Transcripts For CSPAN3 Hearing On The FDA And Food Safety 20221118

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 Lack of communication, outdated ways of thinking, and overall lack of leadership have negatively impacted the agency.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. Ral the Previous Administration undertook some structural changes, with the goal of raising the profile of food safety. Dr. Califf, do you believe that these changes were effective or work . First of all, let me say, i dont question the motives of the Previous Administration on this regard. I think the right things were said and efforts were made. But, you know, i heard a resounding chorus from the outside world. And i must say from inside the Foods Program that it hasnt gotten a priority that it deserved. I think over the last couple of years, i would just point out that the pandemic has had an enormous effect on the whole fda, and whats gone largely unnoticed is the amazing work that the Foods Program has done, just to you remember the early days of the pandemic when you couldnt find anything in grocery, on the grocery shelves. We definitely had a problem with that, baby formula. But by and large, people have put in a huge amount of work to be adaptable with regard to regulations and rules to ensure that people had food at a time when there was a question as to whether that would occur. So, the short answer is, i think there is consensus in the food world that whatever was done in the past hasnt been successful in getting the flutes program to the party that deserves. I am sure your all familiar with the politico 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, i ask both doctor mayne and dr. Califf how you responded to such 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 just want to vigorously rebut that the way those comments were made. We have the safest food in the world, and every expert ive talked to, cdc monitors carefully. Our food is the safe as its ever been. So, to say its not working is, in my view, is just incorrect. That doesnt mean it can be a lot better, and that there arent major problems. So, you know, thats why we are doing this top down review. And plan to make significant changes. But some of the people quoted, and that has been in leadership within the fda. I could say they had a chance to fix it. Its not so easy to fix. So, we all need to Work Together on this collaborative, collaboratively. But also, theres accountability. So we only to make changes. Yeah, doctor mayne . Thank you for the question, senator baldwin. I will say, food safety is not a joke. Its our mission within i can tell you its one of our absolute top priorities. That being said, we do take criticism seriously, and are always looking forward to ways that we can continually modernize and improve our work within the center. So, thats a priority for us. Ing back oni will say, reflectin the last ten years, we have accomplished a tremendous amount in the Foods Program. For example, with food safety, establishment of whole gene sequencing, which is Game Changing globally in food safety. That was the work that came out of it. Also, our work with regard to figma implementation, the foundational rules that have come out of 50 guidances to help move industry to the prevention oriented framework, that you all envisioned with figma, and thats it really important progress forward. Also with regard to nutrition, doctor califf highlighted our work on that, but there is much more. Powering consumers with information, really important things like labeling, so consumers have information to make the decisions they need with regard to their personal health. But we know more can be done. Resources are certainly something that was identified and that particular article. I will point out that we are 97 funded by budget authority, and not by user fees. So, its more where comes in, we absorb that work, because we dont have a user fee base to increase our staff, as the work increases. So, that remains relevant, and we look forward to working with that. Dr. Califf also mentioned authorities. There are areas that you are seeking new authorities that would make our work more efficient. This is the type of work to work with you one, resources, authorities, as well as the outcome that doctor 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, id like to call on senator glenn thank you all for joining us this morning. You mentioned efficiencies at work, just in your concluding sentences. Its my understanding that many of the staff at fda continue to work from home. And id be i think its 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 . And whats the plan to return them to the workplace sin . Thank you for your question, senator. And i think there we go. Thanks for the question. And 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, all throughout the pandemic, you know, if your job required that youll be at work, that happened. Or a inspectors, as mr. Rogers will talk about, you know, there were cutbacks because of the barrel of gravel and also difficulty getting even into a facility, when there were outbreaks. But our inspectors have put themselves at risk routinely, going there. The place where people have had the option move virtual or hybrid work has been those who are dealing with data or administrative functions, that really dont require that you are there in person to be most efficient. And i think our productivity is exemplified by the fact that we carried on all the usual activities, plus the pandemic activities. And i if i think if you talk to most of the industries that we regulate, theyre pretty happy with the performance of the fda, but we are in a program now to look at the hybrid environment. In my previous job at google, i spent a lot of time on this, where we have tremendous resources to do the analysis. And i think all of this is best handled by looking at the particular job, at the particular function. And the question is, whats gonna lead to the most productive employee . Who is most satisfied with the work what percentage of the workforce no longer comes to the workplace . No longer comes id say, maybe about half when you say no longer comes, thats a difficult thing to answer. No longer comes, regular daily basis. That is to say, the majority are not in the physical location on a regular daily basis. But remember, with a very large part of the workforce, its out in the field traveling. Well, i dont want at all disparaged you, if i want to compliment those who work through the pandemic, and the risk they took to make certain that the jobs, the responsibilities, were failed. I dont believe that you can have a 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 ongoing method by which the fda employees work. And it doesnt sound like, at the moment, there is a timeline to plan to return them to the office. Are you waving this analysis . Well, i would say, more and more people are returning to work. And as we work out the hybrids, the work environment, theyve been in. As we work on the hybrid data, were gonna make decisions as we go as to whats most efficient and he thought about having people come back to work and then work on the hybrid plan . Go back to what where you were before . I mean, we will certainly discuss that. But right now, it doesnt seem like the most efficient approach, especially right now where we are in the midst of ba. 5 surge. He used to say in previous testimony, ill change a bit the topic. A testimony to congress, the fda intends to pay special attention to formula distribution in rural areas. Would you detail for me ftas plants to prioritize formula distribution in Rural Communities . First of, all of me just say that the formula distribution is a function, not just of fda, but off the entire government, as it doesnt involve, as you, know the department of agriculture, hhs, and the executive branch. But the basic plan, you know, the first thing was to get production up and the u. S. , and use enforcement discretion. I know well 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, and now, there is intense focus on getting to the Smaller Stores as quickly as possible. And thats a matter of hooking up, particularly, the foreign firms that have not distributed in the u. S. Before to these smaller areas. That is one of the two areas of our major focus at this point. Thank you. My time, too, has expired. Opening statement at this i would like to welcome Ranking Member hoeven. Would you be prepared to give an Opening Statement at this juncture . Sure. I certainly can, madam chair. Thank you. All right welcome to our guest, i apologize for being tardy. Thank you so much for being here. Madam chair, thanks so much for convening the hearing, and giving the ongoing formula shortages. Appreciate dr. Mayne having a dialogue with commissioner califf. The panel this morning on that issue, as well as the fdas overall approach to food safety. Weve got an extraordinary mandate to be responsible to make sure that our nations food and drugs are safe and effective. As you may recall, during our earlier budget hearing, the next big concern the fda has had seven commissioners this