Michael Cramer started his food career with Swift and Company at a turkey processing facility in eastern Pennsylvania while attending West Chester University. He graduated in 1977 with a B.S. degree in Health Education. During his career with Swift and Company, he was Quality Assurance (QA) Manager at plants in Pennsylvania and North Carolina, a Production Specialist, and a Documentation Manager at the corporate headquarters.

In 1993, Michael started with Specialty Brands Inc. in Ontario, Canada, where he was Director of Food Safety and Quality. He spent 27 years with the company, and remained as Senior Director of Food Safety and Quality Assurance (FSQA) through the purchase by Ajinomoto Foods North America Inc. He developed and implemented programs to ensure production of safe, quality, ethnic frozen foods. Mike retired from Ajinomoto Foods in July 2021.

Mike has been a member of the International Association for Food Protection (IAFP), and was part of the FSQA team at Ajinomoto Foods that won the prestigious Black Pearl Award in 2020. In addition to authoring Food Plant Sanitation, he is also on the Editorial Advisory Board of Food Safety Magazine and has written articles for Food Safety Magazine dealing with Listeria control, biosecurity, sanitation and sanitary design, and allergens. He was also a contributing member of the American Frozen Foods Institute (AFFI) Listeria Working Group. In addition, he has participated in multiple Food Safety Matters podcasts, conducted food sanitation webinars, and has been a presenter at numerous food safety and quality conferences. He remains active in retirement, giving back to the industry.

In this episode of Food Safety Matters, we speak with Mike [18:25] about:

• What led him to write and publish Food Plant Sanitation and its two subsequent versions, and how the third edition touches on real-life experiences with the Food Safety and Modernization Act (FSMA) in sanitation
• The difference between validation and verification, and what those concepts look like in sanitation
• Guidelines, including regulations and directives for FSQA professionals, for designing effective sanitation standard operating procedures (SSOPs)
• Why FSQA personnel should spend time on the sanitation shift and have conversations with chemical suppliers, testing labs, colleagues at other plants, and consultants
• Trade associations and publications that can be beneficial resources to FSQA professionals
• Mike's experience developing a robust FSQA culture by aligning sanitarians’ purpose, using cross-functional teams, and getting leaders to buy into and understand FSQA
• The difference behind “consumers” and “customers” from an FSQA point of view
• The importance of relationship-building, flexibility, and communication with FSQA staff to ensure that a healthy food safety culture survives and thrives within a company
• Ways in which companies can manage turnover and maintain or transfer skills and knowledge.

News and Resources

FDA, CDC Partner to Strengthen Retail Food Safety with MOU [3:40] Study Examines Listeria, Salmonella Survival in Dry Packaging Facilities, Efficacy of Sanitizers [6:20] FDA Study Will Evaluate Children’s Exposure to Mercury from Seafood [11:21] Seaweed Food Safety Knowledge is Limited; FAO, WHO Call for Research, Regulation [12:42]

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Cintas

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Dr. Alissa Welsher is Associate Senior Consultant at Elanco Poultry Food Safety. Dr. Welsher received her B.S. degree in Biological Sciences from the University of Pittsburgh, as well as an M.S. degree in Poultry Science and a Ph.D. in Cell and Molecular Biology from the University of Arkansas. Her area of expertise is molecular physiology, and she specializes in heat stress and gut health.

In this episode of Food Safety Matters, we speak with Dr. Welsher about:

• Why a comprehensive Integrated Pest Management (IPM) program is crucial in a poultry processing plant
• Why it is important, at the farm level, to consider pests that carry foodborne pathogens upstream, and the types of pests that carry foodborne pathogens
• Pathogens that cause problems in poultry houses
• Why producers should prioritize IPM as an important part of food safety programs
• Strategies to minimize the spread of pathogens and disease from pests throughout farms
• How producers can reevaluate IPMs in response to resistance issues
• Best practices for processors to manage resistance
• How Elanco’s Food Safety team can help poultry producers develop an IPM program to address food safety concerns
• Where listeners can learn more about Elanco and its solutions for developing an IPM program.

Sponsored by:

Elanco

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Stephen Hughes is Prevention Coordinator within the Center for Food Safety and Applied Nutrition (CFSAN), within the Office of Food Safety at the U.S. Food and Drug Administration (FDA). After outbreaks and adverse incidents, he runs a systematic process to identify and implement public health interventions intended to help limit or prevent future outbreaks linked to certain FDA-regulated foods. Before coming to FDA, Stephen worked in a public health program in Virginia, in program areas that included food safety, indoor air quality, aquatic health, and general environmental health.   

