Manufacturing Gluten-Free Foods Jay Berger Miss Roben’s, Inc. AKA The Allergy Grocer

1. Manufacturing Gluten-Free FoodsJay Berger Miss Roben’s, Inc.AKA The Allergy Grocer

2. Who Is Miss Roben’s? • Dedicated gluten-free (GF) manufacturer with 50+ proprietary mixes • Caters both to Celiac & those with multiple food allergies & intolerances • Dedicated plant -no wheat, gluten, dairy, peanuts, tree nuts, eggs, soy (lecithin in one pre-made chocolate chip), shellfish, fish, or sesame in plant • National mail order business for over 1,000 other select GF products • Family owned (husband & wife) • Self-educated to GF & food manufacturing • Wear multiple hats (research & development, plant production & operations, etc) • Always < 15 employees; one operation site so able to change on the ‘fly’ with minimal “red tape”

3. Miss Roben’s Continued • Provide extensive assistance via phone & internet: • Constantly redirect & re-network consumers to more appropriate resources (medical, dieticians, national/local support groups, etc) • Distribute other manufacturer’s contact information • Extensive baking assistance even if using competitor’s products • Belong to over 30 different Celiac & associated email newsgroups • Based on this experience it appears that consumers: • Rely heavily on labels for processed foods • Seek out GF on label • Devote multiple extra hours both to label reading & follow up calls to manufacturers • Typically have poor knowledge of manufacturing process & terms • Often inadvertently purchase unsafe products (esp. Spelt)* • Require assistance in calculating nutritional facts that are not clearly marked per serving analysis

4. Q1: Define GF*: General Industry • No Wheat, Barley, Rye, Oats**, Spelt, Triticale, Kamut • NO derivatives, extracts, or processing aids from any of the above. Exception: distilled vinegars other than malt vinegar • Ingredients &/or finished product test ranges anywhere from <10-200 parts per million (ppm) * Ref: Don Kasarda (grain scientist), National Celiac Support groups, American Dietetic Association, various medical journals ** Potential cross-contamination

5. Q1: Gluten-Free Additionally Defined At Miss Roben’s • Whenever possible (90%) use dedicated, single source ingredient suppliers who do all aspects of production -grow, harvest, mill, package) in-house to provide least possible risk of cross contamination. • Ingredients purchased through a distributor (<10%) must come from supplier already sealed/prepackaged. • Each ingredient supplier (even if distributor is used) must provide written documentation on company letterhead of: • Product specifications & 100 gram analysis • Processing conditions statement (next page) • If possible, written certification from 3rd party that ingredient has been tested by independent lab (lab & testing procedures widely vary) • Further certifications for Kosher, Organic, Vegan • Product label, website, catalog all explain to consumer how we define GF & processing conditions.

6. Allergen Present in same plant? If yes, in the same room? Present in product? Are any ingredients used in product derived from this? Used as a processing aid for this product? In plant & manufactured on same line? In plant & manufactured on same day? Gluten (includes wheat, oats, rye, barley)  Dairy (includes lactose, whey, casein) Soy (lecithin, oil, protein) Product/Ingredient Name: ________________________________________ UPC Code #_______________________________ Contact Person, Title, & Phone #: _____________________________________ Is the ingredient/product produced & packaged in the same facility? ___Yes __ No If it is packaged at another facility, please make a copy of this form to mark & complete it for the conditions where it is packaged. Please use Yes or No statements where appropriate & identify specifics wherever possible (e.g. soy-lecithin, dairy-cream, nuts-whole cashews, further details etc) where applicable.

7. Do you test for Wheat? ___Yes ___No If yes, what PPM is it tested to? Do you test for Gluten? ___Yes ___No If yes, what PPM is it tested to? Do you test for Peanuts? ___Yes ___No If yes, what PPM is it tested to? Do you test for Tree Nuts? ___Yes ___No If yes, what PPM is it tested to? Do you test for Eggs? ___Yes ___No If yes, what PPM is it tested to? Do you test for Dairy? ___Yes ___No If yes, what PPM is it tested to? If used, is your baking powder aluminum-free? ___Yes ___No Is your product/ingredient certified Kosher? If so which certification does it hold? Is your product/ingredient Organic? What is the shelf life of this product/ingredient? Describe your cleaning procedures & other methods for allergen avoidance in processing & packaging? _________________________________________________________________________________ ____________________________________________________________________________________ ___________________________________________________________________________________ Is there anything else we should know to better help us? _________________________________________________________________________________ ____________________________________________________________________________________ ___________________________________________________________________________________

8. ~Q1. Challenges To Defining GF • Since there is no standardized definition for GF manufacturer must: • Educate self & staff using the current confusing & vague explanation of the GF diet (& will they interpret it correctly?) • Decide: • Are oats ok? • When is it GF enough (i.e. not in ingredients, not on shared lines, at ppm, etc)?

