[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,
[email protected].
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
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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 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
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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.
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