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Daily Rules, Proposed Rules, and Notices of the Federal Government

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 317 and 381

[FDMS Docket No. FSIS-2005-0018]

RIN: 0583-AC60

Nutrition Labeling of Single-Ingredient Products and Ground or Chopped Meat and Poultry Products

AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Supplemental Proposed Rule.
SUMMARY: The Food Safety and Inspection Service (FSIS) is issuing this supplemental proposed rule that, if finalized, will amend the Federal meat and poultry products inspection regulations to require nutrition labeling of the major cuts of single-ingredient, raw meat and poultry products, unless an exemption applies.
DATES: Submit comments on or before February 16, 2010.
ADDRESSES: *Federal eRulemaking Portal:This Web site provides the ability to type short comments directly into the comment field on this Web page or attach a file for lengthier comments. Go tohttp://www.regulations.gov.Follow the online instructions at that site for submitting comments.

*Mail, including floppy disks or CD-ROMs, and hand- or courier-delivered items:Send to Docket Clerk, U.S. Department of Agriculture (USDA), FSIS, Room 2-2127, George Washington Carver Center, 5601 Sunnyside Avenue, Mailstop 5474, Beltsville, MD 20705-5474.

Instructions:All items submitted by mail or electronic mail must include the Agency name and docket number FSIS-2005-0018. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, tohttp://www.regulations.gov.

Docket:For access to background documents or to comments received, go to the FSIS Docket Room at the address listed above between 8:30 a.m. and 4:30 p.m., Monday through Friday. All comments submitted in response to this proposal, as well as background information used by FSIS in developing this document, will be available for public inspection in the FSIS Docket Room at the address listed above between 8:30 a.m. and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Sally Jones, Senior Technical Advisor, Labeling and Program Delivery Division, Office of Policy and Program Development, Food Safety and Inspection Service, U.S. Department of Agriculture, Beltsville, MD 20705; (301) 504-0878.
Section I SUPPLEMENTARY INFORMATION: Background

Supplemental Proposed Rule:On January 18, 2001, FSIS published a proposed rule in theFederal Registerentitled, “Nutrition Labeling of Ground or Chopped Meat and Poultry Products and Single-Ingredient Products” (66 FR 4969). Because of the length of time since the publication of the proposed rule, FSIS is providing the public an opportunity to comment on this supplemental proposed rule. FSIS also welcomes comments on relevant issues for which there is new evidence since the proposed rule was issued.

This supplemental proposed rule responds to all comments received on the January 18, 2001 proposed rule and explains how the Agency intends to proceed with a final rule. Although FSIS has come to tentative conclusions regarding the issues raised by the commenters, in this supplemental proposed rule, FSIS is requesting additional comments on policies for which there were significant differences of opinion among commenters.

Specifically, under the “Provisions of the Supplemental Proposed Rule” heading below, FSIS is requesting comments on whether nutrition information should be allowed on point-of-purchase materials for ground or chopped products, as an alternative to requiring nutrition information on the product labels. FSIS is also requesting comments on the use of statements of lean percentages on the label or in labeling of ground or chopped products that do not meet the regulatory criteria for “low fat.” In addition, under the “Provisions of the Supplemental Proposed Rule” heading below, FSIS is requesting comments on whether it should provide an exemption from nutrition labeling requirements for small businesses that include a fat percentage statement and lean percentage statement on the labeling or in labeling of ground or chopped product. FSIS is requesting copies of any studies, surveys, or other data on consumers' perception of and use of point-of-purchase materials versus nutrition labels for ground or chopped product and on consumers' understanding of the nutrient content of ground or chopped products. FSIS is also requesting copies of any studies, surveys, or data on consumers' use and understanding of fat percentage and lean percentage statements on ground or chopped products. FSIS will post on its Web site, with this supplemental proposed rule, all studies and data submitted to the Agency in response to this request. FSIS requests comment on the potential effects of disallowing a statement of lean percentage on ground or chopped products.

FSIS will consider all comments received in response to this supplemental proposed rule. After evaluating the comments, FSIS intends to respond to them, make any appropriate and necessary changes to this rule, and issue the final rule in theFederal Register.

The Proposed Rule

Major cuts:FSIS proposed to require nutrition labeling of the major cuts of single-ingredient, raw meat and poultry products identified in §§ 317.344 and 381.444 that are not ground or chopped, except for certain exemptions. FSIS proposed that “ground beef regular without added seasonings,” “ground beef about 17% fat,” and “ground pork” would no longer be included in the list of major cuts in § 317.344.

FSIS proposed to make the guidelines in place for the voluntary nutrition labeling program mandatory for the major cuts of single-ingredient, raw products that are not ground or chopped. Thus, for these products, FSIS proposed that nutrition information be provided on the label or at point-of-purchase, unless an exemption would apply. For further explanation of the guidelines for voluntary nutrition labeling,see66 FR 4971, January 18, 2001. For further explanation of the proposal to make these guidelines mandatory for the major cuts of single-ingredient, raw products that are not ground or chopped,see66 FR 4973-4975, January 18, 2001.

In the preamble to the proposed rule, FSIS explained that, in its two most recent surveys of the voluntary nutrition labeling of single-ingredient, raw products, FSIS found that significant participation in the voluntary nutrition labeling program did not exist (66 FR 4972, January 18, 2001). FSIS regulations provide that a food retailer is participating at a significant level (1) if the retailer provides nutrition labeling information for at least 90 percent of the major cuts of single-ingredient, raw meat and poultry products it sells; and(2) if the nutrition label on these products is consistent in content and format with the mandatory program, or if nutrition information is displayed at point-of-purchase in an appropriate manner. The required nutrition labeling provisions for multi-ingredient and heat processed products are referred to as “the mandatory program.” The regulations also provide that significant participation by food retailers exists if at least 60 percent of all companies that are evaluated are participating in accordance with the guidelines (§ 317.343 and § 381.443). The term “companies,” as used in these regulations, refers to individual stores. FSIS used a representative sample of stores to assess participation (see58 FR 640, January 6, 1993). Based on the survey data from the two most recent surveys, less than 60 percent of stores evaluated were participating in accordance with the guidelines.

