[Federal Register Volume 67, Number 54 (Wednesday, March 20, 2002)]
[Proposed Rules]
[Pages 12918-12937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-6709]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 01N-0458]
RIN 0910-AA19


Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw 
Fruits, Vegetables, and Fish; Identification of the 20 Most Frequently 
Consumed Raw Fruits, Vegetables, and Fish

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
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. We are taking this 
action because current regulations require the agency to publish 
proposed updates (or a notice that the data sets have not changed from 
the previous publication) at least every 4 years. We also propose to 
revise the guidelines for the voluntary nutrition labeling of raw 
fruits, vegetables, and fish to make necessary changes resulting from 
the updated nutrition information and to provide further clarification 
of the guidelines. Availability of the updated nutrition labeling 
values in retail stores and on individually packaged raw produce and 
fish will enable consumers to make better purchasing decisions to meet 
their dietary needs.

DATES: Submit written or electronic comments on this proposal by June 
3, 2002. See section IX of this document for the proposed effective 
date of a final rule based on this document.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Lori LeGault, Center for Food Safety 
and Applied Nutrition (HFS-840), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-1791, or e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

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), we published final 
regulations in the Federal Register of November 27, 1991 (56 FR 60880) 
(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 us to publish proposed 
updates of the nutrition labeling data for the 20 most frequently 
consumed raw fruits, vegetables, and fish (or a notice that the data 
sets have not changed) at least every 2 years (56 FR 60880 at 60888 and 
60891).
    Next, we published a proposed rule on the voluntary nutrition 
labeling program in the Federal Register of July 18, 1994 (59 FR 36379) 
(the 1994 proposed rule), and a correction in the Federal Register of 
July 21, 1994 (59 FR 37190). The 1994 proposed rule proposed to: (1) 
Update the nutrition labeling values for the 20 most frequently 
consumed raw fruits, vegetables, and fish in the United States; and (2) 
revise the guidelines for the voluntary nutrition labeling of these 
foods to reflect the 1993 mandatory nutrition labeling final rules.
    Finally, in the Federal Register of August 16, 1996 (61 FR 42742), 
we published a final rule entitled ``Food Labeling; Guidelines for 
Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish; 
Identification of the 20 Most Frequently Consumed; and Policy for Data 
Base Review for Voluntary and Mandatory Nutrition Labeling'' (the 1996 
final rule). In the 1996 final rule, among other actions, we revised: 
(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. We also 
modified the guidelines in Sec. 101.45(b) (21 CFR 101.45(b)), in 
response to comments, to state that we 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).
    We are now proposing to update the listing of the 20 most 
frequently consumed raw fruits, vegetables, and fish and their 
nutrition labeling values based on new data submitted or made available 
to the agency. This will enable consumers to have more accurate and up-
to-date nutrition information for these foods.

II. Guidelines for Presentation of the Nutrition Labeling Values

A. Background and Proposed Revisions

    To provide clarity and consistency in the voluntary nutrition 
labeling of raw fruits, vegetables, and fish, we propose to: (1) Divide 
current Sec. 101.45(a)(3)(iii) into two parts (i.e., into 
Secs. 101.45(a)(3)(iii) and 101.45(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. In 
Sec. 101.45(a)(3)(iii), we also propose to change the portion of the 
footnote about the saturated fat content of avocados from ``* * * 
avocados provide 1 gram (g) of saturated fat per ounce (oz)'' to ``* * 
* avocados provide 0.5 g of saturated fat per oz.'' This decrease in 
saturated fat content is based on the most recent

[[Page 12919]]

nutrient data provided by the California Avocado Commission (Ref. 1), 
which is discussed in section IV.B.1 of this document.
    In the 1996 final rule, we modified the language in 
Sec. 101.45(a)(3)(iii) for raw fruits and vegetables but, 
inadvertently, failed to do the same for raw fish. In order to provide 
parallel provisions for raw fish, we are now proposing: (1) To remove 
that portion of Sec.  101.45(a)(3)(iii) which currently states ``* * * 
When the nutrition labeling information for raw fish is provided on a 
chart, the listings for dietary fiber and sugars may be omitted if the 
following footnote is used `Fish provide negligible amounts of dietary 
fiber and sugars''' and (2) to add new 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 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 dietary fiber and 
sugars'.''
    Currently, appendices C and D to part 101 (21 CFR part 101) provide 
the nutrition labeling values in a chart format with horizontal and 
vertical columns. Due to space constraints, we are presenting the 
nutrition labeling values in a chart format (proposed appendices C and 
D); however, we encourage retailers to display quantitative nutrition 
information for raw produce and raw fish as a compilation of nutrition 
labels in the Nutrition Facts format, with allowance for the shortened 
footnote shown in figure 1 at the bottom of the sign, poster, brochure, 
notebook, or leaflet. We are continuing to include the optional 
nutrient, potassium, in proposed appendices C and D because many raw 
fruits, vegetables, and fish are good sources of this nutrient. The 
nutrition label for raw apple shown in figure 1 displays the preferred 
format. However, as Sec. 101.45(a)(4) indicates, when nutrition 
labeling is provided for individual raw fruits, vegetables, or fish on 
packages or in brochures, notebooks, or leaflets (i.e., other than on 
signs and posters), the full footnote required in Sec. 101.9(d)(9) 
should be presented within the Nutrition Facts box.
BILLING CODE 4160-01-S

[GRAPHIC] [TIFF OMITTED] TP20MR02.008

B. Impact of the Trans Fatty Acids Proposed Rule

    FDA has issued a proposed rule for trans fatty acids (also called 
``trans fat'') in nutrition labeling (64 FR 62746, November 17, 1999) 
which, if finalized, will apply to the voluntary nutrition labeling 
program as well. Trans fatty acids are unsaturated fatty acids that 
have hydrogen atoms attached on opposite sides of a double bond 
(``trans'' means ``across'' in Latin). This

[[Page 12920]]

configuration is primarily the result of the hydrogenation process used 
to harden oils, although trans fatty acids are found naturally in some 
animal products. Thus, trans fatty acids would not be expected to be 
present in raw produce. Accordingly, if the November 17, 1999, proposed 
rule is finalized to require mandatory labeling of trans fat, the 
agency tentatively concludes that the footnote required in proposed 
Sec. 101.45(a)(3)(iii) for raw fruits and vegetables should be revised 
to state: ``Most fruits and vegetables provide negligible amounts of 
saturated fat, trans fat, and cholesterol; avocados provide 0.5 g of 
saturated fat per oz.'' We invite 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).

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

A. Fruits and Vegetables

    FDA is not proposing any changes in the list of the 20 most 
frequently consumed raw fruits and vegetables in Sec. 101.44 because we 
are not aware of any new information suggesting that the listing be 
modified. Nevertheless, for ease of use and to be consistent with the 
food names in appendix C to part 101, we are proposing to revise 
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. Thus, we are proposing to revise Sec. 101.44(a) to read 
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.'' We are proposing to revise Sec. 101.44(b) to read 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.''

B. Fish

    FDA is proposing to make three changes to the listing of the 20 
most frequently consumed raw fish. In the previous voluntary nutrition 
labeling rules, we used information provided by the National Fisheries 
Institute (NFI) to identify the most frequently consumed species of 
fish in the United States (59 FR 36379 at 36384 and 61 FR 42742 at 
42743). However, we have obtained more recent information from various 
industry and government sources indicating that mackerel is sold in the 
United States primarily as bait and catfood rather than as fresh fish 
for human consumption (Ref. 2). Furthermore, NFI has reported to us 
that the consumption of fresh tuna and tilapia in the United States has 
surpassed the consumption of mackerel and whiting (Refs. 3 and 4). 
Thus, we are proposing to remove mackerel and whiting from the listing 
of the 20 most frequently consumed raw fish and to add tuna and tilapia 
to the list.
    Next, we are proposing to collapse the three subspecies of salmon 
into two subspecies based on similar nutrient profiles (Refs. 5 and 7). 
In current appendix D to part 101, salmon is divided into three 
subspecies: Atlantic/coho, chum/pink, and sockeye. This was due 
primarily to differences in total fat content (i.e., 6 to 7 grams (g) 
of fat in Atlantic and coho, 4 g of fat in chum and pink, and 9 g of 
fat in sockeye) (59 FR 36379 at 36383). For this proposed rule, 
however, we have used updated data from the U.S. Department of 
Agriculture (USDA), National Nutrient Data Bank (NNDB) (Ref. 6), which 
is described in section IV.A.2 of this document, and determined that 
the nutrient profiles for Atlantic, coho, and sockeye salmon are very 
similar. Specifically, the data show a total fat content of 10 g for 
Atlantic and sockeye salmon and 9 g for coho salmon. Therefore, we are 
proposing to combine Atlantic, coho, and sockeye into one subgroup of 
salmon. Because the data show that chum and pink salmon maintain 
similar nutrient profiles, we are proposing to keep chum/pink as a 
second subgroup of salmon.
    We are proposing to revise Sec. 101.44(c) based on the changes 
discussed above and by listing the fish in alphabetical order to read 
as follows: ``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/sockeye, chum/pink), scallops, shrimp, swordfish, 
tilapia, and tuna.''