9. Q2. Current GF Production • Both food production & plant WIDELY varies • Spans the entire spectrum from suspicious to excellent: • Wheat starch where the gluten proteins processed out (Europe) no gluten in actual ingredients but poor manufacturing protocols to avoid cross contamination Good Manufacturing Practices (GMP) & Good Hazard Analysis & Critical Control Point (HACCP) protocols using “clean” sourced ingredients dedicated plant & ingredients with independent outside lab testing down to <3ppm • Production varies from shared bakeries or personal home (often by Celiac/consumer who decides to start own business  companies with dedicated plants

10. ~Q2. Specific Challenges To GF Production • Dry ingredients often lighter & starchier texture • Form, fill, & sealing dry mixes more difficult • Essential component (xanthan, guar) very minute portion of ingredients (thorough blend) • Flours tend to ‘poof’ & harder to contain • Bag seal clogs if no mechanism to keep flour down in bag • Xanthan/guar (gluten ‘replacer’) very gummy when wet (equipment, floors, walls, clogs A/C unit) • Actual mix preparation (plant AND consumer) • Flours are much more sensitive to environmental conditions • Especially breads-much more prone to failure • Exact liquid content needed can vary from lot to lot • Raw bread dough batter is stickier & looser (changes production process) • Label benefits from more exhaustive directions for success (need to factor in costs for replacements for customer satisfaction)

11. Q2. Methods Most Commonly Used to Remove Gluten from Foods • Absence of gluten in the ingredients (most common practice) • Process out the gluten proteins or denature them • Vinegars made from GF grains • Wheat starch (acceptable in Europe)

12. Q3. Is it Technologically Feasible to Produce GF Products Given Potential For Grain Cross-Contamination? Yes if: • Select ingredients from dedicated grain suppliers & dedicated GF mills • Use good HACCP, GMP, & allergen protocols in plant • Provide in-house staff education to GF • If utilize shared lines or non-dedicated ingredients, perform universally accepted enzyme-linked immunosorbent assay (ELISA) test to confirm any potential contamination on regular basis

13. Q3. Is GF Manufacturing Economically Feasible? • YES • Biggest investment is time required to source ingredients & appropriate equipment (thorough blend & clean xanthan/guar) • Ingredient suppliers & distributors are accessible even to small businesses with poor purchasing power. Ingredient & operational costs are factored into price • Manufacturers can also outsource & utilize co-packers with dedicated GF rooms & equipment or dedicated GF manufacturing plants (that would decrease their operational & ingredient costs) • Customer buying power & interest is already there: • 1:133 with Celiac PLUS wheat allergic consumershuge demand • Mintel Survey 2005 excellent industry potential • As GF industry grows, ingredient & production costs will decline & availability will increase more affordable to small industry • Oats would be great asset to GF manufacturer- enhances product taste, texture, & structure  expand the available product line

14. Q4 & 5. Measures & Costs To Prevent Cross-Contamination at Miss Roben’s • Dedicated plant (No gluten, plus none of the top 8 allergens or sesame) • Dedicated equipment • Purchased new to avoid potential cross contamination • Exhaustive research to find ones that blend, disperse, seal, & clean (no crevices or spots to cake) with minimal time & material waste • Can handle volume runs & wash downs needed to maintain efficient & economical production • Dedicated, single ingredient suppliers with written certificate of analysis (we do quarterly routine checks & also follow up if customer registers concern) • Ongoing written employee allergen training tools to GF & potential methods of cross-contamination • GMP & HACCP system with a thorough sanitation program • Internal policy & procedures for manufacturer recalls & customer complaints

15. Winter 2005: Miss Roben’s Analytical Methods To Detect Gluten • Yearly Celiac branding (undetermined cost) • In-house qualitative ELISA test each batch • Neogen’s Gliadin Alert® Test for wheat, barley, & rye: • Qualitative sandwich ELISA (S-ELISA) test • Shows whether sample contains more or less than 10ppm gliadin than the control provided • Quarterly quantitative ELISA test via independent lab for confidential analysis (U of Nebraska’s Food Allergy Research & Resource Program) • $80 ($55 members) per test • Uses two S-ELISA tests for gliadins from wheat & corresponding prolamines from rye & barley. • Neogen’s Veratox Test for Gliadin-provides accurate sample results in 2.5-25ppm with controls provided for 0, 2, 5, 10, & 25ppm • R-Biopharm’s RIDASCREEN® Gliadin (R7001)-tests down to 1.5 ppm gliadin (3ppm gluten) • Of note: fermented or hydrolyzed samples require special ELISA testing

16. Personal Suggestions • Obtain dedicated ingredient suppliers who can provide written certificate of analysis & analytical testing (ppm based on FDA) • Provide ongoing in-house education to staff • Using universally agreed upon GF definition • Easy-to-follow written educational tools • Test for gluten • Quarterly quantitative analysis by independent lab • If shared lines, in-house every batch