One of the first steps in moving into making gluten-free products is to make sure the manufacturing facility can safely produce such items without the risk of gluten contamination. Bryan Scherer, director of R.&D., Penford Food Ingredient Co., Centennial, Colo., recommended a thorough technical assessment of the site.

“Review of the facility and protocols by an objective third party such as the National Foundation for Celiac Awareness is recommended before starting down the development path,” he said.

Consumers expect the product to be validated as gluten-free, and so must the process. Three organizations — the Gluten Intolerance Group’s Gluten-Free Certification Organization, the Celiac Sprue Association and the National Foundation for Celiac Awareness — currently certify products and companies as gluten-free.

Diligence is a necessity, said Kurt Becker, principal development scientist, ConAgra Mills, Omaha.

“Because even a small amount of gluten can cause symptoms for someone with celiac disease or non-celiac gluten sensitivity, gluten-free foods must be produced on a dedicated line or on a standard line that is rigorously cleaned and certified gluten-free,” he said.

And then there’s sanitation. Ideally, equipment for making gluten-free products will never have “seen” gluten or anything containing gluten. Yet even the most meticulously gluten-free processing plant must still set operating procedures and sanitation practices to meet allergen-level protocols.

Gluten comes under regulations written into the Food Allergen Labeling and Consumer Protection Act of 2004. To be labeled gluten-free, a food must contain less than 20 p.p.m. gluten, according to final regulations published by the Food and Drug Administration in August 2013.

The eye cannot detect amounts this small, yet new rapid testing methods may accurately determine gluten’s presence in as little as five minutes. A new test from Neogen, Lansing, Mich., detects gliadin, an indicator of the presence of gluten, at levels as low as 5 p.p.m. (10 p.p.m. gluten). It uses the R5 gliadin antibody and was developed in cooperation with the University of Nebraska’s Food Allergy Research and Resource Program.

If gluten-free processing is so difficult, why get involved? The market is hot, hot, hot. Sales doubled in the past five years and are expected to double again to $5.5 billion by 2015.

It’s not just the three to four million Americans who suffer from some form of gluten or wheat intolerance or celiac disease. It’s their families, too, and the millions of people who select gluten-free food because they believe it to be a healthier choice. Early last year, the NPD Group reported nearly 30% of Americans indicate they want to cut down or eliminate gluten. The Gluten-Free Agency, a Toronto-based consulting group, estimates the total market could be as high as 44 million people in North America alone.