# 66 FR 4970: Nutrition Labeling of Ground or Chopped Meat and Poultry Products and Single-Ingredient Products

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/FR_PRORULE_01-1119

## Section

- **Citation:** 66 FR 4970
- **Heading:** Nutrition Labeling of Ground or Chopped Meat and Poultry Products and Single-Ingredient Products
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Federal Register / Vol. 66 / 66 FR 4970

## Text

DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Parts 317 and 381 [Docket No. 98-005P] RIN 0583-AC60 Nutrition Labeling of Ground or Chopped Meat and Poultry Products and Single-Ingredient Products AGENCY:
Food Safety and Inspection Service, USDA.

ACTION:
Proposed rule.

SUMMARY:
The Food Safety and Inspection Service (FSIS) is proposing to 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. For these products, FSIS is proposing to make the guidelines currently in place for the voluntary nutrition labeling program mandatory. Thus, the Agency is proposing to require that nutrition information be provided for these products either on their label or at their point-of-purchase. During the most recent surveys of retail stores, the Agency did not find significant participation in its voluntary nutrition labeling program, which covers the major cuts of single-ingredient, raw products. Without nutrition information for these products, the Agency has tentatively concluded that the major cuts of single-ingredient, raw meat and poultry products would be misbranded under the Federal Meat Inspection Act and the Poultry Products Inspection Act.
FSIS is also proposing to amend its regulations to require nutrition labels on all ground or chopped meat and poultry products, with or without added seasonings, unless an exemption applies. Under existing regulations, multi-ingredient ground or chopped products, ( e.g., ground pork with seasonings), and heat processed ground or chopped products ( e.g., fully cooked or partially cooked patties) are required to be nutritionally labeled, unless they qualify for an exemption, but single-ingredient, raw ground or chopped products are not required to be so labeled
ess an exemption applies. Under existing regulations, multi-ingredient ground or chopped products, ( e.g., ground pork with seasonings), and heat processed ground or chopped products ( e.g., fully cooked or partially cooked patties) are required to be nutritionally labeled, unless they qualify for an exemption, but single-ingredient, raw ground or chopped products are not required to be so labeled. Without nutrition information for single-ingredient, raw ground or chopped products, the Agency has tentatively concluded that these products would be misbranded under the Federal Meat Inspection Act and the Poultry Products Inspection Act. The Agency has also tentatively determined that single-ingredient, raw ground or chopped meat and poultry products are different from other single-ingredient, raw meat and poultry products in several important respects. Thus, FSIS is proposing to make nutrition labeling requirements for all ground or chopped meat and poultry products consistent with those currently required for products in the mandatory nutrition labeling program (multi-ingredient and heat processed products).
FSIS is proposing to require nutrition labels on packages of single-ingredient, raw ground or chopped products, rather than at their point-of-purchase, largely because these products are similar to products in the mandatory nutrition labeling program (which requires nutrition information to be on the label of individual packages), in that certain parameters, such as their fat content, can be controlled precisely to obtain the desired product
on packages of single-ingredient, raw ground or chopped products, rather than at their point-of-purchase, largely because these products are similar to products in the mandatory nutrition labeling program (which requires nutrition information to be on the label of individual packages), in that certain parameters, such as their fat content, can be controlled precisely to obtain the desired product. Although FSIS believes that nutrition information on labels of individual packages of single-ingredient, raw products is useful, FSIS is proposing that nutrition information for the major cuts of single-ingredient, raw products may also be provided on point-of-purchase materials because FSIS believes that consumers have reasonable expectations as to the nutrient content of these products, the nutrient content of a specific major cut is relatively uniform across the market, and because these products are not formulated in the manner of ground or chopped products. For single-ingredient, raw products that are not major cuts and that are not ground or chopped, FSIS is not proposing to require nutrition information on their labels or at their point-of-purchase because FSIS has not yet assessed whether adequate nutrition information is being provided for these products and, therefore, has not determined whether it would be beneficial to require nutrition labeling for these products.
Finally, FSIS is proposing to amend the nutrition labeling regulations to provide that when a ground or chopped product does not meet the criteria to be labeled “low fat,” a lean percentage claim may be included on the label or in labeling as long as a statement of the fat percentage also is displayed on the label or in labeling.

DATES:
Comments must be received on or before April 18, 2001.

ADDRESSES:
Submit one original and two copies of comments to FSIS Docket Clerk, Docket #98-005P, Food Safety and Inspection Service, Room 102, Cotton Annex, 300 12th Street, SW, Washington, DC 20250-3700
ed on the label or in labeling as long as a statement of the fat percentage also is displayed on the label or in labeling.

DATES:
Comments must be received on or before April 18, 2001.

ADDRESSES:
Submit one original and two copies of comments to FSIS Docket Clerk, Docket #98-005P, Food Safety and Inspection Service, Room 102, Cotton Annex, 300 12th Street, SW, Washington, DC 20250-3700. Reference material cited in the document and any comments received will be available for public inspection in the FSIS Docket Room from 8:30 a.m. to 4:30 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT:
Dr. Robert Post, Director, Labeling and Additives Policy Division, Office of Policy, Program Development, and Evaluation, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250-3700; (202) 205-0279.

SUPPLEMENTARY INFORMATION:
Background
The Current Mandatory and Voluntary Nutrition Labeling Programs
Mandatory nutrition labeling program. The Nutrition Labeling and Education Act (NLEA) of 1990 required nutrition labeling of most foods regulated by the Food and Drug Administration (FDA). FSIS published regulations establishing comparable nutrition labeling requirements for meat and poultry products. As explained in its proposed and final rules, FSIS determined that it had statutory authority to require nutrition labeling based on the Secretary of Agriculture's determination that meat and poultry products, other than single-ingredient, raw products, would be misbranded in the absence of such information, under section 1(n) of the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601(n)(1)) and section 4(h)(1) of the Poultry Products Inspection Act (PPIA) (21 U.S.C. 453(h)(1)) (56 FR 60305 and 58 FR 637). These statutory provisions state that a product is misbranded if it is false or misleading in any particular
an single-ingredient, raw products, would be misbranded in the absence of such information, under section 1(n) of the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601(n)(1)) and section 4(h)(1) of the Poultry Products Inspection Act (PPIA) (21 U.S.C. 453(h)(1)) (56 FR 60305 and 58 FR 637). These statutory provisions state that a product is misbranded if it is false or misleading in any particular. FSIS published an advance notice of proposed rulemaking on nutrition labeling of meat and poultry products on April 2, 1991 (56 FR 13564), a proposed rule on November 27, 1991 (56 FR 60302), a final rule on January 6, 1993 (58 FR 632), and subsequently other amendments to the rule.
FSIS' regulations require nutrition labels on the packages of all multi-ingredient and heat processed meat and poultry products, unless an exemption applies. The required nutrition labeling provisions are referred to as “the mandatory nutrition labeling program.” The regulations include exemptions from nutrition labeling requirements for food products produced by small businesses, products intended for further processing, products not offered for sale to consumers, products in small packages that are individually wrapped packages of less than \1/2\ ounce net weight, custom slaughtered or prepared products, products intended for export, ready-to-eat products that are packaged
The regulations specify the information that must be included on the labels of products in the mandatory nutrition labeling program. The required information includes the levels of total calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, and certain vitamins and minerals in the product. In certain situations, information concerning some of these nutrients is not required. For example, the label declaration of “calories from fat” is not required on products that contain less than 0.5 gram of fat per serving
alories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, and certain vitamins and minerals in the product. In certain situations, information concerning some of these nutrients is not required. For example, the label declaration of “calories from fat” is not required on products that contain less than 0.5 gram of fat per serving. The regulations also provide that information concerning stearic acid, polyunsaturated fat, monounsaturated fat, potassium, soluble fiber, insoluble fiber, sugar alcohol, other carbohydrates, and calories from saturated fat may be included voluntarily. When claims related to these nutrients are made, or when certain related nutrients are declared, information concerning these nutrients is required.
The regulations require that the nutrient and food component quantities on the label of products in the mandatory nutrition labeling program be declared in relation to a serving. The regulations also require that the declaration of nutrient and food component content be on the basis of the product “as packaged”; in addition, the declaration of nutrient and food component content may also be made on the basis of “as consumed,” provided that preparation and cooking instructions are clearly stated. The regulations also prescribe format requirements for nutrient information, which include specified headings that must be used in the presentation of nutrition labeling information.
The regulations include provisions for Agency monitoring of compliance with the mandatory nutrition labeling requirements. FSIS conducts a continuous product sampling program to ensure compliance with nutrition labeling requirements (see §§ 317.309(h)(1)-(8) and 381.409(h)(1)-(8)).
Voluntary nutrition labeling program
ngs that must be used in the presentation of nutrition labeling information.
The regulations include provisions for Agency monitoring of compliance with the mandatory nutrition labeling requirements. FSIS conducts a continuous product sampling program to ensure compliance with nutrition labeling requirements (see §§ 317.309(h)(1)-(8) and 381.409(h)(1)-(8)).
Voluntary nutrition labeling program. In the preamble to the January 6, 1993, final rule, FSIS stated that it would not require nutrition labeling for single-ingredient, raw meat and poultry products because the nutrient values of these products are not modified through various stages of preparation, such as cooking and heat processing. Therefore, the Agency believed that consumers had reasonable expectations as to the nutritional qualities of these products (58 FR 637). In the preamble to the proposed rule, FSIS also stated that nutrition information for single-ingredient, raw products was available to consumers through other means such as the extension service, grocery stores, and trade associations (56 FR 60306). For these reasons, although the Agency adopted a mandatory nutrition labeling program for multi-ingredient products and heat processed products, it chose not to do so for single-ingredient, raw meat and poultry products, including single-ingredient, raw ground or chopped products. Instead, it established guidelines for voluntary nutrition labeling of these products (see §§ 317.345 and 381.445).
Under the voluntary nutrition labeling program, retailers and manufacturers are not required to provide nutrition information for single-ingredient, raw meat or poultry products. Instead, retailers and manufacturers voluntarily may provide nutrition information on the label of these products, or at their point-of-purchase by posting a sign or by making the information readily available in brochures, notebooks, or leaflet form in close proximity to the food
d manufacturers are not required to provide nutrition information for single-ingredient, raw meat or poultry products. Instead, retailers and manufacturers voluntarily may provide nutrition information on the label of these products, or at their point-of-purchase by posting a sign or by making the information readily available in brochures, notebooks, or leaflet form in close proximity to the food. However, if a nutrition claim is made on these materials, all of the requirements of the mandatory nutrition labeling program apply.
If only nutrition information, and not a nutrition claim, is supplied on the point-of-purchase materials of single-ingredient, raw products, the requirements of the mandatory program apply, but the nutrition information may be supplied on an “as packaged” or “as consumed basis”; the listing of percent of Daily Value for certain nutrients and the footnote explaining that the Daily Values are based on a 2,000 calorie diet and that daily values may differ depending on calorie needs (see §§ 317.309(d)(9) and 381.409 (d)(9)) may be omitted; and the point-of-purchase materials are not subject to any format requirements.
