A 15-year-old girl from Saguenay, Quebec, Christina went into anaphylactic shock in November when her boyfriend kissed her. The boy had eaten peanuts hours before. The protein residues in his mouth were sufficient to cause a severe reaction in the peanut-allergic girl. Despite receiving an adrenaline injection almost immediately and being rushed to a local hospital, Christina Desforges died a few days later.
Though such an extreme reaction is rare, food allergies are linked to 30,000 emergency room visits and up to 250 deaths a year in the US. Tragedies like the Desforges case helped pave the way for Congressional approval of FALCPA in 2004, a rare grassroots-inspired regulatory change that ultimately won the support of industry trade groups. Although FALCPA raises the liability of food manufacturers who fail to identify any allergens in their products, the humanitarian and pragmatic aspects of the law carried the day.
As with most new regulations, some misconceptions and uncertainty surround FALCPA, which went into effect January 1, 2006. FALCPA deals with package labels only. Two weeks before the law went into effect, the Food and Drug Administration tried to drive this point home in a final industry guidance. The requirements "do not apply to major food allergens that are unintentionally added to a food as the result of cross-contact," FDA advised. "Cross contact may result from customary methods of growing and harvesting crops, as well as from the use of shared storage, transportation or production equipment."
"The FDA's limitation on the scope of the law is greatly appreciated," notes Attorney Martin J. Hahn, a partner in DC-based Hogan & Hartson LLC. Strict segregation of bulk commodities is almost impossible, which is why the standard of identity allows up to 25 percent wheat in commodities labeled as oats. But leeway on cross contamination is not an excuse for lax sanitation and scheduling routines. "There definitely is a potential financial consequence" if people become ill from consuming improperly labeled foods, Hahn says. And the damage to a manufacturer's reputation in a recall can be even more costly.
FALCPA is intended to help consumers, not punish manufacturers, supporters emphasize. Given the large community of food allergy sufferers-11 million and growing, by some estimates-the act also is an opportunity for processors to build a bond of trust with a fiercely brand-loyal consumer segment.
To hedge or not to hedgeWith two years to prepare, manufacturers had sufficient time to get their labeling houses in order. If a product is derived from or contains an ingredient with protein from any of eight major allergen categories, the label must disclose it in plain English. The allergens are milk, egg, wheat, peanuts, soybeans and specific species of fish, Crustaceans and tree nuts (walnuts, cashews, pistachios, etc.). Manufacturers are free to include "may contain," "processed on equipment used for" or other advisories at their discretion. That is the act's first sticking point.
A sweeping "may contain" statement may minimize liability if someone suffers a reaction to a protein that wasn't supposed to be in a product, but it also discourages millions of potential buyers from purchasing. "FDA is discouraging ‘may-contain' statements, though there's some leeway for interpretation," notes Karen Duester, president of Del Mar, CA-based Food Consulting Company. "The use of advisory statements depends on whether the marketing department or the legal department has more say."
Allergen awareness in the food industry has been building for a decade, and major processors had their label declarations and manufacturing strategies in place well before the January 1 deadline. The situation is different in the rest of the manufacturing community. Unable to dedicate people and resources exclusively to the issue, smaller firms are scrambling to comply. "Beginning in March of last year, we started getting an avalanche of inquiries," says Duester, who provides label consultation and chemical analysis services to small and mid-sized processors. "They want to do the right thing, but they don't know what the right thing is. There are no rules, there is only guidance."
Processing aids such as soy-based oils to lubricate baking pans are a grey area. And FALCPA doesn't cover business-to-business product movement, leaving smaller food processors at the mercy of their suppliers' disclosures and good manufacturing practices (GMP). Switching suppliers for an ingredient may mean all allergen-content bets are off.
The absence of threshold limits for declarations is the biggest sticking point. Although FDA has signaled its willingness to consider thresholds, zero tolerance is the current rule. "It is not unlikely," the agency states, "that FDA will at some point need to consider a threshold level for one or more food allergens in the context of reviewing a petition."
