Nutrition Labeling: Nutrient Content Claims on Multi-Serve, Meal-Type Meat and Poultry Products

AGENCY:

Food Safety and Inspection Service, USDA.

ACTION:

Proposed rule.

SUMMARY:

The Food Safety and Inspection Service (FSIS) is proposing to amend its nutrition labeling regulations to change the definition of “meal-type” products to allow for nutrient content claims on multiple-serve food containers, to adopt the definition of “main dish” used by the Food and Drug Administration (FDA), and to define how meal-type products and main dishes should be nutritionally labeled. The change in the definition of meal-type products would allow nutrient content claims to be based on 100 grams of product rather than on the serving size, which is based on the Reference Amounts Customarily Consumed (RACC) for the food components. These actions are being proposed in response to a petition filed by ConAgra, Inc. (the petitioner). The proposed changes will help to ensure that FSIS' nutrition labeling regulations are parallel, to the maximum extent possible, to the nutrition labeling regulations of FDA, which were promulgated under the Nutrition Labeling and Education Act (NLEA) of 1990.

DATES:

Interested persons are requested to submit written comments by June 16, 2003.

ADDRESSES:

Submit an original and two copies of comments to the FSIS Docket Clerk, Room 102, Cotton Annex Building, 300 12th Street, SW., Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT:

Robert C. Post, Ph.D., Director, Labeling and Consumer Protection Staff, Office of Policy, Program and Employee Development, FSIS, at (202) 205-0279 or by fax at (202) 205-3625.

SUPPLEMENTARY INFORMATION:

Background

The Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the Poultry Products Inspection Act (21 U.S.C. 451 et seq.) authorize the Secretary of Agriculture to establish and maintain inspection programs designed to ensure that meat and poultry products distributed in commerce are wholesome, not adulterated, and properly marked, labeled, and packaged. FSIS regulates the labeling of meat and poultry products, and FDA has responsibility for the labeling of all other foods.

In January of 1993, FSIS and FDA published their final rules on nutrition labeling. Both agencies amended their respective regulations to (1) require either mandatory or voluntary nutrition labeling on most of the food products they regulate; (2) revise the list of required nutrients and food components; (3) specify a new format for declaring the nutrients and food components in nutrition labeling; (4) permit specific products to be exempt from nutrition labeling; (5) establish RACC specific for food categories; and (6) prescribe a simplified form of nutrition labeling and the conditions under which such labeling may be used.

If people are to use the nutrition information to construct healthy diets that include products from across the food supply, the two agencies recognized that the regulations need to be as consistent as possible. There was overwhelming support in response to the proposal on claims for FSIS to proceed with the adoption of FDA-defined nutrient content claims, including adopting a constant value of 100 grams for comparison of nutrient content claims on meal-type products. As a result, both agencies issued regulations establishing, as nearly uniform as possible, definitions for nutrient content claims to allow consumers to make valid comparisons among food product categories.

In addition, the agencies participated in the Interagency Committee on Serving Sizes to jointly establish the RACC for food and the criteria for converting RACC to serving sizes in common household measures. The final FSIS rule, among other things, established RACC for 23 meat (9 CFR 317.12(b)) and 22 poultry product categories (9 CFR 381.412(b)). These amounts were calculated to reflect the amount of food, including snacks, dinners, and condiments, that persons four years of age and older customarily consume. These calculations were based on consumption survey data and on data used by food manufacturers and grocers. RACC are designed to be used by food companies as the basis for determining the serving sizes for nutrition labeling of their products.

Nutrient content claims for both FDA and FSIS are composed of two defined parts: The amount (weight) of the nutrient and the amount (generally a serving) of food in which the nutrient is found. If the food is considered to be an individual food, the amount of food (a serving) is represented as the RACC for the food category. If the food is a meal-type product, the amount of food is measured by weight, i.e., 100 grams. If a “low-fat” or “healthy” claim is used, the amount of fat is limited to a maximum of 3 grams per RACC for individual foods and 3 grams per 100 grams of product for single-serve meal-type products.

