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Report on Food and Drug Administration Nutrition Labeling Information Study-December 1996, Raw Fruit/Vegetables and Raw Fish; Availability


DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0155]

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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 uit, 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 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." [p25636]

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.