
analysis of the food, the FDA will use a scientifically valid method
that can reliably detect the presence of 20 parts per million (ppm)
gluten in a variety of food matrices, including both raw and cooked or
baked products'' (Sec.  101.91(c)). We established this 20 ppm limit
for intact gluten considering multiple factors, including currently
available analytical methods and the needs of individuals with celiac
disease, as well as factors such as ease of compliance and enforcement,
stakeholder concerns, economics, trade issues, and legal authorities.
Although test methods for the detection of gluten fragments in
fermented and hydrolyzed foods have advanced, there is still
uncertainty in interpreting the results of these test methods on a
quantitative basis that equates the test results to an equivalent
amount of intact gluten. Thus, alternative means are necessary to
verify compliance with the provisions of the rule for fermented and
hydrolyzed foods, such as cheese, yogurt, vinegar, sauerkraut, pickles,
green olives, beers, and wine, or hydrolyzed plant proteins used to
improve flavor or texture in processed foods such as soups, sauces, and
seasonings.
    Legal authority: Consistent with section 206 of the Food Allergen

Labeling and Consumer Protection Act (FALCPA) and sections 403(a)(1),
201(n), and 701(a) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 343(a)(1), 321(n), and 371(a)), we are proposing
requirements to permit the voluntary use of the term ``gluten free'' in
the labeling of foods that are fermented, hydrolyzed, or distilled, or
that contain fermented, hydrolyzed, or distilled ingredients.
    Major provisions of the rule: The proposed rule would amend Sec.
101.91(c) to provide alternative means for us to verify compliance
based on records that are maintained by the manufacturer of the food
bearing the ``gluten-free'' claim and made available to us for
inspection and copying. We propose that, for foods fermented or
hydrolyzed by the manufacturer and bearing the ``gluten-free'' claim,
the records must demonstrate adequate assurance that the food is
``gluten-free'' in compliance with Sec.  101.91(a)(3) before
fermentation or hydrolysis. Such adequate assurance can include test
results, certificates of analysis (CoAs), or other appropriate
verification documentation for each of the ingredients used in the
food. Alternatively, adequate assurance can include test results of the
food before fermentation or hydrolysis of the food.
    In addition, the proposed rule would require the manufacturer to
document that any potential for gluten cross-contact has been
adequately assessed, and where such a potential has been identified,
that the manufacturer has implemented measures to prevent the
introduction of gluten into the food during the manufacturing process.
    Further, for foods containing one or more fermented or hydrolyzed
ingredients and bearing the ``gluten-free'' claim, manufacturers would
have to make and keep records demonstrating with adequate assurance
that the fermented or hydrolyzed ingredients are ``gluten-free'' in
compliance with Sec.  101.91(a)(3) including, but not limited to, CoAs
or other appropriate verification documentation from the ingredient
suppliers and/or results of testing conducted by the ingredient
suppliers.
    The proposed rule also would require the manufacturer to retain the
records for at least 2 years after introduction or delivery for
introduction of the food into interstate commerce. The proposed rule
would allow these records to be kept as original records, as true
copies or as electronic records, and manufacturers would have to make
the records available to us for inspection and copying, upon request,
during an inspection. The records would need to be reasonably
accessible to FDA during an inspection at each manufacturing facility
(even if not stored on site) to determine whether the food has been
manufactured and labeled in compliance with Sec.  101.91. Records that
can be immediately retrieved from another location by electronic means
are considered reasonably accessible. The proposed rule would provide
that we would evaluate compliance of distilled foods, such as distilled
vinegar, by verifying the absence of protein using scientifically valid
analytical methods that can reliably detect the presence of protein or
protein fragments in the food.
    Costs and benefits: Full compliance with the proposed rule, if
finalized, would have annualized costs of about $9 million per year and
annual health benefits of about $41 million per year, for net benefits
of $32 million a year:

                    Annual Cost and Benefit Overview
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Costs..........................  Testing of Foods.......      $3,000,000
                                 Standard Operating            1,500,000
                                  Procedure Development.
                                 Labeling (changes for           300,000
                                  non-compliant
                                  products).
                                 Paperwork..............       3,900,000
Benefits.......................  Health Gains for             41,000,000
                                  Individuals with
                                  Celiac Disease.
Net Benefits...................  .......................      32,000,000
------------------------------------------------------------------------

Table of Contents

I. Background
    A. Why do we need this Proposed Rule?
    B. What are fermented or hydrolyzed foods?
    C. Why are there no appropriate analytical methods to quantify
intact gluten in fermented or hydrolyzed foods?
    D. Is it feasible, and under what circumstances, can foods be
processed to remove gluten?
    E. Can beer be labeled ``gluten-free''?
    F. Can a distilled food be labeled ``gluten-free''?
    G. How do I evaluate gluten cross-contact?
    H. Can a fermented or hydrolyzed food be concentrated or dried?
II. What does the proposed rule say?
    A. For foods fermented or hydrolyzed by the manufacturer, what
records must be kept? What must the records demonstrate? (Proposed
Sec.  101.91(c)(2))
    B. For foods that contain one or more fermented or hydrolyzed
ingredients, what records must be kept? What must the records
demonstrate? (Proposed Sec.  101.91(c)(3))
    C. How must records be maintained and made available? (Sec.
101.91(c)(4))
    D. What are the requirements for distilled products? (Sec.
101.91(c)(5))
    E. What are the conforming changes? (Sec.  101.91(b)(1) and (2))
    F. Compliance Date
III. What is our legal authority for this proposed rule?
IV. What is the analysis of impacts--preliminary regulatory impact
analysis
    A. Overview
    B. Regulatory Flexibility Act
    C. Small Business Regulatory Enforcement Fairness Act of 1996
    D. Unfunded Mandates Reform Act of 1995
    E. Public Access to the Analyses
V. The Paperwork Reduction Act of 1995
VI. What is the environmental impact of this rule?
VII. What are the federalism impacts of this rule?
VIII. References

I. Background

A. Why do we need this proposed rule?

    Celiac disease is a hereditary, chronic inflammatory disorder of
the small intestine triggered by the ingestion of certain proteins
referred to as gluten occurring in wheat, rye, barley, and crossbreeds
of these grains. The main protein of wheat gluten is gliadin; the
similar proteins of rye and barley are termed secalin and hordein,
respectively. Both of the major protein fractions of gluten, gliadins
and glutenins, are active in celiac disease. All the gliadins and
glutenins subunits are reported to be harmful for individuals with
celiac disease (Ref. 1). Celiac disease has no cure, and individuals
who have this disease are advised to avoid all sources of gluten in
their diet to protect against adverse health effects associated with
the disease.
    Under section 206 of FALCPA, in the Federal Register of August 5,
2013, we published a final rule that defines the term ``gluten-free''
and establishes requirements as to the voluntary use of that term in
food labeling. The final rule (now codified at 21 CFR 101.91) is
intended to help ensure that individuals with celiac disease are not
misled and receive truthful and accurate information with respect to
foods labeled as ``gluten-free.'' The final rule does not require
manufacturers who label their foods as ``gluten-free'' to test those
foods for the presence of gluten

although they may choose to do so to ensure that the food does not
contain 20 ppm or more gluten. The regulation provides that ``[w]hen
compliance with [the rule] is based on an analysis of the food, FDA
will use a scientifically valid 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'' (Sec.  101.91(c)). We may conduct
such testing to verify that foods labeled ``gluten free'' meet the
criteria for ``gluten-free'' labeling, including the part of the
``gluten-free'' definition that states that ``[a]ny unavoidable
presence of gluten in the food bearing the claim in its labeling is
below 20 ppm gluten (i.e., below 20 mg gluten per kg of food)'' (Sec.
101.91(a)(3)(ii)).
    In comments we received in response to the proposed rule that
appeared in the Federal Register of January 23, 2007 (72 FR 2795), and
to a related notice we published in the Federal Register of August 3,
2011 (76 FR 46671), we became aware that fermented or hydrolyzed foods,
some of which are labeled as ``gluten-free,'' cannot be tested for a
quantitative measure of intact gluten using currently available
analytical methods. In the notice that we published in the Federal
Register of August 3, 2011 (76 FR 46671 at 46673), we stated that FDA
recognized that for some food matrices (e.g., fermented or hydrolyzed
foods) there were no currently available validated methods that could
be used to accurately determine if they contained <20 ppm gluten. FDA
also stated that we were considering whether to require manufacturers
of such foods to have a scientifically valid method that would reliably
and consistently detect gluten at 20 ppm or less before including a
``gluten-free'' claim in the labeling of their foods. FDA requested
comments on this proposed approach as well as on whether FDA also
should require these manufacturers to maintain records on test methods,
protocols, and results and to make these records available to FDA upon
inspection.
    The notice explained that we interpret the term ``scientifically
valid method'' to mean a method that is ``accurate, precise, and
specific for its intended purpose and where the results of the method
evaluation are published in the peer-reviewed scientific literature. In
other words, a scientifically valid test is one that consistently and
reliably does what it is intended to do'' (id.).
    As of November 18, 2015, we know of no scientifically valid
analytical method effective in detecting and quantifying with precision
the gluten protein content in fermented and hydrolyzed foods in terms
of equivalent amounts of intact gluten proteins. Without reference
standards associated with the production of fermented and hydrolyzed
products, such quantification is uncertain and potentially inaccurate
(Ref. 2). Thus, we need other means to verify compliance for these
foods.

B. What are fermented or hydrolyzed foods?

    A fermented food is one that has undergone fermentation--a process
that typically involves the conversion of complex organic compounds,
especially sugars and other carbohydrates, to simpler compounds such as
lactic acid and ethyl alcohol. Fermentation has long been used to
preserve or produce foods with characteristic flavors or textures.
During fermentation, proteins such as gluten break apart into smaller
groups of amino acids known as peptides. Examples of foods that are
subject to fermentation during manufacturing are cheese, yogurt,
vinegar, sauerkraut, pickles, green olives, beers, and wine.
    A hydrolyzed food is one in which a food's chemical components--
such as proteins--are broken into smaller organic compounds by reaction
with water. These reactions are often accelerated by enzymes. One
common application of hydrolysis in food manufacturing is the
hydrolysis of plant proteins--such as soy protein. Hydrolyzed soy
proteins are often used as an ingredient to increase digestibility of
the protein, to enhance flavor, or to improve texture in processed
foods such as soups, sauces, and seasonings. There are many different
types of fermented or hydrolyzed foods as well as food products that
contain fermented or hydrolyzed ingredients (Ref. 3). Examples of foods
that use hydrolyzed plant proteins as flavor enhancers include soups,
chili, sauces, gravies, stews, dips, and some snacks like potato chips
and pretzels.

