SUMMIT-ARGO, Ill. — The National Center for Food Safety and Technology (NCFST), Illinois Institute of Technology (IIT) and Avure Technologies, announced that FDA has accepted the research institute’s filing of a new food sterilization process.
The NCFST filing is the first ever petition to FDA for the commercial use of pressure-assisted thermal sterilization (PATS) processes for application in the production of low acid foods.
PATS is a new technology that improves the quality of thermally processed foods while simultaneously eliminating the food safety risks associated with dangerous bacteria such as Clostridium botulinum and its toxins. The novel process, which combines mild heat with high pressure to produce commercially sterile low-acid food products, underwent a rigorous validation process and safety assessment by NCFST researchers and its Dual Use Science and Technology (DUST) consortium members.
The seven-year, multi-million dollar collaborative effort included scientists and engineers from Avure Technologies, U.S. Army Natick Soldier Research, Development and Engineering Center (RDEC), Baxter Health Care, ConAgra Foods, Hormel Foods, General Mills, Basic American Foods, Unilever, and Mars Co.
NCFST demonstrated that the PATS process is capable of verifiable and reproducible inactivation of C. botulinum spores from ambient, stable low-acid foods. The NCFST team established process efficacy through an inoculated pack study using a multi-strain cocktail of C. botulinum spores and mashed potatoes. An Avure QFP-35-600-S high pressure vessel was used in the validation study to thermally the process mashed potatoes in flexible meals ready-to-eat (MRE)-type pouches.
NCFST worked closely with its process authority, Seattle-based International Product Safety Consultants (IPSC), and FDA to establish validation procedures, protocols and testing for PATS and in developing the requisite reports for the LACF filing. Process validation testing began in 2006 and the application was submitted to FDA in September 2008.
“The threat of botulism makes low acid food production especially challenging for food manufacturers,” says Larry Keener, DUST validation team leader and president of IPSC. “With this FDA LACF filing, NCFST and its industry collaborators have demonstrated proof-of-process efficacy for this exciting new technology. Essentially, PATS combines a nonthermal technology, high pressure processing (HPP), which has been used successfully for many years to pasteurize a variety of refrigerated foods, including meat as well as high-acid and acidified foods, with mild heat to achieve sterilization temperature.”
The PATS process, added Keener, is a step forward for the food industry in providing an alternative to retort processing, which involves extensive exposure of the food to high temperatures. “PATS offers food manufacturers an opportunity to provide consumers value added foods with higher nutritional content, as well. HPP has traditionally provided quality improvements in foods such as avocado, juice and some deli meats. The PATS process extends the quality improvement benefits of classical HPP with the benefit of mitigating the food safety challenge posed by C. botulinum.”
The successful FDA LACF filing allows NCFST to proceed with the production of demonstration products using the PATS process. Patrick Dunne, leader of the DUST consortium and senior science advisor, Department of Defense Combat Feeding Directorate of the U.S. Army Natick Soldier RDEC, which researches, develops and supports production of combat rations for the nation’s warfighters worldwide, notes that the Army greatly appreciates the combined efforts of NCFST and the industrial partners in the consortium.
“We intend to keep working with industry to extend this technology to a variety of other products that will offer major advances in the quality of shelf-stable, highly nutritious foods for our nation’s warfighters, Dunne said. “The increased quality of center of the plate items and the capability to increase the variety of shelf-stable foods or ration components that we can provide our warfighters will have a positive impact on their mood, morale and performance.
“All new candidate rations items, such as the PATS processed mashed potatoes, are tested to be sure they retain quality over the extended shelf life we require and are tested in field exercises to be sure they are highly accepted by our warfighters. We do stress the need for both quality and safety of our combat ration items, and the PATS process provides both,” Dunne said.