[Federal Register Volume 70, Number 116 (Friday, June 17, 2005)]
[Notices]
[Pages 35258-35259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-12041]



[[Page 35258]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0231]


Draft Report of the Threshold Working Group, Center for Food 
Safety and Applied Nutrition: Approaches to Establish Thresholds for 
Major Food Allergens and for Gluten in Food; Availability; Request for 
Comments and for Scientific Data and Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments and for scientific data and 
information.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft report entitled ``Approaches to Establish 
Thresholds for Major Food Allergens and for Gluten in Food.'' The draft 
report was prepared by an interdisciplinary group of scientists from 
FDA's Center for Food Safety and Applied Nutrition (CFSAN). This report 
was prepared to facilitate the further development of CFSAN's policy 
for food allergens, including the center's implementation of the Food 
Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

DATES: Submit comments and scientific data and information by August 
16, 2005.

ADDRESSES: Submit written comments and scientific data and information 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments and scientific data and information to 
http://www.fda.gov/dockets/ecomments.
    Submit written requests for single copies of the draft report to 
Sherri Dennis, Center for Food Safety and Applied Nutrition (see FOR 
FURTHER INFORMATION CONTACT). Send one self-adhesive label with your 
address to assist that office in processing your request. You also may 
request a copy of the draft report by faxing your name and mailing 
address with the name of the document you are requesting to the CFSAN 
Outreach and Information Center at 1-877-366-3322. See the 
SUPPLEMENTARY INFORMATION section for electronic access to this 
document.

FOR FURTHER INFORMATION CONTACT: Sherri B. Dennis, Center for Food 
Safety and Applied Nutrition (HFS-06), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1903.

SUPPLEMENTARY INFORMATION:

I. Background

    Food allergies are estimated to affect approximately six percent of 
infants and children and four percent of adults in the United States. A 
food allergy is an idiosyncratic response of the immune system to 
naturally occurring proteins in a food. The most severe and immediately 
life-threatening food allergic responses are associated with 
immunoglobulin E (IgE) mediated hypersensitivity. In this country, 
eight foods or food groups--peanuts, soybeans, cow's milk, eggs, fish, 
crustacean shellfish, tree nuts, and wheat--account for 90 percent of 
food allergies.
    Food allergic reactions vary in severity, ranging from mild 
symptoms (such as skin or eye irritation) to severe, life-threatening 
responses (such as anaphylaxis or systemic shock.) The amount of 
protein needed to provoke an allergic response varies. Factors that 
affect the severity of an allergic response include the food from which 
the protein is derived, the nature of the processing of the food, the 
food matrix containing the allergenic protein, and the sensitivity of 
the individual. There is a general consensus that, for most food 
allergic individuals, exposure to protein below a certain level is 
unlikely to elicit an allergic response. Although it has not been 
clearly defined, the term ``threshold'' has frequently been used to 
describe the lowest level of protein from an allergenic food that will 
elicit a response in a sensitive individual.
    There is currently no known cure for food allergies. Accordingly, 
strict avoidance of the offending food or foods at levels that will 
elicit an adverse effect is the only means to prevent potentially 
serious reactions. Thus, food allergic consumers need accurate, 
complete, and informative labels on food to protect themselves.
    In August 2004, Congress enacted the FALCPA (Public Law 108-282), 
which amends the Federal Food, Drug, and Cosmetic Act (the 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 ``major 
food allergen'' as one of eight foods or a food ingredient that 
contains protein derived from one of those foods. FALCPA provides two 
processes by which an ingredient may be exempted from the FALCPA 
labeling requirements--a petition process (section 403 of the act (21 
U.S.C. 343(w)(6)) and a notification process (21 U.S.C. 343(w)(7)). 
Under the petition process, an ingredient may be exempt if the 
petitioner demonstrates that the ingredient ``does not cause an 
allergic reaction that poses a risk to human health.'' Under the 
notification process, an ingredient may be exempt if the notification 
contains scientific evidence that demonstrates that the ingredient 
``does not contain allergenic protein,'' or if FDA previously has 
determined, under section 409 of the act (21 U.S.C. 348), that the food 
ingredient does not cause an allergic response that poses a risk to 
human health. Understanding food allergen thresholds and developing a 
sound analytical framework for such thresholds are likely to be 
centrally important to FDA's analysis of, and response to, FALCPA 
petitions and notifications.
    FALCPA also requires FDA to define and permit the use of the term 
``gluten free.'' Such labeling is important to patients suffering from 
celiac disease, an immune-mediated illness. Strict avoidance of gluten 
at levels that will elicit an adverse effect is the only means to 
prevent potentially serious reactions. Thus, consumers susceptible to 
celiac disease need accurate, complete, and informative labels on food 
to protect themselves. Understanding thresholds for gluten will help 
FDA develop a definition of ``gluten free'' and identify appropriate 
use of the term.
    Section 204 of FALCPA directs FDA to prepare and submit a report to 
Congress. The report will focus principally on the issue of cross-
contact of foods with food allergens, and will describe the types, 
current use of, and consumer preferences with respect to advisory 
labeling. Cross-contact may occur as part of the food production 
process where residues of an allergenic food are present in the 
manufacturing environment and are unintentionally incorporated into a 
food that is not intended to contain the food allergen, and thus, the 
allergen is not declared as an ingredient on the food's label. In some 
cases, the possible presence of the food allergen is declared by a 
voluntary advisory statement. Understanding food allergen thresholds 
and developing a sound analytical framework for such thresholds is also 
likely to be useful in addressing food allergen cross-contact and the 
use of advisory labeling.
    Both as part of its ongoing risk management of food allergens and 
in response to FALCPA, CFSAN established an internal, interdisciplinary 
group (the Threshold Working Group). The Threshold Working Group was 
established to evaluate the current state of scientific knowledge 
regarding food allergies and celiac disease, to consider various 
approaches to establishing thresholds

