Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods, 49240-49261 [2020-17088]
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49240
Federal Register / Vol. 85, No. 157 / Thursday, August 13, 2020 / Rules and Regulations
has determined that it has good cause to
adopt this rule without notice and
comment, RFA analysis is not required.
Regulatory Findings
The FAA has determined that this AD
will not have federalism implications
under Executive Order 13132. This AD
will not have a substantial direct effect
on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government.
For the reasons discussed above, I
certify that this AD:
(1) Is not a ‘‘significant regulatory
action’’ under Executive Order 12866,
and
(2) Will not affect intrastate aviation
in Alaska.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation
safety, Incorporation by reference,
Safety.
Adoption of the Amendment
Accordingly, under the authority
delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as
follows:
PART 39—AIRWORTHINESS
DIRECTIVES
1. The authority citation for part 39
continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40113, 44701.
§ 39.13
[Amended]
2. The FAA amends § 39.13 by adding
the following new airworthiness
directive:
■
2020–16–04 Pacific Aerospace Limited:
Amendment 39–21188; Docket No.
FAA–2020–0711; Project Identifier
MCAI–2020–00719–A.
(a) Effective Date
This airworthiness directive (AD) becomes
effective September 2, 2020.
(b) Affected ADs
None.
(c) Applicability
This AD applies to Pacific Aerospace
Limited Model 750XL airplanes, serial
numbers 101 through to 215, 220, 8001, and
8002, certificated in any category.
(d) Subject
Air Transport Association of America
(ATA) Code 27: Flight Controls.
(e) Reason
This AD was prompted by an incorrect
illustration of the screw jack assembly in the
airplane maintenance manual, thus causing
potential errors with installation. The FAA is
issuing this AD to require an inspection of
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the flap screw jack assembly to verify proper
configuration of the assembly and make the
correction if found improperly installed. This
unsafe condition, if not addressed, could
cause fatigue failure of a flap screw jack,
which could result in a failure of the flap
actuator to fully extend the flaps during the
completion of a final approach, a longer
landing distance, and consequent runway
overrun condition.
(f) Actions and Compliance
Unless already done, do the following
actions in paragraphs (f)(1) and (2) of this
AD.
(1) Within 20 hours time-in-service after
September 2, 2020 (the effective date of this
AD), inspect the left hand (LH) and right
hand (RH) flap screw jack assemblies for
proper installation by following the
Accomplishment Instructions, paragraphs
A.1) through A.3), of Pacific Aerospace
Mandatory Service Bulletin (MSB) PACSB/
XL/117, Issue 2, dated August 21, 2019
(PACSB/XL/117, Issue 2). If a flap screw jack
assembly is not properly installed as shown
in figures 1 and 2 of PACSB/XL/117, Issue 2,
before further flight, comply with the
Accomplishment Instructions, Part B, of
PACSB/XL/117, Issue 2.
(2) As of September 2, 2020 (the effective
date of this AD), do not install a LH flap
screw jack assembly P/N 11–45621–1 or RH
flap screw jack assembly P/N 11–45622–1 on
any airplane, unless it is installed in
accordance with the Accomplishment
Instructions, Part B, of PACSB/XL/117,
Issue 2.
(g) Credit for Previous Actions
You may take credit for the actions
required by paragraph (f)(1) of this AD if you
performed those actions before the effective
date of this AD using Pacific Aerospace MSB
PACSB/XL/117, Issue 1, dated June 7, 2019.
(h) Special Flight Permit
Special flight permits may be issued may
be issued for the purpose of operating the
airplane to a location where the requirements
of this AD can be performed with the
following limitations: Flights must not carry
passengers.
(i) Alternative Methods of Compliance
(AMOCs)
The Manager, Small Airplane Standards
Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Send
information to ATTN: Mike Kiesov,
Aerospace Engineer, FAA, General Aviation
& Rotorcraft Section, International Validation
Branch, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone: (816) 329–4144;
fax: (816) 329–4090; email: mike.kiesov@
faa.gov. Before using any approved AMOC on
any airplane to which the AMOC applies,
notify your appropriate principal inspector
(PI) in the FAA Flight Standards District
Office (FSDO), or lacking a PI, your local
FSDO.
