[Federal Register Volume 61, Number 160 (Friday, August 16, 1996)]
[Rules and Regulations]
[Pages 42742-42762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20966]
[[Page 42741]]
_______________________________________________________________________
Part VII
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 101
Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw
Fruits, Vegetables, and Fish and Policy for Data Base Review for
Voluntary and Mandatory Nutrition Labeling; Final Rule
Federal Register / Vol. 61, No. 160 / Friday, August 16, 1996 / Rules
and Regulations
[[Page 42742]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 94N-0155]
RIN 0910-AA19
Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw
Fruits, Vegetables, and Fish; Identification of the 20 Most Frequently
Consumed; and Policy for Data Base Review for Voluntary and Mandatory
Nutrition Labeling
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is revising the
guidelines for voluntary nutrition labeling of raw fruits, vegetables,
and fish and revising the nutrition labeling values for the 20 most
frequently consumed raw fruits, vegetables, and fish. This action is in
response to the requirements of the Nutrition Labeling and Education
Act of 1990 (the 1990 amendments) and will make the voluntary nutrition
labeling program (hereinafter referred to as the voluntary program)
more consistent with mandatory nutrition labeling of other foods
regulated by FDA. The agency is also setting out its policy on its
review of data bases in both the voluntary and mandatory nutrition
labeling programs.
EFFECTIVE DATE: August 18, 1997.
FOR FURTHER INFORMATION CONTACT: Mary M. Bender, Center for Food Safety
and Applied Nutrition (HFS-165), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-205-5592.
SUPPLEMENTARY INFORMATION:
I. Background
In response to requirements of the 1990 amendments (Pub. L. 101-
535), FDA published final regulations in the Federal Register of
November 27, 1991 (56 FR 60880, and corrected at 57 FR 8174, March 6,
1992), that: (1) Identified the 20 most frequently consumed raw fruits,
vegetables, and fish in the United States; (2) established guidelines
for the voluntary nutrition labeling of these foods; and (3) set out
the criteria for substantial compliance by food retailers with the
guidelines for the voluntary nutrition labeling of these foods.
FDA stated in Sec. 101.45(i) (21 CFR 101.45(i)) that it would
publish and provide an opportunity for comment on updates of the
nutrition labeling values for the 20 most frequently consumed raw
fruits, vegetables, and fish (or a notice that nutrition labeling
values have not changed from the previous publication) at least every 2
years. In the preamble to the voluntary nutrition labeling final rule
(56 FR 60880 at 60881), FDA advised that once final regulations
governing nutrition labeling of processed, packaged foods (except for
those foods subject to regulation by the U.S. Department of Agriculture
(USDA)) were finalized, it would revise the guidelines for the
voluntary program to make them as consistent as possible with those
final rules. FDA published the final regulations implementing the 1990
amendments in the Federal Register of January 6, 1993, including
regulations on mandatory nutrition labeling of processed, packaged
foods (58 FR 2079); reference daily intakes and daily reference values
(58 FR 2206); and serving sizes (58 FR 2229). FDA made technical
changes in these final rules on August 18, 1993 (58 FR 44020).
FDA published a proposal in the Federal Register of July 18, 1994
(59 FR 36379) (hereinafter referred to as the July 1994 proposal), and
a correction notice in the Federal Register of July 21, 1994 (59 FR
37190), to update the nutrition labeling values for the 20 most
frequently consumed raw fruits, vegetables, and fish and to revise the
guidelines for the voluntary nutrition labeling of these foods to
reflect the January 6, 1993, final rules as modified. Interested
persons were given until September 16, 1994, to comment. In the Federal
Register of October 17, 1994 (59 FR 52275), FDA reopened the comment
period until November 16, 1994, in response to several requests for an
extension of the comment period.
FDA received 29 responses to the July 1994 proposal, each of which
contained one or more comments. The comments generally supported the
July 1994 proposal. A number of comments suggested modification and
revision in various provisions of the July 1994 proposal. A summary of
the suggested changes and the agency's responses follows.
One comment suggested changes in the definition of ``substantial
compliance'' in Sec. 101.43(c) (21 CFR 101.43(c)) and in the study
design for the required biennial surveys specified in Sec. 101.43(b) to
allow for separate levels of substantial compliance for large and small
stores.
FDA did not raise this issue in the July 1994 proposal. It is
therefore outside the scope of this rulemaking. Persons interested in
this issue may petition the agency in accordance with 21 CFR 10.30.
II. Compliance by Food Retailers
A. Good-Faith Effort/Flexibility
1. One comment encouraged FDA to continue to permit flexibility in
providing information to consumers. The comment stated that the most
appropriate way for retailers to provide information is dependent on
in-store space requirements as well as specific needs of consumers and
grocers. The comment stated that the continually changing rules of the
voluntary program distort compliance efforts and asked that FDA
consider the industry's efforts to comply with ever-changing rules and
to adopt a ``good faith effort'' approach in determining substantial
compliance. The comment stated that retailers are waiting for the
revised nutrition labeling values, that supplies of posters and
brochures that display the old nutrition labeling values have dwindled,
and that new stores may be unable to obtain display information until
sometime after the final rule issues with the new values.
FDA used a good faith effort approach in the survey conducted in
November and December 1994 by finding retailers to be in compliance
with the guidelines if they followed the November 27, 1991, regulations
or used the nutrition labeling values proposed in the July 1994
proposal (59 FR 36379 at 36388 and as corrected at 59 FR 37190).
These final regulations grant retailers flexibility in
disseminating the nutrition labeling information to consumers through
various means and materials. The regulations allow for the information
to be presented in a variety of ways (shelf labels, signs, posters,
brochures, notebooks, or leaflets) (Sec. 101.45(a)(1) (21 CFR
101.45(a)(1))) and provide guidance for retailers who choose to use a
chart format (Sec. 101.45(a)(3)) and for those who use an individual
label format (Sec. 101.45(a)(4)).
In addition, Sec. 101.43(a) recognizes that signs providing
nutrition information may be lost or damaged. Thus the regulation
provides that retailers will be considered to be in compliance if they
provide consumers with at least 90 percent of the nutrition labeling
values for the 20 most frequently consumed raw fruits, vegetables, and
fish. Further, Sec. 101.43(a) states that retailers need only provide
data for items among those most frequently consumed that are sold in
their stores. They need not have nutrition information on items not
sold in their stores.
Although the comment refers to ``continuously changing rules,'' the
agency does not foresee any additional major changes to the voluntary
program
[[Page 42743]]
except for the updating of the nutrition labeling values of the most
frequently consumed foods. The changes that FDA is making at this time
to the guidelines for the voluntary program are primarily to make them
as consistent as possible with the January 6, 1993, mandatory nutrition
labeling regulations for processed, packaged foods.
B. Use of FDA Data for Compliance
FDA proposed in Sec. 101.43(a)(3) and Sec. 101.45(b) that for
retailers to be in compliance with the voluntary program, they must
provide customers with the nutrition labeling values developed by FDA
in Appendices C and D to part 101 (21 CFR part 101) (except that
information on potassium is voluntary). FDA stated that its tentative
view was that use of these values will ensure consistency of values
among retail stores and thus prevent consumer confusion.
2. One comment supported retailer use of data provided by FDA.
Another comment supported the continued revisions to labeling values to
reflect newer data and changes in labeling to be consistent with
labeling of other foods. This comment endorsed providing consumers with
the most accurate and complete information in a consistent format to
alleviate customer confusion. However, another comment stated that the
proposed requirement that FDA's values be used for the voluntary
program was too restrictive. The comment supported the use of more
cost-effective, realistic, and workable standards in nutrition labeling
and suggested using food composition data from USDA to provide as much
information to consumers as possible. The comment said that no one
would argue that USDA's data are inaccurate and said that FDA's
nutrition labeling regulations are based on food consumption surveys
conducted by USDA.
FDA finds that its provision to retailers of the nutrition labeling
values for the voluntary program is the most cost-effective method to
transmit this information to consumers, and that this method promotes
consistency in the information received by consumers. Retailers will
incur no costs relating to sampling design, collection procedures,
laboratory analysis, or statistical evaluation of data. The costs that
will be incurred by retailers participating in the voluntary program
will be limited to the purchase or development of the charts,
brochures, or other materials for consumer use.
FDA does not agree that mean values from USDA data bases are
appropriate for nutrition labeling. The nutrition labeling regulations
in Sec. 101.9 (g)(4) and (g)(5) state that FDA will consider a product
misbranded if analyzed nutrient levels for naturally occurring
vitamins, minerals, protein, total carbohydrate, polyunsaturated fat,
monounsaturated fat, and potassium are not at least equal to 80 percent
of the value declared on the label, and if analyzed nutrient levels for
calories, sugars, total fat, saturated fat, cholesterol, and sodium are
more than 20 percent in excess of the value declared on the label. To
meet these requirements, the agency encourages manufacturers to use FDA
compliance calculations to determine the nutrition labeling values for
their products (Ref. 1). Use of mean values (such as those from USDA
data bases) for nutrition labeling, as suggested by the comment, is
less likely to assure manufacturers of being in compliance with FDA's
regulations.
Some of the USDA's food composition data are not truly
representative because they are based on small sample sizes or do not
take into account specific variables, such as geographic area. Thus,
mean food composition values available in various USDA publications
are, generally, not suitable for labeling purposes.
FDA has provided nutrition labeling values for the most frequently
consumed raw fruits, vegetables, and fish in Appendices C and D. The
agency did obtain data for some of these foods from the USDA National
Nutrient Databank and other USDA sources. However, where possible, FDA
applied compliance calculations to the data obtained from USDA (as well
as other data sources) and used the resulting, adjusted values.
It is true, as the comment states, that FDA used information from
USDA food consumption surveys to establish reference amounts
customarily consumed in Sec. 101.12 (quantities of foods commonly
consumed per eating occasions) for use by manufacturers in determining
serving sizes for nutrition labeling. However, FDA does not agree with
the comment that the use of USDA food consumption data by FDA for that
purpose necessitates FDA's use of USDA food composition data for
purposes of nutrition labeling if those data are not adequate for those
purposes. Based on the foregoing, having fully considered the comments,
FDA has adopted Secs. 101.43(a)(3) and 101.45(b) as proposed.
III. The 20 Most Frequently Consumed Raw Fruits, Vegetables, and Fish
A. Plural Versus Singular Food Names
3. One comment requested latitude in the use of plural versus
singular names for fruits and vegetables (e.g., peach versus peaches).
The comment stated that FDA was not consistent in the use of plural and
singular food names and asked for clarification.
In the July 1994 proposal, FDA used singular food names if the
serving was one whole unit (e.g., apple, banana) or part of a whole
unit (e.g., salmon, watermelon, avocado) and plural food names if the
serving was more than one unit (e.g., grapes, strawberries, green peas,
scallops). FDA requests that retailers (and trade associations that
provide nutrition labeling information to retailers) use the plural and
singular designations for food names for raw fruits, vegetables, and
fish provided by FDA in Appendices C and D to part 101 when they
provide nutrition labeling information to consumers. However, the
agency does not consider the use of singular or plural names to be an
issue for the biennial compliance surveys. Noncompliance of a retailer
will be judged as failure to provide the nutrition labeling values as
specified in this final rule.
B. Food Names
4. One comment requested name changes for three foods. The comment
wanted ``lettuce'' to be called ``iceberg lettuce,'' ``sweet cherries''
to be called ``cherries,'' and ``honeydew melon'' to be called
``honeydew.''
FDA notes that ``lettuce'' is specified as ``iceberg lettuce'' in
Sec. 101.44(b) and in Appendix C to part 101. FDA mistakenly used the
more general term ``lettuce'' in referring to this food in Appendix C
of the July 1994 proposal. FDA is not convinced that consumers would be
served by changing the name ``sweet cherries'' to ``cherries'' or
``honeydew melon'' to ``honeydew.'' Use of these alternate names for
sweet cherries and honeydew melon by retailers will not, however,
result in a finding of noncompliance.
C. Changes to the 20 Most Frequently Consumed Fish
FDA received no comments about its proposed changes to the list of
the 20 most frequently consumed fish. Therefore, the proposed changes
to the fish list (i.e., to list flounder and sole as one entry, to have
three subgroups for salmon, and to add swordfish) have been
incorporated in Sec. 101.44(c) and Appendix D to part 101.
[[Page 42744]]
IV. Presentation of the Nutrition Labeling Values
The July 1994 proposal was designed to make the guidelines for the
voluntary program more consistent with the January 6, 1993, nutrition
labeling regulations in terms of what information is required
(content), and how that information is to be presented (format). The
proposed guidelines would allow the information to be presented in a
chart format (Sec. 101.45(a)(3)) as well as in an individual label
format (Sec. 101.45(a)(4)) that is similar to that used for processed,
packaged foods.
There was general support among the comments for the proposed
content and format for the nutrition labeling of raw fruits,
vegetables, and fish. In particular, comments generally agreed that:
(1) Labels on produce should be as consistent as possible with those on
other foods; (2) saturated fat and cholesterol should be allowed to be
listed in a footnote rather than in columns for produce; (3) the entire
footnote for Daily Values (DV's) for two calorie levels should not be
required to be listed on charts; and (4) if producers and packers label
an individual product, they should comply with the format and other
regulations that apply to packaged foods.
A. Optional Nutrients
5. One comment requested that the word ``required'' be omitted from
proposed Sec. 101.45(a)(2) because it provides that only ``required
nutrients'' should be declared in accordance with Sec. 101.9(c) and
makes no provision for voluntary inclusion of information on other
micronutrients. The comment stated that, as long as it is done
accurately, vendors should be allowed to include information for any
essential vitamin or mineral listed in Sec. 101.9(c)(8)(iv), not only
the required nutrients, to the same extent that they are allowed to do
so for the same products in processed form. The comment stated that
removing the word ``required'' would allow for the listing of beta-
carotene under vitamin A (see Sec. 101.9(c)(8)(vi)), and that fruits
and vegetables are a good source of this nutrient.
Two other comments requested that FDA address the use of optional
nutrients in the voluntary program. They stated that information about
optional nutrients is allowed on processed foods, and that they
strongly supported the declaration of optional nutrients as part of the
voluntary program. Another comment requested that FDA permit inclusion
of data on the vitamin B-6 content of bananas because bananas are an
excellent source of this nutrient. The comment stated that inadequate
dietary intake of vitamin B-6 is a potential public health issue, and
that inclusion of vitamin B-6 on the nutrition label will serve an
important public health function.
FDA is persuaded by these comments that providing information on
optional nutrients for foods in the voluntary program will be useful.
Thus, FDA is providing for the declaration of information on optional
nutrients for raw fruits, vegetables, and fish, particularly on labels
for individual foods (e.g., on signs, brochures, or food packages).
Declarations of optional nutrients included on individual labels should
follow the requirements under Sec. 101.9(c). Therefore, FDA is removing
the word ``required'' in Sec. 101.45(a)(2), as suggested by the
comment.
