Transcripts For CSPAN3 Hearing On The FDA And Food Safety 20220930

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 Lack of communication, outdated ways of thinking, and overall lack of leadership have negatively impacted the agency.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 what is most efficient. And he thought about having people come back to work and work on the hybrid plan . Go back to where you were before . We will certainly discuss that but right now, it doesnt seem like the most efficient approach, especially right now when we are in the midst of ba. 5 surge. You stated in previous testimony, i will change the topic to congress, that the fda intends to Pay Attention to formula distribution in rural areas. Would you detail for the fda plans to formalize distribution to rural communities. The formula distribution is a function not just of fda but of the entire government because it involves, as you know, the department of agriculture, hhs, and the executive branch. The basic plan, the first thing was to get production up in the u. S. , then to use the enforcement discretion. I know we will probably talk about this later with doctor mayne and mr. Yiannas, to bring in the international sources. The distribution initially was through the larger chains. Now there is an intense focus on getting to the Smaller Stores as quickly as possible. That is a matter of hooking up, particularly the foreign firms that have not distributed in the u. S. Before to the smaller areas. That is one of the two areas that is a major focus at this point. Thank you, my time has expired. I would like to welcome Ranking Member hoeven. Would you be prepared to give an Opening Statement at this juncture . I certainly can, madam chair. Welcome to our guest, we apologize for being tardy. But thank you a very much for being here. Madam chair, and thanks for convening the hearing. Given the ongoing infant formula shortages, we appreciate the opportunity to have a dialogue with commissioner califf and the rest of the panel on that issue. As well as the fdas overall approach to food safety. Youve done an extraordinary mandate. Be responsible for making sure that our nations food and drugs are safe and effective. As you may recall during our earlier budget hearing, i express the concern that the fda has had seven commissioners this past decade. During the same period, we have increased funding for the fda by 35 for the food programs. The bulk of that is targeted to food safety and inspection improvements. Unlike other Public Safety agencies such as center for Disease Control and prevention, this committee has provided the fta with a lot of budget flexibility as well to ensure that the highest priority needs get addressed. In addition, its been more than a decade since congress enacted the food safety modernization act, as s and a. Regulations regarding Food Production provide fda with additional authorities to enforce the safety of our food supply. Yet, the cdc estimates that more than 120,000 people in the United States are hospitalized and 3000 people die from foodborne illnesses each year. That figure is the same as pre fms and may implementation rates. We talk about that, you have to talk about what youre doing and how we can continue to improve that. Doctor califf, he stated that one of your responses to ongoing shortage of infant formula is to do a top to bottom review of the Food Safety Program which youve talked about. As well as instant changes to ensure that a crisis like that doesnt happen in the future. As a parent and a grandparent, i cant overstate my concern about what happened in that regard and we have to make sure that we dont ever let that happen again. Going forward, i think that fda should treat essential food in the same formula with that, again i apologize if i was late this morning. But i want to thank you madam chair for calling this earring, i will turn it back to our witnesses. Im going to recognize senator heinrich for his questions. Commissioner califf, outside of a contaminated Drinking Water source, people are most exposed to chemicals through the food that they eat. Food can become compounded when it is gone, or what we have seen with new mexico where animals drink laden water, as well as through food packaging. In several parts of the country, contamination has manifested in agricultural posing a food safety risk. What is the fda doing to regulate chemicals in our Agricultural Products and does your agency have the resources it needs to successfully pursue its work. Im used to like phones that come on automatically, thank you for raising this issue. To me, it exemplifies a whole host of issues that we have, we have cameras that are there to some level. The epidemiology of this is very complicated, it takes a lot of silence to figure out where to draw the line and work to intervene in these industries that are so critical to all of our welfare. I will ask dr. To mayne give some details about what were doing on this. Thank you senator, so pfast is a very important priority for us, and not just at the fda but across the inner agency. We are working in partnership with all the key partners including epa. In terms of our role, we have multiple rules with regard to pfast. The first one is just understanding what the dietary exposure is. We need to understand, what is a hazard and what is a and exposure . We have been conducting analyses of the u. S. Food supply through what is called our total diet study. In that testing, weve tested over 500 different samples. We found ten that had detectable levels of pfast in the general food supply. It is very reassuring information with regard to the general food supply. However, of those ten samples, eight of them that were detectable were seafood samples. That is led us to doing additional analysis on pfast and potential contamination in seafood. We released some data very recently on that. That is a key part of our work. The second part of it is when there are instances of local environmental contamination, as has occurred in your state, we work very closely with our state partners. We provide technical assistance, we have done analyses of samples for state partners because our Analytical Labs are capable of doing that. We have done that for new mexico, and then we provided advice on what to do. This is a challenging problem, we are working with usda, especially in the case of pfast exposure. It is an important priority. Last thing is there is unauthorized food contact use of pfast. Are you talking about packaging in that case . Im talking about food packaging. There are certain authorized uses for food contact. If we have a few concerns about safety, we would withdraw those authorizations. That is happened previously. We have had a market withdrawal recently for some short chain pfast, we had some lack of confidence in the safety of those compounds. Those are the rules that we are taking with pfast. With regard to your question about resources, we have absorbed this work in our base budget. But we have requested new resources in the budget, we will be very grateful for support to increase our work in pfast. You mentioned the prevalence of seafood within the samples that didnt test positive, do you understand the mechanism or the vector there . We are early in the days of getting information about seafood contamination with pfast what we did was a targeted sampling assignment of 81 difference even samples. We looked at the most commonly consumed seafood, things like shrimp, salmon, clamps for example. Our results were released, we will be happy to share them with you. What we did see were some very concerning levels in one particular commodity. That was canned clams coming in from china. That is new data that we have. Your question about mechanism of action, we suspect this is due to environmental contamination where those plans are coming from. What we are working with the companies to try to understand that better and prevent those types of exposures. Doctor califf, before my time is expired, it is hypercritical that Families Trust infant formula. I know youve put a lot of effort into bringing offshore formula products up to standards. But here in the u. S. , i have heard complaints of long wait times for review, for responses, for small domestic manufacturers. What is the fda doing to make sure its scarce resources are prioritized as domestic american manufacturers and producers. As you know, we are working 24 7 on this to make sure that we have adequate supply. There is priority given to large quantity suppliers while we are in