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

Published date28 October 2020
Citation85 FR 68333
Record Number2020-23846
SectionNotices
CourtFood And Drug Administration
Federal Register, Volume 85 Issue 209 (Wednesday, October 28, 2020)
[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.
                -----------------------------------------------------------------------
                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.
                [[Page 68335]]
                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
                ----------------------------------------------------------------------------------------------------------------
                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
                [[Page 68336]]
                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
                ----------------------------------------------------------------------------------------------------------------
                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
                

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