[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: 94-6011]
[[Page Unknown]]
[Federal Register: March 16, 1994]
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Part III
Department of Agriculture
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Food Safety and Inspection Service
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9 CFR Parts 317 and 381
Placement of Nutrition Labeling and Other Mandatory Labeling on Meat
and Poultry Products; Proposed Rule
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 317 and 381
[Docket No. 93-020P]
RIN 0583-AB72
Placement of Nutrition Labeling and Other Mandatory Labeling on
Meat and Poultry Products
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to
amend 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 informational 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. This
action would 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. Portions of this proposal parallel a Food and Drug
Administration (FDA) proposal concerning placement of the nutrition
information on food packages.
DATES: Comments must be received on or before May 16, 1994.
ADDRESSES: Written comments to: Policy Office, ATTN: Diane Moore, FSIS
Hearing Clerk, room 3171, South Building, Food Safety and Inspection
Service, U.S. Department of Agriculture, Washington, DC 20250. Oral
comments as provided by the Poultry Products Inspection Act should be
directed to Mr. Charles Edwards at (202) 254-2565. (See also
``Comments'' under ``Supplementary Information.'')
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 proposed rule has been reviewed under Executive Order 12866.
Executive Order 12778
This proposed 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 proposed 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 proposed 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 proposed rule
with respect to labeling decisions.
Effect on Small Entities
The Administrator has determined that this proposed rule would not
have a significant effect on small entities, as defined by the
Regulatory Flexibility Act (5 U.S.C. 601). The proposed rule would
provide 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 would not be affected by the portion of this
proposed rule pertaining to the placement of nutrition information on
the labeling.
The other portion of this proposed rule would provide 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 would
see minimal, if any, impact from this portion of the proposed rule.
Small businesses referred to as label expeditors, however, would be
affected by the portion of the proposed rule pertaining to the generic
approval of nutrition labeling which has been approved in sketch form.
While such entities would be affected because the number of labels
requiring the existing expediting service would decrease, the number of
firms expediting label approvals is not substantial. Moreover, the
Agency believes that since the proposed rule would 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 expeditors are likely to modify the services they offer
and provide consulting services to their existing clients. This portion
of the proposed rule would have a positive, but not significant, impact
on a large number of small meat and poultry processors because it would
reduce their direct labeling application costs.
Paperwork Requirements
This proposed rule would require the category of labels addressed
in this rule to be approved only once by FSIS's Food Labeling Division
(FLD) in sketch, and if no changes are made, no additional approval
would be necessary (generic approval). Therefore, to receive final
approval, establishments would 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 would eliminate
duplication in the labeling approval system and reduce the number of
labels reviewed and processed by FLD. Therefore, this proposal would
expedite the labeling approval process for the specific category of
labeling addressed in this rule and would also reduce official
establishments' paperwork burden.
Comments
Interested persons are invited to submit comments concerning this
proposal. Written comments should be sent to the Policy Office and
refer to Docket No. 93-020P. Any person desiring an opportunity for an
oral presentation of views, as provided by the Poultry Products
Inspection Act, should make such a request to Mr. Charles Edwards, so
that arrangements can be made for such views to be presented. A record
will be made of all views orally presented. All comments submitted in
response to this proposal will be available for public inspection at
the Policy Office from 9 a.m. to 12:30 p.m. and from 1:30 p.m. to 4
p.m., Monday through Friday.
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 final rule permits voluntary nutrition labeling on single-
ingredient, raw meat and poultry products, and establishes mandatory
nutrition labeling for all other meat and poultry products, with
certain exceptions. The rule also specifies 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. Nutrition information
for gift packs 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 final rule 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's recognition that is more important
that the nutrition information be presented on the immediate package
than in any particular place. In addition, FSIS, stated in the preamble
to the final rule that it will consider, on a case-by-case basis,
allowing the modified nutrition label for packages larger than 40
square inches that have a surface area which precludes the presentation
of the full nutrition label. Such determinations are made by FSIS at
the time meat and poultry manufacturers obtain prior approval for the
content and design if labeling for their products before the products
may be marketed.
Following publication of its final rule on nutrition labeling, 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 agrees that new nutrition information displays often require more
space on the label than current nutrition information displays, and
that it is sometimes difficult to fit all required information on the
information panel. 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. 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 anticipates that
approximately 120,000 labels would require nutrition labeling under the
final nutrition labeling regulations. 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. The volume of labels bearing nutrition labeling,
compounded by the routine submittal of labels requiring approval, is
expected to place a tremendous burden upon the current prior label
approval system. FSIS believes this burden would be reduced without
loss of information to consumers by allowing the labeling to be
generically approved once it has been approved by FSIS in sketch form.
