[Federal Register Volume 85, Number 157 (Thursday, August 13, 2020)]
[Rules and Regulations]
[Pages 49240-49261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17088]


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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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is issuing a 
final rule to establish requirements

[[Page 49241]]

concerning ``gluten-free'' labeling for foods that are fermented or 
hydrolyzed or that contain fermented or hydrolyzed ingredients. These 
requirements f 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.'' Currently, FDA knows of no scientifically valid analytical 
method effective in detecting and quantifying with precision the gluten 
protein content in fermented or hydrolyzed foods in terms of equivalent 
amounts of intact gluten proteins. Thus, we plan to evaluate compliance 
of such fermented or hydrolyzed foods that bear a ``gluten-free'' claim 
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 need to provide adequate assurance 
that the food or ingredients used in the food are ``gluten-free'' 
before fermentation or hydrolysis. Once we identify that a 
scientifically valid method has been developed that can accurately 
detect and quantify gluten in fermented or hydrolyzed foods or 
ingredients, it would no longer be necessary for the manufacturer of 
foods bearing the ``gluten-free'' claim to make and keep these records. 
In addition, because currently there is no scientifically valid 
analytical method effective in detecting and quantifying the gluten 
protein content in fermented or hydrolyzed foods the final rule 
requires the manufacturer of these kinds of 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, the final rule 
requires manufacturers of foods that contain fermented or hydrolyzed 
ingredients and bear the ``gluten-free'' claim to make and keep records 
that demonstrate with adequate assurance that the fermented or 
hydrolyzed ingredients are ``gluten-free'' in compliance with the 2013 
gluten-free food labeling final rule. Finally, this final rule states 
that we will evaluate compliance of distilled foods by verifying the 
absence of protein using scientifically valid analytical methods that 
can reliably detect the presence of protein or protein fragments in the 
distilled food.

DATES: 
    Effective date: This rule is effective October 13, 2020.
    Compliance date: The compliance date of this final rule is August 
13, 2021.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule into 
the ``Search'' box and follow the prompts, and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: With regard to the final rule: Carol 
D'Lima, Center for Food Safety and Applied Nutrition (HFS-820), Food 
and Drug Administration, 5001 Campus Dr., Rm. 4D-022, College Park, MD 
20740, 240-402-2371, [email protected]. With regard to the 
information collection: FDA PRA Staff, Office of Operations, Food and 
Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 
20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
    A. Purpose and Coverage of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations and Acronyms Commonly Used in This 
Document
III. Background
    A. Need for the Regulation/History of This Rulemaking
    B. Provisions of the Proposed Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Responses
    A. Introduction
    B. Comments and FDA Responses
VI. Effective and Compliance Dates
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995 Recordkeeping Requirements for 
Gluten-Free Labeling of Fermented or Hydrolyzed Foods
X. Federalism
XI. References

I. Executive Summary

A. Purpose and Coverage of the Final 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. Relevant 
educational materials are available on FDA's website at https://www.fda.gov/food/food-labeling-nutrition/gluten-free-labeling-foods. 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 
2013 gluten-free food labeling final rule). The 2013 gluten-free food 
labeling 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 when compliance with the 
rule is based on an analysis of the food, we will use a scientifically 
valid method that is suitable for the reliable detection of 20 parts 
per million (ppm) gluten in the food and has been validated extensively 
for the detection of gluten in both raw and cooked or baked products 
(Sec.  101.91(c)). In the context of this rule for the Gluten-Free 
Labeling of Fermented or Hydrolyzed Foods, the limit for gluten refers 
to intact gluten. We established this 20 ppm limit for 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 or 
hydrolyzed foods have advanced, currently, we know of no scientifically 
valid analytical method effective in detecting and quantifying with 
precision the gluten protein content in fermented or hydrolyzed foods 
in terms of equivalent amounts of intact gluten. Thus, alternative 
means are necessary to verify compliance with the provisions of the 
2013 gluten-free food labeling final rule for fermented or 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.

B. Summary of the Major Provisions of the Final Rule

    Section 101.91 (21 CFR 101.91) defines the term ``gluten-free'' to 
mean that the food bearing the claim does not contain: (1) An 
ingredient that is a gluten-containing grain; (2) an ingredient that is 
derived from a gluten-containing grain and that has not been processed 
to remove gluten; or (3) an ingredient that is derived from a gluten-
containing grain and that has been processed to remove gluten if the 
use of that ingredient results in the presence of 20 parts per million 
(ppm) or more gluten in the food; or inherently does

[[Page 49242]]

not contain gluten, and that any unavoidable presence of gluten in the 
food is below 20 ppm gluten. A food that bears the claim ``no gluten,'' 
``free of gluten,'' or ``without gluten'' in its labeling and fails to 
meet the requirements for the ``gluten-free'' claim will be deemed to 
be misbranded. This final rule amends Sec.  101.91(c) to provide 
alternative means for FDA to verify compliance based on records that 
are maintained by the manufacturer of the fermented or hydrolyzed food 
bearing the ``gluten-free'' claim and made available to us for 
inspection and copying.
    This final rule requires that, for foods that are fermented or 
hydrolyzed and bear the ``gluten-free'' claim, the manufacturer must 
have records that demonstrate with 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. (A CoA is a document indicating specified test results performed 
on product(s) by a qualified laboratory that has certified the test 
results.) Alternatively, adequate assurance can include results of 
tests on the food itself, rather than the ingredients, before 
fermentation or hydrolysis of the food. In addition, the final rule 
requires documentation by the manufacturer that any potential for 
gluten cross-contact has been adequately assessed, and where such a 
potential has been identified, the manufacturer has implemented 
measures to prevent the introduction of gluten into the food during the 
manufacturing process. Also, for foods containing one or more fermented 
or hydrolyzed ingredients and bearing the ``gluten-free'' claim, 
manufacturers must make and keep records demonstrating with adequate 
assurance that the fermented or hydrolyzed ingredients are ``gluten-
free'' under Sec.  101.91(a)(3) before fermentation or hydrolysis and 
the potential for gluten cross-contact has been adequately assessed, 
and where such potential has been identified, measures have been 
implemented to prevent introduction of gluten during the ingredient 
manufacturing process). This includes, but is not limited to, CoAs or 
other appropriate verification documentation from the ingredient 
suppliers and/or results of testing conducted by the ingredient 
suppliers.
    The final rule also requires that the manufacturer retain records 
for at least 2 years after introduction or delivery for introduction of 
the food into interstate commerce. The final rule allows 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 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 
final rule also provides that we will 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.

C. Legal Authority

    Consistent with section 206 of the Food Allergen Labeling and 
Consumer Protection Act (FALCPA) and sections 403(a)(1), 201(n), and 
701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 343(a)(1), 321(n), and 371(a)), we are issuing 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.

D. Costs and Benefits

    Full compliance with this final rule would have annualized costs of 
about $7 million to $11 million per year at 3% discount rate and 
annualized costs of $7 million to $11 million at 7% discount rate. For 
the rule to break-even with costs, the annualized benefits would need 
to be at least $8.8 million at a 3% discount rate and a $9.1 million at 
a 7% discount rate. Based on our simulation analysis, the rule would 
break-even with primary cost estimates discounted at 7% if at least 
0.07% of estimated individuals with celiac disease following a gluten-
free diet benefit from the rule each year.

II. Table of Abbreviations and Acronyms Commonly Used in This Document

------------------------------------------------------------------------
              Abbreviation                        What it means
------------------------------------------------------------------------
ANPRM..................................  Advance Notice of Proposed
                                          Rulemaking.
CPG....................................  Compliance Policy Guide.
E.O....................................  Executive Order.
FALCPA.................................  Food Allergen Labeling and
                                          Consumer Protection Act.
FD&C Act...............................  Federal Food, Drug, and
                                          Cosmetic Act.
GMP....................................  Good Manufacturing Practice.
------------------------------------------------------------------------

III. Background

A. Need for the Regulation/History of This Rulemaking

    Celiac disease is a hereditary, chronic inflammatory disorder of 
the small intestine triggered by the ingestion of certain proteins 
referred to as gluten, which occur 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 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.
    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 2013 gluten-free food labeling final rule, which is 
codified at Sec.  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 2013 
gluten-free food labeling final rule does not require manufacturers who 
label their foods as ``gluten-free'' to test those foods for the 
presence of gluten. However, they may choose to do so to ensure that 
the food does not contain 20 ppm or more gluten. The regulation 
provides that, when compliance with [the rule] 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, 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 
any 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)).
    Through comments we received in response to the proposed rule for 
gluten-free labeling of foods that appeared in the Federal Register of 
January 23, 2007 (72 FR 2795) and to a related notice reopening of the 
comment period that we published in the Federal Register of August 3, 
2011 (76 FR 46671), we

[[Page 49243]]

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 we 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 those foods contained <20 ppm gluten. We 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. We requested comments on this proposed 
approach as well as on whether we also should require these 
manufacturers to maintain records on test methods, protocols, and 
results and to make these records available to us 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'' (78 FR 47154 at 47165).
    Although test methods for the detection of gluten fragments in 
fermented or hydrolyzed foods have advanced, as of August 13, 2020, we 
know of no scientifically valid analytical method effective in 
detecting and quantifying with precision the gluten protein content in 
fermented or hydrolyzed foods in terms of equivalent amounts of intact 
gluten proteins. Sandwich Enzyme-Linked Immunosorbent Assay (ELISA)-
based methods are not effective in detecting and quantifying gluten 
proteins that are no longer intact as a result of fermentation or 
hydrolysis since the method requires at least two epitopes to work. 
Competitive ELISA-based methods that recognize a single epitope have 
been developed and may eventually overcome the detection problems 
encountered using current sandwich ELISA-based assays with fermented or 
hydrolyzed food. While some studies have validated the reproducibility 
of competitive ELISA-based test methods, the lack of appropriate 
calibration standards or suitable reference materials make accurate 
quantification of gluten content difficult. This uncertainty creates 
problems in equating these test results to an equivalent amount of 
intact gluten in the fermented or hydrolyzed product. Without reference 
standards to gauge the response for detection and quantification of 
gluten to produce fermented or hydrolyzed products, such quantification 
is uncertain and potentially inaccurate (Ref. 2). Thus, we need other 
means to verify compliance for these foods.

B. What did we propose to do?

    In the Federal Register of November 18, 2015 (80 FR 71990), we 
published a proposed rule to establish requirements concerning 
``gluten-free'' labeling for foods that are fermented, hydrolyzed, or 
distilled, or that contain fermented, hydrolyzed, or distilled 
ingredients. In brief, we proposed to evaluate compliance with the 2013 
gluten-free food labeling final rule of such fermented or hydrolyzed 
foods that bear a ``gluten-free'' claim 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 food is ``gluten-free'' 
in compliance with the 2013 gluten-free food labeling final rule before 
fermentation or hydrolysis. In addition, we proposed to 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, we proposed to require 
manufacturers of foods that contain fermented or hydrolyzed ingredients 
and bear the ``gluten-free'' claim to make and keep records that 
demonstrate with adequate assurance that the fermented or hydrolyzed 
ingredients are ``gluten-free'' in compliance with Sec.  101.91. 
Finally, we proposed to evaluate compliance of distilled foods by 
verifying the absence of protein using scientifically valid analytical 
methods that can reliably detect the presence of protein or protein 
fragments in the distilled food. We proposed to revise Sec.  
101.91(b)(1), (b)(2), and (c) to state that when a scientifically valid 
method is not available because the food or ingredient is fermented or 
hydrolyzed, the manufacturer of such foods bearing the claim must make 
and keep records regarding the fermented or hydrolyzed food that 
demonstrate: (1) Adequate assurance that the food is ``gluten-free'' 
before fermentation or hydrolysis; (2) the manufacturer has adequately 
evaluated their processing for any potential for gluten cross-contact; 
and (3) 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. 
For foods for which a scientifically valid method to detect and 
quantify gluten is not available because the food is distilled, 
compliance would be evaluated by verifying the absence of protein (and 
thus gluten) 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.