In the preamble to the proposed rule, FSIS explained that, because the most recent surveys showed that significant participation in the voluntary nutrition labeling program did not exist, FSIS believed that the proposed rule was necessary. FSIS stated that, without nutrition information, consumers are not able to assess the nutrient content of the major cuts and thus cannot make educated choices about these products based on nutrition information. FSIS believed that the lack of nutrition information on the labeling of the major cuts was misleading (66 FR 4973-4974, January 18, 2001) because it fails to disclose material facts about the consequences of consumption of these products. Consumers can compare the fat content in major cuts of poultry based on whether the product has skin and based on the levels of attached fat in the product. Similarly, consumers can compare the fat content among major cuts of meat products based on internal marbling and attached fat. However, without nutrition labeling for the major cuts, consumers cannot assess precise levels of fat (e.g.,10 grams vs. 20 grams of fat per serving) and cannot know the levels of specific nutrients, such as saturated fat, in these products. Therefore, without nutrition labeling of these products, consumers cannot make educated choices about consuming the major cuts.

The FMIA and PPIA provide that product is misbranded if its labeling is false or misleading in any particular (21 U.S.C. 601(n)(1) and 453(h)(1)). Without nutrition information for the major cuts of single-ingredient, raw products, FSIS tentatively concluded that these products would be misbranded under section 1(n) of the FMIA or section 4(h) of the PPIA because the label would fail to reveal significant material facts about the consequences of consuming these products(66 FR 4974, January 18, 2001).

As explained in the preamble to the proposed rule, although FSIS believed that nutrition information on the labels of individual packages of single-ingredient, raw products is useful, the Agency proposed that nutrition information for the major cuts could also be provided on point-of-purchase materials, because consumers have reasonable expectations as to the nutrient content of these products. Also, FSIS stated that the nutrient content of a given major cut is relatively uniform across the market, and these products are not formulated in the manner of ground or chopped products (66 FR 4974, January 18, 2001).

Ground or Chopped Products:Ground or chopped products that are multi-ingredient or heat processed products are subject to the requirements of the mandatory nutrition labeling program; therefore, these products are already required to bear nutrition labels, unless they qualify for an exemption. FSIS proposed to extend mandatory nutrition labeling requirements to all ground or chopped products, including single-ingredient, raw ground or chopped products, unless an exemption applies. Thus, FSIS proposed to require that nutrition labels be provided for all ground or chopped products (livestock species) and hamburger, with or without added seasonings, unless an exemption applies. Similarly, FSIS proposed to require that nutrition labels be provided for all ground or chopped poultry (kind), with or without added seasonings, unless an exemption applies. Under the proposed rule, products that would be required to bear nutrition labels include single-ingredient, raw hamburger, ground beef, ground beef patties, ground chicken, ground turkey, ground chicken patties, ground pork, and ground lamb.

In the proposed rule, FSIS explained that, unlike other single-ingredient, raw products, producers are able to formulate precisely the fat content of ground or chopped products. Therefore, in this respect, these products are similar to products in the existing mandatory program that are required to bear nutrition labels (66 FR 4975, January 18, 2001). FSIS noted that other single-ingredient, raw products cannot be formulated in the same manner or to the same degree as ground beef products (66 FR 4976, January 18, 2001).

FSIS noted that it believed that consumers could not easily see the fat in ground or chopped beef. In ground or chopped beef products, the fat is uniformly distributed throughout the product, and is not clearly distinguishable on the surface of the product (66 FR 4975, January 18, 2001). FSIS also explained that the Agency believed that consumers cannot estimate the level of fat in ground or chopped beef and cannot compare the levels of fat in these products to those in other products (66 FR 4975, January 18, 2001). Similarly, FSIS explained that ground lamb and ground pork may contain varying amounts of fat and varying nutrient content, which consumers cannot visually detect (66 FR 4976, January 18, 2001). Additionally, FSIS noted that producers sometimes use meat from advanced meat recovery (AMR) systems and low temperature rendering in ground or chopped beef or pork products, which can affect their nutrient content (66 FR 4975 and 4976, January 18, 2001). Finally, FSIS noted that, as with the fat on ground meat products, consumers cannot readily detect the fat content of ground poultry products (66 FR 4976, January 18, 2001). For these reasons, FSIS tentatively concluded that ground or chopped meat and poultry products that did not bear nutrition information would be misbranded under section 1(n)(1) of the FMIA and section 4(h)(1) of the PPIA (66 FR 4977, January 18, 2001).

FSIS proposed to require that nutrition information for ground or chopped products appear on the label of these products (unless an exemption applies), as is required for multi-ingredient and heat processed products, rather than on point-of-purchase materials because ground or chopped products are similar to multi-ingredient and heat processed products in that certain parameters, such as their fat content, can be controlled precisely to obtain the desired product. In addition, because there are numerous formulations of ground or chopped products, it would be difficult for producers or retailers to develop point-of-purchase materials that would address all the different formulations that exist for these products. Furthermore, it would be difficult for consumers to find the correct information for a specific ground or chopped product on point-of-purchase materials that include information concerning numerous formulations of these products (66 FR 4977, January 18, 2001).

Exemptions:FSIS proposed that certain exemptions from nutrition labeling requirements would apply to the major cuts of single-ingredient, raw meat and poultry products and ground or chopped meat and poultry products. FSIS proposed the followingexemptions from nutrition labeling requirements for ground or chopped products: ground or chopped products that qualify for the small business exemption in §§ 317.400(a)(1) and 381.500(a)(1); ground or chopped products in packages that have a total surface area available to bear labeling of less than 12 square inches, provided that the product's labeling includes no nutrition claims or nutrition information and provided that an address or telephone number that a consumer can use to obtain the required information is included on the label; ground or chopped products that are intended for further processing; ground or chopped products that are not for sale to consumers; ground or chopped products that are in small packages that are individually wrapped packages of less than1/2ounce net weight; ground or chopped products that are custom slaughtered or prepared; and ground or chopped products that are intended for export.

