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This presentation documents the risks associated with developing, manufacturing, and commercializing gluten free products. It was written for trial attorneys litigating gluten-free cases of adulteration and misbranding and describes the Food Safety Forensics Methodology to track root -cause problems. It also discusses causes of gluten-free adulteration
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Food Safety Risks Food Technical Consulting
Darrel Suderman, PhDFood Technical Consulting
Food Safety Risks: Adulterated & Misbranded Gluten-free
Products
Food Safety Risks Food Technical Consulting
2
3
4
5
6
What are Glutens?
Products: Focused on
Glutens
Litigation
Opportunities
Food Safety Forensic™
Methodology
Conclusion
1 Introduction
Table of
Contents
Food Safety Risks Food Technical Consulting
Introduction
Facts about Darrel Suderman, PhD
Presenter Background
Education
•Ph.D. Food Science @ Kansas State University
•Adjunct Professor @ Johnson and Wales Culinary University in Food Product Development
Experience
•20+ yrs Restaurant Product Development, Quality, and Food Safety•5 years legal Expert Witness food litigation experience•Gluten-Free Consultant•Co-Author of a food processing book and holds 2 patents
IT Consulting
•SAP Business Intelligence Software Partner•INFOR Software Company Partner•10 yrs of food & beverage manufacturing and supply chain management Information Technology software systems consulting
Food Safety Risks Food Technical Consulting
Resources
TASA Papers & Webinars
Protecting Food & Beverage Recipe and Process Ownership: TASA White Paper (2010)
Emerging Issues In Food Products Litigation- TASA Webinar- Sept. 14, 2011
Top 5 Consumer Liability Risks The Public Ignores-TASA Webinar-Feb 8, 2012
Public Safety Liability for Mobile Food Retailers & Quick Serve Restaurants: The Trial Lawyer magazine, Summer 2011, Vol. 1, No.3 pp 18-20.
Food Safety Risks Food Technical Consulting
What are Glutens?
Food Safety Risks Food Technical Consulting
Gluten Examples
What are Glutens?
Food Safety Risks Food Technical Consulting
What are Glutens?
Gluten-free, high-protein and “total indulgence”, those are the
phrases of inspiration for General Mills’ newest grocery
products.
Healthy & Otherwise, July 8, 2014
General Mills Unveils 150 New Products
Food Safety Risks Food Technical Consulting
What are Glutens?
What are Glutens?
Gluten is known as the protein in wheat and related plants such as
barley and rye. There are two main groups of proteins that
comprise gluten, called gliadin (short molecular chains) and the
glutenins (long molecular chains). Gluten gives elasticity to
dough, helping it rise and keep its shape. Gluten is like most
allergens in that they are proteins.
Food Safety Risks Food Technical Consulting
What are Glutens?
What is Celiac Disease?
Celiac disease is an autoimmune disorder that can occur ingenetically predisposed people where the ingestion of gluten leads todamage of the small intestine. When people with celiac disease eatgluten (a protein found in wheat, rye and barley), their body mountsan immune response that attacks the small intestine. Theseattacks lead to damage of the villi, small fingerlike projections thatline the small intestine, that promote nutrient absorption. Whenthe villi get damaged, nutrients cannot be absorbed properly into thebody.
Celiac disease is hereditary, meaning that it runs in families. Peoplewith a first-degree relative with celiac disease (parent, child, sibling)have a 1 in 10 risk of developing celiac disease.
Food Safety Risks Food Technical Consulting
What are Glutens?
Long Term Health Effects
Celiac disease can develop at any age after people start eating
foods or medicines that contain gluten. Left untreated, celiac
disease can lead to additional serious health problems.
These include the development of other autoimmune disorders
like Type I diabetes and multiple sclerosis (MS), dermatitis
herpetiformis (an itchy skin rash), anemia, osteoporosis,
infertility and miscarriage, neurological conditions like
epilepsy and migraines, short stature, and intestinal cancers.
Food Safety Risks Food Technical Consulting
What are Glutens?
Treatment
Currently, the only treatment for celiac disease is lifelong adherence to a strict gluten-free diet. People living gluten-free must avoid foods with wheat, rye and barley, such as bread and beer. Ingesting small amounts of gluten, like crumbs from a cutting board or toaster, can trigger small intestine damage.
