[Federal Register Volume 85, Number 209 (Wednesday, October 28, 2020)]
[Notices]
[Pages 68333-68336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23846]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1030]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food Allergen Labeling and Reporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is

[[Page 68334]]

announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
provisions of the labeling requirements for major food allergens in the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) and the information 
collection provisions of the guidance entitled ``Guidance for Industry: 
Food Allergen Labeling Exemption Petitions and Notifications.''

DATES: Submit either electronic or written comments on the collection 
of information by December 28, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 28, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 28, 2020. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

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-2014-N-1030 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Food Allergen Labeling and 
Reporting.'' Received comments, those filed in a timely manner (see 
ADDRESSES), 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.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on 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.

FOR FURTHER INFORMATION CONTACT: 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: Under the 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, including 
each proposed extension of an existing 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.

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Food Allergen Labeling and Reporting

OMB Control Number 0910-0792--Extension

    This information collection supports the reporting associated with 
the submission of petitions and notifications seeking exemptions from 
the labeling requirements for ingredients derived from major food 
allergens, and the Agency's associated guidance document.

I. Background

    The Food Allergen Labeling and Consumer Protection Act of 2004 
(FALCPA) (Title II, Pub. L. 108-282) amended the FD&C Act by defining 
the term ``major food allergen'' and stating that foods regulated under 
the FD&C Act are misbranded unless they declare the presence of each 
major food allergen on the product label using the name of the food 
source from which the major food allergen is derived. Section 403(w)(1) 
of the FD&C Act (21 U.S.C. 343(w)(1)) sets forth the requirements for 
declaring the presence of each major food allergen on the product 
label. Section 201(qq) of the FD&C Act ((21 U.S.C. 321(qq)) defines a 
major food allergen as ``[m]ilk, egg, fish (e.g., bass, flounder, or 
cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts 
(e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans'' and 
also as a food ingredient that contains protein derived from such 
foods. The definition excludes any highly refined oil derived from a 
major food allergen and any ingredient derived from such highly refined 
oil.
    In some cases, the production of an ingredient derived from a major 
food allergen may alter or eliminate the allergenic proteins in that 
derived ingredient to such an extent that it does not contain 
allergenic protein. In addition, a major food allergen may be used as 
an ingredient or as a component of an ingredient such that the level of 
allergenic protein in finished food products does not cause an allergic 
response that poses a risk to human health. Therefore, FALCPA provides 
two mechanisms through which such ingredients may become exempt from 
the labeling requirement of section 403(w)(1) of the FD&C Act. An 
ingredient may obtain an exemption through submission and approval of a 
petition containing scientific evidence that demonstrates that the 
ingredient ``does not cause an allergic response that poses a risk to 
human health'' (section 403(w)(6) of the FD&C Act) (21 U.S.C. 
343(w)(6). Alternately, an ingredient may become exempt through 
submission of a notification containing scientific evidence showing 
that the ingredient ``does not contain allergenic protein'' or that 
there has been a previous determination through a premarket approval 
process under section 409 of the FD&C Act (21 U.S.C. 348) that the 
ingredient ``does not cause an allergic response that poses a risk to 
human health'' (section 403(w)(7) of the FD&C Act) (21 U.S.C. 
343(w)(7)).