past decade. During that same period, we have increased funding for the fda by 35 for the food programs. And the bulk of that is for targeted food safety, and inspection improvements. Unlike other Public Safety agencies such as centers for Disease Control and prevention, this committee has provided the fda with a lot of budget flexibility, as well, to ensure the highest priority needs get addressed. Additionally, its been more than a decade since congress enacted the food safety modernization act, fsa, dumping it regulations regarding Food Production, providing fda with additional authorities to oversee and enforce the safety of our food supply. Yet the cdc estimates that more than 128,000 people in the United States are hospitalized, and 3000 people die from foodborne illnesses each year. And its hard to understand, that figure is the same as pre fsma implementation rates. So, when you talk about, that you need to talk about what you are doing and how we can continue to work to improve it. At o dr. , you stated one of your responses to the ongoing infant formula shortage, which is to undertake a top to bottom review of the food safety program, which youve talked about. And institute changes necessary to ensure a crisis like that doesnt happen. As a parent and grandparent, i cant overstate my concern about what happened in that regard. And we have to make sure that, you know, we dont have Something Like that happen again. Going forward, i think that fda should treat essential foods such as infant formula, in the same matter it treats essential medicines. With that, again, i apologize, i was late this morning. But i want to thank you, madam chair, for calling this hearing. And i will turn it back to him going to now recognize senator hydesmith for his questions. Thank you, chair baldwin. Commissioner califf, outside of acutely contaminated Drinking Water sources, people are mostly exposed to chemicals through the food that they eat. Food can become contaminated when its grown, and what weve seen in new mexico where animals during water, as well as food packaging, and in several parts of the country, pfas contamination has manifested in agriculture posing food safety risks. What is v fda to regulate pfas chemicals in our agricultural product . And does your agency has the resources it needs to successfully pursue that were . Thank you so used to microphones coming on automatically. Thank you for raising this issue. And to me, it exemplifies a whole host of summer issues that we had with contaminants that are there to some level. The epidemiology of this is very complicated, and it takes a lot of science to figure out where to draw the line, and we are to intervene in these industries that are so critical to all of our welfare. So, i asked doctor mayne to give us some of the details of what were doing on this. Thank you, senator. So, be fast as a very important priority for us, im not just at the fda, but across the inner agency. And were working in partnership with all the different key inter agency partners, including epa. In terms of our role, we have multiple roles with regard to pfas. But the first one is just understanding what the exposure is. We need to understand, you know, whether the hazard, and what are the exposures. So, weve been conducting analyses at the u. S. Food supply through whats called our total indict study. And that testing, weve tested over 500 different samples. We found and that had detectable levels of pfas in the general food supply. So, very reassuring information with regard to the general food supply. Doing ahowever, of those ten, eight of them that were detectable received food samples. And that has led us to doing additional analyses on pfas and potential contamination in seafood, where we released some data very recently on that. So, thats 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. And so, 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 pfas exposures, and apa. So its an important priority. So, the last piece is the food there are certain authorized food contact uses of pfas. If we have a concern about safety, we need to argue largely talking about packaging . Yes, im talking about food packaging, thank you. So, there are certain authorized uses for contact, if you have concern about safety, we would withdraw those authorizations. And that has happened previously. Weve had a Market Growth recently from some short chain pfas that we had some lack of confidence in the safety of those compounds. So, those are the rules were taking in pfas. In regard to a question about resources, we have observed absorb this work at our base budget, but we have requested resources in the fy 23 budget. It will be very great to increase our work in pfas. You mentioned the prevalence of seafood within the sample set, that did not test positive. Do you understand that the mechanism or the fact there . Just early in the days of getting information about seafood contamination with pfas. What we did was a targeted sampling assignment of 81 different seafood samples. We looked at the most commonly consumed seafood in the u. S. , things like tilapia, shrimp, salmon, clams, for example. Our results were released. Well be happy to share them with you. But what we did see were very some concerning levels and one particular commodity, and that was canned clams coming in from china. So that is new detail we have. Your question about mechanism of action, we suspect this is due to environmental contamination where those clouds are coming from. Were working with the companies to try to understand that better and prevent those types of exposures. Dr. Califf, before my times expired, obviously, its hyper critical that families can trust infant formula. To be safe. And i know youve put a lot of effort into bringing offshore formula products up to your standards. But here in the u. S. , ive heard complaints of long wait times for review, for responses, for small domestic manufacturers . So its the fda doing to make sure its scarce resources are, prioritizes domestic american manufacturers and producers. I, mean as you know, working 24 of us, 24 7 on this to make sure that we have adequate supply. Unders part to give large quantities suppliers while we are in shortage. But were not gonna slide u. S. Producers, the house of commons, she is running the diligent work of reviewing this. With regard to the immediate action to try to get more on ourselves, one of the criteria for moving forward with discretion was available product in quantity of aerial product. Because our goal extorted by the administration is get formal on shelves as quickly as possible. At the same time, one of the things we really want to do is make sure we have a diverse infant formula Manufacturing Base Going Forward in time. There is a really Important Role here for u. S. Manufacturers to play. So, we want to encourage u. S. Domestic manufacturers. We have some under review right now for enforcement discretion. But 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 former manufacturing this country for more resilient supply. I madam chair, can i make one more quick comment . Please, dr. Califf, go ahead. I heard that its not all about money and resources. But this is an area where we know we had nine people working on this, and you graciously added four people last year. Given the need, its a scenario were just having enough people to do the work. You know, weve moved a lot of people over from other things to help make this happen. But we cant sustain that without specific funding. Thank you. Senator hoeven . Thanks, madam chair. I guess my first question would be in regard to the infant formula situation. Now, chairman, i did sent a doctor calculator. We got that, i think before yesterday, so kind of short for our staff. And they work hard, got a lot of things they have to get ready for these hearings. So, if you could get responses sooner, it would certainly be considered, considerate of them in their time. Because they try to get stuff. I apologize. I wish i had gotten to you sooner. I did not read the entire thing. Its a number of pages, single spaced its put along, yeah. I couldnt do it. Yeah, i have the same concern myself. If people do a perfect job and gets to before i have a chance to read it, or i have to do something, its not will double down. Yeah, that speech you get will get a little hard to review. You know i know you get it, and i know you care about all the hard work that folks are trying to do. That timeline would be helpful. But obviously, thats been a real concern. I mean, you know, we can all imagine moms and dads, most of us having been moms and dads, in my case, grandparents. You know, as well, i think, you know, trying to get that infant formula. And you know the kind of the whole sequence of events from inspectors, not inspecting that plant, and getting out and inspecting that plant. And the amount of time between inspection of the plant, determination of the problem, and then the leadership at fda being made aware of it. Those are real concerns. I know im going through with the committees staff, what they talked about when the sale and back, when they had the issues back in the