system is archaic. we need to upgrade that, along with our judicial system. especially the supreme court. that's a different topic. what we really need to do is welcome these people and vet them, make sure everybody is honorable. they can be part of a tax structure, the school system. and they should recite their pledge of allegiance in english to be able to work with the united states. we shouldn't be changing our national tongue to spanish. i love spanish, but we are icans and we have english speaking and it should be requir hear from john, chantilly,i virginia, aticcollar. we are taking yostio on the ending of title 42, the vote today in the house on a board of security package good morning. >> good morning. i'm an immigrant who came such

a long time ago. the thing that bothers me is we, like some other countries, we follow the law of this country. we go to t embassy, we filed paperwork, we wait years and years and years. nobdy calls us until you become an american citizen and you challenge the system. the system was to work, they must control every country how much, how many people they can get asylum. >> we will break away at this point for a house hearing on infant formula supply chains and last year's nationwide shortage, fda food safety and nutrition director susan mayne here testifying before the house oversight subcommittee on health care. live coverage on c-span 3. >> first oversight hearing last year's infant formula crisis, and during that hearing we heard from former deputy commissioner in charge of the office of food policy and response, franky yiannis.

mr. diana's testimony highlighted many internal failures within the fda that led to the classic -- to carry out one of the most critical missions which is food safety. his testimony also raised questions of why key facts about the crisis were emitted when commissioner caliph and dr. susan mayne testified before the energy and commerce committee last february. in the so-called independent salman report. today's hearing will continue the long and overdue oversight of the food and drug administration's response to the infant baby formula crisis. we hope to get answers on why the fda has not been fully forthcoming with congress and really the public. today's hearing will examine why it took more than four months for inspectors to arrive at the facility plant in sturgis, michigan, after babies starting getting sick. we will determine why it took

so long for the biden administration to secure the baby formula supply, after a recall left its shelves bare. why was the fda prepared for the crisis? why did they only inspect three of 23 infant formula manufacturing facilities in 2020? three of 23. why did they fail to investigate whistleblower warnings? did the fda follow regulatory protocols? did the fda respond quickly enough? was the fda so-called independent review truly independent or was it a cover-up? today, i will get answers to these questions to better understand exactly what happened so it doesn't happen again. american families must be confident that the fda has the ability to prevent a crisis like this from ever happening again. in our previous hearings, we learned a lot about how the crisis happened and how it could've been handled better. from fda officials. here's what we know so far, to

lay it out. the fda ignored habits employees, 38-page disclosure detailing concerns at easter just plant. the policies and lax approach to oversight elected unprepared to address the supply chain shortages after the sturgis facility was actually shut down. the fda had failed to prioritize food safety. the fda has not taken the action needed to prevent a similar crisis from happening again. the american people paid the fda 6.7 billion dollars last year. 6.7. in next year's budget, the fda wants over 10% more, totaling 7.2 billion. i think the american people have a right to know that if you only took a look at three out of 23 and you were paid fully, now we are at a crisis, we don't really have answers to

the crisis, yet you want more money. listen, we all want everyone to be safe and we all want to make sure we are safe, but i think we all also want to make sure our money is going to do good work. so i think the american people deserve to know that if we are going to have these agencies and we are going to spend a lot of money on these agencies, these agencies need to make sure they are doing their job. as opposed to throwing money at the problem. after a field inspectors should have been doing their jobs but they weren't, and there were not serious consequences. i have yet to hear what the consequence for the fda's other than, give me more money. they didn't do their job, they sat at home, they still got their paychecks. they want more money, which may help, but what is going to change?

now it's time for the current fda leadership to really be held responsible in business there. , stockholders are held responsible, people get fired, and they lose money they lose profits,, there is a consequence to the actions. i have yet to hear who is responsible at the fda and what is the consequence for their failure. i think we deserve that, especially for over $6 million worth of money. here, we will discuss what failures within the fda led to the crisis. we will discuss ways if the fda can improve its internal controls to get ahead of potential disruptions and prevent future supply chains. we will discuss why the fda admitted key facts from the public. we owe it to parents, caregivers, and infants, to get to the bottom of what really happened to fix it. we can't fix a problem that we first can't admit exists. as i said the last, hearing the families of these babies that

died from contaminated formula deserve answers on how this tragedy was allowed to occur in the first place and what we can do to prevent it from happening again. thank you doctor, mayne, for being here today, congratulations on your upcoming -- miss porter for her opening statement. >> thank you very much, madam chairwoman. today, we are having the second part of our subcommittees hearing series on the 2022 infant formula shortage. so far, the chairwoman and i agree on something really important. and infant formula shortage could repeat itself. that's a deadly serious problem. let's think back to a year ago today. 43% of formula products were out of stock across the country. bacterial contamination abbott, which killed nine babies, made hundreds of others fall ill, prompted a recall that shocked our formula supply chain. that this repression of course

interrupted our economy, but more critically threatening the health, nutrition, and lives of our kids, and the american peoples confidence in government. today we are saying, on a bipartisan basis, and that it could happen again. we have a duty to do something meaningful about it. and this hearing is called responsibility for the infant formula shortage. as i said last time, there is a lot of blame to go around. it's clear that with today's witness election and that republicans want to blame the fda. i will level with you, i think some of that blame is well placed. we've had two subsequent input formula recalls in 2023 already, and we are still seeing that the fda can make further improvements on its internal processes, intervene and issue sooner, and follow through with more inspections to prevent further contamination. other lawmakers will blame manufacturers for their negligence and failure to produce of safe products. that is true, to.