IV. Legal Authority

    We are issuing this final rule under section 206 of FALCPA which 
directs the ``Secretary of Health and Human Services, in consultation 
with appropriate experts and stakeholders,'' to ``issue a rule to 
define, and permit use of, the term ``gluten-free'' on the labeling of 
foods.'' 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 that are material 
with respect to the consequences which may result from the use of the 
food to which the labeling relates under 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 establishing requirements for the use of the term ``gluten-free'' 
for fermented and hydrolyzed foods.
    Because there is no scientifically valid analytical method 
available that can both reliably detect and accurately quantify the 
equivalent of 20 ppm intact gluten in foods that are fermented or 
hydrolyzed, or that contain fermented or hydrolyzed ingredients, we are 
establishing requirements for manufacturers to make and keep records 
containing information that provide 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 record requirements would help 
ensure that the use of the term ``gluten-free'' is

[[Page 49244]]

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, 693-694 (D.C. Cir. 1978)).
    The final rule requires records only for foods for which an 
adequate analytical method is not available. The records will allow us 
to verify that the ``gluten-free'' claim on foods that are fermented or 
hydrolyzed, or contain fermented or hydrolyzed ingredients, is truthful 
and complies with the requirements of the definition. 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 authority to 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 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.

V. Comments on the Proposed Rule and FDA Responses

A. Introduction

    We received over 500 comments on the proposed rule. We received 
comments from consumers; consumer groups; trade organizations; 
industry; public health organizations; public advocacy groups; and 
other organizations. We have numbered each comment to help distinguish 
among different topics. We have grouped similar comments together under 
the same number, and, in some cases, we have separated different issues 
discussed in the same comment letter and designated them as distinct 
comments for purposes of our responses. The number assigned to each 
comment topic is for organizational purposes only and does not signify 
the comment's value, importance, or the order in which it was received.

B. Comments and FDA Responses

1. Request for Exemption for Inherently Gluten-Free Ingredients and 
Enzymes
    (Comment 1) Several comments stated that the rule would have the 
unintended consequence of prohibiting certain inherently gluten-free 
foods and ingredients from bearing a ``gluten-free'' claim. The 
comments said that the added recordkeeping requirements were an 
unnecessary burden on manufacturers and that, in other cases, it might 
be impossible to request records from remote geographic regions for 
commodity items that are fermented immediately after harvest (e.g., 
cocoa beans). The comments pointed out that some ingredients are at low 
risk of contact with gluten-containing grains at harvest as well as 
across the supply chain. The comments stated that FDA should make clear 
in the preamble to the final rule that inherently gluten-free foods, 
such as milk and dairy ingredients, vanilla beans, enzymes (grown on 
media containing gluten), flavor extracts, and cocoa beans, that have a 
low risk of gluten cross-contact are exempt from the final rule. The 
comments requested that proposed Sec.  101.91(c)(3) not apply to foods 
containing fermented or hydrolyzed ingredients derived from foods that 
are inherently ``gluten-free'' and do not have a known or reasonable 
probability of gluten cross-contact. Alternatively, some comments 
suggested that we revise the rule to apply only to fermented foods 
produced from gluten-containing grains or having a known or reasonably 
foreseeable risk of cross-contact with a gluten-containing grain (e.g., 
gluten-free beers). The comments suggested that we define ``fermented 
food'' for the purposes of this section as ``a food or ingredient 
derived from a gluten-containing grain by fermentation.''
    The comments also stated that, if we could not create an exemption, 
we should clarify that testing is not required for inherently gluten-
free ingredients when there is no cross-contact with gluten-containing 
ingredients. Also, if testing is done, it should only be at the 
frequency necessary to prove the ``gluten-free'' claim and records 
regarding cross-contact should be flexible based on ingredients and 
facility. Further, the comments stated that we should clarify whether 
documentation providing general information on the commodity and 
regional growing practices in countries of origin would be sufficient 
to meet the ``gluten-free'' claim requirements.
    (Response 1) It is our experience that all foods may, at some point 
during manufacture, have a risk of cross-contact with a gluten-
containing grain depending on manufacturer operations, sources of 
ingredients, movements through the supply chain and distribution, etc. 
There may be inherently gluten-free foods or ingredients that still do 
not meet the definition of ``gluten-free'' due to cross-contact with 
gluten that leads to gluten content in the food that is at or above 20 
ppm. Conversely, there also may be inherently gluten-free foods that 
have some cross-contact with gluten-containing products but are still 
able to bear the ``gluten-free'' claim because the presence of gluten 
in the food due to cross-contact is less than 20 ppm. Just as we 
concluded in the preamble to the 2013 gluten-free food labeling final 
rule (78 FR 47154 at 47168), all food bearing a ``gluten-free'' claim, 
regardless if they are inherently gluten-free or not, must meet the 
definition of ``gluten-free.'' In 2015, we stated in the preamble to 
the proposed rule for gluten-free labeling of fermented or hydrolyzed 
foods that the specific types of records that would provide adequate 
assurance that fermented or hydrolyzed ingredients with a high 
likelihood of gluten cross-contact, such as grains and legumes, may 
differ from the records that would provide adequate assurance for 
ingredients with a lower likelihood of gluten cross-contact, such as 
dairy (80 FR 71990 at 71996 through 71998). 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 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 
low probability of cross-contact with gluten-containing grains may be 
more likely to use other appropriate verification documentation. Thus, 
we decline to modify Sec.  101.91(c)(3) to exclude any group of foods 
or ingredients because doing so does not consider the possibility of 
cross-contact.
    We also decline to define the term ``fermented food'' as a food or 
ingredient derived only from a gluten-containing

[[Page 49245]]

grain by fermentation. The final rule is intended to cover all foods 
that are fermented or contain fermented ingredients and bear the term 
``gluten-free,'' not just those from gluten-containing grains. 
Regardless of whether the food that is subjected to fermentation 
contains gluten, we cannot exclude the possibility that the food could 
be exposed to gluten due to cross-contact. It is important that all 
manufacturers who choose to use the ``gluten-free'' claim on their 
foods that are fermented or contain fermented ingredients evaluate 
their process for potential gluten cross-contact.
    As requested by a comment, we are clarifying that the final rule 
does not require testing of ingredients. The final rule requires 
manufacturers to adequately evaluate their processing for any potential 
for gluten cross-contact. Such assessment involves evaluation of each 
individual manufacturing process to find out if there is a known or 
reasonably foreseeable risk of cross-contact with gluten-containing 
grains and maintenance of records to indicate that measures have been 
implemented to prevent the introduction of gluten into the food during 
the manufacturing process. As noted in the preamble to the 2015 
proposed rule, we are aware that some foods and ingredients are more at 
risk than others (80 FR 71990 at 71996 through 71998). The manufacturer 
is best suited to decide how to adequately evaluate any potential for 
gluten cross-contact during its manufacturing process as well as the 
measures that should be taken to prevent the introduction of gluten 
into the food during that manufacturing process. The final rule 
requires that manufacturers of food products covered by the rule make 
and keep records providing adequate assurance that: (1) The food is 
``gluten-free'' before fermentation or hydrolysis; (2) the manufacturer 
has adequately 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. In some cases, adequate assurance may be 
provided through testing the ingredients when there is a scientifically 
valid method that can reliably detect the presence of 20 ppm gluten. 
Testing should indicate that foods or ingredients contain less than 20 
ppm gluten before fermentation or hydrolysis. To help address potential 
gluten cross-contact during the manufacturing process, the final rule, 
at Sec.  101.91(c)(2) and (3), requires that manufacturers of a 
fermented or hydrolyzed product who wish to use a ``gluten-free'' claim 
make and keep records that provide adequate assurance that they have 
carefully evaluated their processing for any potential for gluten 
cross-contact, and where the potential exists, manufacturers have 
implemented measures to prevent the introduction of gluten into the 
food. Through this process, a manufacturer can assure that the food or 
its ingredients comply with Sec.  101.91(a)(3) before fermentation or 
hydrolysis. As specified in the preamble to the 2015 proposed rule (80 
FR 71990 at 71996 through 71998), the records providing adequate 
assurance that the food is ``gluten-free'' before fermentation or 
hydrolysis could include records of test results conducted by the 
manufacturer or an ingredient supplier, CoA, 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 the sufficient frequency to ensure that the gluten level in the 
food or in each ingredient is below 20 ppm before fermentation or 
hydrolysis. Alternatively, as we noted in the preamble to the 2013 
gluten-free food labeling 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. Similarly, for ingredients received from outside 
suppliers, manufacturers may document a visit to a supplier's facility, 
a review of supplier's records, or a review of written documentation 
from a supplier to verify the compliance with Sec.  101.91(a)(3) for 
these ingredients. We find it is appropriate to allow a manufacturer to 
use any means of verification they develop, if the manufacturer can 
document that such verification provides adequate assurance that the 
ingredients comply with Sec.  101.91(a)(3). We do not specify the types 
of records to be kept, so the manufacturer could, for example, create 
records regarding the ingredients used or maintain records or CoAs 
obtained from a supplier.
    As we discussed in the preamble to the 2013 gluten-free food 
labeling final rule (78 FR 47154 at 47173), we expect foods bearing the 
``gluten-free'' claim to be manufactured using the controls necessary 
to minimize cross-contact with all gluten sources to ensure that any 
amount of gluten in the food from gluten cross-contact is as low as 
possible and that the food has less than 20 ppm gluten. Also, we would 
accept information on growing practices and product segregation as 
records to meet the requirements of this final rule.
    (Comment 2) Several comments expressed concerns regarding some 
aspects of the proposed rule as it could relate to enzymes. For 
example, some comments stated that commercial enzymes are often 
produced by microbes grown on media containing wheat and that these 
enzymes are considered to be processing aids when used in other foods 
produced by fermentation. The comments said that very little gluten 
protein (if transferred to the food by the enzyme) may survive the 
fermentation process. Therefore, the comments said these enzymes should 
not be covered under the rule. The comments stated that the production 
of enzymes includes a bacterial fermentation step, but the enzymes 
themselves are not fermented or hydrolyzed. The comments noted that the 
final product is purified to remove extraneous materials and claimed 
that very small amounts of their enzyme products are used in food 
processing and, therefore, would not present a health risk to patients 
with celiac disease. Finally, the comments explained that wheat is not 
used by the enzymes that form the final product and the enzymes do not 
contain gluten; thus, according to the comments, the enzymes should not 
be classified as fermented or hydrolyzed, and we should exempt the 
enzymes from the rule and allow foods produced with the use of such 
enzymes to bear a ``gluten-free'' claim if the foods meet the ``gluten-
free'' definition under Sec.  101.91(a)(3).
    (Response 2) The issue of purity and potential carry-over of growth 
media containing gluten is a valid concern for both the manufacturers 
and consumers with celiac disease. Wheat may be present in any carried-
over nutrient media used to grow the microbes, and the gluten in the 
media may be subjected to proteolytic digestion (hydrolysis) making its 
quantity and biological activity hard to confirm using currently 
available technology. Further, it is likely that these properties will 
vary with the specific production process (e.g., type of microbe grown, 
temperature, incubation period, etc.). We agree that the enzymes 
produced in this manner are not themselves fermented; however, the 
gluten that may possibly be present in the enzyme may be hydrolyzed due 
to fermentation. An important consideration is the amount of potential 
carryover and how much of the enzyme ingredient is used in the 
production of the final food product. Because these factors may vary