puerto rico, with some issues down there. And there was an instantaneous effort to get after some of those medical equipment and needs and that kind of thing. I got thats on the drug side, but, you know, Something Like baby formula, youre in that mode of, you know, having to have a. And in some ways, almost like you would on the drug side. So, how do we make certain on the food side that weve covered this . That we dont have it happen again . And then, there are still shortages in the stores you. While we are there, i assume were gonna have it moved away, so we dont want to have the empty shelf problem . Id say there was a lot included in your question well, that is a pretty big question. So, let that youre not gonna talk about it anyway. You know, this is something we take very seriously for all the reasons that you pay. And i feel like ive been living with the folks you see at the table pretty much since day one. Since i recall, occurred on the day i was confirmed, and you know, i stepped right into it. Theyve been working night and day. First of all, you raise a question of what are we doing to correct errors that may have been made . Its wellknown that dr. Steve solomon, who runs our center for medicine has a long history of knowledge, of inspections in other parts of fda. And the after action review. Thats moving along the interviews that have been completed. So, im expecting a report soon on that. Were also doing the top to bottom review that we announced yesterday. And dr. Solomons review will be available as part of that. And ill go through it item by item, all the timeline, all the 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 very common issue in health care provision. Nurses, for example, if they see something wrong, escalating the issues. So, i think we have already fixed that problem for the future. In terms of where we are, we are things are getting better. I think thats pretty wellknown. The numbers are looking better. Its not gonna be a sudden fix, but we have each of the manufacturers, both incumbent manufacturers and also those now entering the market with enforcement discretion, we have their production instruments. And id say its a very diversified robust pipeline coming in. But there was adaptation thats gonna take a while to fix. And theres one other issue which i think is important for people to understand, which is that when there is, in any commodity, when there is a shortage, as ive learned, i was not an expert in supply chain management. You know, an industry. When there is a shortage, people change what they make to make it so that there is for example, maybe larger containers to optimize, bringing forward the product for purchasing. So, some of the things that people are used to seeing on the shelves may not be there, even at the total amount of the formula is the same, or higher than it was. Theyre really good news, i, think in this production is exceeding buying by a significant amount now. And we expect that to continue. And you may remember, there was a spike in purchasing when people became concerned, understandably, families went out and stopped their pantries. So, in case there was a problem. Weve seen that now return to a normal, even a little bit below normal level of purchasing. So, that difference between what we are producing and whats being bought should be sustained now over the next few months. So, i would just expect my complaint taking off expectancy or gradual improvement on the shelves. Okay. Thank you. I guess i will just i will refer my additional questions to the next one. Okay so, next is senator hydesmith. Thank you chairwoman baldwin, and Ranking Member. I certainly appreciate our panel being here today. Sorry that i had to leave out of the meeting and come in. Im glad that i had the opportunity to be with you. Commissioner califf, i want to talk about the industry. You know, mississippi, we are a big shrimp state. Its very important to mississippi. And our shippers harvest as much as 10 Million Pounds of shrimp each year and we have a lot of small familyowned processors that make very high health and Safety Standards to deliver our delicious gulf shrimp that we like to advertise so well on the tourism commercials. And to American Consumers across the country. But unfortunately, our strip industry is forced to compete with a lot of evergrowing by ends at the border trap. So much of which is dealt on the market and subsidized by foreign governments. And more than 90 of the shrimp we consume in the u. S. Is imported. You know, thats just the back. And in many cases, from countries where the food Safety Standards that are inferior to ours, even more concerning is the fdas ability or inability to adequately inspect imported shrimp to ensure these imports meet our own health and Safety Standards. States areits no secret that dt approved for use in the United States are often used in Foreign Agricultural operations. And that there is a deuce of these drugs may lead to some cancer, allergic reactions, when consumed by humans because of the cross the jenning effects found there. And very pleased that imported shrimp was selected for of das recently launched Regulatory Partnership Pilot Program. And i hope these Regulatory Partnerships with the exporting nations would lead to Better Safety compliance and oversight. But my question, can you give us an update on the status of this Pilot Program . And any specific improvements youve seen with respect to the regulations of imported shrimp . 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. I am from a charleston family, as evidenced by the great data, i 90 plus degree weather. I think were making great progress, year and i actually like doctor mayne and mr. Yiannas to both comment about the specifics of whats going on. I think were making great progress here. Thank you. Thank you, but ill say 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, and as directed in both f 21 and 22. In terms of the how we review those resources, you mentioned a rigatoni partnerships. One of the things weve done is we focused in on the countries that import the most shrimp into the night states. That includes india, indonesia, ecuador. Weve been establishing Regulatory Partnerships with the government authorities at all three of those countries. A key part of these Regulatory Partnerships is also data sharing agreements, confidentiality commitments, so that we can share information that they can have about their manufacture, their growers, their producers. Thats important for data that we can use for analytics, as we look at protection, at imports, and what we want to screen as imports. Thats one part of this regulatory piece of it. But theres more as well. In terms of what we are doing with these countries, weve 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 trim. Weve been doing that as well, as the partnership agreements. The last thing i mention, were using these new technologies at the border to try to identify the highest rate of violated projects using data analytics. Well turn it over to the commissioner yiannas to discuss more about productive analytics using technology. Thank you. Yeah, 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, were working on that. And the pilot has been very successful. Let me emphasize just a couple of things. Under Regulatory Partnerships, data sharing is going to be key. Can we get data from these regulatory partners and entities that theyre regulating to inform our risk privatization efforts . So, were making progress on. That one other point that ill make, maybe before we get to our eligible approaches, we invested those phones unethical equipment. Some of these products, as you, know agriculture, and so, there are drugs and residue that might be added. And i want to make sure that we can detect it. But i think the big thing that i am very excited about is the use of data. Every single line of shrimp import that comes into the United States gets green, screened by fda through something that we call the predict system. And we try to leverage in this pilot ward victory started earlier on a seafood ai pilot. We are using the power of Artificial Intelligence Machine Learning to strengthen our productive capability of finding those violent products. So, with embedded shrimp in the seafood ai pilot. And early results are very promising, where a third round of piloting in the results suggest we might dramatically increase our ability to find which seafood shipments are violent to. Thank you so very much for that work. And my time is up. I wont comment on whether South Carolina shrimp is better than mississippi shrimp. But i do have an opinion about that. Following the subcommittee, that may make a great lunch. [laughter] senator braun . Thank you, madam chair. Doctor califf, last august, your agency entered into a memorandum understanding with the usdas food safety and Inspection Service to facilitate Information Exchange between the two entities. So, there has to be, i think, ideally, a communication, when its a dual agency responsibility. And in that mo, it requires the fta and of as i as to inform one another in the case of outbreaks adverse cases