If, however, a retailer or manufacturer provides nutrition information on the label of single-ingredient, raw products, this information must be presented in the same format as that prescribed for mandatory nutrition labeling of various products. However, for these products, unlike products in the mandatory nutrition labeling program, the nutrition information may be declared on the basis of either “as consumed” or “as packaged.” If the information is presented on the basis of “as consumed,” the regulations provide that the methods used to cook the product must be specified and should be those which do not add nutrients from other ingredients (see §§ 317.345(d) and 381.445(d)). Also, unlike products in the mandatory program, the declaration of the number of servings per container need not be included on the nutrition label
If the information is presented on the basis of “as consumed,” the regulations provide that the methods used to cook the product must be specified and should be those which do not add nutrients from other ingredients (see §§ 317.345(d) and 381.445(d)). Also, unlike products in the mandatory program, the declaration of the number of servings per container need not be included on the nutrition label.
The regulations provide that the Agency will not conduct compliance sampling and testing of a product subject to the voluntary nutrition labeling program that contains nutrition labeling if the nutrition labeling is based upon the most current representative data base values contained in USDA's National Nutrient Data Bank or in its published form, the Agriculture Handbook No. 8 series, and if there are no nutrition claims made on the basis of the representative database values on the labeling of these products (§§ 317.309(h)(9), 317.345(e), 317.345(f), 381.409(h)(9), 381.445(e), and 381.445(f)).
The Agriculture Handbook No. 8 series is now out of print. The current released form of the USDA's National Nutrient Data Bank is the USDA Nutrient Database for Standard Reference. USDA's Nutrient Data Bank is the Agricultural Research Service's internal system that stores information and has features necessary to produce the released database. The USDA Nutrient Database for Standard Reference is developed and maintained by the Agricultural Research Service and can be found on the internet at the
The Agency may conduct sampling and testing for compliance with nutrition labeling requirements for single-ingredient, raw meat and poultry products if the nutrition information on their labeling is not based on the latest values contained in USDA's National Nutrient Data Bank or the USDA Nutrient Database for Standard Reference, or if there are nutrition claims made on the basis of the representative database values, on the labeling of these products.
Compliance with voluntary nutrition labeling guidelines
ent, raw meat and poultry products if the nutrition information on their labeling is not based on the latest values contained in USDA's National Nutrient Data Bank or the USDA Nutrient Database for Standard Reference, or if there are nutrition claims made on the basis of the representative database values, on the labeling of these products.
Compliance with voluntary nutrition labeling guidelines. FSIS' regulations provide that the Agency monitor compliance with its voluntary nutrition labeling program guidelines by evaluating the participation of retailers in the voluntary program every two years, beginning in May 1995, to determine whether significant participation of at least 60 percent of all companies evaluated exists (§§ 317.343 and 381.443). FSIS stated that it would issue its first report of its survey findings on the voluntary program by May 1995, and that it would reevaluate every two years after 1995 whether significant participation existed in the voluntary nutrition labeling program (56 FR 60306).
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 regulations 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. The regulations provide that the voluntary nutrition labeling program will remain in effect as long as there is significant participation in the voluntary program by retail stores (§§ 317.343 and 381.443).
FSIS contracted with an independent market research contracting firm to conduct the retail surveys in 1995, 1996, and 1999
at are evaluated are participating in accordance with the guidelines. The regulations provide that the voluntary nutrition labeling program will remain in effect as long as there is significant participation in the voluntary program by retail stores (§§ 317.343 and 381.443).
FSIS contracted with an independent market research contracting firm to conduct the retail surveys in 1995, 1996, and 1999. For each of these surveys, the firm surveyed a nationally representative sample of approximately 2,000 retail stores to obtain the information necessary to assess compliance with the guidelines for voluntary nutrition labeling of single-ingredient, raw meat and poultry products.
The first survey to determine participation by retail stores in the voluntary nutrition labeling program was conducted in June 1995. At that time, the National Retail Tracking Index, Inc., found that 66.5 percent of the stores surveyed were providing nutrition information on 90 percent of the major cuts of single-ingredient, raw meat and poultry products. Therefore, this survey showed that significant participation in the voluntary nutrition labeling program existed. FSIS published a notice of availability of the survey results in the January 29, 1996 Federal Register (61 FR 2790). In this survey, stores were counted as participating in the voluntary nutrition labeling program if they used point-of-purchase materials developed by the Food Marketing Institute (FMI) prior to the 1993 final rule on nutrition labeling of meat and poultry products. These materials did not comply entirely with the voluntary nutrition labeling program provisions in the 1993 final rule. For example, the older materials did not include the required percent daily values for certain nutrients. Therefore, the results of this survey may overestimate participation in the voluntary nutrition labeling program.
The second survey was conducted in mid-December 1996. FSIS conducted it jointly with FDA
entirely with the voluntary nutrition labeling program provisions in the 1993 final rule. For example, the older materials did not include the required percent daily values for certain nutrients. Therefore, the results of this survey may overestimate participation in the voluntary nutrition labeling program.
The second survey was conducted in mid-December 1996. FSIS conducted it jointly with FDA. For this survey, the two agencies contracted with the firm that conducted the 1995 FSIS survey, now named Retail Diagnostics, Incorporated (RDI). At this time, RDI found that 57.7 percent of stores surveyed provided nutrition information for 90 percent of the major cuts of single-ingredient, raw meat and poultry products, in accordance with program guidelines. The third survey was conducted in October 1999. At this time, RDI found that 54.8 percent of stores surveyed provided nutrition information for 90 percent of the major cuts of single-ingredient, raw meat and poultry products, in accordance with program guidelines. Therefore, the two most recent surveys did not show significant participation in the voluntary nutrition labeling program, according to the voluntary nutrition labeling program regulations. Reports on the 1996 and 1999 surveys are available electronically on the FSIS web page at http://www.fsis.usda.gov.
Nutrient Content Claims
In addition to establishing the mandatory and voluntary nutrition labeling programs, the January 6, 1993, final rule provided definitions at §§ 317.362 and 381.462 for specific nutrient content claims, including the terms “lean” and “extra lean.” The definitions of “lean” and “extra lean” provide that these terms may be used on the label or in labeling only if the product meets certain criteria (see §§ 317.362(e)(1) and (2) and 381.462(e)(1) and (2))
y nutrition labeling programs, the January 6, 1993, final rule provided definitions at §§ 317.362 and 381.462 for specific nutrient content claims, including the terms “lean” and “extra lean.” The definitions of “lean” and “extra lean” provide that these terms may be used on the label or in labeling only if the product meets certain criteria (see §§ 317.362(e)(1) and (2) and 381.462(e)(1) and (2)). Meat products may be labeled “lean” if they contain less than 10 grams of fat, 4.5 grams or less of saturated fat, and less than 95 milligrams of cholesterol per 100 grams of product and per reference amount customarily consumed for individual foods. Meat products may be labeled “extra lean” if they contain less than 5 grams of fat, less than 2 grams of saturated fat, and less than 95 milligrams of cholesterol per 100 grams of product and per reference amount customarily consumed for individual foods. Ground beef and hamburger seldom meet the criteria that would allow producers to use the terms “lean” or “extra lean” on the label or in labeling of these products.
The existing nutrition labeling regulations also provide that the term “__ percent lean” is a synonym for the term “__ percent fat free,” and that, in order for either term to be used on the label or in labeling of the product, the product must meet the criteria for “low fat” (§§ 317.362(b)(6) and 381.462(b)(6)). To meet the criteria for “low fat,” a product must have a reference amount customarily consumed greater than 30 grams or greater than 2 tablespoons and must contain 3 grams of fat or less per reference amount customarily consumed for individual foods, or must have a reference amount customarily consumed of 30 grams or less or 2 tablespoons or less and must contain 3 grams or less of fat per reference amount customarily consumed and per 50 grams (§§ 317.362(b)(2) and 381.462(b)(2)). Most ground beef and hamburger do not qualify as “low fat.” Therefore, existing regulations preclude the use of the term “__ percent lean” on these products
re contiguous to a statement of the fat percentage. The Agency would have allowed this labeling even when the ground beef or hamburger did not qualify as “low fat.” The Agency proposed to allow the use of the statement of lean and fat percentages only if the product were accompanied by nutrition information presented on the label, or in point-of-purchase materials in close proximity to the product. FSIS stated that it would consider expanding the proposed percentage labeling to ground meat from other species and to ground poultry if information submitted during the comment period demonstrated the need and consumer acceptability of these terms for such products or that differential treatment of ground beef relative to other ground products would inappropriately restrict informed consumer choice (59 FR 26918).
The Agency received a total of 2,732 comments on this proposal. Fifty-five percent (1,504) of the commenters supported the proposal, 39 percent (1,063) opposed it, and 6 percent (165) addressed issues outside the scope of the proposed rule. Supporters of the proposal included trade associations representing food manufacturers and retailers, food manufacturers of both meat and poultry products, a large number of retailers, and State departments of agriculture. Supporters stated that percentage labeling provides useful information to consumers, that “lean labeling” aids consumers in selecting lower fat products, and that percentage labeling has been in use for more than 20 years. Opponents included consumer interest groups, health professionals and organizations, and consumers. They stated that the use of percent lean labeling is inherently misleading to consumers and will cause consumers to view ground beef as “lean” or “low fat.”
Twenty-one of the 1,504 commenters who supported the provisions wanted them to also apply to other species or products
or more than 20 years. Opponents included consumer interest groups, health professionals and organizations, and consumers. They stated that the use of percent lean labeling is inherently misleading to consumers and will cause consumers to view ground beef as “lean” or “low fat.”
Twenty-one of the 1,504 commenters who supported the provisions wanted them to also apply to other species or products. These commenters stated that allowing percentage labeling for lean and fat for other ground meat and poultry products, besides ground beef and hamburger, would allow consumers to compare the fat content of beef or poultry items and to make informed dietary choices.
On August 5, 1994, FSIS published a notice of extension of the date that it would enforce compliance with the nutrition labeling requirements for ground beef and hamburger (59 FR 39941). The Agency extended the compliance enforcement date for these products indefinitely, pending publication of a final rule on percentage labeling for lean and fat on ground beef and hamburger. The Agency has not published a final rule concerning percentage labeling of ground beef and hamburger. Therefore, producers and retailers continue to use the term “lean” in percentage labeling on the packages of ground beef and hamburger.
