High-profile food allergy cases prompted the FDA to issue an allergy warning letter in 1996, putting manufacturers on notice that narrow exemptions from ingredient labeling requirements would no longer be acceptable because of the life-threatening potential of allergic reactions. Food recall actions spiked to 90 that year and have remained near that level ever since.

Processors are under the gun to ensure that today's products contain what they say they do and, in the case of food allergies, don't contain what they don't disclose. And while food companies have made significant strides in dealing with the issue, considerable work remains to be done. Food allergen control, by all accounts, is a growth industry.

The health risks posed by undeclared allergens to North America's 7 million estimated food allergy sufferers surfaced as a public-health issue in Canada in the late 1980s, then spread to the U.S. Major food companies have invested considerable time and attention on the issue, focusing first on the eight food groups that account for the vast majority of allergic reactions. The priority now is validating their allergen-control programs, with in-plant tests of in-process and finished goods and swab tests for detecting trace amounts of allergen proteins on equipment emerging as the latest tools.

Industry-wide response, on the other hand, has been uneven at best. Atlanta-based TFiS Inc. performed 350 plant audits last year on behalf of supermarket chains, foodservice firms and manufacturers that are requiring an allergen protocol as a condition of doing business. The majority of those audits found that the suppliers had not even taken the first step of identifying the allergen-related ingredients in their plants and then determining how to isolate them in the production process.

Road map of industry response

"It's all about good GMPs, good HACCP, good sanitation you should be doing anyway," suggests George Dunaif, director of toxicology and analytical services for Campbell Soup Co., Camden, N.J. "If you focus on controlling one, or two or eight specific allergens, you lose perspective. There's nothing magically different from good, fundamental operating procedures."

To dramatize the human dimension, managers at General Mills Inc. commissioned an employee training video that features coworkers and their family members who suffer from food allergies. The point: an allergen-related food recall isn't just a public-relations black eye and a financial cost for manufacturers. It could result in death for a colleague or loved one.

"We want to be one of the leading companies in this area and spread the word to the entire industry," explains Kevin Farnum, director of food safety at Minneapolis-based General Mills. "Originally we tried to focus on the allergen-control programs of companies that were potential suppliers to us, but then we realized the issue has wider impact. If a competitor's granola bar has a problem with allergens, that affects all manufacturers of granola bars."

Farnum's efforts on the allergen front prompted the Food Allergy Network (FAN) to name him this year's recipient of the Mario C. Furlong Award for Making a Difference. The award is named for the son of Anne Munoz-Furlong, founder and CEO of FAN.

"General Mills has been the industry standard in many respects," according to Munoz-Furlong. "They've done things like boldface allergens in ingredient listings and put messages, 'Allergic consumers: please read' on packages."

FAN's 22,000 members work closely with industry, providing research support and making sure that the most at-risk segment of the population is aware when allergen-related recalls occur and when manufacturers alter formulations to include allergens. Helped in part by a grant from Kraft Foods, FAN is attempting to develop a database of food-allergy patients to improve communications between manufacturers and this segment of the population. A similar effort is under way in Canada, where the Anaphylaxis Network of Canada has championed the cause of food-allergy sufferers since the 1980s.

Restaurants and other away-from-home eating occasions pose the greatest risk to those groups' constituencies, when there is no ingredient panel to consult. Only one food allergy-related death involving packaged food has been documented, but Munoz-Furlong is concerned manufacturers are shifting to excessively broad label language that will severely restrict what allergy patients feel safe eating.

"There have been a couple of cases where every one of the major allergens except fish and shellfish was covered on an ingredient panel with 'This product may contain' language," Munoz-Furlong frets. That could cause people to ignore ingredient panels altogether, and it raises questions about how thoroughly the manufacturer cleans its equipment, she says.

"The rationale for labeling is to help the consumer, and the best way to do that is to be as specific as possible," Munoz-Furlong advises. A statement that an allergen-free product is made on equipment shared with allergen-containing foods is preferable to a "may contain" statement.

Besides effective GMPs and sanitation, Munoz-Furlong says a conscientious approach is the best antidote for cross-contamination, mislabeling and other problems with undeclared allergens. "If a plant engineer notices that something has gone awry, we hope he speaks up," she says.

