Allergen Rules Nothing to Sneeze At: Get a Head Start on Meeting Upcoming FDA Requirements

Editor’s Note: This is the second of a two part series. the first article, “Managing Allergen Labeling Challenges,” was published on p. 49 of the October/November issue.

With additional regulations in the FDA’s 2004 Food Allergen Labeling and Consumer Protection Act set to go into effect in the not-so-distant future, there are ways that food processors can get a head start on complying.

Food businesses will have to employ enterprise business systems to manage and disclose the presence of protein-based allergens for products they make, move and store. Pending voluntary guidelines target the prevention of environmental cross-contamination. Protein-based food allergens can be introduced into normally allergen-free food products when a product containing no such allergens is processed on the same manufacturing line after a food product containing milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat or soybeans, without the necessary level of cleaning processing equipment between production runs.

Consider a hypothetical cookie manufacturer who makes peanut butter cookies and sugar cookies. When demand dictates, both kinds of cookies may end up being made on the same day, one after the other – likely with some or all of the same production equipment.

Imagine the potential for allergen cross-contamination if the first production run of the day on a shared processing line is for peanut butter cookies. As the dough leaves mixing, passes through shaping, moves into an oven, then to packaging, peanut residue remains on each piece of equipment.

The upcoming FDA regulations will encourage food processors to enact practices that support voluntary and mandatory compliance, including the addition of more sophisticated sanitation and changeover procedures. This includes having instructions in place to increase employee awareness about when and how to clean equipment between production runs.

Also, food processors will soon require the identification of allergen properties for all foods at every step of processing, as well as product lots going into inventory. Enterprise business systems will need to allow food processors to clearly define ingredients with allergen properties and describe how to manage work in process inventory (e.g., intermediate recipes such as producing peanut butter cookie dough) and finished food products (e.g., packaged peanut butter cookies). Product formulas and process routes will also need to identify points where cross-contamination could occur when products share processing equipment. Operator instructions regarding the movement and steps to support disclosure of allergens and prevent cross-product contamination should be provided.

Clear operational instructions can also help prevent cross-contamination during the handling of rework material (e.g., broken peanut butter cookies).

Another opportunity for enterprise business systems to help manage cross-contamination is in helping food processors define, record and manage HACCP — of key processing steps with the necessary level of detail. This level of control must be extended to quality testing and recording of results for products and manufacturing processes. This includes enforcing rules regarding material movement, handling, quality testing and operational processing.

Just as important for food producers is understanding when it may not be necessary to stop and perform expanded cleaning of equipment used to manufacture multiple food products in a day between production runs. Using the example of the cookie maker, cleanup and changeover between production runs may be reduced or eliminated with intelligent sequencing of food products sharing common processing lines. Allowing manufacturers to embed business requirements into their processing preferences helps ensure compliance with regulatory mandates and organize daily production runs to fully leverage available equipment capacity – and not merely based on a “first come, first served” basis.

The Food Allergen Act also mandates that the USDA conduct ongoing plant audits of food processing facilities. These audits are meant intended to ensure adherence to the correct level of control around the storage, handling and usage of food allergens during production and to report back on the effectiveness of these preventive measures. Enterprise business systems help food processors pass such audits by acting as a repository of best practices and providing a detailed audit trail of past processing compliance to food allergen and product labeling mandates by inventory and production lot.