Food Labeling:

Federal Register Volume 76, Number 149 (Wednesday, August 3, 2011)

Proposed Rules

Pages 46671-46677

From the Federal Register Online via the Government Printing Office [www.gpo.gov]

FR Doc No: 2011-19620

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 21 CFR Part 101

Docket No. FDA-2005-N-0404; formerly Docket No. 2005N-0279

RIN 0910-ZA26

Food Labeling; Gluten-Free Labeling of Foods; Reopening of the

Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.

SUMMARY: The Food and Drug Administration (FDA) is reopening the comment period for the proposed rule on the ``gluten-free'' labeling of foods, published in the Federal Register of January 23, 2007 (72 FR 2795). In that document, FDA proposed to define the term ``gluten- free,'' for voluntary use in the labeling of foods, to mean that the food does not contain an ingredient that is any species of wheat, rye, barley, or a crossbred hybrid of these grains (collectively referred to as ``prohibited grains''); an ingredient that is derived from a prohibited grain and that has not been processed to remove gluten

(e.g., wheat flour); an ingredient that is derived from a prohibited grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food; or 20 ppm or more gluten. FDA also announced in the proposed rule that we intended to conduct a safety assessment for gluten exposure and seek comments on the safety assessment and its potential use in defining the term

``gluten-free'' in the final rule. A report by FDA discussing a health hazard assessment we conducted, which included a safety assessment for gluten exposure in individuals with celiac disease, has been peer reviewed by an external group of scientific experts, and we revised the assessment, as appropriate, based upon expert comments. FDA is reopening the comment period for the proposed rule on the ``gluten- free'' labeling of foods to, in part, announce the availability of and solicit comments on the report entitled ``Health Hazard Assessment for

Effects of Gluten Exposure in Individuals with Celiac Disease:

Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten'' (``Gluten Report''), which discusses the Agency's gluten safety assessment. The Agency also seeks comments on whether and, if so, how, the safety assessment should affect FDA's proposed definition of ``gluten-free'' in the final rule, and on a number of related issues. Finally, FDA seeks comments on the Agency's tentative conclusions that the safety assessment-based approach may lead to a conservative, highly uncertain estimation of risk to individuals with celiac disease associated with very low levels of gluten exposure; and that the

Page 46672

final rule should adopt the proposed rule's approach to defining the term ``gluten-free,'' because that approach takes into account the availability of reliable analytical methods and also considers other practical factors related to the needs of individuals with celiac disease and their food consumption.

DATES: Submit electronic or written comments by October 3, 2011.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2005-

N-0404 (formerly Docket No. 2005N-0279) 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, disk, 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 number and Regulatory Information Number (RIN) for this rulemaking. 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, 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: Rhonda R. Kane, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100

Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-2371, FAX 301- 436-2636; e-mail: rhonda.kane@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

1. The Proposed Rule

In the Federal Register of January 23, 2007 (72 FR 2795), FDA proposed to define the term ``gluten-free'' for the voluntary use in the labeling of foods to mean that the food does not contain: (1) An ingredient that is any species of wheat, rye, barley, or a crossbred hybrid of these grains (collectively referred to as ``prohibited grains''); (2) an ingredient that is derived from a prohibited grain and that has not been processed to remove gluten (e.g., wheat flour);

(3) an ingredient that is derived from a prohibited grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 ppm or more gluten in the food; or (4) 20 ppm or more gluten. FDA stated in the proposal that establishing a definition of the term ``gluten-free'' and uniform conditions for its use in the labeling of foods is necessary to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled and to respond to a directive of the Food Allergen Labeling and

Consumer Protection Act of 2004 (FALCPA) (Title II of Pub. L. 108-282).

In response to FALCPA, FDA convened an internal, interdisciplinary group to review the available literature and evaluate the current state of knowledge about scientifically sound approaches to establishing labeling thresholds for gluten (as well as for the major food allergens), including the data needs and advantages and disadvantages of each approach, among other issues. The resulting FDA report, entitled ``Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food,'' revised March 2006 (``Thresholds Report'')

(Ref. 1), described four approaches that the Agency might consider using to establish a gluten threshold level, if the Agency chose to do so (Ref. 1 at pp. 2 and 42-45). As stated in the preamble to the proposed rule, the Thresholds Report concluded that an analytical methods-based approach and a safety assessment-based approach were the two viable approaches that FDA could use to establish a gluten threshold level to define the food labeling term ``gluten-free'' (72 FR 2795 at 2803).

Based upon the analytical methods-based approach, FDA proposed in 2007 a gluten threshold level of