[Federal Register: July 19, 2005 (Volume 70, Number 137)]
[Proposed Rules]
[Page 41356-41358]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19jy05-12]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. 2005N-0279]
Food Labeling; Gluten-Free Labeling of Foods; Public Meeting;
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to obtain expert comment and consultation from stakeholders to
help the agency to define and permit the voluntary use on food labeling
of the term ``gluten-free''. The meeting will focus on food
manufacturing, analytical methods, and consumer issues related to
reduced levels of gluten in food. We request that those who wish to
speak at the meeting, or otherwise provide FDA with their written or
oral comments, focus on the questions set out in this document.
DATES: The public meeting will be held on Friday, August 19, 2005, from
8:30 a.m. to 5 p.m. All those attending the meeting must register by
August 12, 2005. See the ``Registration'' heading of the SUPPLEMENTARY
INFORMATION section of this document for details on how to register.
Submit written or electronic comments by September 19, 2005.
ADDRESSES: The public meeting will be held at the Food and Drug
Administration, Center for Food Safety and Applied Nutrition, 5100
Paint Branch Pkwy., Harvey W. Wiley Auditorium, College Park, MD 20740.
You may submit written comments, identified with Docket No. 2005N-
0279, to the Division of Dockets Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.
FOR FURTHER INFORMATION CONTACT:
For general questions about the meeting, to register, to request
permission to speak at the meeting, to request onsite parking, or if
you need special accommodations due to a disability: Marion V. Allen,
Center for Food Safety and Applied Nutrition (HFS-32), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-1584, FAX: 301-436-2605, e-mail: marion.allen@fda.hhs.gov.
For technical questions: Rhonda R. Kane, Center for Food Safety and
Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, 301-436-2371, FAX: 301-436-2636,
e-mail: rhonda.kane@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Celiac disease (also known as celiac sprue) is a chronic
inflammatory disorder of the small intestine triggered by ingesting
certain storage proteins that naturally occur in cereal grains. Celiac
disease is genetically inherited, and its prevalence in the United
States is estimated to be slightly less than 1 percent of the general
population (Ref. 1).
The grains that are considered to cause problems for persons with
celiac disease are wheat, barley, and rye, their related species (e.g.,
durum wheat, spelt, kamut) and crossbred hybrids (e.g., triticale), and
possibly oats (Ref. 2). The scientific literature includes reports of
celiac disease patients who can tolerate oats (Refs. 3 through 5) and
others who cannot (Refs. 6 and 7). This intolerance may be due to the
possible presence in commercially available oat products of trace
amounts of other grains that are harmful to persons who have celiac
disease (e.g., wheat, rye, or barley) (Refs. 2 and 8). However, there
is also some evidence that naturally occurring proteins in
uncontaminated oats may cause adverse effects in some celiac disease
patients (Ref. 7).
Technically, the term ``gluten'' applies to the combination of
storage proteins found in wheat, the prolamin proteins called
``gliadins'' and the glutelin proteins called ``glutenins'' (Ref. 9).
However, in the context of celiac disease, the term ``gluten'' is often
used to refer collectively to any of the proteins in the grains that
may cause harm. Currently, to prevent severe and sometimes life-
threatening complications of celiac disease, sensitive individuals need
to avoid all offending sources of gluten (Refs. 10 through 12). Life-
threatening complications can affect multiple organs of the body (Refs.
10 through 12).
The Food Allergen Labeling and Consumer Protection Act of 2004
(FALCPA) (Title II of Public Law 108-282) at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/dms/alrgact.html
requires FDA to issue, within 2 years of the enactment
date, a proposed rule to define, and permit the use of, the term
``gluten-free'' on food labeling and a final rule within 4 years of
enactment. FALCPA requires FDA to
[[Page 41357]]
consult with appropriate experts and stakeholders during the agency's
development of the proposed rule. Establishing a definition of
``gluten-free'' that is both protective of the celiac population and
that uniformly applies to ``gluten-free'' labeling statements for foods
marketed in the United States will assist Americans with celiac disease
to make more informed food consumption decisions.
II. Purpose and Scope of Meeting
FDA is holding this meeting to solicit comments from appropriate
experts and stakeholders to assist us in developing a proposed rule to
define and permit the use of the term ``gluten-free,'' as required by
FALCPA. The agency is interested in gathering information from the
public, particularly the food industry on how ``gluten-free'' foods are
manufactured, the analytical methods used to verify that foods are
``gluten-free,'' and related costs of manufacturing ``gluten-free''
foods. The agency is also interested in receiving research data or
findings on the food purchasing practices of consumers with celiac
disease and their caregivers related to packaged products labeled or
marketed as ``gluten-free,'' compared to their purchasing practices of
packaged products that are not so labeled.
The public meeting will not address issues regarding a threshold
level of gluten (i.e., the amount of gluten below which it would be
unlikely to elicit harmful effects in celiac disease patients) and the
medical implications of celiac disease. These two issues were addressed
at a meeting of FDA's Food Advisory Committee (FAC) on July 13 through
15, 2005 (70 FR 29528, May 23, 2005). The meeting agenda provided that
the FAC would review and evaluate the Center for Food Safety and
Applied Nutrition Threshold Working Group draft report entitled
``Approaches to Establish Thresholds for Major Food Allergens and for
Gluten in Food,'' which may be found on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/dms/alrgn.html.
