Dockets Management Branch (HFA-305)
Food and Drug Administration
12420 Parklawn Drive, Room 1-23
Rockville, MD 20857
RE: Current Science and Technology on Fresh Juices Docket No. 96N-0449
The American Society for Microbiology (ASM) appreciates the opportunity to provide comments to the Food and Drug Administration (FDA) on the current science, including technological and safety factors, relating to fresh juices and other measures necessary to provide safe fruit juices. The ASM is the largest life science society in the world with an active membership of over 42,000. ASM members include academic, industrial, clinical and governmental scientists - many of whom are involved in detecting, diagnosing and preventing foodborne disease.
Many outbreaks of illness since 1974 have been associated with fresh pressed apple juice. Pathogens implicated include Salmonella, Escherichia coli O157:H7, and Cryptosporidium. In at least one recent outbreak, state of the art processing procedures were used to produce apple juice, including sorting to remove blemished apples, acid washing and brushing to clean apples, and using well cleaned and sanitized equipment to press apples and handle juice. In addition, recent studies indicate that pathogens in contact with apples can enter the apple at the site where the flower forms, hence washing does not remove the bacteria that may migrate into the apple. Furthermore, E. coli O157:H7 has unusual tolerance to acid, hence washing apples with an acid-based cleaner can select for this pathogen.
Considering the past history of illness associated with drinking fresh apples juice and the uncertainty of eliminating E. coli O157:H7 using current industry practices, a step that will kill pathogens (including E. coli. O157:H7) in apple juice processing is essential to assure safety. This can be accomplished by thermal pasteurization, irradiation or possible approved additives that are microbiocidal. Implementation of a well designed Hazard Analysis Critical Control Point (HACCP) program to process fresh apple juice is important in reducing microbiological hazard. The ASM believes that such a HACCP program must include a critical control point that actually kills pathogens to assure the safety of the product.
A few outbreaks of illness have been associated with other fresh juices such as orange juice; however, in most cases the problem resulted from deficiencies in Good Manufacturing Practices (GMP). If GMP's been properly employed, pathogens would not have been introduced. Hence, juices other than apple juice can apparently be safely produced if GMP's and a well designed HACCP program are properly implemented. There does not appear to be a need to mandate pasteurization for juices other than apple juice.
With regard to consumer education, raising consumer awareness of the potential risks associated with unpasteurized apple juice is essential. Since this is a product that does not require any type of cooking procedures prior to consumption, the ASM believes it is important that consumers be aware of the potential pathogens that may contaminate unpasteurized apple juice.
The ASM appreciates the opportunity to provide these comments. If you have any questions please feel free to contact ASM Headquarters.