[Federal Register Volume 87, Number 229 (Wednesday, November 30, 2022)]
[Notices]
[Pages 73561-73565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26110]


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

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Cosmetic Act (Edition 5): Draft Guidance for Industry; Availability; 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.

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

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Federal Food, Drug, and Cosmetic Act (Edition 5): Draft Guidance for 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 The draft guidance, when finalized, will explain FDA's 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 The draft 
guidance is a revision of a currently issued guidance, entitled 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This draft guidance is not final nor is it in effect at this time.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DATES: Submit either electronic or written comments on the draft 
guidance by January 30, 2023 to ensure that we consider your comment on 
the draft guidance before we begin work on the final version of the 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 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: 
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the 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, [email protected].

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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.................................................
                                                      --------------------------------------------------------------------------------------------------
    Total............................................  ..............  .................  ..............  ..............          89,900       1,414,375
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
   FD&C act section; activity        Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
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.....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             168
----------------------------------------------------------------------------------------------------------------
\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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/FoodGuidances, or https://www.regulations.gov. 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