C. Why are there no appropriate analytical methods to quantify intact
gluten in fermented or hydrolyzed foods?

1. Background on Analytical Methods for Gluten
    As discussed in the preamble to our final rule (78 FR 47154 at
47165), we routinely rely upon scientifically valid methods in our
enforcement programs on food labeling. When we established the
requirement that foods bearing the ``gluten-free'' claim contain less
than 20 ppm of intact gluten, we were referring to intact gluten as
measured by sandwich ELISA-based methods. (ELISA stands for an enzyme-
linked immunosorbent assay.) The sandwich ELISA-based methods can both
detect and quantify specific amino acid sequences, known as epitopes,
with the requirement that at least two epitopes be present in a single
strand of amino acids in order to mediate the binding of two antibodies
(hence, the concept of a sandwich). Advantages of sandwich ELISA-based
methods are an increased specificity associated with the requirement
that two antibodies bind the antigen (especially if the two antibodies
recognize different epitopes) and a high sensitivity. As a result, the
sample does not have to be extensively purified before analysis (Ref.
4).
    Sandwich ELISA-based methods are appropriate for foods in which the
gluten is not subject to fermentation or hydrolysis and remains intact.
However, as we discuss in the next section, sandwich ELISA-based
methods are not effective in detecting and quantifying gluten proteins
that are no longer intact as a result of fermentation or hydrolysis.
2. Challenges in Quantifying Gluten in Fermented and Hydrolyzed Foods
    Proteins can be broken into smaller fragments called peptides.
Unless the proteins are sufficiently broken down so as to eliminate all
immunopathogenic elements (e.g., strands of amino acids that cause a
celiac response), the fermented or hydrolyzed gluten can be harmful to
people with celiac disease (Ref. 5). Compared to other processing
methods that physically remove the gluten to produce non-protein
containing ingredients (e.g., wheat starch), fermentation, hydrolysis,
or enzymatic processing methods that chemically break down gluten
peptides may not completely remove the immunotoxic potential of these
peptides. Small gluten peptides resulting from these processes and
remaining in the finished food could still contain sequences of amino
acids which potentially cause adverse reactions in people with celiac
disease. We invite comments, including scientific data, on any studies
that have been conducted to demonstrate whether any fermentation or
hydrolytic processes sufficiently break down gluten into peptides that
are harmless to persons with celiac disease.
    The principal limitation of the sandwich ELISA-based methods is
that they need at least two epitopes recognized by the antibodies used
in the assay to be present in the same continuous amino acid strand.
However, in fermented or hydrolyzed foods, gluten proteins are
typically fragmented

into peptides. Although these peptides may remain immunologically
active and be of potential concern to people with celiac disease, the
antibodies used in the ELISA-based methods may be unable to recognize
the peptides. This affects how one might detect and quantify gluten,
such that the quantity of gluten reported may be incorrect (Ref. 6).
Thus, sandwich ELISA-based methods are not appropriate analytical
methods for detecting and quantifying gluten content in fermented or
hydrolyzed products.
    Competitive ELISA-based methods that recognize a single epitope
have been developed and may overcome the detection problems encountered
with the sandwich ELISA-based assays in hydrolyzed or fermented food.
Although some studies have validated the reproducibility of competitive
ELISA-based test methods (Ref. 7), there is uncertainty about whether
these methods can quantify the amount of protein from which those
fragments were generated by hydrolysis (Ref. 2). This uncertainty
creates problems in equating these test results to an equivalent amount
of intact gluten in the fermented or hydrolyzed product. Further,
without an appropriate reference standard to gauge the response, one
cannot interpret the results on a quantitative basis that equates the
response to a specific amount of intact gluten. As of November 18,
2015, we are not aware of any methods for which there is an appropriate
reference standard to gauge the response for detection and
quantification, with precision, of the gluten content in terms of
intact gluten in fermented and hydrolyzed foods.
    In addition to ELISA-based methods, mass spectrometry (MS) holds
significant potential for analysis of hydrolyzed gluten because of its
unique capabilities for protein and peptide analysis. In general, MS
can provide accurate measurement of peptide molecular weights and
identification of peptide primary amino acid sequences. Qualitative
methods can be used to determine the identity of the peptides, with
quantitative methods able to determine peptide concentrations. As
applied to hydrolyzed gluten analysis, MS analysis may be able to
identify and quantify the gluten protein fragment peptides that result
from food processing. Therefore, for hydrolyzed food, MS could identify
gluten and measure gluten fragment concentrations with high sensitivity
and molecular specificity. However, without an appropriate hydrolyzed
gluten reference standard that would enable interpretation of the test
results in terms of intact gluten, as well as the ability to analyze
for all potential peptides, MS analysis would not be able to provide a
quantitative measure of intact gluten. Therefore, methods are needed
that can not only detect gluten protein hydrolysis fragments, but also
quantify the source gluten proteins. We invite comment on any
additional research into methods that can be used to quantify the
gluten protein content in fermented or hydrolyzed foods in terms of
intact gluten, including the use of ELISA-based methods and MS testing,
as well as any data and information on appropriate reference standards
for such test methods.

D. Is it feasible, and under what circumstances, can foods be processed
to remove gluten?

    In some cases, it is possible to remove or separate the gluten
protein portion of an ingredient derived from a gluten-containing
grain. For example, in processing food starch from various grain
sources including wheat, the starch is extracted and refined from the
grains by wet grinding, washing, and sieving to separate the protein
components from the starch. This starch material can be dried or used
in further processing. However, some gluten may remain in these
ingredients even after they have been processed to remove gluten.
Variations in the processing could result in different trace amounts of
gluten remaining in the starch. Therefore, Sec.  101.91(a)(3)(i)(A)(3)
provides that the use of such ingredients must not result in the
presence of 20 ppm or more gluten in the finished food (i.e., 20 mg or
more gluten per kg of food).
    Our regulations do not allow for processing a food (as opposed to
the food's ingredients) to remove gluten. Section 101.91(a)(3)(i)(A)(1)
requires that the food bearing the claim in its labeling not contain an
ingredient that is a gluten-containing grain (e.g., spelt wheat). The
intent behind Sec.  101.91(a)(3)(i)(A)(1) was to ensure that the food,
as consumed, contains as little gluten as possible. This approach is
consistent with other international standards (see Codex Standard 118-
1979, section 2.1.1 (Ref. 8)).
    Nevertheless, we have heard arguments that we should allow the use
of a ``gluten-free'' label on foods where the food, rather than the
food's ingredients, has been processed to remove gluten. We have not
received sufficient information regarding any specific processes to
remove gluten to determine whether any processes identified would
impact our rationale. Thus, we invite comment and data on the
feasibility and circumstances under which a food can be processed to
remove gluten and the methods by which the absence of gluten can be
determined.

E. Can beer be labeled ``gluten-free''?

    Some comments submitted in response to the 2007 proposed rule and
the 2011 notice wanted us to allow beers subject to FDA labeling
regulations to be labeled ``gluten-free'' if the beers contained less
than 20 ppm gluten, regardless of whether the beer was made from a
gluten-containing grain. Other comments favored prohibiting the use of
a ``gluten-free'' claim on the label of beers made from gluten-
containing ingredients but whose manufacturers claim were later
``reduced'' in gluten by the processing methods.
    The comments favoring the use of ``gluten-free'' labeling on beers
made from gluten-containing grains argued that the beers can be
processed to remove gluten. As with other foods, beers that have been
made using a gluten-containing grain do not meet the gluten-free
definition. Thus, beers made from gluten-containing grains cannot bear
a ``gluten-free'' claim. However, as with other foods, if the gluten-
containing grain has been processed to remove gluten in accordance with
the provisions in the ``gluten-free'' definition prior to making beer,
the beer may be eligible to make the claim under the provisions of this
proposed rule. Regarding the commenters' assertion that beers made from
gluten containing grains can be processed to remove gluten, we are not
aware of any scientifically valid way to evaluate such a claim, and
there is inadequate evidence concerning the effectiveness of the
commenters' gluten removal process.
    Gluten can be at least partially broken down by several processes,
including fermentation. However, as we explained in section I.C.1., the
presence or absence of gluten broken down in this way cannot be
reliably detected with sandwich ELISA-based methods. We are interested
in learning more about the efficacy of competitive ELISA-based methods
(e.g., the R5 or G12 competitive ELISA-based methods), given the beer
industry's practice of adding enzymes to the beer to prevent the
problem of cloudiness or ``haze,'' which can occur as a result of
residual protein substances extracted from grain during the brewing and
fermentation process. The enzyme hydrolyzes or breaks down gluten
proteins at proline residues. As a result, adding these haze control
enzymes may generate peptides that are not detectable

using the commercially available competitive ELISA-based methods that
rely on the presence of proline in the epitopes (Refs. 9 and 10).
However, it is uncertain that cleavage at proline residues totally
eliminates the concern for people with celiac disease because there may
be immunopathogenic protein fragments still present.
    FDA recently completed a study on the effectiveness of proline
endopeptidase (PEP), an enzyme that the beer industry uses to remove
cloudiness in beer, using sorghum beer spiked with gluten as a model
system. The study examined the hydrolysis of gluten and some of the
protein fragments reported to affect people with celiac disease. The
results indicated that fermentation of beer resulted in a gradual
reduction in detectable gluten concentration, and addition of PEP
increased the reduction in the detectable gluten concentration.
However, differences in peptide profiles between the beer and the
calibration standards may lead to inaccurate quantitation of gluten in
the final product (Ref. 11). Due to the lack of clinical data and a
comprehensive understanding of celiac disease, it is not known if
immunopathogenic compounds remain after the use of the enzyme.
Hydrolyzed gluten may contain protein fragments that can trigger
reactions in people with celiac disease which are not recognized by the
ELISA methods used or identified by the MS analysis. For example,
Western Blot testing showed that high molecular weight glutenins were
less susceptible than the low molecular weight fraction of gluten to
the action of PEP during the fermentation of beer. Additional data on
the effect of PEP, and possibly clinical evidence, are needed before
conclusions can be drawn regarding the effectiveness of PEP in breaking
down gluten in a manner that renders the beer, or other foods
containing gluten, safe for consumption by people with celiac disease.
    We are interested in receiving comment, including scientific
research regarding whether beer derived from gluten-containing grains
that may still contain protein fragments from gluten can be shown by
scientifically valid analytic methods to equate to intact gluten on a
quantitative basis. We are also interested in scientific research
regarding how we can use such test methods to determine that beer
derived from gluten-containing grains contains the equivalent of less
than 20 ppm intact gluten proteins, including any data and information
regarding quantification of gluten fragments and determining
appropriate calibration or reference standards. We also invite comment,
including data and any information, on scientific research and methods
to determine if a specific enzymatic treatment (or other treatments, if
known) of beer derived from gluten-containing grains can modify
proteins or protein fragments such that they are present at levels
equivalent to less than 20 ppm intact gluten protein.
    We note that the labeling of beer is subject to oversight by two
separate Federal Agencies. As we explained in the preamble to the final
rule (78 FR 47154 at 47165), the Treasury Department's Alcohol and
Tobacco Tax and Trade Bureau (TTB) is responsible for the issuance and
enforcement of regulations with respect to the labeling of beers that
are malt beverages under the Federal Alcohol Administration Act (FAA
Act). Certain other beers do not meet the definition of a malt beverage
under the FAA Act (27 U.S.C. 211(a)(7)); those beers are subject to
FDA's labeling requirements. We are working with TTB on the issues
associated with ``gluten-free'' labeling of beer to promote consistency
in our approach, while taking into consideration the differences in the
statutes administered by FDA and TTB, respectively.
    As we noted in the preamble to the final rule (78 FR 47154 at
47166) beer manufacturers whose beers are subject to FDA's labeling
requirements that make beer from a gluten-containing grain or from non-
gluten-containing grains are not precluded from using other statements
on the label, such as a gluten statement consistent with the TTB Policy
on Gluten Content Statements in the Labeling and Advertising of Wine,
Distilled Spirits, and Malt Beverages, about processing of beers to
reduce gluten. However, such statements must be truthful and not
misleading. Beers bearing statements related to the gluten processing
or content other than ``gluten free'' are still subject to sections
403(a)(1) and 201(n) of the FD&C Act.

