[Federal Register: June 17, 2005 (Volume 70, Number 116)]
[Notices]
[Page 35258-35259]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17jn05-62]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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