However, FDA is concerned about the size and readability of charts
if they provide information on optional nutrients.
Including optional nutrients on charts will require extra columns
and thus make the charts larger. Some comments (discussed in section
IV.D. of this document) expressed concern that charts carrying only the
required information are too large and unreadable. Therefore, FDA urges
retailers to carefully consider the consequences of including optional
nutrients in charts.
If optional nutrients are included on charts (see
Sec. 101.45(a)(3)), retailers should provide values for the nutrients
for all foods and not leave blanks for some foods. FDA fears that
consumers might interpret blanks for optional nutrients in charts as
zeros. Alternatively, information can be provided on optional nutrients
in a footnote outside the column format of the chart (e.g., ``bananas
contain 35% of the DV for vitamin B-6'').
B. Use of Individual Labels on Posters
6. One comment stated that posters with horizontal and vertical
lines are difficult for consumers to read and provided an alternative
poster with 40 individual produce nutrition labels. The comment asked
whether the exceptions for chart format posters apply to other poster
formats.
In proposed Sec. 101.45(a)(3), FDA stated that when nutrition
labeling information is provided for raw fruits, vegetables, and fish
on signs, posters, brochures, notebooks, or leaflets, it may be
presented in charts in horizontal or vertical columns. This proposed
provision would not have required the use of horizontal or vertical
columns. However, to clarify that other formats may be used, FDA has
modified Sec. 101.45(a)(3) to provide for the optional use of a poster
containing a compilation of individual nutrition labels. FDA has also
modified the first sentence of Sec. 101.45(a)(3) to clarify that it
pertains to materials containing nutrition information for more than
one raw fruit, vegetable, or fish, whereas Sec. 101.45(a)(4) pertains
to nutrition labeling for individual raw fruits, vegetables, or fish.
The exceptions noted in Sec. 101.45 (a)(3)(i) through (a)(3)(iii) for
labeling materials containing nutrition information on more than one
item will apply to all such materials, i.e., signs, posters, brochures,
notebooks, or leaflets.
C. Use of Linear Formats
7. FDA proposed in Sec. 101.45(a)(3) to not permit the use of
linear formats in the voluntary program. One comment opposed this
restriction. The comment encouraged FDA to find retailers in compliance
even if nutrition information is provided in a different format from
those specified in Sec. 101.45 and stated that flexibility and
creativity should be encouraged. The comment said that alternate
formats may be preferable to reach specific populations. The comment
stated that the linear format can achieve the desired results as well
as the columnar format, and that the retailer should be granted the
flexibility to determine what format best suits the needs of its
customers. The comment stated that the other labeling requirements
regarding highlighting, type size, and other format elements will
ensure that the information displayed in a linear format will be
visible and readable.
FDA is not persuaded that the linear format (i.e., display) would
be useful for providing voluntary nutrition labeling. A linear display
is not particularly easy to read, and the difficulties would be
exacerbated on posters that a consumer may have to read from a
distance. Under Sec. 101.9(j)(13)(ii), linear displays can only be used
to present the nutrition label if the food package has less than 40
square inches of space available to bear labeling, and the package
shape and size cannot accommodate a standard vertical or tabular
display. Posters, brochures, and other means for providing nutrition
information under Sec. 101.45(a)(3) are not limited in size and
therefore do not meet these criteria. Thus, FDA has retained the
restriction on the use of linear displays in Sec. 101.45(a)(3). At the
same time, however, the agency modified Sec. 101.45(a)(3) to change
``linear format'' to ``linear display'' to use terminology
[[Page 42745]]
consistent with Sec. 101.9(j)(13)(ii)(A)(2) and to cross-reference that
section.
Linear displays are not precluded under Sec. 101.45(a)(4) for
individual labels as long as the labels meet the criteria in
Sec. 101.9(j)(13)(ii).
D. Use of Abbreviated Charts
To make the charts containing the nutrition labeling values for raw
fruits, vegetables, and fish more readable, FDA proposed in
Sec. 101.45(a)(3)(ii) that the full footnote required in
Sec. 101.9(d)(9)(i), which lists the DV for six nutrients for two
calorie levels, not be required. Because no comments opposed this
action, Sec. 101.45(a)(3)(ii) is included in the final rule as
proposed.
FDA proposed in Sec. 101.45(a)(3)(iii) to provide the option of
omitting the columns for saturated fat and cholesterol for fruits and
vegetables, omitting the columns for sugars and fiber for fish, and
instead providing the following footnotes: ``Most fruits and vegetables
provide negligible amounts of saturated fat and cholesterol; avocados
provide 1 gram (g) of saturated fat per ounce,'' and ``Fish provide
negligible amounts of dietary fiber and sugars.'' FDA proposed these
footnotes to reduce the size of the charts on which nutrition
information is presented (to make them more readable) without reducing
the amount of information provided to consumers.
8. One comment requested that the portion of the footnote regarding
the fat content of raw produce for the voluntary nutrition labeling
chart (i.e., ``* * * avocados provide 1 g of saturated fat per ounce'')
be changed to ``* * * avocados provide 1 g of saturated fat, 1 g of
polyunsaturated fat, and 3 grams of monounsaturated fat per ounce.''
The comment said that this additional information about avocados will
be useful for consumers, especially diabetics, because the new diabetes
guidelines recommend increasing consumption of monounsaturated fatty
acids.
Because information on polyunsaturated and monounsaturated fat may
be provided on processed foods, FDA has decided to revise
Sec. 101.45(a)(3)(iii) to permit the inclusion of information about the
level of these nutrients in avocados (as suggested by the comment) on
an optional basis by retailers. To provide the added flexibility, FDA
revised Sec. 101.45(a)(3)(iii) to make the subject footnote an example
of an appropriate footnote, rather than the required footnote, and
added a sentence stating that information about the polyunsaturated and
monounsaturated fat content of avocados may be included. In addition,
FDA clarified that if the listings of saturated fat and cholesterol are
left off of charts or off of individual nutrition labels used on signs,
posters, brochures, notebooks, or leaflets, the required information on
saturated fat and cholesterol must be included in a footnote.
9. One comment stated that the new charts proposed by FDA will be
less readable than the previous ones because there will be 22 columns
instead of 10, and that much of the information is repetitious because
there are dual listings (i.e., weight amounts and percent DV's) for
some nutrients. The comment stated that the new charts will have too
much information for consumers to handle. The comment stated that
current signs are manageable, but that the new ones will require either
smaller type (making it unreadable to consumers) or larger signs (which
are impractical to hang). Further, the comment stated that the firm
that submitted this comment planned to do away with signs and to use a
manual and leaflets if the July 1994 proposal becomes final. The
comment requested that FDA allow for the use of abbreviated charts as
signs in produce and seafood departments if complete information (e.g.,
in manuals or leaflets) is available to consumers elsewhere in the
store. It stated that a note on the chart could direct consumers to the
more detailed information. The comment suggested that abbreviated
charts for fruits and vegetables could omit calories from fat,
cholesterol, and saturated fat and list only the percent DV's (and not
weight amounts) for nutrients, and that for fish, such charts could
omit sugars, dietary fiber, and potassium and list only the percent
DV's for nutrients. The comment noted that declaration of percent DV's
is the most important information on the nutrition label, as reflected
in FDA's requirement that it be in bold face.
FDA acknowledges that the new charts containing nutrition labeling
for raw produce and fish will contain more information, and thus
require larger charts or smaller print, than the old charts. FDA has
addressed, in part, the issue of the size of the charts by allowing for
the omission of the columns for saturated fat and cholesterol for
fruits and vegetables and the columns for dietary fiber and sugars for
fish (Sec. 101.45(a)(3)(iii)). FDA does not feel that it is appropriate
to omit the column for calories from fat for fruits and vegetables, as
the comment suggests, because seven of these foods have values greater
than zero for calories from fat. Information on calories from fat is
important for consumers, and a footnote to the chart that specifies the
number of calories from fat for seven fruits and vegetables would be
lengthy and difficult to read.
In response to the suggestion that the column for potassium be
included on the chart for fruits and vegetables but omitted from the
chart for fish, FDA notes that the column for potassium is optional on
both charts. However, FDA also notes that potassium provided by fish is
as important as potassium provided by fruits and vegetables. Several
comments agreed that information on potassium is important for
consumers, and that it should be optionally provided.
Any inconsistency between abbreviated charts without columns
listing the quantitative amounts by weight for nutrients for which
percent DV's are declared, as suggested by the comment, and the
nutrition labeling of processed, packaged foods could lead to consumer
confusion. There was general agreement among the comments that
nutrition labeling information for fruits, vegetables, and fish should
be as consistent as possible with labeling provided for other foods.
Additionally, the quantitative amounts by weight continue to be
important to, and used by, many health professionals and consumers. For
instance, the results of FDA's 1995 Health and Diet Survey showed that,
among respondents who used the Nutrition Facts label to obtain
nutrition information on a food product, a majority use the g and
milligram (mg) amounts on the label solely or in combination with the
percent DV's (69 percent). Few of the respondents in the survey used
only the percent DV's (14 percent) (Ref. 4).
Because the size and readability of the charts are important
issues, the agency encourages retailers and educators to experiment
with various chart formats, to test and determine consumer responses to
them, and to share the results of these studies with FDA. However,
after considering the information needs of consumers and the comment's
expressed concern about chart size, FDA concludes that the requirement
that it is adopting strikes an appropriate balance between these
potentially competing factors.
E. Nutrient Values on Individual Labels
FDA proposed in Sec. 101.45(a)(4) that individual nutrition labels
(e.g., over bins or on packaging) for raw fruits, vegetables, and fish
provided by retailers meet the requirements of Sec. 101.9(d). This
proposed provision would have required that individual labels carry the
full footnote set forth in Sec. 101.9(d)(9), which provides
[[Page 42746]]
information about daily values for two calorie levels, rather than the
abbreviated footnote permitted for the chart format under
Sec. 101.45(a)(3)(ii), unless the package is otherwise exempt under
Secs. 101.9(f) or 101.9(j)(13) from such a requirement.
10. Several comments disagreed with the need for the full footnote
on individual labels provided by retailers above or close to food bins
or containers. The comments stated that the modified label, without the
lengthy DV's footnote, would be appropriate because of space and
readability concerns. One comment stated that the sign could direct the
consumer to a source of more complete information in the store. Another
comment noted that short, modified labels are allowed on some processed
foods and should be allowed for foods in the voluntary program.
FDA is persuaded by the comments that the footnote concerning
nutrient requirements at two calorie levels could create concerns about
space and readability for individual labels provided by retailers on
signs that are over or near food bins or containers for raw fruits,
vegetables, and fish. Therefore, FDA has added a sentence to
Sec. 101.45(a)(4) that reads, ``For individual labels provided by
retailers on signs and posters, the footnote required in
Sec. 101.9(d)(9) may be shortened to `Percent Daily Values are based on
a 2,000 calorie diet.' '' The agency also notes that foods that qualify
may use the simplified format (see Sec. 101.9(f)). Thus, FDA has
provided for the use 'of short, modified nutrition labels with
individual raw fruits, vegetables, and fish.
F. Nutrition Labeling Values for a Particular Commodity
11. A commodity group asked whether the nutrition label that was
developed and made available by the group in April 1993 could continue
to be used on bags and boxes of that commodity.
As discussed in section II.B. of this document, to be in compliance
with Sec. 101.45(b) of the guidelines for the voluntary program,
retailers must provide consumers with the nutrition labeling values
provided by FDA in Appendices C and D to part 101 for the most
frequently consumed raw fruits, vegetables, and fish. (As for the date
when use of these values must begin, see section VI. of this document.)
Individual nutrition labels used on raw fruits, vegetables, and fish
that are packaged by a grower, producer, or shipper should provide the
information listed in Sec. 101.45(a)(4). If growers, producers, or
shippers wish to provide individual nutrition labels on packaging
materials for foods included in the voluntary program, they should use
the labeling values provided by FDA.
However, if a nutrition label developed by a commodity group is for
a specific genus or species, then a more specific name for the product
should be used, as stated in Sec. 101.45(c)(1), and the commodity group
should have the data to support the labeling values used for the
product. The nutrition labeling values in Appendices C and D to part
101 are for generic commodities. If a commodity group wishes to amend
the nutrient values for a generic item, FDA encourages the group to
submit the values to the agency as specified in Sec. 101.45(b)(1) for
consideration for inclusion in the agency's next revision of Appendices
C and D. If upon review of the data, FDA decides to use the labeling
values for the generic item, those values will be made available for
public comment. Any nutrition labeling value for a generic item that
the agency decides to incorporate into Appendix C or D will have to be
used by retailers for them to be considered to be in compliance.
FDA is agreeable to having its labeling values used on bags of cut
raw produce that qualify for the voluntary program (e.g., they have
received no further processing or are not packaged with added
ingredients such as salad dressing or croutons).
V. Timeframe for Updating Nutrient Values
12. FDA stated in the July 1994 proposal that the nutrition
labeling values for the most frequently consumed raw fruits,
vegetables, and fish would be revised every 2 years (proposed
Sec. 101.45(b)). Several comments thought that this timeframe was too
short. One comment expressed concern about retailers keeping up with
the 2-year revisions and stated that too frequent changes in the values
will result in confusion in the marketplace. The comment stated that
changes will require education of retail store operators, and that it
is time-consuming and expensive for industry to prepare, obtain, and
display new compliance materials. The comment stated that new materials
cannot be adequately disseminated to the industry in less than 6 months
and asked that FDA consider the administrative and economic burden
imposed on the industry.
Four comments recommended updates every 4 years (every other
compliance reporting period) rather than every 2 years. Reasons given
for extending the time between revisions were: (1) To accommodate the
time lag in relaying information to retailers and industry members; (2)
to use up old packaging in stock; (3) difficulties for retailers,
shippers, and packaging companies in changing packaging materials; (4)
cost of printing educational materials; (5) the shelf life of
educational materials, which is longer than 2 years; and (6) FDA's
inability to complete revisions every 2 years. One comment stated that
growers will choose not to put nutrition labeling information on bags
of produce if the values are changed on a biennial basis.
FDA agrees that biennial updates of the nutrition labeling values
as well as the list of the 20 most frequently consumed raw fruits,
vegetables, and fish are difficult for both FDA and retailers, and that
updates every 4 years are more reasonable and cost-effective.
Accordingly, FDA has revised Sec. 101.45(b) to state that, if
necessary, revisions will be proposed every 4 years.
VI. Effective Date for Compliance
13. FDA proposed that any revision that is made in the voluntary
program would be effective 30 days after publication of the final rule.
A number of comments stated that this time period is too short for
retailers and for growers, shippers, and packers. The comments stated
that more time is needed to: (1) Finalize the updated charts and have
retailers print and distribute their materials throughout their stores;
(2) print labels and posters and devise new advertising campaigns; (3)
order and receive new packaging; and (4) avoid inventory disposal costs
and allow depletion, rather than destruction, of label inventory.
