P97-29 FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE Arthur Whitmore: (202)205-4144
August 26, 1997
Consumer Hotline: (800)532-4440
FDA ANNOUNCES A STRATEGY TO INCREASE SAFETY OF FRESH JUICES
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.
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