The Tuesday workshop program of the 2022 Food Safety Summit concluded with a panel discussion on effectively communicating with the regulatory industry. Moderated by Oscar Garrison, Senior Vice President of Food Safety for United Egg Producers, the panelists included Philip Bronstein, Ph.D., Assistant Administrator, Food Safety and Inspection Service (FSIS) at the U.S. Department of Agriculture (USDA); Mark Moorman, Director of the Office of Food Safety at the Center for Food Safety and Applied Nutrition (CFSAN) at the U.S. Food and Drug Administration (FDA); Steve Mandernach, J.D., Executive Director, Association of Food and Drug Officials (AFDO); Jorge Hernandez, Vice President of Quality Assurance at The Wendy's Company; and Will Daniels, President at AgroThrive Inc.
Communicating with the regulatory community and ensuring compliance with applicable laws, rules, and regulations can be challenging for many in the food industry. During the workshop, regulators and the regulated industry shared suggestions for how to better communicate with one another and meet regulated requirements while maintaining a sensible level of operational necessity.
Regulatory Perspective
Dr. Bronstein kicked off the workshop with an overview of FSIS' mission and work, as well as important legislation that allows FSIS to inspect meat, egg, and poultry facilities in the U.S. FSIS employs around 8,700 people, of which 1,700 are food inspectors who inspect every single carcass in poultry and livestock facilities and ensure that establishments follow codified regulations. FSIS also employs consumer safety inspectors that reinforce sanitation performance standards. Dr. Bronstein urged workshop attendees to talk with their inspectors to understand why faults are found and corrective actions are issued during inspections. "Our goal is compliance. If that can be done with a conversation and you don't need to do it with a noncompliance report, then let's do it with a conversation," he urged.
Mr. Moorman next took the podium to discuss FDA, which regulates around 80 percent of the U.S. food supply. At CFSAN, food safety activities can be broken down into outbreak response; the Office of Food Policy and Response, which focuses on outbreak analysis and prevention; and the Office of Compliance, which deals with food inspections.
Steve Mandernach of AFDO next discussed the benefits of building regulatory relationships, including better communication during outbreaks and emergencies, increased assistance when considering novel solutions and methods, the development of stronger food safety partnerships, and stronger engagement at both the local and brand levels. He encouraged attendees to frequent regulatory meetings like AFDO conferences, FDA retail seminars, and the annual NEHA meeting, and to establish regulatory meetings in states where a company or brand has a strong presence.
Mr. Mandernach also encouraged collaboration for the end goal of ensuring safe food and seeking resolutions as soon as possible. When disagreeing with inspection findings, he noted that it is difficult to dispute observations but easier to dispute the application of regulations. It is also advisable to follow up as quickly as possible—preferably by phone—if disagreement with inspection findings arises. During an outbreak, be prepared to collaborate with regulators and health officials by asking questions and providing information as quickly as possible. Mr. Mandernach also advised attendees to be appreciative of information that is shared ahead of official conclusions—this could help a company save reputation, time, and money in the long run.
Industry Perspective
Mr. Hernandez of The Wendy's Company, who started his career as an inspector, spoke about leading food safety and quality assurance for a multinational foodservice corporation. "The three most important points of advice I can share are: be respectful, be professional, and be factual," Mr. Hernandez said.
Mr. Daniels of AgroThrive spoke about being involved in an investigation of contaminated product wherein FDA and the Federal Bureau of Investigation (FBI) lacked transparency in sharing information. He also talked about the opportunity for improvement in communication between industry and regulators, as well as between regulatory bodies themselves.
Attendee Q&A Session
Dual-Jurisdiction Facilities
Mr. Garrison posed a question to the panel about dual-jurisdiction facilities, which are regulated by both FDA and USDA. Mr. Bronstein advised that when inspectors come into dual-jurisdiction facilities, it is best to be open and transparent and to not "section off" areas of the facility as "FDA only" or "FSIS only," as this will likely cause an inspector from either agency to take a look into the sectioned-off areas to ensure that nothing is wrong. Mr. Mandernach added that any documentation in the facility can be admissible for an inspection performed by either agency.
HACCP
The panelists also discussed the functionality of HACCP and acknowledged the adequacy of FDA regulations in this area. Dr. Bronstein encouraged the development of, and adherence to, a strong HACCP plan where every single process is followed to specification to ensure that food is safe. FSIS is happy to help industry generate outlines for HACCP plans for new processes, and encourages communication with local inspectors to avoid pitfalls, Dr. Bronstein said.
"Don't just spend money to have someone write the HACCP plan," said Mr. Garrison. "Spend the money to hire the consultant to come up with the HACCP plan and help you make sure it's implemented correctly."
"You have to own your individual [HACCP] program," Mr. Daniels said. Mr. Moorman added, "You should be evaluating your hazards and evaluating your preventive controls to control those hazards, and you need to be taking preventive measures, particularly in the agricultural water space. [The regulations] can't just be prescriptive—you need to know your hazards and control them."
Leafy Greens Outbreaks
A conference attendee asked about self-regulated industry, such as the Leafy Greens Marketing Agreement (LGMA), and the issue of accountability for outbreaks. "Those [self-regulating] standards may not be the best to truly control [product contamination]; they are more reactive than proactive, but they are still working to address it," said Mr. Daniels. "But as Mark [Moorman] pointed out earlier, the pathogen transmission routes are very complex, and it's hard to trace exactly where the contamination comes from." In the end, Mr. Daniels said, it sometimes involves following up with a dozen different suppliers to find the root cause.
Mr. Moorman commented on the need to implement faster recalls in response to foodborne outbreaks in produce. "The most important thing we can do is get that food off the market. With your company, you have to take it home and ask, 'how good are we?'"
Mr. Mandernach also noted that outbreak response has improved amid recent outbreaks in leafy greens, although he acknowledged that produce outbreaks are incredibly complex to trace and correct. "It's not perfect, but it's definitely an improving process and a step in the right direction," he said.
Mr. Daniels added that before the LGMA was put into place, no leafy greens producer had a food safety person as a permanent role, but now almost every leafy greens grower has someone who oversees food safety.
Food Safety Culture
The panelists also discussed the differences in food safety culture among companies. Mr. Moorman explained that some companies are forthcoming and provide information before an agency asks for it. "They'll wash their laundry in front of us," he said. "They have nothing to hide. But then there are the others." These "other" companies interact on a "need-to-know" basis and generally dislike having inspectors in their facilities. Mr. Moorman pointed to differences in posture between food companies, some of which might be influenced by legal interests. "We're all trying to work toward public health here," he urged, "so let's work together."
"If you're a food company involved in an outbreak and you're being asked to work with regulators, your answer needs to be 'yes,' and then 'how can we fix this?" Mr. Mandernach said.
"You are there to protect the health of your customers, so you need to start working toward a solution today—not when [an outbreak] happens," Mr. Hernandez stated. "That's the best definition of a good food safety culture."
The 2022 Food Safety Summit is taking place in person at the Donald E. Stephens Convention Center in Rosemont, Illinois from May 9–12. Stay tuned for more conference coverage!
