Nutrition Labeling of Meat and Poultry Products; Technical Amendments

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 317 and 381

[Docket No. 91-006F-TA]

RIN 0583-AB34

Nutrition Labeling of Meat and Poultry Products; Technical

Amendments

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Confirmation of interim rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is confirming

interim regulations amending its final nutrition labeling regulations.

FSIS is taking this action to improve the clarity and accuracy of the

regulations, and to provide regulations that parallel the Food and Drug

Administration's (FDA) nutrition labeling regulations to the maximum

extent possible.

EFFECTIVE DATE: July 6, 1994.

FOR FURTHER INFORMATION CONTACT:

Charles Edwards, Director, Product Assessment Division, Regulatory

Programs, Food Safety and Inspection Service, U.S. Department of

Agriculture, Washington, DC 20250, (202) 254-2565.

SUPPLEMENTARY INFORMATION:

Executive Order 12866

This final rule has been reviewed under Executive Order 12866.

Background

On January 6, 1993, FSIS published in the Federal Register (58 FR

632) final regulations on nutrition labeling for meat and poultry

products. FSIS's nutrition labeling regulations parallel, to the

maximum extent possible, FDA's nutrition labeling regulations

promulgated under the Nutrition Labeling and Education Act. FSIS

published its final regulations on nutrition labeling simultaneously

with FDA's publication.

After the publication of FSIS's final regulations on nutrition

labeling, FSIS received several comments from various interested

parties contending that portions of FSIS's regulations were unclear,

contained technical, unintended consequences in a specific provision,

or were not parallel to FDA's nutrition labeling regulations. Those

portions included provisions related to: (a) Providing nutrition

labeling by alternate means for packages that have a total surface area

available to bear labeling of less than 12 square inches; (b) the

saturated fat criterion for the ``lean'' definition; and (c) the use of

nutrient content claims on infant and toddler foods.

After considering these comments and conducting an in-depth review

of FDA's final nutrition labeling regulations, FSIS believed that its

final regulations were inconsistent with FDA's regulations in certain

areas where uniformity should exist. FSIS also determined that several

provisions were inadvertently omitted in its final regulations.

Accordingly, FSIS issued an interim final rule in the Federal

Register on September 10, 1993. The interim final rule set forth

technical amendments (58 FR 47624) to the FSIS nutrition labeling

regulations to provide more well-defined regulations that reflect

accuracy and clarity regarding the nutrition labeling of meat and

poultry products. The amendments consisted of clarifications that are

essential to understanding and complying with published provisions,

changes that are necessary to avoid technical, unintentional

consequences in specific provisions, and additional provisions that

were inadvertently omitted. FSIS announced in the interim final rule

that there would be a 30-day comment period, and that the Agency would

carefully consider all comments received before finalizing the interim

rule.

Interim Final Rule

In its interim final rule, FSIS allowed for nutrition labeling to

be provided by alternate means for packages that have a total surface

area available to bear labeling of less than 12 square inches.

Accordingly, FSIS added provisions at 9 CFR 317.400(d) and 381.500(d)

to permit manufacturers to provide an address or telephone number on

the package for consumers to write or call for nutrition information,

provided that the labels for these products bear no nutrition claims or

nutrition information. These provisions do not affect the exemption for

individually wrapped packages of less than \1/2\ ounce net weight.

Also, in its interim final rule, FSIS added a small business

exemption provision that was inadvertently omitted from its final

nutrition labeling regulations. The provision at 9 CFR 317.400(a) and

381.500(a) states that the calculation of poundage shall be based on

the most recent 2-year average of business activity.

FSIS defined ``insignificant amount'' in the final nutrition

labeling regulations as that amount that may be rounded to zero in

nutrition labeling, except that for total carbohydrate, dietary fiber,

and protein, it is an amount less than 1 gram. In its interim final

rule, FSIS revised the definition of ``insignificant amount'' at 9 CFR

317.309(g)(1) and 381.409(g)(1) to include sugars as an amount less

than 1 gram. FSIS determined that sugars is another nutrient with a

caloric contribution that is consistent with that for total

carbohydrate, dietary fiber, and protein. Therefore, when used in

reference to the simplified format, an insignificant amount of sugars

is that amount which is less than 1 gram.

FSIS made reference in the final nutrition labeling regulations to

a retailer providing nutrition information on the label of single-

ingredient, raw products without referring to a manufacturer. In the

preamble to its final regulations, FSIS made no distinction between

products packaged in official establishments and those packaged at

retail level. However, to clarify any misunderstanding regarding these

provisions, in its interim final rule, FSIS modified 9 CFR

317.345(a)(1) and 381.445(a)(1) to include reference to a manufacturer.

