[Federal Register Volume 59, Number 151 (Monday, August 8, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19283]


[[Page Unknown]]

[Federal Register: August 8, 1994]


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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service

9 CFR Parts 317 and 381

[Docket No. 93-020F]
RIN 0583-AB72

 

Placement of Nutrition Labeling and Other Mandatory Labeling on 
Meat and Poultry Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the 
Federal meat and poultry products inspection regulations by defining 
the information panel on the labeling of meat and poultry products; 
allowing mandatory labeling information to be shown in the information 
panel, in addition to the principal display panel; allowing nutrition 
information to be shown on other than the principal display panel or 
the information panel of meat and poultry products; and allowing final 
labeling bearing nutrition information, which has been approved by FSIS 
in sketch form, to be generically approved. FSIS is taking this action 
to provide increased flexibility in the placement of nutrition 
information and other mandatory information on the labeling of meat and 
poultry products and streamline the nutrition labeling approval 
process.

EFFECTIVE DATE: August 8, 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:

Background

    FSIS published its final nutrition labeling regulations in the 
Federal Register on January 6, 1993 (58 FR 632). Corrections and 
technical amendments to this final rule were published on August 18, 
1993 (58 FR 43787), and September 10, 1993 (58 FR 47624), respectively. 
The technical amendments, which were issued as an interim final rule, 
were confirmed as final on March 16, 1994 (59 FR 12157). The nutrition 
labeling regulations specify a new format for nutrition information and 
the location of nutrition information on the label of packaged 
products. Nutrition information on a label of packaged meat or poultry 
products must appear on the label's principal display panel or on the 
information panel, except for gift packs where it may be displayed at a 
location other than on the product label, such as label inserts.
    Recognizing label space constraints, FSIS included provisions in 
the nutrition labeling regulations that allow a modified nutrition 
label on products in packages that have a total surface area available 
to bear labeling of 40 or less square inches, so that the required 
nutrition information could be presented on any label panel. The 
flexibility provided by these provisions reflects FSIS' recognition 
that it is more important that the nutrition information be presented 
on the immediate package than in any particular place.
    Following publication of its nutrition labeling regulations, FSIS 
received many comments from the meat and poultry industry requesting 
greater flexibility in the placement of nutrition information on the 
product label. The commenters stated that the type size and spacing 
requirements for the display of the nutrition information prevented its 
placement in compliance with current labeling regulations and policy. 
FSIS has concluded that increased flexibility in regard to the 
placement of nutrition information is necessary to ensure that 
mandatory information on labels is readable and not overcrowded. FSIS 
believes this flexibility can be achieved without hindering consumer 
use of labeling information. The Food and Drug Administration (FDA) 
reached similar conclusions based on its review of layouts to implement 
its nutrition labeling regulations, as well as its review of comments 
received after publication of its final rule. Based on its conclusion 
that greater flexibility in the placement of nutrition information is 
needed, FDA published a proposed rule in the Federal Register on August 
18, 1993 (58 FR 44091), to permit such flexibility.
    Under the nutrition labeling regulations, most meat and poultry 
product labels, with certain exceptions, must be revised and 
resubmitted for review and approval by FSIS. FSIS has acknowledged the 
extensive economic impact of the nutrition labeling requirements, as 
well as the need for substantive Agency resources to review all such 
revised labels. FSIS believes this burden would be reduced without loss 
of information to consumers by allowing the labeling to be generically 
approved (i.e., approved for use without additional authorization) once 
it has been approved by FSIS in sketch form.
    Accordingly, FSIS is amending the Federal meat and poultry products 
inspection regulations by defining the information panel on the 
labeling of meat and poultry products; allowing mandatory labeling 
information to be shown in the information panel, in addition to the 
principal display panel; allowing nutrition information to be shown on 
other than the principal display panel or the information panel of meat 
and poultry products; and allowing final labeling bearing nutrition 
information, which has been approved by FSIS in sketch form, to be 
generically approved.

Proposed Rule

    On March 16, 1994, FSIS published in the Federal Register a 
proposed rule (59 FR 12462) to amend the Federal meat and poultry 
products inspection regulations to provide increased flexibility in the 
placement of nutrition information and other mandatory information on 
the labeling of meat and poultry products and to streamline the 
nutrition label approval process. A summary of the proposed rule 
follows.

Information Panel

    FSIS proposed to amend the Federal meat and poultry products 
inspection regulations to allow mandatory labeling information to be 
placed on the information panel and to define ``information panel.'' 
This action would specify in the regulations the location of mandatory 
information which could not be accommodated on the principal display 
panel due to insufficient space. FSIS proposed to add a new paragraph 
(m) to 9 CFR 317.2 and a new paragraph (c) to 9 CFR 381.116 to define 
the information panel as the first usable surface to the right of the 
principal display panel or alternate principal display panel that can 
be readily seen by consumers. These new provisions would require that 
all information required to appear on the principal display panel or 
permitted to appear on the information panel shall appear on the same 
panel unless there is insufficient space. In determining whether 
sufficient space is available, FSIS proposed that any vignettes, 
designs, and other nonmandatory information would not be considered. If 
either panel could not accommodate all mandatory information, the 
information could be divided between the principal display panel and 
the information panel. However, FSIS proposed that information required 
by any single regulation, such as the ingredients statement, must 
appear complete on a single panel. All information on the information 
panel shall appear in one place without intervening material, such as 
vignettes. FSIS proposed to add the information panel as a location for 
the ingredients statement and the name and place of business of the 
manufacturer, packer, or distributor, except as otherwise specified in 
the regulations, by amending 9 CFR 317.2(f), 317.2(g)(2), 381.118, and 
381.122 to this effect.
    FSIS was aware that, in certain instances, such as when only a 
principal display panel is used on a package with no other surface area 
to place a label, it is not always possible for all mandatory 
information to fit and read in the same direction on the principal 
display panel. To alleviate this problem, FSIS proposed to delete the 
wording from 9 CFR 381.116(a) that requires all mandatory information 
on the principal display panel to read in the same general direction.
    FSIS inadvertently proposed to include in 9 CFR 381.116(a) wording 
that requires all mandatory information on the principal display panel 
to be generally parallel to each other. Because the wording appears to 
contradict FSIS' stated intention to permit mandatory information 
allowed on the information panel to read in any direction, except as 
otherwise specified in this part, FSIS has removed the wording from 9 
CFR 381.116(a) in the final rule.