of adulteration or miss labeling, infestations, et cetera. Now 11 months into this mou is the fda planning to conduct public critical review before this actual implementation. Senator braun, im sure that will be a part of the top to bottom review that we announced yesterday. I know this isnt within mr. Yiannass portfolio, or relationships with other agencies. I might ask him to comment . The answer is yes. We were almost on a daily basis with usa on the shared issues. So theres irregular conversations, and so, the answer is yes, we are closely evaluating our gonna work through these processes together and we are making progress. And do you think the fda has done its part in being a coequal partner and trying to pursue and discuss these issues . Absolute low. Yeah, weve signed an mou with the identification responsibilities, and i can tell, you weve done our part, and my sense is that u. S. , that the usda will tell you that were very happy with the role were playing. Very good. This is on a different topic. And doctor nick califf, last year we suffered a record high of 100,000 opioid overdose deaths, as a result, senator manchin and i sent a letter to you in april, urging you implement recommendations from the natural, National Academies to improve the fdas policies for addressing this epidemic. A report that, i think, you requested during your first step at the fda. 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 cosponsored changing the culture of the fta and the kind of prod into something that looks like being into being taken more seriously. I left to your comments on where we are, because it doesnt look like its getting any better . I would say, in terms of mortality rate, its not getting better. And the fact that the cdc is today reported that its gotten worse. And so, this is something from day one, when i came in, weve been working on it. And my personal energy, i will say, got diverted a bit after the formula. But in a very short period of time, enjoying this summer, were gonna come out with a statement about the things that you are doing in in this regard. There is a lot underway, off the parts of it that are in our control. Including the promise to review the past. And i dont think you saw future problems, just by looking at the past, but you can learn things of the past, so you need to take that into account. You may have noticed yesterday, doctor, doctor sokolowski was promoted into a joint role between the drug part of the eight da and the commissioners, to head up a part of the effort. So, we have a whole team working on it. One of the things thats 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, ill just point to over the counter logs known as an example of something that is very complicated, because the costs may actually go up when you go over the counter and that situation to the person that needs it. But we have approaches so that were gonna put forward. Also, i just want to call attention to the big new thing thats happening that we better all Pay Attention to, which is the essentially mail order high dose chemically synthesized fentanyl and methamphetamine coming in by the mail, direct delivery to people. That is killing some of our most Promising Students who think theyre getting adderall or something to help them study. This is different. The things that weve embarked on in the past are not gonna solve this part, so weve got to work on that. Were out of time here. And you said during the summer, this is a summer. So, when can we expect that to be out there for us in the public to see . I cant give you an exact date other than to say its within the summer for i know you are all ill take that by september 21st, then. I think of that as, i dont, know the way i grew up, i think of some are not officially, but more like september, 1st of september labor day, well, thats even better. Looking forward to seeing it. Thank you. Im gonna begin a second round of questions. And i want to make sure i ultimately involve all the panelists in questions. So, mr. Yiannas, you have Prior Experience working outside of the fda with major food corporations. Can you discuss the, and i know this top, top to bottom review s ongoing, or just commencing. But can you discussed what to this you feel need to occur to make food safety more of a priority at the agency . And do you think the agency is too slow to respond to outbreaks of food borne illnesses . Am very fortunat thank you for those questions. Let me take the first one of the top. Yes, i am very fortunate to have worked for 30 years, into organizations that are worldclass, i would say, large, global footprints. And ive learned a lot in those experiences. But i did come to va 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 but a couple of the best practices that ive learned working for these world class organizations, i think our appropriate fta, let me give you an example to really quickly. Number one, food safety is a priority to fda. But i think we need to go beyond that and making it part of the culture. Its really, it has to be an unwavering commitment that we can do everything that we can to ensure that americans have safe food. And the organizations that i work for, the reason they were great, really, their cultures. And i sometimes, people think thats the soft stuff. Its the hard stuff. Its gonna be part of organizations dna. Number two, their organizations that i work for, i were, i would just say realistic committed to continuous modernization and reinvention. You, no one went from being nonexistent to the Worlds Largest company in 50 years. How did they do that . Because they constantly reinvented what they do. And at fda, were trying to do that under the something we launched in my ten year, called the smart food safety. This is the idea that you are living in modern times, and were gonna need more modern approaches to how we regulate food. And so, thats a second thing that i think could companies do . Well, those companies that go from good to great, and the fda committed to monetization, and i love to tell you more about this new era. But the last thing i would say, those organizations do a really good job of setting very High Performance expectations, having High Expectations standards of themselves, just like this conversation we are having here. We appreciate that you have High Expectations of us. We have High Expectations, too, to do a brilliant job of clarifying roles and responsibilities. So that when you work as a team, there is no duplication of effort. And you get more done. And i would say, the other thing the private sector does really well is the use of Performance Measures and metrics. They measure everything, leading, indicatings, and i know its something that dr. Califf really wants to do, leverages data and measurements. Were doing all of these things, but clearly, there is more that we can do. In terms of the question, and its a good question, i think what too slow responding to outbreaks. I certainly think theres more we can do. Responding to food grown outbreak is fast, and thirdly, is critical. The faster you respond, the quicker you can pull contaminated products off the market and protect others from getting ill. And you have to do a better job of understanding the root cause. Why did the outbreak happen in the first place . So you could prevent it from happening again. Weve publicly stated, we think we can do more. And let me go faster, but before let me give you some took examples of areas where weve improved. When i first arrived at fda three years ago, it was a bit of criticism that we were too slow arriving to, lets say, a field, a farm, or a sight after an outbreak. I can tell you that now, we generally show up quickly and as fast as 24 hours, or shortly thereafter. When i arrived, there was criticisms that when these outbreaks happen, the outbreak reports were too slow, if they ever came. So, the industry could learn from them. I can tell you, weve doubled, nearly tripled the number of outbreak investigation reports that we now published. So, the industry knows whats happening. And we have issued, some as quickly as six weeks, six weeks after the cdc has declared the outbreak. Now, thats fast. Having stated that there is more than we can do and in december, under the new era of smart food safety, we published a report that we are calling the, foodborne outbreaks response and improvement plan. We contracted with the university of minnesotas school of Public Health. They worked with other front partners and did a review of our outbreak investigation procedures. And we published a plan on how we further intend to improve how quickly and throw it will respond. So, thank you for that question. Thank you. We know that the office of Regulatory Affairs act fda as fast responsibility for overseeing and enforcement of fda regulations. One quick system that weve heard is that fda is too slow, that the agency is stuck with outdated ways of thinking and is not nimble to keep up with modern trends. So, mr. Rogers, how do you respond to those sort of questions . Yeah, thank you for the question. You know, 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, or in the facility. I