[Federal Register Volume 59, Number 136 (Monday, July 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17287]


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[Federal Register: July 18, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 94N-0155]
RIN 0905-AB68

 

Food Labeling; Nutrition Labeling of Raw Fruit, Vegetables, and 
Fish; Guidelines for Voluntary Nutrition Labeling of Raw Fruit, 
Vegetables, and Fish; Identification of the 20 Most Frequently Consumed 
Raw Fruit, 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 revise 
the guidelines for voluntary nutrition labeling of raw fruit, 
vegetables, and fish; revise the definition for compliance with respect 
to adherence by retailers to those guidelines; and revise the labeling 
regulations and labeling values for the 20 most frequently consumed raw 
fruit, vegetables, and fish. This action is in response to the 
Nutrition Labeling and Education Act of 1990 (the 1990 amendments).

DATES: Submit written comments by September 16, 1994. The agency is 
proposing that any final rule that may issue based on this proposal 
become effective 30 days after publication.

ADDRESSES: Written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: Jean A.T. Pennington, Center for Food 
Safety and Applied Nutrition (HFS-165), Food and Drug Administration, 
200 C Street SW., Washington, DC 20204, 202-205-5434.

SUPPLEMENTARY INFORMATION:

I. Background

    In response to requirements of the Nutrition Labeling and Education 
Act of 1990 (the 1990 amendments) (Pub. L. 101-535), FDA published 
final regulations in the Federal Register of November 27, 1991 (56 FR 
60880, and corrected at 57 FR 8174, March 6, 1992) (hereinafter 
referred to as the ``voluntary nutrition labeling final rule'') that: 
(1) Identified the 20 most frequently consumed raw fruit, vegetables, 
and fish in the United States; (2) established guidelines for the 
voluntary nutrition labeling of these foods; and (3) determined the 
criteria for substantial compliance by food retailers with the 
guidelines for the voluntary nutrition labeling of these foods.
    Under section 403(q)(4)(C)(i) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 343(q)(4)(C)(i)), FDA was to issue a 
report by May 8, 1993, on actions taken by food retailers to provide 
consumers with nutrition information for raw fruit, vegetables, and 
fish under the guidelines established by the agency for such 
information. The act states that this report is to include a 
determination as to whether there is substantial compliance with the 
guidelines. FDA defined ``substantial compliance'' in Sec. 101.43(c) 
(21 CFR 101.43(c)) to mean that at least 60 percent of all stores that 
are evaluated are in compliance. Under section 403(q)(4)(C)(ii) of the 
act, if FDA were to find that compliance is substantial, then nutrition 
labeling of raw fruit, vegetables, and fish would remain voluntary, 
with compliance to be assessed at 2-year intervals. If the agency were 
to find that compliance is not substantial, section 403(q)(4)(D)(i) of 
the act requires that FDA issue proposed regulations requiring that any 
person who offers raw fruit, vegetables, or raw fish to consumers 
provide, in a manner prescribed by regulation, the nutrition 
information required by section 403 (q)(1) and (q)(2) of the act.
    In the Federal Register of May 18, 1993 (58 FR 28985), FDA 
announced the availability of its ``Report on Voluntary Compliance of 
Food Retailers in Providing Nutrition Labeling Information for Raw 
Fruit and Vegetables and for Raw Fish'' (Ref. 1). This report was based 
on the results of a survey conducted in November and December 1992 by 
the Ehrhart-Babic Group under contract to FDA. Based on the results of 
the survey (Ref. 2), FDA found that compliance of retailers with the 
nutrition labeling guidelines is substantial both for fruit and 
vegetables (75.7 percent compliance) and for fish (73.2 percent 
compliance). Annual commodity volume (ACV) compliance estimates 
(reflecting compliance on the basis of sales volume) were similar to 
compliance based on the number of stores surveyed. For raw fruit and 
vegetables, stores in compliance accounted for 76.9 percent of annual 
sales of all food stores. For raw fish, the estimate was 74.3 percent.
    FDA interprets the ACV data as showing that a minimum of three-
fourths of U.S. consumers are exposed to nutrition labeling information 
for raw fruit, vegetables, and fish. FDA believes that these 
percentages represent a minimum estimate because some consumers shop in 
several different retail stores, which increases their chance of 
exposure to nutrition labeling of raw fruit, vegetables, and fish.
    Thus, the nutrition labeling of raw fruit, vegetables, and fish 
will remain voluntary until at least May 8, 1995. The agency notes, 
however, that a lawsuit challenging FDA's criterion for substantial 
compliance was filed in 1992 (Arent v. Shalala, Civ. No. 92-0148-JLG). 
The outcome of this case could affect whether nutrition labeling of raw 
fruit, vegetables, and fish remains voluntary.
    FDA stated in Sec. 101.45(i) (21 CFR 101.45(i)) that it will 
publish and provide an opportunity for comment on updates of the 
nutrition labeling values for the 20 most frequently consumed raw 
fruit, vegetables, and fish (or a notice that nutrition labeling values 
have not changed from the previous publication) at least every 2 years. 
In addition, in the preamble to the voluntary nutrition labeling final 
rule (56 FR 60880 at 60881), FDA advised that in order to make the 
guidelines as consistent as possible with the regulations governing the 
rest of the food supply (except for those foods subject to regulation 
by the United States Department of Agriculture (USDA)), the guidelines 
would be subject to change after the agency issued its report in 1993 
on compliance by retailers.
    FDA published the final regulations implementing the 1990 
amendments in the Federal Register of January 6, 1993, including 
regulations on mandatory nutrition labeling (58 FR 2079); reference 
daily intakes (RDI's) and daily reference values (DRV's) (hereinafter 
referred to as ``the RDI/DRV final rule'') (58 FR 2206); and serving 
sizes (hereinafter referred to as ``the serving size final rule'') (58 
FR 2229). It made technical changes in these final rules on August 18, 
1993 (58 FR 44020).
    FDA is now proposing to update the nutrition labeling values for 
the 20 most frequently consumed raw fruit, vegetables, and fish and to 
revise the guidelines for the voluntary nutrition labeling of raw 
fruit, vegetables, and fish to reflect the January 1993 final rules as 
modified.

II. Substantial Compliance by Food Retailers with the Guidelines for 
the Voluntary Nutrition Labeling of Raw Fruit, Vegetables, and Fish

    FDA is proposing to make two minor changes and one substantive 
change to Sec. 101.43. As explained in detail below, FDA is proposing 
to revise Sec. 101.45. To reflect these revisions, FDA is proposing to 
amend Sec. 101.43(a)(1) to reference Sec. 101.45(a)(1) and 
Sec. 101.43(a)(2) to reference Sec. 101.45(a)(2), (a)(3), and (a)(4).
    In addition, FDA is proposing to revise Sec. 101.43(a)(3) to 
provide that retailers must use the data provided by FDA in proposed 
Appendices C and D to part 101 (21 CFR part 101) for the 20 most 
frequently consumed raw fruit, vegetables, and fish to be in compliance 
with the guidelines for the voluntary nutrition labeling program. 
Current Sec. 101.43(a)(3) allows for the use of: values that have been 
provided by FDA, (2) values that have been accepted by FDA, or (3) 
values that are consistent with current Sec. 101.45 (d) and (e) and 
have not been found to be out of compliance after a review under 
Sec. 101.9(e). (This reference is to the version of Sec. 101.9(e) in 
effect in 1991 and not that in the January 6, 1993, final rule (see 58 
FR 2079 at 2181).) FDA provided this flexibility because, given the 
time constraints imposed by the 1990 amendments, the agency did not 
have an opportunity to subject the nutrition labeling values that it 
provided for retailer use (see 56 FR 60880 at 60888 through 60889, and 
corrected at 57 FR 8174 (hereinafter referred to as the ``1991 interim 
nutrition labeling values'')) to public comment. Therefore, FDA did not 
require that these values be used to achieve retailer compliance. With 
more time, however, FDA has now developed a set of values that it 
believes are representative and is soliciting comment on those values, 
which are set out in proposed Appendices C and D to part 101. 
Interested persons should comment on the proposed nutrition labeling 
values themselves and provide any relevant information that would 
affect those values. The agency intends to require that these specific 
values be used by those retailers who decide to provide nutrition 
labeling for raw fruit, vegetables, and fish.
    FDA tentatively finds that requiring the use of the nutrition 
labeling values is appropriate because these values reflect available 
data for the covered foods; their use will ensure that consumers 
receive consistent information from retail stores across the country; 
and will facilitate compliance determinations by FDA. Use of different 
values for the same food by different stores will likely cause consumer 
confusion and will only serve to undercut the credibility of the 
nutrition labeling that is provided.
    If this proposal is adopted, retailers who use other data for these 
foods will not to be in compliance with the guidelines.

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

    FDA is proposing to revise the nutrition labeling values for the 
most frequently consumed raw fruit, vegetables, and fish (proposed 
Appendices C and D to part 101) to: (1) Be consistent with the 
nutrition labeling requirements in Sec. 101.9 (b), (c), and (d) that 
affect serving sizes, nutrient content, and label format; (2) reflect 
newer or additional data for these foods that have been submitted or 
made available to the agency; and (3) apply FDA compliance 
calculations, where possible, to data derived from USDA sources.

