Kathy Gombas is a recognized food safety expert with over 30 years of experience in the food industry specializing in preventive controls, supply chain management, food safety auditing, and regulatory affairs.

Kathy retired from the U.S. Food and Drug Administration (FDA) after 10 years of service. She was a senior advisor at FDA’s Center for Food Safety and Applied Nutrition (CFSAN). While at CFSAN, Kathy was in a leadership role supporting the agency’s Food Safety Modernization Act (FSMA) implementation efforts including the Preventive Controls Regulator Training and launch of FDA’s FSMA Technical Assistance Network for industry. Kathy also led the implementation of FDA’s Reportable Food Registry.  

Before joining FDA, Kathy held senior food safety positions at Dean Foods overseeing food safety programs for their Northeast dairy operations and then the corporate supplier management program. Prior to that, she spent 8 years at Kraft Foods conducting food safety audits worldwide and developing corporate food safety policies.

Kathy is currently a member of the Food Safety Preventive Controls Alliance (FSPCA) steering committee and co-chair for the international subcommittee working on industry training, outreach, and technical assistance programs for food companies worldwide. Finally, Kathy is on the Editorial Advisory Board of Food Safety Magazine.

Kathy graduated from Northern Arizona University with a B.Sc. in Microbiology.

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

• The importance of reading and understanding FSMA guidance documents
• Highlights from the Preventive Controls Hazards Guide
• How crucial it is to get your hazard analysis right
• Remembering to look at all ingredients, including process water and overrun air, when it comes to your manufacturing process and the hazards it may present
• Being able to justify what's included--and what's not included--in your hazard analysis
• Why importers need to understand Foreign Supplier Verification Program requirements
• What FSPCA is working on next

Food Safety Magazine Articles Written and Co-Written by Kathy:
Food Safety Preventive Controls Alliance Education and Outreach Goes Global (October/November 2017)
Learning from FDA Food Allergen Recalls and Reportable Foods (April/May 2014)
The Reportable Food Registry: A Valuable New Tool for Preventing Foodborne Illness (June/July 2011)
GFSI's Role in Harmonizing Food Safety Standards (June/July 2009)
Auditing Mechanics 101: A Guide for Auditors and Auditees (April/May 2005)
Food Allergen Awareness: An FDA Priority (February/March 2001)
The Challenge of Food Allergens: An Update (October/November 2001)
Supplier Scorecards: Are They Right for You? (December 2008/January 2009)

Related Content and Resources:
Food Safety Preventive Controls Alliance
All FSMA Rules and Guidance for Industry
FDA's FSVP Importer List
FDA FSVP Guidance Document (Draft)
FSMA Guidance on Enforcement Discretion 
Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by FSMA (Draft)
HARPC Draft Guidance + Appendix 1

News Mentioned in This Episode
UPDATE: Multistate Romaine Lettuce E. coli Outbreak Continues to Spread 
VIDEO: Romaine Lettuce Farmers Frustrated by Government Response to E. coli Outbreak 
Canada Hit by Romaine Lettuce Illnesses 
USDA FSIS New Leadership Announced 
Research: Food Safety Inspection Scheduling Can Positively Impact Foodborne Illness Rates; Harvard Study 

Bill Marler is the most prominent foodborne illness lawyer in America, and a major force in food policy in the U.S. and around the world. Bill’s firm—Marler Clark: The Food Safety Law Firm—has represented thousands of individuals in claims against food companies whose contaminated products have caused life-altering injuries and even death.

Bill began litigating foodborne illness cases in 1993, when he represented Brianne Kiner, the most seriously injured survivor of the historic Jack in the Box Escherichia coli O157:H7 outbreak, in her landmark $15.6 million settlement with the fast food company. For the last 25 years, Bill has represented victims of nearly every large foodborne illness outbreak in the U.S. He has filed lawsuits and class actions against Cargill, Chili’s, Chi-Chi’s, Chipotle, ConAgra, Dole, Excel, Golden Corral, KFC, McDonald’s, Odwalla, Peanut Corporation of America, Sheetz, Sizzler, Supervalu, Taco Bell, and Wendy’s. Through his work, he has secured over $650 million for victims of E. coli, Salmonella, Listeria, and other foodborne illnesses.

Bill Marler’s advocacy for a safer food supply includes petitioning the U.S. Department of Agriculture to better regulate pathogenic E. coli, working with nonprofit food safety and foodborne illness victims’ organizations, and helping spur the passage of the Food Safety Modernization Act. His work has led to invitations to address local, national, and international gatherings on food safety, including testimony before the U.S. House of Representatives Committee on Energy and Commerce, and the British House of Lords.

Bill travels widely and frequently to speak to law schools, food industry groups, fair associations, and public health groups about the litigation of claims resulting from outbreaks of pathogenic bacteria and viruses, and the issues surrounding it. He gives frequent donations to industry groups for the promotion of improved food safety and has established numerous collegiate science scholarships across the nation.

