Whole Foods Market Gluten Free Bakehouse

Submission of Paper to FDA "Gluten-Free" Labeling Public Meeting

Docket: 2005N-0279

**Introduction**

The Whole Foods Market Gluten Free Bakehouse is a dedicated gluten-free
facility that grew out of a dedicated production run in one of our store
bakeries. In addition to screening our ingredients for gluten, we also
exclude ingredients containing artificial colors and flavors, or
preservatives. In some cases, our support of minimally processed
ingredients has made searching for gluten-free ingredients unnecessary.

Our stake in decisions involving gluten-free labeling is threefold. Our
primary concern is the confidence of our consumers: they need to trust
that an item labeled gluten-free meets their expectations of
gluten-free. Second is consistency -- ensuring that other products
labeled gluten-free are set to the same (or similar) standards as those
we have set for ourselves. Last, any standard set for gluten-free or the
labeling of gluten-free products will necessarily govern our production
and the measures we take to exclude gluten.

In this presentation, we will share our framework for defining a product
as gluten-free, and how we ensure our products meet these standards. We
will discuss how we run our dedicated facility, and we will address
concerns shared by our customers. Ultimately, success of any gluten-free
operation hinges on the sharing of information between ingredient
suppliers, production employees, and retail team members to ensure the
safety of food for the customer's special dietary needs.

**Defining "Gluten-Free"**

There are two categories of gluten-free foods that concern a food
manufacturer: inherently gluten-free foods and rendered gluten-free
foods. Most of our ingredients are inherently gluten-free. A few
ingredients such as extracts and emulsions contain a rendered
gluten-free alcohol. Our focus will remain on inherently gluten-free
ingredients and the steps we take to maintain gluten-free status through
the manufacturing process.

There are also considerations involving oats and wheat starches. We have
no plans to use wheat starch in our production; conversely, we may
consider oats in the future if the gluten-free status of the ingredients
can be verified. The dietary fiber and variety provided by oats would be
a welcomed addition to our products; however, cross contamination from
gluten containing grains remains our main concern. Until the safety of
oat ingredients can be confirmed consistently, we will exclude oats from
our production.

There are 3 methods we use in this facility to support our claim of
gluten-free status: by testament from ingredient suppliers, by testable
limits, and by exclusion of gluten from the facility. We are also
looking into participating in a 3^rd^ party testing program. We hope by
enlisting another organization to oversee and evaluate our production,
we can strengthen consumer confidence in the safety of our products.

The decision to dedicate an entire facility and work staff exclusively
to gluten-free production was made on the basis of limiting risks of
contamination. Reducing the number of testing points also played a major
role in this decision since the cost of our chosen testing method was
\$16/test. By decreasing the number of chances for cross contamination,
we reduce the number of tests needed to justify our gluten-free claim.

Establishing Trust with Ingredient Suppliers

When creating gluten-free recipes, one must seek out gluten-free
ingredients. In many cases, this requires educating ingredient suppliers
and manufacturers. While obvious forms of gluten such as wheat, rye, or
barley flours can be excluded from the plant or production line, some
manufacturers are not aware of hidden forms of gluten in processing aids
or anti-caking agents. Some are not aware of cross contamination issues
from shared lines or concurrent production, and testing protocols may
need to be established before the ingredients can be used safely.

Once we have determined that the ingredient is gluten-free, we gather
statements from the supplier for each ingredient. The letters express
understanding of what gluten-free means, as well as assurance that their
ingredient is free of gluten ingredients and contamination.

Setting Testing Limits

Testing protocols are challenging to establish because there is no
method that can test 100% of the products. Samples must be taken at key
points in the process, and the number of samples needed depends on the
level of risk of contamination.

We use a *BioKits* Rapid GLUTEN test from Tepnel Biosystems. This is a
stick test that detects the presence of gliadin as low as 50 ppm. We
test all new ingredients as confirmation that they are free of gluten
contamination. This is the best point in the manufacturing process for
us to ensure exclusion of gluten. Any new source for an existing
ingredient requires testing of the new ingredient for assurance of
gluten-free status as well.