A. Changes Necessary for Consistency With Nutrition Labeling 
Requirements in Sec. 101.9 (b), (c), and (d)

    FDA has designed proposed Appendices C and D to be consistent with 
the final regulations on nutrition labeling.
    Consistent with Sec. 101.9(c) (58 FR 2229 at 2291), which lists the 
nutrients that are to be included in the nutrition label, FDA is 
proposing to add values for calories (cal) from fat, saturated fat, 
cholesterol, dietary fiber, and sugar to the list of nutrients in the 
appendices. The 1991 interim nutrition labeling values included dietary 
fiber for fruits and vegetables, and saturated fat and cholesterol for 
fish. However, these specific values were not required for retailer 
compliance with the guidelines. FDA is proposing to require that these 
items be included in the nutrition label for raw fruit, vegetables, and 
fish to ensure that consistent nutrition information is provided across 
the food supply.
    Consistent with Sec. 101.9(c)(2) and (c)(2)(i) (58 FR 44063 at 
44076, August 18, 1993), FDA is proposing to provide the values for 
total fat and saturated fat in 0.5-gram (g) increments for quantities 
of less than 5 g and in whole gram increments for quantities above 5 g. 
The values for fat and saturated fat in the 1991 interim nutrition 
labeling values were rounded to whole numbers, but FDA has concluded 
that for foods other than raw fruit, vegetables, and fish, the 
available methodology is sensitive enough to present fat and saturated 
fat levels in half g increments up to 5 grams (58 FR 44063 at 44064). 
FDA tentatively finds, based on the need for consistency of nutrition 
labeling among food products (see 58 FR 44063 at 44065), that it is 
appropriate to declare fat and saturated fat in similar increments for 
raw fruit, vegetables, and fish.
    Consistent with Sec. 101.9(c)(5), information on potassium is 
provided in the proposed labeling values as a voluntary component. If 
FDA adopts proposed Sec. 101.43(a)(3) and Appendices C and D to part 
101, retailers could comply with the guidelines even if they do not 
provide the information for potassium. Nevertheless, FDA is proposing 
to include the information on potassium because many raw fruits, 
vegetables, and fish are good sources of this nutrient. Some retailers 
and marketing associations have expressed an interest in providing 
information on potassium levels. FDA tentatively finds that the 
potassium information will be useful to consumers who are attempting to 
increase or restrict their intake of this substance. Inclusion of 
information on potassium in proposed Appendices C and D makes it likely 
that this information will be provided to consumers.
    Consistent with Sec. 101.9(b)(7) (58 FR 2229 at 2292), FDA is 
proposing to declare the serving sizes in the appendices in ounce (oz) 
equivalents, using slashes between metric and oz weights, and rounding 
to the nearest 0.1-oz increment. Consistent with Sec. 101.9(b)(5)(iv), 
28 g is equivalent to 1 oz in the proposed appendices.
    FDA is proposing to change the serving sizes for a number of items 
from those listed in the 1991 interim nutrition labeling final rule. 
FDA is proposing to change the serving size for peach from ``2 medium 
(174 g)(6 oz)'' to ``1 medium (98 g/3.5 oz).'' The value of 174 g for 2 
peaches was derived from Agriculture Handbook No. 8-9 (Ref. 3). 
However, more recent information (Ref. 4) shows that a medium peach 
weighs about 98 g.
    FDA is proposing to change the serving size for avocado from ``\1/
3\ medium (55 g)(2 oz)'' to ``\1/5\ medium (30 g/1.1 oz)'' to be 
consistent with the serving size final rule (Sec. 101.12(b)) for this 
food. The serving size for avocado was 55 g in the serving size 
proposal (November 27, 1991, 56 FR 60394 at 60419), but based on 
comments received in response to this proposal, FDA changed the serving 
size to 30 g in the final regulation (see 58 FR 2229 at 2296).
    FDA is proposing to change the serving size for tangerine from ``2 
medium, 2\3/8\'' diameter (168 g)(6 oz)'' to ``1 medium (109 g/3.9 
oz)'' to reflect newer information available about this fruit from the 
Produce Marketing Association (PMA) (Ref. 5).
    Consistent with Sec. 101.9 (d)(7) and (d)(8) (58 FR 44063 at 
44077), FDA is proposing to provide information on the percent daily 
values (DV's) for potassium and all mandatory nutrients except sugars 
and protein. The agency calculated the percent DV's in the proposed 
appendices by dividing the rounded quantitative values by the DRV's for 
macronutrients and electrolytes and by the RDI's for vitamins and 
minerals. As provided in Sec. 101.9 (c)(8)(iv) and (c)(9) of the RDI/
DRV final rule (58 FR 2206 at 2227), these DRV's are 65 g total fat, 20 
g saturated fat, 300 milligram (mg) cholesterol, 2,400 mg sodium, 3,500 
mg potassium, 300 g total carbohydrate, and 25 g dietary fiber, and the 
RDI's are 5,000 International Units (IU) vitamin A, 60 mg vitamin C, 
1,000 mg calcium, and 18 mg iron.
    Consistent with Sec. 101.9(c)(8)(iii) (58 FR 2079 at 2178), FDA has 
replaced the asterisks that it used to represent less than 2 percent of 
the U.S. recommended daily allowance (RDA) for vitamin A, vitamin C, 
calcium, and iron, with zeros for the percent DV's of these nutrients. 
Section 101.9(c)(8)(iii) allows the use of zeros or asterisks for 
values that are less than 2 percent of the DV for vitamins and 
minerals. However, FDA tentatively finds that the use of asterisks for 
vitamins and minerals on the charts that are likely to be used for raw 
fruit, vegetables, and fish will be inconsistent with the zeros used 
for other nutrients, and that charts presenting a mixture of zeros and 
asterisks will be confusing for consumers. Therefore, where 
appropriate, FDA has used zeros for vitamins and minerals as well as 
for other nutrients in the proposed appendices.

B. Data Submitted or Made Available to the Agency

    In proposed Appendix C to part 101, FDA has used information on the 
composition of bananas submitted to FDA by Nutrition Network on behalf 
of the International Banana Association (Ref. 6). The nutrition 
labeling values that FDA provided for bananas in the 1991 interim 
values were based on data provided by PMA (Ref. 7). The information 
provided by Nutrition Network included the data provided by PMA plus 
data on additional samples of bananas. Therefore, FDA tentatively 
concludes that the revised values for bananas in Appendix C to part 101 
are superior to the 1991 interim nutrition labeling values because the 
revised values are based on a larger number of analytical values.
    In proposed Appendix C to part 101, FDA has used information on the 
serving size and composition of tangerines that was provided by PMA 
(Ref. 5) after the final rule on the nutrition labeling of raw fruit 
and vegetables was published. The new information has permitted FDA to 
arrive at values for tangerines that are based on FDA calculations 
using procedures derived from the FDA Nutrition Labeling Manual (Ref. 
8). The nutrition labeling values that FDA provided for tangerines in 
the 1991 interim values were based on mean nutrient values from the 
Agriculture Handbook No. 8-9 (Ref. 3). Therefore, FDA tentatively 
concludes that the revised values for tangerines in Appendix C to part 
101 are superior to the 1991 interim nutrition labeling values, which 
are based on mean values, because the revised values are more reliable.
    The labeling values previously provided by FDA for grapes reflected 
``American type'' (adherent skin) grapes. USDA informed FDA, after the 
publication of the final rule on nutrition labeling of raw fruit, 
vegetables, and fish, that the grapes described as ``American 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 type of raw grapes consumed in the United States 
(Ref. 9). USDA stated that it would be more appropriate for FDA to use 
data for ``European type'' grapes as the type most frequently consumed 
in the United States.
    Therefore, the nutrition labeling values for grapes proposed in 
Appendix C to part 101 are based on data from the USDA National 
Nutrient Databank (Ref. 10) and reflect European type (slipskin) 
grapes. FDA used the USDA National Nutrient Databank (Ref. 10) as the 
source of data because it provides information on sample size, means, 
and standard deviations. This information is necessary to obtain values 
appropriate for nutrition labeling.

