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December 1, 2000
By: Bruce M. Floyd
This would be simpler if just allergens were the issue. The public does not have a clear understanding of the difference between allergies and intolerances. An allergic reaction can lead to anaphylaxis, a severe allergic reaction involving the respiratory tract and several bodily systems. For instance, lactose intolerance is defined as a metabolic deficiency in which the individual cannot properly digest lactose. This can be confused with a milk allergy. The person with lactose intolerance will have non-life threatening gastric distress after ingesting a food that contains lactose. People with food intolerances may be able to eat the given food in small servings or in combination with other foods. A person with a food allergy can’t tolerate the substance in any quantity.
According to Susan Hefle, Ph.D., assistant professor and co-director, food allergy research and resource program, University of Nebraska, Lincoln, we do not know what the threshold level for allergens is; however, the current level of concern is 10 ppm or greater. This is not a definite number. Research is being conducted to determine the dose/response threshold for various allergenic compounds. Some very sensitive people can be adversely affected at 2.5 ppm. The problem is that allergens are not uniformly dispersed within a food product. A sample may have only 1 ppm of peanut material, but that 1 ppm might actually be a broken piece of peanut which can lead to a single dose much higher than 10 ppm to the unlucky person who eats it.
According to Anne Muñoz-Furlong, president, Food Allergy Network, Fairfax, VA, between 2.0% and 2.5% of the U.S. population has food allergies. Of these, 90% are allergic to eight substances: milk, eggs, peanuts, tree nuts (walnuts, pecans, almonds, etc.), soy, fish, shellfish and wheat. Food allergies result in 100 to 200 deaths and 30,000 emergency room visits annually. According to Muñoz-Furlong, the awareness of food allergies as a public health problem is increasing around the world. "We no longer label a child as sickly. Now the question as to why a child can’t gain weight or hold down food leads to further investigation. As a people, we are much more aware of allergies than in the past," she explains.
At this time, the Food Allergy Research and Resource Program, University of Nebraska (www.farrp.unl.edu) is leading the research effort on food allergies and The Food Allergy Network is spear-heading the consumer information and awareness campaigns associated with food allergies. The Food Allergy Network’s website, www.foodallergy.org, is very informative and easy to navigate.
Knowing what one is allergic to and avoiding that item if at all possible is the responsibility of the individual. Making sure that the consumer knows what each possible danger is within a food product is the responsibility of the food manufacturer. The problem with food, especially processed foods, is for the consumer to recognize that the product contains an allergenic item. According to Hefle, most anaphylactic reactions happen to people who are not aware they have eaten a product that contains a substance to which they are allergic. It is the legal and moral duty of each food processor and distributor to clearly indicate what might be on or in each food product it delivers to the consumer.
The consuming public has little tolerance for companies that hide behind narrow interpretations of the FD&C Act. Actually, if one of your products injures anyone, the burden of proof is on you to show that the product was not "injurious and deleterious to life" which by definition would make it a violation of the FD&C Act. Again, you are not responsible for people with allergies consuming your product unless that person had no way of knowing that it contained an allergenic substance. The problem can be summed up as the unknown, unintentional or unavoidable addition of an allergen to a food product.
How is the consumer supposed to know if a product contains an allergen? The package label is a good place to start. All ingredients must be labeled. On June 10, 1996, the FDA issued a Notice to Manufacturers entitled "Label Declaration of Allergenic Substances in Foods." The letter clarified the definition of "incidental additive" and further stated that due to the very small quantities that can cause an allergic reaction when an allergen is present in a food, no allergen would qualify for inclusion as an incidental additive, under Title 21 of the Code of Federal Regulations (CFR), 101.100(a)(3).
There are over 160 identified food allergens and all derivations of these products would be considered allergens as well. For instance, peanuts would also include peanut butter, flour, protein, hulls, skins, hearts, meal and most flavor extracts. Other food derivatives are much harder to recognize, such as all the different forms of milk byproducts.
The first thing a company must do is assess the likelihood that any of the ingredients it buys or products it makes contain known allergens. This would not be confined to the "big eight," but any that are on the list, such as FD&C yellow #5 and #6. How are they used? They may be the final product, such as tofu or peanut butter. Does the product contain other allergens such as peanuts that are found in Rocky Road ice cream (which is also a dairy product)? This might seem obvious, but the food industry has a lack of understanding regarding food allergens.
