Larry Keener has a long record of involvement, both nationally and internationally, with food industry issues. He is the current vice president and co-chair of the Austrian-based Global Harmonization Initiative, an organization founded in 2004 to promote harmonization of food safety legislation and regulations. He is president and chief executive officer of Seattle-based International Product Safety Consultants, Inc.—a global leader in providing food safety and food technology solutions to the food processing industry for a broad client base of Fortune 500 food companies, academic research institutes, and government agencies. Also, Larry has written and published more than 100 scientific papers and numerous book chapters on food safety, microbiology, and process validation. He is a frequently invited speaker to the food industry, business and scientific conferences, workshops, and seminars. 

Larry is an internationally regarded microbiologist and process authority in the food industry, and frequently works with food companies in this capacity to communicate the processor's regulatory responsibilities, assess risk and adequacy of controls for entire processing operations from raw materials receipt to finished product storage and distribution, and provide advice and direction with regard to regulatory impact and food safety risk that changes in operations might cause. As such, his areas of expertise range from applied food microbiology and sanitation methods, the development and application of thermal and non-thermal processing and preservation technologies, including high-pressure processing, microwave and pulsed electric field, high-powered ultrasound and design and implementation of food safety management and control systems and strategies.

Finally, Food Safety Magazine is proud to have Larry as a member of our editorial advisory board.

In this episode of Food Safety Matters, we speak to Larry once again about:

• Why the concept of validation causes so much confusion for both regulators and food safety professionals 
• The reason why validation and verification are not interchangeable terms
• Verification by way of end product testing
• How the process of validation has evolved over the years
• How FSMA and HARPC have changed the validation process
• Why FDA decided to build validation requirements and HARPC into new FSMA rules
• Whether there really is a difference between HACCP and HARPC
• Types of validation: prospective, concurrent and retrospective
• The reason why concurrent validation is so often overlooked
• The importance of validation when changing or reformulating a food product's manufacturing process
• Examples of how food spoilage was the result of not validating a new process
• The use of a multidisciplinary team to properly perform validation
• HACCP decision trees vs. validation decision trees

Related Content and Resources:
Quality Management Systems - Process Validation Guidance by SG3, 2nd Edition, 2004 (see decision tree on pg. 6)

Larry Keener's Articles Published in 
Food Safety Magazine:
COVER STORY: Key New (and Not So New) Food Safety Challenges (December 2017/January 2018)
Risks of Oligodynamic Silver Use in Food Preservation and Processing Operations (June/July 2017)
Novel Food Safety Technologies Emerge in Food Production (Feb/March 2015)
Shedding Light on Food Safety: Applications of Pulsed Light Processing (June/July 2014)
The Squeaky Wheel: Is Transportation the Watershed for Food Safety and Food Defense? (Aug/Sep 2013) 
Ex Ante or Ex Post Food Safety Strategies: Process Validation versus Inspection and Testing (June/July 2011)
Hurdling New Technology Challenges: Investing in Process Validation of Novel Technologies (Feb/March 2006)

Looking for more by Larry Keener? Search FoodSafetyMagazine.com

News Mentioned in This Episode
Feb. 22 Update | Listeria Outbreak in South Africa | National Institute for Communicable Diseases
Fiscal Year 2019 Budget
Various Dog Foods Recalled for Salmonella, Listeria and Presence of Illegal Drug
 

Additional info on dog food recalls by company/brand: Smokehouse Pet Products, Raws for Paws, Redbarn Pet Products, Arrow Reliance Inc. (Darwin's Natural and ZooLogics), J.M. Smucker (Gravy Train and Kibbles 'N Bits)

Brittney Miller is President of Manchester Farms, America's first quail farm. What started over 40 years ago as a backyard hobby has grown into a nationally recognized, family-owned business that produces more than 80,000 quail weekly, raising them responsibly, without antibiotics or hormones, and shipping premium products to chefs, retailers, and home cooks across the country. Brittney's story is about more than farming: it is about stewardship, innovation, and family values. She combines her passion for sustainable agriculture with modern food safety standards. Her SQF Level 2 certified, HACCP-compliant farm sets the benchmark for quality in specialty poultry.

Mindy Brashears, Ph.D. is the USDA's Under Secretary for Food Safety. Dr. Brashears previously served as Under Secretary for Food Safety from 2020–2021, and Deputy Under Secretary in 2019. Dr. Brashears returns to USDA from Texas Tech University, where she was a Paul Whitfield Horn Distinguished Professor of Food Safety and Public Health, the Roth and Letch Family Endowed Chair for Food Safety, and the Director of the International Center for Food Industry Excellence.

Justin Ransom, Ph.D. is Administrator of USDA's Food Safety and Inspection Service (FSIS), where he oversees FSIS' mission to ensure the safety, wholesomeness, and proper labeling of America's commercial supply of meat, poultry, and processed egg products. He leads the agency's modernization efforts, streamlining inspection systems, strengthening public health protections, and advancing science-based policies. 

Elena Medo, M.B.A. is an entrepreneur, researcher, and inventor who has spent nearly 40 years transforming neonatal care through leadership and innovation. She has secured numerous patents, raised over $40 million across four companies, and built a legacy of firsts, including the first commercially available shelf-stable donor breast milk product; the first milk bank owned exclusively by nursing mothers; and the first medical device designed to analyze human milk. Today, as CEO and co-founder of Leonie Health PBC, established in 2023 with her daughter, Adrianne Weir, Elena is developing a revolutionary product that replicates the immune properties of colostrum to protect preterm infants against the three deadliest neonatal infections—necrotizing enterocolitis (NEC), ventilator-associated pneumonia (VAC), and sepsis—which together claim the lives of more than 30,000 hospitalized infants per year.

Alissa Welsher, Ph.D. is a Senior Consultant at Elanco Poultry Food Safety. Dr. Welsher received a bachelor’s degree in biological sciences from the University of Pittsburgh, as well as a master’s degree in poultry science and a Ph.D. in cell and molecular biology from the University of Arkansas. Her area of expertise is meat and poultry food safety, and she specializes in integrated pest management (IPM).

Lyle Probst is the CEO of NomadX and an accomplished entrepreneur with more than 25 years of experience in operations, product development, engineering, biodefense, and advanced technology commercialization.

Alex LeBeau, Ph.D., M.P.H., CIH is the owner of Exposure Assessment Consulting LLC in Orlando, Florida, where he offers toxicology, industrial hygiene, risk assessment, and public health consulting services. Over his 13-year career, he has evaluated environmental and occupational exposures and has performed toxicological evaluations of chemicals and biological agents. He has also performed human health risk assessments of contaminated sites using U.S. Environmental Protection Agency (EPA) and state regulatory guidelines and has monitored remediation activities at those sites. To evaluate the exposure impacts on building occupants, he has performed indoor environmental quality assessments, including Legionella and water quality assessments, at healthcare, residential, and industrial facilities.