F. Can a distilled food be labeled ``gluten-free''?

    The preamble to the final rule (78 FR 47154 at 47174) noted that we
had received comments expressing concern that distilled vinegar, as a
food product or ingredient, could contain gluten and wanted us to not
allow distilled vinegar to be labeled as ``gluten-free.'' We indicated
that we would consider the comments received on distilled foods,
including distilled vinegar, in this proposed rule.
    The process of distillation involves heating a liquid such that
components with lower boiling points are vaporized and recovered
separate from components with higher boiling points. The remaining
compounds, whose boiling points were too high to undergo vaporization,
are left behind (Ref. 12). We are aware of two commonly used distilled
foods subject to FDA labeling regulations; distilled vinegar and
distilled water. Of these, distilled water is inherently gluten-free.
    There are several different types of vinegars, and not all of them
are distilled, as discussed in the Food and Drug Administration,
Compliance Policy Guide Sec. 525.825, ``Vinegar Definitions--
Adulteration With Vinegar Eels'' (Ref. 13). Some examples of these
include cider vinegar (also known as apple vinegar or simply
``vinegar''), wine vinegar (also known as grape vinegar), malt vinegar,
sugar vinegar, and glucose vinegar. All vinegars are made by alcoholic
and subsequent acetous fermentation, but can be derived from different
substances. Cider vinegar is made from the juice of apples; whereas,
wine vinegar is made from the juice of grapes. In addition, some
vinegars may be made from gluten-containing grains, such as malt
vinegar, which is the product made by the alcoholic and subsequent
acetous fermentation, without distillation, of an infusion of barley
malt or cereals whose starch has been converted by malt.
    Distilled vinegar is commonly made from ethanol derived from corn
or sugar cane, but, to a lesser extent, other raw materials can be used
to derive the ethanol used to make distilled vinegar. Distilled vinegar
(also known as spirit vinegar or grain vinegar) is made by the acetous
fermentation of dilute distilled alcohol. The alcohol derived from the
initial alcohol fermentation undergoes distillation followed by acetous
fermentation. Because distillation is a purification process,
separating volatile components like alcohol and flavors from non-
volatile materials like proteins and sugars, it is unlikely that gluten
(or any other protein or protein fragments) is present in distilled
vinegar if the distillation process is conducted following good
manufacturing practices specific to distillation. Although we are not
aware of any analytical methods that can be used to reliably detect and
accurately quantify the presence of gluten in distilled vinegar, we are
aware of analytical methods that could be used to detect the presence
of protein and protein fragments as a means for manufacturers to ensure
the absence of protein (and thus gluten). We discuss how the proposed
rule addresses these methods in section II.D.

    Vinegars that are made from gluten-containing grains but are not
further processed by distillation may not bear the gluten-free claim
under Sec.  101.91(b). For example, some malt vinegars are the product
of fermentation, without distillation, of an infusion of barley malt or
cereals whose starch has been converted to malt (Ref. 14). Because
these types of malt vinegar are derived from gluten-containing grains
that have not been distilled or otherwise processed to remove gluten,
they may not be used as ingredients in a food bearing a ``gluten-free''
claim or bear such a claim themselves as provided in Sec.
101.91(a)(3)(i)(A)(2). Distilled vinegars that are made from gluten-
containing grains are first subjected to an alcohol fermentation
process followed by distillation and finally an acetous fermentation
process of the distilled, diluted alcohol. Distillation in this case is
considered as the ``process to remove gluten'' from the ingredient
alcohol, which has been derived from the fermentation of the sugars in
the grains, and which is then further fermented to produce vinegar.
Distilled vinegars that meet the definition of gluten-free may bear the
``gluten-free'' claim under Sec.  101.91(b). Thus, when a food or
ingredient bearing the ``gluten-free'' claim is distilled, we will
evaluate compliance by verifying the absence of protein in the food or
ingredient using a scientifically valid method that can reliably detect
the presence or absence of protein or protein fragments in the food.
When choosing a method that will verify the absence of protein, among
the factors that need to be considered is the sensitivity of the test
method for this purpose, such as a limit of detection as close to zero
as possible.

G. How do I evaluate gluten cross-contact?

    As we noted in the preamble to the final rule, ``[i]n the context
of this rule, [gluten] cross-contact occurs when a food without gluten
comes in contact with a gluten-containing food or ingredient, resulting
in the presence of gluten in the food not intended to contain gluten''
(78 FR 47154 at 47173). We recognize that the supply chain for raw
materials, ingredients, and intermediate products used in the food
industry can be complex and involve many suppliers outside the
manufacturer's immediate control. Thus, for raw materials, ingredients,
and intermediate products, the potential for cross-contact with gluten-
containing sources may exist.
    For example, official regulatory standards, notably the U.S.
Department of Agriculture's Grain Inspection, Packers and Stockyards
Administration's (GIPSA's) Federal Grain Inspection Service (FGIS),
allow for the adventitious presence of other grains. The FGIS is
intended to provide farmers, grain handlers, processors, exporters, and
international buyers with information that accurately and consistently
describes the quality and quantity of grain being bought and sold (Ref.
15). However, the GIPSA definitions for soybeans, canola, flaxseed,
sunflower seeds, corn, and oats, by virtue of their allowance of
``other grains,'' do not prohibit the presence of gluten-containing
grains.
    The ``other grains'' for which standards exist under the United
States Grain Standards Act (Pub. L. 64-90) include barley, rye,
triticale, and wheat (see 7 CFR 810.201 (definition of barley),
810.1201 (definition of rye), 810.2001 (definition of triticale), and
810.2201 (definition of wheat)), and these are gluten-containing
grains. Therefore, records demonstrating assurance for raw materials
such as grains, legumes, and seeds may include certificates of analysis
or test results drawn from more frequent sampling or more lots of these
source materials.
    Conversely, there are certain fermented or hydrolyzed foods, such
as those fermented or hydrolyzed from vegetable, meat, and dairy
ingredients, that have a low probability of cross contact with gluten-
containing grains because the source ingredients for these foods are
inherently free of gluten and are less likely to come into contact with
gluten-containing grains before being processed. Examples of such foods
include cheese, yogurt, some vinegars, sauerkraut, pickles, green
olives, meats, and wine. Through the use of manufacturing practices
that can prevent gluten cross-contact situations, these fermented or
hydrolyzed foods made from source ingredients that are inherently free
of gluten may present less potential for the presence of gluten.
    Given the variety of fermented or hydrolyzed foods and different
manufacturing processes for foods fermented or hydrolyzed by the
manufacturer and bearing the ``gluten-free'' claim, we believe that
decisions as to how to adequately evaluate any potential for gluten
cross-contact during the manufacturing process are best left to
manufacturers and their manufacturing operations. Likewise, the
manufacturer must determine what measures they should take to prevent
the introduction of gluten into the food during the manufacturing
process. Manufacturers must keep records adequately evaluating the
potential for gluten cross-contact and documenting the measures used to
prevent the introduction of gluten into the food during the
manufacturing process.
    We invite comment on the potential for source ingredients used in
fermentation (i.e., milk in yogurt) to come in contact with gluten-
containing grains, and on manufacturing practices that can prevent risk
of gluten cross contact.

H. Can a fermented or hydrolyzed food be concentrated or dried?

    As we explained in the preamble to the final rule (78 FR 47154 at
47159), 20 ppm gluten is a concentration level rather than an absolute
quantity of gluten in a food. If a food's ingredients are all below 20
ppm gluten, the food containing those ingredients will have a gluten
concentration less than 20 ppm.
    When water or other liquid is removed from a food, for example a
soup or sauce, or the product is dried, the relative concentration of
the material dissolved or suspended in the product increases as the
water or dissolving material is removed. In the case of gluten in a
product, we are aware that the relative concentration of gluten could
increase if water or other liquid is removed. Given the limitations of
gluten testing and the variety of processes involved in concentration
or drying of fermented or hydrolyzed ingredients, there could be
uncertainty in the determination of the amount of gluten contained in
these materials. For this reason, and because methods that can reliably
detect the presence of 20 ppm intact gluten in fermented or hydrolyzed
foods are not currently available, we are considering several
regulatory options regarding records for fermented or hydrolyzed foods
or ingredients that are concentrated or dried.
    One option would be to require the manufacturer of a food bearing
the ``gluten-free'' claim to document that the food or ingredient is
not concentrated or dried after fermentation or hydrolysis. This would
preclude fermented or hydrolyzed foods or ingredients that are
concentrated or dried from being in foods bearing the ``gluten-free''
claim and reduce the number of such foods labeled as ``gluten-free'' in
the marketplace.
    Another option would require the manufacturer of a food bearing the
``gluten-free'' claim to make and keep records documenting that the
concentrated or dried fermented or hydrolyzed ingredients used in a
food bearing the ``gluten-free'' claim comply with Sec.  101.91(a)(3).
This, in turn, could cause manufacturers to request records from the
ingredient supplier indicating

the gluten content of the materials used in the ingredient prior to
fermentation or hydrolysis, and specific information as to how the
final gluten concentration of the ingredient is determined after
concentration or drying.
    We invite comment on these two possible options, how the options
could be modified, whether another option exists, or whether it is
necessary to address concentrated or dried ingredients in this
regulation. We also invite comment on the potential for fermented or
hydrolyzed foods made from ingredients that are concentrated or dried
to contain less than 20 ppm gluten in their concentrated or dried form,
how this gluten content could be verified and the potential costs
associated with a new option.