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

    We are proposing to revise the nutrition labeling values for the 20 
most frequently consumed raw fruits, vegetables, and fish (proposed 
appendices C and D to part 101) to reflect newer or additional data for 
these foods that have been submitted or made available to the agency. 
FDA has considered whether this updated nutrition labeling information, 
as proposed, could be used on an interim basis prior to completion of 
the rulemaking. Because the agency believes that the proposed nutrition 
labeling values would not be misleading, we do not object to firms 
using these values prior to issuance of a final rule, provided that the 
nutrition information is presented in a manner consistent with this 
proposal. However, firms should be aware that a final rule on this 
issue may differ from this proposed rule.
    Reference 7 provides complete documentation of the derivation of 
each nutrition labeling value for the fruits, vegetables, and fish 
covered in this proposal. The following sections (IV.A through IV.C) 
explain the specific proposed updates.

A. FDA Analysis of the Data

    FDA considered the data from all of the sources identified in 
sections IV.B and IV.C of this document and used these data as the 
basis for deriving the proposed nutrition labeling values. To the 
extent possible (i.e., for those nutrients where sufficient data were 
available), we used the statistical methodology recommended in the 
``FDA Nutrition Labeling Manual--A Guide for Developing and Using Data 
Bases'' (Ref. 8) to produce the nutrition labeling values. The 
recommended statistical method uses compliance calculations that take 
into account the variation of nutrients in foods. The nutrient content 
of foods varies according to inherent, environmental, and processing 
factors, and some nutrients are more variable than others. The FDA 
compliance calculations are based on one-sided 95 percent prediction 
intervals. Thus, the resulting nutrient values are less likely than 
mean values to overestimate class II nutrients (naturally occurring 
vitamins, minerals, protein, total carbohydrate, dietary fiber, 
unsaturated fat, and potassium) (Sec. 101.9(g)(4)(ii)), or to 
underestimate third group nutrients (calories, sugars, total fat, 
saturated fat, cholesterol, and sodium) (Sec. 101.9(g)(5)). In other 
words, the calculated values provide with 95 percent probability that 
the levels of class II nutrients will be at least 80 percent of the 
label value and that the levels of third group nutrients will not be 
more than 120 percent of the label value, as required by the compliance 
criteria in Sec. 101.9(g)(4)(ii) and (g)(5).
    Nevertheless, we frequently found in our analyses of the data that 
the mean

[[Page 12921]]

nutrient value and the value derived from compliance calculations 
rounded to the same nutrition labeling value. We also found, however, 
that when the sample size was small (e.g., three or fewer analytical 
data points), the values derived from compliance calculations sometimes 
resulted in a minimal amount or a complete absence of a nutrient in the 
food. In these cases, the mean value is more likely to represent the 
nutrient level. Thus, when it was more appropriate, we propose to use 
the mean nutrient value rather than the value derived by applying 95 
percent prediction intervals, which is noted in the documentation (Ref. 
7).
1. Nutrients Not Present in Particular Foods
    No analytical data were available for some nutrients due to several 
well-known principles of food composition. As stated in the 1996 final 
rule (61 FR 42742 at 42756) and in the 1993 mandatory nutrition 
labeling final rules (58 FR 2079 at 2109, January 6, 1993), analysis is 
not needed for nutrients where reliable databases or scientific 
knowledge establish that a nutrient is not present in the product. 
Thus, for this proposal, as in the previous voluntary nutrition 
labeling rules (59 FR 36379 at 36383), we have assumed a zero value for 
the following nutrients: (1) Cholesterol in fruits and vegetables 
because cholesterol is found only in animal tissues, (2) saturated fat 
in all fruits and vegetables that have a zero total fat content because 
saturated fat is a component included in total fat, (3) dietary fiber 
in fish because dietary fiber is found only in plant materials, and (4) 
sugars in fish because sugars are not found (or are very low) in fish.
2. Data From USDA
    When using USDA data to update the nutrition labeling values for 
this proposal, we obtained data directly from the NNDB, where possible 
(Ref. 6). The NNDB provides raw data that include a collection of 
statistical parameters representing either a single measurement or 
multiple measurements for nutrients in foods. USDA has compiled these 
data from various sources (e.g., government, academic, industry, and 
private laboratories). From these data, we can identify the number of 
samples, mean nutrient values, and estimates of variance that are 
necessary to complete compliance calculations in deriving the nutrition 
labeling values.
    However, every food item in the NNDB does not always have a 
complete nutrient profile. When the NNDB did not have adequate data for 
nutrients needed for updating the nutrition labeling values, we used 
the values in the USDA Nutrient Database for Standard Reference (SR) 
(Ref. 9). The SR provides aggregated mean values for nutrients, which 
are primarily derived from data in the NNDB. For some foods, the SR 
presents a mean value for a nutrient, but the sample size is zero. In 
these cases, USDA has imputed the nutrient value from other sources, 
such as, from data for foods with a similar nutrient profile. For fish, 
when we were not able to obtain new or adequate data for a specific 
nutrient (e.g., vitamin A and vitamin C), either on the cooked or raw 
basis, we used the value from the SR for the appropriate cooked fish. 
The SR includes all the food composition data published in the 21 
volumes of Agriculture Handbook No. 8 (USDA, 1976-1988) and its 4 
supplements (USDA, 1990-1993). Since 1992, USDA has been publishing 
updated SR data electronically, which became accessible on the Internet 
for searching or downloading in 1996. However, the printed Agriculture 
Handbook No. 8 sections provide more extensive details on specific 
foods. For example, we have used information on the cooking procedure 
and yields of cooked fish contained in the 1991 supplement to 
Agriculture Handbook No. 8-15, ``Composition of Foods: Finfish and 
Shellfish Products; Raw, Processed, Prepared'' (Ref. 10), which is 
discussed in section IV.C.1 of this document.
3. Outlier Screening
    For this proposed rule, we have completed outlier screening of the 
data using the Grubb's outlier screening method (Ref. 11). Outliers are 
unusually extreme data points in a distribution of data that are much 
lower or higher than the majority of the other data points. They are 
called ``influential observations'' because an outlier or outliers in a 
data set will skew the distribution of data so that the mean will be 
lower (with low outlier values) or higher (with high outlier values) 
than it would be for the majority of the data. In addition, the range 
(as a measure of distance) may give a very distorted picture of the 
variability of the data if outliers are included. Although some 
outlying observations may be legitimate values that are extreme, an 
outlier may be the result of imprecise measurement or an error in data 
entry. In developing our proposed nutrient values, we have taken a 
conservative approach to outliers and deleted those data points 
identified through outlier screening.
4. Calories, Calories From Fat, Sugars, and Total Carbohydrate
    In developing our proposed nutrient values, we calculated calories 
and calories from fat based on the Atwater system for determining 
energy values for individual foods or food groups (i.e., specific 
factors) rather than using the general factors of 4, 4, and 9 calories 
per g for protein, total carbohydrate, and total fat, respectively. The 
Atwater energy factors are outlined in USDA Handbook No. 74, ``Energy 
Value of Foods--Basis and Derivation'' (Ref. 12). These specific 
factors take into account the physiological availability of energy for 
the basic food, and therefore, are more accurate. This is the method 
referred to in Sec. 101.9(c)(1)(i)(A) for calculating the caloric 
content of foods. It is the same method used in the previous voluntary 
nutrition labeling rules (Ref. 5 to the 1996 final rule, 61 FR 42742) 
except that we are correcting a slight error in the food factors used 
for green onion and in the carbohydrate factor used for potato. The 
specific Atwater factors used for calculating calories and calories 
from fat for the fruits, vegetables, and fish in this proposal are as 
follows:

 
                                            Calories per gram
             Food              -----------------------------------------
                                 Protein      Carbohydrate         Fat
------------------------------------------------------------------------
  All fruits (except lemon,        3.36   3.60                     8.37
   lime).
  Lemon, lime.................     3.36   2.48                     8.37
  Mushroom....................     2.62   3.48                     8.37
  Potato, sweet potato........     2.78   4.03                     8.37
  Carrot, onion, radish.......     2.78   3.84                     8.37
  Other vegetables............     2.44   3.57                     8.37
  Finfish.....................     4.27   NA                       9.02
  Shellfish...................     4.27   4.11                     9.02
------------------------------------------------------------------------
(Ref. 12)


[[Page 12922]]