can say that your organization thats committed to continuous improvement. We certainly welcome any feedback that would help us better achieve our Public Health mission, and we certainly will react to the recommendations that are part of the ongoing 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 im coming after moran, thats a good day. First of all, welcome to you all. Dr. Califf, its good to have you in front of the committee. Its good to see you got confirmed. I like all i like all that, okay . You are a cardiologist, which means you are dr. , which means you should know medicine, and you know probably better than anybody at the cost of medicine, as part of the familys budgets. This increased significantly over the last few decades. That is the bad news for the budget. The good news for the budget is, of course, the food decreased as far as the overall amount put out for this. Its due to a lot of good signs, quite honestly, developing hybrid plans that people like me, was a farmer, depend upon. , which food is medicine. And i think youll agree on that. Usually, with good food, you have Better Health outcomes. There is a lot of information about their, about peoples allergies to eat, and the ability to not eat it, which by the way, is a status for 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 in bigger yields to be able to feed the world, which we all know their causes . But theyre not so noble if they dont refuse, reduce inflation, inflammation, if they dont, if theyre not good for you. And one of the predecessors, he asked this question, he said we dont need to do and research on wheat, because wheat is wheat, regardless whether its genetically modified, or jeopardized, or anything. Im not arguing against any of that, because quite frankly, i profited from that good signs. But the bottom line is, anybody doing research, make sure what people are eating, actually making them healthier. In the area where the plants have been hybridized. I really appreciate you bringing this up. I mean, this is considered an area of position, nutrition about, it which is a great top. And doctor mayne is a World Authority in this area. Let me just say, in my Opening Statement, i made the point. We, now, as americans live five years shorter than the average of other high income countries. And the foundation of good health is a good diet and not using tobacco products. So, that combination you can say that on both, but go ahead. The question is, whats good died . What could die for an individual . And what our constituents of the diet that make a difference . And with our change to a Digital World of data, there is so much more that we could do. So, doctor mayne, you may want to address that. So, thank you senator tester. A couple of comments. First of all, from and fda perspective with regard to genetically engineered trot crops or gene edged crops. We do play an Important Role through our biotech notification programs. So, 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, improved nutrient levels. Both are the types of innovations that you are seeing. So, our job is to make sure that those crops, when they are introduced into the market, are safe. And that theyre appropriately labeled. How do you do that . Im not only talking about gmos . Im actually even talking about hybridize. Its been around my lifetime, my entire lifetime. So, how do you do actually test to see for example, turkey red, which is a myth that my grandfather raised when he owned a farm, actually reduces inflammation, or at least ive been told that by people who are smart. Is there and ive been told, by the, way that some of the weeds that we raise our very, very common now. Dont do that. That seems to me to add to cause, and people eat wheat because they think its good for. You and im one of those people who think its good for me, because i eat a lot of it. Is there anything that does any research to say, yeah, you know what . Q751 divided by any University Want to see, really dont have these policies with regard to traditionally, hybrid types of crops, that type of research would be done primarily out of usda, working with federal agencies. So, when it comes to basic science research, usda and nih, critical partners. So, is that don because Congress Wants the usda to do it . Because usda aint gonna hunt usda. Im just gonna tell you, theres just no way. Theyve got other stuff that theyre doing. Will why isnt fda doing it . I mean, this is food administration, lets leave drugs out. Food administration yes, how i would respond, we dont have a significant budget to support things like extra research so you need more money . If we need to take on a mission like, that were not resourced to do that. And if i say this, and then ill shut up. Mike i ask, do you have the money to do it, do you think the Science Community will try to stop you from doing that research . We always follow the science and everything that we do. Remember, the signs, disease resistant, drought resistant, buck resistant. All good things, by the way, all good stuff i apply as a farmer when i put it on the ground. On the other side, if it doesnt produce the kind of food effects that you want, and nobody is testing it, dont you think people get a little bit nervous, if you start to test them for this, for the food, nutrition, qualities . When it comes to, again, the engineered gene edited once, if theyre improving nutrient content, we require elements of that, when we are looking at those types of submissions. But we dont review the regular crops. But i make a comment nutrient is one thing, and Health Care Benefits are, i think, another. You showed in my opinion, you showed a lot of wisdom there, senator. You sounded like a researcher. Can i make one quick comment on this. And i think doctor mayne would agree with me on this. I, mean to leave out would be a big mistake. Do not involve usda is a big mistake. I think weve got a lot of expertise, and when hurston health affects. I, mean the point you made about mentoring just implementation, not the Overall Health effect is a really important one. And we couldnt even address this until recently, because we dont have the big data capabilities that we now have to study populations. Ill call your attention to white house conference coming up in september, where all the players are gonna be at the table. I invite you to get your saying, because i think youre saying the right thing. You are very kind. Thank you all for being here. Thank you, madam chair. Do you have a second round of questions, senator moran . [inaudible] thank you, chairman baldwin. Doctor califf, currently, it takes 3 to 5 years for a new animal feed ingredient to be approved. In fiscal year 20, i worked to secure an additional 5 million for fda to hire additional personnel to review feed ingredient approvals. Fiscal year 2022, congress provided another Million Dollar increase to improve, or an attempt to improve this process. Since receiving those Additional Resources, what steps have fda taken to improve this reviewing, and improving animal ingredients . And then, when you answer that question, i want to flag a policy concern i have in that process. Well, you know, the additional founding has been appreciated. I know the doctors solemn and cb and have worked really hard to speed up the process and do the evaluations that are needed. I think senator madison is the most underappreciated part of the fta. So, i need, oversight is good. Support is good. And, you know, i have to go back and talk to dr. Solomon to get more details answered. But i do appreciate the question. If you ask him to contact my staff, it would be wonderful. Well do. The followup to that is a policy concern with the approved process. The livestock industry is looking to offer solutions to meet the challenges related to climate. How are the current fda policies interpretations regulate certain feeding radiance which could reduce Greenhouse Gas emissions as animal drugs, instead of as a feed ingredient . Its my understanding that the fda center for veteran madison policy dictating these decisions have 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 or 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 it. The impact on emissions has got to be an important consideration, and in that overall picture. So, the short answer is yes. Thank you, dr. All right, senator hoeven. Thanks, madam chair. Dr. Califf, you mentioned the top to bottom review, when you expect it to begin . And i trust you will be sure sharing that with congress as well. Correct . I think a lot of the people watching this, and you know, in an interview i did yesterday, pointed out that we have a lot of bosses with what mr. Yiannas said, i agree with. That you guys are our bosses. We cant make the kind of changes were gonna need without your agreements. So i think were gonna have to iterate about what we are finding and what you believe. And we are also part of the executive branch, so we got a lot of ambassadors who say that we have to satisfy. Were gonna start soon as we get the contracting done. You know, the people to do the work, theyre gonna put a lot of time and effort into it. So, we are working