Placement of Nutrition Information

    FSIS proposed to allow the nutrition information to be placed on 
any panel that can be readily seen by consumers when a package has a 
total surface area available to bear labeling of greater than 40 square 
inches, but its principal display and information panels cannot 
accommodate all mandatory information. For example, if the first panel 
to the right of the principal display panel, such as the right side of 
a box, can accommodate all mandatory information other than the 
nutrition information, the nutrition information may be placed on any 
other panel, such as the left side or the top of the box. This action 
provides increased flexibility by allowing establishments to position 
the nutrition information to reduce crowding of mandatory information. 
FSIS believes that providing this flexibility does not cause any loss 
of comprehensibility, understandability, or information for consumers.
    Given the demand for labeling space made by nutrition information, 
FSIS proposed to exclude designs, vignettes, and other nonmandatory 
information on the principal display panel from the category of useable 
space in calculations of amount of available space for determining the 
panel on which nutrition information should appear. Displacement of 
these nonmandatory items could significantly affect the appearance of 
many packages with little gain in comprehensibility for consumers. FSIS 
believes that a different treatment of nonmandatory information on the 
principal display panel is appropriate in deciding where nutrition 
information is to be presented because the graphic requirements for 
nutrition information required by 9 CFR 317.309(e) and 381.409(e) 
result in a ``Nutrition Facts'' panel that is easy to locate regardless 
of its placement on the label.
    These proposed actions required an accompanying modification to the 
nutrition labeling regulations pertaining to relative nutrient content 
claims. The specific provisions modified are provisions of FDA's final 
nutrition labeling regulations of January 6, 1993 (58 FR 2302) (as 
corrected at 58 FR 17341, April 2, 1993, and adopted by FSIS at 58 FR 
43787, August 18, 1993), that FSIS cross-referenced in its codified 
language. To incorporate the modifications into its codified language, 
FSIS proposed to subdivide existing paragraphs and add new paragraphs.
    In its final rule, FSIS cross-referenced 21 CFR 
101.13(j)(2)(iv)(B), which requires that when a relative nutrient 
content claim is made, clear and concise quantitative information 
comparing the amount of the subject nutrient in the product per labeled 
serving with that in the reference food shall appear adjacent to the 
most prominent claim or on the information panel. FDA repeated this 
requirement in each regulation in 21 CFR part 101 pertaining to 
relative claims (i.e., claims about ``more,'' ``light,'' calories, 
sodium, and fat, fatty acids, and cholesterol) and FSIS cross-
referenced most of these provisions. FSIS proposed to amend these 
provisions to require that the comparative quantitative information be 
placed adjacent to the most prominent claim or to the nutrition 
information. Likewise, FSIS proposed to modify the provision that 
pertains to the placement of the statement ``not a sodium free food'' 
on products that are not sodium free and yet whose label bears a claim 
of ``unsalted.'' FSIS proposed to require that the statement be placed 
adjacent to the nutrition information.

Generically Approved Labeling

    The nutrition labeling regulations require extensive revision of 
existing meat and poultry product labels. All labels modified to meet 
the nutrition labeling regulations must be submitted to FSIS for review 
and approval prior to use. The projected increase in the volume and 
complexity of labeling applications submitted to FSIS for approval from 
companies seeking to comply with the nutrition labeling regulations, 
compounded by the routine submittal of labels requiring approval, but 
exempt from nutrition labeling, is expected to place a tremendous 
burden on the current prior labeling approval system.
    On November 23, 1993, FSIS published a proposed rule in the Federal 
Register (58 FR 62014) which proposes to change the prior labeling 
approval system, in part, by allowing final labeling, which was 
approved by FSIS in sketch form, to be used without further FSIS 
authorization. However, because the prior labeling approval proposal 
encompasses various labeling issues, a final rule will not be issued in 
a timely manner to alleviate the burden on the prior labeling approval 
system resulting from nutrition labeling applications. Therefore, FSIS 
proposed to allow final labeling bearing nutrition information to be 
generically approved.
    Under this proposed system, official establishments are permitted 
to use final labeling bearing nutrition information, which has been 
approved by FSIS in sketch form, without additional authorization, 
provided the final labeling has been prepared without modifications or 
with modifications permitted in 9 CFR 317.5(b) and 381.134(b), and the 
final labeling is not false or misleading. Such labeling must be 
designed in accordance with 9 CFR part 317, subpart B, and 381, subpart 
Y. FSIS believes it is an unnecessary burden on industry to require the 
submission of final labeling when the sketch has been previously 
approved. Because the labeling would have been reviewed and approved by 
FSIS in the sketch form, the final action does not compromise the 
truthfulness and accuracy of the meat and poultry product labeling.