Other Nutrition Activities
In addition to developing this proposed nutrition labeling rule, USDA conducts numerous other activities related to nutrition. This proposed rule on nutrition labeling is an integral part of USDA's efforts to educate consumers concerning nutrition and diets. Since 1980 USDA and the Department of Health and Human Services (HHS) have jointly published the Dietary Guidelines for Americans every five years. The Dietary Guidelines provide advice concerning food choices that promote health and prevent disease. USDA and HHS released the Dietary Guidelines for Americans, 2000, at the National Nutrition Summit on May 30, 2000, which was jointly sponsored by USDA and HHS
USDA and the Department of Health and Human Services (HHS) have jointly published the Dietary Guidelines for Americans every five years. The Dietary Guidelines provide advice concerning food choices that promote health and prevent disease. USDA and HHS released the Dietary Guidelines for Americans, 2000, at the National Nutrition Summit on May 30, 2000, which was jointly sponsored by USDA and HHS. The Dietary Guidelines for Americans, 2000, advises consumers to aim for a total fat intake of no more than 30 percent of calories (page 30). In addition, the Dietary Guidelines for Americans, 2000, includes a chart showing the recommended upper limits for grams of saturated fat and total fat per day for a range of total calories per day (page 30). The nutrition information that FSIS is proposing to require on labels of ground or chopped products and on either labels or point-of-purchase materials for the major cuts of single-ingredient, raw products would include the number of calories and the grams of total fat and saturated fat the product contains. The information FSIS is proposing to require would, therefore, assist consumers in following the advice in the Dietary Guidelines for Americans, 2000.
Proposed Changes
Nutrition labeling of the major cuts of single-ingredient, raw products. The Agency is proposing to require nutrition labeling of the major cuts of single-ingredient, raw meat and poultry products, except for certain exemptions. For these products, FSIS is proposing to make the guidelines currently in place for the voluntary nutrition labeling program mandatory. Thus, for all of these products, other than raw ground beef and ground pork which are currently classified as major cuts, FSIS is proposing that nutrition information be provided on the label of these products or at their point-of-purchase
for certain exemptions. For these products, FSIS is proposing to make the guidelines currently in place for the voluntary nutrition labeling program mandatory. Thus, for all of these products, other than raw ground beef and ground pork which are currently classified as major cuts, FSIS is proposing that nutrition information be provided on the label of these products or at their point-of-purchase. As discussed below, at this time, FSIS is not proposing to require nutrition information for single-ingredient, raw meat and poultry products that are not major cuts and that are not ground or chopped products.
In the preamble to the final rule on nutrition labeling of meat and poultry products, under the discussion of its voluntary nutrition labeling program which covered all single-ingredient, raw meat and poultry products, FSIS stated that it believed that it was important to provide nutrition information to consumers (58 FR 640). FSIS also stated that it believed that by allowing for the use of point-of-purchase materials for single-ingredient, raw meat and poultry products, retailers would be able to provide consumers with the necessary nutrition information (58 FR 640). FSIS continues to believe that nutrition information for these products is important and necessary.
In the two most recent surveys, FSIS found that significant participation in the voluntary nutrition labeling program does not exist. FSIS found that less than 60 percent of the stores surveyed provided nutrition information for 90 percent of the major cuts of single-ingredient, raw meat and poultry products. In its proposed and final rules on nutrition labeling of meat and poultry products, 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, 58 FR 640)
ts proposed and final rules on nutrition labeling of meat and poultry products, 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, 58 FR 640).
Because the most recent surveys showed that significant participation in the voluntary nutrition labeling program does not exist, FSIS now believes that this proposed rule is necessary and that it would be beneficial to require the labeling of the major cuts of single-ingredient, raw meat and poultry products to bear nutrition information. FSIS believes that without nutrition information, consumers are not able to assess the nutrient content of the major cuts and thus cannot make educated
If the guidelines currently in place for the voluntary nutrition labeling program are made mandatory, it would ensure that consumers are provided with necessary nutrition information concerning the major cuts. Therefore, the Agency is proposing to make mandatory for the major cuts of single-ingredient, raw meat and poultry products the current provisions for the voluntary nutrition labeling program for presentation of nutrition information on point-of-purchase materials.
FSIS intends to make point-of-purchase materials available over the Internet free of charge. The point-of-purchase materials reflecting the final nutrition labeling regulations that FMI developed show nutrition information in charts with columns covering multiple products. FSIS requests comments on whether the Agency should develop point-of-purchase materials that present nutrition information as a compilation of individual nutrition facts panels for each product or whether the nutrition information on the materials should be presented in charts with horizontal or vertical columns to cover multiple products
ormation in charts with columns covering multiple products. FSIS requests comments on whether the Agency should develop point-of-purchase materials that present nutrition information as a compilation of individual nutrition facts panels for each product or whether the nutrition information on the materials should be presented in charts with horizontal or vertical columns to cover multiple products.
Also, consistent with the existing provisions in the voluntary nutrition labeling program, the Agency is proposing to require that if nutrition information is provided on the label of individual packages of major cuts of single-ingredient, raw products, the current requirements of the mandatory nutrition labeling program will apply, but the nutrition information on the label may be declared either on the basis of “as consumed” or “as packaged.”
FSIS is proposing to allow nutrition information on the label to be declared on the basis of “as consumed” without also requiring that the information on the label be declared on the basis of “as packaged” for the major cuts of single-ingredient, raw products because, as discussed below, most of these products will not need FSIS compliance scrutiny. Also as noted below, nutrition information for products under the existing mandatory nutrition labeling program must be provided on an “as packaged” basis for compliance purposes. Consistent with the existing voluntary nutrition labeling program, FSIS is proposing that the declaration of the number of servings per container need not be included on the nutrition label for the major cuts of single-ingredient, raw products. FSIS is not proposing to require that the number of servings per container be declared for the major cuts of single-ingredient, raw products because all of these products are random weight products, and the number of servings is not currently required on random weight products (see §§ 317.309(b)(10)(iii) and 381.409(b)(10)(iii))
utrition label for the major cuts of single-ingredient, raw products. FSIS is not proposing to require that the number of servings per container be declared for the major cuts of single-ingredient, raw products because all of these products are random weight products, and the number of servings is not currently required on random weight products (see §§ 317.309(b)(10)(iii) and 381.409(b)(10)(iii)).
Although FSIS believes that nutrition information on labels of individual packages of single-ingredient, raw products is useful, FSIS is proposing that the nutrition information for the major cuts of single-ingredient, raw products may also be provided on point-of-purchase materials because, as stated in the 1993 rule, consumers have reasonable expectations as to the nutrient content of these products. Also, 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. Therefore, FSIS believes it would be relatively easy to prepare point-of-purchase materials for the major cuts and relatively easy for consumers to find the nutrition information for a particular major cut on point-of-purchase materials. Although FSIS continues to believe that consumers have reasonable expectations as to the nutrient content of these products, FSIS also continues to believe that it is important to provide nutrition information to consumers, either through labels on packages or point-of-purchase materials. FSIS requests comment on whether consumers have reasonable expectations concerning the nutrient content of the major cuts of single-ingredient, raw products and on whether point-of-purchase materials are appropriate vehicles for conveying nutrition information for these products. FSIS specifically requests comment on whether it should require that nutrition labeling should be provided for these products on their label and, if so, on what basis it would require such labeling
ning the nutrient content of the major cuts of single-ingredient, raw products and on whether point-of-purchase materials are appropriate vehicles for conveying nutrition information for these products. FSIS specifically requests comment on whether it should require that nutrition labeling should be provided for these products on their label and, if so, on what basis it would require such labeling.
FSIS regulations provide that in evaluating whether there is significant participation in the voluntary nutrition labeling program, FSIS will consider only the major cuts of single-ingredient, raw meat and poultry products (§§ 317.343(a) and 381.443(a)). Consistent with the regulations, FSIS' voluntary nutrition labeling surveys only assessed whether nutrition labeling was provided for the major cuts of single-ingredient, raw meat and poultry products.
Examples of single-ingredient, raw products that are not major cuts (and that are not ground or chopped) include pork jowls, pigs feet, pork leg, pork shoulder picnic, and beef round rump. For single-ingredient, raw products that are not ground or chopped and are not major cuts, FSIS is not proposing that nutrition information must be provided. However, FSIS is proposing that if nutrition information is provided, it must be provided according to the existing guidelines for the current voluntary nutrition labeling program. Therefore, if nutrition information is provided for these products, it would be consistent with nutrition information for the major cuts of single-ingredient, raw products.
As the next step in the process of evaluating the need for nutrition labeling of meat and poultry products, FSIS will examine the current state of nutrition labeling for single-ingredient, raw products that are not ground or chopped and that are not major cuts. FSIS will assess whether adequate nutrition information is being provided for these products
or cuts of single-ingredient, raw products.
As the next step in the process of evaluating the need for nutrition labeling of meat and poultry products, FSIS will examine the current state of nutrition labeling for single-ingredient, raw products that are not ground or chopped and that are not major cuts. FSIS will assess whether adequate nutrition information is being provided for these products. Until this assessment is made, FSIS cannot determine whether it would be beneficial to require nutrition labeling for single-ingredient, raw products that are not ground or chopped and are not major cuts. Whether the labeling of these products should be required to bear nutrition information would depend on whether adequate nutrition information is being provided for them and, if it is not being provided, what the effect is of its not being available. If FSIS determines that adequate nutrition information is not being provided for these products, FSIS will consider whether to propose to require nutrition labeling for these products.
FSIS is proposing to revise the nutrition labeling regulations to clarify which provisions apply to nutrition labels on single-ingredient, raw products that are not ground or chopped, including the major cuts, and which provisions apply to point-of-
Nutrition labeling of ground or chopped products. The Agency is proposing to add new provisions at §§ 317.301 and 381.401, in the Federal meat and poultry product inspection regulations. In proposed § 317.301, FSIS is proposing to require that nutrition labels be provided for all ground or chopped (livestock species) and hamburger, with or without added seasonings, unless an exemption applies. In proposed § 381.401, FSIS is proposing to require that nutrition labels be provided for all ground or chopped (kind), with or without added seasonings, unless an exemption applies
lations. In proposed § 317.301, FSIS is proposing to require that nutrition labels be provided for all ground or chopped (livestock species) and hamburger, with or without added seasonings, unless an exemption applies. In proposed § 381.401, FSIS is proposing to require that nutrition labels be provided for all ground or chopped (kind), with or without added seasonings, unless an exemption applies. Products that will have to bear nutrition labeling if this proposal is finalized include single-ingredient, raw hamburger, ground beef, ground beef patties, ground chicken, ground turkey, ground chicken patties, ground pork, and ground lamb. In this discussion, these products will be referred to as ground or chopped products. Ground or chopped products that are multi-ingredient products or heat processed products are already required to bear nutrition labeling, unless they qualify for an exemption. This proposed provision would extend the current mandatory nutrition labeling requirements to single-ingredient, raw ground or chopped products. The proposed provisions do not address sausages or other comminuted products. These products are typically multi-ingredient or heat processed products that are already required to bear nutrition information.