II. What does the proposed rule say?

    Currently, Sec.  101.91(c) states that when compliance with Sec.
101.91(b) (which pertains to requirements for ``gluten-free'' labeling)
is based on an analysis of the food, we will use a scientifically valid
method that can reliably detect the presence of 20 ppm gluten in a
variety of food matrices.
    The proposed rule would amend Sec.  101.91(c) to provide
alternative means for us to verify compliance for fermented or
hydrolyzed foods for which appropriate scientifically valid methods
that can reliably detect and quantify the presence of 20 ppm intact
gluten are not currently available. If the food or the ingredients used
in a food fermented or hydrolyzed by the manufacturer contained less
than 20 ppm of intact gluten before fermentation or hydrolysis, then
the resulting fermented or hydrolyzed food also would contain less than
20 ppm intact gluten as long as gluten was not introduced during the
fermentation or hydrolysis process. For these reasons, the proposed
rule would require that the manufacturer of fermented or hydrolyzed
foods bearing the ``gluten-free'' claim make and keep records regarding
the food demonstrating adequate assurances that the food is ``gluten-
free'' in compliance with Sec.  101.91(a)(3) before fermentation or
hydrolysis and that gluten has not been introduced during the
manufacturing process. Likewise, for foods containing one or more
fermented or hydrolyzed ingredients and bearing the ``gluten-free''
claim, the manufacturer would be required to make and keep records
demonstrating with adequate assurance that the fermented or hydrolyzed
ingredients are ``gluten-free'' in compliance with Sec.  101.91(a)(3).
    We would expect that, in some cases, this adequate assurance would
include test results or a certificate of analysis for the food or
ingredients before fermentation or hydrolysis. Other verification
procedures may be appropriate in some circumstances. We expect that the
accuracy and reliability of any certificate of analysis would be
verified based on initial qualification and periodic requalification of
the supplier through testing of the ingredient with sufficient
frequency to ensure the material contains less than 20 ppm gluten.
Likewise we expect that the ingredients used would be tested with
sufficient frequency to ensure the material contains less than 20 ppm
gluten.
    The content of the records demonstrating adequate assurance that
source materials are in compliance with Sec.  101.91(a)(3) before
fermentation or hydrolysis may depend on the potential for gluten
cross-contact. For example, as discussed in section I.G., a
manufacturer of a grain product, such as corn breakfast cereal, may
keep different records than a manufacturer of a fruit-flavored yogurt
product.
    Specifically, the proposed rule would renumber Sec.  101.91(c) as
Sec.  101.91(c)(1) and would create new paragraphs (c)(2), (c)(3), and
(c)(4) to explain that, when an appropriate method to verify compliance
with the gluten-free regulation is not available because the food is
fermented or hydrolyzed or contains one or more ingredients that are
fermented or hydrolyzed, the manufacturer of the food bearing the
``gluten-free'' claim must make and keep certain records. Proposed
Sec.  101.91(c)(5) would describe how FDA would evaluate compliance for
distilled foods.

A. For foods fermented or hydrolyzed by the manufacturer, what records
must be kept? What must the records demonstrate? (Proposed Sec.
101.91(c)(2))

    Due to the unavoidable presence of gluten that may occur through
gluten cross-contact in food ingredients or during manufacturing, the
proposed rule would require that the manufacturer of foods fermented or
hydrolyzed by the manufacturer and bearing the ``gluten-free'' claim
make and keep records. The records are to provide adequate assurance
that the food or its ingredients are ``gluten-free'' in compliance with
Sec.  101.91(a)(3) before fermentation or hydrolysis and that gluten is
not introduced during the manufacturing process. If the food or its
ingredients comply with Sec.  101.91(a)(3) before fermentation or
hydrolysis, and gluten is not introduced during the manufacturing
process, the resulting fermented or hydrolyzed food should meet the
definition of ``gluten-free.''
1. What records must be kept regarding food before fermentation or
hydrolysis? (Proposed Sec.  101.91(c)(2)(i))
    The records described in proposed Sec.  101.91(c)(2)(i) must
provide adequate assurance that the food or its ingredients comply with
Sec.  101.91(a)(3) before fermentation or hydrolysis. Thus, the records
must provide adequate assurance that the ingredients are not gluten-
containing grains (e.g., spelt wheat), and are not derived from a
gluten-containing grain that has not been processed to remove gluten
(e.g., wheat flour) or not derived from a gluten-containing grain that
has been processed to remove gluten (e.g., wheat starch), if the use of
that ingredient results in the presence of 20 ppm or more gluten in the
food. Further, the records must provide adequate assurance that any
unavoidable presence of gluten in the food is below 20 ppm gluten.
    The assurances could include records of test results conducted by
the manufacturer or an ingredient supplier, CoAs, or other appropriate
verification documentation for the food itself or each of the
ingredients used in the food. We would expect manufacturers of
fermented or hydrolyzed foods that bear the ``gluten-free'' claim, as
part of their routine operations, to test their food or ingredients
with sufficient frequency to ensure that the gluten level in the food
or in each ingredient is below 20 ppm before fermentation or
hydrolysis. This testing could include a single record from testing the
food before fermentation or hydrolysis (i.e. testing milk before
fermentation into yogurt), or could include separate test result
records regarding each ingredient, depending on the type of food being
produced.
    Alternatively, as we noted in the preamble to the final rule (78 FR
47154 at 47167), manufacturers, as part of routine operations, may rely
on records, such as CoAs, from their suppliers to determine that each
ingredient is below 20 ppm gluten. A CoA is a document indicating
specified test results performed on product(s) by a qualified
laboratory that has certified these test results. A CoA should be based
on initial qualification and periodic requalification of the supplier
with sufficient frequency through review of the supplier's
documentation and practices.
    Similarly, other appropriate verification documentation could
provide adequate assurance that a manufacturer has adequately ensured
the food or ingredients comply with Sec.  101.91(a)(3). We tentatively
conclude

that it is appropriate to allow a manufacturer to use any means of
verification that it can develop, as long as the manufacturer can
document that such verification provides adequate assurance that the
ingredients comply with Sec.  101.91(a)(3). We anticipate that most
manufacturers will receive at least some ingredients from outside
suppliers. For ingredients that they receive from outside suppliers,
manufacturers may document a visit to a supplier's facility, review a
supplier's records, and review written documentation from a supplier to
verify the compliance of the ingredients they receive. We invite
comment on other ingredient verification methods that may be
appropriate.
    The proposed rule would not specify the types of records to be
kept, so the manufacturer could, for example, create the records itself
regarding the ingredients that it uses or, if it obtains ingredients
from a supplier, maintain records or CoAs it obtains from a supplier.
The types of records may also vary based on the type of food or
ingredients used. For example, a manufacturer of fermented or
hydrolyzed foods from non-gluten-containing grains, legumes, or seeds
that are susceptible to cross-contact with gluten-containing grains
bearing the ``gluten-free'' claim may be more likely to choose to
obtain a CoA from the ingredient suppliers or test the ingredients
before fermentation and maintain records of the test results. A
manufacturer of products bearing the ``gluten-free'' claim made from
inherently gluten-free ingredients, such as milk, or fruit, that have a
low probability of cross-contact with gluten-containing grains, may be
more likely to use other appropriate verification documentation.
2. What records must be kept to address gluten cross-contact? (Proposed
Sec.  101.91(c)(2)(ii) and (iii))
    As we discussed in the preamble to the final rule (78 FR 47154 at
47173), we expect foods bearing the ``gluten-free'' claim to be
manufactured using whatever controls are necessary to prevent cross-
contact with all gluten sources and to ensure that any amount of gluten
that may be present in the food from gluten cross-contact is as low as
possible and that the food has less than 20 ppm gluten.
    To help address potential gluten cross-contact during the
manufacturing process, proposed Sec.  101.91(c)(2)(ii) and (iii) would
require that a manufacturer wishing to use a ``gluten-free'' claim on a
product that they ferment or hydrolyze make and keep records that
provide adequate assurance that:
     The manufacturer has adequately evaluated their processing
for any potential for gluten cross-contact during the manufacturing
process; and
     where the potential for gluten cross-contact has been
identified, the manufacturer has implemented measures to prevent the
introduction of gluten into the food during the manufacturing process.
    We expect manufacturers of foods bearing the ``gluten-free'' claim
to take proper precautions to reduce the potential for gluten cross-
contact of food, food ingredients, or food-contact surfaces. This may
include careful examination of all phases of their operations,
including, for example, transportation and storage of ingredients and
finished products and the use of additional manufacturing controls that
can prevent gluten cross-contact situations. For example, manufacturers
may use physical barriers (such as walls, curtains, or distance) or air
handling as a means of isolating the production line and by cleaning
and sanitizing equipment between production runs.
    In order to provide adequate assurance that they have evaluated
their processing for the potential for gluten cross-contact, we expect
manufacturers to document their determination regarding the potential
for gluten cross-contact as well as the reasoning and/or support for
their determination. In order to provide adequate assurance that they
have implemented measures to prevent the introduction of gluten during
the manufacturing process, we expect manufacturers to document the
measures they are using as well as how they determined what measures to
use and how those measures prevent gluten cross-contact. Again, the
types of records that would provide adequate assurance for ingredients
with a high likelihood of gluten cross-contact, such as grains and
legumes, may vary from those expected for ingredients with a lower
likelihood of gluten cross-contact, such as dairy.

