Notice2022-26110
Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request; and Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Final Guidance for Industry
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Published
November 30, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Draft Guidance for Industry." The draft guidance, when finalized, will explain FDA's current thinking on a number of issues related to the labeling of food allergens, including requirements in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act). The draft guidance is a revision of a currently issued guidance, entitled "Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4)." This draft guidance is not final nor is it in effect at this time. In addition, the FDA is announcing availability of a final guidance entitled "Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Final Guidance for Industry." This final guidance includes the questions and answers from the currently issued guidance that remain substantively unchanged.
Full Text
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<title>Federal Register, Volume 87 Issue 229 (Wednesday, November 30, 2022)</title>
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[Federal Register Volume 87, Number 229 (Wednesday, November 30, 2022)]
[Notices]
[Pages 73561-73565]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-26110]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0099]
Questions and Answers Regarding Food Allergens, Including the
Food Allergen Labeling Requirements of the Federal Food, Drug, and
Cosmetic Act (Edition 5): Draft Guidance for Industry; Availability;
Agency Information Collection Activities; Proposed Collection; Comment
Request; and Questions and Answers Regarding Food Allergens, Including
the Food Allergen Labeling Requirements of the Federal Food, Drug, and
Cosmetic Act (Edition 5): Final Guidance for Industry
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft
[[Page 73562]]
guidance for industry entitled ``Questions and Answers Regarding Food
Allergens, Including the Food Allergen Labeling Requirements of the
Federal Food, Drug, and Cosmetic Act (Edition 5): Draft Guidance for
Industry.'' The draft guidance, when finalized, will explain FDA's
current thinking on a number of issues related to the labeling of food
allergens, including requirements in the Food Allergen Labeling and
Consumer Protection Act of 2004 (FALCPA) and the Food Allergy Safety,
Treatment, Education, and Research Act of 2021 (FASTER Act). The draft
guidance is a revision of a currently issued guidance, entitled
``Questions and Answers Regarding Food Allergens, Including the Food
Allergen Labeling and Consumer Protection Act of 2004 (Edition 4).''
This draft guidance is not final nor is it in effect at this time. In
addition, the FDA is announcing availability of a final guidance
entitled ``Questions and Answers Regarding Food Allergens, Including
the Food Allergen Labeling Requirements of the Federal Food, Drug, and
Cosmetic Act (Edition 5): Final Guidance for Industry.'' This final
guidance includes the questions and answers from the currently issued
guidance that remain substantively unchanged.
DATES: Submit either electronic or written comments on the draft
guidance by January 30, 2023 to ensure that we consider your comment on
the draft guidance before we begin work on the final version of the
guidance. Submit electronic or written comments on the proposed
collection of information in the draft guidance by January 30, 2023.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2022-D-0099 for ``Questions and Answers Regarding Food Allergens,
Including the Food Allergen Labeling Requirements of the Federal Food,
Drug, and Cosmetic Act (Edition 5): Draft Guidance for Industry.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance documents
to the Office of Nutrition and Food Labeling, Division of Food Labeling
and Standards, Center for Food Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two
self-addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance documents.
FOR FURTHER INFORMATION CONTACT:
With regard to the guidance documents: Carol D'Lima, Office of
Nutrition and Food Labeling (HFS-800), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-2371; or Denise See, Office of
Regulations and Policy (HFS-024), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740, 240-402-2378.
With regard to the proposed collection of information: Domini Bean,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
5733, <a href="/cdn-cgi/l/email-protection#500002110324313636103634317e3838237e373f26"><span class="__cf_email__" data-cfemail="247476657750454242644240450a4c4c570a434b52">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FALCPA (Pub. L. 108-282) was enacted in August 2004 and, in part,
amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by
defining the term ``major food allergen'' and requiring that the
presence of any major food allergen be declared on the labels of FDA-
regulated foods. FALCPA defined a major food allergen as milk, egg,
fish (e.g., bass, flounder, or cod), crustacean shellfish (e.g., crab,
lobster,
[[Page 73563]]
or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat,
peanuts, and soybeans and as a food ingredient that contains protein
derived from these foods (section 201(qq) (21 U.S.C. 321(qq)) of the
FD&C Act). In addition, the FASTER Act (Pub. L. 117-11) was enacted in
April 2021 and, in part, amended the definition of major food allergen
in the FD&C Act to include sesame, effective January 1, 2023.
Exceptions to the definition include highly refined oil derived from a
major food allergen and any ingredient derived from the highly refined
oil. FALCPA also amended the FD&C Act to include provisions to request
an exemption from the food allergen labeling requirements through a
petition process when a food ingredient is demonstrated to not cause an
allergic response that poses a risk to human health or through a
notification process when processing of a food ingredient results in
the removal of the allergenic protein (section 403(w)(6) and (7) of the
FD&C Act (21 U.S.C. 343(w)(6) and (7))).
