[Federal Register Volume 59, Number 51 (Wednesday, March 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6013]
[[Page Unknown]]
[Federal Register: March 16, 1994]
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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