Discussion of Comments

    FSIS received two comments in response to the March 16, 1994, 
proposed rule (59 FR 12462). Both comments were from trade associations 
and supported the proposed rule. One suggestion was made relating to a 
technical issue that was not addressed in the proposed rule.
    One commenter requested that FSIS permit the inspection legend to 
appear anywhere on the information panel because it has readily 
recognizable, strong graphic character, as with the ``Nutrition Facts'' 
panel. The commenter suggested that this provision apply to all food 
packages, not just cylindrical containers. Regarding placement of the 
inspection legend on cylindrical or nearly cylindrical containers, the 
commenter noted that placement is restricted to the ``20 percent 
panel'' where the inspection legend may appear in lieu of showing it on 
the principal display panel in accordance with 9 CFR 317.2(d)(2)(ii) 
and 381.116(b)(2)(ii) for meat and poultry products, respectively. The 
commenter also stated that because the proposal would require all 
mandatory information appearing on the information panel to appear in 
one place without intervening material, any increase in flexibility of 
placement of mandatory information on cylindrical containers would be 
drastically reduced.
    FSIS believes that the inspection legend must be shown on that part 
of a container's label which is most likely to be visible under 
customary conditions of display for retail sale. The Agency also 
believes that if it were to allow the inspection legend to appear on 
the information panel of all food packages, it might appear on the back 
side of a package where it is not likely to be visible under customary 
conditions of display. Such a placement of the inspection legend would 
not be acceptable to FSIS. In those situations where the information 
panel is used on cylindrical containers, the inspection legend may 
appear on the information panel, but must be within the ``20 percent 
panel.'' FSIS considers the ``20 percent panel'' of cylindrical 
containers to be an extension of the principal display panel to its 
right or left, and an area of a container's label that would likely be 
visible to consumers. Because all of the mandatory information 
appearing on the information panel must appear together without 
intervening information, this will, in most cases, result in the 
inspection legend being placed within the ``20 percent panel'' to the 
right of the principal display panel. As presently permitted, other 
allowed information may appear in any order and in any direction on the 
information panel. Thus, flexibility of placement of mandatory 
information on the information panel is not lessened for cylindrical or 
nearly cylindrical containers under the proposed revision.
    After careful consideration of the comments received in response to 
the proposed rule, FSIS is adopting the provisions as published in the 
Federal Register on March 16, 1994 (59 FR 12462).

Executive Order 12866

    This final rule has been determined to be not-significant for 
purposes of Executive Order 12866.

Executive Order 12778

    This final rule has been reviewed under Executive Order 12778, 
Civil Justice Reform. States and local jurisdictions are preempted 
under the Federal Meat Inspection Act (FMIA) and the Poultry Products 
Inspection Act (PPIA) from imposing any marking, labeling, packaging, 
or ingredient requirement on federally inspected meat and poultry 
products that are in addition to, or different than, those imposed 
under the FMIA or PPIA. States and local jurisdictions may, however, 
exercise concurrent jurisdiction over meat and poultry products that 
are outside official establishments for the purpose of preventing the 
distribution of meat and poultry products that are misbranded or 
adulterated under the FMIA or PPIA, or, in the case of imported 
articles, which are not at such an establishment, after their entry 
into the United States. Under the FMIA and PPIA, States that maintain 
meat and poultry inspection programs must impose requirements that are 
at least equal to those required under the FMIA and PPIA. The States 
may, however, impose more stringent requirements on such State 
inspected products and establishments.
    No retroactive effect will be given to this final rule. The 
administrative procedures specified in 9 CFR 306.5 and 381.35 must be 
exhausted prior to any judicial challenge of the application of the 
provisions of this final rule, if the challenge involves any decision 
of an inspector relating to inspection services provided under the FMIA 
or PPIA. The administrative procedures specified in 9 CFR parts 335 and 
381, subpart W, must be exhausted prior to any judicial challenge of 
the application of the provisions of this final rule with respect to 
labeling decisions.

Effect on Small Entities

    The Administrator has determined that this final rule will not have 
a significant effect on small entities, as defined by the Regulatory 
Flexibility Act (5 U.S.C. 601). The final rule provides official 
establishments with additional flexibility in placing nutrition 
labeling and other mandatory information on the labeling of meat and 
poultry products. Small meat and poultry establishments are exempt from 
nutrition labeling, provided the labels of their products bear no 
nutrition claims or nutrition information. Therefore, most small 
establishments will not be affected by the portion of this final rule 
pertaining to the placement of nutrition information on the labeling.
    The other portion of this final rule provides regulatory 
flexibility in placing other mandatory information, such as the 
ingredients statement or the name of the company, on the labeling. Such 
flexibility is already provided to all establishments under current 
labeling regulations and policy. Therefore, small establishments will 
see minimal, if any, impact from this portion of the final rule.
    Small businesses referred to as label expediters, however, will be 
affected by the portion of the final rule pertaining to the generic 
approval of nutrition labeling which has been approved in sketch form. 
While such entities will be affected because the number of labels 
requiring the existing expediting service will decrease, the number of 
firms expediting label approvals is not substantial. Moreover, the 
Agency believes that since the final rule will only affect that 
category of labeling bearing nutrition information, the economic impact 
on the expediting service may not be significant because many of the 
existing label expediters are likely to modify the services they offer 
and provide consulting services to their existing clients. This portion 
of the final rule will have a positive, but not significant, impact on 
a large number of small meat and poultry processors because it will 
reduce their direct labeling application costs.

Paperwork Requirements

    This final rule requires the category of labels addressed in this 
rule to be approved only once by FSIS' Food Labeling Division (FLD) in 
sketch, and if no changes are made, no additional approval is necessary 
(generic approval). Therefore, to receive final approval, 
establishments will not have to complete FSIS Form 7234, ``Application 
for Approval of Labels, Marking or Device,'' which transmits labels to 
FLD for review and approval. This eliminates duplication in the 
labeling approval system and reduces the number of labels reviewed and 
processed by FLD. Therefore, this final rule will expedite the labeling 
approval process for the specific category of labeling addressed in 
this rule and will also reduce official establishments' paperwork 
burden.

