[Federal Register Volume 78, Number 23 (Monday, February 4, 2013)]
[Notices]
[Pages 7785-7786]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02319]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0711]
Request for Comments and Information on Initiating a Risk
Assessment for Establishing Food Allergen Thresholds; Establishment of
Docket; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA or we) is extending to
May 13, 2013, the comment period for the notice entitled ``Request for
Comments and Information on Initiating a Risk Assessment for
Establishing Food Allergen Thresholds; Establishment of Docket,'' that
appeared in the Federal Register of December 14, 2012 (77 FR 74485). In
that document, we requested comments relevant to conducting a risk
assessment to establish regulatory thresholds for major food allergens
as defined in the Food Allergen Labeling and Consumer Protection Act of
2004 (FALCPA). The document requested comments (including data) that we
can use to design and carry out a quantitative risk assessment for
establishing regulatory thresholds for major food allergens. We are
extending the comment period in response to a request from an industry
association.
DATES: Submit either electronic or written comments by May 13, 2013.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-0711, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following way:
Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2012-N-0711. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Steven M. Gendel, Center for Food
Safety and Applied Nutrition (HFS-200), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1056.
SUPPLEMENTARY INFORMATION
I. Background
In the Federal Register of December 14, 2012 (77 FR 74485), we
published a document entitled ``Request for Comments and Information on
Initiating a Risk Assessment for Establishing Food Allergen Thresholds;
Establishment of Docket.'' In that document, we requested comments
relevant to conducting a risk assessment to establish regulatory
thresholds for major food allergens as defined in FALCPA (Title II of
Pub. L. 108-282). The document requested comments (including data) that
we can use to design and carry out a quantitative risk assessment for
establishing regulatory thresholds for major food allergens.
Section 201(qq) of the Federal Food, Drug, and Cosmetic Act (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, (exempting
highly refined oils). FALCPA establishes that foods regulated under the
FD&C Act are misbranded unless they declare the presence of major food
allergens on the product label using the common or usual name of that
major food allergen. FALCPA also provides two mechanisms through which
ingredients may become
[[Page 7786]]
exempt from the major food allergen labeling requirement. An individual
may petition for an exemption by providing scientific evidence,
including the analytical method used, that an ingredient ``does not
cause an allergic response that poses a risk to human health.'' (21
U.S.C. 403(w)(6)(C)). Alternatively, an individual may submit a
notification that contains either scientific evidence showing that an
ingredient ``does not contain allergenic protein'' or that a
determination has previously been made through a premarket approval
process that the ingredient ``does not cause an allergic response that
poses a risk to human health.'' (21 U.S.C. 403(w)(7)(A)).
In addition to their intended use as ingredients, the unintended
presence of major food allergens in foods may occur through cross-
contact. Cross-contact describes the inadvertent introduction of an
allergen into a product that would not intentionally contain that
allergen as an ingredient. Most cross-contact can be avoided by
controlling the production environment. While we have used several risk
management strategies to reduce the risk of exposure to unlabeled major
food allergens, we have not established regulatory thresholds or action
levels for major food allergens. The establishment of regulatory
thresholds or action levels for major food allergens would help us
determine whether, or what type of, enforcement action is appropriate
when specific problems are identified and also help us establish a
clear standard for evaluating claims in FALCPA petitions that an
ingredient ``does not cause an allergic response that poses a risk to
human health'' or ``does not contain allergenic protein.'' Regulatory
thresholds also would help industry to conduct allergen hazard analyses
and develop standards for evaluating the effectiveness of allergen
preventive controls. We have previously evaluated the approaches that
could be used for establishing thresholds for food allergens, as we
reported in March 2006. Since the publication of that report, there
have been significant advances in both scientific tools and data
resources related to food allergens. Therefore, we intend to determine
if the currently available data and analysis tools are sufficient to
support a quantitative risk assessment and, if so, to use these data
and tools to evaluate the public health impact of establishing specific
regulatory thresholds for one or more of the major food allergens.
We recently received requests from trade associations for an
extension of the comment period until either April 1, 2013, or May 13,
2013. These requests conveyed the concern that the current 60-day
comment period does not allow sufficient time to collect responsive
information and data to submit to FDA.
We considered the requests and, through this notice, are extending
the comment period for all interested persons until May 13, 2013.
II. Request for 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.
III. References
FDA has placed the following reference on display. To view the
reference, go to http://www.regulations.gov and insert the docket
number(s), found in brackets in the heading of this document, into the
``Search'' box. The reference may also be seen in the Division of
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.
1. Threshold Working Group. 2006. Approaches to Establish
Thresholds for Major Food Allergen and for Gluten in Food. Available
at http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm106108.htm.
Dated: January 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02319 Filed 2-1-13; 8:45 am]
BILLING CODE 4160-01-P