HACCP/SQF

March 29, 2004

FDA Issues New Juice HACCP Guidance

IDFA Schedules New HACCP Workshop for Dairy and Juice

Earlier this month, the Food and Drug Administration (FDA) released its updated Juice Hazard Analysis Critical Control Point (HACCP) guidance, which contains some important technical changes for dairy processors making 100% juice beverages. This new guidance replaces the FDA draft document issued in September 2002; FDA officials will now use this guide when inspecting juice HACCP systems.

"It is clear that some of the changes that FDA made resulted from IDFA's comments on the 2002 draft document. These revisions have made the guidance much more workable in the dairy plant setting," said Allen Sayler, IDFA senior director of regulatory affairs. Read IDFA's comments.

FDA requires all plants that process 100% juice beverages, including dairy plants, to have in place a written hazard analysis, a HACCP plan and Sanitation Standard Operating Procedures (SSOPs). The guidance is aimed at assisting plants with the implementation of those elements. In comparison to the draft guidance, the new document:

  1. Clearly supports dairy product pasteurization times and temperatures as meeting the 5-log reduction requirement for any juice. This allows dairy processors to use the same processing parameters for both dairy and juice.
  2. Requires plants to develop their own validation times and temperatures for juices with a pH above 4.0, since current scientific studies only apply to juices with pHs below 4.0.
  3. Clarifies that industry HACCP experience is acceptable in lieu of training to develop a juice hazard analysis or HACCP plan, or to perform verification or validation activities.
  4. Identifies partial exemptions for juice processed under the low acid canned food (LACF), aseptic, or acidified food requirements and the necessary HACCP documents for an FDA inspection for these facilities.
  5. Expands FDA recommendations for the SSOP on cleaning of equipment that is used to process both dairy and juice products. This includes initial validation of the cleaning procedures to prove that no milk residues remain after cleaning, but before running juice, as well as recommended swab testing of the processing equipment prior to running juice products. This is intended to prevent milk proteins from getting into juice products. Also, there is additional guidance on lubricants and cleaning chemicals as chemical hazards and on hydrogen peroxide for aseptic packaging operations.
  6. Includes a number of other guidance documents and FDA websites for more information. Improves the models for apple juice, fresh orange juice and not-from-concentrate orange juice given in earlier versions.
  7. References pathogens in water as a hazard to be addressed in the plant's hazard analysis. Includes stronger guidance on metal and glass hazards.
  8. Provides additional guidance on managing the hazards associated with carrot juice.
  9. Specifies 80°C for at least 30 seconds for thermal processing of juice concentrate.
  10. Adds dense phase CO2 as a new method to achieve a 5-log reduction in pertinent pathogens. IDFA encourages all juice processors to review the 2004 guidance, which can be found on FDA's website by clicking here.

Any questions regarding juice HACCP, contact Allen Sayler at (202) 220-3544, asayler@idfa.org.

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