[Federal Register Volume 86, Number 64 (Tuesday, April 6, 2021)]
[Notices]
[Pages 17843-17845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07002]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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, the Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by May 6, 2021.

[[Page 17844]]


ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0792. Also include the FDA docket 
number found in brackets in the heading of this document.

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, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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.
    The Food Allergen Labeling and Consumer Protection Act of 2004 
(FALCPA) (Title II, Pub. L. 108-282) amended the Federal Food, Drug, 
and Cosmetic Act (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). 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).
    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.
    In the Federal Register of October 28, 2020 (85 FR 68333), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although some comments were received, they 
pertained to substantive and/or technical aspects of statutory 
requirements found in section 403(w) of the FD&C Act, or 
recommendations found in related Agency guidance. None of the comments 
discussed the information collection topics found in 5 CFR 
1320.5(a)(1)(B) as requested in the notice, nor did any of the comments 
suggest FDA revise its estimate of the burden for the information 
collection.
    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 Section; Activity         Number of    disclosures per   Total annual    Average burden    Total hours
                                  respondents      respondent      disclosures    per disclosure
----------------------------------------------------------------------------------------------------------------
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........
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ...............  ..............  ...............          77,516
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

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

[[Page 17845]]

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.
    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.

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

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 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.

    Dated: March 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07002 Filed 4-5-21; 8:45 am]
BILLING CODE 4164-01-P


