October 2001

New Strategies for Allergen Labeling

In This Issue:

• What is a Food Allergy?
• 2001 FDA/CFSAN Allergen Priorities
• Legislative Background
• Current FDA/CFSAN Initiatives
• FDA-Minnesota-Wisconsin Food Allergen Partnership
• Food Industry Initiatives
• What's a Manufacturer to Do?

Does your deli meat use casein, a milk derivative, as a binder? Does your Mortadella contain pistachios? Do the noodles in your salads and soups contain eggs? Do you use your deli slicer for meat and cheese, without cleaning between uses? Is there soy in your baked goods? (11) The answers to these questions, along with new guidelines and legislation could preserve the health (or life) of your customers!

Good manufacturing practices have traditionally addressed the problem of cross-contamination of food products with allergens, and numerous industry groups have developed their own guidelines for manufacturing and labeling. At this point, compliance with allergen labeling is voluntary, but that may change as the FDA and Congress take a closer look at consumer concerns. See Table 1, Timeline for Allergen Regulation Activity.

The Food and Drug Administration's Center for Food Safety and Nutrition (FDA/CFSAN) held a public meeting on August 13, 2001 to take comment from manufacturers and consumers regarding three specific food allergen topics: plain English labeling, advisory labeling, and labeling of exempt ingredients. The comments received at the meeting will be considered and incorporated into the fiscal year 2002 Action Plan. Additional public comments are being accepted until October 29, 2001. See Table 2, Web Site Contacts, for information on how to register your comments electronically.

At the August 13 meeting, comments were received from industry representatives regarding: what plain English terms would be understandable; what format would be most informative; possible confusion with multiple formats; consumer impact of advisory labeling and better alternatives; allergenic flavoring/spices/colors still examined on a case-by-case basis; mandatory vs. voluntary labeling; recognition of minor ingredients as incidental additives; better labeling for ingredients of further-processed products. Citizens voiced their frustration and concern regarding the current state of allergen labeling. (16)

Representative Nita Lowey (D-NY) introduced legislation on labeling of food allergens, the Food Ingredient Right to Know Act. This bill (HR1356) was introduced April 3, 2001 in the House of Representatives and referred to the House Subcommittee on Health on April 25 where it remains. The bill would amend the Food, Drug, and Cosmetic Act with the addition of a required statement regarding spices, flavoring, and coloring derived from meat, poultry, or known allergens. (18) Further information on the status of HR1356, and other bills regarding food allergens, is available at http://thomas.loc.gov. To register comments on the bill, contact your local Congressional representative.

What is a Food Allergy?

Wheat, milk, eggs, soybeans, peanuts, tree nuts, fish, and shellfish are potentially deadly ingredients for thousands of people. There are over 50 identified food allergens (1), but these eight foods are the cause of 90% of allergic reactions. They are the focus of the U.S. Food and Drug Administration (FDA) in regards to product labeling. (9)

It's estimated that up to 2% of adults and between 2 and 8% of children have true food allergies, which involve the body's immune system. Reactions can range from mild to severe enough to cause approximately 150 deaths annually. (9) A study in the Journal of Allergy and Clinical Immunology reports peanuts, alone, are responsible for 65% of food-related deaths of victims age 2 to 33. (7)

The protein component of a particular food (the allergen) is what triggers the immune system to produce antibodies in the host. The outpouring of antibodies may affect the mouth (tingling or swelling of lips or tongue), skin (hives, rashes, or eczema), digestive system (cramps, vomiting, diarrhea), or respiratory system (breathing difficulties). An initial exposure to an allergen may cause a mild reaction, but subsequent exposure may prompt a reaction so severe that the whole body is involved in anaphylactic shock (or anaphylaxis), which often results in death. (8)

A food allergy differs from a food intolerance. A food intolerance involves a problem with metabolism of the food product, in which a person is usually lacking a chemical needed to digest a particular type of food. A common example of this is lactose intolerance, in which the enzyme lactase is absent or in short supply. Also, a food intolerance, unlike a food allergy, generally becomes more pronounced with age and a person may be able to eat small amounts of the food before a reaction occurs. Some people have exhibited sensitivities to several food additives: FD&C Yellow No. 5, sulfites, monosodium glutamate, and aspartame. While the additives do not prompt true allergic reaction, they elicit an allergic-type reaction that is severe enough to be a concern. (8)

