[Federal Register Volume 80, Number 118 (Friday, June 19, 2015)]
[Notices]
[Page 35372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15119]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0052]
Food Allergen Labeling Exemption Petitions and Notifications;
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (``FDA'' or ``we'') is
announcing the availability of a guidance for industry entitled ``Food
Allergen Labeling Exemption Petitions and Notifications.'' This
guidance explains FDA's current thinking on the preparation of
regulatory submissions for obtaining exemptions for ingredients from
the labeling requirements for major food allergens in the Federal Food,
Drug, and Cosmetic Act (FD&C Act) through submission of either a
petition or a notification.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Nutrition, Labeling and Dietary Supplements, Center for
Food Safety and Applied Nutrition (HFS-820), Food and Drug
Administration, 5100 Paint Branch Pkwy., 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.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Richard Bonnette, Center for Food and
Applied Nutrition (HFS-255), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, 240-402-1235.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 8, 2014 (79 FR 26435), we announced
the availability of a draft guidance entitled ``Draft Guidance for
Industry: Food Allergen Labeling Exemption Petitions and
Notifications'' and gave interested parties an opportunity to submit
comments on the draft guidance at any time and comments on the proposed
collection of information by September 25, 2014. We received several
comments and revised the guidance accordingly.
The Food Allergen Labeling and Consumer Protection Act of 2004
(FALCPA) (Title II of 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 allergens on the product label using the common or usual
name of that major food allergen. Section 201(qq) of the FD&C Act (21
U.S.C. 321(qq)) now 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 eliminate the allergenic proteins in that derived
ingredient such that it is not a risk for food allergic individuals. 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
presents a risk for food allergic individuals. 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 (21 U.S.C. 343(w)(1)). 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).
The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). This guidance represents the
current thinking of FDA on Food Allergen Labeling Exemption Petitions
and Notifications. It does not create or confer any rights for or on
any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information in this guidance was approved under OMB
control number 0910-0792.
III. Comments
Interested persons may submit either electronic comments regarding
the guidance to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/FoodGuidances or http://www.regulations.gov.
Use the FDA Web site listed in the previous sentence to find the most
current version of the guidance.
Dated: June 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15119 Filed 6-18-15; 8:45 am]
BILLING CODE 4164-01-P