[Federal Register Volume 60, Number 87 (Friday, May 5, 1995)]
[Notices]
[Pages 22400-22401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-11119]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93N-0156]


Report on Nutrition Labeling Information Study; Raw Fruits, 
Vegetables, and Fish; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a report entitled ``Food and Drug Administration 
Nutrition Labeling Information Study, Raw Fruits/Vegetables and Raw 
Fish.'' This report is intended to summarize survey data on actions 
taken by food retailers to provide consumers with nutrition labeling 
information for raw fruits, vegetables, and fish. This report is 
mandated by the Nutrition Labeling and Education Act of 1990 (the 1990 
amendments).

DATES: Comments may be submitted at any time.

[[Page 22401]] ADDRESSES: Submit written comments and requests for 
single copies of the report to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, 
MD 20857. Comments and requests should be identified with the docket 
number found in brackets in the heading of this document. Send two 
self-addressed adhesive labels to assist that office in processing your 
requests. Copies of the document will be available at cost from the 
Freedom of Information Staff (HFI-35), Food and Drug Administration, 
rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857. The report and 
received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday thru Friday.

FOR FURTHER INFORMATION CONTACT: Mary M. Bender, Center for Food Safety 
and Applied Nutrition (HFS-165), Food and Drug Administration, 200 C 
St., SW, Washington, DC 20204, 202-205-5592.

SUPPLEMENTARY INFORMATION: The 1990 amendments amended the Federal 
Food, Drug, and Cosmetic Act (the act) to require, among other things, 
that under section 403(q)(4) of the act (21 U.S.C. 343 (q)(4)), FDA: 
(1) Identify the 20 most frequently consumed raw fruits, vegetables, 
and fish in the United States; (2) establish guidelines for the 
voluntary nutrition labeling of these raw fruits, vegetables, and fish; 
and (3) issue regulations that define ``substantial compliance'' with 
respect to the adherence by food retailers with those guidelines. In 
the Federal Register of July 2, 1991 (56 FR 30458), FDA responded to 
those requirements by a proposal, and, in the Federal Register of 
November 27, 1991 (56 FR 60880), the agency published a final rule on 
the nutrition labeling of raw fruits, vegetables, and fish (corrected 
on March 6, 1992 (57 FR 8174)).
    FDA listed the 20 most frequently consumed raw fruits, vegetables, 
and fish in 21 CFR 101.44. In 21 CFR 101.45, FDA set forth guidelines 
on nutrition labeling for these foods. Under these guidelines, 
nutrition labeling information may be provided within the retail 
departments where raw fruits, vegetables, and fish are sold. 
Information may be made available in signs, posters, brochures, 
notebooks, or leaflets and may be supplemented by video, live 
demonstration, or other media.
    In Sec. 101.43 (21 CFR 101.43), FDA defined substantial compliance 
to mean that at least 60 percent of the food retailers sampled in a 
representative survey provide nutrition labeling information (as 
specified in the guidelines) for at least 90 percent of the foods that 
they sell that are included on the listing of the most frequently 
consumed raw fruits, vegetables, and fish. FDA said that it would make 
separate determinations of substantial compliance for raw fruits and 
vegetables collectively and for raw fish (Sec. 101.43(a)).
    Section 403(q)(4)(C)(ii) of the act states that if substantial 
compliance is achieved by food retailers, FDA is to reassess voluntary 
labeling compliance every 2 years. The act also states that if 
substantial compliance is not achieved, FDA is to propose to require 
that nutrition information be provided by any person who offers raw 
fruits and vegetables or raw fish to consumers (section 403(q)(4)(D)(i) 
of the act).
    In the Federal Register on May 18, 1993 (58 FR 28985), FDA 
announced the availability of a report that found that there was 
substantial compliance under the standard established in Sec. 101.43 by 
food retailers in the provision of nutrition labeling information for 
raw fruits, vegetables, and fish. Aggregate percentages (i.e., 
percentages over all stores sampled) for both raw fruits and vegetables 
and for raw fish showed that approximately three-fourths of the retail 
food stores surveyed provided the voluntary nutrition information.
    Because substantial compliance was achieved in 1993, section 
403(q)(4)(C)(ii) of the act required that FDA reassess voluntary 
labeling compliance and issue a report in 1995. FDA is now announcing 
that this reassessment has been done. The results of that reassessment 
are set forth in the report, ``Food and Drug Administration Nutrition 
Labeling Information Study, Raw Fruits/Vegetables and Raw Fish.''
    Based upon the results of this study that was conducted under 
contract, FDA once again concludes that substantial compliance by food 
retailers in providing nutrition labeling information for raw fruits, 
vegetables, and fish has been met. On a store count basis, three-
fourths (75.3 percent for raw produce and 75.4 percent for raw fish) of 
the sampled stores selling raw fruits, vegetables, and fish provided 
nutrition labeling information in the departments where the raw foods 
are sold.
    Data were also reported on an all commodity volume (ACV) basis. ACV 
data are weighted estimates that represent annual store sales volumes 
and reflect the percent of the market serviced. ACV data approximate 
more representatively than store counts, the percent of the population 
exposed to the nutrition labeling information. ACV values were slightly 
higher than those for sampled store counts.
    For raw fruits/vegetables, stores in compliance account for 81.4 
percent of the annual sales of all food stores, and for raw fish, 
stores in compliance account for 76.8 percent of the annual sales of 
all food stores. These data may be interpreted as evidencing that over 
three-fourths of U.S. consumers are exposed to nutrition labeling 
information for raw fruits, vegetables, and fish because they shop in 
retail food stores that provide the labeling. Because many consumers 
shop in more than one store, the actual level of consumer exposure is 
most likely to be even higher.
    FDA will again survey retail stores in 1997 to determine whether 
substantial compliance in the provision of voluntary labeling 
information for raw fruits, vegetables, and fish continues to exist. If 
at that time substantial compliance is not met, the agency will propose 
to modify Sec. 101.43 to make the program mandatory.

    Dated: May 1, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-11119 Filed 5-4-95; 8:45 am]
BILLING CODE 4160-01-F