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, FSIS is amending 9 CFR 
parts 317 and 381 of the Federal meat and poultry products inspection 
regulations as follows:

PART 317--LABELING, MARKING DEVICES, AND CONTAINERS

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

    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

    2. Section 317.2 is amended by adding paragraphs (f)(4), 
(g)(2)(iv), and (m), and revising paragraph (g)(2)(iii) to read as 
follows:


Sec. 317.2  Labels: definition; required features.

* * * * *
    (f) * * *
    (4) The ingredients statement may be placed on the information 
panel, except as otherwise permitted in this subchapter.
    (g) * * *
    (2) * * *
    (iii) On the front riser panel of frozen food cartons, or
    (iv) On the information panel.
* * * * *
    (m) (1) The information panel is that part of a label that is the 
first surface to the right of the principal display panel as observed 
by an individual facing the principal display panel, with the following 
exceptions:
    (i) If the first surface to the right of the principal display 
panel is too small to accommodate the required information or is 
otherwise unusable label space, e.g., folded flaps, tear strips, 
opening flaps, heat-sealed flaps, the next panel to the right of this 
part of the label may be used.
    (ii) If the package has one or more alternate principal display 
panels, the information panel is to the right of any principal display 
panel.
    (iii) If the top of the container is the principal display panel 
and the package has no alternate principal display panel, the 
information panel is any panel adjacent to the principal display panel.
    (2) (i) Except as otherwise permitted in this part, all information 
required to appear on the principal display panel or permitted to 
appear on the information panel shall appear on the same panel unless 
there is insufficient space. In determining the sufficiency of the 
available space, except as otherwise prescribed in this part, any 
vignettes, designs, and any other nonmandatory information shall not be 
considered. If there is insufficient space for all required information 
to appear on a single panel, it may be divided between the principal 
display panel and the information panel, provided that the information 
required by any given provision of this part, such as the ingredients 
statement, is not divided and appears on the same panel.
    (ii) All information appearing on the information panel pursuant to 
this section shall appear in one place without intervening material, 
such as designs or vignettes.
    3. Section 317.5 is amended by adding paragraph (c) to read as 
follows:


Sec. 317.5  Generically approved labeling.

* * * * *
    (c) Labeling bearing nutrition information which has been approved 
by the Food Labeling Division, Washington, DC., in sketch form (i.e., 
printer's proof or other version that clearly shows all required 
features, size, location, and indication of final color) is approved 
for use without additional authorization by the Administrator: 
Provided,
    (1) That the final label has not been modified, except as permitted 
in paragraph (b) of this section; and
    (2) That the final label is not false or misleading.
    4. Section 317.302 is amended by revising paragraph (a) and adding 
paragraph (c) to read as follows:


Sec. 317.302  Location of nutrition information.

    (a) Nutrition information on a label of a packaged meat product 
shall appear on the label's principal display panel or on the 
information panel, except as provided in paragraphs (b) and (c) of this 
section.
    (b) * * *
    (c) Meat products in packages that have a total surface area 
available to bear labeling greater than 40 square inches but whose 
principal display panel and information panel do not provide sufficient 
space to accommodate all required information may use any alternate 
panel that can be readily seen by consumers for the nutrition 
information. In determining the sufficiency of available space for the 
nutrition information, the space needed for vignettes, designs, and 
other nonmandatory label information on the principal display panel may 
be considered.
    5. Section 317.313 is amended by revising paragraph (j) to read as 
follows:


Sec. 317.313  Nutrient content claims; general principles.

* * * * *
    (j)(1) Products may bear a statement that compares the level of a 
nutrient in the product with the level of a nutrient in a reference 
food in accordance with 21 CFR 101.13(j), except:
    (i) Comparison to product of another manufacturer at 21 CFR 
101.13(j)(1)(ii)(B); and
    (ii) The placement of the comparison statement on the product label 
at 21 CFR 101.13(j)(2)(iv)(B).
    (2) This statement shall appear adjacent to the most prominent 
claim or to the nutrition information.
* * * * *
    6. Section 317.354 is revised to read as follows:


Sec. 317.354  Nutrient content claims for ``good source,'' ``high,'' 
and ``more.''

    (a) Nutrient content claims about a nutrient in a product in 
relation to the Reference Daily Intake (RDI) established for that 
nutrient in 21 CFR 101.9(c)(8)(iv) or Daily Reference Value (DRV) 
established for that nutrient in 21 CFR 101.9(c)(9), excluding total 
carbohydrate, may be used on the label or in labeling, in accordance 
with 21 CFR 101.54, except:
    (1) The placement of the comparison statement on the product label 
at 21 CFR 101.54(e)(1)(iii)(B) and (e)(2)(iii)(B); and
    (2) The meal products definition shall be as prescribed in 
Sec. 317.313(l), and there shall be no provision for main dish 
products.
    (b) Quantitative information comparing the level of the nutrient in 
the individual food product per labeled serving, with that of the 
reference food that it replaces is declared adjacent to the most 
prominent claim or to the nutrition information (e.g., ``fiber content 
of `reference food' is 1 g per serving; `this product' contains 4 g per 
serving'').
    (c) Quantitative information comparing the level of the nutrient in 
the meal product per specified weight with that of the reference food 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``fiber content of `reference product' 
is 2 g per 3 oz; `this product' contains 5 g per 3 oz'').
    7. Section 317.356 is amended by revising paragraph (a) and adding 
paragraphs (c), (d), and (e) to read as follows:


Sec. 317.356  Nutrient content claims for ``light'' or ``lite.''