C. Application of Compliance Calculations to Data From USDA

    In the preamble to the voluntary nutrition labeling final rule (56 
FR 60880 at 60884), FDA stated that if it did not receive new data for 
specific foods, it would subject the 1991 interim nutrition labeling 
values derived from USDA data to FDA compliance calculations and 
publish the revised labeling values in the Federal Register. Compliance 
calculations, which are fully discussed in the ``FDA Nutrition Labeling 
Manual: A Guide for Developing and Using Databases'' (Ref. 8), consider 
the variation of nutrients in foods. The nutrient content of foods 
varies according to inherent, environmental, and processing factors. 
Some nutrients are more variable than others.
    FDA believes that, when possible, the nutrition labeling values 
provided for raw fruit, vegetables, and fish should be based on FDA 
compliance calculations, rather than on mean nutrient values. When mean 
nutrient values are used on a nutrition label, they provide only a 50 
percent confidence level that the declared values accurately reflect 
the nutrient levels in the food. Compliance calculations, on the other 
hand, involve the use of algorithms (formulas) that use mean values for 
nutrients in the food and estimates of variance (i.e., standard 
deviations) to produce labeling values. These values are less likely 
than mean nutrient values to overestimate nutrients like vitamins and 
minerals or to underestimate nutrients like sodium, fat, saturated fat, 
and calories. When compliance calculations are used, they provide 95 
percent confidence that the levels of protein, vitamins, and minerals 
will be at least 80 percent of label declarations, and that the levels 
of calories, fat, saturated fat, cholesterol, and sodium will not be 
more than 120 percent of label declarations.
    Compliance calculations require information on the number of 
samples, mean nutrient content, and estimates of variance (i.e., 
standard deviations). The 1991 interim nutrition labeling values 
derived from Agriculture Handbooks (Refs. 3, 11, and 12), Seafood 
Nutri-Facts (Ref. 13), and other sources (Refs. 14 through 16) had not 
been subjected to compliance calculations because information on number 
of samples and variance was not consistently available from these 
sources.
    When using USDA data for nutrition labeling values for this 
proposed revision, FDA obtained the data, where possible, directly from 
the USDA National Nutrient Databank (Ref. 10) (which is the source of 
the aggregated data provided in Refs. 3, and 11 through 13). The agency 
used the USDA National Nutrient Databank (Ref. 10) because it provides 
individual data points from analyses completed by various sources 
(i.e., government, academic, industry, and private laboratories). The 
other sources of USDA data (Refs. 3, and 11 through 13) provide 
aggregated mean values. The agency used the individual points from the 
USDA National Nutrient Databank to determine the number of samples, 
mean nutrient values, and estimates of variance that are necessary to 
complete the compliance calculations. Statutory deadlines for 
publishing the 1991 proposed and final regulations for the voluntary 
nutrition labeling program did not allow the agency sufficient time to 
obtain, evaluate, and perform compliance calculations on data from the 
USDA National Nutrient Databank (Ref. 10).
    The tentative selection of the USDA National Nutrient Databank 
(Ref. 10) as the preferred source of data for purposes of applying 
compliance calculations results in some changes in the listing of the 
names and descriptors (i.e., presence of skin and cooking method) for 
fish. The listing of fish names in the 1991 interim nutrition labeling 
values was accompanied by specific cooking methods and, where 
appropriate, the term ``skinless.'' These descriptive terms were 
derived from Seafood Nutri-Facts (Ref. 13). The data sources used for 
the proposed fish nutrition labeling values (Refs. 10 and 12) do not 
include a detailed description of how the fish were cooked (although 
they do indicate if dry or moist heat was applied), or whether the skin 
was present or removed. Therefore, FDA is not including detailed 
descriptive terms in the listing of fish names with the proposed 
nutrition labeling values in Appendix D to part 101. The nutrient 
values in Appendix D to part 101 reflect cooking methods that do not 
add fat, breading, or seasoning. The footnote for this appendix states 
this fact.

D. Nutrient Data

    The derivation of each nutrition labeling value in proposed 
Appendices C and D to part 101 is documented in Reference 17. Reference 
17 also lists the 1991 interim nutrition labeling values, so that the 
proposed values can be compared with the previous values.
1. Fruits and Vegetables
    The information that FDA used in arriving at the 1991 interim 
nutrition labeling values for fruits and vegetables included data from 
PMA (Ref. 18) (subjected to compliance calculations), mean values from 
Agriculture Handbooks No. 8-9 (Ref. 3) and No. 8-11 (Ref. 11), and data 
from other sources (Refs. 15 and 16). The data that FDA used in 
arriving at the proposed nutrition labeling values for fruits and 
vegetables include (in descending order of priority):
    a. Market basket sampling and analyses completed by PMA (Refs. 5, 
18, and 19) and Nutrition Network (on behalf of the International 
Banana Association) (Ref. 6). PMA submitted sampling plans, analytical 
data, and suggested nutrition labeling values for various fruits and 
vegetables to FDA for review between 1982 and 1991. PMA subjected the 
data to FDA compliance calculations and subsequently revised the 
nutrition labeling values that it had developed (Ref. 19) to be in 
accordance with the mandatory nutrition labeling final rules (58 FR 
2079) with regard to label content, serving size, DV's, and rounding. 
One of the changes that PMA made in revising its values was to include 
both available carbohydrate and dietary fiber in the values for total 
carbohydrate. The values for raw fruit and vegetables that FDA obtained 
from PMA and used in arriving at the 1991 interim nutrition labeling 
values included only available carbohydrate.
    Nutrition Network (Ref. 6) submitted information on the sampling, 
analysis, and suggested nutrition labeling values of bananas on behalf 
of the International Banana Association. FDA reviewed the data provided 
by Nutrition Network and developed nutrition labeling values for 
bananas based on FDA compliance calculations (Ref. 8). In some cases, 
the nutrition labeling values developed by FDA for bananas (shown in 
Appendix C to part 101) were different than those suggested by 
Nutrition Network.
    b. Data from the USDA National Nutrient Databank (Ref. 10) 
subjected to FDA compliance calculations with appropriate rounding. FDA 
obtained nutrient data tapes and disks from USDA and used the data to 
arrive at mean nutrient values and standard deviations and to develop 
nutrition labeling values, using FDA compliance calculations.
    c. Mean values from Agriculture Handbook No. 8-9 for fruits (Ref. 
3) and from No. 8-11 for vegetables (Ref. 11).
2. Fish
    The information that FDA used in arriving at the 1991 interim 
nutrition labeling values for raw fish included Seafood Nutri-Facts 
(Ref. 13), Agriculture Handbook No. 8-15 (Ref. 12), and a technical 
memorandum from the National Oceanic and Atmospheric Administration and 
the National Marine Fisheries Service (Ref. 14). The data that FDA used 
in arriving at the proposed nutrition labeling values for fish (in 
descending order of priority) are:
    a. Data for cooked fish (3 oz basis) from the USDA National 
Nutrient Databank (Ref. 10), subjected to FDA compliance calculations 
with appropriate rounding. FDA obtained data tapes and disks from USDA, 
estimated mean nutrient values and standard deviations, and developed 
nutrition labeling values using FDA compliance calculations.
    b. Data for raw fish (4 oz basis for finfish and crustacea and 5 oz 
basis for mollusks) from the USDA National Nutrient Databank (Ref. 10), 
subjected to FDA compliance calculations with appropriate rounding. FDA 
obtained data tapes and disks from USDA, estimated mean nutrient values 
and standard deviations, and developed nutrition labeling values using 
FDA compliance calculations.
    c. Mean values for cooked fish from Agriculture Handbook No. 8-15 
for fish (Ref. 12). A special situation is presented by orange roughy. 
Orange roughy is one of the few edible plants and animals that contains 
wax esters. Because the wax esters are extracted with lipids during 
analysis, under Sec. 101.9(c)(2), which requires that the nutrition 
label list the total fat in a serving of food, the fat value for orange 
roughy should reflect the presence of these wax esters (even though 
they do not provide a metabolizable source of energy for humans). The 
value for fat in cooked orange roughy in Agriculture Handbook 8-15 
(1990 Supplement), upon which FDA relied in developing proposed 
Appendix D, does not, however, include the wax esters. FDA is not aware 
of any other source for a value for this nutrient in this food that 
includes the wax esters. Therefore, FDA requests that information that 
provides a basis for establishing a value for total fat in cooked 
orange roughy that reflects the presence of the wax esters be submitted 
in comments on this proposal. If the agency receives acceptable 
information, FDA intends to include that value in any version of 
Appendix D that it adopts.
    d. Mean values for raw fish (4 oz basis for finfish and crustacea 
and 5 oz basis for mollusks) from Agriculture Handbook No. 8-15 for 
fish (Ref. 12).
3. Corrections for Cooking
    As stated above, FDA used analytical data for cooked (rather than 
raw) fish when they were available. If data for cooked fish were not 
available, it used data for raw fish. When it was necessary to use data 
for raw fish, the agency used a weight retention factor of 75 percent 
to convert the weight of raw finfish to a cooked weight and a factor of 
60 percent to convert the raw weight of mollusks to a cooked weight 
(Refs. 12 and 20). Based on information provided by USDA, FDA assumed 
that the weight loss during cooking resulted from moisture only, and 
that there was no loss of fat or minerals with cooking (Ref. 20). 
Therefore, 4 oz of raw finfish were used to obtained data for 3 oz 
cooked finfish, and 5 oz of raw mollusk (clam, oyster, scallop) were 
used to obtain data for 3 oz cooked mollusk.
    FDA applied a retention factor of 90 percent to the vitamin A value 
of raw chum/pink salmon to achieve the value for the cooked chum/pink 
salmon (Ref. 12). The application of this retention factor did not 
change the value of 2 percent DV for this vitamin. All the other 
vitamin A values for the fish were either negligible or were available 
on a cooked basis.
4. Calories from Fat
    FDA calculated calories from fat using 8.37 cal per g of fat for 
fruits and vegetables and 9.02 cal per g of fat for fish. These caloric 
equivalents are provided in Agriculture Handbook No. 8-9 for fruits 
(Ref. 3), No. 8-11 for vegetables (Ref. 11), and No. 8-15 for fish 
(Ref. 12).
5. Saturated Fat
    Saturated fat is defined in Sec. 101.9(c)(2)(i) (58 FR 2079 at 
2176) as the sum of fatty acids without double bonds. Because complete 
fatty acid profiles are not available for most foods in the National 
Nutrient Databank (Ref. 10), FDA was not able to obtain the saturated 
fat value for these foods by summing the individual saturated fatty 
acids or to apply the compliance calculations to this component. FDA 
used mean saturated fat values obtained from Agriculture Handbooks 8-9 
(Ref. 3), No. 8-11 (Ref. 11), and No. 8-15 (Ref. 12) in proposed 
Appendices C and D to part 101.
6. Sugars
    The sugars values included in proposed Appendix C to part 101 
reflect total sugars and are derived primarily from the USDA Home 
Economics Research Report No. 48 (Ref. 21). FDA also obtained some 
newer data on the sugars content of raw fruit from USDA by personal 
communication (Ref. 22). For some fruits, the sugars values from 
reference 19 were high relative to the values for total carbohydrate 
and dietary fiber, i.e., the sugars value when added to dietary fiber 
exceeded total carbohydrate. Ideally, the sugars value when added to 
dietary fiber should be less than or equal to total carbohydrate. FDA 
adjusted the total carbohydrate for apple, watermelon, and grapes to 
reflect the sum of sugars and dietary fiber. FDA considers this 
adjustment to be appropriate because analysis of individual sugars and 
dietary fiber is more accurate than estimation of total carbohydrate, 
which is calculated by subtracting the sum of the weight of water, fat, 
protein, and ash from the weight of the food (i.e., carbohydrate by 
difference) (Ref. 22).
7. Other Values
    Information on the vitamin C content of fish was available for only 
four species on the most frequently consumed list. Two of these values 
were negligible (Atlantic/Pacific mackerel and swordfish), and two of 
them were 4 percent of the DV (ocean perch and rainbow trout). FDA 
assigned a value of zero to the vitamin C content of the other 18 
listed fish based on information provided by USDA (Ref. 20) indicating 
that fish are not a reliable source of vitamin C because the quantity 
of this vitamin in fish flesh is low and variable.
    In the absence of other information, FDA used several well-known 
principles of food composition to develop the nutrition labeling values 
in proposed Appendices C and D to part 101. FDA used a value of zero 
for each of the following: (1) Cholesterol in fruit and vegetables 
because cholesterol is found only in animal tissues; (2) saturated fat 
in all fruit and vegetables that have a zero total fat content because 
saturated fat is 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.

