[Federal Register Volume 71, Number 142 (Tuesday, July 25, 2006)]
[Rules and Regulations]
[Pages 42031-42047]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-6436]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 2001N-0548] (formerly Docket No. 01N-0548)


Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw 
Fruits, Vegetables, and Fish

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
voluntary nutrition labeling regulations by updating the names and the 
nutrition labeling values for the 20 most frequently consumed raw 
fruits, vegetables, and fish in the United States and clarifying 
guidelines for the voluntary nutrition labeling of these foods. 
Availability of the updated nutrition labeling values in retail stores 
and on individually packaged raw fruits, vegetables, and fish will 
enable consumers to make better purchasing decisions to reflect their 
dietary needs.

EFFECTIVE DATE: January 1, 2008.

FOR FURTHER INFORMATION CONTACT: Mary Brandt, Center for Food Safety 
and Applied Nutrition (HFS-840), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-1788.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. Comments on the 2002 Proposed Rule and 2005 Reopening of the 
Comment Period
    A. General Comments
    B. Consistency Among Government Agencies in Providing Nutrient 
Information
    C. Need for Additional Research and Data
    D. Consumer Support for Labeling of Raw Fruits, Vegetables, and 
Fish
    E. Allowable Nutrient Content Claims
    F. Declaration of ``Vitamin A'' or ``Carotenoid''
    G. Updating of Reference Amounts
    H. Inclusion of Magnesium in Nutrition Labeling
    I. Guidelines for Presentation of the Nutrition Labeling Values
    1. Clarity in Guidelines for Raw Fruits and Vegetables and for 
Raw Fish
    2. Trans Fatty Acid Labeling
    J. Identification of the 20 Most Frequently Consumed Raw Fruits, 
Vegetables, and Fish in the United States
    1. Fruits and Vegetables
    2. Fish
    K. Nutrition Labeling Values for the 20 Most Frequently Consumed 
Raw Fruits, Vegetables, and Fish
    1. FDA Analysis of Data
    a. 95 Percent Prediction Intervals
    b. Precision in Estimates
    c. Adjusting Values for Total Carbohydrate
2. Nutrition Labeling of Raw Fruits and Vegetables
a. Apple
b. Avocado
c. Banana
d. Kiwifruit
e. Pear
f. Strawberries
g. Potato
3. Changes to Nutrition Labeling Values Based Upon Reassessment of 
95 Percent Prediction Intervals
4. Summary of Changes for Fruits and Vegetables
    L. Nutrition Labeling of Raw Fish
    M. Effective Date
III. Final Regulatory Impact Analysis
IV. Final Regulatory Flexibility Analysis
V. Unfunded Mandates
VI. Small Business Regulatory Enforcement Fairness Act of 1996 
(SBREFA)
VII. Paperwork Reduction Act of 1995
VIII. Analysis of Environmental Impact
IX. Federalism
X. References

I. Background

    In response to requirements of the Nutrition Labeling and Education 
Act of 1990 (``the 1990 amendments'') (Public Law 101-135), which 
amended the Federal Food, Drug, and Cosmetic Act (the act), FDA (we) 
published final regulations in the Federal Register of November 27, 
1991 (56 FR 60880) (hereinafter identified as ``the 1991 final rule''), 
and corrections in the Federal Registers of March 6, 1992 (57 FR 8174), 
and March 26, 1992 (57 FR 10522), that: (1) Identified the 20 most 
frequently consumed raw fruits, vegetables, and fish in the United 
States, which are those varieties purchased raw but not necessarily 
consumed raw; (2) established guidelines for the voluntary nutrition 
labeling of these foods; and (3) set the criteria for food retailers to 
meet substantial compliance with these guidelines. The 1991 final rule 
also required FDA to publish proposed updates of the nutrition labeling 
data for the 20 most frequently consumed raw fruits, vegetables, and 
fish (or a notice

[[Page 42032]]

that the data sets have not changed) at least every 2 years (56 FR 
60880 at 60888 and 60891).
    Next, FDA published a proposed rule on the voluntary nutrition 
labeling program in the Federal Register of July 18, 1994 (59 FR 36379) 
(hereinafter identified as ``the 1994 proposed rule''), a correction in 
the Federal Register of July 21, 1994 (59 FR 37190), and a final rule 
in the Federal Register of August 16, 1996 (61 FR 42742) (hereinafter 
identified as ``the 1996 final rule''). In the 1996 final rule, among 
other actions, FDA revised the following: (1) The nutrition labeling 
values for the 20 most frequently consumed raw fruits, vegetables, and 
fish in the United States and (2) the guidelines for the voluntary 
nutrition labeling of these foods. FDA also modified the guidelines in 
Sec.  101.45(b) (21 CFR 101.45(b)), in response to comments, to state 
that FDA would publish every 4 years (rather than 2 years) proposed 
updates of the nutrition data or a notice that the data sets have not 
changed from the previous publication (comment 12, 61 FR 42742 at 42746 
and 42760).
    FDA then published a proposed rule on the voluntary nutrition 
labeling program in the Federal Register of March 20, 2002 (67 FR 
12918) (hereinafter identified as ``the 2002 proposed rule''), and a 
correction to the Docket number and extension of the comment period in 
the Federal Register of June 6, 2002 (67 FR 38913). The 2002 proposed 
rule: (1) Updated the names and nutrition labeling values for the 20 
most frequently consumed raw fruits, vegetables, and fish in the United 
States and (2) clarified the guidelines for the voluntary nutrition 
labeling of these foods. Subsequently, FDA again reopened the comment 
period until June 3, 2005 (70 FR 16995, April 4, 2005) (hereinafter 
identified as ``the 2005 reopening of the comment period''), to allow 
all interested parties the opportunity to review its tentative 
nutrition labeling values based upon data FDA received within and after 
the comment period for the 2002 proposed rule, and to comment on the 
additional nutrient data for some of the 20 most frequently consumed 
raw fruits, vegetables, and fish. FDA also stated that it would 
evaluate any new data submissions during the reopened comment period 
and would consider use of those data in a final rule.

II. Comments on the 2002 Proposed Rule and 2005 Reopening of the 
Comment Period

    FDA received 21 responses to the 2002 proposed rule and 30 
responses to the tentative nutrition labeling values set forth in its 
2005 reopening of the comment period document, each of which contained 
one or more comments. New data also were submitted in response to the 
2005 reopening of the comment period. Comments generally supported the 
2002 proposed rule, including the new values set forth in the 2005 
reopening of the comment period document. A number of comments that 
were received are not considered here because they are beyond the scope 
of this regulation, including those comments on labeling of meat, 
poultry, and pork products; labeling of possible positive or ill side 
effects of consuming raw produce and fish; expiration dating; physical 
exercise; inclusion of additional nutrients and amino acids; protection 
of the public from profiteers; genetically modified products; pesticide 
residues, chemicals, and processes; and monosodium glutamate (MSG). 
Several comments suggested modification and revision in various 
provisions of the 2002 proposed rule, as revised by the 2005 reopening 
of the comment period. These latter comments are discussed in detail in 
this section of the document.
    To make it easier to identify comments and FDA's responses to the 
comments, the word ``Comment'' will appear in parenthesis before the 
description of the comment, and the word ``Response'' will appear in 
parenthesis before FDA's response. We have also numbered each comment 
to make it easier to identify a particular comment. The number assigned 
to each comment is purely for organizational purposes and does not 
signify the comment's value or importance or the order in which it was 
submitted.

A. General Comments

    (Comment 1) One comment, which supported the agency's efforts to 
establish accurate, meaningful nutrition information, requested that 
FDA post this information on its Web site and permit retailers who have 
developed Web sites to incorporate links from the retailer Web site to 
the FDA nutrition information.
    (Response) FDA agrees with this suggestion and has posted the 
nutrition labeling values on the Internet at www.cfsan.fda.gov. We 
encourage retailers, industry, trade associations, academia, and other 
government agencies to provide links to that information.

B. Consistency Among Government Agencies in Providing Nutrient 
Information

    (Comment 2) Several comments expressed concern that the proposed 
changes to some of the nutrient values appear inconsistent from the 
U.S. Department of Agriculture (USDA) Nutrient Database for Standard 
Reference (SR) (Ref. 1) and from its data source, the USDA National 
Nutrient Data Bank (NNDB) (Ref. 2). One comment suggested that whenever 
possible, FDA should consider SR values in addition to the agency's own 
95 percent prediction limit when determining label values.
    (Response) FDA agrees that some of its nutrient values differ from 
data found in the USDA SR and NNDB. As we explained in the 1996 final 
rule (61 FR 42742 at 42743), FDA does not agree that mean values from 
USDA databases are appropriate for nutrition labeling.
    We support use of the USDA NNDB and associated USDA SR for many 
nutritional purposes and recognize the USDA SR as the most 
comprehensive nutrient database in the United States and the basis of 
much nutrition software. For this reason, we have used all data 
submitted by USDA to update the nutrition labeling values for raw 
fruits and vegetables, including the data from its 2001-2002 nationwide 
sampling study of fruits and vegetables for 16 of the 20 most 
frequently consumed raw fruits and 12 of the 20 most frequently 
consumed raw vegetables that it submitted in response to the 2002 
proposed rule (see http://www.fda.gov/ohrms/dockets/dailys/02/Aug02/
080602/01n-0548-c000006-vol1.pdf) and (see http://www.fda.gov/OHRMS/
DOCKETS/98fr/01n-0548-bkg0002-03-Tab-01-vol4.pdf) and its data for raw 
mushrooms in response to the 2005 reopening of the comment period, as 
well as data from other sources, as described later in this final rule. 
In addition, we used data from the USDA NNDB to establish nutrient 
levels for Chinook salmon in response to comments to the 2002 proposed 
rule. Raw nutrient data (individual analytical data points) from the 
USDA NNDB also provide the basis of the nutrient levels for most of the 
raw fish. Because of the lack of data for vitamin A and vitamin C in 
raw fish, we have based the values for most fish in the voluntary 
nutrition labeling program on data published in the USDA SR, which are 
mean values.
    As stated in the 1996 final rule (61 FR 42742 at 42743), some of 
USDA's food composition data published in the SR are not fully 
representative because they are based on small sample sizes or do not 
take into account specific variables, such as geographic area. We 
obtained data for many of the raw fruits, vegetables, and fish from the 
USDA NNDB and SR, but, where possible, instead of using the mean 
values, we