    After publication of the 1996 final rule, industry expressed to us 
that the calorie values for some of the fruits and vegetables appeared 
to be inconsistent with the label values for total fat, total 
carbohydrate, and protein. Upon review, we found slight errors in the 
sugars, total carbohydrate, calories, and calories from fat values in a 
few fruits and vegetables (as explained below) that are reflected in 
current appendix C to part 101.
    First, we derived most of the sugars values for the fruits and 
vegetables in current appendix C to part 101 from the USDA Home 
Economics Research (HER) Report No. 48, ``Sugar Content of Selected 
Foods: Individual and Total Sugars'' (Ref. 13) because no other sugars 
data were available to us. While reviewing the values for this proposed 
update, we discovered an error in the total sugars value for 
cantaloupe, sweet cherries, tangerine, and celery in current appendix C 
to part 101. This error was due to an apparent miscalculation in 
converting the sugars per 100 g of product (as in HER Report No. 48) to 
the sugars per gram weight of the serving size for the product (as in 
current appendix C to part 101). Therefore, based on the corrected 
conversions, we are proposing to change the sugars value for cantaloupe 
from 11 g to 12 g, for sweet cherries from 19 g to 20 g, for tangerine 
from 12 g to 8 g, and for celery from 0 g to 1 g.
    Second, after correcting the sugars value for cantaloupe and sweet 
cherries, we found that the sugars value was high compared with the 
total carbohydrate and dietary fiber values (i.e., the sugars value 
when added to dietary fiber exceeded total carbohydrate). Because 
sugars and dietary fiber are components of total carbohydrate, the 
value for total carbohydrate must be greater than or equal to the sum 
of the values for sugars and dietary fiber. The apparent discrepancies 
are because the values for total carbohydrate and dietary fiber were 
derived from different analytical samples than those used to derive the 
value for sugars. Therefore, we are proposing to adjust the total 
carbohydrate value for cantaloupe (from 12 g to 13 g) and sweet 
cherries (from 22 g to 23 g) to reflect the sum of the values for 
sugars and dietary fiber (Ref. 7). 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))).
    Third, the total carbohydrate value for tangerine, reflected in the 
current regulation, was based on the sum of the values for sugars (12 
g) and dietary fiber (3 g), i.e., the total carbohydrate value was 
adjusted from 13 g (the original value, rounded) to 15 g (the sum of 
the values for sugars and dietary fiber) (Ref. 5 to the 1996 final 
rule, 61 FR 42742). However, because the sugars value for tangerine 
should have been 8 g (as explained previously in this section), the 
total carbohydrate value should not have been adjusted. Thus, we are 
proposing to change the total carbohydrate value for tangerine to the 
original value of 13 g (rounded) based on data submitted to the agency 
in 1992 by the Produce Marketing Association (Ref. 12 to the 1996 final 
rule, 61 FR 42742).
    Fourth, we previously stated the following in the 1996 final rule:

    In order to have calories from fat consistent for a given total 
fat value, FDA derived calories from fat for fruits and vegetables 
from the rounded, rather than unrounded, total fat label value. The 
caloric equivalent for fat is 8.37 calories per g for fruits and 
vegetables. Thus, 0.5 g of fat is equivalent to 4.19 calories, and 
according to Sec. 101.9(c)(1)(ii), ``* * * amounts less than 5 
calories may be expressed as zero.'' As a result, Appendix C 
consistently lists 0 calories for 0.5 g of total fat. (61 FR 42742 
at 42750).

    However, in our current review of the calorie values, we found that 
this action (i.e., calculating calories from the rounded total fat 
label value) conflicts with Sec.  101.9(c)(1)(i), which states,

    * * * Where either specific or general food factors are used, 
the factors shall be applied to the actual amount (i.e., before 
rounding) of food components (e.g., fat, carbohydrate, protein, or 
ingredients with specific food factors) present per serving.

Therefore, in addition to calculating calories on the unrounded basis 
for the foods for which we obtained new data (as described in sections 
IV.B and C of this document), we recalculated calorie values for all 
the remaining foods covered by this proposal based on the unrounded 
values for total fat, total carbohydrate, and protein (Ref. 7). As a 
result of these recalculations, we are proposing changes to the calorie 
or calories from fat values for orange, strawberries, tangerine, 
watermelon, asparagus, green (snap) beans, and tomato as shown in table 
1 in section IV.B.9 of this document.
    Reference 7 contains the complete documentation of the nutrition 
labeling values for each of the fruits, vegetables, and fish covered in 
this proposal. The documentation includes the actual (unrounded) values 
for total fat, total carbohydrate, and protein used to calculate 
calories and calories from fat for each food. For some foods in 
proposed appendices C and D, the label value for total fat may be the 
same quantitative amount, yet the value for calories from fat may 
differ (e.g., for a total fat label value of 0.5 g, the value for 
calories from fat may be 0 or 5). The reason for the discrepancy, as 
explained above in this section, is that we calculated calories from 
fat based on the unrounded amount of total fat, as required by 
Sec. 101.9(c)(1)(i), rather than on the rounded label value for total 
fat.

B. Proposed Updates to the Nutrition Labeling of Raw Fruits and 
Vegetables

1. Avocado
    The nutrition labeling values for avocado provided in the current 
regulations are based on 1989-1990 data from the Produce Marketing 
Association and 1993-1994 data for potassium, protein, and vitamin C 
from the California Avocado Commission (CAC). In proposed appendix C to 
part 101, we have used new data on the composition of avocados that the 
CAC compiled from 1993 to 1997 and submitted to the agency. These data 
are the most current available to the agency and the sampling design is 
the same for each of the 5 years, whereas it differs in the other data 
collections. Thus, we are proposing to update the nutrition labeling 
values for avocado by using the 1993-1997 CAC data, which we have 
subjected to FDA compliance calculations based on 95 percent prediction 
intervals (Ref. 1). Table 1 of this document shows the proposed changes 
in the nutrient values for avocado compared with those in the current 
regulations.
2. Grapefruit
    In the 1994 proposed rule, we declared the serving size for 
grapefruit as ``1/2 medium (154 g/ 5.5 oz)'' (59 FR 36379 at 36391). We 
adopted the same serving size in the 1996 final rule; however, the oz 
equivalent was incorrectly printed as 5.3 oz (61 FR 42742 at 42761). 
Also, current appendix C to part 101 contains this misprint. Thus, we 
are proposing to correct this error and declare the serving size for 
grapefruit as ``1/2 medium (154 g/5.5 oz).''
3. Grapes
    The nutrition labeling values for grapes that we originally 
provided in the 1991 final rule were based on data from the NNDB for 
``American-type'' grapes. However, after publication of the 1991 final 
rule, USDA informed us that the grapes described as ``American-

[[Page 12923]]

