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FDA Releases New Guidance
Document On Carrot/Low-Acid Juice

Jim Prevor’s Perishable Pundit, June 12, 2007

In the midst of the spinach crisis, the produce industry faced a second food safety crisis related to one of its fastest growing categories — refrigerated juices. Specifically, there was a recall by Wm. Bolthouse Farms of certain 100% carrot juice products due to concerns about botulism.

We ran an extensive series on the issue, going far beyond the specifics of Bolthouse and carrot juice to analyze important issues regarding the failure of retailers to maintain temperature in their refrigerated cases and the issue of labeling products for consumer safety. We even looked at home appliances and whether thermometers should be required in refrigerators.

Much of this coverage was informed by valuable input from Lou Cooperhouse, Director of Rutgers Food Innovation Center, who has now gotten back in touch to let us know that the FDA has just released a new guidance document on refrigerated carrot juice and other low-acid juices:

Given the recent botulism illnesses associated with refrigerated carrot juice, FDA believes that its existing guidance does not adequately address the risk of serious illness if carrot and other low acid juices that need refrigeration to maintain product safety are subject to severe temperature abuse. FDA is therefore modifying its earlier guidance on this issue and is issuing these recommendations for industry concerning the processing and labeling of refrigerated carrot juice and other refrigerated low-acid juices subject to the pathogen reduction provisions of the juice HACCP regulations…

The juice HACCP regulation only addressed the control of hazards that could occur in juice stored under normal and moderate abuse conditions during the product’s shelf life (21 CFR 120.24(a)). In light of the recent botulism cases, FDA believes 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. Therefore, FDA is modifying its previous guidance on this issue.

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.

Furthermore, FDA recommends 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. Such labeling, when prominently displayed, serves as an additional precautionary measure to minimize the risk that these juices could become unsafe if post processing contamination of the juice by spores of C. botulinum should occur for any reason.

The advisory is actually rather amazing. On the one hand, it asks that the processor “…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.” In other words the product should be done so that it is safe, even if unrefrigerated.

Yet, just to be safe the recommendation goes on “Furthermore, FDA recommends that firms continue to utilize a label statement such as “Keep Refrigerated” … on the juice that the FDA just said should be made safe even if unrefrigerated.

So even though the juice should be made safe as an unrefrigerated product, it should not be marketed that way.

The carrot juice/botulism situation did reveal a big problem with refrigerated carrot juice. Although safe if properly refrigerated, it was very dangerous if not properly refrigerated.

Yet the labeling on the product was unclear as to what temperature constituted proper refrigeration was and what happens if that level is not maintained. It wasn’t clear to a typical consumer that taking a bottle out of refrigeration to go on a cookout could have disastrous consequences.

So now, in a sense, the FDA’s recommendation closes the issue. Rather than urging better labels, it decided to solve the problem by asking that the juice be able to handle temperature abuse.

This tells us about the risk-adverse nature of the FDA. They simply are unable to accept any risk to consumers — which should inform the produce industry as it looks toward future regulation.

We are hesitant about the notion of the FDA suggesting that product which does not require refrigeration should carry a label saying “keep refrigerated.” This strikes us as likely to increase consumer skepticism about the need to follow labels. Honesty in labeling is certainly the best policy.

We thank Lou Cooperhouse for his enormous contribution to our discussion of this subject and for sending us this way to close our coverage of this issue… at least for now.

You can read the FDA’s new guidance for industry regarding refrigerated carrot juice and other low-acid juices right here.

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