This is what democracy it look spirit cspan powered by cable. Its now a top official from the food and Drug Administration or text if with baby formula shortage. Susan main director of the fda center for food safety and applied Nutrition Program also fielded questions on reporting bacteria in the production process and rural distribution formula. On the House Oversight subcommittee this is about an hour and 20 minutes. But the subcommand healthcare and Financial Services will come to order. Welcome everyone. Without objection the chair may declare recess at any time. I recognize myself for the purposes of making opening statement. Thank you again for being here, i appreciate her at six weeks ago the subcommittee held its first Oversight Committee on last years infant formula crisis. During that hearing we heard from former Deputy Commissioner in charge of food, policy and response. Testimony highlighted many internal failures within the fda that led to the crisis in clinic fda port efforts to carry out one of the most Critical Missions which is food safety. His testimony raise questions of why key facts about the crisis were omitted when nick testified before the energy and commerce Committee Last february. And in the socalled independent solomon report. Todays hearing will continue the log and overdue oversight of the food and Drug Administrations response to the infant baby formula crisis. We hope to get answers on why the fda has not been fully forthcoming with congress when really the for todays hearing will examine why it took more than four months for inspectors to arrive at the facility plant in michigan after baby started getting sick. We will determine what took took so long for the bite administration to take act secure the baby formula supply while recalled lofted shelves bear. Why was the fda and prepared for the crisis . Why did they only inspect three of 23 infant formula manufacturing facilities in 2020 . Three of 23. Why they failed to investigate whistleblower warnings quest worked in the fda followed regular two protocol cost . Did they respond quickly enough . Was the fda independent review truly independent or was it a cover up . Today i will get answers to these questions to better understand exactly what happened to accent happen again. American families must be comp at the fda has the ability to prevent a crisis like this from ever happening again. In our previous earrings happen but could have been better from fda officials. How it lays out the fda ignored abbott employee 38 page disclosure detailing concerns of the sturgis plant. The fda telework policies lack of oversight with unprepared accuracy supply Chain Shortages after the sturgis facility section 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 last year. 6. 7. Next years budget the fda once over 10 more totaling sevenpoint to billion. I think the American People have a right to know if you only took a look at three out of 23 and you were paid fully, now we have a crisis, we dont really have answers to the crisis but yet you want more money esther mark lesson, we all want everyone to be safe. We ought to make sure we are safe but i think we all also want to make sure our money is going to do to good work. I think the American People deserve to know if we are going to have these agencies and were going to spend a lot of money on these agencies comment these agencies need to make sure theyre doing their job. As just opposed to throwing money at the problem. Fda field inspectors shouldve been doing the jobs but they werent there were not serious consequences. When you get to hear what the consequence for the fda is other than give me more money. They did not do their job. They sat at home for this talk at their paychecks. They want more money which may help, but what is going to change . No sign of the current fda leadership to be held responsible. In business the stockholders are held responsible. People get fired. They lose money, they lose profits. There is a consequence of the action. 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 fails when the fda led to the crisis we will discuss ways the fda can improve its internal controls to get ahead of potential disruptions and prevent future supply chains. Will discuss why the fda admitted 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 cannot fix a problem that we first cannot admit exists. As a set in the last of 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. So thank you for being here today. Congratulations on upcoming retirement look for it your testimony now yields a mite Ranking Member ms. Porter for her opening statement. Quick stinky very much better charwoman. Today it read in the part of her subcommittee hearing series on the 2022 infant firmament shortage. So far the chairwoman and i agree on something really important. Infant formula shortage could repeat itself. 