Several comments stated that the short effective date would be an
economic hardship for growers and shippers with nutrition labeling on
packaging materials. Two comments recommended an extended effective
date for growers and shippers who voluntarily label produce.
One comment requested that FDA expressly advise that any new
nutrient values for raw fish will not have to be used by manufacturers
in the nutrition labeling of retail-packaged, single-ingredient raw
fish products until, at a minimum, 180 days after publication of the
final rule. The comment stated that FDA focused on the effect of
voluntary nutrition labeling in retail stores but did not consider
manufacturers who use FDA values in nutrition labeling retail-packaged,
single-ingredient products. The comment stated that manufacturers of
packaged raw fish products must create new label plates, print labels,
[[Page 42747]]
package inventory, ship products bearing the new labels, and allow for
transit and holding time if the product is exported to the United
States.
Several comments noted that FDA allowed considerably more time (16
months and then 19 months as extended) in establishing the effective
date for the labeling provisions of the 1990 amendments for processed
foods and asked that the produce and fish industries be given more
time. Comments requesting a longer time period suggested 4 months (one
request), 6 months (one request), 1 year (four requests), 15 months
(one request), and 18 months (one request).
FDA agrees that an effective date of 30 days after publication of
the final rule is too short for retailers to get new nutrition labeling
materials in place. Taking the various suggestions for extended time
frames into consideration, FDA has set the effective date of this final
rule to be 1 year from the date of publication in the Federal Register.
Labeling values in Appendices C and D to part 101 may be and should be
used at the retail level as soon as possible, beginning on the date of
publication. However, because of the relatively short amount of time
before the 1996 FDA Compliance Survey, FDA will consider either the old
(1991) or new (1996) labeling values to be acceptable for retail stores
to be considered to be in compliance with the voluntary program during
the upcoming survey.
Likewise, growers, shippers, and packers who provide nutrition
labeling on packages of raw fruits, vegetables, and fish will have 1
year to come into compliance with this document. While growers,
shippers, and packers will not be assessed for compliance as a part of
the 1996 FDA Compliance Survey for the voluntary program, they will
need to be in compliance with Sec. 101.9 (as modified by
Sec. 101.45(a)(4)). Accordingly, those who use the generic nutrient
values in Appendix C or D to part 101 in nutrition labeling will have 1
year to update nutrient values on the food labels.
VII. Nutrition Labeling Values for the 20 Most Frequently Consumed Raw
Fruits, Vegetables, and Fish
In the July 1994 proposal, FDA stated that the information that it
used to arrive at the proposed nutrition labeling values for raw
fruits, vegetables, and fish included data provided by the Produce
Marketing Association (PMA), Nutrition Network (on behalf of the
International Banana Association), and USDA (for fish and produce). FDA
received a few comments in response to the July 1994 proposal that
included additional data for some foods from other sources. PMA
submitted new labeling values based upon their original raw data that
were referenced in the proposal. FDA considered data from all sources
and used those data, as appropriate, to calculate the labeling values
set forth in this document in Appendices C and D to part 101. In these
calculations, to the extent possible, FDA used the statistical
methodology that it recommends in the ``FDA Nutrition Labeling Manual:
A Guide for Developing and Using Data Bases'' (i.e., using compliance
calculations based on 95 percent prediction intervals) (Ref. 1).
Complete documentation for the nutrition labeling values for raw
fruits, vegetables, and fish is found in Reference 5.
A. Fat Values for Raw Fruits and Vegetables
14. One comment requested that the fat content of all raw fruits
and vegetables containing less than 1 g of fat be listed as zero g.
FDA is not aware of any basis for establishing rules on how
nutrient values are determined for raw fruits and vegetables that are
different from those for other foods. The nutrition labeling
regulations require that the amount of fat be expressed to the nearest
0.5 g increment below 5 g (Sec. 101.9(c)(2)). However, if the amount of
fat is less than 0.5 g, the label value of 0 g may be used. Thus, for
fruits and vegetables containing less than 1 g, but more than 0.5 g of
fat, FDA rounded to 0.5 g if the amount present was 0.74 g or less, and
rounded to 1 g if the amount present was 0.75 g or more. Thus, FDA has
not taken the action requested by the comment.
B. Fat Values for Grapefruit, Kiwifruit, Strawberries, and Tomatoes
15. One comment expressed concern about the fat values for
grapefruit, kiwifruit, strawberries, and tomatoes. The comment stated
that the analytical method (ether extract) that was used to obtain the
data overestimates fat when it is present in trace amounts compared to
current techniques such as high pressure liquid chromatography (HPLC)
or gas chromatography. The comment stated that, consequently, it may be
necessary to reanalyze the fat content for those commodities. Five
other comments questioned the fat content of grapefruit, and four of
those comments suggested that FDA had made an error in rounding. These
comments suggested that the fat content of grapefruit is 0 g rather
than 0.5 g.
FDA looks forward to receiving new data submissions for raw fruits
and vegetables (including grapefruit, kiwifruit, strawberries, and
tomatoes) based upon more current analytical methods. The agency will
consider those data and will make changes, if appropriate, at the next
opportunity for revision of the labeling values for these foods. For
the purposes of this final rule, however, FDA determined the fat
content of kiwifruit, strawberries, and tomatoes based on the PMA data,
using statistical methodology specified in the labeling manual. Revised
fat values are listed in Appendix C to part 101 for kiwifruit (1 g, 2
percent DV), strawberries (0 g, 0 percent DV), and tomatoes (0.5 g, 1
percent DV).
FDA acknowledges that it made an error in tentatively assigning a
0.5 g fat value for grapefruit. After reviewing the PMA data, FDA
concluded that the fat value for grapefruit is 0 g, 0 percent DV.
C. Fiber Values for 12 Fruits and Vegetables
16. One comment stated that FDA's fiber values in the July 1994
proposal were too low for bananas, cucumbers, and radishes and too high
for oranges, grapefruit, tangerines, sweet cherries, kiwifruit, onions,
sweet corn, sweet potatoes, and green beans. The comment provided only
mean values for dietary fiber for these foods based upon five methods.
FDA reviewed the information on dietary fiber provided by the
comment. Unfortunately, the comment did not include raw data, measures
of variance (e.g., standard deviations), or the number of samples or
composites analyzed, information required for FDA to perform compliance
calculations to determine appropriate nutrition labeling values.
Because the comment did not provide adequate information for revision
of the label values for dietary fiber, FDA will make no changes based
upon this comment.
FDA encourages the produce industry to do complete laboratory
analyses and welcomes submissions of data for fiber accompanied by
detailed information. The agency will consider those data and will make
changes, if appropriate, at the next opportunity for revision of the
labeling values for these foods. As discussed in sections VII.F. and
VII.H. of this document, FDA has revised the fiber values for some
foods in this document based on data submitted in other comments.
D. Nutrition Labeling Values for Apples
17. One comment provided FDA with data on the nutrient composition
of apples that, the comment claimed,
[[Page 42748]]
upgraded the data on file with FDA, which were provided by PMA in 1990.
The submission provided data describing the contribution of sugars to
total carbohydrate, the levels of saturated and unsaturated fatty
acids, and the total fatty acid content. The comment requested that
these newer data be included in FDA's revision of the nutrition
labeling values for raw apples because they are more complete and
accurate and reflect the use of more current analytical methods.
FDA reviewed the newer data for apples (Ref. 6) and used these
data, along with other available data, to derive labeling values using
compliance calculations based on 95 percent prediction intervals for
the levels of calories from fat, total fat, saturated fat, total
carbohydrate, and sugars in this final rule. The following summarizes
changes to the nutrition labeling values in Appendix C for apples based
on the data submitted in the comment:
Table 1
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Apple nutrient
(1) Proposed values
(1) Final rule values
----------------------------------------------------------------------------------------------------------------
Calories from fat................ 10 .................. 0
Total fat........................ 1 g 2% DV 0 g 0% DV
Total carbohydrate............... 24 g 8% DV 22 g 7% DV
Sugars........................... 20 g .................. 16 g .................
----------------------------------------------------------------------------------------------------------------
Note: The value for saturated fat remains the same as in the July 1994 proposal at 0 g, 0 percent DV.
FDA made additional changes to the nutrition labeling values for
apples based upon another comment, as described in section VII.H. of
this document.
E. Nutrition Labeling Values for Avocados
18. One comment provided new data for potassium, protein, and
vitamin C in California avocados. Based on the new data, the submission
requested that the value for potassium be changed from 105 mg, 3
percent DV to 170 mg, 5 percent DV; that the value for protein be
changed from 0 g to 1 g; and that the value for vitamin C be changed
from 2 percent DV to 4 percent DV.
FDA reviewed the newer data for avocados (Ref. 7), confirmed that
the label values suggested by the comment were correctly derived using
compliance calculations based on 95 percent prediction intervals, and
used these data in deriving the label values for potassium, protein,
and vitamin C for avocados in this final rule. The changes that FDA has
made to the nutrition labeling values in Appendix C for avocados based
on the comment are summarized below:
Table 2
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Avocado nutrient
(1) Proposed values
(1) Final rule values
----------------------------------------------------------------------------------------------------------------
Potassium........................ 105 mg 3% DV 170 mg 5% DV
Protein.......................... 0 g .................. 1 g .................
Vitamin C........................ .................. 2% DV .................. 4% DV
----------------------------------------------------------------------------------------------------------------
FDA made additional changes to the nutrition labeling values for
avocados based upon another comment, as described in section VII.H. of
this document.
F. Nutrition Labeling Values for Bananas
19. In developing the July 1994 proposal, FDA used data on the
composition of bananas that were submitted on behalf of the
International Banana Association. Those data were derived from data
from a 1982-1983 study by the United Fresh Fruit and Vegetable
Association (UFFVA) and from a 1990 PMA study. FDA calculated nutrition
labeling values for bananas using compliance calculations based on 95
percent prediction intervals and published these values in Appendix C
of the July 1994 proposal.
One comment stated that the 1982-1983 UFFVA data should not be used
for fiber and vitamin C, and that the FDA values for these two
nutrients in bananas should be revised based only on the PMA data. The
comment stated that there are statistically significant differences
between the two data sets for dietary fiber and vitamin C, which
suggests that only one data set may appropriately be used. The comment
stated that the differences are likely attributable to the different
analytical methods used in the surveys. The comment said that the 1982-
83 UFFVA data were based upon a method of analysis that measured crude
fiber, neutral detergent fiber, and pectin, while the 1990 PMA fiber
data were based on the AOAC Enzymatic-Gravimetric Method. The 1982-1983
UFFVA vitamin C data were obtained with a titrimetric assay that
measures ascorbic acid but not dehydroascorbic acid, while the 1990 PMA
data were based on a method that measures both active forms of vitamin
C. The comment stated that based on the 1990 PMA data alone, fiber
should be 4 g, 15 percent DV, and vitamin C should be 9 mg, 15 percent
DV.
FDA accepts the explanation for the data discrepancies for dietary
fiber and vitamin C in bananas presented in the comment. The analytical
methods used by UFFVA in 1982-1983 to analyze fiber and vitamin C are
no longer appropriate for labeling purposes; however, the analytical
methods used for the more recent PMA data are appropriate. As a result,
FDA recalculated the nutrition labeling values for dietary fiber and
vitamin C based on PMA data only. The agency recalculated the nutrition
labeling values for bananas for all other nutrients based on both data
sources (UFFVA and PMA) (Ref. 8), using compliance calculations based
on 95 percent prediction intervals. The following summarizes the
differences between the proposed values and the values in Appendix C
set forth in this final rule:
[[Page 42749]]
Table 3
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Banana nutrient
(1) Proposed values
(1) Final rule values
----------------------------------------------------------------------------------------------------------------
Total fat........................ 0.5 g 1% DV 0 g 0% DV
Potassium........................ 390 mg 11% DV 400 mg 11% DV
Dietary fiber.................... 1 g 4% DV 4 g 16% DV
Vitamin C........................ .................. 0% DV .................. 15% DV
Iron............................. .................. 0% DV .................. 2% DV
----------------------------------------------------------------------------------------------------------------
G. Nutrition Labeling Values for Tangerines
20. One comment stated that FDA used incorrect values for calories,
calories from fat, fat, vitamin C, calcium, and vitamin A in
tangerines. It stated that, based on the PMA report on tangerines (Ref.
9), calories should be 45 (not 80), calories from fat should be 5 (not
10), fat should be 1 g (not 2 g), vitamin C should be 40 percent DV
(not 35 percent DV), and calcium should be 4 percent DV (not 2 percent
DV). The comment disagreed with the proposed value for vitamin A (which
FDA derived from PMA data) for tangerines. It stated that PMA only
tested for beta-carotene, but that the predominant carotenoid in
tangerines is beta-cryptoxanthin. The comment also provided numerous
scientific articles containing data, obtained by a variety of methods
including newer HPLC methods, for the beta-cryptoxanthin (3-hydroxy
beta carotene) content of tangerines. The comment recommended that FDA
use the mean vitamin A value from USDA Handbook 8-9 for its derivation
of the compliance value.
FDA would first like to note that the proposed value for total fat
in tangerines was 1 g, 2 percent DV, and not 2 g of fat, as stated by
the comment. For the tangerine values in Appendix C to part 101, FDA
derived the label values from raw data provided by a comment, using
compliance calculations based on 95 percent prediction intervals. Those
data were the only raw data available. The revised values for
tangerines are 50 calories; 0 calories from fat; 0.5 g, 1 percent DV
total fat; 50 percent DV vitamin C; and 4 percent DV for calcium.
FDA agrees that the method used by PMA measured only beta-carotene
and excluded the contribution of beta-cryptoxanthin to the vitamin A
activity for tangerines. The agency notes that there is more than one
AOAC method for the measurement of carotenes in foods, and that the
method that PMA stated that it used is specific for non-hydroxylated
carotenes and does not measure mono-hydroxylated carotenes such as
beta-cryptoxanthin. However, alternative AOAC methods do permit the
measurement of these substances and have been used historically to
obtain vitamin A values for food composition tables (Ref. 10). It
should be noted that the vitamin A activity of beta-cryptoxanthin has
been considered to be about 50 percent of that for beta-carotene (Ref.
11). As discussed in section II.B. of this document, FDA does not
consider the use of mean values, such as those in Handbook 8-9,
appropriate for labeling purposes.
FDA looks forward to receiving new data submissions for tangerines
based upon more comprehensive analytical methodology for vitamin A. The
agency will consider those data and will make changes, if appropriate,
at the next opportunity for revision of the labeling values. The
labeling value for vitamin A remains at 0 percent DV.
H. Statistical Methodology for Deriving Nutrition Labeling Values From
PMA Data
Before FDA published the July 1994 proposal, PMA provided the
agency with nutrition labeling values for 31 fruits and vegetables that
PMA had derived from the raw data it had compiled using 80 percent
prediction intervals. FDA included many of these nutrition labeling
values in the July 1994 proposal.