Washdown techniques may need adjustment to ensure that sanitarians are removing allergen proteins as well as pathogens from equipment surfaces. Photo: Ecolab Inc.

Allergen-control primer

Beyond that, manufacturers need to be certain that well-intentioned initiatives in other areas do not negatively impact allergen-control efforts. A case in point is the industry's focus on producing pathogen-free foods.

High-temperature steam cleaning of hard-to-reach fittings and other areas is effective in killing pathogens, notes David Hakes, manufacturing quality manager at Ben & Jerry's Homemade Inc., South Burlington, Vt., but thermal treatment is ineffective in ridding equipment of the proteins that are the basis of food allergens. To remove protein, sanitarians need to use chemicals of sufficient concentration.

When developing a firm's allergen-prevention plan, Campbell Soup's Dunaif advocates a multidisciplinary team approach. Representatives from engineering, R&D, purchasing, toxicology, legal and other areas might be involved. "Some large companies use people from 10 disciplines, although the actual number depends on the individual company," he says. "The key is to sit down with a group representing a variety of areas and get them to take ownership of the issue and take pride in understanding what it is you have to do."

Executing the plan demands a top-down approach to the allergen-control message. If training is to be effective, "first you must train the trainer," Dunaif points out. "Not every operations or QA person is going to feel comfortable with the topic initially. The more they understand, the more effective training will be."

General Mills engineers have cut holes and installed doors into existing machinery to provide access for cleaning and visual inspection. "That takes a lot of money, and there's risk involved," allows Farnum, "but there's a cost for having equipment that is not cleanable, as well.

"If sanitation by design principles were used religiously by equipment design engineers, that would help the situation a lot," he adds. Farnum suggests firms specify new equipment with the features needed for optimum sanitation. When changes are suggested to lower the purchase cost, compute the added cleaning and maintenance costs over the equipment's useful life to determine if cost cutting is really economical.

"In most cases, it's cheaper to make equipment without a door, and then there is the issue of dust accumulation," he concedes. "But you have to use the sanitation by design principles: either pay more money up front so it can be easily cleaned, or throw more people at it for 30 years."

UPC scanners in the packaging department can minimize the danger that allergen-containing products might get shipped in the wrong package. At General Mills, Cheerios are packaged in the same plant as Honey Nut Cheerios, which contain almonds. By installing a scanner, managers are more confident that Honey Nut Cheerios won't inadvertently get shipped in a Cheerios box; if a Cheerios box somehow found its way onto the line, the scanner would identify it and shut down the line.

Beyond that, groups like the NFPA's food allergy committee are considering recommending that food companies refrain from using allergens in their formulations unless they add functionality to the product. "That usually doesn't go over too well," comments Susan L. Hefle, a researcher at the University of Nebraska in Lincoln and codirector of the Food Allergy Research and Resource Program (FARRP). "A more successful approach might be to try to make marketing understand the difficulty of cleaning major allergens from the equipment when new foods are being considered."

In some cases, allergens are used gratuitously in formulations. "Product developers sometimes just throw things together, and if you ask them why they included an allergen, they can't tell you," Hefle says. "If there's no functional benefit, why include it?"

Changing when an ingredient is added can be just as effective as elim inating it. To illustrate, she cites a muffin maker that adjusted its process to add nuts in a slurry at the end of the line instead of in the dough mix at the beginning. Cleanup was simplified, and consumers reacted favorably to the change.

Semper vigilans

Most manufacturers produce both dark chocolate, which does not contain milk, and milk chocolate. Wet cleaning is not an option in those plants because the oil in cocoa repels water. To verify that sanitation programs were effectively dealing with the issue, an industry group commissioned an independent audit of finished goods. To everyone's consternation, tests indicated the majority of goods with dark chocolate also contained trace amounts of milk. Dedicated production facilities are not an option for many firms in the segment, so "may contain" labeling became the safeguard.