type'' include varieties, such as concord, that are not generally 
consumed without processing and that the grapes described as 
``European-type'' are the most common types of raw grapes consumed in 
the United States (59 FR 36379 at 36381). USDA stated further that it 
would be more appropriate for FDA to use data for ``European-type'' 
grapes as the type most frequently consumed. Therefore, in the 1996 
final rule, we derived the nutrition labeling values based on data in 
the NNDB for ``European-type'' grapes, which we had subjected to FDA 
compliance calculations based on 95 percent prediction intervals.
    Then in 1998, industry raised questions about the published serving 
size for raw grapes (i.e., 1 1/2 cups (138 g/4.9 oz)) and the 
corresponding nutrient values. Industry noted that a 138 g serving size 
for European grapes would fall between 3/4 cup and 1 cup, rather than 
equate to 1 1/2 cups. When FDA investigated these inquiries, we found 
that the nutrient data for European grapes were correctly used to 
calculate the nutrition labeling values, but we had inadvertently used 
the weight for American grapes to derive the serving size. According to 
the SR, the density of European grapes is 160 g per cup and the density 
of American grapes is 92 g per cup (Ref. 9). Based on these densities, 
the 1 1/2 cup-serving size is equivalent to 240 g for European grapes 
and 138 g for American grapes. Thus, the current regulatory serving 
size, which is supposed to reflect the weight of European grapes, is 
incorrect.
    In proposed appendix C to part 101, we have used 1998 data on the 
composition of grapes that Fleishman-Hilliard, Inc., submitted to the 
agency on behalf of the California Table Grape Commission (CTGC) 
(Ref.14). Because the CTGC submission provides newer data, the serving 
size that we are proposing for grapes is based on the average g weight 
of the 12 samples in this submission (i.e., 168.2 g per cup), rather 
than on the density of 160 g per cup provided in the SR. Following the 
principles in Sec. 101.9(b)(2)(iii) regarding bulk products, the 
serving size must be the amount in a household measure that most 
closely approximates the reference amount for the appropriate product 
category in Sec. 101.12(b). Grapes fit in the product category ``All 
other fruits (except those listed as separate categories), fresh, 
canned, or frozen'' with a reference amount of 140 g. Based on the data 
for the 12 samples, the average weight of 1 cup is 168.2 g and the 
average weight of 3/4 cup is 126.15 g (Ref. 14). Because 126.15 g (3/4 
cup) is closer than 168.2 g (1 cup) to the 140-g reference amount, we 
are proposing a new serving size of 3/4 cup (126 g/4.5 oz) for grapes. 
We have subjected the CTGC data to FDA compliance calculations based on 
95 percent prediction intervals and used these data in deriving the 
proposed nutrition labeling values (Ref. 14). Table 1 of this document 
shows the proposed changes to the serving size and nutrient values for 
grapes compared with those in the current regulations.
4. Nectarine, Peach, and Plums
    In the 1996 final rule, we derived the nutrition labeling values 
for nectarine, peach, and plums from data in the NNDB, which we had 
subjected to FDA compliance calculations based on 95 percent prediction 
intervals. In proposed appendix C to part 101, we have used 1998 data 
on the composition of nectarines, peaches, and plums that Fleishman-
Hilliard, Inc., submitted to the agency on behalf of the California 
Tree Fruit Agreement (CTFA). The CTFA data were comprised of three 
composite samples for peaches, three composite samples for plums, and 
four composite samples for nectarines. However, each of the composite 
samples represents between 2 and 14 different varieties and a different 
share of the market for that particular fruit. Due to the small number 
of composite samples, the varying number of varieties in each composite 
sample, and the differences in how the samples represent the market, we 
chose to analyze the data for each of the three types of fruit by 
weighting the samples according to their market share and to use the 
resulting mean nutrient values (Ref. 15).
    CTFA also provided information on the edible portion weights of 
peaches and plums that represent the majority of the market (Ref. 16). 
Based on this information, we are proposing to change the serving size 
for peach from ``1 medium (98 g/3.5 oz)'' to ``1 medium (147 g/5.3 
oz)'' and for plums from ``2 medium (132 g/4.7 oz)'' to ``2 medium (151 
g/5.4 oz).'' We are not proposing any change to the serving size for 
nectarine (i.e., ``1 medium (140 g/5.0 oz)'') because the CTFA data 
supported the current serving size.
    Table 1 of this document shows the proposed changes in the nutrient 
values for these fruits and the proposed changes to the serving size 
for peach and plums compared with those in the current regulations.
5. Sweet Cherries
    The nutrition labeling values for sweet cherries provided in the 
current regulations are based on 1990 data from PMA. In proposed 
appendix C to part 101, we have used 1996 data on the fat composition 
of raw sweet cherries that Technical Assessment Systems, Inc. (TAS), 
submitted to the agency on behalf of the California Cherry Advisory 
Board. Based on these newer data, which included 12 analytical samples 
that measured the total fat content of sweet cherries, TAS requested 
that the nutrition labeling value for total fat be changed from 0.5 g 
to 0 g. We reviewed the TAS data, confirmed that the suggested label 
value was derived correctly by using compliance calculations based on 
95 percent prediction intervals, and used the TAS data in determining 
the proposed label value of 0 g for total fat (Ref. 17). We also 
propose to revise the total carbohydrate and sugars values as explained 
in section IV.A.4 of this document. Table 1 shows the proposed changes 
to the nutrient values for sweet cherries compared with those in the 
current regulations.
6. Carrot
    In current appendix C to part 101, the serving size for carrot is 
declared as ``7" long, 1 1/4" diameter (78 g/2.8 oz).'' To be 
consistent with Sec.  101.9(b)(2)(i) for products in discrete units and 
consistent with Sec. 101.9(b)(5)(iv) in describing the individual unit, 
we are proposing to include ``1 carrot'' as part of the serving size 
statement, i.e., ``1 carrot, 7" long, 1 1/4" diameter (78 g/2.8 oz).''
7. Green Onion, Sweet Corn, and Sweet Potato
    In the 1996 final rule, we derived the nutrition labeling values 
for raw green onion, sweet corn, and sweet potato by using the NNDB 
data available at that time. In proposed appendix C to part 101, we 
have used updated nutrient data from the NNDB for these raw vegetables 
to derive the proposed nutrition labeling values using compliance 
calculations based on 95 percent prediction intervals (Ref. 18). Table 
1 of this document shows the proposed changes in the nutrient values 
for green onion, sweet corn, and sweet potato compared with those in 
the current regulations.
    We also are proposing a correction to the serving size for sweet 
potato. In current appendix C to part 101, the serving size for sweet 
potato is declared as ``medium, 5" long, 2" diameter (130 g/4.6 oz).'' 
Consistent with Sec. 101.9(b)(2)(i) for products in discrete units, we 
are proposing to include the number of units in the serving size 
statement for sweet potato (i.e., ``1 medium, 5" long, 2" diameter (130 
g/4.6 oz).'')

[[Page 12924]]

8. Potato
    The nutrition labeling values for potato that we provided in the 
1996 final rule were based on 1983-1984 data from PMA. In proposed 
appendix C to part 101, we have used 2000 market basket data on the 
composition of potatoes that Ketchum submitted to the agency on behalf 
of the National Potato Promotion Board (NPPB). The NPPB nutrient data 
were comprised of three composite samples for each variety of red, 
russet, and white potatoes. However, according to the NPPB, each of 
these potato varieties represents a different proportion of the market 
(i.e., 12 percent for red, 70 percent for russet, and 18 percent for 
white (Ref. 19). Thus, NPPB requested and we agreed that the data 
should be weighted by the market share in deriving the nutrient values. 
After weighting the data, we subjected the values to FDA compliance 
calculations based on 95 percent prediction intervals to determine the 
proposed nutrition labeling values (Ref. 19). Table 1 of the document 
shows the proposed changes in the nutrient values for potato compared 
with those in the current regulations.
9. Summary of Proposed Changes for Fruits and Vegetables
    Table 1 of this document shows a summary of the proposed changes to 
the nutrition labeling values for 19 raw fruits and vegetables and to 
the serving size for grapefruit, grapes, peach, plums, carrot, and 
sweet potato, as compared with those in the current regulations. We are 
not proposing any changes to the other values in current appendix C to 
part 101.

         Table 1.--Proposed Changes to the Nutrition Labeling Information for Raw Fruits and Vegetables
----------------------------------------------------------------------------------------------------------------
                                               Current Values                         Proposed Values
        Food and Nutrient         ------------------------------------------------------------------------------
                                                         % Daily Value                          % Daily Value
----------------------------------------------------------------------------------------------------------------
Avocado, California:                                   ..................
Calories.........................  55                  ..................  50
Total Fat........................  5 g               8%..................  6 g               9%
Saturated Fat....................  1 g               5%..................  0.5 g             3%
Potassium........................  170 mg            5%..................  160 mg            5%
Total Carbohydrate...............  3 g               1%..................  2 g               1%
Dietary Fiber....................  3 g               12%.................  1 g               4%
----------------------------------------------------------------------------------------------------------------
Cantaloupe:                                            ..................
Total Carbohydrate...............  12 g              4%..................  13 g              4%
Sugars...........................  11 g                ..................  12 g
----------------------------------------------------------------------------------------------------------------
Grapefruit:                                            ..................
Serving Size.....................  1/2 medium (154     ..................  1/2 medium (154
                                    g/5.3 oz)                               g/5.5 oz)
----------------------------------------------------------------------------------------------------------------
Grapes:                                                ..................
Serving Size.....................  1 1/2 cups (138     ..................  3/4 cup (126 g/
Calories from Fat................   g/4.9 oz)          ..................   4.5 oz)
Total Fat........................  10                2%..................  0                 0%
Sodium...........................  1 g               0%..................  0 g               1%
Potassium........................  0 g               8%..................  15 mg             7%
Total Carbohydrate...............  270 mg            8%..................  240 mg            8%
Sugars...........................  24 g                ..................  23 g
Protein..........................  23 g                ..................  20 g
Vitamin A........................  1 g               2%..................  0 g               0%
Vitamin C........................                    25%.................                    2%
Iron.............................                    2%..................                    0%
 
----------------------------------------------------------------------------------------------------------------
Nectarine:                                             ..................
Total Fat........................  0.5 g             1%..................  0 g               0%
Potassium........................  300 mg            9%..................  290 mg            8%
Total Carbohydrate...............  16 g              5%..................  17 g              6%
Dietary Fiber....................  2 g               8%..................  1 g               4%
Sugars...........................  12 g                ..................  13 g
Vitamin A........................                    4%..................                    8%
----------------------------------------------------------------------------------------------------------------
Orange:                                                ..................
Calories.........................  70                  ..................  80
----------------------------------------------------------------------------------------------------------------
Peach:                                                 ..................
Serving Size.....................  1 medium (98 g/     ..................  1 medium (147 g/
Calories.........................   3.5 oz)            ..................   5.3 oz)
Potassium........................  40                5%..................  70                7%
Total Carbohydrate...............  190 mg            3%..................  260 mg            6%
Sugars...........................  10 g                ..................  18 g
Vitamin A........................  9 g               2%..................  14 g              8%
Vitamin C........................                    10%.................                    15%
Iron.............................                    0%..................                    2%
 
----------------------------------------------------------------------------------------------------------------

[[Page 12925]]

 
Plums:                                                 ..................
Serving Size.....................  2 medium (132 g/    ..................  2 medium (151 g/
Calories from Fat................   4.7 oz)            ..................   5.4 oz)
Total Fat........................  10                2%..................  0                 0%
Potassium........................  1 g               6%..................  0 g               7%
Total Carbohydrate...............  220 mg            6%..................  250 mg            7%
Sugars...........................  19 g                ..................  21 g
Vitamin A........................  10 g              6%..................  13 g              8%
Vitamin C........................                    20%.................                    10%
Iron.............................                    0%..................                    2%
 