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

    FDA is not proposing any changes in the listing of the 20 most 
frequently consumed raw fruit and vegetables in Sec. 101.44 (21 CFR 
101.44) because it is not aware of any information that suggests that 
different or additional fruit or vegetables need to be added to the 
list. However, FDA is proposing to make four changes to the list of the 
20 most frequently consumed raw fish.
    First, FDA is proposing to list chum, pink, and sockeye subspecies 
of salmon instead of just Atlanta/Coho. FDA initially listed in 
Sec. 101.44(c) only the subspecies ``salmon, Atlantic/Coho'' (56 FR 
60880 at 60890). However, comments that the agency has received (Refs. 
23 and 24) since the publication of the voluntary nutrition labeling 
final rule have requested that FDA include listings for salmon 
subspecies that have different nutrient profiles than the Atlantic/Coho 
subspecies. In addition to Atlantic and Coho (silver), other subspecies 
of salmon consumed in the United States include chum, pink, chinook 
(king), and sockeye (red) (Ref. 23).
    The U.S. market for fresh salmon species varies with availability 
of the catch, and economic factors dictate which species are sold fresh 
or canned and which are exported (Ref. 23). In addition to Atlantic and 
Coho salmon, chum, pink, and sockeye salmon are generally available in 
the fresh fish section of retail stores, whereas chinook salmon is most 
often smoked before retail sale or is sold to restaurants (Ref. 23). 
Atlantic and Coho salmon contain 6 to 7 g of fat and 160 cal per 3 oz 
cooked (proposed Appendix D to part 101). Chum and pink salmon are 
lower in fat and calories than other species. They contain 4 g of fat 
and 130 cal per 3 oz cooked (proposed Appendix D to part 101). Sockeye 
salmon has higher fat and calorie levels, containing 9 g of fat and 180 
cal per 3 oz cooked (proposed Appendix D to part 101).
    Based on the differences in fat and calorie levels of salmon 
subspecies, FDA is proposing to revise Sec. 101.44(c) to add chum/pink 
salmon and sockeye salmon to the list of the most frequently consumed 
raw fish as subspecies under salmon. FDA has tentatively concluded that 
chinook salmon should not be added to the list because it is not widely 
available in the fresh fish section of retail stores (Ref. 23).
    Secondly, FDA is proposing to consolidate the listing for flounder 
and sole as one item, ``flounder/sole,'' because the nutrient data for 
these two species are very similar, and they are grouped together in 
Agriculture Handbook No. 8-15 (Ref. 12), the primary source of the 
values for these fish that are presented in proposed Appendix D to part 
101. Agriculture Handbook No. 8-15 groups these fish together under the 
heading of ``flatfish.'' FDA is continuing to use ``flounder/sole,'' 
however, because the agency notes that these names are commonly used at 
the retail level. The agency's tentative view is that the term 
``flatfish'' would not be commonly known or understood among consumers 
and could lead to consumer confusion.
    The nutrition labeling values for flounder and sole in the 1991 
voluntary nutrition labeling final rule were obtained from Seafood 
Nutri-Facts (Ref. 13), which provided separate nutrient profiles for 
these fish. As explained in section III.C. of this document, FDA has 
tentatively decided to use the USDA National Nutrient Databank as the 
primary source for data on fish, when available, and the Agriculture 
Handbook No. 8-15 (Ref. 12) as the secondary source. These sources are 
more up-to-date, and provide more documentation, than Seafood Nutri-
Facts (Ref. 13).
    Thirdly, FDA is proposing to remove the word ``jack'' from the 
description of mackerel. FDA is proposing this change because the 
previous data source used for determining the nutrition labeling 
values, Seafood Nutri-Facts (Ref. 13), provided a single nutrient 
profile for ``Pacific & jack mackerel,'' whereas the data source that 
FDA is using as a basis for the proposed nutrition labeling for this 
fish, the USDA National Nutrient Databank (Ref. 10), describes the 
species as ``Pacific mackerel.'' Nutrient data for both Atlantic and 
Pacific mackerel are available in the USDA National Nutrient Databank 
(Ref. 10), but data for jack mackerel are available only on the canned 
form from this source. Therefore, to include both the Atlantic and 
Pacific subspecies (which have similar nutrient profiles); to reflect 
raw, rather than canned, mackerel; and to accurately identify the fish 
associated with the nutrition labeling values, FDA is proposing to 
describe the fish as ``Mackerel, Atlantic/Pacific.''
    Fourthly, FDA is proposing to add swordfish to the list to keep the 
number of fish at 20. The 1990 amendments directed FDA to identify the 
20 most frequently consumed raw fruit, vegetables, and fish (section 
403(q)(4)(B)(i) of the act). FDA used information provided by the 
National Fisheries Institute (Ref. 25) to identify the most frequently 
consumed species of fish in the United States for the voluntary 
nutrition labeling final rule. According to this information, swordfish 
is the next fish in decreasing order of consumption after lobster.
    FDA is proposing to revise Sec. 101.44(c) based on the four changes 
discussed above to read as follows: ``The 20 most frequently consumed 
raw fish are: Shrimp, cod, pollock, catfish, scallop, salmon (Atlantic/
Coho, chum/pink, sockeye), flounder/sole, oyster, orange roughy, 
Atlantic/Pacific mackerel, ocean perch, rockfish, whiting, clam, 
haddock, blue crab, rainbow trout, halibut, lobster, and swordfish.''

V. Updating the Guidelines for the Nutrition Labeling of the 20 Most 
Frequently Consumed Raw Fruit, Vegetables, and Fish