Celiac disease is also known as coeliac disease, celiac sprue, non-tropical sprue, and gluten sensitive enteropathy.
An environmental STRESS can activate celiac disease. In people with celiac disease, gluten exposure evokes an immune mediated response throughout the body and measurable damage to the intestinal lining. Some of the most common symptoms are joint pain, anemia, diarrhea, constipation, fatigue and irritability
Food Safety Risks Food Technical Consulting
What are Glutens?
Secondary Gluten Health Risks
Iron deficiency anemia
Early onset osteoporosis or osteopenia
Infertility and miscarriage
Lactose intolerance
Vitamin and mineral deficiencies
Central and peripheral nervous system disorders
Food Safety Risks Food Technical Consulting
What are Glutens?
Secondary Gluten Health Risks
Pancreatic insufficiency
Intestinal lymphomas and other GI cancers (malignancies)
Gall bladder malfunction
Neurological manifestations, including ataxia, epileptic
seizures, dementia, migraine, neuropathy, myopathy and
multifocal leucoencephalopathy
Food Safety Risks Food Technical Consulting
What are Glutens?
5 Myths About Gluten Free
1. Myth 1: It's a Weight-Loss Guarantee – yet 32% doctors recommend it
2. Myth 2: Your Taste Buds Will Suffer – yet people rate gluten-free products and gluten products equal in taste
3. Myth 3: Less Gluten Means a Less Upset Stomach – but only if you have celiac disease
4. Myth 4: You’ll Improve Your Diet – but the opposite may occur if nutrients aren’t supplemented
5. Myth 5: Gluten-Free Foods Are Healthier Than Their Counterparts – yet this hasn’t been proven
Source: Prevention Magazine, August, 2014, Zahra Barnes
Food Safety Risks Food Technical Consulting
Products: Focused on
Glutens
Food Safety Risks Food Technical Consulting
Focused on Glutens
Popular Gluten Product Ingredients
Gluten-free Ingredients
Rice, corn, oats, gums, and other milk, soy, and egg proteins
Ingredients with Gluten
Wheat and related varieties, Rye, Barley,
Food Safety Risks Food Technical Consulting
The gluten-free products market is projected to grow at a CAGR of 10.2% from 2014
to 2019. North America is estimated to be largest market, followed by Europe and
Asia-Pacific in 2014. North America is projected as the fastest-growing market,
followed by Europe and Rest of the World.
Focused on Glutens
2012–2019
Annual Gluten-Free Products Market Share
Source: MarketsandMarkets Analysis
2012 2013 2014-e 2015-p 2016-p 2017-p 2018-p
Food Safety Risks Food Technical Consulting
Focused on Glutens
Most Popular Gluten-free Products
Breads (Gluten-free)
Corn Bread
Pancakes
Batters and Breadings
Hamburger/Hot Dog Buns
Danish
Sweet Rolls
Brownie Mixes
Pizza Crusts
Food Safety Risks Food Technical Consulting
Focused on Glutens
Udi’s & Rudi’s Products Denver, CO
French Baguettes
Muffins
Cookies
Tortillas
Bagels
Frozen Meals
Chips
Granola Bars
Food Safety Risks Food Technical Consulting
Litigation Opportunities
Food Safety Risks Food Technical Consulting
Litigation Opportunities
FDA Labeling Law
What is the Food Allergen Labeling and Consumer
Protection Act (FALCPA) of 2004?
FALCPA is an amendment to the Federal Food, Drug, and
Cosmetic Act and requires that the label of a food that
contains an ingredient that is or contains protein from a
"major food allergen " declare the presence of the allergen in
the manner described by the law.
Food Safety Risks Food Technical Consulting
Litigation Opportunities
Principle Litigation Opportunities
Adulteration - If any substance has been mixed and packed with
it so as to reduce or lower or injuriously affect its quality or
strength. And if any substance has been substituted wholly or in
part for the article (FDA)
Misbranding - If it be labeled or branded as to deceive or
mislead the purchaser (FDA)
Food Safety Risks Food Technical Consulting
Litigation Opportunities
“The use of an ingredient that results in the presence of 20 parts
per million (ppm) or more gluten in the food (i.e., 20
milligrams (mg) or more gluten per kilogram (kg) of food); or
inherently does not contain gluten; and that any unavoidable
presence of gluten in the food is below 20 ppm gluten (i.e.,
below 20 mg gluten per kg of food). A food that bears the claim
“no gluten,” “free of gluten,” or “without gluten” in its
labeling and fails to meet the requirements for a “gluten-free”
claim will be deemed to be misbranded.” Federalregister.gov
Udis branded products owned by Boulder Brands has set a
10ppm limit – above and beyond the Federal limit.