All the people doing supplier surveys require an understanding of what they are looking for. It is necessary to compile all the different names and byproducts of the different allergenic foods to fully understand the challenge. The people reviewing ingredient specifications and label statements must receive training to recognize families of foods — the same training given to the consumer to recognize what the ingredient declaration means.
If a company only produces one product on a single line, no major issues exist. However, as plants have become larger, the number of different products manufactured in one facility has grown. A manufacturer of chicken breasts might make broiled, roasted, broasted, breaded, Cajun, barbecue, Oriental, glazed, stuffed, Parmesan and Italiano versions. If a company produces the above line of frozen chicken breasts, then what would be the critical control points (CCPs) for allergens? Since this is a U.S. poultry plant, the existence of a HACCP plan can be assumed. Raw material receiving would be one CCP, ingredient weighing would be another, as would ingredient addition. Along with this, add the standard sanitation operating procedure (SSOP) for washing the equipment and a line clearance inspection.
A good HACCP plan includes raw material sourcing that does not change when trying to prevent allergen contamination. This is where an on-site HACCP audit of each supplier is very important. Ingredient addition, which might not be considered a microbiological CCP due to a later cooking step, can become a CCP due to the possibility of allergen contamination. What might these ingredients be? Many blended products are suspect, but pure ingredients could be packaged on a line that makes frequent product changeovers. Look at the supplier’s plant and warehouse. Where are the raw materials stored? Are there dedicated lines to keep allergens separate? Do the plant personnel know what allergens are?
One thing to look for is control of ingredients in the weighing area. This would extend to ingredient staging and addition. If the company does not stage and tag ingredients, it needs improved control. Ingredients are often weighed in one central area, which permits cross-contamination due to dust drift, as well as confusion as to the ingredients being weighed. Add to this the possible functional illiteracy of the worker and poor lighting, and there’s an accident waiting to happen.
Once a company has audited its suppliers, the same scrutiny needs to be applied to its own plant.
Simple measures can be taken to reduce the chance of unknown or unintentional contamination in any plant. They are scheduling, separation, staging, line clearance and verification. How do they work?
Scheduling: Schedule non-allergenic products first. If possible, wash the system completely, then start up with products which do not contain an allergenic ingredient. For instance, to produce ice cream, the manufacturer would start with the plain vanilla variety. This would create little chance that the product would contain peanuts or tree nuts. Since ice cream would be made on 3A-approved equipment, the system would be free from organic residues if washed according to verified cleaning procedures. The manufacturer could also change the process to delay the addition of allergenic ingredients to a later step in the process, thereby minimizing the amount of equipment that must be thoroughly washed between products.
Washing the equipment to eliminate allergens may make the system susceptible to pathogenic contamination. Before equipment-washing can be considered, the nature of the plant, product and equipment must be carefully examined. If one begins washing equipment not designed to be washed, the real threat of pathogenic contamination to the product and resultant injury to the consumer can be far worse than the allergic reaction one is trying to prevent.
Separation: Do not store allergenic materials next to non-allergenic materials. Manufacturers often store classes of materials in the same part of the warehouse. Isolated soy protein and sodium caseinate may both be protein, but they are in different allergenic groups. It would make more sense to store all ingredients from the same family together, such as powdered egg whites, powdered egg yolks, and egg noodles.
Have dedicated bins for raw materials. This includes scoops and weighing buckets. Do not weigh minor ingredients for different products at the same time. In addition, label all containers of minor ingredients with the ingredient name, manufacturer and lot number.
Separation includes dust control. Hefle mentioned that dust from a previous product that has accumulated over a production line could fall off and enter a product in a random manner. In some plants, this can be dust from a previous day’s production. This is a cGMP’s (current good manufacturing practices) issue, and a real one.
Another problem is dust from another line entering a product. The level is very low — we are speaking of 10 grams in a metric ton of finished product. If you can sweep dust up from the floor on a frequent basis, you have a dust problem. This is especially a problem in areas where new processes have been added to older systems. Dust control is a matter of maintaining or installing gaskets, proper equipment venting and the addition of properly designed dust-control equipment at product transfer points.
Staging: In plants that run many lines and different products at the same time, staging the ingredients prior to the point of introduction into the process will eliminate many errors. Staging is putting all of the ingredients for a specific batch on a pallet prior to taking them to the processing area. There is usually a batch record that is attached to the pallet which indicates the final product, production date, batch number and what is on each pallet, including the lot numbers. Any minor materials are married to the batch at this time.
