April, 1998

FDA proposes HACCP, labeling in fresh juice regulations

 Features of the Food and Drug Administration fresh juice safety proposed regulations:

  • Requires implementation of a HACCP plan.
  • Requires means of achieving a five-log microbial kill step by pasteurization or other methods.
  • Requires warning labels on all juices not treated to eliminate pathogens.
  • HACCP to be phased in over three years - larger firms get less time, smaller firms get more time.

Proposed Food and Drug Administration fresh juice safety guidelines were released April 21 for public comment. As expected, they contain requirements for product labeling and Hazard Analysis of Critical Control Points (HACCP) procedures.
FDA proposed two regulations. The first would require processors of packaged fruit and vegetable juices to implement HACCP plans at their plants to prevent microbiological, chemical and physical contamination of their products. This provision includes requiring makers of unpasteurized juice to be able to achieve a five-logarithm reduction in the number of pathogens in the finished product. This "five-log" step is equivalent to a 99.999% kill rate on the microbes.
At present, pasteurization is the only known single treatment that can achieve this five-log reduction. However, juice processors would be free to use methods such as washing, scrubbing, anti-microbial solutions, alternative technologies or a combination of techniques.
The second proposal requires warning labels on all packaged juice products that have not been pasteurized or otherwise treated to eliminate harmful microbes. The Clinton administration expects to have the labeling proposal finalized in time for this autumn's main apple processing season, and thus has established a much shorter comment period for these rules than for the HACCP regulations.
After finalization of the HACCP regulations, a phase-in period would begin. Larger manufacturers would get a year, small businesses would get two years and very small businesses could take three years.
FDA's warning label would read: "WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria which can cause serious illness in children, the elderly, and persons with weakened immune systems."
The label would be required for all packages of untreated juices, with the exception of unpackaged juice sold for immediate consumption, such as freshly squeezed juice served at a restaurant, juice bar or a child's lemonade stand.
Each proposed regulation now goes into the public comment stage. Comments will be accepted 75 days from the April 21 release data on the HACCP proposal and for 30 days on the labeling proposal. Make comments 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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