[[Page 35259]]

for food allergens and for gluten, and to identify the biological 
concepts and data needed to evaluate the scientific soundness of each 
approach. The draft report entitled ``Approaches to Establish 
Thresholds for Major Food Allergens and for Gluten in Food'' is the 
result of the working group's deliberations.
    In the Federal Register of May 23, 2005 (70 FR 29528), FDA 
announced a meeting of the agency's Food Advisory Committee (FAC) on 
July 13, 14, and 15, 2005. At this meeting, the FAC will be asked to 
evaluate the draft report entitled ``Approaches to Establish Thresholds 
for Major Food Allergens and for Gluten in Food.'' In particular, the 
FAC will advise FDA whether, in the committee's view, the draft report 
is scientifically sound in its analyses and approaches and adequately 
considers available relevant data on food allergens and on gluten. In 
seeking the committee's advice, FDA plans to pose a series of 
scientific questions. These questions will be posted on CFSAN's Web 
site at http://www.cfsan.fda.gov/lrd/vidtel.html on July 12, 2005. 
Members of the public who may wish to participate in the FAC meeting, 
by written submission or an oral presentation, should consult the 
meeting notice for information regarding such participation.
    In addition to the FAC proceedings, the agency believes it would be 
useful to receive public comments on the Threshold Working Group's 
draft report. The draft report describes a number of areas in which the 
working group concluded that the body of scientific data relating to 
food allergen thresholds is incomplete. Accordingly, FDA requests that 
members of the public submit comments and any relevant scientific data 
and information, particularly data and information that can fill the 
data gaps identified in the draft report.

II. Request for Comments and for Scientific Data and Information

    Interested persons should submit comments and scientific data and 
information to the Division of Dockets Management (see ADDRESSES). 
Three copies of all comments and scientific data and information are to 
be submitted. Individuals submitting written information or anyone 
submitting electronic comments may submit one copy. Submissions are to 
be identified with the docket number found in brackets in the heading 
of this document and may be accompanied by supporting information. 
Received submissions may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday. Information submitted 
after the closing date will not be considered except by petition under 
21 CFR 10.30.

III. Electronic Access

    The draft report is available electronically at http://
www.cfsan.fda.gov/dms/wh-alrgy.html.

    Dated: June 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12041 Filed 6-15-05; 8:45 am]
BILLING CODE 4160-01-S