----------------------------------------------------------------------------------------------------------------
Strawberries:                                          ..................
Calories.........................  45                  ..................  50
----------------------------------------------------------------------------------------------------------------
Sweet Cherries:                                        ..................
Total Fat........................  0.5 g             1%..................  0 g               0%
Total Carbohydrate...............  22 g              7%..................  23 g              8%
Sugars...........................  19 g                ..................  20 g
----------------------------------------------------------------------------------------------------------------
Tangerine:                                             ..................
Calories from Fat................  0                   ..................  5
Total Carbohydrate...............  15 g              5%..................  13 g              4%
Sugars...........................  12 g                ..................  8 g
----------------------------------------------------------------------------------------------------------------
Watermelon:                                            ..................
Calories.........................  80                  ..................  100
----------------------------------------------------------------------------------------------------------------
Asparagus:                                             ..................
Calories.........................  25                  ..................  20
----------------------------------------------------------------------------------------------------------------
Carrot:                                                ..................
Serving Size.....................  7" long, 1 1/4"     ..................  1 carrot, 7"
                                    diameter                                long, 1 1/4"
                                                                            diameter
----------------------------------------------------------------------------------------------------------------
Celery:                                                ..................
Sugars...........................  0 g                 ..................  1 g
----------------------------------------------------------------------------------------------------------------
Green (snap) Beans:                                    ..................
Calories.........................  25                  ..................  20
----------------------------------------------------------------------------------------------------------------
Green Onion:                                           ..................
Sodium...........................  5 mg              0%..................  10 mg             0%
Calcium..........................                    0%..................                    2%
----------------------------------------------------------------------------------------------------------------
Potato:                                                ..................
Calories.........................  100                 ..................  40
Sodium...........................  0 mg              0%..................  10 mg             0%
Potassium........................  720 mg            21%.................  650 mg            19%
Total Carbohydrate...............  26 g              9%..................  7 g               2%
Dietary Fiber....................  3 g               12%.................  4 g               16%
Sugars...........................  3 g                 ..................  2 g
Protein..........................  4 g                 ..................  3 g
Vitamin C........................                    45%.................                    40%
Iron.............................                    6%..................                    8%
----------------------------------------------------------------------------------------------------------------
Sweet Corn:                                            ..................
Calories.........................  80                  ..................  90
Calories from Fat................  10                  ..................  20
Total Fat........................  1 g               2%..................  2.5 g             4%
Potassium........................  240 mg            7%..................  250 mg            7%
Total Carbohydrate...............  18 g              6%..................  16 g              5%
Dietary Fiber....................  3 g               12%.................  2 g               8%
Protein..........................  3 g                 ..................  4 g
----------------------------------------------------------------------------------------------------------------

[[Page 12926]]

 
Sweet Potato:                                          ..................
Serving Size.....................  medium, 5" long,    ..................  1 medium, 5"
Calories.........................   2" diameter        ..................   long, 2"
Potassium........................  130               10%.................   diameter         10%
Total Carbohydrate...............  350 mg            11%.................  140               11%
Iron.............................  33 g              2%..................  340 mg            4%
                                                                           32 g
 
----------------------------------------------------------------------------------------------------------------
Tomato:                                                ..................
Calories from Fat................  0                   ..................  5
----------------------------------------------------------------------------------------------------------------

C. Proposed Updates to the Nutrition Labeling of Raw Fish

    For this proposal, we obtained new data 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 
(described below). Therefore, in addition to updating the nutrient 
values based on new data, we reanalyzed the data for the remaining 
fish, when we used data for raw fish, and adjusted the nutrient values 
accordingly (Ref. 7).
1. Corrections for Cooking
    a. Cooking yield for raw fish. The nutrition labeling values for 
fish provided in current appendix D to part 101 are based on the cooked 
edible portion (i.e., 84 g/3 oz) in accordance with Sec. 101.45(a)(2). 
However, most of the nutrient data used to derive the nutrient values 
were available only for raw fish. When using data for raw fish, we 
first had to determine the raw fish weight that would yield 84 g (3 oz) 
of cooked fish. This adjusted raw fish weight would provide the basis 
upon which to derive the nutrient values. We calculated the raw weight 
by dividing the cooked weight (3 oz) by the appropriate cooking yield 
(i.e., a 75 percent cooking yield for finfish (based on dry heat 
cooking) and crustaceans (based on moist heat cooking) and a 60 percent 
cooking yield for mollusks (based on dry heat cooking)) (Refs. 10 and 
20).
    Therefore, we used data for 4 oz of raw finfish and crustaceans (3 
oz  0.75) and 5 oz of raw mollusks (3 oz  0.60) to 
derive the nutrient values for 3 oz of cooked fish (59 FR 36379 at 
36382 and 36383).
    Since publication of the 1996 final rule, NFI has informed us that 
oysters are cooked predominately by dry heat while clams and scallops 
are cooked predominantly by moist heat (Ref. 21). Therefore, based on 
the cooking procedure and yields of cooked fish provided in Agriculture 
Handbook No. 8-15 (Ref. 10) for mollusks, we used a 50 percent cooking 
yield for clams and scallops (moist heat cooking) to determine the 
correct raw weights on which to base the nutrient data for this 
proposed rule. We continued to use a 60 percent cooking yield for 
oysters (dry heat cooking).
    We also discovered in the previous data analyses for finfish and 
crustaceans that instead of using the precise raw weight of 112 g (84 g 
cooked weight  0.75 cooking yield) to calculate the nutrient 
values, we used an approximate raw weight of 110 g. We have corrected 
this error in proposed appendix D to part 101. Thus, when we used 
nutrient data for raw fish, we used 4 oz (112 g) of raw finfish and raw 
crustaceans (blue crab and shrimp), 5 oz (140 g) of raw oysters, and 6 
oz (168 g) of raw clams and scallops to obtain nutrition labeling 
values for 3 oz (84 g) of cooked fish (Refs. 5 and 7).
    b. Nutrient retention factors. In 1998, USDA issued an updated 
table of nutrient retention factors that is a major source of nutrient 
retention data for U.S. food composition databases (Ref. 22). The 
nutrient retention factors for the type of fish and corresponding 
cooking procedure are as follows:

 
        Cooking Procedure/               Nutrient Retention Factors
 
                                               Vitamin  Vitamin
            Type of Fish            Potassium     A        C       Iron
 
 
Dry Heat:--------------------------------  --------  -------  -------  -
  Finfish:
    Less than 5% fat..............     100%       90%      80%     100%
    More than 5% fat..............     100%       85%      80%     100%
  Shellfish:
    Oysters.......................     100%       95%      85%     100%
Moist Heat:
  Shellfish (except oysters)......      90%       90%      80%      90%
------------------------------------------------------------------------
 

    The NNDB and SR provide data for both cooked and raw varieties of 
fish, but for most varieties, vitamins A and C have very little data (0 
to 3 analytical samples). Rather than apply nutrient retention factors 
to such small samples of data for raw fish, we have used vitamin A and 
vitamin C values from the SR, adjusted to the appropriate serving size, 
for cooked finfish (except catfish and tilapia) and cooked shellfish 
(except scallops) in proposed appendix D to part 101. Because we are 
using the vitamin A and vitamin C values for these cooked fish, the 
nutrient retention

[[Page 12927]]

factors do not need to be applied. For catfish, application of the 
nutrient retention factors to vitamins A and C does not change the 
current value of 0 percent DV. For tilapia, we used data obtained from 
industry on the raw fish and applied the appropriate nutrient retention 
factors (Ref. 23). The only SR data that were available for cooked 
scallops were for breaded and fried, a cooking method that greatly 
affects the nutrient profile of the fish. Thus, we used data for raw 
scallops and applied the appropriate nutrient retention factors for 
potassium, vitamin A, vitamin C, and iron. For blue crab, clams, and 
shrimp, we used data for the raw fish and applied the appropriate 
nutrient retention factors for potassium and iron.
2. Catfish
    In proposed appendix D to part 101, we have used 1997 data on the 
fat composition of raw farm-raised catfish that ABC Research Corp. 
submitted to the agency on behalf of NFI. The nutrition labeling values 
that we provided for farm-raised catfish in the 1996 final rule were 
based on values derived from information published in ``Nutrients and 
Chemical Residues in One-to-Two Pound Mississippi Farm-Raised Channel 
Catfish,'' by Joyce Nettleton et al. (61 FR 42742 at 42753). For this 
proposal, we reviewed the newer NFI data consisting of 30 analytical 
samples that measured the total fat content of farm-raised catfish. We 
completed compliance calculations based on 95 percent prediction 
intervals and used these data in determining the proposed label value 
of 6 g for total fat (Ref. 24). We also have recalculated the values 
for calories (130) and calories from fat (60) based on the newer data 
for total fat. Table 2 of this document shows the proposed changes in 
the nutrient values for catfish compared with those in the current 
regulations.
3. Flounder/Sole, Rainbow Trout, Orange Roughy, Oysters, Salmon 
(Atlantic/Coho/Sockeye), Shrimp, and Swordfish
    In proposed appendix D to part 101, we have used updated nutrient 
data from the NNDB for the following fish: Flounder/sole (raw); rainbow 
trout (cooked, dry heat, farmed); orange roughy (raw); oysters (raw); 
Atlantic salmon (cooked, farmed); coho salmon (raw, farmed); sockeye 
salmon (raw); shrimp (raw); and swordfish (raw). We subjected the data 
to FDA compliance calculations using 95 percent prediction intervals 
and used these data in deriving the proposed nutrition labeling values 
for these fish (Ref. 5).
4. Tilapia
    In proposed appendix D to part 101, we have used 1999 data on the 
nutrient composition of raw tilapia that Southern Testing & Research 
Laboratories, Inc., submitted to the agency on behalf of the American 
Tilapia Association. The results of analytical testing done by Southern 
Testing & Research Laboratories, Inc., provided all the required 
nutrients but not potassium, which may be declared voluntarily. We 
completed compliance calculations based on 95 percent prediction 
intervals and determined that the mean values better represent the 
nutrient levels because of the small number of samples (n=3) analyzed 
(Ref. 23). To be consistent with our decision to include the optional 
nutrient, potassium, we have used data published in the journal article 
entitled ``Comparison of Processing Yield and Nutrient Composition of 
Cultured Nile Tilapia (Oreochromis niloticus) and Channel Catfish 
(Ictalurus punctatus)'' by Clement and Lovell to derive the potassium 
content of tilapia (Ref. 25).
5. Tuna
    In proposed appendix D to part 101, we have used data from the NNDB 
and SR (Refs. 6 and 9) for yellowfin tuna. We selected yellowfin 
because the Tuna Research Foundation informed us that the species of 
tuna most commonly eaten fresh is yellowfin (Ref. 26). We subjected the 
data to FDA compliance calculations using 95 percent prediction 
intervals and used these data in deriving the proposed nutrition 
labeling values for tuna (Ref. 5).
6. Summary of Proposed Changes for Fish
    Table 2 of this document shows the proposed changes in the 
nutrition labeling values for fish compared with those in the current 
regulations. As explained in section III.B of this document, the 
proposed changes include removal of mackerel and whiting and the 
addition of tilapia and tuna.