B. For foods that contain one or more fermented or hydrolyzed
ingredients, what records must be kept? What must the records
demonstrate? (Proposed Sec.  101.91(c)(3))

    When a scientifically valid method is not available that equates
the test results in terms of intact gluten because the food contains
one or more ingredients that are fermented or hydrolyzed, proposed
Sec.  101.91(c)(3) would require the manufacturer of such foods bearing
the claim to make and keep records providing adequate assurance that
that the fermented or hydrolyzed ingredients are ``gluten-free.'' When
the entire food is not hydrolyzed or fermented, the analytical methods
discussed in the current ``gluten-free'' regulation at Sec.  101.91(c)
would be able to detect intact gluten that had been introduced through
the manufacturing process or through ingredients that were not
hydrolyzed or fermented. Therefore, we are only proposing to require
records regarding the specific ingredients that have been fermented or
hydrolyzed.
    For an ingredient that was fermented or hydrolyzed by a supplier,
one way for the manufacturer of a food bearing the ``gluten-free''
claim to provide adequate assurance that the ingredient is ``gluten-
free'' would be to obtain records from that supplier supporting that
the ingredient meets the definition of ``gluten-free,'' including that
the ingredient was manufactured or processed to avoid gluten cross-
contact and to contain less than 20 ppm gluten. Adequate assurance
regarding the ingredients fermented or hydrolyzed by an ingredient
supplier can include documentation regarding the supplier's
manufacturing procedures, records of test results from tests conducted
by the ingredient supplier on the components of the ingredient before
fermentation or hydrolysis, CoAs, or other appropriate documentation
provided by the ingredient supplier for the fermented or hydrolyzed
ingredient. As discussed previously in section II.A.1, the types of
records that would provide adequate assurance for ingredients with a
high likelihood of gluten cross-contact, such as grains and legumes,
may vary from those expected for ingredients with a lower likelihood of
gluten cross-contact, such as dairy.
    Manufacturers may wish to verify the accuracy and reliability of
these records by checking whether and how the supplier of the
ingredient documents that the components used in the fermented or
hydrolyzed ingredient each meet the definition of ``gluten-free,''
including that the supplier manufactured or processed the ingredient to
avoid gluten cross-contact and contain less than 20 ppm gluten before
fermentation or hydrolysis. In addition, manufacturers may wish to
verify records documenting the supplier's manufacturing or processing
with regard to concentration.

C. How must records be maintained and made available? (Proposed Sec.
101.91(c)(4))

    Proposed Sec.  101.91(c)(4) would establish the timeframe for
keeping

records and making them available to FDA. In brief, the proposed rule
would:
     Require the records be retained for 2 years after
introduction or delivery for introduction of the food into interstate
commerce;
     allow records to be kept as original records, true copies,
or as electronic records; and
     state that the records must be available to FDA for
examination and copying during an inspection upon our request.
    Proposed Sec.  101.91(c)(4) would establish a minimum 2-year
recordkeeping period because we consider 2 years to be a reasonable
period of time for most foods to be available for purchase in the
marketplace. Such a time period is consistent with other FDA
regulations, but we invite comment on whether we should use a different
recordkeeping period. In addition, the records may be kept in any
format, paper or electronic, provided they contain all the necessary
information. Paper records can include true copies such as photocopies,
pictures, scanned copies, microfilm, microfiche, or other accurate
reproductions of the original records. All electronic records
maintained under Sec.  101.91 would need to comply with part 11 (21 CFR
part 11). The use of electronic records is voluntary and thus, a paper
record system could be used to comply with the proposed recordkeeping
requirements. The proposed requirements for electronic records extend
to electronic signatures. We issued final guidance for industry on this
topic. The guidance, entitled ``Part 11, Electronic Records; Electronic
Signatures Scope and Application,'' sets out our enforcement policies
with respect to certain aspects of part 11. The guidance is available
at http://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm.
This guidance would apply to any electronic record, including
electronic signatures, established or maintained to meet a proposed
requirement in this rule, if finalized as proposed. This would give
manufacturers the maximum flexibility to use whatever recordkeeping
system they find most appropriate. We request comment on the proposed
requirements for the types of records that must be made and kept and
the length of time that the records must be kept.
    The proposal also would state that the records must be made
available to us for examination or copying during an inspection upon
request; this is consistent with our other recordkeeping regulations
(see, e.g., 21 CFR 111.605 and 111.610). The records would need to be
reasonably accessible to FDA during an inspection at each manufacturing
facility (even if not stored onsite) to determine whether the food has
been manufactured and labeled in compliance with Sec.  101.91. Records
that can be immediately retrieved from another location by electronic
means are considered reasonably accessible. We anticipate that
manufacturers may have questions about the confidentiality of the
information inspected by us under this proposal. We would protect
confidential information from disclosure, consistent with applicable
statutes and regulations, including 5 U.S.C. 552(b)(4), 18 U.S.C. 1905,
and 21 CFR part 20.

D. What are the requirements for distilled products? (Proposed Sec.
101.91(c)(5))

    If good manufacturing practices are followed, the process of
distillation itself removes all protein. Scientifically valid methods
to measure the protein content should find no detectable protein
present and thus no gluten in distilled ingredients or distilled foods.
The detection of any protein indicates poor manufacturing practices or
controls and could point to the potential presence of gluten in the
distilled ingredient or product. Likewise, the absence of protein or
protein fragments in the distilled product should mean that the
product's gluten level is below 20 ppm.
    Consequently, proposed Sec.  101.91(c)(5) would provide that, when
a food or ingredient bearing the ``gluten-free'' claim is distilled, we
will evaluate compliance by verifying the absence of protein in the
food or ingredient using a scientifically valid method that can
reliably detect the presence or absence of protein or protein fragments
in the food. When choosing a method that will verify the absence of
protein, among the factors that need to be considered is the
sensitivity of the test method for this purpose, such as a limit of
detection as close to zero as possible.
    The detection of any protein or protein fragments in the food or
ingredient may indicate poor manufacturing controls and indicate the
presence of gluten in the distilled ingredient or product. We invite
comment, especially including data, concerning the effectiveness of
good manufacturing practices on distillation. We also invite comment,
especially including data, concerning the effectiveness of other
processes that can be used to remove gluten from food ingredients or
food products. We also invite comment on measures food manufacturers of
distilled products or products containing distilled ingredients can
take to ensure that the distilled product or distilled ingredients do
not contain protein or protein fragments.

E. What are the conforming changes? (Proposed Sec.  101.91(b)(1) and
(2))

    The proposed rule would make two conforming changes to Sec.
101.91(b)(1) and (2). In brief, Sec.  101.91(b)(1) states that a food
that bears the claim ``gluten-free'' in its labeling and fails to meet
Sec.  101.91(a)(3) (the definition for the term ``gluten-free'') will
be deemed misbranded. Section 101.91(b)(2) creates a similar
requirement if the food bears the claim ``no gluten,'' ``free of
gluten,'' or ``without gluten'' and fails to meet Sec.  101.91(a)(3).
Because proposed Sec.  101.91(c)(2) through (4) would establish
requirements by which we would determine whether fermented foods,
hydrolyzed foods, or foods containing a fermented or hydrolyzed
ingredient are ``gluten-free'' within Sec.  101.91, the proposed rule
would amend Sec.  101.91(b)(1) and (2) to add, ``if applicable,
paragraphs (c)(2) through (4) of this section'' to the requirements
that must be met if the food is not to be deemed misbranded.

F. Effective and Compliance Dates

    We are proposing that the compliance date for any final rule
resulting from this rulemaking be 1 year from the date of its
publication. We recognize that we usually establish a uniform
compliance date for food labeling changes that occur between specific
dates. For example, January 1, 2016, is the next uniform compliance
date for food labeling changes for food labeling regulations issued
between January 1, 2013, and December 31, 2014 (77 FR 70885, November
28, 2012). In this case, however, we believe there is sufficient
justification for establishing the compliance date of 1 year after the
date of publication of a final rule, rather than use the next uniform
compliance date for other food labeling changes that we periodically
establish for such changes.
    We believe that 12 months from the date of publication of the final
rule for gluten-free labeling of fermented or hydrolyzed foods is
sufficient time for manufacturers of fermented or hydrolyzed foods to
review their products to ensure that these foods comply with that final
rule or to remove ``gluten-free'' or similar claims from the label if
their foods do not comply. This period of 12 months is consistent with
what we have used in the past for compliance with the requirements of
voluntary food labeling claims. We believe that waiting until FDA's
next uniform compliance date would create

an unnecessary delay in the enforcement of a final rule because
fermented or hydrolyzed foods bearing the voluntary label claim
``gluten-free'' that do not comply with FDA's requirements for use of
the term ``gluten-free'' could have an adverse public health impact on
persons with celiac disease who may be consuming those foods.
    Therefore, we propose to establish the compliance date to enforce
the provisions of a final rule for the gluten-free labeling of
fermented or hydrolyzed foods as 1 year after the date of publication
of the final rule in the Federal Register. By that time, manufacturers
of fermented or hydrolyzed foods labeled with the ``gluten-free'' claim
would have to comply with the final rule. We also propose an effective
date of 30 days after publication in the Federal Register.

III. What is our legal authority for this proposed rule?

    Section 206 of FALCPA directs the Secretary of Health and Human
Services, 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. Section 403(a)(1) of the FD&C 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) of the FD&C Act 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 FD&C Act vests the Secretary (and by delegation, FDA)
with authority to issue regulations for the efficient enforcement of
the FD&C Act. Consistent with section 206 of FALCPA and sections
403(a)(1), 201(n), and 701(a) of the FD&C Act, we are proposing
requirements for the use of the term ``gluten-free'' for hydrolyzed and
fermented foods.
    The proposed rule would establish requirements concerning records
necessary to ensure compliance with our ``gluten-free'' labeling
regulation for fermented or hydrolyzed food or that which contains a
fermented or hydrolyzed ingredient. For these foods, there is no
scientifically valid analytical method available that can reliably
detect and accurately quantify the equivalent of 20 ppm intact gluten
in the food. In enacting FALCPA, Congress recognized the importance to
individuals with celiac disease of avoiding gluten (section 202(6)(B)
of FALCPA). Therefore, defining the requirements for using the term
``gluten-free'' in the labeling of fermented or hydrolyzed 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.
    We are proposing requirements for manufacturers to make and keep
records containing information that provides adequate assurance that
their food complies with the definition of ``gluten-free,'' including
information that they gather or produce about their ingredients and the
details of their manufacturing practices. These proposed record
requirements would help ensure that the use of the term ``gluten-free''
is accurate, truthful, and not misleading based on information known to
the manufacturer that FDA would not otherwise be able to access and to
facilitate efficient and effective action to enforce the requirements
when necessary. Our authority to establish records requirements has
been upheld under other provisions of the FD&C Act where we have found
such records to be necessary (National Confectioners Assoc. v.
Califano, 569 F.2d 690, 693-94 (D.C. Cir. 1978)). The records we
propose to require are only for foods for which an adequate analytical
method is not available. The records would allow us to verify that the
``gluten-free'' claim on foods that are hydrolyzed or fermented or
contain hydrolyzed or fermented ingredients is truthful and complies
with the requirements of the definition. Thus, the proposed records
requirements would help in the efficient enforcement of the FD&C Act.
    The authority granted to us under sections 701(a), 403(a)(1), and
201(n) of the FD&C Act not only includes authority to establish records
requirements, but also includes access to such records. Without such
authority, we would not know whether the use of the term ``gluten-
free'' on the label or in the labeling of these foods is truthful and
not misleading under sections 403(a)(1) and 201(n) of the FD&C Act. The
introduction or delivery for introduction into interstate commerce of a
misbranded food is a prohibited act under section 301(a) of the FD&C
Act (21 U.S.C. 331(a)). Thus, to determine whether the food is
misbranded and the manufacturer has committed a prohibited act, we must
have access to the manufacturer's records that we are requiring be made
and kept under sections 403(a)(1), 201(n), and 701(a) of the FD&C Act.
Failure to make and keep records and provide the records to FDA, as
described in proposed Sec.  101.91(c)(4), would result in the food
being misbranded under sections 403(a)(1) and 201(n) of the FD&C Act.