[[Page 49246]]

considerably, we decline to exempt enzymes from the rule.
    Finally, we disagree with the comments' assertions that, because 
wheat is not used by the enzymes that form the final product, the 
enzymes do not contain gluten. Section 101.91(a)(3) requires some means 
of demonstrating that the final product has been processed to remove 
gluten to a level below 20 ppm. During the enzyme production process, 
the microbes make use of wheat in the nutrient medium, and any gluten 
present, because of the carry-over described in the preceding 
paragraph, may have undergone alterations, such as protein 
fragmentation and deamidation, during the bacterial fermentation step. 
We do not know how these changes affect the immunopathogenicity and 
other properties of gluten, and it is not clear whether the means of 
measuring compliance with the 2013 gluten-free food labeling final rule 
for intact gluten would be sufficient to safeguard consumers with 
celiac disease. Thus, until this is known, the final rule is 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.''
    (Comment 3) One comment regarding the effects of various processing 
and treatment technologies noted that it was important to distinguish 
between those that actually remove gluten and those that modify or 
cleave the protein molecules without actually removing anything from 
the food or ingredient. The comment provided an example of production 
of wheat starch that involves a step in which a protein (gluten)-
enriched fraction is physically separated from a protein depleted 
(potentially gluten-free) starch fraction. In this case, gluten has 
been removed. When a food or ingredient is treated by fermentation or 
hydrolysis, it is only possible to state that the gluten has been 
modified, not removed.
    (Response 3) We agree that there is a difference between physical 
removal and modification (processing) of gluten to generate a product 
that does not contain any immunopathogenic elements of concern to 
consumers with celiac disease. When physically removing the gluten, the 
question is whether all of the gluten has been removed so that there is 
no trace left that might cause an adverse health event. Modification of 
the gluten is not definitive unless it is possible to demonstrate that 
all of the modified gluten or its protein components are no longer 
harmful for individuals with celiac disease.
2. Innovation in Developing Methods for Fermented, Hydrolyzed, or 
Distilled Foods
    (Comment 4) A few comments stated that a valid method exists to 
quantify gluten in a product that has been fermented or hydrolyzed, 
like beer, and pointed to the R5 Competitive ELISA test with 
inactivated protease enzyme.
    (Response 4) When compliance with Sec.  101.91(b) 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, cooked, or baked products (Sec.  
101.191(c)). As stated in the 2011 notice and the 2013 gluten-free food 
labeling final rule, a scientifically valid method for purposes of 
substantiating a ``gluten-free'' claim for food matrices where formally 
validated methods (e.g., that underwent a multi-laboratory performance 
evaluation) do not exist is one 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 (76 FR 46671 at 46673; 78 FR 
47154 at 47165). The R5 Competitive ELISA test has potential as a 
quantitative method, and we acknowledge that, under the appropriate 
test conditions, the R5 Competitive ELISA can generate reproducible 
results. The commercial R5 Competitive ELISA marketed for the detection 
of hydrolyzed (or fermented) gluten has, by design, an advantage over 
sandwich ELISA-based methods by not requiring the presence of two 
antigenic epitopes (antibody binding sites) to detect the presence of 
gluten peptides. Further, because the immunopathogenesis associated 
with celiac disease only requires a single immunopathogenic element, 
the R5 Competitive ELISA is theoretically more appropriate as an assay.
    However, as currently designed, the R5 Competitive ELISA method is 
not suitable for the detection and quantification of gluten in any 
fermented or hydrolyzed food (e.g., beer, yogurt). The lack of 
appropriate reference standards for the detection and quantification of 
gluten subjected to fermentation or proteolysis (hydrolysis) makes the 
results generated by the R5 Competitive ELISA difficult, if not 
impossible, to interpret. As currently supplied, the calibration 
standard in the R5 Competitive ELISA is allowed to proceed for a 
specified amount of time at a specific temperature. If the hydrolytic 
conditions (time, temperature, or composition under which the 
hydrolysis is occurring) associated with the production of the sample 
being analyzed were different from those used to make the calibration 
standards, the peptide profile is likely to be different, and the assay 
is unlikely to generate accurate results. The Association of Official 
Analytic Chemists Official Methods of Analysis (AOAC OMA) First Action 
award to the R5 Competitive ELISA stated that the hydrolyzed gluten 
being used as a calibration standard may not be suitable, and users 
should establish their own standards before relying on the calibration 
standard (Ref. 3). Specifically, minor fluctuations in temperature and 
time, as well as the specifics of the proteolysis, could result in a 
different range of peptides, making the calibration standards not 
suitable.
    Further, it is not known how to interpret the immunopathogenicity 
based on the amount and profile of gluten peptides detected. The 
threshold of 20 ppm gluten was based on studies examining the 
immunopathogenicity of intact gluten. Whether the biological activity 
on a per mg basis is the same for gluten peptides, as was measured with 
intact proteins, is unknown; the answer may depend on the peptide 
profile.
    Thus, we have concerns regarding the use of the R5 Competitive 
ELISA in the detection of gluten in fermented or hydrolyzed foods or 
ingredients because of the challenge in demonstrating that it is 
suitable for the intended purpose of interpreting the 
immunopathogenicity based on the amount and profile of gluten peptides 
detected and whether the method performs reliably (i.e., is a 
scientifically valid method). While the method may perform reproducibly 
as indicated by the American Association of Cereal Chemist 
International (AACCI) validation (Ref. 4), it does not mean that the 
method is suitable for the intended purpose of detecting and 
quantifying, with sufficient accuracy, the gluten protein content in 
fermented and hydrolyzed foods, or assessing the immunopahogenicity or 
equivalent amount of intact gluten proteins.
    Finally, the procedure of adding a controlled amount of an 
artificially prepared hydrolysate to food as required by the testing 
protocol (a process called ``spiking'') may give an inaccurate reading 
because it does not reflect the assay's ability to detect gluten that 
has been added to the food before processing and hydrolyzed during 
production. For this reason, it is

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important that, whenever possible, methods be validated using gluten 
that is added to the food before processing. The inability to detect 
any gluten using the R5 Competitive ELISA (below the limit of 
detection) is not an indication of complete elimination or even a 
reduction of gluten. Another complexity is that not all the 
immunopathogenic sequences of gluten have been identified. Further, the 
R5 antibody does not recognize all immunopathogenic sequences (e.g., 
glutenin-derived) and, therefore, gluten could be present in a form 
that is not detectable (Ref. 5).
    (Comment 5) One comment stated that the proposed rule would require 
gluten to be measured using scientifically valid methods. The comment 
would have us revise the rule to address the fact that there are many 
different test methods and that they vary in their ability to provide 
accurate and precise data. The comment suggested that, instead of 
requiring that testing labs merely use ``scientifically valid'' test 
methods, we require that the methods are fully validated, thereby 
establishing performance reliability (the consistency or 
reproducibility of the test).
    (Response 5) The ideal test method for detecting and quantifying 
the gluten content of feremented or hydrolyzed foods is a 
scientifically valid method that is suitable for the intended purpose 
and has been extensively, preferably multi-laboratory validated. 
However, multi-laboratory validation is sometimes conducted for 
conditions that are not suitable for the intended purpose (not 
scientifically valid). For example, in the R5 Competitive ELISA, which 
has undergone multi-laboratory validation for use in the quantitative 
analysis of fermented or hydrolyzed gluten, the calibration standard 
often does not represent the peptide repertoire being measured and, 
thereby, is not suitable for fermented or hydrolyzed foods or 
ingredients. Further, validation should focus on realistic samples. 
Instead, the R5 Competitive ELISA validation employed a calibration 
standard to which a controlled amount of substance, as required by 
protocol, was added into several samples; as such, the recoveries and 
performance of the assay were not reflective of the analysis of 
realistic samples. The R5 Competitive ELISA is not the only example of 
a method that has been promoted for use in an analysis of gluten in 
fermented or hydrolyzed foods, but it is mentioned here because it has 
been promoted for use in the quantitative analysis of fermented or 
hydrolyzed gluten. Although an AOAC Official Method is often a good 
indicator of reliability (not necessarily `suitability for purpose' 
beyond the specifics described in the validation report), there are 
other organizations, such as the American Society for Testing and 
Materials (ASTM), that may develop methods that perform reliably and 
may be appropriate for testing gluten in fermented or hydrolyzed foods.
    Other governmental agencies and industry may adopt their own 
procedures for testing gluten in hydrolyzed and fermented foods as 
well. The focus should be on using the most appropriate, scientifically 
valid method that meets the manufacturer's needs. Realizing 
insufficiencies of existing validation methods, we established our own 
validation protocols. Our validation protocols focus on the detection 
and quantification of analytes under realistic conditions (such as 
using a standard that has been spiked before any food processing 
instead of simply spiking the standard into the final food product). 
Once a method has been validated, the method can only be used for a 
novel food following evaluation and validation of the method 
performance with the specific food matrix.
    (Comment 6) Several comments stated that the proposed rule does not 
offer flexibility for scientific innovation and, therefore, 
unintentionally prevents fermented and hydrolyzed foods from benefiting 
from scientific advancements that are very likely to be achieved. One 
comment stated that the proposed rule is overly restrictive, shows 
disregard to competition and innovation, and threatens to stifle the 
marketplace because it fails to account for new and emerging 
technologies and scientific developments in this area. Other comments 
asserted that the rule will limit options for those suffering from 
gluten-related disorders.
    (Response 6) As with all detection methodology, we support efforts 
to resolve the uncertainty issues associated with quantifying gluten 
fragments and interpreting results in terms of intact gluten. The 
preamble to the 2013 gluten-free food labeling final rule (78 FR 47154 
at 47169) and this final rule reflect our support in encouraging 
innovation in how gluten-free products are produced and the development 
of new analytical methods for detecting the gluten content of foods. 
Other than our discussion of distillation, where testing for the 
absence of protein indicates compliance with the use of the term 
``gluten-free,'' we deliberately did not specify analytical methods 
that should be used. We did this because we believe that specifying 
analytical methods would unnecessarily limit flexibility and possibly 
deter the development of new and better analytical methods as well as 
methods for gluten removal. In the preamble to the 2013 gluten-free 
food labeling final rule (78 FR 47154 at 47169), we stated that we were 
not specifying analytical methods in the final rule even though we had 
included a description of two analytical methods that met our needs for 
the analysis of intact gluten in the 2011 notice that reopened the 
comment period for the proposed rule for gluten-free food labeling of 
foods (76 FR 46671 at 46672). In the 2011 notice, we described the 
methods along with references explaining how the two methods were 
suitable-for-purpose and were validated. The information in the 
preamble to the 2013 gluten-free food labeling final rule provided 
extensive discussion about why we were not specifying analytical 
methods in order to support the development of new and better 
technologies and also demonstrate flexibility for foods that are not 
fermented or hydrolyzed by allowing stakeholders to use the methods 
most appropriate to fit their needs (78 FR 47154 at 47169).
    More importantly, we have written the final rule in a manner that, 
once we identify that a scientifically valid method, pursuant to Sec.  
101.91(c)(1), has been developed that can accurately detect and 
quantify gluten in some or all fermented or hydrolyzed foods or 
ingredients, Sec.  101.91(c)(2)-(c)(4) would no longer be applicable 
for those foods, and it would no longer be necessary for the 
manufacturer of foods bearing the ``gluten-free'' claim to make and 
keep the records required under Sec.  101.91(c)(2)-(c)(4) demonstrating 
adequate assurance that the food meets the ``gluten-free'' definition 
before fermentation or hydrolysis. Should any new scientifically valid 
methods be developed that can accurately detect and quantify gluten in 
fermented and hydrolyzed foods, FDA would determine compliance in 
accordance with Sec.  101.91(c)(1). (On our own initiative, we have 
revised Sec.  101.91(c)(1) to state that the scientifically valid 
method is one that can ``reliably detect and quantify'' the presence of 
20 ppm gluten. We added the words ``and quantify'' to clarify that the 
scientifically valid method needs to do more than detect the presence 
of gluten.) In addition, should any new scientifically valid methods be 
developed for fermented or hydrolyzed foods, we expect that we would 
identify the existence of such methods through guidance or other 
appropriate means.