[[Page 42033]]

applied compliance calculations based on 95 percent prediction 
intervals to those data (as well as to other data sources) and used the 
resulting adjusted values that account for variability in the nutrient.
    To meet the requirements for compliance in Sec.  101.9(g)(4) and 
(g)(5) (21 CFR 101.9(g)(4) and (g)(5)), the agency encourages 
manufacturers to use FDA compliance calculations based on 95 percent 
prediction intervals to determine the nutrition labeling values for 
their products. We provide guidance explaining this calculation and for 
industry to use to develop nutrition labeling values in the ``FDA 
Nutrition Labeling Manual--A Guide for Developing and Using Databases'' 
(the Nutrition Labeling Manual) (Ref. 3). The Nutrition Labeling Manual 
more fully explains the rationale and process for conducting and using 
compliance calculations based upon 95 percent prediction intervals.
    (Comment 3) Several comments stated that it is important to have 
consistency in the nutrition information that is communicated to the 
public and that FDA should do more to bring greater harmony among the 
government's nutrition information, including ensuring that nutrient 
values are consistent with the nutrition messages publicized by the 
2005 Dietary Guidelines for Americans.
    (Response) We believe it is important to have consistency in the 
nutrition information that is communicated to the public; however, 
there are some fundamental differences in the nutrient values being 
established in this final rule and the nutrition messages publicized by 
the 2005 Dietary Guidelines for Americans. The Dietary Guidelines for 
Americans (Ref. 4) recommends the increased intake of fruits, 
vegetables, and fish and cites nutrient data from the USDA SR in the 
report that they released January 12, 2005. The data provided by the 
2005 Dietary Guidelines for Americans were mean values per 100 gram (g) 
of product and were not on the same metric as the nutrition labeling 
values in Appendices C and D to part 101 (21 CFR part 101), which are 
provided on a serving size basis and are required in Sec.  101.45(b) 
for labeling of the 20 most frequently consumed raw fruits, vegetables, 
and fish to ensure uniformity in declared values. Thus, some 
differences in nutrient levels are likely to be noted.

C. Need for Additional Research and Data

    (Comment 4) Five comments requested that the final rule not be 
finalized at this time because they needed an additional 12 months to 
plan, execute, and evaluate additional nutrient research so that 
nutrient data are as complete and extensive as possible. The comments 
asserted that this additional time will allow for sampling products at 
different times of the year which will give them a more accurate 
reflection of the seasonal impact on nutrient content values. One of 
the comments stated the additional time also would allow the industry 
to establish more data points and thus increase the sample size of 
analytical values, which may help in calculating a more reliable mean 
value and improving the standard deviation, both factors needed to 
calculate the one-sided 95 percent prediction interval.
    (Response) The data submitted to FDA in response to the 2002 
proposed rule were available for public review for almost 3 years. We 
believe that this is more than an adequate amount of time for 
interested persons to complete nutrient analyses, provide additional 
data and information on market shares, determine the seasonal impact on 
nutrient content values, and establish more data points for calculating 
a more reliable nutrient value. We therefore have concluded that the 
requested additional time is not warranted. However, we do encourage 
the produce and fish industries to continue to conduct research on 
nutrient values and to submit new data to FDA for consideration in 
future updates, in accord with Sec.  101.45(b).
    (Comment 5) One comment urged that FDA utilize all credible data 
available and not a limited set of data from one study.
    (Response) FDA agrees that it should utilize all credible data 
available in developing its nutritional values for raw fruit, 
vegetables, and fish. We recognize that additional nutrient data are 
needed to support the voluntary nutrition labeling of raw produce and 
fish because some of the current values are based on small sample sizes 
or older data and should be updated. However, many of the commodity 
groups and organizations that represent the produce and fish industries 
have not submitted new data to support the updating and refinement of 
the nutrient levels. We therefore can only use the data we have in 
updating and refining these nutrient levels. As stated in the response 
to comment 4 of this document, we encourage and will continue to 
encourage the produce and fish industries to conduct additional 
nutrient analyses to support the labeling of these foods and to submit 
those data to FDA for consideration in updating the nutrient levels in 
the next review of the voluntary nutrition labeling of raw produce and 
fish.

D. Consumer Support for Labeling of Raw Fruits, Vegetables, and Fish

    (Comment 6) One comment recommended that FDA establish nutrition 
labeling values for more than just the 20 most frequently consumed raw 
products identified in the proposal.
    (Response) Section 403(q)(4)(B) of the act (21 U.S.C. 343(q)(4)(B)) 
provides that FDA establish by regulation a list of the 20 varieties of 
vegetables, fruits, and raw fish most frequently consumed in a year. 
Therefore, we are not granting the comment's request in this final 
rule. However, we have provided for the nutrition labeling of raw 
fruits, vegetables, and fish that are not among the 20 most frequently 
consumed in Sec.  101.45(c). In that regulation, FDA states that 
databases of nutrient values may be used to develop nutrition labeling 
values for specific varieties, species, or cultivars of those foods not 
among the 20 most frequently consumed raw fruits, vegetables, and fish. 
The food names and descriptions for the fruits, vegetables, and fish in 
nutrition labeling or in databases developed and submitted to FDA under 
this regulation should clearly identify these foods as distinct from 
foods among the most frequently consumed list for which we have 
provided data. Guidance in the development of databases for these foods 
may be found in the FDA Nutrition Labeling Manual (Ref. 3).
    (Comment 7) Two comments requested that FDA make the voluntary 
guidelines mandatory and require retailers to provide nutrition 
information for raw fruits, vegetables, and fish products.
    (Response) FDA disagrees with the comments. The compliance surveys 
we conducted in 1992, 1994, and 1996 (Ref. 5) do not support taking 
such action at this time. These surveys found that retailers exceeded 
the 60 percent substantial compliance standard set in Sec.  101.43(c) 
by a large enough margin to provide confidence that the levels were not 
invalidated by statistical error. Levels of compliance for 1992, 1994, 
and 1996 were 76.9 percent, 81.4 percent, and 77.8 percent for raw 
produce and 74.3 percent, 76.8 percent, and 74.0 percent for raw fish. 
As our surveys have found substantial compliance over several years, we 
have no reason to evaluate the marketplace differently than we have in 
past years because there is no evidence that substantial compliance 
does not continue at the present time. Absent information suggesting 
otherwise, our evaluation of the available compliance

[[Page 42034]]

data and our projections based on those data indicate that compliance 
remains substantial at this time. Thus, at this time, we continue to 
encourage retailers to provide quantitative nutrition information for 
raw fruits, vegetables, and fish but will not publish regulations to 
make the provision of nutrition information mandatory.

E. Allowable Nutrient Content Claims

    (Comment 8) One comment expressed concern that changing the 
existing nutrition label values for several key fruits and vegetables 
will weaken their perceived nutrient values (e.g., a fruit or vegetable 
that was previously an ``excellent source'' would now be considered a 
``good source'') and some micronutrient claims would have to be dropped 
altogether because these fruits and vegetables will not be able to bear 
the same nutrient content claims that they once did under Sec.  101.54. 
This situation could cause only fortified processed foods to be able to 
use the claim ``excellent source'' for some nutrients. The comment 
stated that the changes the agency is making would mean the loss of 
positive nutrition content claims for several vegetables and fruits 
that are currently considered to be the ``gold standard'' of nutrition 
among consumers.
    (Response) We recognize and agree that based upon new data, some of 
the fruits and vegetables may no longer be able to bear the same 
nutrient content claims. We want to clarify, however, that as described 
in Sec.  101.54, nutrient content claims must be based on the reference 
amounts customarily consumed (RACCs) and not on the serving sizes of 
products, which are derived from the RACCs. Specifically, Sec.  
101.54(b) states the provisions for ``high claims'' (``high,'' ``rich 
in,'' or ``excellent source of''), and Sec.  101.54(c) provides those 
for ``good source claims'' (``good source,'' ``contains,'' or 
``provides'').
    Section 101.12(b) states that reference amounts shall be used as 
the basis for determining serving sizes for specific products. The 
RACCs shown in Table 2 of Sec.  101.12 for fruits, vegetables, and fish 
in the voluntary nutrition labeling program include 140 g for fresh 
fruits, 30 g for avocado, 280 g for watermelon, 55 g for lemon and 
lime, 30 g for green onion, 110 g for fresh potatoes, 85 g for fresh 
vegetables, and 85 g for cooked, plain fish and shellfish. The serving 
sizes of raw produce displayed in Appendix C to part 101, while based 
on the RACCs, are generally not equivalent to the RACCs, which are 
listed in grams only, but are provided on the basis of a ``household 
measure'' of a food as well as in g and ounces (oz), such as 1 medium 
banana (126 g per (/) 4.5 oz) or 5 asparagus spears (93 g/3 oz). The 
serving size for all raw fish displayed in Appendix D to part 101 is 84 
g/3 oz.

F. Declaration of ``Vitamin A'' or ``Carotenoid''

    (Comment 9) One comment stated that fruits and vegetables contain 
carotenoid, which is the precursor of vitamin A, but not vitamin A 
itself, so the term ``vitamin A'' for fruits and vegetables should be 
changed to ``carotenoid''.
    (Response) We believe it would be inaccurate to change the term 
``Vitamin A'' to ``carotenoids'' for fresh fruit and vegetables given 
the understanding of the term ``Vitamin A'' and the relatively limited 
understanding of the functions of the hundreds of naturally occurring 
carotenoids. Vitamin A comprises a family of molecules containing a 20-
carbon structure with a methyl substituted cyclohexenyl ring and a 
tetraene side chain with a hydroxy group (retinol), aldehyde group 
(retinal), carboxylic acid group (retinoic acid) or ester group 
(retinyl ester) at carbon 15. The term ``Vitamin A'' includes 
provitamin A carotenoids that are dietary precursors of retinol. The 
term ``retinoids'' refers to retinol, its metabolites, and synthetic 
analogues that have a similar structure. Carotenoids are 
polyisoprenoids, of which more than 600 forms exist. Of the many 
carotenoids in nature, several have provitamin A nutritional activity. 
Food composition data are available for only three (alpha-carotene, 
beta-carotene, and beta-crypotoxanthin). Because the term ``Vitamin A'' 
typically encompasses pro-vitamin A carotenoids, and most carotenoids 
have no food composition data available at this time, the suggested 
change would be inaccurate.