43 of formula products were out of stock continued which killed nine babies eight hundreds of others felt ill. Prompted a recalled shopper from the supply chain. That disruption of course interrupted our economy. But were critically threaten the health, nutrition and lives of our kids and confidence in government. Today we are sitting on a bipartisan basis that it could happen again. We have a duty to do something meaningful about it. This year is called responsibility for the infant formula shortage. And as i said last time there is a lot of blame to go around. With todays witness election republicans want to blame the fda. I will level it with you, some at that blame is wellplaced. To subsequent input form it recalls in 2023 already were still seeing the fda can make further improvements on internal processes, enter being an issue sooner and follow through with more inspections to prevent further contamination. Other lawmakers today will blame formula manufactured for their negligence and failure to produce safe products. And that is true to priscilla others will blame washington for allowing just three manufacturers do have control over 90 of the farm market. Im for failing to invest the resources and authority in the fda that it needs to produce the results we demand. I think those folks are correct to break the thing about this issue though it does not come down to the fault of one person for one agency, one company or one political party. We cannot fire or attack so what expect formula contamination shortages to just go away. That is why today i propose we go be on the title of this hearing but we need to move beyond just assigning responsibility toward delivering solutions that can prevent a shortage from happening again. To think the chair with her work with me on that. We need to use these hearings to identify what art were the proposals were the innovations made to transform them into legislation. We do not do that were failing to solve the future problems would risk blaming and shaming rather than preventing and problemsolving. If if we Work Together we can address the deficiencies and inefficiencies that risk the supply of safe healthy infant formula. Likely be up fda expert us who can help us with that. Look, doctor mayne can handle what we are going to throw at her. We should ask hard questions. We should push her on ares we the fda can and should do better. But we should also use her knowledge to figure out what congress should be doing better. Right now the fda is reorganizing its human Goods Program to reduce fragmentation improve coordination. That is not going to solve all the fundamental issues. Even with the best structure, leadership and resources the fda is only as wellequipped and as accountable as Congress Makes it be. So, what we called the fda and others responsible what can congress be doing to help . First we have to provide the fda of the resources to its inspection and food safety capacity. You cannot expect an agency to get better when youre taking away the funding for the personnel and technology needed to make it happen. Thats within that 22 cut to the fda the republicans voted for would make this problem worse. Lets not go down that path of expect the fda to do better when to set it up for success and hold it accountable to deliver on a better outcome. Whether we reach bipartisan consensus on proper funding or not, there are some nocost reforms we should be able to agree on. We need better processes for reporting and tracking contaminations. For that thats making a nationally known viable disease, or make it your all contaminations and critical food factories are promptly improperly reported. If we use doctor mayne as a resource we can find solutions we could all agree on to save kids and stop shortages. Lets come out of this year with next steps just complains about missteps. I yield back. X thank you ms. Porter. Now im pleased to introduce a witness who is here to discuss the fdas response to that 2022 infant baby formula shortage. Doctor susan is the director of the center for food safety and applied nutrition at the food and Drug Administration. She has been in this role since january of 2015. Doctor mayne has received a ba in chemistry from the university of colorado. Jess also earned a phd in Nutritional Sciences with the minor some biochemistry and toxicology from cornell university. Pursuant to rule 98 witness will please stand and raise her right hand. Do you solemnly swear or affirm the testament youre about to give is a truth, the whole truth and nothing but the truth so help you god . Thank you for that the records show the witness answered in the affirmative. And now we appreciate being here today. I really do look forward to your testimony. Let me remind the witness we have read or written statement that will appear in full and the hearing record. Please limit your oral statements to five minutes. And as a reminder please press the button on the microphone in front of you so it is on the members here but when the begin to speak the light from the looks are great after four minutes about will be yellow in the red light comes on your five minutes has expired would ask that you please wrap up for this i recognize your opening statement. Chairwoman mcclain, joe cromer, Ranking Members porter, rested members of the subcommittee thank you provide me testify the safety and supply of infant formula in the United States for as a parent myself, i know nothing is more important than the health and safety of our children. Lesters infant formula repose shortage put a strain on parents and caregivers across the u. S. Which of the egregious conditions of Abbott Sturgis facility we knew a rico could stress an already unstable marketplace but we had to put our childrens safety first. Fda takes the situation extremely seriously and has applied many Lessons Learned resulting in greater confidence in infant formula safety. When the most important lessons we learned was agency must do all that it