“The average cost of a recall is $540,000, according to some statistics we have seen,” says Mary Ann Platt, executive vice president, RQA Inc., Darien, Ill., a company that specializes in product recall and withdrawal services. “It can vary in the range of $10,000 to $7,000,000. These are direct product and retrieval costs and do not include such 'soft' costs as loss of sales or disruption to business operations.”
Add the cost of a recall to the number of people affected by food allergies, and companies quickly will see the importance of preventing undeclared food allergens in their products. Six to seven million Americans suffer from a food allergy, according to The Food Allergy & Anaphylaxis Network (FAAN). They estimate that up to 200 people die each year from food allergy-related reactions.
“The number of food allergy cases and recalls are increasing,” notes Anne Munoz-Furlong, founder and CEO of FAAN. “Consumers are more educated and are reporting more incidences to the FDA.” However, with solid management programs, testing and allergen labeling, companies can reduce risks to both consumers and themselves while still formulating products with the most optimal and functional food ingredients.
Precautionary Steps“We recommend that food facilities develop an allergen management program as part of their standard operating procedures to prevent cross contamination,” states Platt. “They should evaluate incoming materials for the presence of allergens and identify them. Sanitation and changeover procedures should be developed and documented with pre-operation inspections and, if possible, validation should be performed with the test kits now available for certain allergens.”
In addition to proper sanitation, Medallion Laboratories, Minneapolis, offers additional preventative tips.
If possible, try to dedicate the processing systems that produce allergenic products to that allergenic food only. Dedicate process equipment, employees, ingredient receipt, storage and transfer, packaging materials and maintenance equipment.
Avoid cross contamination. Allergens inadvertently appear in a product through a number of avenues, including poor equipment design and human error. Cross-contamination occurs when ingredients are not adequately controlled. This can be due to a lack of control of ingredient sources, storage and handling.
Schedule products that do not contain allergens at the start of a production run and follow with the allergen-containing product at the end of the production run.
Control rework. Color-coded tags, coupled with complete documentation that monitors when the reworked product is produced, where it is stored, which product it is reworked back into, and the time it is added back into the line, will help minimize cross-contamination.
A crucial step after identifying allergenic ingredients is to accurately include them in the ingredients listing on the label. It also is important to identify allergenic sub-components in ingredients, such as flavors. Once an allergen has been identified in the product, a process control step that verifies and documents the allergen is correctly listed on the label must be initiated.
Testing, TestingCompanies can test for the presence of allergens via commercially available test kits or through outsourcing to analytical laboratories. Currently, there are commercial test kits available for peanut and egg allergens. Outside laboratories can test for additional allergens, such as casein and whey.
“Allergen testing should be conducted to benchmark the effectiveness of cleaning programs and used as a piece of data in long-term validation,” says Kevin Farnum, director of food safety for General Mills/Medallion Laboratories. “Testing could also be used when consumer complaint patterns warrant them, when plant audits show potential failures, when new information or scientific discoveries are made, or for verification of operational or procedural mishaps.”
Harry Leichtweis, senior analytical chemist, Medallion Laboratories, adds that a company can integrate sampling and testing to determine the effectiveness of allergen programs, such as sampling a final rinse after a clean in place (CIP). “This helps you to determine program effectiveness and allows for constant validation. It is important to make sure your samples are representative of your whole process,” he says.
The Food Allergy Research & Resource Program (FARRP) works on developing enzyme linked immunoassays (ELISA) to detect allergenic food residues. In the FARRP ELISA format, antisera are developed using crude extracts of allergenic foods or specific proteins from allergenic foods as the antigens. Immunoglobulin G (IgG) antibodies against certain proteins in the crude extracts are produced. While the IgG antibodies may be directed at proteins that are not allergens, FARRP believes that the detection of any protein or group of protein from the allergenic food signifies the presence of the allergenic proteins.
Allergen LabelingIn the future, food companies may have to follow labeling guidelines for food allergens.
Allergens on the Web
The Food Allergy & Anaphylaxis Network
Food Allergy Research & Resource Program
National Food Processors Association: Food Allergen Labeling Guidelines
Food Allergen Labeling GuidelinesThe Food Allergy Issues Alliance (FAIA) is a group of food trade associations and other organizations that convene to discuss issues related to food allergy. In May 2001, it adopted the Food Allergen Labeling Guidelines and presented them to the FDA and USDA. FAIA encourages all companies in the food industry to adopt and adhere to the following labeling guidelines for major food allergens:
A. Identify the major food allergens.
B. Advocate the use of terms commonly understood by consumers for major food allergens within, or in immediate proximity to, the ingredient declaration, to provide clear communication with the food allergic consumer.
C. Call for manufacturers to disclose the presence of major food allergens when they are an intentional part of the food, regardless of source. Thus, major food allergens would be disclosed regardless of the fact they may otherwise be exempted from declaration (e.g., as part of a flavor, or as an incidental additive or processing aid).
D. Establish guidelines for conditions when the use of supplemental allergen statements is appropriate.
We hope to see an improvement in product labels,” says Munoz-Furlong. “For those with food allergies and their families, ingredients must be clear, consistent and reliable. Labels should be written for consumers, not scientists.” Allergen labeling was among the topics discussed at an August 13th FDA public meeting on food allergens. The agency is focusing on issues related to labeling and manufacturing of food allergens.
In April 2001, Representative Nita Lowey (D-NY) announced the Food Allergen Consumer Protection Act. According to Munoz-Furlong, it may be introduced during the next Congress. If passed, the act would:
1. Require that food statements list in common English, what, if any, of the eight main food allergens (peanuts, tree nuts (walnuts, pecans, etc.), fish, shellfish, eggs, milk, soy, and wheat) are contained in the product.
2. Require ingredient statements to take into account if any allergens were used in the spices, natural or artificial flavorings, additives, and colorings.
3. Require food manufacturers to include a working telephone information number on food labels.
4. Require manufacturers to better prevent cross-contact between products produced in the same facility or on the same production line.
5. Allow the FDA to assess civil penalties against processors and plants that are in violation of the Act.
6. Require the Center for Disease Control (CDC) to track food-allergic related deaths.