This guidance is intended for processors of refrigerated carrot juice and other refrigerated low-acid juices, which can pose a risk of botulism poisoning if juice that is not processed to eliminate or prevent the growth of Clostridium botulinum spores that may be present is subsequently stored without proper refrigeration.
The recommendations in this guidance only pertain to low-acid juice products subject to the pathogen reduction provisions of the Hazard Analysis and Critical Control Point (HACCP) requirements of 21 CFR Part 120 (the juice HACCP regulations). This guidance does not pertain to low acid and acidified juice products subject to the requirements of 21 CFR Parts 108, 113 and 114. (Such products are not subject to the pathogen reduction provisions in the juice HACCP regulations, 21 CFR 120.24.) Further, these recommendations do not pertain to any other foods that need refrigeration by consumers to maintain product safety. For other foods that need refrigeration by consumers to maintain product safety, see the guidance for the labeling of such foods at http://www.cfsan.fda.gov/guidance.html.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as a recommendation, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
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