can to ensure no infant formula facility ever has the level of in sanitary conditions are present at Abbott Sturgis in early 2022. I made progress in the post extent of our authorities to address Lessons Learned preventing another shortage in the future will require a continual whole of government approach, increase industry accountability and cooperation and help from Congress Rate today i like to talk about the future of infant formula safety and our vision for modern regulatory approach. First, the ultimate responsibility to produce a product is on infant formula manufacturers. Many industry to comply with our requirements and to adopt enhanced food Safety Measures to deliver the safest possible infant formula. Two months ago issued a call to action to industry to take specific steps improve food Safety Practices for the protection of infants. Second, we were diligent to increase the supply formula on u. S. Market. The insect great performance near 90 which is harder than prerecall levels. Overall production exceeds sales week after week. Market consolidation is a serious concern and contributed significantly to shortages for their currently only three major domestic producers of formula. This means any disruption a recall, International Conflict or Natural Disaster could impact formula supplier temporary exercise of Enforcement Discretion enables a product to enter the u. S. Market, doubling the number producing infant formula for the u. S. Almost all of the manufacturers participated under the Enforcement Discretion policy are taken 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 them to encourage a stronger more diversified more resilient u. S. Infant formula market. Third, the industry should be able to address product contamination near or in realtime. Our inspections are currently a snapshot in time. More realtime oversight can transform infant formula regulation by ensuring firms promptly investigate product contamination and destroy adulterated product before it reaches consumers. The to do this we need modern authorities including explicit authority to require industry to notify us when formula test positive. Even if the product is not left the facility and the ability to obtain records remotely from all three manufacturers. Fourth, we continue to advance the science around a very common package in the environment but one about which you have limited information. Infection chevy at nationally notify about disease to local, state Public Health partners can reliably collect information on all cases. We can rapidly link cases to potential sources of contamination. Fifth, we are intent on delivering empowered unified Foods Program worldclass field force that will deliver modern integrated oversight. As part of the spill creating office of critical foods as required by the act. Routes are actively hiring for specialized infant formula inspection staff that will execute a modern preventive approach to infant formula inspections. Lastly come the early days of covid 2020 and well before the abbott recall infant ford shortage, we recognize the critical need to better resource our infant Formula Program. We are grateful for the resources we have received but our human Foods Program are still in dire need of additional investment in update to meet current as well as future challenges. Are you familiar with the fda internal Agency Review led by doctor salomon . Yes, i am. Weve interviewed by doctor salomon during course of the review. No i was interviewed by the same group of folks who were interviewing all of the people of who have participated in the interviews that information was consolidated put together for dr. Solomon. Why didnt you think you were interviewed . Sorry . Why didnt you think . He didnt for individuals there were large number of people done across all of the interviewee. Anyone in the hhs author the report . Did anyone sorry did anyone apart from doctor solomon did anyone else at hss offer the report . No not to my knowledge. What was Principle Committee in the report . I believe she was one of the individual who is called for the report so that we would look internally at our process 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. We received witness testimony that implies that she was involved ill give you another chance to answer. Did he report in any way . She asked that it was conducted the data was compiled produced in the report she asked that the report be conducted along with commissioner. Comptroller general gene stated in april 26th, 2023 House Oversight hearing that the fda is not, quote, not doing enough to improve to Food Security and food castes. Food safety has been on the gao high risk in 2007. Doctor mean do you think fda is doing enough tone sure food safety . We can always do more to ensure food safety and ill come here today with things we can do to ensure formula manufacturing having said that weve worked closely with u. S. Department of agriculture as we assure the food safety for the u. S. Okay did the foundation for the fda conduct an operational evaluation of fda food human Foods Program . The Reagan Foundation did not conduct evaluation but they convene a group of independent experts that conducted that evaluation so it is not done by the foundation but independent experts. This report describes fda Food Division in a culture of constant it describes their Food Division in a culture of constant turmoil. Do you agree