In an age of risk-based food inspection, it may be worthwhile to compare morbidity and mortality statistics on two food-safety hazards: E. coli O157:H7 and food allergens. Based on Centers for Disease Control and Prevention (CDC) estimates E. coli O157:H7 is responsible for 73,000 cases and 61 deaths per year in the United States1. Food allergies, meanwhile, are linked to 29,000 emergency-room visits and 150-to-200 deaths a year. The meat industry’s implementation of interventions and control strategies targeting E. coli O157:H7 is commendable. It's time now to address food allergens — arguably the most important chemical hazard posing a threat to processed meat and poultry products.

A food allergy is triggered when a natural substance is mistaken for a hostile invader forcing immune systems to mobilize to repel the invader. Food allergies are mediated by IgE antibodies to proteins – a characteristic shared with other allergies such as hay fever (an acute allergic nasal condition) and wasp-sting reactions. Characterization of IgE antibodies is used to clinically diagnose food allergies. In contrast, celiac disease involves a cell-mediated immune response against glutens (proteins found in wheat, barley, rye, and related cereals). Oats are sometimes blamed for celiac reactions, but the real culprit in these situations may be North American commodity handling practices that result in wheat being present in loads of oats.

Food allergies are more common in young children; estimates are that 4-to-8 percent of infants and young children have food allergies versus 2-to-3 percent of adults. Most infants diagnosed with food allergies outgrow them within several months but some food allergies (e.g. peanuts, shellfish) are more persistent, often lasting a lifetime. Overall, it is estimated that 3.5-to-4 percent of the Americans have food allergies.  

The severity of food-allergy symptoms varies between people — some allergic individuals may experience serious or life-threatening reactions when exposed to food proteins ("allergens") to which they are sensitized. There is no cure for food allergies; avoidance is the only preventative measure available to the allergic consumer.  

Celiac disease does not produce acute life-threatening reactions; rather, it is insidious and chronic in its damage to the absorptive gastrointestinal cells of affected individuals. Recent estimates are that one in 133 Americans have a predisposition to celiac disease, and approximately one in 2000 has clinical symptoms of the disease. Celiac disease symptoms can include severe diarrhea, anemia, vitamin and mineral deficiencies, and painful skin blisters. Celiac disease is not outgrown, and can begin at any point in one's lifetime.

Internationally, eight foods are recognized as contributing to more than 90 percent of serious IgE-mediated food allergies (FAO, 1995). These foods, often referred to as the "Big 8" allergens, are: cow's milk, egg, wheat, soybean, fish, crustacean shellfish (e.g. shrimp, lobster, crab, and crawfish), peanuts, and tree nuts (e.g. almond, walnut, and hazelnut).

Use of ingredients derived from several of the "Big 8" food allergens (soy, milk, wheat, and egg) is becoming more common as meat and poultry product manufacturers search for ways to lower product fat levels and provide customers with an array of differently priced proteins.

Recently, Congress and President Bush acted to accelerate the implementation of food-allergen programs. On August 2, 2004, President Bush signed the Food Allergen Labeling and Consumer Protection bill, making it Public Law 108-2822, and acknowledging a fundamental truth: food-allergic consumers and especially the parents and care-givers of food-allergic children, rely primarily on product labeling to tell them if a food product is safe.

Public Law 108-282 specifically amends the Federal Food, Drug, and Cosmetic Act. The labeling law is applicable to food products labeled on or after January 1, 2006. FDA-regulated food manufacturers will be required to label the food source for all ingredients that are, or are derived from, the eight major food allergens (= the "Big 8"). The food source must be indicated by the "common or usual name". The law also applies to flavorings, colorings, and incidental additives and describes the conditions necessary to petition for a labeling exemption. More information on the mechanism for petition will be outlined by regulatory agencies in coming months. The law provides a labeling exception for highly refined oils derived from the "Big 8" allergens and for ingredients derived from such oils. The law will force processors to actively engage their ingredient suppliers to determine whether any allergens are present in the ingredients they purchase. That information must then be used to revise product labels in accordance with the new law. A beef flavor, for example, might contain hydrolyzed soy protein; if the product contained no other soy-derived ingredients, the label would have to be reworded to indicate "beef flavor (containing soy)" or a "contains soy" statement would have to follow the ingredient listing.

Under The Food Allergen Labeling and Consumer Protection Act, regulators must evaluate industry practices and provide specific reports to Congress at scheduled intervals. For example, regulators must conduct inspections to ensure that establishments act to reduce or eliminate allergen cross contact and properly label major food allergens. Regulators must also identify routes and estimated frequency of unintentional contamination in processing facilities and provide progress reports on the implementation of allergen-control practices. In addition to food-industry provisions, the new law requires that CDC improve the collection of data on food-allergy prevalence and on the incidence of clinically significant or serious adverse food allergic events.

Available information indicates that USDA-Food Safety and Inspection Service (FSIS) will follow FDA's lead on complying with the new law based on the following comment from Robert Post, Ph.D. (Director of the Labeling and Consumer Protection Staff, FSIS):

 "Because FDA has the authority to establish the common and usual names and labeling conventions for ingredients under their jurisdiction, FSIS will likely endeavor to be as consistent as possible with the requirements that FDA establishes in response to the Food Allergen Labeling and Consumer Protection Act. As such, meat and poultry manufacturers will be expected to label the ingredients they use in concert with the FDA requirements when they are set. FSIS expects to convey this in a FSIS notice as soon as FDA publishes the labeling regulations that are responsive to the new law."