Children are most often allergic to milk, eggs, wheat, or soy, but may outgrow their allergies. Adults are most often allergic to tree nuts, peanuts, fish, or shellfish. (8) Peanut, tree nut, fish, and shrimp allergies are frequently lifelong. (9) And it's not just the food itself that can cause an allergic reaction, but derivatives of the food, as well. For example, an allergic reaction to peanuts may be set-off by peanut butter, peanut flour, peanut hulls/skins/hearts, peanut meal, peanut protein, and most peanut-flavor extracts. (1) A "non-dairy" statement on a product label can be misleading, as the food may still contain milk by-products which could elicit an allergic reaction. (9)

The occurrence of food allergies is on the rise, according to some physicians. They attribute this to foods being introduced at an earlier age and food allergens being used more often, such as milk and soy as protein supplements in prepared foods, and consumption of greater quantities and more exotic types of fish, according to Robert Metcalfe, M.D., National Institute of Allergy and Infectious Diseases, Bethesda, MD. (8) Robert Wood, director of the pediatric allergy clinic at Johns Hopkins Medical Institute, Baltimore, reports that both developed and developing countries have a rapidly-increasing number of people with food allergies, while it is not that great a problem in underdeveloped areas of the world. Wood also says that the fewer germs we are exposed to in the environment, the more the immune system "has time to worry about things like allergens." (9)

Preparing food at home is hard enough when trying to deal with a food allergy, but imagine the difficulty when dining out. Results of a study presented by Scott Sicherer, M.D., to the American Academy of Allergy, Asthma and Immunology, showed 13.6% of a group of over 5,000 people who were registered with the National Peanut and Tree Nut Allergy Registry experienced at least one allergic reaction while eating at restaurants. Of the 706 people having a reaction, 38% had told their server in advance about an allergy concern. Half of the reactions were caused by undisclosed allergens in sandwiches or sauces; other reactions were caused by cross-contamination, e.g., a utensil used in preparing the food touched an allergen, and was then used for the supposedly allergen-free food. The study recommends foodservice staff be advised on the seriousness of food allergies and customers should be persistent in telling servers about their allergy. (12) The National Restaurant Association offers a pamphlet and poster on the subject. (8)

2001 FDA/CFSAN Allergen Priorities

Recalls of food products containing undeclared allergens have increased from an average of 35 per year in the early 1990s to an average of 90 per year in the late 1990s. It is due to this dramatic increase that the CFSAN made it a high priority item in 2000 to make consumers and the food industry more aware of the allergen danger. (4)

CFSAN priorities in 2001 include:

• continuing their consumer and industry education,
• developing a strategy for better understanding of allergens on food product labels,
• publishing a Compliance Guide for Manufacturing and Labeling (see below),
• issuing a Field Guide for inspection of food manufacturers (see below), and
• publishing a proposed rule to require carmine/cochineal extracts to be declared on food product labels. (4)

Other divisions of FDA are also involved in the allergen issue by:

• conducting surveys to determine the number and extent of food allergy reactions,
• developing food allergen test kits (kits are available for egg, milk, and peanuts; others are in development), and
• researching threshold levels (if any) for safe levels of undeclared allergens. (4) Ten parts per million (ppm) is the current amount which causes concern, but some individuals are affected by as little as 2.5 ppm. Another concern is that, due to the physical form of an allergen, e.g., a piece of peanut, it may not be uniformly distributed within a food, parts of the food may be void of the allergen, and other parts may contain what would be a lethal dose. (1)

Legislative Background

Before the Nutrition Labeling and Education Act (NLEA) was enacted in 1990, allergens were required to be listed on food labels, except for foods that were considered "standardized." A standardized food would be something like mayonnaise, a product that has standard, known ingredients. There was a time when everyone knew what was in mayonnaise. "Nowadays they have to be told that mayonnaise contain both eggs and oil," says Elizabeth Campbell, director of programs and enforcement policy, CFSAN. The NLEA was designed to make it easier for consumers to discern what is in a food product, standardized foods and all. (8)

