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)

William Weichelt is in the newly created position of director, Food Safety & Industry Relations, for the National Restaurant Association (NRA) and has over 20 years of experience in the foodservice and food manufacturing sectors. 

The NRA is the largest foodservice trade association in the world by membership—supporting over 500,000 restaurant businesses. They represent and advocate for foodservice industry interests—with a focus on financial and regulatory obstacles. They also provide tools and systems that help members of all sizes get significantly better operating results as well as networking, education and research resources.

Specific to food safety their ServSafe Program provides comprehensive educational materials to the restaurant industry through face-to-face and online instruction. More than 5 million foodservice professionals have been certified through the ServSafe Food Protection Manager Certification Examination.

In this episode of Food Safety Matters, we speak to William Weichelt about:

• Challenges the NRA faces with the start of their new Food Safety Industry Relations department
• NRA’s current top priorities to help the industry going forward
• Using food safety best practices that have been applied in manufacturing to create new best practices in foodservice and hospitality
• Working with an industry that runs the gamut—from large operators with their own systems in place to independent operators who have no food science staff or expertise
• The challenge of figuring out what topics to educate the industry on in the short-term, based on need, from edible marijuana to implementing a food safety management system
• NRA's training and resources offered to smaller operators who do not have food safety staff
• Challenges related to keeping ServSafe relevant and always in line with the FDA Food Code
• Milestones that NRA has achieved as the organization's 100th-anniversary approaches
• The importance of having everyone in an organization from the top down involved in the implementation and maintenance of a food safety management system
• The new Food Safety Industry Relations department's future plans to help the industry in new areas: food fraud, food defense, traceability and figuring out how to apply these topics to the restaurant level, not just to manufacturers
• How changing trends, consumer demand and product innovations impact how the food industry operates and how it all affects the industry’s approach to food safety

Related Content and Resources
For National Food Safety Month, Restaurants Focus on Food Allergens
National Restaurant Association
ServSafe 

News Mentioned in This Episode 
The "Best .gif Ever," tweeted by the Safe Food Alliance
A Look Back at 2017 Food Recalls
Norovirus Sickens More than 100 at 2018 Winter Olympic Games
New USDA, FDA Joint Venture to Improve Food Safety Oversight and Inspection Process
Lactalis Official Statement Regarding Salmonella Tainted Baby Formula
List of Lactalis Recalled Products 
South Africa's Listeriosis Outbreak Death Toll Exceeds 100
Chicken Line Speed Changes
PCA's Remaining Appeals Denied
What's in Your Sushi?

Bob Ferguson's Food Safety Insights Articles:
Food Safety Insights: Testing and Sanitation for Allergen Control (February/March 2018) 
Food Safety Insights: Outsourcing: Pathogen Testing under the Microscope ( December 2017/January 2018)
Food Safety Insights: The New Face of Sanitation Programs: New Rules, New Challenges (October/November 2017)
Food Safety Insights: A Closer Look at Environmental Monitoring in the Processing Plant (August/September 2017)
Food Safety Insights: What Industry and FDA Are Thinking About FSMA Implementation (June/July 2017)
Food Safety Insights: The Drivers of Differences in Food Safety Testing Practices (April/May 2017)
Food Safety Insights: A Look at the Microbiology Testing Market (February/March 2017)

Barbara interviews Deirdre Schlunegger, the CEO of Stop Foodborne Illness. Stop Foodborne Illness is a national nonprofit public health organization dedicated to the prevention of illness and death from foodborne pathogens. Their mission is to promote sound food safety policy and best practices, build public awareness and assist those impacted by foodborne illness.

Stop Foodborne Illness was founded in 1993 in the wake of the Jack-in-the-Box E. coli outbreak by a group of foodborne illness victims and friends in order to address the void they saw in the national food policy arena.

Since then, Stop Foodborne Illness has become a respected leader in consumer advocacy and is regularly consulted by government officials, industry leaders, academia, public health organizations, members of Congress, and the media on issues concerning food safety.

Deirdre joined Stop Foodborne Illness in August 2010 bringing over 25 years of nonprofit and leadership experience. She serves as an advisory member of the Joint Institute of Food Safety and Nutrition and is a participating member of the Safe Food Coalition and the Make Our Food Safe Coalition and serves as Commissioner of the International Food Science Certification Commission.

If you would like to become involved with Stop Foodborne Illness's advocacy work, you can call them directly at 773-269-6555 or visit StopFoodborneIllness.org.