FSIS proposed the following exemptions for major cuts of single-ingredient, raw products that are not ground or chopped: major cuts intended for further processing; major cuts not for sale to consumers; major cuts in small packages that are individually wrapped packages of less than1/2ounce net weight; major cuts that are custom slaughtered or prepared; and major cuts that are intended for export.

FSIS proposed to exempt ground or chopped products that qualified for the small business exemption from nutrition labeling requirements for the main reason stated in the January 6, 1993, final rule: because these requirements would create undue economic hardship for small businesses (58 FR 638). FSIS stated in the proposed rule that it did not believe that the reasons that necessitated the establishment of the small business exemption, as explained in the January 6, 1993 final rule, are applicable to the major cuts of single-ingredient, raw meat and poultry products produced by small businesses. For these products, FSIS proposed that nutrition information may be provided on labels or, alternatively, at their point-of-purchase. In addition, FSIS explained that it intended to make point-of-purchase materials available over the Internet free of charge. Therefore, the nutrition labeling requirement for major cuts of single-ingredient, raw products should not impose an economic hardship for “small businesses”, including those that are retail stores (66 FR 4978, January 18, 2001).

In the preamble to the January 6, 1993, final rule, FSIS explained that it was proposing an exemption from nutrition labeling requirements for products intended for further processing and products not for sale to consumers because consumers do not see the nutrition information on products used for further processing or products that are not for sale to consumers. The Agency also explained that it would exempt individually wrapped packages of less than1/2ounce net weight, provided no nutrition claim or nutrition information was made on the label, because these products are an insignificant part of the diet. With regard to the custom exemption, the Agency explained that an exemption should apply because these custom services are performed solely for individuals. Finally, the Agency explained that products intended for export should be exempt because these products are labeled according to the requirements of the country where the product is to be exported (58 FR 639, January 6, 1993). In the January 18, 2001, proposed rule, the Agency proposed these exemptions because the Agency had tentatively determined that the bases for these exemptions, as explained in the January 6, 1993, final rule, are valid as applied to nutrition labeling for ground or chopped products and for major cuts of single-ingredient, raw products. Therefore, FSIS proposed that any ground or chopped product or major cut of single-ingredient, raw product that qualifies for any of these exemptions will continue to be exempt (66 FR 4979, January 18, 2001).

Under current regulations, products in packages that have a total surface area available to bear labeling of less than 12 square inches are exempt from nutrition labeling, provided the product's labeling includes no nutrition claims or nutrition information and provided that an address or telephone number that a consumer can use to obtain the required information is included on the label. FSIS allowed for nutrition information to be provided by alternative means for products of this size in order to incorporate sufficient flexibility in the regulations (58 FR 47625, January 6, 1993). As explained in the proposed rule, for ground or chopped products, FSIS believes it is necessary to provide this flexibility for products in packages that have a total surface area available to bear labeling of less than 12 square inches, provided that the labels for these products bear no nutrition claims or nutrition information. However, because nutrition information for the major cuts of single-ingredient, raw meat and poultry products may be provided on point-of-purchase materials, FSIS proposed that the provisions for providing nutrition labeling by alternate means for products in packages that have a total surface area available to bear labeling of less than 12 square inches would not apply to the major cuts of single-ingredient, raw meat and poultry products (66 FR 4979, January 18, 2001).

In the preamble to the proposed rule, FSIS explained that restaurant menus that include ground or chopped products generally do not constitute nutrition labeling or fall within the scope of the proposed regulations. Similarly, although a restaurant menu would most likely not include a major cut of single-ingredient, raw product, if it did, the menu would not fall within the scope of the proposed regulations. Finally, the preamble explained that, under the proposed rule, any ground or chopped product or major cut of single-ingredient, raw product represented or purported to be specifically for infants and children less than 4 years of age would not be allowed to include certain nutrient content declarations, because infants and children less than 4 years of age have different nutrition needs than adults and children older than 4 years of age (66 FR 4979, January 18, 2001).

In the 1993 final rule on nutrition labeling, FSIS exempted from mandatory nutrition labeling requirements multi-ingredient products processed at retail, and ready-to-eat products packaged or portioned at retail. The reasons that FSIS provided these exemptions in the 1993 final rule were that FSIS believed that it would be impractical to enforce nutrition labeling requirements on these products prepared or served at retail and because the Agency concluded, based on a review of National Food Consumption Survey (NFCS) data, that the average person's diet consisted of an insignificant proportion of ready-to-eat retail packaged products or retail processed products (58 FR 639, January 6, 1993).

The proposed rule did not provide an exemption for ready-to-eat ground or chopped products packaged or portioned at retail, or multi-ingredient ground or chopped products that are processed at retail because, as FSIS explained in the 2001 nutrition labeling proposed rule, there may be a significant amount of multi-ingredient ground beef retail processed products or ready-to-eat retail packaged products. Also, FSIS explained that the Agency no longer believes enforcement of nutrition labeling requirements at retail stores to be impractical because FSIS is already conducting testing forEscherichia coli (E. coli) O157:H7 at retail (66 FR 4979, January 18, 2001).

For further explanation of the reasons for the proposed exemptions,see66 FR 4978-4980, January 18, 2001.

Nonmajor Cuts of Single-Ingredient, Raw Meat and Poultry Products That Are Not Ground or Chopped:FSIS did not propose to require nutrition information for single-ingredient, raw meat and poultry products that are not major cuts and that are not ground or chopped. However, FSIS proposed that if nutrition information is provided for these products, it must be provided according to the existing guidelines for the current voluntary nutrition labeling program. Therefore, under the proposed rule, if nutrition information were provided for these products, it would be consistent with the nutrition information required for the major cuts of single-ingredient, raw products. In the preamble to the proposed rule, FSIS explained that the Agency could not determine whether it would be beneficial to require nutrition labeling for nonmajor cuts that are not ground or chopped until it assessed whether adequate nutrition information is being provided for these products (66 FR 4974, January 18, 2001).