[[Page 49248]]

Therefore, we disagree with the assertion that the final rule is overly 
restrictive, adversely affects competition or innovation, or fails to 
account for emerging technologies.
    (Comment 7) One comment asked us to give insight regarding which 
analytical methods might be of greater utility for verifying absence of 
protein in distilled foods and ingredients.
    (Response 7) We decline to discuss in detail the pros and cons of 
the various analytical methods available for verifying the absence of 
protein in distilled food and ingredients because the best method may 
depend on factors such as food matrix, the experience of the analyst, 
the business decision of the company, etc. Additionally, a list of 
methods may be misinterpreted as indicating that we consider other 
approaches that are not included on the list to be unacceptable or of 
comparatively less value or usefulness.
3. Distilled Food
    (Comment 8) One comment stated that FDA claimed that there is no 
proof that gluten does not volatilize during the distillation process 
because the temperatures are not high enough to allow gluten to pass 
through a still. The comment went on to state that, rather than banning 
a ``gluten-free'' claim on any product that had not been tested for 
gluten, FDA should rely on existing science that proves that gluten 
does not pass through a distillation still and, therefore, would not 
end up in a distilled product. The comment said that testing every 
batch is a hardship on small craft and farm distillers and prevents 
marketing of these kind of products to those with gluten intolerance. 
The comment also said that we should commission a scientific study to 
confirm that gluten may be present in distilled spirits or that gluten 
does not pass through a still and, therefore, all distilled spirits do 
not contain gluten.
    (Response 8) The comment may have misunderstood our position. We 
did not claim that there is no proof that gluten does not volatilize 
during the distillation process because the temperatures are not high 
enough to allow gluten to pass through a still. If good manufacturing 
practices are followed, the process of distillation must remove all 
protein (and thus gluten), regardless if the product has been distilled 
from gluten-containing grains. As discussed further in Response 9, 
distillation is considered a process to remove gluten and it is 
unlikely that residual gluten may be present in the final distilled 
products. Transfer of gluten into the distillate would only be expected 
to occur under poor manufacturing practices in which the initial 
material is splashing into the distillate due to poor design of the 
still. Protein testing can be done to confirm that protein (and thus 
gluten) is absent in the distilled product. We note that testing of 
each batch is not required under existing regulations, and this rule 
specifies the methods we will use to verify compliance for distilled 
foods in Sec.  101.91(c)(5). In addition, we note that any ingredients 
(such as flavors) added to the distilled product would need to comply 
with our regulations defining ``gluten-free'' in Sec.  101.91(a) for 
the finished product labeling to bear the gluten-free claim.
    (Comment 9) A few comments opposed different requirements for 
distilled foods because, according to the comments, distilled foods 
have caused reactions in some people and, therefore, are not safe. The 
comments stated that the exception for distilled foods is in direct 
conflict with the gluten-free food labeling rule and creates an uneven 
playing field within the overall alcoholic beverages category. The 
comments pointed out that malt beverages or other products that have 
undergone a process to remove or reduce gluten content are not treated 
the same as distilled spirits.
    One comment suggested a tiered labeling system for distilled foods 
with varying labels (``Gluten-free,'' ``gluten-free'' with a 
disclaimer, ``gluten-reduced,'' no gluten claim allowed) that allows 
``gluten-free'' labeling when testing is possible with the caveat that 
if the starting material was a gluten-containing grain, a disclaimer is 
used to disclose this fact. The comment claimed that this tiered 
labeling standard would provide full disclosure to the consumer, place 
the burden on industry to provide accurate labeling, and be 
transparent.
    (Response 9) As we explained in the preamble to the proposed rule 
(80 FR 71990 at 71995, 71999), while creating distilled vinegar does 
involve fermentation, the process of distillation heats a liquid, which 
vaporizes components with lower boiling points and separates them from 
components with higher boiling points. The remaining compounds, whose 
boiling points are too high to undergo vaporization, are left behind. 
If distillation is done properly, the process removes gluten because 
gluten does not vaporize. Therefore, there should not be any gluten 
remaining in the final distilled product. For this reason, a distilled 
product labeling may bear a ``gluten-free'' claim and should be safe 
for people with celiac disease to consume.
    We also disagree that the regulations for distilled foods or 
ingredients is in direct conflict with our regulations defining 
``gluten-free.'' Our regulations permit ingredients derived from a 
gluten-containing grain that has been processed to remove gluten if the 
use of that ingredient does not result in the presence of 20 ppm or 
more gluten in the food (Sec.  101.91(a)(3)(i)(A)(3)).
    We are aware that the process of distillation is capable of 
separating gluten and other proteins from the remaining compounds and, 
therefore, we make this distinction for foods or ingredients that are 
distilled. Scientifically valid methods for protein testing can 
determine if a product is free of protein and, therefore, also free of 
gluten. Thus, we will evaluate compliance 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. Furthermore, we note that 
malt beverages, as defined under the Federal Alcohol Administration Act 
(FAA Act) (27 U.S.C. 211(a)(7)), do not undergo distillation and, 
therefore, would not be subject to Sec.  101.91(c)(5).
    As for the comment regarding a tiered labeling system, to be 
consistent with Sec.  101.91, which defines the term ``gluten-free,'' 
we decline to introduce a tiered labeling system along with a 
disclaimer because Sec.  101.91(b)(2) provides for the use of the label 
claims ``gluten-free,'' ``no gluten,'' ``free of gluten,'' or ``without 
gluten'' if the product meets the definition under Sec.  101.91(a)(3). 
Use of any of these terms on products that were made from gluten-
containing grains would not meet the definition of ``gluten-free'' in 
Sec.  101.91(a)(3) and would, therefore, misbrand the products unless 
the ingredients used to formulate the food have been processed to 
remove gluten and the final food product contains less than 20 ppm of 
gluten. We note that this rule does not prohibit other truthful and not 
misleading labeling statements about the presence or absence of gluten 
in food products that do not meet a ``gluten-free'' definition, 
provided the statements do not expressly or implicitly suggest that the 
food meets FDA's ``gluten-free'' definition.
    (Comment 10) One comment stated that we should revise the rule to 
distinguish between distilled vinegar made from raw material naturally 
free from gluten and vinegar made from raw material containing gluten. 
The comment recommended that if the original feedstock is ``gluten-
free,'' then no further testing is needed. The comment pointed out that 
distilled

[[Page 49249]]

vinegar is made from distilled ethanol which is further fermented into 
vinegar by bacteria. Distilled ethanol is generally produced from non-
gluten-containing raw material such as corn, beet or sugar cane but in 
some cases, also gluten-containing cereals. Vinegar itself is not 
distilled; only the main raw material to make the vinegar is distilled. 
Therefore, according to the comment, proteins and/or protein fragments 
may be present due to the use of yeast or yeast extract in the 
fermentation of distilled vinegar.
    Other comments asked us how we plan to distinguish proteins or 
protein fragments that may originate from the ethanol feedstock from 
those proteins and protein fragments that may originate from the 
ethanol fermentation process. The comments stated that such a 
distinction for any protein detected is important.
    (Response 10) As we explained previously in the preamble to the 
proposed rule (80 FR 71990 at 71995, 71999), distillation is a process 
capable of separating gluten and other proteins from the remaining 
compounds and, therefore, we make this distinction for foods or 
ingredients that are distilled. Due to the distillation process, no 
protein fragments should be in the ethanol feedstock. Scientifically 
valid methods for protein testing can determine if a product is free of 
protein and, therefore, also free of gluten. Only those vinegars made 
from distilled ethanol that are further processed in a manner to avoid 
the introduction of gluten can be considered ``gluten-free.'' As for 
the possible introduction of gluten from those proteins and protein 
fragments that may originate from the ethanol fermentation process, as 
with any product, it is the manufacturer's responsibility to implement 
measures preventing the introduction of gluten into the food elsewhere 
in the manufacturing process for an ingredient made ``gluten-free'' by 
distillation. Further, the manufacturer could request from their 
supplier that the raw materials, such as bacteria or yeast used in the 
fermentation of distilled vinegar, be ``gluten-free.'' One way this can 
be accomplished is by avoiding the use of bacteria grown on any gluten-
containing source material or by using appropriate testing to confirm 
that the material (bacteria) are ``gluten-free.'' Thus, the vinegar 
manufacturer would have assurance that the distilled ethanol was used 
in a manner that prevented the introduction of gluten into the food 
during the manufacturing process.
    Scientifically valid analytical methods are readily available to 
detect the presence or absence of protein and protein fragments (and 
thus gluten) in distilled foods. Therefore, as indicated in Sec.  
101.91(c)(5) of this final rule, we will evaluate compliance with Sec.  
101.91(b) 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.
4. Different Compliance Standard
    (Comment 11) Some comments stated that the rule concludes that 
fermented or hydrolyzed foods should be subject to a different labeling 
compliance standard than other foods bearing a ``gluten-free'' claim 
based upon the assumption that no scientifically valid method will be 
developed to accurately detect the presence of gluten in these food 
products.
    (Response 11) There is research underway within FDA and elsewhere 
to develop methods to accurately detect and quantify the presence of 
gluten in fermented or hydrolyzed foods. However, as we noted in the 
proposed rule (80 FR 71990 at 71991), although test methods for the 
detection of gluten fragments in fermented or hydrolyzed foods have 
advanced, there is still uncertainty in interpreting the results. The 
currently available test methods are not capable of producing results 
on a quantitative basis that equate to an equivalent amount of intact 
gluten, and thus, we are making available alternate means by which 
these kinds of foods can comply with Sec.  101.91. Once we have 
identified a scientifically valid method, it would no longer be 
necessary for the manufacturer of foods bearing the ``gluten-free'' 
claim to make and keep the records required under Sec.  101.91(c)(2)-
(c)(4), and FDA would determine compliance in accordance with Sec.  
101.91(c)(1). If or when a scientifically valid method to detect and 
quantify the presence of gluten in fermented or hydrolyzed foods become 
available, we will identify this change through a guidance document or 
other appropriate means. In addition, FDA may consider changing our 
regulations if warranted.
    (Comment 12) Several comments questioned whether fermented or 
hydrolyzed foods should be subject to a different compliance standard 
than other foods bearing a ``gluten-free'' claim when there is a high 
probability that a scientifically valid method will be developed in the 
very near future to accurately detect the presence of gluten in such 
foods. The comments suggested that we remove the reference to any 
particular food that is distilled, fermented, or hydrolyzed in the 
wording of proposed Sec.  101.91(c)(2) through (c)(5). This would mean 
that the labeling requirements would apply equally to all food 
categories for which a scientifically valid method is not available to 
confirm compliance with the 20 ppm gluten threshold. The comments said 
this would provide FDA with the necessary compliance authority to 
impose a higher standard on certain foods where we determine that a 
valid scientific method does not currently exist. Later, when a 
scientifically valid analytical method is established, no regulatory 
amendment process would be required. The comments further explained 
that the proposed language does not offer any flexibility for 
scientific innovation in this area and unintentionally prevents this 
group of foods from ever benefiting from scientific advancements that 
are likely to be achieved.
    (Response 12) When we developed the proposed rule, there were no 
scientifically valid methods for the purposes of analyzing fermented or 
hydrolyzed foods to determine compliance with Sec.  101.91. Because, 
currently, there are no analytical methods to reliably detect and 
quantify gluten in fermented or hydrolyzed food nor methods to equate 
test results in terms of intact gluten, we will evaluate compliance of 
these foods that bear a ``gluten-free'' labeling claim with the 2013 
gluten-free food labeling final rule based on records that provide 
adequate assurance that the foods are ``gluten-free'' before 
fermentation or hydrolysis. Fermented or hydrolyzed foods are subject 
to the same labeling compliance standards as any other food that would 
bear a ``gluten-free'' claim. This final rule describes how 
manufacturers of fermented or hydrolyzed foods or distilled foods would 
be able to demonstrate compliance and how FDA will evaluate compliance. 
For this reason, we decline to remove reference to distilled foods and 
fermented or hydrolyzed foods from Sec.  101.91(c)(2) through (c)(5). 
Further, as we noted in Response 6, if or when a scientifically valid 
method for fermented or hydrolyzed foods becomes available, FDA will 
identify such a method through a guidance document or other appropriate 
means. Once FDA identifies such a method, it would no longer be 
necessary for the manufacturer of foods bearing the ``gluten-free'' 
claim to make and keep the records required under Sec.  101.91(c)(2) 
though (c)(4), and FDA would determine compliance with the ``gluten 
free'' labeling requirements under Sec.  101.91(c)(1).
    (Comment 13) One comment stated that the proposed rule appears to