Since the passage of FALCPA, FDA has received numerous questions
about food allergen labeling requirements. To explain FALCPA's
requirements as well as FDA's current thinking on issues relating to
the regulation of food allergens, on October 5, 2005, FDA issued the
first edition of a guidance entitled ``Guidance for Industry: Questions
and Answers Regarding Food Allergens, including the Food Allergen
Labeling and Consumer Protection Act of 2004.'' We subsequently updated
the guidance in December 2005 (Edition 2), April 2006 (Edition 3), and
October 2006 (Edition 4).
FDA is issuing a draft guidance for industry entitled ``Questions
and Answers Regarding Food Allergens, Including the Food Allergen
Labeling Requirements of the Federal Food, Drug, and Cosmetic Act
(Edition 5).'' The draft guidance is a revision of Edition 4 originally
entitled ``Questions and Answers Regarding Food Allergens, Including
the Food Allergen Labeling and Consumer Protection Act of 2004'' that
contains revised and new questions and answers relating to food
allergens, including questions and answers about FALCPA and the FASTER
Act. Editorial changes, such as renumbering and organizational changes
have also been made in this revision.
FDA is also issuing a final guidance, ``Questions and Answers
Regarding Food Allergens, Including the Food Allergen Labeling
Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5),''
that contains the questions and answers from Edition 4 that remain
unchanged, with the exception of editorial changes such as renumbering
and organizational changes, and are therefore being reissued as final
guidance. FDA is issuing the draft guidance document to receive
comments on the new or revised questions and answers, and, as
appropriate, will move the questions and answers to the final guidance
document, after reviewing comments and incorporating any changes to the
questions and answers, when appropriate. Note that some questions and
answers that were in Edition 4 of the final guidance have been
withdrawn and moved to the draft guidance document if FDA determined
that the question and answer should be revised in some respect and
reissued in draft for comment. For ease of reference, a question
retains the same number when it moves from the draft guidance to the
final guidance and we use the term ``RESERVED'' after some question
numbers, where appropriate, to facilitate this process.
We are issuing these guidance documents consistent with our good
guidance practices regulation (21 CFR 10.115). The guidance documents
do not establish any rights for any person and are not binding on FDA
or the public. You can use an alternate approach if it satisfies the
requirements of the applicable statutes and regulations.
The draft guidance (``Questions and Answers Regarding Food
Allergens, Including the Food Allergen Labeling Requirements of the
Federal Food, Drug, and Cosmetic Act (Edition 5)'' responds to new
questions about food allergen labeling requirements, including, but not
limited to, the labeling of sesame, milk, eggs, incidental additives,
highly refined oils, dietary supplement products, and certain specific
packing and labeling situations (e.g., individual units within a
multiunit package). For example, we have included draft questions and
answers regarding our historical interpretation of the terms ``milk''
and ``eggs;'' for purposes of the definition of a ``major food
allergen'' under section 201(qq) of the FD&C Act and complying with the
food allergen labeling requirements of the FD&C Act. FDA has
historically interpreted ``milk'' as milk from the domesticated cow and
``eggs'' as eggs from the domesticated chicken.
Since 2005, when we first issued the guidance document, there have
been changes in our laws as well as in the overall food marketplace.
For example, in 2011, the FDA Food Safety Modernization Act (FSMA)
added new allergen control provisions for major food allergens. We are
also aware that, while the market in the United States for milk and
eggs from species other than domesticated cows and chickens remains
limited, it has increased in recent years. Given that, we are
considering whether we should modify our historical interpretations of
``milk'' and ``eggs'' for purposes of the definition of ``major food
allergen'' under 201(qq) of the FD&C Act and complying with the food
allergen labeling requirements of the FD&C Act as set forth in the
guidance document.
For example, for ``milk,'' we note that our regulation, at 21 CFR
131.110, defines ``milk'' as the lacteal secretion, practically free
from colostrum, obtained by the complete milking of one or more healthy
cows, and our historical interpretation of ``milk'' in the context of a
major food allergen under the FD&C Act has been consistent with this
definition. However, we are aware that foods from ruminant species such
as goat's milk, sheep's milk and buffalo's milk are sold or used in
human food, and that allergic reactions associated with consumption of
milk from other ruminants have been reported in some individuals. While
consumption of such foods in the United States is limited, in light of
the risk of allergic reactions associated with consumption of milk from
other ruminants, we invite comment on whether we should revise our
interpretation of ``milk'' for this guidance, what a revised
interpretation should be, and the potential implications or impact of a
revised interpretation.
Similarly, some FDA documents interpret ``eggs'' as coming solely
from chickens, and our historical interpretation in the context of a
major food allergen under the FD&C Act has been to consider eggs as
coming from chickens. However, we are aware that eggs from various bird
species (such as turkey, duck, goose, and guinea) can be purchased and
are used as human food. In addition, we are aware that allergic
reactions associated with eggs from birds other than chickens have been
reported in some individuals. Thus, we invite comment on whether we
should revise our interpretation of ``eggs'' for this guidance, what a
revised interpretation should be, and the potential implications or
impact of a revised interpretation.