He is a frequent writer on topics related to foodborne illness. Among other accolades, Bill was awarded the NSF Food Safety Leadership Award for Education in 2010.

In this episode of Food Safety Matters, we speak to Bill Marler about: 

• The circumstances under which he met the late Dave Theno
• The Jack in the Box case and how it propelled his career
• The current listeriosis outbreak in South Africa, and how it compares to the Jack in the Box case 25 years ago
• Why foodborne illness cases involving hamburger and Escherichia coli are no longer a huge problem
• How the Odwalla apple juice outbreak could have been avoided
• Whether or not Salmonella should be officially declared an adulterant
• The responsibility of food safety: consumer vs. food industry
• His thoughts on the ongoing Peanut Corporation of America case and whether or not Stewart Parnell's attempts at a new trial are valid
• FSMA, and how the new regulations can be improved
• Blockchain, whole-genome sequencing, and other technologies that are changing the food safety for the better
• His newfound interest in public health as it relates to food safety

Related Content
Poisoned: The True Story of the Deadly E. coli Outbreak That Changed the Way Americans Eat 
20 Years of Marler Clark's Top Foodborne Illness Cases

News Mentioned in This Episode
Deadly Listeria Strain Confirmed at South Africa Meat Plant 
UPDATE: One Death Caused by Romaine Lettuce as E. coli Outbreak Spreads 
New USDA Report Breaks Down Food Recalls 2004-2013; Trends in Food Recalls 2004-2013
UPDATE: Study: Fresh Produce Bacteria Can Thrive Despite Routine Chlorine Sanitizing; Official Study

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Melanie Neumann is the president of Neumann Risk Services, and executive vice president of Matrix Sciences—a firm that focuses on food safety risk management, business and brand protection, regulatory compliance, and industry best practices. Melanie leverages her 19 years of industry experience as a food law attorney along with her Masters of Science in Food Safety to help clients manage the risks relating to each step in the supply chain, from supplier assessment and procurement, manufacturing, distribution and sale of food globally. 

She is a graduate of Mitchell-Hamline Law School for her Juris Doctorate degree, and Michigan State University for her M.S. in Food Safety. She has worked for multi-national food companies such as Hormel Foods, The Schwan Food Company, private law firms focusing on food law and intellectual property law, was instrumental in launching national food safety risk management practices for one of the “Big 4” tax and auditing firms as well as for other well-known consulting firms.

She is an Adjunct Professor at Michigan State University and serves on advisory panels and boards of several notable organizations.  Melanie is a frequent speaker on executive liability in food production and food regulations including FSMA regulations. Outside of her profession, Melanie is an avid triathlete, to date completing 25 marathons and six Ironman triathlons.

In this episode of Food Safety Matters, we speak to Melanie Neumann about:

• The level of difficulty involved when it comes to food companies having to implement FSMA

• The difference between understanding a regulation vs. implementing it vs. operationalizing it

• How much legal interpretation is really required to understand how to properly implement FSMA

• Melanie’s view of how FDA regulators and food companies are working together during inspections in the beginning stages of FSMA

• The importance of explaining the "why" behind FSMA regulations, why they exist, and why behaviors in the food facility need to change

• FSMA's effect on global food companies

• How FSMA stacks up against ISO, GFSI and international standards in general

• What happens during an FDA inspection if a QA manager or food safety staff member cannot answer questions accurately or knowledgeably

• The number one factor that causes a food plant to be non-compliant with some part of a FSMA rule or regulation

• How poor records management can make or break a food company, and the benefits of electronic record-keeping

• What's involved in a readiness assessment? 

• Crisis management planning and after-action assessments

• Melanie's thoughts on mock recalls and crisis simulations

• Why food companies can no longer afford to ignore social media and what people are saying about their products

News Mentioned in This Episode
Update: Romaine Lettuce Named as Source of Multistate E. coli Outbreak 
Over 200 Million Eggs Recalled After East Coast Salmonella Outbreak 
Salmonella Outbreak Traced to North Carolina Leads to Largest Egg Recall in Nearly a Decade
Study: Expensive Foodborne Outbreaks Could Be Prevented If Sick Employees Are Given Adequate Sick Time 
2018 Dirty Dozen and Clean 15 Lists Rank Produce Items by Pesticide Level

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

Don Schaffner is distinguished professor and Extension Specialist in food science at Rutgers University. He has published over 150 peer-reviewed papers on a variety of topics including handwashing, cross-contamination, quantitative microbial risk assessment, and predictive food microbiology. Dr. Schaffner is active in several scientific associations, including the International Association for Food Protection where he is a past-president.

