[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