In this episode of Food Safety Matters, we speak to Deirdre Schlunegger about:

• The founding of Stop Foodborne Illness
• How the organization has helped to motivate regulatory reform, particularly via the U.S. Department of Agriculture, and the Food Safety Modernization Act
• Stop Foodborne Illness's consumer outreach efforts, especially for food outbreaks and recalls
• Consumer materials made available via Stop Foodborne Illness on topics such as handwashing, grocery shopping, food handling and preparation
• Positive cultural shifts that have taken place within the organization to a more cooperative approach with industry
• The impact of telling stories to workers in the food industry vs. relying on training/technical videos
• The Stop Foodborne Illness honor wall, a collection of stories from families who have been personally impacted by foodborne illness
• The Dave Theno Food Safety Fellowship
• Future projects and collaborations with food companies, government groups, and consumer communities

Related Content and Resources:
Donate Now: Stop Foodborne Illness
Dave Theno Food Safety Fellowship
Stop Foodborne Illness Stories & Honor Wall
Video: The WHY Behind Food Safety
Food Marketing Institute
Fightbac
Ask Karen
USDA Meat and Poultry Hotline: 888-MPHotline or 800-535-4555 

News Mentioned in This Episode: 
U.S. Says E. coli Outbreaks is "Likely Leafy Greens" While Canada Declares Outbreak Over
FSIS Works to Make Eggs Safer
Worst Ever Listeria Outbreak Plaguing South Africa

Dr. Lee-Ann Jaykus is a William Neal Reynolds Distinguished Professor in the Department of Food, Bioprocessing and Nutrition Sciences at North Carolina State University, having been employed with the university for over 22 years. 

Dr. Jaykus received a Ph.D. (1993) in environmental sciences and engineering from the School of Public Health at the University of North Carolina in Chapel Hill. She previously earned B.Sc. (1979) and M.Sc. (1982) degrees in food science from Purdue University, as well as serving in industrial positions for seven years. Her research efforts are varied but she is best known for her work in food virology. She is currently serving as the scientific director of the USDA-NIFA Food Virology Collaborative. Also called NoroCORE, the Collaborative is a seven-year, $25 million project intended to reduce the burden of disease associated with enteric viruses, particularly noroviruses. Prevention and control of norovirus contamination and subsequent transmission is one of her particular passions. 

Dr. Jaykus’ professional activities have included membership on the National Advisory Committee on Microbiological Criteria for Foods, on several Institute of Medicine-National Research Council consensus committees, and on the executive board of the International Association for Food Protection, for which she served as president in 2010-2011. Dr. Jaykus has also worked closely with the FDA Office of Foods in facilitating the implementation of risk-based food safety management systems. She has taught food microbiology/safety on the undergraduate and graduate levels, has mentored over 50 graduate students and post-doctoral research associates and authored or co-authored over 150 scientific publications.

In this episode of Food Safety Matters, we speak to Lee-Ann Jaykus about:

• How NoroCORE got started, including the major players and institutions that have contributed to the initiative's success and outreach efforts
• Why NoroCORE focuses so much on engaging stakeholders from the foodservice industry
• The history of norovirus first identified in the 1960s
• Work done by Baylor College of Medicine to produce replication of norovirus for the first time
• Human challenge studies, popular among cash-strapped college students but necessary for continued and timely norovirus research
• The most surprising findings she's come across in her years researching norovirus
• Clarifying the source of norovirus
• What foodservice can do to prevent norovirus outbreaks from occurring
• Social media's effect on educating the public about norovirus

Lee-Ann Jaykus's Articles Published in Food Safety Magazine:
Updates from the NoroCORE Project: Progress Toward Reducing the Burden of Foodborne Viruses
Food Virology Collaborative: NoroCORE Tackles Foodborne Viruses

News Mentioned in This Episode:
Similar E. coli Outbreaks Persist in U.S. and Canada
Audits Criticize FDA on Food Recalls
Enforcement Discretion Policy Announced for Some FSMA Regulations

In this episode of Food Safety Matters, the Food Safety Magazine team discusses:

• Top news stories and trending topics we covered on the podcast this year
• A look back at the Food Safety Modernization Act's rules that took effect in 2017
• Food Safety Magazine's most-viewed content in 2017
• Trends observed via Bob Ferguson's Food Safety Insights series and forecasts for 2018
• Commentary on some of our most memorable expert guests, and continuing themes we heard in various interviews
• Some podcasting lessons learned

News Mentioned in This Episode:

• Study: Effective Handwashing Does Not Require Hot Water
• 3.7 Million Pounds of Recalled Meat Products Linked to One Breadcrumb Supplier
• 7 Million Pounds of Meat Products Recalled After Consumers Find Bone Pieces
• Chipotle Customers Report Foodborne Illness Symptoms Online (includes links to previous Chipotle stories)
• Significant Foodborne Outbreaks of 2017
• FSMA Infographic

Food Safety Magazine's Most-Viewed Articles of 2017

1. Food for Thought: The Federal GMO Labeling Law
2. Nanotechnology in the Food Industry: A Short Review
3. Consumer Food Trends Create Food Safety Challenges for the Foodservice Industry
4. A Look at the Microbiology Testing Market
5. Food Fraud Vulnerability Assessment and Pre-Filter for FSMA, GFSI and SOX Requirements

This special BONUS episode of Food Safety Matters focuses on Allergens. Concerns about food allergens have been around now for quite some time, and the food industry has done a respectable job of proactively guarding against unintended food allergens in their products. However, with the introduction of the Food Safety Modernization Act (FSMA), continued globalization of the food supply and increased regulatory activities, food manufacturers will need to keep diligent in their food allergen control plans.

