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.

• Gene Grabowski
  

COMMENT
• September 1, 2001  Scientific Analysis Regarding Objectionable Matter in Food
NEWS RELEASE
• August 13, 2001  Food Industry Leading Efforts To Better Inform Consumers About Food Allergies
• May 31, 2001  GMA, Food Allergy Alliance Develop "Easy to Understand" Labeling Guidelines
TESTIMONY
• August 13, 2001  Advisory Labeling of Major Food Allergens
• August 13, 2001  GMA Testimony to FDA on Common English Name Labeling

COMMENT
• April 5, 2002  The Codex “Proposed Draft Amendment to the General Standard for the Labeling of Prepackaged Foods: Quantitative Declaration of Ingredients”
• December 21, 2001  Traceability & Labeling Provisions of Proposed Regulations on Genetically Modified - Food & Feed and Traceability & Labeling
• August 30, 2001  Traceability & Labeling Provisions of the Proposed Regulations on Genetically Modified Food & Feed and the Traceability & Labeling of Genetically Modified Organisms
• July 10, 2001  ICGMA Comments on Australian Country-of-Origin Labeling Proposal
• March 28, 2000  Guidance on Significant Scientific Agreement
CORRESPONDENCE
• January 14, 2003  GMA Letter to FDA Calling for Mutual Recognition of Labeling Standards in North America
• September 12, 2001  GMA Urges Mutual Recognition on Food Labeling between the U.S. and Canada
• November 30, 2000  GMA Supports Canadian Move to Harmonize Nutritional Labeling
• November 12, 1999  In Letter to Clinton, 38 Food, Farm Organizations Urge President to Support FDA Food Biotechnology Policy
NEWS RELEASE
• July 22, 2003  GMA SAYS BIOTECH TRACEABILITY, LABELING RULE WILL INHIBIT TRADE
  EU Labeling Rule Not Supported by Science
• May 29, 2003  GMA RECOMMENDS NEW, EFFICIENT QUALIFIED HEALTH CLAIMS APPROVAL PROCESS
• November 6, 2002   OREGONIANS REJECT MANDATORY BIOTECH LABELING
• May 8, 2002  GMA Says Lawsuit Calling for Warning Labels Unfounded; FDA and California Attorney General Say Chocolate is Safe
• May 7, 2002  .
• August 13, 2001  Food Industry Leading Efforts To Better Inform Consumers About Food Allergies
• July 27, 2001  CURRENT LABELING LAWS ALLOW CONSUMERS TO MAKE "SMART BUYING DECISIONS"
• May 31, 2001  GMA, Food Allergy Alliance Develop "Easy to Understand" Labeling Guidelines
• May 23, 2001  GMA Says Massachusetts Mandatory Labeling Bill "Unnecessary And Redundant"
• May 4, 2001  U.S. Industry and Government Position Prevails on Biotech Labeling at Codex
• May 3, 2001  FDA POLICY KEEPS IMPORTANT HEALTH INFORMATION FROM PUBLIC, GMA TELLS CONGRESS
• January 17, 2001  FDA PROPOSAL FOR BIOTECH LABELING AND PRODUCT APPROVAL "A VICTORY FOR CONSUMERS"
• November 18, 1999  GMA: FDA Biotech Labeling Policy Protects Consumers, "Serves The Public Interest"
• November 15, 1999  Three Dozen Food, Farm Groups Urge President to Support FDA Biotech Policy
• June 11, 1999  GMA: NATIONAL UNIFORMITY FOR FOOD ACT REPRESENTS "COMMON SENSE CONSUMER INITIATIVE" House Bill Introduced by Rep. Burr; Companion to Sen. Roberts' Measure
• May 27, 1999  GMA: COMMON SENSE BILL PROVIDES UNIFORM, SCIENCE-BASED FOOD LABELING STANDARDS FOR CONSUMERS
• May 11, 1999  GMA: "TIME IS RIPE" FOR FDA TO RECONSIDER AND REVISE HEALTH CLAIMS APPROVAL PROCESS
• September 1, 1998  FOOD INDUSTRY URGES FDA NOMINEE TO PUT FOOD ISSUES ON EQUAL LEVEL
TESTIMONY
• March 10, 2003  GMA Testimony in Opposition Connecticut Biotech Food Labeling Bill
• April 8, 2002  GMA Letter of Opposition to California Trans Fatty Acids Labeling Bill
• March 25, 2002  GMA Letter of Opposition to Mandatory Rhode Island rBST Labeling Bill
• February 5, 2002  GMA Letter of Opposition to Hawaii Biotech-Free Food Labeling Bill
• October 9, 2001  GMA Letter of Opposition to Puerto Rico Biotech Food Labeling Bill
• August 13, 2001  Advisory Labeling of Major Food Allergens
• August 13, 2001  GMA Testimony to FDA on Common English Name Labeling
• June 28, 2001  GMA Testifies in Opposition to Suffolk County, NY Bottled Water Labeling Resolution
• May 31, 2001  Food Allergy Issues Alliance Labeling Guidelines
• May 30, 2001  GMA Letter in Opposition to New York Product Dating Labeling Bill
• May 23, 2001  GMA Testifies Against Massachusetts Bill for Mandatory Labeling of Biotech Foods
• May 7, 2001  GMA Testifies in Support of FDA Biotech-Free Labeling Guidance at New York Hearing
• May 3, 2001  FDA POLICY KEEPS IMPORTANT HEALTH INFORMATION FROM PUBLIC
• April 17, 2001  GMA Comments on USDA/GIPSA Advanced Notice of Proposed Rulemaking
• April 13, 2001  GMA Letter of Opposition to Mass. Green Dot Labeling Legislation
• April 11, 2001  GMA Testifies in Support of FDA-Based Maine "Biotech-Free" Labeling Bill
• March 29, 2001  Expert Witness Testifies on Behalf of GMA in Opposition to Maine Mandatory Biotech Food Labeling Bill
• March 29, 2001  GMA Letter in Opposition to Maine Mandatory Biotech Food Labeling Bill
• March 21, 2001  GMA Testifies in Opposition to New Hampshire Mandatory Food Biotechnology Labeling Bill
• March 21, 2001  GMA Testifies in Support of FDA GMO-Free Labeling Guidance at Minnesota Hearing
• March 21, 2001  Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering
• March 15, 2001  Letter in Opposition to Connecticut Prop 65 Clone Bill
• February 15, 2001  GMA Letter in Opposition of Nebraska Product Origin Labeling Bill
• February 14, 2001  GMA Letter in Opposition to Florida "Sell By" Product Dating Bill
• February 9, 2001  GMA Letter of Opposition to Colorado Biotech Food Labeling Bill
• February 9, 2001  GMA Letter of Opposition to Rhode Island rBST Labeling Bill
• February 7, 2001  Biotech Labeling Legislation Pending In Mexico
• February 29, 2000  GMA Testimony, Connecticut Warning Label Legislation, SB 433
• November 18, 1999  GMA Testimony on Biotechnology: FDA Biotech Labeling Policy Protects Consumers, "Serves The Public Interest"
• June 23, 1999  GMA Urges Veto Of Senate Bill 945
• May 10, 1999  GMA Opposes HB 3136
• April 12, 1999  GMA Opposes Legislative Docket 1985
• April 12, 1999  GMA Opposes Legislative Docket 713
• March 10, 1999  GMA Opposes House Bill 887
• July 28, 1998  The Transatlantic Economic Partnership