Written programs are the primary means by which food manufacturers address allergen-control issues. The main goals of an allergen-control program are to ensure that product labels accurately describe a food's ingredients; and to prevent cross contact between allergen-containing products and allergen-free products or between products containing different allergens. Below, we've described the initial steps involved in developing an allergen-control Program.  

Allergens of interest should be identified in the program. At a minimum, the program should address allergens that are, or are derived from, the "Big 8" allergens. Additional allergens may need to be addressed if the company exports products to a country with an expanded allergen list. Canada, for instance, is concerned about sesame seeds and mollusks (e.g. clams, mussels) in addition to the "Big 8" allergens.    

In USDA-FSIS-inspected establishments, allergen-control programs are typically regarded as prerequisite programs but establishments may choose to address allergen control in their HACCP (hazard analysis critical control points) plans. If the prerequisite program approach is used, facility personnel must also determine whether "undeclared allergens" should be listed as a potential chemical hazard in the ingredient-receiving step of the hazard analysis.

Identifying all ingredients and processing aids used in the facility is the first step in allergy-control program development. These ingredients should be cross-referenced to a list of current product code formulations. Suppliers of ingredients should be contacted in writing and asked whether any of the ingredients or processing aids they provide include components sourced from the allergens of interest (e.g. the "Big 8" allergens"). A standardized allergen questionnaire may be used for this purpose. Other relevant questions can include:
•Does the supplier have an allergen-control program?
•What is the degree of hydrolysis for hydrolyzed protein ingredients (since the extent of hydrolysis affects allergenicity)?
•Concerning oils derived from the "Big 8" allergens, are they highly refined, bleached, and deodorized (and, hence, exempt from the new law)?

Similar questions should be posed to packaging suppliers, etc. to determine if any allergen-derived substances are present in packaging. Once the suppliers' responses are received, information on allergen-containing ingredients should be entered into the ingredient spreadsheet.

Once the facility has identified all allergen-containing ingredients and processing aids and cross-referenced them against product formulations, we suggest that the facility take the following steps:
• Cross-check the allergen listing for each ingredient against labels of finished products containing that ingredient. Determine if the "common" name of the allergenic source is indicated on the product label. If not, we suggest revising the label to include the common name of the allergenic source and submittiing the revised label to FSIS for approval.
• On a line-by-line basis, identify which products (and, by extension, which allergens) are run on each line and how long the runs typically last.
• Based on production volume estimates and order considerations, determine whether lines can be dedicated to a specific type of allergen/formulation (e.g. soy-containing ground beef patties). Whenever possible, dedicated lines should be used to run allergen-containing products.
• If lines cannot be dedicated to products containing a specific allergen (or allergen-derived ingredient), consider the following scheduling options:
Run allergen-containing products at the end of the last production shift prior to the full sanitation procedure.

Perform an "operational allergen sanitation procedure" after running a product with an allergen and before changing over to an allergen-free product or a product containing a different allergen. The minimum cleanliness standard is that all food-contact surfaces must be visibly clean. It may be necessary to partially disassemble equipment before cleaning in order to achieve this standard. Both the sanitation procedure and the subsequent pre-operational inspection must be documented.

 Determine which product codes share the same formulation and are, therefore, eligible to be reworked into one another. Obviously, allergens are just one issue addressed under the rework policy so pathogen considerations may further limit rework addition. Be sure that rework is labeled with product code, formulation number, allergen, line number, and date. Always document rework generation, usage and, if applicable, disposition as inedible.
Train all relevant personnel on allergen-control measures.

Controlling allergens in your plant is a sound business practice for a variety of reasons. First and foremost, consumers expect manufacturers of the foods they consume to control known threats to health. Food manufacturers' consumer-response lines are fielding an increasing number of questions about allergens and gluten-containing ingredients. Also, more customers are demanding implementation of allergen-control programs. That demand will only increase as restaurant chains, contract foodservice providers, and grocery store delis gear up to comply with the allergen-related Food Code revision mandated by the new Food Allergen Labeling and Consumer Protection Act.

As illustrated in Table 2, undeclared food allergens are an increasingly common cause of meat and poultry recalls. Allergen-related recalls rose from around 9.7 percent of total recalls of FSIS-inspected products in 1999 to 23.5 percent (almost a quarter of the total recalls) in 2003. This trend is observed across the entire food industry and across national boundaries as well.  From 2000 to 2001, for example, allergens were responsible for some 75 percent of the Class I recalls in Canada3.

Processors of 100 percent beef or poultry products do not need to concern themselves with food allergens. As the marketplace looks for points of differentiation, however, there are fewer processors in that category and more engaged in making marinated, enhanced, flavored, and value-added products. Any processor using non-meat/non-water ingredients needs to be aware of the potential risk that undeclared allergens pose to consumers and to the company's bottom line. Be proactive — don't wait till you're on the verge of calling the FSIS recall committee before learning how often allergens appear in the ingredients you buy and in the products you manufacture. NP