IV. What is the analysis of impacts--Preliminary Regulatory Impact
Analysis

A. Overview

    FDA has examined the impacts of this proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct 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). FDA has developed a preliminary regulatory impact analysis
(PRIA) that presents the benefits and costs of this proposed rule (Ref.
16). FDA believes that the proposed rule will not be an economically
significant regulatory action as defined by Executive Order 12866. FDA
requests comments on the PRIA.
    The summary analysis of benefits and costs included in this
document is drawn from the detailed PRIA (Ref. 16), which is available
to the public in the docket for this proposed rule at http://www.regulations.gov (enter Docket No. FDA-2014-N-1021), and is also
available on FDA's Web site at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because many small businesses may need to implement
a number of new testing and recordkeeping activities, FDA acknowledges
that the proposed rule, if finalized, will have a significant economic
impact on a substantial number of small entities.

C. Small Business Regulatory Enforcement Fairness Act of 1996

    The Small Business Regulatory Enforcement Fairness Act of 1996
(Pub. L. 104-121) defines a major rule for the purpose of congressional
review as having caused or being likely to cause one or more of the
following: An annual

effect on the economy of $100 million or more; a major increase in
costs or prices; significant adverse effects on competition,
employment, productivity, or innovation; or significant adverse effects
on the ability of U.S.-based enterprises to compete with foreign-based
enterprises in domestic or export markets. In accordance with the Small
Business Regulatory Enforcement Fairness Act, OMB has determined that
this proposed rule, if finalized, is not a major rule for the purpose
of congressional review.

D. Unfunded Mandates Reform Act of 1995

    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, 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
$144 million, using the most current (2014) Implicit Price Deflator for
the Gross Domestic Product. FDA expects that the proposed rule, if
finalized, will not result in a 1-year expenditure that would exceed
this amount.

E. Public Access to the Analyses

    The analyses that FDA has performed in order to examine the impacts
of this proposed rule under Executive Order 12866, Executive Order
13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) are available to
the public in the docket for this proposed rule (Ref. 16) at http://www.regulations.gov (enter Docket No. FDA-2014-N-1021).

V. The Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). A description of these provisions is given in
this section of the document with an estimate of the annual
recordkeeping burden. Included in the burden estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
    We invite comments on the following topics: (1) Whether the
proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
    Title: Recordkeeping Requirements for Gluten-Free Labeling of
Fermented or Hydrolyzed Foods.
    Description of Respondents: Manufacturers of foods that are
fermented, hydrolyzed, or contain fermented or hydrolyzed ingredients
and bear the claim ``gluten-free,'' ``no gluten,'' ``free of gluten,''
or ``without gluten.''
    Description: If the rule is finalized as proposed, we would require
manufacturers of food products covered by the rule to make and keep
records providing adequate assurance that: (1) The food is gluten-free
before fermentation or hydrolysis; (2) the manufacturer has evaluated
the potential for cross-contact with gluten during the manufacturing
process; and (3) if necessary, measures are in place to prevent the
introduction of gluten into the food during the manufacturing process.
    Manufacturers using an ingredient that is a hydrolyzed or fermented
food only would be required to make and keep these records for the
hydrolyzed or fermented ingredient. We estimate that the manufacturers
would satisfy the recordkeeping requirements of this proposed rule, if
finalized, by maintaining records of their tests or other appropriate
verification procedures, their evaluation of the potential for gluten
cross contact, and their standard operating procedures (SOPs) for
preventing gluten cross-contact. It is also possible that manufacturers
would instead comply with this proposed rule by obtaining and
maintaining records of Certificates of Analysis, test results, or other
appropriate verification procedures from their suppliers.
    Written SOPs and records of testing and other activities are
essential for FDA to be able to determine compliance with Sec.  101.91
(the gluten-free regulation) for these products. Records would need to
be reasonably accessible at each manufacturing facility and could be
examined periodically by FDA inspectors during an inspection to
determine whether the food has been manufactured and labeled in
compliance with Sec.  101.91 Records that can be immediately retrieved
from another location by electronic means are considered reasonably
accessible.
    We estimate the burden of this collection of information as
follows: We base our estimates of the average burden per recordkeeping
on our experience with good manufacturing practices used to control the
identity and composition of food and to limit contaminants and prevent
adulteration. The hour estimates for the recordkeeping burdens
presented here are averages. We anticipate that the records kept would
vary based on the type of ingredients used. Some manufacturers, such as
those producing fermented dairy products, would likely maintain fewer
records overall. Other manufacturers, such as those producing foods
with fermented or hydrolyzed grains, legumes, or seeds, would likely
maintain more extensive records.
    Our estimates of the numbers of manufacturers/recordkeepers
reported in column 2 of tables 1 and 2 are based on the number of food
products that would be covered by the proposed rule. We searched the
FoodEssentials database (Ref. 3) for foods that are hydrolyzed,
fermented, or contain fermented or hydrolyzed ingredients and bear the
claim ``gluten-free,'' ``no gluten,'' ``free of gluten,'' or ``without
gluten,'' and found about 2,500 products that would be affected by the
proposed rule. We estimate that this database has at least half of all
products that would be covered by the proposed rule, so that there
would be, at most, 5,000 products affected by the proposed rule.
    We do not have any data about how many products are produced in
each facility, so we assume that each product and its production line
would be tested separately and would require a separate evaluation and
SOP. Thus, we estimate the number of food production facilities and,
accordingly, the number of manufacturers/recordkeepers to be 5,000. If
multiple products are produced in the same facility and can share
testing, evaluation, and SOPs, then the recordkeeping burden would be
less than these estimates.
    We do not know how many of these products are already being
manufactured using gluten-free ingredients and/or with a process
designed to prevent gluten introduction. A survey of food industry
practices (Ref. 17) shows that about 45 percent of all food production
facilities have a written allergen control plan, and about 39 percent
require certificates of analysis for ingredients. Given that producers
of

foods labeled ``gluten-free'' are marketing to customers who care more
about gluten cross-contact, we estimate that about 75 percent of the
5,000 foods with a ``gluten-free'' labeling claim already have a
written plan for preventing the introduction of gluten into the food
product that includes the testing of ingredients and also procedures
for evaluating and preventing gluten cross-contact. Therefore, we
estimate that 1,250 facilities would incur new SOP development and
ingredient testing burdens and all 5,000 facilities would incur certain
new recordkeeping burdens.
Recordkeeping Burden Related to Standard Operating Procedures
    We estimate that 1,250 facilities do not have a written SOP for
preventing the introduction of gluten into the food product. For these
facilities, developing an SOP would be a first year burden of the
proposed rule. We estimate that it would take a facility an average of
7 hours to develop an SOP for gluten control. Thus, we estimate that in
the first year of compliance with the proposed rule if finalized, 1,250
facilities would develop an SOP for a burden of 8,750 hours (1,250 x 7
= 8,750), as reported in table 1, row 1.
    Updating the facility's SOP for gluten control would be a recurring
burden of the proposed rule for the 1,250 facilities that do not
currently have an SOP. We estimate that it would take a facility about
0.7 hours (42 minutes) annually to update its SOP for gluten control,
for a burden of 875 hours (1,250 x 0.7 = 875), as reported in table 2,
row 1.
    We estimate that maintaining records of their updated SOPs would be
a recurring burden of the proposed rule for all 5,000 facilities. We
estimate that it would take each facility 1 hour annually to maintain
records of its updated SOPs for gluten control, for a burden of 5,000
hours (5,000 x 1 = 5,000), as reported in table 2, row 2.
Recordkeeping Burden Related to Testing
    In order to demonstrate that the food is gluten-free before
fermentation or hydrolysis, we expect that most manufacturers would
test their incoming ingredients or obtain Certificates of Analysis from
their ingredient suppliers. A manufacturer may test their ingredients
for gluten by sending ingredient samples to a testing company or by
using test kits to test ingredient samples on site at their facility.
Test kits would first undergo method validation for the testing
situation in which they are to be used (Ref. 18). We assume that a
manufacturer that begins a program of testing the gluten content of an
ingredient will start by sending several samples to a lab and obtaining
method extension for a test kit for the ingredient. Obtaining a
validation for a test kit is a first-year burden only.
    After the first year of testing, we assume the manufacturers would
then use test kits to test the ingredient on a regular basis, and may
also send one or two samples a year to an outside lab for testing.
These are recurring testing burdens. We estimate that an average of two
ingredients per product would be tested in this manner. Most foods
affected by this proposed rule are those that contain a single
hydrolyzed or fermented ingredient, so any testing would have been done
by the ingredient supplier before that supplier performed hydrolysis or
fermentation. Other products contain several ingredients that would be
tested before fermentation or hydrolysis.
    In the first year of compliance, we estimate that the 1,250
manufacturers not currently testing their ingredients and production
facilities for gluten and would incur additional testing burdens as a
result of the proposed rule. For these manufacturers, obtaining a
method extension for a test kit would be a first year burden of the
proposed rule. We estimate that 1,250 manufacturers would conduct seven
tests for method extension, for each of two ingredients, for a total of
14 samples. We estimate that it would take a manufacturer 5 minutes to
collect each sample, for a total of 1,453 hours (1,250 x 14 x (5 / 60)
= 1,453) as reported in table 1, row 2. We estimate that this proposed
rule would result in manufacturers conducting 17,500 laboratory tests
in the first year (1,250 x 14 = 17,500). These tests have an average
cost of $84.33, which means that the estimated capital costs related to
this first year paperwork burden is about $1.5 million (17,500 x $84.33
= $1,475,833) as reported in table 1, row 2.
    We estimate that, as a first year burden of the proposed rule if
finalized, all 5,000 manufacturers would begin retaining records of the
method extension tests. We estimate that it would take a manufacturer
30 minutes per record, for a total of 35,000 hours (5,000 x 14 x 0.5 =
35,000), as reported in table 1, row 3.
    We estimate that testing ingredients on a regular basis would be a
recurring burden of the proposed rule, if finalized, for the 1,250
manufacturers not currently testing their ingredients and production
facilities for gluten. We estimate that 1,250 manufacturers will use 21
test kits annually on average per ingredient, for a total of 42 kits,
and that each test will require 5 minutes to collect a sample and 30
minutes to process and file the test results. We estimate that the
burden of collecting samples for these tests would be 4,358 hours
(1,250 x 21 x (5 / 60) = 4,358), as reported in table 2, row 3. We
estimate that this proposed rule, if finalized, would result in
manufacturers using 52,500 test kits each year (1,250 x 42 = 52,500).
These test kits have an average cost of $11, which means that the
estimated capital costs related to this recurring paperwork burden is
about $0.6 million (52,500 x $11 = $577,500), as reported in table 2,
row 3. We estimate the burden to process and maintain records of the
test results would be 105,000 hours (5,000 x 42 x 0.5 = 105,000), as
reported in table 2, row 4.
    We estimate that a recurring burden of the proposed rule, if
finalized, for all 5,000 manufacturers would be to send one or two
samples a year to an outside lab for testing. We estimate that 5,000
manufacturers will conduct one outside test annually on average per
ingredient, for a total of 2 tests, and that each test will require 5
minutes to collect a sample and 30 minutes to process and file the test
results. We estimate that the burden of collecting samples for these
tests would be 208 hours (1,250 x 2 x (5 / 60) = 208), as reported in
table 2, row 5. We estimate that this proposed rule would result in
manufacturers conducting 2,500 laboratory tests in the first year
(1,250 x 2 = 2,500). These tests have an average cost of $84.33, which
means that the estimated capital costs related to this recurring
paperwork burden is about $0.2 million (2,500 x $84.33 = $210,833), as
reported in table 3, row 5. We estimate the burden to process and
maintain records of the test results would be 5,000 hours (5,000 x 2 x
0.5 = 5,000), as reported in table 2, row 6.

