FDA Gluten-Free Labeling Public Meeting Compiled by: Jill A. Kuzo, Food Scientist Presenter: Lee Tobin, Team Leader August 19, 2005

Reasons to Define “Gluten Free” Consumer confidence Truly GF ingredients Gluten contamination Direct brand comparison Equality of GF products Safety of GF products Standards set by FDA will directly impact our production

Consumer confidence

Truly GF ingredients

Gluten contamination

Direct brand comparison

Equality of GF products

Safety of GF products

Standards set by FDA will

directly impact our production

Methods of Ensuring “Gluten Free” Status With supplier statements By testable limits By facility dedication Through certification

With supplier statements

By testable limits

By facility dedication

Through certification

Partnerships with Ingredient Suppliers Educate Ingredient Suppliers and Manufacturers Research ingredient sources for hidden gluten Identify points of possible contamination Identify precautionary measures: dedicated runs, lines, equipment Gather statements No artificial colors, preservatives, or flavors Ingredient is free of gluten content or contamination Lot tracking

Educate Ingredient Suppliers and Manufacturers

Research ingredient sources for hidden gluten

Identify points of possible contamination

Identify precautionary measures: dedicated runs, lines, equipment

Gather statements

No artificial colors, preservatives, or flavors

Ingredient is free of gluten content or contamination

Lot tracking

Ideal GF Ingredients Crops harvested with GF equipment Crops grown in GF fields Stored in GF silos Milled in GF Environment Packaged in GF environment Tested for contamination Transported in GF trucks To bakery

Testing for Gluten BioKits Rapid GLUTEN Test (Tepnel Biosystems) Qualitative detection of gliadin Detects gluten from wheat, triticale, rye, and barley Testing limitations Screens for significant levels (above 50 ppm) Particulates can obscure results Points to test for gluten Each lot of incoming ingredients Random sampling of finished products

BioKits Rapid GLUTEN Test (Tepnel Biosystems)

Qualitative detection of gliadin

Detects gluten from wheat, triticale, rye, and barley

Testing limitations

Screens for significant levels (above 50 ppm)

Particulates can obscure results

Points to test for gluten

Each lot of incoming ingredients

Random sampling of finished products

Defining Dedication Dedicated Run Dedicated Equipment Dedicated Line Dedicated Facility

Cross Contamination Facility team members Uniforms supplied Thorough cleaning Taking breaks Other allergens Store team members Thorough cleaning Sampling procedures Other allergens

Facility team members

Uniforms supplied

Thorough cleaning

Taking breaks

Other allergens

Store team members

Thorough cleaning

Sampling procedures

Other allergens

Setting Labeling Standards Consumer Needs Standards for Safety Consistency in Definitions Reasonable Cost Manufacturer Needs Feasibility of Standards Fair comparison between products Reasonable Cost

Consumer Needs

Standards for Safety

Consistency in Definitions

Reasonable

Cost

Manufacturer Needs

Feasibility of Standards

Fair comparison between products

Reasonable Cost