Friend of the barfblog.com, Roy Costa, writes that a recent spat of food product recalls due to undeclared allergenic agents illustrates the problem the food industry has in preventing allergen exposures.

While food manufacturers usually have allergen controls in place, protecting those in the population with food allergies can be particularly challenging. Undeclared allergens are considered a significant chemical hazard in food and thus a critical control in many processes, yet most product recalls are due to undeclared allergens.

The US Food and Drug Administration (FDA), requires manufacturers to list on the food label the eight most common ingredients that trigger food allergies. At-risk consumers rely on the labels on foods to guide them in making healthy choices, and to protect themselves from allergens. Therefore, the failure to properly label foods when they contain allergenic ingredients, or when they have the potential to contain an allergenic compound is a massive failure of company’s food safety system.

Allergens are proteins and other substances known to react with a susceptible person’s immune system to precipitate an allergic reaction; there are approximately 15 million at- risk consumers in the US population. Persons with allergies may develop sometimes-serious medical consequences, such as breathing difficulties or go into anaphylactic shock after exposure to a host of allergens in food.

There are eight major allergens that cause 90% of allergic reactions:

• Milk
• Eggs
• Peanuts
• Tree nuts (such as almonds, cashews, walnuts)
• Fish (such as bass, cod, flounder)
• Shellfish (such as crab, lobster, shrimp)
• Soy
• Wheat

Food labeling laws require food allergens to be identified even in very small amounts — but only when they’re contained as an ingredient. Manufacturers aren’t required to include warnings about food allergens accidentally introduced during manufacturing or packaging (cross-contamination). The label lists the type of allergen — for example, the type of tree nut (almond, walnut) or the type of crustacean shellfish (crab, shrimp) — as well as any ingredient that contains a protein from the eight major food allergens. The labels also include any allergens found in flavorings, colorings or other additives.

Many manufacturers voluntarily include warnings, but these advisory labels aren’t always clear. Manufacturers have different ways of saying a food allergen may be present. For example, labels may say, “manufactured in a factory that also processes wheat” or “may contain soy.” Work is needed to make the format of these advisory labels more consistent so that it’s easier to identify which products contain allergens. Medical authorities advise consumers in doubt about whether a product contains something they are allergic to, to avoid it until and they check with their doctor.

When foods contain an undeclared allergen, or when allowable levels of a food additive, such as sulfites, used as a preservative are exceeded, such foods are deemed adulterated and a recall is initiated.

A product recall is a crisis for a company; it results in serious economic loss and legal entanglements, and can be a major challenge to the viability of a brand.

Hazard Analysis Critical Control Point (HACCP) controls during manufacturing

Product contamination and adulteration can take several forms; we classify substances as foodborne hazards if they are reasonably likely to cause illness or injury when out of control. We can classify them into 4 broad categories, such as chemical, physical, biological and radiological (thanks Fukashima). We develop controls for the particular hazards that are expected to occur, and critical controls for the likely ones with the most potential for harm. Food safety plans built on the principles of Hazard Analysis Critical Control Point (HACCP) must consider the likelihood of occurrence of these chemical hazards in most food manufacturing processes. While producers of commodities such as eggs, fresh meat or fresh produce do need to list allergens, most other foods require some type of allergen control and/or label.

Control starts with identifying the specific allergenic ingredients. Then, an operator must determine how they are handled and how they flow through a production system. Such studies often reveal points where cross contamination with allergens may occur. Controlling cross contamination between allergenic and non-allergenic ingredients on production lines is necessary when the line runs both allergenic and non-allergenic food, or when a variety of allergens are run. However, cross contamination controls begin at the time a firm receives an allergen-containing ingredient and continue during its storage, internal transport and during packing.

Proper cleaning between product runs is the most fundamental control. Visual inspection of the equipment to detect particles remaining post-cleaning is a useful effort, but unseen residues of allergens may linger and cross contaminate the next product run, as even the best cleaning may not result in 100% removal of particles. The cleaning process must also consider the forms, i.e., pastes or films, encountered and match that with the appropriate cleaner. Some plants must use dry cleaning methods when water in a production environment is detrimental, such as when manufacturing confectionaries, or in bakery environments. Such dry methods can be ineffective and can lead to cross contamination. Even when detergents and water can be applied to equipment, applications may be uneven, leaving traces behind. As better laboratory methods of detection have increased the specificity of tests, investigators looking for allergens can detect smaller and smaller amounts of them.