                Table 2.--Proposed Changes to the Nutrition Labeling Information for Cooked Fish
----------------------------------------------------------------------------------------------------------------
                                               Current Values                         Proposed Values
        Food and Nutrient         ------------------------------------------------------------------------------
                                                         % Daily Value                          % Daily Value
----------------------------------------------------------------------------------------------------------------
Blue Crab:                                             ..................
Cholesterol......................  90 mg             30%.................  95 mg             32%
Sodium...........................  320 mg            13%.................  330 mg            14%
Potassium........................  360 mg            10%.................  300 mg            9%
Vitamin C........................                    0%..................                    4%
Calcium..........................                    8%..................                    10%
----------------------------------------------------------------------------------------------------------------
Catfish:                                               ..................
Calories.........................  140                 ..................  130
Calories from Fat................  80                  ..................  60
Total Fat........................  9 g               14%.................  6 g               9%
----------------------------------------------------------------------------------------------------------------
Clams:                                                 ..................
Calories.........................  100                 ..................  110
Cholesterol......................  55 mg             18%.................  80 mg             27%
Potassium........................  530 mg            15%.................  470 mg            13%
Total Carbohydrate...............  0 g               0%..................  6 g               2%
Protein..........................  22 g                ..................  17 g
Calcium..........................                    6%..................                    8%
Iron.............................                    60%.................                    30%
----------------------------------------------------------------------------------------------------------------

[[Page 12928]]

 
Cod:                                                   ..................
Calories from Fat................  0                   ..................  5
Total Fat........................  0.5 g             1%..................  1 g               2%
Cholesterol......................  45 mg             15%.................  50 mg             17%
Sodium...........................  60 mg             3%..................  55 mg             2%
Potassium........................  450 mg            13%.................  460 mg            13%
Vitamin C........................                    0%..................                    2%
----------------------------------------------------------------------------------------------------------------
Flounder/Sole:                                         ..................
Calories from Fat................  14                  ..................  15
Saturated Fat....................  0.5 g             3%..................  0 g               0%
Cholesterol......................  60 mg             20%.................  55 mg             18%
Sodium...........................  90 mg             4%..................  100 mg            4%
Potassium........................  290 mg            8%..................  400 mg            11%
Protein..........................  21 g                ..................  19 g
Calcium..........................                    2%..................                    0%
Iron.............................                    2%..................                    0%
----------------------------------------------------------------------------------------------------------------
Haddock:                                               ..................
Cholesterol......................  80 mg             27%.................  70 mg             23%
Sodium...........................  85 mg             4%..................  75 mg             3%
Vitamin A........................                    0%..................                    2%
----------------------------------------------------------------------------------------------------------------
Halibut:                                               ..................
Calories.........................  110                 ..................  120
Calories from Fat................  20                  ..................  15
Potassium........................  490 mg            14%.................  500 mg            14%
Vitamin A........................                    2%..................                    4%
Iron.............................                    4%..................                    6%
----------------------------------------------------------------------------------------------------------------
Lobster:                                               ..................
Vitamin A........................                    0%..................                    2%
Calcium..........................                    4%..................                    6%
----------------------------------------------------------------------------------------------------------------
Ocean Perch:                                           ..................
Saturated Fat....................  0 g               0%..................  0.5 g             3%
Vitamin C........................                    0%..................                    2%
----------------------------------------------------------------------------------------------------------------
Orange Roughy:                                         ..................
Calories from Fat................  10                  ..................  5
Potassium........................  330 mg            9%..................  340 mg            10%
Vitamin A........................                    0%..................                    2%
Calcium..........................                    0%..................                    4%
Iron.............................                    0%..................                    2%
----------------------------------------------------------------------------------------------------------------
Oysters:                                               ..................
Total Fat........................  3.5 g             5%..................  4 g               6%
Cholesterol......................  115 mg            38%.................  80 mg             27%
Sodium...........................  190 mg            8%..................  300 mg            13%
Potassium........................  390 mg            11%.................  220 mg            6%
Total Carbohydrate...............  4 g               1%..................  6 g               2%
Vitamin C........................                    0%..................                    6%
----------------------------------------------------------------------------------------------------------------
Pollock:                                               ..................
Calories.........................  90                  ..................  100
Potassium........................  360 mg            10%.................  370 mg            11%
Vitamin A........................                    0%..................                    2%
----------------------------------------------------------------------------------------------------------------
Rainbow Trout:                                         ..................
Cholesterol......................  60 mg             20%.................  55 mg             18%
Protein..........................  21 g                ..................  20 g
Calcium..........................                    6%..................                    8%
----------------------------------------------------------------------------------------------------------------
Rockfish:                                              ..................
Calories from Fat................  20                  ..................  15
Total Fat........................  2 g               3%..................  1.5 g             2%
Potassium........................  430 mg            12%.................  440 mg            13%
Calcium..........................                    0%..................                    2%
----------------------------------------------------------------------------------------------------------------

[[Page 12929]]

 
Salmon, Atlantic/Coho/Sockeye:     Atlantic & Coho/    ..................  Atlantic/Coho/
Calories.........................   Sockeye            ..................   Sockeye
Calories from Fat................  160/ 180            ..................  190
Total Fat........................  60/ 80            11%/ 14%............  90                15%
Saturated Fat....................  7 g/ 9 g          5%/ 8%..............  10 g              10%
Cholesterol......................  1 g/ 1.5 g        17%/ 25%............  2 g               22%
Sodium...........................  50 mg/ 75 mg      2%/ 2%..............  65 mg             3%
Potassium........................  50 mg/ 55 mg      14%/ 9%.............  65 mg             9%
Protein..........................  490 mg/ 320 mg      ..................  320 mg
Vitamin A........................  22 g/ 23 g        0%/ 4%..............  24 g              2%
Vitamin C........................                    0%/ 0%..............                    2%
Calcium..........................                    0%/ 0%..............                    2%
Iron.............................                    4%/ 2%..............                    2%
 
----------------------------------------------------------------------------------------------------------------
Salmon, Chum/Pink:                                     ..................
Potassium........................  410 mg            12%.................  420 mg            12%
Calcium..........................                    0%..................                    2%
Iron.............................                    2%..................                    4%
----------------------------------------------------------------------------------------------------------------
Scallops:                                              ..................
Calories.........................  120                 ..................  140
Cholesterol......................  55 mg             18%.................  60 mg             20%
Sodium...........................  260 mg            11%.................  310 mg            13%
Potassium........................  280 mg            8%..................  430 mg            12%
Total Carbohydrate...............  2 g               1%..................  5 g               2%
Protein..........................  22 g                ..................  27 g
Vitamin A........................                    0%..................                    2%
Vitamin C........................                    0%..................                    6%
Calcium..........................                    2%..................                    4%
----------------------------------------------------------------------------------------------------------------
Shrimp:                                                ..................
Calories.........................  80                  ..................  100
Total Fat........................  1 g               2%..................  1.5 g             2%
Cholesterol......................  165 mg            55%.................  170 mg            57%
Sodium...........................  190 mg            8%..................  250 mg            10%
Potassium........................  140 mg            4%..................  220 mg            6%
Protein..........................  18 g                ..................  21 g
Vitamin A........................                    0%..................                    4%
Vitamin C........................                    0%..................                    4%
Calcium..........................                    2%..................                    6%
Iron.............................                    15%.................                    6%
----------------------------------------------------------------------------------------------------------------
Swordfish:                                             ..................
Calories.........................  130                 ..................  120
Calories from Fat................  35                  ..................  50
Total Fat........................  4.5 g             7%..................  6 g               9%
Saturated Fat....................  1 g               5%..................  1.5 g             8%
Protein..........................  22 g                ..................  16 g
----------------------------------------------------------------------------------------------------------------
Tilapia:                                               ..................
Calories.........................                      ..................  110
Calories from Fat................                      ..................  20
Total Fat........................                      ..................  2.5 g             4%
Saturated Fat....................                      ..................  1 g               5%
Cholesterol......................                      ..................  75 mg             25%
Sodium...........................                      ..................  30 mg             1%
Potassium........................                      ..................  360 mg            10%
Total Carbohydrate...............                      ..................  0 g               0%
Dietary Fiber....................                      ..................  0 g               0%
Sugars...........................                      ..................  0 g
Protein..........................                      ..................  22 g
Vitamin A........................                      ..................                    0%
Vitamin C........................                      ..................                    2%
Calcium..........................                      ..................                    0%
Iron.............................                      ..................                    2%
----------------------------------------------------------------------------------------------------------------