still others will blame washington for allowing just three manufacturers to have monopolistic control over 90% of the formula market and for failing to invest the resources and authorities in the fda that it needs to produce the results we demand. i think those folks are correct, to. the thing about this issue though is it doesn't come down to the fault of one person or one agency, one company, or one political party. we can't fire or attack someone and expect formula contaminations and shortages to just go away. that's why today i propose we go beyond the title of this hearing, we need to move beyond just assigning responsibility and toward delivering solutions that can prevent a shortage from happening again. i want to thank the chairwoman for her work with me on that. we need to use these hearings to identify what are worthy proposals, worthy innovations, and we need to transform them into legislation. if we don't do that, we are failing to solve the future problems. we risk just blaming and

shaming rather than preventing and problem solving. if we work together though we can address the efficiencies and inefficiencies that risk the supply of safe and healthy infant formula. we have an fda expert before as you can help us with that. look, doctor mayne can handle what we will throw at her. we should ask hard questions. we should push her on areas where we think the fda can and should do better. we should also use in doctor mayne's knowledge to figure out what congress should be doing better. right now, the fda is reorganizing its human foods program to reduce fragmentation and approve coordination. but that's not going to solve all the fundamental issues. even with the best structure, leadership, and resources, and the fda is only as well equipped and as accountable as congress makes it to be. while we hold the fda and others responsible, what can congress be doing to help? first, we have to provide the fda with resources to increase its inspection and food safety

capacity. you can't expect an agency to do better when you are taking away the funding for the personnel and technology needed to make it happen. that's why i think the 22% cut to the fda that republicans have voted for would make this problem worse. let's not go down the path, that path. we expect the fda to do better. we need to set it up for success and then hold it accountable to deliver on a better outcome. whether we reach bipartisan consensus on proper funding or not, there are some no cost reforms we should be able to agree on. we need better processes for reporting and tracking contamination, whether that is making -- nationally notify will disease or making sure all contaminations and critical food factories are promptly and properly reported. if we use dr. mayne as a resource, we can find solutions we all agree on to save kids and stop shortages. let's come out of this hearing with next steps, not just complaints about missteps.

i yield back. >> thank, you miss porter. now i'm pleased to introduce our witness, who is here to discuss the fda's response to the 2022 infant formula, baby formula shortage. dr. susan mayne it is the director of the center for food safety and applied nutrition at the food and drug administration. she's been in this role since in january of 2015. a doctor mayne has received a b.a. in chemistry from the university of colorado. she's also earned a ph.d. in nutritional sciences with minors in biochemistry and toxicology from cornell university. pursuant to rule nine g, the witness will please stand and raise her right hand. do you solemnly swear or affirm that the testimony you are about to give is the truth, the whole truth, and nothing but the truth, so help you god? thank you. let the record show the witness answered in the affirmative. now we appreciate you being

here today. i really do look forward to your testimony. let me remind the witness that we've read her written statements. it will appear in full in the hearing record. please limit your oral statements to five minutes. as a reminder, please press the button and the microphone in front of you so that it is on and members can hear you. when you begin to speak, the light in front of you will turn green. after four minutes, that light will be yellow. when the red light comes, on your five minutes has expired. we would ask you please wrap up. for this, i.e. -- recognize your opening statement, miss mayne. >> chairwoman mcclain, chair comer, ranking more members chair and -- thank you for inviting me to testify on the safety and supply of infant formula in the united states. as a parent myself, i know nothing is more important than the health and safety of our children, and last year's infant formula recall in shortage put a strain on parents and caregivers across the u.s.. when we saw the egregious

conditions of abbots sturgis facility, we knew a recall could stress an already unstable marketplace. but we had to put our children safety first. fda takes in the situation extremely seriously and has applied many lessons learned resulting in greater confidence in infant formula safety. one of the most important lessons we learned is that the agency must do all it can to ensure that no infant formula facility ever has the level of in sanitary conditions and that were present at abbots sturgis in 2022. we have made progress and are using the full extent of our authorities to address the lessons learned. preventing another shortage in the future will require a continued hold of -- increased industry accountability and cooperation, and help from congress. today, i would like to talk about the future of infant formula safety and our vision for modern regulatory approach. first, the ultimate responsibility to produce safe

products is on infant formula manufacturers. we need industry to comply with our requirements and to adopt enhanced food safety measures to deliver the safest possible infant formula. two months ago, we issued a call to action to industry to take specific steps to improve food safety practices for the protection of infants. second, we worked diligently to increase the supply formula on the u.s. market. and the institute rate for formula is near 90%, which is higher than pre-recall levels and -- exceeds sales week after week. market consolidation is a serious concern and contributed significantly to shortages, there are currently only three domestic producers of infant formulas, which means -- international conflict, or natural disaster could impact formula supply. our temporary exercise of -- safe products to enter the u.s.

market, doubling the number of firms producing formula for the u.s.. almost all the manufacturers participating under the enforcement discretion policy are taking the necessary steps to stay in the u.s. market. federal agency partners also have an important role in helping to address market consolidation. we will continue to work with him to encourage a stronger, diversified, and more resilient u.s. infant formula market. third, fda and industry should be able to address product contamination in or near realtime. our inspections are currently a snapshot in time. more realtime oversight can transform infant formula regulation by ensuring first promptly investigate investigation and destroy adulterated product before it reaches consumers. to do this, we need modern authorities, including explicit authority to require industry to notify us when formula tests positive for corona bachter.

even if the product has not left the facility, and the ability to obtain records remotely from all food manufacturers. fourth, we continue to advance the science around corona backed, are a very common pathogen in the environment, but one about which we have limited information. corona bachter infections should be a -- local state and federal public health partners can reliably collect information on all cases and we can rock. we are intent on delivering an empowered unified human foods program and a world-class field force that will deliver modern, integrated oversight. as part of this will be creating an office of critical foods as required by the food and drug omnibus reform act. we are also actively hiring for specialized infant formula inspection staff that will execute a modern preventive approach to infant formula expect inspections.

in the early days of covid, in 2020, and well before the abbott recall in infant formula shortage, we recognized the critical need to better resource our infant formula program. we are grateful for the resources we have received but our human foods programs are still in dire need of additional investments and updates to meet current as well as future challenges. as we emerge from the public health emergency, the food industry still has fragile supply chains. preventing shortages will take continued cooperation among all the players and additional authorities and resources to modernize our programs. we look forward to working with you all to make this a reality. i welcome any questions you may have. >> thank, you doctor mayne. i now recognize mr. grothman. >> thank you. and dr. mayne, are you familiar with the fda's internal agency

review, led by dr. sullivan? >> yes i am. >> we were interviewed by dr. solomon in course of the review. >> i was interviewed by the same group of folks who were interviewing all the people who participated in the interviews, that information was consolidated and put together for dr. solomon. >> why don't you think you were interviewed? >> i'm sorry? >> why don't you think he interviewed you? >> he didn't interview any of the individuals. there were a large number of people who were interviewed and it was consistently done across all the interviewees. >> apart from dr. solomon, did anyone else in the f. d. a or hhs author the report? >> i'm sorry? >> and apart from dr. solomon, did anyone at fda or hhs author the report? >> no, not to my knowledge. >> okay. principal deputy commissioner janet woodcock's who owned the report. >> i believe she was one of the individuals who called for the report so we would look internally at our processes and see what changes could be made expeditiously in the spirit of

