Document ID: FDA-2014-N-1021-0001
Agency: fda
Document Type: Proposed Rule
Title: Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods
Posted Date: 2015-11-18T05:00Z

[Federal Register Volume 80, Number 222 (Wednesday, November 18, 2015)]
[Proposed Rules]
[Pages 71990-72006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

[[Page 71991]]

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: 202-395-7285, or email to 
oira_submission@omb.eop.gov. 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, 240-402-2371, FAX: 301-436-2636.
    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, PRAStaff@fda.hhs.gov.

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

[[Page 71992]]

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
------------------------------------------------------------------------
 
------------------------------------------------------------------------
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

[[Page 71993]]

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

[[Page 71994]]

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

[[Page 71995]]

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.

[[Page 71996]]

    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

[[Page 71997]]

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

[[Page 71998]]

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

[[Page 71999]]

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

[[Page 72000]]

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

[[Page 72001]]

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

[[Page 72002]]

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.

[[Page 72003]]

                                                   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: 202-395-7285, 
or emailed to oira_submission@omb.eop.gov. 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

[[Page 72004]]

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

[[Page 72005]]

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:

[[Page 72006]]

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