This article originally appeared in the September-October 1998 FDA Consumer and contains revisions made in May 1999. The article is no longer being updated. For additional information on this topic, visit the Center for Food Safety and Applied Nutrition.
Fresh squeezed orange juice. Sparkling apple cider. All-vegetable cocktail. Americans quench their thirst with these and other fruit and vegetable juices, and the vast majority of those juices are not only healthy but safe. Very rarely, however, juice can turn dangerous.
Such was the 1996 case of a 16-month-old child in Colorado who died of heart damage and kidney failure after drinking contaminated apple juice. In another 1996 case involving contaminated apple juice, 3 1/2-year-old Amanda Berman of Chicago was hospitalized for 24 days. In both cases, the apple juice was unpasteurized and the culprit was E. coli O157:H7, the same microbe that claimed the lives of four children during a 1993 outbreak from undercooked hamburger.
This strain of E. coli, according to the national Centers for Disease Control and Prevention, is the most worrisome food-related threat to public health. Unlike other food-borne pathogens, E. coli O157:H7 has no margin for error. It takes only a microscopic amount to cause serious illness or even death. In fact, CDC estimates that E. coli O157:H7 bacteria are responsible for at least 20,000 cases of severe food-borne illness in the United States each year.
Because certain food poisoning outbreaks have been traced to fresh juices that were not pasteurized or otherwise processed to eliminate harmful bacteria, the Food and Drug Administration proposed in April measures to reduce the risk of illness from disease-causing microbes in unpasteurized fruit and vegetable juices.
HACCP--A Tried and True Measure
Traditionally, industry and regulators have depended on spotchecks of manufacturing establishments and random sampling of final products to ensure safe foods. While these inspections provide a general picture of circumstances at the time, little is known about conditions before and after the inspections, as well as beyond the facility, which can all have a bearing on the safety of the finished product.
A 1997 study by FDA's Center for Food Safety and Applied Nutrition found that while contamination of juice products most likely occurs during the growing and harvesting of the raw product, it may occur at any point between the orchard and the table. Therefore, FDA's proposed regulations will require juice processors to implement a Hazard Analysis and Critical Control Point (HACCP) plan that addresses all points of production.
HACCP is a science-based system designed to prevent, reduce or eliminate hazards in food products through appropriate controls during production and processing. Key components of the system include:
"Since 1973, there have been no reported cases of botulism in foods processed under FDA's low-acid canned foods regulations, which is based on the HACCP principle," says Shellee Davis, a consumer safety officer with FDA's Office of Plant and Dairy Foods and Beverages. "We think an adequate HACCP program is an effective way to ensure that juices are safe as well." A summary of the 1997 study is available on the FDA Website.
Warning Label Required
In addition to HACCP, a warning is now required on unpasteurized juices. This warning, part of the April proposal, was published as a final rule on July 8.
The warning label must be visible on the information panel or on the principal display panel of the container's label and must read: "WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems." For apple juice or apple cider, the warning statement is required beginning Sept. 8. For all other unpasteurized juices, the effective date is Nov. 5, 1998.
"The new labeling is only intended to be an interim measure [because] we have proposed a 3-year phase-in period for processors to implement their HACCP programs," says LeeAnne Jackson, Ph.D., a science policy analyst with the Center for Food Safety and Applied Nutrition's executive operations staff. "Large manufacturers will be given one year while small and very small businesses will be given two and three years, respectively," she added.
FDA received requests from several manufacturers of fresh citrus juice for additional time, beyond the Nov. 5 compliance date for the warning statement requirement, to permit such firms to develop and validate procedures that will achieve the 5-log reduction. In consideration of these requests and the confusion among juice manufacturers as to how FDA expects the 5-log reduction to be achieved, as well as other information from some juice manufacturers in identifying effective mechanisms for pathogen reduction, FDA developed a two-part strategy to address these concerns.
First, the agency announced in the Oct. 28, 1998, Federal Register two technical scientific workshops to be held in November 1998 for the citrus juice industry. Second, in the same notice, FDA announced a process by which individual manufacturers of citrus juices may request additional time, beyond the Nov. 5, 1998, compliance date to implement a validated system of control measures that achieves the required reduction in pathogenic microorganisms. Those individual firms requesting additional time were allowed until July 8, 1999, to comply with the warning label final rule.
What Can Consumers Do in the Meantime?
FDA urges high-risk individuals--children, the elderly, and those with weakened immune systems--to drink only pasteurized juices. And while manufacturers were asked before the date in the regulation to voluntarily place warning statements on the labels of juices that haven't been pasteurized, the agency advises people to be aware that a product without a warning label at this time might still be unpasteurized. A good rule of thumb for high-risk individuals, says FDA, is if you cannot determine whether a product has been pasteurized, the best choice is to not use the product. Another choice is to bring the juice to a boil to kill any possible harmful bacteria.
The agency also advises consumers to be aware of the following symptoms commonly associated with food poisoning: diarrhea, abdominal pain, cramping, vomiting, fever, and headache. If you have any of these symptoms, you should contact your physician immediately.
The Future of HACCP
New challenges arising from the growing size of the food industry and the diversity of products and processes have prompted FDA to consider requiring HACCP regulations as a standard throughout much of the remaining U.S. food supply. If adopted, the regulations would cover both domestic and imported foods.
"Any process that helps eliminate contamination in our food and beverages is a positive sign," says Adam Berman, who also said his daughter Amanda, now 5, is recovering well from her illness. "I'd like to think that there is no way we would forego or compromise any precautions necessary to ensure safe foods."
Carol Lewis is a staff writer for FDA Consumer.
The Center for Food Safety and Applied Nutrition found in its preliminary study that unpasteurized juices accounted for 76 percent of contamination cases reported between 1993 and 1996. In addition, the study concluded that illnesses associated with unpasteurized juices tended to be more severe than those associated with pasteurized products. Therefore, FDA believes that pasteurization, or a comparable process that would eliminate or reduce the level of harmful pathogens that can cause food-borne illness, appears to offer an effective way to control the significant hazards that have become a problem with juice.
--C.L.
Publication No. (FDA) 99-2324
This is a mirror of the page at http://www.fda.gov/fdac/features/1998/598_juic.html