Dr. Jennifer McEntire is Chief Food Safety and Regulatory Officer at the International Fresh Produce Association. Prior to the merger of United Fresh and Produce Marketing Association, Jennifer was Vice President of Food Safety and Technology at United Fresh Produce Association.

A food microbiologist by background, she has always worked in the Washington D.C., area, bringing a scientific perspective to food safety regulatory issues. She was previously Vice President of Science Operations at the Grocery Manufacturers Association. She has served as Vice President and Chief Science Officer at The Acheson Group and as the Senior Staff Scientist and Director of Science and Technology Projects at the Institute of Food Technologists.

Jennifer earned a Ph.D. from Rutgers University as a U.S. Department of Agriculture (USDA) National Needs Fellow in food safety. She serves as an advisory board member of the Global Food Traceability Center, the technical committee of the Center for Produce Safety, and she is on the executive committee of the Food Safety Preventive Controls Alliance.

In this episode of Food Safety Matters, we speak with Stephen and Jennifer [3:35] about:

• FDA’s three main reasons—epidemiological, logistical, and relational—for taking a commodity-specific, collaborative approach to reducing foodborne illness outbreaks
• The key importance of prevention in mitigating food safety incidents, and how collaboration between FDA and industry enables food producers to help inform and adopt effective prevention strategies
• The types of conversations taking place between FDA, industry, academia, and public health partners throughout the development of prevention strategies
• The learnings from past foodborne illness outbreaks that are considered when creating prevention strategies and identifying future work areas to align cross-sector stakeholders
• The possibility of filling some of the gaps in the Produce Safety Rule with commodity-specific prevention strategies
• The challenges of conducting root-cause analysis in the produce sector, the benefits of getting industry to buy in to the practice, and how the conversation around root-cause analysis could be improved
• Why educating industry to be critical thinkers about produce safety (rather than which minimum requirements to fulfill) provides the greatest opportunity for improving outcomes
• FDA’s intent to develop a prevention strategy for powdered infant formula in light of recent events, and how the agency is collaborating with stakeholders to identify other commodities that are deserving of prevention strategies.

Resources

FDA Releases Food Safety Prevention Strategies for Salmonellosis, Listeriosis from Mushrooms, Onions

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Kimberly (Kim) Livsey is a Senior Emergency Response Coordinator in the U.S. Food and Drug Administration’s (FDA's) Office of Regulatory Affairs' (ORA’s) Office of Human and Animal Food Operations. In addition to more than 20 years of federal service at FDA, she has leveraged her expertise in food safety oversight and emergency management at the state and local government levels. Prior to her time at FDA, she was an environmental health specialist with the DeKalb County Board of Health in Decatur, Georgia, where she served as a supervisor and trainer in the food protection program.

Kim has led incident response, management, and command activities on the frontlines of multiple natural disasters, including Hurricanes Katrina, Rita, Gustav, and Irma. She has also contributed to leadership and planning for food safety and defense at numerous special event operations, including the international G-8 summit, The World Games 2022, Democratic and Republican political conventions, and Presidential inaugurations.

In March 2022, Kim spent seven weeks leading the ORA Incident Management Team in response to adverse events associated with the use of powdered infant formula products. She and her 37-person team took action as part of FDA’s response, including facility inspection, product sample analysis, consumer complaint triage, state sample request coordination, media inquiry response, and enforcement action initiation. 

In this episode of Food Safety Matters, we speak with Kim [26:12] about:

• How FDA leverages the Incident Command System (ICS) to coordinate multiple FDA organizational components to manage incidents, such as foodborne illness outbreaks
• What Incident Management Teams (IMTs) are, as well as their purpose, structure, and activities
• The various roles that exist on an IMT and how the personnel to fill those roles are chosen
• How FDA mobilized an ORA-wide IMT at the field level, for the first time, to investigate and respond to the recent, highly publicized foodborne illness outbreak associated with Abbott Nutrition powdered infant formula
• Kim’s experience leading an IMT with the Jefferson County Department of Health in Birmingham, Alabama to ensure the safety of food served at the 2022 World Games
• Essential qualities for an IMT Incident Commander (IC) to embody, and the ways in which efficacious leadership and use of IMTs can impact industry and consumers
• How FDA responds to foodborne illness outbreaks through its Coordinated Outbreak and Response Network (CORE); its four standing, geographical IMTs; and its rapid response teams (RRTs)
• The working relationship between FDA’s four standing IMTs and state jurisdictions
• Why working with and on IMTs can be rewarding.