21. Several comments expressed concern about the rounding of the
nutrition labeling values for fruits and vegetables in the July 1994
proposal, specifically the values obtained from PMA. One comment stated
that FDA was inconsistent in rounding labeling values (e.g., in
calculating the values for total fat for grapefruit, apples, and
tangerines) and requested that FDA be consistent. Other comments
specifically questioned how percent DV's were derived from the rounded
or unrounded labeling values (e.g., dietary fiber and iron in onions).
FDA recalculated labeling values derived from the raw data that PMA
had submitted (described later in this section of this document) and is
using those recalculated values in this final rule. With respect to the
rounding issues raised by the comments, FDA points out that the
nutrition labeling regulations (Sec. 101.9(d)(7)(ii)) allow percent
DV's to be calculated from the original or rounded nutrient values. PMA
calculated percent DV's based on the original values. In recalculating
the percent DV's, FDA used rounded values. The agency did so to provide
consistency in the chart format (i.e., to be sure that the same
quantitative amount of a nutrient is associated with the same percent
DV). FDA notes that if percent DV's are calculated from original
values, it may lead to inconsistencies in the chart that would be
confusing to consumers. FDA applied the rounding rules (Sec. 101.9(c))
consistently to the data used for calculating the values in this final
rule. Therefore, FDA has responded fully to these comments.
22. Two comments expressed concern that FDA's use of PMA's
nutrition labeling values derived from 80 percent prediction intervals
was not consistent with the way the food industry develops nutrition
labeling values for processed, packaged foods. The comments stated that
fruits and vegetables will be placed at a marketing disadvantage
compared to other foods subject to the 1990 amendments, and that
consumers will receive less useful and consistent information.
FDA agrees with the comments. The 80 percent prediction values
provided by PMA and used in the July 1994 proposal were not entirely
appropriate because they were not based on 95 percent prediction
intervals. As stated elsewhere in this document, FDA recommends that
labeling values be derived from compliance calculations based on 95
percent prediction intervals and be consistent with statistical
methodology in the ``FDA Nutrition Labeling Manual: A Guide for
Developing and Using Databases'' (Ref. 1).
During the comment period, the agency received data from various
sources and considered all of those data in determining the final
values. In a comment, PMA submitted a new set of nutrition labeling
values for 31 raw fruits and vegetables and asked that those values be
used in the final rule. The nutrition labeling values in PMA's comment
were derived by using a
[[Page 42750]]
different statistical methodology than PMA used in its original
submission. Instead of values based upon 80 percent prediction
intervals, the nutrition labeling values in the comment were derived by
using 95 percent confidence intervals.
When the agency reviewed these values, it found the following
concerns with the statistical methodology (Ref. 12) that PMA had used:
(1) PMA used a one-sided 95 percent confidence interval to do the
compliance calculations rather than the FDA-recommended one-sided 95
percent prediction interval. (A confidence interval is used to
confidently bracket the true parameters of a population. A prediction
interval is associated with confidently bracketing the mean or any
number of future samples from the same population. A compliance value
based upon FDA laboratory analysis consists of a composite of 12 units.
The value is necessarily considered by the industry as the mean of 12
future units, which is expected to be in line with the labeled values.
The limit of the prediction interval is lower (or higher, depending on
the applications) than the corresponding limit of the confidence
interval for a given level of significance (Ref. 1).)
(2) PMA did not always use the minimum of the means and compliance
calculations for class II nutrients (naturally occurring vitamins,
minerals, protein, total carbohydrate, complex carbohydrate, dietary
fiber, unsaturated fat, and potassium) and the maximum of the means and
compliance calculations for third group nutrients, as listed in
Sec. 101.9(g)(5) (calories, sugars, total fat, saturated fat,
cholesterol, and sodium).
(3) In Sec. 101.9(g)(4)(ii), total carbohydrate is defined as a
class II nutrient. PMA derived total carbohydrate values under the
assumption that total carbohydrate is a third group nutrient (see
Sec. 101.9(g)(5)), rather than a class II nutrient.
FDA is grateful to PMA for submitting the nutrition labeling values
for 31 fruits and vegetables as a comment, but the agency has decided
not to use these values. Instead, FDA recalculated the nutrition
labeling values for those raw fruits and vegetables (Ref. 12) using the
raw data submitted by PMA, with 95 percent prediction intervals. These
nutrition labeling values are presented in Appendix C to part 101.
Additional differences between the nutrition labeling values in
this final rule and those provided by PMA in their comment can be
attributed to the following factors:
(1) Although PMA submitted revised data for bananas, the agency
used other data (described in section VII.F. of this document) that
were submitted during the comment period to update the nutrition
labeling values for this food.
(2) FDA used data from PMA and from other comments to update
nutrition labeling values for apples (described in section VII.D. of
this document) and avocados (described in section VII.E. of this
document).
(3) PMA calculated percent DV's based on the original values rather
than the rounded values. FDA recalculated the percent DV's based on
rounded values to avoid consumer confusion (as discussed in section
VII.H. of this document).
(4) FDA did not use the values for calories from fat provided by
PMA because PMA used 9 calories per g of fat rather than 8.37 calories
per g of fat, the appropriate factor to be used for fruits and
vegetables (Refs. 13 and 14).
(5) For watermelon, oranges, strawberries, tangerines, and leaf
lettuce, FDA adjusted the total carbohydrate value to reflect the sum
of dietary fiber and sugars. Total carbohydrate is generally determined
``by difference'' (i.e., it is the weight remaining when the weight of
the sum of protein, fat, water, and ash are subtracted from the total
weight of the food). In theory, the sum of dietary fiber and sugars
should be equal to or less than total carbohydrate because both dietary
fiber and sugars are forms of carbohydrate. However, for watermelon,
oranges, strawberries, tangerines, and leaf lettuce, the weight of
total dietary fiber (values derived from PMA data) and sugars (values
obtained from USDA (Ref. 15)) exceeded the weight of total
carbohydrate. In the July 1994 proposal, FDA explained that the agency
adjusted for this discrepancy in several foods by increasing the weight
of total carbohydrate to be at least equal to the sum of dietary fiber
and sugars (59 FR 36379 at 36383; Ref. 16). FDA explained that because
the values for dietary fiber and sugars are determined by laboratory
analysis, they are more accurate than the value for total carbohydrate,
which is determined by difference. The agency received no comments
expressing disapproval with this adjustment. Therefore, the agency made
this adjustment in calculating the values for total carbohydrate in
watermelon, oranges, strawberries, tangerines, and leaf lettuce in this
final rule.
(6) In order to have calories from fat consistent for a given total
fat value, FDA derived calories from fat for fruits and vegetables from
the rounded, rather than unrounded, total fat label value. The caloric
equivalent for fat is 8.37 calories per g for fruits and vegetables.
Thus, 0.5 g of fat is equivalent to 4.19 calories, and according to
Sec. 101.9(c)(1)(ii), ``* * * amounts less than 5 calories may be
expressed as zero.'' As a result, Appendix C consistently lists 0
calories for 0.5 g of total fat.
The following is a summary of changes from the proposed nutrition
labeling values for 30 raw fruits and vegetables that FDA derived from
the raw data provided by PMA during the comment period, using
compliance calculations based on 95 percent prediction intervals:
Table 4
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Food nutrient
(1)Proposed values
(1)Final rule values
----------------------------------------------------------------------------------------------------------------
Apple:
Potassium...................... 160 mg .................. 170 mg .................
Dietary fiber.................. 4 g 16% DV 5 g 20% DV
Vitamin A...................... .................. 0% DV .................. 2% DV
Vitamin C...................... .................. 6% DV .................. 8% DV
Iron........................... .................. 0% DV .................. 2% DV
Watermelon:
Calories....................... .................. 90 .................. 80
Total carbohydrate............. 26 g .................. 27 g .................
Dietary fiber.................. 1 g 4% DV 2 g 8% DV
Vitamin A...................... .................. 10% DV .................. 20% DV
Calcium........................ .................. 0% DV .................. 2% DV
Iron........................... .................. 2% DV .................. 4% DV
[[Page 42751]]
Orange:
Calories....................... .................. 80 .................. 70
Potassium...................... 250 mg .................. 260 mg .................
Dietary fiber.................. 5 g 20% DV 7 g 28% DV
Vitamin A...................... .................. 0% DV .................. 2% DV
Vitamin C...................... .................. 120% DV .................. 130% DV
Calcium........................ .................. 4% DV .................. 6% DV
Iron........................... .................. 0% DV .................. 2% DV
Cantaloupe:
Sodium......................... 35 mg .................. 25 mg .................
Potassium...................... 210 mg 6% DV 280 mg 8% DV
Total carbohydrate............. 13 g .................. 12 g .................
Vitamin A...................... .................. 80% DV .................. 100% DV
Grapefruit:
Calories....................... .................. 70 .................. 60
Potassium...................... 210 mg 6% DV 230 mg 7% DV
Total carbohydrate............. 18 g 6% DV 16 g 5% DV
Dietary fiber.................. 5 g 20% DV 6 g 24% DV
Vitamin A...................... .................. 10% DV .................. 15% DV
Vitamin C...................... .................. 80% DV .................. 110% DV
Calcium........................ .................. 4% DV .................. 2% DV
Strawberries:
Calories....................... .................. 70 .................. 45
Total Fat...................... 0.5 g 1% DV 0 g 0% DV
Potassium...................... 220 mg 6% DV 270 mg 8% DV
Total carbohydrate............. 17 g 6% DV 12 g 4% DV
Dietary fiber.................. 3 g 12% DV 4 g 16% DV
Vitamin C...................... .................. 130% DV .................. 160% DV
Iron........................... .................. 0% DV .................. 4% DV
Honeydew melon:
Sodium......................... 45 mg 2% DV 35 mg 1% DV
Potassium...................... 290 mg 8% DV 310 mg 9% DV
Total carbohydrate............. 14 g 5% DV 13 g 4% DV
Vitamin A...................... .................. 0% DV .................. 2% DV
Vitamin C...................... .................. 40% DV .................. 45% DV
Avocado:
Calories....................... .................. 60 .................. 55
Calories from fat.............. .................. 50 .................. 45
Total fat...................... 6 g 9% DV 5 g 8% DV
Total carbohydrate............. 2 g .................. 3 g .................
Dietary fiber.................. 1 g 4% DV 3 g 12% DV
Lemon:
Calories....................... .................. 20 .................. 15
Sodium......................... 10 mg .................. 5 mg .................
Potassium...................... 65 mg 2% DV 90 mg 3% DV
Total carbohydrate............. 6 g .................. 5 g .................
Vitamin C...................... .................. 35% DV .................. 40% DV
Pineapple:
Calories....................... .................. 70 .................. 60
Potassium...................... 100 mg .................. 115 mg .................
Total carbohydrate............. 17 g 6% DV 16 g 5% DV
Protein........................ 0 g .................. 1 g .................
Calcium........................ .................. 0% DV .................. 2% DV
Iron........................... .................. 0% DV .................. 2% DV
Tangerine:
Calories....................... .................. 80 .................. 50
Calories from fat.............. .................. 10 .................. 0
Total fat...................... 1 g 2% DV 0.5 g 1% DV
Sodium......................... .................. 5 mg .................. 0 mg
Potassium...................... 120 mg 3% DV 180 mg 5% DV
Total carbohydrate............. 20 g 7% DV 15 g 5% DV
Protein........................ .................. 0 g .................. 1 g
Vitamin C...................... .................. 35% DV .................. 50% DV
Calcium........................ .................. 2% DV .................. 4% DV
Sweet cherries:
Calories from fat.............. .................. 10 .................. 0
Total fat...................... 1 g 2% DV 0.5 g 1% DV
Potassium...................... 260 mg 7% DV 300 mg 9% DV
Total carbohydrate............. 23 g 8% DV 22 g 7% DV
Protein........................ 1 g .................. 2 g .................
Vitamin A...................... .................. 0% DV .................. 2% DV
Vitamin C...................... .................. 8% DV .................. 15% DV
Iron........................... .................. 0% DV .................. 2% DV
[[Page 42752]]
Kiwifruit:
Calories from fat.............. .................. 15 .................. 10
Total fat...................... 1.5 g .................. 1 g .................
Potassium...................... 450 mg 13% DV 480 mg 14% DV
Total carbohydrate............. 25 g .................. 24 g .................
Vitamin C...................... .................. 200% DV .................. 240% DV
Potato:
Calories....................... .................. 120 .................. 100
Sodium......................... 5 mg .................. 0 mg .................
Potassium...................... 680 mg 19% DV 720 mg 21% DV
Total carbohydrate............. 27 g .................. 26 g .................
Dietary fiber.................. 2 g 8% DV 3 g 12% DV
Protein........................ 3 g .................. 4 g .................
Vitamin C...................... .................. 40% DV .................. 45% DV
Calcium........................ .................. 0% DV .................. 2% DV
Iceberg lettuce:
Calories....................... .................. 20 .................. 15
Potassium...................... 85 mg 2% DV 120 mg 3% DV
Vitamin A...................... .................. 2% DV .................. 4% DV
Vitamin C...................... .................. 4% DV .................. 6% DV
Calcium........................ .................. 0% DV .................. 2% DV
Iron........................... .................. 0% DV .................. 2% DV
Tomato:
Calories from fat.............. .................. 10 .................. 0
Total fat...................... 1 g 2% DV 0.5 g 1% DV
Potassium...................... 300 mg 9% DV 360 mg 10% DV
Vitamin A...................... .................. 15% DV .................. 20% DV
Vitamin C...................... .................. 35% DV .................. 40% DV
Calcium........................ .................. 0% DV .................. 2% DV
Onion:
Potassium...................... 200 mg 6% DV 240 mg 7% DV
Total carbohydrate............. .................. 16 g .................. 14 g
Protein........................ .................. 1 g .................. 2 g
Vitamin C...................... .................. 15% DV .................. 20% DV
Iron........................... .................. 0% DV .................. 2% DV
Carrot:
Calories....................... .................. 40 .................. 35
Sodium......................... .................. 50 mg .................. 40 mg
Potassium...................... 220 mg 6% DV 280 mg 8% DV
Total carbohydrate............. .................. 9 g .................. 8 g
Vitamin A...................... .................. 220% DV .................. 270% DV
Vitamin C...................... .................. 8% DV .................. 10% DV
Celery:
Calories....................... .................. 25 .................. 20
Sodium......................... 125 mg 5% DV 100 mg 4% DV
Potassium...................... 300 mg 9% DV 350 mg 10% DV
Vitamin C...................... .................. 10% DV .................. 15% DV
Broccoli:
Calories....................... .................. 50 .................. 45
Sodium......................... 70 mg 3% DV 55 mg 2% DV
Potassium...................... 480 mg 14% DV 540 mg 15% DV
Total carbohydrate............. .................. 9 g .................. 8 g
Dietary fiber.................. 4 g 16% DV 5 g 20% DV
Protein........................ 4 g .................. 5 g .................