G. Updating of Reference Amounts

    (Comment 10) One comment recommended that FDA not revise nutrient 
values for the 20 most frequently consumed raw fruits, vegetables, and 
fish until we finalized the April 4, 2005 (70 FR 17010) Advanced Notice 
of Proposed Rulemaking (ANPRM) (the April 2005 ANPRM), that requested 
comments on, among other issues, whether we should update the RACCs, 
the basis for serving size. The comment was of the view that we should 
wait until the reference amounts are revised to reflect what is 
currently available in the U.S. market.
    (Response) FDA disagrees with the comment. We believe we should 
publish this final rule at this time and not wait until completion of 
the rulemaking process that we initiated by the April 2005 ANPRM. We 
are currently reviewing comments submitted in response to the ANPRM and 
have not determined whether or when we will update the RACCs. If we do 
decide to go forward with that rulemaking and revise the RACCs, we will 
then update the serving sizes of raw fruits, vegetables, and fish to 
reflect those revisions in future rulemaking for the voluntary 
nutrition labeling program.

H. Inclusion of Magnesium in Nutrition Labeling

    (Comment 11) One comment suggested that FDA include the magnesium 
content of seafood in the voluntary nutrition labeling regulations. 
Cooked fish, the comment noted, can provide substantial amounts of 
magnesium in the U.S. diet, which would provide health benefits to 
American consumers. Another comment requested that magnesium be added 
to the banana's nutrition labeling profile in Appendix C to part 101. 
The latter comment noted that the 2005 Dietary Guidelines for Americans 
recommend that both adults and children increase their intake of 
magnesium from food sources.
    (Response) FDA is not granting either of these requests. We note 
that the 2005 Dietary Guidelines state that based on dietary intake 
data or evidence of public health problems, intake levels of magnesium 
may be of concern for both adults and children (Ref. 4). However, none 
of the comments included nutrient data for magnesium for any of the 
fish in the voluntary nutrition labeling program, and we do not have 
access to magnesium data for any of the fish or the raw fruits and 
vegetables. Thus we cannot grant the request in the comment without 
such supporting data.
    However, we consider magnesium an optional nutrient for both 
mandatory nutrition labeling and the voluntary nutrition labeling of 
raw fruits, vegetables, and fish. In the 1996 final rule, we noted that 
providing information on optional nutrients for foods in the voluntary 
program will be useful, and declarations of optional nutrients included 
on individual labels should follow the requirements under Sec.  
101.9(c).

I. Guidelines for Presentation of the Nutrition Labeling Values

1. Clarity in Guidelines for Raw Fruits and Vegetables and for Raw Fish
    To provide clarity and consistency in the voluntary nutrition 
labeling of raw

[[Page 42035]]

fruits, vegetables, and fish, FDA proposed in Sec.  101.45(a)(3) to: 
(1) Divide current Sec.  101.45(a)(3)(iii) into two parts (i.e., into 
Sec.  101.45(a)(3)(iii) and (a)(3)(iv)) so that Sec.  101.45(a)(3)(iii) 
pertains only to raw fruits and vegetables and Sec.  101.45(a)(3)(iv) 
pertains only to raw fish and (2) revise the wording for consistency 
and increased readability. No comments were received, and therefore 
these guidelines were adopted as proposed.
2. Trans Fatty Acid Labeling
    FDA stated in the 2002 proposed rule that trans fatty acids would 
not be expected to be present in raw produce and that the footnote 
required in proposed Sec.  101.45(a)(3)(iii) should be revised to 
state: ``Most fruits and vegetables provide negligible amounts of 
saturated fat, trans fat, and cholesterol * * *.'' Comments supported 
FDA's proposed revisions to Sec.  101.45(a)(3)(iii), and therefore we 
have adopted it as proposed.
    Also, FDA requested comments that provide data on the trans fat 
content of raw fish (or cooked fish without the addition of any 
ingredients, e.g., fat, breading, or seasoning).
    (Comment 12) Several comments requested that FDA revise Sec.  
101.45(a)(3)(iv) to state that fish provide only negligible amounts of 
trans fat, or no trans fat. A comment from the fish industry noted 
that, unlike some animals, fish do not typically accumulate measurable 
levels of trans fat as a result of their metabolized food sources, and 
it is particularly true of wild-caught fish.
    (Response) FDA agrees with the comments and has revised Sec.  
101.45(a)(3)(iv) to read as follows: ``When retailers provide nutrition 
labeling information for more than one raw fish on signs or posters or 
in brochures, notebooks, or leaflets, the listings for trans fat, 
dietary fiber and sugars may be omitted from the charts or individual 
nutrition labels if the following footnote is used, `Fish provide 
negligible amounts of trans fat, dietary fiber, and sugars'.'' 
Appendices C and D to part 101 will show 0 g of trans fat for all 
varieties of raw fruits, vegetables, and fish.

J. Identification of the 20 Most Frequently Consumed Raw Fruits, 
Vegetables, and Fish in the United States

1. Fruits and Vegetables
    There were no comments that recommended changing the top 20 most 
frequently consumed raw fruits and the top 20 most frequently consumed 
raw vegetables. For ease of use and to be consistent with the food 
names in Appendix C to part 101, we revised Sec.  101.44(a) and (b) by 
listing the items in alphabetical order and by using the plural form of 
the food name when the serving size is more than one unit. Revised 
Sec.  101.44(a) reads as follows: ``The 20 most frequently consumed raw 
fruits are: Apple, avocado (California), banana, cantaloupe, 
grapefruit, grapes, honeydew melon, kiwifruit, lemon, lime, nectarine, 
orange, peach, pear, pineapple, plums, strawberries, sweet cherries, 
tangerine, and watermelon.'' Revised Sec.  101.44(b) reads as follows: 
``The 20 most frequently consumed raw vegetables are: Asparagus, bell 
pepper, broccoli, carrot, cauliflower, celery, cucumber, green (snap) 
beans, green cabbage, green onion, iceberg lettuce, leaf lettuce, 
mushrooms, onion, potato, radishes, summer squash, sweet corn, sweet 
potato, and tomato.''
2. Fish
    (Comment 13) Two comments requested that FDA revise Sec.  
101.45(a)(3)(iv) to add Chinook salmon to the salmon species. One 
comment stated that the vast majority of Chinook salmon is sold raw to 
the U.S. consumer, and the nutrient profile is most similar to the 
proposed category for the values for Atlantic/coho/sockeye salmon.
    (Response) We agree with this suggestion and have revised 
101.45(a)(3)(iv) to combine Atlantic, coho, Chinook and sockeye into 
one subgroup of salmon based upon similarity in nutrient values.
    (Comment 14) One comment requested that FDA report information for 
farmed salmon separately from that for wild salmon because food supply 
and water quality greatly affect nutrition value of the food whether it 
is raised or caught.
    (Response) We are not granting this request because there were no 
nutrient data submitted that supported providing nutrition information 
separately for farmed versus wild species of salmon or other types of 
fish.

K. Nutrition Labeling Values for the 20 Most Frequently Consumed Raw 
Fruits, Vegetables, and Fish

1. FDA Analysis of the Data
    FDA considered the data from all of the sources identified in 
sections II.K.2 and II.K.3 of this final rule and used these data as 
the basis for deriving the updated nutrition labeling values for the 20 
most frequently consumed raw fruits, vegetables, and fish in Appendices 
C and D to part 101. Reference 6 of this document provides complete 
documentation of the derivation of each nutrition labeling value for 
the raw fruits, vegetables, and fish covered in this final rule. The 
documentation also includes the actual (unrounded) values for total 
fat, total carbohydrate, and protein used to calculate calories and 
calories from fat for each food.
    To the extent possible (i.e., for those nutrients for which 
sufficient data were available), we used the statistical methodology 
recommended in the FDA Nutrition Labeling Manual to produce the 
nutrition labeling values. The recommended statistical methodology uses 
compliance calculations that take into account the variation of 
nutrients in foods, as described in greater detail in the 2002 proposed 
rule.
    a. 95 Percent Prediction Intervals.
    (Comment 15) One comment stated that proposed values appear to be 
imprecise and not representative when calculating for the one-sided 95 
percent prediction interval. As a solution, the comment recommended 
that FDA use predicted values that fall within the range of the actual 
data points.
    (Response) We agree with the comment that the 95 percent predicted 
value should fall within the range of the interval of all raw data 
points and have reviewed all nutrient data for all foods. If the 95 
percent predicted value falls within the interval of all raw data 
points, then it is reasonable that it represent the nutrient level of 
the product. If for any reason, the 95 percent predicted value shows an 
invalid complete absence of a nutrient, if it is a negative value, or 
if it does not fall within the interval of all raw data points, it is 
likely that the mean will provide a better estimate of the nutrient 
than the predicted value. We also noted in the 2002 proposed rule that 
we frequently find that the mean and the predicted value round to the 
same value. In addition, we found that when the sample size was small 
(e.g., three or fewer analytical data points), the values derived from 
compliance calculations (using 95 percent prediction intervals) were 
less likely than the mean to represent the nutrient level. Thus, after 
a careful review of statistical and analytical data and considering all 
criteria listed in section II.K.1 of this document, we selected those 
values that more appropriately represent the nutrient level in the 
food.
    (Comment 16) One comment asked that FDA provide clarification of 
the agency's compliance with the Data Quality Act in issuing the 
proposed nutrient labeling values.
    (Response) In the Information Quality Act (IQA), Public Law No. 
106-554,