The widening circle of allergenic foods is another challenge. Even as major manufacturers are developing confidence that the eight major allergens are under control, a second tier of allergens is emerging as a new battlefront. Poppy seeds, sunflower seeds and sesame seeds -- a frequent ingredient in vegetarian dishes -- are coming under the auspices of some firms' allergen programs, and they are just the tip of the iceberg.

Five years ago, Hefle's research identified 168 allergenic foods. Today, she estimates 220 have been identified, and the list will grow. "Any food that has protein has the potential to be allergenic," she points out, "but there is no way that food manufacturers can control for all 220."

Another troubling issue is the lack of consensus on what constitutes acceptable trace levels of allergens. FDA advises manufacturers that any level that can cause an allergic reaction is significant and therefore must be disclosed on the label, but no one agrees on what that level is. However, the levels that are being discussed -- as little as 2 parts per million (ppm) in the case of peanut oil -- suggest dedicated facilities with hypoallergenic environments.

Steve Taylor, Hefle's colleague at FARRP, has suggested 10 ppm as a standard, and FDA officials have indicated they hope to make a significant announcement in this area within a year. But an FDA scientist also says the threshold is likely to vary between allergens.

Lack of a standard has stymied efforts to validate the in-plant testing kits being marketed by four testing laboratories (see resource guide, p. 20). When used by trained technicians, those kits can render results in minutes, rather than days, regarding the presence of allergens.

"These are bench assays meant to be used by QC/QA people with pipettes and basic lab facilities," says Bruce Ritter, president of Gainesville, Fla.-based ALISA Technologies Inc. Like the other kit suppliers, Ritter would like to secure validation from AOAC International for his tests, but until there is agreement on the detection level and what constitutes a suitable reference material, there is no standard to validate against.

FARRP researchers developed similar assays for test kits marketed by Neogen Laboratories, including a sanitation assessment assay that uses swab tests for equipment inspections. "A decided minority of companies are using them currently," Taylor says, but he expects that will change as more and more state health agencies use the tests and punish firms that don't pass muster.

"We used to tell people that visibly clean was good enough, but that will not be the case," once validation standards are determined, Hefle says. "Eventually, there should be no reason not to test."

There is some concern that the tests will be used as a crutch, substituting for stringent sanitation and operation practices. Some advocate making them a part of the production process, with tests made of every batch. But others feel that approach would be ineffective and impractical.

"I don't know what all that data would really add," says Campbell's Dunaif. "If you set up a good control strategy and then test to verify, that's better than testing at the back end," when the only response to a positive test result might be to destroy the entire batch.

Until the kits receive the endorsement of AOAC, "visual inspection will remain the standard," says Ben & Jerry's Hakes. Farnum of General Mills seconds that, adding, kits "are great, but it doesn't do any good to take a swab if you see ingredient accumulations. Visibly clean is still the first priority."

A lab technician tests for allergens in a finished product using one of the test kits designed for on-site evaluation. Photo: Neogen Technology Inc.

The legal quagmire

Allergen suits are almost always settled out of court, but the settlements run from tens of thousands to millions of dollars, says attorney Martin J. Hahn, a partner in Hogan & Hartson, Washington, D.C. "It depends on the circumstances, but unless you have taken preventive steps, you can take out the checkbook and start adding zeroes.

"Test kits are a blessing for the industry," Hahn believes, but they also could be used against a manufacturer. Test results would be subject to pretrial discovery, and a firm that knew peanut protein was present but took no corrective action would be at significant risk.

Reliable statistics on the number of food-allergy victims is nonexistent, with the 125 annual deaths attributed to anaphylactic shock a best-guess estimate. That likely will change in the coming years. Because of the efforts of Boulder, Colo., allergist Allan Bock, the Centers for Disease Control created new codes in the Index to Diseases covering shock or reactions due to food, with seeds and food additives joining the major allergen categories. Now emergency room physicians are being contacted, Dr. Bock explains, to encourage them to use the new codes. In the past, asthma, heart attack or some other diagnosis often was used in these cases. "We finally have some decent codes, and we'll get some decent numbers," he says.

That will mean even more pressure on the food industry to demonstrate good faith in delivering allergen-free products. For some companies, it will require continuing the work that's been ongoing for years; for others, it will mean catching up to industry standards in a hurry.