shortage. We are not going to slide u. S. Producers, i might ask dr. Mayne to also comments and she is running the diligent work on the review. With regard to the immediate action to get more formula on shelves, one of our criteria for moving forward with enforcement discussion was available product, the quantity of available product. Our goal as directed by the administration is to get formula on shelves as quickly as possible. At the same time, one of the things that we really want to do is make sure that we have a diverse infant formula Manufacturing Base Going Forward in time. There is a really Important Role for u. S. Manufacturers to play. We want to encourage u. S. Domestic manufacturers, we have some under review right now for enforcement discretion. At the same, time we are also looking beyond the current shortage and we would like to support them in terms of providing more diversity to infinite for me that manufacturing in this country for a more resilient supply. But im sure, to make one more quick comment . Please, go ahead. I heard your admission, its not all that money and resources, but this is an area where we had nine people working on this. You graciously added four people last year. Given the need where just having enough people to do the work. We moved a lot of people over from other things to make this happen. But we cant sustain it without specific funding. Senator hoeven thank you madam chair, my first question would be with in regard to the infant formula situation. Chairman baldwin and i did send the doctor a letter. Weve got that the day before yesterday. It is kind of short for our staff. They work hard and theres a lot of things to get ready for these hearings. If you could get responses sooner, it would certainly be considerate get to them and their timeline. I apologize for that, i wish it is going to be sooner. I did read the entire thing, it is a number of pages, single spaced. I know i have the same concern myself. People do a perfect job and it gets to me before i have a chance to get to it when have to do something, its not very helpful. We will double down on that. That speech you get as youre walking on stage, i know you get it, i know you care about all the hard work with folks around here. Theyre trying to do the job. That timeline would be helpful. But, obviously it has been a real concern. You know, we can all imagine moms and dads, most of us having been moms and dads, in my case grandparents, you as well i think. What im trying to get that infant formula, the whole sequence of events from inspectors, not inspecting that planned thing getting out and inspecting the plant, then the amount of time between inspection of the plant and termination of the problem, termination of the problem and leadership at fda being made aware of it. Those are the real concerns. I know going through with our committee staff, they talked about when they had the issues in puerto rico with some facilities down there, there was an instantaneous effort to get after some of those medical equipment and needs, that kind of thing. I get that that is on the drug side but, Something Like baby formula, you are in that mode of having to handle it. In some ways, almost like you would other drugs. How do we make certain on the food side that we have covered this, and we dont have it happen again . There are still shortages in the stores, where are we there . How soon are we gonna have it squared away so we dont have the empty shelf problem . There was a lot included in there. I warned you on the phone there was gonna be a lot in the question. This is something that we take seriously for all the reasons that you gave. I feel like i have been living with the folks you see here at the table pretty much since day one, since the recall occurred on the day i was confirmed. I stepped right into it, they have been working night and day. First of all, you raise the question of what are we doing to correct errors that may have been made, it is wellknown that dr. Steve solomon who runs our center for medicine has a long history of medicine of inspections and other thinks and acts after action review. That is moving along. The interviews have been completed so im expecting a report soon on that. We are also doing the top to bottom review that we announced yesterday. Dr. Solomons review will be available as part of that. And then i will go through item by item on the timeline, all things that happened and corrective action for many of these things like the escalation issue that you raised. We already have instituted policies as a health care person, this is a common issue. Health care provision, nurses for example. If they see something wrong, escalating the issue. I think we have already fixed that problem for the future. In terms of where we are, things are getting better. [inaudible] its not going to be sudden fix, but we have each of the manufacturers, both incumbent manufacturers and also those who have now entered the market with enforcement discretion. We have their production estimates. I would say it is very diversified, robust pipeline coming in. But there was a deficit that is going to take a while to fix. There is one other issue, which i think is important for people to understand, which is that when there is, in any quantity when there is a shortage, i was not an expert in supply Chain Management in industry, when theres a shortage people change what they make to make it so that they are for example larger containers to optimize bringing for the product for purchasing. Some of the things that people are used to seeing on the shelf may not be there, even if the total amount of formula is the same or higher than it was. The really good news is the production, it is exceeding buying by a significant amount now. We expect that to continue. You may remember that there was a spike in purchasing when people became concerned, understandably families went out and stop their pantries in case there was a problem. We have seen that return to a normal level, even a little bit below normal level of purchasing. That difference between what we are producing and what is being about should be sustained over the next few months. I would just expect, like a plane taking off, our expect to see a gradual improvement in the shelves. Thank you, i guess i will defer my additional questions to the next round. Next, senator hydesmith. Thank you chairwoman baldwin, i certainly approve our panel being here today. Im sorry i had to leave another meeting and come in, im glad i had the opportunity to be with you. Commissioner califf, i want to talk about the shrimp industry. Mississippi, we are a big shipping state and it is very important to mississippi. Our shippers harvest as much as 10 Million Pounds of shrimp each year. We have a lot of small, familyowned processors that meet a very high health and Safety Standards to deliver gulf shrimp that we like to advertise so well on our tourism commercials. To American Consumers across the country. Unfortunately, our shrimp industry is forced to compete with a lot of evergrowing imported shrimp. Much of which is dumped on our market and subsidized by foreign governments. In more than 90 of the, we consume in the u. S. , it is important. That is just the fact. In many cases, from countries where the food Safety Standards that are inferior two hours. Even more concerning is the fdas ability to adequately inspect to ensure these imports meet our own health and Safety Standards. It is no secret that drugs not approved for use in the United States are often used in foreign agriculture operations and the residents of these drugs may lead to some cancer or allergic reactions when consumed by humans because of the cars eugenics that are found there. Im very pleased that imported shrimp was selected for fda recently launched regulatory Pilot Program. I hope these partnerships with exporting nations will lead to Better Safety compliance and oversight. My question is, can you give us an update on the status of this Pilot Program and any specific improvements you have seen with respect to the regulations of imported trump . Thank you senator for bringing that up. I think you may be the only senator in this group that appreciates my love for shrimp and grits. Im from the charleston family, as evidenced by the seersucker, its a great day to wear seersucker in the 90 plus degree weather. I think were making great progress here. I actually like doctor mayne and mr. Yiannas to comment on the specifics of what is going on. I think we are making great progress here. Thank you, i would like to say that we are grateful for the resources that we have received. 