[[Page 42036]]

section 515 (2000), see 44 U.S.C. 2516 note, Congress directed the 
Office of Management and Budget (OMB) to issue governmentwide 
guidelines designed to ensure and maximize the ``quality, objectivity, 
utility, and integrity of information * * * disseminated by Federal 
agencies,'' and in turn required agencies to issue their own guidelines 
concerning information quality and to establish administrative 
mechanisms to allow affected persons to seek and obtain correction of 
information maintained and disseminated by the agency that does not 
comport with the agency's guidelines. OMB's guidelines were published 
in the Federal Register of February 22, 2002 (67 FR 8452); HHS's 
guidelines were announced in the Federal Register of September 30, 2002 
(67 FR 61343), and can be found at http://aspe.hhs.gov/infoquality/
guidelines/fda.shtml. (FDA has verified the Web site address, but we 
are not responsible for subsequent changes to the Web site after this 
document publishes in the Federal Register.)
    The nutrition labeling values that we provide in the voluntary 
nutrition labeling program are developed using a transparent process 
that provides data that are reproducible and are otherwise in 
compliance with FDA's IQA guidelines and the IQA. The process of 
setting and updating these values is identified in Sec.  101.45(b) and 
(c) and in the FDA Nutrition Labeling Manual, described in Sec.  
101.45(b) and (c). The manual provides the general methodology that we 
recommend and follow to determine nutrition labeling values based on 95 
percent prediction intervals, and FDA has provided detailed 
explanations of its methodology in the proposed rule and in response to 
comments in this preamble. In addition to the FDA Nutrition Labeling 
Manual, FDA staff members are available to answer questions and to 
provide further direction on the analytical, statistical, and 
methodological questions that arise concerning determination of 
nutrition labeling values. Stakeholders with new or additional nutrient 
data for any of the most frequently consumed raw fruits, vegetables, 
and fish are encouraged in Sec.  101.45(b) and (c) to submit data to 
the agency for review and evaluation by the agency, and these data may 
be incorporated into subsequent revisions of the nutrition labeling 
information.
    b. Precision in Estimates.
    (Comment 17) One comment suggested that USDA and FDA emphasize in 
the regulation that the [serving] sizes given for produce items are 
expressed for the edible portion even though, as another comment noted, 
consumers buy foods in ``as purchased'' quantities. For example, a 
consumer buying a fruit with a large amount of inedible content (e.g., 
cantaloupe or peach), would likely believe that they are getting more 
nutrients than they are. The comment stated that having yield 
conversion factors would be necessary to make the nutrient information 
truly usable to the consumer.
    (Response) We do not believe the emphasis requested is necessary, 
as we are not aware of consumer research that describes consumers' 
perceptions of the size of fruits and vegetables they purchase with 
respect to interpretation of nutrient information available on signs in 
retail outlets, which is based on a serving size set by FDA and 
reflects the amount customarily consumed. We are therefore not 
convinced that most consumers will require the precision in knowing at 
the point of purchase the yield information of the raw fruits and 
vegetables they purchase.
    (Comment 18) One comment expressed concern that the proposed 
changes in nutrient levels mislead the public because listing the 
weight of any fruit or vegetable in unrounded numbers gives an 
impression of an unwarranted level of accuracy, when in fact fruits and 
vegetables vary in size.
    (Response) FDA agrees that fruits and vegetables vary in size but 
disagrees that listing the weight in unrounded numbers gives an 
impression of an unwarranted level of accuracy. The nutrition labeling 
values in Appendix C to part 101 provide serving sizes for each fruit 
and vegetable that is expressed in a visual unit of measure (e.g., 1 
medium apple; 2 slices pineapple; 5 spears asparagus; 1/2 medium summer 
squash; 1 medium, 5' long, 2' diameter sweet potato), as well as the 
gram and ounce equivalent. Visual units of measure vary and are not 
intended to be precise. We expect that consumers will treat them as an 
approximation but will also have the option of referring to the gram 
and ounce serving size measures if greater precision is needed.
    c. Adjusting Values for Total Carbohydrate.
    (Comment 19) One comment objected to FDA adjusting the total 
carbohydrate values where the sum of sugars and dietary fiber exceeded 
the value for total carbohydrate. The comment stated that the sugar 
value should be adjusted when sugars and fibers exceed total 
carbohydrate, and the sugar values are from a different source than the 
proximate, fiber, and other nutrient values. This, the comment stated, 
would more accurately represent the sugar and carbohydrate content, as 
well as the caloric value, of the samples from which most of the 
nutrition labeling values have been derived.
    (Response) We disagree that the sugars value should be adjusted. 
The sum of the sugars and dietary fiber values, which were derived from 
analytical data submitted by USDA, exceeded the value for total 
carbohydrate for cantaloupe, honeydew melon, and watermelon. For these 
foods only, we adjusted the value for total carbohydrate to reflect the 
sum of sugars and dietary fiber. As stated in the 2002 proposed rule, 
we consider this adjustment to be appropriate because the values for 
sugars and dietary fiber are determined by laboratory analysis, and 
therefore, are more accurate than the value for total carbohydrate, 
which is determined ``by difference'' (i.e., the weight remaining after 
subtracting the sum of the protein, fat, moisture, and ash from the 
total weight of the food (Sec.  101.9(c)(6))).
2. Nutrition Labeling of Raw Fruits and Vegetables
    In the 2002 proposed rule, FDA updated nutrition labeling values 
for 12 of the 20 raw fruits and 9 of the 20 raw vegetables. We used new 
data for six of the fruits from the California Avocado Commission 
(CAC); the California Table Grape Commission; the California Tree Fruit 
Agreement (CTFA) for peach, plums, and nectarine; and the California 
Cherry Advisory Board for fat in sweet cherries. We also used new data 
for four vegetables from the National Potato Protection Board and the 
USDA NNDB for green onion, sweet corn, and sweet potatoes. In other 
nutrition label changes, we corrected slight errors in sugars, total 
carbohydrate, calories, and calories from fat values in a few fruits 
and vegetables (cantaloupe, orange, strawberries, sweet cherries, 
tangerine, watermelon, asparagus, celery, green (snap) beans, and 
tomato) and corrected the serving size for grapefruit, carrot, and 
sweet potato.
    As indicated in section II.B of this final rule, USDA submitted 
data in response to the 2002 proposed rule from its 2001-2002 
nationwide sampling study of fruits and vegetables, which it 
incorporated into its NNDB and SR, for 16 of the 20 most frequently 
consumed raw fruits (apple, avocado (California), banana, cantaloupe, 
grapefruit, honeydew melon, kiwifruit, nectarine, orange, peach, pear, 
pineapple, plums, strawberries, sweet cherries, and watermelon) and 12 
of the 20 most frequently consumed raw vegetables (bell pepper, 
broccoli, carrot, celery, cucumber, iceberg lettuce, leaf lettuce, 
onion, potato, radish, sweet potato, and

[[Page 42037]]

tomato). At the time USDA submitted the comment, the data results for 
vitamin C, sodium, and potassium were not yet available, and the 
analysis of carotenoids for carrots, sweet potatoes, cucumbers, onions, 
and sweet peppers had not been completed. In June and July of 2003, 
after the close of the comment period, USDA provided sodium, potassium, 
and some carotenoid values that it did not submit earlier, including 
vitamin C values for pineapple. In other comments to the 2002 proposed 
rule, the Citrus Research Board and Food Research, Inc., provided 
nutrient data from 1998 for oranges, grapefruit, tangerines (Mandarin 
oranges), and lemons. We used all of the new data to update the 
nutrition labeling values in the 2005 reopening of the comment period.
    In response to the 2005 reopening of the comment period, the Pear 
Bureau Northwest submitted market share data for four varieties of 
pears; USDA submitted data for raw mushrooms; Food Research, Inc., 
submitted data for total fat in kiwifruit; and the California 
Strawberry Commission (CSC) submitted data for sugars, calcium, and 
iron in strawberries. After the close of the comment period, the U.S. 
Apple Association (USApple) submitted data for fiber and new serving 
size information. We considered all data submitted in response to the 
2005 reopening of the comment period and used those data to update the 
nutrition labeling values for raw fruits and vegetables in this final 
rule. The following will address individual fruits and vegetables for 
which we received data in response to the 2005 reopening of the comment 
period.
    a. Apple.
    (Comment 20) USApple requested that FDA use its new serving size 
information and new data for dietary fiber for five varieties of apples 
(Red Delicious, Golden Delicious, Granny Smith, Gala, and Fuji) in 
updating the nutrient values for apples. USApple stated that based on 
current market data, retailers are selling significantly larger apples 
than those represented by the existing serving size of 154 g or 5.5 oz 
edible portion, which is based on 1975 market data. They noted that the 
154 g serving size for apples does not reflect the majority of apples 
for sale in the retail market and that a large apple (264 g whole, 242 
g edible portion) is customarily consumed in the United States. They 
stated apple growers have adapted to consumers' tastes and preferences 
by growing and marketing larger apples, and, as a result, apple 
production and the apple market have changed significantly. In 
addition, only small and large apple sizes exist in today's 
marketplace. There is no inventory management or price look-up (PLU) 
sticker that designates a ``medium'' size apple at the retail level, 
and smaller apples typically go to processing. USApple recommended that 
a large apple (242 g edible portion) should be listed as the serving 
size.
    (Response) We agree with the USApple request. We are convinced by 
the data submitted by USApple that ``1 large (242 g/8 oz)'' better 
represents the serving size for apple. Thus, we combined the data for 
dietary fiber from the USApple research study (n=8) with data provided 
by USDA for the same five varieties of apples in response to the 2002 
proposed rule (n=15) and conducted weighted compliance calculations of 
all nutrients based on market share using 95 percent prediction 
intervals (Ref. 7). Based upon our analysis of the data, we determined 
that there would be changes in nutrition labeling values for calories 
(130 from 80), potassium (260 milligrams (mg), 7 percent daily value 
(DV), from 160 mg, 5 percent DV), total carbohydrate (34 g, 11 percent 
DV, from 21 mg, 7 percent DV), dietary fiber (5 g, 20 percent DV, from 
3 g, 12 percent DV), sugars (25 g from 16 g), protein (1 g from 0 g), 
calcium (2 percent DV from 0 percent DV), and iron (2 percent DV from 0 
percent DV). Table 1 of this document includes changes in nutrition 
labeling values for apples, and Appendix C to part 101 provides the 
listing of all values.

