BI Nutraceuticals has called on industry participants to demand product-specific kill step validation procedures stating that a “5-log reduction on a product that is too numerous to count is still potentially harmful.” With the vast proliferation of hospitalizations and deaths that result from foodborne diseases each year, BI emphasized the urgency on industry participants to be vigilant in the implementation of the FDA’s Hazard Analysis and Critical Point (HACCP) plan, as well as validation of supply chain testing. 

Validation of kill step is essential, the company said. More importantly, the type of validation protocol used, should be fit for purpose. BI stated that having a 5-log reduction is neither adequate nor safe in protecting consumers from pathogens. A 5-log reduction may be an acceptable kill step validation for almonds or some other food products, but not for all botanicals. 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.

“We recently came across a situation with a customer that concerns us deeply,” stated George Pontiakos, CEO/president of BI. “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 recall. During the recall analysis, it was discovered that the raw material starting point had a pathogen load that was too numerous to count and the 5-log reduction did not bring the raw material into a safe parametric region.  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. This includes maximum kill and minimal deterioration of the desired attributes by providing thorough evidence of process validations and product stability studies. These verifications, along with retesting consistently, can help a finished product manufacturer ensure that the finished dosage they are purchasing is safe in terms of pathogens, consistency, uniformity, and overall micro stability.” 

According to the Food and Drug Administration, an HACCP plan, when properly implemented, will effectively control hazards. BI adds that it is critical to ensure the sterilization processes of natural ingredients have a validated kill step, in addition to HACCP adherence, because of the variance of ingredients found in nature. BI’s Protexx HP Green Steam sterilization method remains the industry’s only species-specific, organic steam sterilization method with a validated kill step. Protexx HP Green Steam utilizes more than 40 settings, which control heat, moisture, time, and pressure parameters, tailored for each individual species. All products require their own specific combination to provide the maximum reduction in potential contaminants while preserving the color, flavor and bioactive attributes. BI has fine-tuned more than 350 product-specific, validated protocols across its five steam units that utilize the highest pressure and temperature settings in the industry, resulting in shorter treatment times to eliminate pathogens which help maintain the product’s characteristics. It also has the only steam unit in the industry validated using the USP method.