Enforcement and Compliance:FSIS conducts sampling and nutrient analysis of products that fall under the mandatory nutrition labeling program. FSIS proposed that the procedures set forth for FSIS product sampling and nutrient analysis in §§ 317.309(h)(1) through (h)(8) and 381.409(h)(1) through (h)(8) would be applicable to ground or chopped meat and to ground or chopped poultry products, respectively. FSIS explained that under the proposal, FSIS would sample and conduct nutrient analysis of ground or chopped products to verify compliance with nutrition labeling requirements, even if nutrition labeling on these products is based on the most current representative data base values contained in USDA's National Nutrient Data Bank or the USDA National Nutrient Database for Standard Reference and there are no claims on the labeling. Therefore, FSIS would treat these products as it treats other products required to bear nutrition labels (66 FR 4980, January 18, 2001).

FSIS explained that it would treat ground or chopped products in this way because the fat content of these products can vary significantly. In addition, the preamble to the proposed rule stated that FSIS employees cannot visually assess whether nutrition information on the label of ground or chopped products accurately reflects the labeled products' contents because, in most cases, it is not possible to visually assess the level of fat in a ground or chopped product (66 FR 4980, January 18, 2001).

FSIS also proposed that if nutrition labeling of the major cuts of single-ingredient, raw products (other than ground beef or ground pork) is based on USDA's National Nutrient Data Bank or the USDA's National Nutrient Database for Standard Reference, and there are no nutrition claims on the labeling, FSIS would not sample and conduct a nutrient analysis of the products. The preamble explained that, for the major cuts, FSIS personnel can visually identify the particular cut. FSIS further explained that, if the nutrition information for these products is based on USDA's National Nutrient Data Bank or the USDA National Nutrient Database for Standard Reference, and there are no nutrition claims on the labeling, it is not necessary for FSIS to verify the accuracy of the data because they are USDA data. USDA has already evaluated these USDA data and determined that they are valid (66 FR 4980, January 18, 2001).

Permitting Percent Lean Statements on labels or in labeling of ground or chopped products:FSIS also proposed to permit a statement of lean percentage on the label or in labeling of ground or chopped meat and poultry products that do not meet the regulatory criteria for “low fat,” provided that a statement of the fat percentage is also displayed on the label or in labeling. FSIS proposed that the required statement of fat percentage be contiguous to, in lettering of the same color, size, and type as, and on the same color background as, the statement of lean percentage. FSIS stated that many consumers have become accustomed to this labeling on ground beef products, and that FSIS believed this labeling provided a quick, simple, and accurate means of comparing all ground or chopped meat and poultry products (66 FR 4981, January 18, 2001).

Provisions of the Supplemental Proposed Rule

Major cuts and nonmajor cuts that are not ground or chopped:Consistent with the proposal, should this rule become final, FSIS will require nutrition information for the major cuts, either on their label or at their point-of-purchase. The provisions of the voluntary nutrition labeling program will be mandatory for the major cuts. As FSIS proposed, “ground beef regular without added seasonings,” “ground beef about 17% fat,” and “ground pork” will no longer be included in the list of major cuts in § 317.344 because FSIS has decided to treat ground meat and poultry products differently than single cuts of meat for the purposes of this regulation. Should this rule become final, ground meat and poultry products will be required to bear nutrition labeling on their packages, unless an exemption applies. Nutrition information at the point-of-purchase for ground or chopped products will not meet the requirements of these regulations.

FSIS believes that without nutrition information, consumers are not able to assess the nutrient content of the major cuts and, thus, cannot make educated decisions about these products based on nutrition information. FSIS has concluded that the lack of nutrition information for the major cuts of single-ingredient, raw products, either on their label or at their point-of-purchase, makes these products misbranded under 21 U.S.C. 601(n)(1) and 453(h)(1). Although FSIS believes that nutrition information on the labels of individual packages of the major cuts of single-ingredient, raw products is useful, this final rule provides that nutrition information for these products may be provided at their point-of-purchase.

In the 1991 proposed rule and the 1993 final rule on nutrition labeling, FSIS stated that if it determined, during any evaluation of its voluntary guidelines, that significant participation did not exist, it would initiate proposed rulemaking to determine whether it would be beneficial to require nutrition labeling on single-ingredient, raw meat and poultry products (56 FR 60306, November 27, 1991; 58 FR 640, January 5, 1993). Therefore, FSIS initiated rulemaking to propose requiring nutrition labeling for the major cuts of single-ingredient, raw products. Through this rulemaking, FSIS has determined that because nutrition information has not been universally available for the major cuts of single-ingredient products, consumers have not been able to assess the nutrient content of these products and, thus, cannot make educated choices about them, and about the significant portion of their diet that these products represent, based on nutrition information. Without nutrition information, the labeling of major cuts of single-ingredient, raw meat and poultry products fails to include material facts about the consequences of consuming these products. FSIS has concluded that the lack of nutrition information for the major cuts of single-ingredient, raw products, either on their label or at their point-of-purchase, makes these products misbranded under 21 U.S.C. 601(n)(1) and 453(h)(1). FSIS has determined that this rule is necessary to ensure that consumers obtain nutrition information concerningthese products. Through the supplemental proposed regulatory impact analysis (PRIA), FSIS has determined that this rule would result in benefits to consumers and net benefits to society.

Consistent with the proposed rule, this supplemental proposed rule will not require nutrition information for nonmajor cuts of single-ingredient, raw meat and poultry products that are not ground or chopped.

FSIS has determined that it is not appropriate or necessary to require nutrition information for nonmajor cuts that are not ground or chopped at this time. They do not contribute in a major way to the diet. Thus, at this time, the consequences of consuming these products cannot be considered to be a material fact. In the future, FSIS will reassess the production and consumption volume of nonmajor cuts that are not ground or chopped and will determine the levels of consumption of these products and whether sufficient nutrition information is being made available about them. After FSIS assesses the volume of these products and assesses the adequacy of nutrition information provided for them, FSIS will determine whether it is necessary to propose nutrition labeling requirements for these products, and whether nutrition labeling requirements for these products would be beneficial.

Should this rule become effective, if establishments or retail facilities voluntarily provide nutrition information for nonmajor cuts of meat and poultry products that are not ground or chopped, they will have to provide it according to the nutrition labeling requirements for the major cuts. Should establishments or retail facilities choose to provide nutrition information for these products, they will have to either provide it at the point-of-purchase, in accordance with § 317.345 or § 381.445, or on their label, in accordance with § 317.309 or § 381.409. Thus, the nutrition labeling provisions for these products will be consistent with those for the voluntary nutrition labeling program.