                                  Table 1.--Changes to the Nutrition Labeling Information for Raw Fruits and Vegetables
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            2005 Reopening Comment Period Values                        Final Rule Values
                  Food and Nutrient                  ---------------------------------------------------------------------------------------------------
                                                                                         % DV                                              % DV
--------------------------------------------------------------------------------------------------------------------------------------------------------
Apples (242 g)                                                        (154 g)  .......................                  (242 g)  .......................
 Calories                                                                  80  .......................                      130  .......................
 Potassium                                                             160 mg                       5%                   260 mg                       7%
 Total Carbohydrate                                                     21 mg                       7%                    34 mg                      11%
 Dietary Fiber                                                            3 g                      12%                      5 g                      20%
 Sugars                                                                  16 g  .......................                     25 g  .......................
 Protein                                                                  0 g  .......................                      1 g  .......................
 Calcium                                              .......................                       0%  .......................                       2%
 Iron                                                 .......................                       0%  .......................                       2%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Avocado (30 g)                                        .......................  .......................  .......................  .......................
 Calories from Fat                                                       45 g  .......................                       35  .......................
 Total Fat                                                                5 g                       8%                    4.5 g                       7%
 Saturated Fat                                                            1 g                       5%                    0.5 g                       3%
 Total Carbohydrate                                                       2 g                       1%                      3 g                       1%
 Iron                                                 .......................                       0%  .......................                       2%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Banana (126 g)                                        .......................  .......................  .......................  .......................
 Sodium                                                                  5 mg                       0%                     0 mg                       0%
 Dietary Fiber                                                            2 g                       8%                      3 g                      12%
 Vitamin A                                            .......................                       0%  .......................                       2%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cantaloupe (134 g)                                    .......................  .......................  .......................  .......................
 Calcium                                              .......................                       0%  .......................                       2%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Honeydew melon (134 g)                                .......................  .......................  .......................  .......................
 Calcium                                              .......................                       0%  .......................                       2%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Kiwifruit (148 g)                                     .......................  .......................  .......................  .......................

[[Page 42038]]

 
 Total Fat                                                              1.5 g                       2%                      1 g                       2%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Lemon (58 g)                                          .......................  .......................  .......................  .......................
 Dietary Fiber                                                            1 g                       4%                      2 g                       8%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nectarine (140 g)                                     .......................  .......................  .......................  .......................
 Dietary Fiber                                                            1 g                       4%                      2 g                       8%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Orange (154 g)                                        .......................  .......................  .......................  .......................
 Vitamin A                                            .......................                       0%  .......................                       2%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pear (166 g)                                          .......................  .......................  .......................  .......................
 Potassium                                                             180 mg                       5%                   190 mg                       5%
 Total Carbohydrate                                                      25 g                       8%                     26 g                       9%
 Dietary Fiber                                                            4 g                      16%                      6 g                      24%
 Protein                                                                  0 g  .......................                      1 g  .......................
 Calcium                                              .......................                       0%  .......................                       2%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pineapple (112 g)                                     .......................  .......................  .......................  .......................
 Iron                                                 .......................                       0%  .......................                       2%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Plums (151 g)                                         .......................  .......................  .......................  .......................
 Dietary Fiber                                                            1 g                       4%                      2 g                       8%
 Iron                                                 .......................                       0%  .......................                       2%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Strawberries (147 g)                                  .......................  .......................  .......................  .......................
 Sugars                                                                   6 g  .......................                      8 g  .......................
 Calcium                                              .......................                       0%  .......................                       2%
 Iron                                                 .......................                       0%  .......................                       2%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tangerine (109 g)                                     .......................  .......................  .......................  .......................
 Sodium                                                                  5 mg                       0%                      0 g                       0%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Broccoli (148 g)                                      .......................  .......................  .......................  .......................
 Total Carbohydrate                                                      10 g                       3%                      8 g                       3%
 Protein                                                                  2 g  .......................                      4 g  .......................
 Iron                                                 .......................                       4%  .......................                       6%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Carrot (78 g)                                         .......................  .......................  .......................  .......................
 Iron                                                 .......................                       0%  .......................                       2%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Celery (110 g)                                        .......................  .......................  .......................  .......................
 Dietary Fiber                                                            1 g                       4%                      2 g                       8%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cucumber (99 g)                                       .......................  .......................  .......................  .......................
 Calories                                                                  15  .......................                       10  .......................
 Total Carbohydrate                                                       3 g                       1%                      2 g                       1%
 Sugars                                                                   2 g  .......................                      1 g  .......................
 Protein                                                                  0 g  .......................                      1 g  .......................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Green Onion (25 g)                                    .......................  .......................  .......................  .......................
 Iron                                                 .......................                       0%  .......................                       2%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Leaf Lettuce (85 g)                                   .......................  .......................  .......................  .......................
 Calcium                                              .......................                       4%  .......................                       2%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mushrooms (84 g)                                      .......................  .......................  .......................  .......................
 Sodium                                                                   0 g                       0%                     15 g                       0%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Onion (148 g)                                         .......................  .......................  .......................  .......................
 Potassium                                                             160 mg                       5%                    190 g                       5%
 Calcium                                              .......................                       2%  .......................                       4%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Radishes (85 g)                                       .......................  .......................  .......................  .......................
 Potassium                                                             160 mg                       5%                   190 mg                       5%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tomato (148 g)                                        .......................  .......................  .......................  .......................
 Sodium                                                                 35 mg                       1%                    20 mg                       1%
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 42039]]

    b. Avocado.
    (Comment 21) In comments submitted in response to the 2005 
reopening of the comment period, CAC requested that FDA establish a 
nutrition labeling value of 0.5 g for saturated fat, 2 g for dietary 
fiber, and 150 mg for potassium.
    CAC also submitted a comment in response to the 2002 proposed rule 
stating that it is well established that the fat content of an avocado 
varies and increases throughout the season and asked that we consider 
seasonal data in determining the content of fat. To support their 
request, CAC also noted that the State of California regulates the 
percent oil (fat) that must be present in an avocado before it can be 
sold. Not only does the fat content vary throughout the season, but as 
with many fruit crops, avocado sales start slow, build and then decline 
at the end of the season. Seasons and corresponding market share for 
avocado include: Primary season (January through September), 93 percent 
of crop; pre-season (November and December), 2.4 percent of crop; and 
post-season (October), 4.6 percent of crop.
    (Response) We agree with the comment on the seasonal variation of 
fat in avocados and reevaluated the total fat and saturated fat levels 
for this final rule. We used the seasonal market share data that CAC 
provided along with their nutrient data, combined these data with those 
provided by USDA in response to the 2002 proposed rule, and conducted 
weighted compliance calculations based on 95 percent prediction 
intervals (Ref. 8). The resulting nutrition labeling value for 
saturated fat is 0.5 g. In addition, we found that other nutrient 
levels changed from those we published in the reopening of the comment 
period for total fat (4.5 g, 7 percent DV, from 5 g, 8 percent DV), 
calories from fat (35 from 45), total carbohydrate (3 g, 1 percent DV, 
from 2 g, 1 percent DV), and iron (2 percent DV from 0 percent DV).
    We have also provided a correction in this final rule in Sec.  
101.45(a)(3)(iii) that ``* * * avocados contain 1 gram (g) of fat per 
ounce'' should read ``* * * avocados contain 0.5 gram (g) of saturated 
fat per ounce.'' In addition, we have revised the footnote that follows 
in Sec.  101.45(a)(3)(iii) that states ``avocados provide 1 g of 
saturated fat per ounce'' to read ``avocados provide 0.5 g of saturated 
fat per ounce.''
    We will make no changes to the nutrition labeling values for 
dietary fiber and potassium. We completed weighted compliance 
calculations based on 95 percent prediction intervals with nutrient 
data submitted by CAC and USDA, and determined that the 95 percent 
predicted value for dietary fiber fell outside the interval of the raw 
data points. We selected the mean value for dietary fiber, with a 
resulting nutrition labeling value of 1 g. For potassium, the 95 
percent predicted value of 142.9 mg fell within the interval of the raw 
data points, so we selected the rounded value of 140 mg for nutrition 
labeling. Thus, FDA calculated final values for dietary fiber and 
potassium, in accord with the statistical methods described in the 2002 
proposed rule, the 2005 reopening of the comment period, and in 
response to comments in this final rule. Table 1 of this document 
includes all changes in nutrition labeling values for avocado, and 
Appendix C to part 101 provides the listing of all values.
    c. Banana.
    (Comment 22) The International Banana Association (IBA), in 
response to the 2005 reopening of the comment period, questioned the 
accuracy of FDA's calculations for the 95 percent prediction intervals 
for bananas. Specifically, IBA recommended that the nutrition labeling 
values for sodium, dietary fiber, and sugars be 0 mg, 3 g, and 16 g, 
respectively.
    (Response) We agree that the nutrition labeling values for sodium 
and dietary fiber in banana should be changed to the levels recommended 
by IBA (0 mg from 5 mg for sodium, and 3 g, 12 percent DV, from 2 g, 8 
percent DV for dietary fiber) (Ref. 9). Based upon our review of the 
USDA data submitted in response to the 2002 proposed rule and 
reassessment of 95 percent prediction intervals, as discussed in 
section II.K.3 of this document, we determined that there would be 
changes in the values for sodium, fiber, and vitamin A (2 percent DV 
from 0 percent DV). However, we did not find reason to change the 
nutrition labeling value for sugars and have not changed the 19 g 
listed in Appendix C to part 101. Table 1 of this document provides 
changes in nutrition labeling values for banana, and Appendix C to part 
101 lists all values.
    d. Kiwifruit.
    (Comment 23) Food Research Inc., on behalf of kiwifruit growers 
that combined represent an estimated 98.75 percent of all kiwifruit 
sold in the United States, recommended that FDA label total fat as 0.5 
g (1 percent DV) per serving. The comment stated that because a large 
coefficient of variation due to two high values in the USDA data raise 
uncertainties, and because so much of the sample information, country 
of origin, and method of analysis were not reported, it would be more 
appropriate to use the results of the Food Research Inc., study for the 
basis of labeling total fat. In support of their request, the comment 
provided nutrient data for total fat in kiwifruit from three of the 
countries they represent, which account for 88 percent of the kiwifruit 
sold in the United States (Chile, the United States (California), and 
New Zealand).
    (Response) We do not agree with the 0.5 g (1 percent DV) total fat 
value recommended by the comment. We combined the data for total fat 
from the kiwifruit research study (n=6) to data provided by USDA in 
response to the 2002 proposed rule (n=8) and conducted weighted 
compliance calculations based on 95 percent prediction intervals (Ref. 
10). The resulting nutrition labeling values for total fat are 1 g, 2 
percent DV, a change from the 1.5 g, 2 percent DV published in the 2005 
reopening of the comment period (see table 1 of this document). 
Appendix C to part 101 provides the listing of all nutrition labeling 
values for kiwifruit.
    e. Pear.
    (Comment 24) The Pear Bureau Northwest (Pear Bureau) submitted 
market share data for four varieties of pears and requested that FDA 
use these data to weight the nutrient data submitted by USDA in 
response to the 2002 proposed rule. The varieties and market share 
include Bartlett (37 percent), Bosc (17 percent), Green Anjou (2 
percent), and Red Anjou (28 percent), accounting for 84 percent of 
fresh pears sold domestically. The Pear Bureau requested nutrition 
labeling values for dietary fiber and total carbohydrate be updated to 
5 g and 26 g, respectively.
    (Response) We agree that the market share data submitted by the 
Pear Bureau should be used to weight the nutrient data for pears. We 
reviewed the market share data for pears submitted by the Pear Bureau 
and used their market share percentages to weight USDA nutrient data 
for the four varieties of pears and derive nutrition labeling values 
using compliance calculations based on 95 percent prediction intervals 
(Ref. 11). The resulting nutrition labeling values include changes for 
potassium (190 mg from 180 mg, both 5 percent DV), total carbohydrate 
(26 g, 9 percent DV, from 25 g, 8 percent DV), dietary fiber (6 g, 24 
percent DV, from 4 g, 16 percent DV), protein (1 g from 0 g), and 
calcium (2 percent DV from 0 percent DV). Table 1 of this document 
includes changes in nutrition labeling values for pear, and Appendix C 
to part 101 provides the listing of all values.
    f. Strawberries.
    (Comment 25) CSC requested nutrition labeling values of 8 g for 
sugars and 2 percent DV for calcium and iron. In support of their 
request, CSC submitted the results of analytical