In the meantime, informal industry standards that exempted peanut proteins below 10 parts per million (ppm) are out the window. The threshold for a reaction varies from protein to protein and patient to patient; establishing thresholds places regulators in the uncomfortable position of leaving some people with compromised immune systems outside the protection of the law. Realistically, 100 percent protection is impractical. "A reasonable certainty of no harm should be applied to threshold levels of major food allergens," suggests Principal Scientist Jupiter Yeung of the Food Products Association, Washington, DC.
Take it insideFood plants aren't run by lawyers or marketing executives but operations managers and engineers. Many know people or have family members with food allergies or sensitivities, and the overwhelming majority is conscientious about controlling allergens in their facilities. Their interest is reflected in the swelling attendance numbers at workshops sponsored by Food Allergy Research and Resource Program (FARRP). The workshops, which typically draw 110 food industry professionals, have gradually expanded from one or two annually to four or five.
The first Canadian allergen-control program was staged in February, drawing a capacity crowd of 75, according to Susan L. Hefle, FARRP's co-director and an expert on food toxicology/immunology. Managers from major food processors, particularly cereal manufacturers and others with products catering to children, have been program mainstays since the workshops began. Now the audience is broadening, and specialized workshops for plant sanitarians and QA professionals are being offered. "People want more in-depth information," Hefle says. "In the next year, the demand for these workshops will increase."
Higher standards in facility design are being set as manufacturers try to limit the potential for allergen cross contact, notes Darryl Wernimont, a director with the Haskell Co., Jacksonville, FL. "Facility expenditures are being dedicated to improving the segregation and isolation protocols for product movement and exposure in and out of a facility," he says. In new construction, special attention is being paid to air-handling and drainage systems and other utilities and services.
Improved sanitation practices are the best option in existing plants, and the FARRP workshops provide a forum to share strategies. Vacuum cleaning and other dry sanitation approaches are gaining interest, given the ineffectiveness of hot water in removing allergen residues. Some processors are using enzyme-linked immunosorbent assays (ELISA) and other tests and swabs to detect the presence of proteins on food-contact surfaces as a way to validate and document their sanitation procedures. ELISA tests for most of the major allergens were developed and validated by Hefle and are distributed by Neogen Technology. They usually can detect to 1-5 ppm. The tests are designed for finished goods, however; using them daily on processing-equipment evaluation would be overkill.
The perniciousness of allergen proteins-and the ability of science to detect them-was underscored eight years ago at a European meeting of immunoassay specialists, recalls Bruce Ritter, president of Gainesville, FL-based ELISA Technology Inc. A major manufacturer of hypoallergenic baby foods used an ELISA test to detect trace amounts of peanut protein. Despite repeated CIP cycles through the plant's stainless steel pipes, the allergen could not be eradicated. The contamination ultimately was traced to a valve that could not be cleaned out automatically.
"There's work underway to try to reduce the allergenicity of foods, as well as to detect it," Ritter adds. Hydrolysis, blending and other processes may neutralize the effects of some proteins. "Process manipulation could knock down many of the proteins," he says.
Ice cream manufacturers typically produce both nonallergenic and allergenic products on the same lines. They are dipping into technology's equipment arsenal to cope with the allergen-control challenge. Dreyer's Grand Ice Cream installed more than 100 mix-proof valves at its Bakersfield, CA, plant to enhance its ability to clean out egg, peanut and other allergen residues from lines before a nonallergenic product is run.
Package mixup is another danger. To minimize that possibility, Dreyer's used a vision system to confirm bar codes on carton-forming equipment. In Bakersfield, it migrated to tiny 2-D codes that are read by sensors. Intense light illuminates the 2-D marker, which, unlike the bar code, is unique to each SKU.
The core technology was installed by De Soto, KS-based Huhtamaki. "It's unlikely anything will get through our system," believes Huhtamaki's Paul Carter, director of continuous improvement, "but to protect themselves, many companies implement redundant systems." The switch to sophisticated scanner technology lowered software configuration costs and enabled the system to keep pace with Huhtamaki's fastest carton-formers, which output up to 190 units a minute.