FDA will consider all pertinent
information, including the recommendations of the FAC and comments from
this public meeting, in developing a definition and establishing the
permissible use of the term ``gluten-free'' in food labeling.
III. Questions
FDA has drafted a series of questions to help focus the comments
presented at the public meeting or otherwise communicated to the
agency. Those who comment are invited to address any or all of these
questions. FDA is particularly interested in receiving related
technical, scientific, and cost data from the food industry as well as
research data or findings about the food purchasing practices of
consumers with celiac disease or their caregivers. For the purpose of
the list of questions in this document, FDA is using the following
terms:
``Gluten'' refers to the proteins found in any of the
grains that can cause harm to persons with celiac disease;
``Grains of concern'' refers to wheat, rye, barley, and
oats, and their related species (e.g., durum, spelt, kamut) or
crossbred hybrids (e.g., triticale); and
``Gluten-free foods'' refers to foods currently marketed
in the United States that are either represented to be free of gluten
or that contain statements or symbols on their labeling that identify
the products as ones that do not contain gluten.
A. Definitions of ``Gluten-Free''
1. How do food manufacturers define ``gluten-free''? What is the
generally accepted definition in the food industry of ``gluten-free''?
Please identify any entities that ``certify'' finished foods or raw
ingredients to be ``gluten-free''. Describe how they define ``gluten-
free'' and how they determine whether a food product satisfies this
definition.
B. ``Gluten-Free'' Product Development
2. How are ``gluten-free'' foods produced? For example, are
``gluten-free'' foods made by using only ingredients that do not
contain any gluten (i.e., they are inherently ``gluten-free'') or are
they made by processing ingredients or the finished food to remove
gluten? What methods are most commonly used to remove gluten from food?
3. Due to potential grain cross-contact situations, is it
technologically feasible to produce ``gluten-free'' flour from grains
other than those of concern (e.g., corn, millet)? Is it technologically
feasible to produce oat-based products that do not contain gluten from
grains of concern other than oats (e.g., wheat)? If so, what additional
measures in the milling or manufacturing process would be needed to
produce these products? Is it economically feasible to produce such
products, and if so, what would be the incremental costs?
C. Good Manufacturing Practices and Analytical Methods
4. What measures do you have in place during the manufacturing,
packaging, or holding of ``gluten-free'' foods to prevent them from
coming into contact with any grains of concern? For example, do you use
dedicated facilities, dedicated equipment, or dedicated production
lines?
5. What analytical method(s) do you use to evaluate your ``gluten-
free'' products? How often to do you perform these analyses? For
example, do you test every batch of finished product? Do you test bulk
containers of each ingredient? What is the cost of such testing?
6. The following questions seek data and information about
available gluten detection test kits or analytical methods to detect
gluten:
In what grains can the test kit or method detect gluten?
What specific mechanism is used to indicate the presence
or absence of gluten?
What is the sensitivity or lowest level of detection of
your test kit or method?
Is your test kit or method qualitative (i.e., establishes
only the presence or absence of gluten) or quantitative?
If quantitative, what is the limit of quantification of
your test kit or method?
What is the false positive rate of your test kit or
method? What is its false negative rate?
Is the effectiveness of your test kit or method affected
by the nature of the processing of the ``gluten-free'' food, and if so,
how? Is it affected by the food matrix, and if so, how? (FDA is
especially interested in information that addresses the influence of
the presence of fermented or hydrolyzed proteins, of xanthan gum, of
guar gum, or of any other dietary fibers.)
If your test kit or method has been validated, please
indicate by whom it was validated and the level (e.g., parts per
million) of detection at which it was validated.
If your test kit or method has not been validated, have
the results of its performance or an evaluation of its performance been
published in a peer-reviewed scientific journal?
What is the cost of your test kit or the cost to perform
your method of analysis?
7. What analytical methods are currently available or under
development to detect the presence of oat proteins in food? Please
specify which proteins. What is the cost to conduct such analyses? Have
any of these methods been validated or published in a peer-reviewed
scientific journal?
D. Foods Marketed as ``Gluten-Free''
8. Are there available research data or findings on what consumers
with celiac disease or their caregivers believe the term ``gluten-
free'' means? For example,
[[Page 41358]]
do the research data or findings show consumers' beliefs as to which
specific grains or other ingredients are not present in foods labeled
``gluten-free''?
E. Consumer Purchasing Practices
9. Are there available research data or findings on how consumers
with celiac disease or their caregivers identify packaged foods that do
not contain gluten? Do the data establish how much time these consumers
devote to identifying such foods?