In its interim final rule, FSIS also amended table 1 of 9 CFR

317.312(b) and 381.412(b) to include product categories for plain meats

and meat sticks and plain poultry and poultry sticks with reference

amounts of ``55 g.'' These product categories were inadvertently

omitted from the final rule.

Also, for purposes of clarification and to more fully harmonize

with FDA requirements, FSIS, in its interim final rule, amended table 2

at 9 CFR 317.312(b) and 381.412(b) by moving the lasagna examples to

the category of mixed dishes measurable with a cup and also adding meat

and poultry filled pasta as further examples of products in this

category. FSIS also revised footnote 4 to table 2 at 9 CFR 317.312(b)

and 381.412(b) by adding the following words at the end: ``except for

products in which both the solids and liquids are customarily

consumed.''

In its interim final rule, FSIS modified the ``lean'' definition to

reflect the change in the saturated fat definition. The final

regulations defined saturated fat as the sum of all fatty acids

containing no double bonds. Inclusion of all fatty acids with no double

bonds in the definition of saturated fat can inflate the level of

saturated fat by approximately 15 percent. To offset this unintended

effect, FSIS increased the saturated fat criterion for the ``lean''

definition from less than 4 grams to 4.5 or less grams.

In addition, in its interim final rule, FSIS clarified the

provisions concerning nutrient content claims on foods for infants and

children under 2 years of age by removing the language ``except that

nutrient content claims may not be made on products intended

specifically for use by infants and toddlers less than 2 years of age''

from 9 CFR 317.313(a) and 381.413(a). FDS believes that the complete

prohibition of nutrient content claims on foods for infants and

children under 2 years of age may have been overly broad. FSIS agrees

with this position.

It was FSIS's intent to allow percentage labeling of vitamins and

minerals on foods intended for use by infants and children less than 2

years of age, as provided for by FDA at 21 CFR 101.13(q)(3). Therefore,

in its interim final rule, FSIS amended 9 CFR 317.313(q)(3) and

381.413(q)(3) to allow percentage labeling of vitamin and minerals on

such foods.

In cross-referencing FDA's final regulations, FSIS inadvertently

omitted paragraphs (e) and (f) as contained in 21 CFR 101.66, Label

statements relating to usefulness in reducing or maintaining body

weight. Generally, for meat and poultry products, ``sugar free'' claims

are not particularly relevant. However, to harmonize with FDA

regulations, FSIS, in its interim final rule, added provisions

regarding the labeling of products as ``sugar free'' and ``no added

sugar,'' and the use of label terms suggesting low calorie or reduced

calorie foods. FSIS amended 9 CFR 317.380 and 281.480 to incorporate

the provisions of 21 CFR 101.66(e) and (f).

Discussion of Comments

FSIS received no comments in response to the interim final rule.

Therefore, FSIS is adopting the interim final rule as published in the

Federal Register on September 10, 1993 (58 FR 47624).

List of Subjects

9 CFR Part 317

Food labeling, Food packaging, Meat inspection.

9 CFR Part 381

Food labeling, Poultry and poultry products, Poultry inspection.

Final Rule

For the reasons discussed in the preamble:

Sec. 317.309, 317.312, 317.313, 317.345, 317.362, 317.380,

317.400 [Amended]

1. In part 317, the amendments to Sec. 317.309(g)(1); Table 1 and 2

in Sec. 317.312(b); Sec. 317.313 (a) and (q)(3); Sec. 317.345(a)(1);

Sec. 317.362(c)(1); Sec. 317.380; and Sec. 317.400 (a)(1)(iii) and (d)

published on September 10, 1993 (58 FR 47624), are confirmed as final.

Sec. 381.409, 381.412, 381.413, 381.445, 381.426, 381.480,

381.500 [Amended]

2. In part 381, the amendments to Sec. 381.409(g)(1); Tables 1 and

2 in Sec. 381.412(b); Sec. 381.413 (a) and (q)(3); Sec. 381.445(a)(1);

Sec. 381.462(c)(1); Sec. 381.480; and Sec. 381.500 (a)(1)(iii) and (d)

published on September 10, 1993 (58 FR 47624), are confirmed as final.

Done at Washington, DC, on March 9, 1994.

Patricia Jensen,

Acting Assistant Secretary, Marketing and Inspection Services.

[FR Doc. 94-6013 Filed 3-15-94; 8:45 am]

BILLING CODE 3410-DM-M