However, FSIS and FDA have established different criteria for what constitutes a meal. FSIS defined a “meal-type” product (9 CFR 317.313(l) and 381.413(l)) as a product for consumption by one person on one eating occasion that constitutes the major portion of a meal. For purposes of making a nutrition claim, a meal-type product must (1) make a significant contribution to the diet by weighing at least 6 ounces, but no more than 12 ounces per serving (container); (2) contain ingredients from two or more food groups, depending on the weight of the product; and (3) represent, or be in a form commonly understood to be, a meal (breakfast, dinner, etc). In addition, the serving size for meal-type products is defined as the entire content (edible portion only) of the package

FDA defined a “meal-type” product (21 CFR 101.13(l)) for the purpose of making a claim as a product that makes a major contribution to the total diet by (1) weighing at least 10 ounces per labeled serving; (2) containing not less than three 40-gram portions of food or combinations of foods from two or more of the four food groups; and (3) representing, or being in a form commonly understood to be, a meal (breakfast, dinner, etc). FDA's regulations do not restrict the use of the meal-type product claims to single-serve containers.

FDA also defined a “main-dish” product (21 CFR 101.13(m)) for the purpose of making a claim as a food that makes a major contribution to the meal by (1) weighing at least 6 ounces per labeled serving; (2) containing not less than 40 grams of food, or combinations of foods from at least two of four food groups; and (3) representing, or being in the form commonly understood to be, a main dish (i.e., not a beverage or dessert). FSIS regulations do not define a “main-dish” product.

FSIS' and FDA's rationale for allowing different criteria to serve as the basis for evaluating nutrient content claims on meal-type products versus other types of foods is that meal-type products have potentially large variations in amounts customarily consumed, and the average serving size would not be an appropriate basis for comparison of nutrients. Rather, a constant value of 100 grams was determined to be an appropriate basis. It was further reasoned that restricting this category to a single-serving criterion and requiring that products within the category be represented as a meal would adequately distinguish these products from other similarly formulated products.

ConAgra's Petition

In September 1998, ConAgra petitioned FSIS to amend the definition of “meal-type” products in its regulations to allow nutrient content claims on multi-serve food containers based on the same criteria as for meals that are sold in single-serving containers. Specifically, the petitioner sought an amendment of the definition of “meat” (9 CFR 317.313(l)) to include product in multiple-serving containers in the general principles (9 CFR 317.313) and the “healthy” regulations (9 CFR 317.363). FSIS' initial response was that the few changes requested by the petitioner would not be sufficient to address all of the issues and amend the regulations so that manufacturers can make consistent nutrition content claims on multi-serve containers. FSIS requested that the petitioner provide additional data to justify the changes it is seeking and clearly state the need for consistent definitions for main dish and meal-type products that do not compromise the established RACC for food products and that are consistent with the intent of the NLEA.

After several follow-up discussions with FSIS, ConAgra provided the Agency with marketing and consumption data that FSIS termed insufficient to justify granting the change in the regulations. FSIS said that it was concerned that to allow such claims could confuse and mislead consumers, create market inequities between sellers of individual food products and sellers of meal-type products, and discourage the development of products eligible for such claims. The Agency said that the data submitted by the petitioner did not alleviate those concerns.

In 2001, FSIS concluded that more conclusive data submitted by the petitioner indicated that there was a market for multi-serve meals that did not exist in 1993 when the nutrition labeling regulations were issued. Because of the increasing popularity of multi-serve meals and evidence that a significant number of consumers were purchasing such meals, FSIS said it was prepared to consider changing the regulatory definition of “meal-type” products and allowing nutrient content claims based on a 100 gram criterion as long as there are no established RACC for the food product category in question. It also said that consistency in nutrient content claims and RACC criteria for all meat and poultry products must be maintained in accordance with the regulations. The Agency noted that if Federal regulations regarding the basis for which nutrient content claims are made are modified for consistency, FSIS and FDA need identical definitions for what constitutes a meal and a main-dish product. FSIS granted the petition in November 2001. The petition and the supporting documentation are available in the FSIS Docket Room (see ADDRESSES) and on the FSIS Web site at http://www.fsis.usda.gov.

Costs and Benefits Associated With the Proposal

No significant cost impact is seen as a result of this proposed rule. All costs would be borne by industry, which petitioned for the change. The only labels that would be affected would be those of multi-serve, meal-type products above 6 ounces that would be able to bear nutrient content claims. The Agency believes that no more than 300 products currently on the market will be affected by the change. Lean and extra-lean products that have the same definition for meal-type products as main-dish products would not be affected. Therefore, the expected additional labeling costs would be nominal for the industry.

A more consistent format across similar food products would be of benefit to consumers, who would be able to make more informed choices in their food purchases. There is evidence that consumers are experiencing some confusion about how some food products are labeled.