By testing new ingredients before they are brought into the production
area, we prevent gluten contamination from ever occurring on food
contact surfaces. In addition, we take random samples of finished
products as an additional verification.

Our testing methods are not without limitations. The rapid test we use
is a qualitative detection of the gliadin protein in wheat. The test
detects to a lesser extent the proteins found in durum wheat, triticale,
rye, and barley. The test only screens for significant levels of gliadin
content (\>50 ppm). Final products need to be sampled carefully so that
particulates do not obscure test results. Several tests on finished
products gave questionable results, and retesting of samples was needed
to confirm gluten-free status.

Dedication to Gluten Free Processing

There are no scientific methods used, either chemically or biologically,
to ensure the complete removal of allergen proteins from food contact
surfaces. This means that facilities processing wheat or gluten
ingredients will always run a higher risk of contamination if they also
choose to process gluten-free products. The only way to absolutely
minimize the possibility of cross contamination is to dedicate the
entire facility to gluten-free production only.

In addition to separating gluten-free production from production of
other products, many other steps are taken to reduce gluten
contamination risks. Full uniforms including shoes, pants, and shirts
are provided for all regular employees, and replaced daily. Aprons are
worn over uniforms but remain in the work area during breaks. Visitors
to the facility are supplied with lab coats as a barrier between any
gluten on their street clothes and food contact surfaces. Signage
throughout the facility alert all to the gluten-free production area and
the exclusion of gluten-containing flours from the facility.

**Sharing of Knowledge**

Sharing information related to gluten-free products and production is an
ongoing process that extends beyond ingredient suppliers and
manufacturers. Facility team members need to learn and understand the
methods employed to reduce cross contamination risks. Store team members
need to be educated on the needs of those on a gluten-free diet as well
as on risks of cross contamination while sampling products for
customers. Because our products are sold only in our stores, we have an
advantage over other gluten-free manufacturers in that we have greater
influence over the handling of our products and the information shared
about our products after they leave our facility. All new data and
research needs to be shared with all involved, including the ingredient
suppliers, retail team members, and the customer.

The primary communication we have with our customers is the labeling of
our product. The company name, "Whole Foods Market Gluten Free
Bakehouse", announces our intentions of a product free of gluten
ingredients. Directly beneath the brand name is a logo stating "Produced
in a Dedicated Gluten-Free Facility". This illustrates our understanding
of cross contamination concerns, as well as our method to reduce risks
of accidental inclusion of gluten.

We have a unique advantage in that our bakery retail team members can be
educated to answer the questions gluten-free dieters will have. In
addition, the company website shares information for gluten-free
lifestyles, and the Gluten Free Bakehouse website has an email link for
customer inquiries.

Our customers are attentively involved in the education process and have
developed many support groups and web forums to share information among
gluten-free dieters. We get numerous questions from concerned consumers
about specific ingredients and the methods employed to exclude gluten.
In addition, many customers ask about risks of cross contamination for
other allergens in the products.

Understanding and practicing safe handling of all allergens is important
in our facility. Once an allergen is excluded from production, other
allergens come under scrutiny. Methods employed to exclude gluten and
reduce cross contamination also affect the contamination that can occur
from other allergen proteins. Team members at the production and retail
level must be aware of the presence of other allergens and risks as well
as what concerns customers may have.

The language used to describe these products must be used carefully.
While we exclude gluten completely from our production, we do not
exclude dairy, eggs, soy, peanuts, or tree nuts. When a customer asks
about exclusion of another allergen, we have to be careful to inform
them that while the product might be "free of xx ingredients" there is
still a chance of trace inclusions from another product containing xx.

**Conclusion**

Any standard set for gluten-free labeling must meet the expectations of
the consumer. If the standard does not have consumer support and
confidence, we will be no further along in this process. The consumer
needs to trust that foods labeled gluten-free are safe for consumption.
On the balance, the standards must be feasible for manufacturers to
meet. Feasibility is determined by relative difficulty to administer,
reliability of results, and cost.

There also needs to be consistency in definitions for fair comparison of
products, and the definitions must be easy to understand by the general
public. Education of consumers, manufacturers, and lawmakers is
essential to creating a label that easily distinguishes gluten-free
foods from the rest.