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Back To Vidyya FDA Publishes Final Rule To Increase Safety Of Fruit And Vegetable Juices

Final Rule Designed To Improve The Safety Of Fruit And Vegetable Juice And Juice Products

The Food and Drug Administration on Friday announced a final rule designed to improve the safety of fruit and vegetable juice and juice products. Under the rule, juice processors must use Hazard Analysis and Critical Control Point (HACCP) principles for juice processing. Implementation of a HACCP system will increase the protection of consumers from illness-causing microbes and other hazards in juices.

"This rule will help ensure the safety of the juice that American families consume each day," said Jane E. Henney, M.D. Commissioner of Food and Drugs. "It is another step in protecting the public health through the safety of our food."

The rule comes after a rise in the number of foodborne illness outbreaks and consumer illnesses associated with juice products during the past several years, including a 1996 E. coli O157:H7 outbreak associated with apple juice products and two citrus juice outbreaks attributed to Salmonella spp. in 1999 and 2000. The apple juice outbreak sickened 70 people in the western United States and Canada, including a child who died from hemolytic uremic syndrome caused by the infection. The Salmonella Enteritidis outbreak in 2000 was caused by unpasteurized orange juice and resulted in 88 illnesses in six western states. The Salmonella Muenchen outbreak in 1999 was caused by unpasteurized orange juice and resulted in 423 illness in 20 states and 3 Canadian provinces and contributed to one death. Foodborne infections are especially dangerous for young children, older adults and those with weakened immune systems. FDA estimates that there are between 16,000 to 48,000 cases of juice-related illnesses each year. It is estimated that the action taken due to the rule will prevent at least 6,000 illnesses per year.

HACCP systems call for a science-based analysis of potential hazards, determination of where the hazards can occur in processing, implementing control measures at points where hazards can occur to prevent problems, and rapid corrective actions if a problem occurs. Firms will be required to maintain records in association with implementation of their HACCP plans and verification of those plans. HACCP systems are already federally required for seafood, meat processors and poultry processors.

The juice HACCP regulation applies to juice products in both interstate and intrastate commerce. Juice processors will be required to evaluate their manufacturing process to determine whether there are any microbiological, chemical, or physical hazards that could contaminate their products. If a potential hazard is identified, processors will be required to implement control measures to prevent, reduce, or eliminate those hazards. Processors are also required to use processes that achieve a 5-log, or 100,000-fold, reduction in the numbers of the most resistant pathogen in their finished products compared to levels that may be present in untreated juice. Juice processors may use microbial reduction methods other than pasteurization, including approved alternative technologies (such as the recently approved UV irradiation technology) or a combination of techniques.

Citrus processors may opt to apply the 5-log pathogen reduction on the surface of the fruit, in combination with microbial testing to assure that this process is effective.

Processors making shelf-stable juices or concentrates that use a single thermal processing step are exempt from the microbial hazard requirements of the HACCP regulation. Retail establishments where packaged juice is made and only sold directly to consumers (such as juice bars) are not required to comply with this regulation.

Large companies will have one year after publication of the regulation to implement HACCP programs. Small companies must comply 2 years after publication and very small companies must comply 3 years after publication. Processors must continue to use the previously required warning label statement until they implement HACCP programs. In the interim, FDA will continue to inspect juice processing facilities to assure that they are producing safe juice and juice products.

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Editor: Susan K. Boyer, RN
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