As proposed, the supplemental proposed rule would allow nutrition information for the major cuts and nonmajor cuts of single-ingredient, raw products that are not ground or chopped to be declared on either an “as packaged” basis or an “as consumed” basis because most of these products will not need FSIS compliance scrutiny. If FSIS conducts nutrient analysis of products under 317.309(h) or 381.409(h), it does so on the packaged product. If nutrition information for these products is based on USDA's National Nutrient Database for Standard Reference, and there are no claims on the labeling, FSIS will not conduct a nutrient analysis of these raw products and, therefore, will not evaluate “as packaged” nutrition labeling information for these products.

Also consistent with the proposed rule, under this supplemental proposed rule, the declaration of the number of servings per container would not need to be included on the nutrition label for the major or nonmajor cuts of single-ingredient, raw products that are not ground or chopped, because these products are typically random weight products. Existing regulations do not require the number of servings on the nutrition label of random weight products (see§§ 317.309(b)(10)(iii) and 381.409(b)(10)(iii)).

Ground or Chopped Products:Consistent with the proposed rule, this supplemental proposed rule would extend the mandatory nutrition labeling requirements to all ground or chopped products, including single-ingredient, raw ground or chopped products, unless an exemption applies. Should this rule become effective, FSIS will require that nutrition labels be provided for all ground or chopped products (livestock species) and hamburger, with or without added seasonings, unless an exemption applies. This rule would also require that nutrition labels be provided for all ground or chopped poultry products, with or without added seasonings, unless an exemption applies. After analyzing the comments and for the reasons discussed in the proposed rule and discussed below in the response to comments section, FSIS has concluded that ground or chopped meat and poultry products that do not bear nutrition information on their label are misbranded under 21 U.S.C. 601(n)(1) and 453(h)(1).

FSIS recognizes that single-ingredient, raw ground or chopped products have not been required to bear nutrition labels. In the proposed rule, FSIS explained that, on June 3, 1997, the Center for Science in the Public Interest (CSPI) submitted a petition to the Agency stating that FSIS should require complete “Nutrition Facts” on ground beef labels that make nutrient content claims. This petition brought many of the issues concerning the need for nutrition labeling of ground or chopped products to FSIS's attention. Consistent with CSPI's petition, FSIS has determined that nutrition information should be required on packages of all ground or chopped meat and poultry products, unless an exemption applies. (For more information on the petition from CSPI,see66 FR 4975, January 18, 2001).

Most industry commenters did not support requiring on-package nutrition information for ground or chopped products. Some of these commenters supported requiring nutrition labeling for these products at their point-of-purchase. Individuals, consumer organizations, and nutrition organizations supported mandatory nutrition labeling on the packages of ground or chopped products.

FSIS requests comments on how retailers or official establishments would prepare point-of-purchase materials that would address all possible combinations of percent fat and percent lean in ground or chopped products. FSIS also requests comments on how point-of-purchase materials would convey the nutrient values of ground or chopped products that contain AMR product or product from low temperature rendering (e.g.,finely textured beef or lean finely textured beef). In addition, FSIS requests comments on how consumers would identify which nutrient values on point-of-purchase materials correspond to specific ground or chopped products available in the store, if a statement of fat percentage or lean percentage is notrequiredon the product. Such statements would not be required under this supplemental proposed rule. Finally, FSIS requests surveys, studies, or other data on consumers' perception and use of point-of-purchase materials versus nutrition labels for ground or chopped products and on consumers' understanding of the nutrient content of such products.

Exemptions:This supplemental proposal would provide all the exemptions that it proposed for the major cuts of single-ingredient, raw meat and poultry products and for ground or chopped products for the reasons set forth in the proposal. Consistent with the proposed rule, it does not provide an exemption for ready-to-eat ground or chopped products packaged or portioned at retail or multi-ingredient ground or chopped products that are processed at retail. As FSIS explained in the 2001 nutrition labeling proposed rule, there may be a significant amount of multi-ingredient ground beef retail processed products or ready-to-eat retail packaged products. Also, as was stated in the proposed rule, FSIS no longer believes enforcement of nutrition labeling requirements at retail stores to be impractical because FSIS is already conducting testing forE. coliO157:H7 at retail.

In response to comments, the supplemental proposal provides anexemption from nutrition labeling requirements for products that are ground or chopped at an individual customer's request and that are prepared and served or sold at retail, provided that the labels or labeling of these products bear no nutrition claims or nutrition information.

Enforcement and Compliance:Consistent with the proposed rule and the reasons discussed in it, under this supplemental proposed rule, FSIS would sample and conduct nutrient analysis of ground or chopped products to verify compliance with nutrition labeling requirements, even if nutrition labeling on these products is based on the most current representative database values contained in USDA's National Nutrient Data Bank or the USDA National Nutrient Database for Standard Reference and there are no claims on the labeling. Also consistent with the proposed rule, for the major cuts that are not ground or chopped, if nutrition labeling of these products is based on USDA's National Nutrient Data Bank or the USDA's National Nutrient Database for Standard Reference, and there are no nutrition claims on the labeling, FSIS would not sample and conduct a nutrient analysis of these products.

Permitting Percent Lean Statements on labels or in labeling of ground or chopped products:Consistent with the proposed rule, the supplemental proposed rule would permit a statement of lean percentage on the label or in labeling of ground or chopped meat and poultry products that do not meet the regulatory criteria for “low fat,” as long as a statement of fat percentage is contiguous to, in lettering of the same color, size, and type as, and on the same color background as, the statement of lean percentage. Because the percent fat statement must be contiguous to the percent lean statement and must be in lettering of the same color, size, and type as, and on the same color background as, the lean percentage statement, FSIS believes that the percent lean statements will not mislead consumers.

