United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2011_register executive 2011-08-03 article Proposed Rules D09002ee1c7ff83a1 D09002ee1c7ff8439 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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 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. 76 FR 46671 https://www.govinfo.gov/app/details/FR-2011-08-03/2011-19620 2011-19620 fr03au11-16 RIN 0910-ZA26 4160-01-P Docket No. FDA-2005-N-0404 formerly Docket No. 2005N-0279 https://www.govinfo.gov/app/details/FR-2011-08-03/2011-19620 https://www.govinfo.gov/content/pkg/FR-2011-08-03/html/2011-19620.htm https://www.govinfo.gov/content/pkg/FR-2011-08-03/pdf/2011-19620.pdf 7 p. 46671 46677 76 FR 46671 Title 21 Part 101 21 CFR Part 101 RIN 0910-ZA26 Food Labeling; Gluten-Free Labeling of Foods; Reopening of the Comment Period; Federal Register Vol. 76, Issue PRORULE 2011-19620 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2011-10-03 Docket No. FDA-2005-N-0404 formerly Docket No. 2005N-0279 4160-01-P 2011-19620 Proposed rule; reopening of comment period.

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 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.

Submit electronic or written comments by October 3, 2011. 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. Food Labeling: Gluten-Free Labeling of Foods; Reopening of Comment Period , rhonda.kane@fda.hhs.gov http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:016:0003:0005:EN:PDF http://europa.eu/about-eu/countries/index_en.htm http://www.aoac.org/testkits/2010_120601_Certificate.pdf http://www.ars.usda.gov/Services/docs.htm?docid=14531 http://www.codexalimentarius.net/download/standards/291/cxs_118e.pdf http://www.codexalimentarius.net/web/index_en.jsp http://www.codexalimentarius.net/web/members.jsp?lang=EN http://www.fda.gov/downloads/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/UCM192048.pdf http://www.fda.gov/downloads/Food/ScienceReseacrh/ReseacrhAreas/RiskAssessmentSafetyAssessment/UCM264152.pdf http://www.fda.gov/downloads/Food/ScienceResearch/ResearchAreas/RiskAssessmentSafety http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm106108.htm http://www.miobs.com/english/product/food_allergen_elisa_kits/dl/gdrev1.pdf http://www.miobs.com/english/product/food_allergen_elisa_kits/index.html http://www.r-biopharm.com/product_site.php?product_id=252&product_class_one=QWxsZXJnZW5z&product_class_two=R2xpYWRpbg==&product_class_three=&product_class_four=&product_range=Food%20and%20Feed%20Analysis& http://www.regulations.gov Vol. 76, no. 149 Office of the Federal Register, National Archives and Records Administration 2011-08-03 continuing daily deposited born digital 468 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2011-08-03 P0b002ee180dc163f 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr03au11 https://www.govinfo.gov/app/details/FR-2011-08-03 https://www.govinfo.gov/content/pkg/FR-2011-08-03/pdf/FR-2011-08-03.pdf https://www.govinfo.gov/content/pkg/FR-2011-08-03/xml/FR-2011-08-03.xml fdlp 46595 47054 DGPO 2011-08-03 2024-06-04 FR-2011-08-03 machine generated eng FR FR-2011-08-03 76 149