Nima Labs Inc.

USDA Meeting: Preventing Undeclared Allergens

The US Department of Agriculture (USDA) held a meeting on March 16, 2017, to cover off on a very important topic: reducing food recalls. There is a lot of good information on the incidence of food allergies, recalls due to food allergies, best practices for food manufacturers and restaurants, and some information about how consumers perceive food labels. We reviewed all the presentations and pulled together key highlights.

Food Allergies Are Still A Huge Problem

Life with Food Allergies

Dr. Stefano Luccioli, MD, the food allergen program coordinator at the Center for Food Safety and Applied Nutrition of the FDA, presented on Assessing the Public Health Burden and Risks of Food Allergen Exposures. Dr. Luccioli noted that food allergies affect 3 to 4 percent of Americans and that there is a decreased quality of life for people who have to avoid certain foods. We have observed this in extensive interviews with our Nima community. Having to follow a specific diet can be socially isolating. Picking a restaurant for two divergent diets can lead to a lot of guilt on both sides when both people may just want to feel at ease when dining out.

Scott Riccio, senior vice president of Education and Advocacy at Food Allergy Research & Education, shared Consumer Perceptions of Allergen Labelling at the meeting. According to his most recent data, 9 million adults have food allergies, while nearly 6 million children do. Childhood allergies are fading more slowly than in previous decades, which means that people aren’t aging out quickly, with allergies lingering until children are older. Food allergies increased approximately 50 percent between 1997 and 2011.

Avoidance of these allergens is not easy for many reasons: they are abundant in the food supply; there is a proliferation of allergen labeling, which limits food choices; consumers distrust or ignore food labels; and food hazards are hard to control in the production process.

Teenagers and young adults with food allergies are at the highest risk of fatal food-induced anaphylaxis. Anecdotally we at Nima have heard from many parents that teenagers want to be seen as cool by their friends and the social isolation of food intolerances and allergies means many are willing to chance eating something that may be harmful. Technology tools can help to change the conversation – whether it’s an app that helps to source appropriate dining venues, fun ways to evoke one’s need via stickers or emoji, or sensors such as Nima.

FARE conducted a consumer research study on food labeling in both the U.S. and Canada. In the U.S., 90 percent of people never purchase items that say “may contain allergens,” 59 percent never purchase items labeled “Manufactured in a Facility that Also Processes Allergen,” and 83 percent never purchase items labeled “Manufactured on Shared Equipment with Products Containing Allergen.” It has been consistent in our qualitative research and in feedback from consumers that they are carefully considering not only each label, but professional expertise where available – whether a doctor, nutritionist, or advocacy group. Consumers well understand these labels are there to provide guidance.

As with Dr. Luccioli’s presentation, allergen thresholds are notoriously hard to define. This is why when we developed our gluten sensor, we made it so that we report any gluten we detect. For peanut, milk, and tree nut versions, we are working to make the level of detection as sensitive as possible.

USDA Meeting: Chart of Food Reactions

Undeclared Allergens Still Reign as Recall Culprits

Kis Robertson Hale, the deputy director, applied epidemiology staff, Food Safety and Inspection Service, U.S. Public Health Service, and Scott Seys, senior data analyst at Food Safety and Inspection Service, presented Food Safety and Inspection Service Policy and Recall Analyses covering recalls since 2000.

Of the 1,356 recalls since 2000, 31 percent were due to undeclared ingredients. Non-top eight allergen-associated recalls were: MSG, nitrates and other additives, other. Nima currently maintains a list of 125+ items people have asked us to create sensors for testing.

Top causes of recalls were incorrect label, ingredient-related errors, incidental contact, and root causes suggest that most recalls are not due to trace amounts of an allergen – this means that if you’re exposed, you’re going to be exposed to more than cross-contamination. However, we do see that Nima results are showing trace amounts of gluten in items that people have been sold as gluten-free. While Nima can detect below 20 ppm, it may be that people are being exposed to gluten on a more regular basis than they anticipated. Once we begin testing for other allergens, we will share that data.

Only 68 percent of establishments evaluated had an allergen control plan/program. We have found that manufacturers in the free-from space are well aware of the impact of their products and the expectations of the audience. This percentage may well be different for those who are in these specific spaces.

What’s being done to preserve food safety for those afflicted with food allergies? FALCPA (Food Allergen Labeling and Consumer Protection Act) defines major food allergens and the current standard for gluten-free, among other items. It involves packaged foods and dietary supplements but not drugs, cosmetics, or retail/restaurants. It also does not address cross-contact. Nima community members often ask about using Nima to test drugs and cosmetics. We have not conducted any testing on these products with Nima. We have done extensive restaurant testing, which shows about 30 percent of restaurant food ordered as gluten-free contains gluten. We look forward to providing similar data for peanut and milk.

FSMA (Food Safety and Modernization Act) also defines cross-contact and guidance is pending. You can track guidance and other public meetings on the FDA website.

Jeff Canavan, deputy director of Labeling and Program Delivery Staff at Food Safety and Inspection Service, also gave a complete overview of labeling requirements by various food types in Food Safety and Inspection Service Labeling.