continuous improvement. >> okay. was she involved in the report? >> other than asking that the report be executed, not to my knowledge. >> okay. we received testimony before the subcommittee that implies that she was involved in it. i will give you another chance to answer. the doctor woodcock influence the solomon report in anyway? >> she asked that the report be conducted. people were interviewed. the data was compiled, produced in her report. she asked about the report be conducted along with commissioner caliph. >> okay. comptroller general jean stated in april, 2023, house oversight hearing, that the fda is not, quote, not doing enough to improve its food security and food safety. food safety has been on the most high-risk list since 2007. doctor mayne, do you think the fda is doing enough to ensure food safety? >> we can always do more to

ensure food safety. i'm going to come here today with solutions on things we can do to ensure better food safety in infant formula manufacturing. having said that, we work very closely with the u.s. department of agriculture, as we assure the food safety for the u.s.. >> did the reagan udall foundation for the fda conduct an operational evaluation of ftas human foods program? >> the reagan udall foundation did not conduct the evaluation but they convened a group of independent experts that conducted that evaluation. it was not done by the foundation, but by independent its books. >> if this were sport -- ftas food division and the culture of constant -- it describes their food division and a culture of constant but turmoil. do you agree with the reagan udall's foundation assessment? >> my -- the reporting of decision-making needed to be streamlined, which is something

i agree with. that organizational changes could make a more efficient and effective program, which i also agree with. that's what the primary recommendations coming out of the reagan udall foundation. >> okay. covid-19 was used as an excuse for fda not receiving a whistleblower complaint about the abbott plant. commissioner caliph testified before congress that the whistleblower report was not transmitted to key officials like yourself, because the covid-19 -- covid-19 mail room issue. do you believe the report was actually lost in the mail? >> i can't speak as to what happened to the report itself being lost in the mail. what i can speak to is the report was received at fda and was received by our field inspection force and they were worked on the report. they acknowledged that they received the report. they then went ahead and reviewed the report. there were some very serious allegations in the report.

they sought information from the office of criminal investigations. they did act upon it. it is correct that senior leadership was not made aware of that. it was not that fda didn't act upon it, that senior leadership was not aware of that. >> so everybody on it but they didn't tell the leadership? >> that's correct. it wasn't escalated, there was no process with an fda to escalate this particle whistleblower complaint. fda receives a large number of whistleblower complaints. it was a failure of escalation. i do wish i had been made aware of this particular wish a bear complaint and to reiterate the complaint was acted upon the leadership was not aware of that. >> but it surprise you? >> that the complaint itself? >> yeah. >> the complaint was very lengthy, very, it had a lot of agree just claims in there. statements, allegations in there. they were very troubling things in there. what surprised me was language about data falsification and

trying to hide information from federal regulators. given the nature of some of those allegations that is why the inspector engage the office of criminal investigations with regard to that whistleblower complaint. >> thank you. >> thank you mister >> -- ranking member porter. >> in our first infant formula hearing. i asked majorities witnesses simple question. and the -- the answer caused a little bit of bipartisan shock. i saw chairman mcclain's had shoot upward, i asked the same question again. i'll start by asking at one more time. this time, the you doctor mayne, let's say a major formula manufacture finds bacteria in its supply today. does the law will acquire to tally fda? the answer is no. >> so, we all heard that correctly. the law puts no one at the fda

in charge or a notice if a major formula manufacture finds bacteria in the supply. if we want to solve formula safety issues someone needs to be monitoring realtime bacterial contamination. doctor mayne, who can change the law to put someone in charge of this, is it up to the fda to change this rule, the manufacturers, or congress? >> we need congress is held to modify that we, we've sought that from congress. >> so, i think lawmakers can and must point some fingers at the fda. and a manufacturers, but we need to be able to point the finger back at ourselves. the truth is, we didn't do enough in last years omnibus. yes, we gave the fda's authority. one was requiring manufacturers to notify the fta of any interruption that would likely lead to a meaningful disruption in infant formula supply.

dr. me, i'm wondering if you spot the same problem i do, let's think like parents here, like moms. if there is deadly bacteria and formula, that your infant could be eight would you want the fda to know about it only when it might cause a supply shortage? or would you want the fda to know any time your infant could get contaminated formula? >> to be clear. what we really need in the production, in the manufacturing facility before it ever leaves that facility. that's what we're seeking. the industry windowless before i would ever leave the facility so we can make sure that the proper amount of formula is just right protected vents. >> so you do want to know if there was a bacterial contamination, weather will cause a supply chain shortage or not, the fda should know? >> correct, by knowing in realtime that's a good way to prevent a supply chain shortage. >> exactly. >> we keep kids safe, and we

protect supply chain. but we didn't do enough last year. this was a democratic-controlled congress last year, it's on us. i think to lead the way here. congress did not provide the authority for a full reporting process and so now we have more work to do. in the meantime, this has real world consequences. we've had two major infant formula recalls. so far in 2023 from reckoning gerber, what either of these have been reportable to the fda under the new provision of the law? >> that was no. sorry. >> now. so, i'm leading legislation that would establish a process for the fda to be notified when manufactures critical food products has positive for food borne pathogens. dr. maine, it's no secret that the fda has had some struggles in responding to instances a formula contamination. but the fda has identified this legal change as something that

it needs in order to do better. i'm ready to push congress to deliver for you, until ever expect you to deliver back to. as i'm ready to whip republicans and democrats to join together and, act i want to think through the oversight piece of this. can you tell us a little bit about how required reporting of contamination with better a clip the fda to address contamination issues before they impact, you mentioned biden-ing identifying the right amount of formula to be destroyed. are there other features with regard to cleaning, other protocols? >> yes, by knowing in realtime that there's been product contamination in a manufacturing facility, our experts, our food safety experts are compliance experts can work with the manufacturers to determine, to break it or scope the amount of product that needs to be destroyed. that essentially means any product that was produced, since the last sanitation break, and before the next sanitation break.