Under the proposed rule, if small businesses produced ground or chopped product and included a statement of lean percentage and fat percentage on the product's label or in labeling, the business would have been required to include nutrition information on the product label. Based on the National Cattleman's Beef Association (NCBA) National Meat Case Study in 2004, 93 percent of ground beef packages had statements of lean or fat percentages. Sixty-eight percent of packages with such statements had nutrition facts panels and 25 percent did not. Because 25 percent of ground beef packages in the NCBA study had statements of lean or fat percentages but did not have nutrition facts panels, FSIS found it reasonable to conclude that many small businesses may include a statement of the lean percentage on the label of ground products but may not include nutrition facts panels on the product label. On this basis, FSIS concluded that requiring small businesses that use the lean percentage statement on the label of ground products to also include nutrition information on the label of such products may result in significant expenses for small businesses. Therefore, in this supplemental proposed rule, small businesses that use statements of percent fat and percent lean on the label or in labeling of ground products would be exempt from nutrition labeling requirements, provided they include no other nutrition claims or nutrition information on the product labels or labeling.

The majority of industry associations supported the use of a statement of lean percentage on the label or in labeling of ground products that do not meet the regulatory criteria for “low fat.” Because of the longstanding use of the statements of percent fat and percent lean on the label or in labeling of ground beef and hamburger products, FSIS has concluded that such statements on the label or in labeling of ground products produced by small businesses will not mislead consumers, even if the small businesses do not include nutrition information on the products' labels.

However, individuals and consumer and nutrition organizations generally did not support the use of statements of lean percentages on the label or in labeling of ground or chopped products that do not meet the regulatory criteria for “low fat.” Therefore, FSIS requests comments on whether such statements should be prohibited on the label or in labeling of ground or chopped products that do not meet the regulatory criteria for “low fat.” FSIS requests comments on whether lean percentage statements are inherently misleading to consumers on the label or in labeling of ground or chopped product that does not meet the regulatory criteria for “low fat” when contiguous to fat percentage statements, as the rule would require. FSIS also requests comments on whether lean percentage statements are redundant on the label or in labeling of such products when contiguous to fat percentage statements. If commenters believe the regulations should prohibit lean percentage statements on the label or in labeling of ground or chopped products that do not meet the “low fat” criteria, FSIS requests comments on whether a fat percentage statement on the label or in labeling of such products would be useful. If commenters believe such a statement would be useful, do they believe it should be required on the label or in labeling for these products?

FSIS also requests comments on whether the final rule should allow a lean percentage statement and fat percentage statement on the label or in labeling of ground or chopped products produced by small businesses if such product does not include nutrition information on the product label. If commenters believe that nutrition information should be required on labels of any ground or chopped product for which a lean percentage and fat percentage statement is provided on the label or in labeling, FSIS requests comment on the costs of this requirement for small businesses.

FSIS requests copies of surveys, studies, or other data on consumers' use and understanding of lean percentage and fat percentage statements on ground or chopped products.

Effective Date

Should this rule become final, FSIS intends that the requirements for ground or chopped products would become effective on January 1, 2012. FSIS issued final regulations to establish this date as the uniform compliance date for new food labeling regulations that are issued between January 1, 2009, and December 31, 2010 (73 FR 75564; December 12, 2008). As is discussed in the response to comments below, FSIS issued the uniform compliance regulations to minimize costs associated with on-package labels. Because this supplemental proposed rule would allow for the presentation of nutrition information for the major cuts of single-ingredient, raw meat and poultry products at their point-of-purchase, FSIS intends to make the labeling requirements for the major cuts effective one year from the date of publication of the final rule. FSIS requests comments on these two planned effective dates.

Availability of Nutrition Information

FSIS intends to make available nutrition labeling materials that can be used at the point-of-purchase of the major cuts at the following Internet address:http://www.fsis.usda.gov.Also, the Food Marketing Institute (FMI) has made available materials that can be used at the point-of-purchase of the major cuts at the following Internet address:http://www.fmi.org/consumer/nutrifacts/.

The USDA National Nutrient Database for Standard Reference is developed and maintained by the Agricultural Research Service (ARS) and can be found on the Internet at the following address:http://www.ars.usda.gov\nutrientdata. Information is available at this site for ground beef products containing 5%, 10%, 15%, 20%, 25%, and 30% fat. In addition, ARS has included a calculator on the Internet, with the Database. Parties can enter the amount of fat (5% to 30% percent fat) or lean (70% to 95% lean) in a particular raw ground beef product, and the calculator will calculate the nutrient values for the product based on the fat value entered.

The USDA National Nutrient Database for Standard Reference also includes a set of tables with nutrient values for ground pork with fat levels from 4 to 28%, in one percent increments. ARS did not develop a calculator because, at this time, labeling for ground pork at retail does not include statements of percentage fat or percentage lean. The USDA Nutrient Database also includes nutrient values for raw and cooked ground chicken but does not include nutrient values for such product at varying fat levels. Ground chicken is not typically produced over a wide range of fat levels. ARS also has nutrient data for three types of commonly marketed ground turkey products. Nutrient values for these products are not yet in the database. However, ARS expects that the nutrient values for these ground turkey products will be available in the database by August 2010. Most ground poultry products are produced and labeled at Federal establishments rather than at retail.

FSIS requests comments on whether provision of nutritional tables will be sufficient for retailers and establishments to provide nutrition labels for ground pork. FSIS also requests comments on whether the available data for ground chicken and ground turkey in the USDA Nutrient Database will be sufficient for retailers and establishments.

Below are examples of nutrition labels for ground or chopped products that would meet the requirements of the supplemental proposed rule. Should this rule become final, FSIS will make additional examples of acceptable nutrition labels for ground or chopped products available on the Agency's Web site.

BILLING CODE 3410-DM-P EP18DE09.421 EP18DE09.422 BILLING CODE 3410-DM-C Summary of and Response to Comments

FSIS received approximately 5,000 comments on the proposed rule from individuals, consumer advocacy organizations, academia, trade and professional associations, health and nutrition organizations, two county health departments, meat and poultry producers, and food retailers. The majority of the comments (approximately 3,500) were generated from a letter writing campaign initiated by a consumer organization. In addition, there were approximately 450 form letters that expressed consumers' concerns and did not identify an affiliation with any organization, approximately 60 form letters from a consumer co-op organization, and two sets of form letters from relatively small retail chains (approximately 10 letters in each set).