                                                   Table 1--Estimated First Year Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of
     Activity/Proposed 21 CFR section          Number of      records per    Total annual        Average burden per         Total hours    Capital costs
                                             recordkeepers   recordkeeper       records             recordkeeping                         (USD Millions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Developing an SOP for gluten control;                1,250               1           1,250  7...........................           8,750               0
 proposed 101.91(c)(2) and (3).
Collecting samples for testing; proposed             1,250              14          17,500  0.083 (5 minutes)...........           1,453            $1.5
 101.91(c)(2) and (3).
Maintaining records of method extension              5,000              14          70,000  0.5 (30 minutes)............          35,000               0
 tests; proposed 101.91(c)(2) and (3).
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ..............  ..............  ..............  ............................          45,203            $1.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
There are no operating or maintenance cost associated with this collection information.

                                                    Table 2--Estimated Recurring Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of
     Activity/Proposed 21 CFR section          Number of      records per    Total annual        Average burden per         Total hours    Capital costs
                                             recordkeepers   recordkeeper       records             recordkeeping                         (USD Millions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Updating SOP for gluten control; proposed            1,250               1           1,250  0.7 (42 minutes)............             875               0
 101.91(c)(2) and (3).
Maintaining records of the updated SOP for           5,000               1           5,000  1...........................           5,000               0
 gluten control; proposed 101.91(c)(2) and
 (3).
Collecting samples for test kit testing;             1,250              42          52,500  0.083 (5 minutes)...........           4,358            $0.6
 proposed 101.91(c)(2) and (3).
Maintaining records of test kit test                 5,000              42         210,000  0.5 (30 minutes)............         105,000               0
 results; proposed 101.91(c)(2) and (3).
Collecting samples for testing by an                 1,250               2           2,500  0.083 (5 minutes)...........             208            $0.2
 outside lab; proposed 101.91(c)(2) and
 (3).
Maintaining records of testing by an                 5,000               2          10,000  0.5 (30 minutes)............           5,000               0
 outside lab; proposed 101.91(c)(2) and
 (3).
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ..............  ..............  ..............  ............................         120,441            $0.8
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating or maintenance costs associated with this collection of information.

    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3407(d)), we have submitted the information collection provisions of
this proposed rule to OMB for review. Interested persons are requested
to send comments regarding information collection by January 19, 2016,
to the Office of Information and Regulatory Affairs, OMB.
    To ensure that comments on information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX:<PHONE_NUMBER>,
or emailed to<EMAIL_ADDRESS>All comments should be
identified with the title ``Recordkeeping Requirements for Gluten-Free
Labeling of Fermented, Hydrolyzed, or Distilled Foods.'' These
requirements will not be effective until we obtain OMB approval. We
will publish a notice concerning OMB approval of these requirements in
the Federal Register.

VI. What is the environmental impact of this rule?

    We have 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.

VII. What are the federalism impacts of this rule?

    We have analyzed the proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of
Executive Order 13132 requires Agencies to ``construe * * * a 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.'' Here, as in the final rule published in the
August 5, 2013, issue of the Federal Register (78 FR 47154 at 47175),
we have determined that certain narrow exercises of State authority
would conflict with the exercise of Federal authority under the FD&C
Act.
    In section 206 of FALCPA, Congress directed us 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, to be followed by a proposed rule for the use of such
term in labeling. In the preamble to the proposed rule regarding the
``gluten-free'' labeling of foods (72 FR 2795 at 2813 through 2814), we
indicated that we had consulted with numerous experts and stakeholders
in the proposed rule's development and in the final rule we determined
that certain narrow exercises of State authority would conflict with
the exercise of Federal authority under the FD&C Act. Different and
inconsistent amounts of gluten in foods with ``gluten-free'' labeling
result in the inability of those

individuals with celiac disease who adhere to a gluten-free diet to
avoid exposure to gluten at levels that may result in adverse health
effects. ``Gluten-free'' labeling, for purposes of this discussion,
also includes the use of the terms ``no gluten,'' ``free of gluten,''
and without gluten,'' as indicated in Sec.  101.91(b)(2). There is a
need for national uniformity in the meaning of the term ``gluten-
free,'' which includes the manner in which the definition is enforced,
so that most individuals with celiac disease can make informed
purchasing decisions that will enable them to adhere to a diet they can
tolerate without causing adverse health effects and can select from a
variety of available gluten-free foods.
    This proposed rule would establish additional requirements for
manufacturers of hydrolyzed and fermented foods or foods that contain
hydrolyzed and fermented ingredients wishing to use the terms ``gluten-
free,'' ``no gluten,'' ``free of gluten,'' or ``without gluten'' on
their products, thus these requirements are a component of how we
permit the use of the ``gluten-free'' claim. If States were able to
establish different requirements regarding what manufacturers of
hydrolyzed and fermented foods would need to demonstrate in order to
use the term ``gluten-free,'' then individuals with celiac disease
would not be able to rely on a consistent meaning for that term and
thereby use the term to identify appropriate dietary selections. As a
result, individuals with celiac disease may unnecessarily limit their
food choices, or conversely, select foods with levels of gluten that
are not tolerated and that may cause adverse health effects. Food
manufacturers, if confronted by a State or various State requirements
that adopted different requirements for hydrolyzed and fermented foods
than this proposed rule, might decide to remove the ``gluten-free''
label, and such a result would make it more difficult for individuals
with celiac disease to identify foods that they can tolerate and
achieve a dietary intake from a variety of foods to meet an
individual's nutrient needs. Moreover, consistent requirements
regarding the way compliance with the final rule is determined,
including the records that would need to be maintained in order for a
hydrolyzed or fermented food manufacturer to use the ``gluten-free''
claim and the use of a scientifically valid method to detect the
absence of protein to determine compliance for distilled products,
enables us to more efficiently enforce the use of the ``gluten-free''
claim across all hydrolyzed and fermented foods to ensure labels
bearing a ``gluten-free'' claim are truthful and not misleading.
    Therefore, the objective of this proposed rule is standardizing use
of the term ``gluten-free'' in the labeling of hydrolyzed and fermented
foods so that foods with this claim in labeling, and foods with a claim
of ``no,'' ``free of,'' and ``without'' gluten, which connote a similar
meaning to that of ``gluten free,'' are used in a consistent way and
will therefore prevent consumer confusion and assist individuals with
celiac disease to make purchasing decisions.
    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.'' The proposed rule meets the preceding requirement
because it would preempt State law narrowly, only to the extent
required to achieve uniform national labeling with respect to the
requirements related to the use of the term ``gluten-free,'' as well as
the terms ``no gluten,'' ``free of gluten,'' or ``without gluten'' on
hydrolyzed and fermented foods. As we explain later in this section, we
are proposing to preempt State or local requirements only to the extent
that they are different from the requirements in this section related
to the use of the terms ``gluten-free,'' ``no gluten,'' ``free of
gluten,'' or ``without gluten'' for hydrolyzed and fermented foods. In
addition, we cannot foresee every potential State requirement and
preemption that may arise if a State requirement is found to obstruct
the federal purpose articulated in this proposed rule. This proposed
rule, like the final rule, is not intended to preempt other State or
local labeling requirements with respect to other statements or
warnings about gluten. For example, a State would still not be
preempted from requiring a statement about the health effects of gluten
consumption from hydrolyzed and fermented foods on persons with celiac
disease or information about how the food was processed.
    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 Executive Order 13132 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 will
invite the States' participation in this rulemaking by providing notice
via fax and email transmission to State health commissioners, State
agriculture commissioners, and State food program directors as well as
FDA field personnel of the publication of the proposed rule.
    In 2009, the President issued a memorandum entitled ``Preemption''
(74 FR 24693, May 22, 2009). The memorandum, among other things,
instructs Agencies to ``not include in regulatory preambles statements
that the department or agency intends to preempt State law through the
regulation except where preemption provisions are also included in the
codified regulation'' and ``not include preemption provisions in
codified regulations except where such provisions would be justified
under legal principles governing preemption, including the principles
outlined in Executive Order 13132''. Because of the May 22, 2009,
memorandum we explain in detail the principles underlying our
conclusion that this proposed rule may result in preemption of State
and local laws under a narrow set of circumstances and describe how the
final rule's codified provision regarding preemption, which is now
Sec.  101.91(d), would apply to hydrolyzed and fermented foods.
    Under the Supremacy Clause of the Constitution (U.S. Constitution;
Art. VI, clause 2), State laws that interfere with or are contrary to
Federal law are invalid. (See Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1,
211 (1824).) Federal preemption can be express (stated by Congress in
the statute) or implied. Implied preemption can occur in several ways.
For example, Federal preemption may be found where Federal law
conflicts with State law. Such conflict may be demonstrated either when
``compliance with both federal and state [law] is a physical
impossibility'' (Florida Lime and Avocado Growers, Inc. v. Paul, 373
U.S. 132, 142-143 (1963)), or when State law ``stands as an obstacle to
the accomplishment and execution of the full purposes and objectives of
Congress'' (Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 372-74
(2000) (citing Hines v. Davidowitz, 312 U.S. 52, 67 (1941))). State law
is also preempted if it interferes with the methods by which a Federal
law is designed to reach its goals. (See Int'l Paper Co. v. Ouellette,
479 U.S. 481, 494 (1987); Michigan Canners & Freezers Ass'n v.
Agricultural