News and Resources

FDA Releases Food Safety Prevention Strategies for Salmonellosis, Listeriosis from Mushrooms, Onions [5:13] FDA Releases Review of Response to Infant Formula Supply Crisis, Addresses Improvements [9:47] FDA Highlights Key Food Code Recommendations for Mitigating Norovirus in Restaurants [14:53] Resource Library for Retail Food Regulators Conducting Foodborne Illness Outbreak Investigations

Sponsored by:

Cintas 

Download the Cintas Program for Food Processing Apparel brochure.

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Michael R. Taylor is a member of the board of Stop Foodborne Illness, a consumer organization supporting and representing the victims of foodborne illness and their families. From January 2010 to June 2016, he served as Deputy Commissioner for Foods and Veterinary Medicine at the U.S. Food and Drug Administration (FDA). He led FDA's implementation of the Food Safety Modernization Act (FSMA) and oversaw FDA's other food-related activities, including its nutrition, labeling, food additive, dietary supplement, and animal drug programs. Previously, Mike served at FDA as a staff attorney and Deputy Commissioner for Policy, and at the U.S. Department of Agriculture (USDA) as FSIS Administrator and Acting Under Secretary for Food Safety. Prior to re-joining FDA in 2009, he spent nearly a decade in academia conducting food safety, food security, and public health policy research, most recently at George Washington University's School of Public Health. Mike is a graduate of Davidson College and the University of Virginia School of Law.

In this episode of Food Safety Matters, we speak with Mike [2:52] about:

• His experience as Administrator of USDA’s FSIS after the Jack in the Box coli outbreak of 1992–1993, including why the agency did not consider pathogenic bacteria to be an adulterant requiring regulation prior to the pivotal outbreak
• How Mike's time at FDA influenced his approach to his work at USDA, such as shifting cultural mindsets and implementing a preventive-based plan for reform in meat and poultry inspection
• USDA's challenges with getting industry to accept new standards for coli and Salmonella, which was in part overcome due to the efforts of forward-thinking advocates within industry like David Theno
• The way in which industry’s concept of microbial testing standards and Hazards Analysis and Critical Control Points (HACCP) requirements differed at the time of their regulatory introduction, and the role that difference played in industry’s levels of acceptance
• Mike's perspective on the recent USDA declaration of Salmonella as an adulterant in breaded and stuffed raw chicken products, and what it may mean for the future of Salmonella regulation
• Clarification of what a pathogenic “adulterant” is to USDA, and how the agency regulates adulterated foods
• Positive cultural changes that have occurred over the last 30 years, such as industry’s acceptance of accountability for prevention and the willingness to collaborate between regulators, industry, and the scientific community
• How USDA’s efforts to reform meat and poultry inspection in the mid-1990s laid the groundwork for future food safety successes such as FSMA
• The positive significance of the recent focus on food safety culture, and why Mike believes it would be difficult to regulate the concept in the U.S.
• How the Jack in the Box coli outbreak gave political momentum to food safety regulation, as well as how the stories of the outbreak victims personally motivated Mike to sustain his involvement with food safety to this day, including serving as a board member of Stop Foodborne Illness.

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An accomplished attorney and national expert in food safety, William (Bill) Marler has become the most prominent foodborne illness lawyer in America with his firm, Marler Clark: The Food Safety Law Firm, and a major force in food policy in the U.S. and around the world. For the past 26 years, Bill has represented victims of nearly every large foodborne illness outbreak in the U.S. He began litigating foodborne illness cases in 1993, when he represented Brianne Kiner, the most seriously injured survivor of the historic Jack in the Box E. coli O157:H7 outbreak, in her landmark $15.6-million settlement with the company. The 2011 book, Poisoned, by best-selling author Jeff Benedict, chronicles the Jack in the Box outbreak and the rise of Bill Marler as a food safety attorney.

Bill'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 2010–2011 FDA Food Safety Modernization Act (FSMA). 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.

