Food Safety Magazine

PROCESS CONTROL | October/November 2008

Building a World-class Allergen Control Program, Part 1

By Richard F. Stier

Building a World-class Allergen Control Program, Part 1

Allergens are serious business in today’s food processing industry. There are eight major allergens that cause approximately 90% of reactions. However, there are literally hundreds of other products that can elicit an allergic reaction. The "Big Eight" as they are known are shown in Figure 1.

Other potential allergens include sesame seeds, celery, buckwheat and mustard. Part of a company’s allergen program must include knowing the markets into which products are to be shipped, especially the export market. For example, the European Union considers sesame seeds, mustard and celery to be allergens, whereas Japan and Korea have similar opinions of buckwheat. Japan has also identified a number of other products as potential allergens, so again, know your markets.

There are also food additives and ingredients, such as sulfites, which do not interact with the human immune system, but are sensitizing agents. Many companies treat these food additives and ingredients like allergens and include them in their allergen control program.

Symptoms of allergens include respiratory concerns such as a runny nose, asthma and/or constriction of the throat; skin problems including hives, swelling and rashes; gastrointestinal distress including cramps, diarrhea, nausea and vomiting; and anaphylactic shock. The latter is the worst case scenario in extremely sensitive individuals. Without prompt treatment, persons exposed to allergens may go into shock and die. Most persons with food allergies are label readers and take great care in avoiding the food to which they are sensitive. However, in cases of accidental ingestion of an allergen, they immediately inject themselves with syringes containing adrenaline and head for the hospital.

There are reportedly 12—14 million Americans with food allergies; 4—8% of infants and young children are sensitive to one or more foods. Approximately 2—3% of adults have food allergies. The two products to which most people are sensitive are crustacean shellfish and peanuts.

Since allergen cross-contact poses a serious health risk for sensitive persons, food processors have taken a number of steps to develop, implement and maintain programs that minimize the potential for allergen cross-contact of the products that they manufacture. Good operations ensure that programs are not simply established but are constantly reviewed and upgraded as new learning or technology becomes available. Accepting the status quo is not acceptable.

So, what must a food processor do to ensure that they not only protect sensitive consumers, but protect their own reputation and business?

Team Approach
In any food processing operation, allergen control must be a team effort. It is everyone’s responsibility. Quality assurance should coordinate the program. However, research and development, purchasing, production, shipping and receiving, labeling, warehousing, sanitation, human resources and the training coordinator must all be integrated into the program. For each and every operation within the facility where allergens are handled or used, it is imperative that there be documented procedures describing what to do, how to monitor compliance, how to verify compliance and what to do in the event there is a deviation. Persons responsible for these different tasks must be properly trained and records of those training sessions maintained as hard copy and/or as electronic records. In fact, allergen control reaches beyond production. It should encompass research and development, product formulation, and vendor evaluation and approval. Then, once a company has established a network of vendors, purchasing must buy only from those operations. Allergen control must be an integrated system.

Part 1 of this article will discuss research and development, vendor approval and selection (purchasing), shipping and receiving, warehousing and human resources. In our subsequent issue, part 2 will cover production, labeling and sanitation.

Research and Development
Today, many companies outsource their product development efforts. Whether the work is done internally or outsourced, one of the charges to the R&D group should be to minimize the use of potential allergens. This is not to say that allergens should not be incorporated into products. Product development specialists should take care to utilize ingredients that do not contain allergens as a minor ingredient. For example, many potential allergens are healthy ingredients. Soy protein, tree nuts and certain fish are known to be heart healthy. The challenge is to minimize the use of potential allergens. If there is a choice between using an ingredient that contains a small amount of allergen and one that does not, focus on eliminating the allergen. By doing this upfront, potential risks to consumers and the challenges of monitoring and controlling allergens in the plant are reduced.

Vendor Approval and Selection (Purchasing)
Vendor evaluation and approval could be a complete publication unto itself. When it comes to allergen control, the program must address not only vendors of raw materials and ingredients but certain service providers. Specifically, those companies who buy bulk ingredients, such as milk, spring water, juices, soy sauce or other materials, must expand their vendor program to include transport companies and tank wash facilities. According to Kathy Gombas at Dean Foods Company, some plants test incoming bulk tankers for allergens and have discovered that not all tanker washing facilities are created equal. They found and rejected tankers that tested positive for allergens that had supposedly been cleaned.

The vendor quality program should include protocols for the following:

1. Selection of potential vendors
2. Conduction of a preliminary evaluation of the operation’s technical, quality and financial capabilities
3. Vendor audits to confirm their capabilities
4. Corrective actions for any deficiencies noted during preliminary evaluations and on-site audits
5. Final approval
6. Performance monitoring

The same criteria should be applied to current vendors. Ideally, every processor should have detailed files on the capabilities of all vendors and service providers. These files should flag any materials that contain allergens or sensitizing agents.

As part of the preliminary evaluation, many operations demand that potential and current (including long-time) suppliers fill out a questionnaire about their operations. This helps to build the vendor database and allows a better understanding of where your ingredients originate. You may also discover something that needs to be addressed. This questionnaire should include questions specific to allergen handling and control programs. Potential buyers want to know what allergens are used in the plant, the control programs and what is done to verify that cross-contamination is not an issue. Auditing the facility should be part of the initial approval process and an ongoing vendor quality program. Many operations utilize third-party services for these exercises. However, it is much better to conduct these audits internally. It lets you know your vendor much better. There are some large operations that have made business decisions to audit only those operations with which they do large volumes of business. This is a bad idea. Problems can come from both small and large operations, and from small and large purchases. The procedures for selecting and maintaining the vendor quality program must be fully documented; such documentation should clearly state who is responsible for each phase of the program and actions to be taken if there are deviations or failures to meet established standards.

