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U.S. Department of Health and Human Services

Food

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Public Meeting on Gluten-Free Food Labeling - Text Version of PowerPoint Presentation by Jay Berger

Public Meeting: Gluten-Free Labeling main page



 

Slide 1 - Manufacturing Gluten-Free Foods

Jay Berger

Miss Roben’s, Inc.

AKA The Allergy Grocer

Slide 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”

Slide 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

Slide 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
 

Slide 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.


Slide 6 - Processing Conditions Sheet page 1

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.

photo - conditions grid

Slide 7 - Processing Conditions Sheet page 2

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?
___________________________________________________________________________________
 
___________________________________________________________________________________
 
 
___________________________________________________________________________________

Slide 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)?


Slide 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


Slide 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)


Slide 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)


Slide 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


Slide 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


Slide 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


Slide 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


Slide 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