GMA supports the use of supplemental statements such as “may contain peanuts” consistent with the criteria established in the Food Allergen Labeling Guidelines prepared by the Allergy Issues Alliance. These guidelines clearly state that, consistent with the FDA policy on this issue, supplemental allergen statements should not and cannot be used in lieu of good manufacturing practices. In addition, the guidelines restrict the instances in which a manufacturer can use supplemental allergen statements. Under the guidelines, supplemental statements only can be used when:

1)The presence of a Major Food Allergen is documented through visual examination or analytical testing of the processing line, equipment, ingredient or product, or other means;

2)The risk of presence of a Major Food Allergen is unavoidable even when current GMPs are followed;

3)A Major Food Allergen is present in some, but not all, of the product; and,

4)The presence of a Major Food Allergen is potentially hazardous.

If some, but not all of these four criteria are met, the guidelines do not allow the manufacturer to use a supplemental allergen statement. In such instances, the manufacturer must either consider an additional food allergen control measure and/or some other labeling strategy.

With regard to the placement of the supplemental allergen statement, the guidelines require the statement to appear at the end of, or in immediate proximity to, the ingredient statement. The guidelines require the statement to be as accurate and as conspicuous as possible. Examples of the type of supplemental statements that are being used include “may contain peanuts” and “processed on the same equipment as milk.” The guidelines provide the manufacturer with the flexibility to determine the type of supplemental statement that will best describe the product.

Supplemental allergen statements are an integral component of the Alliance’s labeling document. Although the food industry is diligent in its efforts to prevent major food allergens from inadvertently ending up in food products, the nature of the food supply and our manufacturing processes in some instances makes it impossible to avoid. Farmers generally grow numerous crops and use the same equipment to harvest, store and transport corn, soybeans, wheat, peanuts, and other crops. This can lead, for example, to the presence of soy in corn or wheat in peanuts. Inadvertent contact also can occur in the manufacturing facility where the same processing equipment is used to manufacture a wide variety of products.

In an attempt to prevent the inadvertent presence of allergens in products, many in the food industry have adopted a three-tiered approach to minimize inadvertent contact with allergens. This approach involves dedication, when possible, separation and as a last resort, labeling.

First, when possible, the industry will use a dedicated system. This may be possible for some large volume products where continual production on the same or multiple lines is needed to meet consumer demand. It is not financially possible, however, to have a dedicated system for each product that is manufactured by a company.

When a dedicated system is not a possibility, the company will then use “separation” as a means to minimize inadvertent contact. This can be accomplished by physical barriers, the use of dedicated containers for raw materials that contain allergens, and other means to prevent the inadvertent contact of the major allergen with non-allergenic ingredients. Companies also will schedule production so that when possible, a non-allergen containing product will be manufactured on a line before a product that contains a major allergen. And, companies will thoroughly clean a line that has been used to a manufacture a product containing a major allergen before manufacturing a product that does not contain that allergen. Cleaning, however, will not always succeed in removing the allergens from all surfaces of the equipment.

It has been proven time and time again that water is the most efficient method for removing allergenic proteins from processing equipment. There are numerous foods and food systems, however, where water cannot be used as part of the cleaning process due to the nature of the food or due to microbiological safety concerns. Chocolate and peanut butter manufacturing systems are examples of processes where water cannot be used to clean the machinery because these foods are not readily dissolved by water and the use of water can lead to microbiological concerns due to the puddling of water in the system. Water also cannot be used in the cleaning of certain packaging and electrical equipment such as baking ovens and cooling tunnels, for obvious reasons.

In instances when water cannot be used for cleaning, the food industry frequently will use a dry process for cleaning, such as flushing the line with a safe, non-allergenic dry ingredient or food, that removes the food from the system. The use of these dry ingredients is recognized as an appropriate good manufacturing practice and in many instances is dictated by the microbiological concerns that are presented by wet cleaning. The use of dry ingredients to clean a system, however, is not always successful in removing allergens. Systems that rely on this type of cleaning frequently cannot be cleaned to remove all residues of a major allergen.

In those instances when neither dedication nor separation can prevent the inadvertent contact with the major allergen, the industry will resort to labeling, consistent with the four criteria established in the Alliance’s labeling program. These criteria are designed to ensure that supplemental allergen statements are used only in limited situations and not as a substitute for complying with GMPs.

Supplemental allergen statements are designed to alert the food allergic consumer that the product in question may have an allergen that they need to avoid. We recognize that a certain percentage of a given product bearing the supplemental allergen statement may be free of the named allergen and safe for consumption by the food allergic consumer. However, the allergen may be present in some of the foods manufactured on that line, thus, necessitating the use of a supplemental statement that alerts the food allergic consumer to the possible presence of the major allergen.

As stated in my comments earlier today, we believe that the allergen labeling issues can be best addressed through the voluntary program and that additional regulations are unnecessary. Although the existing regulations do not mandate the use of common English names or establish criteria for the use of supplemental allergen statements, the industry, through the Allergy Issues Alliance, has reached agreement on these labeling issues and is now in the implementation phase.

We believe that continued educational efforts will be one of the most effective means to address this issue. GMA has educated its member companies about the importance of the allergen issue and as stated this morning, the senior management from each of our member companies is being asked to adopt the labeling program. We recognize, however, that we also have to reach the small and medium sized companies that may not be members of GMA or of the other associations that are part of the Allergy Issues Alliance. The Allergy Issues Alliance is in the process of developing educational programs for these other companies.

Moreover, FDA has the existing statutory and regulatory tools to take enforcement action against those companies that market products with undeclared allergens. The unacceptably high level of recalls due to the presence of undeclared allergens is perhaps the strongest evidence supporting the agency’s ability, under its existing regulatory framework, to address this issue.

We also encourage FDA to develop and maintain a strong enforcement presence for food allergens. One of the best ways to effect change and to encourage all companies, regardless of size, to make certain that their products are properly labeled and that their foods are manufactured in accordance with GMPs is through continued inspections, and when necessary, enforcement actions. We believe that a strong FDA presence and the knowledge that there is a “cop on the beat” would be a much more effective use of agency resources than additional regulations.

In conclusion, GMA supports the use of supplemental allergen statements in those limited instances when the four criteria in the Alliance’s labeling program are satisfied. Consistent with FDA’s guidance on this issue and the terms of the Alliance’s labeling program, supplemental allergen labeling, cannot and should not be used as a substitute for GMPs. Thank you.

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