(j) Related Information
Refer to mandatory continuing
airworthiness information (MCAI) New
Zealand Civil Aviation Authority AD No.
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DCA/750XL/38A, dated September 5, 2019,
for related information. You may examine the
MCAI on the internet at https://
www.regulations.gov by searching for and
locating Docket No. FAA–2020–0711.
(k) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference of
the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
(2) You must use this service information
as applicable to do the actions required by
this AD, unless the AD specifies otherwise.
(i) Pacific Aerospace Mandatory Service
Bulletin PACSB/XL/117, Issue 2, dated
August 21, 2019.
(ii) [Reserved]
(3) For Pacific Aerospace Limited service
information identified in this AD, contact
Pacific Aerospace Limited, Airport Road,
Hamilton, Private Bag 3027, Hamilton 3240,
New Zealand; phone: +64 7843 6144; fax:
+64 7843 6134; email: pacific@
aerospace.co.nz; internet: https://
www.aerospace.co.nz/.
(4) You may view this referenced service
information at the FAA, Airworthiness
Products Section, Operational Safety Branch,
901 Locust, Kansas City, Missouri 64106. For
information on the availability of this
material at the FAA, call (816) 329–4148. It
is also available on the internet at https://
www.regulations.gov by searching for Docket
No. FAA–2020–0711.
(5) You may view this service information
that is incorporated by reference at the
National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA,
email fedreg.legal@nara.gov, or go to: https://
www.archives.gov/federal-register/cfr/ibrlocations.html.
Issued on July 29, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives,
Compliance & Airworthiness Division,
Aircraft Certification Service.
[FR Doc. 2020–17607 Filed 8–12–20; 8:45 am]
BILLING CODE 4910–13–P
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.
The Food and Drug
Administration (FDA or we) is issuing a
final rule to establish requirements
SUMMARY:
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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 ‘‘glutenfree.’’ 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 ‘‘glutenfree’’ 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 crosscontact 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.
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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, Carol.Dlima@
fda.hhs.gov. 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, PRAStaff@fda.hhs.gov.
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 GlutenFree 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-freelabeling-foods. In the Federal Register
of August 5, 2013 (78 FR 47154), we
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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 § 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
(§ 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 glutencontaining grain and that has not been
processed to remove gluten; or (3) an
ingredient that is derived from a glutencontaining 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
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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 § 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 § 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 § 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
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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 § 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.
Compliance Policy Guide.
Executive Order.
Food Allergen Labeling and Consumer Protection Act.
Federal Food, Drug, and Cosmetic
Act.
Good Manufacturing Practice.
CPG ...............
E.O. ................
FALCPA .........
FD&C Act .......
GMP ...............
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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 ‘‘glutenfree’’ 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
§ 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
(§ 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)
(§ 101.91(a)(3)(ii)).
Through comments we received in
response to the proposed rule for glutenfree 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
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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 ELISAbased test methods, the lack of
appropriate calibration standards or
suitable reference materials make
accurate quantification of gluten content
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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 ‘‘glutenfree’’ 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 § 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 § 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
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hydrolysis; (2) the manufacturer has
adequately evaluated their processing
for any potential for gluten crosscontact; 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 ‘‘glutenfree,’’ 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
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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 § 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
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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
§ 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 glutencontaining grains or having a known or
reasonably foreseeable risk of crosscontact 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 crosscontact 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 crosscontact should be flexible based on
ingredients and facility. Further, the
comments stated that we should clarify
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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 crosscontact 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 crosscontact 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 glutencontaining 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 crosscontact, 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-glutencontaining 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 § 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
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grain by fermentation. The final rule is
intended to cover all foods that are
fermented or contain fermented
ingredients and bear the term ‘‘glutenfree,’’ not just those from glutencontaining 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 crosscontact. 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 crosscontact 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 crosscontact 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 ‘‘glutenfree’’ 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
§ 101.91(c)(2) and (3), requires that
manufacturers of a fermented or
hydrolyzed product who wish to use a
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‘‘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
§ 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 ‘‘glutenfree’’ 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 § 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 § 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
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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
§ 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
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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 ‘‘glutenfree.’’
