[Federal Register Volume 62, Number 90 (Friday, May 9, 1997)]
[Notices]
[Pages 25635-25636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12158]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 94N-0155]


Report on Food and Drug Administration Nutrition Labeling 
Information Study--December 1996, Raw Fruit/Vegetables and Raw 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--December 1996, Raw Fruit/
Vegetables and Raw Fish.'' This report summarizes survey data on 
actions taken by food retailers to provide consumers with nutrition 
labeling information for raw fruit, 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.

ADDRESSES: Submit written comments and requests for single copies of 
the report to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, 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, 5600 Fishers 
Lane, rm. 12A-16, Rockville, MD 20857. The report and received comments 
are available for public examination at the Dockets Management Branch 
(address above) between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Nancy T. Crane, Center for Food Safety 
and Applied Nutrition (HFS-165), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-205-5615.

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 do 
the following: (1) Identify the 20 most frequently consumed raw fruit, 
vegetables, and fish in the United States; (2) establish guidelines for 
the voluntary nutrition labeling of these raw fruit, 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 November 27, 1991 (56 FR 60880), FDA 
responded to those requirements by publishing a final rule on the 
nutrition labeling of raw fruit, vegetables, and fish (corrected on 
March 6, 1992 (57 FR 8174)). In the Federal Register of August 16, 1996 
(61 FR 42742), FDA published another final rule that revised the 
guidelines and updated the nutrition labeling values for the voluntary 
nutrition labeling of raw fruit, vegetables, and fish. This action made 
the labeling under the voluntary nutrition labeling program more 
consistent with mandatory nutrition labeling of other foods regulated 
by FDA.
    FDA lists the 20 most frequently consumed raw fruit, vegetables, 
and fish in Sec. 101.44 (21 CFR 101.44). In Sec. 101.45 (21 CFR 
101.45), FDA set forth guidelines on how these foods are to be 
nutrition labeled. Under these guidelines, nutrition labeling 
information may be provided by food retailers in the parts of their 
stores where raw fruit, 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 defines ``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 fruit, vegetables, and fish. FDA makes separate 
determinations of substantial compliance for raw fruit and vegetables 
collectively and for raw fish (Sec. 101.43(a)).
    Section 403(q)(4)(C) of the act directed FDA to issue a report 30 
months after enactment of the 1990 amendments that includes a 
determination of whether there is substantial compliance with the 
agency's implementing regulations. The act also states that if 
substantial compliance is achieved by food retailers, FDA is to 
reassess voluntary labeling compliance every 2 years. If substantial 
compliance is not achieved, FDA is to propose to require that nutrition 
information be provided by any person who offers raw fruit and 
vegetables or raw fish to consumers (section 403(q)(4)(D)(i) of the 
act).
    In the Federal Register of May 18, 1993 (58 FR 28985), and May 5, 
1995 (60 FR 22400), FDA announced the availability of reports that 
found that, under the standard in Sec. 101.43, there was substantial 
compliance by food retailers in the provision of nutrition labeling 
information for raw fruit, vegetables, and fish. These determinations 
were based on compliance surveys that were conducted in November/
December of 1992 and 1994. For both time periods, aggregate percentages 
(i.e., percentages over all stores sampled) for both raw fruit 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 1995, section 
403(q)(4)(C)(ii) of the act requires that FDA reassess voluntary 
labeling compliance and issue a report in 1997. FDA is now announcing 
that this reassessment has been done. The results

[[Page 25636]]

of this reassessment are set forth in the report entitled ``Food and 
Drug Administration Nutrition Labeling Information Study--December 
1996, Raw Fruit/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 fruit and 
vegetables and for raw fish has been met. On a store count basis, more 
than 70 percent (73.0 percent for raw produce and 71.2 percent for raw 
fish) of the sampled stores selling raw fruit, vegetables, and fish 
voluntarily provided nutrition labeling information in an appropriate 
manner for these raw foods.
    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 higher 
than those for sampled store counts.
    For raw fruit/vegetables, stores in compliance account for 77.8 
percent of the annual sales of all food stores. For raw fish, stores in 
compliance account for 74.0 percent of the annual sales of all food 
stores. A possible interpretation of these data is that about three-
fourths of U.S. consumers are exposed to nutrition labeling information 
for raw fruit, vegetables, and fish. 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 1999 to determine whether 
substantial compliance in the provision of voluntary labeling 
information for raw fruit, vegetables, and raw 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: April 30, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-12158 Filed 5-8-97; 8:45 am]
BILLING CODE 4160-01-F