    As stated above, FDA is proposing to revise the guidelines in 
Sec. 101.45 for the nutrition labeling of raw fruit, vegetables, and 
fish to make them as consistent as possible with the nutrition labeling 
requirements that FDA has established in Sec. 101.9 (b), (c), and (d). 
The agency believes that consistency in nutrition labeling among 
various types of food products is necessary to help consumers compare 
products and make appropriate food choices. It is also consistent with 
section 2(b)(1)(A) of the 1990 amendments because it will foster 
consumer understanding of the nutrition label and help consumers to put 
the nutrient values that are presented into the context of the total 
daily diet.
    The agency is proposing to subdivide Sec. 101.45(a) into four 
parts. In Sec. 101.45(a)(1), FDA is proposing to provide how the 
nutrition labeling of raw fruit, vegetables, and fish should be 
displayed. The agency states that the information should be displayed 
at the point of purchase by appropriate means, such as by a label 
affixed to the food or through labeling including shelf labels, signs, 
posters, brochures, notebooks, or leaflets. The agency also states that 
the information should be readily available and in close proximity to 
the foods. Proposed Sec. 101.45(a)(1) remains the same as current 
Sec. 101.45(a), except that the agency has made editorial changes to 
the first sentence to distinguish between nutrition labels (nutrition 
information affixed to foods), and nutrition labeling (nutrition 
information in proximity but not necessarily attached to foods), and to 
clarify that shelf labels and posters may be used as a form of labeling 
for raw fruit, vegetables, and fish.
    To be consistent with the final mandatory nutrition labeling rule 
(58 FR 2079), FDA is proposing in Sec. 101.45(a)(2) that serving sizes 
should be determined, and required nutrients should be declared, in 
accordance with Sec. 101.9 (b) and (c).
    Current Sec. 101.45(b) provides that nutrition labeling on raw 
fruit, vegetables, and fish should be provided in accordance with 
Sec. 101.9, but it does not explicitly refer to the provisions of 
Sec. 101.9 that have direct application to the nutrition labeling of 
raw fruit, vegetables, and fish. Proposed Sec. 101.45(a)(2) 
acknowledges the specific applicability of new Sec. 101.9 (b) and (c) 
to the voluntary nutrition labeling program. If consumers are to make 
meaningful comparisons between raw and processed foods, the serving 
sizes on which those comparisons are based must have a consistent 
basis. By cross-referencing Sec. 101.9(b), which it adopted in response 
to section 403(q)(1)(A)(i) of the act, FDA is proposing to ensure that 
the serving sizes for raw fruit, vegetables, and fish are consistent 
with the serving sizes for processed foods.
    By cross-referencing Sec. 101.9(c), FDA is proposing to make 
explicit the list of nutrients that must be included in nutrition 
labeling for raw fruit, vegetables, and fish, if the nutrition labeling 
is to be in compliance with FDA's regulations. Under this proposal, and 
to reflect the changes made by the January 1993 final rules, this list 
will supersede the nutrient list in current Sec. 101.45(b)(1), which 
allows for voluntary labeling of thiamine, riboflavin, and niacin, as 
well as complex carbohydrates, sugars, dietary fiber, saturated fat, 
and cholesterol. In addition, proposed Sec. 101.45(a)(2) incorporates 
current Sec. 101.45(b)(4), which states that the nutrition label values 
should be based on a raw edible portion for fruit and vegetables and on 
a cooked edible portion for fish, and that the methods used to cook the 
fish must not add fat, breading, or seasoning.
    In proposed Appendices C and D to part 101, FDA is providing 
serving sizes and nutrient values that fully comply with proposed 
Sec. 101.45(a)(2) for the 20 most frequently consumed fruit, 
vegetables, and fish.
    Proposed Sec. 101.45(a)(3) provides that nutrition labeling may be 
presented on charts in horizontal or vertical columns. Proposed 
Sec. 101.45(a)(3) will allow for increased flexibility over current 
Sec. 101.45(b)(2) in the development of posters, brochures, and other 
labeling materials by allowing for horizontal columns. However, to be 
consistent with Sec. 101.9(d)(2), adopted as part of the January 1993 
final rules, the agency is proposing that any nutrition labeling that 
is provided must bear the heading ``Nutrition Facts'' in type larger 
than all other print used in the nutrition label. Consumers will be 
familiar with this heading and understand its significance from its use 
on packaged foods.
    Under proposed Sec. 101.45(a)(3), nutrition labeling on raw fruit, 
vegetables, or fish that is presented in a linear (as opposed to 
columnar) format will not be considered to be in compliance by FDA. 
Although presentation of nutrition information in lines is allowed by 
current Sec. 101.45(b)(2), FDA is concerned that this format is too 
difficult for consumers to read when so many items are listed. Given 
that the space constraints that apply to labels on food packages do not 
apply to the signs, placards, and notebooks that are used to label raw 
fruit, vegetables, and fish, FDA tentatively concludes that there is no 
basis to permit the use of this format in the labeling of these 
products. Therefore, FDA is proposing to provide that it will not 
accept the use of this format. FDA requests comment on this change from 
the current regulation.
    FDA is also proposing in Sec. 101.45(a)(3) that the nutrition 
information be clearly presented and of sufficient type size and color 
contrast to be plainly legible. This provision is authorized by section 
2(b)(1)(A) of the 1990 amendments, which states that nutrition labeling 
must be readily observable and comprehensible. Moreover, FDA's view is 
that nutrition information will only be of use to consumers if it is 
clearly visible.
    Consistent with Sec. 101.9(d)(1)(iv), FDA is proposing in 
Sec. 101.45(a)(3) that the values for percent DV's be highlighted in 
contrast to the quantitative amounts by weight. FDA believes that this 
highlighting, which may be accomplished by bolding the percent DV's, 
will assist the consumer in focusing on the most important information 
on the label.
    Proposed Sec. 101.45(a)(3)(i) provides that the number of servings 
per container need not be included in the nutrition labeling of foods 
under the voluntary program. This provision remains the same as in 
current Sec. 101.45(b)(3). FDA's view is that retailers need not 
provide the number of servings per container because raw fruits, 
vegetables, and fish are not usually available in containers, and even 
when they are, retailers may not be able to determine the number of 
servings per container because it could vary from one container to 
another. The number of servings is variable and difficult to predict 
because whole sizes of fruits, vegetables, and fish vary, and when 
containers are used the number of items per container varies. Thus, FDA 
tentatively concludes that it is not reasonable to expect retailers to 
predict the number of items per container.
    In proposed Sec. 101.45(a)(3)(ii), FDA provides that the statement 
``Percent Daily Values are based on a 2,000 calorie diet'' be a 
required part of the nutrition labeling information (i.e., on posters, 
brochures, or other labeling materials) for raw fruits, vegetables, and 
fish. Requiring that this information be included is consistent with 
information requirements for other foods under Sec. 101.9(d)(9)(i). 
However, FDA is not proposing to require that the entire footnote 
specified in Sec. 101.9(d)(9)(i), which lists the DV's for six 
nutrients for two levels of caloric intake. FDA tentatively concludes 
that the space required for this footnote is likely to be such that 
retailers will make it so small that it will be difficult for consumers 
to read or will simply not provide nutrition labeling at all because 
the poster that would be needed to provide all the required information 
would be so large as to be unwieldy. However, FDA does encourage the 
use of this footnote when nutrition labeling information for raw fruit 
and vegetables or for raw fish is provided in brochures, notebooks, or 
leaflets, where the space in which to present information is less at a 
premium.
    In proposed Sec. 101.45(a)(3)(iii), FDA is providing that when the 
nutrition labeling information for raw fruits and vegetables is 
provided on a chart, the columns for saturated fat and cholesterol may 
be omitted with use of the following footnote, ``Most fruits and 
vegetables provide negligible amounts of saturated fat and cholesterol; 
avocados provide 1.0 g of saturated fat per oz.'' FDA is also proposing 
in this section that when the nutrition labeling information for raw 
fish is provided on a chart, the columns for dietary fiber and sugars 
may be omitted with use of the following footnote, ``Fish provide 
negligible amounts of dietary fiber and sugars.'' FDA is proposing 
these changes, as stated above, because fruits and vegetables (other 
than avocados which contain saturated fat) do not contain saturated fat 
and cholesterol, and because fish do not contain dietary fiber or 
sugars. FDA tentatively concludes that these changes will reduce the 
size of the charts (making them easier to read) without reducing the 
amount of information that is provided to consumers.
    FDA is aware that producers and packers who package fruit, 
vegetables, and fish may wish to put nutrition information directly on 
food packages. When that is done, FDA believes that the nutrition label 
format can and should be entirely consistent with the format 
requirements in Sec. 101.9(d) if there is sufficient space for meeting 
the nutrition label format requirements. The nutrition label format 
requirements under proposed Sec. 101.45 are designed to cover the 
situation in which raw fruit, vegetables, and fish are sold in bulk and 
nonpackaged form, circumstances that create space constraints on the 
voluntary presentation of nutrition information and that require the 
use of such mechanisms as posters, signs, or shelf labels. If producers 
and packers choose to provide nutrition labeling on raw fruit, 
vegetables, or fish that are sold in packaged form, that labeling 
should comply with format and other regulations that apply to other 
foods sold in packaged form. In addition, if retailers or producers 
wish to provide nutrition labeling on individual signs posted above, or 
in close proximity to bins or containers of raw fruit, vegetables, or 
fish, the nutrition information should be presented in a format that is 
consistent with the format requirements in Sec. 101.9(d).
    Therefore, proposed Sec. 101.45(a)(4) states that when nutrition 
information is provided on foods sold in packaged form or on signs for 
individual foods in retail stores, it should be displayed in accordance 
with Sec. 101.9(d), except that consistent with proposed 
Sec. 101.45(a)(3)(i), the declaration of the number of servings per 
container need not be provided. As stated above, the number of servings 
is variable and difficult to predict because whole sizes of fruits, 
vegetables, and fish vary, and the number of items per container 
varies. FDA tentatively concludes that it is not reasonable to expect 
producers and packers to predict the number of items per container.
    FDA is also proposing in Sec. 101.45(a)(4) to accept the use of the 
simplified format set forth in Sec. 101.9(f) if the food contains 
insignificant amounts of seven or more of the following food 
components: Calories, total fat, saturated fat, cholesterol, sodium, 
total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin 
C, calcium, or iron. FDA allows the use of simplified nutrition label 
formats on packaged, processed foods under section 403(q)(5)(C) of the 
act and is not aware of any reason why the simplified nutrition 
labeling format should not be allowed on raw fruit, vegetables, or fish 