The batch record can also be used to verify the addition of each ingredient to the batch at the time of production. Errors are difficult to detect in addition, especially with minor materials. Some items are obvious, such as colors. Other items require extensive analysis to verify their addition. A system to make sure that an ingredient does indeed go into a batch can save a lot of time and effort by eliminating the potential for errors before they occur.
Line clearance: This is simply removing all of the ingredients for one product from the weighing and production areas before beginning the next product. It also means removing any packaging materials, especially labels, from the packaging line before bringing in those for the next product. This process must be formalized so that someone in authority physically checks the areas and signs-off that all of the old materials were removed before the new materials were brought to the area.
Clearance forms that list all of the items to be removed and have space for the verifier’s signature will eliminate many mistakes. Care during production can be quickly undone by the application of the wrong label.
Line clearance also means looking inside the equipment to make sure it is clean. This is not as simple as it sounds, and is almost impossible on some systems. Put this on a checklist when looking for possible unavoidable contamination.
Verification: According to Hefle, test kits are available that can detect the presence of some allergens down to very low levels. At this time they are available for peanut, egg and milk, and they will detect a range of 1 to 2 ppm. These reasonably sophisticated kits require a technically experienced person who will need additional training. Remember that random, inadvertent contamination will be difficult to detect through testing, just as it is with pathogenic organisms. A good system builds all of the testing and verification into the front-side of the process. Design a safe system and use the testing to help verify that the system is working, because testing alone will not produce a safe product.
Unavoidable contamination: What can be done about unavoidable contamination? This can occur in a number of scenarios. In some equipment, it is impossible to verify removal of all of the product. In some cases, the design of the plant prevents the separation of the various lines, making the potential for dust drift or carry-over high. Potential cross-contamination of raw material at the farm level might be completely beyond your control. In this case, the company can choose to redesign the plant and/or process or add warning labels to the packaging.
Warning labels should be a last resort. Adding warning labels to products eliminates potential customers. This loss could be higher than the percentage of the population that has an allergy to the product, since their immediate families may choose not to have the products in the house.
However, if unavoidable contamination is a real problem, then the product label requires a warning statement. With all labeling issues, the advice of qualified legal consul should be secured.
What are enlightened 21st century food companies to do? One idea would be to examine the ingredients that are being used to develop a new product. This sounds simple, but if a company’s processing lines run many products that contain allergens, then it may make sense to limit the total number of allergens to those already in use. To get to this point, one needs to understand the company’s manufacturing process as well as its target audience. A company making soy-based products could eliminate the introduction of egg whites that would add another group for exclusion from the customer base.
The more allergens a product contains, the wider the group of people that are eliminated from the target audience. In a full line of ice cream products, the elimination of tree nuts and peanuts is out of the question; however, it may be possible to avoid eggs, shellfish, soy and other non-dairy protein products. With good cleaning and proper scheduling the people with peanut and tree nut allergies would only be excluded from the flavors that contain those ingredients.
Consider a redesign of the production facility. Just as poorly designed equipment is one of the major causes of pathogenic contamination, it can also cause allergenic contamination. This not only applies to equipment, but also to plant layout. Airflow, traffic patterns and process separation need to be addressed. When one problem in a plant is solved, often other problems are eliminated at the same time. Good quality programs designed into the production process usually save money as well as produce safer, better-quality products.
It is important that allergens be addressed during HACCP training and program development. Allergens are still treated as footnotes in many training designs since their inclusion can add greatly to the number of CCPs.
Researchers are trying to find a cure for allergies. In the meantime, the food industry must face the issue with common sense. Allergen contamination prevention boils down to improved equipment design, improved plant layout, improved material handling within the plant, supplier control and verification and strong, ongoing, employee training programs. When an allergen cannot be avoided, products should carry a warning on their labels. Complete disclosure of all ingredients in nomenclature easily understood by the average consumer, will aid those who have allergies to make knowledgeable purchase decisions.
Bruce Floyd established Process Systems Consulting, Iowa City, IA, after working more than 30 years in the food processing industry. He has had extensive experience in sanitation, quality control, regulatory relations, and product and process development (both domestic and international), and specializes in integrating ingredient and manufacturing specifications into total process systems. A graduate of Georgia State University, he has successfully completed all areas of the Better Process Control School at the University of Minnesota, and has been qualified by the International HACCP Alliance as an instructor. He can be reached via e-mail at [email protected].
© 2000 by Weeks Publishing Company
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