To explore how the food industry can improve their odds of avoiding allergen risks, Food Safety Magazine’s Editorial Director, Barbara VanRenterghem, speaks with Tim Hendra from Neogen. Tim has been with Neogen for 21 years, specializing in diagnostic applications such as rapid testing and allergens. He has been a very active member of technical committees at various food industry associations, such as the Food Allergen Research and Resource Program (FARRP) and International Association for Food Protection (IAFP), and has co-authored several food allergen handbooks.

In this episode, we speak to Neogen’s Tim Headra about:

• Why allergens continue to be such an important issue for food manufacturers.
• Food allergen trends and recalls
• Risks to consumers and the business in the food industry
• How manufacturers and retailers can work together when allergen recalls occur
• Importance of transparency (for manufacturers)
• Reasons for allergen recalls other than mislabeling
• What the “Big 8” allergens mean on a global scale, and what allergens in other countries mean for the U.S.
• Efforts to harmonize allergen lists and threshold levels between countries
• Detecting allergens vs. proteins, and the relationship between the two
• FSMA and food allergen control programs, types of allergen testing kits and methods
• Limitations with PCR tests and LC-MS methods vs. ELISA tests
• What food manufacturers can do when they are faced with allergen issues

Resources

Visit Neogen’s Allergen website for information on Neogen’s complete line of allergen solutions. 
Food Allergen Monitoring Handbook
Validation and Verification Handbook

To speak to a Neogen representative call 1-800-234-5333

Sponsored by:

Will Daniels is president of the produce division at IEH Laboratories and Consulting Group. In this role, Will is responsible for lab and consulting services for the produce industry. Prior to joining IEH, Will was president and CEO of Fresh Integrity Group, Inc., a consulting firm specializing in operations and food safety consulting for the fresh produce and perishables industries. He was recently involved in the cold-pressed juice industry, working with two startups to develop their operations. Prior to his involvement with start-up companies, Will was with Earthbound Farm from 1999 until 2014. Having leadership roles in both quality assurance and operations, he helped the company grow from a small, regional salad producer to the nation’s largest grower, packer, and shipper of organic produce. As Earthbound Farm’s Chief Food Integrity Officer, Daniels was responsible for food safety, food quality, and the company’s organic integrity program. Before joining Earthbound Farm, Will worked for 15 years as a consultant in the foodservice sector; working in the back of the house designing menus, introducing food safety and, improving costs; he even had his own catering business. 

Will is a sought-after speaker and has addressed key issues in food safety in the produce industry at meetings of the National Academy of Sciences, the National Restaurant Association, the Institute of Food Technologists and the International Association for Food Protection. He was the keynote speaker at the 2013 Food Safety Summit in Washington, DC, was one of the Packer 25 annual list of produce leaders for 2013 and was named one of the food industry’s top food safety leaders by Marler/Clark’s Food Safety News in 2013. He has also been featured in a variety of national news stories on food safety with media such as The New York Times and ABC News’s Good Morning America; he is the author of two book chapters, “Effectively Managing through a Crisis,” in Microbial Safety of Fresh Produce, published by Wiley in 2009 and “Pathogen Testing in Fresh Produce: Earthbound Farm,” in Global Safety of Fresh Produce; A Handbook of Best Practice, Innovative Commercial Collations and Case Studies, published by Woodhead Publishing in 2014. An active leader in the food industry, Will serves on a variety of boards and technical committees. 

In this episode of Food Safety Matters, we speak to Will Daniels about:

• How Earthbound Farm responded to a deadly E. coli 0157:H7 outbreak linked to fresh spinach
• The complexities and challenges of the supply chain
• Balancing food safety needs with marketing objectives
• The importance of education along every point of the supply chain
• Low product pricing and its effect on food safety
• Misconceptions about FSMA regulations
• Getting the C-suite to understand the value of investing in food safety 

Articles by Will Daniels in Food Safety Magazine
Nationwide Produce Outbreak: A Moment You Never Forget
Earthbound Farm: Balancing Food Safety From Seed to Shelf
Industry Perceptions of Proposed FSMA Rule on Preventive Controls

News Mentioned in This Episode
Study: Raw Flour Linked to E. coli Food Poisoning
Ells Departs as Chipotle CEO
A Food Fight Has Broken Out Between the USDA and FDA
Editors Note: Our apologies to FiveThirtyEight for crediting the article to Politico in the episode.

Danone Welcomes Arbitration Award in Fonterra Case
Joining us for this discussion is Larry Keener, CFS, PCQI, president and CEO of International Product Safety Consultants and a member of the Editorial Advisory Board of Food Safety Magazine.

Other resources for Fonterra-Danone Story:
Danone Damages Anger Fonterra
2013 Fonterra Recall (Wiki page)

Download Incident Report from Government of New Zealand: 
The WPC80 Incident: Causes and Responses Government Inquiry into the Whey Protein Concentrate Contamination Incident