Bill travels widely and frequently to speak to 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 them. He gives frequent donations to industry groups for the promotion of improved food safety, and has established numerous collegiate science scholarships across the U.S. He is also a frequent writer on topics related to foodborne illness and the Publisher of the online news site, Food Safety News, and his award-winning blog, www.marlerblog.com. He is frequent media guest on food safety issues and has been profiled in numerous publications.

In 2010, Bill was awarded the NSF Food Safety Leadership Award for Education, and in 2008 he earned the Outstanding Lawyer Award by the King County Bar Association. He has also received the Public Justice Award from the Washington State Trial Lawyers Association. Bill graduated from the Seattle University School of Law in 1987, and in 1998 was the Law School's "Lawyer in Residence." In 2011, he was given Seattle University's Professional Achievement Award. He is a member of the board of directors of Bainbridge Youth Services and a member of the Children's Hospital Circle of Care.

In this episode of Food Safety Matters, we speak with Bill [4:24] about:

• How taking on and winning the various lawsuits related to the 1993 Jack in the Box coli outbreak helped shape the rest of Bill's career, and what he took away from these cases on a personal level
• How his career in defending victims of foodborne illness has become an "avocation" in addition to his "vocation," and his desire to do more work to advance food safety policy
• How Jack in the Box, under Dave Theno's leadership, turned around its operations following the outbreak and set new standards for the fast food industry
• The significant regulatory and industry changes that were enacted by USDA as a result of the 1993 coli outbreak
• Bill's advice for companies that want to shore up their food safety programs before it's too late, and the "warning signs" he sees in every foodborne illness case he defends
• How food safety culture, as communicated from the top management down, can successfully shape food safety practices and empower employees company-wide
• Potential strategies for recall modernization, including improved traceability technologies for supply chains and better ways to communicate recall information to consumers
• Bill's shortlist for critical food safety improvements that need to happen over the next five to ten years.

Sponsored by:

Michigan State University Online Food Safety Program

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John Butts, Ph.D., is the Principal at Food Safety By Design LLC and the Advisor to the CEO at Land O' Frost Inc., where he was in the primary technical role for 47 years, having retired in 2021. As part of his succession plan, Dr. Butts founded Food Safety By Design LLC in 2010. Food Safety By Design helps producers of high-risk products learn how to prevent and manage food safety risks. Dr. Butts' specialty is the incorporation of food safety practices into company culture, including root cause identification using the "Seek and Destroy" scientific strategy for identifying and eliminating harborage sites for pathogens, which Dr. Butts developed earlier in his career.

In the early 1980s, Land O' Frost entered the shelf-stable meal business, which Dr. Butts facilitated with product development, process controls, quality assurance, and the invention of a proprietary sealing method. He also provided technical and management support to Frigorifico Canelones, the largest beef processing plant in Uruguay, from 1991–2001 when Land O' Frost owned and managed the business.

Dr. Butts is actively involved in pathogen reduction and control of pathogenic organisms in cooked processed meat products, seafood, leafy greens, and other ready-to-eat products. His current work includes the application of scientific principles and quality management technology to develop sanitation process control methods and procedures.

Dr. Butts is the recipient of many prominent awards throughout his professional career from NSF International, the American Meat Science Association, the North American Meat Institute, Purdue University, the Meat Industry Hall of Fame, and Food Safety Magazine's Distinguished Service Award. He has published dozens of technical articles and delivered numerous presentations, workshops, classes, and interviews over the years. He is an active member of the North American Meat Institute's Scientific Affairs Committee for over 40 years and was a founding member of the Special Poultry Research Committee to obtain approval of nitrite in poultry during the Carter Administration. He is also a member of the Editorial Advisory Board of Food Safety Magazine.

In this episode of Food Safety Matters, we speak with John [2:49] about:

• How the visceral language used to describe the meatpacking industry in The Jungle sparked public outcry that prompted further investigation into the scientific link between spoilage and disease
• The way in which available technology and present need enables innovation, including specific examples from the meat industry’s modernization at the turn of the 20th century and beyond
• Key changes since the era of The Jungle to improve occupational safety for line workers in the meat and poultry industry
• The dangers that sanitation workers face in processing plants today, and how the food industry can leverage the most advanced techniques and technology available to support sanitarians and mitigate the health risks they face on the job
• The role that food safety culture plays in managing the relationship between sanitation, hygiene, and food safety
• The areas related to food safety for which industry needs to better understand root causes and preventive controls in the present day, such as allergens, crisis management and recall efficiency, animal and plant disease control, genomics, and other topics
• John’s opinions on where he sees food safety progress heading over the next half-century, including changes related to the industry’s growing focus on protein.