As discussed under the “Background” heading above, the existing regulations include exemptions from nutrition labeling requirements, such as an exemption for products produced by small businesses, custom slaughtered or prepared products, and certain products that are packaged, portioned or processed at retail. As discussed below under the “Exemptions” heading, most of these exemptions would apply to ground or chopped products that qualify for the exemptions
ng regulations include exemptions from nutrition labeling requirements, such as an exemption for products produced by small businesses, custom slaughtered or prepared products, and certain products that are packaged, portioned or processed at retail. As discussed below under the “Exemptions” heading, most of these exemptions would apply to ground or chopped products that qualify for the exemptions. However, FSIS is proposing that the current exemptions from nutrition labeling for ready-to-eat products packaged or portioned at retail stores and similar retail-type establishments and for multi-ingredient products processed at retail stores and similar retail-type establishments not apply to ground or chopped meat and ground or chopped poultry products, unless the retail store or similar retail-type establishment meets the requirements of the small business exemption. This issue is discussed further under the “Exemptions” heading below.
The terms “ground” and “chopped” are synonymous (see § 319.15). FSIS is proposing to use both terms because both are used in FSIS regulations and by industry. In the discussion below, any statements made regarding the nutrient values or the production of “ground” products would also apply to “chopped” products.
On June 3, 1997, the Center for Science in the Public Interest (CSPI) submitted a petition to FSIS stating that FSIS should require complete “Nutrition Facts” on ground beef labels that make nutrient content claims; should prohibit “% lean” claims on ground beef; should require ground beef to meet the same definitions of “lean” and “extra lean” that apply to other foods; and should require ground beef labels to replace “% lean” and “% fat” claims with the same “% less fat” claims used by other foods. CSPI also submitted information illustrating the variations in ground beef labels that include information on the lean or fat percentages of the product
beef; should require ground beef to meet the same definitions of “lean” and “extra lean” that apply to other foods; and should require ground beef labels to replace “% lean” and “% fat” claims with the same “% less fat” claims used by other foods. CSPI also submitted information illustrating the variations in ground beef labels that include information on the lean or fat percentages of the product.
Consistent with CSPI's petition, the Agency has tentatively determined that nutrition information should be required on packages of all ground or chopped meat and poultry products, unless an exemption applies. FSIS is proposing to require this information even if there are no nutrient content claims on the label.
With regard to the statements in CSPI's petition concerning the use of “% lean,” “lean,” “extra lean,” and “% less fat” claims on ground beef labeling, FSIS is not revising the regulations as the petitioner requested. As discussed below, FSIS is proposing to permit a statement of lean percentage on the label or in labeling of all ground or chopped meat and ground or chopped poultry products that do not meet the regulatory definition for “low fat” as long as a statement of the fat percentage is also provided, because consumers have become accustomed to this information, and because FSIS believes that this information provides a quick, simple, accurate means of comparing these products.
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. The fat content of ground beef products can be formulated to range from under 6 percent to 30 percent. Below is a table that compares the nutrient values of three ground beef products that contain different levels of fat. All values are based on raw product.
Nutrient values per 100 g Ground beef 17% fat Ground beef 21% fat Ground beef 27% fat Calories 234 264 310
the existing mandatory program. The fat content of ground beef products can be formulated to range from under 6 percent to 30 percent. Below is a table that compares the nutrient values of three ground beef products that contain different levels of fat. All values are based on raw product.
Nutrient values per 100 g Ground beef 17% fat Ground beef 21% fat Ground beef 27% fat Calories 234 264 310. Cholesterol 69 mg 75 mg 85 mg. Fatty acids, saturated 6.8 g 8.3 g 10.8 g. Source:
USDA Nutrient Database for Standard Reference (1985 data)
FSIS believes that consumers cannot 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. Therefore, consumers cannot estimate the level of fat in these products and cannot compare the levels of fat in these products to those in other products.
Fat is not the only factor that contributes to the nutrient variability of ground beef products. Producers sometimes use beef from advanced meat recovery (AMR) systems and low temperature rendering in ground or chopped beef products, which affect the nutrient variability of ground beef products. Product derived from low temperature rendering of beef tissue that is not fatty tissue, such as fat reduced beef or finely textured beef, is considered beef and can be used in ground or chopped beef or hamburger and other ground or chopped meat products. The regulations currently do not address the use of fat reduced beef or finely textured beef. FSIS may address the use of such products derived from low temperature rendering in a future rulemaking
ef tissue that is not fatty tissue, such as fat reduced beef or finely textured beef, is considered beef and can be used in ground or chopped beef or hamburger and other ground or chopped meat products. The regulations currently do not address the use of fat reduced beef or finely textured beef. FSIS may address the use of such products derived from low temperature rendering in a future rulemaking.
An American Meat Institute (AMI) survey found that the use of product derived from AMR systems in ground beef was becoming more prevalent, although AMI did not obtain specific information concerning the volume of product from AMR systems (The American Meat Institute Foundation, Relative Ground Beef Contribution to the United States Beef Supply (May 1996): 10). This survey also found that producers use product such as finely textured beef recovered via technology (a product derived from low temperature rendering) in ground beef products to achieve specific lean contents (The American Meat Institute Foundation, Relative Ground Beef Contribution to the United States Beef Supply (May 1996): 11). It should be noted that beef from AMR systems is not used at retail, unless the retail establishment is grinding beef product produced at a Federal establishment. Ground beef produced at retail from a single cut of meat, such as ground chuck or ground round, would not typically include beef from AMR systems. However, ground beef produced at retail from trimmings produced at a Federal establishment could include beef from AMR systems.
Typically, meat from AMR systems does not comprise more than 10 percent of ground meat products, including ground beef (R.A. Field, “Bone Marrow Measurements for Mechanically Recovered Products from Machines that Press Bones,” Meat Science 51 (1999): 206). Similarly, meat from low temperature rendering usually does not comprise more than 10 percent of ground products, including ground beef
tems.
Typically, meat from AMR systems does not comprise more than 10 percent of ground meat products, including ground beef (R.A. Field, “Bone Marrow Measurements for Mechanically Recovered Products from Machines that Press Bones,” Meat Science 51 (1999): 206). Similarly, meat from low temperature rendering usually does not comprise more than 10 percent of ground products, including ground beef. However, because beef from AMR systems or low temperature rendering generally has higher levels of cholesterol, iron, and calcium than other beef, the use of these types of beef in ground beef products can affect the nutrient content of these products. The table below shows the percentage fat and the levels of iron and calcium per 100 grams of product for regular ground beef, for beef from AMR systems, and for product made from 90 percent regular ground beef and 10 percent beef from AMR systems. For regular ground beef and for beef from AMR systems, the table shows values from different studies (R.A. Field, “Bone Marrow Measurements for Mechanically Recovered Products from Machines that Press Bones,” Meat Science 51 (1999): 206, 209). FSIS calculated the nutrient values for product comprised of 90 percent ground beef and 10 percent AMR product based on the values from the studies. FSIS calculated values for product made from 90 percent ground beef and 10 percent AMR product because, as stated above, typically meat from AMR systems does not comprise more than 10 percent of ground meat products. All values shown below are based on raw product
ed the nutrient values for product comprised of 90 percent ground beef and 10 percent AMR product based on the values from the studies. FSIS calculated values for product made from 90 percent ground beef and 10 percent AMR product because, as stated above, typically meat from AMR systems does not comprise more than 10 percent of ground meat products. All values shown below are based on raw product.
Nutrient values per 100 grams Regular ground beef (Anderson et al., 1986) Beef from AMR (Hasiak and Marks, 1997) Beef from AMR product (Leising, 1997) Ground beef, 10% AMR product (Hasiak and Marks) Ground beef, 10% AMR product (Leising) Cholesterol 85 mg 115 mg 102 mg 88 mg 86.7 mg Iron 1.7 mg 2.8 mg 5.6 mg 1.81 mg 2.09 mg Calcium 8 mg 108 mg 115 mg 18.0 mg 18.7 mg Even if producers do not use beef from AMR systems or beef derived from low temperature rendering, they are able to precisely control the amount of fat in the beef that is ground or chopped to create packages of ground or chopped beef. A study concerning testing for the fat content of ground beef found that, using two testing methods, ground beef formulated for a certain fat percentage varied by only 2 percentage points around the average fat percentage. Although this study found some problems concerning blending of ground beef and testing for the fat content in ground beef, its results show that the product can be and is precisely formulated and within the control of the producer (Robert Campbell, “Ground Beef Testing: Determining Fat Content and Distribution,” Meat and Poultry (October, 1997): 67-69). Many ground beef producers have quality control programs to control the fat content of their product. These producers conduct regular sampling and testing for fat in ground beef products. Thus, producers are able to formulate these products to control the amount of fat in them more precisely than the fat can be controlled in other cuts. Other single-ingredient, raw products cannot be formulated in this manner or to this degree
e quality control programs to control the fat content of their product. These producers conduct regular sampling and testing for fat in ground beef products. Thus, producers are able to formulate these products to control the amount of fat in them more precisely than the fat can be controlled in other cuts. Other single-ingredient, raw products cannot be formulated in this manner or to this degree.
Although ground beef comprises the majority of ground meat products sold at retail, products such as ground lamb and ground pork are also available. Similar to ground beef products, these products may contain varying amounts of fat and varying nutrient content, which consumers cannot visually detect. In addition, ground pork may include product from AMR systems or from low temperature rendering, which may affect the nutrient content of these products. Therefore, FSIS is proposing to require nutrition labeling on these products and other ground or chopped meat products. As noted above, meat from AMR systems or low temperature rendering typically does not comprise more than 10 percent of ground meat products, including ground pork. Product from AMR systems or low temperature rendering is generally not used in ground or chopped lamb. Because products such as ground pork and ground lamb may contain varying amounts of fat and nutrient content, which consumers cannot visually detect, and because ground pork may include product from AMR systems or low temperature rendering, FSIS is proposing to require nutrition labeling on all ground or chopped meat products.
The fat-to-lean content of ground poultry products does not vary as greatly as that of ground beef products; however, the fat content of ground poultry can vary depending upon whether the product is ground light or dark meat, and whether the product includes poultry skin. As with the fat on ground meat products, consumers cannot readily detect the fat content of ground poultry products
products.
The fat-to-lean content of ground poultry products does not vary as greatly as that of ground beef products; however, the fat content of ground poultry can vary depending upon whether the product is ground light or dark meat, and whether the product includes poultry skin. As with the fat on ground meat products, consumers cannot readily detect the fat content of ground poultry products. The table below shows values for light and dark turkey meat, with skin and without skin. All values are based on raw product. The nutrient content of ground turkey would vary depending on which types of meat were used to produce the product.
Nutrient values per 100 grams Turkey, dark meat and skin Turkey, dark meat only Turkey, light meat and skin Turkey, light Meat only Calories 172 130 165 116 Cholesterol 65 mg 62 mg 62 mg 58 mg Fatty acids, saturated 2.99 g 1.64 g 2.19 g .53 g Source:
USDA Nutrient Database for Standard Reference (1985 data)
Because the characteristics of ground or chopped poultry are similar to those of ground or chopped meat, FSIS is also proposing to require nutrition labeling on ground or chopped poultry products. The Agency is also proposing comparable requirements for ground or chopped meat and poultry products because it is committed to equitable treatment of meat and poultry products. FSIS has consistently taken the position that similar products should be regulated in a similar manner to facilitate consumers' ability to make comparisons among these products.
