The widely-used 5-log technique, where manufacturers achieve a 100,000-fold reduction in the amount of microorganisms, isn’t sufficient, according to executives at BI.
"A 5-log reduction may be an acceptable kill step validation for almonds or some other food products, but not for all botanicals,” according to the statement.
“Some botanicals, such as roots, have such a high bacterial and pathogen count to begin with that a 5-log reduction may not be sufficient. Also, 5-log reduction of targeted, known pathogens is not sufficient in botanicals, where there is a host of unknown pathogens."
Original material having too much pathogens for a 5-log to be safe
What prompted this call from BI was an experience the manufacturer had with one of its customers, which George Pontiakos, CEO and president of BI, said “concerns us deeply.”
He continued: “One of our customers purchased product in the market that the supplier claimed had been steam sterilized on the C of A. The product was put into production and distributed to customers. A number of complaints occurred, which ultimately resulted in a large re-call.”
The raw material's pathogen load was so high that even a 5-log reduction wasn't enough, according to analysis of the product during the recall.
“A validated kill step that was ‘fit for purpose’ would have preempted this recall. The supplier, manufacturer, and customer are all at risk if we do not apply the appropriate measures to adhere to HACCP and demand fit for purpose validation,” he added.
Industry efforts so far
With increased scrutiny on the supply end of dietary supplement businesses, many efforts for transparency and safety are being championed by big industry players. One example is trade group American Herbal Products Association (AHPA), which had begun a decade ago with its Good Collections Practices document.
Today, the association is prepping to address significant changes in the regulatory landscape, such as the Food Safety Modernization Act (FSMA), by extending the document to ingredient makers as well.
FSMA is expected to greatly affect the dietary ingredient suppliers, who up to now have been exempt from Part 111 requirements that apply to the consumer-facing dietary supplement manufacturers.
“We…saw that the rules were changing with implementation of the Food Safety Modernization Act. All of the sudden the Food and Drug Administration can come onto your farm, and that is an all new idea," Michael McGuffin, president of AHPA, told NutraIngredients-USA at the SupplySide West show this year.