Ben Chapman is associate professor and food safety Extension Specialist at North Carolina State University. There, with the goal of less foodborne illness, his group designs, implements, and evaluates food safety strategies, messages, and media from farm-to-fork. Ben is also a contributor to the very popular Barfblog.

Together, Don and Ben are co-hosts of the Food Safety Talk podcast.

In this episode of Food Safety Matters, we speak to Ben Chapman and Don Schaffner about:

• Current research involving berry harvesting and norovirus
• The impact that social media may or may not have on consumers' food safety behaviors
• Blockchain and other innovative technologies
• Inspiring and worthwhile published works about food safety and related research
• The benefits of industry tradeshows like IAFP

Related Content:
Parameters for Determining Inoculated Pack/Challenge Study Protocols 
Prevention of Foodborne Illness by Time-Temperature Control of Thawing, Cooking, Chilling and Reheating Turkeys in School Lunch Kitchens 
Health Department Inspection Criteria More Likely to be Associated with Outbreak Restaurants in Minnesota 

Ben Chapman's Articles Published in Food Safety Magazine:
The Role of the Cooperative Extension in Food Safety (October/November 2014)
Crisis Management: How to Handle Outbreak Events (June/July 2012) 
Food Safety for Food Handlers (December 2010/January 2011)

News Mentioned in This Episode
FDA Issues First Mandatory Recall for Food Product
Fifth Recall Reveals Known Contamination at Raw Pet Food Plant 
Health Officials Release Statement Clarifying Source of South Africa's Listeria Outbreak
Ridiculous History Podcast: The Poison Squad

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Jorge Hernandez is the chief food safety and compliance officer for Wholesome International, a restaurant company with different concepts and brands in the quick and fast casual foodservice markets in the U.S. He is responsible for food safety, quality, regulatory compliance, and sustainability for the organization. This includes developing structure and reporting lines for the staff, risk-based policies and procedures that meet or exceed FDA, USDA, and/or state regulations, as well as the department leadership and oversight over the company’s suppliers, restaurants, processing facilities, and distribution.

Previously, Hernandez worked for 12 years as the senior vice president for food safety and quality assurance at US Foods where he developed the food safety, quality, and food regulatory program for a corporation that included more than 80 distribution centers, 14 processing facilities, and over 550 private label co-packers with 1,600 facilities across all segments of the food industry.

Earlier, Jorge was the vice president of food safety and risk management at the National Restaurant Association where he led the development of the award-winning ServSafe food safety training program for the restaurant industry.

Jorge started his career as a regulator and held positions at the state and the Winnebago County health departments in Illinois, U.S. He has earned degrees in biology from Rockford University, microbiology from the Centro de Estudios Medico-Biologicos in Mexico City Mexico, and languages and literature from la Universite de la Sorbonne, Paris, France.

Jorge is the board member of several industry organizations, including STOP Foodborne, the International Food Protection Institute, and GFSI, where he co-leads the development of the International Standards for the Food Warehouse and Distribution and is currently the co-chair of the GFSI U.S./Canada Group.

Hernandez has published many articles and is a recognized consultant in the areas of food safety, food safety management systems, food safety accreditation, food safety training, and food safety operations. 

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

• The art of balancing food safety science with common sense and making decisions based on both
• Food safety culture and how it allows employees to speak up when food safety is at risk
• Challenges of temperature control, contamination, and traceability while distributing food
• The importance of working with supply chain partners who are knowledgeable about food safety and take it seriously
• Why having the most sophisticated, up-to-date technology is not always enough to ensure the safety of food
• Challenges faced by large food transporters that are not always problematic for smaller, local, or regional operators
• The importance of using technology properly to ensure the best data and integrity possible
• Best practices for transporting mixed loads 
• Why documentation and record-keeping are so important for times when technology may fail
• His thoughts on why food distribution is not a huge target for intentional contamination
• How the introduction of FSMA has helped make it safer to transport both raw product and ready-to-eat product on the same truck without cross-contamination issues
• Common transportation issues and the use of trucks that are not fit to safely transport food
• Working with GFSI to create international standards for transportation and warehousing
• How GFSI standards compare to the FSMA Sanitary Transportation rule
• Positive trends he sees with technology, big data, analytics, epidemiology, DNA, traceability, blockchain, and more.

Related Content:
FSMA's Final Rule on Sanitary Transportation of Human and Animal Food 
The Supply Chain and Food Safety Culture: Distribution (June/July 2017)
The State of Food Safety: Regulation, Collaboration and the Advancement of a Globally Safe Food Supply (August/September 2012)
Foodservice Distribution: Maintaining the Cold Chain (August/September 2009)

News Mentioned in This Episode
South African Poultry Plant Closes Amid Deadly Listeria Outbreak Investigation
A Spoor-Marler Team Plans Class Action for South African Listeria Victims
Family of 5-Year-Old Awarded $6.5 Million in Salmonella Chicken Case

In this BONUS episode of Food Safety Matters, we focus on next-generation sequencing and the advantages of using 16S Metagenomics to identify spoilage organisms in your facility thereby reducing the possibility of spoiled products reaching your consumers.