[[Page 12930]]

 
Tuna:                                                  ..................
Calories.........................                      ..................  130
Calories from Fat................                      ..................  15
Total Fat........................                      ..................  1.5 g             2%
Saturated Fat....................                      ..................  0 g               0%
Cholesterol......................                      ..................  50 mg             17%
Sodium...........................                      ..................  40 mg             2%
Potassium........................                      ..................  480 mg            14%
Total Carbohydrate...............                      ..................  0 g               0%
Dietary Fiber....................                      ..................  0 g               0%
Sugars...........................                      ..................  0 g
Protein..........................                      ..................  26 g
Vitamin A........................                      ..................                    2%
Vitamin C........................                      ..................                    2%
Calcium..........................                      ..................                    2%
Iron.............................                      ..................                    4%
----------------------------------------------------------------------------------------------------------------

V. 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.

VI. Preliminary Regulatory Impact Analysis

    FDA has examined the economic implications of these proposed 
guidelines as required by 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). Executive Order 12866 
classifies a rule as significant if it meets any one of a number of 
specified conditions, including: Having an annual effect on the economy 
of $100 million, adversely affecting a sector of the economy in a 
material way, adversely affecting competition, or adversely affecting 
jobs. A regulation also is considered a significant regulatory action 
if it raises novel legal or policy issues. FDA has determined that 
these proposed guidelines are not a significant regulatory action as 
defined by Executive Order 12866.
    Title II of the Unfunded Mandates Reform Act of 1995 (Public Law 
104-4) requires cost-benefit and other analyses before any rulemaking 
if the rule would include a ``Federal mandate that may result in the 
expenditure by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100 million or more (adjusted annually 
for inflation) in any one year.'' The current inflation-adjusted 
statutory threshold is $115 million. FDA has determined that this 
proposed rule containing nutrition labeling guidelines does not 
constitute a significant rule under the Unfunded Mandates Reform Act.

A. Costs of These Guidelines

    The costs of a labeling regulation are the incremental 
administrative, analytical, redesign, and label inventory disposal 
costs associated with the regulatory action. Because FDA is providing 
nutrition values that retailers must use, we expect no analytical or 
other information costs. The typical sign, the most common means of 
labeling raw products, has an expected useful life of 6 months. This is 
well within the compliance period, so we also expect little to no 
inventory disposal costs.
    Administrative and redesign costs depend on retail store behavior. 
The 1996 final rule had a 1-year compliance period. These guidelines 
propose compliance at the next applicable uniform compliance date 
(UCD), which is no sooner than 1 year after the final rule is published 
in the Federal Register. The redesign cost due to this proposed 
guidance depends crucially on the length of the compliance period: FDA 
assumes that, all other things equal, the longer the compliance period 
the lower the cost of implementing the proposed guidelines. Retail 
stores periodically redesign signs and displays. FDA has information 
that a normal redesign cycle of a product label is 2 years. This cycle 
may not apply to retail level signs, but it provides a basis on which 
to estimate the lifecycle of a display. We assume that some of the 
retail stores would have redesigned their displays before the effective 
date of compliance, lowering the redesign cost attributed to these 
proposed guidelines. FDA invites comments on the normal length of 
redesign time and cost associated with retail level signs or posters.
    The most likely timeline of these guidelines is that they will be 
published during 2002. Therefore, the effective compliance date of 
these guidelines would be the next UCD of January 1, 2004, or between 1 
and 2 years after the publication of the final guidelines. FDA will 
modify this analysis if the actual publication date differs from the 
one described here.
    If the final compliance period is 18 months and companies redesign 
normal labels every 2 years, then 75 percent of companies could be 
expected to normally redesign their labels during the compliance 
period. FDA assumes that an informational display will be redesigned 
with less frequency than a product label since it has a smaller 
potential impact on the profitability of the food product. We assume a 
median display redesign cycle of 3 years, which implies that 50 percent 
of retailers would have redesigned their store displays between their 
publication and when the new guidelines take effect. A normal redesign 
still will incur cost associated with verifying that the design 
conforms to the new guidelines. FDA estimates an average cost of a 
complete redesign of $100 per store, and estimates that the partial 
redesign cost allocated to changing the values on the informational 
signs will be $50 per store, allocated evenly among the years 2002 and 
2003.

[[Page 12931]]

    Approximately 83,000 grocery stores fall under these compliance 
guidelines. This estimate is based on a Dunn and Bradstreet database 
search, where the total of 197,000 grocery stores was decreased by the 
110,000 stores exempted by Congress since they have annual sales of 
less than $500,000. Seven thousand six hundred of the remaining stores 
did not have sales data available. Since 42 percent of the stores that 
have sales data had sales over $500,000, we assign 42 percent of the 
stores without sales data to the population subject to compliance. 
According to the last (1996) compliance survey, approximately 72 
percent of stores (73.0 percent for raw fruits and vegetables and 71.2 
percent for raw fish) adequately displayed acceptable signs. Although 
slightly down from the previous (1994) survey, compliance is still well 
over the 60 percent threshold that would trigger a mandatory rule 
proposal. FDA assumes that 72 percent or 59,923 stores--the same 
percentage as the most recent compliance survey--will continue to 
choose to follow the guidelines.
    Table 3 of this document presents the total cost estimates based on 
the number of stores and the effect of the compliance date. The present 
value (as of January 2002) cost of complying with the guidelines (the 
sum of the values in row e in table 3) would be $4,066,000. Firms incur 
this cost every 4 years (if the nutrient values are revised). If the 
rate of increase in the cost of redesigning a sign is equal to the 7 
percent discount rate used in this analysis, then the present value 
cost of each redesign would be the same. Because of the uncertainty in 
nutrition science, the effect of the UCD, the percent of stores 
following the guidelines, and the rate of cost increase, FDA does not 
estimate the cost of future guideline updates.

                 Table 3.--Compliance Schedule and Cost
------------------------------------------------------------------------
  (a) Adoption Year          2002             2003             2004
------------------------------------------------------------------------
(b) Number of Stores   14,980           14,980           29,962
------------------------------------------------------------------------
(c) Cost ($) per       $50              $50              $100
 Store
------------------------------------------------------------------------
(d) Total Cost ($) [b  $749,025         $749,025         $2,996,200
 x c]
------------------------------------------------------------------------
(e) Present (Year
 2002)                 $749,025         $700,023         $2,616,997
Value, 7% discount
 rate
------------------------------------------------------------------------

B. Benefits of These Guidelines

    In the Regulatory Impact Analysis (RIA) of the Proposed Rules to 
Amend the Food Labeling Regulations (56 FR 60856, November 27, 1991), 
FDA stated that the benefit of labeling of raw fruits, vegetables, and 
fish is a change in purchase behavior that would happen if the 
information presented was new to some consumers and was important to 
their consumption decisions. Since a majority of retail stores have 
displayed this type of information for several years, any incremental 
change from a single update of the list of foods affected or 
nutritional values is likely to be small and unmeasurable.
    However, these guidelines as amended in the proposed rule would be 
voluntary; grocery stores would probably not choose to display signs 
with the updated nutrition information if they felt the information 
would have no impact. In addition, informational signs must be 
truthful, and without periodic updates the incremental errors that 
would build up might eventually erode the ability of these signs to 
help consumers choose products. This guidance is designed not to create 
an effective label, but to preserve the effectiveness of existing 
nutrition labels.
    Truthful signs and placards can have an impact on consumer 
behavior. One of the studies used to estimate the impact of product 
information on consumer choice for the 1991 RIA was the Special Diet 
Alert study, or SDA. The SDA is relevant to this analysis because the 
mode of disseminating truthful and accurate nutrition information in 
the study, based in retail grocery stores in Baltimore and Washington, 
DC, was a store display similar to the ones recommended in these 
guidelines. According to SDA, the presence of a sign displaying 
nutrition information caused a modest switch by consumers to products 
with relatively large positive attributes (vitamins and minerals) and a 
modest switch away from products with relatively large negative 
attributes (fat and cholesterol). If these guidelines are not 
periodically revised in light of the best available nutrient data, FDA 
believes the modest beneficial effect they have on consumer behavior 
may steadily diminish.

