Document ID: FDA-2012-N-0711-0009
Agency: fda
Document Type: Notice
Title: Reqest for Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds; Establishment of Docket; Extension of Comment Period
Posted Date: 2013-02-04T05:00Z

[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