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Deborah Blum, Director of the Knight Science Journalism program at MIT and the Publisher of Undark magazine, is a Pulitzer-Prize winning science journalist, columnist and author of six books, most recently, The Poison Squad, a 2018 New York Times Notable Book. That book, as with all her recent books, focuses on influential moments in the history of science. She has worked as a science columnist for The New York Times, a blogger for Wired, and has written for other publications ranging from The Wall Street Journal to Mother Jones, The Guardian to Lapham’s Quarterly. Her work has been anthologized in Best American Science Writing, Best American Nature Writing, and Best Science On-Line.

Before joining MIT in the summer of 2015, she was the Helen Firstbrook Franklin Professor of Journalism at the University of Wisconsin–Madison, a position she held for 18 years. Previously, she worked at five different newspapers, including as a staff science writer for The Sacramento Bee, where she won the Pulitzer in 1992 for her reporting on ethical issues in primate research. She received her A.B.J. from the University of Georgia in 1976 and her M.A. from the University of Wisconsin–Madison’s School of Journalism in Mass Communication in 1982.

Deborah is a past president of the National Association of Science Writers and a former board member of the World Federation of Science Journalists. She serves on the advisory boards of the Council for the Advancement of Science Writing, Chemical and Engineering News, Spectrum, The Scientist and the MIT Museum. She is a fellow of the American Association for the Advancement of Science and a lifetime associate of the National Academy of Sciences, both in recognition of her work in public understanding of science.

Larry Keener, C.F.S., P.A., P.C.Q.I., is President and CEO of International Product Safety Consultants Inc. (IPSC), based in Seattle, Washington. IPSC is 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. IPSC is engaged in the conformity, risk assessment, and food safety verification business.

Larry is an internationally regarded microbiologist and process authority in the food industry. His areas of expertise range from applied food microbiology to the development and application of novel preservation technologies including: high pressure processing (HPP), microwave, pulsed electric field (PEF), high-powered ultrasound, atmospheric plasma, and low-energy electron beam technology. He is a past president of IFT's Nonthermal Processing Division.

Larry is a 2013 Fellow of the Institute of Food Technologists (IFT), a board-certified food scientist (International Food Science Certification Commission), and a 2018 recipient of an International Union of Food Science and Technology's (IUFoST) lifetime achievement award for his work in microbiology and food safety. He is a two-term past president of Tuskegee University's Food and Nutrition Sciences Advisory Board. Larry is also a 2022 inductee into the George Washington Carver Society. He has received numerous other awards and honors, and he has published more than 100 papers on subjects related to food production and food safety science.

Larry is a frequently invited speaker to food industry, business and scientific conferences, workshops, and seminars. He is also a member of the Editorial Advisory   Board of Food Safety Magazine.

In this episode of Food Safety Matters, we speak with Deborah [04:18] about:

• The shocking discoveries Deborah made about food safety in the 19th century while writing her book, The Poison Squad, which chronicles the passage of the 1906 Pure Food and Drug Act
• How the unregulated food industry’s prioritization of profits over public health led to food being one of the top ten causes of death during the latter half of the 19th century, which is also sometimes referred to as the period of the “Great American Stomachache”
• The different kinds of risk associated with food in urban versus rural environments
• The issues of adulteration and the lack of labeling requirements in the 19th century
• The questionable ethics of the Hygienic Table Trials that were conducted by U.S. Department of Agriculture (USDA) Chief Chemist Dr. Harvey Wiley, in an effort to convince industry, regulators, and the public that the compounds being added to foods were harmful to human health
• The impacts that Dr. Wiley’s experiments had on public perceptions of food safety and the progression of U.S. food regulation, and the role that media played in disseminating Dr. Wiley's findings
• How behind-the-scenes relationships between food industry regulators, politicians, and the scientific community may weaken the law, both in present day and the 19th century
• Deborah’s biggest revelation from researching and writing The Poison Squad—a grim case of formaldehyde in milk.