Restaurants are the Wild Wild West of Allergens

Laura Brown, a behavioral scientist at the National Center for Environmental Health, Centers for Disease Control and Prevention, discussed Restaurant Food Allergen Knowledge and Practices. Restaurant food is a significant cause of allergic reactions – 34 percent of people in a survey conducted at the Food Allergy and Anaphylaxis Network Conference reported at least one restaurant reaction. Nima survey data confirms this – with varying levels of reactions from consumers based on what they avoid. Those who report getting sick in a restaurant once a week or more frequently based on surveys per allergen (milk, shellfish, peanut, tree nut):

  • 37% Milk, for those with a milk allergy
  • 26% Shellfish, for those with a shellfish allergy
  • 25% Peanut, for those with a peanut allergy
  • 13% Milk, for those with lactose intolerance
  • 1% Tree Nuts, for those with an allergy to any tree nut

The CDC did a study to understand which practices and staff characteristics are associated with best practices. Research was conducted in six states in 278 randomly selected restaurants and involved manager, food worker, server interviews along with observations. Only 68 percent of restaurants have a plan for answering questions from food allergic customers. The same percentage have a plan for making food for allergic customers. Yet only 62 percent have a plan if a customer has an adverse reaction. This data does not surprise the Nima team, based on the reported incidences of exposure when dining out.

Seventy-eight percent do have utensils or equipment for making allergen-free food, with 91 percent having special areas in the kitchen for making allergen-free food with nearly 100 percent changing gloves before making the order. However, 68 percent always/often use a separate surface for making the order, and 67 percent use a separate cooking surface or pan. We find some of these numbers to be elevated, but since this study was among 278 restaurants of an estimated total of 630,000 there’s a lot of opportunity for variance.

Not surprisingly, restaurants that serve more allergen-free consumers tend to have better plans. This definitely is something the Nima community has shared – they tend to visit the same places on a regular basis. Many people with food intolerances and sensitivities are more comfortable with chains that have and adhere to an articulated set of standard operating procedures.

Lauren Jackson, chief of the Process Engineering Branch at the FDA’s Center for Food Safety and Applied Nutrition, shared The Role of Cleaning and Sanitation at Preventing Allergen Cross-Contact. Five to 15 percent of all recalls are associated with consumer reactions. Most common food types associated with recalls due to food allergens: bakery, snack, candy, dairy, and dressing. These are the items most often cited by those with peanut and milk allergies for testing. Gluten-free consumers are additionally concerned with sauces, shared fryers, and other areas where gluten may be a predominant ingredient.

Jackson also noted, “Microbiologically clean is not equivalent to allergen clean. Proteins are notoriously ‘sticky’- difficult to remove from food contact surfaces, especially if the protein has been heated.” This has been a good conversation starter when dealing with restaurants. Some do not realize this thinking that heat will kill a protein. When you’re ordering out with a Nima, we recommend having a detailed conversation with restaurant staff.

This presentation further covers factors affecting allergen removal and methods of removing protein soils, along with analytical tools in use. We recommend restaurants and manufacturers review this presentation for an overview of the latest thinking.

The Future of Allergen Thresholds and Testing

Joe Baumert, associate professor in the Department of Food Science and Technology and co-director of the Food Allergy Research and Resource Program (FARRP) at the University of Nebraska-Lincoln, discussed Advances in Food Allergen Threshold and Quantitative Risk Assessment Research. Public health authorities have not established regulatory action levels for any of the allergenic foods – with the exception of Japan (10 µg/g protein limit for labeling). Baumert covers the peanut in cumin story among other testing for peanuts – this shows that allergens may hide in places that you would not have previously considered.

Recommendations from “Finding Safety in Food Allergy” report calls for the FDA and USDA to establish thresholds for allergenic foods. This report, which came out earlier in 2017, provided a list of suggestions for the future. This will be helpful for both manufacturers, dining establishments, and consumers. Clinical data exist on individual threshold doses of various allergenic foods from oral challenges conducted for diagnosis, threshold trials, and immunotherapy trials – published and unpublished. It will require an overview of all literature to provide solid guidance.

Baumert suggests QRA and reference doses could be used by regulatory agencies to determine which ingredients need to be labeled by source, curtail use of excessive precautionary labeling, determine the degree of risk posed by undeclared allergens in recalls, and assess the effectiveness of preventive allergen controls.

USDA Meeting: FARRP-TNO Food Allergen Threshold Database Numbers

Eric Garber, a research chemist at the FDA’s Center for Food Safety and Applied Nutrition, presented Testing for Food Allergens: Avoiding Potential Pitfalls. This presentation seems to posit that current testing with ELISA is not sufficient. On the plus side, ELISA has good specificity, but the extraction/preparation methods seem highly variable, and are probably overstated. As well, ELISAs can only detect one analyte (target) at a time. The way they are used, often running single tests and without using controls, leads to questionable data. Also, when standards are used, they may not be appropriate for the analyte (sample) being evaluated. Dr. Garber advocates using multiple methods for testing, including orthogonal methods (PCR, mass spec), and xMAP FADA where you can test for multiple analytes at once.

Case studies show that testing is not done rigorously, often based on single tests (no replicates) and lack of controls. This way of testing also questions the validity/accuracy of the ELISA tests – more rigor is needed.

We’re looking forward to seeing more from the FDA and USDA on how we can reduce recalls and ultimately unnecessary reactions for those with food allergies.

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