that's where we've seen issues with recent recalls. more companies had destroyed product that they identify to be contaminated. but we didn't determined that they destroyed a sufficient amount between those sanitation breaks. so, working in realtime with the industry to make sure that proper amounts of products are destroyed. it's critical to help support future supply chains and enhanced food safety. it also allows industry to do a root cause analysis, working with fda and our experts to identify why did it can get contaminated closer in time to win the actual contamination of that occurred. >> thank you very much. i know that members on this subcommittee kara lot about this issue. i know that subcommittee chairwoman mcclain does too. i'm excited about the potential to move this legislation forward on a bipartisan basis. i want to invite all of our colleagues on the subcommittee, and oversight committee to join me in this legislation. we need to give the fda the information it needs in realtime to be able to both

prevent supply shortages, but more importantly, keep everyone safe. together we can help solve this problem. i yield back. >> thank you miss porter, i now recognize myself. it is amazing to me, it saddens me a little bit that we actually need to legislate this. but if that's what it takes to keep people safe. it's just a shame that we need to legislate if there is a problem fixing. with that said, i think we also know that there's enough blame to go around. this isn't a one specific i have the lucky star here, and i'll fix everything. but i have you in front of me so i want to look at focus my questions around the fda. i'm concerned by the lack of inspections at the abbott facility, i'm not saying that

you're the only one to blame. but between the fall of 2019, and the fall of 2020. when there was not a lot of ex buck shunts going on. the fda's may 2021 resiliency roadmap claim that the agency prioritized and i quote, mission critical inspections during the pandemic and according to the fda the criteria for mission critical inspections is a product is used to treat a serious disease or medical condition and there's no substitute. is that partially correct? >> that's my understanding. >> a product with no substitute, to me that sounds like baby formula. other than mothers breast milk. but some others can't breastfeed for whatever reason. inspections are also mission critical when there isn't evidence of serious adverse

advance or outbreaks of a foodborne illness. and again, that sounds to me like they have a plan. >> at the time in 2020 there was no evidence about breaks or illnesses. at a time when the routine surveillance inspections were not in progress. >> so, can you repeat that one more time? there was no evidence in 21? >> this was in 2020. when you are talking about the mist expected in 2020. there was an inspection in 2020. line >> in the fall of 2021? four months after i believe. >> the first complaint came in to 2021 which is when we actually were doing the inspection. so, they were in the same time, at the same time. >> i think from what i show, it was four months, it was discovered in february? but there were no inspections done. in fact despite, that's 20 of the 23 infant formula

production planning and distribution plans in the u.s. were not inspected for nearly two years. so, if you go back to critical, and i think we need to change what is critical. why is infant formula not considered mission critical to the fda? >> so, first of all i don't oversee the inspection all branch of the agency. there is a roadmap that came out of the inspection will branch, i can share with you what i know. but there may be things i need to take back. essentially, the inspections and march 2020, the routine surveillance inspections were not executed during the early phases of covid. they were reinstitute in july of 2020. >> let me stop you right there. this is part of the concern. we have inspectors not doing inspections because of covid. >> that's correct. during that brief interval -- >> where they getting paid during that period of time? i >> want to be clear, that was routine -- were conducted throughout the

pandemic. >> i appreciate that. can you answer my question, where they pay? >> yes, the inspectors continue to be paid. they were doing mission critical inspections. >> the baby baby formula is not mission critical? >> baby formula manufacturer inspected in 2020. my records indicate that there were 500 formula and spectrums during 2020. our congressional and -- the food safety monitor act. worthless to inspect them once every three years. our practice has been to inspect them annually. >> when you didn't inspect the manually. i'm gonna ask my question again, is baby formula critical? deemed mission critical? >> -- office of regulatory affairs. i do not know all the criteria that determined mission criticality for inspection. >> okay. >> i wanna make sure i have everything because i understand that it took until january 31st of 2022. for the fda to inspect the

abbott facility. then sturgis, is that not correct? >> no we inspected in september of 2021. at that inspection we noted several violations for which abbott russia, on the issue to 43, noting the violations. they came back to us with a 28-page report saying that they would investigate and correct those actions committing to make the changes when we went back in january of 2022, they had not made those corrections. in fact, rather than correcting the deficiencies we identified in september of 2021. the situation deteriorated. which is what led us to deciduous even leading to the recall. >> with that, i'm out of time. and all be respectful. so, the chair now recognizes, one moment, miss bland from vermont. >> thank you madam chair. i'm focused on the future, like my colleagues here and preventing this from ever happening again, our colleagues

across the aisle have promised to collaborate with us to prevent assume are -- florida jen i appreciate that. however at the height of the formula shortage. the crisis 192 house republicans voted against investing $28 million in funding, to help the fta conduct oversight and hold companies accountable. and in may 2022, the republicans chose not to join democrats on this committee and our investigation into abbott's role in the infant formula shortage. now at the house republicans default on america act, they are proposing massive cuts to non-defense discretionary spending. to a lays person that means all that other stuff that takes care of americans. dr. mayne, how about the kind of approximately 22% affect the fda's ability to employ

inspectors, conduct inspections of formula manufacturing facilities? >> probably, across the fda can say would be devastating. that would translate to about a 790 million dollar cut in our budget authority. and, broadly across the agency that means that that could result in a loss of 32% of our domestic inspections, and 22% of our foreign inspections. including countries like india and china. in terms of the foods program like i am, our budget is largely based upon budget authority. 97% of our budget's budget authority. we have very few user fees in the human foods authority. what that means is that couplet impact the human foods program. it would also impact our ability to support innovation, food industry needs a strong regulator as they're embarking on innovation. so it would dry, it would damage us, it would damage constantly we are hearing from injuries they want strong regulator is for predictability,

for timeliness and we do have a pre market approval program as well. all of those would be adversely impacted and we will be unable to do what i think americans consumers expect us to do. given that the eat food every single day. >> dr. mayne, to be clear, you said 790 million. is that correct? >> that is correct. >> thank, you and january 2023 fda commissioner caliph, began implementing recommendations of internal and external reviews by announcing the restructuring of the human food program. and by unifying several offices under a single new deputy commissioner. so, i'm wondering how would the budget cuts affect fda's ability to implement those recommendations from its internal and external views, to make sure that we have that oversight over infant formula. which is what we all want. >> it would be devastating. >> -- we wouldn't have the people, all the necessary oversight,

i've kind of that magnitude and human foods program we would be back to the same number of ftes that we've had in our lowest points in the last 40 years. just as a point of reference, but -- in 1978 we had 1000 ftas. right now we're at 1100. if we took a 22% cut, given most of our budget is in payroll we'd be below the number of employees that we had in 1978. and of course, our mandate has expanded dramatically since 1978. >> sure. dr. mayne, let's talk about the bottom line. who in fact will get hurt if ftas human food program does not get the resources that it needs? let's make it clear for people. >> i think the american consumers would be impacted adversely by that, all of our surveillance, the sampling, all the things we do, the interception through the

international mail facilities. they all require resources and people. and that would be adversely impacted. but i also think it would adversely impact industry. >> tell me about? that >> every time industry wants to put new, to new innovation whether it be self cultured mate. whether be genetically engineered crops to support drought resistance, climate change challenges into the future. our reviewer is work to help bring these products to market. safely and successfully. if there are concerns about food safety, these products will never be successful in the market. so, it's imperative that we are there to do that. with regard to our infant formula programs you know we run a notification program where we review new formulas before they come into the u.s. market. we've been doing that with nine infant formula reviewers. we saw an increase in complexity coming in, applications that in the past would've been 30 pages long, they're now 1000 pages long.

how would we have the capability to review those products appropriately before they come into the market, as a source of nutrition for infants. >> thank you, dr. mayne, i'll. back >> the chair now recognizes miss lee for five minutes. >> thank you madam chair. the infant formula shortage has been horrible for all parents. but it's been even more devastating for low income families, who don't have the luxury of switching to more expensive brands, or easy access to multiple stores to search for formula. because they lived in food deserts. my district was hit hard, with pittsburgh among the top ten areas with the work shortage as. i can't imagine the stress and uncertainty that those fabulous families felt as they did everything they could to find food for their babies. we need to learn from the shortage and do better. the answers of course not the 22% across the board cuts, as

passed by republicans last month. a cut that would meet 1.7 million women, infants, and children would lose nutritionists. -- in march of this year, the fda issued an immediate national strategy territories increasing the resilience and the infant formula supply chain. we dr. mayne, how do the long term and short on plans and sure that both low income and rural families get the formula supply they need in the future? >> i think for the immediate future. we have been building a supply chain. as you heard me say, the in stock rates are now at 90%. which is better than they were before the recall. formula manufacturers are producing more than is being purchased, the after week, after week. the supply is building up, it's been building up steadily, and that's really important. there are still challenges for distribution right now, and what we keep hearing is that it's not equitable across the country, that rural areas have

harder challenges getting the formula there need. and especially people who are served by private or independent grocers. what we're doing is working with the national grocers association, use what data they can give us to give to the infant formula manufactures and say, this is where the distribution is most challenging. we don't control that distribution, but we could certainly help provide information to make sure that areas, food deserts, rural areas, areas that are more challenged to getting access to products can access that. for the future, obviously, there are things looking as you mentioned the usda program, i know many members of congress are looking at that program. to see how can that help support resilience. as you know many of our lowest income women, it's a critical source. the program to provide formula for those in fence. gaining greater resilience through wick is another critical aspect. i know congress is interested in that, it's another thing we can do. >> that was meanest question. i will move to another --

evaluation suggests that reorganization of a human foods program, how will that improve how fda operates in overseas infant formula safety in production? >> infant formula safety is one part of that. but -- he's looking at the food program. and it's really taking a deep dive in how we can do things more effectively. we've heard from so many of our employees, would make our jobs easier, where are their inefficiencies and how do we redesign a modern program to be more effective and efficient for the future. with regard to infant formula, it's a special case that were really very, very laser focused on how to do that better. for example, we made a commitment to have an inspector that's really dedicated to infant formula. and increasing the number. these are inspectors that would only be doing, or dedicated to infant formula manufacturing. the training, working through our scientific experts, we're

committed to doing so much more. working with industry, making sure they understand all of our. standards how to produce infant formula in a safe way. there are a number of actions that we've identified in the national strategy. on the steps that we can take to get to a better place in the future. i think that's a good roadmap for the future. >> i understand that your agencies considering asking congress to give it the authority to require companies to submit net positive results for contamination, as we were discussing -- how it granting that authority prevent a shortage in the future? >> i think it's an important authority. it means that we could be working with a manufacture in realtime. to make sure that no contaminated product enters the market. and as i noted earlier, to make sure that industry is trying to get to the root causes. we need to prevent contamination in the manufacturing facilities in the first place. and doing that in realtime, is easier than waiting until many months later when we may be coming aware of positive

products contamination. in addition to seeking that authority, we're also asking industry to do more environmental monitoring. that means sampling your food facilities, finding that bacteria and eradicating it, getting it out of facility in the first place. and retaining the isolates, we rely on -- as a major scientific advancement in food safety. we need to get the bacteria isolates in order to utilize the technology for better food safety. >> thank, you that's my. time i yield back. >> thank you, the chair now recognizes mr. grossman. >> thank you. in previous congressional testimony before the energy and commerce committee. in may of 22, commissioner caliph provided a document entitled, timeline of infant formula related activity. which is here, i'd like to ask you to end this consent to enter this diagnosis to the record. >> thank you.

as this timeline completing quarter to the agencies activity up to that point? >> the timeline did not entail every single activity we did. because we were working around the clock day in and day out. but it's a synopsis of the major activities that the agency conducted during the months leading up to and following the february 17th -- >> okay. in a document recently provided by hhs to the committee, there appears to be more than two extra pages of information that have been added to this original timeline. most of the additional information predates the may 2022 hearing. why was this information omitted in the previous congressional -- ? >> i don't know what the timing of those new informational events are. i haven't seen that document. so, i would assume it's more updated document. i haven't seen the document so i cannot comment. >> okay, one pennies -- for the fda actually received a

complaint about the conditions of the rapid facility in sturgis, in february 2021. that they didn't take it seriously. why do you feel it's important to not sure the american people at that time? >> we were not aware that that complaint had been sent into the fda. it was forwarded from oh shot into a mailbox of the fda. i don't have firsthand knowledge of that particular mailbox. but my understanding is that it wasn't processed and addressed promptly, and in fact i was not aware of that complaint at all and we testified in may of 2022. >> somebody should've told. it's been brought to our attention that the fda had the opportunity to highlight the vulnerability of infant formula, and the u.s. the report on american supply changed in august. 2021. why did your office ultimately oppose the inclusion of infant formula in that report? >> i have no information about that. i'm not sure what report that was. but what i can say was that we

work, fda, with usda on a supply chain task force. and we've been working with usda throughout the pandemic on supply chain, including consideration of various commodities that were at risk in usda, fda were both aware but infant formula was potentially commodity at risk. that's one of the reasons why i came to the appropriators in 2021 seeking additional resources for infant formula. and we are grateful to receive those in 2022. >> the remaining, fact the fda's withholding from congress or the american people? >> i'm not aware that we withheld anything from the american people. we did not know about the whistleblower complaint, that was not covered up, we had no information about that complaint. >> okay, one final thing today we're talking with the vulnerability of the infant formula supply chain. during the covid-19 pandemic, fda funded a 20 1:40 initiative to assess pandemic supply chain vulnerability. why was this program or other

supply chain analytics not utilized to evaluate in stock rates of infant formula at the national level until was too late? >> part of our food cosmetic act authority, food safety and nutrition. we do not have authorities, resources to do supply chain monitoring. we did what we covered with the information that we had. we purchased through our budgets, without resources received, publicly available data such as the eye are eye data, to understand what was happening with supply chains. and that's an initiative that we took on out of concern of what could happen with infants arm -- >> it's been reported that staff requests were made in 2021 for funding from covid-19 supplemental funds. to further develop 21 for -- a data analytical to monitor the food supply chain. however, that acting mission or

janet woodcock cut the supply chain monitoring, opting to find similar requests for increase monitoring of drug supply james. i was the food supply monitoring or a classic art yet but one for the drug supply chain monitoring approved? >> i cannot confirm anything about that i have no information on that. i didn't participate in any of that. >> okay, thank you. >> thank you mister grothman, we now recognize miss porter. >> to understand how the infant formula shortage happened. i want to take a look at more detail at abbott sturgis production facilities. let's look to 2021, 2022 when dr. mayne, you lead -- according to the fda's timeline of the infant formula shortage. fda conducted an initial inspection of the abbott

manufacturing facility in sturgis in september 2021. is that correct? >> that's correct. >> and that inspection revealed multiple unsanitary, improperly maintain working conditions, correct? >> that's correct. >> the fda bannon's shared a further inspection of the sturgess michigan plant from january to march 2022, correct? >> yes. >> dr. mayne, with those additional inspections in 2022, early 2020 to reveal. ? >>, so we noted many deficiencies and the plan. sanitation -- and september 21. those were delivered to the company through a 43 and in regulatory meetings with their leadership. they committed to lead drives our concerns and writing back to us. the run investigation and commitment to making those controls. when we got there in january 2022, those things had not happen. in, fact the plans conditions

had deteriorated that led us to do our own environmental monitoring -- abbott also did environmental monitoring the path, given the conditions we saw. that's when we identified five different strains of cronobacter in the manufacturing facilities. so, all that information, along with the whistleblower complaint, and the consumer complaints that we'd received. led to the voluntary recalling in february of 2020 to. >> i would also, when i'm chairman give you permission to enter into the record the march 2022 fda inspection report. and -- infant formula in activities from u.s. dea. this march 22 inspection report which detailed the fda's observation of these multiple unsanitary conditions that you described. it says that the fda inspection team observed had habit, clothes, did not establish a system of process controls. designed to ensure that infant formula does not become

adulterated, unquote. the team also found that abbott, who did not ensure that all surfaces that contacted intern formula were maintained. to protect infant formula from being contaminated by any source. and. quote the inspector found employees work directly with formula, a failing to where the necessary protective apparel, and of its own self investigation failed to conclude whether its operations were a health hazard. it's unacceptable, i think you agree based on how you described when you start in september 21, what you saw in early 2022. it's unacceptable for a company that manufactures won more than 40% of the infant formula sold in the united states, it's a major recipient of government dollars, you get the program, to keep its facilities -- it puts babies at risk. and as a result of all, this failure to follow the rule, failure to respond to regulators despite promises to

do that you wind up with a recall in february 2022. dr., mean what lessons learned from abbott's failure to keep its planned inappropriate condition, amendments -- but failure to follow through on those commitments to do better by 2022. what can we learn from that, from this experience to make sure that the next time the fda tells a formula manufacturer, clean up your plant, that they don't arrive six months later and find things have actually gotten worse. >> yes, we agree. the conditions were egregious. and in fact, that was why we took the exaggerated step of putting into place a consent decree. where the presumption of manufacturing would be overseen by an independent expert. we've been working with our investigators and our subject, our experts to make sure they can resume safe production. it's an unusual step we talk.

-- but we've worked on, is really trying to recalibrate the manufacturers broadly. that's the call to action be released in march of this year. we identified many deficiencies in the abbott inspection. we need -- infant formula manufacturers as well. , so the call to action is for all informing on manufacturers to do better. we've been endgame in gauging with them regularly, with the prevention strategies, our food safety experts are working directly with their food safety experts, to explain what we expect for safe formula production. we're on a path to be a better food safety situation, and not running into the situation we found ourselves in. in the abbott plant situation in january 2022. >> thank, you i yield back. >> thank you miss porter, we now recognize mr. langworthy for five minutes. >> thank you madam chair. it seems like the more information that we get, the more questions that are created.

it really seems that there is a pattern of delay, delay, delay here. the chairwoman of re-asked why took so long for the fda to inspect the sturgis plant. why was there a three month delay between the abbott recall, and the closure of february to 17, and the decision to waive fda strict formula labeling in the importation requirements in may 2022, despite the national shortage of? >> if i heard her, there are many questions embedded in there. let's take it one of the time. you mention labeling, we put in place, and enforcement of suppression policy to allow safe nutritious formula to come into this country and to help make sure the parents could find product on store shelves. during this period of this national shortage. we did have certain or why are men's and there are primarily for things like safety, for example a baby that has a cow's milk allergy, needs to know if formulas based on cows milk, or

sway. so, there are certainly real issues that are critically important for safety, like allergen information. also have a fair formula, some formulas need to be diluted to different amounts than others. over diluting risks having infants not get enough nutrition. under diluting means the product won't flow through a bottle, and babies won't get the necessary nutrition. >> i understand why we have labeling, but why is there a delay from federal -- to three months later when that labeling took place? why was there such a delay? >> the formula lowry call started on february 17th. we then went through a series of steps to try and address the shortages regarding infant formula given the market concentration in this country, it's not an easy step. there were a number of things we. dead for example, we received product from across our borders, from domestic manufacture that have plants in other countries. we expedited the country of those coming into the country. we worked with the. infant formula manufacturers

that were not at the abbott plant, not the start as planned. to increase their production -- we did a number of different stops. to get that into place. we wanted to bring unsafe products from abroad, we had to put out a guidance document, and tell others, tell us if you want to bring product to this country. this is what we need to see from you. we need to know you need to know that those products meet our criteria, we need to make sure they've been tested for safety, the same way expected domestic products to be tested. we've got applications, we started bringing those products into this country. in, totally issued i think it was, 36 different, 20 letters, 36 different products including specialty and medical products. they were allowed to come into this product country under enforced -- discretion. and now we have doubled the number of infant formula manufactures bringing product into this country. that's through ftas actions. , so we jump to, actually is what levers we had to try and address the formula shortage.