We also speak with Larry [59:42] about The Poison Squad from industry’s point of view, including conversations about:

• Possible reasons why the food industry neglected to ensure the safety of substances it was adding to food products in the 19th century, including a lack of technical capability and regulation
• Changes in regulations and public sentiment around food safety over the last century, and how the general approach to food safety has been guided by discordant views among different stakeholder groups
• How the antagonism that occurred at the highest levels of the federal government during the events chronicled in The Poison Squad set in motion a series of events that gave passage to future food safety legislation
• The successes that scientifically minded food safety advocates in the U.S. have made since the enactment of the 1906 Pure Food and Drug Act, and improvements that need to be made regarding international harmonization
• Results that can arise from the friction between industry’s need to turn a profit versus the drive to do right by consumers, as well as the economic value of ensuring food safety versus cutting corners.

Food Safety Education Month Resources

CDC FDA USDA The Partnership for Food Safety Education Food Safety Magazine  ​

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Conrad Choiniere, Ph.D., is the Director of the Office of Analytics and Outreach at the U.S. Food and Drug Administration's (FDA's) Center for Food Safety and Applied Nutrition (CFSAN). Dr. Choiniere provides executive leadership for a broad portfolio of scientific and regulatory functions including risk and decision analysis, social and behavioral sciences, epidemiology, biostatistics and informatics, education and outreach, and food defense. Dr. Choiniere currently co-leads a core element of FDA's New Era of Smarter Food Safety focused on fostering and supporting food safety culture across the food system. He also chairs FDA's Toxic Elements Working Group, which prioritizes the Administration's efforts to reduce exposures to lead, arsenic, and other heavy metals from foods to the greatest extent feasible. Dr. Choiniere holds a Ph.D. in Agricultural and Resource Economics from the University of Maryland and a B.S. degree in Chemical Engineering from Johns Hopkins University. 

Kruti Ravaliya, M.S., Consumer Safety Officer in the Division of Produce Safety at FDA's Center for Food Safety and Applied Nutrition, joined the Division of Produce Safety as an Oak Ridge Institute for Science and Education (ORISE) Fellow in July 2013, and transitioned to be a Consumer Safety Officer in April 2015. She has been involved with the Division of Produce Safety in a variety of ways, most significantly in developing the Supplemental and Final Agricultural Water Quality provision in the Produce Safety Rule. She earned her M.S. degree in Food Science, with minors in Biotechnology and Food Safety, at North Carolina State University in 2013, and a B.S. degree in Food Science and Spanish from the University of Massachusetts, Amherst, in 2007. Previously, Ms. Ravaliya worked in food product development with the International Food Network.

In this episode of Food Safety Matters, we speak with Kruti [22:16] about:

• FDA’s recent updates to Subpart E of the Produce Safety Rule, including the recently extended compliance dates for pre-harvest agricultural water requirements
• The nuances of microbial quality testing for water, and why it is a “tool within the grower’s toolbox,” rather than a requirement for growers
• How stakeholder feedback has informed FDA’s updates to its regulation of pre- and post-harvest agricultural water
• Ways in which FDA intends to partner with state and local officials to educate and train growers on compliance with the Proposed Agricultural Water Rule

We also speak with Conrad [33:47] about:

• His work within FDA's Toxic Elements Working Group and its considerations when assessing the risk to public health from toxic elements in certain foods
• How scientific advancements and regulatory changes over time have affected actual and detected levels of toxic elements in the U.S. food supply
• Actions that growers and manufacturers can take to reduce the uptake of toxic elements into foods, and to ensure that toxic elements are not introduced at the production level
• FDA’s intent to collaborate with the U.S. Department of Agriculture (USDA) and industry to develop and disseminate guidance regarding preventive controls for toxic elements in food production
• The purpose of action levels in signaling to industry the importance of monitoring and finding solutions for reducing certain contaminants
• FDA’s “cycle of continual improvement” approach in its Closer to Zero initiative, including four key steps to understanding and mitigating the health risk of toxic elements in baby foods
• Why it is crucial to consider nutrition when setting action levels
• The importance of FDA’s collaboration with USDA in expanding upon and executing the goals of its Closer to Zero initiative
• FDA’s current and future work to understand and reduce the presence of toxic elements in food, including the agency’s sampling activities, its intent to target cadmium and arsenic, and other initiatives
• Key achievements of FDA's Toxic Elements Working Group since its inception in 2017
• The importance of collaborating with relevant agencies and industry stakeholders to find appropriate solutions for the not-so-simple task of reducing toxic elements in the U.S. food supply.

