[Federal Register Volume 77, Number 241 (Friday, December 14, 2012)]
[Notices]
[Pages 74485-74486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-30123]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or we) is establishing a 
docket to obtain 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.

DATES: Submit either electronic or written comments by February 12, 
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 ways:
     Fax: 301-827-6870.
     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

    Food allergy is an immune-mediated sensitivity to foods that can 
lead to life-threatening adverse reactions. Because there is no cure 
for food allergy, allergic consumers must use avoidance to prevent 
allergic reactions. Successful avoidance requires, among other things, 
that allergic consumers and their caregivers be able to read and 
understand the ingredient lists on packaged foods.
    To help consumers more easily identify ingredients in foods that 
may cause an allergic reaction, the President signed the Food Allergen 
Labeling and Consumer Protection Act of 2004 (FALCPA) (Title II of Pub. 
L. 108-282), which amended the Federal Food, Drug, and Cosmetic Act 
(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 major food allergens 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.
    FALCPA provides two mechanisms through which ingredients may become 
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. These controls can include a 
wide range of activities, such as establishing personnel and traffic 
patterns that minimize the potential to transfer an allergen from one 
product to another.
    FDA has used several risk management strategies to reduce the risk 
from unlabeled major food allergens, such as targeted inspections or 
discussions with industry organizations. However, 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

[[Page 74486]]

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.

II. Food Safety Risk Assessment for Establishing Food Allergen 
Thresholds

    The FDA Threshold Working Group (the working group) has previously 
evaluated the approaches that could be used for establishing thresholds 
for food allergens (Ref. 1). Of the four approaches that were 
identified (methods-based, safety assessment-based, risk assessment-
based, and statutorily-derived), the working group identified the 
quantitative risk assessment-based approach as being the ``strongest, 
most transparent'' approach. Further, the working group determined that 
this approach provides the most insight into both the level of 
protection and the degree of uncertainty associated with an exposure 
level. The working group also acknowledged the need for clinical and 
epidemiological data to support a quantitative risk assessment and to 
develop applicable risk assessment tools.
    Since the working group's report was published in March 2006, 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.

III. Establishment of a Docket and Request for Information

    We are establishing a docket to provide an opportunity for 
interested individuals to submit comments (including data) that we can 
use to design and carry out a quantitative risk assessment for 
establishing regulatory thresholds for major food allergens. In 
particular, we invite comments on the following matters:
    1. How should we define ``an allergic response that poses a risk to 
human health?''
    2. Which major food allergens are of greatest public health concern 
and what is the size of the at-risk population?
    3. How should clinical dose distribution data be used when 
establishing regulatory thresholds for the major food allergens?
    4. What approaches exist for using biological markers or other 
factors related to the severity of allergic responses in a threshold 
risk assessment?
    5. What data and information exist on dietary exposure patterns for 
individuals on allergen avoidance diets?
    6. What data or other information exist on current levels of 
exposure associated with the consumption of undeclared major food 
allergens in packaged foods?
    7. What other information or data should we consider in 
establishing regulatory thresholds for major food allergens?

IV. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. 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.

V. Reference

    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, accessed 
December 5, 2012. (FDA has verified this Web site address, but FDA is 
not responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register).

    Dated: December 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30123 Filed 12-13-12; 8:45 am]
BILLING CODE 4160-01-P