Vitamin A...................... .................. 10% DV .................. 15% DV
Vitamin C...................... .................. 200% DV .................. 220% DV
Iron........................... .................. 4% DV .................. 6% DV
Green cabbage:
Sodium......................... 25 mg .................. 20 mg .................
Potassium...................... 170 mg .................. 190 mg .................
Total carbohydrate............. 6 g .................. 5 g .................
Vitamin C...................... .................. 60% DV .................. 70% DV
Iron........................... .................. 0% DV .................. 2% DV
Cucumber:
Potassium...................... .................. 160 mg .................. 170 mg
Dietary fiber.................. 0 g 0% DV 1 g 4% DV
Vitamin C...................... .................. 8% DV .................. 10% DV
Bell pepper:
Potassium...................... 240 mg 7% DV 270 mg 8% DV
Vitamin A...................... .................. 6% DV .................. 8% DV
Vitamin C...................... .................. 150% DV .................. 190% DV
Calcium........................ .................. 0% DV .................. 2% DV
Iron........................... .................. 0% DV .................. 2% DV
[[Page 42753]]
Cauliflower:
Sodium......................... 40 mg 2% DV 30 mg 1% DV
Potassium...................... 250 mg 7% DV 270 mg 8% DV
Leaf lettuce:
Sodium......................... 40 mg 2% DV 30 mg 1% DV
Potassium...................... 210 mg 6% DV 230 mg 7% DV
Total carbohydrate............. 3 g .................. 4 g .................
Dietary fiber.................. 1 g 4% DV 2 g 8% DV
Vitamin A...................... .................. 30% DV .................. 40% DV
Vitamin C...................... .................. 4% DV .................. 6% DV
Calcium........................ .................. 2% DV .................. 4% DV
Mushrooms:
Potassium...................... 280 mg 8% DV 300 mg 9% DV
Protein........................ 2 g .................. 3 g .................
Vitamin C...................... .................. 0% DV .................. 2% DV
Iron........................... .................. 0% DV .................. 2% DV
Green (snap) beans:
Potassium...................... 190 mg 5% DV 200 mg 6% DV
Vitamin A...................... .................. 2% DV .................. 4% DV
Vitamin C...................... .................. 8% DV .................. 10% DV
Iron........................... .................. 0% DV .................. 2% DV
Radishes:
Calories....................... .................. 20 .................. 15
Sodium......................... 30 mg .................. 25 mg .................
Potassium...................... 180 mg 5% DV 230 mg 7% DV
Total carbohydrate............. 4 g .................. 3 g .................
Protein........................ 0 g .................. 1 g .................
Calcium........................ .................. 0% DV .................. 2% DV
Summer squash:
Potassium...................... 240 mg .................. 260 mg .................
Dietary fiber.................. 1 g 4% DV 2 g 8% DV
Vitamin A...................... .................. 4% DV .................. 6% DV
Vitamin C...................... .................. 25% DV .................. 30% DV
Asparagus:
Calories....................... .................. 20 .................. 25
Potassium...................... 210 mg 6% DV 230 mg 7% DV
Total carbohydrate............. 5 g 2% DV 4 g 1% DV
Vitamin C...................... .................. 10% DV .................. 15% DV
Calcium........................ .................. 0% DV .................. 2% DV
Iron........................... .................. 0% DV .................. 2% DV
----------------------------------------------------------------------------------------------------------------
I. Fat and Calorie Values for Catfish
23. For the July 1994 proposal, FDA used data on catfish obtained
from the USDA National Nutrient Databank which included both farmed and
wild catfish. Three comments expressed concern that the proposed values
for fat (9 g) and calories (170) were too high and did not accurately
reflect the farmed catfish available in retail markets in the United
States, which constitute the vast majority of the catfish consumed in
the United States. The comments stated that the fat content of catfish
is affected by species, size of fish, diet of fish, season of year,
stocking rate of pond, pond size, and sex of fish. The comments also
provided data from Nettleton et al. (Ref. 17) on farmed catfish
composition and requested that FDA consider this information in
developing revised labeling values for this fish.
Based on the comments, FDA was concerned that the proposed labeling
values for catfish did not accurately reflect the farmed catfish
available in retail markets. FDA calculated new nutrition labeling
values from data for farm-raised catfish available from Nettleton et
al. (Ref. 17) and with 95 percent prediction intervals. Although the
comments had only pointed to problems with the values for fat and
calories, FDA applied compliance calculations to the other nutrients
for which information was available in reference 17 to be sure that the
full nutritional profile for this fish is accurate and consistent (Ref.
18). The resulting changes in labeling values are summarized below:
Table 5
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Catfish nutrient
(1) Proposed values
(1) Final rule values
----------------------------------------------------------------------------------------------------------------
Calories......................... 170 140
Saturated fat.................... 1.5 g 8% DV 2 g 10% DV
Cholesterol...................... 55 mg 18% DV 50 mg 17% DV
Potassium........................ 350 mg 10% DV 230 mg 7% DV
Protein.......................... 21 g .................. 17 g
----------------------------------------------------------------------------------------------------------------
[[Page 42754]]
Because FDA confirmed that the consumption of catfish in the United
States is predominantly farmed catfish (Ref. 19), the agency concluded
that the data from Nettleton et al. provided more accurate label values
for catfish and is thus adopting these values in this document. The
values for total fat did not change.
J. Fat and Calorie Values for Orange Roughy
24. Because of the lack of acceptable information concerning the
total fat content, inclusive of wax esters, of orange roughy, in the
July 1994 proposal, FDA used a fat value for this fish that did not
include wax esters. FDA requested information on the total fat content
of this fish and stated that it would provide a value for total fat in
the next revision of the nutrition labeling values if such a value were
available. This action would make the listing of total fat in orange
roughy consistent with the definition of total fat in Sec. 101.9(c)(2)
(i.e., the amount of total lipid fatty acids present expressed as
triglycerides).
No comments were received that provided information on the total
fat content of orange roughy. One comment questioned why FDA wanted a
value for total fat in orange roughy that includes the presence of wax
esters because wax esters are not a metabolizable source of energy in
humans and have no dietary significance. The comment stated that
nutrition labeling should provide consumers with information with which
to make dietary choices, and that it is misleading to add
nonmetabolizable fat to the value for fat in orange roughy. The comment
stated that the elevated levels of fat that would result from the
addition of wax esters would falsely suggest to consumers that orange
roughy was contributing a substantial amount of metabolizable fat to
daily intake. The comment said that providing such levels in the
nutrition label would be a disservice to consumers who are seeking
foods, such as orange roughy, that contribute a minimum amount of fat
to their diet. The comment recommended that FDA retain the fat value
for orange roughy presented in the July 1994 proposal.
Because FDA did not receive any data on the total fat content of
orange roughy, the agency will continue to use values for fat that do
not include the wax esters despite the fact that the labeling of total
fat for orange roughy remains an exception to the definition of total
fat in Sec. 101.9(c)(2). FDA continues to request information that
would provide a basis for revising the declaration of total fat to
reflect the presence of wax esters in orange roughy but that would not
be misleading to the consumer.
The agency understands the point made in the comment. It intends to
address the issue of declaration of available fat in a separate
rulemaking.
K. Saturated Fat Value for Atlantic/Pacific Mackerel
25. One comment stated that FDA's proposed value for saturated fat
for Atlantic/Pacific mackerel is 6 g, while USDA's mean value for 84 g
of cooked Atlantic mackerel is 3.5 g, and asked that this discrepancy
be examined.
The proposed value for saturated fat in Atlantic and Pacific
mackerel was based upon data obtained from the USDA National Nutrient
Databank. However, in response to the comment, FDA reviewed the data
for saturated fat. After consulting with USDA, FDA discovered that the
saturated fat data that FDA received were not in the units indicated in
the data file. The saturated fat data were actually presented as
percentages of the total fat content, rather than as g amounts. After
converting the saturated fat values to g, FDA applied compliance
calculations to the data (Ref. 20). As a result, the agency found that
the labeling value for saturated fat for Atlantic/Pacific mackerel is
1.5 g with 8 percent DV. Appendix D has been modified accordingly.
L. Sodium and Cholesterol in Ocean Perch
26. One comment disagreed with FDA's proposed values for sodium
(200 mg) and cholesterol (75 mg) for ocean perch. It stated that USDA's
mean sodium value for raw ocean perch from the National Nutrient
Databank is 78.80 mg, with a range of 59 to 109.02 mg, and that using
the 75 percent retention factor would result in a mean value of 88.26
and a range of 66.08 to 122.10 mg. This comment suggested that FDA set
the sodium value for ocean perch at 90 mg, the rounded mean value. The
comment said that USDA's mean value for cholesterol in ocean perch is
47.05 mg, with a range of 32.48 to 60.93 mg, and suggested that FDA use
a rounded value of 45 mg for this nutrient.
FDA applied compliance calculations based upon 95 percent
prediction intervals to data obtained from the USDA National Nutrient
Databank to develop the sodium and cholesterol values of ocean perch
that it included in Appendix D in the July 1994 proposal. In response
to this comment, FDA compared the statistical parameters (mean,
standard error, and sample size) in Handbook 8 to those derived from
data provided by USDA from the National Nutrient Databank.
After discovering these parameters did not match, FDA asked USDA to
review the data that it had sent to FDA. In its review, USDA discovered
that the data file sent to FDA contained entries for species of fish
other than ocean perch. Because this data file was incorrectly labeled,
FDA used inappropriate nutrient data to derive the nutrition labeling
values for ocean perch.
After consulting with USDA, FDA identified and extracted the
nutrient data for ocean perch from the data file and rederived
nutrition labeling values for this document (Ref. 21). In table 6 of
this document is a summary of changes to the nutrition labeling values
for ocean perch that FDA derived from these data, with compliance
calculations based on 95 percent prediction intervals.
Table 6
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Ocean perch nutrient
(1) Proposed values
(1) Final rule values
----------------------------------------------------------------------------------------------------------------
Calories from fat................ .................. 25 .................. 20
Total fat........................ 3.5 g 5% DV 2.0 g 3% DV
Cholesterol...................... 75 mg 25% DV 50 mg 17% DV
Sodium........................... 200 mg 8% DV 95 mg 4% DV
Potassium........................ 330 mg 9% DV 290 mg 8% DV
Protein.......................... 20 g .................. 21 g .................
Vitamin C........................ .................. 4% DV .................. 0% DV
Calcium.......................... .................. 4% DV .................. 10% DV
Iron............................. .................. 2% DV .................. 6% DV
----------------------------------------------------------------------------------------------------------------
[[Page 42755]]
M. Calories From Fat for Lobster
27. In the July 1994 proposal, FDA made an error in the
determination of calories from fat for lobster. Lobster contains 0.5 g
total fat, and the calories from fat should have been zero ((9.02
calories per g)(0.5 g fat)) = 4.51 calories, which rounds to zero
according to Sec. 101.9(c)(1)(ii)), instead of 5 calories as indicated
in the July 1994 proposal. FDA has corrected this error in Appendix D
of this document.
VIII. Nutrient Content Claims and Health Claims for Raw Fruits,
Vegetables, and Fish
28. One comment expressed concern about nutrient content and health
claims for raw fruits, vegetables, and fish and asked that FDA clarify
two points. The comment asked whether labeling information on a chart
in a retail store for a raw fruit or vegetable in the voluntary program
would suffice for a packaged commodity that has a claim on the package.
The comment also asked whether a nutrient content claim or health claim
for a raw fruit or vegetable not among the 20 most frequently consumed
follows the same rules applicable to produce within the voluntary
program (i.e., if point-of-purchase nutrition labeling suffices for
packaged commodities).
FDA addressed the question of the need for nutrition labeling for
packaged raw fruits and vegetables that bear a claim in a publication
on frequently asked questions that it issued in August 1993 (Ref. 22).
At that time it stated: ``Claims subject the food to nutrition labeling
in accordance with Sec. 101.45, which means that nutrition information
will have to be available at point of purchase although not necessarily
on the package.''
FDA encourages processors and packers of raw fruits, vegetables,
and fish who put nutrient content or health claims on their packaging
to also include nutrition label information because it is not possible
to predict whether the products will be sold in stores where retailers
make the nutrition information available to consumers. Even if
processors and packers are able to control the flow of their products
into specific retail stores, they will have no control over retailers'
decisions to display (or to continue to display) nutrition labeling
information for these products. Depending upon retailers to provide
nutrition labeling values to justify nutrient content or health claims
would be a gamble for the processors and packers, who assume liability
for their products with claims. FDA encourages processors and packers
who provide nutrient content or health claims on the packaging of these
foods to also include the nutrition information.
For raw fruits, vegetables, and fish that are not among the 20 most
frequently consumed, it is even less likely that nutrition information
for that particular commodity will be available in retail stores.
Therefore, FDA encourages processors and packers who provide nutrient
content or health claims on the packaging of these foods to also
include the nutrition information.
IX. FDA Review of Submitted Data Bases
FDA encourages industry to submit data for raw produce and raw fish
to the agency for consideration for the next revision of nutrition
labeling information for raw commodities. In addition, FDA continues to
request food manufacturers and trade associations representing products
falling under mandatory nutrition labeling regulations to submit
proposed studies to collect nutrient data for nutrition labeling data
base compilation. In the July 1994 proposal for the voluntary program,
the agency acknowledged that problems existed in the process for data
base review and sought feedback on how to improve upon that process (59
FR 36379 at 36387). The agency specifically solicited comments
regarding evaluation criteria related to: (1) The nature and rigor of
the evaluation process and (2) the policy of interim approvals, as well
as followup procedures and time frames to ensure long-term interest in
continued data collection.
In response, FDA received comments regarding all aspects of the
data base review process. Most comments expressed general support for a
modification of the data base review process. In addition, some
comments commended FDA for attempting to provide industry with a
nutrient data base policy that would reduce the costs of labeling their
products.
29. Several comments cited the enormous effort and expense needed
to abide by the requirements in the ``FDA Nutrition Labeling Manual: A
Guide for Developing and Using Databases'' (Ref. 1). One comment stated
that if the manual's requirements serve as the gold standard, and
companies will never be able to meet that standard, then the standard
must be changed into one that is more cost-effective, realistic, and
workable. Another comment recommended that FDA scale back its
evaluation criteria. It stated that the current manual's evaluation
criteria require enormous effort and expense for data base development,
primarily because the number of samples required for a single raw
commodity may be in the thousands. The number of samples selected for
analysis directly relates to the total cost of the nutrition labeling
of products.