6 million to help advance this work on imported shrimp and the safety of imported shrimp is directed in fy 21 and 22. In terms of how we have use those resources, you mentioned a regulatory partnership. One of the things that weve done is we have focused in on the countries that import the most trump into the United States. That includes india, indonesia, and ecuador. We have been establishing regulatory partnerships with the government authorities in all three of those countries. A key part of these regulatory partnerships is also data sharing agreements, confidentiality agreements so we can share information that they can have about their growers, their producers. That is important for data that we can use for analytics as we look at protection and what we want to screen in imports. That is one part of this regulatory partnership. But there is more as well. In terms of what were doing with these countries, we have also been doing training, we have actually sent some of our seafood Safety Experts to these countries to improve the training around seafood safety with regard to shrimp. We have been doing that, as well as the partnership agreements. The last thing i will mention is, we are using these new technologies at the border to try to identify the highest rate of violating products using data analytics. Ill turn it over to Deputy Commissioner yiannas to discuss more about our Predictive Analytics using technology. Thank you for that question. We understand that American Consumers want their food and shrimp to be safe, regardless of where it comes from. So, we are working on that. The pilot has been very successful. Let me emphasize a couple of things. On the regulatory partnership, data sharing is going to be key, can we get data from these regulatory partners and entities that they are regulating to inform our risk prioritization efforts . One other point i will make before we get to our analytical approach. We have invested those funds in analytical equipment. Some of these products, as you know, our agricultural. There are drugs in residue that might be added, we want to make sure that we can detect them. I think the big thing that im very excited about is the use of data. Every single line of shrimp import that comes into the United States, it is green to the fda. We are trying to leverage work that we started earlier on a seafood pilot. We are using the power of Artificial Intelligence and Machine Learning to strengthen our predictive capability of finding those products. We have embedded shrimp in the ai pilot, the early results are very promising. We are on our third round of piloting and the results suggest that we might dramatically increase our ability to find them. Which seafood shipments are violated. Thank you very much for that work. My time is up. I want to comment on whether South Carolina trump is better than mississippi shrimp, but i do have an opinion about that. Following the subcommittee, that would be great, lunch. Senator braun. The think you madam chair. Doctor califf, last august your agency entered into a memorandum of understanding with the usdas food safety and Inspection Service to facilitate Information Exchange between the two entities. There has to be, ideally a communication when there is dual agency responsibility. In that mo, you require the fda and the f s i. S. To inform one another in the cases of outbreaks, adverse cases of alteration or misleading, infestations, et cetera. Now, 11 months into this m o u, is the fda planning to conduct a critical review force actual implementation . Senator braun, im sure that will be part of the top to bottom review that we announced yesterday. I know this is within mr. Yiannass portfolio, the relationships with the other agencies. I will ask him to comment. We were almost on a daily basis with usda. There were regular conversations. The answer is yes, we are closely evaluating how we want these progresses to go. Do you think the fda has done its part in being a coequal partner in trying to pursue and discuss these issues . Absolutely, we have signed an mou with the identification of responsibilities, i can tell you weve done our part. My sense is that the usda will be very happy with the role that we have played. This is on a different topic, doctor califf, last year we suffered a record high of 100,000 opioid Overdose Deaths as a result senator and i sent a letter to you in april urging that you implement recommendations from the National Academies to improve the fdas policy for addressing this epidemic. A report that i think you requested during your first stint at the f. D. A. I know that was a critical part of the questioning when you went through the process of heading the fda. Have we taken meaningful steps to do something about it . I know that yesterday manchin and i cosponsors changing the culture of the fda two kind of products into something that looks like it is being taken more seriously. I would love to hear your comments on where we are there because it doesnt look like it is getting any better. I would say, in terms of mortality rate from overdoses not getting better, in fact cdc yesterday reported that it has gotten worse. This is something from day one when i came in we have been working on. My personal energy, i will say got diverted from infant formula. In a very short period time, during the summer we are gonna come out with a statement about the things that we are doing in this regard. There is a lot underway. The parts of it that are in our control, including the promise review of the past. I dont think you saw a feature problem just by looking at the past, but you can learn things from the past that you need to take into account. You may have noticed, yesterday doctor, he was promoted into a joint role between the drug part of the fda and the Commissioners Office to head up this part of the effort. We have a whole team working on it. One of the things that is really difficult and frustrating about this is in our list of things to do, almost every one of them involves interaction with some other entity that has some say or control over. We point to over the counter as an example, it is something that is very complicated because the cost may actually go up when you go over the counter to the person that needs. It but we have approaches to that that we are going to put forward. I want to call attention to the big new thing that is happening that we better all Pay Attention to, the essentially mail order high dose chemically synthesized fentanyl and methamphetamine coming in by the mail, direct delivery to people. It is killing some of our most Promising Students who think theyre getting adderall or something to help them study. This is different. The things we have worked on the past are not going to solve this. We are out of time, you said the summer, this is the summer. When can we expect that to be out there for us and the public to see . I can give you an exact date other than to say it is within the summer. I know i will take that by september 21st then. Do we need it . The way i grew up, i think the summer more like september, 1st of september, labor day. That is even better, look forward to seeing it, thank you. Im gonna begin a second round of questions. I want to make sure that i ultimately involve all the panelists in questions. Mr. Yiannas you, have Prior Experience working outside of the fda with major food corporations. Can you discuss, and i know this top to bottom reviews ongoing, was just commencing, but can you discuss what changes [inaudible] thank you for those questions. Let me take the first one at the top. Yes, im very fortunate to have worked for 30 years with two organizations that are worldclass i would say, large global footprints. I have learned a lot in those experiences. I did come to fda a few years ago to try to make a difference in the Public Sector serving the American People who ultimately i think we all agree are our bosses, the American People. A gobble of the best practices that ive learned working for these worldclass organizations are appropriate at fda. Let me give you three, really quickly. Number one, food safety is a priority in fda, but i think we have to go beyond making it a priority and making it part of the culture. It really has to be an unwavering commitment that we are going to do everything we can to ensure that americans have safe food. The organization that i work for, the reason they were great really was their cultures. Sometimes people think that is the