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food regulation, or the acidified foods regulation,
as appropriate, and all of the other requirements
of the juiceHACCP regulation.
Retailestablishmentsorbusinesses thatmake
andsell juicedirectly toconsumersanddonot sell
or distribute juice toother businessesareexempt
from the juiceHACCP regulation,butmustcomply
with FDA’s food labelling regulation in 21 CFR
101.17(g) that requires a warning statement on
packaged fruit and vegetable juice products that
have not been processed to prevent, reduce, or
eliminatepathogenicmicroorganisms thatmaybe
present,andwithanyapplicablestate regulations.
Reference
Department of HealthandHumanService, “21CFRPart 120HazardAnalysis andCritical Control Point (HACCP)
Procedure for theSafeandSanitary Processingand Importingof Juice; Final Rule”, January 19, 2001.
Dr. LuciaAnelich. “Technical report: Compilationof aHACCPplan for a fruit concentratesprocessingplant”.
Regional Center for SouthernAfrica, U.S. Agency for International Development, July 2003.
FoodandDrugAdministration, “Guidance for Industry: JuiceHACCPHazardandControls”, Guidance first
edition; final guidance.March3, 2004.
JuiceHACCPAlliance. “JuiceHACCPTrainingCurriculum”. First editionAugust 2002.
R.M. GoodrichSchneider andK.R. Schneider. “The JuiceHACCPProgram: AnOverview”. IFASExtension
University of FloridaUSA.
The regulations mandate the application of HazardAnalysis and Critical Control Point
(HACCP) principles to the processing of these foods. HACCP is a preventive system
of hazard control. FDA is taking this action because there have been a number of food
hazards associated with juice products and because a system of preventive control
measures is themost effectiveandefficient way toensure that theseproducts are safe.
Citrus juice producers who do not want to
pasteurize their juicesaregivenanoption toapply
acumulative5-log reduction to fruitsurfacesovera
seriesofsteps in themanufacturingprocess.These
processors are not exempt from the requirement
topackage the juice in thesame facilitywhere the
5-log reduction occurs.
Juice processors that meet the definition
of “Retail” establishments are not covered by
the federal juice HACCP regulation but must
comply with other federal and state rules that
regulate juice production. Retail establishments
aremanufacturers that prepare and provideall of
their juice production directly to consumers and
do not sell or distribute (wholesale) juice to other
businesses. For example, supermarkets that
produce, package, and sell juicedirectly.
The juiceHACCPregulation includes in21CFR
120.13;a requirement that individualswhoperform
certain specified functions, e.g., developing the
hazard analysis or the HACCP plan, “shall have
successfully completed training in the application
of HACCP principles to juice processing at least
equivalent to that received under standardized
curriculum recognized as adequate by the
U.S. Food and Drug Administration, or shall be
otherwise qualified through job experience to
perform these functions.”
The U.S. Food and Drug Administration is
adopting final regulations to ensure the safe and
sanitary processing of fruit and vegetable juices.
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