    (a) General requirements. The following nutrient content claims 
using the term ``light'' or ``lite'' to describe a product may be used 
on the label and in labeling, provided that the product is labeled in 
compliance with 21 CFR 101.56, except:
    (1) The placement of the comparison statement on the product label 
at 21 CFR 101.56 (b)(3)(ii), (c)(1)(ii)(B), (c)(2)(ii)(B), and (g); and
    (2) The meal products definition shall be as prescribed in 
Sec. 317.313(l), and there shall be no provision for main dish 
products.
* * * * *
    (c) Quantitative information comparing the level of calories and 
fat content in the product per labeled serving size with that of the 
reference food that it replaces is declared adjacent to the most 
prominent claim or to the nutrition information (e.g., ``lite `this 
product'--200 calories, 4 g fat; regular `reference product'--300 
calories, 8 g fat per serving''); and
    (d) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference food it replaces, 
regardless of the level of calories and fat content in the reference 
food, is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``lite `this product'--500 mg sodium per 
serving; regular `reference product'--1,000 mg per serving''; or ``lite 
`this product'--170 mg sodium per serving; regular `reference 
product'--350 mg per serving'').
    (e) The term ``lightly salted'' may be used on a product to which 
has been added 50 percent less sodium than is normally added to the 
reference food as described in 21 CFR 101.13(j)(1)(i)(B) and 
(j)(1)(ii)(B), provided that if the product is not ``low in sodium'' as 
defined in 21 CFR 101.61(b)(4), the statement ``not a low sodium food'' 
shall appear adjacent to the nutrition information and the information 
required to accompany a relative claim shall appear on the label or 
labeling as specified in 21 CFR 101.13(j)(2).
    8. Section 317.360 is revised to read as follows:


Sec. 317.360  Nutrient content claims for calorie content.

    (a) Nutrient content claims about the calorie content of a product 
may be used on the label or in labeling in accordance with 21 CFR 
101.60, except:
    (1) The placement of the comparison statement on the product label 
at 21 CFR 101.60(b)(4)(ii)(B), (b)(5)(ii)(B), (c)(4)(ii)(B), and 
(c)(5)(ii)(B); and
    (2) The meal products definition shall be as prescribed in 
Sec. 317.313(l), and there shall be no provision for main dish 
products.
    (b) Quantitative information comparing the level of calories and 
sugars in the individual food product per labeled serving size with 
that of the reference food that it replaces is declared adjacent to the 
most prominent claim or to the nutrition information (e.g., ``calorie 
content has been reduced from 150 to 100 calories per serving''; or 
``sugar content has been lowered from 8 g to 6 g per serving'').
    (c) Quantitative information comparing the level of calories and 
sugars in the meal product per specified weight with that of the 
reference food that it replaces is declared adjacent to the most 
prominent claim or to the nutrition information (e.g., ``calorie 
content has been reduced from 110 calories per 3 oz to 80 calories per 
3 oz''; or ``sugar content has been reduced from 17 g per 3 oz to 13 g 
per 3 oz'').
    9. Section 317.361 is revised to read as follows:


Sec. 317.361  Nutrient content claims for the sodium content.

    (a) Nutrient content claims about the sodium content of a product 
may be used on the label and in labeling in accordance with 21 CFR 
101.61, except:
    (1) The placement of the comparison statement on the product label 
at 21 CFR 101.61 (b)(6)(ii)(B), (b)(7)(ii)(B), and (c)(2)(iii); and
    (2) The meal products definition shall be as prescribed in 
Sec. 317.313(l), and there shall be no provision for main dish 
products.
    (b) Quantitative information comparing the level of the sodium in 
the individual food product per labeled serving with that of the 
reference food that it replaces is declared adjacent to the most 
prominent claim or to the nutrition information (e.g., ``sodium content 
has been lowered from 300 to 150 mg per serving'').
    (c) Quantitative information comparing the level of sodium in the 
meal product per specified weight with that of the reference food that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``sodium content has been reduced from 220 
mg per 3 oz to 150 mg per 3 oz'').
    (d) If the product is not sodium free, the statement ``not a sodium 
free food'' or ``not for control of sodium in the diet'' appears 
adjacent to the nutrition information of the product bearing the claim.
    10. Section 317.362 is amended by revising paragraphs (a)(2), 
(a)(3), (a)(5), (a)(11), (a)(13), and (a)(16), and adding paragraphs 
(d), (e), and (f) to read as follows:


Sec. 317.362  Nutrient content claims for fat, fatty acids, and 
cholesterol content of meat products.

