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From: Food Quality & Safety magazine, October/November 2006

Managing Allergen Labeling Challenges

Enterprising Business Applications will need to Continue Expanding Functionality to Support Compliance with the Food Allergen Labeling Act

by Beth Berndt

The first article in this two-part series is focused on how enterprise business solutions can help food processors manage industry challenges around the current enacted regulations in the 2004 Food Allergen Labeling and Consumer Protection Act. This FDA legislation addresses better management and disclosure of food allergens in the manufactured foods we eat every day. In addition to regulations that are in place today, such as requiring disclosure of food allergens on product labels by manufacturers, food processors know there are further regulations outlined in this legislation which are scheduled to go into effect in the near future. This article focuses on how enterprise business solutions can also help food processors comply with these upcoming new guidelines, related to managing the presence and disclosure of protein-based allergens during the manufacturing process, for food products they make, move and store.

One such challenge facing food processors is the pending enactment of regulations targeting the prevention of inadvertent cross-contamination of food allergens into unrelated food products being produced around the same time, often using the same processing equipment. Environmental cross-contamination, i.e., the introduction of protein-based food allergens into normally allergen-free food products, can occur when a product, without allerges in its recipe, is processed on the same manufacturing line after a food product whose formula contains milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat or soybeans, without the necessary level of cleaning processing equipment between production runs.

Consider the example of a hypothetical cookie manufacturer who makes both peanut butter and sugar cookies. During production, making both types of cookies often includes similar processing steps; mixing separate batches of cookie dough for each kind of cookie, forming individual cookie shapes, baking cookies in the oven, and finally packaging one or more package sizes for each produced flavor of cookie. When sales demand and available inventory supply levels dictate, both kinds of cookies may end up being made on the same day, even in direct processing sequence, one after the other. It’s also likely that some or all of the same production equipment will be used to manufacture many types of cookies, allowing food processors consistent quality while being as efficient and cost-effective as possible, i.e., making the best use of capital equipment investments. As a result, both allergen- and non-allergen-based food products often utilize the same production line, during the same workday and shift.

Now imagine the potential exposure of cross-contamination for allergen and non-allergen based foods if the first production run scheduled for the day on a shared processing line is for peanut butter cookies. As peanut butter cookie dough leaves mixing, passes through cookie shaping, moving directly into a cooking oven, and finally on to packaging, peanut residue remains behind on each piece of equipment used. Upcoming enactment of regulations in the Food Allergen Act focus on minimizing the risk of such allergen residue potentially ending up in subsequent batches of non-allergen food products - products whose formulas and package labels don’t specify the presence of these allergen ingredients (in this example, preventing peanuts from ending up in sugar cookies).

So how can enterprise business applications help? Pending enactment of these regulations will require voluntary compliance by food processors, including the addition more sophisticated quality control-mandated sanitation and changeover procedures for production equipment and operations as a key part of manufacturing processing. This includes having employee training instructions in place to support adherence to food allergen prevention-based procedures. This provides increased awareness about when and how to clean equipment during changeovers and between production runs to prevent cross-contamination of food allergens. In this example, it means integrating procedures about when to clean the mixer, shaper, oven and packaging equipment after making peanut butter cookies and prior to beginning sugar cookie production, along with related operational instructions about how to perform these operations.

This example certainly illustrates governmental concerns about the need to prevent cross-contamination of food allergens during the manufacturing of multiple food products in the same time period, through one or more common processing steps in the plant. It also highlights the opportunities for enterprise business systems to help food processors better manage their people, processes and products, as a critical part of supporting compliance across all departments regarding these pending regulations.

Another way enterprise business systems can help food processors comply with upcoming regulations in the Food Allergen Act is by providing an automated way to imbed both product standards and critical manufacturing processing control points in support of strict adherence to policies and operational business rules to help prevent allergen cross-contamination of food products.

This includes the ability to record and display both target and actual quality properties of ingredients, intermediate bulk production, and finished products for every inventory and production inventory quantity and lot. 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. This means enterprise business systems will need to allow food processors to clearly define ingredients with allergen properties and to imbed business rules as part of standard product formulations that describe how to manage work in process inventory and finished food products, because ingredient lists reflect known food allergens directly from formulated recipes. Product formulas and process routings will also need to identify potential cross-contamination points between products that share common processing equipment, including providing operator instructions based on best practices, regarding the movement and operational processing steps necessary to support disclosure of allergens and prevent cross-product contamination. A clear example of the value of preventing cross-contamination by defining clear operational instructions during processing is to establish strict operating guidelines around the handling of rework material (i.e., broken peanut butter cookies) during production.

Another opportunity for enterprise business systems to help manage disclosure and prevention of cross-product contamination of food allergens, is to help food processors define, record, and manage critical control points of key processing steps and management points, at the necessary level of detail, for processing allergen based foods. It will also be important to extend this level of control to the execution and recording of quality testing and related results, for both products and manufacturing processes. This includes enforcing business rules regarding material movement, handling, quality testing and operational processing of allergen based foods, in support of disclosure of allergens, and thus preventing the inadvertent cross-contamination of actual manufactured inventory lots.

But for food manufacturers to be successful today, it’s just as important that both employees and enterprise business systems understand when it may not be necessary to stop and perform expanded cleaning procedures of equipment used to manufacture multiple types of food products in a day, between production runs. Using the same example of the cookie manufacturer who might choose to first make sugar cookies, and then move on to make peanut butter cookies, the need for the same level of clean-up and change over between production runs may be reduced or eliminated, along with any risk of cross-contamination of peanuts into sugar cookies. This simple example illustrates how important enterprise business systems will be in honoring food allergen mandates, while still providing intelligent sequencing of food products sharing common processing lines, thereby protecting both the end consumer and the food processor’s capital equipment investment. Allowing manufacturers to imbed such business requirements into their processing preferences helps ensure compliance with regulatory mandates, while also organizing daily production runs to fully leverage available equipment capacity, and not merely based on a “first come, first serve” basis.

The Food Allergen Act also mandates that USDA will conduct ongoing plant audits of food processing facilities. These audits are meant to ensure adherence to the correct level of control around the storage, handling and usage of food allergens during production, as put in place by food processors, and to report back if these preventative business processes are operating effectively. Certainly, enterprise business systems help food processors pass such audits, by acting as a repository of current best practices for food processors, while providing a detailed historical audit trail of past processing compliance to food allergen and product labeling mandates, by individual inventory and production lot.

Based on the existing Food Allergen Act, for both enacted regulations and those mandates yet to come, it is obvious requirements for increased control, management, and disclosure of food allergens will continue to evolve. Regulators are already pointing to upcoming legislation regarding use of “gluten-free” labeling on foods. The development of guidelines is also already underway for the handling, preparation, and disclosure of allergen-free foods, beyond existing retail food product labeling and into food service organizations such as restaurants, bakeries, schools, etc. Such pending requirements mean an added level of upcoming control for food processors, as well as distributors, and other involved parties along the food product supply chain. Based on both current and future regulatory requirements around managing and disclosing the presence of food allergens for consumers, enterprise business applications will need to continue expanding functionality to support compliance with the Food Allergen Labeling Act by food processors and their related trading partners.

Beth Berndt is director of industry solutions for consumer products at Ross Systems. Reach her at 770-351-9600 or



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