For the reasons discussed above, the Agency has tentatively concluded that ground or chopped meat and poultry products that do not bear nutrition information would be misbranded under section 1(n)(1) of the FMIA and section 4(h)(1) of the PPIA
aken the position that similar products should be regulated in a similar manner to facilitate consumers' ability to make comparisons among these products.
For the reasons discussed above, the Agency has tentatively concluded that ground or chopped meat and poultry products that do not bear nutrition information would be misbranded under section 1(n)(1) of the FMIA and section 4(h)(1) of the PPIA. As noted above, in the January 6, 1993 final rule, the Agency did not require nutrition labeling on packages of single-ingredient, raw meat and poultry products because FSIS believed that consumers had reasonable expectations as to the nutritional qualities of such products since they are not modified through various stages of preparation, such as cooking and heat processing (58 FR 637). FSIS now believes that the variation in the fat and nutrient content of different ground or chopped products, the formulated nature of these products, and the fact that the fat content of these products cannot be readily visually assessed makes it difficult for consumers to have a reasonable expectation as to the nutritional quality of these products. Further consideration of the issues raised in the petition from CSPI brought many of these issues to FSIS' attention. If this proposal is adopted, the existing mandatory nutrition labeling provisions in §§ 317.309 and 381.409 would apply to these products, unless they are subject to an exemption.
Although current labeling on ground beef products often includes information concerning the percentage of fat in the product, as noted in the CSPI petition, without complete nutrition labeling, consumers cannot easily determine the amount of fat per serving of ground beef. Also, without complete nutrition labeling, consumers cannot assess how much saturated fat, cholesterol, protein, or calories the product contains
beling on ground beef products often includes information concerning the percentage of fat in the product, as noted in the CSPI petition, without complete nutrition labeling, consumers cannot easily determine the amount of fat per serving of ground beef. Also, without complete nutrition labeling, consumers cannot assess how much saturated fat, cholesterol, protein, or calories the product contains. Furthermore, consumers cannot easily compare fat percentages on the labeling of ground beef products with the information concerning grams of fat per serving or with the information concerning the percent daily values that is found on the labeling of products that are currently covered by the mandatory nutrition labeling program.
The Agency tentatively concludes that information concerning the nutritional qualities of ground or chopped meat and poultry products is particularly important because these products, especially ground beef, are widely consumed. Pertinent nutrition information is integral to consumer purchase decisions because use of this information may result in prevention of health problems and reduction of health risks for some consumers. Additional information about the nutrient values of ground or chopped meat and poultry products would enable consumers to make informed decisions about including these products in their diets and, therefore, will help consumers to construct healthy diets.
FSIS is proposing to require that nutrition information for ground or chopped meat and poultry products appear on the label of these products (unless an exemption applies), as is required for other products in the current mandatory nutrition labeling program, rather than on point-of-purchase materials. Ground or chopped products are similar to products in the mandatory nutrition labeling program, which requires nutrition information to be on the label of products, in that certain parameters, such as their fat content, can be controlled precisely to obtain the desired product
quired for other products in the current mandatory nutrition labeling program, rather than on point-of-purchase materials. Ground or chopped products are similar to products in the mandatory nutrition labeling program, which requires nutrition information to be on the label of 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. For these reasons, FSIS tentatively concludes that nutrition information should be required on the label of these products, consistent with the requirements in the existing mandatory nutrition labeling program. FSIS requests comments concerning whether nutrition information should be required on individual packages of ground or chopped product or whether the information should be allowed at their point-of-purchase.
In addition, consistent with requirements for products that fall under the existing mandatory nutrition labeling program, FSIS is proposing that the declaration of nutrient and food component content for ground or chopped products be required on an “as packaged” basis. The preamble to the final rule explained why products in the mandatory nutrition labeling program would be required to be labeled on an “as packaged” basis: “There are varieties of cooking methods that affect the nutrient values of food products differently. Therefore, there is no method to assure the accuracy or measure compliance of the nutrient values of food labeled on an ‘as consumed’ basis.” (58 FR 648)
to the final rule explained why products in the mandatory nutrition labeling program would be required to be labeled on an “as packaged” basis: “There are varieties of cooking methods that affect the nutrient values of food products differently. Therefore, there is no method to assure the accuracy or measure compliance of the nutrient values of food labeled on an ‘as consumed’ basis.” (58 FR 648). These reasons for requiring nutrition information on an “as packaged” basis for products in the current mandatory nutrition labeling program also are the basis for requiring that ground or chopped products be required to be labeled on an “as packaged” basis. Whether or not the fat is drained off during the cooking of ground or chopped products would affect the nutrient values of ground or chopped products. As discussed below, ground or chopped products will be subject to FSIS compliance. Therefore, FSIS tentatively concludes that it is necessary to require that nutrition information be presented on an “as packaged” basis for ground or chopped products in order to assure the accuracy of nutrient values and to measure compliance of the nutrient values of these products. FSIS requests comment on whether it would be difficult for producers to comply with this requirement.
However, consistent with the provisions of the existing mandatory program, FSIS is proposing that nutrition information for ground or chopped products may be presented on an “as consumed” basis, in addition to the required “as packaged” basis, provided that preparation and cooking instructions are clearly stated. FSIS is proposing to allow nutrition
FSIS requests comments on whether all Federal establishments and retail stores are able to control the fat and nutrient content of ground or chopped meat and poultry products. FSIS also requests comment on the practices of retail stores that grind or chop meat and poultry
packaged” basis, provided that preparation and cooking instructions are clearly stated. FSIS is proposing to allow nutrition
FSIS requests comments on whether all Federal establishments and retail stores are able to control the fat and nutrient content of ground or chopped meat and poultry products. FSIS also requests comment on the practices of retail stores that grind or chop meat and poultry. FSIS is interested in whether retail stores that grind or chop product mix trimmings from one Federal establishment with trimmings from other Federal establishments. In addition, FSIS is interested in data on the extent to which product from AMR systems or product from low temperature rendering is used in ground or chopped products.
FSIS requests comments concerning whether consumers have reasonable expectations as to the nutritional quality of ground or chopped product, whether consumers know which ground or chopped products are lowest in fat, whether consumers understand that the fat content of ground or chopped product can affect other nutrients, whether consumers can see the fat in ground or chopped meat and poultry products, and whether consumers can make comparisons among ground or chopped products and other products.
Exemptions
Under §§ 317.400(a)(1) and 381.500(a)(1), food products produced by small businesses are exempted from mandatory nutrition labeling if the product labels bear no nutrition claims or nutrition information. The regulations provide that a small business is any single-plant facility or multi-plant company or firm that employs fewer than 500 people and, as of July 1996, that produces 100,000 pounds or less annually of the product that qualifies the establishment for the exemption from mandatory nutrition labeling
nutrition labeling if the product labels bear no nutrition claims or nutrition information. The regulations provide that a small business is any single-plant facility or multi-plant company or firm that employs fewer than 500 people and, as of July 1996, that produces 100,000 pounds or less annually of the product that qualifies the establishment for the exemption from mandatory nutrition labeling. The Agency stated in the preamble to the January 6, 1993, final rule, that it would exempt small businesses from mandatory nutrition labeling requirements because these requirements would create undue economic hardship for small businesses and would create disincentives for these small businesses to develop more nutritious food products (58 FR 638).
For the reasons stated in the January 6, 1993 final rule, FSIS continues to believe that small businesses should be exempt from the mandatory nutrition labeling requirements proposed for ground or chopped meat and ground or chopped poultry products. Therefore, under this proposal, ground or chopped products produced by establishments that qualify for the small business exemption would be exempt from the proposed nutrition labeling requirements.
As discussed below, a significant amount of ground beef is processed at retail. Therefore, FSIS is proposing to revise the regulations to make clear that a single retail store or multi-retail store operation could qualify for the small business exemption. To qualify for this exemption, the retail facility must either be a single retail store that employs 500 or fewer people or a multi-retail store operation that employs 500 or fewer people. In addition, to qualify for the exemption, the retail establishment could produce no more than 100,000 pounds per year of the product that qualifies the establishment for an exemption
e small business exemption. To qualify for this exemption, the retail facility must either be a single retail store that employs 500 or fewer people or a multi-retail store operation that employs 500 or fewer people. In addition, to qualify for the exemption, the retail establishment could produce no more than 100,000 pounds per year of the product that qualifies the establishment for an exemption. Consistent with existing regulations, the qualification of a multi-retail store operation for an exemption from nutrition labeling would be based upon its total annual production of the product for all of its stores that qualifies the operation for the exemption and the total number of employees for all of its stores (see 58 FR 638 for guidance on existing regulations).
As under current regulations, for the purposes of the small business exemption, a food product is a formulation, not including distinct flavors which do not significantly alter the nutritional profile of the product, sold in any size package in commerce. Therefore, ground or chopped products formulated to have different levels of fat would be considered different food products for purposes of the small business exemption. For example, if a multi-retail store operation employed 500 or fewer people in total and produced, in total among all of its stores, 70,000 pounds of ground beef that is 10 percent fat and 60,000 pounds of ground beef that is 20 percent fat annually, the multi-retail store operation would not be required to include nutrition information on the label of these specific products if the labels for these products bore no nutrition claims or nutrition information
r fewer people in total and produced, in total among all of its stores, 70,000 pounds of ground beef that is 10 percent fat and 60,000 pounds of ground beef that is 20 percent fat annually, the multi-retail store operation would not be required to include nutrition information on the label of these specific products if the labels for these products bore no nutrition claims or nutrition information. However, for example, if a multi-retail store operation employed in total 500 or fewer employees and produced 130,000 pounds of 10 percent fat ground beef annually in total among all of its stores, it would not be exempt from nutrition labeling requirements on the basis of the “small business exemption.” FSIS is interested in comments on whether the exemption proposed is appropriate for purposes of ground or chopped products produced at retail establishments.
FSIS does 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 is proposing that nutrition information may be provided on labels or alternatively at their point-of-purchase. FSIS intends to make point-of-purchase materials available over the Internet free of charge; therefore, the proposed 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. FSIS is proposing to revise §§ 317.400(a)(1) and 381.500(a)(1) to provide that the small business exemption would not apply to the major cuts of single-ingredient, raw products
t free of charge; therefore, the proposed 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. FSIS is proposing to revise §§ 317.400(a)(1) and 381.500(a)(1) to provide that the small business exemption would not apply to the major cuts of single-ingredient, raw products.