soft stuff, but is the hard stuff. It has to be part of the organization, the dna. Number two, the organizations that i work for, they were ruthlessly committed to Continuous Improvement and modernization, reinvention. One went from being nonexistent to the Worlds Largest committee, 50 years. How did they do that . Because they constantly reinvented what they do. At fda, youre trying to do that under the auspices of something we have launched during my tenure, called the new era of smart food safety. This is the idea that we are living in modern times and we are going to need more modern approaches to how we regulate food. That is a second thing that i think Good Companies do well, those companies that go from good to great. At fda we are committed to continued modernization, i like to tell you about the new era. The last thing i would say is, those organizations do a really good job of setting a very High Performance expectations, having High Expectations standards of themselves, just like this conversation that we are having here. We appreciate that you have High Expectations of us, we have High Expectations to. They do a brilliant job of clarifying roles and responsibilities so when you work as a team, there is no duplication of effort. I would say, the other thing, the private sector does really well is the use of Performance Measures and metrics. They measure everything leading indicators, i know its something that doctor califf really wants to do, leveraged data and measurements. We are doing all these things things but clearly theres more that we can do. In terms of the question, and it is a good question. Do i think were too slow to responding . I certainly think there is more we can do. Responding to foodborne outbreaks fast is critical. The faster you respond, the quicker you can pull contaminated products off of the market and protect others from getting ill. We have to do a better job of understanding the root cause, why did outbreak happen in the first place . So you can prevent it from happening again. We have publicly stated that we think we can do more we can go faster, but let me give you two examples of areas where we have improved. When i first arrived at fda three years ago there was quite a bit of criticism about arriving to slow after an outbreak. I can tell you, we generally show up quickly and as fast as 24 hours, shortly thereafter. When i arrived, there is criticisms that when these outbreaks happened the outbreak reports were too slow if they ever came so the industry could learn from them. I can tell you, we have doubled, nearly tripled the number of outbreak investigation reports that we now publish. The industry knows what happened. We have issued some as quickly as six weeks, six weeks after the cdc has declared the outbreak over. That is fast. Having stated that, there is more we can do and in december under the auspices of our new era of food safety, we published a report that we are calling the foodborne outbreak response and a proven plan. We are contracting with the university of Minnesota School Public Health. They work with other federal partners and did review of our outbreak investigation procedures. We published a plan on how we further intend to improve, how quickly and thoroughly we respond. Thank you for that question. We know that the office of Regulatory Affairs and fda has vast responsibility for overseeing inspections and enforcement of fda regulations. One criticism that we have heard is that fda is too slow, the agency is stuck with outed ways of thinking and is not nimble to keep up with modern trends. Mr. Rogers, how do you respond to those kinds of criticisms . Thank you for the question. I think we have demonstrated the ability to be nimble, especially in response to foodborne outbreaks and emergencies. As Deputy Commissioner yiannas mentioned, we have on many occasions in response to an emergency been able to get boots on the ground within 24 hours, on the farm and in the facility. I cant say that we are an organization that is committed to Continuous Improvement. We certainly welcome any feedback that would help us better achieve our Public Health mission. We will certainly react to the recommendations that are part of the ongoing internal review. I am going to suspend the second round so we can give senator tester his first round of questions. Thank you, madam chair. Anytime i can come in front of moran, that is a good day. First of all, welcome to you all. Doctor califf it is good to have you in front of the committee, i like all that. You are a cardiologist with means to a doctor, which means you should own medicine and you know probably better than anybody that the cost of medicine is part of the familys budget. There is increased significance over the last few decades. That is the bad news for the budget. The good news for the budget is the price food has decreased as far as the overall amount for this. It is due to a lot of good science, quite honestly, developing hybrid plans that people like me as a farmer depend upon. But the truth is, i dont know if were doing enough to find out if the food we eat is still medicine, which food is medicine. I think you would agree on that. When you eat good food, you usually have Better Health outcomes. There is a lot of information about peoples allergies to wheat and their ability to not eat it, which is the staff of life. The question is, is the fda, or is there anybody doing research on the work that man has done to modify plants to make them so they produce higher protein, bigger yields to be able to feed the world, which are all noble causes. If they dont produce inflammation, if they are not good for you i think i told you this, [inaudible] week is week, regardless of whether it has been genetically modified or hybridized or anything. Im not arguing with any of that, i profited from that good science. But the bottom line is, is anybody doing any research to make sure what people are eating actually is making them healthier . In the areas that have been hybridized. I really appreciate you bringing this up, this gets into the area of precision nutrition in my view which is a great topic. Doctor mayne is a World Authority in this area. Let me just say, i made the point, americans live five years shorter than the other high income countries. The foundation of a good diet, it cuts me out of both. The question is, what is good diet for the individual and what are the constituents of a diet that make the difference . With our change to a Digital World of data, there is much more we can do. Doctor mayne, you may want to address that. Thank you senator tester. From an fda perspective with regard to jean edited crops, we do play an Important Role through our biotech notification programs. We look at the types of changes that are being intentionally made to these crops for very important characteristics. For example, drought resistance, resistance to viruses, improve nutrient levels, those are the types of innovations that we are seeing. Our job is to make sure that those crops, when they are introduced into the market are safe and that they are appropriately labels. How do you do that . Im not only talking about g m owes, im even talking about hybridization, it has been around in my lifetime. How do you do actually test to see, for example, turkey red which is a wheat that my grandfather raised when he was on the farm, it reduces inflammation. Or at least ive been told that by people who are smart. Ive been told by the way that some of the ways that we raise our very, very common now they, dont do that. That seems to me to add to cost and people eat because they think its good for you. And one of those people who think its good for me because i eat a lot of it. Is there any buddy who does research to say, you know what, you 7431 developed by whatever university really doesnt have those inflammation production qualities. How i would respond is, with regard to traditionally bread hybrid types of crops, that type of research would be done primarily out of you s d a working with the federal agencies. When it comes to basic science research, usd a do is that down because Congress Wants the usda to do it . Usda, that dog is not going to hunt in usda, theres no way, they have other stuff that theyre doing. Why isnt fda doing it . This is food administration, will leave drugs out. How i would respond is that we dont have a significant budget to support extra mural research. If we were to take on a mission like that, we are not resourced to do that. If i might madam chairman, ill shut up. If you had the money to do it, do you think that the Science Community we try to stop you from doing that research . We always follow the science on anything that we do. Remember, the science is disease resistant, drought resistant, drug resistant, all good things, all stuff that i applaud as a former. But on the other side, if it doesnt produce the kind of food effects that you want and nobody is testing it, dont think people get a little bit nervous if you Start Testing it for the food, nutrition, qualities . When it comes the kitty genetically engineered once, if theyre improving nutrient content, we require evidence of that when we are looking at those types of submissions. We dont review the regular crops. Can i make a comment . I dont to beat this dog to death, nutrients are one thing, health care is another. You showed a lot of wisdom there, senator. You sound like a researcher. I can make one quick comment about this, and i think doctor mayne agrees me with this. Nutritional Research Needs to be a government effort. Do not involve usda would be a big mistake. I think the fda should has a bigger role, we have a lot of expertise and we understand health effects. The point you made about measuring inflammation, not just the Overall Health effect is a really important one. We can even address this until recently because we didnt have the big data capabilities that we now have to study populations. Ill call your attention to a white house call that is coming up in september where all the players are gonna be at the table. I would urge you to get your say in because i think youre saying the right thing. You are very kind, thank you, thank you madam chair. Do you have a second round of questions senator . Thank you, chairman baldwin. Doctor califf, it currently takes for a new animal feed ingredient to be approved. In fiscal year 20, i righteous cure an additional 5 million for fda to hire additional personnel to review beating agreement approvals. In fiscal year 2022, congress provided another Million Dollar increase to approve or attempt to approve this process. Since receiving those Additional Resources, what steps has fda to improve improve animal ingredients. Im going to flag a policy concern i have in that progress. Well, the additional founding has been appreciated. I know dr. Solomon has worked really hard to speed up the process and do the evaluations that are needed. I think the senator for venerate medicine is the most underappreciated part of the. Oversight is good, support is good, i have to go back and talk with dr. Solomon to get a more detailed answer but i do appreciate the question. If youd ask him to contact me or my staff, that would be wonderful. Well do. The followup to that is, a policy concern with the approval process. The livestock industry is looking to offer solutions to meet the challenges related to climate. However, the current fda policy interpretations regulate certain ingredients which could reduce Greenhouse Gas emissions as animal drugs instead of as a feat ingredient. Is my understanding that the policy manual decaying these decisions has not been updated since 1998. Would you commit to reviewing those policies related to categorizing feed ingredients as animal drugs and working with me to improve the approval process so livestock producers can get these Climate Solutions available in a more timely fashion . I know there are several issues in that category, so im definitely committed to reviewing the impact on emissions. It has to be important, an important consideration in that overall picture. The short answer is, yes. Thank, you doctor. All right, senator hoeven. You mentioned the top to bottom review, when you expected to begin . I trust you will be sharing it with congress as well, correct . I think a lot of people are going to be watching this and during an interview i did yesterday, i pointed out that we have a lot of the public, i agree with that. You guys our our bosses, we cant make the kind of changes we are going to need without your agreement. I dont see it as just informing you, were gonna have to iterate about what we are finding and what we believe. Also part of the executive branch, we have a lot of masters there that we have to satisfy. We are going to start as soon as we get the contracting done. The people who do the work are going to put a lot of time and effort into it. We are working on that right now through the foundation. We are committed to having a report within 60 Business Days at the time the work begins. Thank you. Budget transparency, also brought the spoof safety modernization act. Both the performance before and after, can you incorporate in your budgeting process, reporting process, how you are trying to implement that flexibility and improve your processes . Will that be part of this review as well . Short answer is yes. I will say, i worked in just about every kind of organization. The federal Agency Budgets i would say are among the more difficult to decide because of the mixed mission and all these things coming into play. I think on the food side, one thing about the user fees on the medical products side is that it brings a discipline to the budget that is very clear. That has some value. We dont have that on the food side. We are committed to making the budget much more transparent and understandable. Mr. Yiannas, i talked to doctor califf about this as well. I know youre trying to use technology to create a safer food supply, more traceable food supply, all that kind of thing. You have worked with large companies, i certainly understand how they can implement the idea to do that kind of thing. But there is a lot of small companies, how are they going to be part of this effort . It seems like a very worthy effort, but how are they going to have the Resource Base to do this . Thank you for that question, you are right, we have to be very cognitive of this. You have acknowledged, we want to use technology such as Machine Learning to strengthen the predictive capabilities. We have an interest in leveraging technologies such as distributive ledger to see if we can track and trace food faster. But we have to be cognitive and very careful of what we ask or require of the industries that we regulate. We are taking that into consideration, let me give you one quick example of how we are doing that. I think many of you know that we have a proposed food traceability when we issued that food traceability rule, it was for certain foods that were most likely to be involved in foodborne outbreaks. Number two, when we propose the rule we said that the records can be kept for each node in the system, not for the entire continuum, but for each node. It can be kept on paper. We are not requiring that to be kept digitally. We have carved out exemptions for small Food Producers, for small retailers. We are being cognitive, we know that some in the Food Industry as the Food Industry becomes increasingly digitized. It hasnt happened really quickly as it is happening in other industries because of the margins of food. But it is going to happen because that dries efficiencies. As that happens, we have to be careful that we dont create what i call a digital divide. One of the things that we did just last year was, we did something that was a little bit less traditional. We dont write rules, we did it right guidance, but we helped what we call the food traceability challenge. We called it a low to no cost food traceability challenge. Let me emphasize, it was low to no cost. We know data can be digitized, weve been digitizing data for decades. We went out to food traceability Solution Providers and we said, can you create solutions that are low to no cost so they can scale for Food Producers and all sizes . Are called action was answered in a big way. We had over 90 submissions, representing 12 countries around the world. We have selected winners, a lot of those solutions are low to no cost. If you think about social media platforms, many of us are in them, how do you pay to participate . Most of us, none. Because they have created economic models that allow those solutions to scale. Rest assured that we are very careful with this and we wont require something that is not doable. We will make sure that our food Safety Policies and rules are sustainable and that they can be executed by Food Producers of all sizes. Thank you, i appreciate that answer. Clearly, it is something that youve been thinking about. Doctor califf, this relates to what youre talking to tester about. There are 21 federal agencies that all have the different programs, standards, requirements, recommendations, suggestions. You name it. But they all want to tell you how you should improve your diet to make you more healthy. That can create a lot of challenges out there for a lot of folks like School Nutritionists for example, who know quite a bit about nutrition and what those School Children should eat, will eat, wont eat. Sometimes, all these mandates from high up, someone knows how to hundred million folks have to eat every day, that creates some real challenges out there. As the lead agency on food safety, how do you weigh in on that and kind of rationalized thing in a way that works for consumers and for folks, the professionals out there that are trying to do it, but you still have to give People Choice and discretion. They might want to eat mississippi shrimp, or they might want to each South Carolina shrimp, so they should be informed but they should also have the choice. Im gonna turn to dr. Mayne. Let me just say, she and i, i remember going back to 2015, we had arguments about this on the scientific basis of how you derive the conclusions that you need to derive. You could write a book about any diet and so it to a lot of people. It might not be good for any of them. Doctor mayne is in charge of this Food Labeling effort, its amazing. In my life, there is a state base about this big to inform through 120 Million People who speak different languages and have Different Levels of education, its a big task. I would say, we are very committed to doing what you just said, which is empowering consumers with information. We want consumers to have the information that they need to make those types of choices. And labeling is a coup tool, you mentioned 21 federal agencies, but only a few of them are regulatory like fda. We do have some unique levers to empower consumers with information. That is a key part of what we do. In terms of consumer choice, we agree with consumer choice, we are trying to support innovation throughout the food supply, to make sure those products are safe. Also they are properly labeled so those consumers do have those choices. In terms of the foundation of dietary recommendations, that is the dietary guidelines process. That is a joint process that is done every five years, it is a partnership between the u. S. Department of agriculture and health and human services. We do play a role in that as a part. All the guidance derives from the guy it occurs every five years. How about standards of identity . In one case, there is one that dates back to 1988. How are we making sure that these standard of identity are being, those decisions are being made, they are being may well, and theyre being made more timely . Thank you, should i take that . My next one is going to be mississippi and South Carolina shrimp, so its gonna get tougher after this one. There are large numbers of standards of identity, some of them need to be updated. We have petitions that we and working our way through, we are very committed to updating, modernizing standards. We have some request to create new standards of identity for example. One of the challenges with regards to standards of identity, it is not designed to be an agile process. This process to update the stand of identity involves rulemaking and rulemaking always takes time. With certain standards of identity, it involves formal rulemaking which in some ways isnt even more complicated process. It is not a quick process. The other piece is, as we work to update a standard of identity, it is really critical that we have extensive Stakeholder Engagement to understand the practices that are used by the folks are making those standards eyes foods so the modernized standard of identity really reflects what is in their. We are very committed to doing that, were making progress on that. We appreciate new resources that we have received from you all. This has been a very underresourced area, one of the most under resourced in the past. That created a backlog, like the 1980 81 that you mentioned. With the new resources that we have been able to hire 13 people with, we have five new recruits that were looking to get through the process. I will mention that the Foods Program does not have the authority that is as agile as the medical products, so it takes us longer to get those new hires on board. We know we have had conversations with many of you about hiring authorities that the medical products centers have. If the food programs had the same higher 30s, your sources would translate into bodies on board more quickly. I appreciate that. Thats a good recommendation. Im glad you brought up the additional funding. I was gonna do it. You did. Good for you. The flexibility this is a challenging area. Im sure the German Cartel you. For example, milk products. A very important area. Thank you for your response. Thank you. I want to share my gratitude with all the witnesses from fda. I think we had a good discussion and i want to assure you that the committee is here to support you in the important work you do. Im now going to dismiss this panel and invite the second panel to come forward. I will be introducing them as that transition is taking place. You are excused. Thank you again for appearing. I want to welcome our second panel. Mr. Is the director of food policy at Consumer Reports. Brian leads Consumer Reports advocacy efforts with regard to food safety. He was previously a deputy undersecretary for food safety at usda. He also served as an agriculture appropriations associate for representative rosa delauro. Miss sarah gallo is the Vice President of product policy a Consumer Brands association. In her role, she oversees the Consumer Brands regulation issues from advocacy through education. She has also served as Vice President of agriculture and environment for the biotechnology innovation organization, otherwise known as bio. These witnesses bring years of expertise and experience. We are looking forward to hearing from both of you today. If ive given you enough time to get settled, i will start with miss gallo. Plenty of time to get settled. Thank you, senator. Chairwoman baldwin, Ranking Member hoeven, and other members of the subcommittee, thank you for the invitation to testify today. As you noted my name is sarah gallo, and i served as Vice President of product policy for the Consumer Brands association. Consumer brands champions of the industry whose products americans depend on every day. Representing more than 2000 iconic parents. From cleaning and personal care to food and beverage products, the consumer packaged goods industry plays a vital role in powering the u. S. Economy, contributing two trillion dollars to u. S. Gdp and supporting more than 20 million american jobs. The cpg industry depends on fda to perform its regulatory role transparently. As we look to the future of our industry, modernizing and reforming fda is top of mind. For food, beverage, and personal Care Companies we represent. Their experiences provide real world evidence of why a modernized fda is more intended. Consumer brands is calling on fda to unify its food program under a Deputy Commissioner for foods, with accountability to the commissioner, and direct Line Authority over and the food related components and operations of o r a. The lack of a single fulltime fully empowered Expert Leader affects all aspects of the fdas food program. Inefficient decisionmaking has slowed reviews, hindering progress, and even rendering innovation obsolete. Inexperienced and under trained expect yours are being sent into the field. A split in siloed food program undercuts communication and collaboration. There is an urgent need for this change to be made and the appointee should have relevant and appropriate food credentials to quickly implement modifications that will benefit consumers and our industry. A unified structure and a fulltime Senior Leader translates into results we all care about. Focused leadership, accountability, and effective dialogue with myriad stakeholders. Fda can make this change now. The creation of a Deputy Commissioner for foods does not require an act of congress or rulemaking. In fact, the position existed under the Obama Administration and worked to ensure programs and oversight worked at optimal levels. We know that fdas food program may require increased funding to fulfill this mission. We also appreciate that congress has provided considerable funding going back to fiscal year 2050. I Strategic Review and realignment around priorities could help fta and its stakeholders make the case for additional funding, if needed. Organizing under a Deputy Commissioner for food is step one. But its not the only step. Consumer brands had a goal to product related policies that reframe ftas food operations. A decade ago, we would have thought about modernizing fda to move at the speed of this mess. Years later, its essential that fda is reformed to move at the speed of the consumer. Meaning they are rapidly changing preferences and demands. We are in the progress of articulating these policies with our Member Companies and look forward to sharing our plan with you in the coming months. Modernizing the agency also should be business critical for the agency. Reforms stand to position fda as a leader and a subject matter expert, facilitating innovation, assisting industry to meet state mandates, and enabling data to drive decisionmaking. Consumer brands calls on fda to convene an independent, outside panel of experts to address modernization of food Program Policy and operations. Finally, i would note that the covid19 pandemic demonstrates that regulators like fta and industry can Work Together to improve the regulatory environment. Ill note a few policies that worked during the pandemic and that continue to work in todays operating environments. First, incorporating remote regulatory assessments in modernized expectation practices has the potential to save ours or even days worth of time for companies, as well as for Government Agencies and departments. Second a, process for quickly creating just in time industry best practice documents clearing them, subsequently sharing them with appropriate federal and state Government Agencies and then posting to a website should be the new normal. The federal government should partner with industry to achieve this goal. Labeling flexibility is provided by the fda during the pandemic to address those persistent supply chain challenges that were critical to this industries ability to deliver essential to consumers, particularly when they were home bent more nimble, allowing us to better navigate shortages while ensuring consumer safety. Working at the speed of the consumer requires a strong, modernized fda, when that is structured, governed, and funded for success. That might not be the case today but it also doesnt need to be the fate of tomorrow, if fda chooses to make needed changes. We look forward to working with the committee to achieve this goal. I would look forward to your questions and appreciate the opportunity to present our perspective. Thank you. Thank you miss gallo. Next, we will hear from mr. Ronholm. Thank you, madam chair. And ill take a moment to make some brief comments. I know during his testimony today, dr. Califf made a mention of top and bottom reviews that will be conducted as part of their process. I would just point that the critical points to these top to bottom reviews are, as sarah alluded to, independent and transparent. Yesterdays announcement about the foundation conducting the evaluation is an Interesting Development that will deserve monitoring. Given that the purpose of the foundation is to support the fdas mission, we certainly are eager to learn more details about how the foundation will ensure that that process is independent. We are also eager to learn more about how the foundation will ensure the transparency of their process. How they intend to engage with internal stakeholders within fda, particularly cvs, ora, those offices. And how they intend to engage with external stakeholders, state voter regulators, having as much input as possible throughout this process will be critical to their process and conducting a true, comprehensive top to bottom review. I know coalition of groups, including Consumer Brands, and Consumer Reports, are certainly looking forward to working with the Foundation Throughout that process to resolve the concerns. Its those concerns that link to my testimony, which focuses on how the structure, governance, and performance of the food Program Impacts recalls and food policy decisions. Between inadequate responses to recalls, a failure to implement a culture of illness prevention, and a failure to move quickly on proposed rules and initiatives, there are a number of questions about whether the fda is performing its regulatory role effectively. It is struggling in its role to protect consumers. Its preventing the Food Industry from operating effectively. The recent infant formula crisis was merely one symptom that exposed a greater organizational structure and culture problem. Its clear that the confidence in the food program is eroding. A big reason for the lower confidence is the food program has second class status within fda. It has resulted in serious problems. The fda also lacks a single fulltime, fully empowered Expert Leader to provide strategic leadership and management accountability to a set of offices that are responsible for approximately 80 of the food supply. Its a fragmented structure in the food program that led to an Unprecedented Coalition of consumer groups, Industry Trade associations, and state and local regulators to join together to call on fda to unify the food program under a Deputy Commissioner for foods. This is what sarah alluded to in her testimony. This position would have accountability to the commissioner and direct Oversight Authority over simpson, cbsn, and the food related operations at a war a. That would be focused leadership and accountability to the food program at the agency. The current framework often results in an overall lack of urgency and making compliance decisions, including recalls, and an aggressive lack of ambition on policy initiatives. Another area where there are serious questions, and certainly appropriate to the subcommittee, is how funding is allocated within the food program. Ora, which is responsible for inspections and complaints, receives approximately 70 of all fda food program funding. And despite defending increases that the fda has received post figma, weve seen inspections decline in the year following the enactment of death is not, even before the pandemic shut down. While there is general agreement among stakeholder groups for the need for increased funding for the food program at the agency, it should come with more accountability and more transparency. Ty unlike those other programs at fda, fda coregulates food safety with state local programs. These programs have had funding in recent years. Ora also significantly reduced fda funding state expects which can be connected at a lower cost. Meanwhile, ora a seeking to count spay state infect towards its fears my mandate. The success of the food Program Overall requires a fulltime, empowered Expert Leader who could lead culture change and ensure accountability for resource management. We are fortunate that the person with immense expertise and abilities like doctor califf serving as fda commissioner. His assertions about investing in technology to leverage oversight activities certainly makes sense. However, investing in technologies and implementing structural changes to our governance are not usually mutually exclusive opportunities. We are not going to algorithm our way out of the existing problems in the food program. We also need structural and governance changes, stronger leadership, and a higher priority that puts food and nutrition policy at the same level at the agency with drugs, devices, biologics, and tobacco. Thank you for the opportunity to testify today. I look forward to your questions. Thank you for your testimony. I would like to start by asking miss gallo about how your Member Companies interact with the fda, and how you believe those interactions can be improved. Then i want to get more specific about how, during this top to bottom review, you would like to see that input take place. Thank, you senator. I would say, to start off, its absolutely critical that industry and fda have the predictable and functional working relationship. We want and need that regulatory system to be successful in order to provide a safe food supply. Certainly, our industries interest is making a more productive agency that serves consumers. A key component of that is the food program that speaks with one voice. We appreciate when the agency reaches out proactively. That does need to become the new norm. I think you heard many of the fda officials note Stakeholder Engagement, and the importance of stakeholder in engagement. We entirely concur with that. We like to see an agency. That is less siloed and less fragmented. Industry needs that unified Foods Program to provide a strategic and proactive