Once you are satisfied that the vendor can meet your needs and it is time to work with purchasing to sign contracts, ask that the supplier clearly mark all products that contain allergens. Many companies are currently doing this. I have had reports from ingredient suppliers that by clearly tagging their cases or bins with markings such as: "ALLERGEN" or "ALLERGEN — WHEAT," they have been able to increase their sales. This helps potential users both in receiving and in their warehouses.

Shipping and Receiving
At the plant level, allergen control begins at the receiving docks. The person or persons who manage receiving should be provided with a complete list of all ingredients containing allergens and what specific allergens are in each of those products. Purchasing, quality assurance or whomever is designated as the manager for the vendor quality program must provide receiving with this list. It is wise to update this list at a regular basis (e.g., quarterly) since materials are constantly being added and deleted from the ingredient list. If, as noted above, suppliers do place allergen tags on their materials, they help ease the burden at the receiving docks.

The basics of receiving apply whether incoming materials are allergenic or allergen free. The receiving crew should first check seals on containers to ensure that they match the bill of lading (BOL). If loads are received as less than loads or seals are not mandated, they should check for product damage, ensure that the van or container is not infested and is clean and be sure that the BOL matches the delivery. If the load contains refrigerated or frozen products, temperatures should be checked. All of these procedures must be documented and include instructions for handling deviations.

Many companies mandate that each delivery be accompanied by a certificate of analysis (COA). This is a good idea but hard to put into practice. Do the COAs come to receiving, quality or purchasing? What should be done if a COA is not received? Finally, when one requests a COA, it is normal that that COA be verified analytically at least once a year either in-house or by an outside laboratory. The question is, "Is a COA necessary for each and every ingredient, raw material and packaging material?" This is something that can be addressed during vendor approval using risk assessment. Ideally, only those materials that pose a significant risk to the business should require a COA and, therefore, should be verified.

Once the load is accepted, the receiving crew should place an allergen tag on each case, bag or tote containing allergens. Some companies have gone so far as to not only label the containers as containing an allergen, but they use tags that designate the type of allergen.

Also, as noted earlier, care must be taken when receiving bulk ingredients. Tank trucks or rail cars must have proper documentation and seals. The documentation must include wash tags, preferably from an approved wash station.

Food processors must develop, document and implement strict procedures for controlling allergens in their storage facilities. Allergens must be segregated from non-allergens. In addition, storage racks or areas designated for allergen storage must be clearly marked. Warehouse personnel must be trained to move allergens from the loading docks into these areas. If allergens and non-allergens are to be stored on the same racks, the materials containing allergens must be placed on the lowermost racks. Never store two different allergens on the same set of racks. These guidelines have been established to ensure that there is no top-down contamination. Warehouse personnel must also be trained to clean all spills immediately. This is especially important for allergens; one does not want to have these moved throughout the plant on the wheels of fork trucks or on the shoes of workers.

It is imperative that those areas in the warehouses delineated for allergen storage be clearly marked. The use of large, easily visible labels, plus icons and/or colors for different allergens, will help ensure that materials are properly stored.

Education and Management of Staff
To ensure that allergen control programs work, processors must make a commitment to properly educate both management and line workers. These programs should include but need not be limited to the following:

1. Basic education on allergens. There is a great deal of good material out on the market today. Find what is best for your facility.

2. Basic education on food safety (HACCP), sanitation and personal hygiene.

3. Training for all personnel on procedures pertaining to allergen control. All parts of the allergen control program addressed in this article must have documented procedures that describe not only how to do the work, but what records must be kept and how any deviations are to be handled. Plants must document that the managers supervising any one of these areas and the plant workers doing the work are trained on these procedures. Training programs must be documented and refresher sessions should be conducted on a regular schedule.

If your plant has employees who speak other languages as their first language, it would be a good idea to conduct training sessions in that language and develop a cadre of qualified persons to do such training in these languages.

Product Identification and Recalls
Recalls for allergen contamination of foods (real or perceived) have increased steadily over the past ten years (Figure 2). The United States Congress enacted legislation (Food Allergen Labeling and Consumer Protection Act of 2004 available at that modified food labeling regulations to ensure that potential allergens in foods are clearly identified.

Recalls are a fact of life today. It is imperative that each and every food and ingredient processor, plus companies that manufacture packaging materials, development and implement a product tracking and recall program. The first element of this program must be good product identification. Once this program is implemented, the company must maintain the program. A recall program should consist of a number of different elements, including training of management and any staff who might be involved handling a recall, training all employees as to what they should do in a recall, documenting procedures for what people should be doing in the event of a recall and developing procedures for conducting mock recalls. Many people simply do not know what their role would be if their company had a real recall. It is much more than simply tracking product. A real recall entails finding the product, rapidly collecting all quality and production data related to the product in question, establishing programs to ensure it is recovered, implementing studies to determine what happened and why, addressing legal issues and dealing with the public and the media. All of these points and more are issues that processors must address if a recall becomes reality.

Stay Tuned
In the next issue, we will finish our discussion of the allergen control elements of production, labeling and sanitation.

Richard F. Stier is a consulting food scientist with international experience in food safety (HACCP), food plant sanitation, quality systems, process optimization, GMP compliance and food microbiology. Among his many other affiliations, he is a member of the Institute of Food Technologists and an editorial advisor to Food Safety Magazine. He can be reached at

Categories: Contamination Control: Allergens; Process Control: Intervention Controls, Best Practices