Under existing §§ 317.400(a)(7) and 381.500(a)(7), retail stores and similar retail-type establishments are exempted from nutrition labeling requirements for multi-ingredient products processed at retail establishments and ready-to-eat products packaged or portioned at retail establishments (which would include ready-to-eat and multi-ingredient ground or chopped products) if the products bear no nutrition claims or nutrition information. As stated in the preamble to the January 6, 1993 final rule, FSIS exempted retail establishments from mandatory nutrition labeling requirements for these products because the Agency determined 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).
Most ground poultry is processed and packaged outside retail establishments. However, most ground beef is ground and packaged at retail. An AMI report states that retail survey respondents reported that an average 18.5 percent of their ground beef sales was from product arriving in a finely ground state, ready to sell or ready for repackaging at retail. Retail stores or distribution centers ground or re-ground 81.3 percent of ground beef sold (The American Meat Institute Foundation, Relative Ground Beef Contribution to the United States Beef Supply (May 1996): 7)
survey respondents reported that an average 18.5 percent of their ground beef sales was from product arriving in a finely ground state, ready to sell or ready for repackaging at retail. Retail stores or distribution centers ground or re-ground 81.3 percent of ground beef sold (The American Meat Institute Foundation, Relative Ground Beef Contribution to the United States Beef Supply (May 1996): 7).
As noted above, in the preamble to the January 6, 1993, final rule, the
As noted above, in the January 6, 1993 final rule, FSIS also exempted retail establishments from mandatory nutrition labeling partly because the Agency determined that it would be impractical to enforce nutrition labeling requirements on products prepared or served at retail. The Agency no longer believes enforcement of nutrition labeling requirements at retail stores to be impractical because FSIS is already conducting testing for Escherichia coli O157:H7 at retail.
Because a significant amount of ground beef is processed at retail, the Agency believes that there may be a significant amount of multi-ingredient ground beef retail processed products or ready-to-eat retail packaged products. FSIS also believes that enforcement of nutrition labeling at retail would not be impractical. Further, FSIS has tentatively concluded that ground or chopped products that do not include nutrition information would be misbranded for the reasons stated above. Therefore, the Agency is proposing that the current exemptions from nutrition labeling for ready-to-eat products packaged or portioned at retail stores and similar retail-type establishments and multi-ingredient products processed at retail stores and similar retail-type establishments not apply to ground or chopped meat and ground or chopped poultry products, unless the retail store or similar retail-type establishment meets the requirements of the small business exemption
labeling for ready-to-eat products packaged or portioned at retail stores and similar retail-type establishments and multi-ingredient products processed at retail stores and similar retail-type establishments not apply to ground or chopped meat and ground or chopped poultry products, unless the retail store or similar retail-type establishment meets the requirements of the small business exemption. FSIS requests comments and data on the volume of ground or chopped products that are multi-ingredient retail processed products or ready-to-eat retail packaged products.
FSIS is also proposing to revise the current retail exemptions discussed above to make clear that if a retail establishment qualifies for the small business exemption discussed above, ground or chopped ready-to-eat products packaged or portioned at retail and ground or chopped multi-ingredient products processed at retail would be exempt from nutrition labeling requirements. Although most ground poultry is processed and packaged outside retail establishments, FSIS believes it is important to propose consistent requirements for all ground or chopped products. Therefore, for all ground or chopped products, including ground poultry, these exemptions would not apply, unless the retail store or similar retail-type establishment meets the requirements of the small business exemption.
The exemptions for ready-to-eat products packaged and portioned at retail stores and for multi-ingredient products processed at retail stores would not apply to the major cuts of single-ingredient, raw products because they are not ready-to-eat or multi-ingredient products.
As discussed above, in addition to the small business and retail exemptions, existing §§ 317.400 and 381.500 provide other exemptions from nutrition labeling requirements
ed and portioned at retail stores and for multi-ingredient products processed at retail stores would not apply to the major cuts of single-ingredient, raw products because they are not ready-to-eat or multi-ingredient products.
As discussed above, in addition to the small business and retail exemptions, existing §§ 317.400 and 381.500 provide other exemptions from nutrition labeling requirements. These exemptions include products intended for further processing, products not for sale to consumers, products in small packages that are individually wrapped packages of less than \1/2\ ounce net weight, custom slaughtered or prepared products, and products intended for export. To qualify for the first three exemptions, the product's label cannot bear nutrition information or a nutrition claim. In the preamble to the January 6, 1993, final rule, FSIS explained that it was providing an exemption 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 than \1/2\ ounce 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). The Agency has 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
ort 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). The Agency has 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, under this proposal, 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 even if the proposed nutrition labeling requirements are adopted.
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). 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 is proposing 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
major cuts of single-ingredient, raw meat and poultry products may be provided on point-of-purchase materials, FSIS is proposing 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.
As stated in the existing regulations, restaurant menus generally do not constitute labeling or fall within the scope of these regulations. Likewise, restaurant menus that include ground or chopped products generally do not constitute nutrition labeling or fall within the scope of these 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 these regulations.
Finally, the current regulations provide that foods represented or purported to be specifically for infants and children less than 4 years of age must not 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. Under this proposal, 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 be required to meet these same requirements.
FSIS requests comments on whether its proposed revisions to the nutrition labeling exemptions are appropriate and
Enforcement and Compliance
Ground or chopped products. FSIS conducts a continuous sampling program of products that fall under the mandatory nutrition labeling program
pecifically for infants and children less than 4 years of age would be required to meet these same requirements.
FSIS requests comments on whether its proposed revisions to the nutrition labeling exemptions are appropriate and
Enforcement and Compliance
Ground or chopped products. FSIS conducts a continuous sampling program of products that fall under the mandatory nutrition labeling program. If the proposal to mandate nutrition labeling of ground or chopped meat and ground or chopped poultry products is adopted, the procedures set forth for product sampling and nutrient analysis in §§ 317.309(h)(1)-(8) and 381.409(h)(1)-(8) will be applicable to ground or chopped meat and to ground or chopped poultry products, respectively. Under this proposal, the Agency will 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 Nutrient Database for Standard Reference and there are no claims on the labeling. Therefore, if these proposed provisions for ground or chopped meat and poultry products are adopted, the Agency will treat these products as it treats all other products for which regulations already require nutrition labels on their package.
FSIS is proposing that ground or chopped products be subject to compliance 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 Nutrient Database for Standard Reference because the fat content of different ground or chopped products can vary significantly, depending upon the level of fat in the product being ground and depending on whether product from advanced meat recovery systems is used
hese products is based on the most current representative data base values contained in USDA's National Nutrient Data Bank or the USDA Nutrient Database for Standard Reference because the fat content of different ground or chopped products can vary significantly, depending upon the level of fat in the product being ground and depending on whether product from advanced meat recovery systems is used. Additionally, at this time, there are a limited number of ground or chopped products in the database ( e.g., ground beef, 17% fat, 21% fat, and 27% fat).
Further, FSIS program 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 product. For example, FSIS program employees cannot visually determine whether product that is labeled 17 percent fat ground beef is actually 17 percent fat ground beef as opposed to 27 percent fat (or another percentage of fat) ground beef. Therefore, even if the retailer or other producer uses information from the USDA database to label these products, FSIS will need to conduct compliance sampling and nutrient analysis to ensure that the information on the label accurately reflects the nutrient content of the labeled products.
The Agency is also proposing to revise §§ 317.345(e) and 381.445(e) so that they refer to USDA's National Nutrient Data Bank and its released form, the USDA Nutrient Database for Standard Reference, and to remove current references to the Agriculture Handbook No. 8 series, because this handbook series is now out of print.
For the nutrition labeling of some ground or chopped meat or ground or chopped poultry, nutrient data may be immediately available through the USDA Nutrient Database for Standard Reference ( e.g., ground beef with 17 percent fat, ground beef with 21 percent fat, and ground beef with 27 percent fat)
rences to the Agriculture Handbook No. 8 series, because this handbook series is now out of print.
For the nutrition labeling of some ground or chopped meat or ground or chopped poultry, nutrient data may be immediately available through the USDA Nutrient Database for Standard Reference ( e.g., ground beef with 17 percent fat, ground beef with 21 percent fat, and ground beef with 27 percent fat). Private databases may be available to assess the nutrient content of other products. In addition, producers are able to provide the nutrition information for many products produced to meet purchase specifications. Because producers know the different cuts of meat that go into ground or chopped product, they have the information necessary to determine the nutrient content of the products. FSIS believes that if they need to conduct nutrient analysis, the analysis should not impose an excessive burden. FSIS will develop a list of published sources of information concerning the nutrient content of ground or chopped products, so that industry could obtain available literature from local libraries. This information would facilitate the development of nutrition labels for ground or chopped products. FSIS requests comments and supporting data on the costs that Federal and retail establishments would incur for conducting nutrient analysis of ground or chopped products.
For ground or chopped products that are nutritionally labeled at official establishments, FSIS program employees will collect samples for nutrient analysis at official establishments, consistent with the Agency's existing sampling program of products that fall under the mandatory nutrition labeling program. For ground or chopped products that are produced and nutritionally labeled at retail, it is likely that FSIS program employees will collect samples for nutrient analysis while they are conducting other program activities at retail stores
analysis at official establishments, consistent with the Agency's existing sampling program of products that fall under the mandatory nutrition labeling program. For ground or chopped products that are produced and nutritionally labeled at retail, it is likely that FSIS program employees will collect samples for nutrient analysis while they are conducting other program activities at retail stores. When collecting samples for nutrient analysis, FSIS will not typically collect samples of the same product from both Federal establishments and retail establishments, unless circumstances warrant sampling the same product at both locations. In general, if a product from a Federal establishment is further processed at retail, FSIS would only collect samples of that product at retail, where it would be packaged for sale to consumers. FSIS can distinguish between product packaged at retail versus product packaged at a Federal establishment.
Major cuts of single-ingredient, raw products. 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 Nutrient Database for Standard Reference, and there are no nutrition claims on the labeling, FSIS will not sample and conduct a nutrient analysis of these products. The Agency's sampling and testing policy for these products will be consistent with its policy under the current voluntary nutrition labeling program for these products.
For the major cuts of single-ingredient, raw products, FSIS personnel can visually identify the particular cut. If the nutrition information for these products is based on USDA's National Nutrient Data Bank or the USDA 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 this data because it is USDA data
For the major cuts of single-ingredient, raw products, FSIS personnel can visually identify the particular cut. If the nutrition information for these products is based on USDA's National Nutrient Data Bank or the USDA 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 this data because it is USDA data. If the nutrition information is based on USDA data, and there are no nutrition claims, FSIS program employees would only have to verify that the data presented accurately pertains to a particular major cut of single-ingredient, raw product. Therefore, FSIS does not need to conduct nutrient analysis for these products.
If the nutrition information on the label or at the point-of-purchase of major cuts of single-ingredient, raw products is based on databases other than the above referenced USDA ones or other data, or if there are nutrition claims on the labeling, these products would be subject to FSIS compliance analysis. Most nutrition information for the major cuts of single-ingredient, raw products is based on USDA data and, typically, no nutrition claims are made on the labeling of these products. Therefore, these products are and would generally continue to be exempt from the FSIS nutrition labeling compliance verification program.