The Proposed Rule

The proposed rule would provide consumers of meat and poultry products with additional consistency in nutrition labeling with FDA's requirements by amending § 317.309 and the parallel poultry regulations at § 381.409 to provide for the nutrition labeling of multi-serve meal-type products and of main-dish products. The proposal also would amend § 317.313(l) and § 317.313(m) and the parallel poultry regulations at § 381.413(l) and § 381.413(m) by revising the definitions of a “meal-type” product and a “main-dish” product for the purpose of making a claim on the packaging of the food products. In addition, the proposal would amend the individual nutrient content claim regulations for both meat and poultry products.

FSIS' paramount objectives in considering modification to its nutrition labeling regulations were that such changes not undermine the basic principles or intent of the misbranding provisions of the Federal Meat Inspection Act and the Poultry Products Inspection Act, and that such modifications result in labels that would not mislead consumers or create unfair marketing advantages for any segment of the food industry. The Agency also was concerned about extending the use of the 100-gram criterion for nutrient content claims to include products not in single-serve containers. Although useful, the 100-gram criterion does not provide nutrient information to consumers that is as definitive as the amount of nutrient per RACC.

However, in the interests of maintaining consistency between FSIS and FDA and of providing incentives to industry to develop meals and main dishes in multi-serve containers that are able to bear nutrient content claims, FSIS is proposing changes in its nutrition labeling regulations. The Agency believes that consumers will benefit from the information on the containers of products that were formulated to qualify to bear such claims.

Executive Order 12866 and the Regulatory Flexibility Act

This proposed rule has been determined to be not economically significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget. FSIS is responding to an industry petition for a labeling change affecting approximately 300 food products.

Executive Order 12778

This proposal has been reviewed under Executive Order 12778, Civil Justice Reform. When this rule becomes final:

(1) All State and local laws and regulations that are inconsistent with this rule will be preempted: (2) no retroactive effect will be given to this rule: and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.

Effect on Small Entities

The Administrator, FSIS, has made a determination that this proposed rule will not have a significant economic impact on a substantial number of small entities. This proposal would change the definition of “meal-type” products to allow for nutrient content claims on multi-serve food containers and adopt FDA's definition of “main-dish” products. In addition, small entities are exempt from nutrition labeling regulations if their products do not make nutrition claims or bear nutrition information.

Additional Public Notification

Public involvement in all segments of rulemaking and policy development is important. Consequently, in an effort to better ensure that minorities, women, and persons with disabilities are aware of this proposed rule and are informed about the mechanism for providing their comments, FSIS will announce it and make copies of this Federal Register publication through the FSIS Constituent Update, which is communicated via Listserv, a free e-mail subscription service. In addition, the update is available on-line through the FSIS Web page located at http://www/fsis.uisda.gov. The update is used to provide information regarding FSIS policies, procedures, regulations, Federal Register, FSIS public meetings, recalls, and any other types of information that could affect or would be of interest to our constituents and stakeholders. The constituent Listserv consists of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other persons who have requested to be included. Through the Listserv and Web page, FSIS is able to provide information to a much broader, more diverse audience.

For more information, contact the Congressional and Public Affairs Office, at (202) 720-9113. To be added to the free e-mail subscription service (Listserv), go to the “Constituent Update” page on the FSIS Web site at http://www.fsis.usda.gov/oa/update.htm. Click on the “Subscribe to the Constituent Update Listserv” link, then fill out and submit the form.

Paperwork Requirements

This proposed rule has been reviewed under the Paperwork Reduction Act and imposes no new paperwork or recordkeeping requirements.

List of Subjects

9 CFR Part 317

• Food labeling
• Food packaging
• Meat inspection
• Nutrition

9 CFR Part 381

• Food labeling
• Food packaging
• Nutrition
• Poultry and poultry products

Proposed Rule

For the reasons discussed in the preamble, FSIS is proposing to amend 9 CFR, Parts 317 and 381, as follows:

PART 317—LABELING, MARKING DEVICES AND CONTAINERS

1. The authority citation for 9 CFR part 317 continues to read as follows:

Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

2. Section 317.309 would be amended by revising paragraph (b)(12) to read as follows:

PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS

10. The authority citation for Part 381 continues to read as follows:

Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.18, 2.53.

11. Section 381.409 would be amended by revising paragraph (b)(12) to read as follows: