Providers, giving you a front row seat to democracy. Officials from the food and Drug Administration assured lawmakers that food safety remained a top priority for the agency after politico published a report on how the fda had repeatedly failed to take timely action on foodborne outbreaks. They were also asked about the recent Baby Formula Shortage and other regulatory challenges facing the agency. This hearing is one hour 45 minutes. Good morning everybody, i want to welcome everyone to our hearing today. We have a distinguished panel of witnesses here to discuss the important food Safety Mission at i want to welcome everyone to our hearing today. We have a distinguished panel of witnesses here to discuss the important food Safety Mission at the food and Drug Administration. For our first panel, i would like to welcome dr. Robert k. Lift, fda administrator, commissioner. He is joined by doctor susan mayne, and mr. Frank yiannas, and mr. Michael rogers. Thank you for being here this morning. He fda is charged with a Critical Mission of protecting americas food supply. Yet, recent reports have highlighted a lack of leadership, poor communication, and slow governance at the agency that it had a detrimental impact on the safety of the food that every american relies upon. This hearing will highlight, not only fdas decisionmaking with regards to food safety, but also the impact those decisions have on industry and the overall food supply. The question we need to ask today is, is food safety a priority of the fda . America has the safest food in all the world. But serious concerns remain about the priority that fda gives to food safety and the steps that have led to outbreaks, or critical shortages and individuals getting sick. And easy explanation is that fda does not have the resources or personnel to oversee such a massive industry. There may be some truth to that, but there is more to the story. Since the passage of the food safety and modernization act, or the fsma, this committee has provided the fda with hundreds of millions of dollars for food safety. Yet, inspections continue to decline and outbreaks remain. Additional resources are not the only answer. That is why this hearing is so important. The fda needs to do better. Lack of communication, outdated ways of thinking, and overall lack of leadership have negatively impacted the agency. We have seen that with the recent infant formula crisis. Since 2002, the fda has had seven different commissioners. Over the last 20 years, fda has gone without a Senate Confirmed commissioner for almost six years of that time. That is not acceptable. There is no way and agency as large as the fda can be leaderless and not have serious issues. I commend the career employees at the fda. They have forged ahead even when acting commissioners were in charge. The role of this committee is to provide the agencies we oversee with support and resources that they need. Fda has had so many different and complex responsibilities. I want to assure you that im committed to providing the fda with what it needs to get the job done. With that, i will reserve the time for the Ranking Member to give his Opening Statement when he arrives. Senator, would you like to make an Opening Statement . Very good. Let us start with doctor califf. [inaudible] i assure you that the safety of our nations food supply is one of my absolute top priorities. Although foodborne outbreaks continue to occur, all experts with whom i have consulted agree that americas food supply as different safer than it is today. As the industry, the environment, and the International Landscape change, we must prepare for future challenges. As envisioned in the era of for smart food safety and accord put together for my arrival, the combination of tech enabled thank you. The combination of tech enabled traceability, smarter tools for prevention and response, new business models, and retail modernization, and a collaborative food Safety Culture where industry is implemented the vision bias, paint an exciting picture for the future. The recent acceleration of Digital Technologies enabling traceability and productive capabilities, innovation facilitating outbreak response, and advances in Agricultural Biotechnology that allowed Food Production to resist the effects of Climate Change and feed the glowing global population, bringing them even closer within reach. Further, food is a foundation of health. Smarter food safety, better nutrition, and ongoing efforts to reduce environmental contaminants is a constant enough food supply, they are critical for improved health of the whole u. S. Population. I anticipate a future in which people are more reliably safe with food. More access to variety and certainty about availability, and the agricultural ecosystem thrives enabling it to feed the u. S. And the rest of the world. To realize this future, we must reexamine and reinvent the ways we approach to our food safety and nutrition. During my confirmation, i was contacted by multiple experts and concerned groups about the perception that the fda food program is not adequately organized or supported. In my first five months back in the job, i met with stakeholders and experts to discuss fdas food program and food priorities for the next decade. My assessment is that the Foods Program has a staff of highly dedicated people. I cant stress enough how hard they work and the depth of their knowledge. But theyre working in a suboptimal environment that needs to be reformed. Accordingly, we have initiated a full review of the Foods Program, including its structure, function, leadership, authorities, and funding. I want to assure you that i intend to communicate and implement any organizational and strategic changes that will further improve the performance of the agencies food program. Several key issues must be addressed and will not wait for the results of the full assessment to get started. Hiring and retaining Foods Program staff has long been a concern, im grateful that the ease or authorization bills in both chambers recognize the great need to get the right staff on board quickly. The supply chain throughout the pandemic, in particular the infant formula crisis has shown the important of new authorities to anticipate and respond to supply shortages. As the world moves to digitize information, the Foods Program must upgrade is technology and modernize its work processes to enable its workforce to be maximally productive. Using Machine Learning and virtual methods to keep up with be a bass and rapidly expanding ecosystem. Food contamination and recall events will always capture the headlines. But we must balance the food safety plan with work on nutritional science and labeling that enables consumers to make informed dietary changes and facilitates industry reformulation. When fda added transit, intake decreased by 80 . The results of their work is largely unseen. Only becoming evident to generations of health data. Yet, turning the tide on die related chronic disease is a critical priority for me, and for this administration because of the potential to impact the health of every american. Dramatically reduce Health Care Cost and close our Life Expectancy gap. Currently, we live five years shorter in the United States than the average of other high income in countries. As we Work Together to implement needed changes and identify critical gaps in authorities and resources, i will continue to engage with congress as we all share the same goals of a safer food supply. In conclusion, our food is never been safer, yet challenges remain and we must do better. One food outbreak is one too many, i appreciate your attention to this and look forward to continuing to work with you to ensure the Foods Program and fda has the right structure, people, budget, and authority to keep our food supply safe. Next, i will call on mr. Frank yiannas. Next, i will turn to member questions, i understand that you have provided the Opening Statement on behalf of all of the witnesses. Im trying to speak for the group here. Excellent. Doctor califf, we had a discussion when you are here to testify on the fiscal year 23 budget request. I wanted to follow up with you. As the commissioner of fda, what do you see as the biggest challenge facing the agency with regard to your food Safety Mission and every agency as i mentioned can use Additional Resources that cant be the only solution to the problem. What changes do you believe need to occur to make food safety a higher priority . Let me start by thanking you for bringing up the fact that we have an agency that is had multiple commissioners in very short tenures, im getting ready to turn 71, i dont plan to be here forever but i hope im wrong here enough to get a situation in place that is sustained, regardless of who is administrator. That is the number one goal. When you ask what is most important, i look at the overall situation and see a rapidly expanding group of industries that are producing food, i dont need to tell anyone today about Climate Change with the heat that we are seeing and the impact that is going to have, not to mention the war in ukraine having and enormous impact on attrition in the world. We have this increasingly complex critical instead of industries that we need to regulate. I think we have to look at the whole picture, it is a structure, it is a function, it is a leadership thing. You mentioned that resources are not the only issue, i completely agree with that, but i do believe that when we finish our complete top to bottom evaluation, we will be coming to you with specific requests for places that Additional Resources can make a difference. I know it has already been discussed in some of the budget plans. That is much appreciated. I think its very hard to pick up one or two things, it is a multi dimensional industry where so much good can be done with people, plentiful supply at a time when it is going to be very stressed in the future. The Previous Administration undertook some structural changes with the goal of raising the profile of food safety. Dr. Califf, do you believe these changes were effective or worked . First of, all i dont question the motives of the Previous Administration in this regard. I think the right things were said and efforts were made. I heard a resounding chorus from the outside world and i must say, from inside the Foods Program it hasnt gotten a priority that it deserves. I think over the last couple of years, i will just point out that the pandemic has had an enormous effect on the whole fda. What has gone largely unnoticed is the amazing work that the Foods Program has done. You remember the early days of the pandemic when you couldnt find anything on the grocery shelves. We have definitely had a problem with infant formula, but by and large these people have put in a huge amount of work to be adaptable with regard to regulations and rules to ensure that people have food eat at a time when there was a question as to whether that would occur. The short answer is, i think there is consensus in the food world that whatever was done in the past has not been successful in getting the Foods Program to the priority that it deserves. Im sure you are familiar with political article that was published in april. It quoted several people who agreed that the agency is simply not working in order to advance food safety. Some of the quotes included broken, byzantine, ridiculous, a joke. Id ask both dr. Maine and dr. Califf how you responded to such a very strong criticism and how you responded to the article