on that right now through the Reagan Foundation. We are committed to having a report within 60 business days, the time that the work begins. Okay, thank you. But to transparency, i also brought up that food safety modernization act. And both performance before and after can you incorporate into your budgeting process, all reporting process, how you are trying to implement that flexibility and improve your processes . Will that be part of the review as well . The short answer is yes. I will say, i worked to the federal agency budgets, i would say, are one of the more difficult to decide, because of the mix mission, and sort of all these things coming into play. I think on the food signed, you know, one thing about it is the medical site it brings in discipline to the budget thats very clear. Which has some value. We dont have that on the food side. But we are committed to making a budget much more transparent and understandable. So, mr. Yiannas, and i talked to doctor califf about this, as well. I know you are trying to use technology, to create a safer food supply, and more traceable foods supply, that kind of thing. Youve worked with large companies. I certainly understand how they can implement the idea to do that kind of thing. There is a lot of Small Companies out there. How are they gonna be part of this effort . I, mean it seems like a very worthy effort. But how are they gonna have the resources base to do this . Thank you for that question. And you are, right we have to be very competitive of this. Youve acknowledged, we want to use technology such as Machine Learning, to strengthen our predictive capabilities. We have an interest in leveraging technology such as distributed ledger to see if we can track and trace foods faster. Ire of thebut we have to be cogd very careful of what we ask or require of the industries that we regulate. And so, we are taking that into consideration. That may give you one quick example of how were doing that. I think many of you we have a proposed food traceability out there, and we issued that proposed food traceability role, it was just for a certain food that were most likely to be involved in food borne out breaks. Number one. Thats number one impose the rules, the records can be kept for each node in the system, not for the entire system, but for each node. And it can be kept on paper. So were not requiring that theyd be kept digitally with a carve out exceptions for small Food Producers and for small retailers. And so, we are being cognitive. We do know that some Food Industry, as the Food Industry becomes increasingly digitized, because its happening. It hasnt happened real quickly as has happened in other industries because of the margins of food. But its gonna happen because it drives efficiencies. And as that happens we need to be careful that we dont create what i call a digital divide. And so, one of the things we did just last year, we did something that was a little bit less traditional. We did not write rules. We did not write guidance. But we held to what we call a food traceability challenge. And we called it a low to no cost food traceability each out. Let me emphasize, it was a low to no cost. We know that data can be digitized. Weve been getting digitized data for decades. You creatbut when it comes to d traceability and mission providers, we said can you create solutions that are low to no cost, so they can stay up for Food Producers of all sizes. And our quota action was answered in a big way. We had over 90 submissions, representing 12 countries around the world. Weve selected winter winners. And a lot of the solutions are low to no cost. If you think about social media platforms, many of us are in them. How much do you pay to participate . Most of us none. Because theyve created economic mouths that allow those solutions to scale. And, so rest assured that you are very careful of those and we wont require something our Food Producers thats doable. And will make sure that our food Safety Policies and rules are sustainable. And that there can be executed by Food Producers by on both sides. Thank you. Appreciate that answer. Clearly, something weve been thinking about. Yes, sir. Doctor califf, this brings us to a little bit about the talking about. There are 21 federal agents agencies that all have different programs, standards, requirements, suggestions, i mean, you name it. But they all want to kind of tell you how you gotta improve your diet to make you more healthy. Okay . Well, that can create a lot of challenges out there for a lot of folks, like school and intuition, for example. I think quite a bit nutrition and what those School Children should eat, will eat, wont eat. And sometimes, they use mandates from on high were Somebody Just knows all 20 plus million folks out to eat every day. And, you know, creating some real challenges out there. As the lead agency on food safety, how do you kind of weigh in on that, and kind of rationalize the thing in a way that works for consumers and for the folks, the professionals out there that are trying to do it . But you still got to give people a choice and discretion, and you know, i mean, they might want to eat shrimp each shrimp, or South Carolina strung. So, they should be informed, but they should also have their choice. Im gonna turn to dr. Let me just say, i remember going back 2015, have arguments about this on the scientific basis of how you derive that conclusion that you need to derive. Because you could write a book just about anything now, and sell it to a lot of people. It might not be good for any of them. But doctor mayne descends in charge of this Food Labeling effort. Its just amazing. I just think of it, in my letters between fta and usda, getting a space about the spectrum from 20 Million People and speak different languages and have Different Levels of education. Its a big task. Which is empo id say we arey committed to doing what you just said, which is empowering consumers with information. We want consumers to have the information they need to make this choices. And labeling is a key cool. And you mentioned 21 federal agencies, but only a few of them are regulatory alike fda. And, so we do have some unique actors to really help empower consumers with information. So thats 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 are safe. And then, they are properly labeled so consumers do have those choices. And in terms of the foundation and the dietary recommendations, that is the dietary guidelines process, that is a joint process that is done every five years. Its a partnership between the u. S. Department of agriculture and health and human services. We do play our role in that, as part of hhs, but all the federal dietary guidance derives from the dietary guidelines process that 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 standards of identity are being those decisions are being made, theyre being contained well, and theyre being made more kindly . Thank you, so i take that one . Yes, thank you for that question. My next question is gonna be mississippi and South Carolina trumps. So, its gonna get tougher to you, after this one for you. There are a large number of standards of identity. Some of them definitely need to be updated, and we have some petitions that weve been working on our way through, and we are very committed to updating, modernizing standards of identity. And we are appropriate, reaching new standards of identity. We have some requests to create new standards of identity, for example. But one of the challenges with regard to standards of identity is not designed to be an actual process. This process to update a standard of identity involves rulemaking and rulemaking also takes time. And with certain standards of identity, it involves formal rulemaking, which is in some ways and even more complicated process. So, its not a quick process. The other piece is as we work to update a standard of identity, its really critical that we have extensive stakeholder engagement, to understand the practices that theyre used by the folks who are making those standardized foods, so that the modernized standard of identity really reflects whats in there. So, we are very committed to what doing that. We are making progress on that. We appreciate your resources that we have received from you all. , yes this has been a very under resourced area, and asked a look at one of the most under resourced in the past, and that waited a backlog. Like, the 1980 81 that you mentioned. But with the new resources weve been able to hire 13 new people. We have five new recruits that we are working to get through the process. I will mention that the Foods Program does not have the cares hiring authority that is as agile as a medical products, so it takes us longer to get those new hires on board. So, we know weve had conversations with many of you about hiring authorities, that the medical products centers have, if the Foods Program had those same hiring authorities, your resources would translate into the bodies on board more quickly into the fix program. I appreciate that. Thats a good recommendation. And im glad you brought up the initial funding. I was gonna do it. You did. Good for you. And the flexibility that we should look into, i appreciate that recommendation. These, this is a challenging area. Im sure the chairman can tell. You know, for example, milk products, you know . One of the very important areas. So, 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 and the important work you do. And i am now going to dismiss this panel and invite the second panel to come forward. And i will be introducing them as that transition is taking place. So, you are excused, and thank you again for appearing one. I want to welcome our second panel. Mr. Brian ronholm is the director of food policy at Consumer Reports. Brian leads, Consumer Reports advocacy efforts with regards to food safety. He was previously a deputy undersecretary for food safety at usda. And he also served as an agricultural appropriations associate for representative rosa delauro. Miss sarah gallo is the Vice President of product policy at 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 experience and expertise, and we are looking forward to hearing from both of you today. So heads, if ive given you enough time to get settled, i will start with ms. 