    (a) * * *
    (2) 21 CFR 101.62(b), except: (i) The placement of the comparison 
statement on the product label at 21 CFR 101.62(b) (4)(ii)(B) and 
(5)(ii)(B), and
    (ii) The meal products definition shall be as prescribed in 
Sec. 317.313(l), there will be no provision for main dish products, and 
the following provision shall be added: A synonym for the term ``______ 
percent fat free'' is `` ______ percent lean'';
    (3) 21 CFR 101.62(c), except:
    (i) The placement of the comparison statement on the product label 
at 21 CFR 101.62(c) (4)(ii)(B) and (5)(ii)(B); and
    (ii) There will be no disclosure of the level of total fat and 
cholesterol in the food in immediate proximity to such claim each time 
the claim is made, the meal products definition shall be as prescribed 
in Sec. 317.313(l), and there will be no provision for main dish 
products;
* * * * *
    (5) 21 CFR 101.62(d)(1)(i) (A) through (D) and (d)(1)(ii)(F), 
except the placement of the comparison statement on the product label 
at 21 CFR 101.62(d)(1)(ii)(F)(2), and there will be no provision for 
main dish products;
* * * * *
    (11) 21 CFR 101.62(d)(2)(iii)(E), except the placement of the 
comparison statement at 21 CFR 101.62(d)(2)(iii)(E)(2);
* * * * *
    (13) 21 CFR 101.62(d)(4)(i) (A) through (C), except the placement 
of the comparison statement at 21 CFR 101.62(d)(4)(i)(C)(2);
* * * * *
    (16) 21 CFR 101.62(d)(5)(i) (A) through (C), except the placement 
of the comparison statement at 21 CFR 101.62(d)(5)(1)(C)(2).
* * * * *
    (d) (1) Quantitative information comparing the level of fat in the 
individual food product per labeled serving with that of the reference 
food that it replaces is declared adjacent to the most prominent claim 
or to the nutrition information (e.g., ``fat content has been reduced 
from 8 g to 4 g per serving'').
    (2) Quantitative information comparing the level of fat in the meal 
product per specified weight with that of the reference food that it 
replaces is declared adjacent to the most prominent such claim or to 
the nutrition information (e.g., ``fat content has been reduced from 8 
g per 3 oz to 5 g per 3 oz'').
    (e) (1) Quantitative information comparing the level of saturated 
fat in the individual food product per labeled serving with that of the 
reference food that it replaces is declared adjacent to the most 
prominent claim or to the nutrition information (e.g., ``saturated fat 
reduced from 3 g to 1.5 g per serving'').
    (2) Quantitative information comparing the level of saturated fat 
in the meal product per specified weight with that of the reference 
food that it replaces is declared adjacent to the most prominent claim 
or to the nutrition information (e.g., ``saturated fat content has been 
reduced from 2.5 g per 3 oz to 1.5 g per 3 oz'').
    (f) (1) Quantitative information for claims of cholesterol free, 
low cholesterol or reduced cholesterol comparing the level of 
cholesterol in the individual food product per labeled serving with 
that of the reference food that it replaces is declared adjacent to the 
most prominent claim or to the nutrition information (e.g., ``contains 
no cholesterol compared with 30 mg in one serving of `reference food'; 
contains 11 g of fat per serving''; or ``cholesterol lowered from 30 mg 
to 5 mg per serving; contains 13 g of fat per serving'').
    (2) Quantitative information comparing the level of cholesterol in 
the meal product per specified weight with that of the reference food 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``cholesterol content has been reduced 
from 35 mg per 3 oz to 25 mg per 3 oz'').

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    11. The authority citation for part 381 continues to read as 
follows:

    Authority: 7 U.S.C. 138F; 7 U.S.C. 450; 21 U.S.C. 451-470; 7 CFR 
2.17, 2.55.

    12. Section 381.116 is amended by revising the second sentence of 
paragraph (a) and adding paragraph (c) to read as follows:


Sec. 381.116  Wording on labels of immediate containers.

    (a) * * * Such items of information shall be in distinctly legible 
form. * * *
* * * * *
    (c) (1) The information panel is that part of a label that is the 
first surface to the right of the principal display panel as observed 
by an individual facing the principal display panel, with the following 
exceptions:
    (i) If the first surface to the right of the principal display 
panel is too small to accommodate the required information or is 
otherwise unusable label space, e.g., folded flaps, tear strips, 
opening flaps, heat-sealed flaps, the next panel to the right of this 
part of the label may be used.
    (ii) If the package has one or more alternate principal display 
panels, the information panel is to the right of any principal display 
panel.
    (iii) If the top of the container is the principal display panel 
and the package has no alternate principal display panel, the 
information panel is any panel adjacent to the principal display panel.
    (2) (i) Except as otherwise permitted in this part, all information 
required to appear on the principal display panel or permitted to 
appear on the information panel shall appear on the same panel unless 
there is insufficient space. In determining the sufficiency of the 
available space, except as otherwise prescribed in this part, any 
vignettes, designs, and any other nonmandatory information shall not be 
considered. If there is insufficient space for all required information 
to appear on a single panel, it may be divided between the principal 
display panel and the information panel, provided that the information 
required by any given provision of this part, such as the ingredients 
statement, is not divided and appears on the same panel.
    (ii) All information appearing on the information panel pursuant to 
this section shall appear in one place without intervening material, 
such as designs or vignettes.
    13. Section 381.118 is amended by adding paragraph (e) to read as 
follows:


Sec. 381.118  Ingredients statement.

* * * * *
    (e) The ingredients statement may be placed on the information 
panel, except as otherwise permitted in this subchapter.
    14. Section 381.122 is amended by revising the last sentence of the 
paragraph to read as follows:


Sec. 381.122  Identification of manufacturer, packer, or distributor.

    * * * The name and place of business of the manufacturer, packer, 
or distributor may be shown on the principal display panel, on the 20-
percent panel of the principal display panel reserved for required 
information, on the front riser panel of frozen food cartons, or on the 
information panel.
    15. Section 381.134 is amended by adding paragraph (c) to read as 
follows:


Sec. 381.134  Generically approved labeling.

* * * * *
    (c) Labeling bearing nutrition information which has been approved 
by the Food Labeling Division, Washington, DC, in sketch form (i.e., 
printer's proof or other version that clearly shows all required 
features, size, location, and indication of final color) is approved 
for use without additional authorization by the Administrator: 
Provided,
    (1) That the final label has not been modified, except as permitted 
in paragraph (b) of this section; and
    (2) That the final label is not false or misleading.
    16. Section 381.402 is amended by revising paragraph (a) and adding 
paragraph (c) to read as follows:


Sec. 381.402  Location of nutrition information.