It is likely that FSIS program employees will verify that nutrition information is provided for the major
Percentage Labeling
FSIS is withdrawing its proposed rule of May 24, 1994 (59 FR 26916), discussed above, which sought to amend the regulations by permitting percentage labeling for lean and fat on ground beef and hamburger, when the product did not meet the regulatory criteria established for “low fat,” if the product had nutrition information on its labeling or in point-of-purchase materials that were in close proximity to the product. FSIS is withdrawing this proposal and proposing revised percentage labeling requirements in this rule
by permitting percentage labeling for lean and fat on ground beef and hamburger, when the product did not meet the regulatory criteria established for “low fat,” if the product had nutrition information on its labeling or in point-of-purchase materials that were in close proximity to the product. FSIS is withdrawing this proposal and proposing revised percentage labeling requirements in this rule. In this proposal, FSIS is expanding the categories of ground or chopped products that can have lean percentage labeling.
FSIS is proposing 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.” The Agency is proposing to do so because many consumers have become accustomed to this labeling on ground beef products, and because FSIS believes this labeling provides a quick, simple, accurate means of comparing all ground or chopped meat and poultry products. The proposed regulatory language requires that a 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. The Agency is proposing these requirements concerning size, type, and color to ensure that the statement of the fat percentage is as clear and readily observable as the statement of the lean percentage.
FSIS requests comments on whether percent fat/percent lean information provides a quick, simple, accurate means of comparing all ground or chopped meat and poultry products. Also, FSIS is specifically requesting comments concerning whether its proposed percent fat/percent lean labeling provisions for ground or chopped meat and ground or chopped poultry products that do not meet the regulatory criteria for “low fat” would be misleading in any way. FDA's regulations do not provide for the nutrient content claim, “X percent lean.” Similarly, FDA does not allow a statement of “percent fat/percent lean” on the products it regulates
ether its proposed percent fat/percent lean labeling provisions for ground or chopped meat and ground or chopped poultry products that do not meet the regulatory criteria for “low fat” would be misleading in any way. FDA's regulations do not provide for the nutrient content claim, “X percent lean.” Similarly, FDA does not allow a statement of “percent fat/percent lean” on the products it regulates. FSIS requests comment on whether these discrepancies between FDA's and FSIS' regulations will cause confusion among consumers. Finally, FSIS is not requiring the statement of fat percentage to precede the statement of lean percentage but will allow the statements to appear in either order. FSIS requests comment on whether consumers are more likely to read and understand the statement of fat percentage when it precedes the statement of lean percentage than when it follows the statement of lean percentage.
Executive Order 12866—Preliminary Analysis
This action has been reviewed for compliance with Executive Order 12866. As this action is determined “significant” for purposes of Executive Order 12866, the Office of Management and Budget (OMB) has reviewed it.
Need for the Rule
During the 1996 nutrition labeling survey, RDI found 57.7 percent of stores surveyed provided nutrition information for 90 percent of the major cuts of single-ingredient, raw meat and poultry products, in accordance with program guidelines. In the 1999 nutrition labeling survey, RDI found that 54.8 percent of stores surveyed provided nutrition information for 90 percent of the major cuts of single-ingredient, raw meat and poultry products, in accordance with program guidelines. Therefore, the most recent surveys did not show significant participation in the voluntary nutrition labeling program as defined in the regulations. Without significant participation, the Agency has tentatively concluded that a lack of consistent and complete nutrition information for the major cuts of single-ingredient, raw products exists
poultry products, in accordance with program guidelines. Therefore, the most recent surveys did not show significant participation in the voluntary nutrition labeling program as defined in the regulations. Without significant participation, the Agency has tentatively concluded that a lack of consistent and complete nutrition information for the major cuts of single-ingredient, raw products exists. FSIS has also tentatively concluded that producers' ability to control the formulation of single-ingredient, raw ground or chopped products results in variations across these products that may be difficult for consumers to detect. Without nutrition information, FSIS believes that these products would be misbranded under section 1(n) of the FMIA or section 4(h) of the PPIA and that further action is necessary in order to provide consumers with adequate nutrition information that is consistent with the provisions of the 1993 final nutrition labeling rule.
Baseline
In the analysis below, FSIS assumes that the level of voluntary labeling, absent any Federal action, would remain at the current level. The 1999 RDI nutrition labeling survey found that 54.8 percent of the stores surveyed provided nutrition information for 90 percent of the major cuts of single-ingredient, raw meat and poultry products, in accordance with program guidelines. As there has been little change in the level of compliance over the last several years (see discussion of previous surveys above), FSIS believes that it is appropriate to assume that this level of participation in the voluntary nutrition labeling program would not change unless the regulations are revised.
In the analysis below, FSIS also assumes that 80 percent of the retail establishments and processors have made investments in the equipment necessary to print, stamp, or affix nutrition labels on products. This assumption is based on the results of the 1999 RDI safe handling labeling compliance survey
n the voluntary nutrition labeling program would not change unless the regulations are revised.
In the analysis below, FSIS also assumes that 80 percent of the retail establishments and processors have made investments in the equipment necessary to print, stamp, or affix nutrition labels on products. This assumption is based on the results of the 1999 RDI safe handling labeling compliance survey. This survey revealed that 96.7 percent of large chains, 90.5 percent of large independent retailers, and 84.1 percent of medium/small independents had already complied with the Mandatory Safe Handling Statements on Labeling of Raw Meat and Poultry Products final rule. FSIS used the 80 percent assumption in order to be conservative and not overestimate the percentage of processors and retailers that have already invested in the necessary equipment. Because the equipment needed to print, stamp, or affix nutrition labels is similar to the equipment used to print, stamp, or affix labels to meet the “safe handling” rule's requirements, FSIS assumes that 80 percent of establishments would not have to install new machines for stamping, printing, or affixing nutrition labels for ground or chopped products. FSIS is assuming that the same percentage of processors have invested in this equipment as retailers. Again, this is a conservative assumption. FSIS requests comments concerning whether the 80 percent
To determine how many entities would be affected by this rulemaking, the Agency used a combination of FSIS developed databases and industry sources. Table 1 indicates that in 1999, 63 establishments produced ground poultry and 2,426 establishments produced ground meat. FSIS developed this data on establishments from its Enhanced Facilities Database (EFD). This source does not provide separate data for ground pork, lamb and beef. The number of establishments producing ground pork or lamb is, however, likely to be very small based on information from the AMI survey discussed below in the preliminary cost analysis
ltry and 2,426 establishments produced ground meat. FSIS developed this data on establishments from its Enhanced Facilities Database (EFD). This source does not provide separate data for ground pork, lamb and beef. The number of establishments producing ground pork or lamb is, however, likely to be very small based on information from the AMI survey discussed below in the preliminary cost analysis. One plant that produced either meat or poultry and did not have employment size specification is excluded from Table 1.
Table 1.—Size Distribution of Meat and Poultry HACCP Plants Producing Ground Products Poultry Meat Total Very Small 10 1,470 1,480 Small 23 843 866 Large 28 68 96 Missing Values 2 45 47 Total 63 2,426 2,489 Note: Very small=9 or less employees; small=10 to 499 employees; large=500 or more employees. FSIS believes that a significant amount of ground beef is processed at retail. Table 2 shows the number of retail stores in 1999. Most of these stores grind beef. However, FSIS does not have specific data concerning the levels of ground beef ground at retail or on the size of retail stores that process ground beef. FSIS researched Census data for this information, but specific information related to retail establishments processing ground or chopped product was unavailable. Table 2 reports data from FMI. FSIS combined the first two categories of supermarkets with sales in excess of $2 million per year to compare their share with “other stores” with sales of less than $2 million per year. In 1999, there were 127,000 retail grocery stores.
Table 2.—Number of Retail Grocery Stores, 1999 1999 number 1999 % of total Total 127,000 100 Supermarket Chains & Independent 31,500 25 Other Stores 37,200 29 Convenience Stores 57,500 45 Wholesale Clubs 800 0.6 Note: “Supermarkets” are defined to have sales of $2 million or more per year. “Other Stores” are defined to have sales of under $2 million. Source:
FMI Information Service, Progressive Grocer, 67th Annual Report of the Grocery Industry. April 2000, p.20
total Total 127,000 100 Supermarket Chains & Independent 31,500 25 Other Stores 37,200 29 Convenience Stores 57,500 45 Wholesale Clubs 800 0.6 Note: “Supermarkets” are defined to have sales of $2 million or more per year. “Other Stores” are defined to have sales of under $2 million. Source:
FMI Information Service, Progressive Grocer, 67th Annual Report of the Grocery Industry. April 2000, p.20.
With respect to consumers, FSIS assumes that without further action, they would have access to the current level of labeling information and continue with their current dietary habits. The 1999 RDI survey estimated that nutrition labeling, in accordance with the program guidelines, for the major cuts of single-ingredient, raw meat and poultry products was available to 62.8 percent of shoppers. This estimate was based on the sales volume of the stores surveyed. Consistent with the Agency's assumption about compliance among retail stores, FSIS assumes that this level of available nutrition information, in accordance with program guidelines, would not change without further regulatory action.
FSIS used data from USDA's Continuing Survey of Food Intake by Individuals (CSFII), and the associated Diet and Health Knowledge Survey (DHKS) to establish a baseline for fat, saturated fat, and cholesterol intake. The CSFII collects data on food intakes by individuals. Most recently, USDA conducted three separate one-year surveys for 1994-96. These surveys recorded two nonconsecutive days of food consumption, and collected information on what and how much individuals ate, and where the food was obtained. This information was used to develop estimates of nutrient intake for each individual respondent. The DHKS gathered data on consumers' knowledge of issues related to diet and heath, and contained several questions relating to the use of nutrition information labels and nutrition information for food products
llected information on what and how much individuals ate, and where the food was obtained. This information was used to develop estimates of nutrient intake for each individual respondent. The DHKS gathered data on consumers' knowledge of issues related to diet and heath, and contained several questions relating to the use of nutrition information labels and nutrition information for food products. Linking information from the two surveys allowed FSIS to correlate use of nutrition information from the DHKS with nutrient intake data from the CSFII. The Agency focused here on two key questions pertaining to nutrition information use on all food products and on meat and poultry in particular:
Q: When you buy foods, do you use the nutrition panel that tells the amount of calories, protein, fat, and such [e.g., sodium, total carbohydrate] in the serving of a food: Often (always), sometimes, rarely, or never? (Question 16-c, DKHS)
Q: When you buy raw meat, poultry, or fish, do you look for nutrition information: Often (always), sometimes, rarely, or never? (Question 17-I, DHKS).
Using data from the CSFII and the DHKS, FSIS estimated rates of nutrition information usage, based on these two questions. The results are presented in Table 3. Note that rates of label usage are uniformly higher for women than for men, and that rates of nutrition label usage are higher for food products as a whole than for raw meat, poultry and fish products.
