FDA Warning of Stay Fresh Raises Questions Over Low-Acid Juice Policy

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In another example of the growing confusion and conflict between toll processors and the U.S. Food and Drug Administration (FDA) with regards to food and beverage safety, Connecticut-based Stay Fresh Foods is the latest high pressure processing (HPP) firm to institute changes after receiving a warning letter from the agency over its handling of low-acid juices.

The letter, written by FDA New England district director Joseph Matrisciano, Jr. to Stay Fresh managing director Amy Lawless on November 21, 2016, points out several “serious violations” of juice Hazard Analysis and Critical Control Point (HACCP) regulations that were discovered during an inspection of the firm’s Meriden, Conn. facility that took place from Aug.t 2 through 12, 2016. The letter states: “The 100% juices processed for your customers by your firm are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.”

The violations hinge on an issue that has long been a flashpoint between federal regulators and toll processors: how to safely process low-acid juices — defined as having a pH level of about 4.6 — which are susceptible to the growth of Clostridium botulinum (C. bot) bacterial spores. HPP, a non-thermal pasteurization method in which the bottled product is pressurized in a cold water chamber, is used in some low-acid juices to retain nutrient content while extending product shelf life by destroying harmful pathogens and inhibiting bacterial growth.

Beyond the Stay Fresh case, the uncertainty surrounding this issue has affected manufacturers’ willingness to process low-acid juice products, such as coconut water and nut-based milks, as some consider the risk of creating conditions for C. bot spore growth too high to justify. Adding to the uncertainty: while both regulators and industry experts have indicated skepticism about the ability of HPP to inhibit spore growth to an acceptable level in a low-acid beverage, there seems to be no definitive rule that clearly indicates their safety or acceptability.

Killing Spores

The FDA requires that all HACCP plans include measures that will consistently produce a minimum 5-log reduction of C. bot for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions. C. bot is capable of initiating growth at temperatures of over 10℃ (50℉), making cold supply chain a critical component for low-acid juice products.

HPP is an approved process for achieving a 5-log reduction in certain harmful pathogens, such as salmonella. Yet, as stated in the FDA’s letter, the combination of HPP and refrigeration are not validated processes for reducing the growth of C. bot spores in low-acid juices.

In an interview with BevNET, Dr. Errol Raghubeer, senior vice president of HPP food science and technology at HPP equipment manufacturer Avure, said that a lack of understanding and clear policy from federal regulators is contributing to the questions around HPP. He explained that fulfilling the requirement stated in the letter that Stay Fresh provide scientific data that specifically validates the use of HPP and refrigeration as a method for preventing bacterial growth would be impossible, as no such evidence exists.

Dr. Errol Raghubeer, senior vice president of HPP food science and technology at Avure

Dr. Errol Raghubeer, senior vice president of HPP food science and technology at Avure

“If I go to any of my customers who use HPP and I show them this letter, then they have to shut down also,” Dr. Raghubeer said. “It doesn’t matter what you do with HPP — it does not inactivate bacterial spores. They did say that refrigeration and HPP, you have to validate that you will get a 5-log reduction of C. bot. We have been trying for over 30 years to do that.”

The only verified method for inactivating C. bot spores is high heat with pressure. The underlying issue relates to the divergent characteristics of the two types of C. bot spores, protolytic and non-protolytic. The former grow in temperatures over 50℃, while the latter tend to germinate and produce toxins at lower temperatures. Therefore, refrigeration by itself does not address non-protolytic spores, while storing liquids at temperatures over 50℃ can foster protolytic spore growth.

The result, Dr. Raghubeer explained, is that producers are taking a risk every time they work with low-acid juices; many have simply opted to stop making those types of products. The alternatives are either to raise the pH level (by the addition of acid ingredients) or to add an inhibitor that would prevent spore growth.

Moreover, Dr. Raghubeer said, the FDA only has legally enforceable regulations in place for food and fruit juices with pH below 4.6. For low acid juices derived from sources not defined as a fruits, such as carrots and nuts, the agency has only issued guidelines, which he says is contributing to some of the confusion.