[[Page 49250]]

impose a stricter requirement on electronic records related to the 
gluten-free voluntary labeling standard than the requirements for other 
food safety records under other regualtions. For example, the comment 
states that section II.C. of the proposed rule (80 FR 71990 at 71998 
through 71999) indicates that electronic records, including electronic 
signatures, established or maintained to meet the requirements of this 
rule would be subject to the electronic records and electronic 
signatures requirements in part 11 (21 CFR part 11). However, the 
comment states that Sec.  117.305(g), FDA's regulation concerning 
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
Preventive Controls for Human Food, establishes that electronic records 
established or maintained to meet the requirements of part 117 and that 
meet the definition of electronic records in Sec.  11.3(b)(6), are 
exempt from the requirements of part 11.
    (Response 13) Although the proposed rule indicated that electronic 
records would need to comply with part 11, we also note that the use of 
electronic records is voluntary and thus, a paper record system could 
be used to comply with the proposed recordkeeping requirements. This 
would give manufacturers the maximum flexibility to use whatever 
recordkeeping system they find most appropriate (80 FR 71999).
    The final 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. Records that can be 
immediately retrieved from another location by electronic means are 
considered reasonably accessible. Compliance with FDA's regulation 
concerning Current Good Manufacturing Practice, Hazard Analysis, and 
Risk-Based Preventive Controls for Human Food in 21 CFR part 117 has no 
bearing on this rule.
    (Comment 14) One comment said that, in the preamble to the proposed 
rule, but not in the proposed codified language, FDA recognizes that 
there is a significant difference between fermented or hydrolyzed foods 
produced from gluten-containing grains and those that are not. 
According to the comment, proposed Sec.  101.91(c)(2) would require the 
manufacturer of such foods bearing the claim to make and keep records 
demonstrating adequate assurance that the fermented or hydrolyzed 
ingredients are ``gluten-free.'' The comment said that the preamble to 
the proposed rule stated that ``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.'' The comment suggested that this can be interpreted as 
imposing a greater recordkeeping requirement on the ``low likelihood'' 
foods than is required in part 117, ``Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human 
Food'' (21 CFR part 117) for food safety hazard analysis. In 
particular, the comment said that, in Sec.  117.130(b)(1), 
manufacturers only must address hazards that are ``known or reasonably 
likely.'' The comment said that it would be appropriate to only require 
records in cases where the potential presence of gluten or gluten-
containing grains is ``known or reasonably likely.'' The comment stated 
that manufacturers should be required to document the information and 
process used to reach this conclusion but should not be subject to 
further recordkeeping requirements.
    (Response 14) The comment asked that we only require records in 
cases where the potential presence of gluten or gluten-containing 
grains is ``known or reasonably likely.'' While the ``known or 
reasonably likely'' standard is established in part 117 for food safety 
hazard analysis, this final rule was specifically developed to 
establish the requirements for the voluntary use of the ``gluten-free'' 
claim that allows consumers to practice dietary avoidance and benefits 
individuals suffering from celiac disease. Although we acknowledge that 
there is a difference in the likelihood of gluten cross-contact in some 
fermented or hydrolyzed foods, because there is no scientifically valid 
method to quantify the gluten protein content in fermented or 
hydrolyzed foods, manufacturers who wish to produce and label such 
foods as ``gluten-free'' still need to make and keep records, as 
described in the new requirements of Sec.  101.91(c), to provide 
adequate assurance of the type of ingredient used is ``gluten-free'' 
before fermentation or hydrolysis and to address the potential for 
cross-contact with gluten-containing grains or ingredients. The records 
for different foods can have different levels of detail needed to 
demonstrate compliance. As we have noted in section III.A. and 
elsewhere in this document, the results of current gluten test methods 
for fermented and hydrolyzed foods do not provide accurate quantitive 
results sufficient to be suitable for use with fermented or hydrolyzed 
foods. Thus, to evaluate compliance of such fermented and hydrolyzed 
foods that bear a ``gluten-free'' claim, we need to rely on records 
made and kept by the manufacturer providing adequate assurance that the 
food is ``gluten-free'' in compliance with Sec.  101.91(a)(3) before 
fermentation or hydrolysis. In addition, this rule requires 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, implemented measures to 
prevent the introduction of gluten into the food during the 
manufacturing process.
    It is, therefore, appropriate and reasonable to impose the 
recordkeeping requirement established under Sec.  101.91(c)(4) in this 
final rule for fermented or hydrolyzed foods bearing a ``gluten-free'' 
claim to substantiate a firm's compliance with Sec.  101.91(a). 
Therefore, we decline to change the rule as suggested by the comment 
and have finalized Sec.  101.91(c)(4) without change.
5. ``Gluten-Free'' Labeling of Beer
    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 
FAA Act. Certain other beers that do not meet the definition of a malt 
beverage under the FAA Act (27 U.S.C. 211(a)(7)) are subject to FDA's 
labeling requirements. Beer manufacturers whose beers are subject to 
FDA's labeling requirements and do not meet the ``gluten-free'' 
definition are not precluded from using other statements on the label, 
such as a gluten statement consistent with the TTB Revised Interim 
Policy on Gluten Content Statements in the Labeling and Advertising of 
Wine, Distilled Spirits, and Malt Beverages, about processing of beers 
to reduce gluten (Ref. 6). However, such statements must be truthful 
and not misleading in accordance with our general labeling provisions 
in sections 403(a)(1) and 201(n) of the FD&C Act.
    In the preamble to the 2013 gluten-free food labeling final rule 
(78 FR 47154 at 47166), we said that, under limited circumstances, we 
would exercise enforcement discretion with respect to the requirements 
for ``gluten-free'' labeling for FDA-regulated beers that already made 
a ``gluten-free'' claim before the rule was published and that were: 
(1) Made from a non-gluten-containing grain; or (2) made from a gluten-
containing grain, where the beer

[[Page 49251]]

had been subject to processing that the manufacturer had determined 
would remove gluten. We said that the enforcement discretion pertained 
only to those beers subject to FDA's labeling requirements that made a 
``gluten-free'' claim as of August 5, 2013, pending completion of the 
rulemaking process with respect to fermented or hydrolyzed products. We 
also said that any beer manufacturer that wanted to make a new 
``gluten-free'' claims should contact FDA regarding the possible 
expansion of our consideration for the exercise of enforcement 
discretion related to such labeling. With the publication of this final 
rule, we complete the gluten-free labeling rulemaking and the 
enforcement discretion described in the preamble to the 2013 gluten-
free food labeling final rule (78 FR 47154 at 47166) is no longer 
valid.
    On February 11, 2014, TTB issued a revised interim policy on gluten 
content statements in the labeling and advertising of beverages or 
beers it regulates. The ``Revised Interim Policy on Gluten Content 
Statements in the Labeling and Advertising of Wines, Distilled Spirits, 
and Malt Beverages'' allows the use of the following qualifying 
statement to inform consumers: ``Product fermented from grains 
containing gluten and [processed or treated or crafted] to remove 
gluten. The gluten content of this product cannot be verified, and this 
product may contain gluten,'' or ``This product was distilled from 
grains containing gluten, which removed some or all of the gluten. The 
gluten content of this product cannot be verified, and this product may 
contain gluten.'' (Ref. 6).
    We stated in the preamble to the proposed rule (80 FR 71990 at 
71994) that, as with other foods, beers 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 (e.g., wheat starch) in accordance with the provisions 
in the ``gluten-free'' definition before making beer, the beer may be 
eligible to make the claim.
    As far as the claims that beer 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 gluten removal 
processes. We acknowledge that gluten can be at least partially broken 
down by several processes, including fermentation. However, as we 
explain in section III.A. of this rule, the presence or absence of 
gluten broken down in this way cannot be reliably detected with 
sandwich ELISA-based methods.
    In the preamble to the proposed rule (80 FR 71990 at 71994), we 
requested comments to learn more about the efficacy of competitive 
ELISA-based methods, given the beer industry's practice of adding 
enzymes to the beer to prevent the problem of cloudiness or ``haze.'' 
The enzyme hydrolyzes or breaks down gluten proteins at proline 
residues. Thus, using these haze control enzymes may generate peptides 
that are not detectable using the commercially available competitive 
ELISA-based methods that rely on the presence of proline in the 
epitopes. As we noted in the preamble to the proposed rule (80 FR 71990 
at 71995), it is uncertain that cleavage at proline residues eliminates 
the concern for people with celiac disease because there may be 
immunopathogenic protein fragments still present. In other words, we do 
not know whether the protein fragments can trigger a reaction in people 
with celiac disease.
    In the preamble to the proposed rule, we requested 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 (80 FR 71990 at 71995). We 
also were interested in scientific research regarding how we can use 
such test methods to determine whether 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 invited comment, including 
data and any information on scientific research and methods, to 
determine if a specific enzymatic treatment 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 proteins (80 FR 71990 at 71995).
    We received several comments related to these specific questions as 
well as some other beer-related topics.
    (Comment 15) Many comments opposed the use of the terms ``made to 
remove gluten,'' ``crafted to remove gluten,'' and other similar such 
terms on beer labels. The comments stated that such terms are not the 
same as ``gluten-free'' and that consumers may think they are the same, 
especially because these products are often marketed as ``gluten-
free.'' Other comments stated that ``gluten-free'' was not the same as 
``gluten-reduced,'' and that products treated to remove gluten should 
be clearly differentiated from those that are inherently gluten-free.
    (Response 15) Our regulations at Sec.  101.91 seek to eliminate 
confusing and potentially misleading language that might hinder people 
with celiac disease from properly identifying food safe for 
consumption. In the preamble to the 2013 gluten-free food labeling 
final rule (78 FR 47154 at 47164), we explained that, under Sec.  
101.91(b)(2), a food that bears the claim ``no gluten,'' ``free of 
gluten,'' or ``without gluten'' in its labeling and fails to meet the 
requirements for a ``gluten-free'' claim will be deemed to be 
misbranded.
    Based upon comments that we received during a public meeting on 
August 19, 2005, to discuss the topic of gluten-free food labeling and 
comments that were submitted in writing to the related FDA Docket No. 
FDA-2005-N-0404 (formerly 2005N-0279), we believe that a uniform 
definition of the term ``gluten-free'' prevents confusion and 
uncertainty among both consumers and food manufacturers about what this 
food labeling claim means. Therefore, we have not defined the terms 
``gluten-reduced,'' ``crafted to remove gluten,'' or ``made to remove 
gluten,'' and we do not consider those terms to be equivalent to 
``gluten-free.'' Although some products may be labeled with these terms 
as long as the label is truthful and not misleading (e.g., so as to not 
imply that they are gluten-free), we reiterate that consumers with 
celiac disease should rely only on the terms specified in Sec.  
101.91(b)(2) to indicate that a food is ``gluten-free'' or safe for 
them to consume.
    This final rule does not change the definition of ``gluten-free,'' 
but only adds compliance requirements for hydrolyzed, fermented, or 
distilled foods.
    (Comment 16) Several comments stated that it would be appropriate 
for beers made with gluten-containing grains to be labeled as ``crafted 
to remove gluten,'' along with a statement that ``the beer is fermented 
from grains containing gluten and crafted to remove gluten.'' The 
comments stated that the gluten content of the beer cannot be verified 
and that a statement that the beer may contain gluten is truthful, 
accurate, and not misleading and provides the consumer with adequate 
information to make a purchase decision. The comments said that our 
proposed rule is too narrow in focus and that TTB's Policy authorizing 
qualified ``crafted to remove gluten'' claims for fermented alcohol 
beverages made with

[[Page 49252]]

gluten-containing grain ingredients is appropriate. The comments said 
that our proposal fails to incorporate TTB's Policy requirements or 
distinguish between the claims that are subject to FDA's gluten-free 
requirements from TTB's qualified ``crafted to remove gluten'' claim. 
The comments strongly urged FDA to adopt the TTB Policy authorizing 
qualified ``crafted to remove gluten'' claims.
    (Response 16) As we have noted previously, the statutory directive 
for this rule was to define the term ``gluten-free,'' and this 
rulemaking, like the 2013 gluten-free food labeling final rule, is 
intended to implement that statutory directive. The intent in this 
rulemaking is to provide an alternative for showing compliance with the 
``gluten free'' definition in Sec.  101.91(a)(3) because current 
analytical methods are not suitable for the quantification of gluten in 
fermented or hydrolyzed foods (like beer). Thus, beers under our 
jurisdiction that are 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 before the 
fermentation process to make beer, the beer may be eligible to make the 
claim under the final rule.
    We do not agree with the comments stating we should adopt TTB's 
Policy. In the preamble to the proposed rule, we noted that the 
labeling of beer is subject to oversight by two separate federal 
agencies (80 FR 71990 at 71995). In addition, we stated that 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 (80 FR 71990 at 71995).
    We appreciate the efforts of TTB to provide terminology for 
products they regulate that do not meet the definition of ``gluten-
free,'' and as the proposed rule for gluten-free labeling of fermented 
or hydrolyzed foods clearly states, and we are reiterating here, FDA-
regulated beers are not precluded from using other statements on the 
label, such as a gluten statement consistent with the TTB Policy (80 FR 
71990 at 71995). Such statements must be truthful and not misleading. 
Beers that do not meet the definition of malt beverage are not subject 
to the labeling provisions of the FAA Act, but can be subject to the 
food labeling provisions of the FD&C Act and implementing regulations. 
This includes the provisions concerning the use of ``gluten-free'' 
claims, and such statements may not expressly or implicitly suggest to 
the consumer that the product is ``gluten-free'' when it does not meet 
the requirements of Sec.  101.91.
    (Comment 17) A few comments pointed out that fermented beverages 
are different from other foods. One comment further stated that 
prohibiting ``gluten-free'' claims for fermented products that are made 
with gluten-containing grains, without regard for whether gluten is 
present in the finished product, would conflict with the policy of the 
Codex Alimentarius \1\ (Codex) on gluten claims. The comment stated 
that the rule does not provide clarity that fermented alcoholic 
beverages currently labeled as processed/treated to remove gluten in 
accordance with the TTB Policy will be permitted to continue being so 
labeled. Without clear guidance from FDA with respect to the 
permissibility and standards of such labeling, the comment said that 
the conditions may exist for potential disparate ``crafted to remove 
gluten'' standards to arise.
---------------------------------------------------------------------------