In 1996, the FDA issued a Notice to Manufacturers, (available at www.cfsan.fda.gov/~lrd/allerg7.html) detailing the FDA's concern with allergens and food product labeling. The labeling regulations list two exemptions to ingredient labeling: incidental additives and insignificant levels. Misinterpretation of these exemptions is believed to be the cause of many cases of allergic reactions. (13)

The FDA clarified the passage regarding incidental additives by stating that, to qualify under this exemption, the additive must be at an insignificant level AND not have any technical or functional effect in the finished food. (13)

As for ingredients not listed on the label because they are at "insignificant levels," the FDA states that for any substance which causes an allergic reaction, no level is insignificant. (13)

Traditionally, spices, flavors, and colors could be lumped together on a label, being listed just that way. The Notice to Manufacturers further stated that the FDA would consider, on a case-by-case basis, whether any substance that fell under these categories, but caused an allergic reaction, should be listed separately on a food label. The FDA asked manufacturers to examine their food products for allergens and recommended more specific labeling for spices, flavors, and colors. (13)

Also in this Notice to Manufacturers, manufacturers were made aware of the dangers of running multiple product lines consecutively, in which a non-allergenic product may inadvertently pick-up an allergen from the equipment used for a previous run. The FDA was considering ways to notify consumers about this situation. They were aware that some manufacturers use the statement "May contain _____," but they warned against overuse of the phrase, in place of good manufacturing practices. (13)

Current FDA/CFSAN Initiatives

In 2001, FDA/CFSAN released their Compliance Policy Guide (CPG), designed to provide guidance to FDA compliance staff, field investigators, and the regulated food industry on the FDA's allergen policy. The CPG restates concerns and recommendations in the Notice to Manufacturers, and also addresses issues discovered in the FDA/Minnesota and Wisconsin Partnership study (see below). (17)

FDA also issued the Guide to Inspections of Firms Producing Food Products Susceptible to Contamination with Allergenic Ingredients, to aid FDA field offices in their on-site inspections of food manufacturers. (17)

FDA-Minnesota-Wisconsin Food Allergen Partnership

To test allergen inspection and compliance systems, a partnership was formed in 1998 between the FDA, the Minnesota Department of Agriculture, and the Wisconsin Department of Agriculture. The study looked for peanut and egg residue in a total of 85 ice cream, candy, and bakery product manufacturers in the two states. There was a significant rate of non-compliance 25% had allergenic raw ingredients missing from their product label. Of product samples collected, 10% showed positive results for egg protein and 25% showed positive results for peanut protein, when neither were listed on the labels. (6)

The study found allergens had been inadvertently introduced by:

• inadequate scheduling to prevent cross-contamination
• improper cleaning
• allergen-containing rework in an allergen-free product ("rework" is leftover product at the end of a batch, often added to the next batch)

The study recommends that to prevent allergen introduction, methods of control should focus on raw material assessment, examining use of rework, equipment/system design, production scheduling, sanitation, packaging, and labeling. (6,15)

As a result of this study, many of the manufacturers in Minnesota and Wisconsin did change their operating procedures. Nearly half altered production schedules to address cross-contamination issues. Equipment was dismantled, cleaned, and sanitized, with procedures recorded in a log. Some firms dedicated equipment to peanut products, including baking pans, utensils (using labels and color-coding), and even a peanut-only cookie-cutting machine. Employees at two firms are now required to wash their hands between product runs which involve allergens. Nearly a quarter of the firms implemented procedures to verify label accuracy and 15% began using tests to check for undeclared allergens. While many of the firms examined their practices and implemented changes, several manufacturers simply abandoned their products which contained peanuts. (6) The partnership study results may be accessed at www.cfsan.fda.gov/~dms/alrgpart.html.