    (a) Nutrition information on a label of a packaged poultry product 
shall appear on the label's principal display panel or on the 
information panel, except as provided in paragraphs (b) and (c) of this 
section.
* * * * *
    (c) Poultry products in packages that have a total surface area 
available to bear labeling greater than 40 square inches but whose 
principal display panel and information panel do not provide sufficient 
space to accommodate all required information may use any alternate 
panel that can be readily seen by consumers for the nutrition 
information. In determining the sufficiency of available space for the 
nutrition information, the space needed for vignettes, designs, and 
other nonmandatory label information on the principal display panel may 
be considered.
    17. Section 381.413 is amended by revising paragraph (j) to read as 
follows:


Sec. 381.413  Nutrient content claims; general principles.

* * * * *
    (j) (1) Products may bear a statement that compares the level of a 
nutrient in the product with the level of a nutrient in a reference 
food in accordance with 21 CFR 101.13(j), except:
    (i) Comparison to product of another manufacturer at 21 CFR 
101.13(j)(1)(ii)(B); and
    (ii) The placement of the comparison statement on the product label 
at 21 CFR 101.13(j)(2)(iv)(B).
    (2) This statement shall appear adjacent to the most prominent 
claim or to the nutrition information.
* * * * *
    18. Section 381.454 is revised to read as follows:


Sec. 381.454  Nutrient content claims for ``good source,'' ``high,'' 
and ``more.''

    (a) Nutrient content claims about a nutrient in a product in 
relation to the Reference Daily Intake (RDI) established for that 
nutrient in 21 CFR 101.9(c)(8)(iv) or Daily Reference Value (DRV) 
established for that nutrient in 21 CFR 101.9(c)(9), excluding total 
carbohydrate, may be used on the label or in labeling, in accordance 
with 21 CFR 101.54, except:
    (1) The placement of the comparison statement on the product label 
at 21 CFR 101.54 (e)(1)(iii)(B) and (e)(2)(iii)(B); and
    (2) The meal products definition shall be as prescribed in 
Sec. 381.413(l), and there shall be no provision for main dish 
products.
    (b) Quantitative information comparing the level of the nutrient in 
the individual food product per labeled serving, with that of the 
reference food that it replaces is declared adjacent to the most 
prominent claim or to the nutrition information (e.g., ``fiber content 
of `reference food' is 1 g per serving; `this product' contains 4 g per 
serving'').
    (c) Quantitative information comparing the level of the nutrient in 
the meal product per specified weight with that of the reference food 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``fiber content of `reference product' 
is 2 g per 3 oz; `this product' contains 5 g per 3 oz'').
    19. Section 381.456 is amended by revising paragraph (a) and adding 
paragraphs (c), (d), and (e) to read as follows:


Sec. 381.456  Nutrient content claims for ``light'' or ``lite.''

    (a) General requirements. The following nutrient content claims 
using the term ``light'' or ``lite'' to describe a product may be used 
on the label and in labeling, provided that the product is labeled in 
compliance with 21 CFR 101.56, except:
    (1) The placement of the comparison statement on the product label 
at 21 CFR 101.56 (b)(3)(ii), (c)(1)(ii)(B), (c)(2)(ii)(B), and (g); and
    (2) The meal products definition shall be as prescribed in 
Sec. 381.413(l), and there shall be no provision for main dish 
products.
* * * * *
    (c) Quantitative information comparing the level of calories and 
fat content in the product per labeled serving size with that of the 
reference food that it replaces is declared adjacent to the most 
prominent claim or to the nutrition information (e.g., ``lite `this 
product'--200 calories, 4 g fat; regular `reference product'--300 
calories, 8 g fat per serving''); and
    (d) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference food it replaces, 
regardless of the level of calories and fat content in the reference 
food, is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``lite `this product'-- 500 mg sodium per 
serving; regular `reference product'--1,000 mg per serving''; or ``lite 
`this product'--170 mg sodium per serving; regular `reference 
product'--350 mg per serving'').
    (e) The term ``lightly salted'' may be used on a product to which 
has been added 50 percent less sodium than is normally added to the 
reference food as described in 21 CFR 101.13(j)(1)(i)(B) and 
(j)(1)(ii)(B), provided that if the product is not ``low in sodium'' as 
defined in 21 CFR 101.61(b)(4), the statement ``not a low sodium food'' 
shall appear adjacent to the nutrition information and the information 
required to accompany a relative claim shall appear on the label or 
labeling as specified in 21 CFR 101.13(j)(2).
    20. Section 381.460 is revised to read as follows:


Sec. 381.460  Nutrient content claims for calorie content.

    (a) Nutrient content claims about the calorie content of a product 
may be used on the label or in labeling in accordance with 21 CFR 
101.60, except:
    (1) The placement of the comparison statement at 21 CFR 
101.60(b)(4)(ii)(B), (b)(5)(ii)(B), (c)(4)(ii)(B), and (c)(5)(ii)(B); 
and
    (2) The meal products definition shall be as prescribed in 
Sec. 381.413(l), and there shall be no provision for main dish 
products.
    (b) Quantitative information comparing the level of calories and 
sugars in the individual food product per labeled serving size with 
that of the reference food that it replaces is declared adjacent to the 
most prominent claim or to the nutrition information (e.g., ``calorie 
content has been reduced from 150 to 100 calories per serving''; or 
``sugar content has been lowered from 8 g to 6 g per serving'').
    (c) Quantitative information comparing the level of calories and 
sugars in the meal product per specified weight with that of the 
reference food that it replaces is declared adjacent to the most 
prominent claim or to the nutrition information (e.g., ``calorie 
content has been reduced from 110 calories per 3 oz to 80 calories per 
3 oz''; or ``sugar content has been reduced from 17 g per 3 oz to 13 g 
per 3 oz'').
    21. Section 381.461 is revised to read as follows:


Sec. 381.461  Nutrient content claims for the sodium content.

