RULES AND REGULATIONS

Juice Contamination

This article appeared as "Food Safety Report," Volume 3, Number 4, January 24, 2001, published by BNA, Inc.

Juice processors must put in place measures to prevent contamination of fruit and vegetable juices by pathogens under a final Food and Drug Administration rule, published January 19 (66 Fed. Reg. 6138).

The rule requires all juice manufacturers to develop and implement a Hazard Analysis and Critical Control Points plan (HACCP), Robert Buchanan, senior science adviser at FDA, told BNA. Under the HACCP rules, juice processors must develop an analysis of potential hazards, identify those points in processing where hazards can occur, and implement control measures to prevent, reduce, or eliminate these hazards, Buchanan said. Manufacturers must provide appropriate verification of these plans, and maintain appropriate records, he said. The HACCP rule pertains not only to microbiological hazards but to chemical and physical ones, he said. In addition, processors are required to treat juice as a "5-log," or 100,000-fold reduction in pathogens, according to Buchanan. With the exception of citrus fruit, this treatment, which could include heat, pressure, or ultraviolet irradiation, must be done after the juice is produced, he said.

Citrus Exempt.
FDA exempted the citrus industry because that industry successfully demonstrated it is extremely unusual for bacteria to get inside the fruit, according to Buchanan. The rule allows citrus processors to apply the 5-log pathogen reduction on the surface of the fruit, in combination with microbial testing, to assure the process is effective. Processors who make shelf-stable juices -- those that do not require refrigeration -- are exempt from the microbial hazard requirements of the HACCP rule, Buchanan said. "The amount of treatment they do is so overwhelming, that microbiological concerns associated with pathogens are nil," he said. Since almost all producers will have to treat to 5-log reduction, "warning labels on most products will disappear," he said. An exception is retail firms that make a juice product for direct consumption by their customers, he said.

Effective in 2003, 2004.
FDA estimates the rule will cost industry about $50 million the first year of implementation and about $23 million annually thereafter, agency spokesman Sebastian Cianci told BNA. Currently, there are about 48,000 cases of juice-related illnesses each year, according to FDA. The new rule will prevent about 6,000 illnesses per year, including two deaths, Cianci said. The value of prevention is estimated at about $150 million per year, he said. The rule will take effect January 19, 2002. Small systems will have until January 19, 2003 to comply, and very small businesses until January 19, 2004.

Industry Emphasizes Pasteurization.
The National Food Processors Association is "happy that FDA did not exempt small processors from pasteurization or equivalent treatment," Allen Matthys, vice president of regulatory affairs for the group told BNA. "That's where the problem is -- in the unpasteurized juices," he said. NFPA also lauds FDA for exempting shelf-stable products from part of the HACCP rule, Matthys said. In these products "instead of a 5-log reduction, you're getting about a 50,000-log or greater reduction in pathogens," he said. However, the HACCP rule will impose an additional burden on those companies already operating under good manufacturing regulations and "doing a good job," Matthys said. The regulation requires all manufacturers to have a HACCP program and have it evaluated, he said. NFPA also is pleased that FDA's rule reflects recent research showing that some pathogens can 'internalize', so cleaning the outside of the fruit is not always adequate, Matthys said.

The HACCP rule comes after a number of illness outbreaks associated with juice products in recent years, FDA said. In 1996, an outbreak linked to apple juice products contaminated with E. coli sickened about 70 people in the western United States and Canada, and caused one death, the agency said. In 2000, about 88 people in six western states became ill from unpasteurized orange juice contaminated with Salmonella, the agency said.