Based on the results of the FDA-Minnesota-Wisconsin Partnership, the FDA will soon embark on a nationwide inspection of food manufacturers, with a special focus on allergen control. (3,14)

Food Industry Initiatives

The food industry has initiated several of its own food allergen awareness programs: The Allergen Usage Guidelines published by the American Bakers Association in 2000, the Code of Practice on Managing Food Allergens, by National Food Processors Association in 2001, and Food Allergen Labeling Guidelines by the Food Allergy Issues Alliance (FAIA), also in 2001. The FAIA is a coalition of 18 food industry and consumer associations, headed by the Food Allergy and Anaphylaxis Network (FAAN), the Grocery Manufacturers of America (GMA), and the National Food Processors Association (NFPA). (2,4,5) See Table 2 for Web sites to view each program.

These programs all encourage voluntary participation in allergen labeling, good manufacturing practices and industry cooperation, with the idea that regulation will not be needed if manufacturers comply. Regina Hildwine, food labeling director of the NFPA, said, "We are hoping the marketplace will drive this issue. Allergic consumers are going to choose the product that gives them more information." (5) The NFPA is currently working on a Manual for Food Allergen Management, giving guidance to food processors who implement the Code of Practice. (10)

What's a Manufacturer to Do?

To prevent unintentional allergen contamination in a manufacturing process, Bruce Floyd, Process Systems Consulting, Iowa City, IA, offers these guidelines:

1. Production run scheduling. Schedule nonallergenic products to be run first. Be careful in washing equipment to eliminate residues: systems may become susceptible to pathogenic contamination if equipment is not designed to be washed.
2. Product separation. Keep allergens separate from nonallergens and keep classes of allergens together, e.g., powdered egg whites and egg noodles. Bins, scoops and weighing buckets should be dedicated to each raw material. Weigh minor ingredients for one product at a time; they should be labeled with product name, manufacturer, and lot number.
3. Dust control. Be vigilant in maintenance of equipment, ventilation, and dust control equipment.
4. Staging. Keep all ingredients for a specific batch, including minor ingredients, on a pallet to transport to the processing area. Keep a detailed batch record, detailing contents of pallet, production date, and final product.
5. Line clearance. Before beginning another production run, verify that all ingredients from a previous run have been removed from the weighing and production area. Remove packaging materials, especially labels. Also, look inside equipment to check for cleanliness (may not be possible with some equipment).
6. Verification. Conduct regular testing for presence of allergens; occasional testing may not pick-up inadvertent contamination. Kits are available to test for presence of egg, milk, or peanuts to 1-2 ppm. Testing, used in conjunction with a well-designed system, will help verify the system's safety measures are working.
7. Unavoidable contamination. It may be impossible to control dust drift, run separate lines, verify complete product removal from equipment, or prevent/detect cross-contamination of raw ingredients at manufacturer or farm level. At this point, it may be necessary to redesign the manufacturing plant or process, or add warning labels to product package. (1)

Floyd emphasizes the importance of the inclusion of allergens in a HACCP plan, even though that may cause the number of Critical Control Points in the plan to greatly increase. (1)

There is no cure for food allergies, but diligent manufacturing practices and efforts by trade associations and government agencies to raise awareness in both industry and with consumers can help stem the tide of food-induced allergic reactions.

TABLE 1. Timeline for Allergen Regulation Activity

1990 National Labeling and Education Act

1996 Notice to Manufacturers, FDA

1998 FDA-Minnesota-Wisconsin Partnership formed

2000 Allergen Usage Guidelines, ABA

2001:

• Compliance Policy Guide and Guide to Inspection of Firms Producing Food Products Susceptible to Contamination with Allergenic Ingredients, FDA
• Code of Practice, NFPA
• Food Allergen Labeling Guidelines, FAIA
• Food Ingredient Right to Know Act, introduced April 2001
• August 13, 2001, public meeting, FDA
• October 29, 2001, deadline for public comments regarding Food Allergen Labeling, FDA
  