Several comments presented estimates of the cost of analyzing
commodities based on the requirements in the manual. They argued that
these high costs were so burdensome to small businesses that the
manufacturers would opt not to nutrition label their products and thus
defeat the purpose of the 1990 amendments. Comments also argued that if
manufacturers could not afford nutrition labeling, they would have a
strong marketing disadvantage in selling their products. Another
comment suggested that if historical information indicates that the
level of a particular mandatory nutrient is zero, and it is generally
accepted as such, then no individual analyses should be necessary
(e.g., fiber in milk). Still another comment stated that sample sizes
need not be as large as the manual suggests to be statistically valid,
and that smaller sample sizes would reduce the total costs of analyses.
The comment stated that FDA did not balance the cost of a nutrient
analysis with the marginal increase in accuracy that may come from
doing more analyses.
FDA continues to acknowledge the potential usefulness of data bases
to reduce costs associated with nutrition labeling. A data base
compiled and submitted by a trade association representing a large
number of members would represent less cost than would be required if
each member company were to analyze its own products and submit its own
individual data base. The agency wishes to emphasize that submission of
a data base to FDA for the purpose of nutrition labeling is voluntary.
Each manufacturer, however, is responsible for ensuring the validity of
the nutrient values that appear on its label.
The manual provides generic guidelines for industry to use in
preparing and developing data bases. Industry may choose to follow
these guidelines or may use alternative procedures even though they are
not provided for in the manual. If industry wishes to submit a data
base to FDA, but chooses to use alternative procedures, the
organization preparing the data base may wish to discuss those
procedures with the agency to prevent expenditure of money and effort
on activities that the agency may later find unacceptable. The agency
recognizes that everything recommended in the manual cannot be achieved
at the present time for most
[[Page 42756]]
commodities, even by some of the larger trade associations. FDA does
expect, however, that all planned studies will continue to be based
upon consideration of the statistical random sampling, methodology,
design, and treatment of data that are described in the manual. The
agency has stated that analysis is not needed for nutrients where
reliable data bases or scientific knowledge establish that a nutrient
is not present in the product (58 FR 2109, January 6, 1993).
A great deal of information already exists for some foods regarding
factors that influence nutrient variability (e.g., variety, season,
species). As a result, it may be possible to reduce the number of
samples to be assayed on the basis of data and knowledge of which
nutrients vary with changing parameters. In addition, information
describing the effect of various factors on nutrient content of foods
may be obtained through the completion of experimental pilot studies.
These data in turn may provide information on nutrient variability that
will also provide a basis for reducing the number of samples necessary
for a valid data base.
30. Questions continue to arise over the issue of whether data base
submitters may use USDA Handbook 8 data, data obtained through
literature searches, or historical data with limited quality assurance
from manufacturers. Several comments were in favor of FDA allowing data
base developers to use USDA Handbook 8 values in their data base
submissions. Other comments suggested that the use of historical data
would add depth and broad coverage and would, therefore, provide a
positive aspect to the data bases. They argued that such allowances
would lessen the number of nutrient analyses needed to arrive at an
appropriate label value while reducing the total cost of conducting
nutrient analyses.
FDA continues to acknowledge the value of data available from USDA
Handbook 8 and from the scientific literature, but as stated in
response to comment 2, mean composition values derived from those
sources are generally not suitable for labeling purposes. The agency's
policy is to recommend that products be labeled according to nutrient
composition based upon laboratory analysis.
In response to the comments, FDA reassessed how best to consider
historical data submitted for review. The agency has decided to review
and to allow the use of historical data submitted for labeling
purposes, as long as those data are accompanied by a planned study to
collect additional data for updating the label values. FDA will
evaluate the historical data for completeness and reasonableness. If
analytical methods have changed substantially from those used in
gathering the data, or if it is obvious that the sampling design used
to develop the data is incorrect, the agency may choose not to accept
the historical data. Otherwise, if FDA determines that the historical
data are complete and reasonable, the agency will allow use of the
data, as long as the manufacturer plans to collect additional data to
update those values.
31. One comment suggested that data should be presented on a per
100-g basis as well as the reference amount.
FDA agrees with the suggestion and recommends that industry
submitting data bases to FDA provide those data on both the 100 g and
the reference amount bases. The agency continues to encourage industry
to submit data not only to FDA but also to USDA for use in compilations
such as Handbook 8. Data submitted for inclusion in Handbook 8 should
be provided on a mean 100-g basis and not as label values that have
been derived by FDA compliance algorithms.
32. One comment urged FDA to revise the analytical methods section
of the manual to make the text compatible with nutrition labeling
regulations in Sec. 101.9(g)(2). The comment noted that this regulation
allows for non-AOAC analytical methods if AOAC methods are neither
available nor appropriate. The comment further suggested that there
would be improvement in the accuracy of the data as a result of using
diverse analytical methods. Another comment suggested that FDA require
companies or trade associations to submit a table of proposed
analytical methods with accompanying information concerning specific
validation of the method used by the on-site or commercial lab for the
matrix of interest.
The manual's recommendations are consistent with Sec. 101.9(g)(2),
wherein the agency advises companies or associations to use non-AOAC
methods where no AOAC method is available or appropriate. The manual
recommends the use of non-AOAC methods only in the absence of AOAC-
validated methods. The agency agrees that the process of refining
methods of analysis will reduce variability in nutrient levels but does
not agree that use of diverse analytical methods will reduce
variability. FDA respects the worldwide consensus surrounding the
applicability, specificity, sensitivity, accuracy, precision, and
detectability of methods validated by AOAC International and continues
to recommend the use of those methods in obtaining measures of nutrient
content.
The agency agrees with the comment that suggested that data base
developers should submit a table delineating proposed analytical
methods for each nutrient, with accompanying information concerning
specific validation of the method used by the onsite or commercial lab
for the matrix of interest. In fact, in response to FDA's requests for
such data, several submissions to FDA have already included a table of
the analytical methods used and accompanying documentation validating
the use of the method.
33. One comment suggested that manufacturers should be able to send
data in an electronic format. The comment noted that if software were
developed in the form of a template, then FDA would greatly improve its
review process.
FDA strongly agrees with this comment and will consider use of
electronic methods for data collection as it continues to assess and
improve its data base submission and review process.
34. FDA received the greatest number of comments regarding interim
approvals for nutrient data bases. This issue relates specifically to
data bases for products having mandatory labeling. The comments
addressed the following three primary issues: (1) Whether submitters
should receive interim approvals; (2) if so, at what point in the
process; and (3) for what time period. All comments on the subject
expressed support for the issuance of interim approvals. Some comments
suggested that an interim approval should be granted if the submitter
has made a good faith effort to abide by the guidelines, as discussed
in the nutrition labeling manual. Several comments proposed various
criteria for granting interim approvals. One comment suggested a
grading scale for data bases that would also take into account the
length of time for an interim approval. Another comment proposed that
FDA create a checklist to serve as the basis for interim approvals and
thus expedite the review process. Suggested time periods for interim
approval ranged from 1 to 10 years.
FDA has carefully examined and fully considered the thoughtful
comments submitted in response to this issue. Based on its review of
the comments, FDA has decided to modify its approach to data bases that
are submitted to the agency for review. The new policy directly
addresses concerns relevant to interim review and approval of data
bases. FDA implemented a new
[[Page 42757]]
discretionary enforcement strategy for those manufacturers who submit
interim data to the agency for approval. Interim data in the form of
nutrition label values should be accompanied by raw data. If there are
data that the manufacturer has determined to be unsuitable, they should
also be submitted with explanation. FDA will continue to evaluate
interim data (i.e., historical or newly collected) submitted for review
if those data are accompanied by a plan to collect additional data for
the purpose of updating label values. However, in order to facilitate
the use of the developing nutrient data base and to limit the
uncertainty that could result from an unforeseen delay in agency review
of the data base, firms are free upon submission to begin use of the
nutrient label values and to initiate the planned studies to collect
and update nutrient values. During this interim period, FDA does not
anticipate that it will take action against a product bearing label
values included in a data base submitted to the agency for review. If
any product is identified through FDA compliance activities as
including label values that are out of compliance, contingent on the
company's willingness to come into compliance, the agency intends to
work with both the manufacturer and the data base developer to
understand and correct the problem label values.
When FDA receives the interim data and planned studies referred to
above, it will first evaluate the label values relative to the raw
data. FDA will recalculate label values based solely on the raw data
that have been submitted. The agency will derive label values using
compliance calculations based upon 95 percent prediction intervals and,
when appropriate, will use weighting procedures, as recommended in the
nutrition labeling manual. FDA will evaluate the data for completeness
and reasonableness, e.g., it will consider whether or not there are
enough samples, and whether all nutrients are included. FDA requests
that supporting documentation, such as analytical methodology and a
sampling plan, accompany interim data. The agency acknowledges,
however, that a large amount of the interim data available from
manufacturers and trade associations are based upon historical data,
where the analytical methodology and sampling plan are not available.
Hence, FDA will not refuse to accept data solely on the basis that it
is not accompanied by comprehensive documentation, so long as the
reason such documentation is not provided is fully explained and is
acceptable to the agency.
FDA will review the accompanying planned studies to collect
additional data, concentrating on analytical methodology and on the
reasonableness of the factors that could account for nutrient
variability (e.g., style, region), rather than on the rigor of sampling
design or statistical treatment of the data. FDA cautions, however,
that data base submitters should follow FDA's recommendations regarding
sampling strategies, weighting procedures, and statistical treatment of
data that are described in the nutrition labeling manual.
FDA will respond in writing after review of the data and the
planned studies. FDA will address the nutrient label values that were
submitted and will indicate whether it has any objection to continuing
the planned studies or to continued use of the label values for 2 years
from the date of the agency response.
After those 2 years, manufacturers will be expected to provide the
agency with a summary update that reassesses the interim label values
based upon completion of the planned laboratory analyses. The agency
will evaluate how the study findings bear on the interim label values
and will consider whether it would have any objection to continued use
of the updated interim values for up to an additional 5 years. At the
same time, however, the agency may suggest modifications to the ongoing
plan of study. If after review of data and planned studies, FDA
determines that the label values or studies are not appropriate, as
indicated above, the agency will notify the manufacturer of that
decision.
Please note that a primary focus of FDA's compliance review of
product labels is on nutrient content claims (e.g., ``high fiber'',
``low fat'') that are used. FDA will continue to closely monitor
products making such claims and expects that the manufacturer, packer,
or distributor will have sufficient data to support the validity of
such claims.
X. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(11) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
XI. Analysis of Impacts
FDA has examined the economic implications of the final rule as
required by Executive Order 12866 and the Regulatory Flexibility Act (5
U.S.C. sections 601 and 612). Executive Order 12866 directs agencies to
assess all costs and benefits of available regulatory alternatives and,
when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity).
If a rule has a significant economic impact on a substantial number
of small entities, the Regulatory Flexibility Act requires agencies to
analyze regulatory options that would minimize the economic impact of a
rule on small entities. FDA finds that this final rule is not a
significant rule as defined by Executive Order 12866, and finds under
the Regulatory Flexibility Act, that the final rule will not have a
significant impact on a substantial number of small entities.
A. Costs of the Regulation
The costs of a labeling regulation are the incremental
administrative, analytical, redesign, and label inventory disposal
costs associated with the regulatory action. Because FDA is requiring
that retailers use the nutrition values provided by FDA, there are not
expected to be any analytical costs or other costs of obtaining the
information. FDA has information that the typical sign, which is the
most frequently used form of labeling of raw products, has an expected
useful life of 6 months. Therefore, there will be no label inventory
disposal costs because existing signs normally would have been replaced
during the compliance period. However, FDA does not believe that signs
normally would have been redesigned during that period. Therefore, the
costs of the regulation are administrative and redesign costs.
In the July 1994 proposal, FDA estimated that the average cost of
redesigning signs to label raw fruits, vegetables, and fish is $100 per
year per store. There are approximately 31,000 chain stores and 68,000
independent grocery stores that fall under the compliance guidelines.
Therefore, if those stores currently complying with the guidelines
continue to do so, annual costs of compliance will be approximately
$7.5 million. Because these regulations require that the nutrition
values for raw fruits, vegetables, and fish be readdressed and possibly
revised every 4 years, FDA anticipates that stores may need to incur
these redesign costs as frequently as once every 4 years.
[[Page 42758]]
B. Costs Incurred by the Federal Government
Executive Order 12866 requires agencies also to estimate costs to
Government. The 1990 amendments require that FDA determine every 2
years whether there is substantial compliance with the labeling
guidelines. If substantial compliance does not exist, FDA must make
compliance mandatory. FDA estimates that the costs incurred by
Government are approximately $150,000 every 2 years to establish a
contract to survey food retailers, oversee the contract, and publish a
report on the status of voluntary compliance. Total costs incurred by
Government, discounted to infinity at 7 percent are $1 million.
If compliance with the guidelines becomes mandatory, costs incurred
by the Government would not significantly change because the costs
associated with determining whether there is substantial compliance
would be replaced by enforcement costs. Also, if FDA were to make
compliance mandatory, costs incurred by retailers would increase to
$9.9 million in the first year and recurring every 4 years as values
are modified, or $42 million discounted to infinity at 7 percent.
Total costs of this regulation are $7.5 million in the first year,
or $32 million discounted to infinity at 7 percent.
C. Benefits of this Regulation
In the Regulatory Impact Analysis of the Proposed Rules to Amend
the Food Labeling Regulations (56 FR 60856, November 27, 1991), FDA
stated that the benefit of labeling raw fruits, vegetables, and fish is
a change in purchase behavior that would happen if the information
presented was new to some consumers and was important to their
consumption decision. At present, however, the majority of consumers
have been exposed to the labeling on these products. Based on results
of the 1992 survey, 76 percent of retailers (representing 77 percent of
annual sales) of raw fruits and vegetables were in compliance with
current nutrition labeling guidelines. In addition, 73 percent of
retailers (representing 74 percent of annual sales) of raw fish were in
compliance. Results from the 1994 survey establish that compliance is
75 percent for raw produce (representing 81.4 percent of annual sales)
and 75 percent for raw fish (representing 77 percent of annual sales).
The actions in this document are designed to produce consistency
between voluntary nutrition labeling of raw fruits, vegetables, and
fish and the nutrition labeling of processed, packaged foods.
Similarly, FDA is specifying that compliance requires that retailers
use the nutrition values provided by FDA for the 20 most frequently
consumed raw fruits, vegetables, and fish, thus providing consistency
among retailers. FDA has concluded that the flexibility of allowing
manufacturers to use other values does not outweigh the consumer
confusion caused by different values for the same food in different
stores. However, FDA is allowing commodity groups to develop a
nutrition label for a specific genus or species provided that they have
the data to support the labeling values presented to the consumer, and
they use a more specific name for the product. Therefore, the agency
intends to avoid a tradeoff between consistency and accuracy.
