[Federal Register Volume 79, Number 89 (Thursday, May 8, 2014)]
[Notices]
[Pages 26435-26436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-10578]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0052]
Draft Guidance for Industry: Food Allergen Labeling Exemption
Petitions and Notifications; Availability
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announcing the availability of a draft guidance for industry entitled
``Draft Guidance for Industry: Food Allergen Labeling Exemption
Petitions and Notifications.'' The draft guidance, when finalized, will
explain our 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 (the FD&C Act) through submission of either a petition or
a notification.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before we begin work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 5, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Food Additive Safety, Center for Food Safety
and Applied Nutrition (HFS-200), 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
draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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. All comments should be identified with
the
[[Page 26436]]
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Steven Gendel, Center for Food and
Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, 240-402-1056.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a draft guidance entitled,
``Draft Guidance for Industry: Food Allergen Labeling Exemption
Petitions and Notifications.'' This draft guidance is intended to help
industry prepare petitions and notifications seeking exemptions from
the labeling requirements for ingredients derived from major food
allergens. 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
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 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 (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).
This draft guidance is being issued consistent with our good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent our current thinking on this topic. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), 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 publish
notice in the Federal Register soliciting public comment on each
proposed collection of information before submitting the collection to
OMB for approval. To comply with this requirement, we will publish a
60-day notice on the proposed collection of information in a future
issue of the Federal Register.
III. Comments
Interested persons may submit either electronic comments regarding
this document 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: May 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10578 Filed 5-7-14; 8:45 am]
BILLING CODE 4160-01-P