(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
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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
§ 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
(§ 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 peerreviewed 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
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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
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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 glutenfree 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
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49247
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 glutenfree 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 § 101.91(c)(1), has
been developed that can accurately
detect and quantify gluten in some or all
fermented or hydrolyzed foods or
ingredients, § 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
§ 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 § 101.91(c)(1). (On our own
initiative, we have revised § 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.
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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
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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
§ 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 § 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,’’ ‘‘glutenfree’’ with a disclaimer, ‘‘glutenreduced,’’ no gluten claim allowed) that
allows ‘‘gluten-free’’ labeling when
testing is possible with the caveat that
if the starting material was a glutencontaining 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.
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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 (§ 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 § 101.91(c)(5).
As for the comment regarding a tiered
labeling system, to be consistent with
§ 101.91, which defines the term
‘‘gluten-free,’’ we decline to introduce a
tiered labeling system along with a
disclaimer because § 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
§ 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
§ 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
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vinegar is made from distilled ethanol
which is further fermented into vinegar
by bacteria. Distilled ethanol is
generally produced from non-glutencontaining 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
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protein fragments (and thus gluten) in
distilled foods. Therefore, as indicated
in § 101.91(c)(5) of this final rule, we
will evaluate compliance with
§ 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 § 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
§ 101.91(c)(2)–(c)(4), and FDA would
determine compliance in accordance
with § 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
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wording of proposed § 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 § 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 ‘‘glutenfree’’ 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 § 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
§ 101.91(c)(2) though (c)(4), and FDA
would determine compliance with the
‘‘gluten free’’ labeling requirements
under § 101.91(c)(1).
(Comment 13) One comment stated
that the proposed rule appears to
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impose a stricter requirement on
electronic records related to the glutenfree 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 § 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 § 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 RiskBased 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 § 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 ‘‘glutenfree.’’ The comment said that the
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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 RiskBased Preventive Controls for Human
Food’’ (21 CFR part 117) for food safety
hazard analysis. In particular, the
comment said that, in § 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 § 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
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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 § 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
§ 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 § 101.91(a).
Therefore, we decline to change the rule
as suggested by the comment and have
finalized § 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 glutenfree 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 ‘‘glutenfree’’ 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-glutencontaining grain; or (2) made from a
gluten-containing grain, where the beer
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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
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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 ‘‘glutenfree’’ and that consumers may think
they are the same, especially because
these products are often marketed as
‘‘gluten-free.’’ Other comments stated
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49251
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
§ 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 § 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 ‘‘glutenreduced,’’ ‘‘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 § 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
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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 ‘‘glutenfree,’’ 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 § 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
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statements may not expressly or
implicitly suggest to the consumer that
the product is ‘‘gluten-free’’ when it
does not meet the requirements of
§ 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 glutencontaining 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.
(Response 17) The Codex Standards
for ‘‘gluten-free’’ labeling (see Codex
Standard 118–1979, section 2.1.1b)
require that foods labeled as ‘‘glutenfree’’ 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 FDAregulated 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 § 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
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.
https://siweb.dss.go.th/standard/Fulltext/codex/
CXS_118E.pdf.
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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 ‘‘glutenfree’’ 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 ‘‘glutenfree’’ 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
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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 § 101.91, gluten-containing grains
(e.g., wheat, rye, barley) are not to be
used in the production of ‘‘gluten-free’’
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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 ‘‘glutenfree.’’
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 ‘‘glutenfree’’ 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 glutencontaining 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 glutenfree 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 maltderived ingredients are ingredients
derived from gluten-containing grains
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49253
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, § 101.91(a)(3)(i)(A)(3)
prohibits a food that contains an
ingredient that is derived from a glutencontaining 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 glutenreduced 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
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Federal Register / Vol. 85, No. 157 / Thursday, August 13, 2020 / Rules and Regulations
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 ‘‘glutenfree’’ 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 2018dollar 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 glutenfree diet benefit from the rule each year.
TABLE 1—SUMMARY OF BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF FINAL RULE
[Millions]
Units
Category
Benefits:
Annualized Monetized $ millions/
year.
