[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