[[Page 42040]]

research conducted by Food Research, Inc., to determine the sugars, 
calcium, and iron content of fresh strawberries. Twelve 16-oz 
containers or six 32-oz containers of four brands of strawberries were 
purchased in May 2005 and delivered on the same day to the laboratory 
for analysis.
    (Response) We agree with the changes recommended by CSC. We have 
evaluated the CSC nutrient data, combined those data with the data USDA 
submitted in response to the 2002 proposed rule, and conducted weighted 
compliance calculations based on 95 percent intervals (Ref. 12). The 
resulting nutrition labeling value for sugars is 8 g (from 6 g) and for 
calcium and iron is 2 percent DV (from 0 percent DV). Table 1 of this 
document includes changes in nutrition labeling values for 
strawberries, and Appendix C to part 101 provides the listing of all 
values.
    g. Potato.
    (Comment 26) The U.S. Potato Board (USPB) commented, in response to 
the 2002 proposed rule, that the 2000 market basket data that Ketchum 
(a public relations firm) submitted to FDA on their behalf and that FDA 
used in proposing to update the nutrition labeling values for potatoes 
in the 2002 proposed rule should not be used because the data contain 
inaccuracies due to unusually high moisture content and did not 
represent the average potato that a consumer would eat. USPB 
recommended that FDA use the preliminary data that USDA submitted in 
response to the 2002 proposed rule, as those data were more in line 
with the nutrition labeling values for potato. USPB also noted that the 
data in the current USDA SR are more appropriate for labeling purposes 
than the data that they submitted and that we used in the 2002 proposed 
rule. USPB also, in response to the 2005 reopening of the comment 
period, requested that FDA retain the current nutrition labeling and 
not use the values that FDA published in the 2005 reopening of the 
comment period document, which were derived from the new data that USDA 
submitted in response to the 2002 proposed rule. USPB said they saw no 
compelling reason to have one set of data negatively impact a nutrition 
label that has been acceptable to FDA for the past 10 years.
    (Response) We disagree with the comment. We have determined that 
the Produce Marketing Association nutrient data we used to support the 
nutrition labeling values for potato in the 1996 final rule were based 
upon nutrient data analyzed in 1983 and 1984 and are not likely to be 
valid because they are outdated. In the 2005 reopening of the comment 
period, we used new nutrient data for four types of potatoes that USDA 
submitted in response to the 2002 proposed rule, and conducted 
compliance calculations based on 95 percent prediction intervals to 
determine nutrition labeling values (Ref. 13). Having received no 
additional nutrient data for potato, we are using these nutrition 
labeling values in Appendix C to part 101 to replace the nutrient data 
that are more than 20 years old.
3. Changes to Nutrition Labeling Values Based Upon Reassessment of 95 
Percent Prediction Intervals
    As indicated in section II.K.1.a of this final rule, upon 
completion of all statistical analyses to calculate compliance 
calculations based on 95 percent prediction intervals (Refs. 7 through 
19), we reviewed all nutrient data for all foods to determine if the 95 
percent predicted value fell within the range of the interval of all 
raw data points for each nutrient and food. If the nutrient level 
derived from the 95 percent prediction interval was selected as the 
more appropriate nutrient value (versus the mean), and that level fell 
within the interval of all raw data points, then we determined it would 
be a reasonable choice to represent the nutrient for the raw food. 
However, if the nutrient level based on the 95 percent prediction 
interval did not fall within the interval of all raw data points, we 
determined the mean would be a better estimate of the nutrient level 
for the raw food. As a result of the reassessment of all nutrient 
levels based on 95 percent prediction intervals, we updated the 
nutrient values for 11 of the raw fruits and 9 of the raw vegetables: 
Avocado (iron), banana (sodium, dietary fiber, vitamin A), cantaloupe 
(calcium), honeydew melon (calcium), lemon (dietary fiber), nectarine 
(dietary fiber), orange (vitamin A), pineapple (iron), plums (dietary 
fiber, iron), strawberries (calcium, iron), tangerine (sodium), 
broccoli (total carbohydrate, protein, iron), carrot (iron), celery 
(dietary fiber), cucumber (calories, total carbohydrate, protein), 
green onion (iron), mushrooms (sodium), onion (potassium, calcium), 
radishes (potassium), and tomato (sodium). These changes are listed 
among changes to nutrition labeling values in table 1 of this document.
4. Summary of Changes for Fruits and Vegetables
    Table 1 of this document shows a summary of the changes from the 
nutrition labeling values for 25 raw fruits and vegetables for this 
final rule versus those published in the 2005 reopening of the comment 
period.

L. Nutrition Labeling of Raw Fish

    For the 2002 proposed rule, we obtained new data from USDA NNDB for 
cooked Atlantic salmon and rainbow trout and for the following raw 
fish: Catfish (only on fat content), flounder/sole, orange roughy, coho 
and sockeye salmon, shrimp, swordfish, tilapia, and tuna. We also 
obtained new information on the cooking yield for mollusks, discovered 
a slight error in the raw weight used to calculate the nutrient values 
for finfish and crustaceans, and obtained new data on nutrient 
retention factors. Therefore, in addition to updating the nutrient 
values based on new data, we reanalyzed the data from USDA NNDB for the 
remaining fish and adjusted the nutrient values accordingly (Ref. 20).
Chinook Salmon
    (Comment 27) As indicated in section II.J.2 of this document, two 
comments recommended that FDA include Chinook salmon along with 
Atlantic, coho, and sockeye salmon and use USDA nutrient data to 
support nutrition labeling.
    (Response) We obtained data for Chinook salmon (raw) from the USDA 
NNDB and added those data to the USDA NNDB data we already had for 
Atlantic salmon (cooked, farmed); coho salmon (raw, farmed); sockeye 
salmon (raw). We subjected the data to FDA compliance calculations 
where possible using 95 percent prediction intervals and used the data 
in deriving the nutrition labeling values for these fish (Ref. 20).
    There were no changes in nutrition labeling values for fish in this 
final rule as compared with those in the 2005 reopening of the comment 
period. Appendix D to part 101 contains a comprehensive listing of all 
raw fish and all nutrients in the voluntary nutrition labeling program.

M. Effective Date

    (Comment 28) One comment opposed the proposed changes because they 
will result in unnecessary reprinting costs to industry and those 
producing nutrition education materials.
    (Response) FDA periodically establishes, by final rule in the 
Federal Register, uniform effective dates for compliance with food 
labeling regulations (see, e.g., the Federal Register of December 23, 
1998 (63 FR 71015)). This final rule will become effective in 
accordance with the uniform effective date for compliance with food 
labeling requirements, which is January 1, 2008. However, we will not 
object to voluntary compliance immediately upon publication of the 
final rule. We

[[Page 42041]]

believe that the effective date should allow industry and nutrition 
educators adequate time to update nutrition labeling information.

III. Final Regulatory Impact Analysis

    FDA has examined the impacts of the final rule under Executive 
Order 12866. 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). 
The agency believes that this final rule is not a significant 
regulatory action under the Executive order.
    Option 1 of this document is for no new regulatory action, and 
provides the baseline with which all other options are compared. Option 
2 of this document is for the provision of updated nutrition 
information based on the current data and methodology for computation.
Option 1: No New Regulatory Action
    There would be no costs or benefits if no new regulatory action 
were taken to update the nutrition information for the 20 most 
frequently consumed raw fruits, vegetables, and fish.
Option 2: Costs of Updated Guidelines
    We anticipate, as a result of these guidelines, that some firms 
will expend resources to redesign signs near produce items at retail 
outlets. These expenditures will be voluntary, and we assume that no 
firms will make them if they do not judge that it is in their best 
interests to do so. These are considered in this analysis in order to 
quantify the extent to which nutrition updates likely influence 
resource expenditures.
    While there were no comments on the estimate costs in the proposed 
guidelines, we used 2003 County Business Pattern (CBP) data (Ref. 21) 
collected by the U.S. Census Bureau to update estimates of the number 
of firms that will voluntarily change signs because of these 
guidelines. There are approximately 67,000 supermarkets under the North 
American Industry Classification System (NAICS) code 44511, 
approximately 2,000 fish and seafood markets under NAICS 44522, 
approximately 3,000 fruits and vegetables markets under NAICS 44523, 
and approximately 15,000 other specialty markets under NAICS 44529. We 
assume that many of the markets in NAICS codes 44522, 44523, and 44529 
have annual sales of less than $500,000 and therefore have been 
exempted by Congress from coverage by these guidelines. We use the 
number of supermarkets in NAICS 44511 as a low estimate of the number 
of establishments under consideration, and all establishments in NAICS 
codes 44522, 44523, and 44529 as well as 44511 as an upper bound. Based 
on the most recent survey of adoption of our guidelines, we assume that 
72 percent of establishments (between 48,000 and 63,000 establishments) 
will continue to choose to follow these guidelines.
    We estimated the total voluntary expenditures using the revised 
number of establishments, and the assumptions of expenditure per 
establishment. Consistent with the methodology used in the 2002 
proposed rule, we assume a normal cycle for retailers to redesign their 
labels to be once every 3 years, and that one-half of the 48,000 to 
68,000 stores would redesign after the third year following publication 
of these guidelines. The updating cost expenditures for a partial 
redesign, incurred in the first and second years, are assumed to be $50 
per store, and the updating costs of a full redesign, incurred in the 
third year, are assumed to be $100 per store. Table 2 of this document 
shows these assumptions and estimates. We compute the present value of 
total expenditures for each year using both a 7 percent and 3 percent 
discount rate. The present value of the total of voluntary expenditures 
is between $3,257,000 for the low estimate assuming a 7 percent 
discount rate, and $4,593,000 for the high assuming a 3 percent 
discount rate (i.e., the sum of the present values of the expenditures 
in rows (e) and (f) of table 2 of this document for 2006, 2007, and 
2008).