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 serve as Vice President of product policy for the Consumer Brands association. Consumer brands champions the industry was products americans depend on every day. Representing more than 2000 iconic brands, 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. Egulatorthe cpg industry dependa to perform its regulatory role effectively, efficiently, and transparently. As we look to the future of our industry, modernizing and we forming fda is top of mind for food, beverage, and personal Care Companies that we represent. And their experiences provide real world evidence of why a modernized fda is warranted. Consumer brands are calling on fda to unify their food program under a Deputy Commissioner for foods, with accountability with the commissioner, and direct Line Authority over sand, cbsn, and the food related components and operations of or a. The lack of a single fulltime, fully empowered Expert Leader and affects all aspects of the fdas program. An decisionmaking has slowed reviews, hindering progress and even rendering renovation obsolete. Inexperienced and under trained inspectors are being sent into their field. A split and 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 for credentials, to quickly implement modifications that will benefit consumers and our industry. It unified structure and a fulltime Senior Leader translates into results to be all care about, focused leadership, accountability, and effective dialogue with myriad stakeholders. And fda can make this change now. The creation of the Deputy Commissioner for foods does not require an act of congress, or rulemaking. In fact, the position existed under the obama administration. And it 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 2015. A Strategic Review and realignment around priorities could help fda and important 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 critical to define a series of high value, product related policies, that we frame ftas food operations. A decade ago, we would have thought about modernizing fda to move at the speed of this, business, but heres, later its essential that fta as we formed jim move at the speed of the consumer, meaning the rapidly changing preferences and demand. Ard to sharing our planwe are in the progress that articulating these policies with our Member Companies. And we look forward to sharing our plan with you in the coming months. Modernizing the agency also should be business critical for the agency. Reform stand position fda as a leader and subject Matter Expert and facilitating innovation, assisting industry to meet state mandates, and enabling data to drive decisionmaking. Consumer brands called 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 fda, and in the street, corrupt together to improve the regulatory environment. Ill note a few policies that regarding the pandemic, they continue to work in todays operating environment. For its, incorporating removed regulatory assessments and modernized inspection approaches 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, and subsequently sharing them with appropriate federal and state Government Agencies, and then posting to website, should be the new normal. And then, 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 are critical to the cpg industries ability to deliver essential to consumers, particularly when they were homebound. These flexibilities make supply chains more nimble, allowing us to better make, avoid shortages, while ensuring consumer safety. Working at the speed of the consumer requires a strong modernized fda. One that is structured, governed, and funded for success. That might not be the case today. But it also doesnt need to be at the fate of tomorrow, if fda chooses to make meaningful changes. We look forward to working with a committee to achieve this goal. And i 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 Ranking Member hoeven. I know i wasnt testimonies on the record, but just take a moment to take some, make some brief comments. And i know during his testimony today, doctor califf made a couple of mentions at the top of bottom reviews, that will be conducted as part of the process. And i would just point the critical points to these top to bottom reviews are, as sarah alluded to, independent and transparent. And yesterdays announcement about the Reagan 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. And we are also doing more about how the foundation will ensure the transparency of the process, and how they intend to engage with internal stakeholders within fda, particularly simpson, see pm, or a, those offices. And also, how they intend to engage with external stakeholders, consumer groups, industry, state and local regulators. I think having as much input as possible throughout this process will be critical to the process in conducting a true comprehensive top to bottom review. And i know a 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. And its those concerns that link to my testimony, which focuses on how the structure governance and performance of the food program, the impacts we call food policy decisions between inadequate responses to recalls, a failure to implement a culture of prevention, and a failure to move quickly on proposed rules and initiatives. There are a number of questions about whether the fda is performing regulatory role effectively. Its struggling in its role to protect consumers. And its preventing the Food Industry from operating effectively. The recent infant formula crisis was barely one symptom that exposed a greater organizational structure and culture problem. And its clear that the confidence in the food program is eroding. A big reason for the. Lower confidence that the food program has second class status with an fda. And its resulted in serious problems. The fda also lacks a single fulltime, fully empowered export leaders to provide strategic leadership and management accountability to a set of offices that are responsible for approximately 80 of the food supply. Its the 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 food program under a Deputy Commissioner for foods, and this is what sarah alluded to in her testimony. Autthis position would have accountability to the commissioner and direct Oversight Authority over cifsan, see the, and the food relief operations of ora. That will bring focused leadership and accountability to the food program at the agency. The current framework often results in an over lack of urgency, and making compliance decisions, including recalls, and in an aggressive lack of ambition on policy initiatives. Another area where we are seeing some questions, certainly appropriate to this subcommittee, how funding is allocated within different programs . Ora, which is responsible for inspections and compliance, we ceased approximately 70 of all fda food program funding. And despite the funding increases, that the fda is receiving, those fisma, we see inspections decline in the years following the enactment of fisma, and even before the pandemic shut down. So, while theres general agreement among the stakeholder groups for the need for increased funding, for the food program at the agency, it should come with more accountability, and more transparency. Unlike those other programs act fda, fda go regulates food safety with state and local programs. These programs have had funding cap these years, and they also significantly reduced fda funded state inspections, which can be conducted at lower costs. Meanwhile, ora is seeking to count state inspections conducted without federal funding towards its fisma mandate. The success of the food Program Overall requires a fulltime, and empowered Expert Leader who could lead cultural change and ensure accountability for resource management. We are fortunate to have a person with immense expertise and abilities like dr. 