Taking Control of Allergens through Regulation

Penalties for non-compliance under FALCPA include civil sanctions, criminal penalties, and the potential for the seizure of products or for a request for a recall by the manufacturer or distributor.

While a considerable improvement, these new regulations neither apply to meat, poultry, or egg products, which are regulated by the Department of Agriculture, nor do they address the use of advisory labeling in cross-contact situations. Cross-contamination might occur during food processing, for instance, a package of fish product might have a small amount of prawn mixed in it without being noticed by the manufacturer if they are both made using the same equipment.

But these gaps notwithstanding, the new regulations still require the food industry to pay increased attention to food packaging labeling, and many are now investing billions of dollars towards product reformulation, label modification, and even exploring of niche markets.

Incorporation into Current Quality Control Systems

The new regulations are an important addition to the current food quality regime, but will need to be actively incorporated into the dominant quality control processes and systems. Some, such as the standards that ISO applies to overall quality management, broadly attest to the rigorousness of the processes a business has in place. Others, such as HACCP, generally cover the supply chain and production process, but do not necessarily explicitly address allergens. Thus, the identification of allergens could be illuminated using the former, with labeling being identified as a separate element at the critical control point of packaging.

However, even if incorporated into current quality control schemes, an emphasis on allergen testing becomes all the more important when viewed in light of an existing weakness that cannot be addressed through the new regulations, which is that the national and regional nature of such regulations means they may not effectively extend to the global supply chain, even with stipulations to cover imports, as they do.

Southeast Asia and China are major food exporters, and within those countries, manufacturers are not required to comply with the new regulations. This means they are also less likely to possess allergen management systems (AMS), and have less incentive to do so. We could foresee the possibility of trade barriers or delays in production and delivery time when regulations are being more rigorously adhered to. For example, if products were being shipped abroad and unfortunately being held up by customs because of improper labeling, shipping the products back and forth, and conducting the test would cost remarkable time and resources. Moreover, products being placed on the market shelf will post a significant health threat and potential loss to suppliers and manufacturers. A far-sighted company interested in being a global player should still be aware of the threat of potential allergens present in their foods. As evidence of their responsibility, an importer or manufacturer may find it helpful to obtain production certificates and laboratory testing reports to speak to their diligence regarding the presence of allergens in their products. Thus, practicing due diligence when using major allergens as ingredients, and implementing an effective AMS to detect their presence when not desired should be a key part of any business strategy to enhance brand credibility and reputation.

Food Allergen Management System: Basis for Testing

Given the past scope of the problem, the number of people affected by food allergies and the previously inadequate labeling scheme, along with the more exigent demands that will be placed on the food industry by the new regulations, it becomes quite clear that better food allergen management systems with robust detection methods are needed. What method and technology can best perform this task? There exist at the moment two common technologies used for this purpose: Enzyme-linked immunoSorbent assay (ELISA), a test which uses the traditional protein based immunoassay method, and the advanced DNA testing method, which utilizes the polymerase chain reaction (PCR).

ELISA: The Traditional Method

The traditional detection of food allergens utilizes the molecular biology technique called ELISA for protein detection. This common practice of using antibodies to detect for antigens is applied through the preparation of animal monoclonal antibodies, which detects their presence through the confirmation of an allergen. Very often, the detection of food allergens can be achieved through ELISA. These practices are low-cost and easy to operate. However, a major drawback for the protein method is that it is quite easy for cross-reactivity to occur in between the proteins, and this can consequently affect the judgment of the results, and lead to false positive outcomes. Also, due to the fact that protein will denature after heating, this method is not suited for most processed foods and ingredients, as it is prone to failing in detecting allergens in them. In general, ELISA is also less sensitive than polymerase chain reaction (PCR) which will be described below, and therefore any negative result provided by ELISA may either be finally confirmed as negative or be tested as positive by PCR. This would serve as a much better protection for the industry if regulation enforcement agencies utilize PCR as the testing tool.

DNA Testing: A More Comprehensive Protection from Food Allergy

In 1985, American scientist Dr. K. Miller invented what would become one of the most influential DNA analysis technologies – the polymerase chain reaction (PCR). Through DNA replication by polymerase, millions of copies of DNA could be generated in two to three hours, which could be seen by the naked eye.