Current Regulations and Agency Policy
Currently, 9 CFR 317.2(d) and 381.116(b) define the ``principal
display panel'' as the part of a label that is most likely to be
displayed, presented, shown, or examined under customary conditions of
display for sale. Under 9 CFR 317.2(c), 381.117, 381.118, 381.121,
381.121a, 381.122, and 381.123, this panel must include the name of the
product; the ingredients statement, if the product is fabricated from
two or more ingredients; the name and place of business of the
manufacturer, packer, or distributor; the net quantity of contents; an
official inspection legend and the number of the official
establishment; and any other information required by the regulations.
Section 381.116(a) of the poultry products inspection regulations
(9 CFR 381.116(a)) prescribes that information required to appear on
the principal display panel, except as otherwise permitted in the
regulations, shall be in distinctly legible form, read in the same
general direction, generally parallel to each other, and appear in the
English language, except that Spanish may be substituted for English,
under certain cases, for all information except the inspection legend.
The Federal meat inspection regulations contain similar provisions,
except that mandatory information on the principal display panel is not
required to read in the same general direction and be generally
parallel to each other.
In August 1980, the Food Labeling Division of FSIS issued Policy
Memo 7, Information Panel, which permits the use of an information
panel, in addition to the principal display panel, for providing
mandatory labeling information on meat and poultry products.\1\ This
policy memo was issued because establishments were experiencing
difficulty in providing all required information on the principal
display panel. Policy Memo 7 provides that the mandatory information
that may appear on an information panel includes nutrition information,
an ingredients statement, and the firm's name and address. The
inspection legend and number on cylindrical cans may also appear on the
information panel, but must be placed on the 20 percent area
immediately to the right of the principal display panel.
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\1\A copy of this policy memo is available for public inspection
in the office of the FSIS Hearing Clerk.
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Policy Memo 7 also defines an information panel as the first usable
surface to the right of the principal display panel. Usable surfaces
exclude those having folded flaps, tear strips, opening flaps, heat-
sealed type flaps, or less than adequate space to accommodate the
mandatory information. Surfaces having information, such as vignettes,
UPC codes, preparation instructions, and serving suggestions are
considered usable and such information should be displaced if an
information panel is used. The policy memo specifies that where a
surface is larger than needed to accommodate the mandatory information,
the information panel is a section of that surface and must contain all
mandatory information in one place without intervening nonmandatory
information. The information panel must be located on the left side of
any such large surface.
Sections 317.4, 327.14, 327.15, 381.132, and 381.205 of the
regulations describes FSIS's prior label approval program. Under this
program, official establishments may submit labeling in sketch form
(i.e., printer's proof or other version that clearly shows all required
features, size, location, and indication of final color) to the Food
Labeling Division for approval. After official establishments print
final labels based on approved sketches, the final labeling must be
resubmitted for approval by either the Food Labeling Division or an
inspector-in-charge, depending on the modification made to the final
labeling. In addition, Secs. 317.5 and 381.134 of the regulations
provide that labeling can be generically approved for use without
additional authorization, provided the labeling shows all mandatory
information in a sufficiently prominent manner and is not otherwise
false or misleading in any particular.
The Proposal
FSIS is proposing to amend the Federal meat and poultry products
inspection regulations by allowing mandatory labeling information to be
placed on the information panel and by defining ``information panel.''
This action is necessary to specify in the regulations the location of
mandatory information which cannot be accommodated on the principal
display panel due to insufficient space. These new provisions would
replace current directions on use of the information panel and would
rescind Policy Memo 7. Accordingly, FSIS proposes 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 added provisions
would also 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, any vignettes,
designs, and other nonmandatory information shall not be considered. If
either panel cannot accommodate all mandatory information, the
information may be divided between the principal display panel or the
information panel. However, 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
proposes 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 is 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. In such cases, it is necessary to provide some
information perpendicular to the other mandatory information on the
panel to fit all information on the panel. Therefore, FSIS proposes to
delete the wording from 9 CFR 381.116 that requires all mandatory
information on the principal display panel to read in the same general
direction for the reasons discussed in the preceding section of the
preamble.
FSIS is proposing 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. Thus, 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. The establishment
would also have the option of placing all mandatory information,
including the nutrition information, on the next usable right panel big
enough to accommodate all information, such as the back of the box.
This action would provide increased flexibility by allowing
establishments to position the nutrition information to reduce crowding
of mandatory information. FSIS believes that providing this flexibility
would not produce any loss of comprehensibility, understandability, or
information for consumers.