    (a) Nutrient content claims about the sodium content of a product 
may be used on the label and in labeling in accordance with 21 CFR 
101.61, except:
    (1) The placement of the comparison statement on the product label 
at 21 CFR 101.61(b)(6)(ii)(B), (b)(7)(ii)(B), and (c)(2)(iii); and
    (2) The meal products definition shall be as prescribed in 
Sec. 381.413(l), and there shall be no provision for main dish 
products.
    (b) Quantitative information comparing the level of the sodium in 
the individual food product per labeled serving with that of the 
reference food that it replaces is declared adjacent to the most 
prominent claim or to the nutrition information (e.g., ``sodium content 
has been lowered from 300 to 150 mg per serving'').
    (c) Quantitative information comparing the level of sodium in the 
meal product per specified weight with that of the reference food that 
it replaces is declared adjacent to the most prominent claim or to the 
nutrition information (e.g., ``sodium content has been reduced from 220 
mg per 3 oz to 150 mg per 3 oz'').
    (d) If the product is not sodium free, the statement ``not a sodium 
free food'' or ``not for control of sodium in the diet'' appears 
adjacent to the nutrition information of the product bearing the claim.
    22. Section 381.462 is amended by revising paragraphs (a)(2), 
(a)(3), (a)(5), (a)(11), (a)(13), and (a)(16), and adding paragraphs 
(d), (e), and (f) to read as follows:


Sec. 381.462  Nutrient content claims for fat, fatty acids, and 
cholesterol content of meat products.

    (a) * * *
    (2) 21 CFR 101.62(b), except:
    (i) The placement of the comparison statement on the product label 
at 21 CFR 101.62(b)(4)(ii)(B) and (5)(ii)(B); and
    (ii) The meal products definition shall be as prescribed in 
Sec. 381.413(l), there will be no provision for main dish products, and 
the following provision shall be added: A synonym for the term ``______ 
percent fat free'' is ``______ percent lean'';
    (3) 21 CFR 101.62(c), except:
    (i) The placement of the comparison statement on the product label 
at 21 CFR 101.62(c)(4)(ii)(B) and (5)(ii)(B); and
    (ii) There will be no disclosure of the level of total fat and 
cholesterol in the food in immediate proximity to such claim each time 
the claim is made, the meal products definition shall be as prescribed 
in Sec. 381.413(l), and there will be no provision for main dish 
products;
* * * * *
    (5) 21 CFR 101.62(d)(1)(i) (A) through (D) and (d)(1)(ii)(F), 
except the placement of the comparison statement on the product label 
at 21 CFR 101.62(d)(1)(ii)(F)(2), and there will be no provision for 
main dish products;
* * * * *
    (11) 21 CFR 101.62(d)(2)(iii)(E), except the placement of the 
comparison statement on the product label at 21 CFR 
101.62(d)(2)(iii)(E)(2);
* * * * *
    (13) 21 CFR 101.62(d)(4)(i)(A) through (C), except the placement of 
the comparison statement on the product label at 21 CFR 
101.62(d)(4)(i)(C)(2);
* * * * *
    (16) 21 CFR 101.62(d)(5)(i)(A) through (C), except the placement of 
the comparison statement on the product label at 21 CFR 
101.62(d)(5)(i)(C)(2).
* * * * *
    (d)(1) Quantitative information comparing the level of fat in the 
individual food product per labeled serving with that of the reference 
food that it replaces is declared adjacent to the most prominent claim 
or to the nutrition information (e.g., ``fat content has been reduced 
from 8 g to 4 g per serving'').
    (2) Quantitative information comparing the level of fat in the meal 
product per specified weight with that of the reference food that it 
replaces is declared adjacent to the most prominent such claim or to 
the nutrition information (e.g., ``fat content has been reduced from 8 
g per 3 oz to 5 g per 3 oz'').
    (e) (1) Quantitative information comparing the level of saturated 
fat in the individual food product per labeled serving with that of the 
reference food that it replaces is declared adjacent to the most 
prominent claim or to the nutrition information (e.g., ``saturated fat 
reduced from 3 g to 1.5 g per serving'').
    (2) Quantitative information comparing the level of saturated fat 
in the meal product per specified weight with that of the reference 
food that it replaces is declared adjacent to the most prominent claim 
or to the nutrition information (e.g., ``saturated fat content has been 
reduced from 2.5 g per 3 oz to 1.5 g per 3 oz'').
    (f) (1) Quantitative information for claims of cholesterol free, 
low cholesterol, or reduced cholesterol comparing the level of 
cholesterol in the individual food product per labeled serving with 
that of the reference food that it replaces is declared adjacent to the 
most prominent claim or to the nutrition information (e.g., ``contains 
no cholesterol compared with 30 mg in one serving of `reference food'; 
contains 11 g of fat per serving''; or ``cholesterol lowered from 30 mg 
to 5 mg per serving; contains 13 g of fat per serving'').
    (2) Quantitative information comparing the level of cholesterol in 
the meal product per specified weight with that of the reference food 
that it replaces is declared adjacent to the most prominent claim or to 
the nutrition information (e.g., ``cholesterol content has been reduced 
from 35 mg per 3 oz to 25 mg per 3 oz'').

    Done at Washington, DC, on August 2, 1994.
Patricia A. Jensen,
Acting Assistant Secretary, Marketing and Inspection Services.
[FR Doc. 94-19283 Filed 8-5-94; 8:45 am]
BILLING CODE 3410-DM-P