regulatory agenda. Again, improving Stakeholder Engagement. In addition to rulemaking, there are certainly other ways that the industry can meaningfully engage with fda, like industry round tables, or even other discussions that could inform ftas actions in realtime. As it relates to the top to bottom down review, certainly we welcomed that announcement from fda yesterday, and we were encouraged that they are aligned with our thinking, that there needs to be a holistic evaluation of whats going on there, and how modernization could occur. Like brian referenced, we will be watching very closely the scope of that. There were aspects of the program that were not specifically named. Cem being one of them, as whats on the radar to look at from that top to bottom. We will be watching that and look forward to sharing that information however we can. I would ask pretty much the same question to mr. Ronholm. You said in your testimony how important it would be for this review to be truly independent, certainly at in accountability and transparency. How would you characterize an adequate amount of input . How would you like to see that take place . And if you want to amplify anything about your concern about the foundation maintaining its independence, please do. Sure. Thank you for the question, madam chair. Absolutely. I think in terms of how this process plays out, its absolute critical to have that internal engagement at the agency to ensure that all aspects of the food program are being considered as part of this discussion. That entails we ora, you have simpson, cvm, as sara mentioned, the offered a free policy in response i think incorporating those key officials in all those offices is part of those internal engagement as part of that process, i think, insurers transparency, it ensures the independents, it ensures all aspects of this issue get considered and discussed. From the external standpoint, certainly, as doctor califf alluded to, theres a lot of noise, a lot of groups, involved in this issue from a wide variety of consumer groups and industry associations, the state local regulators. We all want fda to succeed. We all want the food program to succeed. We all have a key seat at the table. To be able to incorporate those critical stakeholders as part of that discussion i think really enhances the recommendation that comes out of it. Very good. Senator huffman. Thank, you manager. I would like to thank the witnesses for being here. Know that you both included in your comments recommendation that the Deputy Commissioner for foods the restored in terms of the management for the fda. I guess what id like to get your thoughts on, from both of you, is the need for additional hiring authorities that fda has requested in their mission. If you could each address that, i would appreciate it. I would be happy to start, senator. Thank you. I would say, we certainly agree that there is a need to fill vacancies with qualified people more quickly. I think the examples that were given around the inspection are certainly ringing true for our members as well. We would support efforts to permit fda to do that. Id also mentioned, while youre asking, because this generally gets to budget questions. Both brian have for us to feel more comfortable going in and advocating, we do think that there needs to be more transparency around the way fda has used the funds you all have appropriated to the agency. I think that level of transparency will give us a lot of confidence. Looking at priorities and seeing how they want to move forward. As far as fdas ability in helping them with the ability to get more qualified individuals out in the field, that is something we would support. Thank you. Yeah, i dont think i can add much to that. We certainly support looking at flexible hiring authorities. I know doctor mentioned, and dr. Califf as well, they have trouble with maintaining qualified experts. Giving them more flexibility to hire these experts. Especially inspectors from the ora standpoint i think, certainly, would be helpful. In consumer production and outbreak response. We like that with the transparency, i think it makes for a better system, for sure. Okay. Thank you very much. No further questions, madam chair. I can wrap up with an additional question. Both of you pointed to the need for a Deputy Commissioner. I would like to hear more amplification and detail on how you belief the commissioner for food would improve food safety overall. But also improve accountability. Thank, you senator. Im glad you asked. I think one thing that we havent said today, and it seems rather obvious, but i think its a good point, is that not having a single entity that is overseeing all those makes it really hard to connect the dots at whats happening at fda. At this time, we are certainly, as was in our testimony, calling on fda to appoint that Deputy Commissioner, one, because you have the authority to do so right now. Thats not something we have to wait on it on a very labourious process to do. Having the ability to do that and get the modernization, or just that general transparency and better collaboration started, its something that we are strongly encouraging the agency to think about. We certainly know that having a Single Person that can look and make sure that the subject Matter Experts are in line with the inspection force, and connecting those dots, really helps the agency speak with one voice. It helps president that unified agenda that makes businesses able to operate more efficiently and to better meet the needs of consumers. I think it helps with consumer can suit communication and consumer expectation. If consumers can see that there is a person overseeing all aspects of a food program, i think that inherently gives a lot of confidence in the ability to know whats in the food supply, feel safe about the food supply, and also that we can bring Innovative Products to market to meet the consumer demand. I would just add to that that a big piece of this, the Deputy Commissioner position, is it would bring focused leadership and accountability that the food program desperately needs. As you all know, the fda commissioners throughout the past few decades have specialized, they are medical professionals. Naturally, their focus is on pharmaceutical products, medical products. Certainly, that has a big impact on Public Health and the pandemic is a good example of that we have that needed focus. But, what happens inevitably is there is this intense competition for the time of the commissioner as it relates to food. What ends up happening is that food gets pushed to the backburner a lot of the time. We it obtains that second class status. When you have that kind of fragmented structure like you saw today, in that theres various people that were reporting directly to the commissioner, mr. Mr. Rogers, they all risk theyll have some say in food programs. You when you have those fragmented voices all having, they are not strategically aligned with an agenda. Thats how you end up with a situation where its fragmented, that impacts response, outbreaks, impacts policy development as well. I want to thank both of you for being here today. Very good compliment to the first panel. I appreciate that. I look forward to working with you in the future as we tackle these complex issues. For the benefit of subcommittee members, questions for the record are due within one week. For all our witnesses, panel one and final two, we would appreciate responses to questions for the record within four weeks. With that, this hearing is adjourned. Very good. We will have a vote momentarily. That tell the american story. At 8 am eastern on lectures in history, Catholic University professor michael discusses the history behind the war in ukraine, including the competing u. S. , russian, and ukrainian interests. From the cold war to the 21st century. A 2 pm eastern, on the civil war. Author of americas buried history. Ken rutherford talks about land mines used for the first time on a widespread basis in the civil war. Exploring the american story. Watch American History tv saturday on cspan two. And find a full schedule on your Program Guide or watch online anytime at cspan. Org slash history. Cspan shop dot orgs cspans online store. Browse through our latest collection of cspan products, apparel, books, home decor, and accessories. There is something for every cspan fan and every purchase help support our nonprofit operations. Shop now or anytime at cspan shop dot org. The chair of the u. S. 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