                                                 Table 2.--Adoption Schedule and Voluntary Expenditures
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Adoption Schedule and Voluntary Expenditures
--------------------------------------------------------------------------------------------------------------------------------------------------------
              (a) Adoption Year                              2006                                2007                                2008
--------------------------------------------------------------------------------------------------------------------------------------------------------
(b) Number of Stores                                            12,000 to 16,000                    12,000 to 16,000                    24,000 to 32,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
(c) Expenditures per Store                                                   $50                                 $50                                $100
--------------------------------------------------------------------------------------------------------------------------------------------------------
(d) Total Expenditures                                      $600,000 to $800,000                $600,000 to $800,000            $2,400,000 to $3,200,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
(e) Present Value (assuming a 7% discount                   $600,000 to $800,000                $561,000 to $736,000            $2,096,000 to $2,800,000
 rate)
(f) Present Value (assuming a 3% discount                   $600,000 to $800,000                $582,000 to $761,000            $2,262,000 to $2,970,000
 rate)
--------------------------------------------------------------------------------------------------------------------------------------------------------

Option 2: Benefits of the Updated Guidelines
    The benefits from updating nutrition information on the 20 most 
frequently consumed raw fruits, vegetables, and fish derive from 
maintaining the accuracy of the information over the long term, and 
giving consumers current information to use in making healthful dietary 
choices. The larger the difference between the updated information and 
the current information, the more likely that consumption behavior will 
change if consumers are aware of the changes made in this final rule. A 
greater change in behavior is likely to provide greater potential for 
improved dietary choices.
    The potential for this particular update to improve dietary choices 
is likely to be small since modest changes in the nutrient profile of a 
food are likely to have a small influence on the demand for that food. 
Table 3 of this document summarizes the extent of changes in foods and 
the nutrient profiles in the proposed and final rules.

[[Page 42042]]



                                             Table 3.--Changes to Guidelines in Proposed Rule and Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Changes to Guidelines in Proposed Rule\1\           Changes to Guidelines in Final Rule\2\
                                                    ----------------------------------------------------------------------------------------------------
                                                         Fruits and Vegetables                 Fish                       Fruits and Vegetables
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of foods with changes                                                      21                            21                                       20
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of nutrients with changes                                                  40                           107                                       38
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\Computed from values in tables 1 and 2 of the 2002 proposed rule.
\2\Computed from the values in this final rule.

    The substantial changes made in this final rule to the current 
nutrition information indicate the importance of updates in nutrition 
information. We proposed changes for approximately one-half of all of 
the most frequently consumed varieties of fruits, vegetables, and fish, 
with an average number of revisions to nutrient information per food 
item of approximately two for fruits and vegetables (i.e., 40 nutrients 
/ 21 whole food items) and approximately five for fish (i.e., 107 
nutrients / 21 whole food items). The guidelines in this final rule 
contain additional revisions for one-half of all of the most frequently 
consumed fruits and vegetables, with an average of approximately 2 
revised nutrients per revised food item (i.e., 38 nutrients / 20 whole 
food items).
    Consumers may use this updated information in making their dietary 
choices. If they use it, the updated information will allow them to be 
more effective at achieving the results that they intend than if they 
were using outdated information. We are not able to quantify the 
benefit that having this updated information will provide.
    Because only substantial compliance with these guidelines is 
mandated by the statute, aggregate costs may be less than would occur 
if they were mandatory for all establishments. Moreover, confusion on 
the part of consumers may arise during the transition period as retail 
stores adopt these guidelines at different times. Confusion may arise, 
for example, if one store displayed an updated set of nutrient values 
while another store displayed an out-dated set of nutrient values for 
otherwise identical raw fruits, vegetables, or fish. Any such confusion 
will reduce the benefit of updating the values in these guidelines.
    As discussed previously in this document, the unquantified benefits 
of providing accurate information for consumers to use in making their 
dietary choices are believed to outweigh the costs associated with this 
rule.

IV. Final Regulatory Flexibility Analysis

    FDA has examined the impacts of the final rule under the Regulatory 
Flexibility Act (5 U.S.C. 601-612). The Regulatory Flexibility Act 
requires agencies to analyze regulatory options that would minimize any 
significant impact of a rule on small entities. Although many of the 
estimated 48,000 to 63,000 stores that may choose to update their 
nutrition displays are small entities, because these guidelines are 
voluntary, no small entity would be required to display the information 
set forth here. Consequently, the agency certifies that the final rule 
will not have a significant economic impact on a substantial number of 
small entities.

V. Unfunded Mandates

    FDA has examined the impacts of the final rule under the Unfunded 
Mandates Reform Act of 1995 (Public Law 104-4). Section 202(a) of the 
Unfunded Mandates Reform Act of 1995 requires that agencies prepare a 
written statement, which includes an assessment of anticipated costs 
and benefits, that includes any ``Federal mandate that may result in 
the expenditure by State, local, and tribal governments, in the 
aggregate, or by the private sector, of $100,000,000 or more (adjusted 
annually for inflation) in any one year.'' The current threshold after 
adjustment for inflation is $115 million, using the most current (2003) 
Implicit Price Deflator for the Gross Domestic Product. FDA does not 
expect this final rule to result in any 1-year expenditure that would 
meet or exceed this amount.

VI. Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA)

    SBREFA (Public Law 104-121) defines a major rule for the purpose of 
congressional review as having caused or being likely to cause one or 
more of the following: An annual effect on the economy of $100 million 
or more; a major increase in costs or prices; significant adverse 
effects on competition, employment, productivity, or innovation; or 
significant adverse effects on the ability of U.S.-based enterprises to 
compete with foreign-based enterprises in domestic or export markets. 
In accordance with SBREFA, OMB has determined that this final rule is 
not a major rule for the purpose of congressional review.

VII. Paperwork Reduction Act of 1995

    FDA concludes that this final rule contains no collection of 
information. Therefore clearance by OMB under the Paperwork Reduction 
Act of 1995 is not required.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(k) 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.

IX. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
will have a preemptive effect on State law. Section 4(a) of the 
Executive order requires agencies to ``construe * * * a Federal statute 
to preempt State law only where the statute contains an express 
preemption provision or there is some other clear evidence that the 
Congress intended preemption of State law, or where the exercise of 
State authority conflicts with the exercise of Federal authority under 
the Federal statute.'' Section 403A of the act (21 U.S.C. 343-1) is an 
express preemption provision. Section 403A(a)(4) of the act provides 
that ``no State or political subdivision of a State may directly or 
indirectly establish under any authority or continue in effect as to 
any food in interstate commerce-- * * * (4) any requirement for the 
voluntary nutrition labeling of food that is not identical to the 
requirement of section 403(q).''
    Currently, this provision operates to preempt States from imposing 
nutrition labeling requirements for raw fruits, vegetables, and fish 
because no such requirement had been imposed by FDA

[[Page 42043]]

under section 403(q) of the act. This final rule amends existing food 
labeling regulations by updating the names and the nutrition labeling 
values for the 20 most frequently consumed raw fruits, vegetables, and 
fish in the United States and by revising the guidelines for further 
clarity and consistency. Although this rule would have a preemptive 
effect, in that it would preclude States from issuing any nutrition 
labeling requirements for raw fruits, vegetables, and fish that are not 
identical to those required by this final rule, this preemptive effect 
is consistent with what Congress set forth in section 403A of the act. 
Section 403A(a)(5) of the act displaces both State legislative 
requirements and State common law duties.
    FDA believes that the preemptive effect of the final rule would be 
consistent with Executive Order 13132. Section 4(e) of the Executive 
Order provides that ``when an agency proposes to act through 
adjudication or rulemaking to preempt State law, the agency shall 
provide all affected State and local officials notice and an 
opportunity for appropriate participation in the proceedings.'' FDA 
provided the States with an opportunity for appropriate participation 
in this rulemaking when it sought input from all stakeholders through 
publication of the proposed rule in the Federal Register of March 20, 
2002 (67 FR 12918), and the reopening of the comment period on April 4, 
2005 (70 FR 16995). FDA received no comments from any States on the 
proposed rulemaking.
    In addition, on May 16, 2006, FDA's Division of Federal and State 
Relations provided notice via fax and e-mail transmission to State 
health commissioners, State agriculture commissioners, food program 
directors, and drug program directors as well as FDA field personnel of 
FDA's intended final rule to update the guidelines for the voluntary 
nutrition labeling of raw fruits, vegetables, and fish. The notice 
provided the States with further opportunity for input on the rule. It 
advised the States of the publication of the final rule and encouraged 
State and local governments to review the notice and to provide any 
comments to the docket (Docket No. 2001N-0548) by June 28, 2006, or to 
contact certain named individuals. FDA received no comments in response 
to this notice. The notice has been filed in the above numbered docket.
    In conclusion, the agency believes that it has complied with all of 
the applicable requirements under the Executive order and has 
determined that the preemptive effects of this rule are consistent with 
Executive Order 13132.

X. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852 and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but we are not responsible 
for subsequent changes to the Web sites after this document publishes 
in the Federal Register.)
    1. U.S. Department of Agriculture, Agricultural Research 
Service, USDA Nutrient Database for Standard Reference, Release 18, 
2005. Available on the Internet at USDA's Nutrient Data Laboratory 
Home Page, http://www.ars.usda.gov/main/site_
main.htm?modecode=12354500.
    2. U.S. Department of Agriculture, National Nutrient Data Bank, 
maintained at the Nutrient Data Laboratory, Agricultural Research 
Service, Beltsville Human Nutrition Research Center, Beltsville, MD.
    3. Bender, M. M., J. I. Rader, and F. D. McClure, ``Guidance for 
Industry, FDA Nutrition Labeling Manual--A Guide for Developing and 
Using Databases,'' Center for Food Safety and Applied Nutrition, 
FDA, 1998. Available on the Internet at http://vm.cfsan.fda.gov/dms/
nutrguid.html.
    4. U.S. Department of Health and Human Services and U.S. 
Department of Agriculture, Dietary Guidelines for Americans, 2005, 
6th ed. Washington DC: U.S. Government Printing Office, January, 
2005. Available on the Internet at http://www.healthierus.gov/
dietaryguidelines/.
    5. Retail Diagnostics, Inc., Food and Drug Administration 
Nutrition Labeling Information Study December 1996, Oradell, NJ, 
March 10, 1997.
    6. Brandt, M. M. ``Documentation for the Nutrition Labeling 
Values for the 20 Most Frequently Consumed Raw Fruits, Vegetables, 
and Fish,'' Center for Food Safety and Applied Nutrition, FDA, 
January 2006.
    7. O'Neill, K. R., ``Statistical Derivation of Nutrition Label 
for Raw Apples from 2001-2002 United States Department of 
Agriculture (USDA) Agricultural Research Service (ARS) Nutrient Data 
Laboratory (NDL) Data and U.S. Apple Association Data for Raw Red 
Delicious, Golden Delicious, Granny Smith, Gala, and Fuji Apples by 
Weighting by Market Share,'' Center for Food Safety and Applied 
Nutrition, FDA, 2006.
    8. O'Neill, K. R., ``Statistical Derivation of Raw Avocado 
Nutrition Label for Appendix C to Part 101: Nutrition Facts for Raw 
Fruits and Vegetables,'' Center for Food Safety and Applied 
Nutrition, FDA, 2005.
    9. O'Neill, K. R., ``Statistical Derivation of Nutrition Labels 
for Raw Banana, Raw Cantaloupe, Raw Sweet Cherries, Raw Honeydew 
Melon, and Raw Watermelon from 2001-2002 United States Department of 
Agriculture (USDA) Agricultural Research Service (ARS) Nutrient Data 
Laboratory (NDL) Data under the Assumption of Simple Random Sample 
(SRS),'' Center for Food Safety and Applied Nutrition, FDA, 2005.
    10. O'Neill, K. R., ``Statistical Derivation of Nutrition Label 
for Raw Kiwifruit from 2001-2002 United States Department of 
Agriculture (USDA) Agricultural Research Service (ARS) Nutrient Data 
Laboratory (NDL) and 2005 Food Research Institute, Inc. (FRI) Data 
Weighted by Variability,'' Center for Food Safety and Applied 
Nutrition, FDA, 2005.
    11. O'Neill, K. R., ``Statistical Derivation of Nutrition Label 
for Raw Pears from 2001-2002 United States Department of Agriculture 
(USDA) Agricultural Research Service (ARS) Nutrient Data Laboratory 
(NDL) Data for Raw Bartlett, Bosc, Red Anjou, and Green Anjou Pears 
by Weighting by Market Share,'' Center for Food Safety and Applied 
Nutrition, FDA, 2005.
    12. O'Neill, K. R., ``Statistical Derivation of Nutrition Label 
for Raw Strawberries from 2001-2002 United States Department of 
Agriculture (USDA) Agricultural Research Service (ARS) Nutrient Data 
Laboratory (NDL) and 1999-2000 California Strawberry Commission 
(CSC) Data Weighted by Variability,'' Center for Food Safety and 
Applied Nutrition, FDA, 2005.
    13. O'Neill, K. R., ``Statistical Derivation of Nutrition Label 
for Raw Potatoes from 2001-2002 United States Department of 
Agriculture (USDA) Agricultural Research Service (ARS) Nutrient Data 
Laboratory (NDL) Data for Raw Russet, White, and Red Potatoes by 
Weighting by Market Share,'' Center for Food Safety and Applied 
Nutrition, FDA, 2005.
    14. O'Neill, K. R., ``Statistical Derivation of Nutrition Labels 
for Raw Broccoli, Raw Carrots, Raw Celery, Raw Cucumber, Raw Green 
Pepper, Raw Iceberg Lettuce, Raw White Mushrooms, Raw Yellow Onions, 
Raw Radishes, Raw Sweet Potatoes, and Raw Tomatoes Derived from 
2001-2002 United States Department of Agriculture (USDA) 
Agricultural Research Service (ARS) Nutrient Data Laboratory (NDL) 
Data under the Assumption of Simple Random Sample (SRS),'' Center 
for Food Safety and Applied Nutrition, FDA, 2005.
    15. O'Neill, K. R., ``Statistical Derivation of Nutrition Label 
for Raw Yellow Nectarines, Raw Yellow Peaches, and Raw Plums from 
2001-2002 United States Department of Agriculture (USDA) 
Agricultural Research Service (ARS) Nutrient Data Laboratory (NDL) 
Data and 1999-2000 California Tree Fruit Agreement (CTFA) Data 
Weighted by Variability,'' Center for Food Safety and Applied 
Nutrition, FDA, 2005.
    16. O'Neill, K. R., ``Statistical Derivation of Nutrition Label 
for Raw Pineapples from 2001-2002 United States Department of 
Agriculture (USDA) Agricultural Research Service (ARS) Nutrient Data 
Laboratory (NDL) Data by Weighting by Market Share,'' Center for 
Food Safety and Applied Nutrition, FDA, 2005.
    17. O'Neill, K. R., ``Statistical Derivation of Nutrition Label 
for Raw Leaf Lettuce from 2001-2002 United States Department of 
Agriculture (USDA) Agricultural Research Service (ARS) Nutrient Data 
Laboratory (NDL) Data for Raw Red and Green Leaf Lettuce Weighted by 
Variability,'' Center for

[[Page 42044]]

Food Safety and Applied Nutrition, FDA, 2005.
    18. O'Neill, K. R., ``Statistical Derivation of Nutrition Label 
for Raw Lemons and Tangerines from 1989-1991 Produce Marketing 
Association (PMA) and 1998 Citrus Research Board (CRB) Data under 
the Assumption of Simple Random Sample (SRS),'' Center for Food 
Safety and Applied Nutrition, FDA, 2005.
    19. O'Neill, K. R., ``Statistical Derivation of Nutrition Label 
for Raw Red Grapefruit and Naval and Valencia Oranges from 2001-2002 
United States Department of Agriculture (USDA) and 1998 Citrus 
Research Board (CRB) Data under the Assumption of Simple Random 
Sample (SRS),'' Center for Food Safety and Applied Nutrition, FDA, 
2005.
    20. O'Neill, K. R., ``Statistical Derivation of Nutrition 
Labeling from USDA Data for Appendix D to Part 101: Nutrition Facts 
for Cooked Seafood,'' Center for Food Safety and Applied Nutrition, 
FDA, 2005.
    21. U.S. Census Bureau, 2002 Economic Census, American 
FactFinder, Geographic Area Series: Summary Statistics. Available on 
the Internet at http://factfinder.census.gov/home/saff/main.html?--
lang=en.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, FDA proposes 
to amend 21 CFR part 101 as follows:

PART 101--FOOD LABELING

0
1. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371; 42 U.S.C. 243, 264, 271.

0
2. Section 101.44 is revised to read as follows:


Sec.  101.44  What are the 20 most frequently consumed raw fruits, 
vegetables, and fish in the United States?

    (a) The 20 most frequently consumed raw fruits are: Apple, avocado 
(California), banana, cantaloupe, grapefruit, grapes, honeydew melon, 
kiwifruit, lemon, lime, nectarine, orange, peach, pear, pineapple, 
plums, strawberries, sweet cherries, tangerine, and watermelon.
    (b) The 20 most frequently consumed raw vegetables are: Asparagus, 
bell pepper, broccoli, carrot, cauliflower, celery, cucumber, green 
(snap) beans, green cabbage, green onion, iceberg lettuce, leaf 
lettuce, mushrooms, onion, potato, radishes, summer squash, sweet corn, 
sweet potato, and tomato.
    (c) The 20 most frequently consumed raw fish are: Blue crab, 
catfish, clams, cod, flounder/sole, haddock, halibut, lobster, ocean 
perch, orange roughy, oysters, pollock, rainbow trout, rockfish, salmon 
(Atlantic/coho/Chinook/sockeye, chum/pink), scallops, shrimp, 
swordfish, tilapia, and tuna.

0
3. Amend Sec.  101.45 by revising paragraph (a)(3)(iii) and adding 
paragraph (a)(3)(iv) to read as follows:


Sec.  101.45  What are the guidelines for the voluntary nutrition 
labeling of raw fruits, vegetables, and fish?

    (a) * * *
    (3) * * *
    (iii) When retailers provide nutrition labeling information for 
more than one raw fruit or vegetable on signs or posters or in 
brochures, notebooks, or leaflets, the listings for saturated fat, 
trans fat, and cholesterol may be omitted from the charts or individual 
nutrition labels if a footnote states that most fruits and vegetables 
provide negligible amounts of these nutrients, but that avocados 
contain 0.5 gram (g) of saturated fat per ounce (e.g., ``Most fruits 
and vegetables provide negligible amounts of saturated fat, trans fat, 
and cholesterol; avocados provide 0.5 g of saturated fat per ounce''). 
The footnote also may contain information about the polyunsaturated and 
monounsaturated fat content of avocados.
    (iv) When retailers provide nutrition labeling information for more 
than one raw fish on signs or posters or in brochures, notebooks, or 
leaflets, the listings for trans fat, dietary fiber, and sugars may be 
omitted from the charts or individual nutrition labels if the following 
footnote is used, ``Fish provide negligible amounts of trans fat, 
dietary fiber, and sugars.''
* * * * *

0
4. Appendices C and D to part 101 are revised to read as follows:
BILLING CODE 4160-01-S

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[GRAPHIC] [TIFF OMITTED] TR25JY06.009


[[Page 42046]]


[GRAPHIC] [TIFF OMITTED] TR25JY06.010


[[Page 42047]]


[GRAPHIC] [TIFF OMITTED] TR25JY06.011


    Dated: July 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-6436 Filed 7-24-06; 8:45 am]
BILLING CODE 4160-01-C