PURE Bioscience submits FCN for antimicrobial
Subject to Food and Drug Administration (FDA) and US Department of Agriculture (USDA) approvals, PURE will begin commercialization in Q1 2015.
SDC is a proprietary combination of stabilized ionic silver and citric acid.
Data from the company showed that SDC achieved an average reduction in Salmonella of 2.75 log10 CFU/cm2 when applied as an online reprocessing (OLR) spray and 6.28 log10 CFU/cm2 when combined with an immersion chilling process simulating current US industry practices.
Data shows that the SDC antimicrobial solution in poultry processing has the potential to enable plants to achieve non-detectable Salmonella levels post-chill process, said the firm.
Significant milestone
Hank Lambert, CEO, said the submission of the FCN last week was a significant milestone.
“Prior to the FCN we had a preliminary meeting with the FDA and USDA and presented the results of Dr. Marsden’s work and that of other labs which shows SDC can reduce Salmonella to less than detectable levels,” he told FoodQualityNews.com.
“The timing is very good, it helps the USDA with a key issue they are battling with FSMA and the focus on ensuring that food producers have preventative controls in place in poultry processing.”
The firm said one of the main things found was that bacteria were not able to build up a resistance.
A sensory evaluation showed no difference in color, appearance or odor in treated poultry.
The company believes that test results exceed current US industry best practices and because it is non-toxic, it offers safety benefits for users, production line personnel and the environment.
Lambert said it has also been tested on produce and other types of meat.
“We have completed testing for three types of produce, spinach, lettuce and cilantro and we are preparing the FCN to submit to the FDA by mid-August,” he said.
“We have also begun tests on four types of meat, beef, pork, lamb and veal which will follow a similar process.”
SDC can come in different forms and concentrations depending on the food product, but for poultry tests the concentrations were 15ppm and 30ppm of SDC solution.
Approval process
The FCN review period is 120 days, after which, if there are no concerns, it automatically becomes effective.
When the FCN is granted PURE will submit it to the Food Safety and Inspection Service (FSIS) of the USDA for a new technology review.
As part of the FSIS review process, PURE will conduct three in-plant process validation and optimization trials with the authorization of the USDA.
After completion of the three in-plant validation trials, PURE expects the USDA to issue a “Letter of No Objection” and list SDC as an OLR poultry processing aid in Attachment 1 of FSIS Directive 7120.1, Safe and Suitable Ingredients Used in the Production of Meat and Poultry Products.
The USDA’s Salmonella Action Plan aims to reduce related foodborne illnesses by driving increased scrutiny to poultry inspection and processing practices.
An ongoing outbreak of multi-drug resistant Salmonella Heidelberg infections linked to Foster Farms brand chicken which has sickened 621 people in 29 states has also brought the issue to the public’s attention.
