FDA Regulations of Botulism in Carrot Juice

Summary. Generally speaking, per FDA regulations, processors of low-acid, uncanned juices must either include a warning label concerning the presence of harmful bacteria or utilize a 5-log reduction in microorganisms as part of their HACCP control measures. Since botulism operates through spores, these regulations do not directly address the risk of botulism in low-acid, uncanned juices. 

Consequently, in 2004, the FDA issued guidance recognizing that Clostridium botulinum could present a potential hazard in low-acid juices and recommended that processors consider appropriate control measures, which could include a combination of processing steps and refrigeration labeling (e.g., “Keep Refrigerated”), particularly where the juice does not receive treatment sufficient to destroy spores. Following the carrot juice botulism outbreak, in 2007, FDA issued further guidance to the industry, recommending additional control measures such as acidification or thermal treatment. Notably, the 2007 FDA guidance recognized the risk of botulism spores in low-acid juices stored without proper refrigeration. This guidance reaches processors of low-acid juices that utilize pathogen reduction measures; however, it may not reach raw low-acid juices with warning labels.

2006 Carrot Juice Botulism Outbreak. In September – October 2006, six cases of botulism (four in the U.S., two in Canada) were linked to refrigerated carrot juice from Bolthouse Farms. Per the FDA, the products “were pasteurized but were not heated to a temperature that would eliminate spores of proteolytic (the most heat-resistant type) C. botulinum.”  Because the spores grow and produce toxin “only under severe temperature abuse conditions,” FDA suspected that distributors or consumers left the juice unrefrigerated for an extended time period.^[1]

At the time, the CDC remarked:

C. botulinum spores are found in the environment and can be present naturally in carrot juice and other foods that have not undergone the retort canning process, which involves high temperatures and high pressure. Anaerobic conditions, low acidity (pH>4.6), low salt and sugar concentrations, and temperatures >39^ºF (>4^ºC) promote germination of C. botulinum spores and botulinum toxin production. Carrot juice has low acidity, with a natural pH of approximately 6.0; therefore, in the absence of another inhibitor, refrigeration at temperatures <40^ºF(<4^ºC) is necessary to prevent germination of C. botulinum spores and production of botulinum toxin. Inhibiting C. botulinum growth in other ways, such as through acidification, can retard its growth in juice that is not properly refrigerated.^[2]

Relevant FDA Regulations. Since the early 2000s, FDA has regulated juices—including low-acid vegetable juices such as carrot juice—under a bifurcated framework that distinguishes between products processed to achieve a specified pathogen reduction and those that are not. 

Processors of juice products processed to reduce or eliminate pathogens must include in their HACCP plans “control measures that will consistently produce, at a minimum, a 5 log (i.e., 10⁵) reduction, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, in the pertinent microorganism.”^[3] By contrast, juices that have not been processed to reduce or eliminate pathogens must bear a warning label:^[4]

FDA Guidance Prior to the Outbreak. The FDA guidance—which is non-binding—regarding botulism risk in low-acid juices has evolved over the years. As of the passing of the HACCP final rule in 2001, FDA stated that “spore-forming bacteria” were not associated with public health problems in juice that was refrigerated, and the FDA therefore did not think that it was a hazard “reasonably likely to occur.”^[5] However, in 2004, the FDA grew concerned that low-acid juices unrefrigerated for a long time could create a hazard due to botulism spores.^[6] Therefore, in its 2004 Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance, First Edition, the FDA recommended the following:

Control measures for such juices are likely to involve multiple measures, e.g., a combination of a process step to destroy the non-proteolytic spores and measures to ensure that “Keep Refrigerated” labeling is used for the juice if the juice does not receive a treatment sufficient to destroy the proteolytic spores.^[7]

In 2004, then, the FDA recommended that processors of low acid juices like carrot juice “give consideration to toxins produced by non-proteolytic and proteolytic strains of Clostridium botulinum as potential hazards to be controlled under its HACCP plan.”^[8]

Relevant FDA Regulations & Guidance After the Outbreak. In 2007—following the carrot botulism outbreak—the FDA issued new Guidance for Industry.  The guidance was addressed to “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.” ^[9] Despite the broad language at the outset, the FDA guidance appears to limit its scope to processors of juice “subject to the pathogen reduction provisions of the juice HACCP regulation”; as such, it is unclear whether and/or to what extent it reaches “raw juice” products with warning labels.

The FDA stated, “that it is now also necessary to address the control of hazards that could occur in low acid refrigerated juice subjected to severe temperature abuse” (above 50ºF for an extended period).^[10] Specifically, the 2007 guidance states:

FDA is now recommending that firms subject to the pathogen reduction provisions of the juice HACCP regulation incorporate validated control measures for all C. botulinum spores into their HACCP plans that will be applied in the processing facility and that will ensure that C. botulinum growth and toxin production will not occur should the juice, as offered for sale by the processor, be kept unrefrigerated in distribution or by consumers. This objective could be achieved by any validated treatment method that is effective for this purpose, e.g., acidification of the juice to a pH of 4.6 or below, thermal treatment of the juice. As part of these control measures or a firm’s sanitation standard operating procedures, we recommend that firms ensure that all post processing equipment that contacts the juice, e.g., container filling equipment, is cleaned and sanitized adequately to prevent post processing contamination of the juice by C. botulinum spores from equipment surfaces. We also recommend that these include control measures to provide for the effective performance of their container closures (plastic caps, foil seals) in minimizing any risk of post process contamination of the juice by C. botulinum spores.

The FDA, in its 2007 guidance, also recommended that “firms continue to utilize a label statement such as ‘Keep Refrigerated,’ along with implementation of the pathogen reduction control measures set forth in this guidance.”^[11]

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^[1] FDA, Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices (June 2007), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-refrigerated-carrot-juice-and-other-refrigerated-low-acid-juices.

^[2] CDC, Botulism Associated with Commercial Carrot Juice—Georgia and Florida, September 2006, 55 MMWR Dispatch 1 (Oct. 6, 2006), https://www.cdc.gov/mmwr/preview/mmwrhtml/mm55d106a1.htm

^[3] 21 C.F.R. § 120.24, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-120 (“For the purposes of this regulation, the ‘pertinent microorganism’ is the most resistant microorganism of public health significance that is likely to occur in the juice.”).

^[4] 21 C.F.R. § 101.17(g), https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-A/section-101.17#p-101.17(g)(7).

^[5] FDA, Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices (June 2007), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-refrigerated-carrot-juice-and-other-refrigerated-low-acid-juices.

^[6] Id.

^[7] FDA, Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance, First Edition (March 2004), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-juice-hazard-analysis-critical-control-point-hazards-and-controls-guidance-first.

^[8] Id.

^[9] FDA, Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid Juices (June 2007), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-refrigerated-carrot-juice-and-other-refrigerated-low-acid-juices.

^[10] Id.

^[11] Id.

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.

Source: https://www.marlerblog.com/case-news/fda-regulations-of-botulism-in-carrot-juice/