Federal Register, Volume 76, Number 149, August 3, 2011, Pages 46595-47054 Page: 46,676
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Federal Register/Vol. 76, No. 149/Wednesday, August 3, 2011 /Proposed Rules
adequately protective of the celiac
disease population. FDA is interested in
receiving data and comments that will
help identify the proportion of the
population of individuals with celiac
disease that may experience adverse
health effects as a result of exposure to
gluten at levels between 0.01 ppm and
< 20 ppm.
C. Gluten Threshold to Define, in Part,
the Term "Low-Gluten"
In the proposed rule (72 FR 2795 at
2804), we noted that Australia and New
Zealand have developed a two-tiered
approach to gluten-related food labeling
by setting regulatory standards for
"gluten-free," meaning no detectable
gluten, and "low-gluten," meaning no
more than 20 mg gluten per 100 g of the
food (which is equivalent to no more
than 200 ppm gluten in the food). In the
Preliminary Regulatory Impact Analysis
section (72 FR 2795 at 2811 and 2812)
and the Regulatory Flexibility Analysis
section (72 FR 2795 at 2813) of the
proposed rule, we evaluated an
alternative regulatory option (referred to
as "Option 6"), under which we would
define and allow in food labeling both
of the claims "low gluten" and "gluten
free." The "Option 6" analysis used <
20 ppm gluten as a criterion for defining
the term "gluten-free," with the
suggestion that an amount higher than
20 ppm would be specified as a
criterion for defining the term "low-
gluten." The proposed rule did not
identify any specific amount of gluten to
define the term "low-gluten" because
we did not have sufficient scientific
data to recommend such a level, nor
does FDA have such data today.
In light of the findings of FDA's safety
assessment and the discussion in this
Federal Register document of factors
that could influence the Agency's
decision on how to define the term
"gluten-free," FDA believes that it
would be helpful to again solicit
comments about any reasons that would
support a gluten threshold level to
define, in part, the food labeling claim
"low-gluten." If such reasons exist, FDA
is also seeking comments on the specific
gluten threshold level and any other
criteria that the Agency should use to
define the term "low-gluten."
IV. Request for Comments
In addition to comments on the issues
raised elsewhere in this Federal
Register document, we are interested in
any data and information not identified
in this Federal Register document, the
Gluten Report, or the proposed rule, that
we should consider in establishing a
gluten threshold level as one of the
criteria to define the food labeling term
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed 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.
VI. Electronic Access
Persons with access to the Internet
may obtain FDA's report on the health
hazard assessment it conducted, the
Gluten Report, at http://www.fda.gov/
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. (FDA has verified the
Web site addresses but FDA is not
responsible for subsequent changes to
the Web sites after this document
publishes in the Federal Register.)
1. The Threshold Working Group,
"Approaches to Establish Thresholds for
Major Food Allergens and for Gluten in
Food," Revised Report, Center for Food
Safety and Applied Nutrition, Food and
Drug Administration, College Park, MD,
March 2006, accessible at http://
ucml 106108.htm and http://www.fda.gov/
2. Mendez, E., V. Carmen, U. Immer, et al.,
"Report of a Collaborative Trial to
Investigate the Performance of the R5
Enzyme Linked Immunoassay to
Determine Gliadin in Gluten-Free Food,"
European Journal of Gastroenterology &
Hepatology, 17(10):1053-1063, 2005.
3. R-Biopharm Gliadin AG Web site,
"Ridascreen@ Gliadin" (Product Code
R7001) Web page, http://www.r-
two=R2xp YWRpbg== &productclass
three= &productclass jour-&product_
July 1, 2011.
4. Codex Alimentarius Commission, "Codex
Standard for Foods for Special Dietary
Use for Persons Intolerant to Gluten
(Codex Stan 118-1979)," Rome, Italy, pp.
1-3, 2008; accessible at
5. AOAC Research Institute, "Certificate of
Performance TestedsM Status, Certificate
No. 120601," AOAC International,
Gaithersburg, MD, 2010; accessible at
6. Matsuda, R., Y. Yoshioka, H. Akiyama, et
al., "Interlaboratory Evaluation of Two
Enzyme-Linked Immunosorbent Assay
Kits for the Detection of Egg, Milk,
Wheat, Buckwheat, and Peanut in
Foods," Journal of AOAC International,
89(6):1600-1608, December 2006.
7. Morinaga Institute of Biological Science,
Inc., Web page: "Product: Food Allergen
Kits: Food Allergen ELISA Kits," http://
Information Sheet Download "Wheat
Protein ELISA Kit (Gliadin)," http://
allergen elisa_kits/dl/gdrevl .pdf
accessed July 1, 2011.
8. Garber, E, Memorandum, "ELISA Methods
Used to Detect Gluten in Foods," Center
for Food Safety and Applied Nutrition,
Food and Drug Administration, College
Park, MD, July 15, 2011.
9. Office of Food Safety, "Health Hazard
Assessment for Gluten Exposure in
Individuals with Celiac Disease:
Determination of Tolerable Daily Intake
Levels and Levels of Concern for
Gluten," Center for Food Safety and
Applied Nutrition, Food and Drug
Administration, College Park, MD, May
2011; accessible at http://www.fda.gov!
10. U.S. Department of Agriculture,
Agricultural Research Service, Beltsville
Human Nutrition Research Center, Food
Surveys Research Group (Beltsville, MD),
"Continuing Survey of Food Intakes by
Individuals 1994-96, 1998 and Diet and
Health Knowledge Survey 1994-96:
or Data Files (csfii9498_data.exe);
accessible at http://www.ars.usda.gov/
11. Codex Alimentarius Web site,
"Welcome" Web page, http://
indexen.jsp, accessed July 1, 2011.
12. Codex Alimentarius Web site,
"Membership of the Commission" Web
July 1, 2011.
13. The Commission of the European
Communities, "Commission Regulation
(EC) No 41/209," Official Journal of the
European Union, Brussels, Belgium, pp.
L 16/3-L 16/5, January 20, 2009;
accessible at http://eur-lex.europa.eu/
14. Europa: Gateway to the European Union
Web site, "Countries" Web page, http://
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