but there are some -- the market concentration. as you, heard we've taken steps to try and address this. more things are needed to prevent this into the future. and we're very willing to work with congress, in all government response to make sure that we don't have this problem again in the future. >> a week before the formula recall on february 10th, fda leadership activated a coordinated outbreak response and evaluation network, core. to your, knowledge with senior white house officials notified at that point? >> i know that white house officials were notified on february 16th. i don't know if they were notified on february 10th. i'm aware that we did send a communication to the supply chain task force. including, which would include the white house on february 16th. the day before the recall. and to be clear,. the science was evolving -- on february 10th, we didn't have the information in place.

that we had, that information wasn't available -- we were doing inspections, collecting samples and the information about cronobacter and the sequences came in on february 13th. so, at that point we had more information that this plant was contaminated on february 13th. that led to the task of abbott, to voluntary recall, we notified the white house and others on february 16th, prior to the recall occurring. >> if the white house was aware, why did it take three months for them to step in, and help address the shortage of baby formula? >> i can't speak to what the white house, what their actions were. but when i can't speak to is that we were working in an all government way, throughout this process including with regard to the enforcement discretion products. we worked very closely with health and human source -- operation fly formula. to bring those products to the u.s. market as quickly as possible. and to help rectify the shortage that parents, in this

country where fear experiencing. >> and lastly, yes or no. did you talk to the white house about the possibility of a formula shortage, if so when? >> i'm aware that we talk to them through a written memo on february 16. whether there were previous conversations with the white house, i cannot say. but i can't say that that information was shared to the white house before the recall occurred. >> thank you, i yield back. >> thank, you the chair now recognizes the miss balint, for five. minutes >> thank you madam chair, in september 22 fda issued an internal evaluation of the agency's response to the infant formula shortage. doctor's even solomon, the director at the center for veterinary medicine, drafted the report. following the subcommittees march 2023 hearing, a few weeks ago, on the infant formula shortage of some my republican colleagues made some claims about how fda conducted its internal review of the infant

formula response. dr. mayne, to your knowledge why didn't fda tap you, mr. yang, as our miss woodcock to write the review, and instead selected dr. solomon? >> dr. solomon was not involved in any way. in the infant formula response. mr. yang, as myself and dr. woodcock or the acting commissioner leading up to february 17. so, all of us were involved in the response and having us evaluate ourselves is a logical. >> got it. you needed somebody impartial, you can't have the fox watching the henhouse it is fake? >> we asked for someone who knew the fda well, through the process and procedure of the fda well. , so that someone would not have to translate all of the acronyms, everything that we've discussed the processes, but he was not involved in the infant formula response in any way.

and one other, thing this was an internal response, we were very committed to improving our process, and our procedure as expeditiously as we could. there were a large number of recommendations that came out of a report we've been, working hard every day, every week to move further, some of those recommendations, we've made great progress. in addressing many of the recommendations. at the same, time there was an external review of our program that was convened by the reagan -- reagan-udall foundation. -- will benefit from an internal review as well as to external reviews. we're always committed to continuous improvement to do better. >> just a follow-up on that, can you explain really quickly how the fda improve its consumer complaint and whistleblower complaint process? >> the processes have been changed. for example, with regard to consumer complaints, we get a lot of consumer plates at the

agency, thousands of complaints. certain criteria, for example, if a consumer complaint comes in, and involves an infant, if it involves the death, hospitalization, anything like that. that's immediately escalated to the leadership. so, i now see those. there's an elevation process based upon criteria, vulnerable populations, hospitalizations, things like that. those processes have been put in place. and the processes are importing given the volume of work that we have. and the foods program, we address something like over 9000 adverse event consumer complaints every year. we have a call center that response to 25,000 calls every single year, we need strong processes, and technology to manage that volume of workload as optimally as we can. >> i appreciate that, the internal review as i understand also revealed that scientific gaps in understanding of the

contamination spread an illness of cronobacter, also hindered fda's response. , what steps has fda taken to remedy some of the knowledge gaps and to improve cronobacter sampling and testing procedures, so we can prevent this from happening again? >> we were in an information deficit here. because cronobacter it's not a notify all disease. when we saw for consumer complaints, or physician complaints about cronobacter, we don't know if that was unusual or not. because we don't know what the denominator is. having a national notify-able disease, completely change the way that we could approach this particular situation. not much was not about the path again. one of the things we can be in the national advisory committee -- microbiological -- affable series of questions about cronobacter, we've given them a chart. they're working on that right now. on the vice chair of that committee. the committee's meeting, next week, to give us some progress on what they've learned about

cronobacter, that's critically important. the work on national notify ability is critically important as it'll work to understand this bacteria. what do we know about its prevalence, where is it located, what are the sources of contamination. our lack of information on whole genome sequencing sequencing for the genome has -- the tools that we had like listeria, salmonella, nicola. we want to advance the science here and make great progress in the months since this is occurred. >> i appreciate that, it's clear that the fda needs adequate resources to prevent this from happening again. i just want to say as a mom, and had to supplement my breastfeeding in order for my son to thrive. i know i'm part of this issue is for parents, all over the country. and this committee i know is really focused on making sure that this doesn't happen. again thank, you dr. mayne. >> we never want to have that

happen again. >> thank, you i now recognize myself. i've still confused and i need you to help me connect the dots. i had taken a toll january 31st, for the fda to inspect the abbott facility in sturgis, michigan? not only did reports of cronobacter infection start in september of 21. but we now know that -- transmitted a workplace complained to fda in february 21, outlining the unsanitary conditions. i need some help filling the gaps. the fda's 2021 that's a geisha operation manual states, all complaints involving infant formula or baby food or to be thoroughly investigated. on a high priority bases. i think four months is a big delay. can you help me fill in the timeline there? >> yeah, typically our goal is to inspect annually.