Table 3.—Consumer Usage of Nutrition Information Often Men Women Sometimes Men Women Rarely/never Men Women Do not buy Men Women Use Nutrition Facts Panel 26.7 41.7 25.6 32.6 47.7 25.6 n/a N/A Look for Nutrition Information on Raw Meat, Poultry, or Fish 16.9 22.1 18.2 18.0 62.7 57.9 2.2 2.0 Note: Percent of respondents, based on 3 year weighted averages, 1994-1996
eat, poultry and fish products.
Table 3.—Consumer Usage of Nutrition Information Often Men Women Sometimes Men Women Rarely/never Men Women Do not buy Men Women Use Nutrition Facts Panel 26.7 41.7 25.6 32.6 47.7 25.6 n/a N/A Look for Nutrition Information on Raw Meat, Poultry, or Fish 16.9 22.1 18.2 18.0 62.7 57.9 2.2 2.0 Note: Percent of respondents, based on 3 year weighted averages, 1994-1996. To establish a baseline of Intake of Fat, Saturated Fat, and Cholesterol, FSIS used the same data sources to estimate dietary intake of fat, saturated fat, and cholesterol, along with the percentage of calories from fat and saturated fat. The CSFII contains information on the intake of these food components, based on the food consumption reported by survey respondents.
Tables 4 and 5 present the estimated intake of fat, saturated fat, and
Table 4.—Dietary Intake of Fat, Saturated Fat, by Usage of Nutrition Facts Panel Often Sometimes Rarely/never Average Men: Total Fat 83.13 92.52 98.14 92.51 Saturated Fat 26.93 31.43 33.67 31.12 Cholesterol 293.39 327.77 353.97 339.07 Women: Total Fat 55.95 62.78 63.98 60.16 Saturated Fat 18. 04 20.77 21.39 19.71 Cholesterol 196.60 216.84 230.03 210.53 Note: Fat intake in grams, cholesterol in milligrams. Table 5.—Dietary Intake of Fat, Saturated Fat, by Usage of Nutrition Information on Raw Meat, Poultry, or Fish Often Sometimes Rarely/never Do not buy Average Men: Total Fat 81.64 92.49 96.09 74.48 92.51 Saturated Fat 27.20 31.09 32.44 24.02 31.12 Cholesterol 311.81 321.49 355.14 236.83 339.07 Women: Total Fat 53.90 61.70 62.18 57.23 60.16 Saturated Fat 17.39 20.60 20.41 17.27 19.71 Cholesterol 194.32 219.27 216.55 135.89 210.53 Note: Fat intake in grams, cholesterol in milligrams. The estimated intake of fat and saturated fat can also be expressed as the percentage of calories from fat. This conversion is done with the following formula:
Percentage Calories from Fat = 900*fat/energy, Where energy is total caloric intake (kilocalories), as measured by the CSFII
17.27 19.71 Cholesterol 194.32 219.27 216.55 135.89 210.53 Note: Fat intake in grams, cholesterol in milligrams. The estimated intake of fat and saturated fat can also be expressed as the percentage of calories from fat. This conversion is done with the following formula:
Percentage Calories from Fat = 900*fat/energy, Where energy is total caloric intake (kilocalories), as measured by the CSFII. Tables 6 and 7 show the percentage of calories from fat (and total cholesterol) broken down by label and nutrition information usage: Table 6.—Percentage of Calories From Fat and Total Cholesterol, by Usage of Nutrition Facts Panel Often Sometimes Rarely/never Average Men: Total Fat 31.54 33.63 35.27 33.44 Saturated Fat 10.19 11.38 12.00 11.19 Cholesterol 293.39 327.77 353.97 339.07 Women: Total Fat 31.14 33.40 34.49 32.49 Saturated Fat 10.00 11.38 11.59 10.64 Cholesterol 196.60 216.84 230.03 210.53 Note: Fat and Saturated Fat values are percentage of calories from fat source; cholesterol in milligrams. Table 7.—Percentage of Calories From Fat and Total Cholesterol, by Usage of Nutrition Information on Raw Meat, Poultry, or Fish Often Sometimes Rarely/never Do not buy Average Men: Total Fat 31.67 34.03 33.88 29.69 33.44 Saturated Fat 10.53 11.36 11.37 9.52 11.19 Cholesterol 311.81 321.49 355.14 236.83 339.07 Women: Total Fat 31.62 32.94 32.87 26.79 32.49 Saturated Fat 10.15 10.82 10.82 9.19 10.64 Cholesterol 194.32 219.27 216.55 135.89 210.53 Note: Fat and Saturated Fat values are percentage of calories from fat source; cholesterol in milligrams
ever Do not buy Average Men: Total Fat 31.67 34.03 33.88 29.69 33.44 Saturated Fat 10.53 11.36 11.37 9.52 11.19 Cholesterol 311.81 321.49 355.14 236.83 339.07 Women: Total Fat 31.62 32.94 32.87 26.79 32.49 Saturated Fat 10.15 10.82 10.82 9.19 10.64 Cholesterol 194.32 219.27 216.55 135.89 210.53 Note: Fat and Saturated Fat values are percentage of calories from fat source; cholesterol in milligrams. Regulatory Options
FSIS considered several regulatory options: (1) Continuing with the existing voluntary program; (2) making the voluntary program mandatory; (3) requiring nutrition information on labels of all ground or chopped products and making the voluntary program mandatory for the major cuts of single-ingredient, raw meat and poultry products; (4) requiring nutrition information on labels of the major cuts of single-ingredient, raw meat and poultry products and on all ground or chopped products; and (5) requiring nutrition information on labels of all single-ingredient, raw meat and poultry products and all ground or chopped products.
Option 1: Continuing with the voluntary program. FSIS could continue with the existing voluntary program and attempt to increase participation by providing additional assistance to the nonparticipants. The 1999 nutrition labeling survey found a significant difference in participation rates according to outlet type. Chain stores showed a 65.5 percent participation rate, large independents showed a 46.5 percent participation rate, and medium and small independents showed a participation rate of 26.3 percent. Thus, FSIS could provide nutrition information or point-of-purchase materials to independent retail stores to encourage their participation in the voluntary nutrition labeling program
rding to outlet type. Chain stores showed a 65.5 percent participation rate, large independents showed a 46.5 percent participation rate, and medium and small independents showed a participation rate of 26.3 percent. Thus, FSIS could provide nutrition information or point-of-purchase materials to independent retail stores to encourage their participation in the voluntary nutrition labeling program.
Retail establishments would continue to provide, on a voluntary basis, nutrition labeling for all single-ingredient, raw meat and poultry products, including major cuts identified in §§ 317.344 and 381.444 (including ground beef and ground pork) and cuts that are not identified as major cuts (including ground or chopped products not covered in §§ 317.344 and 381.444). This information could be provided at the point-of-purchase or on the label of the product.
Option 2: Make the voluntary program mandatory. FSIS could make the voluntary program mandatory by requiring nutrition information, either on labels or at the point-of-purchase, for all single-ingredient, raw meat and poultry products, including the major cuts of single-ingredient, raw products identified in §§ 317.344 and 381.444 (including ground beef and ground pork) and the nonmajor cuts of single-ingredient, raw meat and poultry products (including ground or chopped products not covered in §§ 317.344 and 381.444). Under this option, FSIS would assume that most retailers would display point-of-purchase information for these products rather than nutrition labels, because this is an inexpensive means of providing nutrition information for multiple products. This approach does not allow for any distinction between ground or chopped meat and poultry products and other cuts of meat. In addition, this approach does not distinguish between the major and nonmajor cuts
ers would display point-of-purchase information for these products rather than nutrition labels, because this is an inexpensive means of providing nutrition information for multiple products. This approach does not allow for any distinction between ground or chopped meat and poultry products and other cuts of meat. In addition, this approach does not distinguish between the major and nonmajor cuts.
Option 3: Require nutrition information on labels of all ground or chopped meat and poultry products and make the voluntary program mandatory for the major cuts of single-ingredient, raw meat and poultry products (other than ground beef and ground pork). FSIS could require nutrition information on the labels of all ground or chopped products and could require nutrition information, either on their labels or at their point-of-purchase, for the major cuts of single-ingredient, raw meat and poultry products identified in §§ 317.344 and 381.444 (other than ground beef and ground pork). Retail establishments and producers could continue to voluntarily provide nutrition information for nonmajor cuts of single-ingredient, raw meat and poultry products that are not ground or chopped. This approach allows for a distinction between ground or chopped meat and poultry and other cuts of meat and poultry. It also allows for a distinction between major and nonmajor cuts. Consistent with the regulations, the voluntary nutrition labeling surveys only assessed whether nutrition labeling was provided for the major cuts of single-ingredient, raw meat and poultry products. Until some assessment is made of whether adequate information is being provided for the nonmajor cuts of single-ingredient, raw products that are not ground or chopped, FSIS cannot determine whether it would be beneficial to require nutrition information for these products.
In their June 3, 1997, petition discussed above, CSPI stated that USDA should require complete “Nutrition Facts” on ground beef labels that make nutrient content claims
uate information is being provided for the nonmajor cuts of single-ingredient, raw products that are not ground or chopped, FSIS cannot determine whether it would be beneficial to require nutrition information for these products.
In their June 3, 1997, petition discussed above, CSPI stated that USDA should require complete “Nutrition Facts” on ground beef labels that make nutrient content claims. This option would require complete “Nutrition Facts” on all ground beef labels. Thus, CSPI's petition supports this aspect of this option. However, the CSPI petition also stated that point-of-purchase information is generally a poor substitute for labels and that the “Nutri-Facts” posters and brochures used by many stores have severe flaws. Thus, the CSPI petition does not support providing nutrition labeling at the point-of-purchase.
Option 4: Require nutrition information on labels of the major cuts of single-ingredient, raw meat and poultry products and on all ground or chopped products. FSIS could require nutrition information only on labels of the major cuts of single-ingredient, raw meat and poultry products identified in §§ 317.344 and 381.444 (including ground beef and ground pork) and on all other ground or chopped products not covered in §§ 317.344 and 381.444. As in Option 3, establishments could voluntarily provide nutrition information, either at the point-of-purchase or on the label, for the nonmajor cuts of single-ingredient, raw meat and poultry products that are not ground or chopped. This approach allows for a distinction between major cuts and nonmajor cuts that are not ground or chopped. Until some assessment is made of whether adequate information is being provided for the nonmajor cuts of single-ingredient, raw products that are not ground or chopped, FSIS cannot determine whether it would be beneficial to require nutrition information for these products.
Option 5: Require nutrition labels on all single-ingredient, raw meat and poultry products and on all ground or chopped products
some assessment is made of whether adequate information is being provided for the nonmajor cuts of single-ingredient, raw products that are not ground or chopped, FSIS cannot determine whether it would be beneficial to require nutrition information for

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/FR_PRORULE_01-1119. Check the current official text before relying on it. Not legal advice.