You will learn about a 16S Metagenomics service and how to join the 16S Challenge that gives you a chance to take advantage of the Advanced Microbial Mapping Program and get your facility biomapped at no charge.

To help us explore this new technology and service, our editorial director Barbara Van Renterghem will be speaking with Joe Heinzelmann, who specializes in food safety genomics at Neogen. Joe began his career as a nanotechnology chemist after graduating from Albion College with a bachelor’s degree in chemistry, and with an MBA from Northwood University. Joe tells us more about the practical applications of metagenomics in eliminating spoilage organisms in a food processing facility.

In this episode, we speak to Neogen's Joe Heinzelmann about:

• What is 16S Metagenomics and how it's different from Whole Genome Sequencing
• What type of facilities benefit most from biomapping
• How 16S Metagenomics is different from other technologies currently being used in the market
• Partnering with the Alliance for Advanced Sanitation on research to understand how bacteria communities are affected by sanitation
• What is the 16S Metagenomics Challenge?
• Opportunites presented by using 16S Metagenomics for biomapping
   

Resources
Join the 16S Challenge
16S Metagenomics Overview
Metagenomics for Food Safety and Quality: Webinar Series

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Mike Cramer joins the Food Safety Matters Podcast this week for an in-depth discussion of best practices for food plant sanitation.

Michael Cramer is currently the senior director of food safety and quality assurance with Ajinomoto Windsor, Inc. The company was formed through various acquisitions (Multifoods, Specialty Brands and Windsor Foods) and ultimately the purchase of Windsor Foods by Ajinomoto. He will celebrate his 25th year with the company in October 2018.

Mike is an SQF practitioner, ASQ-certified quality auditor and a preventive controls-qualified individual. CRC Press published Mike's book “Food Plant Sanitation: Design, Maintenance and Good Manufacturing Practices” (2nd Edition, 2013).

Mike is a graduate of West Chester University in West Chester, PA where he earned a B.Sc. Health Science in 1977. He spent 16 years working with Swift & Company (Armour, Swift – Eckrich, ConAgra) in poultry operations, processed meats and poultry, and corporate food safety and quality assurance.

Finally, Mike has been an esteemed member of Food Safety Magazine's Editorial Advisory Board since 2001.

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

• The characteristics of an effective sanitation program
• Balancing cost-savings while implementing an effective sanitation program
• The importance of the sanitation team within a food facility
• His experience with testing for allergen cross-contamination from the lunch room to the plant floor
• Plans for the third edition of his popular sanitation book
• What he thinks is the biggest sanitation challenge in food plants today
• The real reason for allergen-related food recalls
• The success of his "Seek and Destroy" and "Monthly Facility Assessment" programs
• What happens at Ajinomoto Windsor when a positive Listeria monocytogenes sample is detected
• The seven steps of sanitation explained in detail
• The role of sanitors, including what they should and shouldn't do as part of their daily jobs
• The complexities of seemingly simple tasks in sanitation, such as vacuuming and floor sweeping
• His tips for equipment cleaning, including his preferences when it comes to pressure washing and water temperature 
• His thoughts on all-encompassing equipment checks vs. random spot checks
• The benefits of collecting microbiological swabs BEFORE applying sanitizer
• Standard tools that all sanitors need and use
• How to communicate with your chemical supplier to get the tools and resources you need for an effective sanitation program
• The use of UV light in sanitation
• Advice for anyone looking for new technology to improve food plant sanitation
• What can happen when sanitation is not approached correctly

Related Content and Resources:
BOOK: Food Plant Sanitation: Design, Maintenance, and Good Manufacturing Practices, 2nd Edition

Mike Cramer's Articles Published in Food Safety Magazine:
Environmental Listeria Monitoring: Seek and Destroy Pathogens (December 2017/January 2018)
Allergen Management: A Personal and Professional Perspective (August/September 2016)
A Look at GMPs: How FSMA Will Change Expectations (February/March 2016)
Supplier Certification: A Matter of Risk Assessment and Resources (October/November 2015)
Upgrade Sanitation Plan to Work Out Bugs (April/May 2014)

For more articles from Mike Cramer? Access our compiled search FoodSafetyMagazine.com

News Mentioned in This Episode:
New Pesticide Testing Data Touts U.S. Food Supply as "One of the Safest in the World" 
FDA Testing Fresh Herbs, Avocados for Foodborne Pathogens 
Ready-to-Eat Processed Meat: Source of South Africa's Deadly Listeria Outbreak 

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