Annualized Quantified ......................
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Primary
estimate
Low
estimate
High
estimate
..................
..................
..................
..................
..................
..................
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Year
dollars
Discount
rate
(%)
2018
2018
..................
E:\FR\FM\13AUR1.SGM
Period
covered
7
3
7
3
13AUR1
10
10
Notes
49255
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TABLE 1—SUMMARY OF BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF FINAL RULE—Continued
[Millions]
Units
Primary
estimate
Category
Qualitative ........................................
Costs:
Annualized Monetized $millions/year
Annualized Quantified Qualitative ....
Transfers:
Federal Annualized Monetized $
millions/year.
Low
estimate
High
estimate
Year
dollars
Discount
rate
(%)
Notes
Period
covered
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.
$9.09
8.76
..................
$7.34
7.14
..................
$11.46
10.94
..................
2018
2018
..................
7
3
7
3
..................
..................
..................
..................
7
3
From/To ............................................
From:
Other Annualized Monetized $ millions/year.
..................
From/To ............................................
From:
10
10
To:
..................
..................
..................
7
3
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
estimate
(7%)
Item
Present Value of Costs ................................................................................................................
Present Value of Cost Savings ...................................................................................................
Present Value of Net Costs .........................................................................................................
Annualized Costs .........................................................................................................................
Annualized Cost Savings .............................................................................................................
Annualized Net Costs ..................................................................................................................
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
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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–
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$107.12
0
$107.12
$7.50
0
$7.50
Lower
estimate
(7%)
$89.37
0
$89.37
$6.26
0
$6.26
Upper
estimate
(7%)
$130.02
0
$130.02
$9.10
0
$9.10
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.
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Recordkeeping Requirements for GlutenFree 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 crosscontact. 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 § 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 § 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
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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 ‘‘glutenfree’’ 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
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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 ×
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 × 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 × 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 ‘‘glutenfree’’ 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
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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 × 14 samples per
manufacturer × (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 × 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 × $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 × 14
sample records per manufacturer × 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 × 42
test kits per manufacturer × (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 × 42 test
kits per manufacturer = 52,500 test kits).
These test kits have an average cost of
49257
$11, which means that the estimated
capital costs related to this recurring
paperwork burden is about $0.6 million
(52,500 test kits × $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 × 42 test kits per
manufacturer × 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 × 2 tests per
manufacturer × (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 × 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
× $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 × 2 tests per
manufacturer × 0.5 hours per test =
5,000 hours), as reported in table 4,
row 6.
TABLE 3—ESTIMATED FIRST YEAR RECORDKEEPING BURDEN 1
Activity/proposed
21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total
hours
Capital costs
(USD millions)
Developing an SOP for gluten
control; 101.91(c)(2) and (3).
Collecting samples for testing;
101.91(c)(2) and (3).
Maintaining records of method
extension tests; 101.91(c)(2)
and (3).
1,250
1
1,250
7 .....................................
8,750
0
1,250
14
17,500
0.083 (5 minutes) ...........
1,458
$1.5
5,000
14
70,000
0.5 (30 minutes) .............
35,000
0
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
Activity/proposed
21 CFR section
Number of
recordkeepers
Updating SOP for gluten control; 101.91(c)(2) and (3).
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Number of
records per
recordkeeper
1,250
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Total
annual
records
1
Frm 00029
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1,250
Sfmt 4700
Average
burden per
recordkeeping
Total
hours
0.7 (42 minutes) .............
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Capital costs
(USD millions)
875
0
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Federal Register / Vol. 85, No. 157 / Thursday, August 13, 2020 / Rules and Regulations
TABLE 4—ESTIMATED RECURRING RECORDKEEPING BURDEN 1—Continued
Activity/proposed
21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total
hours
Capital costs
(USD millions)
Maintaining records of the updated SOP for gluten control; 101.91(c)(2) and (3).
Collecting samples for test kit
testing; 101.91(c)(2) and (3).
Maintaining records of test kit
test results; 101.91(c)(2) and
(3).
Collecting samples for testing
by an outside lab;
101.91(c)(2) and (3).
Maintaining records of testing
by an outside lab;
101.91(c)(2) and (3).