35. Comments supporting the proposed rules stated that making the
guidelines for the labeling of raw fruits, vegetables, and fish
consistent with the labeling of processed, packaged foods will reduce
opportunities for consumer confusion caused by the current
inconsistencies between retailers who use different nutrient values for
the same commodities. The comments stated that the rules will permit
meaningful comparisons between raw products and other foods. However,
FDA also received one comment that stated that the reduced confusion
that would result will not benefit consumers. The comment stated that
these costs would be borne by consumers for little or no benefit. Using
potatoes as an example, the comment stated that the new rounding rules
provide a disservice for consumers looking for reasonably priced,
readily available, well-liked foods high in potassium. The comment
argued that the new rules would prevent nutrient content claims on
potatoes, thus making it necessary for consumers to scrutinize the
label for information about the potassium content of potatoes.
The nutrition labeling values for potatoes presented in Appendix C
to part 101 are based on PMA data. The revised values for potassium for
potatoes would not preclude a ``high potassium'' claim, as stated by
the comment. Therefore, FDA notes that the comment's concerns that the
new rounding rules would reduce benefits to consumers by prohibiting
nutrient content claims is unwarranted.
D. Regulatory Flexibility
36. One comment stated that FDA should have prepared an initial
regulatory flexibility analysis for the July 1994 proposal and asks
that FDA do so prior to issuing a final rule. The comment stated that
the proposed regulations represent a significant restructuring of food
labeling of new commodities, and that businesses complying with the
regulations confront a number of economic hurdles. Finally, the comment
alleged that the failure of FDA to consider both the effects of the
short phase in period and less burdensome alternatives are inconsistent
with the requirements of the Regulatory Flexibility Act.
The nutrition labeling of raw fruits, vegetables, and fish is a
voluntary program. Retailers may decide whether they wish or do not
wish to participate in the program. However, the comment was concerned
that, in order for the program to remain voluntary, a number of small
retailers must choose to participate in the program.
For the purposes of this analysis, FDA defines a grocery store as
small if its annual sales are under $20 million. This definition is
consistent with the Small Business Administration's size standards (61
FR 3280, January 31, 1996). According to Dun and Bradstreet, as of June
1996, there are approximately 196,000 grocery stores in the United
States. Sales data were available for 183,000 stores. Of these, 99
percent (or 180,500 stores) meet the definition of a small grocery
store. Congress exempted stores with annual sales less than $500,000,
or 109,000 stores with sales data available. There are 71,000 grocery
stores for which data are available with annual sales between $500,000
and $20 million.
For purposes of determining substantial compliance, FDA samples
2,000 grocery stores weighted by size (above and below $2 million
annual sales). The sample is also distributed by sales, region/state,
and chain versus independent. Chain stores with less than $2 million
annual sales are not included in the sample because the majority are
convenience stores. FDA also does not include either fish markets or
fruit and vegetable markets. Substantial compliance was achieved in the
1992 and 1994 surveys without compliance by the smallest stores as a
group (sales under $2 million) because these stores constitute a small
percent of total sales. FDA notes, however, that in order for
substantial compliance to be achieved, many small grocery stores with
annual sales between $2 million and $20 million will have to continue
to comply with these regulations. Therefore, FDA finds that this rule
will impact on a substantial number of small entities. However, FDA has
determined that the cost of compliance per store is $100. This amount
is sufficiently small that it will not cause either a significant
increase in costs or a significant
[[Page 42759]]
decrease in revenues. Therefore, FDA concludes that this rule will not
result in a significant impact on a substantial number of small
entities.
As explained elsewhere in this document, FDA has been convinced by
the comment that it is not feasible for all the materials containing
nutrition labeling information on raw fruits, vegetables, and fish to
be changed before the next compliance survey of the industry. Thus, for
the purpose of determining substantial compliance, FDA will consider a
retail store to be in compliance if the nutrition labeling information
complies with either current (1996) values or values previously
published in the Federal Register (56 FR 60856 at 60880).
Therefore, the short compliance period should not result in any
undue burden.
37. One comment objected to the cost estimates presented in the
analysis of the July 1994 proposal. The comment stated that, although
the voluntary program only applies to the 20 most frequently consumed
raw fruits, vegetables, and fish for which FDA is providing data, the
producers of the other 150+ retail produce items offered would be
required to bear the cost of analyzing their products if they attempted
to provide the same type of information as required of the top 20
fruits and top 20 vegetables. The comment further stated that producers
of commodities not sold in large quantities, most of which are small
entities, cannot afford the cost associated with an analysis that would
be acceptable under FDA's data base review process. These producers
would be at a marketing disadvantage as compared with producers of the
top 20 fruits and vegetables.
FDA agrees that some producers of commodities not listed in the top
20 most frequently consumed fruits, vegetables, or fish may be placed
at a competitive disadvantage as retailers currently shift the costs of
determining the nutrient values of products to producers. However, FDA
is unaware of the extent to which this is a problem for small
businesses. Furthermore, FDA has no data to indicate the importance of
a nutrition profile in marketing these products. However, the more
important these profiles are, the more likely that increased sales
could cover the costs of analysis. FDA also notes that acceptable
nutrient data is available for many of these products through USDA's
Handbook 8 and other databases.
XII. The Paperwork Reduction Act of 1995
This final rule contains no information collection or recordkeeping
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).
XIII. References
The following references have been placed on display in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857.
1. Food and Drug Administration, Center for Food Safety and
Applied Nutrition, ``FDA Nutrition Labeling Manual: A Guide for
Developing and Using Data bases,'' Washington, DC, 1993 ed.
2. Food and Drug Administration, Center for Food Safety and
Applied Nutrition, ``Report on Voluntary Compliance of Food
Retailers in Providing Nutrition Labeling Information for Raw Fruits
and Vegetables, and for Raw Fish,'' Washington, DC, May 8, 1993.
3. National Retail Tracking Index, ``Food and Drug
Administration, Nutrition Labeling Information Study, Raw Fruits/
Vegetables and Raw Fish,'' Englewood Cliffs, NJ, March 1, 1995.
4. FDA 1995 Health and Diet Survey, Food Label Use and Nutrition
Education Module, Food and Drug Administration, Center for Food
Safety and Applied Nutrition, Washington, DC, November 1995.
5. Food and Drug Administration, Center for Food Safety and
Applied Nutrition, ``Documentation for the 1996 Nutrition Labeling
Values for the 20 Most Frequently Consumed Raw Fruits, Vegetables,
and Fish,'' Washington, DC, June 1996.
6. O'Neill, K. R., ``Results of Raw Apple Nutritional Analyses
from PMA and IAI Submissions for Appendix C,'' CFSAN, FDA,
Washington, DC, September 5, 1995.
7. O'Neill, K. R., ``Results of Raw Avocado Nutritional Analyses
for PMA and CAC Submissions for Appendix C,'' CFSAN, FDA,
Washington, DC, September 6, 1995.
8. O'Neill, K. R., ``Results of Raw Bananas Nutritional Analyses
for International Banana Association, Inc., Submission for Appendix
C,'' CFSAN, FDA, Washington, DC, August 15, 1995.
9. Hegenauer, J., and E. Pivonka, ``Tangerine Nutrition Study,''
Produce Marketing Association Nutrition Labeling Program, Newark,
DE, August 3, 1992.
10. Simpson, K. L., and S. C. S. Tsou, ``Vitamin A and
Provitamin Composition of Foods,'' edited by Bauernfeind, J. C.,
Vitamin A Deficiency and Its Control, pp. 461-478, Academic Press,
Inc., 1986.
11. Bauernfeind, J. C., ``Carotenoid Vitamin A Precursors and
Analogs in Foods and Feeds,'' Journal of Agricultural Food
Chemistry, 20(3):456-473, 1972.
12. O'Neill, K. R., ``Results of Raw Fruit and Vegetable
Nutritional Analyses for Produce Marketing Association Submission
for Appendix C,'' FDA memo, August 31, 1995.
13. Gebhardt, S. E., R. Cutrufelli, and R. H. Matthews,
``Composition of Foods, Fruits and Fruit Juices, Raw, Processed,
Prepared,'' Agriculture Handbook No. 8-9, USDA, Washington, DC, p.
8, 120, August 1982.
14. Haytowitz, D. B., R. H. Matthews, ``Composition of Foods,
Vegetables and Vegetable Products, Raw, Processed, Prepared,''
Agriculture Handbook No. 8-11, USDA, p. 10, Washington, DC, 1984.
15. Matthews, R. H., P. R. Pehrsson, and M. Farhat-Sabet,
``Sugar Content of Selected Foods: Individual and Total Sugars.''
USDA Home Economics Research Report No. 48, September 1987.
16. Pennington, J. A. T., ``FDA Voluntary Nutrition Labeling
Program for Raw Fruits, Vegetables, and Fish: Documentation for the
Proposed Nutrition Labeling Values,'' CFSAN, FDA, Washington, DC,
October 1993.
17. Nettleton, J. A., W. H. Allen, L. V. Klatt, W. M. N.
Ratnayake, and R. G. Ackman, ``Nutrients and Chemical Residues in
One- to Two-Pound Mississippi Farm-raised Channel Catfish (Ictalurus
punctatus),'' Journal of Food Science, 55(4):954-958, 1990.
18. O'Neill, K. R., ``Results of Cooked Catfish Nutritional
Analyses for Appendix D to Part 101: Nutritional Facts for Cooked
Fish,'' CFSAN, FDA, Washington, DC, August 17, 1995.
19. Allen, B., Memo to FDA, The Catfish Institute, Belzoni, MS,
February, 9, 1996.
20. O'Neill, K. R., ``Results of Atlantic/Pacific Mackerel
Nutritional Analyses for Appendix D to Part 101: Nutritional Facts
for Cooked Fish (Revised),'' CFSAN, FDA, Washington, DC, March 15,
1996.
21. O'Neill, K. R., ``Results of Ocean Perch Nutritional
Analyses for Appendix D to Part 101: Nutritional Facts for Cooked
Fish,'' CFSAN, FDA, Washington, DC, March 7, 1996.
22. Food and Drug Administration, Center for Food Safety and
Applied Nutrition, Office of Food Labeling, ``Food Labeling
Questions and Answers,'' p. 21, Washington, DC, August 1993.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
101 is amended as follows:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342,
343, 348, 371).
2. Section 101.43 is amended by revising paragraphs (a)(1), (a)(2),
and (a)(3) to read as follows:
[[Page 42760]]
Sec. 101.43 Substantial compliance of food retailers with the
guidelines for the voluntary nutrition labeling of raw fruits,
vegetables, and fish.
(a) * * *
(1) Be presented in the store or other type of establishment in a
manner that is consistent with Sec. 101.45(a)(1);
(2) Be presented in content and format that are consistent with
Sec. 101.45(a)(2), (a)(3), and (a)(4); and
(3) Include data that have been provided by FDA in Appendices C and
D to part 101 of this chapter, except that the information on potassium
is voluntary.
* * * * *
3. Section 101.44 is amended by revising paragraph (c) to read as
follows:
Sec. 101.44 Identification of the 20 most frequently consumed raw
fruits, vegetables, and fish in the United States.
* * * * *
(c) The 20 most frequently consumed raw fish are: Shrimp, cod,
pollock, catfish, scallops, salmon (Atlantic/Coho, chum/pink, sockeye),
flounder/sole, oysters, orange roughy, Atlantic/Pacific mackerel, ocean
perch, rockfish, whiting, clam, haddock, blue crab, rainbow trout,
halibut, lobster, and swordfish.
4. Section 101.45 is revised to read as follows:
Sec. 101.45 Guidelines for the voluntary nutrition labeling of raw
fruits, vegetables, and fish.
(a) Nutrition labeling for raw fruits, vegetables, and fish listed
in Sec. 101.44 should be presented to the public in the following
manner:
(1) Nutrition labeling information should be displayed at the point
of purchase by an appropriate means such as by a label affixed to the
food or through labeling including shelf labels, signs, posters,
brochures, notebooks, or leaflets that are readily available and in
close proximity to the foods. The nutrition labeling information may
also be supplemented by a video, live demonstration, or other media.
(2) Serving sizes should be determined, and nutrients declared, in
accordance with Sec. 101.9 (b) and (c), respectively, except that the
nutrition labeling data should be based on the raw edible portion for
fruits and vegetables and on the cooked edible portion for fish. The
methods used to cook fish should be those that do not add fat,
breading, or seasoning (e.g., salt or spices).
(3) When nutrition labeling information is provided for more than
one raw fruit, vegetable, or fish on signs, posters, brochures,
notebooks, or leaflets, it may be presented in charts with horizontal
or vertical columns or as a compilation of individual nutrition labels.
Nutrition labeling that is presented in a linear display (see
Sec. 101.9(j)(13)(ii)(A)(2)) will not be considered to be in
compliance. The heading ``Nutrition Facts'' must be in a type size
larger than all other print in the nutrition label. The required
information (i.e., headings, serving sizes, list of nutrients,
quantitative amounts by weight (except for vitamins and minerals), and
percent of Daily Values (DV's) (except for sugars and protein) must be
clearly presented and of sufficient type size and color contrast to be
plainly legible, with numeric values for percent of DV highlighted in
contrast to the quantitative amounts by weight and hairlines between
all nutrients.
(i) Declaration of the number of servings per container need not be
included in the nutrition labeling of raw fruits, vegetables, and fish.
(ii) Except for the statement ``Percent Daily Values are based on a
2,000 calorie diet,'' the footnote required in Sec. 101.9(d)(9) is not
required. However, when labeling is provided in brochures, notebooks,
leaflets, or similar types of materials, retailers are encouraged to
include the footnote.
(iii) When the nutrition labeling information for more than one raw
fruit or vegetable is provided on signs, posters, brochures, notebooks,
or leaflets, the listings for saturated fat and cholesterol may be
omitted from the charts or individual nutrition labels so long as the
fact that most fruits and vegetables provide negligible amounts of
these nutrients, but that avocados contain 1 gram (g) of fat per ounce,
is stated in a footnote (e.g., ``Most fruits and vegetables provide
negligible amounts of saturated fat and cholesterol; avocados provide 1
g of saturated fat per ounce''). The footnote may also contain
information about the polyunsaturated and monounsaturated fat content
of avocados. When the nutrition labeling information for raw fish is
provided on a chart, the listings for dietary fiber and sugars may be
omitted if the following footnote is used, ``Fish provide negligible
amounts of dietary fiber and sugars.''
(4) When nutrition labeling is provided for individual raw fruits,
vegetables, or fish on packages or on signs, posters, brochures,
notebooks, or leaflets, it should be displayed in accordance with
Sec. 101.9, except that the declaration of the number of servings per
container need not be included. For individual labels provided by
retailers on signs and posters, the footnote required in
Sec. 101.9(d)(9) may be shortened to ``Percent Daily Values are based
on a 2,000 calorie diet.''
(b) Nutrition label values provided by the Food and Drug
Administration (FDA) in Appendices C and D to part 101 for the 20 most
frequently consumed raw fruits, vegetables, and fish listed in
Sec. 101.44 shall be used to ensure uniformity in declared values. FDA
will publish proposed updates of the 20 most frequently consumed raw
fruits, vegetables, and fish and nutrition label data for these foods
(or a notice that the data sets have not changed from the previous
publication) at least every 4 years in the Federal Register.