(8/5/2013)
FDA Labeling Requirements
Food Safety Risks Food Technical Consulting
Litigation Opportunities
FDA Labeling Requirements Cont
“In addition, a food whose labeling includes the term “wheat”
in the ingredient list or in a separate “Contains wheat”
statement as required by a section of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) and also bears the claim
“gluten-free” will be deemed to be misbranded unless its
labeling also bears additional language clarifying that the wheat
has been processed to allow the food to meet FDA requirements
for a “gluten-free” claim. Federalregister.gov
Food Safety Risks Food Technical Consulting
Litigation Opportunities
Examples of Gluten Free Labels
Food Safety Risks Food Technical Consulting
Litigation Opportunities
Gluten Free Certification Organizations?
What is the mission of the Gluten-Free Certification Organization?
Established in 2005, The Gluten-Free Certification Organization (GFCO) is
dedicated to providing affordable certification services to producers of
gluten-free products using quality assessment and control measures
throughout production, in order to provide assurance to consumers of the
safety of their foods.
What is the value added effect of GF labeling?
GFCO certification provides a certification seal that is easily identified and
provides consumer assurance that the product meets strict standards for
gluten-free.
How many companies utilize the GF logo in N. America, the world?
(4/2014) GFCO currently certifies 21,000 products, sold in 5 countries and
is expanding. Audits are conducted in 25 countries around the globe.
What percentage of the gluten-free market uses the GFCO certification
logo?
In 2013, GFCO certified approximately 26% of the gluten-free product
market, based on SPINS data. SPINS conducts independent market trend
research of a number of markets, including the gluten-free market using
Food Safety Risks Food Technical Consulting
Litigation Opportunities
FDA/USDA Manufacturing Requirements
The food product (should not) inherently contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). This minimal criteria has been established by the FDA, but the inherent implication that each gluten-free product is monitored by a HACCP plan…
In order for products to qualify under the CSA (celiac Support Association) Innovation Category, companies must be able to validate that their processing procedures have removed the offending amino acid sequences from the wheat, barley, rye or common oats used in their product which adversely impacts those with celiac disease. The verification must show the final product has less than 5 ppm quantifiable gluten.
Food Safety Risks Food Technical Consulting
Litigation Opportunities
Minimum FDA/USDA Manufacturing GMP
Requirements
The inherent implication that each gluten-free product is
monitored by any one or more of the following:
HACCP plan
Allergen Management System Certification (AMSC) – based on
Allergie, Haut and Asthma (AHA) standard developed by Service
Allergie Suisse (SAS)
Gluten-free Certification Program (GFCP)(Canada)
Food Safety Risks Food Technical Consulting
Litigation Opportunities
Administration of all aspects of GFCP (Gluten Free
Certification Plan) has been assigned to the Allergen Control
Group. The GFCP can be integrated with GFSI or other food
safety certification scheme audits.
Adherence to Good Manufacturing Practices (GMPs)
And, food allergens need to be tested at every stage of the
manufacturing process.
Minimum FDA/USDA Manufacturing GMP
Requirements
Food Safety Risks Food Technical Consulting
Litigation Opportunities
Product Development- Misidentification of allergen ingredients,
sub-ingredients, or carrier materials
Receiving Raw Ingredients- mishandling, storing, and
documenting for traceback
Equipment- leaving trace allergens due to poor clean-up
Processing- inadequate control measures
Packaging and Labeling- inadequate redundancy checks
Finished Product Testing- using 1 of 2 methods ELISA and PCR
Manufacturing Adulteration Litigation Risks
Food Safety Risks Food Technical Consulting
Litigation Opportunities
Greatest Risk in Restaurants through….
