NCFST Receives Regulatory Acceptance of Novel Food Sterilization Process

The National Center for Food Safety and Technology (NCFST), Illinois Institute of Technology (IIT) and Avure Technologies, Inc., announced today that the U.S. Food and Drug Administration (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 promising new technology that significantly 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 multimillion 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.

The FDA's requirements for registration, manufacturing and process filing of low acid canned foods (LACF) are codified in Title 21, Code of Federal Regulations, Parts 108 and 113. Filers must provide extensive information regarding critical factors and processing steps that show, with a high degree of confidence, that the process used to manufacture a food will not permit the growth of microorganisms of public health significance. 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, WA-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 non-thermal 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. It is truly a breakthrough process in terms of reducing the risk of C. botulinum contamination in these types of foods.”

The PATS process, added Keener, is a big 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.

“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,” says Dunne. “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.”

Pat Adams, CEO of Avure Technologies, the Kent, WA-based global experts in HPP technology, says that regulatory acceptance of this innovative process is an important step for the food industry. “This technology may provide food producers with an alternative processing means that utilizes less energy and creates better-tasting products than some current offerings. Avure is developing the systems to commercialize the process with the expectation that we will further reduce the thermal requirements and enable production of products that equal or exceed frozen foods but that can be distributed without the need of refrigeration.”

Chair of the DUST Microbiology Committee Phillip Minerich, PhD, vice president of research and development with Hormel Foods Corp., notes that the new process will have a big impact on food safety and quality assurance for the low acid foods processing sector. “Any time you can combine an innovative processing technology and food safety is a win for the consumer and industry. The PATS process produces very high quality, commercially sterile foods using a technology that has been studied for decades and is currently used as a food safety intervention for select sliced deli meats, shellfish, avocado, fruits, jams, jellies and juices.”

The National Center for Food Safety and Technology (NCFST) is a unique research consortium located at the Illinois Institute of Technology's Moffett Campus (near Chicago) in Summit-Argo, IL, composed of scientists from the FDA Center for Food Safety and Applied Nutrition (CFSAN), Illinois Institute of Technology (IIT) and the food industry. NCFST’s research addresses the food safety implications of emerging technologies in food processing and packaging and supports the development of safe food with health-promoting properties from farm to fork. For more, visit www.ncfst.iit.edu

Founded in 1890, IIT is a Ph.D.-granting university with more than 7,300 students in engineering, sciences, architecture, psychology, design, humanities, business and law. IIT's interprofessional, technology-focused curriculum is designed to advance knowledge through research and scholarship, to cultivate invention improving the human condition, and to prepare students from throughout the world for a life of professional achievement, service to society, and individual fulfillment. Visit www.iit.edu.