NEWS RELEASE
• May 3, 2001  FDA POLICY KEEPS IMPORTANT HEALTH INFORMATION FROM PUBLIC, GMA TELLS CONGRESS
• May 19, 1999  GMA: REDUCED TARIFFS, GREATER MARKET ACCESS FOR FOOD PRODUCTS MUST BE U.S. GOALS AT WTO TALKS
• March 16, 1999  FOOD INDUSTRY SUPPORTS INCREASED FOOD SAFETY FUNDING, GMA TELLS KEY HOUSE, SENATE PANELS But Says Congress Should Reject General Purpose User Fees
• March 2, 1999  U.S. FOOD INDUSTRY WELL PREPARED FOR YEAR 2000 GMA, FMI Testimony Shows Food Manufacturers and Retailers Ready for Y2K
• October 2, 1998  U. S. Food Safety Can Be Enhanced Within Existing Regulatory Framework, GMA Tells Presidential Panel
• August 20, 1998  U.S. Food Industry Applauds NAS For Including Science-Based Approach For Food Safety Task Force Cautions Against Disruptive Agency Reorganization
TESTIMONY
• August 15, 2001  Food Fight in the New Economy: The Taxation of Food
• August 13, 2001  Advisory Labeling of Major Food Allergens
• August 13, 2001  GMA Testimony to FDA on Common English Name Labeling
• May 3, 2001  FDA POLICY KEEPS IMPORTANT HEALTH INFORMATION FROM PUBLIC
• September 14, 1999  Slotting Allowances
• September 14, 1999  Wisconsin Recycled Content Bill
• June 24, 1998  GMA Comments On FDA CFSAN Priorities
• March 31, 1998  The Administration's FY1999 Proposed Budget
• February 24, 1998  APEC Sectoral Liberalization And The Stability Of Asian Economies