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
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
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
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
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.