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Date: Tuesday, August 26, 1997
FOR IMMEDIATE RELEASE
Contact: FOOD AND DRUG ADMINISTRATION  Arthur Whitmore: (202) 205-4144, Broadcast Media: (301) 827-3434, Consumer Hotline: (800) 532-4440

The Food and Drug Administration today announced measures to reduce the risk of illness from disease-causing microbes in unpasteurized fruit and vegetable juices. The new strategy includes food-safety control programs for the industry, new labeling for products, and education programs for consumers and manufacturers. The new measures affect only a small number of producers because more than 98 percent of all fruit and vegetable juices are already pasteurized.

The agency's plan follows several outbreaks of illness in recent years from pathogenic microbes in fresh juice products, including last fall's E. coli O157:H7 outbreak associated with consumption of products containing unpasteurized apple juice which sickened 66 people in three Western states and Canada and resulted in the death of one child.

William Schultz, FDA deputy commissioner for policy, said the agency later this year will propose a new rule requiring Hazard Analysis and Critical Control Point (HACCP) safety programs at all appropriate juice processing plants. The agency is considering proposing another rule requiring a statement of risk on labels of fresh apple juice products until the HACCP plans are implemented.

"The HACCP measures will take time to be in full effect," Schultz said. "In the interim we are asking the industry, as a voluntary public health service to their customers, to begin immediately labeling fresh apple juice and cider products with a statement of the risk." The labeling being considered by FDA for untreated products would state that those products may contain pathogens known to cause serious or life-threatening illnesses, that the juice has not been processed to destroy such pathogens, and that the risk of serious illness is greatest for children, the elderly, and people with weakened immune systems.

Under FDA's HACCP proposal, some or all plants that manufacture juice products would be required to adopt their own HACCP safety programs. HACCP is a science-based system designed to prevent food safety hazards in food products through appropriate controls during production and processing. HACCP plans, which are tailored to individual manufacturing plants, entail identifying critical control points at which specific safeguards can be implemented to reduce, prevent or eliminate food safety hazards. The agency will publish this HACCP proposal later this year. Once the HACCP proposal becomes final and manufacturers have adopted individual HACCP plans, any labeling requirement may be rescinded.

FDA also will launch public education programs on understanding and reducing the risk of pathogens in fresh juice products. Consumer education programs will focus on communicating the risks of untreated juice products to the most vulnerable populations. Industry education programs will ensure that processing plant managers and workers understand and apply good manufacturing practices in their operations.

FDA developed these measures with industry and public input. In December 1996 the agency convened a public meeting before the Fresh Produce Subcommittee of the National Advisory Committee for Microbiological Criteria in Foods to review the science, technology, and manufacturing practices related to the safe production of fresh juices. Following that meeting, the full committee recommended the adoption of HACCP programs in accord with FDA's forthcoming proposal.

The Notice of Intent announcing these public health measures is on display today and will be published in the Federal Register Aug. 28. The agency invites public comments on the notice and the education program. Comments received within 15 days of the publication of this notice may be considered by FDA as it develops future HACCP and labeling proposals. Comments may be submitted to FDA's Dockets Management Branch, HFA-305, Food and Drug Administration, 12410 Parklawn Drive, Room 1-23, Rockville, Md. 20857.