[Federal Register: December 27, 2005 (Volume 70, Number 247)]
[Notices]
[Page 76463]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27de05-57]


[[Page 76463]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0490]


Guidance for Industry: Questions and Answers Regarding Food
Allergens, Including the Food Allergen Labeling and Consumer Protection
Act of 2004 (Edition 2); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability of guidance.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised guidance document entitled ``Guidance for
Industry: Questions and Answers Regarding Food Allergens, including the
Food Allergen Labeling and Consumer Protection Act of 2004 (Edition
2).'' The guidance explains, using a question and answer format, FDA's
current thinking on a number of issues related to the regulation of
food allergens, including implementation of the Food Allergen Labeling
and Consumer Protection Act (FALCPA).

DATES: Submit written or electronic comments on the guidance document
at any time.

ADDRESSES: Submit written comments on the guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY

INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Rhonda R. Kane, Center for Food Safety
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 301-436-2371, or e-mail: 
rhonda.kane@fda.hhs.gov.


SUPPLEMENTARY INFORMATION:

I. Background

    The FALCPA (Public Law 108-282) amends the Federal Food, Drug, and
Cosmetic Act and requires that the label of a food product that is or
contains an ingredient that bears or contains a ``major food allergen''
declare the presence of the allergen as specified by FALCPA. FALCPA
defines a ``major food allergen'' as one of eight foods or a food
ingredient that contains protein derived from one of those foods. A
food ingredient may be exempt from FALCPA's labeling requirements if it
does not cause an allergic response that poses a risk to human health
or if it does not contain allergenic protein. FALPCA's labeling
requirements apply to products labeled on or after January 1, 2006.

II. Discussion

    FDA has received numerous questions about the application of
FALCPA's requirements to food products. To explain FALCPA's
requirements as well as FDA's current thinking on several issues
relating to the regulation of food allergens, on October 5, 2005, FDA
posted the first edition of a guidance entitled ``Guidance for
Industry: Questions and Answers Regarding Food Allergens, including the
Food Allergen Labeling and Consumer Protection Act of 2004'' on the
agency's Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/~dms/alrguid.html. The

guidance that is the subject of this notice, ``Guidance for Industry:
Questions and Answers Regarding Food Allergens, including the Food
Allergen Labeling and Consumer Protection Act of 2004 (Edition 2)'' is
a revision of the guidance posted on October 5, 2005, and responds to
additional questions about FALCPA and food allergens. The revised
guidance is intended to share with industry FDA's current thinking on
the additional questions presented in the guidance.
    Given the nature of the revisions to the guidance, FDA is issuing
the guidance as a level 1 guidance. Consistent with FDA's good guidance
practices regulation (Sec.  10.115 (21 CFR 10.115)), the agency will
accept comments, but it is implementing the guidance document
immediately, in accordance with Sec.  10.115(g)(2), because the agency
has determined that prior public participation is not feasible or
appropriate. As noted, FALPCA's labeling requirements apply to products
labeled on or after January 1, 2006. Clarifying FDA's current thinking
on the additional issues presented by FALCPA's implementation will help
facilitate the food industry's compliance with FALCPA's requirements.
    FDA expects to continue to receive a large number of questions
regarding the implementation of FALCPA and the regulation of food
allergens generally. The agency intends to respond to these inquires
under Sec.  10.115 as promptly as possible, using a question and answer
format. The agency believes that, at the present time, it is reasonable
to maintain all responses to questions concerning food allergens and
FALCPA in a single document that is periodically updated as the agency
receives and responds to additional questions. The following four
indicators will be employed to help users of the guidance identify
revisions: (1) The guidance will be identified as a revision of a
previously issued document, (2) the revision date of the guidance will
appear on its cover, (3) the edition number of the guidance will be
included in its title, and (4) questions and answers that have been
added to the original guidance will be identified as such in the body
of the guidance.
    This guidance represents the agency's current thinking on issues
related to FALCPA and food allergens generally that are presented in
the guidance. The guidance 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 the applicable statutes and regulations.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this guidance
at any time. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. The guidance and received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain the guidance
document at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/~dms/alrguid2.html Other information about food allergens may be obtained at http://.

http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/~dms/wh-alrgy.html.


    Dated: December 16, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-7803 Filed 12-23-05; 8:45 am]

BILLING CODE 4160-01-S