(1) The agency encourages the submission of data bases with new or
additional nutrient data for any of the most frequently consumed raw
fruits, vegetables, and fish to the Office of Food Labeling (HFS-150),
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, for review and
evaluation. FDA may incorporate these data in the next revision of the
nutrition labeling information for the top 20 raw fruits, vegetables,
and fish.
(i) Guidance in the development of data bases may be found in the
``FDA Nutrition Labeling Manual: A Guide for Developing and Using Data
Bases,'' available from the FDA Office of Food Labeling.
(ii) The submission to FDA should include, but need not be limited
to, information on the following: Source of the data (names of
investigators, name of organization, place of analyses, dates of
analyses), number of samples, sampling design, analytical methods, and
statistical treatment of the data. Proposed quantitative label
declarations may be included. The proposed values for declaration
should be determined in accordance with the ``FDA Nutrition Labeling
Manual: A Guide for Developing and Using Data Bases.''
(2) [Reserved]
(c) Data bases of nutrient values for raw fruits, vegetables, and
fish that are not among the 20 most frequently consumed may be used to
develop nutrition labeling values for these foods. This includes data
bases of nutrient values for specific varieties, species, or cultivars
of raw fruits, vegetables, and fish not specifically identified among
the 20 most frequently consumed.
(1) The food names and descriptions for the fruits, vegetables, and
fish should clearly identify these foods as distinct from foods among
the most frequently consumed list for which FDA has provided data.
[[Page 42761]]
(2) Guidance in the development of data bases may be found in the
``FDA Nutrition Labeling Manual: A Guide for Developing and Using Data
Bases.''
(3) Nutrition labeling values computed from data bases are subject
to the compliance provisions of Sec. 101.9(g).
(i) Compliance with the provisions of Sec. 101.9(g) may be achieved
by use of a data base that has been developed following FDA guideline
procedures and approved by FDA.
(A) The submission to FDA for approval should include but need not
be limited to information on the following: Source of the data (names
of investigators, name of organization, place of analyses, dates of
analyses), number of samples, sampling design, analytical methods,
statistical treatment of the data, and proposed quantitative label
declarations. The values for declaration should be determined in
accordance with the ``FDA Nutrition Labeling Manual: A Guide for
Developing and Using Databases.''
(B) FDA approval of a data base and nutrition labeling values shall
not be considered granted until the Center for Food Safety and Applied
Nutrition has agreed to all aspects of the data base in writing.
Approvals will be in effect for a limited time, e.g., 10 years, and
will be eligible for renewal in the absence of significant changes in
agricultural or industry practices (e.g., a change occurs in a
predominant variety produced). FDA will take steps to revoke its
approval of the data base and nutrition labeling values if FDA
monitoring suggests that the data base or nutrition labeling values are
no longer representative of the item sold in this country. Approval
requests shall be submitted in accordance with the provision of
Sec. 101.30 of this chapter.
(ii) [Reserved]
5. Appendices C and D are added to part 101 to read as follows:
Appendix C to Part 101.--Nutrition Facts for Raw Fruits and Vegetables
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Total fat Saturated Cholesterol Sodium Potassium Total Dietary Sugars Protein Vitamin Vitamin Calcium Iron
Nutrition facts \1\ for raw fruits and vegetables edible Calories --------------- fat ------------------------------------------ Carbohydrate Fiber ----------------- A C ---------------
portion Calories from fat -------------- ---------------------------- ------------------
(g) (%) (g) (%) (mg) (%) (mg) (%) (mg) (%) (g) (%) (g) (%) (g) (g) (%) (%) (%) (%)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Banana, 1 medium (126 g/4.5 oz)............................... 110 0 0 0 0 0 0 0 0 0 400 11 29 10 4 16 21 1 0 15 0 2
Apple, 1 medium (154 g/5.5 oz)................................ 80 0 0 0 0 0 0 0 0 0 170 5 22 7 5 20 16 0 2 8 0 2
Watermelon, \1/18\ medium melon; 2 cups diced pieces (280 g/
10.0 oz)..................................................... 80 0 0 0 0 0 0 0 10 0 230 7 27 9 2 8 25 1 20 25 2 4
Orange, 1 medium (154 g/5.5 oz)............................... 70 0 0 0 0 0 0 0 0 0 260 7 21 7 7 28 14 1 2 130 6 2
Cantaloupe, \1/4\ medium (134 g/4.8 oz)....................... 50 0 0 0 0 0 0 0 25 1 280 8 12 4 1 4 11 1 100 80 2 2
Grapes, 1\1/2\ cups (138 g/4.9 oz)............................ 90 10 1 2 0 0 0 0 0 0 270 8 24 8 1 4 23 1 2 25 2 2
Grapefruit, \1/2\ medium (154 g/5.3 oz)....................... 60 0 0 0 0 0 0 0 0 0 230 7 16 5 6 24 10 1 15 110 2 0
Strawberries, 8 medium (147 g/5.3 oz)......................... 45 0 0 0 0 0 0 0 0 0 270 8 12 4 4 16 8 1 0 160 2 4
Peach, 1 medium (98 g/3.5 oz)................................. 40 0 0 0 0 0 0 0 0 0 190 5 10 3 2 8 9 1 2 10 0 0
Pear, 1 medium (166 g/5.9 oz)................................. 100 10 1 2 0 0 0 0 0 0 210 6 25 8 4 16 17 1 0 10 2 0
Nectarine, 1 medium (140 g/5.0 oz)............................ 70 0 0.5 1 0 0 0 0 0 0 300 9 16 5 2 8 12 1 4 15 0 2
Honeydew Melon, \1/10\ medium melon (134 g/4.8 oz)............ 50 0 0 0 0 0 0 0 35 1 310 9 13 4 1 4 12 1 2 45 0 2
Plums, 2 medium (132 g/4.7 oz)................................ 80 10 1 2 0 0 0 0 0 0 220 6 19 6 2 8 10 1 6 20 0 0
Avocado, California, \1/5\ medium (30 g/1.1 oz)............... 55 45 5 8 1 5 0 0 0 0 170 5 3 1 3 12 0 1 0 4 0 0
Lemon, 1 medium (58 g/2.1 oz)................................. 15 0 0 0 0 0 0 0 5 0 90 3 5 2 1 4 1 0 0 40 2 0
Pineapple, 2 slices, 3'' diameter, \3/4\'' thick (112 g/4 oz). 60 0 0 0 0 0 0 0 10 0 115 3 16 5 1 4 13 1 0 25 2 2
Tangerine, 1 medium (109 g/3.9 oz)............................ 50 0 0.5 1 0 0 0 0 0 0 180 5 15 5 3 12 12 1 0 50 4 0
Sweet cherries, 21 cherries; 1 cup (140 g/5.0 oz)............. 90 0 0.5 1 0 0 0 0 0 0 300 9 22 7 3 12 19 2 2 15 2 2
Kiwifruit, 2 medium (148 g/5.3 oz)............................ 100 10 1 2 0 0 0 0 0 0 480 14 24 8 4 16 16 2 2 240 6 4
Lime, 1 medium (67 g/2.4 oz).................................. 20 0 0 0 0 0 0 0 0 0 75 2 7 2 2 8 0 0 0 35 0 0
Potato, 1 medium (148 g/5.3 oz)............................... 100 0 0 0 0 0 0 0 0 0 720 21 26 9 3 12 3 4 0 45 2 6
Iceberg lettuce, \1/6\ medium head (89 g/3.2 oz).............. 15 0 0 0 0 0 0 0 10 0 120 3 3 1 1 4 2 1 4 6 2 2
Tomato, 1 medium (148 g/5.3 oz)............................... 35 0 0.5 1 0 0 0 0 5 0 360 10 7 2 1 4 4 1 20 40 2 2
Onion, 1 medium (148 g/5.3 oz)................................ 60 0 0 0 0 0 0 0 5 0 240 7 14 5 3 12 9 2 0 20 4 2
Carrot, 7'' long, 1\1/4\'' diameter (78 g/2.8 oz)............. 35 0 0 0 0 0 0 0 40 2 280 8 8 3 2 8 5 1 270 10 2 0
Celery, 2 medium stalks (110 g/3.9 oz)........................ 20 0 0 0 0 0 0 0 100 4 350 10 5 2 2 8 0 1 2 15 4 2
Sweet corn, kernels from 1 medium ear (90 g/3.2 oz)........... 80 10 1 2 0 0 0 0 0 0 240 7 18 6 3 12 5 3 2 10 0 2
Broccoli, 1 medium stalk (148 g/5.3 oz)....................... 45 0 0.5 1 0 0 0 0 55 2 540 15 8 3 5 20 3 5 15 220 6 6
Green cabbage, \1/12\ medium head (84 g/3.0 oz)............... 25 0 0 0 0 0 0 0 20 1 190 5 5 2 2 8 3 1 0 70 4 2
Cucumber, \1/3\ medium (99 g/3.5 oz).......................... 15 0 0 0 0 0 0 0 0 0 170 5 3 1 1 4 2 1 4 10 2 2
Bell pepper, 1 medium (148 g/5.3 oz).......................... 30 0 0 0 0 0 0 0 0 0 270 8 7 2 2 8 4 1 8 190 2 2
Cauliflower, \1/6\ medium head (99 g/3.5 oz).................. 25 0 0 0 0 0 0 0 30 1 270 8 5 2 2 8 2 2 0 100 2 2
Leaf lettuce, 1\1/2\ cups shredded (85 g/3.0 oz).............. 15 0 0 0 0 0 0 0 30 1 230 7 4 1 2 8 2 1 40 6 4 0
Sweet Potato, medium, 5'' long, 2'' diameter (130 g/4.6 oz)... 130 0 0 0 0 0 0 0 45 2 350 10 33 11 4 16 7 2 440 30 2 2
Mushrooms, 5 medium (84 g/3.0 oz)............................. 20 0 0 0 0 0 0 0 0 0 300 9 3 1 1 4 0 3 0 2 0 2
Green onion, \1/4\ cup chopped (25 g/0.9 oz).................. 10 0 0 0 0 0 0 0 5 0 70 2 2 1 1 4 1 0 2 8 0 0
Green (snap) beans, \3/4\ cup cut (83 g/3.0 oz)............... 25 0 0 0 0 0 0 0 0 0 200 6 5 2 3 12 2 1 4 10 4 2
Radishes, 7 radishes (85 g/3.0 oz)............................ 15 0 0 0 0 0 0 0 25 1 230 7 3 1 0 0 2 1 0 30 2 0
Summer squash, \1/2\ medium (98 g/3.5 oz)..................... 20 0 0 0 0 0 0 0 0 0 260 7 4 1 2 8 2 1 6 30 2 2
Asparagus, 5 spears (93 g/3.3 oz)............................. 25 0 0 0 0 0 0 0 0 0 230 7 4 1 2 8 2 2 10 15 2 2
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\1\ Raw, edible weight portion. Percent (%) Daily Values are based on a 2,000 calorie diet.
Appendix D to Part 101.--Nutrition Facts for Cooked Fish
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Total fat Saturated fat Cholesterol Sodium Potassium Total Dietary
Calories ------------------------------------------------------------------------ carbohydrate fiber Sugars Protein Vitamin Vitamin Calcium Iron
Nutrition facts\1\ fish (84 g/3 oz) Calories from fat ---------------------------- (g) (g) A (%) C (%) (%) (%)
(g) (%) (g) (%) (mg) (%) (mg) (%) (mg) (%) (g) (%) (g) (%)
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Shrimp....................................................... 80 10 1 2 0 0 165 55 190 8 140 4 0 0 0 0 0 18 0 0 2 15
Cod.......................................................... 90 0 0.5 1 0 0 45 15 60 3 450 13 0 0 0 0 0 20 0 0 2 2
Pollock...................................................... 90 10 1 2 0 0 80 27 110 5 360 10 0 0 0 0 0 20 0 0 0 2
Catfish...................................................... 140 80 9 14 2 10 50 17 40 2 230 7 0 0 0 0 0 17 0 0 0 0
Scallops, about 6 large or 14 small.......................... 120 10 1 2 0 0 55 18 260 11 280 8 2 1 0 0 0 22 0 0 2 2
Salmon, Atlantic/Coho........................................ 160 60 7 11 1 5 50 17 50 2 490 14 0 0 0 0 0 22 0 0 0 4
Salmon, Chum/Pink............................................ 130 35 4 6 1 5 70 23 65 3 410 12 0 0 0 0 0 22 2 0 0 2
Salmon, Sockeye.............................................. 180 80 9 14 1.5 8 75 25 55 2 320 9 0 0 0 0 0 23 4 0 0 2
[[Page 42762]]
Flounder/sole................................................ 100 14 1.5 2 0.5 3 60 20 90 4 290 8 0 0 0 0 0 21 0 0 2 2
Oysters, about 12 medium..................................... 100 35 3.5 5 1 5 115 38 190 8 390 11 4 1 0 0 0 10 0 0 6 45
Orange roughy................................................ 80 10 1 2 0 0 20 7 70 3 330 9 0 0 0 0 0 16 0 0 0 0
Mackerel, Atlantic/Pacific................................... 210 120 13 20 1.5 8 60 20 100 4 400 11 0 0 0 0 0 21 0 0 0 5
Ocean perch.................................................. 110 20 2 3 0 0 50 17 95 4 290 8 0 0 0 0 0 21 0 0 10 6
Rockfish..................................................... 100 20 2 3 0 0 40 13 70 3 430 12 0 0 0 0 0 21 4 0 0 2
Whiting...................................................... 110 25 3 5 0.5 3 70 23 95 4 320 9 0 0 0 0 0 19 2 0 6 0
Clams, about 12 small........................................ 100 15 1.5 2 0 0 55 18 95 4 530 15 0 0 0 0 0 22 10 0 6 60
Haddock...................................................... 100 10 1 2 0 0 80 27 85 4 340 10 0 0 0 0 0 21 0 0 2 6
Blue crab.................................................... 100 10 1 2 0 0 90 30 320 13 360 10 0 0 0 0 0 20 0 0 8 4
Rainbow trout................................................ 140 50 6 9 2 10 60 20 35 1 370 11 0 0 0 0 0 21 4 4 6 2
Halibut...................................................... 110 20 2 3 0 0 35 12 60 3 490 14 0 0 0 0 0 23 2 0 4 4
Lobster...................................................... 80 0 0.5 1 0 0 60 20 320 13 300 9 1 0 0 0 0 17 0 0 4 2
Swordfish.................................................... 130 35 4.5 7 1 5 40 13 100 4 310 9 0 0 0 0 0 22 2 2 0 4
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\1\ Cooked, edible weight portion. Percent (%) Daily Values are based on a 2,000 calorie diet.
* * * * *
Dated: July 31, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-20966 Filed 8-15-96; 8:45 am]
BILLING CODE 4160-01-P