Cross Contamination
No HACCP Plan
No outside certified audit
No allergen tests
No Ingredient storage space for gluten-free
No segmented smallwares location
No allergen sample /swab testing
Little proof of clean environment
Restaurant Adulteration Litigation Risks
Food Safety Risks Food Technical Consulting
Litigation Opportunities
US Restaurant Alternate Naming
Restaurants could be worst case scenario….
Texas Roadhouse markets its products as “gluten friendly”, and
the Olive Garden makes “no guarantees regarding the gluten
content of these Items”.
Both of these names are cop-outs!
BRIO restaurant menu advisory states that any of the 8
allergens could be present – the ultimate disclaimer.
The risk of eating an allergen in a restaurant is much greater
than a manufactured complete product.
Food Safety Risks Food Technical Consulting
Litigation Opportunities
Adulteration Incident Risk Management Best Practices
Every food manufacturing plant needs an incident risk
management process once a food security breach is reported –
that includes:
Incident Management Plan
Corrective Action Plan
CEO or lead spokesperson
Recall Plan
Previous Mock Recall Experience
Product disposal plan
Food Safety Risks Food Technical Consulting
Litigation Opportunities
Incident Definition
An incident is an event that could lead to loss of, or disruption
to, an organization's operations, services, or functions. If not
properly managed, an incident can escalate into an emergency,
crisis, or a disaster.
Incident Management is therefore the process of limiting the
potential disruption caused by such an event, followed by a
return to business as usual.
Food Safety Risks Food Technical Consulting
Litigation Opportunities
Food Safety Management
Risk Management– In simple terms, this relates to practices
designed to prevent a situation from occurring.
Incident Management– A situation has occurred, and it is time
to limit the damage by stopping the incident from becoming a
crisis.
Heightened Incident – A situation has escalated to near crisis
Crisis Management– At this point, the damage has occurred or
is continuing and the response has to be swift to clean it up and
in some cases limit it (a heightened incident)
Food Safety Risks Food Technical Consulting
Litigation Opportunities
4-Phase Incident Management Process
1. Prevention: Employing a good food safety culture, including
staying current on risk factors
2. Preparation: Proactively planning for a problem and
monitoring public discussion risk
3. Management: Implementing the plan using multiple
messages and media
4. Recovery: Reassessing risk exposure and telling the story of
changes
Food Safety Risks Food Technical Consulting
Litigation Opportunities
ELISA Gluten Test Methodology
ELISA methods detect the actual allergen protein molecule by
binding antibodies to the allergen and then using an enzyme-
linked conjugate to create a colorimetric change that can be
measured. There are certain instances though, that ELISA
methods should not be used. Some matrices can interfere with
the ELISA method, such as chocolate, or can cause cross
reactivity as seen between different types of nuts. This method
is also not the most suitable for cooked or heated products
because the protein molecules are denatured or broken down
and the allergen is no longer detectable, but may still cause
problems to sensitive individuals.
Food Safety Risks Food Technical Consulting
Litigation Opportunities
PCR Gluten Test Methodology
PCR (Polymerase Chain Reaction) methods, which are more sensitive and detect the DNA molecules of these allergens, can be used in raw and cooked products and are not affected by the heating process because DNA typically remains intact after being exposed to the cooking temperatures of most foods. PCR methods are also not subject to the typical interferences that inhibit ELISA-based methods because the DNA is purified away from these inhibitors before analysis begins. PCR, however, cannot be used on all products. Oils and other products, such as milk or egg whites, cannot be tested by PCR because they do not contain DNA. These products must instead be tested using ELISA-based methods for detection.