    \1\ The Codex Alimentarius is a collection of internationally 
recognized standards, codes of practice, guidelines, and other 
recommendations relating to foods, food production, and food safety. 
http://siweb.dss.go.th/standard/Fulltext/codex/CXS_118E.pdf.
---------------------------------------------------------------------------

    (Response 17) The Codex Standards for ``gluten-free'' labeling (see 
Codex Standard 118-1979, section 2.1.1b) require that foods labeled as 
``gluten-free'' not contain gluten-containing grains unless they have 
been processed to remove gluten and the end product has less than 20 
ppm gluten. Thus, contrary to the comment's assertion, our requirements 
are aligned with the policy of Codex on gluten claims.
    As for fermented or hydrolyzed products, the final rule applies to 
FDA-regulated foods, including certain beers, and, as we stated in the 
preamble to the proposed rule, we will work with TTB on the issues 
associated with the ``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 
(80 FR 71990 at 71995). The final rule does not redefine the term 
``gluten-free'' or provide for the use of other statements, but rather 
the rule provides how manufacturers of foods that are fermented or 
hydrolyzed can comply with Sec.  101.91.
    (Comment 18) Some comments stated that the TTB Policy does not 
protect those with celiac disease and creates a competitive 
disadvantage for beers that are truly free of gluten (as opposed to 
having been processed in some manner to reduce gluten). According to 
the comments, the TTB Policy allows products made from gluten-
containing grains to be labeled as being ``processed,'' ``treated,'' or 
``crafted'' to remove gluten, along with a qualifying statement 
indicating that the product's gluten content cannot be determined, and 
that the product may contain gluten. The comments stated that certain 
companies are displaying meaningless gluten test results to their 
consumers. In addition, the comments expressed concern that, if TTB 
adopted the same approach as our rule, manufacturers will sell low 
gluten beers as ``gluten-free,'' and consumers will not be able to 
differentiate between ``gluten-free'' and ``low-gluten'' products.
    (Response 18) Although TTB consults with FDA about the issuance of 
regulations regarding the labeling of ingredients and substances 
contained in alcohol beverages, as we noted in the preamble to the 2013 
gluten-free food labeling final rule (78 FR 47154 at 47165), TTB, and 
not FDA, is responsible for the issuance and enforcement of regulations 
with respect to the labeling of beers that are malt beverages under the 
FAA Act. TTB's Policy states that, ``the term `gluten-free' may be used 
on labels and in advertisements if the product would be entitled to 
make a gluten-free label claim under the standards set forth in the new 
FDA regulations at 21 CFR 101.91'' (Ref. 6).
    We will continue to work with TTB on the issues associated with 
``gluten-free'' labeling of beer to promote consistency in terminology 
to avoid label statements that are either not truthful or are 
misleading.
    (Comment 19) One comment pointed out that proline endopeptidase 
(PEP) (a yeast derived enzyme used by some manufacturers to selectively 
degrade the haze-forming peptides and proteins present in beer) 
provides a suitable and convenient processing aid for preparing 
``gluten-free'' barley-based beverages. The comment mentioned research 
done by Osman et al. 2003 (Ref. 7), which described the gradual 
degradation of barley proteins during the malting stage where barley 
glutens were likely to be digested to peptides. The comment also stated 
that, according to Akeroyd et al. and Panda et al. (Refs. 7 and 8), 
adding the enzyme during the beer fermentation phase helps to further 
reduce the modest gluten concentrations present in conventionally 
brewed beers. More specifically, the enzyme helps in destroying the 
minimal core sequence required for T-cell recognition. The comment also 
stated that if a beer shows an ELISA response below the detection 
level, then the absence of peptides with

[[Page 49253]]

T-cell recognition sites is almost guaranteed. The comment said that, 
after using the PEP in the brewing of beer, no known immunopathogenic 
sequence is detected by mass spectrometry and the R5 Competitive ELISA 
analysis fails to detect any gluten. The comment did, however, 
acknowledge that a final verification on the absolute quantities of 
gluten present in the end product remains necessary.
    (Response 19) It has been well established that barley glutens are 
not completely digested to amino acids during the malting and 
fermentation stage and that the gluten fragments are present in the 
final beer product (Ref. 8, Ref. 10, Ref. 11). Using mass spectrometry, 
multiple research groups have detected gluten peptides in 
conventionally brewed beer and beer brewed in the presence of PEP that 
has tested negative for an ELISA response because the level of gluten 
was below the limit of detection of ELISA test kits (Ref. 8, Ref. 9, 
Ref. 10, Ref. 11). The inability to detect certain known protein 
fragments in gluten that elicit a response in people with celiac 
disease does not mean that all possible fragments related to celiac 
disease are absent because the identities of all possible T-cell 
epitopes have not been established (Ref. 12). Additionally, Fiedler et 
al., were able to demonstrate that gluten peptides that contained 
immunogenic sequences knowns to be associated with celiac disease were 
detected in PEP-containing beer (Ref. 13). Though it is likely that PEP 
breaks down gluten, that is not the goal for the use of PEP. Also, the 
comments acknowledge, there is no scientifically valid analytical 
method able to quantify the gluten content in terms of equivalent 
amounts of intact gluten proteins.
    We established the use of a 20 ppm limit as one criterion in the 
definition of ``gluten-free'' because 20 ppm is currently the lowest 
level at which analytical methods have been scientifically validated to 
reliably and consistently detect gluten across a range of food 
matrices, providing a limit for any inadvertent cross-contact with 
gluten during the manufacturing process. Allowing the ``gluten-free'' 
label claim on food whose ingredients are derived from a gluten-
containing grain and have been processed to remove gluten, but not on 
food containing such ingredients that have not been processed to remove 
gluten, helps to ensure that the finished product meets the requirement 
that the food contain less than 20 ppm. Further, under Sec.  101.91, 
gluten-containing grains (e.g., wheat, rye, barley) are not to be used 
in the production of ``gluten[hyphen]free'' products even if the 
concentration of gluten in the final product was less than 20 ppm.
6. Issues Outside the Scope of This Rule
    Some comments pertained to matters that were outside the scope of 
this rule. However, we address several of these comments here.
    Several comments stated that the term ``gluten-free'' should be 
reserved only for foods that are inherently ``gluten-free.''
    We addressed this issue in the 2013 gluten-free food labeling final 
rule (78 FR 47154). There may be inherently gluten-free foods or 
ingredients that still do not meet the definition of ``gluten-free'' 
due to cross-contact with gluten that leads to gluten content in the 
food that is at or above 20 ppm. The rule defines ``gluten-free'' to 
mean the product does not contain a gluten-containing grain or an 
ingredient derived from a gluten-containing grain unless that 
ingredient has been processed to remove gluten and the use of that 
ingredient does not result in the presence of 20 ppm or more gluten in 
the food. Also, any unavoidable presence of gluten in a product labeled 
as ``gluten-free'' must be less than 20 ppm. We concluded in the 
preamble to the 2013 gluten-free food labeling final rule (78 FR 47154 
at 47168), that all foods bearing a ``gluten-free'' claim, regardless 
if they are inherently gluten-free or not, must meet the definition of 
``gluten-free.'' We chose not to limit the use of the term to only 
foods that were inherently gluten-free because such an approach could 
have the unintended effect of reducing the food choices available for 
individuals who have celiac disease, thereby reducing the variety of 
foods needed to meet their nutrient needs.
    Other comments asked us to clarify our position on the use of 
barley malt and barley malt extract in foods bearing a ``gluten-free'' 
claim.
    We note that malt syrup and malt extract are interchangeable terms 
for a viscous concentrate of a water extract of germinated barley, with 
or without a preservative. The terms barley malt or barley malt extract 
are used also. Malt syrup is usually a brown and viscous liquid 
containing varying amounts of amylolytic enzymes with plant 
constituents. Malt extract and malt syrup are ingredients derived from 
a gluten-containing grain, barley, that have not been processed to 
remove gluten. Food and ingredient manufacturers should be aware that 
malt extract and other similar malt-derived ingredients are ingredients 
derived from gluten-containing grains that have not been processed to 
remove gluten and, therefore, cannot be used in foods that bear 
``gluten-free'' labeling.
    One comment said that some wheat starch contains small levels of 
both intact and hydrolyzed gluten and asked us to clarify which methods 
should be used to test such products because we consider wheat starch 
to be ``processed to remove gluten.''
    We note that wheat starch, when properly manufactured, does not 
involve hydrolysis of the gluten and can be protein-free. However, as 
we explain in the preamble to the 2007 proposed rule for gluten-free 
food labeling, we recognize that there may be different methods of 
deriving wheat starch, and that some methods may remove less gluten 
than others (72 FR 2795 at 2802). Therefore, Sec.  
101.91(a)(3)(i)(A)(3) prohibits a food that contains an ingredient that 
is derived from a gluten-containing grain and that has been processed 
to remove gluten (e.g., wheat starch) if the use of that ingredient 
results in the presence of 20 ppm or more gluten in the food. 
Manufacturers who label their food as ``gluten-free'' should make 
certain that the food does not contain 20 ppm or more gluten, 
regardless of whether or not those foods contain an ingredient that is 
derived from a gluten containing grain that has been processed to 
remove gluten. We would expect manufacturers of products that they wish 
to label as ``gluten-free'' to use good manufacturing practices and be 
aware of the practices used in production of the ingredients they use 
in their products. Also, if the processing does involve hydrolysis 
resulting in hydrolyzed gluten, then the product would be subject to 
the requirements of this rule.
    Finally, one comment asked us to clarify what government entities 
regulate ``gluten-free'' claim for gluten-reduced beer on restaurant 
menus and store shelves. We note that TTB is responsible for the 
labeling requirements for beers, including gluten-reduced beers, that 
meet the definition of malt beverage in the FAA Act (27 U.S.C. 
211(a)(7)). Beers that do not meet the definition of malt beverage are 
not subject to the labeling provisions of the FAA Act, but are subject 
to the food labeling provisions of the FD&C Act and implementing 
regulations, including the provisions concerning the use of ``gluten-
free'' or other type of gluten claims. Regarding restaurant menus that 
bear a ``gluten-free'' claim, we recommend that, for beers subject to 
the food labeling provisions of the FD&C Act and implementing 
regulations, restaurants use the defined food labeling

[[Page 49254]]

claim ``gluten-free'' to be consistent with our ``gluten-free'' 
definition.

VI. Effective and Compliance Dates

    This rule is effective September 14, 2020. We recognize that 
manufacturers of fermented or hydrolyzed foods, or foods containing 
fermented or hydrolyzed ingredients, currently bearing a ``gluten-
free'' claim may need time to review their products to ensure that 
these foods comply with this final rule, or to remove ``gluten- free'' 
or similar claims from the label if their foods do not comply.
    Compliance date: Consequently, the compliance date of this final 
rule is August 13, 2021.
    Although we are issuing the final rule after January 1, 2019, there 
is sufficient justification for establishing the compliance date of 
August 13, 2021, to enforce the provisions of this final rule, rather 
than January 1, 2022, which FDA established as the next uniform 
compliance date for other food labeling changes for food labeling 
regulations issued between January 1, 2019, and December 31, 2020 (83 
FR 65294; December 20, 2018).
    We believe that 12 months from the date of publication is 
sufficient time for manufacturers to review their products to ensure 
that these foods comply with this 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 FDA has 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 of January 1, 2022, would create an unnecessary delay in the 
enforcement of this final rule, as foods bearing the voluntary labeling 
``gluten-free'' that do not comply with FDA's regulatory definition of 
``gluten-free'' could have an adverse public health impact on persons 
with celiac disease who may be consuming those foods.
    Therefore, we are establishing the compliance date to enforce the 
provisions of this final rule at August 13, 2021.

