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

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