10. Are there available research data or findings on whether the
packaged foods consumers with celiac disease or their caregivers
currently purchase or consume are primarily or exclusively those foods
labeled ``gluten-free''? Do the research data or findings identify the
types of ``gluten-free'' packaged foods (e.g., breads, dairy foods,
canned vegetables) purchased or consumed by persons with celiac disease
or their caregivers? Do the research data or findings show whether a
``gluten-free'' label influences the purchasing decision of persons
with celiac disease or their caregivers when presented with products
having identical ingredient lists?
IV. Registration
Please submit your registration information (including name, title,
firm name (if applicable), address, telephone number, fax number (if
available), and e-mail address (if available)) by August 12, 2005. We
encourage you to register online at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/comm/register.html
or by fax to Marion V. Allen at 301-436-2605. We will
also accept registration onsite; however, space is limited and
registration will be closed when the maximum seating capacity is
reached. If you need special accommodations due to a disability (e.g.,
sign language interpreter), please inform Marion V. Allen (see FOR
FURTHER INFORMATION CONTACT) no later than August 12, 2005, when you
register. Please also specify whether you need onsite parking when you
register.
If you wish to make a presentation, indicate this desire when
registering and submit the following information by August 12, 2005:
(1) A brief written statement about the general nature of the views you
wish to present and (2) the names of any copresenters who must also
register to attend. The amount of time allowed for each oral
presentation at the public meeting may be limited (e.g., 5 minutes
each), depending upon the number of persons who request to speak.
Individuals and organizations that do not preregister to make a
presentation may have the opportunity to speak if time permits.
Persons preregistered or wishing to register onsite should check in
between 7:30 and 8:30 a.m. Because the meeting will be held in a
Federal building, meeting participants must present photo
identification and plan adequate time to pass through the security
system.
V. Comments
In addition to attending or presenting oral comments at the
meeting, interested persons may submit to the Division of Dockets
Management (see ADDRESSES) written or electronic comments related to
the questions and the focus of this public meeting. All relevant data
and information should be submitted with the written comments. Submit a
single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified 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.
VI. Meeting Transcript
A transcript will be made of the meeting's proceedings. You may
request a copy in writing from FDA's Freedom of Information Office
(HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16,
Rockville, MD 20857, approximately 30 working days after the public
meeting at a cost of 10 cents per page. The transcript of public
meeting and all comments submitted will be available for public
examination at the Division of Dockets Management (see ADDRESSES)
between 9 a.m. and 4 p.m., Monday through Friday, as well as on the FDA
Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm.
VII. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSESS) and may be viewed
between 9 a.m. and 4 p.m., Monday through Friday.
1. National Institutes of Health, Consensus Development
Conference Statement, Celiac Disease, June 28 through 30, 2004,
accessible on June 2005 at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://consensus.nih.gov/cons/118/118celiacPDF.pdf.
(FDA has verified the Web site address, but is not
responsible for subsequent changes to the Web site after this
document publishes in the Federal Register.)
2. Kasarda, D.D., ``Grains in Relation to Celiac Disease,''
Cereal Foods World, 46(5):209-210, 2001.
3. Janatuinen, E.K., T.A. Kemppainen, R.J. Julkunen, et al.,
``No Harm From Five Year Ingestion of Oats in Coeliac Disease,''
Gut, 50(3):332-335, 2002.
4. Janatuinen, E.K., T.A. Kemppainen, P.H. Pikkarainen, et al.,
``Lack of Cellular and Humoral Immunological Responses to Oats in
Adults With Coeliac Disease,'' Gut, 46(3):327-331, 2000.
5. Janatuinen, E.K., P.H. Pikkarainen, T.A. Kemppainen, et al.,
``A Comparison of Diets With and Without Oats in Adults With Celiac
Disease,'' New England Journal of Medicine, 333(16):1033-1037, 1995.
6. Lundin, K.E., E.M. Nilsen, H.G. Scott, et al., ``Oats Induced
Villous Atrophy in Coeliac Disease,'' Gut, 52(11):1649-1652, 2003.
7. Arentz-Hansen, H., B. Fleckenstein, O. Molberg, et al., ``The
Molecular Basis for Oat Intolerance in Patients With Celiac
Disease,'' PLoS Medicine, 1:84-92, 2004.
8. Thompson, T., ``Gluten Contamination of Commercial Oat
Products in the United States,'' New England Journal of Medicine,
351(19):2021-2022, 2004.
9. Brown A., Understanding Food Principles and Preparation,
Second Edition, Wadsworth/Thomson Learning, Belmont CA, USA, pp.
402-403, 2004.
10. Corrao, G., G.R. Corazza, V. Bagnardi, et al., ``Mortality
in Patients With Coeliac Disease and Their Relatives: A Cohort
Study,'' Lancet, 358:356-361, 2001.
11. Dewar, D., S.P. Pereira, and P.J. Ciclitira, ``The
Pathogenesis of Coeliac Disease,'' International Journal of
Biochemistry & Cell Biology, 36:17-24, 2001.
12. Fasano, A. and C. Catassi, ``Current Approaches to Diagnosis
and Treatment of Celiac Disease: An Evolving Spectrum,''
Gastroenterology, 120(3):636-651, 2001.
Dated: July 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-14196 Filed 7-14-05; 4:31 pm]
BILLING CODE 4160-01-S