In-plant allergen testing of equipment, however, can provide verification that allergens are not present on a surface after cleaning. Some tests used in a plant environment are not allergen-specific, and utilize quick colorimetric tests for proteins, sugars or other markers of allergen contamination. Operators instead should use ELISA kits (enzyme-linked immunosorbent assay); while much more sophisticated and expensive they can be validated and possibly validate the protein or sugar swab methods. ELISA tests may be a better choice for in plant testing. Such testing can be qualitative as well as quantitative (a 5 ppm Level of Detection typically). Operators should also develop protocols to establish the baseline information needed to interpret results. Establishing baseline acceptance criteria requires establishing the levels of allergens in products when various levels of allergens are detected on surfaces of equipment. Off-site labs having more sophisticated methods usually conduct such validation studies. Such validation data may allow operators to accept some trace levels and avoid the pitfall of chasing molecules around a plant, when such levels are shown not to affect the final product.

Operators must designate cleaning tools for specific areas to avoid the tool as a form of cross contamination and Sanitation Standard Operating Procedures must be developed. Such SSOP should contain the designation of a cleaning crew and sanitation employees need ongoing training. The SSOP should contain the items requiring cleaning, the types of cleaners used, dilution values for detergents and degreasers, how to maintain effective levels, water temperature, tools used, how often the cleaning is carried out, and the timing of visual inspections and verification. As in all HACCP based-systems the results of the testing program are recorded and verified.

Cross contamination may occur during storage and internal transport

Storage of allergen containing materials together in the same area can also lead to cross contamination when the operation has not effectively designated the proper storage areas. Storage of allergenic foods above non-allergenic, or a mix up of ingredients or finished products can lead to cross contamination through the environment. Ideally a facility should store sensitive items in separate enclosed areas, but not all plants have the capacity for separate storage. In these situations, careful monitoring and a visual marking or signage is helpful.

Even forklifts and pallet jacks could play a role along with totes and other containers.

Because we have risks in allergen control, and our controls may not always be successful, the label should provide the at-risk consumer with enough information for making a decision. As mentioned earlier however, the use of language such as “may contain…” or “made in a plant that also processes…” make food choices more difficult and impacts the quality of life for such consumers.

Labels are applied to final unit packages by hand, or by a label machine, typically. Rolls of labels have to be run for each batch of product. The timing and staging often lead to the packing of several products at once and different label sets on the plant floor. When the products differ as to allergens it is easy to make an error in the application of labels. Errors can also occur in the printing of labels, and allergenic ingredients may be inadvertently left out if the operator has not done his due diligence and did not realize the product or ingredient contained an allergen. Highly refined oils are hidden ingredients in many products and may contain trace amounts of proteins, for example.

Foodservice allergen control

Patrons of restaurants are often highly at risk to be exposed to allergens. No such menu labeling requirements are required in the USFDA Food Code. Restaurants handle a complex variety of foods and it is nearly impossible to know for every recipe and every product, what allergens may or may not be there or to separate them. Furthermore, the operating conditions of restaurants are very different then processing plants and there is very little that can be done about preparing and storing various allergen sensitive foods together.

The last line of defense is the waiter or waitress who is often the only person except for the cook who can answer a question about whether a food contains a certain ingredient or not. Even then, it may be impossible to know in every case, every allergenic ingredient.

The effectiveness of industry allergen control programs

As illustrated by the recent spate of recalls, the food industry’s response to allergen control has been less than completely successful and more needs to be done. The industry needs better testing regimens and adherence to properly developed cleaning protocols. As in the case with preventing microbial contamination, a company must provide the resources necessary, and have the experience and technical ability to monitor and control a sometimes-complex array of policies, procedures and validation methods.

And for a variety of reasons, some unknown, the situation is getting worse:

• According to a study released in 2013 by the Centers for Disease Control and Prevention, food allergies among children increased approximately 50% between 1997 and 2011.
• Researchers are trying to discover why food allergies are on the rise in developed countries worldwide, and to learn more about the impact of the disease in developing nations. More than 17 million Europeans have a food allergy, and hospital admissions for severe reactions in children have risen seven-fold over the past decade, according to the European Academy of Allergy and Clinical Immunology (EAACI).

As with all things food, the hopeful implementation of FDA’s FSMA will strengthen the backbone of allergen control efforts in the future, but the industry should recognize more is needed now.