Current rules for determining the space available to bear mandatory
labeling information in 9 CFR 317.2(d) and 381.116(b) are that the
principal display panel be large enough to accommodate all mandatory
information with clarity and conspicuousness without it being obscured
by nonmandatory label information or crowding. Thus, nonmandatory
labeling information on the principal display panel must be counted as
usable space for mandatory information in determining sufficiency of
space. The purpose of these provisions is to ensure that mandatory
labeling information is prominently displayed on meat or poultry
product labels, so that consumers can easily locate such information.
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. Given the demand for labeling space made
by nutrition information, FSIS is proposing to exclude designs,
vignettes, and other nonmandatory information on the principal display
panel in calculating the amount of available space for determining the
panel on which nutrition information should appear. To displace these
items could significantly affect the appearance of many packages with
little gain in comprehensibility for consumers. In addition, current
industry practice almost never places the nutrition information on the
principal display panel unless there is no alternative panel on the
package.
These proposed actions would require an accompanying modification
to the nutrition labeling regulations pertaining to relative nutrient
content claims. The specific provisions to be modified would be
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 would subdivide existing paragraphs
and add new paragraphs. The existing portions of text are included only
to define the subdivisions, place the proposed requirements in the
framework of existing provisions, and make the revised sections easier
to interpret.
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 is proposing 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 is proposing 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 is proposing to require that the statement be
placed adjacent to the nutrition information.
FSIS finds that these comparative statements and the statements
about the sodium content of products provide information about the
nutritional content of the product. They are of the greatest value to
consumers when presented in conjunction with other nutrition
information about the product. Because nutrition information may or may
not appear on the principal display panel or the information panel,
FSIS believes that the location of the comparative statements and the
statement on sodium content should be tied to the placement of the
nutrition information rather than placed on the principal display panel
or the information panel.
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. FSIS anticipates that approximately 120,000
labels would require nutrition labeling under the final nutrition
labeling regulations. Since publication of the nutrition labeling
regulations on January 6, 1993, only about 5,000 labels designed to
implement the nutrition labeling regulations have been approved by
FSIS. 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 may not be issued in
a timely manner to alleviate the anticipated burden on the prior
labeling approval system resulting from nutrition labeling
applications. Therefore, FSIS is proposing to allow final labeling
bearing nutrition information to be generically approved.
Under the proposed system, official establishments would be
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 proposed action
would not compromise the truthfulness and accuracy of the meat and
poultry product labeling.
The proposal would eliminate unnecessary duplication in the
labeling approval system and reduce the number of labels reviewed and
processed by FSIS. Consequently, the proposal would improve the
efficiency of FSIS by expediting the label approval process for a
specific category of labeling, and would also reduce the paperwork
burden on official establishments. Since only 5,000 labeling
applications have been approved during the first 11 months of the 18-
month implementation period for the nutrition labeling regulations, the
majority of meat and poultry product manufacturers would benefit from
timely implementation of measures to ease compliance with the
regulations.
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.
Proposed Rule
For the reasons discussed in the preamble, FSIS is proposing to
amend 9 CFR parts 317 and 381 of the Federal meat and poultry products
inspection regulations to read as follows:
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS
1. The authority citation for part 317 would continue to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.
2. Section 317.2 would be 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 ingredient statement may be placed on the information
panel, except as otherwise permitted in the 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 would be 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 would be 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 would be 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 would be 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 would be 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.
(b) * * *
(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 would be 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 on 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 would be 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 would be amended by revising paragraphs (a)(2),
(a)(3), (a)(5), (a)(11), (a)(13), and (a)(16), and adding paragraphs
(d) through (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;
(4) * * *
(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);
(12) * * *
(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 would continue to read as
follows:
Authority: 7 U.S.C. 450, 21 U.S.C. 451-470; 7 CFR 2.17, 2.55.
12. Section 381.116 would be amended by revising the second
sentence of paragraph (a) and adding a new 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 and shall be generally parallel to each other.* * *
(b) * * *
(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 would be amended by adding a new 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 would be 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 would be 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 would be 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.
(b) * * *
(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 would be 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 would be 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 would be 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.
(b) * * *
(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 would be 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 would be 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 form 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 would be amended by revising paragraphs (a)(2),
(a)(3), (a)(5), (a)(11), (a)(13), and (a)(16), and adding paragraphs
(d) through (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;
(4) * * *
(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);
(12) * * *
(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 cholestrol 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 March 9, 1994.
Patricia Jensen,
Acting Assistant Secretary, Marketing & Inspection Services.
[FR Doc. 94-6011 Filed 3-15-94; 8:45 am]
BILLING CODE 3410-DM-M