VII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, Executive Order 13771, 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 us 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). Executive Order 13771 
requires that the costs associated with significant new regulations 
``shall, to the extent permitted by law, be offset by the elimination 
of existing costs associated with at least two prior regulations.'' 
This final rule is not an economically significant regulatory action as 
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because small firms may have annualized costs that do not 
exceed one percent of their annual revenue, we certify that the 
proposed rule will not have a significant economic impact on a 
substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $156 
million, using the most current (2019) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure that meets or exceeds this amount in any year.
    The costs of this rule are the costs to manufacturers of covered 
foods of testing ingredients for gluten, evaluating potential for 
cross-contact, if necessary developing and carrying out written 
standard operating procedures (SOPs) for preventing gluten cross-
contact, relabeling products that cannot be brought into compliance, 
and maintaining records of these activities for FDA inspection. We 
estimate total annualized costs of $7 million to $11 million for the 3% 
discount rate and annualized costs ranging from $7 million to $11 
million at 7% discount rate. All costs are computed in 2018-dollar 
values.
    The benefits of this rule are health gains for people with celiac 
disease using ``gluten-free'' labeled foods while maintaining a gluten-
free diet. To examine the potential scope of these benefits, we 
simulate the harm done by dietary gluten intake from a gluten-free diet 
before and after the rule. Due to uncertainty in this simulation 
analysis, we describe benefits qualitatively. For the rule to break-
even with costs, the annualized benefits would need to be at least $8.8 
million at a 3% discount rate and a $9.1 million at a 7% discount rate. 
Based on our simulation analysis, the rule would break-even with 
primary cost estimates discounted at 7% if at least 0.07% of estimated 
individuals with celiac disease following a gluten-free diet benefit 
from the rule each year.

                                      Table 1--Summary of Benefits, Costs, and Distributional Effects of Final Rule
                                                                       [Millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                   Units
                                                  Primary       Low        High    ------------------------------------
                   Category                      estimate    estimate    estimate      Year      Discount     Period                  Notes
                                                                                      dollars    rate (%)     covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $ millions/year......  ..........  ..........  ..........        2018           7          10
                                                                                          2018           3          10
    Annualized Quantified.....................  ..........  ..........  ..........  ..........           7
                                                                                                         3

[[Page 49255]]

 
    Qualitative...............................  The benefits of this rule are health gains for people with
                                                celiac disease using ``gluten-free'' labeled foods while
                                                maintaining a gluten-free diet. For the rule to break-even
                                                with costs, the annualized benefits would need to be at
                                                least $8.8 million at a 3% discount rate and a $9.1
                                                million at a 7% discount rate. Based on our simulation
                                                analysis, the rule would break-even with primary cost
                                                estimates discounted at 7% if at least 0.07% of estimated
                                                individuals with celiac disease following a gluten-free
                                                diet benefit from the rule each year.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/year.......       $9.09       $7.34      $11.46        2018           7          10
                                                      8.76        7.14       10.94        2018           3          10
    Annualized Quantified Qualitative.........  ..........  ..........  ..........  ..........           7
                                                                                                         3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized $ millions/    ..........  ..........  ..........  ..........           7
     year.                                                                                               3
                                               ------------------------------------------------------------------------
    From/To...................................  From:
                                                To:
                                               ------------------------------------------------------------------------
    Other Annualized Monetized $ millions/year  ..........  ..........  ..........  ..........           7
                                                                                                         3
                                               ------------------------------------------------------------------------
    From/To...................................  From:
                                                To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government:
    Small Business:
    Wages:
    Growth:
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In line with Executive Order 13771, in Table 2 we estimate present 
and annualized values of costs and cost savings over an infinite time 
horizon based on 2016-dollar values. Based on these costs, this final 
rule would be considered a regulatory action under E.O. 13771.

                                        Table 2--E.O. 13771 Summary Table
                           [In $ millions 2016 dollars, over an infinite time horizon]
----------------------------------------------------------------------------------------------------------------
                                                                      Primary     Lower estimate  Upper estimate
                              Item                                 estimate (7%)       (7%)            (7%)
----------------------------------------------------------------------------------------------------------------
Present Value of Costs..........................................         $107.12          $89.37         $130.02
Present Value of Cost Savings...................................               0               0               0
Present Value of Net Costs......................................         $107.12          $89.37         $130.02
Annualized Costs................................................           $7.50           $6.26           $9.10
Annualized Cost Savings.........................................               0               0               0
Annualized Net Costs............................................           $7.50           $6.26           $9.10
----------------------------------------------------------------------------------------------------------------

    The full analysis of economic impacts is available in the docket 
for this final rule (Ref. 14) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VIII. Analysis of Environmental Impact

    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.

IX. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by OMB under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3521). 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.

[[Page 49256]]

Recordkeeping Requirements for Gluten-Free Labeling of Fermented or 
Hydrolyzed Foods

1. 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.''
2. Description
    In this final rule, we require manufacturers of certain 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 fermented or hydrolyzed 
food are only required to make and keep these records for the fermented 
or hydrolyzed ingredient. We estimate that the manufacturers can 
satisfy the recordkeeping requirements of this rule 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 can instead comply with 
this rule by obtaining and maintaining records of Certificates of 
Analysis (CoA), 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 
for these products. Records 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 3 and 4 are based on the number of food 
products that are covered by the rule. Our search of FoodEssentials 
database was completed in November of 2017 (Ref. 15) for foods that are 
hydrolyzed, fermented, or contain fermented or hydrolyzed ingredients 
and bear the labeling claim ``gluten-free,'' ``no gluten,'' ``free of 
gluten,'' or ``without gluten,'' and found about 2,500 products that 
are affected by the rule. Based on our understanding of the market and 
experience with the percentage of the food market covered by this 
database, we estimate that this database has at least half of all 
products that are covered by the rule, so that there are likely, at 
most, 5,000 products affected by the 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 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. 16) 
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 manufacturers of 
foods labeled ``gluten-free'' are marketing to customers who care more 
about gluten cross-contact, we estimate that about 75 percent of the 
5,000 foods with a ``gluten-free'' labeling claim already have a 
written plan for preventing the introduction of gluten into the food 
product that includes the testing of ingredients and 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.
3. 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 is a first year burden of the rule. We 
estimate that it takes a facility an average of seven hours to develop 
an SOP for gluten control. Thus, we estimate that in the first year of 
compliance with this final rule, 1,250 facilities would develop an SOP 
for a burden of 8,750 hours (1,250 facilities x 7 hours per facility = 
8,750 hours), as reported in Table 3, row 1.
    Updating the facility's SOP for gluten control would be a recurring 
burden of the rule for the 1,250 facilities that do not currently have 
an SOP. We estimate that it takes a facility about 0.7 hours (42 
minutes) annually to update its SOP for gluten control, for a burden of 
875 hours (1,250 facilities x 0.7 hours per facility = 875 hours), as 
reported in table 4, row 1.
    We estimate that maintaining records of their updated SOPs would be 
a recurring burden of this rule for all 5,000 facilities. We estimate 
that it takes each facility one hour annually to maintain records of 
its updated SOPs for gluten control, for a burden of 5,000 hours (5,000 
facilities x 1 hour per facility = 5,000 hours), as reported in table 
4, row 2.
4. Recordkeeping Burden Related to Testing
    To demonstrate that a 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 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. 17). 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 for existing products.
    After the first year of testing, we assume the manufacturers would 
then use test kits to test the ingredient on a

[[Page 49257]]

regular basis, and may also send one or two samples a year to an 
outside lab for testing. These are recurring testing burdens. Based on 
the variety of products under FDA's jurisdiction that are fermented or 
hydrolyzed, we estimate that an average of two ingredients per product 
would be tested in this manner. Most foods affected by this rule are 
those that contain a single fermented or hydrolyzed ingredient. As 
explained earlier, adequate assurance that these fermented or 
hydrolyzed ingredient(s) were gluten-free before that supplier 
performed hydrolysis or fermentation can include test results, CoAs, or 
other appropriate verification documentation for each of the 
ingredients. Other products contain multiple ingredients that would be 
tested before fermentation or hydrolysis.
    As described above, we estimate that most manufacturers (75 
percent) already have a gluten control SOP that includes testing, so 
they will not undertake any additional testing as a result of this 
rule. In the first year of compliance, we estimate that the 1,250 
manufacturers not currently testing their ingredients and production 
facilities for gluten would incur additional testing burdens as a 
result of this rule. For these manufacturers, obtaining a method 
extension for a test kit would be a first year burden of this 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 1,458 hours (1,250 manufacturers x 14 samples 
per manufacturer x (5 minutes / 60 minutes per hour) = 1,458 hours) as 
reported in Table 3, row 2. We estimate that this rule results in 
manufacturers conducting 17,500 laboratory tests in the first year 
(1,250 manufacturers x 14 samples to be tested per manufacturer = 
17,500 samples to be tested). 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 tests x 
$84.33 per test = $1,475,833) as reported in table 3, row 2.
    We estimate that, as a first year burden of this rule, all 5,000 
manufacturers would begin retaining records of the method extension 
tests. We estimate that it takes a manufacturer 30 minutes per record, 
for a total of 35,000 hours (5,000 manufacturers x 14 sample records 
per manufacturer x 0.5 hours per sample record = 35,000 hours), as 
reported in table 3, row 3.
    We estimate that testing ingredients on a regular basis would be a 
recurring burden of the rule, 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 is 4,375 hours (1,250 manufacturers x 42 test 
kits per manufacturer x (5 minutes per test kit / 60 minutes per hour) 
= 4,375 hours), as reported in table 4, row 3. We estimate that this 
rule, results in manufacturers using 52,500 test kits each year (1,250 
manufacturers x 42 test kits per manufacturer = 52,500 test kits). 
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 test kits x $11 per kit = $577,500), as 
reported in Table 4, row 3. We estimate the burden to process and 
maintain records of the test results would be 105,000 hours (5,000 
manufacturers x 42 test kits per manufacturer x 0.5 hours per test kit 
= 105,000 hours), as reported in table 4, row 4.
    We estimate that a recurring burden of this rule, for all 5,000 
manufacturers, is 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 is 208 hours (1,250 
manufacturers x 2 tests per manufacturer x (5 minutes / 60 minutes per 
hour) = 208 hours), as reported in table 4, row 5. We estimate that 
this rule results in manufacturers conducting 2,500 laboratory tests in 
the first year (1,250 manufacturers x 2 tests per manufacturer = 2,500 
tests). 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 tests x $84.33 per test = $210,833), as 
reported in table 4, row 5. We estimate the burden to process and 
maintain records of the test results is 5,000 hours (5,000 
manufacturers x 2 tests per manufacturer x 0.5 hours per test = 5,000 
hours), as reported in table 4, row 6.

                                                 Table 3--Estimated First Year Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       Number of
 Activity/proposed 21 CFR section      Number of      records per    Total annual     Average burden per recordkeeping      Total hours    Capital costs
                                     recordkeepers   recordkeeper       records                                                           (USD millions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Developing an SOP for gluten                 1,250               1           1,250  7...................................           8,750               0
 control; 101.91(c)(2) and (3).
Collecting samples for testing;              1,250              14          17,500  0.083 (5 minutes)...................           1,458            $1.5
 101.91(c)(2) and (3).
Maintaining records of method                5,000              14          70,000  0.5 (30 minutes)....................          35,000               0
 extension tests; 101.91(c)(2) and
 (3).
                                   ---------------------------------------------------------------------------------------------------------------------
    Total.........................  ..............  ..............  ..............  ....................................          45,203            $1.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating or maintenance costs associated with this collection of information.


                                                  Table 4--Estimated Recurring Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       Number of
 Activity/proposed 21 CFR section      Number of      records per    Total annual     Average burden per recordkeeping      Total hours    Capital costs
                                     recordkeepers   recordkeeper       records                                                           (USD millions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Updating SOP for gluten control;             1,250               1           1,250  0.7 (42 minutes)....................             875               0
 101.91(c)(2) and (3).

[[Page 49258]]

 
Maintaining records of the updated           5,000               1           5,000  1...................................           5,000               0
 SOP for gluten control;
 101.91(c)(2) and (3).
Collecting samples for test kit              1,250              42          52,500  0.083 (5 minutes)...................           4,375            $0.6
 testing; 101.91(c)(2) and (3).
Maintaining records of test kit              5,000              42         210,000  0.5 (30 minutes)....................         105,000               0
 test results; 101.91(c)(2) and
 (3).
Collecting samples for testing by            1,250               2           2,500  0.083 (5 minutes)...................             208            $0.2
 an outside lab; 101.91(c)(2) and
 (3).
Maintaining records of testing by            5,000               2          10,000  0.5 (30 minutes)....................           5,000               0
 an outside lab; 101.91(c)(2) and
 (3).
                                   ---------------------------------------------------------------------------------------------------------------------
    Total.........................  ..............  ..............  ..............  ....................................         120,458            $0.8
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating or maintenance costs associated with this collection of information.