We also have revised several questions and answers to update and
clarify information presented in previous editions, including, among
other things, questions related to the labeling of tree nuts, fish, and
crustacean shellfish. We also invite comments on these draft questions
and answers.
[[Page 73564]]
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Questions and Answers Regarding Food Allergens, Including the Food
Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic
Act (Edition 5): Guidance for Industry
OMB Control Number 0910-0792--Revision
The draft guidance, when finalized, will explain FDA's current
thinking on the labeling requirements in FALCPA and the FASTER Act. The
draft guidance will assist food manufacturers to comply with new
requirements under the FASTER Act for treating sesame as a major
allergen and declaring sesame on the label of food products, effective
January 1, 2023.
Description of respondents: The respondents to this collection of
information are manufacturers and packers of packaged foods sold in the
United States.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
FD&C act section; activity Number of disclosures per Total annual Average burden Total hours Total capital
respondents respondent disclosures per disclosure costs
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403(w)(1) (FALCPA); Review labels to comply with 77,500 1 77,500 1 77,500 0
sesame labeling requirements pursuant to the FASTER
Act.................................................
403(w)(1) (FALCPA); Redesign labels to comply with 775 1 775 16 12,400 $1,414,375
sesame labeling requirements pursuant to the FASTER
Act.................................................
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Total............................................ .............. ................. .............. .............. 89,900 1,414,375
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\1\ There are no operating and maintenance costs associated with this collection of information.
We base these estimates from our experience with our food allergen
labeling program and our labeling cost model. We estimate that there
are approximately 775,000 Universal Product Codes (UPCs) of FDA-
regulated foods. Using FDA's labeling cost model, we estimate the entry
rate of new UPCs to be approximately 8 percent per year. Based on the
approximate entry rate of new UPCs, we estimate the rate of new or
reformulated UPCs to be approximately 10 percent per year, or 77,500
products (775,000 x 10 percent). Thus, we estimate that 77,500 new or
reformulated products are sold annually in the United States. Assuming
an association of one respondent to each of the 77,500 new or
reformulated products, we estimate that 77,500 respondents will each
review the label of one of the 77,500 new or reformulated products, as
reported in table 1, row 1. We have no data on how many label reviews
would identify the need to redesign the label. Therefore, we further
estimate, for the purposes of this analysis, that 1 percent of the
reviewed labels of new or reformulated products, or 775 labels (77,500
x 1 percent) would need to be redesigned to comply with the labeling
requirements of the FASTER Act. Assuming an association of one
respondent to each of the 775 labels, we estimate that 775 respondents
will each redesign one label. Using our labeling cost model, we
estimate that it will take an average of 16 hours to complete the
administration and internal design work for the redesign of a label to
comply with the labeling requirements of the FASTER Act. Consequently,
the burden of redesigning the 775 labels of new or reformulated
products is 12,400 hours, as reported in table 1, row 2. Thus, the
total third-party disclosure burden would be 89,900 hours.
Table 2--Estimated Annual Reporting Burden \1\
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Number of Average
FD&C act section; activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
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403(w)(6) (FALCPA); petition for 1 1 1 100 100
exemption for sesame...........
403(w)(7) (FALCPA); notification 1 1 1 68 68
for sesame.....................
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Total....................... .............. .............. .............. .............. 168
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\1\ There are no operating and maintenance costs associated with this collection of information.
Based on the number of petitions and notifications under FALCPA
received in recent years, we estimate that we will receive one
additional petition and one additional notification annually for
sesame, over the next 3 years. We base
[[Page 73565]]
our estimate of the average burdens per response reported in table 2 on
our experience with the existing FALCPA petition process. We estimate
that a petition would take, on average, 100 hours to develop and
submit.
The burden of a notification involves collecting documentation that
a food ingredient does not pose an allergen risk. Either we can make a
determination that the ingredient does not cause an allergic response
that poses a risk to human health under a premarket approval or
notification program under section 409 of the FD&C Act (21 U.S.C. 348),
or the respondent would submit scientific evidence demonstrating that
the ingredient when manufactured as described does not contain
allergenic protein. Based on the existing FALCPA notification process,
we estimate that the average time to prepare and submit a notification
for sesame is approximately 68 hours. Thus, the total annual reporting
burden would be 168 hours over the next 3 years.
III. Electronic Access
Persons with access to the internet may obtain the guidance
documents at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, <a href="https://www.fda.gov/FoodGuidances">https://www.fda.gov/FoodGuidances</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Use the FDA website listed in the previous
sentence to find the most current version of the guidances.
Dated: November 23, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26110 Filed 11-29-22; 8:45 am]
BILLING CODE 4164-01-P
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