A. Third-Party Disclosure

    The labeling requirements of section 403(w)(1) of the FD&C Act 
apply to all packaged foods sold in the United States that are 
regulated under the FD&C Act, including both domestically manufactured 
and imported foods. As noted, section 403(w)(1) of the FD&C Act 
requires that the label of a food product declare the presence of each 
major food allergen. We estimate the information collection burden of 
the third-party disclosure associated with food allergen labeling under 
section 403(w)(1) of the FD&C Act as the time needed for a manufacturer 
to review the labels of new or reformulated products for compliance 
with the requirements of section 403(w)(1) of the FD&C Act and the time 
needed to make any needed modifications to the labels of those 
products. The allergen information disclosed on the label or labeling 
of a food product benefits consumers who purchase that food product. 
Because even small exposure to a food allergen can potentially cause an 
adverse reaction, consumers use food labeling information to help 
determine their product choices.
    Description of Respondents: The respondents to this collection of 
information are manufacturers and packers of packaged foods sold in the 
United States that declare the presence of a major food allergen on the 
product label. In terms of reporting, the respondents are manufacturers 
and packers of packaged foods sold in the United States that seek an 
exemption from the labeling requirements of section 403(w)(1) of the 
FD&C Act.
    We estimate the third-party disclosure burden of the collection of 
information as follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                    Number of
     FD&C section; activity         Number of    disclosures per   Total annual   Average burden    Total hours
                                   respondents      respondent      disclosures   per disclosure
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403(w)(1); review labels for             77,500                1          77,500               1          77,500
 compliance with food allergen
 labeling requirements.........
403(w)(1); redesign labels to                 1                1               1              16              16
 comply with food allergen
 labeling requirements.........
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    Total......................  ..............  ...............  ..............  ..............          77,516
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\1\ There are no operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last 
request for OMB approval, we are decreasing our burden estimate for the 
redesign of labels. FALCPA was enacted in 2004, and we issued 
associated Agency guidance in 2015. Firms have had substantial time to 
redesign their labels for compliance with section 403(w) of the FD&C 
Act. We do not anticipate any firms needing to redesign their label to 
come into compliance with section 403(w)(1) of the FD&C Act. Thus, we 
are decreasing the number of respondents redesigning their label from 
3,875 to 1 and the number of hours from 62,000 to 16. We estimate one 
respondent for the purpose of maintaining this information collection 
provision.

B. Reporting

    Under sections 403(w)(6) and (7) of the FD&C Act, respondents may 
request from us a determination that an ingredient is exempt from the 
labeling requirement of section 403(w)(1) of the FD&C Act. An 
ingredient may obtain an exemption through submission and approval of a 
petition containing scientific evidence that demonstrates that the 
ingredient ``does not cause an allergic response that poses a risk to 
human health'' (section 403(w)(6) of the FD&C Act). This section also 
states that ``the burden shall be on the petitioner to provide 
scientific evidence (including

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the analytical method used to produce the evidence) that demonstrates 
that such food ingredient, as derived by the method specified in the 
petition, does not cause an allergic response that poses a risk to 
human health.'' Alternately, an ingredient may become exempt through 
submission of a notification containing scientific evidence showing 
that the ingredient ``does not contain allergenic protein'' or that 
there has been a previous determination through a premarket approval 
process under section 409 of the FD&C Act that the ingredient ``does 
not cause an allergic response that poses a risk to human health'' 
(section 403(w)(7) of the FD&C Act).
    We issued a guidance document entitled ``Guidance for Industry: 
Food Allergen Labeling Exemption Petitions and Notifications,'' which 
is available on our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-food-allergen-labeling-exemption-petitions-and-notifications. The guidance 
sets forth our recommendations with regard to the information that 
respondents should submit in such a petition or notification. The 
guidance states that to evaluate these petitions and notifications, we 
will consider scientific evidence that describes: (1) The identity or 
composition of the ingredient; (2) the methods used to produce the 
ingredient; (3) the methods used to characterize the ingredient; (4) 
the intended use of the ingredient in food; and (5) either (a) for a 
petition, data and information, including the expected level of 
consumer exposure to the ingredient, that demonstrate that the 
ingredient, when manufactured and used as described, does not cause an 
allergic response that poses a risk to human health; or (b) for a 
notification, data and information that demonstrate that the 
ingredient, when manufactured as described, does not contain allergenic 
protein, or documentation of a previous determination under a process 
under section 409 of the FD&C Act that the ingredient does not cause an 
allergic response that poses a risk to human health. We use the 
information submitted in the petition or notification to determine 
whether the ingredient satisfies the criteria of section 403(w)(6) and 
(7) of the FD&C Act for granting the exemption.
    We estimate the reporting burden associated with the collection of 
information as follows:

                                 Table 2--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
     FD&C section; activity          Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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403(w)(6); petition for                        5               1               5             100             500
 exemption......................
403(w)(7); notification.........               5               1               5              68             340
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    Total.......................  ..............  ..............  ..............  ..............             840
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: October 22, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23846 Filed 10-27-20; 8:45 am]
BILLING CODE 4164-01-P