    The information collection provisions in this final rule have been 
submitted to OMB for review as required by section 3507(d) of the 
Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a 
notice in the Federal Register announcing OMB's decision to approve, 
modify, or disapprove the information collection provisions in this 
final rule. An Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

X. Federalism

    We have analyzed this final 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 2013 gluten-free food labeling 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 2007 gluten-free food labeling 
proposed rule (72 FR 2795 at 2813 through 2814), we indicated that we 
had consulted with numerous experts and stakeholders in proposed rule's 
development and determined that certain narrow exercises of State 
authority would conflict with the exercise of Federal authority under 
the FD&C Act. Different and inconsistent amounts of gluten in foods 
with ``gluten-free'' labeling result in the inability of those 
individuals with celiac disease who adhere to a gluten-free diet to 
avoid exposure to gluten at levels that may result in adverse health 
effects. ``Gluten-free'' labeling, for purposes of this discussion, 
also includes the use of the terms ``no gluten,'' ``free of gluten,'' 
and without gluten,'' as indicated in Sec.  101.91(b)(2). There is a 
need for national uniformity in the meaning of the term ``gluten-
free,'' which includes the manner in which the definition is enforced, 
so that most individuals with celiac disease can make informed 
purchasing decisions that will enable them to adhere to a diet they can 
tolerate without causing adverse health effects and can select from a 
variety of available gluten-free foods.
    This final rule establishes additional requirements for 
manufacturers of fermented and hydrolyzed foods or foods that contain 
fermented and hydrolyzed 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'' labeling claim. If States were 
able to establish different requirements regarding what manufacturers 
of fermented or hydrolyzed 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 fermented or hydrolyzed foods 
than this 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 fermented or hydrolyzed 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 fermented and hydrolyzed foods to 
ensure labels bearing a ``gluten-free'' claim are truthful and not 
misleading.
    Therefore, the final rule's objective is standardizing use of the 
term ``gluten-free'' in the labeling of fermented and hydrolyzed foods 
so that foods with this claim in labeling, and foods with a

[[Page 49259]]

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 prevent consumer confusion and help individuals with 
celiac disease 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 final 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 
fermented and hydrolyzed foods. We intend to preempt State or local 
requirements only to the extent that the State or local requirements 
are different from the labeling requirements in this section related to 
the use of the terms ``gluten-free,'' ``no gluten,'' ``free of 
gluten,'' or ``without gluten'' for fermented and hydrolyzed 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 rule. This rule, like the rule 
codified at Sec.  101.91, is not intended to preempt other State or 
local labeling requirements with respect to other statements or 
warnings about gluten. For example, a State is not preempted from 
requiring a labeling statement about the health effects of gluten 
consumption from fermented or hydrolyzed foods on persons with celiac 
disease or information about how the food was processed.
    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 final 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 fermented or hydrolyzed foods.
    Under the Supremacy Clause of the Constitution (U.S. Constitution; 
Art. VI, clause 2), State laws that interfere with or are contrary to 
Federal law are invalid. (See Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1, 
211 (1824)). Federal preemption can be express (stated by Congress in 
the statute) or implied. Implied preemption can occur in several ways. 
For example, Federal preemption may be found where Federal law 
conflicts with State law. Such conflict may be demonstrated either when 
``compliance with both federal and state [law] is a physical 
impossibility'' (Florida Lime and Avocado Growers, Inc. v. Paul, 373 
U.S. 132, 142-143 (1963)), or when State law ``stands as an obstacle to 
the accomplishment and execution of the full purposes and objectives of 
Congress'' (Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 372-74 
(2000) (citing Hines v. Davidowitz, 312 U.S. 52, 67 (1941))). State law 
is also preempted if it interferes with the methods by which a Federal 
law is designed to reach its goals. (See Int'l Paper Co. v. Ouellette, 
479 U.S. 481, 494 (1987); Michigan Canners & Freezers Ass'n v. 
Agricultural Marketing & Bargaining Bd., 467 U.S. 461, 477-478 (1984)).
    Additionally, `` `a federal agency acting within the scope of its 
congressionally delegated authority may preempt state regulation' and 
hence render unenforceable state or local laws that are otherwise not 
inconsistent with federal law'' (City of New York v. FCC, 486 U.S. 57, 
63-64 (1988) (quoting Louisiana Public Service Comm'n v. FCC, 476 U.S. 
355, 369 (1986)). ``Federal regulations have no less preemptive effect 
than federal statutes'' (Fidelity Federal Savings and Loan Ass'n v. de 
la Cuesta, 458 U.S. 141, 153 (1982)).
    When an Agency's intent to preempt is clearly and unambiguously 
stated, a court's inquiry will be whether the preemptive action is 
within the scope of that Agency's delegated authority (Capital Cities 
Cable, Inc. v. Crisp, 467 U.S. 691, 700 (1984); Fidelity Federal 
Savings, 458 U.S. at 154). If the Agency's choice to preempt 
``represents a reasonable accommodation of conflicting policies that 
were committed to the agency's care by the statute [the regulation will 
stand] unless it appears from the statute or its legislative history 
that the accommodation is not one that Congress would have sanctioned'' 
(United States v. Shimer, 367 U.S. 374, 383 (1961)). In Hillsborough 
County, the Supreme Court stated that FDA possessed the authority to 
issue regulations preempting local laws that compromise the supply of 
plasma and could do so (Hillsborough County, Fla. v. Automated Medical 
Laboratories, Inc., 471 U.S. 707, 721 (1985)). We believe we have 
similar authority to preempt State and local laws and regulations to 
the limited extent that they permit use of ``gluten-free,'' ``no 
gluten,'' ``free of gluten,'' or ``without gluten'' for fermented or 
hydrolyzed foods differently from our rule because different State or 
local labeling 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 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 this final rule, consumers throughout the United States can 
understand what is required to use the term ``gluten-free'' on the 
labeling of a fermented or hydrolyzed packaged food. This final rule 
will also allow us to enforce more efficiently the definition on 
product labels of fermented or hydrolyzed 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 these final requirements 
related to the use of the terms ``gluten-free,'' ``no gluten,'' ``free 
of gluten,'' or ``without gluten'' on the labeling of 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 change to Sec.  
101.91(d) regarding preemption, but the new requirements in Sec.  
101.91(c) are part of the requirements covered by Sec.  101.91(d).

XI. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction.

[[Page 49260]]

Some may be available at the website address, if listed. References 
without asterisks are available for viewing only at the Dockets 
Management Staff. FDA has verified the website addresses, as of the 
date this document publishes in the Federal Register, but websites 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. Available at: https://www.ncbi.nlm.nih.gov/pubmed/6692666.
2. * Garber, E.A.E., FDA Memorandum to Administrative Record, 
``Standards Used to Detect and Quantify Fermented and Hydrolyzed 
Gluten in Foods,'' August 25, 2015.
3. Lacorn, M. and Weiss, T. (2015). ``Partially Hydrolyzed Gluten in 
Fermented Cereal-Based Products by R5 Competitive ELISA: 
Collaborative Study, First Action 2015.05.'' Journal of AOAC 
International 98: 1346-1354. Available at: https://www.ingentaconnect.com/content/aoac/jaoac/2015/00000098/00000005/art00023?crawler=true&mimetype=application/pdf.
4. Koehler, P., Schwalb, T., Immer, U., Lacorn, M., et al. (2013). 
``AACCI Approved Methods Technical Committee Report: Collaborative 
Study on the Immunochemical Determination of Partially Hydrolyzed 
Gluten Using an R5 Competitive ELISA.'' Available at: https://www.researchgate.net/publication/251972244_AACCI_Approved_Methods_Technical_Committee_Report_Collaborative_Study_on_the_Immunochemical_Determination_of_Partially_Hydrolyzed_Gluten_Using_an_R5_Competitive_ELISA.
5. Sollid, L.M., Qiao, S.W., Anderson, R.P., Gianfrani, C., and 
Koning, F. (2012). ``Nomenclature and Listing of Celiac Disease 
Relevant Gluten T-Cell Epitopes Restricted by HLA-DQ Molecules.'' 
Immunogenetics, 64(6), 455-60. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3349865/pdf/251_2012_Article_599.pdf.
6. * Revised Interim Policy on Gluten Content Statements in the 
Labeling and Advertising of Wines, Distilled Spirits, and Malt 
Beverages (TTB Ruling No. 2014-2, February 11, 2014, available at: 
https://www.ttb.gov/images/pdfs/rulings/2014-2.pdf).
7. Osman, A.M., S.M. Coverdale, K. Onley-Watson, D. Bell, and P. 
Healy. ``The Gel Filtration Chromatographic-Profiles of Proteins and 
Peptides of Wort and Beer: Effects of Processing--Malting, Mashing, 
Kettle Boiling, Fermentation and Filtering.'' Journal of the 
Institute of Brewing. 109(1), 41-50, 2003. Available at: https://onlinelibrary.wiley.com/doi/epdf/10.1002/j.2050-0416.2003.tb00592.x.
8. Akeroyd, M., S. Van Zandycke, J. den Hartog, J. Mutsaers, et al. 
``AN-PEP Proline Specific Endo-Peptidase Degrades all Known Immuno 
Stimulatory Gluten Peptides in Beer Made from Barley Malt.'' Journal 
of the American Society of Brewing Chemists 74(2), 2016.
9. Panda, R., Fiedler, K.L., Cho, C.Y., Cheng, R., et al. (2015). 
``Effects of a Proline Endopeptidase on the Detection and 
Quantitation of Gluten by Antibody[hyphen]Based Methods during the 
Fermentation of a Model Sorghum Beer.'' Journal of Agricultural and 
Food Chemistry 63: 10525-10535.2015 pg. 35 line 806.
10. Colgrave, M.L., Goswami, H., Blundell., M., Howeitt, C. A., 
Tanner, G.J., (2014). ``Using Mass Spectrometry to Detect Hydrolysed 
Gluten in Beer that is Responsible for False Negatives by ELISA.'' 
Journal of Chromatography A. 1370: 105-14.
11. Knorr, V., Wieser, H., and Koehler, P. (2016). ``Production of 
Gluten-Free Beer by Peptidase Treatment.'' European Food Research 
and Technology 242: 1129-1140.
12. Shewry, P. and Tatham, A. (2016). ``Improving Wheat to Remove 
Coeliac Epitopes but Retain Functionality.'' Journal of Cereal 
Science. 67:12-21.
13. Fiedler, K., Panda, R., and Croley, T. (2018). ``Analysis of 
Gluten in a Wheat-Gluten-Incurred Sorghum Beer Brewed in the 
Presence of Proline Endopeptidase by LC/MS/MS.'' Analytical 
Chemistry 90: 2111-2118.
14. * FDA, Economic Impact Analysis for ``Food Labeling; Gluten-Free 
Labeling of Fermented or Hydrolyzed Foods, 2019. Available at: 
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
15. FoodEssentials. Product Label Database. November 2017 [cited 
2017 October 11,]; Original website retired in mid-2018 and new 
database was launched in late 2018]. Available from: https://www.labelinsight.com/about. Access is provided under a contract.
16. * Eastern Research Group (ERG), Nationwide Survey of Food 
Industry Safety Practices, Final report, Contract No 223-01-2461, 
task order 7. 2011, ERG.
17. * 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 amended as follows:

PART 101--FOOD LABELING

0
1. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority:  15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371; 42 U.S.C. 243, 264, 271.


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


Sec.  101.91  Gluten-free labeling of food.

* * * * *
    (b) Requirements. (1) A food that bears the claim ``gluten-free'' 
in its labeling and fails to meet the requirements of paragraph (a)(3) 
of this section and, if applicable, paragraphs (c)(2) through (4) of 
this section will be deemed misbranded.
    (2) A food that bears the claim ``no gluten,'' ``free of gluten,'' 
or ``without gluten'' in its labeling and fails to meet the 
requirements of paragraph (a)(3) of this section and, if applicable, 
paragraphs (c)(2) through (4) of this section will be deemed 
misbranded.
* * * * *
    (c) Compliance. (1) When compliance with paragraph (b) of this 
section is based on an analysis of the food, FDA will use a 
scientifically valid method that can reliably detect and quantify 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 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

[[Page 49261]]

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: July 29, 2020.
Stephen M. Hahn,
Commissioner of Food and Drugs.
[FR Doc. 2020-17088 Filed 8-12-20; 8:45 am]
BILLING CODE 4164-01-P