that bear individual labels. Fruits and vegetables among the 20 most 
frequently consumed that qualify for a simplified format (based on the 
nutrition labeling values in proposed Appendix C to part 101) include: 
Apple, avocado, pineapple, lime, mushrooms, and radishes. Fish that 
qualify for a simplified format (based on the nutrition labeling values 
in proposed Appendix D to part 101) are pollock, catfish, and orange 
roughy.
    Proposed Sec. 101.45(b) provides that the nutrition labeling values 
provided by FDA in proposed Appendices C and D to part 101 for the 20 
most frequently consumed raw fruit, vegetables, and fish must be used 
by retailers who participate in the voluntary nutrition labeling 
program if they are to be in compliance. As explained above, FDA 
believes that the use of these values will help to ensure uniformity in 
the values presented to consumers in various retail stores, and that 
uniformity will prevent or decrease consumer confusion. Consumers could 
be confused by seeing different values for the same foods in different 
retail stores. FDA believes that the nutrition labeling values that it 
has provided in proposed Appendices C and D to part 101 are the most 
appropriate values for these foods based on data currently available. 
FDA intends to keep these values up-to-date by revising them based on 
additional or newer information and by making the revised values 
available for public comment in the Federal Register at least every 2 
years. This provision is the same as in current Sec. 101.45(i).
    In proposed Sec. 101.45(b)(1), FDA encourages interested persons to 
submit data bases to the agency with new or additional nutrient data 
for any of the 20 most frequently consumed raw fruit, vegetables, and 
fish. FDA intends to review data for these foods as it receives them 
(including data received during the public comment period) and 
incorporate them, as appropriate, into the biennial revisions of the 
nutrition labeling values.
    Proposed Sec. 101.45(b)(1)(i) states that FDA guidance in the 
development of data bases can be found in the ``FDA Nutrition Labeling 
Manual: A Guide for Developing and Using Data Bases'' (Ref. 6), which 
is available from the FDA Office of Food Labeling (HFS-150). This 
provision is an update of current Sec. 101.45(e), which references the 
older version of the FDA Nutrition Labeling Manual.
    Proposed Sec. 101.45(b)(1)(ii) provides that the submission of data 
to FDA should include, but need not be limited to, information on the 
following: Source of the data, number of samples, sampling design, 
analytical method, and statistical treatment of the data. This 
provision remains the same as current Sec. 101.45(c) with editorial 
changes. Proposed Sec. 101.45(b)(1)(ii) also states that proposed 
quantitative label declarations may be included. It states that these 
proposed values should be determined in accordance with the FDA 
Nutrition Labeling Manual (Ref. 6).
    Current Sec. 101.45(c) describes how to submit data bases and 
proposed nutrition labeling values for raw fruit, vegetables, and fish 
to the agency for review and possible acceptance. The current provision 
includes data bases for raw fruit, vegetables, and fish that are not 
among those identified as most frequently consumed, as well as data 
bases for items identified as most frequently consumed.
    FDA is proposing in new Sec. 101.45(c) that data bases of nutrient 
values for specific varieties, species, or cultivars of raw fruit, 
vegetables, and fish, that are not among the 20 most frequently 
consumed, may be used to develop nutrition labeling values for these 
foods and may be submitted for review under Sec. 101.9(g)(8). Although 
these fruits, vegetables, and fish need not bear nutrition labeling, 
FDA is aware that various retail stores and trade associations have 
developed nutrition labeling values for them. While the agency does not 
have resources to develop nutrition labeling values for these foods, it 
encourages the voluntary provision of such information because it will 
assist consumers in making healthy food choices.
    Data bases for these raw fruit, vegetables, and fish may 
voluntarily be submitted to FDA for review if the developers wish to 
avail themselves of the provisions in Sec. 101.9(g). FDA believes that 
individuals or organizations that desire FDA acceptance of data bases 
and nutrition labeling values should be able to submit this information 
to the agency for review. Proposed Sec. 101.45(c)(1) provides that if a 
food retailer decides to provide nutrition information about raw fruit, 
vegetables, and fish not among the most frequently consumed, it should 
use food names and descriptions that clearly identify these raw fruit, 
vegetables, and fish as distinct from those for which FDA is providing 
nutrition labeling values. This provision remains the same, except for 
editorial changes, as the second sentence of current Sec. 101.45(d). 
FDA believes the information for the foods will only be useful to 
consumers if the foods are clearly identified, so that consumers will 
not confuse them with the foods listed in proposed Appendices C and D 
to part 101. For example, retailers might provide nutrition labeling 
values for red cabbage, valencia oranges, or winter squash, foods for 
which FDA is not currently providing values.
    Proposed Sec. 101.45(c)(2) states that guidance on the development 
of data bases may be found in the FDA Nutrition Labeling Manual (Ref. 
6). This provision, like proposed Sec. 101.45(b)(1)(i), is an update of 
current Sec. 101.45(e) which references the older version of the FDA 
Nutrition Labeling Manual.
    In proposed Sec. 101.45(c)(3), FDA states that the nutrition 
labeling values computed from data bases for raw fruit, vegetables, and 
fish that are not among the 20 most frequently consumed, or for 
specific species or cultivars of raw fruit, vegetables, and fish, are 
subject to the compliance provisions of Sec. 101.9(g). This provision 
is the same as current Sec. 101.45(h) except that the reference to 
review and acceptance of data bases is removed. FDA intends to provide 
surveillance of the nutrition labeling of raw fruit, vegetables, and 
fish that are not among the 20 most frequently consumed in the same 
manner that it provides surveillance for foods for which nutrition 
labeling is mandatory.
    In proposed Sec. 101.45(c)(3)(i), FDA states that compliance with 
the provisions of Sec. 101.9(g) may be achieved by use of a data base 
that has been developed following FDA guideline procedures and that has 
been approved by FDA. Proposed Sec. 101.45(c)(3)(i)(A) provides that 
the submission of a data base to FDA should include, but need not be 
limited to, information on the following: Source of the data, number of 
samples, sampling design, analytical methods, statistical treatment of 
the data, and proposed quantitative label declarations. This provision 
remains the same, except for editorial changes, as current 
Sec. 101.45(c). Proposed Sec. 101.45(c)(3)(i)(A) states that the values 
for declaration should be determined in accordance with the FDA 
Nutrition Labeling Manual (Ref. 8).
    Proposed Sec. 101.45(c)(3)(i)(B) provides information about FDA 
approval of data bases, namely the need for written approval by FDA, 
the time limits on approval, revocation of approval, and approval 
requests. This provision replaces current Sec. 101.45(b) and is 
consistent with Sec. 101.9(g)(8), which concerns approval of data bases 
for nutrition labeling of most foods.
    The agency notes that in this document it is modifying the 
terminology that it uses to describe the results of the FDA review 
process from ``accept'' to ``approve.'' The agency is making this 
change in Sec. 101.45 to reflect the terminology that it used in the 
final rule on mandatory labeling of food in Sec. 101.9.
    Although the agency is proposing to change the terminology in 
Sec. 101.45, it is not proposing any change in the underlying process. 
The purpose of Sec. 101.45(c) has been, and continues to be under this 
proposal, to provide a mechanism whereby interested persons may obtain 
agency agreement that the values in the data bases that they have 
developed are an accurate reflection of the nutrient levels in the 
subject food. It is the agency's intent to evaluate data bases whether 
for the voluntary or mandatory labeling programs in a consistent 
manner. Thus, for the purposes of the FDA data base review process, the 
terms ``accept'' and ``approve'' are interchangeable. Because 
``approve'' is the term that FDA used in Sec. 101.9, the agency is 
moving to make its use consistent across its regulations.
    The agency notes, however, that the process by which it reviews 
data bases has been a problem for a variety of reasons, especially 
given the greatly increased interest in data base use following the 
passage of the 1990 amendments. In the preamble to the nutrition 
labeling final rule that issued on January 6, 1993 (58 FR 2079 at 
2164), FDA encouraged manufacturers who wish to use a data base for 
nutrition labeling to follow the statistical procedures outlined in the 
FDA Nutrition Labeling Manual (Ref. 8) and to have the data base 
reviewed and approved by FDA. Several food companies and trade 
associations have submitted data bases, ingredient data base systems, 
and proposed nutrition labeling values to FDA for review and 
evaluation. The agency has found that its resources for data base 
review simply are not adequate to handle the volume of submissions that 
the agency has received. Thus, the agency has been left trying to 
decide how it can accommodate the interest in agency review and 
approval of data bases, and the assurances that approval provides, and 
at the same time maintain a system that is responsive to review 
requests; that is, that provides reasonable and timely responses to 
requests for agency review but that does not overwhelm the resources 
that the agency has available for such reviews.
    Based on its very preliminary review of the situation in the short 
time since the January 6, 1993, final rule was published, FDA believes 
that some modifications in its approach to data bases may be necessary. 
The agency is considering the possibility that it can adequately 
evaluate a data base using less information than it would expect to 
receive under the guidance in FDA's Nutrition Labeling Manual. The 
agency is also considering the possibility that the system can be made 
more flexible and responsive if manufacturers could be authorized to 
begin labeling their products, if they choose to do so, based on an 
abbreviated, preliminary review by FDA. Such a system could offer a 
manufacturer some assurance that FDA would not take action against its 
products, although the manufacturer would have to agree to quickly move 
to modify its labeling should the agency find the data base to be 
unrepresentative or inadequate.
    Thus, FDA is soliciting comments on all aspects of the FDA data 
base review process. The agency is specifically requesting comments 
about the evaluation criteria as related to: (1) The nature and rigor 
of the evaluation process, including the need for information on the 
source of the data, number of samples, sampling design, analytical 
methods, statistical treatment of data, and proposed quantitative label 
declarations; and (2) the appropriate basis for an ``interim'' approval 
and guidelines to determine key minimal criteria for such ``interim'' 
status, as well as guidelines to establish followup procedures and 
timeframes to ensure that data base developers are stimulated to 
continue to collect data and continue to improve their data bases 
intended for nutrition labeling purposes.
    As background information for comments, FDA notes that the ``FDA 
Nutrition Labeling Manual: A Guide to Developing and Using Databases'' 
(Ref. 8) and the ``Guide to FDA's Database Review System'' (Ref. 26) 
are available from the Office of Food Labeling, HFS-150, 200 C Street 
SW., Washington, DC 20204.

