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 

Shannon Sked, Ph.D., BCE is an entomologist and the National Technical Director at Orkin. He received a B.S. degree from Rutgers University, an M.S. degree in Entomology from Penn State University, and a Ph.D. from Rutgers' Urban IPM Entomology lab. Dr. Sked's research focuses on distribution and temporal modeling of insect and rodent communities in order to design effective pest management programs. He began his career as a Navy Entomologist overseeing structural pests, specifically focusing on pests related to imports, exports, and within the logistics chain for Navy operations. He had the unique opportunity to practice applied entomology and invasive species management in the Middle East, North Africa, the Caribbean, and the eastern shore of the U.S.  

Michael Ciepiela is Vice President of Quality and Continuous Improvement at Southern Specialties. He brings over a decade of diverse experience in the food and beverage industry, along with experience in the pharmaceutical sector, specializing in quality assurance and food safety. Throughout his career, he has excelled in multi-site implementation and adherence to GFSI requirements and regulations. Michael has also been instrumental in promoting and educating Lean Six Sigma principles in fast-paced, cross-departmental settings. As a recognized thought leader, he frequently speaks at national conferences. He is also a senior member of the American Society for Quality (ASQ). Michael holds a bachelor's degree in Biology from Alfred University and a Six Sigma Master Black Belt from Villanova University.

Mindy Brashears, Ph.D. is the U.S. Department of Agriculture's (USDA's) Under Secretary for Food Safety. She 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.

Carmen Rottenberg is a leader in food safety and agriculture policy, serving as Managing Director of Groundswell Strategy a Board Member for the Partnership for Food Safety Education. Prior to launching Groundswell Strategy, Carmen served as Administrator of USDA's Food Safety and Inspection Service. Over her 13 years with USDA, Carmen held several leadership roles and was credited with spearheading key agency initiatives including modernizing food safety inspection systems and establishing and updating pathogen performance standards. Carmen has extensive experience achieving collaboration across federal, state, and municipal agencies including with the Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA), with state departments of agriculture and across USDA's 29 agencies and offices.

Jules Shepard is the CEO and Founder of gfJules, the number-one‑voted gluten‑free flour and baking mixes company in the United States. A recognized gluten‑free baking expert, she has authored three award‑winning books in the field and recently released a new cookbook dedicated to gluten‑free bread. A long‑standing and respected leader in the gluten‑free and food allergy community, Jules championed the gluten‑free food labeling movement in 2011. Her tireless advocacy, education, and lobbying efforts culminated in her receiving the first‑ever "Gluten Free Person of the Decade" award in 2020.

Lily Yasuda is the Deputy Director of the Alliance to Stop Foodborne Illness, where she leads national initiatives that bring together food industry leaders to strengthen food safety culture and support continuous learning across the sector.

Athenais Boeffard is a collaborative and people-focused production leader with over a decade of experience in food manufacturing and food safety. 

John Boyce has over 45 years of experience in various aspects of food production, food safety, quality assurance, sanitation, training, and auditing. 

Rhodes Yepsen joined the Biodegradable Products Institute (BPI) in 2015, where he leads the organization's efforts to promote the value of compostable products. Rhodes is passionate about systems-based solutions, where there is synergy in solving for food waste and packaging simultaneously—addressing climate change, ecosystem impacts, and regenerative agriculture. Previously, he served on the Board of USCC, worked for biopolymer producer Novamont, and was a staff editor and writer at BioCycle magazine.