for infant formula manufacturers. our normal high risk flu facilities are inspected once every three years. and nine high risks are inspected once every five -- that congress gave us. but infant formula is a high priority, and that's why our goal is annually. but with regard to the sturgis facility, we were in there in september, we found efficiencies, the industry committed to address those. we typically give time to industry to address those. they didn't. -- >> in september, when you went in there at the original september of 20 -- that was a normal, regular scheduled visit? >> correct. >> then after that is when we unfortunately, some babies passed away, and there were more complaints between that september and january. why the four-month lag,? >> at a high-level, i'm happy to address the timing. first of, all again, i'm not head of the inspectorate, but i

can tell you what i understand. what the dates are, and what i know. we received that four -- investigations where they're at that was followed up on. we always try to interview the parents, obtain product, find medical -- >> but you didn't know about cronobacter at the 21st, in your normal -- you've got reports after that? >> correct. >> and that's -- >> the information, the case report came in but we would not have necessarily pulled the product, test of the products, seen what the evidence pattern lies. bad information uncommon into october. just to be clear. >> i'll give you october. we didn't do anything until january? >> correct. that's the first. up and then october, a whistleblower complaint came in. as i indicated the staff received, it they acknowledged it, they reviewed it. >> it just didn't get to? you >> that's correct. but the staff are working on.

then the attempted to interview the whistleblower, and i think you know the whistleblower based upon a timing -- >> but since october, they didn't do anything from january? >> and they tried to schedule the inspection in december. the inspection was attempted to be scheduled. abbott declined to have the inspection done. they had a covid outbreak in their facility. and then we finally got in the. looking at, that we agree with you, those timelines are less than ideal. and that's why we put in place a whole series of processes based upon the lessons learned from this. once we got in there, we saw the conditions, all of our timelines were met very expeditiously, but i agree with you in the months leading up to that time, that those timelines could've been more ideal. >> thank you. in my few minutes i'm still troubled by during covid, i think baby food is essential, especially in this day in age,

and especially for underserved communities. i show that 2023, the infant formula production packing and distribution plants, in the u.s. were not inspected for nearly two years. why are we blaming that on covid? >> those numbers don't agree with what i have. >> because those numbers from the fda. >> i think we should take that question. back again, that would come from the data from our office of regulatory affairs. >> what do you have as your numbers, where they all inspected in a timely fashion? >> again, some of it maybe calendar years, versus fiscal years. we should take the numbers and get back. but my understanding as we did inspect, even in the early part of covid, five different in -- that >> but there's 23? so i need to give you on the five? >> at that point in time we had 21. that's why -- >> so, let's even say with five of 21. can we least agree that's kind of a problem? >> sorry, then here the last

thing is? that >> can we agree even if it's five of 21, and your numbers are correct. five of 21? what was everyone doing? >> -- i know was covid, but. >> they were inspecting the prioritize inspections. >> and baby formula is not a priority? is that something we need to? change >> certain, it manufacturers were. it was based upon their expectation history. whether there had been complaints associated with product, if a formula manufacturer had a long history of no complaints, they might not be prioritized in that period of time in 2020. >> did abbott have complaints? >> did abbott have complaints. we asked abbott, we go into the facility, is a fact every time -- >> did they have complaints? >> you should ask abbott that question. >> i'm asking you, what do you know of any complaints from abbott, you're the fda, you're the inspection, you're the regulatory agency. >> we get consumer complaints -- >> do they have any? >> we report them to lab. we tao abbott, if we get a

consumer complaint. >> did you get any? >> yes, those are the ones that we talked about. when we're in the plant, we ascap if they've had any similar complaints. >> but you haven't done an inspection with abbott, who had had complaints for the prior two years? my time is up. i will yield back. >> i think we're down, questions. >> we'll go to your closing statement here. i will now recognize miss lee for closing statements. >> thank you madam chairwoman. for holding this hearing on such an important issue, thank you dr. mayne, for your testimony. half of our subcommittee hearings have been on this topic so far. and we've identified some necessary areas for improvement. but now we need to put this information into action. first, we need to pass

bipartisan legislation to create a process that makes fda aware of bacterial contaminations in realtime. then the fda will have no excuse, but to take action on the contamination immediately. second, we need to continue working with the fda, and listen to them. the fda should not be hampered by congressional inaction. we need to keep these lines of communication open to ensure the fda can do its job. third, we need to collect better data on cronobacter, so we can better stop it spread. i appreciate the specs fda is taken so far to increase our understanding of what cronobacter, this public health of jews will be solved just one agency. our one approach. finally, we have to put our money where our mouth as. if we want to stronger system we need to fully fund the fda to protect infants who use formula. now is not the time for fda to, four cuts to the fda, wall

expecting them to monetize and streamline the system. that's definitely not going to happen. with the 22% across the board cuts. a cut that would also mean 1.7 million, women and children will lose nutrition, assistance through wick. look, i believe that the chairwoman and i, we all have the same goals here, avoiding an infant formula shortage. there are things that should be easy for members of both of our parties to agree to do now. and there are some things that will acquire longer conversation. but if we can find a path for that saves kids, kids lives and stop shortages, then it will all be worth. it thank you and i yield back >> today, we've heard some excuses from the fda's inability to do with. jobs excuses for the fda unwillingness to prioritize. -- to address the infant baby for

a shot of the fta prioritizes is critical, there is no excuses for these failures. i do recognize the failures are not just one sided, what i'm talking to the fda right now. and we need we have to first admit we have a problem before we can fix that there is no excuse. the fda has an important job, one that american people pay them to, do and importantly trust them to do. if the fda isn't gonna do their job, we have some serious decisions to do. the fda is responsible for keeping americans food safe. we need to make sure we give that food safety enough responsibility, enough attention, especially when it comes to baby formula. last year the trust was broken, and families lost children as a result. those lives cannot be replaced. and we owe it to those families to demand answers. i think that's what we're doing. the crisis expose significant sailors within the fda's

regulatory, and oversight. process some which are in the process of fixing, others we need to fix. frankly, i'm still concerned that this is happened again. can congress do better, yeah, as ken abbott do better, or. yes can the fda do better, yes. working together we can all get to a better spot. the fda has promised to can do about our, time will tell, i hope it well. only closely following the fda 's effort to revamp its human food program, i think that's critical. as dr. we mayne retires at the end -- food safety program. these vacancies are concerning, but ultimately there needs to be a culture change at the fda. the fda needs to reconsider what they deem critical, what the american people deem as critical. i think some of those changes will help bridge the gaps in the timeline. i am, and will continue to be in communication with the fda to monitor the process of

hiring a new deputy commissioner of human food. and oversight will continue. in closing, i want to thank our panels, once again for your important testimony today. i appreciate it. i really hope that you enjoy your retirement, it's well deserved and without objections, the members will have five legislative days to submit materials and to submit additional written questions for the witnesses which will be forwarded to the witnesses for the response. if there's no further business without objection. the subcommittee sounds adjourned. thank you so much.

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