[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Draft Guidance for Industry: Food Allergen Labeling Exemption 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announcing the availability of a draft guidance for industry entitled 
``Draft Guidance for Industry: Food Allergen Labeling Exemption 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 The draft guidance, when finalized, will 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draft guidance before we begin work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 5, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Food Additive Safety, Center for Food Safety 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draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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