itself. If i may, can i go first and then i would like to definitely give doctor mayne the floor. I want to vigorously rebut the way those comments were made. We have the safest food in the world and every expert ive talked with, the cdc monitors our food which is as safe as it has ever been. To say that it is not working is incorrect. That is not to say that it cannot be better, if theres major problems. Thats why were doing this top and review and plan to make significant changes. Some of the people quoted in that have been in leadership within the fda. I can say they had a chance to fix it, it is not so easy to fix. We all need to Work Together on this, collaboratively. Also, there is accountability so we are going to have to make big changes. Doctor mayne. Thank you for the question. What i will say is, food safety is not a joke. It is our mission. It is one of my absolute top priorities. That being said, we do take all criticism seriously and are always looking for ways that we can continually modernize and improve our work within the center. That is a priority for us. I will say, reflecting back on the last ten years, we have accomplished a tremendous amount in the Foods Program. For example, with food safety, the establishment of whole genome sequencing which is game changing, that was work that came out of also, our work with regard to implementation, the Foundation Rules that have come out, 50 guidances to help move industry to the prevention oriented framework that you envision. That is really important and notable progress forward. Also, with regard to nutrition, doctor califf highlighted our work on trans bat. Empowering consumers with information, really important things like labeling. Consumers have information to make the decisions they need with regard to their personal health. We know more can be done. Resources are certainly something that was identified in that particular article. I will point out that we are 97 funded by Budget Authority and not by the user fees. As more were comes in, we absorb that work because we dont have a user fee base to increase our staff as the work increases. That is relevant and we look forward to working with you on that. Doctor califf also mentioned authorities. There are areas where we are seeking new authorities that would make our work more efficient. This is the type of work we look forward to working with you on, resources from authorities as well as the outcome of the review that dr. Califf mention to make it the strongest possible Foods Program. Thank you, ive exceeded my time already. Im going to reserve time for a second round but next i would call on senator moran. Chairman, thank you very much. Thank you for all joining us this morning. You mentioned efficiencies just in your concluding sentences. Its my understanding that many of the staff at fda continue to work from home. I think it is a reasonable expectation to have our employees back to work in the office in the laboratories and across the agency. Is my understanding about the volume of employees that are still absent from the workplace accurate . What is the plan to return them to the workplace soon . Thank you for your question, senator. There we go, thanks for the question. I think what you said is partially accurate, but i want to be very explicit here about what i think the facts are. People have worked in our laboratories have always gone to work throughout the pandemic. If your job required that you be at work, that has happened. Our inspectors, as mr. Rogers will talk about, there were cutbacks because of the peril of travel and also difficulty even getting into a facility when there were outbreaks. Our inspectors have put themselves at risk routinely going there. The place where people have had the option of virtual or hybrid work has been those who are dealing with a data or Administrative Functions they really dont require them to be most efficient in person. I think our productivity is exemplified by the fact that we carried on all the usual activities, plus the pandemic activities. I think if you talk to the most of the industries that we regulate, theyre pretty happy with her performance of the fda. We are in a Pilot Program to look at the environment. In my previous job at google, i spent a lot of time on this where we had tremendous resources to do the analysis. I think all of this is best handled by looking at a particular job, the particular function. The question is, what is going to lead to the most productive employee who is most satisfied with their worth . What percentage of the workforce no longer comes to the workplace . No longer comes . I would say, maybe about half. When you say no longer comes, thats a difficult thing to answer. No longer comes on a regular, daily basis. I say the majority are not in the physical location on a regular daily basis. Remember, we have a very large part of the workforce that is out in the field traveling. I dont want to disparage, i want to compliment those who work through the pandemic and the risk they took to make certain that their jobs, their responsibilities were fulfilled. I dont believe that you can have, and we will see what your study indicates, but i think its very difficult to have a team effort in the absence of half of your employees on an ongoing basis. I understand the need to do this for the crisis of covid, but i am discouraged by your suggestion that this will be an ongoing method by which the fda employees work. It doesnt sound like it at the moment there is a timeline with a plan to return them to the office while you are waiting this analysis . I would say, more and more people are returning to work. As we work out the hybrid environment they have been in, as we work on the hybrid data, we are going to make decisions as we go as to