A summary of issues raised by commenters and the Agency responses follows.

Nutrition Labeling for the Major Cuts of Single-Ingredient, Raw Meat and Poultry Products

Comment:The majority of letters from individuals, consumer groups, and health organizations stated that FSIS should require on-package nutrition labeling for all single-ingredient, raw meat and poultry products (major and nonmajor cuts). They stated that point-of-purchase materials fail to convey effectively the nutrition information for specific fresh meat or poultry products because the materials are difficult to find and difficult to read. Some of these commenters also stated that nutrition labels are particularly important for meat and poultry products because they are a major source of fat, saturated fatty acids, and calories.

A health organization stated that because the same cut of meat can be labeled by different names, consumers would be better served by nutrition information on the labels of the products. Several commenters stated that an advantage of including nutrition information on the label is that consumers could review the nutrient content once the product is taken home, and others, besides the primary food purchaser, would have better access to the nutrition information. A nutrition association stated that if FSIS permits point-of-purchase information for fresh meat and poultry packages, the Agency should require on-package messages directing consumers to point-of-purchase labeling at another location in the store.

One consumer association noted that a recent telephone survey showed an overwhelming percentage (78%) of the respondents said that it was “more useful” to provide nutrition information about raw meat and poultry products on package labels than on posters or brochures.

Comments from a coalition of health and consumer organizations suggested that the nutrient content for ground products often has less variance than the nutrient content of specific cuts. Thus, the coalition believes that it is more important to provide nutrition information on the labeling of major cuts than on ground products. The coalition also stated that the reasons provided by the Agency for mandating nutrition labeling on the packaging of ground products would be the reasons for mandating nutrition labeling onpackaging of the major cuts of meat or poultry (see66 FR 4977). This coalition also stated that there are more major cuts than there are ground products, and it would be difficult for producers or retailers to develop point-of-purchase materials to address the different formulations and trim levels of the major cuts; and it would be difficult for consumers to locate the appropriate information for a particular cut on the point-of-purchase materials.

One health group stated that although on-package labeling may be a more effective approach for conveying nutrition information than point-of-purchase materials, the organization has historically supported the use of point-of-purchase materials as an acceptable means of nutrition labeling. This commenter also stated that for single-ingredient, raw products, other than ground or chopped products, the use of standardized averages is likely to be the most effective way to provide nutrition information, either on the package or at point-of-purchase. An individual also stated that for many major cuts, having the nutrition label next to the product would be sufficient.

A consumer organization did not believe that consumers have reasonable expectations as to the nutrient content, including the fat, of raw meat and poultry products. The organization referenced a consumer telephone survey in which most respondents were unable to identify which cut of meat had the highest fat content among four choices. One medical organization stated that although it may be true that the nutrient content of the major cuts is relatively uniform, consumers generally have no idea of the nutrient content of these foods.

The majority of industry and industry associations supported the continued use of point-of-purchase nutrition information materials for the major cuts, rather than nutrition labels on the packages of these products. Two of these groups presented results of focus group research demonstrating that consumers currently understand and use point-of-purchase materials in numbers comparable to the number of consumers who read and use the nutrition information on the labeling of products subject to the requirements of the mandatory nutrition labeling program. Additionally, according to the commenters, the focus group research demonstrates that consumers are generally satisfied with the current nutrition information provided for fresh meats.

One industry association stated that the use of individual nutrition labels may result in consumers' viewing a smaller portion of the product and paying a higher amount for the product, because of the cost associated with maintaining a vast number of labels to be placed on the package. Additionally, according to this commenter, if the consumer intends to trim the fat from meat or remove the skin from poultry products, the nutrition information on the label would not adequately represent the product's nutrition information after fat had been trimmed from it or skin from it had been removed.

One industry commenter stated that it is extremely difficult to provide accurate nutrition information for each major muscle cut because nutrient content varies depending on the breed and quality of each animal. Another industry commenter stated that although “average” numbers from the USDA database are appropriate for point-of-purchase materials, because of the potential variations in specific individual cuts, trims and grades, the average numbers are not appropriate for on-package labeling, where consumers justifiably expect a label to accurately define the exact nutrient content of what is in that package.

Two industry commenters stated that according to the Agency's own survey, 62.7% of men and 57.9% of women rarely or never use the nutrition information provided on raw meat, poultry or fish (see66 FR 4982, January 18, 2001). They speculated that this low usage may in part be explained by the fact that consumers already have reasonable expectations regarding the nutrient values of these products as a result of industry's voluntary efforts to provide this information. Similarly, one retail association stated that consumers have reasonable expectations as to the nutrient content of major cuts, and that the nutrient content of a given major cut is relatively uniform across the market. An industry commenter stated that, unlike ground meat, consumers can see and remove the fat from whole muscle meat.

Another industry organization stated that single-ingredient, raw meat and poultry products have a unique quality: the structure of the cut, including the amount of fat, is visible both on the exterior and within the muscle cut. As a result, consumers can visibly discern which products are leanest. However, the commenter also believed that consumers would benefit from additional nutrition information because consumers cannot discern the quantitative nutrient content of single-ingredient, meat and poultry products without the nutrition information provided on point-of-purchase materials.

Response:As FSIS proposed, should this rule become final, it will require that nutrition information be provided for the major cuts of single-ingredient, raw meat and poultry products, either on the label or at the point-of-purchase. Although FSIS continues to agree with the commenters who stated that nutrition labels on the major cuts of single-ingredient, raw products are useful, FSIS believes that consumers have reasonable expectations as to the nutrient content of these products and can make comparative judgments about the fat content of the various cuts. While consumers' expectations for these products may not be perfect, they are significantly more aware of the nutritional content of single cuts of meat than the nutritional content of ground meat. Thus, the rule allows an alternative way of providing nutrition information for major cuts of single-ingredient, raw products. As is discussed above, even though FSIS believes that consumers have reasonable expectations concerning the nutrient content of the major cuts, without nutrition information for these products, consumers cannot assess specific nutrient levels in them and cannot make educated choices about consuming them. These educated choices are significant to a consumer's effort to construct a healthy diet.