Automated data collection to determine where an allergen might have been added is another relevant technical tool. Given system cost, however, there hasn't been a groundswell of interest in the FALCPA era. "I can't say I've seen an uptick in implementations of MES and tracking solutions, and I don't think I will see any," reports Jay Jeffreys, a marketing director at Wonderware Inc.'s Johnson City, TN, office. "This is just more confirmation that food manufacturers have to keep better track of what should and should not be in their products." If processors can meet the 24-hour response requirement of the Bioterrorism Act, "they certainly can manage an allergen recall," Jeffreys says.
Parallel processing networksGeneral Mills and other manufacturers have tried to segregate allergen processing in dedicated facilities. It's an expensive and, often, impractical solution. Just as interest in natural and organic foods has encouraged construction of dedicated processing facilities, the allergen-free market could feed further manufacturing fragmentation.
Frustrated by hard-to-decipher food labels of the past and fearful of feeding the wrong product to their children, some consumers are abandoning mainstream manufacturers and retailers. "I know quite a few people who steer clear of general retailers," says Denise Lewis, founder of the Food Allergy Connection, Lenexa, KS, one of the many grassroots food-allergen awareness organizations. "Some families worry themselves sick over mislabeled products. I'm optimistic FALCPA will make things easier."
Jenny Beith is another mother with a child with a food allergy. She took a more proactive approach: two years ago, Beith opened a gluten-free grocery store in North Aurora, IL. The store is also a bakery, with vegetable gums and gelatin serving as binding agents instead of gluten. A loaf of bread retails for $7, and the company caters to as many special needs as it can. Mail order is a growing part of Special Order Market & Bakery's business, and Beith is developing her web site to accept Internet orders.
Anne Munoz-Furlong would prefer that mainstream food companies adapt their production schedules and train their employees in proper allergen handling than see a parallel production system develop. As founder of the 30,000-member Food Allergy and Anaphylaxis Network (FAAN), her opinion carries weight. "The onus is on food manufacturers to do everything in their power to prevent cross contamination and properly label their products," Munoz-Furlong says, adding, "If you put ‘may contain' on the label, you might as well put, ‘don't eat.'"
Because most food-allergy sufferers are children, the allergen-free community is huge, she notes. "It not only touches 11 million families but their grandparents' households and the families of their friends," Munoz-Furlong says. She cites a FAAN survey that found 94 percent of school nurses reported at least one child with food allergies attended their schools; 60 percent of nurses reported an increase in the affected population in the previous five years.
"It all boils down to trust," she concludes. "If people affected by food allergies trust the information they are given, they will trust that product, and they become very brand loyal and tell everyone else."
Food-related allergies and sensitivities are growing and are part of a larger public health debate. Some theorize there is a link between immune responses and expansion of childhood immunizations. Until 1988, only seven immunizations were given; now children need more than 20 before enrolling in school. Mercury transmitted during the inoculations is suspected by some of compromising children's gastrointestinal tract, allowing undigested food to get into the bloodstream and triggering immune-system reactions.
The autistic population is skyrocketing, with the Centers for Disease Control estimating one in 166 children are affected, up from one in 10,000 in 1990. Many mothers in grassroots organizations have shared their experiences in improving their autistic children's health by eliminating certain allergens from their diets.
Similarly, the cyliac-disease community is booming. According to Beith, "one in 133 people have cyliac disease, but only a third of the cases have been diagnosed."
The public-health implications are beyond the food industry's effect. Manufacturers hold the key to some of the changes needed, beginning with proper labeling. Rather than a regulatory burden, FALCPA may represent the first of many positive changes to come.
For more information:
Bruce Ritter, ELISA Technologies, 352-337-3920, firstname.lastname@example.org
Susan Hefle, FARRP/University of Nebraska, 402-472-4430, email@example.com
Anne Munoz-Furlong, Food Allergy and Anaphylaxis Network, 800-929-4040
Karen Duester, Food Consulting Company, 858-793-4658, Karen@foodlabels.com
Jupiter Yeung, Food Products Association, 202-639-5900, firstname.lastname@example.org
Darryl Wernimont, the Haskell Co., 904-357-4820
Paul Carter, Huhtamaki, 913-583-8292
Jay Jeffreys, Wonderware Inc., 423-282-0281