VI. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(11) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

VII. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the proposed 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because compliance with the guidelines for the 
labeling of raw fruit, vegetables, and fish is voluntary, the agency 
certifies that the proposed rule will not have a significant impact on 
a substantial number of small entities. Therefore, under the Regulatory 
Flexibility Act, no further analysis is required.

A. Regulatory Options

    Executive Order 12866 requires agencies also to estimate costs to 
government. The 1990 amendments require that FDA determine every 2 
years if there is substantial compliance with the labeling guidelines. 
If substantial compliance does not exist, FDA must make compliance 
mandatory. FDA estimates that the costs to government are approximately 
$150,000 every 2 years to establish a contract to survey food 
retailers, oversee the contract, and publish a report on the status of 
voluntary compliance.
    If compliance with the guidelines becomes mandatory, costs to the 
government will not significantly change because the costs associated 
with determining if there is substantial compliance would be replaced 
by enforcement costs. If compliance becomes mandatory, costs to 
retailers would increase to $9.9 million in the first year.

B. Benefits of the Proposed Regulation

    In the ``Regulatory Impact Analysis of the Proposed Rules to Amend 
the Food Labeling Regulations'' (November 27, 1991, 56 FR 60856), FDA 
stated that the benefit of labeling raw fruit, vegetables, and fish is 
``some change in purchase behavior.'' At present, the majority of 
consumers are exposed to the nutrition labeling of raw fruit, 
vegetables, and fish. As stated previously, approximately 75.7 percent 
of retailers (representing 76.9 percent of annual sales) of raw fruit 
and vegetables are in compliance with current nutrition labeling 
guidelines. Approximately 73.2 percent of retailers (representing 74.3 
percent of annual sales) of raw fish are in compliance. Therefore, this 
regulation will continue to inform consumers by providing them with 
information on the nutrient content of raw fruit, vegetables, and fish 
and allowing them to compare the nutrient content of these foods with 
other raw and processed foods. By providing nutrient values for the 20 
most frequently consumed raw fruit, vegetables, and fish, this 
regulation has the benefit of facilitating the provision of this 
information to consumers.
    The actions proposed in this document are designed to promote 
consistency. FDA is revising the guidelines for the voluntary nutrition 
labeling of raw fruits, vegetables, and fish to be more consistent with 
the nutrition labeling of foods subject to Sec. 101.9. Similarly, FDA 
is specifying that compliance requires that retailers use the nutrition 
values provided by FDA for the 20 most frequently consumed raw fruit, 
vegetables, and fish, thus providing consistency among retailers. FDA 
believes that the flexibility of allowing manufacturers to use other 
appropriate values does not outweigh the consumer confusion caused by 
different values for the same food in different stores. Thus, the 
regulations will benefit consumers by helping them to recognize and 
understand nutrition labeling information and to avoid confusion.

C. Costs of the Proposed Regulation

    The costs of a labeling regulation are the incremental 
administrative, analytical, redesign, label inventory, and label 
disposal costs associated with the regulatory action. Because FDA is 
requiring that retailers use the nutrition values provided by FDA, 
there will be no analytical costs or other costs of obtaining the 
information. FDA has information that the typical sign, which is the 
most frequently used form of labeling of raw products, has an expected 
useful life of 6 months. Therefore, there will be no label inventory 
disposal costs because existing with current Secs. 101.42 to 101.45 or 
with the provisions of this proposal. However, for all surveys after 
fall 1994, only values in accordance with the regulations in place at 
the time will constitute compliance.

IX. Comments

    Interested persons may, on or before September 16, 1994, submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposal. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office between 9 
a.m. and 4 p.m., Monday through Friday.

X. 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. Food and Drug Administration, Center for Food Safety and Applied 
Nutrition, ``Report on the Voluntary Compliance of Food Retailers in 
Providing Nutrition Labeling Information for Raw Fruit and 
Vegetables and for Raw Fish,'' Washington, DC, May 8, 1993.
2. The Ehrhart-Babic Group, National Retail Tracking Index, 
``Results of the Survey on the Compliance of Retailers with FDA's 
Guidelines for the Voluntary Nutrition Labeling of Raw Fruit, 
Vegetables, and Fish,'' (FDA contract 223-92-2003), Englewood 
Cliffs, NJ, March 1993.
3. Gebhardt, S.E., R. Cutrufelli, and R. H. Matthews, ``Composition 
of Foods Raw, Processed, Prepared, Fruits and Fruit Juices, 
Agriculture Handbook No. 8-9, Human Nutrition Information Service, 
USDA, Washington, DC, 1982.
4. Gebhardt, S.E., Human Nutrition Information Service, USDA, 
Hyattsville, MD, memorandum of phone conversation between Human 
Nutrition Information Service, USDA, and the Office of Food 
Labeling, FDA, October 15, 1993.
5. Hegenauer J., and E. Pivonka, ``Tangerine Nutrition Study,'' 
Produce Marketing Association Nutrition Labeling Program, Newark, 
DE, August 3, 1992.
6. Rainey, C.J., and L.A. Nyquist, ``Updated Nutrition Labeling 
Values for Bananas,'' Prepared by Nutrition Network for the 
International Banana Association, Irving, CA, February 23, 1993.
7. Hegenauer J., and N.J. Tucker, ``Banana Nutrition Study,'' 
Produce Marketing Association Nutrition Labeling Program, Newark, 
DE, December 13, 1990.
8. McClure, F.D., and J.K. Lee, Division of Mathematics, Office of 
Toxicological Sciences, Center for Food Safety and Applied 
Nutrition, FDA, ``FDA Nutrition Labeling Manual: A Guide for 
Developing and Using Databases,'' 1993.
9. Gebhardt, S.E., Human Nutrition Information Service, USDA, 
Hyattsville, MD, letter to FDA dated February 12, 1992.
10. National Nutrient Databank, maintained at the Human Nutrition 
Information Service, USDA, 6505 Belcrest Rd., Hyattsville, MD.
11. Haytowitz D.B., and R.H. Matthews, ``Composition of Foods--Raw, 
Processed, Prepared, Vegetables and Vegetable Products,'' 
Agriculture Handbook No. 8-11, Human Nutrition Information Service, 
USDA, Washington, DC, 1984.
12. Exler, J. ``Composition of Foods-- Raw, Processed, Prepared, 
Finfish and Shellfish Products,'' Agriculture Handbook No. 8-15, 
Human Nutrition Information Service, USDA, Washington, DC, 1987.
13. Food Marketing Institute and National Fisheries Institute, 
Seafood Nutri-Facts, Fresh Seafood Nutrition Information Program, 
Washington, DC, 1988.
14. Sidwell, V.D., ``Chemical and Nutritional Composition of 
Finfishes, Whales, Crustaceans, Mollusks, and their Products,'' NOAA 
Technical Memorandum NMFS F/SEC-11, National Oceanic and Atmospheric 
Administration (NOAA) and National Marine Fisheries Service, 1981.
15. Paul, A.A., and D.A.T. Southgate, McCance and Widdowson's The 
Composition of Foods, 4th ed. Elsevier/North-Holland Biomedical 
Press, NY, 1978.
16. Davies, J., and J. Dickerson, ``Nutrient Content of Food 
Portions,'' The Royal Society of Chemistry, Cambridge, UK, 1991.
17. Pennington, J.A.T., ``FDA Voluntary Nutrition Labeling Program 
for Raw Fruit, Vegetables, and Fish: Documentation for the Proposed 
Nutrition Labeling Values,'' FDA, Washington, DC, October 1993.
18. ``Individual Reports on the Nutrient Content of Raw Fruits and 
Vegetables,'' Produce Marketing Association (PMA), Newark, DE, 1982-
91.
19. ``Updates on the Nutrition Labeling Information for Raw Fruit 
and Vegetables,'' Produce Marketing Association, Newark, DE, March 
1993.
20. Exler, J., Human Nutrition Information Service, USDA, 
Hyattsville, MD, memorandum of phone conversation between Human 
Nutrition Information Service, USDA, and the Office of Food 
Labeling, FDA, March 1, 1993.
21. Matthews, R.H., P.R. Pehrsson, and M. Farhat-Sabet, ``Sugar 
Content of Selected Foods: Individual and Total Sugars,'' USDA Home 
Economics Research Report No. 48, September 1987.
22. Pehrsson, P.R., Human Nutrition Information Service, USDA, 
Hyattsville, MD, memorandum of phone conversation between Human 
Nutrition Information Service, USDA, and the Office of Food 
Labeling, FDA, November 19, 1992.
23. Weddig, L., National Fisheries Institute (NFI), Arlington, VA, 
memorandum of phone conversation between NFI, and the Office of Food 
Labeling, FDA, February 4, 1993.
24. O'Sullivan, K., Alaska Seafood Marketing Institute, letter to 
FDA dated March 25, 1993.
25. Weddig, L., National Fisheries Institute, Arlington, VA, letter 
to FDA dated January 4, 1991 and updated March 1 and 4, 1991.
26. Pennington, J.A.T., J.I. Rader, and F.D. McClure, ``Guide to 
FDA's Database Review System,'' FDA, Washington, DC, April 1994.