FSIS does not believe that the telephone survey results used by a consumer organization in support of their belief that most consumers do not have reasonable expectations of the nutrient content of raw meat and poultry demonstrate that consumers do not have reasonable expectations concerning the major cuts. FSIS does not believe it is reasonable to expect consumers in a telephone survey to be able to identify which individual cuts of meat or poultry have the highest fat levels. However, if shown pictures of the various cuts (that are not ground or chopped), FSIS believes that most consumers could identify the cut with the most fat, by its internal marbling and external fat cover. The medical organization commenter that stated that consumers generally have no idea of the nutrient content of the major cuts provided no data to substantiate this statement.

Although individuals, and consumer organization commenters, stated that point-of-purchase materials are difficult to read, they provided no explanation for their assertion that these materials are difficult to read. Their other concern about the difficulty of finding point-of-purchase materials will be taken care ofby this rule. Should it become final, the rule will require that point-of-purchase materials be made available in close proximity to the food (§ 317.345(a)(3) and § 381.445(a)(3)).

Regarding the health organization's comment that the same cut of meat can be labeled by different names, and thus consumers would be better informed by nutrition information on a product's label, FSIS is not aware that consumers are confused about the names of the major cuts of single-ingredient, raw products listed on point-of-purchase materials. FMI was involved in developing these materials, and that organization has the most current names used to designate the major cuts. However, if necessary, retail facilities and establishments can include multiple names for a major cut on point-of-purchase materials. In addition, if FSIS is informed of specific cuts that are identified by different names, FSIS will revise the point-of-purchase materials that it is making available on the Internet.

After the comment period for the proposed rule ended, FSIS received correspondence from industry stating that the list of major cuts in the regulations should be changed to reflect more accurately the most popular cuts in the market. This correspondence recommended removing certain cuts and adding others. Because FSIS did not propose to amend the codified list of major cuts in the regulations and did not provide an opportunity for the public to comment on proposed changes to the list, FSIS is not amending the list of major cuts in the regulations at this time. However, FSIS will review this issue, and if the Agency determines that a change in the list of major cuts is warranted to accurately represent the market, FSIS will pursue future rulemaking.

Regarding the comments that noted that an advantage of including nutrition information on the label is that consumers can review the nutrient content of the product once the product is taken home, and others besides the primary food purchaser would have better access to this information, surveys, including the Diet and Health Knowledge Survey (DHKS), show that a majority of individuals report using labels while buying foods. Although the DHKS shows that adults who are not main household shoppers use labels, the survey shows that the main shoppers use labels at a higher rate than those who are not main household shoppers. Also, FSIS assumes that if individuals in a household have certain nutrition practices and needs, the person who purchases food for the household would take other household members' needs and preferences into account. In addition, FSIS assumes that purchased food would typically be consumed by members of the household and not thrown away.

In response to the comment that the nutrient content of the major cuts may be more variable than that of ground products, FSIS recognizes that there is significant variability in the nutrient content of the major cuts depending on the grade of the product and the levels of exterior fat on the products. However, the point-of-purchase materials that FSIS and FMI have developed to convey nutrition information for the major cuts take into account this variability and reflect average nutrition information for these products. The information on the point-of-purchase materials is meaningful and accurate for the major cuts. Consumers can view the point-of-purchase materials to make educated choices based on nutrition information among the different major cuts. In addition, to further distinguish among different packages of the same major cut, consumers can make comparisons based on levels of visible fat on the product.

This coalition's other concern that it would be difficult for producers or retailers to develop point-of-purchase materials to address the different formulations and trim levels of the major cuts need not be a concern. FSIS and FMI have made available nutrition information that can be displayed at the point-of-purchase of the major cuts of single-ingredient, raw meat and poultry products. These point-of-purchase materials will meet the nutrition labeling requirements of this rule, should it become final. Furthermore, requiring that all major cuts of single-ingredient, raw meat and poultry products bear nutrition labels would be a significant cost to the industry based on FSIS's supplemental proposed cost analysis.

Comment:Two industry commenters stated that it was appropriate for FSIS to provide point-of-purchase materials via the Internet. They believed that this would lessen the burden on retailers unable to develop appropriate customized nutrition information. One of these commenters also stated that the Agency should develop point-of-purchase materials so that the nutrition information supplied would be accurate and consistent.

With regard to the type of point-of-purchase materials used to display nutrition information, several commenters stated that easy to understand charts that convey the information would be more helpful and informative to consumers than a collection of individual labels on display. One industry organization commenter, however, stated that each option of the display of nutrition information on charts or on individual display panels had advantages. This industry organization believed that the presentation of information in charts which have vertical and horizontal columns, that cover multiple products, would allow consumers to make comparisons and would consume less space than individual labels. This organization also stated that charts are readily available to retailers. However, this organization felt that consumers might be more familiar with single nutrition panels than with nutrition charts covering multiple products. Nevertheless, this organization believed that the provision of nutrition panels for every major cut at their point-of-purchase would be costly and would consume a significant amount of space in retail settings. Thus, the organization concluded that retailers should have the freedom to present nutrition information in any way that suits customer needs, so long as it is not misleading. Accordingly, the commenter suggested that USDA conduct research to determine the best method of presenting such information.

Several industry commenters stated that the Agency should describe the information required but should not prescribe a specific format or presentation of the information so that retailers that want to develop customized point-of-purchase materials can develop customized materials. These commenters believed it was important to provide as much flexibility in the development of nutrition materials as possible. One of these commenters also stated that the Agency should only prescribe the specific required presentation of the nutrition information after significant consumer testing.

Response:The Agency will provide nutrition information for the major cuts of single-ingredient, raw products that retailers can use at point-of-purchase at the following Internet address:http://www.fsis.usda.gov. Point-of-purchase materials are also available from FMI at the following Internet address:http://www.fmi.org. At this time, FSIS intends to provide information on charts with columns that cover multiple products, rather than providing a compilation of individual nutrition facts panels. The Agency does not intend to conduct consumer surveys or additional research to determine whether individual nutrition labels or charts covering multiple products would best addressconsumer needs because most comments received on this issue supported th