Marketing & Bargaining Bd., 467 U.S. 461, 477-478 (1984).)
    Additionally, '' 'a federal agency acting within the scope of its
congressionally delegated authority may preempt state regulation' and
hence render unenforceable state or local laws that are otherwise not
inconsistent with federal law'' (City of New York v. FCC, 486 U.S. 57,
63-64 (1988) (quoting Louisiana Public Service Comm'n v. FCC, 476 U.S.
355, 369 (1986)). ``Federal regulations have no less preemptive effect
than federal statutes'' (Fidelity Federal Savings and Loan Ass'n v. de
la Cuesta, 458 U.S. 141, 153 (1982)).
    When an Agency's intent to preempt is clearly and unambiguously
stated, a court's inquiry will be whether the preemptive action is
within the scope of that Agency's delegated authority (Capital Cities
Cable, Inc. v. Crisp, 467 U.S. 691, 700 (1984); Fidelity Federal
Savings, 458 U.S. at 154). If the Agency's choice to preempt
``represents a reasonable accommodation of conflicting policies that
were committed to the agency's care by the statute [the regulation will
stand] unless it appears from the statute or its legislative history
that the accommodation is not one that Congress would have sanctioned''
(United States v. Shimer, 367 U.S. 374, 383 (1961)). In Hillsborough
County, the Supreme Court stated that FDA possessed the authority to
issue regulations preempting local laws that compromise the supply of
plasma and could do so (Hillsborough County, Fla. v. Automated Medical
Laboratories, Inc., 471 U.S. 707, 721 (1985)). We believe we have
similar authority to preempt State and local laws and regulations to
the limited extent that they permit use of ``gluten-free,'' ``no
gluten,'' ``free of gluten,'' or ``without gluten'' for hydrolyzed and
fermented foods differently from our proposed rule because different
State or local requirements would be contrary to the Congressional
directive for us to define and permit use of the term ``gluten-free.''
    State or local laws or regulations that permit use of ``gluten-
free,'' ``no gluten,'' ``free of gluten,'' or ``without gluten''
differently from our proposed rule could frustrate the ability of most
consumers to identify gluten-free foods and avoid adverse health
effects and deter manufacturers from applying a ``gluten-free'' label
to their foods. With the proposed rule, consumers throughout the United
States can understand what is required to use the term ``gluten-free''
on a hydrolyzed or fermented packaged food. The proposed rule will also
allow us to enforce more efficiently the definition on product labels
of hydrolyzed and fermented foods, and manufacturers will be able to
comply with a single set of requirements, which may lead to greater use
of this voluntary labeling.
    Therefore, we intend to preempt State or local requirements only to
the extent that they are different from the proposed requirements
related to the use of the terms ``gluten-free,'' ``no gluten,'' ``free
of gluten,'' or ``without gluten'' on fermented or hydrolyzed foods,
including the requirement to make and keep certain records and the use
of a scientifically valid method to detect the absence of protein for
distilled foods. There is no proposed change to Sec.  101.91(d)
regarding preemption, but these new proposed requirements in Sec.
101.91(c) would become part of the requirements covered by Sec.
101.91(d).

VIII. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

    1. Ciclitira, P. J., D. Evans, and N. Fagg, ``Clinical Testing
of Gliadin Fractions in Coeliac Patients,'' Clinical Science, 66:
357-364, 1984.
    2. Garber, E. A. E., Memorandum to the Administrative Record,
``Standards Used to Detect and Quantify Fermented and Hydrolyzed
Gluten in Foods,'' August 25, 2015.
    3. FoodEssentials. Product Label Database. Online version
available at: http://labelbase.foodessentials.com/index.jsp.
    4. Belitz, H.-D., W. Grosch, and P. Schieberle, Food Chemistry,
Berlin: Springer, pp. 141-142, 2009.
    5. Ciccocioppo, R., A. Di Sabatino, and G. R. Corazza, ``The
Immune Recognition of Gluten in Coeliac Disease,'' Clinical and
Experimental Immunology, 140(3):408-416, 2005.
    6. Mena, M. C., M. Lombardia, A. Hernando, et al.,
``Comprehensive Analysis of Gluten in Processed Foods Using a New
Extraction Method and a Competitive ELISA Based on the R5
Antibody,'' Talanta, 91(15):33-40, 2012, available at http://dx.doi.org/10.1016/j.talanta.2011.12.073.
    7. Kohler, P., T. Schwalb, U. Immer, et al., ``AACCI Approved
Methods Technical Committee Report: Collaborative Study on the
Immunochemical Determination of Partially Hydrolyzed Gluten Using an
R5 Competitive ELISA,'' Cereal Foods World, 58(3):154-158, 2013.
    8. Codex Alimentarius Commission, ``Codex Standard for Foods for
Special Dietary Use for Persons Intolerant to Gluten (Codex Standard
118-1979),'' Rome, Italy, pp. 1-3, 2008; available at http://www.codexalimentarius.org/download/standards/291/CXS_118e_2015.pdf.
    9. Garber, E. A. E., Memorandum to the Administrative Record,
``ELISA Methods Used to Detect Gluten in Foods,'' August 25, 2015.
    10. Garber, E. A. E., Memorandum to the Administrative Record,
``Use of Proline Endopeptidases to Make Gluten Containing Products
Safe for Consumption by Individuals With Celiac Disease,'' August
25, 2015.
    11. Panda, R., et al. ``Effects of a Proline Endopeptidase on
the Detection and Quantification of Gluten by Antibody-based Methods
During the Fermentation of a Model Sorghum Beer.'' Journal of
Agriculture and Food Chemistry, November 7, 2015 (web), accessed at
http://pubs.acs.org/doi/abs/10.1021/acs.jafc.5b04205.
    12. Fellows, P.J., ``Chapter 4-Evaporation and Distillation,''
Food Processing and Technology--Principles and Practice (3d
Edition). Woodhead Publishing, 2009. Online version available at
http://app.knovel.com/hotlink/toc/id:kpFPTPPE14/food-processing-technology/food-processing-technology.
    13. Food and Drug Administration, Compliance Policy Guide Sec.
525.825, ``Vinegar Definitions--Adulteration With Vinegar Eels,''
available at http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074471.htm.
    14. Merriam-Webster.com, Merriam-Webster, n.d. Web, available on
January 30, 2014, available at http://www.merriam-webster.com/dictionary/malt vinegar.
    15. United States Department of Agriculture, ``Federal Grain
Inspection Service,'' dated September 1997 and revised April 2004,
available at http://www.gipsa.usda.gov/Publications/fgis/broch/fgisbrochure.pdf.
    16. FDA, ``Preliminary Regulatory Impact Analysis of Gluten-Free
Labeling of Fermented or Hydrolyzed Foods,'' Center for Food Safety
and Applied Nutrition, Food and Drug Administration, College Park,
MD, July 2014, available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/.
    17. Eastern Research Group, 2010 Nationwide Survey of Food
Industry Safety Practices, Draft final report, January 10, 2011, ERG
for FDA under Contract No. 223-01-2461, task order 7.
    18. Thompson, Tricia, ``Should Manufacturers & Consumers Use
Lateral Flow Devices (EZ Gluten) to Test Food for Gluten?'' Online
version available at http://www.glutenfreedietitian.com/should-manufacturers-consumers-use-lateral-flow-devices-ez-gluten-to-test-food-for-gluten/.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

    Therefore under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
101 is proposed to be amended as follows:

PART 101--FOOD LABELING

0
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.

0
2. In Sec.  101.91, revise paragraphs (b)(1), (b)(2), and (c) to read
as follows:

Sec.  101.91  Gluten-free labeling of food.

* * * * *
    (b) Requirements. (1) A food that bears the claim ``gluten-free''
in its labeling and fails to meet the requirements of paragraph (a)(3)
of this section and, if applicable, paragraphs (c)(2) through (4) of
this section will be deemed misbranded.
    (2) A food that bears the claim ``no gluten,'' ``free of gluten,''
or ``without gluten'' in its labeling and fails to meet the
requirements of paragraph (a)(3) of this section and, if applicable,
paragraphs (c)(2) through (4) of this section will be deemed
misbranded.
* * * * *
    (c) Compliance. (1) When compliance with paragraph (b) of this
section is based on an analysis of the food, FDA will use a
scientifically valid 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.
    (2) When a scientifically valid method pursuant to paragraph (c)(1)
of this section is not available because the food is fermented or
hydrolyzed, the manufacturer of such foods bearing the claim must make
and keep records regarding the fermented or hydrolyzed food
demonstrating adequate assurance that:
    (i) The food is ``gluten-free'' in compliance with paragraph (a)(3)
of this section before fermentation or hydrolysis;
    (ii) The manufacturer has adequately evaluated their processing for
any potential for gluten cross-contact; and
    (iii) Where a potential for gluten cross-contact has been
identified, the manufacturer has implemented measures to prevent the
introduction of gluten into the food during the manufacturing process.
    (3) When a scientifically valid method pursuant to paragraph (c)(1)
of this section is not available because the food contains one or more
ingredients that are fermented or hydrolyzed, the manufacturer of such
foods bearing the claim must make and keep records demonstrating
adequate assurance that that the fermented or hydrolyzed ingredients
are ``gluten-free'' as described in paragraph (c)(2) of this section.
    (4) Records necessary to verify compliance with paragraphs (c)(2)
and (3) of this section must be retained for at least 2 years after
introduction or delivery for introduction of the food into interstate
commerce and may be kept as original records, as true copies, or as
electronic records. Manufacturers must provide those records to us for
examination and copying during an inspection upon request.
    (5) When a scientifically valid method pursuant to paragraph (c)(1)
of this section is not available because the food is distilled, FDA
will evaluate compliance with paragraph (b) of this section by
verifying the absence of protein in the distilled component using
scientifically valid analytical methods that can reliably detect the
presence or absence of protein or protein fragments in the food.
* * * * *

    Dated: November 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29292 Filed 11-17-15; 8:45 am]
 BILLING CODE 4164-01-P