Over the past decade, few consumer-driven trends have rivaled gluten-free products. The demand has been a surprise, driven by people who must avoid gluten or choose to not consume it. The “must avoid” consumers typically suffer from celiac disease. This is a serious disease that reduces the small intestine’s ability to properly absorb nutrients from food.

I know the symptoms and required dietary limitations well, as both my daughters have celiac disease. Both were diagnosed in 2001 when finding foods that were labeled as gluten-free was rare. At that time, the only guidance for packaged foods was on the label (at times confusing) and using fresh, unprocessed foods. Fortunately, due to demand from celiac patients and others who choose to avoid gluten, gluten-free labeled products are readily available today.

While gluten is not technically a food allergen, in practice it can — and should — be handled in a manufacturing facility (or your home kitchen if you have a celiac patient joining you for meals) as you would handle any other allergen, such as peanuts or eggs.

Gluten is found in wheat, but it can be found in other grains such as barley and rye, and therefore, it can be confusing if you see items labeled as “wheat free” because they can contain gluten. Also, there is a level of gluten-containing grain contamination typically present in oats, a gluten-free grain that is not ­generally considered as such because of cross-­contamination. Oats must be grown and harvested separately and tested to ensure gluten-free status.

When my daughters were originally diagnosed, we were amazed how limiting a celiac-friendly diet is. At that time, being a celiac patient was very difficult. Think of it: no bread, pizza, licorice, oats and beer (or many other alcohols). However, since then, more ­gluten-free foods have become available in grocery stores and restaurants.

So, what are the optimal food safety programs for making a gluten-free product? Just as with allergens, the best option is to have a dedicated line — or even better, a separate facility — specifically for making gluten-free snacks and baked goods. If that is not possible, as in most cases, a bakery can manage the risk by establishing strict programs to monitor, verify and validate the cleaning and separation protocols. Best practices from allergen control plans such as supplier qualifications, sanitary design, proper scheduling, testing for clean contact surfaces and finished product, segregated and identified allergen materials, and employee training are a few of the prerequisite programs that should be the foundation of a gluten-free control program.

As with any process, the first and most important step for the management team should be a risk assessment and capabilities review, including that of the equipment’s hygienic design and operational process from a sanitation perspective. Important questions need to be asked: What is the makeup of the soil to be cleaned? Are there needed improvements in hygienic design? Will equipment be cleaned manually, clean-in-place (CIP) or clean-out-of-place (COP)? Will the equipment be dry or wet cleaned? Each of these points will guide the team to the proper sanitation program to support a gluten-free claim.

Sanitation and cleaning are common themes in a gluten-free program. How can an operation ensure that a line is gluten-free after producing a gluten-containing product? While finished-product testing is an important part of the program, it does not validate the program or sanitation process. In-process controls and checks are needed to ensure that when the finished product is tested, it is gluten-free.

Cleaning validations should include the equipment and potential cross contamination points. If the equipment/line is dedicated as gluten-free, there should be a review of other processing activities. Do adjacent lines jeopardize the product? Are environmental air handlers or dust collectors properly positioned and designed?

Specific to cleaning, a risk assessment is needed to understand conditions. Is compressed air used to move soils on adjacent lines? Does maintenance understand implications when working on equipment and the possible cross contamination potential? Does the sanitation team fully understand cross contamination potential? If a CIP system is used, is the rinsate water tested for allergens from an earlier circuit? Similar concerns exist with COP systems, sanitation tools and other types of cleaning systems. As with the processing equipment, dedicated assets/resources are the preference, and any compromise from that must be validated.

Before August 2013, the industry had been working only with the proposed gluten-free guidelines from the Food and Drug Administration (FDA). Since then, FDA has made its final ruling and defined “gluten free” as less than 20 ppm of gluten.

A common and recommended tool used to confirm the effectiveness of cleaning for gluten removal includes analytical methods such as lateral flow analysis test kits or ELISA swabs. However, it is critically important to discuss the source and concentration of the gluten in the soil with the test kit or lab. Both are important considerations because not every test method will work with every food matrix or all sources of gluten.

When producing gluten-free products, there is much at risk, and effective sanitation plays a critical part. Unfortunately, it isn’t a one-size-fits-all formula; it takes experience and expertise to develop programs that avoid unnecessary costs but still guarantee a gluten-free product.

On a personal note, I would like to thank the many companies and associations in the food industry, including FARRP, processors, restaurants, food stores, analytical testing companies and others, for working together to accommodate gluten-free diets. Products that taste good and are nutritious are more available than ever (most supermarkets even have a dedicated gluten-free section). Speaking for my family, we appreciate your R&D work, analytical methods and food safety programs that paved the way to for many of these products.