According to Dr. Raghubeer, the “serious violations” detailed in the FDA’s letter to Stay Fresh were actually in reference to not following guidelines, rather than regulations — a circumstance that was misinterpreted by the local inspector.

“This letter really makes no sense,” Dr. Raghubeer said. “It’s a misinterpretation of the guidance the FDA issued for low-acid juices.”

A look back at some of the earlier correspondence between Stay Fresh and FDA regulators following the August inspection helps to indicate additional communication issues affecting HPP processors in their interactions with regulators. r. For its part, the firm’s response to the initial inspection findings stated that it had “no responsibility for the formulation or the production process” of its customers — a common situation when those processes are often protected intellectual property — and that all clients were required to sign a “quality questionnaire” that confirms they have a validated HACCP plan that accounts for “any appropriate hazards.”

The FDA rejected those responses as “inadequate” and reaffirmed Stay Fresh’s responsibility for implementing control measures that can consistently achieve a 5-log reduction of C. bot spores. The letter concludes by requesting a written statement outlining how Stay Fresh plans to correct the violations and prevent their reoccurrence.

The FDA New England District Office did not respond to a request for comment on this story.

Two Businesses

In an interview with BevNET, Amy Lawless, managing director of Stay Fresh Foods, said that the company was working closely with the local FDA district office to make the recommended changes and close out the case as quickly as possible. She explained that Stay Fresh’s two separate roles as a juice producer and a toll processor may have created some confusion for regulators — clouding the issue even further

“For the juice we produce, we use HPP,” Lawless said, adding that Stay Fresh does not produce any low-acid juices. “For all of those products, we have a challenge study on file and we validate that HPP works for that product. For companies that are sending us products for HPP only, we have them sign off that they have validated their HACCP plan. We don’t have control over their manufacturing or ingredients or production, so it is hard for us to do the validation.”

To ensure compliance with FDA regulations, Lawless said Stay Fresh will require customers submitting juice products for HPP to include information to confirm that pH levels are not above 4.6.

“If there’s a juice coming into us and it has a pH of over 4.6, HPP is not a sufficient food safety step,” Lawless said. “We don’t have any customers sending us low-acid juice products so we are now documenting that in our HACCP plan. It’s more of a documentation step for the FDA.”

Lawless said that, while HPP was known to be ineffective in destroying C. bot spores, in the past, the FDA accepted refrigeration as a method of controlling spore growth. She now believes that concerns over temperature abuse that can occur after a product leaves the toll processing facility has caused the agency to shift its focus, and that the FDA is “struggling with enforcing this on a manufacturing level.”

Looking Forward

Stay Fresh is not the first company to be cited by the FDA for HACCP violations. In November 2015, coconut water brand Harmless Harvest received a letter from the agency voicing concerns over the safety of processing methods used at the company’s Thailand production facility. This March, the brand announced it was abandoning HPP in favor of a proprietary multi-step micro filtration system that extends the product’s shelf life to 75 days.

On a scientific level, a recent study commissioned by Avure and completed by the Institute of Food Safety and Health at the Illinois Institute of Technology examined the potential for C. bot spores to grow and produce toxin in HPP-treated coconut water over a 45 day period. The results were negative.

These issues underscore the increasingly precarious business of safely producing low-acid juices under current regulatory conditions. Dr. Raghubeer said that, until the FDA creates clear and enforceable rules relating to low-acid juices that can be implemented on a national scale, the potential risks of handling such products will always be present, regardless of individual FDA district departments interpretation of regulations or guidelines.

“If you end up processing low-acid juices, you can expect that the FDA will come knocking at your door and tell you to shut it down because of the potential risk of clostridium botulinum,” he said. “Even if you are using temperature control, they will throw at you that non-protolytic spores can grow at 4 degrees and produce toxins. So you are between a rock and a hard place of what to do.”