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, it is 
proposed that 21 CFR part 101 be amended as follows:

PART 101--FOOD LABELING

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

    Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act 
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342, 
343, 348, 371).

    2. Section 101.43 is amended by revising paragraphs (a)(1), (a)(2), 
and (a)(3) to read as follows:


Sec. 101.43  Substantial compliance of food retailers with the 
guidelines for the voluntary nutrition labeling of raw fruit, 
vegetables, and fish.

    (a) * * *
    (1) Be presented in the store or other type of establishment in a 
manner that is consistent with Sec. 101.45(a)(1);
    (2) Be presented in content and format that are consistent with 
Sec. 101.45 (a)(2), (a)(3), and (a)(4); and
    (3) Include data that have been provided by FDA in Appendices C and 
D to part 101 of this chapter, except that the information on potassium 
is voluntary.
* * * * *
    3. Section 101.44 is amended by revising paragraph (c) to read as 
follows:


Sec. 101.44  Identification of the 20 most frequently consumed raw 
fruit, vegetables, and fish in the United States.

* * * * *
    (c) The 20 most frequently consumed raw fish are: Shrimp, cod, 
pollock, catfish, scallop, salmon (Atlantic/Coho, chum/pink, sockeye), 
flounder/sole, oyster, orange roughy, Atlantic/Pacific mackerel, ocean 
perch, rockfish, whiting, clam, haddock, blue crab, rainbow trout, 
halibut, lobster, and swordfish.

    4. Section 101.45 is revised to read as follows:


Sec. 101.45  Guidelines for the voluntary nutrition labeling of raw 
fruit, vegetables, and fish.

    (a) Nutrition labeling for raw fruit, vegetables, and fish listed 
in Sec. 101.44 should be presented to the public in the following 
manner:
    (1) Nutrition labeling information should be displayed at the point 
of purchase by an appropriate means such as by a label affixed to the 
food or through labeling including shelf labels, signs, posters, 
brochures, notebooks, or leaflets that are readily available and in 
close proximity to the foods. The nutrition labeling information may 
also be supplemented by a video, live demonstration, or other media.
    (2) Serving sizes should be determined, and required nutrients 
declared, in accordance with Sec. 101.9 (b) and (c), respectively, 
except that the nutrition labeling data should be based on the raw 
edible portion for fruit and vegetables and on the cooked edible 
portion for fish. The methods used to cook fish should be those that do 
not add fat, breading, or seasoning (e.g., salt or spices).
    (3) When nutrition labeling information is provided on signs, 
posters, brochures, notebooks, or leaflets, it may be presented in 
charts in horizontal or vertical columns. Nutrition labeling that is 
presented in a linear format will not be considered to be in 
compliance. The nutrition labeling must bear the identifying heading 
``Nutrition Facts'' in type larger than all other print size in the 
nutrition label. The required information (i.e., headings, serving 
sizes, list of nutrients, quantitative amounts by weight (except for 
vitamins and minerals), and percent of DV's (except for sugars and 
protein)) must be clearly presented and of sufficient type size and 
color contrast to be plainly legible, with numeric values for percent 
of DV highlighted in contrast to the quantitative amounts by weight.
    (i) Declaration of the number of servings per container need not be 
included in nutrition labeling of raw fruit, vegetables, and fish.
    (ii) Except for the statement ``Percent Daily Values are based on a 
2,000 calorie diet,'' the footnote required in Sec. 101.9(d)(9) is not 
required. However, when labeling is provided in brochures, notebooks, 
leaflets, or similar types of materials, retailers are encouraged to 
provide such information.
    (iii) When the nutrition labeling information for raw fruits and 
vegetables is provided on a chart, the columns for saturated fat and 
cholesterol may be omitted with use of the following footnote, ``Most 
fruits and vegetables provide negligible amounts of saturated fat and 
cholesterol; avocados provide 1.0 g of saturated fat per ounce.'' When 
the nutrition labeling information for raw fish is provided on a chart, 
the columns for dietary fiber and sugars may be omitted with use of the 
following footnote, ``Fish provide negligible amounts of dietary fiber 
and sugars.''
    (4) When nutrition information is provided on foods sold in 
packaged form or on signs for individual foods in retail stores, it 
should be displayed in accordance with Sec. 101.9(d), except that the 
declaration of the number of servings per container need not be 
included. The declaration of nutrition information may be presented in 
the simplified format set forth in Sec. 101.9(f) when the food contains 
insignificant amounts of seven or more of the following: Calories, 
total fat, saturated fat, cholesterol, sodium, total carbohydrate, 
dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and 
iron.
    (b) Nutrition label values provided by the Food and Drug 
Administration (FDA) in Appendices C and D to this part 101 for the 20 
most frequently consumed raw fruit, vegetables, and fish listed in 
Sec. 101.44 shall be used to ensure uniformity in declared values. FDA 
will publish proposed updates of the nutrition label data for these 
foods (or a notice that the data sets have not changed from the 
previous publication) at least every 2 years in the Federal Register.
    (1) The agency encourages the submission of data bases with new or 
additional nutrient data for any of the most frequently consumed raw 
fruit, vegetables, and fish to the Office of Food Labeling (HFS-150), 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 200 C Street SW., Washington, DC 20204, for review and 
evaluation. FDA may incorporate these data in the next revision of the 
nutrition labeling information for the top 20 raw fruit, vegetables, 
and fish.
    (i) Guidance in the development of data bases may be found in the 
``FDA Nutrition Labeling Manual: A Guide for Developing and Using Data 
Bases,'' available from the FDA Office of Food Labeling.
    (ii) The submission to FDA should include, but need not be limited 
to, information on the following: Source of the data (names of 
investigators, name of organization, place of analysis, dates of 
analyses), number of samples, sampling design, analytical methods, and 
statistical treatment of the data. Proposed quantitative label 
declarations may be included. The proposed values for declaration 
should be determined in accordance with the ``FDA Nutrition Labeling 
Manual: A Guide for Developing and Using Data Bases.''
    (2) [Reserved]
    (c) Data bases of nutrient values for raw fruit, vegetables, and 
fish that are not among the 20 most frequently consumed may be used to 
develop nutrition labeling values for these foods. This includes data 
bases of nutrient values for specific varieties, species, or cultivars 
of raw fruit, vegetables, and fish not specifically identified among 
the 20 most frequently consumed.
    (1) The food names and descriptions for the fruit, vegetables, and 
fish should clearly identify these foods as distinct from foods among 
the most frequently consumed list for which FDA has provided data.
    (2) Guidance in the development of data bases may be found in the 
``FDA Nutrition Labeling Manual: A Guide for Developing and Using Data 
Bases.''
    (3) Nutrition labeling values computed from data bases are subject 
to the compliance provisions of Sec. 101.9(g).
    (i) Compliance with the provisions of Sec. 101.9(g) may be achieved 
by use of a data base that has been developed following FDA guideline 
procedures and approved by FDA.
    (A) The submission to FDA for approval should include but need not 
be limited to information on the following: Source of the data (names 
of investigators, name of organization, place of analysis, dates of 
analyses), number of samples, sampling design, analytical methods, 
statistical treatment of the data, and proposed quantitative label 
declarations. The values for declaration should be determined in 
accordance with the ``FDA Nutrition Labeling Manual: A Guide for 
Developing and Using Data Bases.''
    (B) FDA approval of a data base and nutrition labeling values shall 
not be considered granted until the Center for Food Safety and Applied 
Nutrition has agreed to all aspects of the data base in writing. 
Approvals will be in effect for a limited time, e.g., 10 years, and 
will be eligible for renewal in the absence of significant changes in 
agricultural or industry practices (e.g., a change occurs in a 
predominant variety produced). FDA will take steps to revoke its 
approval of the data base and nutrition labeling values if FDA 
monitoring suggests that the data base or nutrition labeling values are 
no longer representative of the item sold in this country. Approval 
requests shall be submitted in accordance with the provisions of 
Sec. 10.30 of this chapter.
    (ii) [Reserved]

    5. Appendices C and D are added to part 101 to read as follows:
BILLING CODE 4160-01-P

TP18JY94.001


TP18JY94.002


TP18JY94.003

    Dated: July 11, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-17287 Filed 7-15-94; 8:45 am]
BILLING CODE 4160-01-C