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 for improved governance are not mutually exclusive opportunities. Were not going to algorithm our way out of the sistine sustained problems in the food program. We also need structural and governance changes, stronger leadership, and a high priority that with 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. And i look forward to your question. Thank you for your testimony. I would like to start by asking miss gallo about how how your Member Companies interact with the fda. And how you believe those interactions can be improved . And 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 am also used to microphones being automatically on. I need to say, to start, of its absolutely critical that industry and fda have a predictable and functional working relationship. We want and need the regulatory the regulatory system to be successful, in order to provide a safe food supply. And certainly, our industries are making a more productive agency that serves consumers. And a key component of that is a food program that speaks with one voice. We appreciate when the agency reaches out proactively, but that really does need to be, become the new norm. And i think you had many of the fda officials, stakeholder engagement, and the important thing in stakeholder engagement, we can entirely agree with that we would like to see an agency that is less siloed, less fragmented. Industry needs that unified Foods Program to provide a strategic and proactive regulatory agenda. And, again, proving stakeholder engagement, in addition to rulemaking, there are other ways that the industry can meaningfully engage with fda, like industry roundtables, or even other discussions that i think could inform fdas actions in realtime. As it relates to the top to bottom down review, certainly, we welcome that announcement from fda yesterday, and are encouraged that theyre aligned in our thinking that there needs to be a holistic evaluation of whats going on there. And how modernization could occur. And like brian referenced, well be watching very closely the scope of that. There were aspects of the food program that were not specifically named, for cv and being one of them. As whats on the radar to look to that. Well be cpg watching that and looking forward to share our information when 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 accountability and transparency. How would you characterize the adequate amount of input and 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 mean, i think in terms of how this process plays out, its absolutely 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. So, that entails, obviously, or a, you have cfsan, cvm, as sara mentioned, and the office of food policy response, which is one frank yiannass shop. I think incorporating all these offices is part of this process. I think it enjoys transparency. Its interesting to pendants, and ensures that all aspects of this issue get considered and discussed. From the external standpoint, and 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, Industry Trade associations, state and local regulators, we all want fda to succeed. We all want a food program to succeed. And we all have a key seat at the table. So, to be able to incorporate those critical external stakeholders as part of that discussion, i think that really that will enhanced the recommendations that come out of it. Very good. Senator hoeven . Thank, you madam chair. At like to thank witnesses for being here. I know that you both included in your recommendations that the Deputy Commissioner for foods be restored in terms, and i guess what id like to get your thoughts on from both that the fda has requested them, so if you can kind of address that. Id 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 and i think examples that we were given around the inspection force are certainly. So we would support efforts to permit fda to do that, and i also mentioned some budget questions, and both bryant and i have referenced. That in order for us to feel more comfortable, going in and advocating, would you think that there needs to be more transparency around the way that fda has used the funds that you all have appropriated to the agency. I think that level of transparency will give us a lot of confidence, and looking at properties, and seeing how we want to move forward. But as far as fdas ability and helping them with the ability to get more qualified individuals out in the field, thats something we would support. Thank you. I dont think, we certainly support i know dr. Maine had mentioned and doctor califf as, well they have trouble in maintaining qualified qualified experts staff on board, so certain looking at giving them more flexibility to hear these experts. And especially, inspectors from the or a standpoint, i think certainly would be helpful. And i think to saras point, when you link that, i think it makes for a better system for sure. Okay, thank you very much. No more questions, madam chair. Okay, i can wrap up with an additional question. Both of you pointed to the need for the Deputy Commissioner. Id like to hear a bit more amplification and detail on how you believe a Deputy Commissioner for food would improve food safety overall, but also, improve accountability. So, start with miss gallo. Thank, you senator. Im glad you asked, because one thing that we havent said today, and it seems rather obvious, but i think its a good point, not having a single entity overseeing all of this makes it really hard to connect the dots of whats happening out of da. You know, this time, we are certainly, as was in our testimony, calling on fda to appoint that Deputy Commissioner, one because they have the authority to do so right now. So, thats not something that we have to wait on a very labourious process to do. And so, having the ability to do that and the modernization, or just that general transparency in better collaboration started, its something 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 within inspection force, and connecting those dots, i think, really helps the agency speak with one voice. It helps them externally present that unified agenda that makes businesses able to operate more efficiently and to better meet the needs of consumers. And i think it helps the consumer communication and consumer expectation. If consumers can see that there is the person overseeing all aspects of a food program, i think that inherently gives a lot of confidence in the ability to know its in the food supply, feel safe about the food supply. And also, that we can bring Innovative Products to markets, to meet the consumer demand. I would just add to that, a big piece to this in having an empowered deputy position, is it would bring that focused leadership and accountability that the food program desperately needs. As you all know, the fda commissioners throughout the past few decades have specialized, in medical professionals. Naturally, their focus isnt pharmaceutical products, medical products. Certainly, that has a big impact on Public Health, and the pandemic is a good example of that needed focus. But, inevitably, what ends up happening is theres an intense competition for the time of the commissioner, as it relates to food. What ends up happening, food gets pushed to the backburner a lot of the times, it gains a second class status. So when you have that kind of fragmented structure like you saw today, there are various people who report directly to the commissioner, mr. Yangs reporting directly to the commissioner, meaning, they all report directly to the commissioner, they have some say in the food program. When you have those fragmented voices, all having, they are not strategically aligned with an agenda, that is how you end up with this situation where it is fragmented, it impacts response, it impacts positive development as well. I want to thank both of you for being here today, and a good compliment to the first panel. I look forward to working with you in the future as we tackle these complex issues. For the benefit of subcommittee members, questions are due within one week, and for all of our witnesses, panel one and panel to we appreciate responses for the record and, for weeks. And for that, this meeting is adjourned. Do we have a vote monitor . [inaudible] [inaudible] cspan now is a free mobile app featuring your unfiltered view of what is happening in washington, live and on demand. Keep up with the days biggest events with live streams of floor proceedings, hearings from u. S. Congress, white house events, the courts, campaigns and more from the world of politics. All at your fingertips. And also stay current with the latest episode of washington journal and find scheduling information for cspans tv network and cspan radio, plus a variety of compelling audiences. Cspan is now available at the apple store and google play, download for free today. Cspan now, your front row seat to washington, anytime, anywhere. Cspan 3 unfiltered view of government, funded by these companies and more, including homework can be hard, but squatting in the diner for internet work is even harder. That is why we are providing lower income students access to affordable internet, so homework can just be homework. Cox,