5,000
1
5,000
1 .....................................
5,000
0
1,250
42
52,500
0.083 (5 minutes) ...........
4,375
$0.6
5,000
42
210,000
0.5 (30 minutes) .............
105,000
0
1,250
2
2,500
0.083 (5 minutes) ...........
208
$0.2
5,000
2
10,000
0.5 (30 minutes) .............
5,000
0
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
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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 glutenfree 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 § 101.91(b)(2).
There is a need for national uniformity
in the meaning of the term ‘‘glutenfree,’’ 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
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Fmt 4700
Sfmt 4700
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 ‘‘glutenfree’’ in the labeling of fermented and
hydrolyzed foods so that foods with this
claim in labeling, and foods with a
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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 ‘‘glutenfree,’’ ‘‘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 § 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
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circumstances and describe how the
final rule’s codified provision regarding
preemption, which is now § 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
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49259
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 ‘‘glutenfree.’’
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
§ 101.91(d) regarding preemption, but
the new requirements in § 101.91(c) are
part of the requirements covered by
§ 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.
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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 CerealBased 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. OnleyWatson, 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.20500416.2003.tb00592.x.
8. Akeroyd, M., S. Van Zandycke, J. den
Hartog, J. Mutsaers, et al. ‘‘AN–PEP
Proline Specific Endo-Peptidase
VerDate Sep<11>2014
20:42 Aug 12, 2020
Jkt 250001
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-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 WheatGluten-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
https://www.glutenfreedietitian.com/
should-manufacturers-consumers-uselateral-flow-devices-ez-gluten-to-testfood-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
1. The authority citation for 21 CFR
part 101 continues to read as follows:
■
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Frm 00032
Fmt 4700
Sfmt 4700
Authority: 15 U.S.C. 1453, 1454, 1455; 21
U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C.
243, 264, 271.
2. In § 101.91, revise paragraphs (b)(1),
(b)(2), and (c) to read as follows:
■
§ 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
E:\FR\FM\13AUR1.SGM
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Federal Register / Vol. 85, No. 157 / Thursday, August 13, 2020 / Rules and Regulations
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
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805.
Please note that due to the public
health emergency, the EPA Docket
Center (EPA/DC) and Reading Room
was closed to public visitors on March
31, 2020. Our EPA/DC staff will
continue to provide customer service
via email, phone, and webform. For
further information on EPA/DC services,
docket contact information and the
current status of the EPA/DC and
Reading Room, please visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
ENVIRONMENTAL PROTECTION
AGENCY
I. General Information
40 CFR Part 180
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
A. Does this action apply to me?
[EPA–HQ–OPP–2019–0249; FRL–10011–78]
Novaluron; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
and modifies tolerances for residues of
novaluron in or on multiple
commodities which are identified and
discussed later in this document.
Interregional Research Project Number 4
(IR–4) requested these tolerances and
modifications under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
August 13, 2020. Objections and
requests for hearings must be received
on or before October 13, 2020 and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2019–0249, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
SUMMARY:
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16:05 Aug 12, 2020
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a(g), any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
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Sfmt 4700
49261
identify docket ID number EPA–HQ–
OPP–2019–0249 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing and must be received
by the Hearing Clerk on or before
October 13, 2020. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2019–0249, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of August 30,
2019 (84 FR 45702) (FRL–9998–15),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 9E8746) by IR–4,
IR–4 Project Headquarters, Rutgers, The
State University of New Jersey, 500
College Road East, Suite 201 W,
Princeton, NJ 08540. The petition
requested to amend 40 CFR 180.598 by
establishing tolerances for residues of
the insecticide novaluron, including its
metabolites and degradates, in or on the
following commodities: Brassica, leafy
greens, subgroup 4–16B at 25 parts per
million (ppm); cottonseed subgroup 20C
at 0.6 ppm; kohlrabi at 0.7 ppm;
sunflower subgroup 20B at 0.07 ppm;
tropical and subtropical, small fruit,
inedible peel, subgroup 24A at 9 ppm;
E:\FR\FM\13AUR1.SGM
13AUR1
Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
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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
[[Page 49247]]
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.
https://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 https://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