Food Safety Risks Food Technical Consulting
Litigation Opportunities
Gluten Test Methodology Summary
Two complimentary tests available:
PCR – used for raw & cooked products because unaffected by
heat process
PCR – most sensitive to DNA molecules
PCR cannot be used when no DNA detectible
ELISA detects actual allergen protein
ELISA does not work with chocolate
ELlSA does not work with heated products
Food Safety Risks Food Technical Consulting
Litigation Opportunities
FDA Packaging & Labeling Requirements
Packaging must declare all known allergens in the food product
following the word “contains:”
Country of Origin labeling requirements apply
Certificate of Analysis document required from domestic and
foreign sourced ingredients
Food Safety Risks Food Technical Consulting
FSF Methodology
Food Safety Risks Food Technical Consulting
Food Safety Forensics Methodology
Food Safety Forensics™ Methodology
This methodology fits the Integrated Food Safety Systems
approach currently championed by the Association of Food &
Drug Officials (AFDO)
Food Safety Risks Food Technical Consulting
Food Safety Forensics Methodology
Food Safety Forensics™ Methodology
Holistic Supply Chain Approach
Maps the manufacturing process, equipment locations,
ingredient locations, and environmental air flow in grid-like
schemes
Utilizes “back tracking” of potential allergen contamination
point by bag, by lot, by truck load, by receiving date, by
warehouse inventory location, to individual suppliers
Food Safety Risks Food Technical Consulting
Food Safety Forensics Methodology
Food Safety Forensics™ Methodology
Utilizes forward mapping from incident infraction from
individual product package, case, pallet, to in-house inventory,
outside distribution center, to customer
Once the Incident Mapping has occurred, product swabbing for
protein allergen is meticulously applied to verify or delink the
mapping result.
The goal is allergen process tracking validation
Food Safety Risks Food Technical Consulting
Food Safety Forensics Methodology
Food Safety Forensics™ Methodology
Once the mapping and verification processes have been
documented, then a disposal action plan is implemented and
documented
Upon product removal, then the contaminated production area
or room is washed down to remove the protein allergen – and
repeated until swab testing provides an “All Clear”
Food Safety Risks Food Technical Consulting
Food Safety Forensics Methodology
Celery
Gluten
Eggs
Fish
Lupin
Milk and Dairy Products
Mollusks – clams, mussels, oysters, scallops
Mustard
Nuts
Seafood Crustaceans –crabs, prawns, lobsters
Sesame Seeds Soy
Sulphur Dioxide and Sulphites – at levels above 10 mg/kg or 10mg/L
Other Food Allergens/European Union
Food Safety Risks Food Technical Consulting
Food Safety Forensics Methodology
Pet food (Cats and Dogs)
New Frontiers
Food Safety Risks Food Technical Consulting
Food Safety Forensics Methodology
May 19, 2014 - Middle East Bakery of Lawrence, MA is recalling
all lots of Market Basket Dairy-Free, Gluten-Free Pancakes,
because they may contain undeclared milk. People who have an
allergy or severe sensitivity to milk run the risk of serious or
life-threatening allergic reaction if they consume these
products.
Product Recall Example #1
Food Safety Risks Food Technical Consulting
Food Safety Forensics Methodology
On Monday, June 2, 2014 Frito-Lay initiated the voluntary
recall of select 1 1/8 oz. packages of Oven Baked Lay’s BBQ.
The product is being recalled because its package face is
incorrectly labeled with the Frito-Lay gluten-free (GF) logo,
while the ingredient panel and disclosures on the back of the
packaging correctly indicate that the product contains wheat
and barley. As a result, there could be confusion whether this
product is gluten free. This was an isolated incident and we are
putting parameters in place to prevent this from occurring
again.
Product Recall Example #2
Food Safety Risks Food Technical Consulting
Food Safety Forensics Methodology
FDA- October 24, 2012 - Bumble Bar is recalling certain lots of
Gluten Free Café™ Chocolate Sesame Bars and Gluten Free
Café™ Cinnamon Sesame Bars associated with Sunland Inc.
peanut products, because they have the potential to be
contaminated with Salmonella
Product Recall Example #3
Food Safety Risks Food Technical Consulting
Food Safety Forensics Methodology
May 3, 2011 - The Raymond-Hadley Corp. of Spencer, NY is
expanding the 4/26/11 recall of varieties and date codes of
Better Batter Mixes to include one lot of #1 Gluten Free brand
Chocolate Cake Mix and #1 Gluten Free brand White Cake
Mix because they may contain the undeclared allergen MILK.
Product Recall Example #4
Food Safety Risks Food Technical Consulting
Food Safety Forensics Methodology
U.S. Food and Drug Administration (FDA)
www.fda.gov(Type in FOOD to see the complete list, then type in GLUTEN-FREE to see only GF Foods)
U.S. Department of Agriculture, Food Safety and Inspection
Service
http://www.fsis.usda.gov
FDA & USDA Product Recall Websites
Food Safety Risks Food Technical Consulting
Thank you!
Food Technical
Consulting Dr. Darrel Suderman
www.foodbevbiz.com
Contact
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