FDA Brings the Heat Where There Is None

By Kevin T. Higgins, Managing Editor

May 27, 2016

Food processors who have turned to pasteurization technology that kills pathogens without destroying vitamins and other nutrients are under scrutiny from FDA inspectors.

The technology in question is high pressure processing (HPP), and the issue involves the potential for Claustridium botulinum in low-acid foods. Of particular focus is coconut water.

HPP is effective in destroying viruses and most bacteria. The exception is spore formers, in particular the anaerobic pathogen C. botulinum.

The FDA crackdown began in November, when FDA issued a warning letter to Harmless Harvest Thailand, the foreign affiliate of San Francisco-based Harmless Harvest Coconut Water. The company employed a filtration system for raw juice that was then shipped to the U.S., where HPP pasteurization was done prior to refrigerated distribution. FDA inspectors ruled that the filtration process failed to ensure a 5-log reduction in C. bot and was therefore in violation of the Juice HACCP Hazards and Controls Guidance.

Harmless Harvest responded by enhancing its multi-stage micro-filtration process. The company also suspended use of HPP.

More recently, U.S.-based coconut water processors also have been cited for juice HACCP failures. “The FDA came in yesterday and killed HPP as a viable alternative for coconut water,” one firm’s president told Food Processing. “We are trying to figute out a plan and putting out many fires.”

The issue traces back to 2006, when four individuals who drank carrot juice manufactured by Bolthouse Farms Inc. contracted botulism. The incident eventually led to a reduction to 4.6 pH from 5 pH of the acidity threshold between high-acid and low-acid juice. Because coconut water is above the threshold, juice processors must demonstrate interventions to prevent C. bot contamination prior to the nonthermal HPP process.