VII. Initial Regulatory Flexibility Analysis

    FDA has examined the economic implications of these proposed 
guidelines as required by the Regulatory Flexibility Act (5 U.S.C. 601-
612). If a rule has a significant economic impact on a substantial 
number of small entities, the Regulatory Flexibility Act requires 
agencies to analyze regulatory options that would lessen the economic 
effect of the rule on small entities. FDA finds that these proposed 
guidelines would not have a significant economic impact on a 
substantial number of small entities.
    The Small Business Administration (SBA) defines a grocery store as 
small if its annual sales are under $20 million. In the Dunn and 
Bradstreet search of grocery stores, 98 percent of stores with sales 
data available meet this definition. Not all stores must follow the 
guidelines: Stores with sales of $500,000 or less are exempt. Very 
small non-exempt stores (those of annual sales between $500,000 and 
$2,000,000) are not in compliance as a group in any of the compliance 
surveys. However, the percentage of very small non-exempt stores in 
compliance jumped over 5 percent for fruits and vegetables and just 
over 1 percent for fish in the latest (1996) survey.
    Table 4 of this document presents the store-count percentage levels 
for stores of varying size. The 1996 compliance survey was not designed 
to discriminate between stores with sales over $20 million annually and 
stores with sales between $2 million and $20 million. However, the 
percentages in the second row are probably very good estimates for the 
compliance rate of stores considered small by the SBA standard, since 
so few stores have annual sales over $20 million.
    The cost per store in the final column of table 4 of this document 
takes into account the percent compliance in each category and the 
varying date of compliance. For all categories, the average cost for a 
store that complies with the guidelines is $67.85, which is

[[Page 12932]]

the present value weighted average of the three different possible time 
periods and the either $50 or $100 in compliance costs. The average of 
the two compliance rates is 49.6 percent for stores in the smallest 
category (table 4, row 1), so the average cost per store for this group 
is $33.65 (.496 x 67.85). The equivalent average cost per store for 
table 4, row 2 is $51.70 (.762 x 67.85).

    Table 4.--Compliance Percentages by Store Size and Cost per Store
------------------------------------------------------------------------
                       Fruit and
 Annual Sales ($)  Vegetable Percent  Raw Fish Percent   Cost per Store
------------------------------------------------------------------------
$500,000-$2        48.6%              50.5%             $33.65
 million
------------------------------------------------------------------------
Greater than $2    78.5%              73.9%             $51.70
 million
------------------------------------------------------------------------

    In addition, the maximum cost for any one firm is $87.34, which is 
$100 discounted back 2 years at 7 percent for stores which wait until 
the latest possible date to comply with the guidelines. The smallest 
firm that could incur this cost is a single location store with sales 
of $500,000.01. The maximum cost per firm of this guidance is 
therefore, at most, 0.017 percent of annual revenue.
    Both the per store averages and the maximum possible cost of the 
guidance for a single firm are very small, and will not impose a 
significant cost on even the smallest non-exempt grocery stores. FDA, 
therefore, certifies that these guidelines would not have a significant 
impact on a substantial number of small entities.

VIII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that the labeling requirements proposed 
in this document are not subject to review by the Office of Management 
and Budget because they do not constitute a ``collection of 
information'' under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520). Rather, the proposed nutrition labeling would be a ``public 
disclosure of information originally supplied by the Federal government 
to the recipient for the purpose of disclosure to the public'' (5 CFR 
1320.3(c)(2)).

IX. Effective Date

    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)). We are proposing that any final rule that may issue based 
on this proposal become effective in accordance with the uniform 
effective date for compliance with food labeling requirements, which is 
not sooner than 1 year following publication of the final rule. 
However, FDA will not object to voluntary compliance immediately upon 
publication of the final rule.

X. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this proposal by June 3, 
2002. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Identify all comments with the docket 
number found in brackets in the heading of this document. You may 
review public dockets containing comments to this proposal in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

XI. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.

    1. 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, August 14, 2001.
    2. Memorandum to file, Tom O'Brien, FDA, February 21, 1996.
    3. Memorandum of phone conversation between Lee Weddig, National 
Fisheries Institute and Susan J. Brecher, FDA, June 9, 1997.
    4. Letter from Lee J. Weddig, National Fisheries Institute to 
Susan Brecher, FDA, June 12, 1997.
    5. O'Neill, K. R., ``Statistical Derivation of Nutrition 
Labeling from USDA Data for Appendix D to Part 101: Nutrition Facts 
for Cooked Fish,'' Center for Food Safety and Applied Nutrition, 
FDA, May 9, 2001.
    6. 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.
    7. LeGault, L. A. and S. J. Brecher, ``Documentation for the 
Proposed Nutrition Labeling Values for the 20 Most Frequently 
Consumed Raw Fruits, Vegetables, and Fish,'' Center for Food Safety 
and Applied Nutrition, FDA, August 2001.
    8. 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.
    9. U.S. Department of Agriculture, Agricultural Research 
Service, USDA Nutrient Database for Standard Reference, Release 14, 
2001, available on the Internet at USDA's Nutrient Data Laboratory 
Home Page, http://www.nal.usda.gov/fnic/foodcomp.
    10. U.S. Department of Agriculture, ``Composition of Foods: 
Finfish and Shellfish Products; Raw, Processed, Prepared,'' 
Agriculture Handbook No. 8-15, 1991 Supplement, pp. 10-11.
    11. Grubbs, F. E., ``Procedures for Detecting Outlying 
Observations in Samples,'' Technometrics, vol. 11, no.1, pp. 1-21, 
1969.
    12. Merrill, A. L. and B. K. Watt, ``Energy Value of Foods--
Basis and Derivation,'' Agriculture Handbook No. 74, U.S. Department 
of Agriculture, revised 1973, pp. 24-25, available on the Internet 
at http://www.nal.usda.gov/fnic/foodcomp/Data/Classics/index.html.
    13. Matthews, R. H., P. R. Pehrsson, and M. Farhat-Sabet, 
``Sugar Content of Selected Foods: Individual and Total Sugars,'' 
Home Economics Research Report No. 48, U.S. Department of 
Agriculture, September 1987, available on the Internet at http://www.nal.usda.gov/fnic/foodcomp/Data/index.html#sugar.
    14. O'Neill, K. R., ``Statistical Derivation of Raw Grapes 
Nutrition Label for Appendix C to Part 101: Nutrition Facts for Raw 
Fruits and Vegetables,'' Center for Food Safety and Applied 
Nutrition, FDA, August 6, 2001.
    15. O'Neill, K. R., ``Statistical Derivation of Nutrition Mean 
Values from California Tree Fruit Agreement Data for Raw Nectarines, 
Peaches, and Plums,'' Center for Food Safety and Applied Nutrition, 
FDA, May 9, 2001.
    16. Memorandum to file, Lori A. LeGault, FDA, April 26, 2001.
    17. Letter from F. Edward Scarbrough, FDA, to Tom Tjerandsen, 
representative of the California Cherry Advisory Board, June 18, 
1997.
    18. O'Neill, K. R., ``Statistical Derivation of Raw Vegetable 
Nutrition Labels from USDA Data for Appendix C to Part 101: 
Nutrition Facts for Raw Fruits and Vegetables,'' Center for Food 
Safety and Applied Nutrition, FDA, April 18, 2001.
    19. O'Neill, K. R., ``Statistical Derivation of Raw Potato 
Nutrition Label for Appendix C to Part 101: Nutrition Facts for Raw 
Fruits and Vegetables,'' Center for Food Safety and Applied 
Nutrition, FDA, August 8, 2001.

[[Page 12933]]

    20. Memorandum of phone conversation between Jacob Exler, U.S. 
Department of Agriculture, and FDA, March 1, 1993.
    21. Memorandum of phone conversation between Richard Gutting, 
National Fisheries Institute, and Susan J. Brecher, FDA, October 2, 
1998.
    22. U.S. Department of Agriculture, USDA Table of Nutrient 
Retention Factors, Release 4, 1998, available on the Internet at 
http://www.nal.usda.gov/fnic/foodcomp/Data/index.html.
    23. O'Neill, K. R., ``Statistical Derivation of Raw Tilapia 
Nutrition Label for Appendix D to Part 101: Nutrition Facts for 
Cooked Fish,'' Center for Food Safety and Applied Nutrition, FDA, 
April 18, 2001.
    24. O'Neill, K. R., ``Nutrition Label Values for Total Fat, 
Calories and Calories From Fat in Farm-Raised Catfish,'' Center for 
Food Safety and Applied Nutrition, FDA, May 14, 2001.
    25. Clement, S. and R. T. Lovell, ``Comparison of Processing 
Yield and Nutrient Composition of Cultured Nile Tilapia (Oreochromis 
niloticus) and Channel Catfish (Ictalurus punctatus),'' Aquaculture, 
119:299-310, 1994.
    26. Memorandum of phone conversation between Randi Thomas, Tuna 
Research Foundation, and Susan J. Brecher, FDA, February 11, 1998.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

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

PART 101--FOOD LABELING

    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.

    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/sockeye, chum/pink), scallops, shrimp, swordfish, 
tilapia, and tuna.
    3. Amend Sec. 101.45 by revising the section heading and paragraph 
(a)(3)(iii) and by 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 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 fat per ounce (e.g., ``Most fruits and vegetables provide 
negligible amounts of saturated 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 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 dietary fiber and sugars.''
* * * * *
    4. Appendixes C and D to part 101 are revised to read as follows:
* * * * *
BILLING CODE 4160-01-S

[[Page 12934]]

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[[Page 12935]]


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[[Page 12936]]


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[[Page 12937]]


    Dated: December 26, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-6709 Filed 3-19-02; 8:45 am]
BILLING CODE 4160-01-C