News and Resources:

USDA FSIS Declares Salmonella an Adulterant in Breaded, Stuffed Raw Chicken Products [5:14]FDA Shares Updates on Cyclospora Action Plan [8:20] FDA Plans to Continue Remote Regulatory Assessments [10:52] FDA Releases New Dashboard for Laboratory Accreditation for Analyses of Foods Program [WEBINAR] FDA's Smarter Tools—How Remote Regulatory Assessments Help Ensure Food Safety

FDA has more information on its website about the agency’s continued work to address toxic elements in the food supply. Learn more about FDA’s programs referenced in the podcast:

• Closer to Zero Action Plan for Baby Foods
• Ongoing Total Diet Study Monitoring Nutrients and Contaminants in Foods Eaten by People in the U.S.
• Advice about Eating Fish for Those Who Might Become or are Pregnant or Breastfeeding and Children Ages 1–11 Years
• Toxic Elements in Food and Foodware, and Radionuclides in Food Compliance Program

Food Safety Insights Column, Bob Ferguson

Focusing Ahead—Processors' Priorities for the Near Term [17:37]

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Gillian Kelleher is President and CEO of Kelleher Consultants LLC, as well as the Chairperson of the Educational Advisory Board (EAB) for the 2023 Food Safety Summit. Gillian has significant, global leadership experience in the food industry and in food safety and quality, having lived and worked in Ireland, the UK, France, and the U.S. She has worked in diverse sectors including manufacturing, foodservice, retail, and distribution.

She was formerly Vice President of Food Safety and Quality Assurance for Wegmans Food Markets, where her scope of responsibility included all aspects of food safety and quality for stores, self-manufacturing, distribution, and Wegmans' private-label program. Prior to her tenure at Wegmans, Kelleher also worked at Häagen Dazs, Burger King, Express Foods, and Pillsbury. In addition, she has led the development of food safety and quality programs for many large and small private-label suppliers and distributors.

Kelleher earned her B.S. degree in Dairy and Food Science from University College Cork in Ireland. She is also a member of several professional organizations, including the Institute of Food Technologists (IFT) and the International Association for Food Protection (IAFP). She is a past co-Vice Chair of the Global Food Safety Initiative (GFSI) Board of Directors, a member of the Board of Directors of Stop Foodborne Illness, a longstanding member of Harvard's Private and Public Scientific, Academic, and Consumer Food Policy Committee (PAPSAC), and a member of the Editorial Advisory Board of Food Safety Magazine. Kelleher is also actively involved in the Leafy Greens Safety Coalition (LGSC).

With her significant industry experience and dedication to food safety and quality, Kelleher will work with the esteemed Food Safety Summit EAB and the Summit planning team to shape the educational agenda for the 2023 Food Safety Summit, which will be held May 8–11 at the Donald E. Stephens Convention Center in Rosemont, Illinois.

In this episode of Food Safety Matters, we speak with Gillian [6:04] about:

• Changes that have occurred in the food industry throughout Gillian’s career, stemming from globalization, food safety crises, e-commerce, and other factors
• How suppliers can leverage their relationships with retail partners to inform their food safety and quality (FSQ) programs
• The importance of having top-down commitment to FSQ within an organization and keeping hazards analysis and critical control points (HACCP) at the core of a company’s food safety system
• The ways in which consumer advocacy groups can work with industry to drive improvements in food safety, exemplified by Stop Foodborne Illness’ initiatives such as its Food Safety Culture Toolkit
• Why it is important for food companies to hire the right talent, invest in employee training and resources, and actively work on relationship-building
• The value of industry organizations and events—such as the Food Safety Summit—in driving positive change through collaboration
• How FSQ professionals can find success and satisfaction in their careers and day-to-day duties, including advice for young FSQ professionals who are beginning their professional journeys.

News and Resources:

[WEBINAR] August 18, 2022: ATP Depletion – An Overlooked Concern of Rapid Hygiene Assessments [WEBINAR] August 23, 2022: Pathogen Control in a Low-Moisture Environment [WEBINAR] August 30, 2022: One Size Fits…How to Adapt Your Food Safety Culture Efforts to Functional Ways of Working

Sponsored by:Michigan State University

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