TABLE 2.Web Site Contacts

• August 13, 2001 public meeting, submit comments: www.fda.gov, click on "Dockets" on the lower right of the home page, then click on "Submit Electronic Comments" and scroll to Docket#00P-1322 "Food Safety & Food Labeling; Presence & Labeling of Allergens in Food."
• August 13, 2001 public meeting, transcript:
  www.fda.gov/ohrms/dockets/dockets/00p_1322/tr00001.asc
• FDA-Minnesota-Wisconsin Partnership: www.cfsan.fda.gov/~dms/alrgpart.html
• Food Allergen Labeling Guidelines, Food Allergy Issues Alliance: http://www.affi.com/allergens.pdf
• Food Ingredient Right to Know Act, Rep. Nita Lowey (D-NY): http://thomas.loc.gov, under "Legislation: Bill Summary & Status," select Congress 107, enter "HR1356" in "Bill, Amendment, or Public Law Number."
• Guide to Inspection of Firms Producing Food Products Susceptible to Contamination with Allergenic Ingredients, FDA:
  www.fda.gov/ora/inspect_ref/igs/allergy_inspection_guide.htm.
• Notice to Manufacturers, FDA: www.cfsan.fda.gov/~lrd/allerg7.html

Resources

American Academy of Allergy, Asthma, and Immunology, www.aaaai.org

American Bakers Association, www.americanbakers.org

Food and Drug Administration, www.cfsan.fda.gov/~dms/wh-alrgy.html

Food Allergy and Anaphylaxis Network, www.foodallergy.org

Food Allergy Research and Resource Program, University of Nebraska, www.farrp.org

Grocery Manufacturers of America, www.gmabrands.com

National Food Processors Association, www.nfpa-food.org

National Institute of Allergy and Infectious Diseases, www.niaid.nih.gov

National Restaurant Association, www.restaurant.org

Process Systems Consulting, e-mail Bruce Floyd at bfloyd7192@aol.com

REFERENCES

1. "Battling Allergen Contamination," Food Product Design supplement, December 2000.
2. "FDA Issues Allergen Compliance Policy Guide," Baking & Snack, June 2001.
3. "FDA to Inspect Bakeries for Allergens," Baking & Snack, August 2001.
4. "Food Allergen Awareness: An FDA Priority," Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, February-March 2001, www.cfsan.fda.gov/~dms/alrgawar.html, accessed August 28, 2001.
5. "Food Allergen Labeling Provides Answers," Food Product Design, August 2001.
6. "Food Allergen Partnership," Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, January 2001, www.cfsan.fda.gov/~dms/alrgpart.html, accessed August 28, 2001.
7. "Food Allergies a Serious Issue," Food Product Design, April 2001.
8. "Food Allergies Rare But Risky," FDA Consumer, U.S. Food and Drug Administration, May 1994, www.cfsan.fda.gov/~dms/wh-alrg1.html, accessed August 28, 2001.
9. "Food Allergies: When Food Becomes the Enemy," FDA Consumer, U.S. Food and Drug Administration, July-August 2001, www.fda.gov/fdac/features/2001/401_food.html, accessed August 28, 2001.
10. "Food Allergy Alliance Announces Labeling Guidelines for Milk, Other Food Allergens," Cheese Reporter, June 1, 2001.
11. foodallergy.org/allergens.html, accessed September 26, 2001.
12. "New Study Details Effects of Food Allergies on Restaurant Dining," just-food.com, April 9, 2001, accessed April 9, 2001.
13. "Notice to Manufacturers," Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, June 10, 1996, www.cfsan.fda.gov/~lrd/allerg7.html, accessed August 28, 2001.
14. Personal communication, Kenneth Falci, Director of the Office of Scientific Analysis and Support, CFSAN, FDA, September 25, 2001.
15. Personal communication, Kyle Richmond, Public Information Officer, Wisconsin Department of Agriculture, Trade & Consumer Protection, September 21, 2001.
16. "Transcript of Public Meeting on: The Challenge of Labeling Food Allergens," Docket #00P-1322,
    www.fda.gov/ohrms/dockets/dockets/00p_1322/tr00001.asc,
    accessed September 24, 2001.
17. "Questions and Answers on Allergen Guides," Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, May 3, 2001, www.cfsan.fda.gov/~dms/alrgpgtp.html, accessed August 28, 2001.
18. http://thomas.loc.gov, accessed October 2, 2001.